Co-operative of Safety of Medicines in Children (COSMIC ... · 1.1 Background 14 1.2 Medication errors 14 1.3 Paediatrics 15 1.4 Causes of paediatric dosing errors 16 1.5 Aims and

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Co-operative of Safety of Medicines in Children (COSMIC):

Scoping study to identify and analyse interventions used to reduce errors in calculation of paediatric drug doses

Report to the Patient Safety Research Programme (Policy Research Programme of the Department of Health)

October 2007

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Report to the Department of Health Co-operative of Safety of Medicines in Children (COSMIC): Scoping study to identify and analyse interventions used to reduce errors in calculation of paediatric drug doses Ian Wong, Professor of Paediatric Medicines Research, Centre for Paediatric Pharmacy Research, School of Pharmacy, University of London Sharon Conroy, Lecturer in Paediatric Clinical Pharmacy, Academic Division of Child Health, University of Nottingham Jacqueline Collier, Professor of Health Services Research (HSR), University of Nottingham Linda Haines, Principal Research Officer, Royal College of Paediatrics & Child Health Dimah Sweis, Research Associate, Centre for Paediatric Pharmacy Research, School of Pharmacy, University of London Vincent Yeung, Research Associate, Centre for Paediatric Pharmacy Research, School of Pharmacy, University of London (currently working at MHRA. The views expressed in this report are the authors and not the MHRA) Penny Erskine, Research Associate, Academic Division of Child Health, University of Nottingham Claire Planner, Research Associate, Centre for Paediatric Pharmacy Research, School of Pharmacy, University of London Competing Interests: Professor Wong’s post was funded by a Department of Health Public Health Career Scientist Award and funding from the Medical Research Council, NHS, JAC and First Databank has been received to conduct research on medication errors and electronic prescribing. Correspondence to: Professor Ian Chi Kei Wong Centre for Paediatric Pharmacy Research The School of Pharmacy University of London 29-39 Brunswick Square London WC1N 1AX Tel: 0207 753 5933 Fax 0207 753 5977 Email: [email protected]

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Contents Page List of Abbreviations 5

Abstract 7

Executive Summary 9

Chapter 1: Introduction

1.1 Background 14

1.2 Medication errors 14

1.3 Paediatrics 15

1.4 Causes of paediatric dosing errors 16

1.5 Aims and objectives 17

Chapter 2: Study A- Systematic literature review to identify interventions

to assist in the calculation of drug doses in paediatric medicine

2.1 Introduction 19

2.2 Objectives 19

2.3 Methodology 19

2.4 Results 21

2.5 Discussion 23

2.6 Limitations 26

2.7 Conclusion 26

2.8 Updated search and review in January, 2007 27

Chapter 3: Study B- Survey of healthcare professionals in the UK, US

and EU and UK health IT companies

3.1 Introduction 28

3.2 Methodology 28

3.3 Results 29

3.4 Discussion 31

3.5 Limitations 36

3.6 Conclusion 36

3.7 Corresponding authors of published literature 36

3.8 Community pharmacy 37

3.9 Information Technology Survey: Identification of Paediatric 42

Interventions developed by UK Healthcare Software Companies

Chapter 4: Study C- Observations of selected interventions in practice

4.1 Introduction 45

4.2 Objectives 45

4.3 Methodology 45

4.4 Evaluation framework 48

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4.5 Results 50

4.6 Centre justification 51

4.7 Gaining Research and Development (R&D) approval 53

4.8 Observations and interview findings 54

4.9 Choice of interventions for economic analysis 98

4.10 Discussion 99

4.11 Policy implications 100

4.12 Limitations 102

4.13 Economic analysis 102

4.14 Conclusion 103

Chapter 5: Overall Discussion

5.1 Discussion of interventions 104

5.2 Large scale implementation of interventions 107

5.3 Overall limitations 108

5.4 Implications for practice 109

5.5 Recommendations for further research 110

References 111

Acknowledgements 117

List of Figures 118

List of Tables 118

List of Appendices 118

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List of Abbreviations A/E Accident and Emergency

BNF British National Formulary

BNFC British National Formulary for Children

BTEC Business & Technology Education Council

CF Cystic Fibrosis

CIVAS Centralised Intravenous Additive Service

COREC Central Office for Research Ethics Committee

COSMIC Co-operative of Safety of Medicines in Children

CPD Continuing Professional Development

CPOE Computerised Physician Order Entry

DGH District General Hospital

DOTS Doctors Online Training Scheme

ENDIC European Network for Drug Investigation in Children

ENT Ear Nose & Throat

EP Electronic Prescribing

EPS Electronic Prescribing System

EPSRC Engineering and Physical Sciences Research Council

ESDP European Society of Developmental, Paediatric and Perinatal

Pharmacology

ESRC Economic and Social Research Council

FY1 Foundation Year 1 Doctors

FY2 Foundation Year 2 Doctors

GP General Practitioner

HDU High Dependency Unit

HEPPA Hospital Electronic Prescribing Pilot Assessment

HIS Hospital Information Systems

IT Information Technology

IV Intravenous

META Medication Error Technologies Analysis Network

NICU Neonatal Intensive Care Unit

NPA National Pharmaceutical Association

NPPG Neonatal and Paediatric Pharmacists Group

NSF National Service Framework for Children, Young People and Maternity

Services

NVQ National Vocational Qualification

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PCA Patient Controlled Analgesia

PGD Patient Group Directive

PICU Paediatric Intensive Care Unit

Prn Drugs to be taken as required

RCPCH Royal College of Paediatrics and Child Health

RCT Randomised Controlled Trial

R&D Research and Development

RPSGB Royal Pharmaceutical Society of Great Britain

SCBU Special Care Baby Unit

SHO Senior House Officer

SOP Standard Operational Procedures

Stat Drugs to be given at once

Tds Drugs to be taken three times daily

TEDDY Task-force in Europe for Drug Development for the Young

TPN Total Parenteral Nutrition

TTO Medicines to Take Out

UDDS Unit Dose Dispensing System

WTE Whole Time Equivalent

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Abstract Title Co-operative of Safety of Medicines in Children (COSMIC): Scoping study to identify

and analyse interventions used to reduce errors in calculation of paediatric drug

doses

Authors Ian Wong, Sharon Conroy, Jacqueline Collier, Linda Haines, Dimah Sweis, Vincent

Yeung, Penny Erskine and Claire Planner.

Methods (1) Systematic literature review. (2) Survey of paediatric healthcare professionals and

UK health IT suppliers. (3) Interview study of paediatric healthcare professionals,

community pharmacy representatives and parents/carers. (4) Observational study of

interventions used in clinical practice. (5) Independent expert panel assessment of

selected interventions.

Results The majority of studies identified from the literature review were conducted outside

the UK. The most commonly reported interventions were electronic prescribing

systems, with or without clinical decision support. The surveys identified many

interventions that have been implemented to prevent medication errors in children.

These interventions can be grouped into the following categories: electronic

prescribing; guidelines/formularies; double checking; intelligent infusion pumps;

Centralised Intravenous Additive Services (CIVAS); education and environment. The

interview and observational studies have described how these interventions are used

in practice in UK paediatric clinical environments. After taking the available

information into consideration, the independent expert panel selected double

checking, intelligent infusion pumps, and CIVAS as promising interventions which

have the most potential to reduce calculation errors in paediatric dosing. The panel

and the research team however, have found that there is very little effectiveness data

available from the literature or formal audits to support a comprehensive economic

evaluation of cost effectiveness.

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Conclusion Many interventions have been implemented to prevent dose calculation errors in

children. Double checking, intelligent infusion pumps and CIVAS are interventions

that may potentially reduce calculation errors at various stages of medicine

prescribing and administration particularly if used in combination; however, at present

there is very little evidence to evaluate the clinical and cost effectiveness of these

interventions.

Implications for practice Double checking procedures have been widely used in neonatal and paediatric

patient care for some time. Different systems and different levels of compliance with

the procedures exist however, but the introduction of a standardised robust

procedure has the potential to reduce the risk of dose calculation and other errors.

Intelligent infusion pump systems are becoming increasingly common in UK hospitals

despite being very expensive. Together with the use of standardised drug infusion

concentrations the potential for error reduction can be seen. More research however

is needed to establish whether or not new types of error will become apparent

following their introduction. New technologies in development will further improve

patient safety in the use of these devices.

CIVAS are well established in a number of hospitals in the UK and are particularly

useful for neonatal and paediatric patient care by removing the need for bedside drug

calculations and preparation by nurses. By removing these processes to a controlled

and clean environment with robust information and documentation to support them,

parenteral drug preparation should be safer, cleaner, more accurate and consistent

than when done in the ward environment. These services are required at all times of

day or night however, in order to avoid problems resulting from the deskilling of

nursing staff. The setting up of such a service is expensive and it may be more

rational to share them between hospitals in some circumstances.

The above three interventions if used in combination would be anticipated to reduce

the risk of the majority of neonatal and paediatric dose calculation errors.

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Executive summary

Introduction Medication errors are a common problem in healthcare settings occurring three times

more often in neonatal and paediatric patients compared to adults. Dosing errors are

known to be the most common type of medication errors in children. Interventions are

needed to reduce the risk of them occurring.

Methods and Results The aim of this scoping exercise was to identify interventions to reduce dose

calculation errors in neonates and children and to evaluate their transferability across

the NHS.

A quantitative and qualitative literature review was used to identify published

interventions.

A questionnaire survey was developed and sent to UK, EU and US healthcare

professionals to identify unpublished interventions that were being used locally to

prevent dose calculation errors. Representatives of community pharmacy were

approached to identify interventions in place in the community. Information

technology companies were approached to identify software programs in place or in

development to assist with drug dose calculations.

Interventions identified were broadly grouped into:

� Technological interventions

- Electronic prescribing

- Software to assist in calculation and dose selection

- Intelligent infusion pump systems

� Healthcare professional practice interventions

- Clinical pharmacy services

- Double checking by nurses, pharmacists, doctors and parents

- Professional education

- Feedback of error reports

� Others

- Written guidelines

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- Support references

- Pre-printed prescriptions, proformas and labels

- Paediatric specific prescription charts

- Environment

A multi-disciplinary expert panel selected 22 interventions from these for detailed

study. The COSMIC team visited centres using these interventions to conduct

detailed observations of the interventions in clinical practice and semi-structured

interviews with key stakeholders. Centres included neonatal and paediatric intensive

care units, general paediatric medical and surgical wards, and pharmacy

departments in District General Hospitals and specialised children’s hospitals across

the UK.

An evaluation framework was used to capture (quantitative data gathering, interview

and observations) the dynamic nature of these healthcare interventions. This

framework brings together the structure/process/outcome approach to quality of the

system and forms a matrix with key perspectives such as the technical performance

of the intervention, the humans who use them and the organisational context.

Interview data was transcribed and subsequently analysed using a qualitative data

analysis package (MAXqda). Interview and observational data for each intervention

were placed into individual evaluation frameworks. Details of each intervention were

presented to the multi-disciplinary expert panel in order for them to identify those key

intervention(s) considered to offer the best benefit to patients in terms of reducing

dose calculation errors. The final chosen interventions were nurse double checking

procedures, Centralised Intravenous Additive Services and Intelligent infusion pump

systems.

Discussion

We have identified a wide variety of interventions designed to reduce dose

calculation errors in children, many of which have been implemented in centres

across hospitals in the UK and Europe. It suggests that hospitals have long been

aware of the risk of paediatric drug calculation errors. The nature of interventions

identified by the questionnaire studies is very different from the literature review;

many have not been evaluated; hence are not reported in the literature. Both good

practice and bad practice have been mentioned and observed in the qualitative

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studies, this information will be available to professional bodies and hospitals to

improve the clinical practice of the health professionals.

Generalisability and limitations The COSMIC project was designed as a scoping exercise and as such is constrained

by the information that is available from the literature and from participating health

professionals. In general there is little high quality evidence to support the

effectiveness of the interventions with the exception of electronic prescribing. This

lack of effectiveness data limits the possibility of conducting a high quality economic

study. Another limitation of the study is that the interventions are very diverse making

direct comparison impossible.

In order to increase generalisability, the COSMIC team purposefully chose to

interview and observe health professionals in different clinical settings in hospitals

located in different geographical areas. However, it is accepted that people may

behave differently while they are under observation, known as the Hawthorne effect.

Unfortunately, the observation period was not long enough for the Hawthorne effect

to be considered negligible. Nevertheless, efforts were made by our researchers to

put participants at ease, to stress that their responses and actions were confidential

and anonymised and that processes were being observed not individuals.

Implications for health care practice Double checking procedures have been widely used in neonatal and paediatric













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Future research After reviewing all the literature and data gathered for this scoping exercise, the

COSMIC team makes the following recommendations

1) Develop standardised approach to measuring errors

The development of a standardised approach to measuring errors is needed so that

evaluation and comparison of interventions is possible. This should include the

standardisation of the definition of an error, the describing of error rates (i.e. per

prescription/admission/bed day) and the methodology for detecting errors.

2) Develop standardised approach to evaluating interventions

High quality studies are required to examine the effectiveness of interventions. A

combination of quantitative (e.g. randomised controlled trials and pre-post

intervention evaluation) and qualitative methods (e.g. Cornford’s framework) should

be explored.

3) Conduct a high quality effectiveness evaluation study

Studies are required to evaluate the effectiveness of intelligent infusion pumps,

double checking and CIVAS.

4) Simulation study and economic study

As discussed in the previous section, the team concluded that a cost effectiveness

analysis is not possible; furthermore, very little economic data are available on

paediatric medication errors. Therefore future research should investigate the cost of

paediatric medication errors and cost-effectiveness of any interventions implemented

to prevent them.

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Conclusions Many interventions have been implemented in the UK to prevent calculation errors in

neonates and children. Double checking, intelligent infusion pumps and Centralised

Intravenous Additive Services (CIVAS) may potentially reduce calculation errors in

various stages of medicines prescribing, dispensing and administration; however, to

date there is insufficient research evidence on their clinical and cost effectiveness to

confirm the benefit of these interventions after wide scale implementation.

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CHAPTER 1 INTRODUCTION 1.1 Background Medical errors are a large problem in the UK and in other countries. As such, policy

initiatives have been implemented to reduce them1-4. In the UK an estimated 850,000

adverse events occur annually in NHS hospitals resulting in £2 billion direct costs in

additional hospital days alone, of which half may be avoidable2. In addition there may

be great personal costs to the people involved including patients, their families and

staff together with undermining of public confidence. The UK Department of Health in

2000 recognised that a weakness of the NHS is in preventing serious incidents in

which patients are harmed or experience poor outcomes of care2. They highlighted a

need to learn from such failures to prevent similar incidents occurring again and

again2. It is increasingly recognised that errors are mainly caused by faulty systems,

processes and conditions leading people to make mistakes or fail to prevent them,

rather than individual recklessness1,2.

Recommendations have been made to address deficiencies in systems and

introduce error traps rather than blaming individuals and purely reacting to specific

incidents. Plans are in place to develop a more open culture within the NHS,

encouraging reporting and questioning and creating a single system for

dissemination of lessons to be learnt in a quick and consistent manner2,3.

Initiatives to promote patient safety and implementation of these recommendations

include the establishment of the National Patient Safety Agency, an independent

special health authority. This is collecting and analysing information from NHS

organisations using a National Reporting and Learning System; assimilating safety

related information from reporting systems both in the UK and abroad; learning

lessons to feed back into service delivery; producing solutions to prevent harm;

specifying national goals and establishing mechanisms to track progress3,4,5.

1.2 Medication errors

Medication errors are thought to be the most common type of medical error1-3. There

is great variation in the definitions and categories of medication errors, also

methodologies of research, study settings and countries used in current literature

which change reported error rates several-fold6,7. A definition of medication errors

accepted by the UK Department of Health and US National Co-ordinating Council for

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Medication Error and Prevention (www.nccmerp.org) is: " … any preventable event

that may cause or lead to inappropriate medication use or patient harm, while the

medication is in the control of the health care professional, patient, or consumer.

Such events may be related to professional practice, health care products,

procedures, and systems including: prescribing; order communication; product

labelling, packaging and nomenclature; compounding; dispensing; distribution;

administration; education; monitoring; and use" 4. Studies may include any or all of

the following: prescribing, transcribing, dispensing and drug administration errors and

comparisons of results must be interpreted with caution. It is acknowledged that the

true incidence of medication errors in the UK is unknown5.

1.3 Paediatrics

By far the majority of medication error studies have been carried out in adults,

however potential adverse drug events have been shown to be common in children

and may be up to three times more so than in adults8. Most potential adverse drug

events reported are dosing errors and errors involving the intravenous route of drug

administration. The UK Department of Health has recognised that children are a

particularly challenging group of patients for safe use of medicines4.

Although UK research into paediatric medication errors is scarce, medication

calculation and dosing errors in children have been frequently reported, many with

devastating consequences9-11. Calculation and dosing errors can occur at each stage

of the medicines management process including prescribing, dispensing and

administration. A systematic review previously conducted by our team established

that dosage errors are a significant problem in paediatric practice12 and suggests an

urgent need to introduce interventions to reduce such errors. Published dosing error

rates range from 0.03/100 admissions13 to 10/100 admissions14, and from 0.37/100

medication orders15 to 2.6/100 medication orders16. However, even using the lowest

figure and with approximately 1.6 million hospital admissions for children (0-14 years)

in 2001/2 in England17, the estimated number of paediatric dosing error reports would

be approximately 500. This study13 used a spontaneous reporting system which are

suggested to under-report by a magnitude of 1 in 10007. The true incidence of

paediatric dosing errors therefore could be around 500,000 per year in England.

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1.4 Causes of paediatric dosing errors Individualised dosing

Drug doses in the paediatric population are frequently calculated individually, based

on the patient’s age, degree of prematurity in neonates, weight or body surface area,

and clinical condition. This leads to increased opportunities and risk of dosing

errors18,19. In babies and young children their ability to cope with errors in dosing

may be reduced due to immaturity of metabolism and elimination pathways. Incorrect

use of paediatric dose reference sources can also lead to errors. The introduction of

the BNF for Children has attempted to standardise the way that dose information is

presented, even this is not entirely consistent however.

Calculation errors and lack of appropriate formulations

Evidence shows that some healthcare professionals have difficulties in performing

calculations to achieve the correct dose20-22. Ten-fold and greater dosing errors are

known to occur due to calculation mistakes, misplacement of the decimal point,

omission of zeroes prior to the decimal point, use of trailing zeroes, incorrect

expression of dosage regimen and incorrect units18,23,24,25.

This is compounded by the fact that many formulations are designed for use in adults

with few drugs being commercially available in suitable dosage forms for children.

Unlicensed (drugs which have not been subjected to the licensing process) and off

label (drug use outside license terms) is common26-29.

Prescriptions for intravenous drugs on a neonatal intensive care unit have been

compared to the strength of drug vial available, 31% were less than or equal to one

tenth of the vial, and 4.8% were less then one hundredth of a vial30. The death of a

premature baby following a 100 fold overdose of morphine injection is a sad example

of this very issue9.

The lack of suitable formulations which children can take, in strengths appropriate for

paediatric doses leads to a need for extemporaneous preparation of medicines. This

involves complex calculations and dilutions and is fraught with potential for error.

Mistakes have occurred with devastating consequences31.

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Interface issues

When a paediatric patient is discharged from hospital particularly with an unlicensed

medicine, good communication between the hospital and community pharmacy and

medical staff is essential in order to maintain an uninterrupted supply of the child's

medicines, which may have had to be purchased from a 'specials' manufacturer or

prepared extemporaneously. These preparations are patient-specific and information

about dosing regimes, formulations and monitoring requirements are often not readily

to hand in the community. Errors have occurred where patients have been prescribed

incorrect strengths and doses of phenobarbital suspension with loss of seizure

control; similarly with tacrolimus suspension resulting in graft rejection (personal

communications, Neonatal and Paediatric Pharmacists Group (NPPG) members).

There are therefore, many possibilities for dosing errors to occur in paediatric

patients with numerous factors augmenting the likelihood of such errors. The

research described in this report used extensive resources available to the

collaborators to identify interventions to avoid or minimise the occurrence of dosing

errors in children. These included interventions published in the literature, and also

ones which were not publicly available. Non-published interventions were thought to

be significant as it is known that healthcare professionals regularly attempt to

address problems on a local basis, but do not always publicise or share them with

others who would learn from such experiences.

1.5 Aims and objectives Aim:

The aim of this study was to identify interventions introduced to reduce dose

calculation errors in neonatal and paediatric patients and to assess their impact on

patient care. Throughout this report the word paediatric should be taken to include

neonatal and paediatric settings.

Objectives:

1. To conduct a systematic literature review of quantitative studies to identify

interventions to assist in the calculation of drug doses in paediatric

medicine which have been tested and published.

2. To conduct a systematic literature review of qualitative studies to identify

studies that have: i) described interventions to assist in the calculation of

drug doses in paediatric medicine; ii) used interviews or focus groups to

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seek people’s perspectives of interventions.

3. To survey UK, EU and US paediatric health professionals and medication

errors researchers to identify interventions to assist in the calculation of

drug doses in paediatric medicine which have been tried and tested in

healthcare practice.

4. To survey UK health IT suppliers to identify systems available to assist in

the calculation of drug doses in paediatric medicine.

5. To survey representative Community Pharmacists to identify interventions

being used to assist in reducing calculation errors in prescriptions and the

dispensing of medicines in the community.

6. To provide a descriptive account of the true practice with each

intervention selected by a multidisciplinary panel.

7. To identify intervention(s) for further economic evaluation.

The project included three distinct studies and the report is divided into chapters

describing each one:

Chapter 2: Part 1, Study A - Systematic literature review to identify interventions to

assist in the calculation of drug doses in paediatric medicines.

Chapter 3: Part 1, Study B - Survey of Paediatric Health Professionals in the UK, US

and EU.

Chapter 4: Part 1, Study C - Observations of selected interventions in practice and

interviews with key stakeholders.

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CHAPTER 2 Study A - Systematic literature review to identify interventions to assist in the calculation of drug doses in paediatric medicines.

2.1 Introduction Study A aimed to identify interventions to reduce dose calculation errors in paediatric

patients which were available in the published literature.

2.2 Objectives

1. To conduct a systematic literature review of quantitative studies to identify

interventions used to assist in the calculation of drug doses in paediatric

medicine.

2. To conduct a systematic literature review of qualitative studies to identify

studies that have: i) described interventions assisting in the calculation of

drug doses in paediatric medicine; ii) used interviews or focus groups to seek

people’s views of interventions.

2.3 Methodology The following databases were searched:

• Medline: 1951 – August 2004

• Embase : 1974 - August 2004

• International Pharmaceutical Abstracts – IPA: 1970 – August 2004

• Pharmline: 1978 – August 2004

• Cumulative Index to Nursing and Allied Health

Literature (CINAHL): 1982 – August 2004

• British Nursing Index: 1994 – August 2004

• Allied & Complementary Medicine: 1985 – August 2004

• Cochrane Library (CENTRAL, CDSR, DARE): 1988 to 2003

The search engine Dialog was used to facilitate simultaneous searching of Medline,

Embase, IPA and CINAHL. The search included studies published in all languages, to

ensure that no interventions were missed.

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The search strategy used consisted of the following keywords:

(‘Prescribing error’ OR ‘prescribing mishap’ OR ‘administration error’ OR ‘error

reduction’ OR ‘error rate’ OR ‘prescribing mistake’ OR ‘medication error’ OR

‘administration mistake’ OR ‘medication mistake’ OR ‘medication mishap’ OR

‘dispensing error’ OR ‘medical error’ OR ‘prescribing errors’ OR ‘administration

mistakes’ OR ‘medication mistakes’ OR ‘dispensing errors’ OR ‘medical errors’ OR

‘calculation error’ OR ‘calculation mistake’) AND (‘adolescents’ OR ‘baby’ OR ‘infants’

OR ‘paediatric’ OR ‘child’ OR ‘pediatric’ OR ‘paediatrics’ OR ‘pediatrics’).

After reviewing the results, the reference lists of the final selection of papers were

also reviewed in order to identify additional relevant studies. In addition, volumes

from the last 10 years (1995 – 2006) of 3 journals relevant to drug safety were hand

searched: “Drug Safety”, “Quality and Safety in Health Care” and “British Journal of

Healthcare Computing”. Pharmacy, nursing and medical conference abstracts

(British Pharmaceutical Conference; Royal College of Nursing; Royal College of

Paediatrics and Child Health; Neonatal and Paediatric Pharmacists Group; United

Kingdom Clinical Pharmacy Association) were also searched.

The criteria for their selection were:

• an intervention relevant to paediatrics must be reported

• an intervention must be related to dose calculations

• any interventions, such as computerized physician order entry (CPOE), which

reduced all types of medication errors were included

A search of all the databases, journals and conference abstracts mentioned using all

relevant keywords in the full text, abstract or title resulted in 2774 articles. The

abstracts of these articles were analysed independently by 2 reviewers (R1 and R2)

to identify any materials that did not meet the inclusion criteria. The reviewers then

compared their final list of relevant articles, and articles that were not found on both

lists were analysed by a third reviewer (R3) who made a final decision on relevancy

(Figure 1). A categorisation of eliminated citations can be found in Table 1. The final

results of the search including outcome measures are summarised in Table 2.

Based on our experience in paediatric medication error research, it had been

correctly anticipated that the identified studies would be heterogeneous due to a lack

of standardised methodology and various outcome measures; therefore we did not

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attempt to summarise the data statistically. Instead, the outcomes of the interventions

and the characteristics of each study were summarised and tabulated.

For qualitative analysis the search strategy was combined with the keywords:

interview OR focus group OR qualitative OR view* OR intervention (In the search

strategy, use of the asterix (*) indicates a ‘wildcard’ meaning the root word and all

different endings of the root word were searched). This resulted in 391 articles. One

reviewer evaluated all abstracts, identifying 17 relevant articles which were then

analysed. More thorough investigation showed that 11 of these did not meet the

inclusion criteria, one was not a qualitative study, and 2 described the same

intervention and hospital, therefore one was eliminated leaving a total of 4

interventions (Table 3).

2.4 Results: Quantitative studies The majority of relevant papers described formal outcome measures which varied but

usually reported error rate reduction. None of the articles however, included follow-up

evaluation. Five of the reports were more than 10 years old and may have been

superseded.

The outcomes of the interventions together with the characteristics of each study are

summarised in Table 2. The most common interventions were Computerised

Physician Order Entry (CPOE) and computer aided prescribing. Of the 17 articles

identified, 11 institutions had introduced at least one intervention involving a form of

electronic prescribing. A further 2 hospitals had introduced computerised protocols, 2

had electronic calculators, and 1 updated its electronic information system.

Another common intervention was the introduction of Unit Dose Dispensing System

(UDDS) which was described in 4 articles. Using this system, drugs are provided as

individual single doses and dispensed every 24 hours for each patient1. Three of

these interventions were introduced over 10 years ago. The hospitals that introduced

UDDS found that it led to a great reduction in medication errors, with one study

claiming that dose calculation errors decreased from 5 per month to 0 per month4

(Table 5). It should be noted here that the remaining hospitals claimed a reduction in

general medication errors, not specifically dose calculation errors.

These interventions had been assessed by studies that lasted from 8 weeks to 5

years, with most studies including a pre and post-intervention period. The outcomes

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for all interventions were positive. Although this review aimed to include all clinical,

humanistic, and economic outcomes, most articles only discussed the clinical

outcomes of their interventions.

Both CPOE and computerised assisted prescribing, demonstrated large reductions in

total errors when pre and post intervention error rates were compared. One study

evaluating CPOE stated that they had had no prescribing and calculation errors since

its introduction2. Several other studies revealed similarly high reductions in error

rates (Table 4). The rates of error reduction of CPOE and UDDS have been

calculated from the papers and are summarised in Tables 4 and 5.

One additional study evaluated the use of an anti-infective decision support tool

without an electronic prescribing system3. This study found a 59% reduction in the

rate of pharmacy interventions for incorrect drug doses and a 9% decrease in the

cost of anti-infectives.

Qualitative studies Each of the four interventions identified involved the extended use of computers or

electronic software. Two interventions described software that enabled the

calculation of parenteral nutrition in neonates. One of the remaining two discussed

the use of a computerised anti-infective tool, mentioned previously in the quantitative

analysis, and the final intervention consisted of a series of changes, including

introduction of a computerised neonatal formulary. All four articles assessed the

interventions via surveys given to healthcare professionals who had applied these

changes. All surveys included rating various factors using a Likert-type scale,

including open-ended and closed questions. No articles were found that included the

use of personal interviews or focus group discussions.

Conference abstracts After reviewing the selected conference abstracts, very similar interventions have

been identified from the systematic literature review and questionnaire studies (see

later section): electronic prescribing, handheld device, development of new medical

chart and guidelines. In view of the overlap with the information from other sections,

we will not discuss these results further.

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2.5 Discussion Quantitative studies Only a small number of studies described interventions to reduce the risk of dose

calculation errors in children. These can be grouped into the following areas.

CPOE and electronic prescribing

Comparison of the results from implementation of CPOE reveals that reduction in

errors in the various hospitals ranged from 100% to 40% (Table 4). One of the

reasons for the variation in error reduction could be due to the difference in outcomes

measured. For example, Cordero et al only measured the reduction of calculation

errors, which were completely eliminated after introduction of CPOE2. Alternatively,

Lykowski et al described a 50% reduction in all types of medication errors6. The

populations in which the intervention was studied differed. Potts7 studied small

specialised settings such as neonatal and paediatric intensive care units and showed

a greater reduction in errors when compared to those from a large hospital, such as

Lykowski6 and King8.

The studies identified must however be considered carefully. A recent study

(published after the review was completed) showed that introduction of CPOE

actually resulted in an increased incidence of mortality in patients in one hospital9.

This study also found that there were increased delays in medication administration

when using CPOE as more time was needed to enter orders when compared with

written forms. This may have significant patient care consequences. Nurses were

required to spend more time at a computer terminal, and less time at the bedside

reducing staff-to-patient ratios. CPOE is therefore not necessarily the answer to all

problems. Careful design, implementation and follow up monitoring of EP systems

are essential if they are to reduce errors rather than create new ones.

Several studies described the benefits of computer-aided prescribing; however it was

difficult to determine how similar this form of EP is to the CPOE mentioned earlier2, 10,

11. It is unclear from the literature whether these computer-aided prescribing systems

have any decision support, or are based on ‘homegrown’ programmes developed

specifically for each hospital. However, the importance of EP was shown when the

outcomes measured displayed significant reductions in medication errors regardless

of the system used.

24

Although it seems logical to assume that reduction in reported medication error rates

are sufficient to confirm CPOE efficacy, there is new evidence that this does not

necessarily represent improved patient care. King et al found a 40% decrease in

medication error rates on the wards, but were unable to demonstrate any effect on

patient harm8. Further studies are needed to investigate the benefits or otherwise of

CPOE on patients10.

The UK is in the early stages of a widespread introduction of CPOE9 involving the

NHS Connecting for Health Programme which is working to introduce EP systems in

hospital and community pharmacies12.

Unit Dose Dispensing System (UDDS)

Four hospitals described the use of a UDDS. One study describes application of this

system only for controlled drugs13 while another uses it only for antimicrobials14. Both

Fontan and O’Brodovich described using a UDDS on general wards for all

medicines2, 15. While three studies described fully integrated UDDS 2, 14, 15. Enderlin

used a modified version; although some of the advantages of UDDS were still

apparent 13. In spite of these differences, all studies found that the use of UDDS

greatly improved the rate of medication errors in their hospitals.

Qualitative studies Parenteral Nutrition software

Of the four qualitative studies that were identified, two described the use of software

that calculated parenteral nutrition doses1, 2. One study took place in Vienna, using

the VIE-PNN system1, while the other was in the USA using the TPNCalculator2.

Interventions using TPN software were excluded when analysing quantitative studies,

because they only cover a very narrow scope and cannot be applied to general use.

However, qualitative studies published using TPN software focused on views of

healthcare professionals to the general introduction of electronic software. This may

be useful in determining the qualities of electronic software, and method of

introduction into hospital, that make it more acceptable to staff.

One common feature in the design of both systems was that healthcare

professionals were involved in setting up the software program. This allowed for all of

their needs to be considered and a smoother transition to the computer-based

software. VIE-PNN was immediately accepted by physicians of NICU1, and only a

few minutes of initial training were required for both systems1, 2. In fact, when asked

25

about TPNCalculator, pharmacists and nurses agreed it was easier to learn, easier to

read, and resulted in less need for order clarification2.

Both systems had very high overall rating from the surveyed participants, revealing

that it decreased the opportunity for error, increased safety, saved time, and

increased staff satisfaction. Physicians said that they used VIE-PNN “…mainly for

its time saving (73%) and accuracy improving (73%) features” 1, while prescribers

and pharmacists reported that TPNCalculator resulted in fewer errors, saved time,

and was helpful for data entry2. Users of both systems recommended the

implementation of the software in other hospitals.

As with the implementation of most electronic software, there were a few changes

that were recommended for both TPN systems. Physicians using VIE-PNN had

requested some minor additions to the program. These requirements were quickly

fulfilled and the physicians were satisfied. With TPNCalculator, there were also a few

minor anomalies that were also promptly rectified. This effect was also described by

other institutions that introduced electronic software and information systems in their

hospital 3. Such changes lead to sometimes unpredictable outcomes referred to as

‘human-machine interface flaws’ 4. Both studies advised never to install a system that

requires additional time from nurses and physicians, even if it leads to decreased

errors 1, 2 Results from the VIE-PNN stressed that time savings are the key issues for

success of any system in daily routine 1.

Other interventions

Lucas5 described the implementation of a series of interventions to reduce medical

errors following two serious incidents that occurred in a NICU. These interventions

included:

• Computerised neonatal formulary

• Rules for managing dosage ranges

• Preparation of practice-site reference

• Emergency medication sheets

• Improving quality assurance

• Dispensing oral liquids in amber oral unit dose syringes

Although it may be difficult to determine which of the interventions contributed to

each outcome, there was an overall feeling of acceptance by all staff, where 87% of

26

neonatologists and 96% of pharmacists believed that these changes generally

improved medication safety, although 30-35% of those surveyed did not believe that

these interventions had saved them more time.

The qualitative studies were beneficial in that the participants were able to express

their views on both positive and negative aspects of interventions. These studies

gave a more personal view of the health professionals.

2.6 Limitations It is important to bear in mind that this literature review mainly identified published

articles describing interventions considered successful. It is likely that unsuccessful

interventions are not publicised in the literature, as researchers are more likely to

submit reports with positive results. This publication bias has been demonstrated in

several studies approved by research ethics committees16. Enthusiasm and

institutional bias cannot be excluded either, it is likely that research-orientated

clinicians and institutions are more likely to publish their studies; these clinicians and

institutions could be systematically different from those that do not. Finally, findings

may be subject to time lag bias, which is the delay in the reporting and publication of

negative research findings and the rapid publication of positive findings.

2.7 Conclusions There are a number of interventions described in the literature, which aimed to

reduce medication errors in children, particularly dosing and calculation errors. The

main interventions described in the published studies were CPOE and computer

aided prescribing. Although there was variability in improvement when similar

interventions were compared, they all showed at least a 40% reduction in medication

errors, with some claiming no errors occurring after implementation of the

intervention. A UDDS system was also shown to reduce medication errors.

The interventions identified were very similar in nature in all published studies and

were in the main US-based. Medicines management processes are quite different in

the UK and Europe compared to the US and therefore the results seen in these

studies are not necessarily transferable to the NHS.

The few published qualitative publications offered an insight into the opinions of

healthcare professionals who used the interventions.

27

2.8 Updated search and review in January, 2007 The COSMIC team acknowledge that the reported findings from the systematic

literature review are becoming outdated, and as such have begun to conduct a top-

up review. Initial findings suggest that there has been a large increase in the number

of articles that have been published in this area, suggesting that this is increasingly

becoming an issue of concern for hospitals. We intend to publish our findings from

this supplementary review by the end of 2007, the preliminary summary of the review

are in Table 6.

28

CHAPTER 3 Study B: Survey of Healthcare Professionals in the UK, US and EU and UK health IT companies 3.1 Introduction Chapter 2 described interventions to reduce dose calculation errors in paediatric

patients which have been published in the literature. We recognise that many

interventions have been tried and tested and are currently being used in paediatric

healthcare settings across the world; however, these often remain unpublished and

unavailable to the public domain. Study B surveyed primary, secondary and tertiary

healthcare settings to identify such interventions.

3.2 Methodology The survey consisted of a short questionnaire and a cover letter (Appendix I).

Recipients were asked if they were aware of any interventions in their institution

aimed at reducing errors in dose calculations in paediatric and neonatal patients.

They were asked to describe the intervention and how long it had been in use. They

were also asked to confirm their contact details and whether or not they would be

happy to be contacted by the research team for further information. A follow up

questionnaire was sent after one month to non-responders.

Ethics: The Central Office of Research Ethics Committees advised that ethical

approval was not required as the questionnaire was distributed by the relevant

professional bodies and no patient’s details were disclosed.

Sample population: 1) Clinical Directors of Paediatric Services All Clinical Directors of paediatric services responsible for paediatric services

throughout their Trusts. The questionnaire was distributed by the RCPCH on behalf

of the COSMIC team.

2) Neonatal and Paediatric Pharmacists Group (NPPG) The majority of NPPG are UK neonatal and paediatric pharmacists, other members

are mainly from Europe and Australasia.

29

3) US and EU paediatric health professionals and medication error researchers The questionnaire was also sent to members and collaborators of:

Medication Error Technologies Analysis Network (META), a network of

researchers with multidisciplinary research skills in patient safety. The

network is funded by the UK Medical Research Council (MRC), the

Economic and Social Research Council (ESRC) and the Engineering and

Physical Sciences Research Council (EPSRC).

Task-Force in Europe for Drug Development for the Young (TEDDY), a

Network of Excellence funded under the Sixth EU Framework Programme for

Research and Technological Development (FP6). It involves 19 partners

from 11 countries.

European Society of Developmental, Paediatric and Perinatal Pharmacology

(ESDP) and the European Network for Drug Investigation in Children

(ENDIC). The ESDP and ENDIC are networks of paediatric clinical

pharmacologists who work together to conduct studies in children.

3.3 Results 1) Clinical Directors of Paediatric Services:

283 questionnaires were distributed. 180 questionnaires were returned

(63.6% response rate).

32.8% (59/180) respondents discussed interventions that had been

implemented in their institutions.

2) NPPG: 222 questionnaires were distributed. 96 questionnaires were returned (43.2%

response rate).

62.5% (60/96) respondents discussed interventions that had been

implemented in their institutions.

3) US and EU paediatric health professionals and medication error researchers:

Fifty-four questionnaires were distributed to ESDP/ENDIC members. Forty

three questionnaires were returned (79.6% response rate). Sixty nine percent

(30/43) respondents discussed interventions that had been implemented in

their institutions.

Emails were sent to 8 partners in the META network including 2 US partners.

The 3 UK non-clinical partners replied stating that they were not aware of any

30

interventions to help reduce dose calculation errors in paediatric patients.

Both US partners were identified to us from the literature review undertaken in

Study A. As such, all information available was identifiable in the published

literature. The remaining 3 UK clinical partners replied via the RCPCH and

NPPG survey conducted in Study B.

Emails were sent to 10 partners in the TEDDY network except the UK partner

because they had already been approached through the RCPCH. No

interventions to reduce dose calculation errors were identified. We had

anticipated this response as most of the expert members of the network are

basic scientists and non-practising clinicians.

Overall 148 institutions reported at least 1 intervention (many institutions were the

subject of replies from more than 1 healthcare professional). Of these, 126

institutions were from the UK and 22 institutions from 12 other European countries.

Four hundred and twenty four interventions were identified and analysed.

Questionnaire data was entered into Microsoft Excel 2002. Preliminary categorisation

of these replies revealed 30 types of interventions that were reported. These

interventions were grouped under three main headings (Table 7):

• Electronic Programmes

• Guidelines, Monographs, and Information

• Other

Data was discussed by the COSMIC team, who classified reported interventions to

allow further analysis. This classification resulted in the interventions being grouped

into 3 main categories and a total of 12 sub-categories. These were:

Technological interventions: 1) Electronic prescribing (EP) (n=13)

2) Software to assist in calculation & dose selection (n=53) including hand-held

devices and stand-alone computer-based programmes

3) Intelligent Infusion pump systems (Smart pumps) (n=3) containing software to

calculate required infusion rates for certain drugs and doses

Healthcare Professionals Practice intervention: 1) Clinical pharmacy service (n=35)

2) Double checking by nurses, pharmacists, doctors, parents (n=35)

31

3) Professional education (n=39)

4) Feedback of error reports (n=16)

Others: 1) Written Guidelines (n=83) including:

a. IV Monographs for critical care drugs

b. Good practice procedures for writing prescriptions

c. Dose guidance charts for medicines

2) Support References (n=92) including:

a. Books and formularies

b. Aide memoires for maximum doses

c. Memory cards/ posters/ laminated sheets/ drug information sheets

3) Pre-printed prescriptions, proformas, & labels (n=25) for:

a. Chemotherapy protocols

b. Emergency drugs

c. Analgesics

d. Critical care drugs

e. Stickers as a reminder for therapeutic drug monitoring

4) Paediatric-specific prescription charts (n=8): prescription charts specifically

designed for paediatrics where the prescriber is required to supply certain

information such as weight and age of child, prescribe dosing in ‘unit-by-dose’

format or mg/kg/dose, etc

5) Environment (n=2): This included:

a. the use of a quiet room available for health care professionals to

prescribe, perform calculations & draw up medicines without being

disturbed

b. use of a nurse dedicated to medicines administration responsible for

all drug administration (double checked by the primary nurse for each

patient), ordering of drugs, liaising with pharmacy, addressing queries

on prescriptions and seeking drug advice where needed.

6) Miscellaneous (n=20)

3.4 Discussion The questionnaire survey results confirm that many interventions have been

implemented in paediatric settings in order to reduce dose calculation errors. Some

have already been widely researched and publicised, notably the EP system and use

of clinical pharmacy services. Other interventions however, such as paediatric-

32

specific prescription charts, pre-printed prescriptions, proformas and labels,

dedicated medication nurses and quiet environments have not been well-researched.

Technological interventions

1) Electronic prescribing

In our previous systematic literature review, the COSMIC team identified that EP in

the form of CPOE was the intervention described in most published articles. Only one

publication in UK paediatric patients1 was found regarding a fully integrated EP

system in the UK, though results of the questionnaires highlighted other UK

institutions that have introduced such systems, or are planning to do so in the near

future. Despite this however, EP systems were not the most reported interventions

reflecting that they are still not widely used in the UK.

There were several variations of EP mentioned in the survey replies some with

decision support and others without. There remains controversy regarding the

beneficial effects of a system that is becoming increasingly popular and the

introduction of which is a government requirement in hospitals throughout the UK. It

is important to study some of these systems in practice to objectively determine the

effectiveness of these interventions.

2) Software to assist in calculation & dose selection

These systems can be broadly classified as commercially available devices and

programmes such as:

Chemocare (computer program for prescribing and managing chemotherapy

ref: http://www.clinisys.co.uk/)

Pedisuite (hand-held device with program for prescribing ref

http://www.medicalwizards.com/client/productdesc.aspx?productid=50)

CareVue (clinical management program for patients in the intensive care unit

ref

http://www.heartstream.com/main/products/patient_monitoring/products/Care

Vue_chart/)

Software developed in-house and used to calculate doses of medicines such

as gentamicin and vancomycin.

These programs, particularly the in-house programs could be useful for their specific

settings; however, the COSMIC team was unable to identify any published or

unpublished studies to evaluate their effectiveness. In terms of risk management, the

http://www.clinisys.co.uk/

http://www.medicalwizards.com/client/productdesc.aspx?productid=50

http://www.heartstream.com/main/products/patient_monitoring/products/carevue_chart/

http://www.heartstream.com/main/products/patient_monitoring/products/carevue_chart/

33

COSMIC team would strongly recommend any hospitals using such systems to fully

validate them as well as evaluate their effectiveness and safety.

3) Intelligent Infusion pump systems (smart pumps):

Recently, "smart-pump" technology has become available. Smart pumps incorporate

sophisticated computer technologies for storing drug information (e.g. drug library

with doses, concentration pre-programmed), automating calculations, and checking

information entered against dosing parameters (i.e. safety net). Theoretically they

should reduce medication errors in the infusion of critical care drugs. This has

particular relevance in the high risk area of neonatal and paediatric drug therapy

where 10 fold overdoses are far more common than in adult settings.

Larsen et al reported that "smart syringe pumps" together with other measures

reduced the number of reported errors by 73%, suggesting that smart pumps could

be an effective intervention to reduce medication errors in children2. Unfortunately,

the study used critical incident reports to evaluate their effectiveness, a method

notorious for grossly underestimating the incidence of medication errors. Conversely,

Rothschild et al in the US reported that smart pumps had no impact on serious

medication error rates but this was likely to be due in part to poor user compliance3.

The true effect of "smart pump" technology, therefore, is still unclear. Further studies

are needed to evaluate the cost effectiveness of the smart pump in the UK paediatric

environment.

Healthcare Professionals Practice interventions: 1) Clinical Pharmacy Service

The presence of clinical pharmacists on the wards to monitor drug charts, query

prescriptions and answer medical and nursing staff questions was originally

documented in 2 children’s hospitals almost 20 years ago4. Their presence played a

major role in the reduction of adverse drug events and identifying unsafe practice.

Other studies have confirmed the importance of the pharmacist’s role on wards5,6.

2) Double checking:

Double checking procedures have been widely adopted in the UK medication

administration system; however little research has been published to demonstrate

effectiveness. Indeed no published studies were identified by our systematic

literature review. It is logical that double checking by another health professional

should be able to reduce medication errors; however, one view is that double

34

checking gives a “false sense” of security to both medication administrator and

checker. Further studies are needed to evaluate the effectiveness and, indeed also

the safety of double checking in UK paediatric environments.

3) Education and feedback of errors:

According to Reason’s “Human Error Theory”, poor education and training create

“latent conditions” for medication errors7. Latent conditions, as the term suggests,

may lie dormant within the system before they combine with other conditions to

create an accident opportunity7. Therefore, there is a strong theoretical argument for

education and training in medication errors reduction. However, there is very little

published clinical research that demonstrates the effectiveness of education and

training in errors reduction. Many respondents reported educational interventions to

reduce calculation errors. The reported education programmes were diverse; mainly

targeted at nurses and junior doctors. Some programmes were compulsory and

required nurses and doctors to demonstrate competency by passing tests. However

some were more informal including self-directed learning through computer

programmes and quizzes.

Various methods of feedback of errors to healthcare professionals were reported in

response to our survey. These included: monthly meetings; reviews and reports

where errors and ‘near misses’ were discussed amongst healthcare professionals.

Based on human error theory or root cause analysis, if corrective actions can be

identified and implemented, future errors could be avoided8

(www.npsa.nhs.uk/health/resources/root_cause_analysis). Potentially this approach

is a very powerful tool in preventing medication errors.

The relatively small number of respondents who reported such interventions may be

because healthcare professionals do not regard feedback as an intervention.

However, we cannot exclude the possibility that very few hospitals make use of

information within medication errors reports to improve their practice. Further

research is needed to identify how common it is for hospitals to feedback information

on errors and strategies to healthcare professionals in order to avoid them in the

future. The role of the NPSA National Reporting and Learning System will contribute

to this and deserves further exploration.

http://www.npsa.nhs.uk/health/resources/root_cause_analysis

35

Others:

1) Written Guideline and Support References:

The most reported interventions were guidelines and formularies. These include:

a. IV monographs for critical care drugs, such as the provision of dose

information, reconstitution and administration guidelines e.g. for dopamine or

morphine

b. Good practice procedures for writing prescriptions e.g. instructions to write

the words ‘micrograms’ and ‘units’ in full

c. Dose guidance charts for medicines such as analgesics and anti-emetics

Such interventions have been shown to be effective in a NICU8 and are

recommended by the American Society of Hospital Pharmacists9. Official

reference sources such as Medicines for Children and the British National

Formulary for Children have been made available in almost all UK hospitals;

however it is difficult to assess whether this has lead to a reduction in

medication errors due to lack of research.

2) Pre-printed prescriptions, proformas, labels and paediatric-specific

prescription charts:

Specific printed materials are potentially useful in reducing the errors caused by

transcribing and also miscalculation. Many examples of such materials have been

reported to us, and it would be useful to conduct a systematic review of these

materials in order to identify good practice and disseminate this to other units.

3) Environment:

Interruptions were a common occurrence during drug administration. Nurses have

cited being distracted by patients and other events on the ward as being a major

cause of drug errors10. The creation of a quiet room for dose calculations and drug

preparation is a significant step to reduce the risk of errors. Staff should not be

interrupted when working in these quiet rooms and theoretically should be less likely

to commit errors. However, this may not be a practical intervention in all NHS

hospitals due to lack of space.

An unusual intervention identified by our survey was the use of a dedicated

medicines nurse in one hospital who was responsible for all drug preparation and

administration on a particular day and who was checked by other nurses on the

ward. This nurse took control of all aspects of drug administration including problem

solving allowing the other nurses to concentrate on other duties.

36

3.5 Limitations It is possible that good practice in some centres was not recognised as an

intervention, such as CIVAS, and therefore not reported to us since our definition of

an intervention was deliberately kept loose to encourage reporting. We did however

have reasonable response rates from our survey. It is recognised however that non-

responders may be using interventions which we are still unaware of. There may

have been reporting bias in that only interventions with positive outcomes were

reported to us. Nursing staff were not contacted as part of the survey due to project

resource constraints. A future survey of paediatric nurses may provide information on

other interventions.

3.6 Conclusion This scoping exercise identified many unpublished interventions designed to reduce

calculation errors in children. These are mainly being used on a very local basis and

may offer benefit to greater patient numbers if their use was extended to other NHS

hospitals.

3.7 Corresponding authors of published literature Further questionnaires (Appendix 2) were distributed to the corresponding author(s)

of the articles identified from the systematic literature review (Study A), of which, 47%

(8/17) completed the questionnaire and one was not deliverable. The questionnaires

provide us with supplementary information (Table 8) not available from the articles

particularly regarding sustainability.

In terms of sustainability, the majority of interventions (5/7) were still in use, in the

setting described in the article, when the survey was conducted (one respondent did

not specify whether the intervention was still in use). The length of time since

implementation ranged from 3.5 to 22 years. A high sustainability is likely because

these interventions have been used routinely and as a result, are likely to have

evolved with clinical practice. The only intervention to be discontinued was the unit

dose system for controlled drugs (Enderlin & Summerfield, 1992) because it was

considered too expensive to maintain as well as too labour intensive. The system

was used for 8 years before it was withdrawn. Interestingly, this is a non-electronic

intervention involving mechanical equipment which is likely to be more expensive for

maintenance.

37

None of the respondents reported evaluating the intervention, by means of an audit

or formal inspection, since the study was published. This finding mirrors the results of

the interview study that most of the hospitals were unable to provide audit data

evaluating the effectiveness of their intervention.

None of the responders reported any negative response from staff when the

interventions were implemented or after they were established. This may be because

the interventions were well developed and well supported by staff or they were

effective in reducing medication errors as demonstrated by the original publication.

The results appear to show high sustainability and general acceptance by staff;

however, publication and selection bias could explain positive results. As over half of

the authors did not reply to our questionnaires, it may be that these authors no longer

work for the hospital/university concerned or that the intervention is no longer being

used, hence possibly reducing the incentive to complete the questionnaire.

3.8 Community Pharmacy Interviews were conducted with the superintendent pharmacist and Head of

Pharmacy Operations and Technology of Alliance Boots, the information officer of the

National Pharmaceutical Association (www.npa.co.uk) and the Director of Practice

and Quality Improvement of the Royal Pharmaceutical Society of Great Britain

(RPSGB) (www.rpsgb.org.uk). The interviews aimed to establish what procedures,

policies or interventions would be recommended in community pharmacies to avoid

or decrease the risk of dose calculation errors in children.

Royal Pharmaceutical Society of Great Britain The Society recommends that doses are checked using standard texts such as the

BNF for Children. Problems exist in that community pharmacists do not always know

the indication for the drug; therefore the dose may be thought to be correct when in

fact it may not necessarily be so for the specific indication. The Society recommends

that if any doubts exist the prescriber should be contacted. The patient/parent may

also be helpful. Patient mediation records should be referred to for patients on long

term medicines and if doses are queried a note should be recorded on the PMR.

Good dispensing practice should be followed by all pharmacies to minimise the risk

of dispensing dose calculation errors. The Society’s Code of Medicines, Ethics and

Practice recommends that all calculations and measurements when preparing

http://www.rpsgb.org.uk/

38

extemporaneous preparations should be checked. The checker is not specified, but

such tasks should only be delegated to people competent to perform them. These

recommendations have been in existence for a long time and are good practice

recommendations. They were not introduced in response to any specific incident.

Inspectors inspect all registered pharmacies, checking that procedures are followed

e.g. if extemporaneous preparations are being made. However, it depends very

much on what is being dispensed at the time as to precisely what procedures the

inspector can check.

The Society has investigated whether single or double checks are better. Some

evidence suggests that single checks are safer as that person is then totally

accountable. It is possible that a double checker may assume the dispenser is

competent and not perform a proper check, allowing a mistake to pass. The jury is

still out on this issue, however, the Society still recommends checking to take place.

Anecdotally it has been observed that double checking may increase errors. It is

necessary to establish an evidence base for double checking to ensure whether it is

effective or not. From the point of view of calculations the Society recommends that

they be done independently and then answers compared rather than simply checking

a calculation. The Society recommends that checking of everything takes place

when all medicines are being dispensed however, not all pharmacists have qualified

dispensers and the pharmacist may be the only qualified person in the shop.

However, the check recommended is an accuracy check so the level of skill does not

necessarily require a qualified member of staff. These recommendations are good

practice standards rather than a minimum required standard. Practice does vary and

this is down to individual community pharmacies.

National Pharmaceutical Association

The NPA medical information department provides medical information for

community pharmacists on anything from doses and dose calculations through to

supply issues and what is allowed to be prescribed on prescription by GPs. It

employs a mixture of technicians and pharmacists and handles 700 queries a day.

Queries to the medical information department involve the use of reference sources

such as the BNF-C and other paediatric formularies. All pharmacies are

recommended to use the BNFC when checking children’s prescriptions. The age,

39

weight and indication of the drug should be taken into account if available. Any dose

calculations should be double checked by NPA staff.

NPA recommends community pharmacies to double check any calculations with

other staff if they are available to do so. If other staff are not available then the NPA

recommend a ‘mental break’ to be taken by the pharmacist i.e. to perform the

calculation then go away and do something else and then return to double check the

calculation. Standard operating procedures (SOPs) for community pharmacists have been

published since January 2005 to cover all aspects of the dispensing process,

including dose calculation checking. These were introduced by the NPA in response

to a requirement from the Royal Pharmaceutical Society to have SOPs in place; the

NPA therefore produced templates to guide this. It is not the role of the NPA to make

sure that these procedures are implemented by community pharmacies, they

represent and support members but do not monitor their actions. The Royal

Pharmaceutical Society and PCT inspectors monitor the implementation of the

SOPs. There has been no audit work to assess the impact of the SOPs, but the NPA

supports their introduction and believes they should reduce errors because the

writing and introduction of SOPs are good for new, training and locum staff. They

make people think about how they do things instead of carrying on in the same old

way. They may increase efficiency and are a good training exercise.

Training for the introduction of SOPs included a manual and templates produced by

the NPA, press articles, wholesalers training packages and independent company

training packages were available to provide advice and support.

The NPA have also produced a guide to pharmacy risk management published in

summer 2006. This recommends amongst other things that all dose calculations,

especially those for children should be double checked. When preparing

extemporaneous products the formulation and all calculations should be double

checked. Ingredients and quantities used should be documented e.g. by using the

NPA’s Extemporaneous Record Book.

Community pharmacy chain

The Pharmacy Superintendents of five major pharmacy chains in the UK were invited

to take part in a telephone interview. One chain, Alliance Boots (formally known as

40

Boots the Chemist; Boots the Chemist and Alliance merged on 31 July 2006) agreed

to participate. Telephone interviews using a semi-structured approach were

undertaken with the Pharmacy Superintendent and the Head of Pharmacy

Operations and Technology. Alliance Boots is one of the largest chains of

pharmacies in the UK with 17% of the market.

Avoiding errors in doctors prescriptions

In 2002 Boots began rolling out its Windows® 2000 based electronic pharmacy

system, branded as SmartScript™. First DataBank Europe incorporated the Multilex

Drug Data File (Multilex DDF) into the system providing drug information for clinical

support and endorsing purposes. SmartScript™ was introduced to replace an older

system (that could not be developed to meet future business requirements), and to

provide additional functionality to support pharmacists. The process of

implementation was managed by the Head of Pharmacy Operations and Technology

together with the Delivery Manager.

Interviewees felt that dose calculation errors were rare in community pharmacy

because the majority of paediatric medications prescribed by the NHS are standard

or branded preparations rather than complex bespoke formulations. SmartScript™ is

able to check for age-related restrictions for drugs prescribed; however, there is

currently no capacity for working out doses according to a patient’s weight. Boots

were confident that the system helps to reduce dose calculation errors; however,

there has been no audit of calculation errors pre and post implementation. In the

future a dose-range checking function will be incorporated to check that doses are

within the ‘normal range’ for the product.

Avoiding errors in dispensing

Double checking is performed to prevent errors in dispensing and has been in place

for approximately 30 years. If a prescription has been dispensed by a pharmacist

anyone else in the dispensary can act as a second checker. If anyone else dispenses

the prescription, it has to be checked by a Pharmacist or an ACT. Once the

prescription has been dispensed, normally by a dispensing assistant, the pharmacist

will tick the relevant box on SmartScript™ as an electronic record of the check. In

order to ensure that the double checking policy is used in-store regular audits are

conducted. The effectiveness of using this procedure in reducing errors has not been

studied, however, it is felt that it helps to reduce dose calculation errors.

41

Resources used by pharmacists are the BNFC and pocket Medicines for Children. If

pharmacists are not happy with the accuracy of a prescription they are expected to

refer back to the prescriber or drug supplier.

42

3.9 Information Technology Survey: Identification of Paediatric Interventions Developed by UK Healthcare Software Companies Aim To identify health Information Technology (IT) companies in the UK which have

already introduced or are planning to introduce systems and or software to reduce

calculation errors in paediatric dosing.

Methods A) Identification of UK Healthcare Software Companies The Companies House, DH and NHS websites were searched for health IT

companies and appropriate people were contacted. The exhibitors list of IT

companies participating in the Healthcare Computing Conference 2005 in Harrogate

was also checked. In addition, a Google search limited to UK websites was

conducted using the following search terms:

• The word software was combined with the following prefixes and/or suffixes.

• Prefix: NHS, healthcare, health care, health, GP, pharmacy, hospital, primary

care and secondary care.

• Suffix: supplier(s), vendor(s), company(s), provider(s) and specialist(s).

A list of companies was created and whenever contact details were not provided, a

Google search was performed to obtain information.

B) Paediatric Programmes Identification A survey was designed (Appendix 3) to collect data from the identified companies

and to ascertain whether these companies have or are in the process of developing

systems or programmes to reduce dosing errors in paediatric patients. If so they

were asked to identify in which setting, and whether the company is aware of any

other interventions developed by other companies.

The survey was distributed to 8 companies initially as part of a pilot study. The

survey was sent by email, followed by a reminder email which was sent one week

later.

For the main study, data were collected by telephone, and followed up by email

where necessary. Reminder emails were also sent after 1 week.

43

C) Functionalities of identified programmes and the companies’ customers For companies that already have programmes for paediatric dose calculations, a

further contact was made to find answers to the following questions:

• What functionality does the system have? How does it work?

• According to IT company knowledge, do these practices use it to calculate/check

appropriateness of doses in children or is the function switched off?

• Can you please send a manual/brochure for your system?

Results Healthcare IT companies A total of 75 health IT companies in the UK were identified (Appendix 4).

Response rate Pilot study: 4 of the 8 companies (50%) responded.

Main study: 37 IT companies out of the remaining 67 companies (55%) responded.

Thus the total response for both the pilot and the main study was 55%. In total 12 IT

companies stated that they have or will have in the future interventions aimed at

decreasing errors in paediatric dose calculations. These 12 companies were then

followed up to collect further information.

Paediatric Dosing Errors Interventions Two firms Accenture which uses iSOFT and the Phoenix Partnership which uses

First Databank Multilex, are using systems developed by other companies included in

this survey. This decreases the total number of interventions identified from 12 to 10.

Seven companies already have some kind of calculations software intervention

though the nature and complexity might differ between systems. Table 9 provides a

list of IT companies, calculation interventions and how they work (functionality). Two

of these (First Databank Europe Ltd and JAC) are further developing their systems

(Table 10). Calculations software is also part of the future release for the remaining 3

IT companies (EMIS, CSC, and Cerner) (Table 10).

Discussion This survey has shown that some IT companies have started implementing

functionalities in their computer programmes to reduce dosing errors in children.

Responding companies are also developing primary care software, notably, EMIS.

44

This suggests that some IT systems will be available both in primary and secondary

care settings.

Most of the IT systems currently available use a very simple approach to reducing

dose errors. Some examples of this are; a “Hypertext Link” to a formulary which

allows prescribers to check with the recommended dose; a single default dose per

product helps the prescriber to select the appropriate strength of the medication or

another approach uses the computer to run an automatic check of the prescribed

dose against a “maximum Daily Dosage” for each drug.

Doses of medicines for children are usually age &/or weight dependent; therefore it

would be useful to have an automatic dose calculator in the IT system. The latest

version of Ascribe Electronic Prescribing and Pharmacy System recognises required

patients’ parameters and the dose calculator automatically performs calculations

Companies such as EMIS, are currently developing a similar programme. First

Databank intends to release Dose Range Electronic Decision Support modules for all

clinical settings, all age groups (including children), all products and all indications.

These types of system theoretically can reduce dosing errors in children due to

calculation mistakes.

Limitations of survey Although, great care has been taken to identify as many IT providers as possible, it is

possible that some minor IT providers have been missed. Secondly, not all IT

companies replied; therefore some interventions may not have been identified.

However, responses from major IT providers such as EMIS, JAC, iSOFT and First

Databank are included so the survey is likely to represent all major IT programmes

for prescribing.

Summary Many IT companies, including both primary and secondary care IT providers, have

already begun developing dose calculators and dose range electronic support

modules; these systems may reduce dosing errors in children. Such systems

however, are not currently widely used; hence very little evaluation has been

conducted and conclusions cannot be drawn as to their effectiveness.

45

CHAPTER 4 Study C: Observations of selected interventions in practice.

4.1 Introduction

Studies A and B identified interventions to reduce the risk of dose calculation errors

from both the published literature and others being used in practice worldwide. A

large number of interventions were identified and the most promising ones studied in

more detail. The interventions were prioritised in order to select 20 interventions to

study in more depth in their clinical environment.

4.2 Objectives

To provide a descriptive account of practice with selected interventions in order to

identify intervention(s) for simulation study and economic analysis.

Qualitative outcome measures 1) Descriptive account of practice with each intervention in its clinical setting.

2) Staff reactions to the intervention, both during introduction and once established.

3) Views of the advantages and disadvantages associated with the intervention.

4) Patient’s/carer’s views of the intervention, both before and after its introduction (if

appropriate).

4.3 Methodology As described in Study B (chapter 3), 424 interventions were identified in a survey

sent to healthcare professionals in the UK, US, and EU. To make these interventions

more manageable, they were organised into 12 main categories, as described in

Appendix 5. These interventions were to be analysed by a multidisciplinary panel,

with the aim of choosing the 20 interventions with the greatest potential for

minimising calculation errors and that are most transferable to hospitals throughout

the UK.

An expert multi-disciplinary panel was convened to analyse these interventions. It

consisted of a practicing paediatrician, a paediatric pharmacist, a paediatric nurse, a

deputy chief pharmacist, a regulatory authority medical assessor, the editor of the

British National Formulary for Children and a pharmaceutical industry representative

(also a paediatrician). Each participant received an invitation to participate in the

panel meetings together with a copy of the COSMIC project protocol.

46

Due to limitations in time and resources, it was unrealistic to expect the panel

members to analyse over 400 interventions. Prior to the first panel meeting,

participants were given a brief description of the 12 categories (Appendix 5) by email,

and asked to rank them in order of importance (Appendix 6). Interventions in the

highest-ranking categories were given priority at the first panel meeting.

The top 5 areas of priority were considered by Panel members to be:

_ software used to perform calculations

_ double checking procedures

_ electronic prescribing systems

_ clinical pharmacist activity

_ ‘smart’ infusion pumps

These areas of priority became the main focus of the first panel meeting. The

interventions that were categorised in these 5 areas were presented by the meeting

facilitators to the panel who discussed and rated them using the aid of specifically

designed frameworks (Appendix 7). The panel members rated each individual

intervention, making decisions on the observability, transferability and potential to

avoid harm of the interventions cited in each category. Individual panel member’s

ratings were added together and the interventions with the highest scores were

chosen to make up the sites discussed in the Centre Justification of section 4.6.

After the 5 areas of priority were exhausted, interventions making up the remaining 7

categories were discussed, to ensure that important interventions were not

overlooked. Panel members also suggested further interventions that they believed

should be investigated. At the end of this meeting, the panel members had agreed on

22 interventions that were to be put forward for further investigation by observational

and interview studies.

We conducted qualitative interview-based studies with key personnel involved in the

adoption and use of each chosen intervention along with observation of the

intervention being used in practice. It was recognised that key informants in study B

may have been biased toward the interventions and over-estimated the effectiveness

and acceptability of the intervention. As such, it was essential for us to identify

stakeholders for interview including those who took part in the decision making

process regarding the intervention, those who used the intervention or its outputs and

47

those who were in some way affected by it. The following groups were selected for

interview; senior, middle and low grade managers, clinical staff (doctors, nurses, and

pharmacists), support staff and carers/patients (where appropriate). The exact choice

of interviewees was organised by the local collaborator and depended on the

organisation of the hospital, personnel availability, what the intervention was and the

way in which the intervention was introduced and used. We acknowledge that we

needed to rely on the integrity of the local collaborator in choice of interviewees and

recognise that this may be a source of selection bias. In total 161 participants were

interviewed face to face and a further 3 participants provided written feedback to

intervention specific questions sourced from the relevant topic guide. The length of

interview ranged from 4.36 (mins) to 60.03 (mins) with a mean time of 22.42 mins

and a median time of 19.82 (interquartile range= 13.27 to 29.53). These figures

exclude 2 participants for whom that information was not available, and the 3 who

provided written feedback, see Appendix 8.

An interview schedule was developed based on previous work (An evaluation of

computerised prescribing systems – Hospital Electronic Prescribing Pilot Assessment

(HEPPA) funded by the Patient Safety Research Programme), but subsequently

modified for each of the selected interventions taking into consideration (Appendix 9)

who the intervention was targeted at, along with the hospital setting e.g. NICU, PICU,

Pharmacy or Paediatric General Wards. We likewise developed a data capture form

for the discreet observation of the intervention in practice (Appendix 10) and modified

it for each of the 22 interventions finally studied. We conducted a pilot study prior to

commencing the centre visits in order to test that the schedules would adequately

cover the areas determined by the Panel. It was anticipated that each interview

would take approximately 20 minutes and that the researchers would spend between

3-5 days at each centre collecting data.

Each participant was given an information sheet (Appendix 11) describing the study

prior to taking part and written informed consent was taken from those agreeing to be

interviewed (Appendix 12). Interviews were digitally recorded and subsequently

transcribed verbatim. The transcribed interviews and observation reports were

anonymised and coded using MaxQDA software in order to systematically manage

the large amounts of data collected and to reduce possible researcher bias. The

results were presented in the framework structure described above and summarised

below.

48

Users of the interventions were observed with their permission and details recorded

on the data collection form. A poster (Appendix 13) was displayed in the relevant

clinical areas prior to study commencement to inform staff and families about the

project. This gave them an opportunity to opt out of interviews or observation if they

did not wish to take part. The study was approved by COREC.

4.4 Evaluation framework

Interventions to assist in the calculation of drug doses in paediatric medicine are

likely to be “complex healthcare interventions”1. Complex healthcare interventions are

by definition made up of several components, which may act both independently and

inter-dependently to achieve their desired outcomes and they therefore require a

more complex evaluation strategy.

We adopted Cornford’s Framework for IT health technology assessment (table

overleaf)2 This brings together the structure/process/outcome approach to quality and

forms a matrix with the key perspectives – that of the technical performance of the

intervention, of the humans that use it and the organisation that adopts it.

Framework for intervention evaluation (Adapted from Cornford et al 19942). Example given uses Electronic Prescribing Systems.

Systems function Human perspectives

Health care system

Structure

Technology Detailed description of each intervention, including flow diagrams

Work practice Description of work practices, process variation

Sustainability Interviews with key managers

Process

Processing Electronic prescribing, dose calculation packages, protocol

Social interaction Description of communication patterns– between HCPs and between HCPs and patients

Consequent change Adherence to Trust medication policies

Outcome

Correct Prescribing errors and administration errors

Quality service Delays while patients wait for discharge medication

Contribution to strategy Interviews with managers, availability audit data

N.B Text in italics refers to examples of the outcome measures included in different

studies that relate to each element of the framework; HCPs = Health Care

Professionals

49

This model was first proposed by Donabedian3 as a means to evaluate quality of care

from both the physician and patient perspective. Cornford, Doukidis and Forster2

developed it further to include a matrix of structure, process and outcome as one

dimension and system functions, human perspectives and organisational context on

the other. This framework has been successfully applied to the evaluation of

Electronic Prescribing and was an appropriate framework to evaluate the

interventions selected by the expert multi-disciplinary Panel.

This approach was selected in order to capture staff feelings towards the introduction

of the intervention, experiences of stakeholders and any reduction in dose calculation

errors after the intervention implementation. The approach would also allow us to

capture the sustainability of the intervention in terms of financial support and the

sense of value the individual Trust placed on the intervention.

The team recognised that the effect of interventions may be specific to the health

systems in which they were developed and that overseas interventions may not be

transferable to paediatrics and the UK. Therefore, the transferability of each

component of individual interventions was to be evaluated in order to assess the

likelihood of using them in the UK. The proposed format of assessment is shown

overleaf.

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Example of analysis of transferability of a US ambulatory care electronic prescribing system: US ambulatory care electronic prescribing system:

Systems function

Human perspectives

Health care system

Likelihood of transferable to the UK*

Medium High a) High in hospital out-patient clinics b) Low in GP setting

Modification required

a) Conversion to UK drug name b) etc…..

a) Adaptation of training programme in hospital setting b) etc…..

a)Funding availability from hospital management b) etc…..

Overall transferability

High in hospital Low in GP setting

* classified by the research team: high = no modification is required medium = minor modification required low = major modification or component is not applicable to UK system However, following the scoping survey Study B, many promising interventions

identified were already in place in the UK, therefore it was decided that it would not

be a good use of resources and panel member’s time to assess the non-UK systems,

consequently the above table has not been used.

4.5 Results After meeting, the multi-disciplinary expert panel selected the following interventions

to study qualitatively:

• Electronic Prescribing systems.

• ‘Smart’ infusion pumps.

• Commercial prescribing packages including Chemocare, CareVue, and Pedisuite.

• ‘Home grown’ electronic packages defined as interventions developed in-house.

• Double checking methods.

• Educational interventions.

• Environmental interventions including a quiet room/designated area for

prescribing and administration, and the use of a dedicated medication nurse.

51

• Centralised Intravenous Additive Services (CIVAS).

4.6 Centre Justification Following the Panel recommendations the COSMIC team selected 22 interventions

for further investigation. The justification for each centre is described below:

1. ELECTRONIC PRESCRIBING SYSTEMS (EPS) The Panel chose 2 centres using EPS. Site 4 had had the Meditech EPS in place for

many years. Site 6 had been using Alltel TDS 7000 for several years. However, the

survey and literature search had identified 2 more centres using EPS in a paediatric

setting. Both additional centres were contacted requesting more information. Site 5

was subsequently also included in the study as EPS was comparatively new for the

centre and it was thought that early views of the implementation process could be

captured.

2. CAREVUE Site 7 was selected as it is the European Reference Centre for the CareVue system

and is promoted by CareVue in their company literature. Site 8 was selected as the

only other centre identified to us as using CareVue.

3. CHEMOCARE Site 9 was selected as Chemocare is well established and staff are expert users of

the system. Site 8 was selected because the system is still at the implementation

phase enabling us to identify any implementation issues and determine staff opinions

at this early stage.

4. ALARIS ‘SMART’ INTRAVENOUS INFUSION PUMP WITH GUARDRAILS Sites 1 and 2 were the only 2 hospitals identified in our survey as using the

Guardrails software package in a paediatric setting in the UK.

5. ENVIRONMENT Site 10 was the only centre identified to us as using a ‘Quiet Room’ for drug

preparation. Site 11 had introduced dedicated Medication Nurses who had sole

responsibility for preparing and administering medicines for the entire ward.

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6. DOUBLE CHECKING A number of centres identified the use of double checking interventions. We

conducted an additional scoping exercise, in order to identify which of the centres

had introduced double checking: in response to a specific incident; using nurse

competency assessments; or with clear guidelines in place. Site 3 included double

checking competency assessment. Site 10 had 2 nurses checking each other’s

calculations and an additional “check chart”. Site 12 had introduced double checking

in response to a specific incident.

7. SOFTWARE CALCULATION PACKAGES These were divided into hand-held, PC based and spreadsheet systems. Site 3

identified Pedisuite which is a hand-held device used in an emergency/crash

situation. Site 3 also identified Archimedes, a diagnostic tool also containing a

medical calculator and dose information software which is free to download onto a

hand-held device. NeoCalc was identified by several hospitals as a comprehensive

system to perform calculations for diluting IV therapy in neonates. Site 13 was

selected for further study as the developer of the NeoCalc programme is based there

and staff are highly trained in the system’s function. Another site had established a

Paediatric Intensive Care Retrieval Team drug calculation spreadsheet which was in

use across the South West of England. (However, due to extensive problems, and

delays, in obtaining R&D approval from this Trust we were unable to conduct

interviews and observations at this centre.)

8. EDUCATION We conducted a scoping exercise of the 34 centres mentioning educational

interventions in order to establish further details. Out of 21 responses the COSMIC

team selected the following centres for further study as all focussed on assessment,

competency and testing.

The intervention at Site 14 is aimed at medical staff and involves passing an exam on

the hospital intranet. Site 14 additionally identified a paper based calculation test for

midwives which they are required to pass before being able to prepare and

administer IV drugs.

The intervention at Site 15 is directed at nurses and medical staff and is available on

the hospital Intranet site.

53

Site 16 has a pharmacy led education package which involves four levels of nurse

training. For each level, nurses are required to undertake theoretical training which

includes the completion of drug calculations along with supervised practice.

Furthermore, the centre has published a paper documenting that medication errors

have decreased since the introduction of the package4.

Another site had presented a paper at an NPPG conference describing a

comprehensive assessment workbook for medical staff. However, this centre was

eventually excluded from the study due to extensive problems, and delays, in

obtaining R&D approval from this Trust.

9. CIVAS The expert panel requested the COSMIC team conduct an additional scoping

exercise in order to identify centres using CIVAS. The team conducted a rapid survey

of NPPG members to establish information about which medicines were prepared,

the number of products made and the availability of the service. We selected Site 17

as it offered a comprehensive service including out of hours support. Site 18 reported

to have audit data showing a reduction in error rates as a result of the introduction of

the CIVAS (this data is not available).

4.7 Gaining R & D approval

COREC approval for the study was granted by Wandsworth Local Research Ethics

Committee. The process of submission for R&D Trust approval for the selected

interventions began with a request to each R&D department asking for their specific

Trust requirements.

In some cases gaining R&D approval was straightforward. In many cases however,

the subsequent process of obtaining Honorary Contracts, Occupational Health

Screening and repeated CRB checks required a disproportionate amount of time and

communications which resulted in significant delays.

Some departments would issue Honorary Contracts prior to R&D approval whilst

others would only allow us to apply for the contracts once R&D approval had been

granted. For example, one Trust was able to process the R&D application within 2

weeks of submission. However, this exceptional turnaround was subsequently

54

followed by a 3 month wait to process Honorary Contract applications involving

extensive Occupational Health Screening.

Our experiences of gaining complete Trust approval is that this process can take up

to 6 months and is a time limiting factor for studies attempting to meet deadlines and

requirements set by study Sponsors.

4.8 Observation and interview findings The following section provides a summary of the information provided by and the

views of staff at each site regarding their intervention unless otherwise stated.

Additional information can be found in the frameworks in appendices 14-36. We

describe some advantages and disadvantages of each intervention highlighted

during site visits below.

‘Smart’ intravenous infusion pumps These were studied at 2 sites. The infusion pumps and software studied were

supplied by Alaris, part of the Cardinal Health Group. The company developed the

Guardrails software package to help prevent programming errors on infusion pumps.

Dose limiting software identifies and assists in helping to prevent medication errors in

intravenous infusion administration by alerting the doctor or nurse if a rate has been

set that is inadvisable for the drug being administered. The principle is to prevent

dangerously high/low doses of drugs being administered by accident. The software

can warn against or actually prevent the user from setting a rate that exceeds a given

limit. The limits are set to the individual Trust specification.

• Hard limits – these are absolute limits set by the dose limiting software, at

the upper and/or lower end of the dose range. These cannot be overridden or

exceeded by the user.

• Soft Limits – these are advisory limits set by the dose limiting software for a

user changeable parameter. These limits raise an alarm when attempts are

made to exceed them but they can be overridden.

The software is programmed specifically with the optimum range set in

accordance with the individual Trust drug dosing policy. The pump is able to

store and operate a drug catalogue of up to 10 profiles and can switch between

them. The neonatal profile has three weight banded profiles <1kg; 1- <2.49kg

55

and >2.5kg. Once the drug profile has been selected the pump automatically

configures itself.

Alaris - Site 1

Site 1 is one of the largest neonatal units in the UK with approximately 1000

admissions in 2005. The Unit covers a large area and has 48 cots: 16 ICU, 18 HDU

and 14 low dependency. It has 7 consultant neonatologists. There are 205.5 wte

nursing staff with a minimum of 19 per shift. In addition the Unit has 10 SpRs and 9

SHOs who work on a 6 month paediatric rotation and 8 advanced neonatal nurse

practitioners.

Guardrails software was purchased in 2005. 64 pumps are available at one time

(minus ones for repair or fault). A “docking station” with the ability to support 6 pumps

is situated at the cotside. It is used for all drugs apart from fluids which are run

through a separate pump. Doctors are not trained to use the system but check it on

ward rounds to verify drug, infusion rate and volume which we were informed they

find easier than looking at the prescription chart. Existing drug data sheets were

modified to accommodate the programming of the pump using standardised rather

than weight based concentrations. This was considered to be very time consuming,

but is now preferred. The prescribing doctor uses the data sheet as a guide to

prescribing. Nurses check the data sheet to ensure that the doctor has followed the

instructions for dose calculation.

The system works as follows. Nurses check that the prescription matches the baby’s

name, date of birth and hospital number before programming the pump. The pump

prompts users to select the weight and asks for confirmation. A drug dictionary is

displayed and the nurse selects the drug. A potential for error exists at this stage as

there is a choice of loading/maintenance dose for some drugs or double/quadruple

strength for others. Two errors have happened at Site 1 since the pump introduction

due to nurses selecting the wrong loading/maintenance for morphine resulting in the

wrong infusion rate being given to the baby. After drug choice and confirmation the

nurse enters the baby’s weight. We observed that a further potential source for error

may exist if the incorrect weight is entered. The pump calculates the infusion rate for

the baby and requests confirmation before proceeding. The pump gives a final

display which asks for the nurse to confirm all the selections before the infusion

begins.

56

Reported Advantages:

• Standardised IV drug concentrations

• Less time needed checking infusions

• Standard method of prescription writing

• Easier to check dose/volume/rate

• Pump acts as third checker

• Always requires confirmation before proceeding

• Nurses feel more confident administering infusions

• Staff consider Guardrails to have high potential to prevent dose calculation

errors

Reported Disadvantages:

• It was felt that nurses could become deskilled if independent checks are not

completed

• The way that the units and figures are prescribed e.g. 1.0 is not clear and

people could be interpreted as 10.

• Abbreviations for dose should be written in full text

• Use of trailing zeros and inappropriate symbols.

• Potential for error if wrong dose selected

• Potential for error if wrong weight entered

• Cost

Alaris - Site 2

Guardrails software was introduced at Site 2 in 2001 in response to the manufacturer

wanting to establish the programme in a UK hospital. It took approximately 6 months

to become fully operational with a team of consultant neonatologist, two lead nurses,

pharmacy and Alaris representatives developing the drug protocols to programme

the pump. Once the pumps had been installed regular meetings were held to discuss

any changes to the protocol e.g. make changes to the “soft limits” if they were being

repeatedly overridden or adding additional drugs.

The system was initially piloted in 1 room of the neonatal unit with approximately 40

pumps in operation. This was extended across the unit using 60 pumps, although

approximately 10 are being repaired/serviced at any one time. The pumps require

57

servicing annually and alarm when this is due, a potential problem if all the pumps

were bought at the same time. The service takes 2-3 days to complete and is quite

labour intensive. During the service all data is removed and stored on a computer,

the pump tested at different infusion rates, and re-calibrated prior to being put back

into service.

Conversion to the pumps was relatively simple and we were informed that the

company offered good support in terms of integration, training for medical staff,

nurses and engineers. IT staff were initially provided with extensive training and were

expecting further technical support but this had not happened to date. The company

trained some of the senior nurses to become core trainers and expert users so that

these nurses can train and assess new staff members along with offering support on

the day to day running of the pump and provide update training. Staff are still able to

contact Alaris support at anytime if there are problems which cannot be addressed

locally. All nurses are required to pass an assessment before using the pumps which

entails being able to programme the pump, being aware of how it works, how to

access information from the pump as well as a series of dose calculations to

complete. More training is offered for individuals who do not pass first time. Medical

staff are not given specific training as they do not use the pump on a daily basis.

All data is stored from the pump and used as an audit trail. It records all attempts to

exceed limits, which is useful when updating protocols or in case there is a drug error

investigation. We were told that nurses can sometimes be too heavy-handed and

exceed the limit by mistake then reduce the dose. This is recorded as an attempt to

override. The audit data is subsequently difficult to interpret.

Initial concerns were that using the pumps would de-skill nurses and that they would

overly rely on the pumps to do the calculations. Nurses told us, however, that they

are “aware of the dangers of becoming too complacent” with Guardrails and do not

rely on the pump to pick up all errors, rather they still refer to formularies and

references for decision making support. Two nurses still independently double check

all calculations and only use the pump to act as a third checker.


58

• Fewer prescribing errors reported after pump introduction

• Solutions are standardised and strengths and doses set according to baby’s

weight-band, so prescription, calculation, and infusion errors are reduced.

• Standardised solutions relieve the nurses of deciding and calculating the

concentration of the infusion, making the process quicker, easier, and safer.

• Nurses are still vigilant and do not rely on Guardrail to pick up all errors.

• Pumps are reliable and robust


• Substantial amount of input from the company needed to implement.

• Cost

• Potential for nurses to over rely on the pump calculations

• Despite being relatively easy to maintain engineers do not always rate them

as a priority.

The panel raised a number of concerns and queries about these infusion pumps

which were subsequently answered by the manufacturer:

The pump is guaranteed to 0.1ml/hour accuracy and not to 2 decimal places.

Other factors affecting the degree of accuracy must also be considered e.g.

accuracy of measurement of drug, patient movement etc. Rates lower than

0.1ml/hour are not recommended by company.

Pump operators are not identifiable so that responsibility for any errors made

is not possible at the moment but this is under development.

Which syringes are compatible with the pump? Is it possible for other syringes

to be used on the pump but then the rate of delivery be incorrect? Pump is

calibrated for certain types of syringe and recognises them when put into

pump. It then asks for the user to confirm the syringe type and size before

pump can be operated. The pump will alert the user if they try to use a

syringe for which it is not calibrated, however they are capable of using all

common syringes.

Different syringes for a patient do not yet ‘talk’ to each other but this is under

development. There is the Asena Gateway available which is a docking

station which will provide a degree of networking, it will link with the Badger

system of fluid monitoring if that is being used. This could be provided if the

59

patient management system is available in the hospital, and it will then check

for drug incompatibilities etc.

The pump is capable of delivering bolus doses and limits can be set for these

if desired.

Pressure is variable and limits can be set at configuration. It can be different

for each drug line e.g. different for peripheral/central delivery of e.g. dopamine

at different strengths for occlusion alarm pressure

The company claim that they could cope from a training/support angle if lots

of hospitals bought this pump. They have just won a tender in South

Yorkshire for all infusion devices and recruitment and resources will be

increased if necessary. So far the rate limiting step for introduction of the

system has been NHS staff providing the information for configuring the

pumps (as is quite a big time commitment needed initially from Drs, nurses,

pharmacists)

Concerns were expressed about enough fully trained competent staff always

being available to use the pumps, however the company do not agree to go

live in a unit until ≥ 70% of staff are trained – which means that usually at

least one trained member per shift available. They also work on a cascade

training system where they ‘train the trainers’. Training is done in the clinical

area; it is down to the staff being made available for training however. The

hospital must share the responsibility for that.

The drop down menu for drugs was of concern as staff may pick the wrong

strength of an infusion. At present this does rely on staff to check that they

have chosen the correct strength against what they are setting up in the

syringe. However, pumps will soon (1-2 years) be equipped with barcode

readers and proprietary (or hospital produced) barcoded syringes will be

available so that the pump can check that the syringe loaded correlates with

the drug line selected.

Pedisuite - Site 3 Site 3 is a District General Hospital (DGH) with 2 paediatric wards: Ward A with 20

beds and 2 cubicles admits children aged 8-16 years including orthopaedic,

ophthalmic and ENT patients; Ward B takes children between 0-8 years and has 22

beds and 11 cubicles. The wards merge at weekends to reduce overheads and

staffing costs. There are 28 nursing staff with usually 4-5 nurses on duty per shift in

each ward and 2 ward clerks. There is at least 1 SHO on duty during the day with 1

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Registrar and a Consultant on call. Children are transferred to other hospitals if PICU

beds are required.

Pedisuite was introduced a few years ago as a means of support for doctors and

nurses in emergency situations. All bleep holders (nurse, doctor and consultant)

should carry the hand-held device with them at all times. The system is American

and uses non-UK doses and drug names. On introduction the Paediatric Pharmacist

was asked to go through the system’s drug catalogue. Several problems were found

including incompatibility with Trust Guidelines and a tendency to under-dose

compared to standard UK doses.

Pedisuite drug protocols have not been updated since its introduction despite policy

changes and the introduction of the BNF for Children. Additionally, there is no facility

to re-programme the device for individual Trust requirements. Nurses do not find

Pedisuite user friendly and do not feel confident using it in an emergency when

speed and accuracy is essential. It was felt that there was too much information on

the screen and the text too small. It was anticipated that the bleep holders would

wear Pedisuite on a separate belt but nurses felt that they have to carry enough

equipment already without an additional device. It was felt that the system might be

more appropriate for doctors to use as a diagnostic tool once the emergency

situation has resolved.

At the time of our observations there were no members of staff using Pedisuite. Staff

said that they have no confidence in the system and can see no benefits in its use

and that it has high potential for causing error. On demonstration of Pedisuite we

noted that the user has to accept the Terms and Conditions every time the system is

switched on, potentially time wasting in an emergency. The system uses a touch

screen and pen. The screen defaults to the menu which displays 12 modules for the

user to select from. It is not clear which module to initially select e.g. cardiovascular

(acute Rx) or cardiovascular (chronic Rx), and drugs commonly used in emergency

situations e.g. epinephrine were not available in the selected module.

Once the module has been selected the patient’s weight is entered which then opens

a drug category (this may be useful for diagnostic purposes as it highlights drug

interactions etc). It is extremely difficult to identify the correct drug and finger slip

errors switching between categories can happen. The device offers no decision

support, does not set dose limits or ask the user for confirmation. Once the weight is

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entered and the correct drug selected the system calculates the dose and provides

contra-indications. It was felt that Pedisuite may introduce more errors than it

prevents and is no longer used by nurses or doctors despite being recommended to

our study by a senior paediatrician.


• Possible use for doctors as a diagnostic tool as it highlights drug interactions

and contraindications.

• Concept of a transportable handheld device containing information needed to

calculate doses.

• Offers advice on how to make up infusions.

• Useful when a weight has not been measured as offers average weights for

different ages (NB although recognised that this could be problematic if a

child is over/under weight).


• Incompatibility with UK drug names and doses.

• Incompatibility with Trust protocols.

• Potential to underdose.

• Potential for finger slip errors.

• Staff have no confidence in it.

Archimedes - Site 3 This intervention was also observed at site 3. Archimedes is a medical calculator

powered by Skyscape which can be downloaded freely from the Internet onto a

desktop, and then loaded onto an iPaq handheld device (originally purchased for the

PediSuite software). Archimedes provides 70 pre-programmed commonly used

formulas in medical specialties such as Cardiology, Pharmacology, Haematology and

Paediatrics. The Paediatrics section includes: Apgar scores, Glasgow Coma scale for

children; Critical Care Infusions- maintenance and deficit fluids and maintenance

fluids.

There are three ways of accessing formulas: alphabetical listing, category listing and

historical listing. Doctors are thought to occasionally use it for diagnostic purposes

and it works as an electronic dose calculator and can be located on the same hand-

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held device as Pedisuite above. We were unable to find anyone in the hospital who

used the system and able to demonstrate its use despite being recommended to our

study by a senior paediatrician.

The panel considered both the Pedisuite and Archimedes interventions to be a good

idea in principle but the attempt to introduce them into this hospital was fraught with

problems. They also felt that without IT support there is potential to cause harm as

the products had not been tested before implementation and unanticipated errors

may be manifested.

Electronic Prescribing - Site 4 Site 4 is a 460 bed DGH providing acute care plus a range of community-based and

outreach services to around 200,000 people living in the area. The majority of wards

and departments operate on a “paperless” basis via the Meditech Hospital

Information System (HIS) which can be accessed from anywhere in the hospital. The

introduction of the Meditech HIS modules began in 1991 with electronic prescribing

being amongst the last to be introduced in 1997. The paediatric wards and the

special care baby unit were the last to be rolled out in April 2002. The system has

been subject to several upgrades since its introduction, the latest being early in 2006.

There are 2 paediatric wards with 26 beds, 5 day case beds & 1 emergency bed.

There are a minimum of 4 qualified nurses on a shift and usually 2 Health Care

Assistants. There are 4 laptops and 7 desktops spread between the wards with

wireless connection throughout. Connectivity was an issue initially and despite the

fact that it has been upgraded it still causes problems with the laptops in certain

areas. Nurses told us that this can mean that when they are using it the system might

fail and they have to start again which is time consuming. They feel that the system

takes more time generally, in terms of medicine administration and care plans, but

there are far less transcription errors and overall opinion was that it had speeded up

the ordering of TTO medications. Laptops wear out quickly and the older ones are un

reliable. Problems with batteries needing to be replaced reduces their availability and

is an extra cost.

At the time of observation Ward 2 was closed and Ward 1 was not very busy hence

the laptops were easily accessed and were constantly in use by both the doctors and

the nurses. Pharmacists visit the ward on a daily basis (Mon-Fri) despite being able

to access the patient’s drug chart remotely from pharmacy. Medicines are checked

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on the wards 2-3 times daily from pharmacy. If there are any queries regarding

prescriptions the pharmacist calls the ward to discuss with the nurses. Likewise,

nurses can call pharmacy if they have any concerns over a child’s prescription. The

system is very useful when a patient is admitted as demographic details are

immediately to hand before the patient arrives on the ward and nurses can be

prepared in advance.

Two laptops were used during medical ward rounds, one for the nurse, who was able

to complete patient care plans during the ward round, and the other for the doctors

who prescribed and discontinued medicines, completed TTOs and accessed lab

results at the trolley. Any abnormal results are easily visible as they are highlighted in

red. As the ward was not busy during our observation discharge letters were

completed and printed off simultaneously which is time effective for both doctors and

patients waiting to be discharged. When the ward is busy notes are put into the

doctor’s “to do book” and then entered retrospectively on the system. Nurses care

plans are accessed by doctors but medical notes are hand written.

The system is password protected. The EP screen follows the same pattern as the

paper drug chart asking the doctor to select the drug from a drop-down menu. This is

done by entering the first 4 letters of the drug name which will then display all

combinations of spelling of the drug in question. The doctor then selects the route,

dose, start and stop times. Another screen shows what drugs have been prescribed

and what has been discontinued. Once the drug has been ordered the dose is

calculated manually using the BNFC before entering on the system. The system is

able to advise if a high dose has been prescribed but the doctors are able to override

the warning. “Look-up” functions offer advice regarding drug names, doses and

routes, possible drug interactions, and detailed monographs. The monographs are

also available as hard copies in the drug preparation room.

For drug administration nurses have to rely on knowing what medicines are due and

have to check each child individually, which is more time consuming than collecting

charts and having a look. The drugs due are easily highlighted but to see when they

were last administered, and by whom, involves accessing another screen. It was

easy to access the Order History to see which drugs had been scheduled but not

given and the reason why e.g. patient refused. Nurses double check everything

including administration and the drug is signed off by both nurses.

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Special Care Baby Unit (SCBU) The SCBU has 14 cots divided between 4 rooms and operates at Level 3. The unit is

funded for 1 Intensive Care cot and 1 High Dependency cot but often has more than

2 babies requiring high levels of care. SCBU was the last area to adopt EP in 2002.

Each room has a desktop and there are 8 desktops in total. There is 1 laptop

available which is kept in the clean utility room where medicines are prepared.

The laptop is kept in the treatment room and is not taken to the cot side for drug

administration so the baby’s name and number are hand written on a cardboard drug

tray. This can be a problem in that by the time the drug has been administered and

nurses have gone back to the drug room to sign on the screen the computer has

timed out and they have to start the whole process again. We were told that the

nurses felt that the laptop on the unit was old, unreliable and subject to crashing and

freezing, possibly due to the location of the drug room which was small, totally

enclosed thus restricting wireless connectivity, and interference from other equipment

such as freezers etc.

The doctors said that being able to access the baby’s clinical information prior to

starting ward rounds was very helpful both in terms of patient care and time

management. Unlike the paediatric wards doctors still record results on paper charts

in case the system has planned or unplanned downtime but nurses care plans are

recorded electronically.

Nurses tend not to use monographs on the EP module as they are worried if they

switch between screens the computer might crash or freeze. As a result they refer to

hard copies in a file but this practice depends on the paper version being updated

manually as opposed to electronically.

An additional issue raised by nurses on SCBU was that patients are transferred

directly from the Delivery Suite and sometimes the baby has not yet been allocated a

hospital number. In this situation medicines are prescribed and then retrospectively

entered onto the system once the baby has a number. This is a cause of potential

error as it relies on nurses remembering to go back to enter the patient’s medicines.

Overall, nurses on SCBU think EP is more time consuming than paper drug charts

but accept that there are probably less transcribing and prescribing errors. SCBU

was the unit with most resistance with some nurses telling us that they were initially

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reluctant to learn how to use computers but are now reliant on them. There was little

doubt that EP makes staff more accountable for their actions and this in itself may be

the cause of resistance in nurses to the concept of EP.


• No transcribing errors

• Faster time for take home medication

• Ability to check patient’s clinical information from anywhere in hospital

• Time saving for doctors

• Care Plans easily accessible

• Nurses can prepare for new admission in advance

• Clear Audit trail

• Improved contact with pharmacy


• Reliability of laptops

• Connectivity

• Need to frequently replace batteries

• Longer time for administering medicines if laptop unavailable

• Potential for error in SCBU with new admissions

The panel considered that the system had great potential to reduce dose calculation

errors particularly in terms of decision support etc but it has not been implemented

fully and therefore new problems which may be created are unknown.

Electronic Prescribing - Site 5 Site 5 is an Acute Trust providing a wide range of hospital services. It has over 970

acute beds and employs over 5,000 members of staff. The General Paediatric

Service is the largest service in the area with 3 children's wards for surgical and

medical patients and one for the under 2s. The Neonatology service has a Special

Care Baby Unit and an Intensive Care Unit as part of a regional service. In 2005

there were 3,414 admissions coded to Paediatrics. Children requiring Intensive Care

are transferred to another hospital. The Trust has used Meditech since 1993 and the electronic prescribing module was

added to the system in 2003 at a cost of approximately £250,000, fully supported by

the Trust, and driven forward by a multidisciplinary steering group who controlled the

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budget and time-scale. A project plan was written to go live in 2004. This was

implemented in one Directorate at a time each over a 24hr period at which point all

paper documentation was discontinued. Paediatrics was one of the last areas to go

live and to date the neonatal unit still does not have EP.

The day-to-day running of the project was left to the implementation group consisting

of the Medical Director, Pharmacy, IT, Anaesthetist, Consultants and Junior Doctors.

This team still meets on a bi-monthly basis. However, the Trust no longer funds the

ongoing support or upkeep of the system. This was suggested to be a problem as no

department has, or is willing to take, ultimate responsibility for the system.

We were told that medical staff are funded for 1hr training but there is no funding for

nurse training. The system is not supported by the staff many of whom would prefer

to go back to a paper based system. The system has different modules for

pharmacy, doctors, and nurses and as such nurses are not able to assist junior

doctors if they need help in prescribing.

If the system crashes there is facility in the hospital to print out details for each

patient within 2 hours and it is the responsibility of each area to update the system

once it is live again.

The EP module interfaces with several other modules including the patient

administration system, nursing modules, biochemistry, haematology module and the

pharmacy module. It is also possible to access Trust monographs and guidelines and

it is hoped that the system will soon include the BNFC on its dictionary. It can also

access the hospital intranet but is reportedly slow and therefore rarely used.

The system is password protected. Entering weights and heights for each patient is

not mandatory and the system is not able to calculate drug doses automatically. The

pharmacy department has introduced “dose steps”. This means that any children

over 1 year old have doses incrementally increased in a 2.5ml or 5ml dose step. This

is set up to cover 90% of pain relief and antibiotics used. Infants under 1 year have

drugs calculated in the traditional way mg/kg. We were told that the system has the

facility to double check but this has not been activated, is not seen as cost effective

and would be too time consuming for staff to maintain. Essentially, it was felt that

introducing substantial decision support, e.g. contraindication prompts may increase

error in that doctors might skip screens if they were under pressure. We were told

that the module is based around decision constraint rather than decision support.

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The system has “order sets” which are ward or location specific. This restricts which

drugs doctors can prescribe for that specific area. However, some doctors do not use

the paediatric order set and continue to individually prescribe. There are problems

with formulation choice even for common drugs. Medicines may be entered on the

system prior to admission for elective patients but if a 12 year old patient is

prescribed post-operative analgesic tablets but they are only able to take syrup the

doctor has to re-prescribe the medicine. Previously, the doctor would have written up

paracetamol but left the nurse to select the route of admission.

We were told of several other problems with the system. E.g. the system allows a

doctor to tick yes to all take home medicines even if the drug has been discontinued.

We were told that “it’s a good idea in principle but doesn’t always work in practice”.

Nurses feel that the system increases the time taken for drug administration as there

are no alerts to notify when a patient needs medicines and they have to

systematically go through each drug. Additionally, there can be a time delay between

an emergency admission and the prescribing details (such as the drugs that have

been given, and when they were given). This can result in both paper and electronic

versions being in use simultaneously. As a result errors have occurred when children

have been given double doses of medicine.

Some of the errors documented:

• Codeine and Morphine prescribed together because the system allows

doctors 2 medications to be prescribed at the same time.

• IV dose of Co-amoxiclav prescribed as 1.84g TDS. This exceeded the

maximum dose of 1.2g TDS. System did not alert the doctor.

• Co-amoxiclav injection prescribed as 870g but should have been 870mgs. IV

Ceftriaxone prescribed as 800g but should have been 800mg. Both of these

were finger slip errors but the system does not alert. All these errors were

picked up by nurses before administration.


• Creates an audit trail, deemed particularly useful when investigating

medication errors and complaints.

• Complete and accurate records for prescribing and administration.

• Order sets provide a quick way of prescribing a number of drugs at once.

• Drug specific guidelines presented as alerts or monographs are considered

useful.

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Reported disadvantages:

• Nurses feel that they have decreased patient contact due to excessive time

spent on the computer.

• Medication error potential as described above.

The panel considered that the system had great potential to reduce dose calculation

errors particularly in terms of decision support etc but it has not been implemented

fully and therefore new problems which may be created etc are unknown.

Electronic Prescribing – Site 6 Site 6 is a DGH with 1100 beds and serves a population of approximately 350,000.

There are 40 paediatric beds and a 24 cot SCBU. All paediatric patients requiring

intensive care are transferred to another hospital.

The implementation of EP was part of the Trust installation of a Patient Care

Information System (PCIS) and went live in 1992. The system, Alltel TDS 7000, was

developed in the 1970’s and runs on a DOS application. The Trust will be moving to

a more up to date server in the future, despite staff remaining very pleased with the

current system they are concerned that the new system will be too complicated. EP

operates throughout the hospital with the exception of A/E, Outpatients and SCBU

which still use a paper system. Paediatric wards were amongst the last to go live in

2000.

A Paediatric Common Drugs List was developed in collaboration between pharmacy,

clinicians and IT support. The software company offers the flexibility for the hospital

to amend the package to suit individual requirements. The development of the

screens was time-consuming and originally had a limited number of drugs but this

has been increased and currently contains approximately 20 of the most common

drugs covering about 80% of medicines prescribed for children. Once the drug,

age/weight have been selected, the prescriber is presented with a choice of pre-

determined doses. E.g. a baby weighing 2.15kg is prescribed trimethoprim oral liquid

2mg/kg once daily. This works out as 4.3mg in 0.43 ml dose automatically rounded to

4mg in 0.4ml. Hence the doctor does not have to independently calculate the dose.

Each member of staff is trained to use the PCIS as part of their induction process

and are issued with a PIN once they have completed their training. The PIN allows

different levels of access to the system and is used as the identifier and signature for

the prescribing and administration of medicines. Doctors have access to prescribing

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pathways and nurses have access to drug administration, careplans and prescribing

a limited range of drugs. Pharmacy has full access to the EP module and also have

supplementary prescribing rights. Pharmacy visit wards on a daily basis and although

they are able to check patient drugs remotely do not consider that EP can replace

contact with patients and staff on the ward.

A doctor can prescribe for any patient from any terminal within the hospital and all

current, discontinued or take home medicines can be seen by doctors, nurses and

pharmacists for both the current episode or previous inpatient stays in hospital.

Doctors and nurses can access lab results and order requests for tests via the

system and can track the progress of take home medicines. Nurses use the system

for the administration of all drugs except IV fluids which are still charted on a drug

chart as the fluid rates are changeable and the system is not flexible to manage that.

Nurses are able to reorder drugs from pharmacy when stocks are running low on the

ward.

There is a scheduled downtime every day in the early hours of the morning at which

time nurses refer to printouts for drug administration. The printout lists all the

patient’s drug administration details, including the time of the last dose, for the last 24

hours. This sheet is kept in a book on the drug trolley and is requested immediately

before the nurse gives a medicine. It is used to check when the patient last received

a dose of a drug and how many doses they have received over the preceding 24

hours. The list is destroyed as soon as a new one has been requested. A Drugs Due

list is printed 6 times a day for both scheduled and PRN drugs.

A 7 Day Meds List is printed out every morning for every patient. It documents the

times of administration of all drugs, current or discontinued, which have been charted

as given or not given over the last 7 days. Every Monday the automatically generated

report is filed in the patient’s notes as a permanent record of drug administration.

There are 2 static computers on each ward. There are usually 6 nurses per shift

divided into 2 teams across the ward. If the ward is busy it is difficult to manage with

just 2 computers and 2 drug trolleys.

All paediatric doctors are trained to prescribe for children using the Paediatric

Common Drug List which is accessed off the main screen. Once the doctor selects a

drug, they are presented with either a weight or age range e.g. <4 weeks or >4

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weeks or 2-4kg or 4-10kg. If the drug is age based the doctor is asked to select a

weight. The next screen gives a dosing screen with some drug information and an

option of regular dose or severe infection (dependent on drug). The doctor clicks the

dose required. At this point the doctor reviews the prescription before clicking “enter”.

It is essential for the calculation that the weight is entered. Occasionally, there is a

fault in the system whereby the weight does not register in which case an estimated

weight is used. There is also a chance that a nurse might weigh a child in stones and

the system is based on kilograms. There is the facility for a doctor to select a different

dose if they wish.

Doctors who are familiar with prescribing for children will always refer to the list first.

There have however, been issues with non-paediatric clinicians prescribing

inappropriate doses of drugs from the Main Index (mainly for adult patients). This

requires nurses to get these drugs prescribed correctly before administration.

If a drug is not available on the paediatric screen the doctor must select the drug

from the main index and refer to the BNFC for the dose. This could be a problem with

junior doctors who do not calculate drugs regularly. Conversely doctors seemed to

think it made them more careful with their calculations than if they were calculating

drugs on a daily basis. The calculations are additionally checked by nurses and

pharmacy before the drug is administered.

The system records allergies and doctors are alerted to these before the drug

selection. However this only acts as a warning and does not prevent the doctor from

prescribing the drug. Likewise, if a doctor selects a drug from the main index rather

than the paediatric common drugs list, there are no warnings to prevent them

prescribing high/low doses, alerts of drug interactions, contraindications or any other

decision support.

Nurses initially refer to the ‘drugs due’ printout followed by the 24 hour drug sheet (to

see the time of the last dose of medicine) before drug administration. The process is

slightly different if they are giving either a Stat or PRN drug. For PRN the nurse

selects the time the drug is being given followed by the patient name. The medication

given list brings up all the medicines given since admission. The nurse selects

unscheduled medicine and selects the drug from the list. The drug is taken to the

bedside and both nurses double check the administration of the medicines. Only the

nurse who is responsible for the patient signs for the medicine on the system. For a

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scheduled drug the nurse enters the time and the screen will show all children

requiring medication at that time. If a drug is not given for any reason e.g. child

vomited/refused, this is also recorded.

One area of concern involves children admitted from A/E where EP is not used.

Doses have been duplicated due to being prescribed on paper and not noticed in

other parts of the hospital where EP is used. Other types of error include doctors

selecting the wrong medicine from the main index and the wrong patient being

selected.


• Paediatric Common Drugs List reduces errors by restricting prescriber drug

choice

• Paediatric Common Drugs List reduces errors as has dose decision support

including computerised dose calculation and automatic rounding of doses to

practical, measurable amounts

• Increased staff confidence in prescribing


• Having to independently calculate drugs not included in the Paediatric

Common Drugs list

• Excessive paper work which could get lost

• De-skilling junior doctors

• Allergy alerts can be over-ridden

• If a doctor accesses the drug from the main index no decision support is

available

• EP not available in Accident & Emergency so potentially patient can receive

duplicated doses

CareVue CareVue is an intensive care recording system for all patient monitoring parameters

(blood pressure, temperature, heart rate, weight, ventilator support etc) and interacts

with pathology systems for results. Most of the information recording is automated

directly from the relevant machines and systems, but some has to be entered

manually e.g. fluid balance. CareVue has replaced traditional end of bed nursing

documentation paper charts for observations.

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CareVue - Site 7 Site 7 is a 500 bed DGH opened in 1999. The 20 cot neonatal unit cared for 234

babies in 2005 and offer Levels 1, 2 and 3 Categories of neonatal care. The unit has

8 ICU cots, each with a CareVue terminal; 6 HDU cots with 4 terminals and a 6 cot

nursery with 1 terminal. The nursery is not big enough to have more than 1 terminal

and this was reported to be problematic if the room is busy. There is an isolation cot

with 1 terminal. Some members of staff have remote access to CareVue including

Consultants, Pharmacy and nurse managers. All the terminals on the unit are static.

There are 43 members of staff in the team with 5-6 staff on duty per shift. CareVue

was introduced on the Unit 5 years ago with the prescription module added 2-3 years

ago.

Members of staff were very confident with the system and referred to it frequently.

We were told by nurses that they much prefer not having paper notes and

prescription charts at the cotside as it saves space and “clutter”. All the information

from the monitors is updated onto CareVue every hour. The text on the screen is

quite small and if there is a great deal of information on the system there is a few

seconds delay between the screens. Doctors thought this added extra time at the

cotside but was compensated for by having everything to hand and not having to go

through patient notes for results.

The system links with pathology with results automatically updated onto the system.

Radiology is also linked into CareVue. There is no drug decision support.

We observed that the system works well on a one-to-one basis but if the terminal is

shared between patients there is a risk that the wrong patient‘s chart is on display.

Staff are advised to log off once completing care but while we were there some

terminals were left on. This potentially leaves confidential information on the screen

which other parents can see.

Registrars and SHOs are trained to initially use drug information monographs and

calculate independently before using CareVue for prescribing. Drugs monographs

are available in a hard copy file and are also available electronically in the CareVue

Prescribing Module. The list of drugs appears on a pick-list in the medication box.

Once the drug has been selected the route box is selected which asks what route is

required. The dose is calculated manually and entered into the system followed by

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the frequency. Options are to select duration or set number of doses, the frequency

and the time the drug is to commence. There is a free text box to add any further

instructions. The doctor then initials the prescription. Two nurses are required to

check and they also initial as does the pharmacist.

Infusions are selected from the IV Drug Infusion list which shows a picklist of

premixed infusions. The doctor specifies a dose and frequency. Experienced nursing

staff help junior doctors who are not familiar with the system and likewise locum

doctors working on the unit. There is sometimes a delay setting up a password and

log-in for locum doctors.

There is general concern that CareVue will have to be replaced in 2007/8 as the

system has been around for 20 years and struggles with Windows XP. Nurses are

keen to stay with a CareVue upgrade but the Trust is looking to possibly replace the

system with a comprehensive EP system.


• Paperless

• System linking with patient monitors, other support departments

• Automatic hourly update

• Space saving

• Prescribing module ensures clear prescribing


• System needs updating

• Delays in staff being issued with PIN

• No decision support for drug/dose selection

• Data protection if system left running

• Cost

CareVue - Site 8

Site 8 offers some of the widest range of paediatric specialities in the UK, including

21 medical, 11 surgical and 8 diagnostic specialities. There are 314 beds available,

including 30 intensive care beds, 8 high dependency beds and 5 transitional care

beds. Approximately 1,200 patients per year are admitted to PICU. The NICU has 10

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funded neonatal cots treating approximately 500 patients per year. There is no

obstetric facility within the hospital so this is not a traditional NICU.

Each bed or cot side has a static terminal and there is at least 1 additional terminal at

the nurse’s station and in the doctor’s office. The terminals are used to access all the

Trusts information systems i.e. PACS (X-rays), PIMS (admissions, discharges and

transfers), pathology, e-mail and CareVue.

CareVue is used on the PICU, NICU and cardiac critical care unit. Due to time

constraints we conducted our observations and interviews in the first 2 units only.

The default view displays data for the patient admitted to the associated bed, but all

patients’ data can be accessed from any terminal. The main screen displays the

menu and tabs for other screens i.e. drugs, fluid input-output, ventilation, routine care

etc. These can be selected to display data individually or all together i.e. can view

drugs and ventilation data together or just drugs. Data can be displayed by time

intervals ranging 5 minutes to 24 hours, but is usually set to a default value of 1 hour.

The system is mainly used by nurses who enter and update most of the information

at least hourly and more frequently if necessary. All data can be viewed without

password access but a password is required to store new information and any

changes. Doctors use the system for documenting changes in ventilation and when

reviewing patients. Pharmacists mainly use the system to review results and check

fluid balance. Physiotherapists also use the system for ventilation information.

CareVue is used to record details of all drug administration, but does not replace the

traditional paper drug chart. Doctors prescribe on and nurses administer from the

paper drug chart. All drug information is then transferred to the electronic system to

keep accurate electronic records in addition to records on the drug chart.

Drugs are selected from a list which is maintained by the bio-engineering department

under direction from pharmacy. There is a 20 character limit for the drug name on

file and an 8-10 character limit for the drug name on the display screen. If a drug is

not on the selection list, then it is ‘free-texted’ using the fluid therapy chart. Once a

drug has been selected, varying information is displayed depending on what has

been entered for that drug. This includes, dose range, starting dose and additional

information e.g. compatibility with other drugs and infusions, stability of infusion fluid.

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The information is not consistent for all drugs. Any error messages are displayed in a

red framed box.

The nurse selects the drug, quantity and volume (if infusion) on the system. This

displays a rate of infusion in micrograms/kg/hr or min and ml/hour according to a pre-

set dose and format. Occasionally, the pre-set dose has to be changed to match the

prescription.

Once a drug has been entered, a ruler like scale is visible displaying the dose and

rate of infusion. This can be used to alter the infusion rate by sliding the arrow up or

down if the dose changes.

A separate dose calculator is available for drugs that are on the system. The infusion

rate is displayed in ml/hour calculated using information entered by the nurse (i.e. the

required dose, amount of drug added, infusion fluid volume). However, not all staff

were aware that there was a separate dose calculator facility on the system. An

emergency drugs calculator is also built in. This appears on the demographics page

and displays the doses of emergency drugs needed for that particular patient based

on the weight entered. The actual drugs and the basis for calculation are pre-

determined.


• Clear drug prescriptions – avoids hand writing illegibility

• In an emergency situation, CareVue can record vital signs to assess the

patient every 15 minutes

• CareVue is considered more efficient than a paper system

• Information cannot be lost or misplaced


• No password protection

• Nurses can access patient without going to bed/cot side

• Retrospectively entering drug information onto CareVue

• Information about drugs not consistent

• Data protection

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Chemocare - Site 9 Site 9 provides acute and general paediatric services and has 38 beds on the

paediatric ward used for patients requiring medical, surgical and oncology services.

There are an additional 39 beds available in the Young Person’s Unit which is the

largest in Europe. Of these beds 18 are dedicated to the Teenage Cancer Unit which

provides supra-regional sarcoma and haematology services including bone marrow

transplants.

There are 3 ward areas using Chemocare:

Adolescent oncology has 18 beds, normally with 5 members of nursing staff

per shift. The inpatients on the Unit are usually half haematology patients and

half patients admitted for weekly chemotherapy.

Paediatric oncology ward has 12 beds available but there are rarely more

than 6 patients admitted at any time. Approximately 2-3 patients are admitted

each week for chemotherapy. The ward operates with 2-3 members of staff.

Paediatric/adolescent daycare service sees between 20-30 patients weekly

for outpatient chemotherapy. Usually 3 members work on each shift but

sometimes this is reduced to one.

A chemotherapy prescribing meeting is held once weekly, and lasts for approximately

two hours. It is attended by a paediatric/ adolescent pharmacist and paediatric

registrar. The pharmacist observes and assists the registrar as they use the system

to prescribe chemotherapy drugs. Firstly, the prescriber logs onto the system using

their unique username and password (level of access to the system is determined by

staff grade and position). A patient is selected using either hospital number or

surname. If the prescriber is unsure of the spelling an asterix can be used to conduct

a wider search. Once the appropriate patient is selected, the prescriber is presented

with a screen which details the chemotherapy for that patient. The right course of

chemotherapy needs to be selected. An annotations function can be used to

communicate any useful information for prescribing. Patients’ weight should be

regularly updated as this updates the drug doses; however, there were a couple of

patient records where latest available weight had not been entered. Any changes

made are saved and the prescriber is sent back to the patient review screen to

confirm the chemotherapy; the option to defer treatment is also available, for

example, if awaiting critical test results. Once the prescription has been authorised it

can be printed. Previously, an authorised prescription would automatically be printed

in the Cytotoxic unit, however due to problems with the printer this is no longer the

case and staff are expected to contact the Cytotoxic unit to order drugs.

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-Audit demonstrates that Chemocare can reduce the frequency of errors for both

chemotherapy and supportive care drugs.

- Considered less labour intensive than writing handwritten prescriptions.

- Useful in a disparate and spread out organisation as the record of the prescription

can be accessed from different locations.


- If staff forget to update patients’ weights doses calculated by Chemocare will be

inaccurate.

- The system has become loaded with protocols.

- There is no way of knowing via Chemocare whether a drug that has been

authorised has actually been administered.

- The annotations section has not been used to its full potential.

Chemocare - Site 8 Site 8 offers some of the widest range of paediatric specialities in the UK. The

approximate number of oncology admissions per month is 60 patients. There are 2

main chemotherapy wards with 20 beds in total and a Day Care Unit with 13 beds. In

addition, there is provision for 4 private patient beds on a separate ward.

Chemocare is currently limited in use at this site as the majority of chemotherapy

protocols have not been inputted onto the system. At the time the site visit was

conducted, approximately only 5-10% of chemotherapy was prescribed using

Chemocare. Chemotherapy prescribing meetings are held once weekly, in a meeting

room on one of the chemotherapy wards and are attended by registrars and a

cytotoxic pharmacist. However, in the time spent at the site none of the

chemotherapy drugs prescribed were handwritten as the relevant protocols were not

available on Chemocare. The length of time taken to input the protocols has had an

impact on how staff view the system and increasingly staff are feeling more cynical

about the system. Staff have also found it more difficult to learn to use the program

as the opportunity to prescribe using Chemocare is irregular.


-Once staff are comfortable using the system, it is considered faster, safer and less

time consuming to prescribe chemotherapy using Chemocare.

-Good on-site support available.

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-Registrars feel well supported by pharmacy.


- Chemocare is not considered very good at delivering warning prompts.

-It is supposed to be a ‘paediatric friendly’ system and yet staff are not convinced it

works well for prescribing to small children.

-If you modify a dose it doesn’t automatically modify the volume. It is something that

will have to be taught to the doctors so that they don’t just think about the dose but

the volume as well when prescribing.

-There is not enough character space on some of the lines, so abbreviations have to

be used- which is considered problematic.

Quiet Room - Site 10 Site 10 is part of a Neonatal Network covering a 25 mile radius although the Unit

takes admissions from a wider area if necessary. The Neonatal Unit had 420

admissions in 2005 and offers Level 2 care. Neonates <26 weeks are sent to another

hospital. The Unit has 3 nurseries with 20 cots in total. Intensive Care (Nursery 1)

has space for 6 cots but has been known to hold 9 cots at peak times. High

Dependency (Nursery 2) is a small nursery and has space for 4-6 cots. Most babies

in high dependency have progressed through ICU and are no longer having

complicated drug regimes. Nursery 3 (Low Dependency) has enough room for 6 cots

and the babies are mostly cared for by the parents/carers. There are also 2 side

rooms which primarily are identified as isolation rooms but were being used as an

overspill area.

The Unit operates with 32.9 wte staff of which 0.86 are housekeeping and 1.33

nursery nurses. Five members of nursing staff are usually on duty on any shift. When

the Unit is operating at full capacity staffing levels cause problems in terms of nurses

being able to double check medicines and use the Quiet Room.

The Quiet Room was introduced in response to a series of incidents where nurses

felt that errors had occurred as a direct result of interruptions during the preparation

of medicines. The room is never locked and contains resuscitation equipment, spare

pumps, scales, controlled drug cabinet and all the drugs for medicine/IV preparation.

It is also used as a Treatment Room for inserting central lines or performing lumbar

punctures. When the room was introduced signs were put on the doors stating that if

nurses were involved with preparing medicines they were not to be interrupted under

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any circumstances. However due to shortage of staff this has never been feasible

e.g. if 2 nurses are working in ICU both cannot be out of the nursery at the same

time. Rather than being a Quiet Room it has a dedicated area for dose calculations

and drug preparations and has resources including calculators, spare batteries, the

BNFC and other drug information sources.

The Quiet Room is accessed directly off ICU, where more intensive drug regimes are

implemented, and links to the unit reception desk. It is sometimes used as a cut

through between the reception desk and the nursery. The room is not “quiet” as the

phone on the desk is often ringing or parents “stick their head round the door” to

speak to the nurse. The area is mainly used by ICU, if there is sufficient cover, and is

not practical for the nurses to use in the other nurseries where only one member of

staff is on duty.

In HDU the nurse on duty is not allowed to leave the room if a patient is having

oxygen therapy in which case another nurse is asked (providing they are free) to get

the medicine from the Quiet Room and then the drug is prepared and checked in the

nursery. Alternatively, the nurse on duty may ask the nurse to stay in the nursery

while she goes and fetches the drugs. The nurse helping out is used as the second

checker while the drugs are prepared in the nursery. Nurses say “it’s not easy” and

feel that the practice is very unsatisfactory and “worry about safety”. The

consequences of this mean that medicines are sometimes late if a second nurse is

not available at the appropriate time.

The nurses stated that they would recommend and value the use of a dedicated

area, with no interruptions, for dose calculations and preparations of medicines. They

appreciate having resources and drugs to hand and consider that a no interruption

policy improves safety for patients and significantly reduces the risk of medication

errors. However, the use of the area is only sustainable if there is sufficient staff

cover to support nurses in leaving their designated nursery to make use of the room.


• Drug preparation without interruption

• Able to concentrate whilst undertaking complicated calculations

• Having reference sources close to hand

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• Not having enough staff to use the quiet room

• External distractions e.g. phone, entry buzzer

• Finding space for dedicated room or area

• Location not good for HDU or Nursery

Dedicated Medication Nurse - Site 11 The Neonatal Unit at Site 11 provides Level 2 care. All surgical cases, babies <27

weeks gestation and <1000g are transferred elsewhere. The baby unit has 16 cots; 1

ITU, 3HDU and 12 special care cots. There were 4000-4500 deliveries at Site 11

during 2005 with 318 admissions. There are 5 members of staff per shift. The

paediatric ward has 27 acute beds: 10 surgical; 6 medical and 2 HDU. There is 1

Head of Nursing, and on average each shift on the acute side has 7/8 acute and 2/3

surgical nursing staff.

The introduction of a medication nurse was an initiative developed by the paediatric

clinical improvement group because minor incidents were occurring on a regular

basis. These errors included drugs not being signed for, drugs not being double

checked, or not being given due to staff getting distracted whilst preparing medicines.

There were occasions where nurses needed to wait for second checkers to check

medicines resulting in patients receiving drugs later than prescribed. The aim was to

elevate the priority of medicines. It was also thought that the introduction of a

medication nurse would act as a link to pharmacy and deal with queries and

problems with prescriptions.

There is no specific training required, although only senior nurses who are IV

competent fulfil the role.

The name of the medication nurse is written on the whiteboard in the unit so all staff

are aware of who it is for their shift (paediatric ward only). The medication nurse is

not allocated patients; it is their responsibility to check the drug charts, make sure

that the patients receive their medicines on time, and that the double check and

administration process is followed and completed correctly. Additionally, the

medication nurse handles pharmacy queries, monitors drug supplies on the ward and

informs pharmacy if stocks are running low and keeps the drug preparation area tidy.

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During busy periods it may not be possible to allocate a medication nurse, however

on such occasions drugs are still always supposed to be double checked.

There were some initial concerns that the introduction of the medication nurse would

effectively leave the unit short of a member of staff. However, the interviewees

believed that it can be time saving and can decrease errors.


• Medicines given on time and as prescribed

• Dedicated nurse available to check medication and deal with queries from

pharmacy.

• Reported calculation errors dropped from 10/week to 2-3/week

• Familiarity with all patients means nurse can prioritise administration of drugs


• Over reliance on the medication nurse by junior staff

• Sufficient cover for night shift and busy times is an issue

• Medication nurse role could be more clearly defined

• Feasibility on large unit

Double Checking - Site 3 Double checking was introduced because of errors in medicine administration and an

incident where a drug was administered to the wrong patient. See site 3 – Pedisuite/

Archimedes for details of hospital, wards etc.

There is no formal drug round and medicines are prescribed on an as and when

basis. Each ward has 1 drug trolley which is kept locked and is situated just off the

nurse’s station. The Trust policy is for 2 nurses to double check the prescription,

calculation and administration of every medicine used (including saline) on the

paediatric wards. The Medicines Charter on the Hospital Intranet, developed over a

year ago, clearly states that “where there are 2 practitioners involved in the

administration of medicines, the person who actually administers the medicine is

solely responsible for the correctness of the whole procedure”. Nurses are either a

first or second checker but both feel that they are equally accountable for medicine

management despite the Medicines Charter. There is no visible identification

between first and second checkers on the wards. In order to become a first checker

the nurse must pass a competency assessment, usually within 6 months of being in

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post. During the initial 6 months the nurse observes and is allocated a mentor but is

never allowed to act or sign as one of the checkers. In addition, nurses must

complete an IV Study Day before preparing and administering IVs on the wards.

Becoming a first checker:

• To become a first checker a nurse will have undergone assessment, demonstrating

competency in medicines management and administration. The nurse will be

RSCN/Child Branch, E grade or above and have at least 6 months paediatric

experience.

Becoming a Second Checker:

• A second checker can be any registered nurse/midwife; Doctor; Pharmacist;

Operating Department Practitioner. Although in practice a second checker is

normally another nurse.

Becoming an Assessor

• The assessing nurse will have successfully completed assessment of competency

of Patient Group Directions (PGD’s) and have a recognised teaching and assessing

qualification.

The Trust promotes a no blame culture and no formal action is taken in the instance

of an error unless the same nurse is repeatedly making mistakes. If an error occurs,

the doctor(s) responsible for the patient are informed along with parents and the error

is reported using an incident reporting system. The nurse then discusses the event

with the unit manager and is asked to write a reflective piece examining any

contributing factors leading to the error and what could be done to prevent the error

happening again. This document is stored in an informal staff file and kept on the

ward. If a first checker makes an error they are not demoted to second checker

status unless there are repeated mistakes at which time the nurse in question would

be sent for further training.

Nurse Competency Assessment The Practice Development Nurse at Site 3 is currently piloting a scheme to evaluate

the assessment of nurse competencies. The aim of the scheme is to standardise

procedures in all areas of practice across the Trust. All grades of nurses have been

sent a questionnaire asking for written proof of competency in all areas of practice,

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and whether they thought themselves competent. The responses to the

questionnaire are stored on a database which will be updated annually. All nurses

will be assessed at baseline regardless of existing competencies against set criteria.

There has been some resistance to the procedure from senior nurses who felt

devalued but generally staff accept that safety is paramount for patients and that it is

a method of protecting them from litigation. Nurses will be asked at their annual

appraisal if they feel competent and be offered further training if appropriate with the

database being used as supporting evidence.


• Clear guidelines as to who is responsible for drug administration

• Well defined roles for First and Second Checkers

• Nurses comply with Trust Double Checking procedures

• Competency assessment for all nurses

• All competencies documented and updated annually


• Policy is dependent on having sufficient First Checker nurses on duty

• May be difficult to implement on a large paediatric ward

Double Checking - Site 10 The Trust policy states that all medicines, including vitamins and eye drops should be

checked through to administration. Some nurses felt it was “a waste of time”

checking pain relief medicines such as paracetamol. During our observations the unit

was busy and the staffing level low, as a consequence medicines were not always

doubled checked to the point of administration and were sometimes given later than

they should be. We were told that this was quite common and more frequent during

the winter months when the unit operates at full capacity.

There are no set drug rounds but IVs and TPN are usually changed between 5-7pm

daily. In addition to the regular drug chart nurses are required to complete a drug

“check chart”. The check chart contains the date, drug given, route of administration,

time, and actual dose in milligrams or mls. Two nurses sign the ‘check chart’ and the

nurse administering the medicine signs the drug chart. It is kept alongside the

prescription chart. Some nurses found completing the “check chart” repetitive and

time consuming.

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Any trained nurse, D grade upwards can double-check, but newly appointed nurses

are not allowed to check each other, unless they have completed their IV

competencies and are considered fully competent in actually administering drugs on

the unit. There is no formal assessment or training to be a double checker and no

difference between first and second checkers.

The Trust promotes a no blame policy and if an error occurs the line manager or the

senior nurse is informed, a clinical risk incident form is completed and doctors and

parents are informed. The error is studied in detail by the directorate lead nurse to

find out what exactly went wrong and the staff involved are interviewed by the lead

nurse and if necessary given extra training. The majority of the mistakes are usually

checking errors, where staff have not adhered to the correct checking procedures.

The person who administers the drug is responsible if an error is made. If a checking

error is identified, nurses are asked to retrain and complete their IV competencies.

They are not able to check drugs until they have completed the training and have

been signed off as competent.


• Nurses felt more confident especially when using drugs or performing

calculations they are unfamiliar with.


• Trust Policy is not always followed.

• Medicines not always double checked to the point of administration.

• Check chart is time consuming.

• Medicines are sometimes late due to staffing levels.

Double Checking - Site 12 Site 12 is a DGH with 2 paediatric wards and a SCBU. Approximately 2200 children

were admitted onto the inpatient ward which has up to 20 beds for children between

the ages of 0 -16 years. However, most children are admitted onto the Day Care Unit

which is nurse led and has 12 beds caring for approximately 5300 patients a year.

The SCBU had 265 admissions in 2005 and holds 15 cots providing high

dependency care and short term intensive care. There are 3-4 trained nurses, 1

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Health Care Assistant and a Nursery Nurse per shift for inpatients and 1 ward sister

available in each area.

Double checking was introduced in response to a calculation error where 2 nurses

checked together using a calculator instead of checking independently. As a result a

policy was introduced whereby all nurses are required to perform individual manual

calculations. The Ward manager believes that errors occur when calculators are

used because the nurses are tempted to agree with the answer the calculator gives

rather than check manually. However, during our observation we were told that many

nurses do not like calculating manually. This was more evident when agency staff

were on the wards and not familiar with manual calculations. Additionally, nurses felt

that using calculators would reduce calculation errors further especially when the

ward is busy.

All medicines are double checked and both first and second checkers are

responsible for checking the dose, drawing up of medicines and administration but

the first checker is deemed to be accountable for any errors. All qualified grades of

staff are allowed to check, the only exceptions being agency staff who are allowed to

act as second checkers only. Student nurses observe but can only act as third

checkers.

Nurses complete a series of competencies and are assessed and observed during

drug rounds. Senior staff nurses determine when nurses are able to act as first

checkers. Nurses are trained for IV preparation and administration by completing a

training booklet followed by passing a calculation assessment with a 100% pass

mark. After passing this training, they can become a first checker and are able to

administer IV drugs. There is no formal training course for second checkers; they

receive training on the ward.

The Trust operates a no blame culture. We were told however, that in the event of an

error, many junior nurses feel blamed and under close scrutiny which makes them

less confident. If an error occurs doctors are informed and the patient is placed under

close observation. The error is investigated by the ward sister who presents the case

to the ward manager who decides if a formal hearing will be conducted. A risk

management report goes through the hospital and paediatric systems. We were told

of an incident where there was a formal hearing and disciplinary action was taken to

prevent harm to other patients. The nurse in question was deemed incompetent and

86

unable to administer any medicines until retraining and assessments were

completed.


• Nurses independently check using paper. This can be followed by a calculator

check. This increases confidence knowing calculations agree.


• Nurses feel manual calculation can be more time consuming.

• Nurses not sure that manual calculations reduce errors.

• Problem with agency staff not familiar with manual calculations.

NeoCalc - Site 13 The Maternity and Children’s Services unit is situated on 2 wings, with 40 Cots

funded: 15 Level 1 & 2 cots and 25 SCBU cots. There are 550-600 admissions per

year. There are 15 - 20 nurses on duty over the day (12 hours) and 12- 15 at night;

2 Ward Managers and six G grades /Band 7s.

NeoCalc was developed around 1990 and was introduced in response to an incident

in which a complex dose calculation took a considerable length of time to complete.

A professor of computer services, the principal pharmacist and a second pharmacist

were responsible for developing and implementing the programme. It took

approximately 6 months to develop followed by a period of validation. The

programme is available on computers on the neonatal unit but the consultant

neonatologist and principal pharmacist have additional remote access. NeoCalc is

not linked into the hospital network due to concerns that the server may go down

leaving the unit without access.

The aim of NeoCalc is to help doctors prescribe and to dilute concentrated drugs into

an infusion. It uses standard flow rates for 19 infusions that are provided in the

neonatal unit formulary and is effective providing the baby weighs <5.5kg. The drug

is chosen from a menu; the required dose/kg, flow rate, and baby’s weight are

entered, and the programme calculates the volume and dilution that is appropriate.

Specifications are printed out and copied onto the baby’s notes. The infusion is made

up on the wards following instructions from the print off. Doctors are encouraged to

perform a rough mental calculation to ensure that the results from NeoCalc are

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similar to their own estimation. Nurses can use NeoCalc to check calculations but

during our observations most nurses calculated manually. Either way, nurses are

expected to double check NeoCalc prescriptions to ensure the babies weights are

entered correctly.

Medical staff are trained at induction, provided with the formulary to use alongside

the programme and are shown laminated standard flow rates accessible on the unit.

Nurses are not given specific training for NeoCalc but are shown how the programme

works by a senior nurse. However, we were told that learning to use NeoCalc was

very straightforward and was comparable to using a standard calculator.

When NeoCalc was introduced nurses were apprehensive but some have since

come to rely on it to check calculations. Medical staff use the printout to write medical

notes and the nurses use the printout to double check prescriptions. However, some

staff were concerned that over-reliance on the programme could deskill staff causing

problems if they move to another hospital.


• Standard flow rates are considered effective in reducing calculation errors.

• Time saving for infusion prescription writing, therefore babies receive drugs faster.

• Useful for junior doctors or for prescribing drugs that are not used regularly.


• Some staff admit to not double checking NeoCalc calculations.

• Risk of de-skilling.

• Danger of entering wrong weight and programme calculating wrong dose for

patient.

Education (Medical Staff) - Site 14 Site 14 is a 92 bedded paediatric wards and a neonatal unit with 22 cots, 8 Intensive

Care and 14 Special Care cots. There are 3 intakes of junior doctors per year who

work on a 4 month rotation. All medical staff are required to undertake training and

pass an exam on the hospital intranet.

The intranet package is part of the Scottish Doctors Online Training Scheme (DOTS),

a modular online training system for trainee doctors. DOTS is accessed via the

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internet and each doctor is issued a unique username and password at the start of

their training. They are able to access the programme from any computer in the

hospital or at home. Electronic resources available include the BNF (not paediatric),

calculator, ELibrary (databases NHS education for Scotland) and Toxbase (drugs

and pregnancy module).

Once a module is completed, it is sent via email, to the course tutor to sign off before

moving to the next set of modules. The neonatal package is primarily aimed at

Foundation Year 2 doctors, is currently only being used at Site 14 and is specifically

based on the hospital formulary. There have been accessing problems for the current

intake at Site 14 due to the IT department being busy setting up essential FY1

modules (DOTS). As such we were not able to interview trainees who had used the

online version of the test.

The test was devised by the neonatal pharmacist based on the most common errors

seen at the hospital. There are 10 questions, presented as scenarios, followed by 3

questions with true/false options for each statement. The trainee is able to save and

return later to finish the test but are allowed only 1 submission. The test submission

should take place within 2 weeks of starting the rotation. The computer automatically

marks the questions and the tutor is alerted by email that a student has completed

the test. In the case of the neonatal package the neonatal pharmacist is notified. The

emails give the mark and copy of the test results and how each student answered

each question. Students are expected to achieve around 70%. If they do not, they

are contacted by the pharmacist or tutor and given subsequent one to one training to

help them pass the module. There is no facility to complete another online test and a

paper version is used instead.

Once the test has been completed and submitted the trainee can access the results

on a feedback screen. This screen shows the pass mark and then systematically

goes through each question and, where there is an error, gives a brief explanation of

what the correct answer should be.


• Doctors can access the module from home and do not take time off the ward to

attend teaching sessions.

• Good basic assessment tool which gives a baseline understanding of prescribing

issues.

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• Flexible approach to teaching.

• Easy for staff to monitor whether students have completed the module.


• Ensuring that online training does not replace practical teaching sessions.

• No help function, if additional information is required.

• Some of the questions are ambiguous.

• Insufficient user feedback has been collected.

Education (Nurses) - Site 14 All new neonatal nurses are required to complete a paper based calculation test

(introduced in 2004) before being deemed competent to prepare and administer IV

infusions. The pass rate is 100%. The test is currently very contentious due to a high

fail rate causing poor morale. The test is generic for all nursing staff but with

additional neonatal questions. It is sat under exam conditions and takes

approximately 2 hours to complete. Nurses are allowed to use a calculator.

Prior to the test nurses attend a half day workshop where they are given practice

calculations. The test is run periodically so there may be a substantial gap between

training and taking the test. If a nurse fails it may be another 3 months before they

are able to resit. During our visit issues regarding the content of the test were

highlighted to us. These included ambiguity of questions, focus on adult doses which

neonatal nurses are not familiar with and the format of questions. Problems arise as

in clinical practice, nurses use monographs on the unit which clearly describe how to

make up infusions; these are not available during the test. Nurses who have failed

the test previously are nervous about resitting and predict that they will fail again.

Until they have passed the test they are not able to prepare, administer or check IV

infusions. Some nurses had been on the unit for up to 3 years and still not passed

the test.

The programme is nurse led from the Practice Development office and has no input

from pharmacy or the neonatal unit in terms of the content of the test or how it is

presented. Despite making several recommendations to practice development no

changes have been made to the test, which we were told was very frustrating.

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Reported Advantage:

• Nurses agreed that testing was a good idea but not in the current format.


• Many nurses felt misinformed about the support available for preparation for the

examination.

• Feedback received after sitting exam is insufficient and nurses often remain

unaware of what mistakes have been made.

• Nurses would prefer more study days before the examination.

• Nurses believe examination should be more specific to neonates.

• Nurses are sitting the test expecting to fail and only 2 out of 6 nurses recently

attended the test.

• The exam is not a useful guide to the competency of the nurses, because many of

those who have failed have been described as very competent by their seniors.

Education - Site 15 Site 15 is a children’s hospital with 254 beds including 14 PICU, 6 HDU and 23

surgical neonatal. The remaining beds include paediatric medical and surgical beds

with a number of specialities including ENT, burns, ophthalmology, cardiac,

nephrology and psychiatry.

A medicines administration intranet site was set up as part of an overall risk reduction

strategy within the hospital. The hospital had had a formal scheme for reporting

medication errors in place since 1994. However, it was felt that the forums used to

disseminate medication error reports to staff, particularly junior members, were

ineffective. The intranet was seen as a means to involve, educate and feedback

error-related information within the hospital, especially to front-line staff. The site was

developed by the Chief Pharmacist, Clinical Risk Manager and the Clinical

Effectiveness Administrator with input from the Regional Clinical Risk Manager and

senior nurses with full support of management.

The medication errors section details different types of error that can occur e.g.

wrong dose; dose omitted; dose duplication; wrong infusion rate; dispensing/labelling

errors; wrong IV concentration; wrong patient or wrong route used. Case studies are

described illustrating these types of error and learning points for understanding how

such errors can be prevented. Real data is used but anonymised and is not placed

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on the website until after a time delay to prevent either the patient or members of

staff involved in treating that patient from being identified. There are additional tips

offering advice on the prescribing, dispensing and administration of medicines and

the site aims to raise awareness regarding the use of abbreviations in prescribing

medicines. A section is dedicated to mock calculation tests and unit conversion

sheets. The questions have been sourced from the published literature and the

answers are also available, clearly showing workings out. The calculation test is not

compulsory, is unsupervised and not formally assessed. Likewise, it is not completed

as part of the nurse Continuing Professional Development or is it part of the Trust

requirement.

In addition nurses are given formal IV training sessions which include a series of

lectures, supervised practice observation and culminating in a formally assessed

calculations test which is taken under exam conditions. Nurses are allowed a

calculator and conversion sheets are available for reference. The pass mark is 100%.

Staff can choose not to have a calculation marked if, for example, they don’t

understand the wording of a question. These questions are later discussed with the

Sister. Once the exam has been passed a certificate of completion is kept in the

Continuing Professional Development file.

Junior medical staff are expected to complete an education workshop. This has been

available for a couple of years and is run by either the Clinical Services Manager or

senior pharmacy staff before the FY1 doctors begin their placement. The workshop

takes place over the course of a day and the content covers general prescribing

issues including dose calculations. The trainees are given dose calculations to work

on independently, prior to the start of their clinical rotation, and are given feedback by

pharmacy.

Reported Advantages of intranet site:

• Site receives approximately 100 hits per month.

• Staff considered site to be a good idea.

• It may have increased number of reported errors through raising awareness of the

need to report.

• Has the potential to reduce dose calculation errors through raising awareness and

providing staff with an accessible resource.

Reported Disadvantages of intranet site:

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• Some staff not aware that the site existed.

• Difficulty keeping the site up to date

• Computers on ward are slow and often being used by other members of staff.

• Issue as to whether staff have time to sit down and access the site while at work

and not available remotely.

Reported Advantage of workshop:

• Provides a good opportunity for the junior doctors to meet staff from pharmacy.

Reported Disadvantage of the workshop:

• Doctors who arrive from another rotation do not have access to the workshop as it

currently only runs once a year.

Reported Advantages of IV training:

• Chief pharmacist believes that IV training has reduced risk of dose calculation

errors.

• Opportunity for nurses to practice calculations.

Reported Disadvantage of IV training:

• One nurse felt that they already have experience of giving other drugs and

performing calculations and so not particularly any more confident after a

calculations test.

Education - Site 16 Site 16 is a Maternity Hospital with 98 beds including 10 NICU and 18 SCBU cots. An

education programme was introduced approximately 4 years ago for neonatal nurses

and midwives in response to the number of errors that were being identified by

Pharmacy. Prior to the introduction of the programme junior doctors were responsible

for administering IV drugs but this frequently resulted in infusions being delayed and

as a result nurses were trained to administer the most common infusions. Nurses,

particularly those who had been in post for a long time, were resistant to the idea of

giving IV drugs as this was seen as the role of the doctor.

There are 4 levels of training involved in the programme:

Introductory level training- administration of oral drugs - all nurses must complete this

but progressing further is not compulsory. The aim is for nurses to complete the

introductory level as soon as they join, if possible, on induction day.

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• Level 1- administration of IV drugs by bolus injection via peripheral cannula.

• Level 2- administration of IV drugs by intermittent infusion.

• Level 3- checking, preparation and administration of level 3 IV drugs.

Each level involves theory, practice of drug calculations and supervised practice. The

drug calculations are worked on individually and the answers are returned to

pharmacy for assessment within a 2 week period. The pass rate is 100% and if this is

not achieved individual teaching sessions are organised and the test is re-taken. The

drug dose calculations become more complex as the nurses progress through each

training level and progression to the next level is dependent on the individual having

completed and passed all requirements from the current level. Nurses can only

double check those drugs that they have received training on. Whilst some nurses

were initially nervous about completing the calculation questions they tended to feel

more confident when they completed them and valued having a certified record of

their achievements to put into their CPD folders.

Junior doctors have a multi-disciplinary induction programme which lasts

approximately 2 days. It is taught through a combination of workshops, lectures,

practical demonstration and support on both medical and pharmacy ward rounds.

Doctors are asked to complete a series of advanced calculations to work through

which are then returned to pharmacy who individually feedback the results to each

student. Extra support is given to doctors who fail to meet the 100% pass rate. A

certificate is issued upon completion which is stored in the doctor’s portfolio and a

further copy is sent to the individual’s mentor.

Reported Advantages of the education programme:

• Reported to help to reduce dose calculation errors

• Provides staff with an opportunity to become familiar with protocols and formulary.

• Sessions were considered to be well organised, comprehensive, yet informal.

• Substantial input and support from pharmacy to staff with problems.

• Considered more in depth than programmes offered at other hospitals.

• Fulfils college requirements for training of nurses and doctors.

• Staff have confidence in doctors’ competence on the ward knowing they have gone

though the induction.

• Standardised practice.

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Reported Disadvantages of the education programme are:

• Difficulties in arranging lectures and workshops to suit both staff and pharmacy

staff.

• Doctors felt that there was considerable information to take on board.

• Enforcing 2 week return for completed calculations.

Central Intravenous Additive Service (CIVAS)- Site 17 Site 17 is a 92 bed Children’s Hospital with 3 paediatric wards, PICU and with a

NICU with a total of 24 cots: 6 intensive care, 3 high dependency and the remainder

low dependency. The CIVA service was introduced in approximately 1984 served by

a central unit based at the local DGH. In 1999 a satellite unit was opened next to the

PICU and is available Monday to Friday 9-5. Products prepared include Patient

Controlled Analgesia (PCA), all IV drugs for which stability data exists including

antibiotics for Cystic Fibrosis patients at home. Initially, 900 to 1000 items per month

were prepared but this has steadily increased to an average of 1500 items per

month. On average, an individual item can take 20 minutes to prepare but if a batch

of medicines are required (e.g. 3 days worth) it can take up to 3 hours to prepare.

Out of hours expensive and critical care drugs are prepared in the main Pharmacy

aseptic unit by a resident pharmacist.

Four members of staff are employed to work in the aseptic unit. Technicians who

work in CIVAS must attain the standard BTEC Pharmacy and Pharmaceutical

Sciences. The chief technician also completed a written test along with a practical

checking test aimed at assessing competency to check and release aseptic products.

Other staff have to be assessed as being competent to work in aseptic areas.

A pharmacist visits wards each weekday to check patient’s drug charts for new IV

prescriptions and continuing IVs. It is preferred that all IV orders are placed by 11am.

To meet the deadline the pharmacist collects and checks all new and continuing IV

prescriptions and then rings them through to the satellite, followed by a written

requisition. This written request acts as Pharmacy Supervision as the pharmacist

does not complete the final check or sign for the release of the IV drug to the ward.

IV drugs are not released by the satellite until the paper request has been received.

We were told that the 11am deadline for lunchtime dose orders means that pharmacy

and medical ward rounds occur simultaneously, sometimes causing problems in

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accessing patient’s notes. The system is time consuming for clinical pharmacists who

need to check other patient’s drug charts once the IV orders have been placed.

Once the request has been received it is issued with a batch number and a pre-

printed and authorised worksheet is completed. This contains patient details,

location, batch number, instructions for medicine preparation, equipment list, labelling

instructions, manufacturer’s batch number and space for a preparation and final

check signature. The raw consumables are collected and checked before being

placed into a one-way transfer hatch. All consumables, syringes, vials and equipment

are sterilised and sprayed with IMS and wiped with impregnated alcohol wipes and

stowed in the isolator “in” hatch for 2 minutes to dry. They are then wiped again in the

isolator and are ready for preparation. All products are prepared according to aseptic

procedures. Once prepared the product is placed in the isolator “out” hatch for 2

minutes and then put in the one-way transfer hatch ready for the Chief Technician to

make the final check. Medicines are delivered to the ward by satellite staff, although

nurses collect when the unit is very busy.

Nurses value the service as it is both time saving and increases confidence in the

quality of the product that the patient receives. We were told that there is potential for

nurses to become de-skilled in the preparation of IV drugs, however, nurses are still

responsible for preparing most drugs in emergency situations along with many

preparations out of hours. Although most nurses considered CIVAS as a safer way to

prepare IV drugs one nurse did have concerns that there was no way for nurses to

double check the product themselves on the ward.


• All doses prepared by CIVAS have been checked by a clinical pharmacist who

should have identified any prescribing errors.

• Reduces potential for nurse reconstitution and calculation errors.

• Provides a more peaceful and quiet environment.

• CIVAS preparations are checked by at least 3 members of staff.

• Satellite unit is situated just off ward areas.

• Having antibiotics ready to administer is helpful for carers/patients e.g. CF children

because they can take them to administer themselves and therefore the child does

not have to remain in hospital.

• Time saving for nursing staff to devote to other duties.

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• Cost savings when more than one dose can be taken from a single vial.


• Limited out of hours and weekend service.

• When service is very busy drugs may not be prepared on time and nurses have to

make them on the wards.

• Can cause problems for the ward pharmacist having to have orders sent to the

satellite by 11am.

• Has increased length of pharmacy ward rounds.

• Not enough staff to work on rotation in the clean room.

CIVAS - Site 18 Site 18 is a dedicated Children’s Hospital with 8 wards, ICU, a Neonatal Surgical Unit

and a new Burns Unit. There are 3 technicians trained to NVQ Level 3, 2.75 wte

assistants trained to NVQ Level 2 and a pharmacist working in the unit. Both the

NVQ level 2 and 3 are completed on-the-job and take approximately 6 months. The

unit has 2 isolators, a unit for preparing TPN and a separate unit for preparing

cytotoxic drugs. It can take the CIVAS unit between 5 and 30 minutes to prepare a

drug(s). The service was introduced in response to requests from medical and

nursing staff as an initiative to release medical and nursing time on the wards. It

operates Monday to Friday, 8.30-5.30pm and Saturday mornings.

Nurses do not have access to the unit. The unit is keypad entry only but there is a

bell for visitors. The unit makes all infusions and IV boluses. Morphine is not

prepared in the unit as there are no standard doses and it is not administered at set

times. The unit does not encourage “one-off” requests unless it is an emergency.

Orders are prioritised according to when they are needed. Each worksheet is

allocated a coloured paperclip so that it is easily identifiable to staff what time it is

needed. All requests are encouraged to be at the unit by 4pm and most are tied to

ward rounds but ICU have a 2pm microbiology round and the unit will wait for those

to come to avoid waste if the doses change. Medicines are delivered to the wards by

an assistant, although if the unit is very busy a nurse will collect.

The ward pharmacist collects the orders, checks the doses with the drugs chart and

writes them on a sheet. The pharmacist takes the sheet to the aseptic unit and

prepares a worksheet for each patient. The worksheets are kept in the unit and are

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never taken to the ward in order to prevent contamination. Once the pharmacist has

checked the calculations the worksheet and consumables are placed on an individual

tray for preparation in the sterile area of the unit. The item is prepared using aseptic

technique and is checked and signed off by the pharmacist before being released to

the ward.

Staff were initially sceptical as to the impact of the service on the preparation of

medicines. However, since its introduction it has become invaluable and has

increased communication between medical, nursing and pharmacy staff. The service

has relieved excessive demands placed on the nursing staff in making up infusions.


• Reduces number of drugs that have to be made up on ward and reduces

workload for nurses.

• Cuts cost in preparation of drugs.

• Cuts wastage of drugs.

• Purpose built unit so quality of product is greatly improved.

• Medicines prepared without distraction.

• Having a ward pharmacist visit the ward every day facilitates knowledge

transfer and nurses feel that they have a better understanding of the drugs

that they administer.


• Possible over reliance on the service and de-skilling of nurses.

• Nurses may be less likely to perform adequate checks because they know

that the drug should have already been checked by staff working in CIVAS.

• When doses are prepared in advance, wastage is more likely.

• If the unit is short staffed there may be delays in delivering drugs to the ward.

• Labels can be obscured when using small syringes.

• The service breaks down up to 3 times a year, leaving the hospital reliant on

the CIVAS service provided at the nearby general hospital, and nurses on

ward to prepare drugs.

• Service not available 24hours a day, 7 days a week.

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4.9 Choice of interventions for economic analysis The findings from Study C were presented in the framework format previously

described. They were reviewed at 2 meetings of the expert multidisciplinary panel in

order to evaluate and rate each of the interventions. The overall aim of the panel

days was to rate 1-2 interventions above all of the others for economic analysis.

Panel members were asked to rate each intervention in terms of potential to avoid

harm and cause harm using the table below. A separate table was used for each

intervention.

Comments

Potential to avoid harm:

•

•

•

•

•

•

Potential to cause harm:

•

•

•

•

•

•

Overall Safety*

Low 1 2 3 4 5 High

* Please note that the main aim of this exercise is to evaluate each intervention in terms of it’s capacity to reduce dose calculation errors and to highlight any possible risk of the intervention increasing dose calculation errors. At the panel meetings the team presented the findings from the studies of each

intervention. This was followed by a discussion amongst panel members and any

questions were answered and points clarified regarding the intervention by the team

members. Panel members were then given time to rate each intervention using the

table above. Panel member’s ratings were subsequently compared and an average

score for each intervention was calculated.

The top 5 interventions as rated by the Panel were:

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Double Checking Site 3 (score 3.86)

NeoCalc Site 13 (score 3.86)

CIVAS Sites 17/18 (score 3.78)

Chemocare Site 9 (score 3.7)

Alaris Sites 1/2 (score 3.57)

The panel was asked to individually rate, out of the top 5 interventions, and in order

of preference, the 2 interventions that they thought were most likely to help reduce

dose calculation errors in paediatric patients. This was followed by group discussion

to finally select the intervention(s) to undergo economic analysis.

The Criteria for selection was (a) the potential of the intervention to reduce dose

calculation errors and (b) use in different settings. The Panel agreed that CIVAS,

double checking and the smart infusion pumps are, if introduced together, likely to

provide an error proof system for reducing calculation errors in that one intervention

was nurse led, one pharmacy led and one a dedicated piece of equipment. The panel

concluded that all 3 interventions should be included for economic analysis. NeoCalc

and Chemocare were not selected because of their limited application in different

settings.

4.10 Discussion The purpose of Study C was to provide a descriptive account of practice with each

selected intervention in its clinical setting. We stated in our funding application that

20 interventions would be evaluated; however, the short questionnaires identified

more interventions than anticipated. Consequently, the team and panel decided to

evaluate 22 . The evaluation involved specialised Children’s Hospitals and District

General Hospitals. We used qualitative methods including observation (on paediatric

and neonatal wards and pharmacy) and semi-structured interviews to gain an insight

into the practical application, user’s experiences of and feelings towards the

interventions used in clinical practice. We applied the Cornford Framework2 to

capture the dynamic and contextual nature of each individual intervention.

Using the framework we captured the interpersonal relationships between

stakeholders involved with the intervention. In some instances the intervention had

improved communication between staff, for example, the introduction of a dedicated

medication nurse improved relationships with the pharmacy department as nurses

felt able to contact pharmacy with any queries. Conversely, some nurses felt that

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introducing technical systems such as EP, CareVue and Chemocare resulted in less

contact and communication with patients. Likewise, technical systems that can be

accessed remotely could potentially result in the reduced presence of pharmacists on

the ward. In this way a patient may no longer be seen as an individual and vital

clinical information could be overlooked. Conversely, remote access allows

pharmacists and doctors to review patient drug charts continually during the day or

prior to ward rounds which is a benefit in terms of time for staff and patients.

Change of practice was to be expected as a result of implementing an intervention

and we were able to identify several areas where this had been the case. The CIVA

service in one hospital required the majority of orders to be in the aseptic unit by

11am. This increased the workload for ward pharmacists but decreased the workload

for nurses who were no longer responsible for preparing IV drugs (during CIVAS

working hours). Concerns were raised as to whether this change in practice would

de-skill nurses but this was not found to be the case.

Likewise, the introduction of “smart” pumps involved the re-writing of Trust

monographs and retraining of nurses to use standard concentrations for infusions.

This was met with resistance but nurses would not revert to their former practice

now. We found that overall most centres would recommend their intervention and

that they were mostly seen as safer, or potentially safer than what had been in place

prior to its introduction. Most members of staff had accommodated and embraced the

intervention and the resulting change of practice.

4.11 Policy Implications How the intervention is implemented is important in relation to how staff

accommodate it. We found that in those centres where staff felt the intervention was

“imposed” on them there was greater resistance to the new system. Staff felt

powerless and that in some cases they had had no influence in the roll out of the

intervention. This confirms that the views of staff are important and should be taken

into consideration before the implementation of any intervention. The expectations of

staff should be taken into account, for example, we found that staff, at one centre,

expected EP to be “all singing and dancing” and were disappointed with the system

once it was introduced. This resulted in little value being placed on the system and

most staff wanting to revert back to a paper based system. Likewise, once an

intervention is established, hospital Trusts need to provide ongoing support so that

staff remain positive and willing to invest in it. Staff valued using the Quiet Room

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feeling that it was a much safer environment for dose calculations and preparations

of medicines, but low staffing levels on the unit made the use of the room non-viable.

Similarly, we found that one centre invested a great deal of involvement and financial

support at the implementation phase but at the time of our visit no department was

willing to take ownership of the system.

Training and staff support is necessary for the successful maintenance of

interventions. We found that at some hospitals nurses did not always adhere to Trust

policy in terms of Double Checking procedures, however, it appeared that nurses at

hospitals with clear guidelines and training were more receptive to maintaining Trust

procedures and viewed competency assessment as a source of protection from

litigation. Training for new members of staff is essential to maintain adequate

expertise on wards. One centre we visited experienced problems in the number of

nurses qualified to double check and administer IV infusions due to an inappropriate

Trust calculation test. Likewise, the length of time between training sessions for one

EP system resulted in additional strain and workload for trained nurses and this was

of great concern during winter months.

Pre/post audit is required to measure the effectiveness of the intervention in helping

to reduce dose calculation errors. The majority of the hospitals we visited stated that

they had “a gut feeling” that the interventions actually reduced dose calculation errors

but only one hospital had evidence to support this. However, this may be due to the

fact that many interventions had been in place for several years and that using the

intervention had become accepted as good practice. This also highlights that, in

general, hospitals do not plan in advance to assess the effects of change in practice.

This made it difficult for the COSMIC team to make firm recommendations due to the

lack of information on effectiveness and safety of interventions.

Many interventions impacted on the workload of staff. Some were positive in that the

intervention reduced workload whilst others felt that workload had increased since

the intervention was introduced. Again, this type of information is important in the

evaluation of any intervention. The measurement of medication error rates was

problematic in that the introduction of an intervention had, in some cases, made staff

more accountable for their actions. In terms of EP and the “smart” pumps we were

told that “what was vague is now black and white”. Everything is now auditable and

the whole process from prescribing to administration can be directly traced back to

an individual. This was viewed both positively and negatively by staff particularly prior

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to the implementation of the intervention. However, most of the centres operated a

no blame culture and as such staff felt able to report errors without the risk of

disciplinary action being taken. As such, reported medication errors may have

increased since the introduction of the intervention. We were however, unable to test

this due to (1) many interventions were introduced many years ago and some have

been introduced gradually over many years; (2) many interventions are Trust-wide

and it is not possible to separate the effects on adults from children; (3) the

establishment of the NPSA has significantly affected medication error reporting rates.

4.12 Limitations

• Some interventions were only evaluated in one centre making it difficult to

determine applicability to other centres.

• Lack of objective evidence to support reduction in medication errors for most

interventions. Although many interviewees reported that errors were reduced

following the introduction of the interventions, they were often unable to

provide objective research or audit data to demonstrate effectiveness.

• Study C relies on qualitative methodology. Bias and subjectivity of researcher

and interviewees cannot be excluded.

• Generalisability in terms of appropriateness of the intervention for other

centres (CIVAS for smaller hospitals with low paediatric population may not

be economically viable)

• Economic evaluation is not possible due to lack of existing data.

• Further quantitative research is needed before interventions are rolled out

across NHS.

4.13 Economic analysis: As discussed in the previous section, the team concluded (with the agreement of

external reviewers and the director of the PSRP) that a cost effectiveness analysis

was not possible.

The COSMIC team therefore proposed two possible ways to move forward:

A) To conduct a cost-implementation study i.e. how much it would cost to implement

the selected interventions in a range of hospitals but without commenting on

effectiveness.

B) To conduct a simulation study followed by a cost-effectiveness analysis based on

the simulation.

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However, after reviewing the existing data available from paediatric medication errors

literature and unpublished studies, the team concluded that there is insufficient data

to conduct a simulation study; hence the economic analysis is not feasible. After

consultation with the Director of Patients Safety Research Programme, the COSMIC

team decided it was not in the best interests of the team, NHS staff or patients to

conduct a study of limited use as such the funding for economic analysis will be

reimbursed to the Patients Safety Research Programme.

4.14 Conclusion A range of interventions were studied, some in more than one centre. Positive and

negative issues were identified for most. Implementing and studying an intervention

is more complex than is perhaps recognised by healthcare professionals and the

research community. We attempted to overcome this using the

structure/process/humanistic approach to tease apart all relevant issues. Although

most users were enthusiastic about their interventions, most had no firm evidence to

confirm that their introduction had reduced dose calculation errors in children. Future

recommendations include completion of the audit cycle around implementation of

interventions to provide pre and post-introduction information to confirm or refute

efficacy and safety. Trusts should also be encouraged to publicly disseminate

information on interventions tried and tested for the benefit of the rest of the NHS.

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CHAPTER 5 OVERALL DISCUSSION This scoping exercise aimed to identify interventions to reduce calculation errors in

children’s medicines. The COSMIC team used a systematic literature review and

questionnaires to identify interventions; and subsequently used interviews,

observations and panel assessment to evaluate them. Unfortunately hospitals were

unable to provide high quality objective data to confirm efficacy and safety of their

interventions in dosing error reduction. The COSMIC study therefore, was unable to

provide the complete picture but has conducted an innovative study to provide in-

depth evaluation of a number of important initiatives around the country. We

understand that this may attract criticism but it is hoped that will stimulate much

needed debate.

We found a wide variety of interventions designed to reduce dose calculation errors

in children many of which had been implemented in centres across the UK and

Europe. Evidence suggests that dosing errors are the commonest form of medication

error in neonates and children.

5.1 Discussion of interventions Lack of post-implementation evaluation

The most striking finding of this study is the lack of post-implementation data. The

absence of adequate audit, quality and performance data from so many health care

organisations make it impossible to draw firm conclusion as to the effectiveness of

the intervention; hence limits the type of economics analysis that can be performed.

Electronic Prescribing systems:

The literature shows that the most common interventions used to reduce the risk of

medication errors are CPOE and computer aided prescribing. Not many centres are

using EP in this country. Most work has been published from the US but more

research is needed here to establish safety and efficacy. We studied 3 hospitals

using CPOE in different forms. Staff from two hospitals praised their systems highly

and a sense of ownership was apparent. However, in another hospital which has

recently implemented the system, staff were highly critical and felt they were not

sufficiently engaged in the planning and implementation stages which consequently

had detrimental effects on staff acceptance of the system.

We learned that some IT companies have started to develop functionalities in their

computer programs to reduce dosing errors in children including for primary care.

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Currently most are simplistic however, and little work has been done to evaluate their

effectiveness when used in practice.

The panel did not choose EP as one of their promising interventions as (1) they felt

that the National Programme for IT is inevitable; (2) it will take a very long time to

fully implement EP NHS-wide and other interventions could be put in place sooner;

(3) paediatric dose calculation is likely to be one of the most difficult functions to

operationalize.

Nevertheless, the literature review revealed that EP can be an effective intervention

in reducing different types of medication errors including calculation errors in

children. The Chief Investigator (IW) is currently evaluating the effects of EP at Great

Ormond Street Hospital and will report in two years time.

Unit Dose Dispensing System (UDDS):

Four articles described the introduction of Unit Dose Dispensing System (UDDS). In

this system, drugs are provided as individual single doses and dispensed every 24

hours for each patient1. Although, UDDS is common in North American hospitals, the

COSMIC team was unable to identify a UK hospital that has implemented it. Given

that there are many promising UK existing interventions requiring evaluation, the

panel decided not to evaluate UDDS further.

Double checking:

Double checking is widely practised in the NHS; however, we were unable to identity

literature evaluating its effectiveness. In our observations, we identified different

“models” of double checking, but as data on effectiveness is often not available, we

are unable to support one model over another. It is however, clear to us, and

acknowledged by some nurses that Trust procedures are not always adhered to, for

example, due to lack of trained staff and when the ward is busy. Nevertheless, the

panel has chosen double checking as a promising intervention. The panel agrees

that when performed properly, double checking could catch all types of errors

including prescribing, dispensing and administration errors; however, they also

acknowledge the dangers of tokenistic checking and over-reliance on each other.

More research is needed to support and improve double checking practices.

Furthermore, appropriate training and education is a pre-requisite.

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The Royal Pharmaceutical Society of Great Britain considers that ‘the jury is still out

on double checking’ and that research is still needed to establish whether it should or

should not be advocated. They do however recommend it for pharmacy services.

The National Pharmaceutical Association also recommend that all dosage

calculations in community pharmacy, especially those for children and when

preparing extemporaneous products, should be double checked. Both organisations

acknowledge that there is not always more than one person present in a community

pharmacy to do this however. Lack of clinical information can also be a problem in

dose checking for community pharmacists.

Intelligent infusion pumps:

The “top up” literature review (Table 6) identified two studies evaluating the ‘smart

pump’ but the results were difficult to interpret due to methodological short-falls.

Nevertheless, preliminary experience from UK nurses suggests that (1) Solutions are

standardised, strengths and infusion rates are set according to baby’s weight-band,

so prescription, calculation, and infusion errors are reduced; (2) Standardised

solutions relieve the nurses of deciding and calculating the concentration of the

infusion, making the process quicker, easier and safer. The panel selected intelligent

infusion pumps as a promising intervention due to their ability to reduce the need for

calculations and minimise the risk of wrong infusion rates. However, there are

currently no high quality studies which have evaluated the effectiveness of these

pumps; in particular, there is no data available on their effectiveness in the UK.

Centralised Intravenous Additives Service (CIVAS):

CIVAS were first introduced in the UK in the late 1970's. The aim was to reduce the

risks associated with the preparation of intravenous drugs. By centralising this, the

service concentrates the work in one location with a high level of expertise

(pharmacy) and allows the use of dedicated equipment (clean rooms and isolators)

which significantly reduces the risk of microbiological contamination, cost and errors.

The preparation of IV injections and infusions for children centrally under controlled

conditions in the pharmacy was recommended by the National Service Framework

for children2. Although, CIVAS has been widely adopted by large UK hospitals, we

were unable to identify effectiveness data regarding medication errors, but we

identified one economic study published in 19963. This study highlighted that all

doses prepared by CIVAS have been checked by a clinical pharmacist to identify

prescribing errors; furthermore, the service reduces potential for nurse reconstitution

calculation errors. Our expert panel selected CIVAS as a promising intervention due

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to its potential to reduce prescribing and administration errors. CIVAS may not be

viable for small hospitals however, because the cost of setting up facilities is

relatively high whereas paediatric hospitals have a higher demand for IV drugs.

Education and competency assessment for health professionals:

Education and competency assessments were reported frequently in our survey.

Although, the literature describes the effects of education and training in tests and

simulation environments very few studies investigate their effect in reduction of errors

in clinical settings (Table 6). Training and competency assessment are fundamental

tools to ensure health professionals have the appropriate skills to practice safely and

effectively. The COSMIC project identified various types of training and assessment

such as intranet (computer) training programmes, workshops and supervised

practice observation. Different hospitals have developed their own material for

training and different acceptable standards, some are compulsory and some are not.

Some paediatric nurses resent being required to participate in generic training

projects in which they were taught very little relevant to their paediatric practice. It

suggests that paediatric-orientated training programmes are vital to motivate

paediatric health professionals to take part. Furthermore, we propose that the

government and professional bodies work together to develop national programmes

for training and competency assessment for all paediatric healthcare professionals in

order to set standards as well as reduce the cost of developing and providing training

and assessment.

5.2 Large scale implementation of interventions In this section we will briefly discuss the three interventions chosen by the expert

panel; they are double checking, ‘smart’ pumps and CIVAS. The aim of this section is

to set out the important points which need to be addressed for implementation of

these interventions on a large scale.

Double checking:

The Department of Health and professional bodies have recommended double

checking to reduce errors. Indeed, it is standard practice in most UK hospitals. In

principle therefore, implementation on a large scale is possible; however, the

challenge will be to ensure that double checking is performed in accordance with

protocol. The COSMIC project observed evidence that double checking does not

always take place and various models exist of varying robustness. The panel

commented that the complicated system used at Site 10 may potentially create more

errors.

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CIVAS:

CIVAS has been widely adopted by large UK hospitals; unfortunately, CIVAS is less

suitable for small hospitals because the cost of setting up the facilities is relatively

high. This is more likely a useful solution for paediatric hospitals which have a high

use volume potentially making it more cost-effective. However, a regional CIVAS

model, i.e. a regional CIVAS centre to provide services for several small hospitals is

possible.

‘Smart’ pumps:

‘Smart’ pumps have already been adopted by a few hospitals and many more may

follow. It is important for the NHS and the Department of Health to encourage

hospitals to conduct and publish pre and post audits to establish if these pumps are

effective and whether they introduce unanticipated new errors. In terms of

generalisability, intelligent infusion pumps are likely to be particularly useful for

neonatal and paediatric intensive care units because of high IV use. However, they

will be less useful in general paediatric wards where complex IV drug therapy is rare.

5.3 Overall limitations The limitations of individual studies have been discussed in the previous sections;

this section will mainly discuss overall limitations.

The project was a scoping exercise; therefore by definition, is limited by the

information available from the literature and participating health professionals. In

general little high quality evidence could be obtained to support the effectiveness of

the interventions except EP. The possibility of conducting a high quality economic

study became untenable due to the lack of available effectiveness data. As we

pointed out in our funding application:

“.. the COSMIC team wishes to emphasise that an economic evaluation can only be

as good as the underlying effectiveness data, and the highest quality economic data

will not be able to overcome any deficiency in the effectiveness data. Our experience

in paediatric medication errors research so far suggests that high quality research in

this area is still insufficient; particularly the cost benefit of interventions remains to be

determined.” (direct quotation from the COSMIC funding application.) The team has

therefore concluded that a cost effectiveness analysis is not possible based on the

existing data from the literature and COSMIC project (please see section 5.4 for

further work).

109

Another limitation of the study is that because such a diverse range of interventions

were identified direct comparison, for example, using RCTs is impossible. Qualitative

techniques were used extensively in the part 2 study including observation and

interviews. It has been suggested that people behave differently while they are under

observation i.e. the “Hawthorne effect”, and unfortunately our observation period was

not long enough to counteract this. We did however explain to all participants that the

study was anonymous and that we were interested in systems and processes not in

individual performance. Nevertheless, interviewees openly admitted and discussed

procedural violations and the teams were also able to observe procedural violations

which indicate that participants were not putting a ‘rosy tint’ on the situation.

5.4 Implications for practice Double checking procedures have been widely used in neonatal and paediatric





















110

5.5 Recommendations for further research The COSMIC team makes the following recommendations:

1) Develop standardised approach to measuring errors The development of a standardised approach to measuring errors is needed so that

evaluation and comparison of interventions is possible. This should include the

standardisation of the definition of an error, the describing of error rates (i.e. per

prescription/admission/bed day) and the methodology for detecting errors.

2) Develop standardised approach to evaluating interventions High quality studies are required to examine the effectiveness of interventions. A

combination of quantitative (e.g. randomised controlled trials and pre-post

intervention evaluation) and qualitative methods (e.g. Cornford’s framework) should

be explored.

3) Conduct a high quality effectiveness evaluation study Studies are required to evaluate the effectiveness of ‘smart’ pumps, double checking

and CIVAS.

4) Simulation study and economic study As discussed in the previous section, the team concluded that a cost effectiveness

analysis is not possible; furthermore, very little economic data are available on

paediatric medication errors. Therefore future research should investigate the cost of

paediatric medication errors and cost-effectiveness of any interventions implemented

to prevent them.

111

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Nurs 1999;8:496-504.

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Medical Research Council 2000

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Chapter 5 1. Fontan JE, Maneglier V, Nguyen VX, Loirat C, Brion F. Medication errors in

hospitals: computerized unit dose drug dispensing system versus ward stock

distribution system. Pharmacy World & Science 2003;25(3):112-117.

2. Getting the right start: National Service Framework for children, Standard for

Hospital Services, Department of Health, 2003.

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pharmacy-based central intravenous additive service for paediatric patients.

Pharmacoeconomics. 1996 Oct;10(4):386-94.

4. Fortescue EB, Kaushal R, Landrigan CP, McKenna KJ, Clapp MD, Federico F, et

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pediatric inpatients. Pediatrics 2003;111(4):722-729.

117

Acknowledgements We thank all the staff and patients of the hospitals we visited for their assistance with,

and participation in, the COSMIC study. We are also very grateful to the members of

the Study Steering Committee and expert multidisciplinary panel: Simon Keady,

Alastair Sutcliffe, Carol Hall, Mary McHale, Deborah Pritchard, Ian Costello and

Steve Tomlin.

We also thank Lekaa Abuzayed, David Upton, Imogen Savage, Yogini Jani, Nick

Barber and Tony Cornford for protocol development and data collection.

118

List of Figures Figure 1: Selection process for relevant articles

List of Tables Table 1: Reasons for exclusion from literature review

Table 2: Intervention articles

Table 3: Relevant qualitative articles

Table 4: Reduction in error rates using computerised physician order

entry (CPOE) or computer-assisted prescribing

Table 5: Reduction in error rates using unit dose dispensing system

Table 6: Top up literature review

Table 7: Interventions

Table 8: Corresponding authors survey

Table 9: IT companies and their paediatrics interventions to reduce dosing errors

Table 10: IT companies with future release of calculations software

List of Appendices Appendix 1: Survey to NPPG and RCPCH

Appendix 2: Questionnaire survey of corresponding authors of relevant published

literature

Appendix 3: Survey of UK Health IT Suppliers and the accompanied covering letter

Appendix 4: List of identified healthcare IT companies in the UK

Appendix 5: Categories of Interventions to Reduce Calculation Errors in Children

Appendix 6: Letter to panel members prior to interventions selection meeting

Appendix 7: Panel ratings

Appendix 8: Interviewee details

Appendix 9: Interview schedule- EP

Appendix 10: Observation form- EP

Appendix 11: Patient information sheets

Appendix 12: Consent form for interviews

Appendix 13: Observation information poster

Appendix 14: Alaris- Site 1 framework

Appendix 15: Alaris- Site 2 framework

Appendix 16: Pedisuite- Site 3 framework

Appendix 17: Archimedes- Site 3 framework

Appendix 18: Electronic prescribing- Site 4 framework


119


Appendix 21: CareVue- Site 7 framework

Appendix 22: CareVue- Site 8 framework

Appendix 23: Chemocare- Site 9 framework

Appendix 24: Chemocare- Site 8 framework

Appendix 25: Quiet room- Site 10 framework

Appendix 26: Dedicated medication nurse- Site 11 framework

Appendix 27: Double checking – Site 3 framework



Appendix 30: NeoCalc – Site 13 framework

Appendix 31: Education (Doctors) – Site 14 framework

Appendix 32: Education (Nurses) – Site 14 framework

Appendix 33: Education framework - Site 15 framework

Appendix 34: Education framework - Site 16 framework

Appendix 35: CIVAS framework - Site 17 framework

Appendix 36: CIVAS framework - Site 18 framework

120

Reviewer 1 and Reviewer 2 both read the articles cited.

Articles that were not present on both lists were analysed by

Reviewer 3 who read the articles and decided if it was

relevant or not

Figures Figure 1: Selection Process for Relevant Articles in literature review

Consensus Meeting Excluded from Reviewer 1’s Excluded from Reviewer 2 Final Choice Choice Choice

Angalakuduti et al 27(2003) Barker et al 28(1984) Bizovi et al 11(2002) Cordero et al 2(2004) Cox et al 20(2001) Enderlin et al 13(1992) Farrar et al 18(2003) Fontan et al 1(2003) Kelly et al 23(1984) King et al 8(2003) Koren 19(2002) Lehmann et al 29(2004) McMahon et al 30(1997) Menke et al 31(2001) Mullet et al 3(2001) Myers et al 21(1998) O’Brodovich et al 15(1991) Olsen et al 22(1997) Potts et al 7(2004) Slishman et al 32(2002)

Bizovi et al 11(2002) Cordero et al 2(2004) Cox et al 20(2001) Enderlin et al 13(1992) Farrar et al 18(2003) Fontan et al 1(2003) Fortsecue et al 24 (2003) Gard et al 4(1995) Hazinski et al 25(1986) Kelly et al 23(1984) King et al 8(2003) Koren 19(2002) Lykowski et al 6(2004) Myers et al 21(1998) O’Brodovich et al 15(1991) Olsen et al 22(1997) Strom et al 26(1991) Wong et al 17(2004)

Bizovi et al 11(2002) Cordero et al 2(2004) Cox et al 20(2001) Enderlin et al 13(1992) Farrar et al 18(2003) Fontan et al 1(2003) Gard et al 14(1995) Kelly et al 23(1984) King et al 35(2003) Koren 19(2002) Lykowski et al 6(2004) Mullet et al 3(2001) Myers et al 21(1998) O’Brodovich et al 15(1991) Olsen et al 22(1997) Potts et al 7(2004) Wong et al 17(2004)

Angalakuduti et al 27(2003) Barker et al 28(1984) Lehmann et al 29(2004) McMahon et al 30(1997) Menke et al 31(2001) Slishman et al 32(2002)

Fortsecue et al 24(2003) Hazinski et al 25(1986) Strom et al 26(1991)

121

Tables Table 1: Reasons for exclusion from literature review

Categories Citations

1 Intoxication and poisoning 83

2 Interventions on the effects of overdoses 50

3 TPN 10

4 Evaluation of treatment complications 159

5 Legal implications 83

6 Review, letter, comments 267

7 Case reports 243

8 Educational reports 31

9 Non Calculation intervention 43

10 Medication error causes/rate 99

11 Duplication 387

12 Medical error 566

13 Irrelevant or wrong indexing 736

Relevant quantitative interventions or reports 17

Total 2774

122

Table 2: Intervention articles

Author Cordero et al2

Lykowski & Mahoney6 Wong & Tam17 Potts et al7 Farrar et al18 Fontan et al [1]

Year 2004

2004 2004 2004 2003 2003

Country USA

USA Hong Kong USA UK France

Setting NICU at a State University Medical Centre

370-bed tertiary care children’s hospital

District Teaching Hospital

20-bed Paediatric Critical Care Unit in Children’s Hosp

District General Hospital

Nephrology ward at a paediatric and maternity hospital

Duration

1 year: 6 months (pre-CPOE) 6 months (post-CPOE)

5 years (1998-2003) 9 years (since 1996)

Pre-intervention: 2 months Post-intervention: 2 months

Not available 8 weeks (1/2/99-31/3/99)

Nature of Intervention

CPOE Electronic prescribing, drug administration, inventory management

ICIS: CPOE, clinical documentation, web-based portal, medication/IV charting, rules engine, longitudinal clinical repository

Computer aided prescribing

CPOE Electronic order pathways for paediatric medicines

Computerised prescribing & computerised unit dose drug dispensing system (UDDDS)

Reasons for Setting up Intervention

Not available

Participated in a Child Health Accountability Initiative on Medication Errors, where a paediatric multi-site consortium identified significant opportunities for improvement and reduction in medication errors related to prescribing practices

Overhaul of clinical management system

To prevent medication errors that occur during the medication ordering process

To reduce potential error in prescription of medicines for children

The computerised UDDDS and prescribing systems had already been set up. This study was done to evaluate the error rates in comparison to a non-computerised dispensing scheme

123

Who was involved

Doctors, nurses and pharmacists

Doctors, nurses and pharmacists

Not available Clinical pharmacists, Physician, Reviewer

Physicians pharmacists, paediatricians, IT analysts

Physicians, Pharmacist, nurses, pharm technicians, fifth year pharm students

Outcome

Medication turn-around times: pre (10.5±9.8 hrs) to post (2.8±3.3 hrs); Prescription medication errors: pre (13%) to post (0%); Calculation errors: pre (6%) to post (0%) Radiology turn-around times: pre (42±12 min) to post (32±16 min)

- 100% compliance with pain assessment documentation requirements - 52% improvement in medication turnaround times - 50% reduction in all medication errors - 24% reduction in verbal orders for controlled substances - 20% improvement in care consistency - reduced clinician/service provider pages/phone calls to clarify orders - elimination of medication transcription errors

Reduction in rate from over 100 per year to 40 per year (reduction of 60%) Error types not defined

Per 100 orders: - Potential ADEs: reduced by 40.9% - MPEs: 30.1 (pre) – 0.2 (post) - RVs: 6.8 (pre) – 0.1 (post) - Total errors: 39.1 (pre) – 1.6 (post) - overall: 95.9% reduction in all types of errors associated with medication ordering 99.4% decrease in MPEs 97.9% decrease in RVs

Error rate by non-paediatricians reduced from 76% to 12%; error rate by paediatricians reduced from 26% to 4%

prescription error rate: a) Computerized prescriptions =10.6% b) Handwritten prescriptions = 87.9% potentially clinically significant errors a) Computerized prescriptions = 2.9% b) Handwritten prescriptions = 4.8%. administration error rate: a) Computerized prescription + UDDDS = 22.5% inc admin time errors 9.7% exc admin time errors b) Handwritten prescription +ward stock dispensing system = 29.3% inc admin time errors 24.3% exc admin time errors other impacts: - taskforce implemented to improve PCS software - real time printing of medication administration reports - module for prescribing drug infusions

124

Author King et al8

Bizovi et al11 Koren19 Mullett et al3 Cox et al20 Myers et al21

Year 2003

2002 2002 2001 2001 1998

Country Canada

USA Canada USA USA USA

Setting

Tertiary care paediatric teaching hospital 2 medication wards (intervention) 1 med and 2 surgical wards (control)

Emergency Department at Oregon Health & Science University (OHSU)

Children’s hospital PICU Tertiary care teaching hospital

NICU

Duration

Pre-intervention: 3 years (4/93-4/96) Post-Intervention: 3 years (1/97-12/99)

2 months pre- (05/99-06/99) 2 months post- (5/00-06/00)

1992-1993 (pre-intervention) 1998-1999 (post-intervention)


4 years 4 years


CPOE Computer assisted prescription writing

CPOE; double calculation check for hazardous drugs, review errors and implement changes; removal of hazardous drugs; participation of medical trainees in calculation of drug doses; computerised system in PICU to calculate drug doses and stock solution volume

Anti infective decision support tool

-Recording weights into Medical Information System (MIS) - limitation of verbal orders - MIS initiatives (update screens, make system more user-friendly) - pharmacy intervention reporting -incident report modification (anonymisation of reports)

Computer assisted prescribing system; neonatal medication ordering pathway

Who was involved

Physicians to review reports to determine severity of errors, nurses

Doctor, Pharmacist

Pharmacists, pharmacologists, nurses, physicians, paediatricians, administration

Resident physicians, nurse practitioners, & pharmacists

Doctors pharmacists, secretaries, nurses

Not available

125

Author King et al8

Bizovi et al11 Koren19 Mullett et al3 Cox et al20 Myers et al21

Reasons for intervention

To reduce error rates of serious medication errors

Hospital recognised that medication errors are iatrogenic and preventable source of morbidity and mortality

Tool was already being used successfully in adults and was modified for use in paediatrics

To increase the use of CPOE and decrease medication errors

Outcome

CPOE decreased error rate by 40%. CPOE would prevent 1 medication error for every 490 patient days. Large decrease in potential ADEs on the control as compared with intervention wards

overall error: 2.32% (pre) – 0.69% (post) incorrect dose: 0.13% (pre) – 0.06% (post) clarification rate: 3.9% (pre) – 0.8% (post)

- Total errors decreased by 50% (nurses & physicians), 75% (pharmacists) - Errors by nurses reduced from 1190 (0.11%) to 650 (0.06%) - Errors by pharmacists reduced from 0.04% to 0.01% - total number of actual incidents reduced by 50% -severity of errors reduced by 72% (minor) 69% (moderate) 73% (severe)

clinical: 59% reduction in rate of pharmacy interventions for incorrect drug doses; 36% decrease in rate of anti-infective sub-therapeutic patient days; 28% reduction in excessive dose days humanistic: paediatricians & nurses reported that intervention has beneficial impact economic: 9% decrease in estimate of the cost of anti-infective used in the intervention group

-Elimination of weight interventions by pharmacists - decrease to a near 0 unsigned orders at discharge - use of MIS system by residents increased by 86%; overall direct-order entry increase 61% - number of interventions reported by pharmacists tripled & continued to increase - increased reporting of drug errors

-Error rate reduced from 3.2 to 0.6/1000 patient days (no breakdown – inc transcription, dosage, formulation, prep and admin for 1993-1994 -All types of errors were reduced -Substantial decrease in ave total hosp cost per infant and decrease in average length of stay during 1993-1996

126

Author Olsen22 Gard et al14 Enderlin & Summerfield 13

O’Brodovich & Rappaport 15

Kelly et al23

Year 1997 1995 1992 1991 1984 Country Denmark USA USA Canada USA

Setting Children’s Hospital & satellite pharmacy at a regional hospital

NICU Children’s hospital Children’s Hospital; 2 paediatric medical wards

Children’s Hospital (PICU)

Duration 2 months pre 2 months post

2 years 6 months pre intervention 6 months post intervention

1 month pre-intervention 7 weeks intervention 1 month post-intervention

Max 30 minutes per examination – there were 2 examinations so max 60 minutes


Unit dose pharmacy satellite service

Computer generated antimicrobial dosing protocol consisting of programmed spreadsheet for antibiotics dosing plus unit dose dispensing system

Unit dose system for controlled drugs

Unit dose dispensing system Programmed calculator for Constant Infusion Medication Calculations

Who was involved

Pharmacists, prescribers and nurses

Doctors, nurses, pharmacists Nurse, pharmacist Pharmacist and nurses Nurses, pharmacists paediatric residents


To avoid dosing error problems

Hospital discovered that the reported error rate associated with controlled drugs was approximately twice that of the overall medication error rate

The hospital was in the process of converting wards from traditional system of drug distribution to the unit dose system

To improve the accuracy and speed of personnel handling constant-infusion vasoactive medications

Outcome

Error type and rate: wrong doses reduced from 7.7% (66/856) pre-intervention to 0% (0/544) post-intervention

Dosing calculation errors: Pre- 5x per month, Post- no errors

• Number of controlled substance doses reduced from 8.6% of total (pre) to 5.7% of total (post) • Number of controlled substance errors reduced from 19% of total (pre) to 5.8% of total (post) • Controlled substances errors: 31 (pre) – 15 (post) - error rate: 0.22% (pre) – 0.12% (post) • Non-controlled substances: - errors: 130 (pre) – 242 (post) - error rate: 0.086% (pre) – 0.12% (post)

-Percentage of nurses’ time spent on medication-related activities decreased 2.1% - total error rate decreased from 10.3% (pre) to 2.9% (post) - wrong dose error decreased from 6.4% (pre) to 1.2% (post) - wrong time errors decreased from 27% (pre) to 18% (post) - time that pharmacists spent on drug distribution increased from 33% (pre) to 35% (post) - pharmacist clinical activities increased 8% - average medication cost per patient day decreased by 4%

- Reduction in calculation error from 61.9% test score (pre) to 100% test score (post) - significant reduction in time required for calculations for all except pharmacists - All pharmacists felt the calculator would help their computation and felt reassured by the calculator as a second check of their own figures

127

Note: CPOE = Computerised Physician Order Entry ICIS = Integrating Clinical Information System MPE = Medication prescribing errors NICU = Neonatal Intensive Care Unit Pharm = Pharmacy PICU = Paediatric Intensive Care Unit RV = Rule violation

128

Table 3: Relevant qualitative articles

Author Lucas AJ Mullet CJ et al Horn et al Lehmann CU et al Year 2001 2001 2001 2003 Country USA USA Austria USA Setting 45-bed level III NICU 26 bed PICU 2 hospital NICUs NICU

Duration 6 months after implementation of interventions

evaluate 6 months pre- intervention versus 6 months post-intervention

After 2 years of VIE-PNN operation, a clinical study was performed to evaluate the system

evaluation during: • control period before intervention

(10/00-11/00) • during intervention introduction

(11/00-12/00) • after implementation (8/02-10/02)


• Computerised neonatal formulary

• Rules for managing dosage ranges

• Preparation of practice-site reference

• Emergency medication sheets

• Improving quality assurance

• Dispensing oral liquids in amber oral unit dose syringes

Anti-infective decision support tool to improve anti-infective choices and dosage selections and reduce ADRs accounting for: • therapeutic indication, • age and weight of the

patient, • renal function, • level of pre-maturity

Vienna Expert System for Parenteral Nutrition of Neonates NICU support that: • calculates daily nutritional plans, • reduces time needed for calculation, • combines parenteral and enteral feeding, • provides continuous increase of daily nutrition

supply and a forced change from parenteral to oral nutrition,

• creates a case history, • maintains hospital standard for neonatal

nutrition management, • enables experts to keep the rules up-to-date

• online total parenteral nutrition order entry system (TPN-Calculator)

• performs all necessary fluid and component calculations on the basis of provider input via an Internet browser

• contains nutritional guidelines, osmolality calculator, and 62 rule-based alerts and reminders

Method of evaluation

three surveys were distributed for: • nurses and physicians • pharmacists • pharmacy support staff

• during last week of each 4-week residential rotation, resident physicians were surveyed using a questionnaire composed of 5-point Likert-type scales

• PICU paediatric nurse practitioners were surveyed once, at the end of 6 month period

questionnaire distributed to all neonatologists working with VIE-PNN system

after 6 months, 84 prescribers, pharmacists, and nurses were surveyed online on their experiences and opinions in the course of using TPNCalculator

129

Author Lucas AJ Mullet CJ et al Horn et al Lehmann CU et al

Type of evaluation

closed and open-ended questions, along with questions answerable with 'always' 'sometimes' 'rarely' and 'never' Staff members were asked if they were aware of the changes, and if so, what they were

5-point Likert-type scales and a favourable response was defined as 1 on the 'beneficial' or 'positive effect' side of neutral response

questionnaire asked for the frequency of system use, degree of contentedness with the system (on a 5 grade scale), various reasons for using the system, and for desired modifications

online questionnaire was composed of 5-point Likert-type scale questions asking to rate characteristics of TPNCalculator

Who was involved

multidisciplinary team including neonatal pharmacy specialists, pharmacy information technologists, neonatologists and neonatal nurses

paediatric infective specialist VIE-PNN software designers, neonatologists, physicians

Prescribers and pharmacists were used as programmers, designers, and testers of TPNCalculator, eliminating the need for extensive life cycle assessment


after two serious medication errors occurred in the hospital

adult decision support program was very successful, so similar benefit in paediatrics was anticipated

to create a program for the routine support of NICU combining standard textbook knowledge about neonatal nutrition with practical knowledge of expert neonatologists

medication ordering process was identified as a significant risk for ADEs

How intervention was developed

• systematic review of medication-use process

• used root cause analysis of two serious errors,

• and survey of literature pertaining to patient safety,

• assessment of pharmacy policies and procedures and information technology support

• systematic approach used in evaluating and revising medication-use process on NICU

adult version of decision support tool served as a template and was modified for paediatric purposes. The modified system was rigorously tested for 5-6 months then introduced into PICU

Designed an interactive support system for calculating daily nutritional plans and parenteral nutrition

• interface design was based on existing paper forms to provide users with familiar format and maximum comfort level, while minimizing required training

• created using a routine web development tool, based on paper order form. Total development and testing time was about 3 weeks

Positive Outcomes

• increased access to information

• decrease in opportunity for error

• increased safety • increased staff satisfaction

• decrease in opportunity for error

• increased safety • cost effectiveness • increased staff satisfaction

• decrease in opportunity for error • increased staff satisfaction • time saving

• decrease in opportunity for error • increased safety • increased staff satisfaction • time saving

Negative Outcomes • less participants (under • unable to document patient • physicians required the implementation of new • deployment of a new software tool

130

Author Lucas AJ Mullet CJ et al Horn et al Lehmann CU et al 35%) believed that timeliness of pharmaceutical services had improved

benefit due to insensitive outcome measures

rules for vitamin and calcium prescription in extreme low birth weight infants

• physicians required the addition of new bypass medications, adaptation of value ranges tolerated and rounding rules

may introduce a new type of failure mode in the form of programming software errors, although survey participants did not estimate the risks of TPNCalculator to be higher than paper based system

• when first created, it led to a drastic increase in TPN orders without order identification (page number). Problem was identified and modified to prompt for page number

Recommendations for Others

• may be instituted in other institutions that care for high-risk patients

• most reported that they learned something from the system, and nearly all would recommend it to others

• VIE-PNN supports portability to other hospitals with a demo site outside the hospital. Can be installed at every hospital running an HTTP-server and clinical workstations with access to this server

• designers experienced tremendous pressure to make it available to all units in the children's hospital and to an affiliated hospital NICU

131

Table 4: Reduction in error rates using computerised physician order entry (CPOE) or computer-assisted prescribing

*These figures have been calculated from the articles

Table 5: Reduction in error rates using unit dose dispensing system

CPOE Computer-Assisted Prescribing

Authors Cordero et al [2]

Lykowski

& Mahoney

[6]

Potts et al [7] Farrar et al [18] King et

al [8] Koren et al [19] Myers et al [21]

Wong & Tam [17]

Fontan et al [1]

Bizovi et al [11]

Reduction of Total Errors

100% reduction

50% reduction

95.9% reduction

Non-

paediatricians: 84%

reduction* Paediatricians:

84.6% reduction*

40% reduction

Nurses/physicians: 50% reduction pharmacists:

75% reduction

81% reduction

60% reduction

88%

reduction

70% reduction

Unit Dose Dispensing System

Authors Fontan et al [1] Gard et al [14]

Enderlin & Summerfield [13]

O’Brodovich & Rappaport [15]

Error

Reduction

Administration errors:

24.3% 9.7% 60% reduction

Dosing calculation

errors: 5 errors per month 0

errors per month 100% reduction

Medication errors of controlled

substances: 0.22% 0.12% 45% reduction

Dosing errors: 6.4% 1.2% 81% reduction

132

Table 6: Top up literature review- provisional findings

Author Larsen et al White et al

Frush et al

Lehmann et al

Year 2005 2005 2006 2006

Country USA USA USA USA

Setting

242-bed university-affiliated tertiary pediatric hospital

16-bed tertiary care pediatric intensive care unit

-Children’s hospital with referring hospitals and Advanced Life Support (ALS) ground/air transport systems in the southwest. -Tertiary academic medical centre with referring hospitals, ALS system ground/air transport systems in the southeast -Private health system with referring hospital and ALS ground transport in mid Atlantic region

Children’s hospital at an academic medical centre

Duration

Pre-intervention: 1 year Post-intervention: 1 year

Not applicable Approx 1-3 months for subjects to complete educational course (if in intervention group) and participate in simulation scenario

Observation period: Phase A: pre-intervention : February to March 2003 Phase B: post-intervention: February to April 2004


-Standard concentrations -“Smart” syringe pumps -Pharmacy-generated medication labels

A Drug Request Form (DRF) for ordering intravenous potassium chloride

Web-based education program on proper use of the Broselow Pediatric Resuscitation Tape

Web-based calculator & decision support system

Who was involved

Nurses, pharmacists, clinical engineering, physicians (neonatologist, pediatric intensivist, cardiothoracic surgeon, anaesthesiologist), hospital safety manager

Multiple disciplines: pharmacy, nursing, pediatric nephrology, PICU medicine (PICU residents, fellows, and attending), senior staff members and administrators.

Physicians, advanced practice nurses and paramedics

Pharmacists


To examine whether standard drug concentrations, smart pumps and redesigned labels reduce continuous medication infusion errors

To investigate whether ‘proximal causes of errors’ (PCEs) could cause morbidity after intravenous KCL infusion

To examine the impact of Web-based educational program on reducing medication dosing error and time to determine doses for all medications prescribed in pediatric emergency care providers.

To investigate the impact of the Web-based calculator on infusion ordering & decision support system errors on infusion ordering errors

Outcome

-After interventions, error rate decreased from 3.1 per 1000 doses (pre- intervention) to 0.8 per 1000 doses (post-intervention) for an absolute risk reduction of 2.3 errors per 1000 doses (95% confidence interval: 1.1-3.4; p< .001) -Preparation errors that occurred in pharmacy decreased from 0.66 to 0.16 per 1000 doses

-the incidence rate of post infusion elevation in serum K declined from 7.7% before the DRF to 0% (p<0.001). -the rate of PCEs was significantly decreased after DRF intervention

-Median dosing deviation was significantly lower in intervention than control group (p=0.0002) -Median dosing time was significantly lower in education than control group (p=0.02)

-Errors significantly fewer in calculator-generated compared to handwritten orders (13.6%:27%; p<0.01). -Calculator-generated orders eliminated high-risk errors (incorrect decimal, dose, or unit of measure) (0%:26%; p<0.00001)

133

Author Kirk et al Abboud et al Cimino et al Kim et al

Year 2005 2006 2004 2006

Country Singapore USA USA USA

Setting

The National University Hospital

A 423-bed tertiary care children’s hospital

PICUs in nine freestanding, collaborating tertiary care children’s hospitals

Pediatric Oncology in an academic medical centre

Duration

March 2003 to August 2003


2wk pre-intervention data collection; 3 months site specific error reduction interventions; 2 wk post-intervention data collection

2001-2004


A computer calculated dose program

Computerized provider order entry (CPOE) & clinical decision support: aminoglycoside corollary order screen

Communication/ educational; dosing ‘assists’ ; floor stocks

CPOE

Who was involved

Physicians Physicians, pharmacists, nurses, information services analyst

Not specified Not specified


To investigate the impact of computer calculated doses on medication errors for two commonly prescribed drugs.

To improve the safety of aminoglycoside medication use in children

Evaluate a matrix for determining the predominant type, cause, category, and rate of medication prescribing errors, and to explore effectiveness of hospital-based improvement initiatives

To implement and evaluate the impact of CPOE on reducing ordering errors in pediatric chemotherapy

Outcome

-Error rate was reduced in the computer calculated dose system (299/2381; 12.6%) compared with traditional method (534/1893; 28.2%). -Computer calculated dose was a significant variable influencing the error rate, yielding a relative risk 0.436 (95% CI: 0.336, 0.520; p<0.001).

No significant differences in frequency of therapeutic, toxic or subtherapeutic values between the two study periods

Baseline rate of errors with disorders, 11.1% compared to 7.6% following implementation of hospital specific error reduction interventions (Z= 10.5, P < .001). However, site results varied considerably

After CPOE implemented less likely to have improper dosing (RR, 0.26; 95% CI, 0.11-0.61), incorrect dosing calculations (RR, 0.32; 95% CI, 0.14-0.77), incomplete nursing checklists (RR, 0.51; 95% CI, 0.33-0.80). No difference in likelihood of improper dosing on treatment plans and higher likelihood of not matching medication orders to treatment plans (RR, 5.4; 95% CI, 3.1-9.5)

134

Author Blackledge et al Han et al

Simpson et al Upperman et al

Year 2006 2005 2006 2005

Country USA USA UK USA

Setting

Tertiary, acute care pediatric facility

Tertiary, acute care pediatric facility

Tertiary referral neonatal intensive care unit (NICU)

Tertiary care pediatric hospital

Duration

March-May 2003 to assess accuracy of manual calculations prior to 8 week trial period. Dates of follow-up studies not provided

1st October, 2001 to 31st March, 2003

January 2002 to January 2003

Control period: Jan 2002- Oct 2002 Intervention period: Started in Nov 2003


A Web-based pediatric arrest medication calculator that calculates medication dosage requirements during emergency situations

Computerised physician order entry (CPOE) system

Risk management/ clinical pharmacy led education programme

Computerised physician order entry (CPOE) system

Who was involved

Domain experts included a paediatrician, a pediatric nurse, and a paediatric pharmacist

Physicians Risk management, pharmacy

All layers of management and personnel


To prevent adverse drug events for pediatric patients, increase care provider efficiency, and reduce stress for care providers

To reduce medical errors and mortality

Describe the medication errors occurring

To assess whether hospital-wide implementation of CPOE would lead to a decrease in medication errors

Outcome

Follow-up studies have shown a 0% error rate on the emergency card, 100% legibility and the almost total elimination of the need to perform manual calculations during emergency situations. Anecdotal evidence suggests a significant decrease in the level of stress among team members during an emergency because they are no longer checking and double checking calculations

Mortality rate significantly increased from 2.80% before CPOE implementation to 6.57% after CPOE implementation. Multivariate analysis revealed that CPOE remained independently associated with increased odds of mortality (odds ratio: 3.28; 95% CI: 1.94-5.5)

Monthly medication errors fell from a mean (SD) of 24.1 (1.7) per 1000 neonatal activity days to 5.1 (3.6) per 1000 days (p<0.001)

-ADEs in pre-CPOE

period, 0.3 ± 0.04 per 1000 doses. Post-CPOE

errors 0.37 ± 0.05 per 1000 doses (P= .3). -Harmful ADEs pre-CPOE 0.05 ± 0.017 per 1000 doses. Post-CPOE decreased 0.03 ± 0.003 per 1000 doses (P= .05)

Table 7: Interventions

Electronic Programmes

Monographs, Guidelines, & Information

Other

Chemocare CareVue IV monographs Information sheets

Education Ward pharmacy

Pedisuite Hand held devices

IV reconstitution guidelines

Memory cards/ posters

Double checking (nurse, pharmacist, doctor)

other (e.g.: open culture of errors, using a dose ‘wheel’)

Electronic Prescribing

Internet pharmacopoeia

Administration guidelines

Drug chart development

Double checking by pharmacist

Meetings and reports

Calculator ‘Smart’ Infusion pump

IV compatibility guidelines

Pre-printed prescriptions, proformas, labels

Parental involvement

Medication nurse

Computer programme for calculations

Electronic patient data management system including calculator

Drug monographs/ dose tables/ spreadsheets

Prescribing guidelines & protocols

Drug standardisations

Process standardisation

Books & Formularies

Table 8: Corresponding authors survey

Corresponding author

John Gard4 Marc Summerfield13 Charles Mullett3

Article Reducing Antimicrobial Dosing Errors in a Neonatal Intensive Care Unit

Implementation & Analysis of a Non-Floor Stock Controlled Substance Unit Dose System in a Pediatric Hospital

Development & Impact of a Computerised Pediatric Anti-infective Decision Support Program

Year 1995 1992 2001 Country USA USA USA Nature of intervention Computer generated

antimicrobial dosing protocol consisting of programmed spreadsheet for antibiotics dosing plus unit dose dispensing system

A modified unit dose dispensing system for schedule II controlled substances

Anti infective decision support tool

Clinical setting where intervention is/ was used

The neonatal intensive care unit of General hospital and teaching hospital

All wards of a specialist children’s hospital

The paediatric intensive care unit (PICU) of a children’s teaching hospital

Why intervention was introduced

Change in local policy, to improve prescribing

Following a local investigation into a near miss and following an audit

One of the team had used it elsewhere; the program had been developed at the adult hospital where it was found to be beneficial. It was modified for paediatrics

Staff groups involved in initiating the use of the intervention

Nurses, paediatricians, pharmacists

Pharmacists Paediatricians

Staff groups using the intervention

Nurses, paediatricians, neonatologists, pharmacists

Nurses, pharmacists Nurses, paediatricians, pharmacists

Staff groups involved in training others in the use of the intervention

None recorded Nurses, pharmacists Paediatricians

External expert advice or consultants used to implement, maintain, troubleshoot or evaluate the intervention

No No The medical corporation has broad expertise in informatics interventions

Is the intervention currently being used in patient care

Yes, in setting described in article. In addition, all nursery settings

No, too expensive to maintain & too labour intensive. The system was used for approximately 8 years before it became redundant

Yes, in setting described in article. It has not been successfully expanded to use on wards

How long has the system been used

10 years N/A 6 years 6 months

How frequently is it used

Routinely N/A Routinely used in PICU for ordering antibiotics

Response to intervention when it was introduced

Positive response from nurses, paediatricians, pharmacists, management

Positive response from nurses, paediatricians, pharmacists, management

Positive response from nurses, paediatricians, pharmacists & management. Neutral response from non-paediatric physicians, surgeons, anaesthetists, operating dept assistant, parents/carers, patients

Response to intervention once it was established

Positive response from nurses, paediatricians, pharmacists & management

Positive response from nurses, paediatricians, pharmacists & management

Positive response from nurses, paediatricians, pharmacists. Neutral response from surgeons, Anaesthetists,


John Gard4 Marc Summerfield13 Charles Mullett3

operating dept assistant, management, parents/carers, patients

Formal user feedback sought since introduction

Yes, in the form of a questionnaire

No Yes, in the form of a questionnaire

Intervention evaluated by audit or formal inspection

No No Not that aware of

Substantial changes or updates to intervention since publication of paper

Updates yearly regarding new Antibiotics dosing regimens

N/A No

Plans to develop intervention further

Yes, to allow access from an Excel base which allows for a database

N/A Not specified

Any problems not identified in the publication that were encountered during & following introduction

No No Not specified

Any lessons to be learnt from introduction of intervention that would be useful for someone else wanting to introduce a similar system

Ensure that all disciplines that the intervention will impact upon are involved, so that embrace the system

Automate paperwork Not specified

Private company involved in the setting up or maintenance of intervention

No No No

Cost to set up & maintain the intervention

Windows software; number of PCs; pharmacy and/or information services personnel to maintain updates

Minimal costs The medical corporation (IHC) has experts on staff (programmers, informaticists, and physicians) who can pull this type of project off. Salaries are an important cost


Myrna O’Brodovich15 Kenneth Wong17 Neal Patel7

Article A study Pre and Post

Unit Dose Conversion in a Pediatric Hospital

Computer Aided Prescribing - Electronic Prescribing is Helpful in Children Too

Computerized Physician Order Entry and Medication Errors in a Pediatric Critical Care Unit

Year 1991 2004 2004 Country Canada Hong Kong USA Nature of intervention Unit dose dispensing

system Computer aided prescribing

Computerized physician order entry


Two paediatric medical wards of a specialists children’s hospital

Paediatric surgical ward of a children’s teaching hospital

Paediatric intensive care unit of a specialist children’s hospital


Study undertaken to demonstrate benefits of unit dose distribution

Introduced at local and national level following an investigation into an error which occurred; following an investigation into a near miss which occurred and due to a change in policy to improve prescribing. In addition, it was considered a management requirement

Management requirement


Pharmacists Not specified Not specified


Nurses, pharmacists Paediatricians, non-paediatric physicians, pharmacists, surgeons, chief executive

Paediatricians, non-paediatric physicians


Pharmacists Not specified Paediatricians, non-paediatric physicians


Consulted expert at faculty of pharmacy to assist in statistical analysis

No Not specified


Yes, in setting described in article and in a different setting (not specified).

Yes, in setting described in article

Not specified


22 years 9 years 3 years, 6 months


Routinely Routinely Not specified


Neutral response from nurses

Positive response from paediatricians, non-paediatric physicians, pharmacists, surgeons, parents/carers, patients. Neutral response from nurses. Not applicable to anaesthetists, operating dept. assistant, management

Not specified


Positive response from nurses, paediatricians, pharmacists

Positive response from paediatricians, non-paediatric physicians, pharmacists, surgeons, parents/carers, patients.

Not specified


Myrna O’Brodovich15 Kenneth Wong17 Neal Patel7

Neutral response from nurses. Not applicable to anaesthetists, operating dept. assistant, management


Author not able to respond as has not worked at site since 1994

No Yes, however, form of feedback not specified


Author not able to respond as has not worked at site since 1994

No Not specified


Yes, physician order entry introduced

No Not specified


Unable to comment Yes, automatically asking for user to input drug allergies

Yes, incorporation of paediatric-specific decision support tools into COPE systems


Unable to comment- study conducted too long ago to recall

No Not specified


Unable to comment- study conducted too long ago to recall

N/A Not specified


No No Not specified


Not specified Not known Not specified


Neil Caldwell18 Hedges11

Article Use of Structured Paediatric-Prescribing Screens to Reduce the Risk of Medication Errors in the Care of Children

The Effect of Computer-Assisted Prescription Writing on Emergency Department Prescription Errors

Year 2003 2002 Country UK USA Nature of intervention Electronic order

pathways for paediatric medicines

Computer assisted prescription writing


Used on the paediatric medical/ surgical ward and the neonatal intensive care unit of a general, teaching hospital

Emergency department of a children’s teaching hospital


Management requirement- existing practice was observed to be potentially lacking in safety

Change in local policy to improve prescribing


Paediatricians, pharmacists

Emergency physicians


Nurses, paediatricians, non-paediatric physicians, pharmacists, surgeons, anaesthetists

Paediatricians, non-paediatric physicians, emergency physicians, pharmacists, family physicians, internists training in emergency department


Pharmacists, other clerical staff

Non-paediatric physicians


No Assistance with computer programming by software consultants. Pharmacist provided feedback during development





Screens went live in August, 2001

5 years, 5 months. Has been used continuously with improvements since initiation 3/7/2000


Routinely Routinely as it is the only method of prescription writing in the emergency department


Positive response from nurses, paediatricians, non-paediatric physicians, pharmacists, surgeons, anaesthetists,

Positive response from nurses (fewer call backs from pharmacy), paediatricians, non-paediatric physicians, pharmacists,


Neil Caldwell18 Hedges11

pharmacy technicians (because of dose rounding so dispensing volumes can be measured). Not applicable to operating dept. assistant, management, parent/ carers, patients

management, parents/carers, patients. Considered an immediate success because of better documentation, legible prescriptions, less look-up by physicians


Positive response from nurses, paediatricians, non-paediatric physicians, pharmacists, surgeons, anaesthetists, pharmacy technicians. Not applicable to operating dept. assistant, management, parent/ carers, patients

Positive response from nurses, paediatricians, non-paediatric physicians, pharmacists, management, parents/carers, patients


Yes, in the form of discussion at directorate audit sessions

Yes, in the form of a discussion group


No No


Yes, Medicines available for selection increased from 14 to 21

Yes. Drugs could be ordered by inputting (choosing) a “blank” prescription- used 10% of time. These were reviewed


No, as new e-prescribing system will be developed

Yes, pick list of drugs updated to address prescription of agents using blank prescription option


Not specified Drug interactions must still be addressed within pharmacy. Some nurses are still using weight in pounds rather than kg


Not specified For weight based dosing keep only a kg reading scale in dept and have a trainer available during last 2 weeks to assist with computer use


No Emergency department tracking and documentation system software vendor


Not specified A yearly license is paid to the software vendor. The license was unchanged but 10k was spent on a software modification on one occasion

Table 9: IT companies and their paediatrics intervention to reduce dosing errors

IT company

(Name) Description of programme

Ascribe

(Ascribe) Electronic prescribing and pharmacy system 1) Patient parameters such as patient age band for each patient are used to offer the prescriber suitable dosage regimens. 2) Dose calculator: where dosing calculations are normally based on patient size (e.g mg/Kg body weight or mg/m2 BSA) the system can pick up these patient parameters and perform the calculation automatically.

iSOFT (Torex)

General programme which is not only specific to deal with risk issues in paediatric prescribing. Key principles with paediatric prescribing approach to system design are: 1) Ensuring that certain formulations can only be prescribed by appropriate specialists. 2) Ensuring that dose algorithms used are appropriate for the age and weight of the patient (esp. with chemotherapy). 3) Context sensitive display of initial doses/dose adjustments (ie that the dose details displayed are appropriate to the age and weight of the patient). 4) Transparency of dose calculation process - so that a user can see the exact steps taken to arrive at a calculated dose. 5) Clear flagging of the method and route of administration.

Systeria -Cardiology Heartsuite

(HeartSuite) Departmental electronic record with all documentation regarding the patient being stored including drug prescription information. A link to a third party hypertext formulary is added.

hiCom -Diabetics Twinkle

(Twinkle Diabetic Database) Database capturing demographic and clinical data as regards to paediatric diabetes. Diabetic tablet and insulin medication is validated against maximum daily dosage figures recorded against each drug.

Paediatric Audit Systems -Audit DataEase

Access database where data can be entered and an application can be created to do the calculation.

JAC

(JAC Electronic Prescribing & Medicines Administration System), Electronic prescribing system: A single default dose per product is provided.

First Databank Europe Ltd The (Multilex) drug data file product by First DataBank (Europe) Licensed doses for children are held as text.

Table 10: IT companies with future release of calculations software

IT Company Functionality of Programme in Development

EMIS

Doses will be calculated using the patient’s weight taken from the medical record.

CSC

Nothing has been deployed yet.

Cerner

Cerner presently is scoping out with clinicians from the southern cluster the paediatric electronic prescribing component which falls into their Release 2 planned for 2007.

First Databank Europe Ltd

1) New functionality in development will provide a check against the prescribed dose to indicate both whether too high a dose has been prescribed (potential overdose) and whether the dose prescribed is too low (therapeutically inactive). 2) Further functionality in development will include indicative dose for adults and children for different indications..

JAC

(JAC Electronic Prescribing & Medicines Administration System) Electronic prescribing system: 1) Dose calculator: where dose is entered in mg/kg etc and the system will calculate the dose. 2) For the release after that the system will offer the ability to define default doses in any of absolute, weight or BSA terms by age band.

Appendices

Appendix 1: Survey to NPPG and RCPCH NPPG or RCPCH logo

Co-operative of Safety of Medicines in Children (COSMIC)

Scoping study to identify and analyse interventions

to reduce errors in the calculation of paediatric drug doses

Dear Colleague,

Medication calculation and dosing errors in children have been frequently reported in the

mass media. Some have had devastating consequences. Errors can occur at each stage of

the medicines management process including prescribing, dispensing and administration.

Reported rates of neonatal and paediatric dosing errors vary. However based on the

literature we have estimated that the true incidence in England alone could be around

50,000 per year.

NPPG is working with the Co-operative of Safety of Medicines in Children (COSMIC) to conduct research on behalf of the Patient Safety Research

Programme, Department of Health, to identify interventions which are being used to reduce dosing errors in children.

A literature search has identified those which have been published, but we recognise that

pharmacists, nurses and medical staff regularly address problems which have occurred in

their centres by introducing systems to avoid them in the future. This is often done on a

local basis. We wish to find out details of such interventions and their impact on patient

care. We hope to learn from such experiences in order to identify interventions which could

be used in other places to benefit patients across the country.

We would therefore like to ask whether you have introduced or are aware of any

interventions designed to reduce dosing errors in neonatal and paediatric patients in the

places where you work or have worked in the past. These may be interventions which have

been tried and tested and are currently in use, or ones which have been tried but failed

and therefore dismissed as unhelpful.

We would be most grateful if you would spare a few minutes to complete the attached

questionnaire and return it to us in the envelope provided. If you are happy for us to

contact you for further information please indicate this by signing the section at the end of

the questionnaire. Please be assured that all information will be treated in complete

confidence.

Linda Haines Principal Research Officer, RCPCH Or Sharon Conroy, Research and

Audit Officer, NPPG

Interventions to reduce errors in dose calculation for neonates and children.

1. Have you introduced or are you aware of interventions aimed at reducing errors in dose calculation for neonates and children? Examples may include electronic prescribing systems, hand-held devices, programmes for dose calculation, patient involvement in checking, drug information sheets.

Yes No (please return the questionnaire in the envelope provided)

If yes, for each intervention please answer the following questions:

2. Briefly describe the nature of the intervention.

2a. When and where was the intervention introduced into practice?

3. Is the intervention currently being used in patient care? Yes No

If no, why is the intervention no longer being used?

***** Many thanks for your time and interest in completing this questionnaire. *****

(Feel free to provide extra information)

The project team plan to evaluate all responses and identify a number of interventions for

further exploration. They aim to determine transferability to other hospitals or clinical settings.

If your intervention is chosen they would like to contact you to find out more and possibly

come and see it in practice. If you are happy for them to contact you and explain the study to

you, please complete the missing details and sign in the box below.

Name Names & other details to be completed in advance by RCPCH/NPPG

Position

Work address

Work telephone number

e-mail address

Signature

please sign if you are happy to be contacted by the project team

Appendix 2: Questionnaire survey of corresponding authors of relevant published literature


Scoping study to identify and analyse interventions to reduce errors in the

calculation of paediatric drug doses

Dear Colleague,

Medication calculation and dosing errors in children have been reported frequently in the

mass media. Some have had devastating consequences. They can occur at each stage of

the medicines management process including prescribing, dispensing and administration.

Reported rates of neonatal and paediatric dosing errors vary. However based on the literature

we estimate that the true incidence in England alone could be around 50,000 per year.

We are conducting research on behalf of the UK National Patient Safety Agency to

identify interventions which are being used to reduce dosing errors in children.

A literature search has identified published interventions and we have found that you have

been involved with one of them. We also recognise that pharmacists, nurses and medical

staff regularly address problems which have occurred in their centres by introducing systems

to avoid them in the future. This is often done on a local basis and not always published. We

therefore also wish to find out details of such interventions and their impact on patient care

and to learn from such experiences in order to identify interventions which could be used in

other places to benefit patients.

We would like to ask you a little more about the intervention in your publication, plus whether

you have introduced or are aware of any unpublished interventions designed to reduce dosing

errors in neonatal and paediatric patients in your workplace. These may be interventions

which have been tried and tested and are currently in use, or ones which have been tried but

failed and therefore dismissed as unhelpful.

We would be most grateful if you would spare a few minutes to complete the attached

questionnaire and return it to us in the envelope provided. If you are happy for us to contact

you for further information please indicate this by signing the section at the end. Please be

assured that any information disseminated for the benefit of others will be completely

anonymised.

Dr Ian Chi Kei Wong Principal Investigator Director and Reader Centre for Paediatric Pharmacy Research The School of Pharmacy University of London 29-39 Brunswick Square London WC1N 1AX

Interventions to reduce errors in dose calculation for neonates and

children.

You have been identified as being associated with an intervention that has been published in

the literature (enclosed copy of paper). We have looked carefully at your paper and

completed this questionnaire as best we could from the information retrieved in your

publication, but are still a few more unanswered questions. We would be very grateful if you

could complete this questionnaire. Please feel free to make any amendments to our replies.

1. What is the clinical setting where the intervention is/was used? (please

tick all that apply, and supply the number of hospitals/units involved)

General hospital � n=..…

Specialist children’s hospital � n=..…

Community � n=..…

Teaching hospital � n=..…

Children’s teaching hospital � n=..…

Neonatal intensive care unit � n=..… Paediatric intensive care unit � n=..…

Paediatric medical ward � n=..… Paediatric surgical ward � n=..…

Paediatric med / surg ward � n=..… Out-patient dept � n=..…

Accident & Emergency Department � n=..… Other (please specify)………………………..

2. Why was the intervention introduced? (please tick all that apply)

Following an investigation into an error which occurred locally � nationally � both

�

Following an investigation into a near miss locally � nationally � both

�

Change in policy to improve prescribing locally � nationally � both

�

Following an audit �

Heard at a conference and recognised to be good idea � Who &

where?.............................................

Read an article and recognised to be good idea � Author /

journal?.............................................

One of the team had used it elsewhere �

Management requirement �

Other (please expand)…………………………………………………………………………

3. Which staff groups were involved in initiating and using the intervention? (please tick all that apply) Initiating Using Training

Nurses � � �

Paediatricians � � �

Non-paediatric physicians � � �

Pharmacists � � �

Surgeons � � �

Anaesthetists � � �

Operating dept assistant � � �

Chief executive � � �

Risk manager � � �

Other………………………… � � �

4. Did you use external expert advice or consultants to implement,

maintain, troubleshoot or evaluate the intervention? If yes, please

expand.

5. Is the intervention currently being used in patient care?

Yes, in setting described in article �

Yes, in different setting � please expand………………………………………………………………………

No � (go to Q6)

Unsure � (if possible supply a suitable contact name/address)

How long has the system been used?

………years…………months (approximately)

How frequently is it used?

Routinely � Occasionally � In exceptional

circumstances �

By whom?

Nurses �

Paediatricians �

Non-paediatric physicians �

Pharmacists �

Surgeons �

Anaesthetists �

Operating dept assistants �

Other………………………… �

(Please go to Q7)

6. If no, why is the intervention no longer being used? (please tick all that apply)

Better intervention found �

Too expensive to maintain �

Staff resistance �

Patient resistance �

Caused more errors �

Didn’t reduce errors �

Too complex in practice �

Other……………………………………………

Any other comments…………………………………..

6. a How long had the system been used before it was redundant?

………years…………months (approx)

7. In general, how did the following groups respond to the intervention when it was introduced? (please tick)

Positive Neutral Negative Not applicable

Nurses � � �






Management � � �

Parents/carers � � �

Patients � � �

Other………………………… � � �

Any comments?..................................................................

Instruction for questions 7 to 16

N.B. If substantial changes to the intervention have taken

place since publication please try to answer the following

questions for the intervention as it was published. If

this is not possible, please make a note to this effect

alongside your responses. Thank you.

8. In general, how did the following groups respond to the intervention once it was established? (please tick)

Positive Neutral Negative Not

applicable

Nurses � � �



Pharmacists � � �




Management � � �

Parents/carers � � �

Patients � � �

Other………………………… � � �

Any comments?..................................................................

9. Has formal user feedback been sought since its introduction? Yes �

No �

If yes what form did that take: questionnaire �

discussion group �

other (please state)……………………………………………..

10. 10. Has the intervention been evaluated by audit or formal

inspection? (other than the study mentioned in this paper)

Yes � No �

Who did it? What organisation did they belong to

..................................................................................................................

If yes what were the results? If possible please state in terms of clinical (e.g. error/near miss rate reduction), humanistic (patient and healthcare practitioner experience) and economic outcomes. Please send us copies of any available reports.

11. Has the intervention been substantially changed or updated since your paper was published? Yes � No � Not known �

If so, in what way, for what reason, and when?

12. Are there any plans to further develop it? Yes � No � Not known �

If so, how?

13. Do you remember any problems not identified in the publication

that were encountered during and following introduction of the intervention? If so please give brief details. (Please use extra paper if you wish to do so)

14. If someone else wanted to introduce a similar system are there any lessons that could be learnt from your experience of the intervention and its introduction?

(Please use extra paper if you wish to do so)

15. Was a private company involved in the setting up or maintenance

of the intervention? If so please provide basic details.

(Please use extra paper if you wish to do so)

16. We need to carry out an economic evaluation. Please provide as

much information as you are able/willing to about how much it

cost to set up & maintain the intervention? Alternatively please

provide a name and contact number of someone who could provide the

finance information.

17. Do you have any other information about the intervention that has

not been mentioned?

Have you introduced or are you aware of any unpublished interventions in your area aimed at reducing errors in dose calculation for neonates and children?

Yes � No �

If yes, please supply a suitable contact name/address:

.........................................................................

.........................................................................

Many thanks for your time and interest in completing this questionnaire.

We plan to evaluate all responses and identify a number of interventions for

further exploration with a view to determining their transferability to other

hospitals or clinical settings in order to protect more patients. If your

intervention is chosen would you mind if we contacted you to find out more

and possibly come and see it in practice and talk to your colleagues about it?

If you are happy for us to do so please sign below:

Name SENT OUT ALREADY COMPLETED

Article: SENT OUT ALREADY COMPLETED

e-mail address

Signature

Please indicate if willing to be contacted: Yes you can contact me / No I don’t want contacting further

Please return by (date) to:……………………………………………………….

Thank you very much for telling us more about your published intervention it is most appreciated.

One last question:

Appendix 3: Survey of UK Health IT Suppliers and the accompanied covering letter

Dear Sir/Madam

Our team at the Centre for Paediatric Pharmacy Research (CPPR) in the School of

Pharmacy, University of London, is currently undertaking a research project to

identify and analyse interventions used to reduce errors in calculation of

paediatric drug doses.

The main aim of the Centre is to improve paediatric medicines through the safe

use of medication. Chaired by Dr. Ian Wong, we are currently funded by the

Patient Safety Research Programme at the Department of Health. This project is a collaborative venture between the Centre, the Royal College of Paediatrics & Child

Health, Neonatal and Paediatric Pharmacists Group, Royal College of Nursing,

British National Formulary and University of Nottingham.

Calculation and dosing errors are the most common medication errors in children

and can sometimes lead to fatal consequences. Previous research has reported

that some health care professionals have difficulties in performing calculations to

achieve the correct dose. Appropriate IT systems have significant potential in

reducing or eliminating calculation errors. We are undertaking this project to

identify health IT systems which have already incorporated or will incorporate

programmes to reduce calculations needed in paediatric dosing.

We would greatly appreciate your help in providing us with some information

regarding any particular intervention/s (such as software, etc) that you may have

introduced to avoid or minimise the possibility of dosing errors in children (age 0-

12 years).

Please complete the attached form and return it to me by August 16th. Simply

click on the shaded area to mark a box or write a reply. It should not take more

than 5 minutes to complete. If you have any queries, please do not hesitate to

contact me at [email protected]

Thank you in anticipation of your co-operation.

Lekaa AbuZayed

Survey of UK Health IT Suppliers

Name of the IT supplier

1) Have you introduced a programme to reduce calculation and

dosing errors in children or neonates? Yes (please go to Question 2)

No (please go to Question 3)

2) Please indicate if you have introduced a programme in any of the

following settings. If yes, please specify the name and describe the

nature of the programme.

i) Hospitals: Yes No If yes: name of programme:

nature/description of programme:

ii) Community Pharmacy: Yes No If yes: name of programme:


iii) General Practice: Yes No If yes: name of programme:


3) If you have not introduced a programme to reduce calculation

and dosing errors in children or neonates, are you in the process of

introducing such a programme?

Yes No If yes: name of programme:

nature/description of programme: 4) Are you aware of other interventions being used to minimise the

dosing errors in children? Yes No

If yes, please name/s the supplier/s

Thank you for your co-operation

Dr. Lekaa AbuZayed

Appendix 4: List of identified healthcare IT companies in the UK1

IT Company

Email Address

Telephone

EMIS [email protected] xxx

Healthy Software [email protected] xxx

In Practice Systems [email protected] xxx

Microtest [email protected] xxx

The Phoenix Partnership [email protected] xxx

Protechnic Exeter (now part of Ascribe)

[email protected] xxx

Seetec [email protected] xxx

iSOFT (Torex) [email protected], [email protected] xxx

The computer room Nottingham


Visual Productions Ltd [email protected] xxx

Trustmarque Solutions Not available xxx

Civica Services Ltd [email protected] Not available

SCC [email protected] Not available

Computacenter Not available xxx

PC World Business Direct Not available xxx

IBM [email protected] xxx

IMS Maxims [email protected] xxx

Intergraph Not available xxx

Sx3 Not available xxx

Siemens [email protected] xxx

UNISYS Not available xxx

Fujitsu Alliance [email protected] xxx

Accenture [email protected] xxx

CSC [email protected] xxx

BT [email protected] xxx

Barwick http://www.barwicksystems.co.uk/contact/contact.html, [email protected]

Not available

Cerner [email protected] xxx

IDX (now GE Healthcare) Not available xxx

1 Symbol XXX denotes information kept anonymous

IT Company

Email Address

Telephone

Anglia [email protected] xxx

Capula Healthcare [email protected] xxx

FileTek UK Ltd [email protected] xxx

In4tek Not available xxx

Jade Direct [email protected] (universal) xxx

Maracis Solutions Ltd (MSL) [email protected] xxx

Parys Snowdon (NOW: PART OF Supporta plc)


Strand Technology Not available xxx

System C Healthcare [email protected] xxx

Systeria -Cardiology Heartsuite [email protected] xxx

hiCom -Diabetics Twinkle [email protected] xxx

Paediatric Audit Systems -Audit DataEase


JAC [email protected] xxx

UCL Chime [email protected] xxx

Eclipsys [email protected] xxx

Mckesson Not available xxx

Health solutions Wales [email protected] xxx

CAS services Ltd [email protected] xxx

First Databank Europe Ltd (Check with piloting - used by The Phoenix Partnership)


Serco Health [email protected] xxx

Ethitec [email protected] xxx

Health Intelligence Ltd [email protected] xxx

Healthcare Software Systems [email protected] xxx

SCHIN Ltd [email protected] xxx

Ulyssess [2000] Ltd [email protected] Not available

Graphnet <health solution> [email protected] xxx

Adastra Software Ltd [email protected] Not available

ExtraMed Limited [email protected] xxx

Strand Technology Ltd [email protected] xxx

CSW Health Ltd [email protected] xxx

IT Company

Email Address

Telephone

PhysioTools [email protected] xxx

TrakHealth [email protected] xxx

Liquidlogic [email protected] xxx

Pharmaceutical Press [email protected] xxx

UK Trade & Investment [email protected] xxx

RWA Data Management Ltd [email protected] xxx

Polycom UK Ltds [email protected] xxx

Initiate systems [email protected] xxx

Dictaphone International [email protected] xxx

Cromwell Supply Systems [email protected] xxx

Olympus osyris [email protected] xxx

CSE-Servelec Limited [email protected] xxx

Ultrasis plc [email protected] xxx

Woodward Associates (UK) Limited

[email protected] Not available

Softcare Medical [email protected] xxx

ClinSaver Software Ltd [email protected], xxx xxx

Cerrus International Ltd Not available xxx

Appendix 5: Categories of Interventions to Reduce Calculation Errors in Children

• Electronic prescribing: This is a fully integrated electronic system that is used

to replace written prescriptions. Prescriptions are entered into the computer by the doctor and can be sent directly to pharmacy. The system may be able to perform dosage calculations and provide decision support in terms of drug/dose selection for individual patients or conditions. However not all systems are so sophisticated.

• Software to assist in calculation & dose selection: These systems do not replace prescriptions. They may be either hand-held devices or computer-based programmes. Examples are Chemocare, Pedisuite, and Carevue. Some software mentioned were ‘home-grown’ (such as an Excel program) used to calculate doses of medicines such as gentamicin and vancomycin. These can also be used to calculate infusion dilutions and infusion rates. Protocols & guidelines are sometimes available on these electronic devices.

• Intelligent Infusion pump systems: e.g. the Alaris pump with Guardrails software. These pumps contain software to calculate drug infusion rates for individual patients and that would alert the user of possible overdose or non-adherence to guidelines.

• Written Guidelines: These could take the form of o IV Monographs for critical care drugs, such as the provision of dose

information, reconstitution and administration guidelines for dopamine, or morphine.

o Procedures in writing prescriptions leading to good prescribing practice. This includes instructions to write the words ‘micrograms’ and ‘units’ in full

o Dose guidance charts for medicines such as analgesics, and anti-emetics

• Feedback of errors: This included monthly meetings, reviews, reports where errors ‘near misses’ were discussed and possible corrective action taken to avoid future errors

• Pre-printed prescriptions, proformas, & labels: e.g. for chemotherapy protocols, emergency drugs, analgesics, critical care drugs, and gentamicin stickers as reminder for recording & taking levels

• Support References o Books (Medicines for Children & home grown formularies) o Aide memoires for maximum doses o Memory cards/ posters/ laminated sheets/ drug information sheets

• Paediatric-specific prescription charts: prescription charts specifically designed for paediatrics where the prescriber is guided to supply certain information such as weight and age of child, prescribe dosing in ‘unit-by-dose’ format or mg/kg/dose, etc

• Education: Given in the form of formal lectures, induction programs, self-directed learning through computer programs, tests, quizzes

• Double checking: done by nurses, pharmacists, doctors, parents

• Clinical pharmacist: Pharmacist available on wards for answering queries, going on ward rounds, interventions, screening prescriptions

• Environment: quiet rooms available for nurses to do calculations & draw up medicines. Nurses are not to be interrupted when in these quiet rooms.

Appendix 6: Letter to panel members prior to interventions selection meeting

Dear all, We have been receiving replies regarding interventions in reducing calculation errors in children for the past few months. Analysis of these replies reveals about 150 institutions worldwide that have implemented at least one intervention to minimise calculation errors in children. This resulted in over 400 interventions to be analysed. These interventions have been organised in a manner that allows better handling. They have been grouped into 12 main categories that will require further detailed analysis. Due to the large number of interventions, and limited time and resources available, not all interventions can be studied on the day of the Panel Meeting. It is vital that we know your opinion on the most important categories so that they could be analysed further. Therefore, it would be very helpful if you could reply to this short questionnaire as soon as possible, so that we can minimise the number of interventions that will be analysed at the meeting. Please find attached a short description of each category based on the information given to us from the institutions. This is followed by a very short questionnaire asking you to rank these categories in order of importance from 1-12, where (1) will be given for the category of greatest importance and (12) for the category of least importance. Please do not use a number more than once. You are asked to rank these categories twice. The first ranking is to determine your opinion on the priority of these categories in minimising general medication errors in children. In the second ranking, please give your opinion on the priority of these categories specifically in minimising calculation errors in children. Your rapid reply would be extremely helpful in preparation for the imminent panel meeting. If you have any queries, please feel free to contact me at 07930 337268 or e-mail me at [email protected]. Looking forward to your reply. Many thanks. Dimah Sweis

Appendix 7- Panel ratings Software for Dosage Calculations

Observability Transferability Potential to avoid harm

Recommendation for observation

Highly observable

Highly unobservable

Highly transferable

Highly untransferable

High potential

Low potential

Highly recommended

Not highly recommended

Basic calculator

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

General dosage calculator

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Standard dilutions & infusion rates

Unit-specific standardisation

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Age/weight standardisation

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Calculator for “crash drugs”

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Calculator for CPR drugs

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Calculator for IV monograph drugs

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Calculator for TPN

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Calculator for gent & vanc

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Electronic system with calculator

Pedisuite 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Chemocare 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Carevue 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Clinical Pharmacist



Highly observable

Highly unobservable

Highly transferable


High potential

Low potential

Highly recommended


Designated clinical pharmacist on ward daily

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

24 hour on-call service via telephone

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Pharmacist participate in medical ward rounds

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Pharmacist conducing pharmacist ward rounds

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Pharmacist supervised prescribing sessions (BMT/ haematology)

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Drug dispensing pharmacy satellites

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Double checking



Highly observable

Highly unobservable

Highly transferable


High potential

Low potential

Highly recommended


Who Checks?

all staff 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 2 nurses 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 Nurse & pharmacist

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

2 pharmacists

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

What is checked?

Cross-check prescriptions

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Double check calculations

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

IV procedures

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Dose & prescriptions

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Calculations of discharge patients

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Doses for IV digoxin

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

All daily charts

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

In-patient prescriptions

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

All cytotoxic prescriptions

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Observability Transferability Potential to

avoid harm Recommendation for observation

Highly observable

Highly unobservable

Highly transferable


High potential

Low potential

Highly recommended


All hand scripts

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Triple check all pharmacy dilution syringes

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Double check all TPN order entry

1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Electronic Prescribing & Infusion Pump



Highly observable

Highly unobservable

Highly transferable


High potential

Low potential

Highly recommended


Electronic prescribing

Example a 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Example b 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Home-

grown 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Infusion Pump

Alaris 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

other 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5

Appendix 8- Interviewee details

Intervention Site Interviewee code Profession

Length of service (years)

Length of interview (mins)

Alaris

Alaris 1 DS2300301 Clinical Educator >10 17.46

Alaris 1 DS2300212 Consultant Neonatologist & Clinical Director >10 21.39

Alaris 1 DS2300221 Clinical Risk Management Co-ordinator >10 13.14

Alaris 1 DS2300231 Sister >10 21.38

Alaris 1 DS2300241 Consultant Neonatologist 5 - 10 29.53

Alaris 1 DS2300251 Neonatal Nurse/ Staff Nurse 1 - 4 12.43

Alaris 1 DS2300261 D Grade Staff Nurse <1 7.24

Alaris 1 DS2300271 D Grade Staff Nurse 1 - 4 10.12

Alaris 1 DS2300281 Medical Engineering Department Manager 5 - 10 16.21

Alaris 1 DS2300291 F Grade Nurse Practitioner 5 - 10 11.56

Alaris 2 DS230003 Lead Consultant for Neonatology >10 53.13

Alaris 2 DS230004 SHO <1 20.27

Alaris 2 DS230005 Senior Sister 5 - 10 36.02

Alaris 2 DS230006 Consultant Neonatologist 5 - 10 33.59

Alaris 2 DS230009 Senior Sister >10 34.12

Alaris 2 DS230010 Engineer 1 - 4 13.21

Alaris 2 DS230011 F Grade Sister 5 - 10 18.37

Alaris 2 DS230012 E Grade Nurse 1 - 4 22.39

Alaris 2 DS230014 Acting Head of Pharmacy >10 9.18

Pedisuite

Pedisuite 3 DS230032a Matron for Children's Services >10 20.00

Pedisuite 3 DS230032b Sister 5 - 10 20.00

Pedisuite 3 DS230037 Ward Sister 5 - 10 22.00

Pedisuite 3 DS230041 Paediatric Pharmacist >10 11.00

Pedisuite 3 DSNR001 Consultant Paediatrician >10 WrC

Archimedes

Archimedes 3 DS230037 Ward Sister 5 - 10 22.00

Archimedes 3 DS230041 Paediatric Pharmacist >10 11.00

Archimedes 3 DSNR002 Consultant Paediatrician >10 WrC

Electronic Prescribing (EP)

EP 4 DS230056 Principal Pharmacist >10 37.11

EP 4 DS230057 Paediatric Registrar 5 - 10 12.27

EP 4 DS230058 Senior Staff Nurse 5 - 10 19.05

EP 4 DS230059 Senior Staff Nurse 5 - 10 11.44

EP 4 DS230060 Pharmacist >10 49.49

EP 4 DS230061a Advanced Neonatal Nurse Practitioner >10 23.42

EP 4 DS230061b Staff Grade Medical Officer 5 - 10 23.42

EP 4 DS230062 Senior Nurse Governance Support >10 30.01

EP 5 DS230041 Senior Pharmacist for Child & Family Health/ Emergency Care 1 - 4 49.46

EP 5 DS230042 Chief Pharmacist 1 - 4 49.12

EP 5 DS230043a Staff Nurse >10 30.31

EP 5 DS230043b Staff Nurse 5 - 10 30.31

EP 5 DS230044 Consultant Anaesthetist 5 - 10 22.40

EP 5 DS230045 Paediatric Registrar 1 - 4 26.25

EP 5 DS230046a Staff Nurse 1 - 4 24.39

EP 5 DS230046b Support Manager >10 24.39

EP 5 DS230047 Poor audio quality Not given 41.59

EP 5 DS230048 Deputy Business Manager for Paediatrics 1 - 4 11.03

EP 5 DS230049 SHO <1 7.21

EP 5 DS230050a HIS Services Manager >10 32.03

EP 5 DS230050b HIS Application Coordinator 5 - 10 32.03

EP 5 DS230051 Matron for Paediatrics & Child Health 1 - 4 21.43

EP 6 DS230063 Assistant Director of Pharmacy Clinical Services >10 45.52

EP 6 DS230064 Acting Ward Manager >10 20.05

EP 6 DS230065 Consultant Paediatrician 5 - 10 18.35

EP 6 DS230066 Pre-reg House Officer <1 15.59

EP 6 DS230067 Consultant Paediatrician >10 19.34

EP 6 DS230069 Associate Nurse 1 - 4 14.32

EP 6 DS230070 Primary Staff Nurse >10 9.04

EP 6 DS230071pe Electronic Prescribing Pharmacist 5 - 10 36.34

CareVue

CareVue 7 DS230010 Ward Manager >10 40.54

CareVue 7 DS230011 Senior Staff Nurse 5 - 10 40.08

CareVue 7 DS230012 E Grade Staff Nurse 1 - 4 26.51

CareVue 7 DS230013 Neonatal Pharmacist >10 49.03

CareVue 7 DS230014 Consultant Neonatologist >10 45.27

CareVue 7 DS230015 Specialist Registrar 1 - 4 24.50

CareVue 7 DS230016 Services Manager for Critical Care & Acute 1 - 4 31.02

CareVue 7 DS230017 Emergency Specialist in Paediatrics >10 48.32

CareVue 7 DS230018 Senior Nurse for Paediatrics >10 21.59

CareVue 7 DS230019 SHO <1 26.01

CareVue 7 DS230020 Parent n/a 4.36

CareVue 8 DS230033 Practice Educator 5 - 10 60.08

CareVue 8 DS230034 PICU Pharmacist 5 - 10 34.00

CareVue 8 DS230035 Staff Nurse 1 - 4 21.13

CareVue 8 DS230036 Matron 5 - 10 20.25

CareVue 8 DS230037 Nurse 5 - 10 17.51

CareVue 8 DS230038 Staff Nurse 1 - 4 18.25

CareVue 8 DS230039 Sister/ Practice Educator >10 23.52

Chemocare

Chemocare 8 DS230015 Specialist Registrar in Oncology and Haematology <1 13.17

Chemocare 8 DS230016 Registrar 1 - 4 26.46

Chemocare 8 DS230017 Staff Nurse 1 - 4 5.52

Chemocare 8 DS230018 E Grade Nurse 1 - 4 12.47

Chemocare 8 DS230019 Divisional Pharmacist 5 - 10 27.19

Chemocare 8 DS230020 Clinical Nurse Specialist for Leukaemia 5 - 10 15.47

Chemocare 8 DS230021 Database Administrator 1 - 4 15.56

Chemocare 8 DS230032 Pharmacist <1 37.30

Chemocare 8 DSNR003 Senior Haematology / Oncology Pharmacist 5 - 10 WrC

Chemocare 9 DS230033cp IT Project Manager 1 - 4 25.35

Chemocare 9 DS230034 Chemotherapy Liaison Nurse 1 - 4 23.30

Chemocare 9 DS230035 Paediatric Adolescent Pharmacist 1 - 4 41.51

Chemocare 9 DS230036 Clinical Fellow (Middle Grade Registrar) 1 - 4 25.51

Chemocare 9 DS230037 Sister 5 - 10 14.22

Chemocare 9 DS230038 Lead Director (at the pharmacy school, in children’s services) 1 - 4 30.19

Chemocare 9 DS230039cp Clinical Fellow 1 - 4 29.53

Chemocare 9 DS230040 Senior Asceptic Pharmacist 5 - 10 27.48

Quit Room

Quiet room 10 DS230048 E Grade Staff Nurse 5 - 10 16.14

Quiet room 10 DS230049 Staff Nurse 5 - 10 13.17

Quiet room 10 DS230050 Registered Nurse 1 - 4 9.44

Quiet room 10 DS230051 Directorate Pharmacist 5 - 10 14.49

Dedicated med. Nurse (DM)

DM 11 DS230060 Head of Nursing >10 60.03

DM 11 DS230061 Student Midwife 1 - 4 5.39

DM 11 DS230062 Practice Development Facilitator 5 - 10 19.58

DM 11 DS230063 Staff Nurse (band 6) <1 11.46

DM 11 DS230064 Consultant Paediatrician 1 - 4 11.26

DM 11 DS230065 Acting Paediatric Pharmacist 5 - 10 11.37

DM 11 DS230066 Lead Nurse for Paediatrics 1 - 4 15.12

DM 11 DS230067 Senior Staff Nurse 1 - 4 26.08

DM 11 DS230068 Poor audio quality <1 10.05

DM 11 DS230069 D Grade Staff Nurse <1 20.10

DM 11 DS230070 Head of Nursing >10 17.20

Double Checking (DC)

DC 3 DS230031 Matron for Children's Services >10 29.00

DC 3 DS230035 F Grade Sister >10 22.11

DC 3 DS230036 SHO Not given 9.10

DC 3 DS230038 Senior Staff Nurse 1 - 4 12.00

DC 3 DS230039 Senior SHO <1 11.00

DC 3 DS230040 Medicine Information Pharmacist >10 18.00

DC 3 NDS 20060406 Parent n/a 10.00

DC 3 NDS 20060126 Sister <1

Not available

DC 10 DS230052 Registered Nurse 5 - 10 15.10

DC 10 DS230053 Directorate Lead Nurse >10 24.15

DC 10 DS230054 Staff Nurse 5 - 10 16.51

DC 10 DS230055 Parent <1 5.19

DC 12 DS230063 Staff Nurse <1 11.46

DC 12 DS230064 Consultant Paediatrician 1 - 4 11.26

DC 12 DS230071 Children’s Services Manager >10 24.04

DC 12 DS230072 Paediatric Sister >10 30.25

DC 12 DS230073 D Grade Staff Nurse 1 - 4 11.44

DC 12 DS230074 E Staff Nurse 1 - 4 17.39

DC 12 DS230075/76 Paediatric Trained Nurse >10 16.60

DC 12 DS230077 Senior Sister 1 - 4 24.25

Neocalc

Neocalc 13 DS230053 SHO <1 8.14

Neocalc 13 DS230054 SHO <1 11.13

Neocalc 13 DS230055 Neonatal Specialist Registrar <1 14.13

Neocalc 13 DS230056 Principal Pharmacist/ Computer Services >10 34.38

Neocalc 13 DS230057 Consultant Neonatologist/ Clinical Director for Paediatrics 5 - 10 34.56

Neocalc 13 DS230058 Ward Manager >10 17.59

Neocalc 13 DS230059 Staff Nurse 1 - 4 8.07

Education

Education 14 DS230074 Neonatal Services Coordinator 1 - 4 17.27

Education 14 DS230075 Senior Clinical Pharmacist 5 - 10 43.55

Education 14 DS230076 F Grade Midwife 1 - 4 17.25

Education 14 DS230077 Not given Not given Not available

Education 14 DS230078 IT Project Manager 5 - 10 16.44

Education 14 DS230079 Staff Midwife/ F Grade Nurse >10 14.35

Education 15 DS230090 Chief Pharmacist >10 25.09

Education 15 DS230091 Clinical Effectiveness Facilitator 1 - 4 13.09

Education 15 DS230092 FY2 Dr <1 47.09

Education 15 DS230093 D Grade Staff Nurse 1 - 4 12.38

Education 16 DS230094 Pharmacist in Charge of Clinical Services >10 41.15

Education 16 DS230095 Sister 1 - 4 16.00

Education 16 DS230096 SHO <1 13.10

Education 16 DS230097 Consultant 1 - 4 13.58

Education 16 DS230098 SHO <1 18.42

Education 16 DS230099 Practice Development Midwife >10 10.37

Education 16 DS230101 P/T Teaching Pharmacist 5 - 10 18.40

Education 16 DS230100 Medical Technical Officer 1 - 4 14.59

CIVAS

CIVAS 17 DS230042 Directorate Nurse Manager for Children's Services 1 - 4 30.57

CIVAS 17 DS230043 Staff Nurse (band 6) >10 6.50

CIVAS 17 DS230044 Consultant Paediatrician/ Director of Children's Services >10 16.18

CIVAS 17 DS230045 Senior Staff Nurse 1 - 5 13.43

CIVAS 17 DS230046 Chief Technician for the Paediatric Satellite >10 30.15

CIVAS 17 DS230047 Directorate Pharmacist in Paediatrics 1 - 5 20.48

CIVAS 18 DS230081 Senior Sister >10 11.21

CIVAS 18 DS230082 Senior Technician 1 - 4 26.22

CIVAS 18 DS230083 Senior Pharmacist for Education, Training and Research >10 23.45

CIVAS 18 DS230084 Unit Manager on the Neonatal Surgical Unit >10 14.12

CIVAS 18 DS230085 Senior Pharmacist for Asceptic Services 5 - 10 17.45

CIVAS 18 DS230087 Specialist Registrar in Haematology 1 - 4 6.32

Key

WrC Written correspondence

Appendix 9: Interview schedule- EPS2

Interview Topic Guide

-How long have you been working at xxx? What is your position? -How long has the intervention been used at xxx? (pilot, long term investment) -What prompted the introduction of the intervention (e.g. seen at a conference, read in literature? Was it introduced in response to a specific incident?) -Who was involved in the introduction of the intervention? -Can you tell me about intervention and how you use it? (how does it reduce calculation errors, flexibility- timing of doses) -Are you confident that the intervention helps to reduce calculation errors, has this been audited or studied before and after introduction of the intervention? -Do you have any concerns that it has introduced new or other types of errors? -What are the advantages of using intervention? Did it meet your expectations? (easier to prescribe due to decision support, easier to administer medicines, clearer prescriptions, fewer dosing errors, faster drug rounds, workload, advantages for the patient, hospital, profession?) -Have you had experience with paper-based systems? If yes, do you think the system makes you think more or less about what you do compared to paper-based systems? (prompts: are some things too easy? Does it encourage people to think, to “engage the brain”?) -What are the disadvantages of using intervention? (time-consuming, hard work to keep up to date, new demands for summary and audit data, loss of personal contact between HCPs, non-use of decision support, sustainability, forsee any problems in the future?) -Have you experienced it malfunctioning? (Is data backed up, system support). What back-up systems are in place if the system fails? -What do you do if there is something you think could be improved? Are there procedures in place to deal with system improvement? E.g. users groups? (Probe: How easy is it to get things changed? Feeling of involvement in system development over the years) -What was it like learning to use the system? Did you have any problems when you first started? How were these resolved? (smooth roll-out) -What training did you receive? When was this delivered? (in-house/ external, ongoing, online, nominated trainers, assessment, sufficient, regular assessment to ensure competency is maintained) -What was the reaction to the introduction of intervention? How do staff feel about it now? How did the patients respond? (did everyone react the same, conflict between different stakeholders regarding its implementation, highlighted problems with other departments e.g. IT) -What has the impact been on staff-staff, patient- staff relationships? (increased/ decreased contact time between patients and staff). Has it had any impact on relationships at the staffing/ management level?

2 Interview schedules were tailored to each of the selected interventions taking into consideration who the

intervention was targeted at, along with the hospital setting e.g. NICU, PICU, Pharmacy or Paediatric General Wards.

-Would you recommend it to other centres? (economically viable, set up costs, staff training, software updates/ network) -How is the audit trail used? What do you think of the fact that there is an audit trail of everything that every system user does? (raised awareness in the Trust of medicine management, helped to develop a no-blame culture) - If someone else was about to introduce this intervention into their work area are there any key bits of advice you would want to give them?

Appendix 10: Observation form-EPS3

COSMIC Observation Form Description of intervention (wireless, static, mobile, home-grown)

Location (ward, pharmacy, IT)

How many terminals (per ward, dept., hospital)

Applications (Windows, MS-DOS)

3 Tailored to each of the selected interventions.

Networked (interface with other HIS, other interventions)

Is system used to full capacity

How dose is calculated using intervention (process)

How intervention prevents calculation errors (safety features/ can safety features be ignored/ checking procedures)

Violations (procedural, calculation errors)

System outputs (printed prescriptions, TTO prescriptions, administration guides)

Who uses/ accesses the intervention (clinicians, pharmacists, technicians, IT, parents, patients, higher level management/ How accessed- key fobs, passwords)

When is the intervention used (time, duration)

How the intervention is used (screens, functions)

System support (IT, guidelines)

Impact on relationship between different stakeholders (pharmacists- staff, staff-patients)

Training facilities (written guidelines to hand, on-line system support/ tutorials)

Accessibility of data (flexibility, current/past medication history, allergies, patient weight)

Confidence in using intervention (novice/ expert, positive/negative interaction with intervention)

Time implications

Transferability (problems)

Additional notes

Appendix 11: Patient information sheets

Child: 5-8years


A project to identify ways to make the use of medicines in children safer.

Children’s letter We are doing a project about children’s medicines. We would like you to help. Why me? Your hospital has a new way of using children’s medicines. We want to ask what you think. Do I have to help? It is up to you. If you want to you can keep this letter. You can change your mind any time. You don’t need to say why. If you don’t want to help that is OK. You hospital will carry on looking after you in just the same way. What will I have to do if I help? Talk to us about your medicines. We will ask what you think. It will take a few minutes. You can tell us as much or as little as you want. We will use a tape machine to help us remember what you say. Will my taking part be kept secret? Only you, your family and our project person will know what you tell us. What will happen then? We will talk to other children too. We will write about the project. You and your family can see this if you want to. No names will be in it, they will be kept secret. What we find will help make things better for other children taking medicines like you.

Child 8-13years



Children’s Information Leaflet This is to tell you about a project we are doing to look at children’s medicines. We would like to tell you a bit more about it and ask if you would like to help us. Why is the project being done? We want to find out ways of making children’s medicines safer to use. Why have I been chosen? Your hospital is using a new way of giving medicines to children. We want to find out more about it. We want to know if it could be used in other hospitals to make things better for their children as well. We would like to find out what you know and feel about it. Do I have to help? It is up to you if you help us or not. If you want to help you can keep this letter. We will ask you and the person who looks after you to sign a form saying that you are happy to help us. You can change your mind at any time without telling us why. If you change your mind or if you do not want to help at all then that is OK. Your hospital will carry on looking after you just the same way. What will happen if I help? We will talk to you about what you know about the new way of using medicines in your hospital. We will ask what you think about it. You can tell us what you want to. It will take a few minutes. We will record what is said using a tape recorder to help us remember what you told us. Will my taking part in this study be kept private? Anything you tell us will only be seen or heard by our project team. What will happen to the results of the project? When the results are ready, we will write a report about it. This is to try to help make things better for children in other hospitals. We can send you a copy if you would like to see it. Your name will not be used in the report.

Adolescent



Patient Information Leaflet This is to tell you about a project we are doing to look at ways of making children’s medicines safer to use. We would like to tell you a bit more about this project and ask if you would like to help us. Why is the project being done? Quite often, when medicines are prescribed by a doctor, given to patients by a nurse or made up by a chemist, difficult sums are involved. We want to find out ways to make doing these sums easier. Why have I been chosen? Your hospital is already using a way to help make sure that sums are done correctly and it involves patients like you. We want to learn more about this to see if it could be used by other hospitals to make things safer for their patients. We would like to find out what you know and how you feel about it. Do I have to take part? It is up to you whether you take part. If you decide to you can keep this letter and we will ask you to sign a form saying that you are happy to take part. You can change your mind at any time without telling us why. If you change your mind, or if you decide not to take part at all this will not affect how you are looked after in any way. What will happen if I take part? We will talk to you about what you know about this way of making sure medicines are given correctly in your hospital. We will ask you what you think about it. This will take about 15 minutes or less depending on how much you want to tell us. We will record what is said using a tape recorder to help us remember what you told us. Will my taking part in this study be kept private? Anything you tell us will only be seen or heard by our project team. What will happen to the results of the project? When the results are ready, we will write a report to share them with others. We can send you a copy if you would like to see it. Your name will not be used in the report. Who has asked for the project to be done? Who is paying for it? The Department of Health.

Who has checked the project? Independent people have looked at it to make sure it is OK to go ahead. What if something goes wrong? This is not likely to happen since all we want to do is talk to you. But if you have any complaints about the project please first talk to the staff on the unit or the project person who talked to you. If you are still not happy or if or you wish to say anything else, please contact: Dr Ian Chi Kei Wong Director and Reader Centre for Paediatric Pharmacy Research The School of Pharmacy University of London 29-39 Brunswick Square London WC1N 1AX Telephone: 020 775 35933 Fax: 020 775 35977 Email: [email protected]

Parent/carer


A project to identify ways to make the use of medicines in children safer. Parent Information Leaflet We would like to invite you to take part in a project to find out ways to make sure that children’s medicines are given correctly. What is the purpose of the study? Occasionally, medicines are not given correctly to patients. There has not been much work done in the UK to study this in children. Difficult calculations are sometimes needed when children’s medicines are prescribed by doctors, given to patients by a nurse or dispensed from a pharmacy. In this project we want to find out ways of avoiding problems with these calculations. Why have I been chosen? This hospital has introduced a way to ensure that medicines are given to children correctly. In this project we want to learn more about it. We want to find out if it could be used by other hospitals to make things safer for their patients. We would like to find out from you what you know and how you feel about it. Do I have to take part? It is up to you whether or not to take part. If you decide to take part you will be given this information sheet to keep and be asked to sign a form saying that you agree to take part. If you decide to take part you can change your mind at any time without telling us why. If you change your mind, or if you decide not to take part at all this will not affect how your child is cared for in any way. What will I have to do if I take part? We will ask you what you know about how your hospital is making medicines use in children safer.. We would like to know how it affects you and your child and what you think about it – good and bad. We will talk to you for about 15 minutes depending on how much you want to tell us. We will also record what is said using a tape recorder to help us remember everything that is talked about. Will my taking part in this study be confidential? Any information which is collected about you will only be seen by members of our project team. Your name will not be used in any reports we write. What will happen to the results of the project? Reports will be written to help other people learn from our findings. When the results are available, we can send you a copy if you would like to see them. No one will be named or identified in any report. Who is organising and funding the research? The study is funded by the Department of Health.

Who has reviewed the study? Independent advisers and a Research Ethics Committee have reviewed the study. What if something goes wrong? If you have any complaints about this project, please, in the first place, discuss them with a member of the unit staff or the project person who talked to you. If you are still not happy or if or you wish to say anything else, please contact: Dr Ian Chi Kei Wong Director and Reader Centre for Paediatric Pharmacy Research The School of Pharmacy University of London 29-39 Brunswick Square London WC1N 1AX Telephone: 020 775 35933 Fax: 020 775 35977 Email: [email protected]

Appendix 12: Consent form for interviews

Centre Number:

Study Number:

Participant Identification Number for this study:

CONSENT FORM


Scoping study to identify and analyse interventions used to reduce errors in calculation of

paediatric drug doses

Name of Researcher:

Please initial each box

1. I confirm that I have read and understand the information sheet dated ............................ � (version ............) for the above study and have had the opportunity to ask questions.

2. I understand that my participation is voluntary and that I am free to withdraw at any time, � without giving any reason, without my medical care or legal rights being affected.

3. I agree to take part in the above study. �

________________________ ________________ __________________

Name of Subject Date Signature

_________________________ ________________ __________________

Name of Person taking consent Date Signature

(if different from researcher)

_________________________ ________________ __________________

Researcher Date Signature

Appendix 13: Observation information poster


A study to identify ways to reduce errors in calculation of paediatric drug doses

We would like your help to identify effective interventions to reduce

mistakes in the calculation of children’s medicines doses. Your hospital is using a method to reduce the risk of such mistakes. We would like to watch staff and patients when this intervention is being used to help us decide whether this is something that could be used in other hospitals to help make children’s care safer. Our researchers have done observational studies in other hospitals and we can assure you that we will not interfere with patient care, or the usual ward routine. After we have watched what happens in real life we may wish to talk to you about what you think of the method and the benefits and problems it brings. Your involvement is completely voluntary. If you do not wish to take part just let us know and we will not watch you at work or ask to talk to you. There is an opt-out form available for you to sign if you do not wish to be involved. If you are happy to be involved you can be assured that whatever we see, or whatever you say will remain confidential. If we think the method for reducing errors may be useful for other hospitals we may ask your Trust managers for permission to tell others about it. No individuals will be identifiable in any reports or papers we write about this project. The project has been approved by senior managers in your Trust and by an independent ethics committee. If you have any questions, please contact ………………….at the number below.

Thank you for thinking about being involved in our study.

Researcher name …………………………………… Contact number ……………………………

Appendix 14: Alaris - Site 1 Framework

Systems Function

Human Perspectives Health Care System/Organisational Context

Str

uctu

re

• The pumps are mounted on a fixed Gateway which acts as a docking station. This weighs approximately 26/28 kilograms with the 5 pumps on it.

• The pumps are pre-programmed allowing the nurse to select the drug and the baby’s weight. The nurse programmes the concentration and dose of the drug and then the pump calculates the rate per hour based on the standard dose and the weight of the baby.

• Guardrail has a soft upper limit (soft rail) and a hard upper limit (hard rail). Soft rail prompts nurses when inappropriate dose for the weight of baby is entered so that they can recalculate. Warnings come up as flashing arrows on the screen. Soft rail warnings can be overridden, subsequent to a conscious decision, usually in emergencies when giving blood and saline, or under special instructions from the doctor or pharmacy. The pumps retain a record of the number of times that soft rails are exceeded in their memory. Hard rails cannot be overridden using the Guardrail software. The user must come out of the software and programme ml per hour manually.

• The pumps have the facility to use ml per hour for anything that is out of the ordinary or not actually included in the Guardrail software.

• In the case of an error, an ACE (a critical event) form would be filled in. This goes to the lead risk consultant who would assess that risk to determine if an investigation should be conducted which would involve taking reports from all individuals involved, along with a root cause analysis. If pump-failure is one of the root causes, the manufacturer is contacted. Also, members of staff involved in the incident are retrained in procedure and policies regarding use of the pumps if necessary.

• If a pump is faulty, it is withdrawn from use to isolate the problem; then the medical engineer department is contacted. The medical engineers have a twenty-four hour service for breakdowns. If they need to obtain the pump history they will contact Alaris; they will keep the pump out of the clinical area until Alaris have downloaded the history. Nurses have to fill in a decontamination service request form.

• There was a run-in period of about a month where staff had hands-on training, using dummy pumps, training pumps and a training regime for nursing staff (delivered jointly by the hospital education team as well the Alaris team). Training included PowerPoint presentations and practical study days with assessment and competency sheets at the end. Nurses were very impressed with the Alaris training, leading to a smooth transition.

• Refresher sessions are offered as well.

• At first, some staff were worried about putting too much trust in the pump software, and generally wary of technology. Others were very accepting, with no great resistance, wanting to move with technology.

• At first, some found it difficult to learn to use the pumps, but felt better with experience, practice and training.

• The pumps were introduced as the way forward in good practice for using drugs in the neonatal area, as for some time there were several medication errors and critical incidents reported; therefore the need for safety software was recognised.

• Alaris pumps were also introduced because the unit plans to eventually go paperless.

• The decision to introduce the pumps was taken by the directorate, clinical risk lead for clinical governance, the EBME department consultants and the Nurse Manager after discussion with Pharmacy

• Subsequent to purchase, Pharmacy were heavily involved in writing the programmes.

• The pumps have a finite life of ten years.

• Lead educators from the hospital, as well as two employees from Alaris were involved in education and training. Neonatal pharmacists were involved in double checking the datasheets that were prepared. The medical engineering team was involved in the introduction of the pumps and providing technical support.

Systems Function

Human Perspectives

Health Care System/Organisational Context

Pro

ce

ss

• The pumps were initially introduced as a pilot prior to purchase, allowing staff to assess them. After a clinical evaluation, they were purchased. Staff nurses received training for about a month, using dummy and training pumps, then they were introduced on the wards in a twenty-four hour or thirty-six hour period.

• A list of the top ten or fifteen drugs used in neonatology were programmed into the pumps.

• All the infusion datasheets had to be changed because drug concentrations and solutions had to be standardised; this was very time consuming. This consisted of the 80 most commonly prescribed drugs.

• Initially, using the pumps was a slow process and very time consuming.

• Initially, the Alaris pumps would not infuse less than 0.1 ml per hour; sometimes lower volumes were needed, so the infusions had to be adjusted.

• Staff were pleased about the introduction of pumps, and nurses embraced the change.

• Changing the datasheets was very time consuming and took a lot of work, but nurses found them to be very helpful in terms of guiding how to make up infusions.

• There were worries about nurses becoming de-skilled.

• Pump was seen as a third checker confirming the calculations attained by two nurses.

• Consultants prescribe and the nurses make up the infusions and run them using Guardrails.

• Nurses prefer it if the doctors do not use the pumps, so they are not trained to do so.

• There has been no impact on the relationship between staff members and nurses and doctors in terms of having control of medication.

• If staff have any recommendations or suggestions, they would approach the directorate pharmacist or the engineering department depending on the nature of the recommendation.

O

utc

om

e

Advantages

• Pumps are fairly robust, reliable, the software is very stable, no problems with system breaking down; they work well and are easy to use by following the prompts.

• Pumps use standard infusions with standard dosage, reducing error and improving safety.

• Pumps allow nurses to easily determine what infusions a baby is having, and the dose and rate, as well as assuring a standard infusion.

• Pumps provide a system of double checking which reduces calculation errors.

Disadvantages

• Pumps are too big and can’t be moved; and the plunger carrier sticks out at the end of the pump and can get knocked easily.

• Pumps are very expensive, time consuming and increase workload.

• There were two incidents of user error with morphine and although the staff made the morphine solution correctly in the syringe, they tapped in the wrong strength on the Alaris pump, because all the strengths come up in a drop-down menu making it possible to select the wrong strength.

• Pumps don’t allow for two decimal places, so often nurses have to round up or down and cannot give exact dose. As a result, nurses were consistently overriding the soft limit, this was considered bad practice. Therefore, the soft upper limit was increased by 10%.

• Nurses have to work in pairs when using the pumps, adhering to the protocol of checking the contents of a prescription and making up the infusion. This makes them more cautious when administering medicines

• Nurses see no difference in practice, other than having standard solutions which they prefer because it’s easier to check and easier to understand.

• Nurses believe that doctors do not need to use the pumps or infuse medicines to avoid possibility of error.

• Nurses all like the pump and would recommend it.

• Perceived introduction of the pumps as better than previous system and the changeover went more smoothly than expected.

� All staff members would recommend the pumps to other hospitals.

� There are mixed views regarding cost-effectiveness, some say it’s too expensive while others believe it to be very cost-efficient.

� Set up costs and maintenance costs were quite high, as well as training costs.

� Free updates and downloads are included which would otherwise be quite costly.

Appendix 15: Alaris - Site 2 Framework

Systems Function

Human Perspectives Health Care System/ Organisational Context

Str

uctu

re

• There are approximately 60 pumps on the ward, with about 10 in repair at any one time. Staff feel that there is always an adequate number of pumps available for use.

• Protocols for all regularly used drugs are programmed into the Guardrails software and stored in the pumps. These protocols are based on different formularies and professional/clinical knowledge. The protocols use standard solutions for each drug depending on the profile, and different infusion rates are programmed in for these solutions. Guardrails is always used for drugs included in the protocols, as well as for blood and intralipid transfusions.

• Guardrails has soft and hard limits, which were set by the consultants.

• Software is upgraded as modifications are made to the protocols and more drugs are included in the list. Alterations to the limits are also made.

• The baby’s name is confirmed and its weight range, drug details, rate of infusion, and syringe type are entered into Guardrail. The programme and profile needed for the particular drug is chosen.

• The pump can be either set to infuse in ml/hour or set to stop when a certain amount is delivered.

• The pump always specifies the drug being given, which is shown on the panel at the front of the pump.

• Users can override soft limits after confirming it is done intentionally. Users cannot override the hard limit. In this way, the user could not accidentally overdose/underdose a patient by misplacing the decimal point.

• If it is vital to give a drug that is over the hard limit, it can be keyed in as a drug that is not on the protocol and run in ml per hour, but this is rarely done.

• Guardrail keeps an audit of all attempts to override the limits.

• When the pump is turned on and has already been set to infuse, it asks the user if he/she wants to clear the previous specifications or re-use them.

• The syringe must be placed very accurately; otherwise the pump will give an error message and sound an alarm. Also, if the pump has not been loaded properly or the sensors are not in place, the pump will stop working.

• The pump is plugged into a base that powers it and also collects data. This is connected to the hospital computer system which will calculate the overall infusions given for that pump

• Pumps have intelligent docking stations that are streamlined, which are more aesthetically pleasing, and organised, and making it easier to add another pump if needed

• At first the senior sister was apprehensive about introducing the pumps, but the nurses learned very quickly and the transition was very smooth.

• In general, nurses were very receptive to the pumps and happy to start using them. At first a few were apprehensive and did not like working with machines, but after they were more familiar with the pumps they were much happier.

• The company trained certain nurses to become core trainers for others. Training lasted 3 hours. It involved general pump care and an understanding of the buttons, menus and warning signs. It also involved dealing with some of the problems, and error messages, as well as occlusion of the pumps. It was quite extensive training and there was a written assessment at the end. Trainers from the company had a very positive impact on the unit.

• New nurses are trained for at least 2 hours and given an assessment at the end, provided by the company. They should be able to set up the pump, be familiar with what it does and how to access information. They also had to complete a sheet of calculations. If they do not pass the assessment, they are given more training. They also have update in-house training.

• Nurses found the training informative and sufficient and felt fully confident in using the pumps afterwards.

• New doctors are not given full training because they do not use the pumps on a daily basis. They get an overview of how to prescribe fluids and how to use the basic functions of the pump. They are harder to train than nurses.

• The transport team gets extensive training because they’re out on the road and they need to know how to use them to repatriate and transport patients.

• When nurses make an error they must talk through their mistake. If it becomes evident that they need more training, it will be provided, but mostly mistakes are due to high pressures on the ward, so if the nurse is removed from the ward for training it only increases staffing pressures on the ward. Learning through understanding why a pump alarm has been triggered is considered sufficient.

• The lead consultant at the hospital had an extensive background in infusion devices and heard about Guardrails being implemented in the States, so they were aware of the technology and its potential value.

• When Alaris needed a unit to try out Guardrails, the hospital volunteered. Alaris offered free software upgrades as it was a trial.

• Introduction took around 6 months, but gained momentum in the final 2-3 months of that period.

• It was started, as a pilot, on the neonatal ward, with hopes that it would be useful in improving data collection.

• Initiation was discussed with the lead consultant, two nurses and Alaris. Afterwards, the head of pharmacy was also involved.

• It was hoped that Guardrail would later provide a system that would calculate the overall amount of fluid, drug, and electrolytes infused from several pumps- this has not yet happened.

• The pumps and their software are very robust and sustainable and do not require too much maintenance.

• Pumps seem to be most useful in paediatrics, intensive care, and A&E.

• Consultants wanted the capability to override hard limits at first, but after discussions agreed that it would lead to negative results.

Systems Function


S

tru

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• Pumps require a forward flow to work. When the catheter is inserted into the vein, there must be some pressure in the vein to allow a fluid exchange. Also, the motor which pushes the syringe into the barrel only works when it receives a natural impulse, so it is not a smooth continuous flow.

• Only Alaris syringes can be used with the Alaris pump.

• The pumps have to be serviced once a year; they display an error code and alarm when they need to be serviced. Error and alarm also go off if the system breaks down if dropped, etc.

• When being serviced, the data in the pumps is removed and stored on a computer. The pumps are checked at different infusion rates so it usually takes 2-3 days for each pump to be checked. After servicing, the data is loaded back onto the pumps. There is also a syringe test that checks the stop on the syringe and the calibration.

• The hospital experienced board failure on the pumps. When the company was made aware of this, they came and fixed the unit, free of change.

• Pumps break down on an average of one every 2 months.

• Nursing staff seem very competent when using the pumps. They are responsible for their own knowledge of the system and are expected to ask for help when they need it.

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• Engineers had to go through separate training provided by the company and attend a course. They were promised more technical training, but company has not yet provided it.

• Nursing staff seem very competent when using the pumps. They are responsible for their own knowledge of the system and are expected to ask for help when they need it.

• Engineers had to go through separate training provided by the company and attend a course. They were promised more technical training, but company has not yet provided it.

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• There was an initial meeting where all protocols and details of drugs regularly used were supplied to Alaris engineers who programmed them into the pump within a few months (lead consultant claimed 15 months). Subsequently, bi-annual meetings were held to discuss any changes to the protocols. This includes making changes if soft limits were constantly exceeded, or adding drugs that were not previously included. They tried to cater for all the needs of hospital staff.

• Conversion of the pumps to Alaris was very quick, taking around 6 months. Introduction required some effort and discussion, but it was not very difficult. The company rep and an ITU trained nurse, helped to integrate and programme the pumps. They started with 40 pumps, and then increased to 60. There were no real problems in setting up the pumps.

• The pump does not have decision support and makes no recommendations; it only informs the user if the limits are reached.

• The syringe pump can have a volume of up to 50-60 ml. It is useful in neonates because they are given a very small amount of fluid. If the baby is having less than 2 ml an hour a 50 ml syringe will last for 24 hours. This is also useful if giving a drug with short half life, when a continuous infusion of very small amounts is needed.

• When they are sent to the hospital IT department for routine service, emergency equipment takes priority, and the pumps are a lower priority, which sometimes causes a problem.

• Guardrail will sound an alarm if the dosage is not suitable, so it acts as a third checker.

• Alaris can run at lower volumes than other pumps allowing for more TPN to be given.

• The hospital has an exceptional level of support from the company, and they are very prompt in answering queries, giving advice and fixing problems.

• There were some minor programming problems with certain drugs, and when a new syringe was installed, but they were easily fixed. Also, the pump case was constantly cracking, probably from falling over so the company changed the case so it has more protection when dropped. Finally, there was a slight IT problem, and the engineers needed to get a converter to download information from the pumps to their PCs.

• At first, it was a bit difficult learning to read prescriptions and do calculations for 25ml volume syringes instead of the usual 24 ml volumes. Also, consultants wanted the option to override hard limits at first, until they got used to the new protocols.

• It is vital that the hospital has sufficient financial and technical support from the company

• The staff quickly adapted to the pump and there was a large reduction in the error rate.

• Nurses made up the infusions based on the standardized concentrations in the protocol. Standardising solutions led to fewer prescription errors by doctors, since they abide by the Guardrail protocols when writing prescriptions. Therefore, nurses did not have to go back and ask them to adjust their prescriptions as much as before.

• Doctors do not handle the pumps as much as nurses do.

• Nurses had to learn to perform calculations for 25ml syringes instead of the 24ml syringes which were used previously.

• Nurses learned a lot about clinical risk if they made mistakes using the pump. They learned from their errors and were more aware of what could cause them. If a serious error occurred, an RS (instant reporting) form was completed and discussed at a regularly held meeting where they are given advice on what to do in the future.

• There was one error documented where the concentration of the solution was changed but was not entered into the pump. The baby was still within the margin of error, and it was only picked up the next day during a routine check.

o Nurses do not have to approach doctors as much as before regarding prescribing, so there is less tension between staff.

o The correct dose and standardised solution of any drug programmed into the pump is available. Therefore there is no need for discussions between nurses and doctors on the correct dosage and infusion rates. Also, nurses are more confident in challenging a doctor if the pump verifies their reasons.

o There was one complaint about doctors from Pakistan generally being more difficult to approach and challenge.

o The ability to programme individual protocols allows for greater flexibility; the pump can be used in different wards with different protocols.

o Nurses may get so accustomed to the pump that they avoid giving boluses because it is more work, although it might sometimes be better for the baby.

o Nurses would feel better if a pharmacist was on the wards to double check the IVs.

o Guardrail has had an impact on new doctors, and how they write prescriptions.

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• The pumps are very robust, compact and easy to use and programme. They are easy to clean and have a display panel instead of using sticky labels. Very few break down and give error messages, and if they do they are easily serviced.

• The display panel makes it easy for nurses to see exactly what drug is being given and the rate of infusion, including bloods and intralipids. This allows for easier double checking and verification. Also, the information on the display panel is always shown using a standardized format.

• With Guardrail the solutions are standardized and strengths and doses are set according to the baby’s weight-band, so prescription, calculation, and infusion errors are reduced. Also, it highlights the units that are used, so fewer errors are made. However, some nurses claim that they are tempted not to double check each other because they rely on Guardrail to be a third checker; although most nurses do double check regardless of Guardrail. Also, there is no Guardrail programme for bloods and TPN because it is too complicated so there is bigger potential for errors.

• Using standardized solutions and strengths simplifies calculations and reduces the time needed to prepare the medicines. Monthly reviews of drug errors show that most are prescription errors, not infusion or calculation errors, particularly those with misplaced decimal points. These reductions in errors also lead to reductions in litigation costs. However, there is a problem with using standardized solutions when medicating a very fluid restricted baby and the solution available is too dilute.

• Guardrail acts as a third checker, sounding an alarm if a calculation error was not picked up or the dosage is not within its limits. The alarm is loud and sometimes described as annoying.

• It records all attempts to exceed limits, which is useful when updating the protocol or in case there is an investigation. However, sometimes nurses are too heavy-handed and exceed the limit by mistake, then bring the dose down if they’ve shot past the intended dose, and this is recorded as an attempt to override. Also, the audit data is difficult to understand and requires translation to be legible.

• The option and ability to update the protocol allows for greater flexibility while still using the drugs safely. Also, the ability to override the soft limits give additional flexibility, while ensuring that this is a conscious decision requiring confirmation. Although protocols are updated every 6-8 months, some nurses find it more useful if updates could be done on a monthly basis.

• Using the Alaris pumps, sticktion is minimized and flow is smoother. Sticktion results from the stickiness of the liquid in the syringe, and the friction that results as the syringe plunger goes through the barrel. It leads to periods of very low or no flow.

• When infusions are given extremely slowly, flow from the pumps is very sporadic which may lead to the formation of a clot. This is because the pumps require a continuous forward flow to work. If there is no forward flow in the vein over a period of time then the end of the catheter gathers blood and cuts off. Also, the motor which pushes the syringe into the barrel only works when it receives a natural impulse. For slow infusions, impulses are not regular so flow is sporadic.

• Although the pumps are usually easily fixed, they are not always a priority so engineers might take some time before getting to them. The pumps can be very sensitive and pressure centre sometimes gets broken if the pump gets dropped.

• Although it may be easier to use, it may result in deskilling the nurses because they don’t have to do as many calculations. Some medical staff have said that they had to re-learn how to calculate fluids after going to other hospitals. Also, staff tend to lose confidence if they have to calculate something that is not in Guardrail.

• Before the introduction of the pump, nurses had to check all prescriptions. If they found an error they had to approach the doctors and ask them to recalculate. This built up some tension between staff. When pump was introduced, doctors had standardized solutions making calculations easier, with fewer erroneous prescriptions- making the process safer and quicker.

• There were fewer RS (error) forms submitted after the pumps were introduced

• There are some worries that pumps could make the nurses lazier and they would forget their calculations. Conversely, nurses claim that they do not rely on the pump, they do the calculations separately and only use the pump as a double checker. They realize the dangers of becoming too complacent with Guardrail.

• Nurses are still very vigilant and do not rely entirely on Guardrail to pick up all the errors. Nurses still refer to formularies and references to back up their work. Also, they always work in pairs and double check each other’s work.

• Having standardized solutions relieves the nurses of deciding the concentration of the infusion, making the process quicker , easier, and safer.

• When nurses have to administer drugs where standardized infusions of Guardrail do not apply and the patient does not fall within the protocol, nurses may lose confidence when working out infusions for that particular patient because they do not have the safety of a third checker.

• There has been no negative feedback from the nurses and they try to use the pumps whenever possible.

• The company was very responsive to any problems that the staff had, making implementation much easier.

• The senior sister recommended Alaris to a friend in another hospital, mostly advocating how different protocols can be used, and how it provided various profiles for different children’s weights and drugs.

• Another hospital rang senior nurse to ask her advice on installing Alaris and she fully recommended it.

• Most nurses would recommend the pump to other hospitals

• It is considered transferable between wards and between hospitals.

• Hospital would prefer to be able to do their own programming of software instead of waiting for Alaris to come every 6 months and update the protocols.

• Installing the pumps is recommended provided the staff are familiar with technology and sufficient trainers are available and training is given to nurses.

• The pump is particularly useful in paediatrics where calculation errors are common and doses are very small so an error can be fatal

• It was suggested that the pump would be very useful in an A&E resuscitation scenario.

• It is vital that the hospital has sufficient financial and technical support from the company

• There is further potential for the pumps, such as programming protocol and calculations for blood products or for treatment of specific diseases. This potential should be investigated. Their use for boluses should also be investigated.

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• A new volumetric pump will be introduced and it is very similar to the syringes so it will be very easy to learn to use. It was promised to the hospital 15 months ago.

• Only specific syringes can be used with the Alaris pump. Also, the smallest syringe available is 10ml, so if an infusion is needed for a smaller volume, a different pump must be used.

• Dosing using the pumps can sometimes get complicated when trying to wean the child off a drug. If a very low rate is required, and the pump will not go below that rate, then staff have to start making more dilute concentrations every time they need a lower rate.

• Guardrail only works for infusions, not boluses. Therefore it is still easy to overdose or make errors when administering boluses.

• Hope to have pumps that help nurses in decision-making process

• There are plans for a new volumetric pump to be introduced at the end of this year.

• The pumps cost about £1800 each, and the new volumetric ones approx. £2200 each.

• Hospital would like to have Guardrail in the entire hospital but may be too costly.

Appendix 16: Pedisuite - Site 3 Framework

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• Portable handheld computers (iPaq) purchased and loaded with the pre-programmed PediSuite software developed by the Medical Wizards Company.

• Designated bleep holders (one nurse, doctor and consultant) are required to carry handhelds at all times, to be used in emergency situations.

• PediSuite provides 12 modules enabling the user to perform instant calculations for drug dosages, antibiotics, fluids e.t.c.

• The only module intended for use at this unit was PALS (Pediatric Advanced Life Support Protocols).

• The nurses’ handheld is charged up in the Ward sister’s office, situated on the ward. The doctors’ handheld is charged in the doctors office, also situated on the ward.

• Handheld has a touch screen and pen.

• Customised belts are available which can be used to carry the handhelds.

• System driven forward by one of the senior paediatric consultants.

• Doctors and nurses had little to no input in the procurement and subsequent implementation of the system and some considered this problematic.

• Informal Training involved teaching “the basics” to senior doctors and nurses, who were then encouraged to learn through practice.

• No formal assessment of competency.

• No formal on-going training.

• A senior paediatric consultant introduced the Pedisuite after personal use indicated its potential value in emergency situations.

• Seen as a long term investment. A resource which could be used to help staff work out dosages and dilutions of emergency drugs quickly and help to reduce errors.

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How it was integrated

• A selection of doses calculated by the PALS module calculator were checked by the Medicines Information Pharmacist prior to implementation.

• The system was not formally launched

• Rapid implementation, not gradually introduced. No pilot/test phase. How it works in practice

• Staff Rota system identifies who will attend emergencies (one registrar and one senior nurse) and thus carry the handhelds.

• User has to accept terms and conditions every time handheld is switched on.

• Screen defaults to the menu displaying the 12 modules.

• Once module has been selected, patients weight (or age with concomitant average weight) is entered which then opens a drug category list. The required drug is selected and the dose is calculated.

• Information regarding contra-indications, allergies and recommendations for practice also appear.

• Offers advice on how to make up infusions. Problems with integration

• On-site IT support not available and IT dept felt to be non-supportive by senior consultant responsible for implementing the system. IT department refused to load software on to desktops in the wards.

• Most felt that the implementation process was inadequate and that formal training was required, especially for those unconfident working with IT systems.

• Nurses felt that their knowledge base was at a high level and the handheld was more of a hindrance than a benefit.

• Having no input into software development, and an inability to adapt the system to a UK format was problematic.

• Not considered to have had any impact on staff/patient relationships.

• Staff did not feel that a change in practice resulted.

• Perceived as a potential source of conflict if doctors were prescribing doses that didn’t tally with resources used by nurses.

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Advantages:

• The concept of a transportable handheld device which would contain the information needed to calculate doses quickly in an emergency was well received and considered especially useful when paper copies of Monographs/Protocols could not be found.

• Additional information, for example, contra-indications was thought useful.

• Useful when a weight has not been measured as offers average weights for different ages (NB although recognised that this could be problematic if a child is over/under weight).

• Nurses could see value of the system in diagnostic terms.

• Offers advice on how to make up infusions.

• Senior consultant also found it a useful resource in clinics and on ward rounds.

Disadvantages:

• Small screen and lack of a print out were seen to limit its value.

• Difficult to navigate between the different modules and screens.

• Difficult to search for the drug required, especially problematic as time-consuming in an emergency situation. No facility for an A-Z drugs search.

• System is American and uses non-UK doses and drug names. It is not compatible with Trust guidelines and tends to under-dose compared to standard UK doses, for example, recommended in the BNFC.

• IV concentrations do not correlate with Trust guidelines which staff are using in emergency situations.

• Doses had not been checked against the most recent version of BNFC and updated accordingly.

• No facility to re-programme the device for individual Trust requirements.

• Staff would forget to charge the handhelds.

• Some doctors had accidentally uninstalled the software.

• Nurses felt the handheld was too bulky to carry along with the bleep, so it was stored in the sister’s office until needed.

• Nurses did not think it was user-friendly.

• Staff recognised the need for a resource which could help to work out doses quickly and accurately in an emergency situation, but many felt the PediSuite had not met their expectations.

• Variable uptake: the system was not integrated into the daily practice of nurses attending emergency situations as they did not feel it was user-friendly and were not comfortable using it when speed and accuracy is of essence and they needed to be hands on.

• It was felt that nurses attending emergencies already had a solid knowledge base and were able to work more effectively without the PediSuite.

• Doctors were required to carry the Pedisuite and some did use it in emergencies.

• It was not always carried, as required, by designated staff

• New SHOs are not introduced to the Pedisuite.

• Some doctors were not familiar with the Pedisuite, but were encouraged by the idea.

• Nurses did not feel that it reduced dose calculation errors or improved emergency care and preferred to use Monographs. However senior consultant felt that it had improved practice because it avoided having to make calculations for solutions in resuscitation (no evidence to support).

• Nurses would not recommend the PediSuite in its current format to other hospitals. A UK version, based on BNFC for drug calculation and choice of drugs, is needed for desktops and handhelds.

• The senior consultant responsible for procuring the system felt it was better than what was in place before but nurses did not agree.

• Upon retirement responsibility for the PediSuite was passed to the replacement consultant- leaving the future of its usage uncertain.

• Training seen as an issue with staff changeovers.

Appendix 17: Archimedes - Site 3 Framework

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• The Archimedes medical calculator is powered by Skyscape.

• Downloaded, for free, onto a desktop, then loaded onto the iPaq handhelds (originally purchased for the PediSuite software).

• Archimedes provides 70 pre-programmed commonly used formulas in medical specialties such as Cardiology, Pharmacology, Haematology and Paediatrics.

• Paediatrics section includes: scores- Apgar scores, Glasgow Coma scale for children; Critical Care Infusions- maintenance and deficit fluids, maintenance fluids; ETT- Urine output.

• Three means of accessing formulas: alphabetical listing, category listing and historical listing.

• Calculator implemented by one of the senior paediatric consultants.

• Doctors and nurses had no input into the initiation and subsequent implementation of the system.

• No training provided; senior consultant encouraged staff to learn through practice.

• No assessment of competency.

• No on-going training.

• To be used as a mobile reference source on ward rounds/ in clinics to help staff work out calculations quickly and accurately.

• Senior paediatric consultant downloaded the Archimedes calculator onto the iPaq handhelds after personal use indicated its potential value.

• There was no input from other staff members into the initiation of Archimedes.

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How it was integrated

• The system was not formally launched.

• Rapid implementation, not a gradual process/ no pilot phase. How it works in practice

• Staff Rota system identifies bleep holders who will attend carry the handhelds containing Archimedes calculator software.

Problems with integration

• Staff were unaware that the Archimedes calculator had become functional and was available for use.

• Most had never heard of Archimedes.

• Staff felt that the implementation of Archimedes was inadequate as it had not been formally introduced or promoted to staff.

• The Archimedes was not considered to have had any impact on staff.

• Staff did not feel that the Archimedes had any impact on staff organisation as they were not aware it existed. As such, there were no concomitant changes to practice.

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• Staff in general were unable to comment on the advantages and disadvantages of the system as they had no experience of using it.

• Staff recognised the need for a resource which would help to reduce dose calculation errors; however were unable to comment on the value of this particular system.

• The system was not integrated into the daily practice of staff.

• Staff were not able to recommend Archimedes to other hospitals as had no experience of using it.

• The senior consultant responsible for procuring the system felt it would help to reduce dose calculation errors.

• Upon retirement senior consultant responsible for Archimedes was passed to the replacement consultant- leaving the future of its usage uncertain.

Appendix 18: Electronic Prescribing - Site 4 Framework

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• The Electronic Prescribing (EP) system is for prescribing as well as administering medicines. It is a hospital information system which incorporates care plans, assessments, blood results, clinic/ hospital attendances as well as prescribing. Pharmacists’ interventions can be logged as well.

• The system is used for oral, IV and infusions of medicines. In emergency situations, information is usually entered retrospectively.

• All drugs (paediatric and adult) are available on the system. Paediatric drugs are restricted to paediatric areas, adult drugs are not restricted

• Drugs are searched by using common trade name or synonyms. They are selected on the first screen by typing the first 4-5 characters. This brings up a smaller list to select from. Drug must be selected by name, formulation and strength in most cases. The second screen is for entering dose, which has to be calculated by the prescriber for most drugs.

• Each drug has an associated monograph.

• Drugs are linked to routes i.e. drugs for oral use cannot be prescribed to be given by other routes e.g. IV and vice versa.

• Some drugs are set up with alerts when the maximum recommended dose or dose range is exceeded, but not all. These are set up as either warning alerts which can be overridden or prohibitive ones which prevent prescribing.

• Alerts are produced for conflicting allergy information and drug interactions.

• Computer access is controlled by a mnemonic and password; access to EP requires an additional PIN number.

In case of error

• A risk assessment is completed and sent to the governance department. Each incident/ error is discussed at the multidisciplinary Medical Practice Group.

In case of breakdown

• Planned down time - IT department print out the medicine charts directly to each ward printer (alphabetical order by ward name).

• Unplanned down time - a back up system which feeds to a separate PC in the out of hours cupboard is used to print out charts. Crashes are rare and of short duration; system is normally back before back up print out is needed.

• Prescribing is done manually and entered on the system afterwards.

• IT department is responsible for putting system back on line after down time.

• All staff received training on how to use the entire system.

• Nurses had a set two and a half hour session.

• Doctors are trained for an hour on the entire system of which half an hour is for EP.

• For dose calculations, more advanced training is arranged separately.

• Pharmacists are trained in-house.

• Locums are not trained if they are only working for <48 hours.

• There is no on-going training, but following non-major updates and changes to the system, e-mail messages are sent to inform all users. One to one training would be available on request if needed.

• For major changes all nurses would be retrained.

• There is no competency assessment for using the EP system. However, if there was a concern, trainers would withhold access to the live system.

• There was considerable resistance to change initially due to unfamiliarity with computers as well as the EP system; the paper system was considered to be quicker.

• Paediatrics and neonates were the last areas to go live with the EP system.

• EP system was initially used as a 3 month trial, but then policy decision was made at Trust level to continue using it.

• Dedicated trainers were employed by the Trust and were available 24 hours a day in the initial implementation phase.

• 5 people support the system: formulary, purchasing and stock control, medication administration record and clinical aspects.

• The IT system support is contracted out to an agency that is not managed by the Trust.

• There is a project managers group with representation for all modules of the hospital information system.

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• System is used in pre-admission clinics, anaesthetics and casualty for items likely to be continued on the ward.

• Initially each ward had 3 PCs; 2 laptops were added for ward rounds (1 for each team in case a ward was split into 2 teams).

• Drug trolley and laptop are taken to bedside for most drug administration, unless each room has a computer, but not for one off drugs.

• Medicines trolleys had not been adapted in any way due to cost issues.

• Initially wards had terminals, but now all have PCs. Laptops were a problem initially due to dropped wireless signals and battery related issues.

• Prescribing is formulary controlled i.e. doctors have access to ‘medical formulary’; nurses can only prescribe stat doses and drugs on PGDs (patient group directions) but cannot change or enter orders already placed; pharmacists have access to all drugs.

• Order sets have been developed for complex regimens e.g. TPN and routine schedules e.g. vaccination programme.

• Rules have been set up for some drugs to calculate infusion rates, weight based doses, default doses, dose rounding and to display dose ranges.

• Doctors can sign for administration, but cannot co-sign since the new version has been implemented.

• All drugs including oral ones had to be double signed initially, which proved to be a difficulty; this was later changed to double signing for IV drugs only.

• Changes to ‘take home prescriptions’ have to be made on the in-patient record as nurses use this to print sheet for patient.

• Initially nurses were very negative and it was difficult to gain the confidence of staff. Doctors were less resistant, as some had used the system in another area.

• At first, there were difficulties with administration times of drugs as they have to be specified by the prescriber, whereas previously the nurses could decide.

• Lack of set drug round times meant staff had to be trained to check the computer system at regular intervals to see if doses were due.

• Locums who had not been trained either prescribed on paper or asked a colleague to prescribe for them.

• Initially searching for the correct drug from the list was considered to be a problem, until staff became more familiar with system and drugs.

• Fewer devices were available initially, making it difficult to access the system for drug administration.

• Some staff felt there was no difference whether prescribing and administering on paper or electronically; other saw a greater need for precision and accuracy (e.g. timings of drugs, clear drug name).

• Staff felt supported and involved with the implementation and development.

• All staff would contact the lead pharmacist in case of suggestions for changes or improvements or if drugs were not on the system.

• For IT specific issues, e.g. laptop not working, system slowing down or crashing, staff would contact system support/ IT department.

• When implementing, project team cannot work in isolation - requires multidisciplinary commitment.

• GPs can dial into the system and are trained to enable this.

• All staff reported that there was no change in staff relationships as a result of the system. Some stated it was easier to get drugs prescribed as charts can be accessed from any location within the hospital.

• Each ward has an EP link person who acts as key trainer/ liaison.

• The Trust has a no blame culture and the directorate has a Risk Committee that looks at all errors.

• There is a 2 year developmental cycle for new and revised software, so requests that require external input may take longer. There is a user group for developments; the company is American.

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Advantages:

• Take home prescription turn around time is believed to be quicker.

• Prescriptions are more legible, complete and there is a clear audit trail.

• New laptops are better for taking to patient’s bedside, but the main problem with these laptops now is battery life.

Disadvantages:

• Other problems include ‘blindspots’ with wireless network and slowness of system at lunchtime (when anti-virus program is run)

• Printouts are small print and not very easy to read or understand.

• There is a potential for increasing errors due to erroneous drug selection either due to similar names or wrong selection of formulation/ salt form.

• Default dose values potentially introduce risk of error if prescriber accepts them without considering each case.

• Software change to include drug formulation and strength on display resulted in more administration errors. This had to be changed back.

• Double signing policy is to be reviewed again following review of errors.

• Cannot prescribe without hospital number which is a limitation for neonates where there is a lag before this is available.

• For certain drugs e.g. gentamicin once daily or variable dose insulin, paper charts are still used in conjunction with the EP system as the system does not meet the requirements.

• After the initial concerns, all staff generally preferred the electronic system as it was less messy, more informative and clearer; staff would prefer not to revert back to paper. However, some still believed paper chart was quicker and easier to look at.

• Clarity and completeness of prescriptions were seen as the main advantages for nurse administration. A clear audit trail increased awareness of accountability and was considered a benefit.

• Most staff highlighted dose ranges as one of the key areas for future development by all. A few would also like to see more dose calculation aids, especially as doses are weight based in paediatrics.

• Other developments include further integration of pathology results, integrated care pathways and improved clinical decision support.

• However, one doctor felt the system will get more complicated with increased decision support and that dose rounding would be inappropriate in neonates where there is a smaller margin of error.

• Key personnel involved with system development felt put off and restricted by lack of interest of some clinicians in developing decision support.

• The system was considered easy to use, especially as use was not restricted to prescribing. Dedicated trainers reported that doctors who were more familiar with computers tended to adapt more easily to using the EP system.

• It was easier to spot errors and highlight poor practice with the system compared to paper.

• Staff had mixed views about impact on dose calculation errors. Some felt the system was not set up optimally for this even though there were some alerts; others feel doctors can be trained to make dose calculations safer. Most would double check the dose calculated by the computer.

• A few saw it as a way of improving communication and recording of medicines.

• The monographs were considered easier to access detailed drug information.

• All users interviewed recommended the system to others.

• There are resource implications for training, equipment and developing rules, order sets and maintaining drug dictionary.

• Training regularly is expensive, but considered worthwhile as it provides training on how to use the system as well as procedures.

• Development of clinical rules and dose ranges is not considered a priority unless an actual error takes place.

• In-house order sets are resource intensive and need at least 2 people to check. Potential errors cannot be prevented pre-emptively due to lack of resources.

• Development of the system slowed following launch of National Programme for IT, but has resumed due to delays in national program.

• Dose ranging has been held back partly to await a national solution.

• Dose calculation raises mixed views, with concern for ‘spoon feeding’ junior doctors vs benefits for reducing errors.

• New version has potential for greater integration with other systems e.g. microbiology and pathology results, and with other care pathways, but this has not yet been done.

• EP is considered one part of the whole and requires a multidisciplinary team approach to ensure successful implementation. Implementation team should have management support, senior medical staff support and pharmacy department input.

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• Checking which drugs are due is considered time

consuming by a few nurses, as have to log in to each patient separately – cannot move from one patient to another. One doctor shares this perception of increased time for nurses.

• Pharmacists feel selection by formulation and strength informs and educates junior doctors.

• Pharmacists feel they save time and can check prescriptions more often. They are able to check prescriptions remotely, but still visit the wards on a daily basis.


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Human Perspectives

Health Care System/ Organisational context

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• Electronic prescribing (EP) system is a Trust-wide integrated system, which links pathology results, nursing care records, prescribing, administration and dispensing; medical notes are not included.

• Each in-patient episode is given a specific account number which can be used to retrieve information from previous admissions for up to 120 episodes. The data is then archived.

• EP system is used for most drugs including IVs. Paper charts are still used for insulin and other IV infusions, warfarin and drugs that are not on the system.

• A list of all the drugs and formulations is displayed, including non-formulary items. A second screen takes the user through the steps of prescribing i.e. dose, how often etc.

• Weight can be entered to help with dose calculation, but is not compulsory. There is an alert if weight or allergy information has not been entered, but no prompt to update a weight value after a given period.

• A rule has been set so that a given dose can be prescribed only up to nine times to prevent 10 fold dosing errors. Alerts for exceeded maximum dose appear for some drugs e.g. ibuprofen but not all. The system has not been set up to calculate doses for most drugs.

• System can be set up to restrict choice of route and to round doses to the most practical dose unit e.g. half tablet.

• There is an automatic lock out after a set period and a two hour window around the prescribed time, for drug administration. If this is exceeded, an alert appears, but can be overridden.

• For warfarin, system displays INR results with dose given.

• Each ward has at least two laptops which are for drug administration/ ward rounds in addition to PCs on the ward.

• The system can be accessed remotely from anywhere in the hospital. In case of error

• There is a process for ward managers to follow. Each error is recorded, relevant staff spoken to, and a formal letter written and placed in personnel file.

• Nurses making repeated errors would be retrained.

• System related errors are reported to pharmacy.

• All new staff are trained at induction; nurses for half an hour and doctors for 2 hours.

• Nurses were originally trained by the software company.

• The training session follows a set guide and there is competency assessment at the end. Those not considered competent have to be retrained.

• There is no refresher course or reassessment.

• Most nursing staff were positive about the system before it was implemented, but felt they had not been consulted about implementation.

• Nurses were initially concerned about the way in which the system would work as they felt the system was designed ‘the old fashioned way’ and there were no set drug rounds in paediatrics.

• Doctors were resistant initially and anaesthetists were concerned that it would be more time consuming.

• Staff thought the system would reduce errors and delays in prescribing.

• The system is part of the Trust’s information strategy and falls in with the national initiative for electronic prescribing.

• A steering group was set up to provide the strategic direction, the ultimate sanction of whether the project went ahead or not and the different phases. It included the chair of the drugs and therapeutics committee, consultants, pharmacy business manager, head of IT dept, systems managers, and project nurse.

• Beneath that there was an implementation group, which consisted of the project nurse, project pharmacy staff, IT, consultant and a junior (Not specified whether dr/ nurse).

• A modernisation board, chaired by the medical director, was set up to review processes e.g. doctors prescribing.

• There is a team of EP/hospital information system trainers. There are also departmental co-ordinators for each area that uses the system.

• Clinician interest and involvement was sought, but limited initially.

• EP system is used hospital wide and paediatrics was the last area to go live. It is not used in adult ICU, CCU, NICU and A&E.

• EP was intended to be at least as safe as paper. Initially started as a pilot with an implementation phase review.

• There is a need to ensure hardware is upgraded centrally by IT.

• The system is upgraded every 18 months.

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In case of breakdown

• Breakdowns are rare and of short duration. The back up system is a dedicated PC which records data every hour (system manager) OR quarter of an hour (pharmacist) and a printer in IT is used to produce printouts.

• It is the nurses’ responsibility to collect printouts in case of breakdown or planned downtime Paper printouts are filed in medical notes and the system updated that doses have been given/not given during downtime.

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• Different staff have different levels of access as set by the systems manager. Access levels can be set to view certain screens and certain drugs only – there are different views for nurses, doctors and pharmacists.

• Dieticians are able to prescribe enteral feeds from a specific list.

• Staff can log in using a pin code and 7-9 character password. Then they select a patient using name, hospital number or location.

• Drugs can be selected individually or as order sets (a series of drugs/doses that have been pre-entered based on protocol) by typing in the first few letters of the name. Drugs and order sets can be restricted by location, user group e.g. prescriber grade or individual user e.g. named consultant.

• Doctors are responsible for allergy and weight information entry.

• Medication can only be prescribed if the patient has been admitted unless they have been ‘pre-in’d. However the prescribing process is slightly different to normal and in most cases, prescribing is done on the ward. Facility to ‘pre-in’ helps deal with patients coming from A&E. It is logged into the system that the child has been admitted and when they get to the ward the nurse on the ward has to log in to say they have been admitted.

• Doctors prescribe by formulation. Pharmacy report the first one in the alphabetical list often the most prescribed formulation..

• Nurses draw up the dose, and take it to the bedside with the laptop. Both checkers have to log-in to indicate double check.

• Set drug rounds were introduced, in addition to ad hoc rounds, on the surgical paediatric ward to enable using the laptop with the drug trolley when administering drugs.


• There were initial problems with logistics of taking laptop + drug trolley especially for bulky items/ CDs that are not stored in the trolley and IV drugs.

• There was an initial problem with number of terminals as everyone is trying to use/ access system and therefore pharmacists would preferentially review charts off the ward.

• Some decision support is available, but not fully based on experience from other hospitals which use the system e.g. need to enter number of days for antibiotics

• Nurses found EP more time consuming than paper charts and had to find alternative ways of working to deal with this.

• The system required a change in medicines administration processes in some areas: double checking of all drugs not just IVs; night staff started doing morning drugs; 2 nurses are allocated to do drugs on the EP system rather than the named nurse.

• The doctors needed to change their approach to prescribing to consider which formulation as well as which drug to prescribe.

• Initially staff felt scared, frustrated and not very confident with using the system.

• A multi-disciplinary group which is led by clinicians and includes IT and pharmacy is needed when implementing such a system.

• The change process, rather than the actual software was perceived to be the bigger factor in implementation.

• Changes in practice had to be made as a direct result of EP e.g. double checking.

• Pharmacy staff set up and maintain the drug dictionaries, and therefore the EP system is perceived to be a pharmacy system.

• Order sets have to be agreed by the clinical director and are expected to be evidence based.

• IT department maintains a doctors register, provides daytime system support and an on-call service out of hours.

• Planned downtime for 18 monthly updates or 3 monthly generator tests are scheduled around use of the system and are carried out at night or in the early hours when minimal drugs are given.

• Responsibility for training Doctors was transferred from IT department to nurses following review of questions that arose during training sessions.

• Mixed views on impact on staff-staff and staff-patient relationships as a result of the EP system: there is a feeling of increased phone contact with pharmacy; frustration from nurses due to drugs not being prescribed in A&E; more tense between staff and management or pharmacy.

• Ideas for improvement get forwarded to the ward pharmacist, EP nurse or the implementation team. There is a ‘wish list’ which is prioritised (it is not clear who by). These can be paid for as bespoke, or as an all UK users enhancement.

• Some departments have informal user groups to discuss issues with the system.

• Implementation of the EP system was seen to result in the loss of the ‘fast-track’ discharge system.

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Advantages

• Advantages include clear legible prescriptions, an audit trail for all stages in the medicines use process, no transcription errors, complete and accurate records for prescribing and administration (no gaps).

• Audit trail particularly useful when investigating medication errors and complaints.

• Quick way of prescribing several drugs if using order sets.

• Remote access is a benefit as users can see a chart from any device within the Trust.

• Enables policy enforcement e.g. double checking.

• Drug list is a good way of knowing ward stock and formulary drugs.

• Drug specific guidelines presented as alerts or monographs are useful for nurses and doctors.

• Process of ‘prescribing’ discharge medication is quicker as doctor is only required flag the items that are needed on discharge.

Disadvantages

• More time-consuming for nurses and doctors compared to paper system.

• Continued use of paper for certain drugs and in certain areas causes confusion and potential for error e.g. dose omissions and duplications; missing items when reviewing remotely.

• Delays occur when prescribing medication for patients transferred from areas that do not have EP e.g. A&E, ICUs or if doctors do not have access e.g. locums, following consults from other sites.

• Different access levels for users causes problems as there may be differences in the information each professional group can view e.g. information on patient’s weight not entered all the time and is displayed in several places, often not available to all users due to access limits.

• Drug restrictions can be a problem e.g. if order sets are location specific, they are not available to prescribe when the patient transfers to another location.

• Difficult to set alerts for high and low doses based on drug formulation as extremes are often used in paediatrics.

• There are insufficient PCs/ laptops, poor wireless connections and laptops slower than PCs.

• There appears to be a lag time between entering patient on the system and actually being available for prescribing.

• Discharge prescription cannot be processed if the patient is discharged from the system.

• Certain complicated prescriptions e.g. reducing doses cannot be done.

• Log on procedure and reviewing drugs can be time consuming and so system is often not used on ward rounds.

• Need to go through several screens to see when the last dose was given.

• Doctors are no longer able to initiate prescriptions in clinic for patients being admitted.

• Laptops freeze and lock out often and battery life is an issue.

• A lot of staff feel the EP system has not met their expectations.

• All staff found the system difficult to use initially and felt that the training alone was not sufficient to learn the system. Using the system regularly and learning from others was more helpful.

• Most doctors and nurses like the principle of EP and can see many advantages, but do not like the system they have as it is ‘old’, time consuming, inflexible, does not dose check and does not alert to duplicate prescribing, allergy-drug and drug-drug interactions.

• Some doctors consider having more clinical decision support e.g. dose calculation would deskill them.

• Most staff would prefer weight entry to be a compulsory field and to be displayed in a central location.

• Some doctors perceive prescribing by formulation a useful way of learning about different strengths and formulations of drugs; one felt they learnt less about drugs as a result of the electronic system.

• Anaesthetists consider the doctors role to prescribe the drug by name only and the ‘specialist nurse’ to select the actual formulation.

• Staff do not think it has any impact on medication errors, and is no different to the paper system in terms of errors.

• Staff perceive there is potential for error reduction if appropriate systems are put in place.

• A few consider the alerts within system not very effective as they can be overridden.

• Nurses believe discharge prescriptions would be produced quicker using the system, but this is not evident since they are not done until the end of the day

• There was a feeling of reduced contact between patients and staff as nurses were looking at and entering information into the computer rather than facing the patient (on the ward and in theatres recovery).

• Doctors felt pressured as they could not use locums to cover them in case of absence, since locums had no training or access to EP. ).

• Most would not recommend this particular system to other users, but would recommend a ‘good’ EP system.

• The initial cost of implementation was estimated to be approximately £250,000-£300,000. On-going costs need to be factored in for hardware, training, EP project team.

• It is an American system so improvements take time as there are only 3 UK customers.

• Future plans from a pharmacy perspective include consideration of a closed medication system using barcode technology; revising the use of EP system to facilitate quicker discharge of short stay patients; recording interventions within the system.

• Time, effort and resource are cited as factors that affect having more decision support.


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Technical Detail

• PCIS (Patient Care Information System) is the electronic prescribing system used at this hospital

• PCIS has a lot of design and safety features built into the system. In the hospital it can be accessed using one of two terminals on each ward. No laptops are taken on ward rounds.

• It contains a Paediatric Common Drugs List that was developed in collaboration with pharmacy and IT. This is integrated in the Paediatric Pathways where once the doctor has selected the age or weight and drug the calculations are done for that patient.

• It offers unique intelligence for a small range of medicines that are on the Paediatric Common Drugs List. If a medicine is not already in the system, then little guidance is available on how to prescribe it for children.

• Doses can be given in accordance with the child’s size or age (injection doses given in mg/kg and oral medications doses given in terms of age).

• Information and recommendations for PCIS are determined either by licensed dosing recommendation or common paediatric practice; these recommendations are signed off by the Clinical Director and agreed on by nursing management.

• The recommendations are pre-programmed into the system, but if an alteration is necessary or a different protocol is preferred, changes can be made to the software.

• PCIS also has a free type facility where the prescriber can choose a drug from a Main Menu type in all the required information without going through the Paediatric Common Drugs List and Paediatric Pathways. However, when not going through the pathways, there is no decision support or dose calculation facility. Prescribers must ensure correct medication by verification using the BNF-C or other sources.

• The Paediatric Pathways also provide information on accompanying fluids given for IVs so that there are no problems with compatibility of solvents

• Paediatric Pathways also tailors the dosing frequency to suit children, so the child does not have to be woken up to take the medication

• If the medication required is not on the Paediatric Common Drug List nor on the Main Menu, then the prescriber can type it out, but this rarely occurs.

• PCIS is not used for IV infusions or continuous IV infusions which are usually charted on paper

• Staff are given a few orientation sessions and then practice using the system for 2 weeks

• There is a 2 week induction programme during which 3 PCIS training sessions were given. Then the doctors spend time on the wards shadowing other experienced doctors and eventually prescribing under supervision.

• In paediatrics, the pharmacist talks newcomers through using PCIS to prescribe for children using the Paediatric Pathways

• Paediatric pharmacist presents doctors with a monthly review of all the medication errors so that they are aware of the common mistakes

• Some staff say it was very difficult to learn and the training was very complicated at first

• Any new staff are sent on courses and have training days allocated to them; most learn the system very quickly, especially the younger generations

• There was some resistance when the system was first introduced because the hospital was the first in the country to have electronic prescribing

• PCIS was the first electronic prescribing system to be introduced in the country. The technology was developed in the 1970s

• Prior to this, doctors had to do their own calculations leading to a potential in calculation errors. Also, results of calculations may not be practical (eg. 4.25ml or 9.5mg of a 10mg tablet).

• Paediatricians, pharmacists and IT department convened to develop the paediatric pathway.

• The pathway was first developed for 12-14 drugs and went live in 2000. It was audited initially, then constantly updated to the current version of over 20 drugs which cover about 80% of drugs prescribed to children.

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• After charting a prescription it cannot be amended because the system understands that a medicine is charted after it is already given.

• The system provides full access to patient’s pathology and lab results as well as information of previous admissions and pharmacist notes

• Results are printed off every day and filed in the patient’s notes Errors/breakdown

• If the system crashes there are paper prescribing sheets that can be used. Staff print out the ‘Down Time Pack’ that contains the latest 24-hour drug list and the updated pharmacy sheet showing prescriptions for that day.

• System rarely crashes, not more than once a year; there was a very bad crash 3-4 years ago where the whole system was down for 2-3 days and the prescribing module was down for 2 weeks.

• System goes off (down time) for one hour every night to do its updates. All staff are always made aware of this so they can make provisions.

• There was one crash that lasted days and staff had to go back to paper prescribing, and doctors who had been used to PCIS for very long had a lot of difficulty

• After the crash, the system prints out everything so staff are overwhelmed with printouts that have to be filed and sorted out. Also staff had to enter all that was done and the backlog of prescriptions, which was very time consuming

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How it worked

• All members of staff must use the electronic prescribing system

• If prescribing through the Paediatric Pathways, the prescriber identifies the drug, and enters the size of the patient. Then the computer will guide prescriber to determine the appropriate drug and dose. Prescribers do not have to do any calculations and minimal decisions.

• Paediatric Pathways do not account for uncommon illnesses that may require different dosing regimes. Doctors must revert to free typing to prescribe doses that are not within the normal range

• When not prescribing through the Paediatric Pathways, it does not offer any decision support or reaction to data that is inputted.

• PCIS gives alerts when blood levels are due. It also alerts prescribers of allergies when the patient’s details are entered, but it still allows the doctor to prescribe a drug that the patient is allergic to.

• PCIS allows for changing frequency of doses (eg. once daily to twice daily) by clicking an option instead of having to rewrite a new prescription

• Nurses have access to the prescriptions and lab results, and can only prescribe stat doses of paracetamol and ibuprofen, but they can’t prescribe standard drugs or change drugs that are prescribed. They can also prescribe saline flush and nebulisers.

• Nurses also have access to care plans and admissions details, including allergies. They can see lab results, X-rays, ultrasounds, etc. Different level nurses can request various lab tests. Nurses do not have access to the doctors’ screens

• There are different levels of access dPCISending on grade and profession

• In an emergency, drugs are not prescribed by PCIS. They are given as needed, then written up and documented on PCIS at a later stage

• For IV drugs, they could be given either in a minibag or as a bolus

• Two paediatric pharmacists verify all orders for all patients on a daily basis and print out a care plan that would be used for all patient-related interventions

• The printed care plans are available at the end of every patient’s bed, and are updated daily with the patient’s drugs and doses. There is also a printout of ‘7 Day Meds’ which is the medication received by the patient in the past 7 days. ‘Drug Due’ lists are also printed out to show the specific times that drugs are due as well as a 24-hour ‘Drugs Given’ list. All of those printouts are placed in a folder at the patient’s bedside.

• Printed sheets can sometimes be more difficult to read than hand-written ones, because hand written sheets are easy to follow and understand. Printouts cover so much information that it is difficult to read and understand sometimes.

• After getting used to the system, staff did not want to go back to paper prescribing

• After some training staff found the use of PCIS quite straightforward and had no problem with it

• Many doctors who have only been trained at this hospital have no experience in completing a paper prescription chart

• Staff can opt out of using the Paediatric Pathways if they prefer but if they do, they are not informed of changes and alterations in recommendations so they do not benefit from new and alternative ways of medicating children

• There was no noticeable increase in errors when new members started (this was staff opinion, and no audit was done)

• Sometimes junior doctors are more confident in prescribing than senior doctors because they have more practice since they are usually told to write the prescriptions by their seniors

• Some doctors found it difficult to taper doses and make constant changes using the PCIS

• Although Paediatric Pathways are very useful, many clinicians require the flexibility to deviate from the pathways and have more clinical freedom. As long as they are given an option to deviate, they are happy with using the PCIS and pathways.

• After getting used to the system, staff did not want to go back to paper prescribing

• Pharmacists and staff did not have to contact the doctors to determine if certain lab results were ordered, because everything is on the system. This helps to decrease distraction of doctors and staff.

• The Paediatric Pathways rounds calculations to most practical doses to be given. However if non-paediatric pharmacists who are unaware of this check the doses, they sometimes see rounded dose as an error and might call the doctors to change the dose. This causes some friction particularly if they call a junior doctor who complies, then is told by superiors that the original dose was correct.

• Consultants usually instruct the SHOs or junior doctors to prescribe so they do not use the PCIS as often

• It is pharmacy’s responsibility to update the Paediatric Common Drugs List

• Pharmacists are always on the wards asking doctors and nurses for reasons why a patient is not on recommended doses

• Although nurses cannot prescribe, they are comfortable to approach doctors when a prescription is inappropriate and ask the doctor to change it

• Sometimes nurses get annoyed when non-paediatricians make so many mistakes while prescribing

• Increased communication between doctors and nurses is essential, especially when doctors make changes to a patient’s medications. The nurses must be made aware because they might still be using an older printout for their careplans.

• Some doctors believe that junior doctors should only be prescribing drugs on the Paediatric Common

• Drugs list. Anything not on the list should only be prescribed by a paediatrician or paediatric pharmacist.

• If there are any changes in guidelines, the paediatric team must inform the electronic prescribing pharmacist to change it on the Paediatric Pathways

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• When a child is admitted from A&E where PCIS is not used, all drugs are recorded on paper. Thus there may be no record of the drugs they received on the ward or even if they were in surgery, if doctors only refer to the PCIS for their drug history.

• PCIS is not used for IV infusions. They are written on a blue sheet that goes at the end of the bed.

• Two nurses check the prescription on PCIS, ensure that the drug was not already given, and then administer it. Only the nurse who administered the drug signs, PCIS does not have the facility for both nurses to sign.

• PCIS is only used for in-patients, not for out-patients

integration

• Member of staff is currently employed to input new drugs into the system and make necessary modifications

• The system was designed based on the knowledge that doctors are very good at diagnosing and selecting appropriate medication, but make more errors when defining times of administration and dosing for children; so PCIS makes those decisions for them.

• The Paediatric Common Drugs List and Paediatric Pathways was developed after many many medication errors were found with paediatrics. It was very time consuming to develop this list, it was mainly developed by pharmacy.

• Updating the Paediatric Pathways is very labour intensive and updates can sometimes pile up. Even simple changes require a lot of work and man-hours. Most updates can be done locally and do not need to be sent back to software manufacturers

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Advantages

• When the system crashed a few years ago and paper based prescriptions were written, many errors were found, highlighting the number of errors that PCIS has the potential to avoid. (may also be a result of deskilling, particularly junior doctors)

• Nurses find that a big advantage with electronic prescriptions is that they are legible. Also, they contain all the patient’s information including demographics, allergies and ward identifiers.

• It was described as a good communication tool

• It is very useful for audit trail and contains full electronic data archived for all entries, prescriptions and responses.

• It reduces risk of calculation errors because it provides doctors with formulas for calculating doses

• It reduces risk of dosing error because suggestions for drugs and doses are listed on the screen

• When using the Paediatric Common Drugs List, the doctor must enter the age or weight and it calculates the dose automatically, rounding it to the most practical figure

• When Paediatric Pathways was initially started, an audit showed that the number of prescribing errors decreased dramatically.

Disadvantages

• PCIS gives doses based on the child’s weight but sometimes when a child is admitted, their weight is guessed and the medication is prescribed according to an inaccurate weight.

• PCIS might give a false sense of security where if a prescriber sees something on a computer then they believe that it is right. Eg: if a drug was discontinued but still on the software it can be prescribed.

• When prescribing on paper staff is more inclined to look for supporting material such as the BNF, but with PCIS they automatically assume that the research has already been done for them and if it was not appropriate or safe then it would not have been available as an option.

• The current PCIS system does not allow interaction with the BNF-C and is not fully compatible with Windows Applications

• It is unable to upload a drug dictionary into the system because it is not a Windows Application

• The system does not readily enable a changing schedule and continuous charting of infused fluid volume which are essential for continuous infusion.

• After charting a prescription it cannot be amended because the system understands that a medicine is charted after it is already given. This is usually the case unless giving a continuous infusion where regular charting and alteration of medication is sometimes required.

How it affected staff

• Although PCIS allows pharmacists to view and check prescriptions remotely, the pharmacists prefer to go on the wards and see the patients before looking at the prescriptions electronically.

• Many doctors who have been using PCIS for a very long time would not know what to do if the system crashes

• The system produces a lot of print outs and paper work that is updated daily by a team coordinator.

• Since terminals can be very busy, nurses tend to stagger their timing so that they don’t all go to the computer at the same time to print out their care plans

• Staff worry about how the system will cope with the changing hospital environment; they feel that a more updated version might be more useful although they have reservations about relearning a new system

• Sometimes if doctors forget to write that a medication is given PRN, then staff can waste a lot of time looking for it on printouts and not realise that it was not used.

• Since there are no laptops, during ward rounds every time PCIS is needed one of the two SHOs on the round goes to the terminal to enter prescription or retrieve information. SHOs alternate on going, and the SHO at the terminal misses a part of the ward round.

• The Chief Pharmacist presents the doctors with a monthly list of medication errors that have occurred

• The Paediatric Pathways is usually the first port of call when prescribing for paediatrics, particularly by junior doctors

• If not using the Paediatric Pathways, doctors usually look up doses in the BNF prior to prescribing and are more careful with calculations

• Some non-paediatricians are unaware of the Paediatric Pathways and prescribe from the Main Menu making many errors that are usually caught by nurses

• The system only informs staff of allergies when the patient’s details are entered, and most doctors don’t see the warning because they are in a rush. If they do prescribe a drug that the patient is allergic to and they are not using the Paediatric Pathway, then there is no decision support and so PCIS allows it, which may lead to serious allergic reaction.

• Although the system is outdated, it was decided not to invest major resources in updating it. An alternative supplier and possibly more dated PCIS system might be installed in a few years instead.

• Staff would recommend the system to others; many would recommend a newer or more updated version

• Staff hope that in the future they will have a terminal at every bedside.

• Since the system is old and very basic, it is easy to follow that the system is doing. There are concerns that a newer system may be more complicated leading to problems understanding why certain things were happening (eg mysterious calculations, etc)

• The hospital got recognition in the Harrogate IT conference for the work that they did on the Paediatric Pathways

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• There is increased error when new doctors come in who have never worked with PCIS. Because they don’t understand the system and what they type in does not get translated back to them, many of their prescriptions don’t make sense and are not what they intended.

• There is increased error when the systems go down and doctors have to revert to paper based systems, but staff say that the system rarely goes down and many cannot remember the last crash

• Problems arise when locums work because they don’t have access to PCIS, so they have to get the registrar or SHO to prescribe, making the registrar or SHO ultimately responsible. Even with locums, paper prescribing is not used

• Errors can occur using the drop down menus by accidentally clicking on the wrong drug or dose or selecting the wrong patient

• Errors can occur if using the Main Menu and doctors have not verified their drug and calculations by using a BNF and double checking

• There are too many printouts at the patient’s bedside and organising them is very time consuming.

• If some printouts are missing or not complete at the bedside it may lead to problems because they are used a lot by doctors and nurses.

• Nurses usually print out the medication to be taken during a particular period, and follow that printout. If there is any change in medication during that time, the nurse could be unaware of it

• Nurses usually print out the medication to be taken during a particular period, and follow that printout. If there is any change in medication during that time, the nurse could be unaware of it

• After one crash that lasted a few days, the system printed out the backlog of lists so nurses were overwhelmed with printouts that had to be filed and sorted out. Also staff had to enter all that was done and the backlog of prescriptions, which was very time consuming.

• There are only 2 PC terminals and they can get very busy because doctors use the system to prescribe and nurses use it to do care plans

• Increased potential for error if the terminals are very busy after a drug is administered and the nurse does not have a chance to sign that the drug was given. It could be assumed that the patient did not receive the medication and they are given a second dose.

• PCIS prescribing is much slower but still had its advantages; nurses found that pharmacists take longer to have ‘take home’ drugs ready

• When not using the Paediatric Pathways system, there is no decision support and the PCIS will allow the doctor to prescribe anything regardless of dosing limits and medication errors. Thus non-paediatric doctors or junior doctors are more prone to make errors.

• Some of the screens and drug menus need to be updated; and updates are very labour intensive

• If a patient has an allergy, the Paediatric Pathways informs the doctor, but if the doctor does not notice and prescribes the drug anyway, there are no alerts to stop the drug from being prescribed

• Doctors who do not normally prescribe for paediatrics tend to forget about the Paediatric Pathways

• Nurses have sometimes administered a drug and forgotten to sign it in because they were too busy. Everything is also written in the Cardex as well.

• If a doctor prescribes a tablet for a child who is too young to take tablets, nurses would sometimes give the syrup without informing the doctor. They have to be careful that the prescription is changed for the take home medication, however.

• There are worries about deskilling staff by decreasing the calculations that they are required to do. However prior to introduction of Paediatric Pathways there was a large amount of calculation errors as well. Also, to avoid deskilling, although the system always presents the calculations it has performed so that the prescriber can follow the logic.

Appendix 21: CareVue - Site 7 Framework

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Technical Detail

• Described as a prescription chart on a computer.

• All information pertaining to the patients is stored electronically for 99 days after discharge. Then, the information is electronically archived for 5 years and can be accessed on the web-based portal.

• CareVue has an interface with pathology systems (microbiology/haematology/TPN) so that all pathology lab results automatically appear in CareVue; this also applies with ventilators providing the patient’s vitals such as heart rate, respiratory rate, fluid input and output (no need to enter any of this manually).

• Observations and results are usually updated on the system every hour but can be updated every 5 minutes during emergencies.

• All drugs on the monograph are programmed into CareVue and updated every 12-18 months to include new drugs or drugs used in emergencies. However, it is not necessary to wait for the yearly update in order to add new drugs.

• There is a terminal at pharmacy where all the patients’ information and records can be accessed.

• The only limit set is for babies weighing over 6 kg, so smaller babies do not have an inbuilt warning system if overdosed.

• It has no decision support, it does not tell the user how to make up drugs but it rounds doses to more practical figures. If the dose surpasses the 6kg limit, it gives an error message. Therefore it would stop most errors involving misplaced decimals leading to tenfold or 100-fold overdose.

• The system asks for mandatory admissions information that must be entered, or else it won’t allow the user to move to the next screen.

• It only gives advice on how to make up and run infusions, it gives no advice on dosing standard drugs.

• It has a separate calculator that can be used but it does not do the calculations for standard medications, nurses must know how to do the calculations; calculations are done for infusions.

• It does not have alerts to check levels or look out for side effects/contraindications.

Errors/breakdown

• It rarely breaks down; there was a phase during first 6-9 months where system went down a few times, but no problems since then.

• If there is a breakdown, IT is very supportive and are available 24/7. There is always someone on call at any time of the day, any day of the week.

• If there is a problem that IT cannot fix, they contact the manufacturers Phillips

• Most of the training is given by IT and staff are given exercises, so that they know how to prescribe different types of drugs in different ways.

• Doctors were being trained for 1-2 days, but claim that they learned most when they were working on the system. There is specific training on how to prescribe using the system.

• After training sessions, they were formally assessed and received feedback.

• Many were confident after training although they were more comfortable with a nurse watching them the first few times.

• The IT department was very helpful in setting up induction courses for every new doctor. They also offer refresher sessions for any member of staff who needs retraining.

• Every time there is a change of rotation, doctors are sent to IT for induction.

• IT also provided out of hours training and emergency passwords to locums on short notice.

• Nurses were trained for 2-3 hours by IT with ongoing in house training afterwards.

• Members of staff who are more experienced offer continuous help to those who are new to the system.

• If staff fail the assessments or are constantly making mistakes they get sent back for retraining.

• There is a training module available that is not live and staff can practice on it whenever they have some time.

• There was mixed reaction from staff when CareVue was first introduced; some were suspicious nobody was overtly resistant. Most were enthusiastic about new technology.

• Many were apprehensive regarding computer literacy and typing skills. They found computers daunting and felt safer using paper.

• The entire system went live at the same time.

• A project manager, a consultant neonatologists, pharmacy, and IT were all involved in the introduction of the system.

• They went as a group, visiting other sites and going through the tendering processes to find a system that could be implemented in the critical care setting.

• The chief executive of the Trust was very supportive of CareVue introduction.

• Clinicians were involved in very early stages of implementation.

• The neonatal unit was pushed first because it already had a monograph so it would have been easier to implement CareVue.

• The system was not introduced due to a specific incident. It was seen as a long term investment and a move towards electronic prescribing.

• The CareVue Classic version being used in the hospital will be terminated in 2008, and staff are unsure whether they will consider other systems first or if they will obtain a CareVue upgrade.

• If the Trust move to an electronic prescribing system, staff would like it to be compatible with CareVue.

• Staff feel that CareVue is sustainable within the trust and they have become very dependent on it.

• Since implementation, the hospital has been receiving free updates and patches from CareVue, but they pay a supporting fee to Phillips.

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• Paper backups are available but they have not had to resort to this. All pathology and vitals can be accessed through another system, so all that would be lost is the monitoring and prescription charts that are backed up and could be printed

• IT sometimes runs checks on the system and warns staff that it will be down for a couple of hours, but this does not cause too much disruption.

• CareVue has RAID (Redundant Array of Independent Discs) meaning that it works on paired servers, so if one server goes down the other can take over.

• These servers are specific to CareVue so they are unaffected by the rest of the hospital.

• Every night a nightly backup tape is made.

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How it worked

• Only doctors are able to prescribe, nurses are unable to prescribe on the system and different grade nurses have different levels of access. Prescribing and accessibility rights are determined by the passwords used.

• Locums are not given passwords unless they come in regularly, so doctors have to prescribe for them.

• Nurses check everything that is being prescribed and go on wards to administer and double check the medication. Two nurses have to sign electronically when checking.

• Prescriber follows a flow sheet depending on the patient’s weight, then goes to the prescribing module to choose the medication. All drugs are listed on the right hand side of the screen and the prescriber must choose the drug needed and enter dosage.

• Prescriber must choose the medication on CareVue, then must choose the route and give the dose and frequency which can be chosen from a menu. CareVue does not do calculations for standard medications, so the doctor has to calculate the dose, then prescribe. There is also a box for additional/special instructions available; then the prescriber signs electronically and enters the password.

• There is a dose calculator for infusions to help determine the dosing interval. It remembers the baby’s weight and if a dose is chosen, it will calculate the volume and rate needed. This is not done for standard medication, only infusions.

• If a patient is given a drug that is not in the system, and probably will never be used again, it is prescribed on paper; this is very rare.

• If prescriber wants to give a loading dose and maintenance dose, two separate prescriptions must be written.

• When patients are discharged to post-natal ward where CareVue isn’t used, they go back to using paper prescriptions.

• Information is accessed either online through the web-based portal or by pulling out the archived information retrospectively for audits and studies.

• Any change in configuration or addition of drugs is carried out by IT.

• The system has a form-based interface for discharge letters which is much quicker than the paper forms that sometimes take days to be sent out.

• Information in the last 24 hours of the patient’s stay are printed out along with special instructions and trends to help with discharge or moving to another ward.

• Older staff were more resistant to change and found computers very daunting.

• It was awkward at first but after they were accustomed to it most staff found CareVue indispensable.

• Four nurses had extra training and were experts at the system, so others can come to them for help. Also, more approachable nurses were identified and approached for help at anytime.

• Nurses used to worry about using the system but are much more comfortable with it now.

• To make staff more comfortable, the paper system continued to run when CareVue was introduced, but staff took to CareVue and discontinued the paper system after ten days.

• Nurses do not prescribe on CareVue but they will question a doctor if they believe that the dose prescribed is inappropriate.

• IT are constantly checking the system to ensure that it is running efficiently.

• Staff found that looking up information using CareVue was much more efficient than looking through papers and documents.

• When it was first introduced, doctors who were rushed neglected to enter all patient details when prescribing on CareVue. To avoid this, certain fields became mandatory to complete, and the computer would not go on to the next screen unless the information was entered.

• Staff were given a questionnaire prior to introduction and many expressed worries about using a computer-based system, then they repeated the questionnaire after introduction and found they were very comfortable with using the system.

• The IT department was essential to the introduction and implementation of the system.

• Pharmacists are able to check the system remotely before attending ward rounds with doctors, and they are better prepared to discuss patients’ medications and make changes.

• Nurses do not prescribe on CareVue but they are willing to challenge prescribers if an inappropriate medication is given.

• There is no standardised approach from different Trusts in implementation of electronic systems. If developments were more compatible it would be possible for them to form links with each other. This is impossible because each Trust has different priorities for its funding.

• Prior to CareVue, there was some tension between doctors and nurses due to missing/misplaced prescription charts and paperwork. These tensions have dissipated with electronic availability of information.

• Cooperation of staff was essential for successful implementation.

• CareVue heightened Trust approach to medicines management.

• Becoming a reference site gave the hospital a higher status worldwide.

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How system became functional

• When it first started, staff had to do both electronic and paper charting, but after ten days they decided to go fully electronic.

• IT support was crucial to the success of CareVue implementation.

• CareVue was designed specific to the needs of the hospital.

• Development of a monograph was very useful to CareVue implementation because they already had a protocol for all the commonly used drugs on the ward.

• If a new drug was to be added to the prescribing module, the pharmacists must complete a form providing the drug brand and generic name, doses, upper and lower limits, side effects, and other details. This form must be signed off by IT before entering into the system.

• Flow sheets were created specific to the neonatal unit. They were based on the paper charts with modifications to improve on the charts. Then the prescribing module was configured separately from the rest of the system based on the neonatal monograph.


• The prescribing module went live after the system was launched because it was too big. So staff had to use both electronic and paper charting for about 6 months.

• There were many problems with interfacing software and compatibility.

• Setting up the prescribing module was very time consuming although it was made much easier due to the presence of a monograph; it would be impossible to programme in the entire BNF.

• There were a few initial problems when switching the network from cable to fibre connections, as well as setting up the dual servers (RAID) but they have all been solved now.

• When the computers were upgraded to Windows XP, CareVue was not compatible.

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Advantages

• The prescribing module features make CareVue most applicable in the critical care environment.

• It can be seen as a starting point for electronic prescribing, allowing the hospital to prepare and foresee any problems that might arise when EP is introduced.

• CareVue is easiest to apply in neonates because of the limited variety of drugs. Also, since CareVue does not have the facility to prescribe inhalers, neonatal ward is most applicable because inhalers cannot be given to these patients.

• Prescribing is quick and efficient using the prescribing module, although prescriber still has to calculate dosages for standard drugs.

• Medications are listed specific to route of administration so prescribers don’t have to look up available routes.

• CareVue does not allow more than 1 decimal place, reducing calculation errors.

• With infusions, standardised infusion strengths are used making calculations much easier and reducing error. It also calculates dosing intervals for infusions reducing calculation errors; one interviewee said that there have been no calculation errors with infusions since CareVue.

• It is useful when running audits because all the information is archived electronically. Vital data, medications and fluids are easily available and trends can be drawn at the click of a button.

• Vitals are updated at least hourly so if something goes wrong, doctors are able to look back for trends and determine what was happening prior to the event. Also in emergencies vitals can be updated every 5 minutes so similarly doctors are able to continually assess the patient’s condition during the course of resuscitation.

• It helps to resolve litigations easily because the information retrieved is of good quality and easily accessible.

• It eliminates paper-based work hence the clutter and potential for misplacement of information. Also, it is easier to look up information rather than sifting through written notes making research and audits much easier.

• It enhances privacy and patient confidentiality since prescription charts are not easily accessible.

• It creates a more calm environment which is better for the patient and parents.

• The hospital was considered a reference site for CareVue and was visited by people from all over the world to observe the system and implement it in their own hospitals.

• After discharge, GP notification is much quicker as well, occurring within hours instead of days.


• Staff have a better idea of what to expect from an electronic prescribing system.

• Staff received a lot of support from IT who provided a 24 hour service and full training. Implementation and transition would not have been possible without their support.

• If staff are not trained properly there may be more potential for error.

• Many members of staff dread the thought of returning to a paper based system.

• Nurses have more limited access than doctors. Different levels of nurses have different levels of access.

• Doctors use it on their ward rounds to prescribe medications.

• Clinical pharmacists can check the system from pharmacy before joining the ward rounds, thus they can prepare any questions or points that they want to bring up at the ward round. They are also able to make notes on the system that can be discussed with doctors during the rounds.

• Since CareVue is less time consuming, nurses can give more attention to the patients.

• Staff feel supported by CareVue, not threatened by it. It allows them to recognise potential problems with patients much earlier.

• Although staff would like CareVue to do more calculations, they believe that it should only be used as a third checker and they must double check their work as well.

• There are worries about deskilling staff due to infusion calculations and trusting CareVue too much

• Tension between nurses and doctors is decreased because charts do not get lost or misplaced so all staff can concentrate more on the patient.

Quality of service

• It saves staff a lot of time and allows them to work more efficiently and provide better care for the patient.

• Staff rely greatly on CareVue and find it essential for their work. They are very happy with it, although they all agree that the prescribing module could be better.

• The new version of CareVue will have a CarePlan installed which staff are very excited about

• Staff would like to keep CareVue even if electronic prescribing is introduced. There was a suggestion to eliminate the prescribing module but keep remaining aspects of CareVue..

• Staff feel that CareVue has a lot of potential and can be developed further. There are facilities that have not been utilised to their full potential.

• The hospital was very active in giving suggestions for the newer version of CareVue.

• It is recommended to other hospitals as a patient information system, more than a prescribing system.

• After introducing CareVue it would be easier to introduce electronic prescribing systems in the hospital.

• Some suggest the system be taught to student pharmacists so that they are familiar with it prior to working.

• The new version is much better and has a full BNF interface and many options that are not available in the CareVue Classic. It will cost £253,000. CareVue Classic had cost them £500,000.

• CareVue has been very helpful during litigations because good quality data was retrieved very easily and the cases were dropped quickly.

• CareVue Classic is recommended for small wards with limited variety of medication, however the newer version may be more universally compatible.

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• Discharge summaries can be completed online and updated daily so when the patient is finally discharged most of the paperwork is already completed.

Disadvantages

• The hospital had an old version of CareVue running, and it was not compatible with Windows XP, and it was ‘hacked’ to run on Windows 2000 but not very well.

• It has many restrictions on use, for example it does not have a copy/paste feature and CarePlan could not be implemented. Also, staff are unable to magnify or zoom in on the screen if their eyesight is not very good

• CareVue Classic does not have a dose calculator for standard medicines. Correct doses, volumes and intervals can only be calculated for infusions.

• Staff were having difficulty with one of the ventilators that was not compatible with CareVue.

• It is less flexible than paper prescribing and does not calculate dosage for standard drugs or have alerts for blood levels to be taken.

• It is more useful for audits than for prescribing. The prescribing module did not have any decision support, alerts or warnings, and did not do any calculations for standard medicines.

• It cannot be used for wards with a large variety of medicines, such as ITU because programming the entire BNF into CareVue is not possible or practical. Also programming inhalers was shown to be difficult.

• It does not have limits to avoid medication errors. There is only one limit for a 6 kg baby, but no dosing limits per kg.

• Potential for error when new doctors are introduced, but they usually learn very quickly. If users are not trained properly, there is greater potential e.g.: giving a drug for X days instead of X doses. Also CareVue is on a 24 hour clock so if doses are programmed on a 12 hour system afternoon doses will be missed.

• Locums cannot work alone because they are not trained to use the system.

• Staff were told that it will produce regular printout data for audits, but they haven’t received anything.

• Screens can be too slow, especially when very busy.

• CareVue Classic version will be terminated in 2008 and the new system which is completely Windows-based must be purchased. Since this hospital only has the old version, they are no longer a reference site for other countries and hospitals.

• Staff like the ability to prescribe medicines, see the drugs that the baby is on, and see the pathology reports at the click of a button.

• Staff believe that a lot more can be done with CareVue and they would like to see it used in other ways. They are hoping that this is possible in the new version.

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• Sometimes when a medication is discontinued, nurses do not make changes in CareVue so on the system the medication is still being given although the patient is not receiving it. This usually happens with TPNs. Although it could be a potential for error, no incidents have occurred so far.

• There is a potential for other parents to look over at the screen and breach patient confidentiality.

Appendix 22: CareVue - Site 8 Framework

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Technical Detail

• It records all the drugs that a patient is on as well as the formulations (oral, IV, bolus, PRN etc)

• It records all lab results and blood tests and interfaces with pathology; results for all blood tests are automatically downloaded into the system or staff will be informed of the time and date when they would be available

• It records hourly observations of the patient’s vital signs; during emergencies it can make record every 5 minutes to continuously assess the patient.

• It calculates the volumes for IVs and maintains fluid balance in children

• It has a minimum and maximum limit that is very broad and can be overridden; it will alert the user that the limit has been exceeded but does not prevent it

• It does not provide legal prescriptions such as in electronic prescribing

• It has a drug calculator but this does not function automatically. It must be opened separately and asked to calculate a dose. It only does calculations for infusions

Error/breakdown

• Down time could be a result of power failure, computer failure or planned downtime by IT to update or reconfigure the system

• During downtime, the unit reverts to paper based system

• The system rarely crashed, once every 5 years There are special downtime forms that can be used when reverting to paper system until CareVue is fixed

• Pharmacist was not trained to used the system.

• A nurse from biomedical engineering came to the hospital to train the nurses on CareVue. There was also a tape/MP3 to help with the training.

• Nurses listen to the tape during orientation periods lasting three days. (another nurse said 4 hours) Then they are put on to a training unit to practice using the system

• Nurses practice in a training room for 2 hours to learn how to use the system. If they have not mastered it in 2 hours, they have more 2 hour sessions until they become competent in it.

• At first, nurse found it difficult to get used to because it is much easier to visualise everything on paper rather than open different screens to find the information needed.

• Nurses are very wary if they have not had much experience with computers

• At first it took a very long time to enter information on CareVue and it was very time consuming but after nurses learned how to use it, they became much faster

• Nurses learn how to use CareVue much better when they are using it on the wards

• There are some wards in the hospital that have CareVue but don’t use it because they didn’t have the training

• Initiated when hospital moved to new building

• It was introduced mainly to have an audit trail for all the patients on the wards

System Function Human Perspectives Healthcare System/ Organisational Context

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How it worked

• It is used by nurses, physiotherapists, pharmacists, doctors and other healthcare professionals

• Only staff who are given a password can input information, but all staff can access and look at it

• It is used mostly for recording basic information about the child and staff put in their comments to qualify or verify reasons for specific treatments or tests

• Doctors mostly use it to look for trends, find information and input information such as ventilation changes

• It does not replace the drug chart; so the drug chart is always looked at first.

• It is most used for infusions because it does the calculations, so nurses input the amount of drug to be used and the system calculates the volume

• Nurses use it to document anything that is done with a patient, such as giving drugs and taking blood samples

• CareVue does not generate prescriptions, it only documents medications.

• When patients are discharged their medications are written up from their drug charts, not CareVue

• Although the drug charts tell what time doses are supposed to be given, CareVue will show when the drug was actually given and when samples are sent off for tests

• Pharmacists compare the drug chart to CareVue to ensure that they are the same. If there is a discrepancy, it would usually be picked up by CareVue and the nurses would have been waiting for a doctor to come around to change it

• Emergency drugs are given to the patient first then prescriptions are written and drugs are documented in CareVue retrospectively

• Any changes on CareVue can be tracked by who made the change and at what time

• If a child is readmitted, their previous information can easily be retrieved with CareVue


• The PICU and critical care pharmacists continuously update the drugs on CareVue, and no drugs can be put onto the system without going through them first. Problems with integration

• When CareVue was installed, many of the drug limits were wrong or outdated. The PICU pharmacist and the critical care pharmacist went through and checked all the drugs in the system

• When system was first introduced, there were many changes that were made, such as changing the drug list on the menu

• Not all nurse know about the drug calculator because it does not automatically come on

• As nurses gain more experience in CareVue they become more dependent on it, and do not want to return to the paper based system

• When it was first introduced, CareVue and the paper system were running together so everything was slower and less efficient. Many of staff were tempted to go back to paper, so this was overcome by stopping the paper system. There were many questions and a lot of training to be done.

• CareVue has no impact on how staff interact with each other or with the management

• Nurse representative work with the CareVue team and convey the opinions of the nurses

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Advantages

• CareVue reduces the rate of calculation errors in children because it can act as a double checker

• In an emergency situation, CareVue can record vital signs to assess the patient every 15 minutes

• There is less paperwork and clutter and information is easier to find on screen than sifting through mounds of paper; CareVue is more efficient than paper system

• Information cannot be lost or misplaced

• Writing is legible leading to less potential for error

Disadvantages

• Drug names have to be abbreviated to a maximum of 8-10 characters and many generic names are longer. The abbreviations could be misread and lead to potential drug errors

• There was a mix-up with IT regarding difference between IV infusion and IV bolus

• CareVue is not available remotely (eg. from pharmacy)

• Sometimes the prescribed drug is not in the system so it cannot be put on CareVue

• Sometimes when nurses are weaning a patient off an IV drug, the nurses have the correct dose in the syringe and on the drug chart, but do not enter it into CareVue. So the patient is getting the right medication but it is not documented electronically

• Sometimes the concentration in the infusion is changed but it is not documented in CareVue; so if CareVue is not updated there might be a potential for error as well as inaccurate documentation

• The drug calculator only does calculations for infusions

• CareVue does not have an alert system if a drug dose is not within the recommended limits

• When inputting doses for IVs and NGEs, CareVue automatically gives a generic dose that must be modified to the dose actually prescribed.

• The screens freeze occasionally, but this is a mild inconvenience

• The blood results available are not complete and there are certain results that are not entered


• Nurses are more likely to rely on CareVue for calculations and when the system goes down and they have to do it manually they struggle (pharmacist’s opinion

• Some nurses do not do the calculations for drugs. They just check whether the dose given by CareVue is the same as that on the prescription.

• After getting used to CareVue, nurses are very uncomfortable if it crashes and they are told to revert to paper.

• Since it takes more of the nurses’ time to document information on CareVue when they are beginners, they sometimes feel torn between working on CareVue or caring for the child

• Nurses feel that it is a nightmare when the system goes down

• Staff are encouraged to input as much information as possible into CareVue so that it would be there if needed at a later date (eg litigation or queries)

Quality of service

• Nurses find the drug calculator extremely helpful, especially when calculating infusions

• Computerised systems are much better than paper systems where the papers can get lost or misplaced

• CareVue shows vital trends and all results by a few clicks and it is much easier than going through papers.

• Nurses do not see CareVue as a tool to reduce dose calculation errors because they do the calculations first and use CareVue to double check

• Pharmacist would recommend CareVue to ICU or wards with many IV infusions and ventilations, but not for a regular children’s ward

• If staff want to make any improvements or changes to the system, they go to the biomedical engineers who helped to set it up

• Hope to get nursing documentation on to CareVue in the future; difficult to get it to appear in CareVue in a useable format

• If a very big change is required, the manufacturers of CareVue get involved as well.

Appendix 23: Chemocare - Site 9 Framework

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• Chemocare is a Protocol based electronic system for prescribing chemotherapy drugs.

• Developed by CliniSys.

• Uses a client server application.

• An outsourced managed IT service run by Logica CMG back up data off-site and have specific guidelines about how servers are kept, how data is backed up, how it’s taken off-site, how it would be restored in the event of failure, in line with how other hospital systems are looked after.

• The data on Chemocare is accessed via desktops situated throughout the trust.

• All chemotherapy drugs, for all patients are prescribed using Chemocare.

• Uses a Windows type application.

• Integrates with patient administration system allowing patient demographic information to be transferred to Chemocare. Also linked to the pathology system for lab results; important for maintaining integrity between the systems used within the trust.

• 3 levels of user access dependent on staff position and grade.

• Calculates patients’ surface area.

• Calculates doses and infusion rates.

• Doses can be capped with a maximum level.

• Ability to enter changes in weight during treatment course- recalculates doses accordingly.

• Ability to defer treatments, for example, if a patient too unwell to continue treatment.

• Uses an ideal weight-for-age table; ability to check weight against an age (not useful if a child is over/under weight).

• Different prescription charts (with a different format) produced for parenteral, oral and intrathecal drugs.

• Can view status of patient and treatment course.

• Cytotoxic pharmacy unit use Chemocare worksheets to make up chemotherapy.

• Generates worksheets for chemotherapy production and labels.

• Audit/ reporting function.

• Staff attend a formal training session given by the Lead Director at the Pharmacy School (Children’s Services) or the Paediatric Adolescent Pharmacist.

• Trainers introduce Chemocare and its main features, and observe staff using the system.

• Staff work through a series of practice exercises using the Chemocare training system.

• Competency is not formally assessed as the system has many ‘idiosyncrasies’ which staff are expected to learn through practice.

• Upon completion of training session staff are allocated a unique username and password.

• Weekly chemotherapy prescribing meetings are also seen as mini-training sessions providing an opportunity for pharmacists to support doctors as they prescribe.

• Staff were given approximately 2 hours of training per week for two weeks during the implementation period, as well on-ward support when required.

• Introduced into the haematology directorate to replace handwritten prescribing of chemotherapy regimes.

• Chemocare considered the main electronic chemotherapy prescribing system available supporting prescribing for adult and paediatric patients.

• Implemented as part of the North London Cancer Network Initiative. Idea being to aid continuity of care throughout the network, so all of the hospitals involved are implementing Chemocare (albeit at different stages in the process).

• Seen as a long term investment.

• Two pharmacists and two consultants were involved in the implementation of the system.

• Cancer IT support team which consists of two and a half people, full time, look after Chemocare and other systems for cancer services.

• Initially a pharmacist was employed as a Chemocare pharmacist (responsible for training new staff/ maintaining files and Protocols).

• A testing site so overheads from CliniSys in terms of support costs were low and continue to be low, site pays less than most trusts.

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How it works

• Staff log into Chemocare using unique username and password (restricted access according to staff grade and position); search for patient by entering surname or hospital number; select appropriate patient; select correct chemotherapy course; prescribe chemotherapy (making any relevant updates/ changes); confirm and authorise; print prescription.

• Patient age and weight must be entered in order for Chemocare to calculate correct surface areas and concomitant doses according to Protocol.

• Prescription must be confirmed and authorised before it can be printed. A nurse and a pharmacist will subsequently check the prescription.

• Staff must ring Pharmacy Cytotoxic Unit before 3pm if chemotherapy is to be made the same day.

• Annotations facility used to communicate information useful for prescribing or checking chemotherapy.

• Aide memoirs indicate which blood tests & critical tests are required.

• Warning prompts indicate if a more up to date weight is available; if critical tests are needed. Some warning prompts can be overridden.

How system became functional:

• Protocols agreed and checked by Cancer Research Network so most of the set-up process involved inputting data for specific protocols.

• When Chemocare went live, protocols were gradually entered onto the system.

• One pharmacist will enter the Protocol (can be entered by the oncology, clinical, haematology and paediatric pharmacists); a second pharmacist, and consultant checks it. The time this takes is dependent on the size and complexity of the protocol (in some instances months).

• A designated pharmacist was employed, for a time, to work entirely with Chemocare; responsible for training new staff/ maintaining files and Protocols.) Position was no longer required as staff became familiar with using the system

• Formal training was provided by CliniSys.

• The project, from procurement to roll-out, took approximately two years for the whole trust.

• Support from suppliers was essential.

• Chemocare has benefited from other projects such as EPR project – which has delivered PCs to most of the desktops in the trust.

• During the roll-out there was a lot of solidarity between the people who were using it e.g. Cytos pharmacists, IT project managers etc.

• New staff were more resistant to using Chemocare.

• Staff found it took a while to learn and become familiar with the system but much easier to use with practice.

• A chemotherapy prescribing meeting is held once weekly, which a paediatric registrar and the paediatric adolescent pharmacist attend. This usually lasts for 2 hours. This time is protected.

• Pharmacy and registrars have developed a close working relationship because of the weekly prescribing meetings. Good lines of communication develop between the two.

• Previously SHOs had been able to prescribe chemotherapy, however in line with the policy of two hospitals joining the Trust at that time this was stopped.

• Inter-staff relationships: nurses do not prescribe using the system but feel comfortable challenging doctors, if they perceive a dose to be incorrect.

• Nurses do not have to continuously ask doctors about prescriptions.

• Continuous rotation of new staff means that constant training, ‘hand-holding’ is needed from the more experienced users.

• Nurses do not believe that Chemocare has changed their practice.

• Doctors believe that Chemocare has made writing chemotherapy prescriptions less labour intensive than writing them by hand.

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Advantages:

• Audit forms were completed for a pre-implementation and post-implementation audit. Conclusion: protocol based electronic system for prescribing chemotherapy can reduce the frequency of prescribing errors for both chemotherapy and supportive care drugs when compared to handwritten prescriptions.

• Standardised prescribing.

• Less labour intensive/ quicker than writing prescriptions out by hand.

• Legible, clearly presented prescriptions.

• Useful in a disparate spread-out organisation as the system can be accessed from different locations throughout the hospital, so aids communication- allowing two people to check one Chemocare record on different PCs.

• Prompts the user to conduct critical tests/ scans/ blood tests at specific times throughout the Protocol.

• Annotations can be time-saving as imparts important information rather than referring someone back to the patient’s notes.

• Prescriptions are electronically prescribed, so data can be audited/ retrieved in a sensible format.

• Useful for seeing chemotherapy prescribed in the past/ what is due in the future.

• Rounds doses to a figure that is considered practical. Disadvantages:

• On occasion, staff forget to update weights correctly- thus doses calculated by Chemocare may not be accurate. Staff can over-ride warning prompt that informs user that a more recent weight is available.

• If a weight is updated after a drug modification is made, the system will not update the prescription accordingly.

• Modifications, for example, dose adjustments (ie. as a result of toxicity) can result in unplanned changes to other parts of the protocol.

• Annotation facility is not widely used- important information, such as allergies and toxicities could be missed.

• Oral chemotherapy has to be transcribed onto a drug chart as there is not sufficient space for the nurses to sign off that each separate dose has been administered.

• There are a number of system bugs, for example, doses can sometimes appear as 0.

• Auditing requires quite a lot of resources (human). The System is not particularly good at generating audit data.

• The system can become loaded with protocols and there is no way of telling who set up the Protocol, the dates, making it difficult to identify the most up-to-date version.

• Generally perceived as safer than using a paper-based system and most feel that it does reduce dose calculation errors.

• Takes away much of the human error associated with calculating doses and writing prescriptions by hand.

• Staff are, on the whole, positive about Chemocare.

• Seen as a good step in terms of modernising pharmacy and prescribing.

• Recognition that it can potentially make people more complacent, as placing too much trust in the system and not looking at, or learning the actual Protocols.

• Patients do not see staff using Chemocare but are shown the printed prescription before treatment commences, which is then stored in their share care files/ records. Nurses report that patients value this approach.

• Cytotoxic Unit would find it difficult to return to the old system of generating worksheets by hand. Thus, would find it difficult to work without Chemocare.

• The trust plans to implement an EPR system which it is hoped Chemocare will interface with. This will be dependent on whether CliniSys (a small organisation) can enable this.

• Plan to allow nurses greater level of access to the system, for example, to enter test results; also plan to allow SHOs to prescribe, however in a limited capacity.

• In the future, audit data will be used to better plan care with share-care hospitals, identifying delays etc.

• Potential for the system to be used to record when treatment has been made up in the Cytotoxic Unit and when it has been administered by nurses.

• Potential for a prescription, once authorised, to print automatically in the Cytotoxic Unit (function previously disabled as other items were being printed accidentally- nurses would like it enabled to prevent delays esp. with TTOs)

• Chemocare steering group for the whole of the North London Cancer Network meets every few months to discuss system improvements required. CliniSys hold meetings twice a year providing centres that use it nationally, an opportunity to make suggestions about modifications to the software. Majority vote determines modifications made.

• New version currently due, which will hopefully address many of the problems experienced with the current version of the system.

• In terms of server hardware, hospitals need to look at the total cost of ownership of the system, the IT support, training requirements, the server hardware, the server refresh and updates.

• It was noted that there are problems in other hospitals implementing Chemocare which have inadequate infrastructure, inadequate support or where the interfaces are not tested properly.

• Staff would recommend Chemocare to other hospitals.

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• Support overheads- having people on the ground to train others, and to support people day to day.

• Whilst a prescription can be authorised there is no way of confirming, whether or not the drugs have been administered.

• Too easy not to check whether there is a more recent weight/ surface area.

• Reliability of the interfaces could be improved.; PAS; pathology systems and the reporting system- clinical data repository.

• Suppliers do not always provide sufficient levels of support.

Appendix 24: Chemocare - Site 8 Framework

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• Chemocare is a Protocol based electronic system for prescribing chemotherapy drugs.

• Developed by CliniSys.

• Uses a client server application.

• The data on Chemocare is accessed via desktops situated throughout the trust.

• Users have unique usernames and passwords.

• Calculates patients’ surface area.

• Calculates doses and infusion rates.

• Doses can be capped with a maximum level.

• Ability to enter changes in weight during treatment course- recalculates doses.

• Ability to defer treatments.

• Uses an ideal weight for age table; ability to check weight against an age (not useful if a child is over/under weight).

• Chemocare produces flowsheets used by the nurses administering chemotherapy. The flowsheets contain information about blood counts; investigations; weight reductions; pre hydration, post hydration; dose meant to be given, and over how long.

• Not linked to any HIS.

• Not used for work sheets; nursing care plans or as a scheduling tool.

• Some felt positive about the introduction of Chemocare as it was hoped it would help to reduce errors. Some were apprehensive because it meant a change in practice.

• Currently only registrars are trained to use the system.

• Informal training is provided by a cytotoxic pharmacist. A Chemocare guide book is also available.

• Ad hoc training sessions are provided when necessary.

• Staff are expected to learn to use the system through practice.

• Chemocare was not introduced in response to a specific incident.

• It was chosen because, in comparison to other systems, it best suited the needs of the hospital.

• Seen as a long term investment.

• A project board was set up to write a specification outlining what the hospital required from a chemotherapy prescribing system; to evaluate the systems available and to select the most appropriate system.

• The chief pharmacist, a cytotoxic pharmacist, consultants and IT were on the project board.

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How it works

• Chemocare is used to prescribe chemotherapy for those Protocols that have been set up on the system; at present approximately 5-10% of chemotherapy is prescribed on Chemocare. For leukaemic patients only intrathecal chemotherapy can be prescribed using Chemocare.

• Chemotherapy prescribing meetings are held weekly which registrars and a cytotoxic pharmacist attend. Chemotherapy is handwritten for those Protocols not on the Chemocare system.

• Staff log into Chemocare using unique username and password (restricted access according to staff grade and position); search for patient by entering surname or hospital number; select appropriate patient; select correct chemotherapy course; prescribe chemotherapy (making any relevant updates/ changes); confirm and authorise; print prescription.

• Patient age, weight must be entered in order for Chemocare to calculate correct Surface areas and concomitant doses according to Protocol.

• Prescription must be confirmed and authorised before prescription can be printed.

• When Chemocare was introduced the length of time taken to implement the system along with IT problems made staff more cynical about it.

• Staff do not feel that the system has had any real impact because it is not used often enough to make a noticeable difference.

• Staff do not feel that Chemocare has had any impact on relationships between staff or between staff and patients.

• Writing prescriptions using Chemocare took longer than to handwrite them in the initial stages.

• Doctors have become frustrated when trying to learn the system.

• Chemocare is providing an opportunity for staff to become familiar with the concepts of electronic prescribing.

• Staff do not feel that the introduction of Chemocare has affected staff organisation.

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• Staff enter the patients weight and Chemocare calculates surface area and the doses required.

• Chemocare produces ‘flow sheets’ used by the nurses which list the chemotherapy prescribed; blood counts; investigations; weight reductions; dose to be given and over how long. This information is double checked against hard copies of protocols kept in the treatment room.

• Chemotherapy prescriptions are also checked twice in pharmacy.

• The main pharmacist involved in implementation and training is the main contact for any problems. There is also on-site IT support provided.

How it became functional

• This hospital is still in the process of implementing Chemocare.

• One pharmacist worked for a year on the implementation of Chemocare and a nurse for 6 months.

• Initially the intention was to put the most commonly used Protocols onto the system. However, some of these were the most complicated, as such, a couple of the more simplistic Protocols were the first to be put on. Staff now try to get any new protocols onto Chemocare before they start to use them.

Problems with implementation

• The more complex Protocols can take a considerable time to enter onto the system, so only a limited number of Protocols have been inputted.

• Putting Protocols onto the system took much longer during the implementation phase as staff were not very experienced and many amendments were needed.

• It required a lot of checking to ensure that the Protocols were accurately entered.

• Implementation coincided with registrars leaving and there were concerns that there wasn’t going to be very much continuity.

• There were IT problems during implementation.

• Plans to set up nursing care plans had to be put on hold as it was holding up the implementation of Chemocare.

• There were initially talks with other hospitals about the prospect of sharing Protocols. However, it was felt that it was quite difficult to have a consensus with hospitals that have adult practices as well. Furthermore, the hospital treats a lot of babies which some hospitals don’t deal with at all.

• Staffing issues have meant that it has been difficult to get Protocols onto the system now that the full time pharmacist working on it has been taken off the project.

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Advantages

• Once staff are comfortable using the system, it is considered faster, safer and less time consuming to prescribe chemotherapy using Chemocare.

• Good on-site support available.

• Nurses feel that the flow sheets are advantageous as they are clearly presented, and much easier to use than having to search through numerous bits of paper.

• Registrars are well supported by pharmacy.

• There are some bugs in the system, for example, doses sometimes wrongly appear as 0.

• Computers are considered slow, increasing the time it takes to prescribe using Chemocare.

Disadvantages

• Chemocare is not considered very good at delivering warning prompts.

• It is supposed to be a ‘paediatric friendly’ system and yet staff are not convinced it copes well with small children.

• If you modify a dose it doesn’t automatically modify the volume. It is something that will have to be taught to the doctors so that they don’t just think about the dose but the volume as well when prescribing.

• There is not enough character space on some of the lines, so abbreviations have to be used- which is considered problematic.

• Nurses feel that the information printed on the flow sheets could be slightly bigger, because it is all squeezed into a small space.

• There have been some issues with access, and some staff have not been able to log into the system.

• Staff feel that the system needs to be used more regularly if people are to become familiar with it and in order to accept it.

• Pharmacy believes that the system can reduce dose calculation errors. Although some raised doubts about its ability to cater to the complexities of prescribing chemotherapy to children.

• Doctors also believe that it can reduce the risk of error in that calculations are not performed by hand. However, that is providing the correct data has been inputted and staff are aware of dose modifications that need to be considered when prescribing chemotherapy.

• Nurses are impressed by the flow sheet it produces.

• Some feel that the system has not met their expectations and has taken a lot of work for little gain.

• Staff generally recognise that Chemocare could encourage staff to become complacent about learning Protocols and checking Chemocare prescriptions against hard copies of the Protocol.

• Staff agree with the principle of Chemocare but have been disappointed with how it has been implemented.

• There are future plans to make more use of the system, for example, linking it to pathology and using it for nursing care plans.

• The purpose of the Chemotherapy Standards Group is to try and standardise the way chemotherapy drugs are given, for example, so that Isotemine is not given over twenty four hours in one hospital and three hours in another, or with different doses. Ultimately it is hoped that as Protocols become more standardised, it will be easier to enter Protocols and share Protocols .

• A user group is attended, at which various users vote on the upgrades that are required. Majority vote wins.

• Will be used in the future for prescribing to neonatal patients.

• Responses were mixed regarding whether it is something that would be recommended to other hospitals.

• It is hoped that Protocols will be entered more quickly as there are now two pharmacists who can input the data.

Appendix 25: Quiet Room - Site 10 Framework

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Human Perspectives

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• The quiet room is located next to the intensive care unit and reception area and is not locked.

• It contains a desk, reference sources including what is sometimes referred to as ‘the bible’ (a reference source about the unit’s drugs, dosages, reconstitutions) and the BNFC. The room is sometimes used to store ventilators, because of its close proximity to ICU. Staff also have easy access to emergency equipment, such as the emergency grab bag, neonatal emergency drug boxes as well as all drugs and fluids stored in the room. Furthermore, syringes and equipment needed for inserting cannulae in, etc. are stored in the cupboards.

• The quiet room is mostly used as a place to prepare drugs for ICU babies

• Staff working in the other nurseries, will only go to the quiet room to perform drug calculations if they can get away or if administering a sterile product via a long line or a central line.

• The quiet room is used for sterile procedures such as preparing TPN

• The pharmacist /on-call pharmacist visits the quiet room to check stock levels and to check drug charts.

• In the case of an error, both serious and non-serious, reports are compiled using CRN (incident) forms, For serious errors, nurses report straight to their manager, nurse in charge, pharmacist or the doctor on call that day, depending on the nature of the error. Parents would also be informed.

• Nurses are shown the quiet room and informed of when to use it (for checking the drugs and making up medication) at induction).

• The quiet room was introduced in response to a medication error. Review of the incident indicated that possible contributory factors were distractions and lack of concentration when calculating and preparing drugs. An area away from all other activity for drug preparation was suggested by the senior nurses.

• According to Trust drug administration policy, when a nurse is giving a drug, it is part of his/her duty to know what the dose is, what the side effects are, what it is being used for as well as how to make it up and administer it. The quiet room was introduced to help fulfil these Trust requirements.

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• The quiet room is used for calculating and making up drugs. Both nurses take the prepared drugs to the child for administration.

• It is used for calculating and preparing doses because the calculator and all relevant books are stored there. If a nurse was in the room drawing up drugs, it would not be used for other purposes .

• In addition, the quiet room is occasionally used as a procedure room. For example, it is used for lumbar punctures or inserting cannulas. Curtains are available to provide privacy for the patient.

• If babies with high dependencies cannot be left alone, another nurse must retrieve the medication and supply it to the two nurses to perform a double check.

• Initially it was intended that the Quiet Room doors would be kept shut, to allow nurses to perform calculations without distractions. As such, the following notice was put on the door: “If someone is checking drugs, please do not disturb them unless it’s an emergency”. Because of staffing levels this is no longer applicable.

• Staff in the other nurseries had some difficulty accessing the cupboards because they had to find the nurse who has the keys to then go to the drug cupboards.

• The quiet room is used frequently by all nurses

• When it was initially introduced, the concept of a quiet room was met with some reluctance, cynicism and a certain fear.

• Initially it was intended that the Quiet Room doors would be kept shut, to allow nurses to perform calculations without distractions. As such, the following notice was put on the door: “If someone is checking drugs, please do not disturb them unless it’s an emergency”. However, it was recognised that there are times when nurses are urgently required.

• The quiet room is most likely to be used in instances where additional information is required, such as a dose calculation check.

• One nurse felt is was better to use the quiet room to look up information away from others because/he might lose credibility, if seen to be looking up information constantly.

• The unit pharmacist was involved with transporting the references, monograph file and the calculators to the room.

• The lab was rearranged so that nurses could have a separate area for checking drugs, an area where they could work and not be disturbed.

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Advantages:

• Having an area that is used specifically for drug preparation is considered a “big plus” and staff believe it helps to reduce dose calculation errors. Drug preparation is considered generally faster and less stressful as all information is at hand and nurses are able to “lock themselves away”, for example, if they need to prepare complicated drugs. This reduces the likelihood of being distracted.

• The quiet room stores all equipment, references and drugs needed for drug preparation. Several people commented that it is a good concept, but highly dependent on having enough staff around. Although it is unlikely to introduce different types of errors , using the quiet room may affect care of babies because nurses have to leave them while working in the quiet room. Therefore, use of the room is dependent on having sufficient staff on the unit.

Disadvantages:

• It is not always possible to shut the doors to the room as it can get hot. Furthermore, some nurses like to observe the babies whilst retrieving drugs from the room.

• The main distractions for staff working in the quiet room are interruptions from others, buzzers to let people in and out of the unit and telephone calls.

• Preparing drugs in the quiet room is thought to take more time at weekends because there is no-one on the front desk and nurses have to manage the ward entry buzzer.

• The space is also used as a store room, therefore it can become cluttered and increases ‘traffic’ in the room.

• Staff in other nurseries sometimes find it difficult to access locked cupboards within the quiet room due to the unavailability of keys.

• Nurses all like to have a separate place, off the unit where they can go to prepare drugs and concentrate on calculations.

• Nurses believe it has helped to improve confidence in preparing medicines, as it allows more time to check and verify their information.

• One nurse felt that having a dedicated room for drug administration added importance and value to the task.

• One nurse thought it improves the service to patients.

• Most nurses feel it would work extremely well if there was adequate staffing.

• Interruptions are considered annoying but unavoidable.

• All staff members would recommend the use of a quiet room to other hospitals.

• Ease of implementation is considered more dependent on availability of space, rather than cost.

• Nursing staff in the Trust have an understanding of the value of a quiet room.

Appendix 26: Dedicated Medication Nurse - Site 11 Framework

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Technical Detail

• The lead nurse is the most senior nurse in charge, and she takes the role of looking after the unit.

• The lead nurse will have a team of two support nurses, a senior staff nurse and a junior nurse to work with her.

• The lead nurse is dedicated to several babies depending on their categories of care.

• The hospital has 15 dedicated cots. The cots with high dependency or intensive care babies may require one dedicated nurse per baby.

• The night time shifts are run in the same way as the daytime shifts, with the same rules and protocols for the entire unit.

• During an emergency, the lead nurse must be involved in the admission as well as a senior nurse who has the knowledge and skills to handle the situation. The senior nurse is dedicated to receive the baby and the lead nurse helps with the admission. There are always two nurses to support each other when a baby is received.

• Each day, a medication nurse is appointed to fulfill the sole role of looking after the medication. This is always a senior nurse.

• The medication nurse leads the dedicated medication rounds. Her main job is to ensure that the babies are given their medication at the right time during the medication rounds.

• The dedicated medication rounds are timed so that the medication is given at the times that it is due.

• The medication nurse is responsible for double checking and administering the medication. She checks the drug name, dose, amount, allergies, and documentation. She cross checks the patient’s name with the name band before administering the drugs. She gives IV drugs after double checking the drugs, data, and treatment cards. She handles any queries with pharmacy, stocks up on drugs on the wards, ensures the drug trolley is stocked and locked, informs pharmacists if stocks are running low, checks on the patient’s own medication, and keeps the drug preparations area tidy.

• The main purpose of the medication nurse is to ensure that there are no mistakes in the prescription chart and medication of the child.

• The name of the medication nurse is put up on the whiteboard, so that all other staff would know who she is.

• There is no specific training for a medication nurse; but she must have gone through all the basic training given to all nurses at the hospital.

• All members of staff were given a drug calculation test that was then marked and fed back to them. After receiving feedback, they retook the tests. Staff are expected to achieve a 100% in this test to pass.

• If staff do not pass the test, they are given a Competency Booklet that they must bring to the clinical area and work through before re-sitting the test.

• Staff are also given a Paediatric ID Assessment book that contains some useful calculations.

• Staff cannot use a calculator for their test, although calculators are allowed on the ward.

• A practice development facilitator is available on the unit to assess the competency of the nurses.

• IV therapy is only given by nurses who had completed the IV course and study days and have been supervised and signed off for giving an IV a few times.

• All newly qualified nurses must attend paediatric IV therapy study days.

• Refresher courses are given to all staff yearly.

• Agency staff can act as a checker but they cannot administer drugs unless they are trained.

• Initially staff felt that having a medicine nurse meant that there was one less nurse on the ward to do the work of the other staff nurses, and they felt that there would be more pressure on the remaining nurses left on the ward. However, this did not happen, and having a medicine nurse relieved them of many pressures.

• Staff have clinical risk meetings every month where they analyse clinical risks that were raised and make changes and run an audit to improve service.

• Nursing staff meet every other month and newsletters are given to inform them of the issues to be discussed.

• The lead nurse initiated the introduction of a medicine nurse to the ward.

• Introduction of a medicine nurse was due to the recurrence of many minor incidents, such as drugs not being signed, not being double checked, not being given, incidents of staff being pulled away from other work, and nurses having to wait a long time for the drugs to be checked and administered.

• Also, it was decided that it would be useful to have one person dedicated to dealing with queries and problems with pharmacy.

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• Nurses have a medication room where they can check the medication, and when they are in the room they must not be disturbed.

• Medication nurse is only available on paediatric wards, not neonatal because one to one or two nursing is more common on neonatal wards.

In case of error

• If the error is done on an infusion the infusion is stopped immediately and the child is assessed.

• If a nurse makes an error, the doctor is informed and an incident form is completed.

• Incident forms can be used to detect trends in medication errors.

• The nurse who made the error is interviewed to determine the nature of the error and the reasons why the error was done. There is no blame culture; the interview is mainly to determine what can be done to avoid future errors.

• Other nurses say that nurses who had made errors may be disciplined depending on the severity of the error.

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How it worked

• Nurses double check the drug, dose, and patient details, and both sign that a drug was checked and administered. All drugs are double checked, preferably with a medication nurse. The presence of a medication nurse is better because she has more time to spend ensuring that the appropriate drugs are administered correctly.

• Nurses encourage doctors to prescribe medication at a suitable time to coincide with the dedicated medication rounds, so that all babies are medicated around the same time. Sometimes the first dose does not coincide with the dedicated rounds, due to the time that the baby was admitted.

• Most of the oral medication is prescribed around the dedicated medication rounds, but IV drugs could require more specific times that do not coincide with the dedicated rounds.

• Nurses are assigned to the babies depending on their category of care. Babies who require more intensive care are assigned one nurse to look after each. Those who require general care such as feeding and observations share one nurse between seven babies.

• The lead nurse analyses the workload for each day then allocates the nurses to the babies depending on their requirements. She also allocates the medication nurse for the day. During the medication rounds, the medication nurse will come to each baby and check the medication with the allocated nurses. Her main role is to be second checker for medication.

• The medication nurse and the allocated nurses check the medication, expiry, and dosage according to weight. They calculate the dose separately and both nurses must reach the same result before the drug can be prepared and administered. After working it out on paper it can be double checked using a calculator.

• The medication nurse is able to focus on what she is doing because she does not have any distractions. She does not answer the phone and cannot be interrupted, so she is able to ensure that the correct medicine is being given.

• Medication nurses are also responsible for ensuring that correct doses are given to patients who are discharged from hospital or returning to hospital after discharge.

• The medication nurse is responsible for administration of IV antibiotics.

• The allocated nurses are responsible for each individual baby that they are assigned, ensuring that they receive their medication at the relevant time

• Each or the nurses takes responsibility for drug administration because they need to support each other when giving medicines, especially to children. This means that if they do not agree with a treatment, they have the responsibility to challenge the doctor. Therefore, it is a joint responsibility between the nurses and the doctor.

• The lead nurse allocates the nurses to the babies depending on the level of care required by the child

• Nurses are expected to communicate with each other, ensuring that two are double checking, and that they are familiar with the medicine.

• Nurses believe that when a mistake is done, it is important to admit it to minimize the dangers.

• Initially doctors felt that nurses were being too picky but they are finding it better these days because they are more able to approach a nurse and ask for advice.

• One nurse claimed that not all nurses are happy to confront medicine nurses if they do not agree with treatment. Some may feel intimidated or uncomfortable.

• If the medication nurse is not very motivated, her presence may not have a great effect. However if she is very good, she can have a very positive effect on the ward. So the effect of a medication nurse varies depending on the nurse assigned and her level of motivation on that day.

• Medication nurses accept the role if they only have to do it for the day, but they do not enjoy being medication nurses all the time, because there is very little patient contact.

• Meetings are held with nursing staff every other month and a newsletter is distributed to inform them of the issues to be discussed. When a meeting is called, only 6-8 of the 32 nursing staff available would be able to attend.

• If any nurses would like to introduce a new method or treatment, they can talk to the practice development facilitator or the lead nurse.

• The lead nurse encourages staff to talk to her if they are unhappy with a situation. She believes that the nurses whom she works with do find her approachable. She does not believe that there is a level of seniority when working on children’s medicines, because she is just as capable of learning from junior staff.

• The lead nurse does not find that the presence of a dedicated drug nurse has any impact on the relationships between staff.

• Presence of medication nurses help to build a good relationship with pharmacy because of better communication and greater efficiency in dealing with queries.

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• Two nurses must be present during administration. If the medication nurse is unavailable or must leave, then another senior nurse should replace her for the checking and administration of the drug. Although one nurse said that two nurses are not necessary when the drug is being administered. She also said that the medication nurse is not used during an emergency situation.

• If a dose is perceived to be incorrect, the nurses will recheck their calculations. If the lead nurse is not present, she is informed of the situation and discusses it with the prescribing doctor until an agreement is reached.

• If the ward is busy, they sometimes cannot afford to have a medication nurse. In these cases, all drugs are still double checked, but there is no medication nurse to do all the double checking.

• There is a medication nurse during the night shift as well as the day shift. However in the night shift, the pharmacy is closed so occasionally the medicine nurse in the night shift must take the patient in admission if nobody else is available. One nurse said that half the time that she was on the night shift, there was no medicine nurse allocated.


• There were a few problems when medicine nurses were first introduced. It was difficult to establish the role of the medicine nurse and distinguish it from other nurses.

• Initially staff felt that having a medicine nurse meant that there was one less nurse on the ward to do the work of the other staff nurses, and they felt that there would be more pressure on the remaining nurses left on the ward. However, this did not happen, and having a medicine nurse relieved them of many pressures

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Advantages

• The main advantage is that medicines are given out on time because the medication nurse is not interrupted. There is always someone available to check medication and deal with queries from pharmacy. This helps to build a good relationship with pharmacy

• It is also a good source of communication instead of having several nurses dealing with the same issue.

• The medication nurse is given the opportunity to monitor every baby on the ward, so she can be familiar with all the babies throughout the ward. In this way, she is more able to prioritise the way that medicines are given, and can ensure that medicines in which timing is critical are given at the correct times.

• The medication nurse is more able to ensure that a correct patient history is taken and has a more in-depth relationship with the babies and the parents because her main role is to focus on each baby’s medication.

• The presence of a dedicated medication nurse reduces calculation errors because she is more focused on each baby’s medication without interruptions. The amount of reported errors dropped from 10/week to 2-3/week.

• Double checking reduces errors because if two nurses have different results, a third party will check before a drug is given.

• No nurses have experienced any problems with using a medication nurse.

• The presence of a medication nurse makes it possible for small errors that could have been missed to be picked up because her main role is to ensure correct medications.

• Due to the experience, medication nurses become experts in the way that drugs are given and they way that they work.

• Having a medications nurse who to ensure that IV antibiotics are given properly takes the weight off the rest of the nurses on the ward.

• Medication nurses also help to sort out issues for other nurses, such as trying to contact doctors or pharmacy for TTAs and dose checks. This allows allocated nurses to focus their attention on the patient instead of chasing up people.

• Having a medication nurse highlights the importance of double checking, and reinforces the policies around administration.


• Each nurse believes that she has the responsibility of carrying out correct treatment and if she disagrees with the treatment she must advocate for the child.

• Having a medicine nurse and her supporters give the staff a team feeling.

Quality of service

• Staff believe that double checking is invaluable and cannot be removed

• Staff are very accepting of a medicine nurse because they can discuss the medication and they can rely on the medicine nurse to conduct the dedicated ward round.

• None of the staff members have said that they are uncomfortable with the second round.

• Nurses found it very useful that a medicine nurse deals with the IV antibiotics that are very time consuming and difficult.

• Some staff members feel that a medication nurse is pointless depending on who the medication nurse is. If she is not very good, it makes others have to work harder.

• On a day where there are few patients and few IV medications to be given, the presence of a medication nurse may not be very useful.

� Nurses would recommend having a medicine nurse in small wards, however it might be too overwhelming for large hospitals with a large paediatric nurse.

� If the ward is very busy, it might not be feasible to have a medication nurse.

� There are plans to extend the role of medication nurse throughout the trust.

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Disadvantages

• Because a medication nurse ultimately oversees the medication, there are worries that junior staff members do not take enough ownership in remembering medication and have to be reminded when medications are due.

• Due to the increase in the role of medicine nurse during the night shift, it does not run as smoothly as the day shift because at night the medicine nurse is also responsible for patient admission and is unable to focus entirely on patient medication.

• Some nurses have doubts that one medication nurse for the entire ward is good enough.

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• Medication nurses may not be able to get much time with patients, because they are mainly checking medications of all the babies.

• The role of the medication nurse is not explicitly defined, so each assigned medication nurse approaches it in her own way.

• Since a medication nurse is not assigned to particular patients, it could be perceived that she has a very light workload, which is not usually the case.

Appendix 27: Double Checking – Site 3 Framework

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Technical Detail

• The Trust states that any medication given to a child/infant (0-16) nursed in a designated Paediatric area, should be checked by two nurses, one of whom must have first checker status.

• Each nurse is responsible for the administration of drugs to his/her patients; medicines are not given on a general ward round for drug administration.

• Second checkers must not be asked to confirm the first checkers answer until after they have performed the calculation. The use of calculators to determine the volume or quantity of medication should not act as a substitute for arithmetical knowledge.

• There is no visible means of distinguishing between a first and second checker.

• Student nurses double check as part of their training, but there will always be a first and second checker to complete the checking procedure.

• Controlled drugs are stored in the treatment room in a separate locked cupboard. The sister-in-charge is responsible for the keys to the cupboard.

• The cupboard displays a red alert light, at the cupboard and in the nurses’ office, when opened. When a controlled drug is prescribed the nurse enter the details in the controlled drug book.

• Pharmacy visit the wards every day (Monday to Friday) and check doses, interactions, allergies, pharmacy supplies and to collect TTO prescriptions before discharge (approx a half a day turn around for TTOs)

In case of error

• The hospital promotes a no blame culture; as such no formal action is taken in the instance of an error.

• If an error occurs, the doctor(s) responsible for the patient are informed along with parents.

• An error is reported using an incident reporting system. The nurse then discusses the event with their manager. The nurse will write a reflective piece examining possible contributing factors leading to the error. This is stored in an informal staff file. It is hoped that this process helps to avoid repeat incidents in the future.

• If a first checker makes an error they are not demoted to second checker status.

General Training:

• New nurses are given an induction where they are taught about medicines, drug charts, and hospital medicine’s policy. Pharmacy provide training on reading prescriptions for infusions and other medications.

• Some of the training is tailored to the individual requirements of the nurse.

• IV medications have separate competencies that have to be completed. Nurses can become second checkers even if they have not passed the IV competencies, however only for non-IV medicines.

Becoming a first checker:

• To become a first checker a nurse will undergo assessment, demonstrating competency in medicine management and administration. The nurse will be RSCN/ Child Branch, E grade or above and have at least 6 months paediatric experience.

Becoming a Second Checker:

• A second checker can be any registered nurse/ midwife; Doctor; Pharmacist; Operating Department Practitioner. Although in practice a second checker is normally another nurse.

Becoming an assessor

• The assessing nurse will have successfully completed assessment of competency of Patient Group Directions (PGD’s) and have a recognised teaching and assessing qualification.

Reaction to implementation of checking procedures

• Initially nurses did not want double checking to be introduced because it was considered too time consuming and there wasn’t enough staff.

• Double checking was introduced because of errors in medicine administration, and an incident where a drug was administered to the wrong patient.

• Nurses and consultants were shown how double checking in other hospitals was more useful in providing an audit trail.

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How it works

• There is no formal drug round, medicines are prescribed and administered on an as and when basis.

• Each ward has a locked drug trolley situated close to the nurses station.

• The first checker and second checkers check the prescription (challenging the prescriber if there are any concerns) at the trolley.

• Firstly, they check the patient’s name, drugs prescribed for that day (correctness of the preparation: drug name; prescribed dose appropriate for weight of patient; no allergies to drug; time dose is due to be administered)

• Both checkers independently calculate the dosage using their own method and then confirm the answer. Another nurse stated that double checkers check together, not separately on common medicines, but for IVs or medicines requiring complex calculations, they work separately then compare answers.

• The first and second checker check the label on drug container; expiry date; date medicine opened.

• They measure/ draw up the drug together, checking the amount.

• Lock the drugs trolley and take medicines to patient.

• First checker checks the patient’s name, date of birth and hospital ID number.

• The second checker checks that the administration of the medicine is started correctly on the right patient. Parents may administer medicine.

• The first and second checker sign the appropriate drug chart (or controlled drugs book) initialling one box for each drug administered, providing evidence of their role in the checking procedure. IV preparations are not signed off until the pump is set up and the drug is infusing correctly.

• Nurses feel that double checking helps them to avoid making mistakes. As such, they are more confident when administering medicines.

• One of the nurses went to another hospital where there was no double checking, she was very uncomfortable with this and asked other nurses to perform a double check.

• Nurses were happy with having to achieve the competencies because their confidence increases with each competency that they are signed off for.

• If nurses are unhappy with a prescription, they can challenge the doctor or approach the consultant.

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• No audit has been conducted but staff feel that introducing this type of double checking procedure has reduced medication errors.

• The biggest problem is staff resources and having enough staff around to double check, particularly during busy periods.

• Nurses are more confident when administering medication using this type of double checking process.

• Parent interviewed recognised that two nurses always came to the bedside when drugs were administered and thought it was a good idea to have double checkers.


• Some nurses believe that nursing staff are ultimately responsible for correct the administration of medicines.

• Some worry that staff become too dependent on having a second checker and may become careless. (other nurses believe that double checking makes them more vigilant)

• Both first and second checkers feel that they are equally responsible for the correct administration of drugs, they are both accountable for their actions and so do not rely on the other to take responsibility.

• Current staff could not remember what it was like before double checking was introduced.

• All staff acknowledged the benefits of having such double checking procedures.

• Staff feel that double checking gives them a comfort zone knowing that somebody else would make sure no errors were made.

• but nurses who make the error do not fear disciplinary action or blame.

Quality of service

• There are thought to have been less medication errors since the introduction of double checking.

• Staff do not believe that double checking increases the risk of drug calculation errors.

� All nurses would recommend Double Checking to other hospitals.

� The Practice Development Nurse is piloting a scheme to evaluate the assessment of nurse competencies.


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What is being checked

• All medicines are double-checked. Two nurses sign the ‘check chart’ and the nurse administering the medicine sign the drug chart. The check chart contains the date, drug given, route of administration, time, and actual dose in milligrams or mls.

• Checking involves determining the accuracy of the prescription sheet details i.e. the consultant’s name, baby’s name, hospital number, weight etc. on the front of the chart. The prescription is checked to ensure that it is the right prescription, frequency, and route. It is also checked for signature, legibility, and that it is written in the correct ink. Finally, a check is made that the drug is due at that time and that the baby hasn’t already been given it.

• The protocol is checked to confirm the drug, correct dilutant and correct quantity along with the expiry date of the dilutant. The vial is double checked for the quantity withdrawn.

• At cot side - the baby’s name is checked against its name band and the prescription chart. If in an incubator, the name band is stuck on top. Staff will go through the chart again to make sure that they have got the right drug at the right time before administration.

• A double check is also performed on the yellow labels on the prepared medicines that go through the infusion pump. This check is written in a book and double signed. Whoever administers the drug signs column one and whoever witnesses the preparation and administration signs the second column.

Who does the checking

• Any trained nurse, D grade upwards can double-check, but newly appointed nurses are not allowed to check with another newly appointed nurse, unless they had completed their IV competencies and are fully competent in actually administering drugs on the unit. Doctors are not asked to second check.

• There is no specific first and second checker, but usually there is a junior nurse with a more senior nurse, or a nurse that is more experienced.

In case of an error:

• What happens in case of an error depends on the seriousness of the error. Usually, the line manager or the senior nurse is informed, then a CRN (clinical risk incident) form is completed and doctors as well as parents informed. The error is studied in detail by the directorate lead nurse to find out what exactly went wrong.

• At induction staff have an orientation period where a mentor (usually a senior nurse) goes through the double-checking process, explaining what drugs to double-check and how to fill out the charts.

• Nurses have a specific IV training course.

• Nurses have a competency check list to be signed off before preparing and administering IV drugs.

• There is no formal assessment or training to be a double checker.

• A refresher IV update including calculations practice, and ‘dummy’ medication charts takes place yearly.

• New staff work at their own pace, but are usually signed off as competent within three to six months.

• Nurses are assessed once a year.

• Double checking is a Trust wide policy.

• Nursing and Midwifery Council guidelines stipulate that a part of the role of nurses is to check calculation and administration of drugs

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• Usually errors are picked up before an incident occurs; the majority of the mistakes are checking errors, where staff have not adhered to the correct checking procedures.

• Ultimately the person who administers the drug is responsible if an error is made. Those involved

• in an incident are spoken to about it and the appropriate action taken.

• If a checking error is identified, nurses are asked to re-train and complete their IV competencies and to be signed off; they don’t check drugs until they have completed their IV competencies.

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• Certain medicines, such as eye drops and vitamins do not require two signatures on the check chart although a second person usually does check them.

• IV and oral drugs are always double checked using the check chart, but not nebulised drugs.

• The drug and the dose are checked independently on calculators or mentally, by two nurses who subsequently compare answers. If the calculations are not compatible then they double-check again.

• Both checkers confirm the hospital number, then one nurse administers the drug, and the presence of the second checker is not required. Ideally, the second checker should wait until the drug is administered but this is not always possible.

• If a doctor has prescribed incorrectly, nurses would feel comfortable challenging the doctor.

• Most staff do not consider finding a second checker a problem as they consider double checking to be important.

• Nurses double check each other if drug timings for different babies coincide.

• Some feel that double checking is important for IV drugs, but not for all drugs, especially when time is short and staff could be doing something else.

• On the whole there is a no blame culture, but if are errors are found to involve the same individual, remedial action would be taken.

• If a doctor has prescribed incorrectly, nurses would challenge the doctor

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Advantages

• Double checking is useful because it makes it easy to track drug errors that have occurred, and in the instance of an error to identify where things have gone wrong.

• Double-checking reduces the risk of dose calculation errors (but errors are still made in spite of double-checking).

• Although double checking slows down the process and increases workload it is still considered to make drug calculations and administration safer.

Disadvantages

• Double checking should decrease the risk of other errors, but in practice it may increase risk if a junior nurse is too reliant on the senior nurse’s checking or is not assertive or confident enough to actually challenge the senior nurse’s results.

• Some staff felt that it might cause difficulties if they had to challenge their friends.

• Nurses could get distracted by other things such as monitors, parent’s entry buzzer, telephone etc.

• Nurses may become too reliant on the experience or knowledge of the second checker and not complete a full check of the preparation and/or administration of medicines.

• If the unit is busy or nurses are unable to leave the intensive care areas, there may be delays in the drugs that are given.

• Nurses all agree that double-checking is a good idea, especially when tired e.g. middle of the night.

• It is considered good use of time, especially with IV drugs.

• Nurses consider double checking a priority, so if a drug needs to be administered, they will make themselves available as a double-checker.

• Nurses are happy to challenge and be challenged if a dose is perceived to be incorrect, but feel some junior nurses may not have the assertiveness or confidence to challenge more senior nurses.

• Nurses feel they should be responsible for their own actions in relation to drug administration.

• Nurses find that it gives more confidence and reassurance, especially when using drugs or performing calculations they are unfamiliar with.

• Parents are reassured by double-checking knowing that nurses are double checking what they are doing.

• All nurses would recommend double checking to other hospitals to reduce the risk of drug errors.

• Some would not recommend the writing ‘check’ chart to other hospitals as it can be repetitive.

• It is considered economically viable for other centers to use double checking procedures, even considering the time the nurses’ time taken up while the checks are. The consequences of making an error could actually cost a lot more in terms of resources.

• Staff try to review any errors and make positive improvements to prevent them occurring in the future, such as introducing a quiet area to avoid errors that occur due to distractions.


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Technical Detail

• All drugs administered are double checked at all times (regardless of whether the ward is busy) and regardless of the type of medication,

• Nurses are expected to calculate doses manually without the use of a calculator.

• Double checking is considered essential during emergencies.

• All grades of staff are allowed to double check, but agency staff are never allowed to be first checkers, they can only act as second checkers.

• Student nurses can never act as second checkers, only third checkers and so do not sign the drug chart.

• If a dose is incorrect, nurses either speak to a senior doctor or pharmacy.

• The second nurse is responsible for checking the medication, dose, drawing up, and administration.

• First checkers are considered accountable for errors. In case of error

• If an error is made, the doctors must be informed and the patient is put under observation.

• The error is investigated by the ward sister who presents the case to the ward manager. The ward manager decides if a formal hearing will be conducted. A risk management report goes through the hospital and paediatric systems.

• If a particular nurse has a history of making errors, extra training may be needed.

• One nurse who made a drug error was subject to a formal hearing and disciplinary action was taken in order to prevent harm to other patients. As a result the nurse was unable to administer drugs and deemed incompetent, re-training was undertaken and all tests were re-sat and passed .

Training

• Nurses are trained on the wards, and are given an assessment to complete, which is currently being updated.

• All first checkers are assessed during drug rounds, they then complete a series of competencies.

• There is no formal training course for second checkers. They receive training on the wards.

• Senior staff nurses assess new nurses and determine when they are ready to perform checks.

• There were no separate assessments for double checking different routes of administration.

• IV training is given at the hospital Nurses are given a day of lectures, and then assessed on administering an IV infusion.

• During IV training nurses are given a training booklet and have to get 100% in their calculations assessment to be deemed competent. After passing this training, they can become a first checker and are able to administer IV drugs.

• Nurses who double check have to be qualified nurses; if IV antibiotics are given, nurses have to have completed their IV competencies.

• Two nurses made a calculation error because they checked together using a calculator instead of checking independently. As a result of this error a new policy was instigated to double check separately on paper without a calculator.

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How it worked

• Drugs are prepared on the drug trolley or in the drug preparation room, depending on the drug, and then taken to the patient.

• Nurses check the patient details including name, age, any known allergies, the drug chart, observation charts, and fluid charts. They also check the medication for expiry date, form, route and dose in accordance with the paediatric formulary to ensure that it is safe and correct.

• Calculations are performed independently on paper, then checked together. Calculators can only be used after nurses have performed the calculations manually, although this is not encouraged..

• If two nurses perform manual calculations separately and do not agree with each others answer after the second try, a third person is asked to recalculate. If the nurses are still in doubt they will ring the pharmacist to check.

• Nurses stand next to each other by the trolley when they are double checking.

• Nurses check the doses with the BNF, if the dose is wrong they will refer to the paediatric doctor on the ward.

• Double Checking is most important when the ward is busy or a drug is being given very early in the morning.

• Nurses always check the BNF while checking, especially if they are giving the first dose.

• There is a space for each of the nurses to sign the drug chart when double checking.


• When double checking was first introduced calculators were allowed, but now they are not.

• Initially, nurses would calculate together using a calculator and many errors were considered to be made because of this. As a result all nurses are now required to undertake individual manual calculations.

• Ward manager believes it is easier to have a calculation error when calculators are used, and believes nurses are tempted to go with answer the calculator gives.

• Nurses are encouraged to calculate manually, especially student nurses.

• Many nurses do not like having to calculate manually; this is especially so for agency staff who are allowed to use calculators in the other hospitals they work at.

• Many nurses feel that using a calculator would decrease calculation errors further, especially if the ward is busy.

• Double checking is generally accepted by all nurses.

• If nurses find an inappropriate prescription and are unsure about approaching the doctor, they sometimes go to the senior nurse and double check with her first to ensure that the prescription is correct.

When an error is made

• Although staff nurses claim that it is a no blame culture when an error is made, many junior nurses feel that they are blamed.

• Nurses feel very unconfident if they make an error because of the way they are treated.

• Nurses feel that they are under close scrutiny if they make an error.

• Nurses are not hesitant about challenging doctors if a wrong dose is prescribed.

• Junior nurses are not hesitant about challenging more senior nurses.

• If a junior nurse is unsure about challenging a doctor, they would approach a senior nurse first.

• Some of the more senior nurses worry that the new nurses are not confident enough to say that their calculations are different when double checking.

• Nurses do not believe that double checking has any effect on their relationship with other members of staff.

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Advantages

• Double checking protects the patient and the nurse, and ensures that nurses are not blasé about drug administration.

• Nurses believe it reduces the risk of dose errors and calculation errors. Disadvantages

• May cause problems if nurses are reliant on the checker and become careless.

• Nurses feel that not using a calculator delays drug treatment, sometimes by up to an hour.

• Many nurses feel that using a calculator would decrease calculation errors further


• Nurses are responsible for more patients, because they have to ensure correct administration for their own patients and for other patients when they act as second checker.

• Nurses feel safer double checking before drugs are administered. They feel comfortable suggesting changes if an error has been made.

• Nurses are more aware of calculations and more accountable when double checking.

• It increases their confidence knowing that another member of staff agrees with the calculations.

• Some nurses feel that they are ultimately responsible for administration because they are the ones actually giving the medicine and caring for the child; others believe that the entire team of professionals is responsible.

• If a junior nurse second checks a more senior nurse and finds an error, it demonstrates to the junior nurse how easily mistakes can occur and highlights the benefits and the necessity of double checking.

• Some nurses are not very happy about not being able to use calculators, especially if they are not mathematically minded and feel that manual calculations increase the risk of error; others are indifferent about using calculators.

Quality of service

• Nurses believe that double checking reduces the likelihood of dose calculation errors.

• Nurses have learned important lessons from double checking.

• Nurses feel that not using a calculator delays drug treatment, sometimes for up to an hour.

� Ward manager would recommend double checking to other hospitals, especially paediatric departments.

� Double checking is cost effective and was not seen as having a financial implication.

� Nurses would recommend double checking in other hospitals, but some would recommend it with the use of calculators.

Appendix 30: NeoCalc – Site 13 Framework

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Technical detail- NeoCalc

• NeoCalc was first developed in 1990.

• Both NeoCalc and NeoTPN are stored on the hospital C drive and can be accessed via PCs. Neither are presently stored on the network because of concerns that it may go down.

• NeoCalc and NeoTPN are available on the principal pharmacist’s PC in hospital and at home, the consultant neonatologist’s PC and on 5 PCs in the neonatal unit. There are current problems with accessing PCs because half the neonatal ward is undergoing refurbishment leaving only two PCs available at any one time.

• NeoCalc is a Delphi programme.

• The 14 drugs that are currently prescribed in the neonatal unit are programmed into the system. If new drugs need to be added, the programmer is called in to re-programme the software.

• NeoCalc informs staff how to dilute a concentrated drug into an infusion. It generates a print off specifying the amount of drug required, the concentration of drug and volume of infusion.

• NeoCalc does not store information entered for future use (others have said it does have a storing facility but is not being used).

• NeoCalc rounds to one decimal place.

• With NeoCalc, although standard flow rates are used, the user must look them up and enter them. It was programmed not to automatically default to the standard flow rate because there are rare occasions when standard rates must be overridden and a dose rate calculation is needed.

Training

• Junior staff have a day and a half induction in the first week. During this induction, some time is dedicated to introducing NeoCalc & NeoTPN. There is no formal assessment of competency.

• A senior nurse will show nurses how NeoCalc works.

• Doctors are provided with the formulary to use with NeoCalc and standard flow rates are laminated and can be found readily on the wards.

• Staff described learning to use NeoCalc as very easy and straightforward, it was said to be comparable to a standard calculator.

• New registrars receive an hour’s training by pharmacy on how to use NeoTPN.

• NeoTPN is considered more complicated, because there is a lot to consider when determining fluids and doses given as TPNs.

NeoCalc

• NeoCalc was introduced in response to an incident in which a complex calculation took hours to perform.

• A professor of computer services, the principal pharmacist and a second pharmacist were responsible for the introduction of NeoCalc.

NeoTPN

• NeoTPN was introduced because the hospital was experiencing difficulties using individual TPN bags and became aware that other hospitals were using standardised bags.

• The consultant who introduced NeoTPN had also introduced it to a previous hospital.

• The Principle pharmacist secured funding for development of NeoTPN.

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Technical detail- NeoTPN

• NeoTPN was introduced in March, 2005

• The programme took an IT programmer approximately one year to develop.

• NeoTPN was designed as a simple programme taking into account the baby’s TPN as well as other IVs that the baby is given.

• NeoTPN has upper and lower limits that are based on the hospital formulary, but these limits are very broad. Neither NeoCalc nor TPN have decision support on compatibility or remembering the baby’s information and drug history.

• NeoTPN rounds flow rates to one decimal point; there were more errors when 2 decimal points were used.

• NeoTPN has dials that show the ranges of sodium, potassium, calcium and other TPN constituents. The dials allow staff to see if the baby is at a high or low range for each constituent.

• Standardised TPN bags for NeoTPN have a shelf life of one month, when vitamins and minerals are added locally, the shelf life becomes one week.

• There are written guidelines on how to use NeoTPN and there is a formulary for NeoCalc. (pharmacist doubts that anybody uses them).

• No experiences of system error or malfunctioning.

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How it works NeoCalc:

• NeoCalc performs calculations for diluting IV therapy in neonates; it is not used for oral dosages. The drug is chosen from a menu; the required dose/kg, flow rate, and baby’s weight are entered, and the programme calculates the volume and dilution that is appropriate. Specifications are printed out and copied onto the baby’s notes. The infusion is made up on the wards following instructions from the print off.

• NeoCalc involves the use of standard flow rates for all infusions that are provided in a formulary. Provided that the baby weighs less than 5.5kg, the calculations work well using the standard flow rates given.

NeoTPN:

• NeoTPN involves using standardised TPN bags. There are two TPN bags used, one containing sodium and one without sodium. The standard bags can be supplemented with other fluids such as dextrose or just water.

• Instead of asking for certain concentrations of certain constituents to be in the TPN bags, a standard bag is used and the flow rate is altered to suit the patient.

• Staff enter the baby’s weight and volume/kg/day used, and NeoTPN will inform user if TPN administered is given at a safe range for the baby. If any supplements are at a low range, they can be added to TPN, or if at high range the flow rate can be dropped.

• Only babies with renal failure need individualised TPN and cannot use the standardised bags; this occurs about once a year.

• The TPN bags are made up in pharmacy but supplementary fluids added to the bags can be done on the ward.

• Both NeoCalc and NeoTPN keep a record of what has been done, but this information has not been used for audit purposes.


• Neocalc was written by a professor in computer sciences. It took approximately 6 months of evening work to complete followed by a further. few months necessary to validate the program.

• Validation consisted of testing numerous examples and ensuring that the correct answers were given and documented.

• When NeoCalc was initially introduced it was a considered to be a very plain black and white presentation; the newer versions are more aesthetically pleasing.

• NeoTPN was developed by an external commercial professional programmer and underwent similar validation to NeoCalc.

NeoCalc

• The doctors use NeoCalc to prescribe, but consultants rarely use it.

• Some nurses use NeoCalc to check calculations.

• There are still nurses who prefer to calculate manually; this is still acceptable according to hospital policy.

• Nurses are expected to double check NeoCalc prescriptions in case the birth weight is entered incorrectly.

• Doctors are taught to perform a rough mental calculation to ensure that the results from NeoCalc are similar to their own.

NeoTPN

• Only the registrars and middle grade staff responsible for prescribing TPN would use NeoTPN. It is not used by SHOs or nurses.

• Most staff find training and induction useful and for those that have used standardised TPN prescribing previously they pick it up quickly.

• There was some difficulty at first getting used to NeoTPN because if the amount of fluid changed then the entire TPN prescription had to be rewritten, and it was difficult keeping track.

• After staff understood the paperwork, it became much easier to use.

• Some staff described using standardised TPN as a ‘culture shock’ at first.

• Doctors are not required to perform mental calculations to cross-check results with NeoTPN.

• The IT department is trying to get NeoCalc and NeoTPN put onto the network. However, pharmacists feel that the network is not presently secure enough as it occasionally goes down.

• Prior to the introduction of NeoTPN there was tension between doctors and the Aseptic Department because TPNs had to be prescribed before a certain deadline and a day in advance in order to be prepared on time. With standard TPNs, they can be prepared very quickly so deadlines are not needed and tension is reduced.

• Previously, unusual TPNs caused confusion between technicians and doctors because the technicians were interrupting ward rounds by calling doctors to check prescriptions. Standardised TPNs reduce confusion and interruptions.

• Medical staff feel reassured that nurses use NeoCalc to double check prescriptions, particularly the more advanced nurses. Younger nurses would turn to the senior nurses for clarification if a prescription is thought to be inappropriate.

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• A consultant and principle pharmacist decided on TPNs that would be used for the programme, and were validated over a 6 month period.

• Because the chief pharmacist and consultants were considering the design of NeoTPN for years, they were easily able to determine the constituents needed for standardised TPN bags

Advantages Neocalc

• The use of standard flow rates with Neocalc has been very effective in reducing calculation errors. After introducing standard flow rates, the only drug errors occur if junior doctors try to override the standard flow rate.

• NeoCalc is time saving for staff who want to write a prescription for an infusion, so babies get their medication much faster. It is also much easier to use than the programme that was in place before it.

• NeoCalc is useful for doctors who are less experienced or for prescribing drugs that are not used regularly. It was described as a good safety mechanism in addition to the formulary, and thought to reduce the risk of dose calculation errors.

Disadvantages NeoCalc

• Some staff have admitted that they do not double check NeoCalc calculations, and have become very dependent on the programme.

• There is a danger of putting the wrong weight into NeoCalc and thus the programme will calculate a dosage inappropriate for the patient, especially if staff do not double check manually.

• There was one case of a wrong dose being calculated by NeoCalc, this was for a drug that was rarely used, so it wasn’t picked up during validation of the NeoCalc programme.

Advantages NeoTPN

• NeoTPN improves the quality of parenteral nutrition given to babies and offers more flexibility in prescribing.

• Using standardised TPN bags makes prescribing TPN much easier. Bags can be made and administered much quicker. Babies can receive TPN in the first 24 hours when they are born.

• Availability of standardised bags mean that nurses can change TPN without having to wait for pharmacy.

• Staff are able to see exactly how much glucose is being given to a baby without having to calculate it, so there are fewer episodes of hyperglycaemia in smaller babies when they receive large fluid volumes.

• Prescriptions do not have to be sent to pharmacy before a certain deadline.


• Pharmacists have become very dependent on NeoCalc/NeoTPN and so would have concerns about putting the programmes onto the network in case it went down

• There are worries that the use of NeoCalc will deskill doctors and they will not learn to perform the calculations manually.

• Although staff are taught to double check NeoCalc manually, many admit that they do not double check the calculations (others said that they do double check)

• Doctors take a print-out of NeoCalc to help them with their paperwork, and sometimes leave the printout with the nurses; this is especially helpful if nurses cannot read their handwriting.

• Some staff believe that they will have difficulty performing the calculations if the programme is unavailable or they move to another hospital.

• Nurses were afraid of NeoCalc when it was introduced but now they rely on it, although some still prefer to do manual calculations and don’t like computers.

• NeoCalc is used when double checking a calculation if the drug infused is not a standard drug that staff are familiar with.

• Doctors find it reassuring that nurses use NeoCalc to double check their work, and nurses find it reassuring to have NeoCalc to check their own calculations.

• Pharmacists mostly use NeoTPN to double check administration, flow rate, final volume and constituents against the print out.

• When a new doctor starts there is greater possibility for error because they don’t use the standard flow rate of NeoCalc.

• Doctors rely on nurses to double check their work and read through the print outs.

� There are future plans to put NeoCalc/NeoTPN on the network, when the network is secure enough.

� There are future plans to introduce other standardised TPN bags, such as low/high potassium bags.

� NeoTPN & NeoCalc can only be used in other hospitals if they accept the concept of standard infusions/dose/flow rate.

� NeoTPN is half owned by the programmer, who charges £500 for the software. Most hospitals are not willing to pay this amount for NeoTPN.

� Using standardised bags does not lead to substantial cost savings unless the hospital decides to supply them to other hospitals and commercialises standardised TPN bags.

� The consultant who introduced NeoTPN is currently trying to persuade other hospitals in the network to use standardised TPN bags but is finding it very difficult.

� Many hospitals who are interested in introducing NeoTPN are concerned about validation and want to conduct their own validation.

� The consultant would recommend a standardised TPN system with a computerised prescribing programme, but not sure if NeoCalc and NeoTPN are ideal for this purpose.

� Most staff would recommend NeoCalc and NeoTPN to other hospitals.

� After using standard TPN bags, some staff think that all hospitals should standardise their TPN.

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Disadvantages NeoTPN

• NeoTPN is more complicated than NeoCalc and requires more training as if the wrong information is entered, it will give erroneous results

• Staff have to remember to put in the amount of fluid used for the infusion, but NeoTPN does not actually prescribe the infusion

• Since NeoTPN uses standardised bags, if one constituent is over the limit for a baby, the flow rate must be reduced, resulting in a decrease of the other constituents and possibly decreasing nutrition to the baby.

• Junior doctors do not learn as much as they should about TPN because the ba gs are standardised.

Quality of service

• There are current problems with accessing the programmes because half the neonatal unit is being rebuilt so only 2 of the 5 PCs are functional.

• Principle pharmacist preferred less decision support because decision support sometimes leads to too many warnings and prompts that can easily be ignored.

• Standardised TPN is more simple and practical for staff, but does not save time.

• Staff found that using standardised bags was reassuring because the constituents are already pre-mixed and the only variable to worry about is flow rate.

• Doctors are very happy with the dials on NeoTPN.

• Staff feel that NeoCalc and NeoTPN reduce dose calculation errors in children.

• Staff feel that NeoCalc allows them to prescribe correctly, especially staff who are new, not very experienced, or are very tired after a long shift. They feel they have a back up in case their mental calculations were wrong.

• It is seen as a teaching tool to help juniors and nurses learn about prescribing and calculating.

• Sufficient PCs and IT support are essential for both NeoCalc and NeoTPN to work

Appendix 31: Education (Doctors) – Site 14 Framework

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Technical detail • The module can be used by anyone with access to the Doctor Online

Training Scheme (DOTS) but is targeted at the FY2 doctors. It is essential for doctors to complete the test within 2 weeks of starting their rotation. (Doctors thought they had a month to complete).

• The paper based version of the test was introduced around 2003. The computerised module was introduced in 2005.

• There are ten questions with sub-questions. It gives you a scenario and then 3 related questions to answer. Answers are dichotomous True/False.

• Answers can be saved and re-visited but they are only allowed to submit once.

• The test takes approximately one hour to complete. (Pharmacy thought it would take less than this).

• The content of the questions are based on queries and questions that midwives and doctors raise in the prescribing of drugs, as causing most difficulty for trainee doctors and areas that they would be most frequently asked to work within.

• Resources include a calculator; there is a link to the BNF, (not BNFC as no electronic version available). Access requires individual log in for trainees. Toxbase (poison information database) generic username and password available.

• They have the Trust monograph on the intranet, which they can access. This gives doctors all the information about the strengths of the products used and the doses and rates that are recommended for running medicines at. It is easy to switch between screens quite.

• Trainees get electronic feedback once the test has been completed and submitted; an answer is collected, they are told whether or not it is correct and then given an explanation as to why it is right or wrong.

• The pass rate is normally around 90%. Pharmacy accept a pass as anything over 70% because that is what the rest of the Trust uses with regards to calculations..

Training

• No formal training on how to access the module as it is part of the DOTS site and training for this is provided during the doctor foundation year (FY1).

• Trainees are told about the module during induction. Pharmacy is given a one hour slot and trainees have 2 weeks from that point to complete the test.

• There is no calculation training other than the module. Doctors without paediatric prescribing experience rely on a monograph folder that tells them exactly what to do.

• The neonatal module was developed by pharmacists but the overall development and maintenance of the DOTS website, which encompasses it, is covered by NHS education for Scotland.

• It was introduced in 2003 and went electronic in 2005.

• Pharmacy prompted the introduction of calculation training for doctors. It was introduced to establish how competent doctors were with calculations.

• It changed to computer based because of the introduction of DOTS .

• It was not introduced in response to a specific incident, but the first time it was completed it did highlight a doctor who had real trouble with calculations.

• It was introduced in order to support good practice and for risk management purposes,

• The questions were developed by the neonatal pharmacist and reviewed by the lead neonatologist. The paediatric questions were developed by the paediatric pharmacist and were in line with the clinical directive for paediatrics.

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• The calculations test is compulsory on a local level but not an essential DOTS module. It is unsupervised and not completed as part of the Continuing Professional Development or kept in the trainee portfolio.

• It is not necessarily seen as a pass mark; it is used as an indicator of how well that person can prescribe. It is more of a competency assessment tool.

• The data is stored and an electronic report is emailed to the pharmacist advising that the module has been completed. The email gives the mark and shows how the trainee answered the questions.

• If the score is below 70% the trainee is contacted by the pharmacist and any issues will be discussed. The trainee is given a paper based test to complete. The pharmacist will discuss with consultants, midwives and nurses and establish if the trainee is still able to prescribe.

• Pharmacy review the questions every year and make amendments and update as necessary.

• Rather than decreasing dose calculation errors it gives a good awareness of how to use the drug monographs and things

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How it became functional

• There were two parts: a) Gathering the content from the pharmacists; the initial talks and

development lasted over 6 months. It involved the pharmacists going back to their own groups again to discuss the content. Once the module was created two groups of pharmacists tested it in the first instance and amended it as necessary.

b) There was a team of three developers who were, and still are involved, so the team is big enough to make changes if necessary. Technically it was just a simple implementation of on-line learning tools so it was fairly straight forward.

• The information is stored on a secure web server in a database.

• The initial development was time consuming. It can take a couple of weeks to a month to get a module on line but once it’s done then there is a minimal maintenance.

• IT aimed for the minimum standards that are accessible so there no flashy gimmicky works.

• The content of the site was sourced from reports produced by the pharmacy department, in particular, concentrating on existing error reports, frequent mistakes junior doctors made and focusing on the area in which they practice.

• Pharmacy review the content of the module annually and the IT department updates the site accordingly.

• Validation of the site content was carried out by the pharmacy department. Modernising Medical Careers Group (MMC) in Scotland have agreed that the module should be made more available to other hospitals.

• DOTS as a whole has been audited with regards to the wording of the questions pass rates of individual in terms of wording and whether specific questions were causing difficulty and this has been applied to the neonatal package but the actual neonatal paediatric package hasn’t been audited.

• There has been a problem where FY2s have not been allocated to the right specialty so somebody on the neonatal unit has ended up doing the paediatric module. This was a coding issue on the web server. (this has since been resolved but the impact has been that the module has not been available for the current FY2 trainees and they have had to resort to the paper version)

• It’s easy enough to register people on the system but there is a major bottleneck with getting information about FY2s from Personal Departments. This delays issuing user name and passwords.

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Advantages of site

• Doctors can access the module from home and are not having to take time off the ward to attend teaching sessions (this was also seen as a problem in that they finish a day’s work and then have to complete it in their own time).

• Staff considered the site to be a good idea. It is a very good basic assessment tool which gives a baseline on how someone has a grasp of pharmacy prescribing issues.

• It is a flexible approach to teaching.

• Easy for staff to monitor whether students have completed the module. The computer automatically generates a report and sends it to pharmacy.

• It has the potential to reduce dose calculation errors but to early to comment.

Disadvantages of intranet site

• Online training should not replace practical teaching sessions.

• You can’t ask a computer a question.

• Some of the questions were a bit ambiguous.


• Because of IT problems pharmacy are relying on how the midwives and consultants rate the competence of the trainee “the midwives are very good at flagging up if there are any concerns about any medical staff, they would flag them up straight away”. They will still have to complete the assessment when they have access.

How doctors felt about the programme after implementation

• Not a great deal of feedback has been collected as the programme is too new.

• Not many trainees have been able to complete the online test due to IT teething problems.

• It went through the doses for paediatricss; what some of the prescribing issues are; when to give certain drugs.

• Doctors felt that overall it was a good idea but it didn’t actually go into the background of any of the calculations and so without sufficient information weren’t sure how to answer.

• Doctors are not sure that a 4 months rotation is sufficient time to become competent at prescribing for paediatrics.

• There is no guarantee that a person who passes perfectly will be a better doctor than someone who does not do that.

• The whole portfolio and online training is no reflection of competence in a clinical setting at all.

• Completing the module one month into training means that any mistakes are likely already to have occurred.

• Trainees may complete the online modules collectively rather than individually just to get them finished.

• Online training is not the same as getting practical teaching sessions

• Doctors feel that an awful lot of information is put into the computer but at the end of it they are no better for having done it.

Future plans:

• Develop additional questions for the module so that if a trainee does not reach the 70% there are sufficient questions online for them to re-sit electronically.

• Staff would recommend the site to other hospitals once the initial teething problems have been ironed out..

• Modernising Medical Careers Group (MMC) in Scotland have agreed that it should be made more available to other hospitals.

• Not considered difficult to implement as long as there is IT support and that the pharmacy department is willing to contribute and deliver the content for the module..

• Publicise the site more widely to increase its usage.

Appendix 32: Education (Nurses) – Site 14 Framework

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Technical Detail

• The Practice Development Department set up a calculations exam that nurses have to pass in order to be allowed to check and administer IV drugs.

• The test was introduced approximately 2 years ago.

• Any error in the unit calculation paper is an automatic fail.

• The test is in two parts. The generic test covers both adult and neonatal questions. The questions were originally based on adult scenarios and not relevant to neonatal nurses.

• The Neonatal Primer Test , which is part of the overall test, consists of 10 questions covering unit conversions and dose calculations.

• The tests are carried out under exam conditions and nurses have one hour (another nurse said 2 hours) to complete. Nurses are allowed to use a calculator, but not the BNFC or monographs.

• One nurse revealed that there were two practice papers that can be done before the exam, but she was not told about them.

• If nurses fail the exam, they must re-sit. However they are not given a fixed date for when the next exam would be given.

• The exam is administered by Practice Development with no in-put from pharmacy or the neonatal Unit Manager.

• The test is not offered at regular intervals.

• Nurses are sent on a generic half study day where they cover specific areas including ethics, dose calculations, protocols etc.

• Before the test was introduced nurses were given a competency based workbook to complete. Once they had completed the workbook they were able to prepare and administer IV drugs .

• The neonatal unit uses monographs for drug preparation. The test is not presented in a familiar format and does not include monographs.

• The test is considered very hard and some nurses felt they panicked under exam conditions.

• Nurses felt that the test does not reflect practice in the unit, where time is spent carefully preparing the infusions and working through calculations methodically.

• Nurses feel that the test should be more focused on neonatal and paediatric calculations.

• They would like the pass rate to be reduced.

• The nurses felt that the exam was much harder than they expected.

• The calculation test is Trust wide policy and is designed so that their nursing staff have all passed a calculation test.

• Before this test was introduced nurses attended five study days, completed a workbook and achieved competencies with their mentors.

• Practice Development tried to introduce educational testing. Practice Development did not consult with senior nurses or pharmacy on the format and level of calculations on the exam.

• Senior nurses have tried to revert back to competency based learning, but Practice Development have refused.

• These tests were originally set up for nurses working within adult medicine, and questions were written up by pharmacy.

• The calculation tests were introduced as a method of formalizing the IV training.

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How it worked

• Nurses must attend a generic workshop where issues such as drug errors, ethics, calculations, and fluid incompatibilities are discussed. They are briefly taught how to calculate drug doses, and given a small workbook to complete before sitting for the test.

• The test was given about a month after the workshop. (some nurses had waited approximately 3-4 months for a test)

• After sitting the test, the examiner checks it and feeds the results back to the nurses.

• Nurses who fail the exam can still practice, but they cannot second check or administer IV drugs.

• If Nurses fail they are given additional support from pharmacists and from Practice Development. They also have access to a software package known as Authentic World, which offers support. (None of the nurses interviewed mentioned this extra support).

• Pass mark used to be 100% but nobody was achieving it, so it was reduced to 80% and many nurses are still failing.


• The senior clinical pharmacist wrote the original questions, and they were originally based on adult scenarios.


• Nurses and pharmacists feel that the exam does not reflect the nurses’ competence and it goes beyond IV training. This is to be discussed with management and further changes to the exam will take place.

• Nurses did not believe that they had enough training in preparation for the test.

• Some nurses were only told that they had to take the test the week before.

• Nurses would have preferred more time with a pharmacist instead of Practice Development.

• The nurses feel that the feedback is insufficient and the examiner does not spend enough time going over the exam results.

• Nurses who failed the first exam are very nervous and anxious about retaking it.

• Nurses believe that the test was made harder because they were unfamiliar with many of the drugs and adult doses.

• Many of the senior nurses who had been practicing for years do not think that they would have passed the test.

• More senior nurses are affected because they must be available on every shift since the newer members are unable to administer IV drugs.

• Practice Development would not listen to the senior nurses regarding a better approach to educational testing.

• There is a lot of tension between Practice Development and the neonatal service coordinator because she wants to return to competency based education while Practice Development insist on the calculation exam.

• There are many complaints with regards to the structure and content of the exam, as well as the limited resources available to the nurses while taking the exam. These are all to be reviewed by the Board.

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Advantages

• Doing calculations exams is very helpful in refreshing the nurses’ minds and enhancing their maths skills.

Disadvantages

• Many of the nurses were misinformed about the amount of support available to them in preparation for the exam.

• The feedback that the nurses receive after taking an exam is insufficient, and they often do not know what mistakes have been made.

• Nurses would prefer more study days before the exam.

• Nurses believe the exam should be more specific to neonates.

• Nurses complained that there is no structure to the induction, study days or examination.

• Nurses are sitting the test expecting to fail and only 2 out of 6 nurses recently attended the test.

• The exam is not a useful guide to the competency of the nurses, because many of those who have failed have been described as very competent by their seniors.

• The wording of the questions was considered very confusing and vague.


• Very few nurse and midwives pass the exam. In the past year only three nurses passed.

• One nurse has been in the unit for 3 years and is still unable to check or administer IV drugs.

• Nurses cannot check or administer IV drugs unless they pass the exam. This causes staffing problems since most of the nurses fail the exam and therefore only senior nurses are able to administer IVs.

• Nurses are very anxious about retaking the exam because they are not sure what they were doing wrong to fail it the first time. They did not receive enough feedback.

• Many nurses have lost their self confidence after failing the exam, although one said she was not affected by it because she knew that everybody fails it.

• Newer and more senior nurses feel very deflated at the high failure rate. It was described as a ‘huge stumbling block’.

• New nurses are devastated when they fail, and although they know the calculations there are numerous reasons why they do not answer correctly e.g. nerves, ambiguity of questions, not enough time to complete the questions, not being able to work methodically through questions etc.

Quality of service

• Many nurses believe that education testing is a good idea, but disagree with the programme at their hospital.

� Nurses would only recommend the test if it was more structured, but most said they would not recommend it all.

Appendix 33: Education – Site 15 Framework

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Technical detail • The intranet site is a resource that can be used by anyone with

access to the hospital intranet. • It was developed in 2004. • Medication errors section details different types of error that can

occur (wrong dose given; dose omitted; wrong drug given; dose duplicated; infusion at wrong rate; dispensing/ labeling errors; wrong IV concentration; wrong patient; wrong route used), case studies illustrating these types of error and learning pointers for understanding how such errors can be prevented are available. Real data is used but anonymised and publicised on the website after a delay so as to prevent either the patient or members of staff involved in treating that patient from being identified.

• Tips to stop medication errors section offers advice on prescribing drugs; dispensing drugs and administering drugs.

• Dangerous Abbreviations and Procedures section intends to raise awareness of common abbreviations and procedures that need extra care and attention to ensure errors are not made, for example, U Units can be mistaken as a zero or cc if written badly.

• Reporting errors section includes a link to reporting form. Staff are encouraged to complete the form for near misses.

• Medication Error Trends section displays analyses of medication error data.

• Test your calculation skills section includes a calculation test; mock test and answers for nurses (IV drugs test) and a converting quantities sheet.

• Medication and Prescribing Policies section with links to Trust policies.

• Queries and feedback link. • The calculations test is non-compulsory, unsupervised and not

formally assessed. It is not completed as part of the Continuing Professional Development or is it part of Trust requirements to complete.

• Questions have been sourced from the published literature. Answers are also available showing clearly the working out.

• News and safety alerts are also publicised on the site.,

Training

• No formal training on how to use the intranet site is provided as it is considered easy to use.

• Pharmacy report that new staff joining the hospital are given an induction, at which the site is introduced. (in practice it appeared that staff were not aware of the site).

• The site is publicised to current staff via the HIS email system; posters and flyers and clinical effectiveness news letter.

• The workshop for FY1 doctors takes place over the course of one day and to-date has been delivered by the chief pharmacist. Content covers general prescribing issues including dose calculations.

• Nurses receive formal training sessions (delivered by one of the Sisters) which includes attendance at a series of lectures; observation of practice (supervised by IV co-ordinator); and a formally assessed calculations test taken under exam conditions.

How staff felt about the programme before implementation

• Nurses were initially apprehensive about having to take a calculations test.

• An administering medicines intranet site was set up as part of an overall risk reduction strategy within the hospital.

• The hospital has had a formal scheme for reporting medication errors in place since 1994. However, it was felt that the forums used to disseminate medication error reports to staff, particularly junior members, were ineffective. The intranet was seen as a means to involve, educate and feedback error-related information within the hospital, especially to front-line staff.

• Also envisaged as a resource to support good practice, challenge staff to keep their skills up-to-date and to promote guidelines for medicating safely.

• It was felt that by using the intranet information could be kept up-to-date, relevant and more easily accessible.

• The site was developed by the Chief Pharmacist, Clinical Risk Manager and the Clinical Effectiveness Administrator with input from the Regional Clinical Risk Manager and senior nurses with full support of management.

• Medication errors have had a high profile in the hospital so providing resources to set it up was not an issue.

• The site was considered complimentary to the FY1 workshop and nurses IV training.

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In conjunction with the intranet site: Workshop for Foundation Year 1 doctors

• The workshop has been available to FY1 doctors for approx 2 years. • The workshop will be delivered by either the Clinical Services

Manager or senior pharmacy staff before the FY1 doctors begin their placement. However, to date the chief pharmacist has been running the workshop.

• Takes place over the course of one day. • Content covers general prescribing issues including dose

calculations. • FY1’s are given calculations to work on over them summer, which

pharmacy provide feedback on before they start work. IV training for nurses

• IV training given to nurses joining the hospital. • Introduced 10-12 years ago. • Formal training sessions includes attendance at a series of lectures;

observation of practice (supervised by IV co-ordinator); and a formally assessed calculations test taken under exam conditions.

• A calculator can be used and a conversions sheet is available. Pass mark is 100%; in the event of failure, the exam can be re-taken.

• Staff can choose not to have a calculation marked if, for example, if they don’t understand the wording of a question. These questions are later discussed with the Sister.

• If the nurse passes the exam a certificate of completion is kept on file in their CPD folder. This is updated yearly to ensure continued competency.

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How it became functional • The site was created using FrontPage, utilising HTML and Java

programming. • It took approximately 8 months part time to develop. • It was developed off-line and added to the main intranet site after

approval from stakeholders within the division. As such there were no technical problems uploading the programme.

• The content of the site was sourced from reports produced by the pharmacy department, in particular, medication error reports. Information was also obtained from published literature. Any real life case studies used were anonymised, removing any details that would enable patient or practitioner to be identified.

• An editorial group was set up to provide feedback on a beta version of the site which was then passed to the directorates, clinical boards and the divisional management team to obtain clearance to upload.

• The editorial group also discusses any changes that need to be made to the site and then the Clinical Effectiveness Administrator updates the site accordingly.

• Validation of the site content was carried out by the pharmacy department.

How staff felt as system was introduced

• Feedback received at the time the intranet site went live was generally positive.

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Advantages of intranet site

• Site receives approximately 100 hits per month.

• Staff considered the site to be a good idea.

• It may have increased the amount of reported errors through raising awareness of the need to report.

• It has the potential to reduce dose calculation errors through raising awareness and providing staff with an accessible resource.

Disadvantages of intranet site

• Staff were not generally aware that the site existed.

• Editorial group has not met recently and the site hasn’t had much work done on it over the last 6-9 months because of all the major organisation restructuring that has been taking place.

• Clinical Effectiveness Administrator was unsure of whether the intranet site had reduced medication errors.


• Computers on the ward are slow and often being used by other members of staff.

• Issue as to whether staff have time to sit down and access the site while at work and not available remotely.

Advantages of workshop

• Provides a good opportunity for the junior doctors to meet staff from pharmacy.

Disadvantages of workshop

• Need to provide 2nd

year doctors, who are coming straight from another part of the rotation with a similar workshop. This is not currently available.

Advantages of IV training

• Chief pharmacist believes that IV training has reduced the risk of dose calculation errors.

• Opportunity for nurses to practice calculations. Disadvantages of IV training One nurse felt that they already have experience of giving other drugs and performing calculations and so not particularly any more confident after a calculations test.

How staff felt about the programme after implementation

• Not a great deal of feedback has been collected recently.

• Chief pharmacist believes that any member of staff that has looked at the internet page and been through the training process will have found it useful, and would increase confidence in prescribing, preparing and administering medicines.

Future plans: Intranet site

• Conduct an audit to quantify the impact of the intranet site and investigate what other materials staff would find useful.

• Develop additional sections on complaints i.e. feedback from patients and their families, infection control and health & safety.

• Staff would recommend the site to other hospitals. Not considered difficult to implement as long as there is member of IT personnel to work on it. Clinical Effectiveness Administrator at this site will shortly be leaving which may have knock on implications for the site and its maintenance.

• To add more examples of errors

• Getting staff to submit their calculations to be marked by pharmacy identifying those that may need extra support.

• Expand the range of calculations.

• Publicise the site more widely to increase its usage.

• Organisational changes throughout the locality will mean that the site will be available to more hospitals.

Future plans: Workshop

• To provide a workshop for 2nd

year doctors.


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• The structured education programme began in the mid 1990s and evolved into the current programme within the last 3 to 4 years.

Education programme for neonatal nurses/ midwives

• 4 levels of training: introductory; level 1; level 2; level 3.

• Introductory level training- administration of oral drugs.

• Level 1- administration of intravenous drugs by bolus injection via peripheral cannula.

• Level 2- administration of intravenous drugs by intermittent infusion.

• Level 3- checking, preparation and administration of level 3 intravenous drugs.

• For each level, nurses undertake theoretical training which includes completion of drug calculations (to take home) along with supervised practice.

• There is a 2 week time limit for completing the drug calculations (this doesn’t appear to be enforced). All answers along with working out are submitted to pharmacy, who feedback on an individual basis. 100% pass rate is required.

• If 100% is not achieved an individual teaching session will be organised. Further calculations will be given to try and identify what the problems are. If the nurse is still causing concern after this session they would be referred back to the practice development nurse.

• Calculations become increasingly complex the higher the level.

• It is expected that nurses will work on the calculations independently.

• Nurses cannot progress to the next level until all requirements have been met and final supervised practice has been completed.

• Nurses can only double check those drugs that they have received training on.

• All nurses must complete introductory level training but progressing further is not compulsory. The aim if for nurses to complete the introductory level as soon as they join, if possible, on induction day.

• Refresher courses are available for staff who request it, for example, those returning from maternity leave.

• There is no visible means of identifying the level of attainment reached by a nurse, staff just become aware through experience.

How staff felt before the programme was implemented

• Nurses, particularly those who had been in post for a long time, were hugely resistant to the idea of giving IV drugs as this was seen as the role of the doctor.

• Some nurses were concerned about taking assessments, and the potential stigma they might face if they didn’t pass a level or continue to attain higher levels.

• The programme was introduced in response to the number of errors that were identified by Pharmacy.

• IV drugs were previously administered by SHOs but because of workload issues there was often a problem with giving them on time. Thus it was decided that nurses would be trained to administer the most common IVs.

• It was agreed that there was a need to standardise practice through education. As such, standardised drug monographs were developed.

• A multi-disciplinary group was responsible for the development of the programme for nurses and doctors.

• Trust accredited the training programme, but it is not a formal Trust requirement.

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Education programme for doctors

• Induction programme for medical staff takes place every 4 months to coincide with rotations. This is a multi-disciplinary induction and lasts approximately 2 days.

• It is taught through a combination of workshops, lectures, practical demonstration and support on ward rounds either on medical or pharmacy ward rounds.

• Doctors take away advanced calculations to work through. There is a 2 week time limit for completing the drug calculations (this doesn’t appear to be enforced). All answers along with working out are submitted to pharmacy, who feedback on an individual basis.

• A 100% pass rate is required. Extra support is required for those that need it before completing the exercise and afterwards if required.

• A certificate is issued upon completion which is stored in their portfolio; a copy goes to their mentor.

A locum can be organised for those staff whose shift pattern would make it difficult for them to attend any session.

• For both nursing and medical staff there is ongoing assessment of ability to perform drug calculations and drug administration. If someone is having difficulties pharmacy offer extra support.

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How it works for neonatal nurses/ midwives

• The practice development nurse and pharmacy are responsible for organising training sessions for nurses.

• Nurses attend lectures organised by pharmacy and other departments (according to level). These can last up to an hour.

• For each level, nurses undertake theoretical training which includes completion of drug calculations (to take home) along with supervised practice.

• There is a 2 week time limit for completing the drug calculations (this doesn’t appear to be enforced). All answers along with working out are submitted to pharmacy, who feedback on an individual basis. 100% pass rate is required. Results are fed back to practice development nurse.

• If 100% is not achieved an individual teaching session will be organised. Further calculations will be given to try and identify what the problems are. If the nurse is still causing concern after this session they would be referred back to the practice development nurse.

• Most of the calculation work involves using drug monographs and the formulary (which can be accessed online), they are also encouraged to look at the preparation itself.

• Results from calculations exercise are fed back to practice development nurse.

• A training record for each level attained is stored in a Continuing Professional Development folder.

How it works for doctors

• Induction programme for medical staff takes place every 4 months to coincide with rotations. This is a multi-disciplinary induction and lasts approximately 2 days.

• Taught through a combination of workshops, lectures, practical demonstration and support on ward rounds either on medical or pharmacy ward rounds.

• Doctors take away advanced calculations to work through. There is a 2 week time limit for completing the drug calculations (this doesn’t appear to be enforced). All answers along with working out are submitted to pharmacy, who feedback on an individual basis.

• A 100% pass rate is required. Extra support is required for those that need it before completing the exercise and afterwards if required.

• A certificate is issued upon completion which is stored in their portfolio; a copy goes to their mentor.

Problems with implementation

• It took a considerable amount of time to change practice because of staff resistance.

• Staff who were joining the unit, already with quite a lot of experience, were not keen on being assessed.

How programme began to influence staff

• Began to encourage a close working relationship between medical/ nursing staff and pharmacy, who are seen as very approachable.

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• Staff feel that the structured education programme helps to reduce dose calculation errors (neonatal pharmacist noted that this reduction has been dramatic).

• A pre audit was conducted (the background error rate on the unit before programme was introduced) and over a period of time the number of serious incidents have decreased. However, because staff are more aware of the reporting system, the reporting of less serious incidents is actually increasing so overall numbers are looking broadly similar.

• Neonatal pharmacist noted that the lack of standardised practice nationally in treating neonates could make dose calculations less safe.

Advantages of structured education system

• Provides staff with an opportunity to become familiar with protocols and the formulary.

• Sessions were considered to be well organised, suitably comprehensive, yet informal.

• A lot of input and support from pharmacy in feedback back to staff when there are problems.

• Considered more in depth than programmes offered at other hospitals.

• Offers reassurance that staff are aware of what they are meant to be doing on the ward.

• Fulfils the college requirements for training of nurses and doctors.

• Pharmacy feel it is comprehensive, for example, nurses learn about pharmacokinetics- teaching them topics they wouldn’t normally have an opportunity to learn about.

• Staff have confidence in doctors’ competence on the ward knowing they have gone though the induction.

• Standardised practice. Disadvantages

• There are sometimes difficulties in arranging lectures and workshops, because pharmacy are often busy, and trying to organise a sufficient number of people to participate in order to make it worthwhile can be difficult (one nurse- from initial lecture to completion has taken approx six weeks, which was considered quite quick).

• Doctors felt that there was quite a lot of information to take on board (but felt it was difficult to get round this as they wanted a comprehensive programme)

• Some felt that errors made by doctors were due to workload and working hours rather than a gap in knowledge.

• One pharmacist felt that doctors making dose calculation errors were uncommon and errors were mainly omission mistakes.

How programme affected staff

• It is considered to be an effective and comprehensive programme which has been very well received by staff who have accepted the need to standardise practice.

• It is seen as a means to become familiar with systems and processes.

• Whilst some nurses were quite nervous about completing the calculation questions they tended to feel more confident when they completed them and pleased to be able to put certificates into their CPD folders.

• The programme is seen as especially useful for those coming straight from medical school or into a unit for the first time.

• Has encouraged a good working relationship between medical/ nursing staff and pharmacy staff who are seen as very approachable.

• No stigma now- nurses know their limitations and that is accepted.

• It makes staff more competent and confident.

• All staff would recommend a structured education programme to other hospitals.

• Neonatal pharmacist considers it relatively easy to set up a similar programme. However, would advise multi-site training rather than single site.

• Its success is reliant on the commitment of pharmacy and involvement from a multi-disciplinary team of staff.

Future plans

• Future intention to make the programme more computer based and interactive. Reducing the difficulties associated with organising pharmacy talks/ lectures. Some modules will be available on the intranet in a few months but is expected to be fully completed in 2-3 years.

• Would like to offer more practical sessions earlier on in the programme.

• To develop further multi-site training within the area. For example, through the use of video conferencing, which this site has begun to utilise.

• To extend the programme to postnatal nursing staff. This has begun, however, staff are very nervous about doing it, and up-take to date has not been very high although this could be due to conflicting shift patterns.

• The programme is still being fine tuned and pharmacy are still looking at what needs to be changed to improve it.

• Pharmacy would like to have input into the training doctors receive before they reach the unit e.g. while at University.

Systems Function


Context

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computers at home can be trickier

• Another SHO already felt confident but perhaps slicker

• Again better than experienced in previous places.

• Can be problematic if a member of staff is not deemed competent in terms of how they feel and how their peers feel.


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• CIVAS is available Monday to Friday 9-5. Medicines are prepared for the following 24 hours. Weekend preparations are made on Friday.

• Products prepared include Patient Controlled Analgesia (PCA), all IVs, Antibiotics, Monoclonal Antibodies, TTOs (including IV for Cystic Fibrosis patients at home).

• No TPN or Cytotoxic drugs prepared.

• The details of the preparation are transferred from an order form into a diary and is allocated a sequential batch number. The diary entry contains the date, name of the drug, number of doses and ward name.

• A pre-printed and authorised worksheet is completed. This contains the patient details, patient location, batch number, instructions for medicine preparation, equipment list, labelling instructions, manufacturer’s batch number and space for a preparation and final check signature.

• The Paediatric/ Neonatal worksheets have been authorised and signed off by the Paediatric Clinical Directorate Pharmacist.

• The Chief Technician signs the final check for the individual products before they leave the satellite.

• Once the worksheet is complete, labels are automatically generated and printed on a computer. Enough labels are printed for each syringe, each packet and one for the worksheet.

• The raw consumables are collected and checked before being placed into a one-way transfer hatch for two minutes.

• All consumables, syringes, vials and equipment are sterilised and sprayed with IMS and wiped with impregnated alcohol wipes and stowed in the isolator “in” hatch for two minutes to dry. They are then wiped again in the isolator and are ready for preparation. Once prepared the product is placed in the isolator “out” hatch for 2 minutes and then put in the one-way transfer hatch ready for the Chief Technician to make the final check.

• Products are prepared according to aseptic procedures, with final checks that the medicine and volume is correct, the preparation is accurate, the dose is complete, there are no leaks, and it is not contaminated. Orders are prepared according to morning or afternoon requirements on the wards. Satellite will prepare extras if necessary outside these times.

• Medicines are delivered to the ward by the satellite staff, although nurses do collect when they are very busy.

• Operators can be in the clean room for anything up to 3 hours at a time.

• Due to short staffing there is no rotation available.

• Technicians who work in CIVAS must attain the standard BTEC Pharmacy, Pharmaceutical Sciences. The chief technician at completed a written test along with a practical checking test assessing their ability to check and release aseptic products. The rest of the staff have to do be assessed as being competent to work in aseptic areas. It is an ongoing process.

• CIVAS staff had to undergo training, which included visiting the Unit, observing all aspects of the process, from when a product is ordered from CIVAS until it is sent to the wards. Furthermore, staff were trained by the pharmacists on how to check the products

• New nurses have to attend a competency based apprenticeship programme, which is tailored to meet their needs post-qualifying. The CIVA Service is discussed within this programme, and the nurses are given in-patient booklets which contain information about CIVAS.

• The Trust has an IV study day where a pharmacist or a representative from pharmacy provides a session on drug errors, drug treatment charts, how to access pharmacy, times and who to contact. Further information can easily be obtained from the ward pharmacist who is readily available as well as informative posters that are easily found on the wards.

• It was introduced pre-1984

• It was thought that it might be cost saving in terms of wastage.

• Introduced for good practice. Drugs being prepared in a controlled sterile manner. Safer than preparing drugs on the ward. All items checked against a prepared worksheet

Systems Function


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• Initially, CIVAS prepared 900 to 1,000 items a month. This has increased to 1,500 items a month

• Pharmacists visit the wards in the morning to identify the items that will be required for that day. Orders are rung through to the Satellite by 11.00am. A written Order Form is completed by the pharmacist. The Order Form acts as the pharmacist supervision for the product. The pharmacist does not complete the final check or sign for the release of the medicine back to the ward.

• It takes about 10-15 minutes to prepare a medicine in an emergency .

• On average it takes 20 minutes to prepare 1 item but up to 3 hours to prepare approximately 20 items.

• On the ward, nurses double check the label on the syringe and bag to check they have the correct patient.

• If a medicine is needed in an emergency, in less than 10-15 minutes, or when the Satellite is closed nurses use the treatment room on the wards to prepare drugs. Pharmacy will cover drugs which are very complicated but prefer nurses to use the protocols available on the ward.

• Full cleaning of the satellite occurs every morning. There is a sessional clean every time a product is made.

• There is a 2 stage checking process a) before the product is made; worksheet correct; calculations correct; labels match worksheet; sufficient ingredients in tray: b) final check of product signed by the Chief Technician.

• If ward staff identify a problem with the product it is returned and if there is any doubt the order is re-made

• Nurse welcomed the introduction of the service.

• Their main concern is having confidence in the products prepared by CIVAS because they have no way of double checking the contents and sterility of the items.

• Medical staff are encouraged to check with a nurse if IVs are prepared by CIVAS, and use their services for IV administration whenever possible.

• CIVAS staff have to be professional and competent.

• Through risk reporting, staff were trying to put in place a policy that would minimize the errors involved in processes such as drawing up of medication.

• If CIVAS is started in a hospital it must be used consistently or else it would increase many of the risk factors if a preparation is done on the wards at times and in CIVAS other times.

• If CIVAS satellite is very busy, they can call someone from the main CIVA to come and help. Discussing these problems with senior management makes managers more aware of the problems faced by CIVAS staff.

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Advantages:

• Staff working in CIVA Services are considered to be more experienced in making up children’s doses thus more likely to identify errors; the service has reduced drawing-up errors as well as dose calculation errors (there is no clear evidence to support this but it is expected since CIVAS staff are more experienced)

• CIVAS is considered efficient and any errors that might occur (usually labeling) are perceived as negligible compared to the number of preparations that they produce.

• It reduces the potential for error, especially when the ward is very busy and many IVs need to be made up.

• It provides a more peaceful and quiet environment to work in, as opposed to a busy ward where staff are constantly harassed and interrupted.

• There have been many documented errors caused by the misplacement of the decimal point when diluting medication for neonates; with CIVAS it is checked by at least 3 different people, reducing the risk of error.

• The CIVA service has a satellite clinic just off the ward where drugs can be prepared. The location is considered very convenient making the clinic indispensable to the staff on the wards.

• CIVAS preparations are double checked when sent on wards, and this can be seen as another site for double checking the formulations.

• Having antibiotics pre-made and pre-drawn is helpful for the patients, especially parents of CF children because they can take the IV antibiotics home and administer it themselves as such children do not have to remain in hospital.

Disadvantages:

• The biggest complaint regarding CIVAS is that there is no out of hours service.

• This is problematic on very busy weekends, and especially if wards are understaffed.

• If CIVAS is very busy drugs may not be prepared on time and nurses have to make them on the wards.

• In an emergency situation preparation might take too long and drugs are made on the wards.

• Can cause problems for the ward pharmacist having to have the orders sent to the satellite by 11.00am.

• Has increased length of pharmacy ward rounds.

• Not enough staff to work on rotation.

• Not enough staff for CIVAS to offer extended/out of hours service.

• There are worries that the CIVA service could be deskilling nurses because they are not regularly preparing IVs possibly causing them to lose competency and proficiency.

• Staff try to encourage doctors to rely on CIVAS rather than attempting to draw up an IV, in order to decrease the potential for error

• CIVAS gives prescribers more confidence that their prescriptions are being double checked and will be drawn up and administered appropriately

• The Satellite staff are encouraged to extend their knowledge and interest by reading product information and keeping up to date with aseptic techniques. Staff become more experienced.

• CIVAS can prepare IVs faster than on the wards because the protocols are easily available and the staff are more experienced.

• Some nurses have concerns about IVs prepared by CIVAS, because they have no way of double checking the content and sterility of the product.

• Although labels are checked nurses have to rely that the requested drugs have been prepared accurately. Nurses can not double check the product themselves. Staff believe that it is a very robust and useful system.

• It is valued for time saving and staff have come to rely on the service.

• It is mainly described as an excellent service.

• Nurses are not concerned that it could deskill them because they still prepare IVs when CIVAS is not available..

• Most staff would recommend CIVAS to other hospitals. Although it is very expensive, the amount of errors that it prevents makes it very worthwhile.

• CIVAS is considered to improve the relationship between manager and staff because the manager will strategically plan for better support and ways to move forward with the service

• The service reduces the ward workload because it stores all the items needed for IV preparation and cuts down the risk of error.

• It is positioned off the wards and is very easily accessible for staff.

• Consumables may be expensive but in the long term reduces waste.

• Possibly cheaper to employ technicians than extra nursing staff to prepare drugs.

• There are hopes to extend the hours of service. This may not be financially viable at the moment, but it is hoped that the reducing errors will be seen as positive investment for the Trust.

• It is hoped that CIVAS will branch out into other areas such as TTOs

• There were plans to purchase second isolator, but there was no space for it.

• Staff feel that both Paediatric and Neonatal patients would benefit from extending the existing service.

• CIVAS is an important service and is recommended to other hospitals, unless demand is too small rendering it not cost-effective in terms of waste and space.

• Staff may become deskilled

• Staff believe that it is a sustainable system.

• Understaffing may be an issue.


Systems Function

Human Perspective


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• A CIVA service has been in operation for approximately 10 years.

• Staff include: 3 technicians (1 rotational); 2 3/4

assistants; 1 pharmacist

• CIVAS is located in a specially constructed unit, which contains two isolators; a half unit for preparing TPN and a separate unit for preparing Cytotoxic drugs. There is also an area for checking calculations (BNFC available), preparing worksheets, telephone, visitors. This is situated before entering the sterile part of the unit.

• Staff can access the unit using the keypad entry system; visitors can use the bell to alert staff.

• CIVAS is available Monday to Friday, 8.30am to approx 17.30pm and Saturday mornings.

• Drugs are prepared in advance, where possible, to cover times when the service is not available.

• If a new patient is admitted, outside of opening times, doses will be made up on the ward.

• It can take the CIVAS unit between 5 and 30 minutes to prepare a drug(s).

• Drugs can be provided in an emergency situation, however the delivery time will depend on the drug required and how complex it is to prepare. The maximum time it should take is approx 30 mins.

• The Portfolio of drugs prepared by the unit covers most of the products used on the ward. If a drug required is not in the portfolio (these tend to be one off doses) it may take longer to prepare as the unit has to research the stability of the drug etc.

• Morphine cannot be prepared as doses are not standardised and it is not administered at set times.

• Orders are prioritised. Each worksheet is allocated a paperclip so it is easily identifiable to staff at what time the drug is required (red for 12pm; blue for 2pm; yellow for 4pm).

• All requests for drugs are encouraged to be in by 4pm, but in the main are tied to ward rounds. ICU have a 2pm microbiology round and so unit waits for results to come back before preparing drugs, to avoid wastage.

• Technicians and assistants are responsible for most of the hands on work carried out by the unit but a pharmacist checks the medicines before they are released to the ward.

Training

• Assistants complete an NVQ Level 2. Technicians complete an NVQ level 3. Both the NVQ level 2 and 3 are completed on-the-job and take approx 6 months.

• When technicians are familiar with the routine of the unit and competent in preparing IVs they are allowed to perform calculation checks.

• New pharmacists working in the unit will be trained to perform and check calculations and produce worksheets. They take a small test to determine competency.

• Training is skewed towards new joiners. However, if staff want to take further courses they can.

• Staff who have not previously worked in a CIVA service have to pass a Broth test. They are trained in aseptic preparation followed by a series of tests and validations which they are expected to pass.

• Staff have a training folder containing details of the training completed.

Staff opinion of CIVAS before implementation

• Possible scepticism among medical staff who felt it might not make a great deal of difference.

• Others felt it would help to reduce workload on the wards.

• CIVAS was introduced in response to requests from medical and nursing staff for an initiative to release medical and nursing time on the wards.

• CIVA was also seen as a service that would reduce the risk of errors and a means to reduce wastage and concomitantly save money.

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• Staff wash their hands thoroughly and use hand scrub, wear gowns, gloves, hats and masks (masks - especially if there is any risk that they have an infection such as a cold).

• The service can also prepare TTA drugs, for example, chemotherapy and IVs administered at home but are rarely required to do so.

• If the wards are busy, workload concomitantly increases in the CIVA unit. Both isolators are not always in operation, so in times of high demand the second isolator can be opened to relieve the load.

Systems Function

Human Perspective


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Process

• Every morning, ward pharmacists visit their allocated wards and check drug cardexes, as well as identifying any new drugs and IVs that are required. This information is written up in a notebook.

• The information is taken to the unit and a worksheet is written up for each patient. Worksheets detail the drugs required and dosages. NB the worksheets enable subsequent days’ requirements to be listed, so a new worksheet is not required each day.

• Worksheets are pre-printed and have information about the following: drug presentation; reconstitution; administration; stability; information from the CIVAS manual. Worksheets are kept in the unit to avoid contamination from the ward.

• Calculations are checked before being placed in the hatch for transfer to the aseptic unit.

• The worksheet is allocated a batch number. It is also entered in a book which has the patients name, date, drug name and initials of technician. The batch number reflects how many items have been dispensed per month.

• Labels are prepared for the order. These are computer generated and printed automatically. One extra label is printed and is attached to the worksheet so the batch number and product information can be traced back to the unit. The technician initials on the worksheet that the labels have been printed.

• Each product is prepared on an individual tray onto which all the consumables are placed e.g. vials, syringes, drugs etc. The tray and worksheet are placed in the one-way “in” hatch.

Aseptic room

• The aseptic room has the 2 isolators and a half unit for the TPN.

• The contents of the tray are sprayed with industrial methylated spirit (IMS) before being placed in the isolator hatch. This is time locked for 2 minutes.

• The worksheet is placed at the side of the isolator and is reviewed by the operator. The isolators have a Baxter Repeater Pump (calibrated every morning at 10ml and then 20 ml and then another check at 15ml). This gives pre-set volumes of dilutant.

• The operator swabs all the items in the tray again and prepares the drug. The completed drug and all items (apart from sharps) are placed in the transfer hatch of the isolator. This is time locked but for only 1 minute. The operator initials the worksheet.

• All the items are kept so that the pharmacist can check the product has been made to the right constitution. The tray is placed in the one-way “out” hatch and transferred to the cooler unit for checking by the pharmacist.

Reaction to implementation

• Reaction to the implementation of the system was positive.

• The service was quickly accepted as the norm.

How service has affected staff organisation

• New staff were employed.

• Ward pharmacists became responsible for recording all IV drugs required for their allocated ward and liaising with the CIVAS unit, which increased workload.

• The workload for nursing staff decreased as nurses were no longer required to prepare all of IV drugs on the ward only those for new patients and doses needed outside of CIVAS operating hours and those not prepared in advance. Considered to have facilitated a team approach to work.

Systems Function

Human Perspective


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• If an infusion or infuser is being prepared the operator will prepare the drug but then ask for a second checker. This can only be a technician or a pharmacist – not an assistant. If it is a bag the dilutant is checked as well as the drug and the patient’s initials and drug name are put on the bag in case the tray gets knocked over and prevents medicines getting mixed up. Multiple bags are capped off one by one in order to prevent drugs being added twice.

• The pharmacist checks the medicine for accuracy, that it’s not leaking, that the labels are correct, that it is the right patient and ward and the correct volumes in the syringes or bags. The pharmacist initials the worksheet and the medicine is released, bagged and sealed by the assistant and either placed in the cooler unit or worktop (if to be kept at room temperature) until it is delivered or is collected by the ward

• Assistants can check labels but are not able to check worksheets

• There is a log book in the clean room where operators sign in and out.

• Operators work on rotation for a couple of hours max. This is to avoid operator fatigue.

• Two nurses check the product on the ward. NB One nurse noted that not all doses are checked depending on expertise of staff who have been trained long enough to “look at a dose and know it seems right”.

• Drugs are made up in advance to cover the periods when the unit is closed, for example, on Fridays.

• Senior staff are supposed to meet once monthly, at which suggestions for improvements to the unit can be discussed. However, these have fallen by the wayside.

• Staff feel comfortable approaching senior members of the unit if they have suggestions for improving the service provided.

Implementation

• The service took approx 6 months to introduce, including the time involved in setting up the new unit.

• New staff were employed to work in the unit. Problems with implementation

• In response to the Farwell report isolators had to be shut down and a full aseptic unit developed.

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• Staff feel that the service can prevent dose calculation errors.

• The service has met the expectations of staff.

• The service is expensive to implement but staff feel the benefits warrant the expenditure required.

Advantages

• Reduces the number of drugs that have to be made up on the ward and reduces the workload for nurses.

• Cuts the cost in preparation of drugs.

• Cuts wastage of drugs.

• It is considered better to prepare drugs in a unit specially developed for that purpose, rather than on the wards where there are other distractions.

• Products are aseptically prepared, so the aseptic quality of the product is greatly improved, whereas on the ward comparable facilities do not exist.

• Having a ward pharmacist visit the ward every day facilitates knowledge transfer and nurses feel that they have a better understanding of the drugs that they administer.

• Parents and patients can become familiar with the ward pharmacist and if there is a pharmacy issue they have an opportunity to discuss it with a pharmacist on a one to one basis.

• Having standard protocols for infusions and concentrations helps to ensure that infusions are given in the correct way.

• Using set worksheets with set calculations can ensure that stability information etc is correct for each product.

Disadvantages

• Some staff feel that nurses have become reliant on the service and deskilled in terms of preparing drugs. NB nurses still prepare drugs on the ward, for example, outside of the opening times of the service, or when a new patient is admitted.

• Nurses may be less likely to perform adequate checks because they know that the drug should have already been checked by staff working in CIVAS.

• When doses are prepared in advance, wastage is more likely.

• Whilst drugs will be double checked by nurses before they are administered, this check is against the label that is on the syringe or bag. Staff are reliant on that label being correct.

• If the unit is short staffed there may be delays in delivering drugs to the ward.

• CIVA is a service valued by medical staff, nurses and pharmacists alike.

• The service is considered to have increased communication between staff working on the wards and in the CIVAS unit. Medical staff are more likely to inform pharmacy when changes are made to cardexes, and when introducing new medications. This helps to prevent wastage.

• It has increased communication and improved the working relationship between ward staff.

• It is thought to have facilitated a team approach to work.

Recommendations

• Staff would recommend CIVAS to other hospitals.

• The appropriate resources need to be available i.e. space, facilities, finances to cover set up, maintenance and staff costs.

• Setting up the service requires the development of appropriate, easy to use worksheets and labelling system.

• Organising how the service will work and interact with the routine of ward round.

• It is important to have a contingency plan if the service breaks down.

Future plans

• Agenda for Change may impact upon service provision in this area.

• Current resource issues restrict the expansion of the service.

• Pharmacy hope to introduce an assessment tool based on NVQ standards to ensure staff continue to work to the level to which they have been trained.

• To explore the possibility of pharmacy technicians visiting the wards to collect information regarding the IV drugs prescribed.

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• Labels can be obscured when using small syringes.

• Resource issues can impact upon the time it takes to get drugs delivered to the ward, which means that, on occasion, a dose may be missed or given late.

• The service breaks down up to 3 times a year, leaving the hospital reliant on the CIVAS service provided at the nearby general hospital, and nurses on the ward to prepare drugs.

• The service is not available 24hours a day, 7 days a week.

Report to the Department of Health

Co-operative of Safety of Medicines in Children (COSMIC): Scoping study to identify and analyse interventions used

to reduce errors in calculation of paediatric drug doses

END

Documents

Co-operative of Safety of Medicines in Children (COSMIC ... · 1.1 Background 14 1.2 Medication errors 14 1.3 Paediatrics 15 1.4 Causes of paediatric dosing errors 16 1.5 Aims and