Reporting

Patient Focused Products

David Cousins

What Is Patient Safety?

Patient safety is the freedom from accidental injury in health care.

A patient safety incident is any unintended or unexpected incident which could have or did lead to harm for one or

more patients receiving NHS funded healthcare.

This is also referred to as an adverse event/incident, mistake or clinical

error, and includes near misses.

ERROR TYPES – based on the work of James Reason

Unsafeacts

Unsafeacts

Unintendedactions

Intendedactions

Mistakes

Violations

Basic error types

Skill based errorsAttentional failures

Skill based errorsMemory failures

Rule & Knowledge Based errors

RoutineReasoned

Reckless & Malicious

Slips

Lapses

Learning from other safety critical industries

To minimise patient safety incidents, the NHS should learn from other safety-critical industries and target the underlying systems failures.

The Importance of Design for Patient Safety

2003 http://www-edc.eng.cam.ac.uk/medical/

Human factors – confront two myths

• The perfection myth.

– If people try hard enough they will not commit patient safety incidents.

• The punishment myth.

– If we punish people when they make patient safety incidents they will make fewer of them.

The Seven Steps to Patient Safety.NPSA

(2003).

EU DIRECTIVES ON MEDICINE PRODUCTS

• Currently do not require design or user testing to:

• Take into consideration human factor considerations

• Safety in use

• Or pharmacovigilence of these factors – which are usually classified as ‘user error’

European Initiatives for Improving Medication Safety

Committee of ExpertsOn Safe Medication Practice

Council of EuropeReport 2006

Forms of NPSA Advice

• A patient safety alert requires prompt action to address high risk safety problems

• A safer practice notice strongly advises implementing particular recommendations or solutions

• Patient safety information suggests issues or effective techniques that healthcare staff might consider to enhance safety

NPSA Safe Medication Practice Activity

• Potassium chloride• Oral methotrexate• Confusing labelling, packaging

and presentations• Vaccines• Diamorphine and morphine

• Epidural infusions• Wrong route errors • Injectable Medicines• Anticoagulants• Paediatric Infusions• Dispensed medicines

• Psychotropic medicines• Insulin• Lithium • Medication histories on admission and

discharge

Purchasing for Safety

• Risk assessment of products as part of healthcare contracting and purchasing.

• Safety before price; purchase products with the following:– Clear labelling and packaging.– Well differentiated from similar products to prevent

misidentification.– Appropriate secondary and warning labels.– Bar codes.– Ready to administer/use or simple preparation and

administration.– Adequate information for practitioners, patients and

carers.

Diamorphine and Morphine Injections• Between 2000 and 2005 there have been seven published

case reports of deaths due to the administration of high dose (30mg or greater) diamorphine or morphine to patients who had not previously received doses of opiates.

• Between January and October 2005, the NPSA received 16 reports of similar patient safety incidents of which two had resulted in the death of the patients.

Diamorphine and Morphine Injections

• Many of these incidents involved diamorphine and morphine 30mg ampoules being selected in error for lower strength ampoules and overdoses were administered.

• In addition 30mg doses or higher were sometimes prescribed as first doses for patients who had not previously received doses of opiates and this can result in overdose, respiratory depression, loss of consciousness and death if support procedures are not implemented.

Problems with labellingAmpoule Labelling

Ampoule Labelling

Repevax and Revaxis Vaccine

• In January 2005 the NPSA received a report that 93 teenage school children were vaccinated with Repevax instead of Revaxis.

• Repevax (diphtheria, tetanus, 5 component acellular pertussis, and inactivated polio vaccine dTaP/IPV) This vaccine is supplied as a pre-filled syringe and is administered by intramuscular injection as a pre-school booster following primary vaccination. The vaccine may be given from the age of three years onwards.

• Revaxis (tetanus, diphtheria and inactivated polio vaccine Td/IPV)This vaccine is supplied as a pre-filled syringe. The vaccine may be administered by intramuscular injection from the age of six years, and may be used for adolescents and adults as a booster following primary vaccinations.

Royal College of Arts / NPSA January 2006

www.npsa.nhs.uk

Critical Information In The Same Field of Vision On At Least Three Non-Opposing Faces

Orientate Text In The Same Direction

Use Blank Space To Emphasise Critical Information

Use Colours To Differentiation to Highlight Information

Optimum Font Size, Font, and Spacing

Do Not Use Trailing Zero’s

Use of Tall Man Lettering to Differentiate Look Alike and Sound Alike Names

Allocate Space for a Dispensing Label

Put Medicine Name and Strength Clearly on Each BlisterUse Non-reflective Foil

Match Styles of Primary and Secondary Packaging

Machine Readable Codes On Medicines

Poor Systems of Use

Ready to Administer Products

Conclusion

• It cannot be assumed that all medicine products are equally safe in use.

• Risk assessment and purchasing for safety initiatives are integral to the NHS Patient Safety Strategy

• The NHS should clearly specify to industry the patient safety requirements for medicine products ( these may exceed those required by the EU Medicines Directive)

• NPSA safer practice recommendations will increasingly include purchasing for safety and supply chain initiatives.