The National Patient SafetyAgency (NPSA) has identified

oral anticoagulants and heparin asmajor causes of adverse events andhospital admission. According to itsresearch, anticoagulants are impli-cated in 8-10 per cent of pre-ventable drug-related admissions1,2

and are increasingly associated withadverse incidents, including somefatalities, reported to medicaldefence agencies (see Figure 2).3

The NPSA lists 15 high-risksteps in the use of anticoagulants,reflecting shortcomings in allaspects of management (see Table1).3 Its response is a new patientsafety alert (see Figure 1), backedup by a comprehensive range ofsupport materials.4

The deadline for agreeing anaction plan and starting implemen-

tation is 2 July 2007; all actionsshould be completed by 31 March2008.

What is a patient safetyalert?There are three formats by whichthe NPSA disseminates its adviceand recommendations for solvingproblems:• patient safety information suggestsissues or effective techniques thathealthcare staff might consider toenhance safety• safer practice notices strongly adviseimplementing particular recom-mendations or solutions• patient safety alerts require promptaction to address high-risk safetyproblems.5

A patient safety alert includesconcise and detailed summaries of

the action the NPSA recommendsto tackle a particular risk. It isaddressed to the relevant bodies inthe NHS and independent healthsectors, eg acute trusts or all organ-isations, and identifies which per-sonnel should take action andwhich other staff should beinformed.

The anticoagulant alert is foraction by the chief pharmacist orpharmaceutical adviser inEngland and Wales and responseby all NHS and independent sec-tor organisations.

Alerts are published in full onthe NPSA’s web site (www.npsa.nhs.uk) and form part of theDoH’s Safety Alert BroadcastSystem.6 There are four categoriesof alert (see Table 2); the anticoag-ulant alert calls for ‘action’.

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Analysis

Safer use of anticoagulants: theNPSA patient safety alertSteve Chaplin MSc, MRPharmS

Steve Chaplin describes the

NPSA’s anticoagulant patient

safety alert and the mea-

sures it recommends for

making the supply and

administration of anticoagu-

lant therapy safer.

Figure 1. The anticoagulant patient safety alert calls for action to be taken, highlight-ing 15 high-risk factors and listing nine action points to improve patient safety

Making anticoagulantssaferThe anticoagulant alert includes alarge number of documents fordownloading from the NPSA web-site. These include: the patientsafety alert itself, a briefing forpatients, educational modules forhealth professionals, detailedwork competencies for differentaspects of using anticoagulantsand a summary of the NPSA’s con-sultations.

An additional section containsstandards and guidelines of theBritish Society of Haematology(BSH), and information forpatients and carers includes analert card, a treatment record formand a treatment record booklet.

Actions to improve safetyThe patient safety alert lists nineaction points covering staff train-ing, clinical protocols, anticoagula-tion services, patient information,monitoring standards, standardis-ing prescribing and improving safepractice in social care settings (seeTable 3).

Staff competencyTraining in the use of anticoagu-lants should be provided to staff.This includes not only doctorsand nurses but also medical stu-dents, pharmacists and biomed-ical scientists.

The NPSA has developed sixwork competencies for initiatingtreatment, maintaining treatment,management in patients needingdental surgery, dispensing oralanticoagulants, preparing andadministering heparin, andreviewing the safety and effective-ness of services. This is supportedby two e-modules on the BMJ e-learning website covering the ini-tiation and maintenance oftreatment. The competencies donot include the use of anticoagu-lants in children.

The competencies are intendedfor adaptation to local practice butat the same time the NPSA wants toensure that skills are transferablebetween organisations and health-care sectors.

Revised competencies will bedeveloped by Skills for Health

( w w w. s k i l l s f o r h e a l t h . o r g .uk) following consultation withstakeholders.

Updating proceduresAll organisations should have writ-ten procedures on the use of oraland injectable anticoagulants,based on standards set out by theBSH (www.bcshguidelines.com).These should cover risk assessmentof treatment, providing patientinformation, initiating, adjustingand monitoring treatment, safedocumentation, communication,annual review and treatment dis-continuation.

AuditThe NPSA and the BSH havejointly developed safety indicatorswith which to audit the initiationand maintenance of treatment;these are provided as part of thealert. For example, indicators forpatients established on treatmentinclude the percentages with INR(international normalised ratio)>5.0 or >8.0, and the percentagesuffering adverse outcomes such asa major bleed.

Indicators to audit the safe useof heparin are not included andshould be developed locally.

The audit results should beused to improve services as part ofclinical governance but also to aidperformance management by com-missioners. A template audit formis available online.

Patient informationPatients should be given verbal andwritten information about theirtreatment before the first dose ofanticoagulant is administered; thisshould be recorded in the notes.The messages should be reinforcedon discharge from hospital, at thefirst clinic appointment, and whennecessary thereafter.

The BSH has revised the yel-low booklet for patients, which is

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Analysis

Figure 2. Number of reports involving anticoagulants received by the MedicalDefence Union, 1977-2002 (from reference 3)

25

20

15

10

5

0

Number of adverse events involving prescribing, supply oradministration of anticoagulant therapy

19771980

19851990

19952000

2002

Year of notification

now titled Oral AnticoagulantTherapy: Important Information forPatients. It has three sections: acredit card-sized alert card to becarried by the patient, generalinformation about anticoagulanttreatment and a record of INRresults, doses and clinic appoint-ments. These records should bemaintained even when patientsare in hospital.

The booklets are available in arange of languages and can bedownloaded from the NPSA website.

NHS trusts and others can orderhard copies from NHS suppliers.

Checking INRA repeat prescription should notbe issued unless the patient is reg-ularly attending the clinic, the INRis within safe limits, and the patientunderstands what dose to take.This information should be addedto the patient-held record.

Responsibility for ensuring thatit is safe to issue or dispense arepeat prescription lies with the

prescriber and the pharmacist.Prescribers should check thepatient-held record and obtain anymissing data that are needed.Pharmacists should not assume thishas been done and should checkthe record for themselves.

Drug interactionsWhen possible, drugs should be pre-scribed that do not interact withanticoagulants. When this is notpractical, the health professionalswho prescribe or dispense othermedicines must ensure that patientsare aware of the potential effect oftheir new treatment (or the effectsof discontinuing an establisheddrug). They should be instructed tohave an INR test within four toseven days and tell the clinic why;

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20 Prescriber 19 May 2007

High risks identified 1. Not all staff who prescribe and monitor anticoagulants have received the

necessary training and have the required work competencies. 2. Inadequate clinical audit of anticoagulant services and/or failure to act on

audit results to improve the service. 3. Failure to initiate anticoagulant therapy (including thromboprophylaxis)

where indicated. 4. Poor documentation of reason and treatment plan at commencement of

therapy. 5. Prescribed wrong dose or no dose of anticoagulant (especially loading

doses). 6. Unconsidered co-prescribing and monitoring of NSAIDs and other inter-

acting medicines. 7. Incorrect selection, preparation and administration of heparin products. 8. Unsafe arrangements and communications at discharge from hospital. 9. Insufficient support and monitoring of warfarin therapy for the first 3

months and for vulnerable groups. 10. Inadequate safety checks at repeat prescribing and repeat dispensing in

the community. 11. Confusion over anticoagulant management for dentistry, surgery and other

procedures. 12. Nonstandardised supply/use of 0.5mg, 1mg, 3mg and 5mg tablets. 13. Yellow book (patient-held information) in need of revision and translation

into other languages. 14. Inflexible medicines presentations and arrangements in care homes to

implement anticoagulant dose changes. 15. Inadequate Quality Assessment (QA) for near-patient testing equipment.

Important observations Failure to implement professional guidelines concerning the prescribing, coun-selling, monitoring and administering of anticoagulants is an important under-lying problem identified by the risk assessment process. It has beenperpetuated by local failure to audit anticoagulant services effectively, to acton audit results to improve clinical and process outcomes, and to alert clinicalgovernance structures in NHS organisations to the extent of the risk.

Table 1. High-risk factors in the management of anticoagulants highlighted in thepatient safety alert

Immediate action: Used in caseswhere there is a risk of death orserious injury and where the recipi-ent is expected to take immediateaction on the advice.

Action: used where the recipient isexpected to take action on theadvice, where it is necessary torepeat warnings on long-standingproblems, or to support or follow-up manufacturers’ field modifica-tions.

Update: used to update the recipi-ent about previously reported inci-dents or series of incidents,possibly on a topical or devicegroup basis, and where further fol-low-up safety information is judgedto be beneficial.

Information request: used to alertusers about a specific issue thatmay become a problem and wherefeedback is requested. These alertswill be sent out with additionalquestions to be completed.

Table 2. Patient safety alert categorydescriptions

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subsequent tests and dose adjust-ments are carried out by the clinic.

Dental treatmentIn most cases, dental treatmentcan proceed as normal and nochange to anticoagulant therapyis needed.

Every dental practice inEngland and Wales is to receive aposter, developed by the NPSA,BSH and the British DentalAssociation, outlining safe practice.A patient leaflet in a range of lan-guages is available from the NPSAwebsite.

Standardising anticoagulantsThe NPSA has found wide variationbetween NHS organisations in thesupply and dosing methods for war-farin. It recommends standardisa-tion according to principlesdeveloped by patients and carergroups:• use the least number of tabletseach day• use constant daily dosing, notalternate-day dosing• do not use half tablets.

All strengths of warfarin tabletsshould be used to implement theseprinciples. Doses should beexpressed as mg and not numberof tablets.

Ad hoc dilution of concentratedheparin solution for intravenousinjection should be minimised.The NHS should standardise on aready-to-administer heparin solu-tion of 1000units per ml inampoule, vial or prefilled syringe.When prescribing, doses should beexpressed as ‘units’, not ‘U’.

Social settingsWritten policies for medicines usein care homes should include a spe-cific section on oral anticoagulants.Written confirmation of dosageshould be included in the medi-cine administration record; verbalinstructions should be followed

only in emergencies and should beconfirmed in writing.

Anticoagulants should not beincluded in monitored dosage sys-tems because they are not suffi-ciently flexible to accommodate

frequent dose changes. Instead,oral anticoagulants should beadministered from original packsdispensed for individual patients.

Health professionals shouldensure that the latest prescribed

1. Ensure all staff caring for patients on anticoagulant therapy have the nec-essary work competencies. Any gaps in competence must be addressedthrough training to ensure that all staff may undertake their duties safely.

2. Review and, where necessary, update written procedures and clinical pro-tocols for anticoagulant services to ensure they reflect safe practice, andthat staff are trained in these procedures.

3. Audit anticoagulant services using BSH/NPSA safety indicators as part ofthe annual medicines management audit programme. The audit resultsshould inform local actions to improve the safe use of anticoagulants, andshould be communicated to clinical governance and drugs and therapeu-tics committees (or equivalent). This information should be used by com-missioners and external organisations as part of the commissioning andperformance management process.

4. Ensure that patients prescribed anticoagulants receive appropriate verbaland written information at the start of therapy, at hospital discharge, on thefirst anticoagulant clinic appointment, and when necessary throughout thecourse of their treatment. The BSH and the NPSA have updated thepatient-held information (yellow) booklet.

5. Promote safe practice with prescribers and pharmacists to check thatpatients’ blood clotting (INR) is being monitored regularly and that the INRlevel is safe before issuing or dispensing repeat prescriptions for oral anti-coagulants.

6. Promote safe practice for prescribers co-prescribing one or more clinicallysignificant interacting medicines for patients already on oral anticoagu-lants; to make arrangements for additional INR blood tests, and to informthe anticoagulant service that an interacting medicine has been pre-scribed. Ensure that those dispensing clinically significant interacting med-icines for these patients check that these additional safety precautionshave been taken.

7. Ensure that dental practitioners manage patients on anticoagulantsaccording to evidence-based therapeutic guidelines. In most cases, dentaltreatment should proceed as normal and oral anticoagulant treatmentshould not be stopped or the dosage decreased appropriately.

8. Amend local policies to standardise the range of anticoagulant productsused, incorporating characteristics identified by patients as promotingsafer use.

9. Promote the use of written safe practice procedures for the administrationof anticoagulants in social care settings. It is safe practice for all dosechanges to be confirmed in writing by the prescriber. A risk assessmentshould be undertaken on the use of Monitored Dosage Systems for anti-coagulants for individual patients. The general use of Monitored DosageSystems for anticoagulants should be minimised as dosage changes usingthese systems are more difficult.

Table 3. Nine action points listed in the patient safety report for implementation toimprove patient safety

dose is provided for patients livingin the community who use compli-ance aids.

SummaryThe NPSA’s alert on anticoagulantsis a comprehensive and detailedpackage of practical measures toimprove safety in clinical practice.It is relevant to everyone in pri-mary and secondary care involvedin supplying or monitoring treat-ment and offers an achievablemeans of reducing the morbidityand mortality associated with anti-coagulants.

References1. Howard RL, Avery AJ, Slavenburg Set al. Which drugs cause preventableadmissions to hospital? A systematicreview. Br J Clin Pharmacol 2007;63:136-47.2. Pirmohamed M, James S, Meakin S etal. Adverse drug reactions as a cause ofadmission to hospital: prospectiveanalysis of 18,820 patients. Br Med J2004;329:15-9.3. National Patient Safety Agency. Riskassessment of anticoagulant treatment.January 2006 (www.npsa.nhs.uk/site/media/documents/2506_NPSAanticoagulantriskassessment2006.pdf;accessed 2.4.07).4. National Patient Safety Agency.Actions that can make anticoagulantssafer. (www.npsa.nhs.uk/health/display? contentId=5754; accessed2.4.07).5. National Patient Safety Agency. Asummary of the NPSA’s disseminationprocess. (www.npsa.nhs.uk/health/alerts/formats?contentId=3092;accessed 2.4.07).6. Department of Health. Welcome tothe Safety Alert Broadcast System(www.info.doh.gov.uk/sar/cmopatie.nsf; accessed 2.4.07).7. National Patient Safety Agency.www.npsa.nhs.uk/site/media/documents/2436_Anticoag_alert_FINAL.pdf accessed 12/04/07.

Steve Chaplin is a pharmacist whospecialises in writing on therapeutics

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