risk assessment grid - sps · risk assessment grid this risk assessment grid accompanies the...

Risk assessment gridThis risk assessment grid accompanies the NPSA’s Risk assessment of anticoagulant therapyreport. In the report, 66 individual risks associated with the current systems for usinganticoagulants were identified. This grid details these risks and their scores.

The risks are scored using a risk assessment matrix. For a full explanation of the risk assessmentmatrix, see page 33 of Risk assessment of anticoagulant therapy. The possible safer practicesolutions for anticoagulant use that are referred to in the grid are explained on page 3 of Riskassessment of anticoagulant therapy.

The grid is separated into the following stages of the anticoagulant process:

• Decision to treat

• Document and communicate diagnosis and treatment plan

• Arrange monitoring

• Prescribe

• Prepare/dispense/supply

• Administer dose

• Monitor treatment

• Discontinue treatment

• Communication with patient: use of yellow book/patient held information

2 Risk assessment of anticoagulant therapy Risk assessment grid

National Patient Safety Agency January 2006 ©

Decision to treat

Undesired event Cause

Currentpreventive and mitigationmeasures

Current riskAdditionalpreventative andmitigationmeasures

Riskswith allaction

F C R F C R

Clinical thrombotic event,e.g. stroke, PE, DVT.

Failure to initiateanticoagulant therapywhere indicated.

Secondary care

Surgical thromboprophylaxis.

Inadequate consideration of thrombosis inpre-operative assessment.

Therapeutic guidelines. 6 C H No change. 6 C H

Secondary care

Thromboprophylaxis of non-surgicalpatient.

Inadequate consideration of thrombosis inmedical assessment.

6 C H No change. 5 C H

Primary and secondary care

Misdiagnosis.

Failure to check the requirement foranticoagulant therapy in higher risk patients.

Service capacity issue – reluctance toincrease patient numbers on anticoagulants– continue to use aspirin when patient maybenefit from warfarin therapy.

Lack of knowledge and use of treatmentguidelines when therapy should beinitiated.

Conflicting treatment guidelines.

Inadequate review of previous medical history.

Absent or incomplete medical andmedication history available. Wronginformation or lack of information.

Fear/reluctance to prescribe due to risk ofbleeding/stroke – especially in elderly.

National ServiceFramework (NSF)guidelines for atrialfibrillation (AF) –although reviews todate have focused uponthe costs of prescribing rather than audit patient outcomes.

Education and training.

5 D H No change. 5 C H

Failure of patient to seek treatment. 6 D H No change 6 D H

Key:F = FrequencyC = ConsequenceR = RiskH = High riskM = Medium risk L = Low risk

Decision to treat




Riskswith allaction

F C R F C RBleed.

Anticoagulant prescribedfor patient with contra-indication.


Absent or incomplete medical andmedication history available. Wronginformation or lack of information.

Difficult to find information in notes.

Failure to consider risk versus benefit.

Delegated to individual with inappropriateknowledge or skills (e.g. junior doctors).

Lack of time.

Failure to fully consider medical andmedication history prior to prescribinganticoagulants.

Case notes unavailable in clinic – absenceof records.

Failure to do pre-treatment INR.

Consideration of complementary therapy,e.g. St John’s Wort.

Information is collectedfrom any/all availablesources including GPpre-admission letter, GPnotes, patient-heldrepeat prescription,previous hospitalrecords, and verbalinformation of patientor carer.

5 B M Proposed saferpractice solutions1, 2 and 5.

4 B L

Bleed.

Inappropriate initiation ofanticoagulant treatment.

Treated for suspected DVT. Baker cyst –reason for swollen leg. No need fortreatment.

Doppler test delayed or not done.

For AF in primary care assumption made that the anticoagulant service willconfirm diagnosis and assess suitability fortreatment.

In some places doppleron same day.

Minimise time betweenstarting therapy andconfirming diagnosis.

5 A L No change 5 A L

3Risk assessment of anticoagulant therapy Risk assessment grid





Document and communicate diagnosis and treatment plan


Current preventive and mitigationmeasures


Riskswith allaction

F C R F C RIncreased risk of overdose – bleeds, underdose –thrombotic events.

Lack of informationand possibleconfusion overtreatment plan,increasing risk of wrong or delayedtreatment, dose orduration of therapy.

• Warfarin risks.

Secondary care

Failure/incomplete/unclear recordindicating reason for treatment, targetINR, duration of therapy/plannedcessation date and medication history.

Failure to record and communicateplan to nurses, pharmacists,receptionist, anticoagulant clinic/GP.Discharge/handover informationincomplete. Pre-screeninginformation/treatment cessation plan missing.

Lack of clarity over which member of the medical team is responsible for recording this information andwhen this information should berecorded: at the same time theanticoagulant is prescribed; before orat the same time the patient isdischarged from hospital?

NHS pressures of discharge. Lack oftime, lack of knowledge, inability to findtemplate referral forms or poordocumentation system, or assumptionthat some other member of the team isresponsible, or failure to understand theimportance of recording thisinformation for safe and effectiveanticoagulant treatment. No treatmentplan. Discussions/decisions notrecorded.

Failure to understand the importance ofthis information for the work of theother members of the hospitalmultidisciplinary team e.g., nurses,pharmacists, ward clerks, therapists andsocial care.

A minority of specialistanticoagulant nurses andclinical pharmacists may helpensure that the treatmentplan is recorded andcomplete. However, themajority of specialistanticoagulant nurses focusexclusively on providingservices for hospitaloutpatients.

Anticoagulant services and GPs providing ongoing care request completeinformation before acceptingclinical responsibility.

(Template forms can be usedfor the inpatient record andcopies sent to theanticoagulant clinic/GP).

GPs accepting repeatprescribing responsibilitiesrequest completeinformation prior toaccepting clinicalresponsibility.

In some cases the GP is givenaccess to treatment plan fromanticoagulation service.

Shared care guidelines.

None – failure to plantreatment, or reliance uponyellow booklet (or local similarrecord).

Template/pro forma to collectinformation to share with alldisciplines.

6 + B H Proposed saferpractice solutions 1, 2 and 5.

4 B M

• Heparin risks. Heparin – less of an issue – lessfrequent continuation into thecommunity – patient keen to stopinjections as soon as possible.

4 A L Proposed saferpractice solutions 1, 2, 3, 5 and 12.

4 A L


Document and communicate diagnosis and treatment plan




Riskswith allaction

F C R F C RIncreased risk ofoverdose – bleeds,underdose –thrombotic events.

Lack of informationand possible confusionover treatment plan,increasing risk ofwrong or delayedtreatment, dose orduration of therapy.

Primary care


Less complex, less urgent need fortreatment group of patients beingreferred to anticoagulant service.Usually diagnosis AF.

Sometimes referral forms used, at othertimes letters.

Patients can arrive to anticoagulantservice with no forms due to GP error orpatient error.

Diagnostic information but no drugdetails provided.

Electronic record keeping better thanpaper records but GP systems havedifferent layouts – (standard pro formawould improve record keeping).

Consider standard pro forma.

Anticoagulant serviceensures full informationbefore taking responsibilityfor patient (possible delay intreatment).

Assess to GP records.

Clinic in GP surgery.

Involvement of patient.

6 A M Proposed saferpractice solutions 1, 2, 3 and 5.

5 A M






Arrange monitoring




Riskswith allaction

F C R F C RBleeding, overdose,underdose.

Failure to arrange bloodtest monitoring inhospital.

Secondary care

Lack of time or poor documentationsystem; assumption that some othermember of the team is responsible; orfailure to understand the importance ofcommunicating to the team for safe andeffective anticoagulant treatment.

Specific referral form –for use within hospital which may betransmitted/shared with GP.

5 B M Proposed saferpractice solutions1, 2 and 5.

4 B M

Bleeding, overdose,underdose.

Failure to arrange bloodtest monitoring.

Primary care – where the GP isresponsible for providinganticoagulant monitoring

Lack of time or poor documentation system;assumption that some other member of theteam is responsible; or failure to understandthe importance of communicating to theteam for the safe and effectiveanticoagulant treatment.

Ad hoc vs anticoagulant service.

Standard OperatingProcedure (SOP).

GP computer system.

Arrangement foranticoagulant servicewithin GP practice.

4 B M Proposed saferpractice solutions1, 2, 5, 6, 8,9 and10.

3 B M


Failure to arrange bloodtest monitoring.

Primary care – where the GP isresponsible for providinganticoagulant monitoring and thepatient is housebound or in a caresetting and requires a visit from adistrict nurse to get sample.

Failure of GP to arrange/communicationerrors.

Failure of district nurse to arrange/turn up.

Repeat visits to obtain sample.

Good system/co-ordination.

Communityphlebotomy services.

5 B M Proposed saferpractice solutions1 and 2.

4 B M


Arrange monitoring




Riskswith allaction


Failure to arrangeappointment with theoutpatientanticoagulant service.

Secondary care

Standardisation of systems/referralform is lacking – causes confusion.

Lack of clarity over when referral formshould be completed. When theanticoagulant is prescribed, sometimeduring the inpatient stay, immediatelyprior to discharge from hospital. If it isnot completed at the same time as theinitial prescription then a differentpractitioner who was not involved inthe initial treatment decision may beasked to complete information aboutdiagnosis, target INR, and duration oftherapy that is not recorded in thepatient’s care record.

Lack of orientation; systems exist but juniors not aware/informed of systems.

Date for next (first) appointment is sentdirect to patient.

Patient fails to attend first clinicappointment as unaware of need;either not communicated prior todischarge or method ofcommunication post-discharge fails.

Confirmation that GP has taken overresponsibility not transferred back, i.e.one way communication route.

Unclear handover – who has‘ownership’ of patient care?

Difference between weekday ‘normal hours’ service and weekendout of hours.

Secondary referral form toGPs which is separate tohospital system.

Team sees patient and firstclinic appointment isagreed/communicated priorto discharge.

Audit of completion ofinformation provision andfollow up of patients toconfirm understanding andawareness of clinicattendance.

DAWN® system may alerthospital/clinic to DNApatients; default system tochase patient.

Dosing managed by hospitalactively during periodbetween discharge and first clinic appointment/handover to GP. May beconducted via a stabilisationclinic or on the ward. Daily clinics?

6 A M Proposed saferpractice solutions1,2,5 and 6.

5 A M






Arrange monitoring



Current risk Additionalpreventative andmitigationmeasures

Riskswith allaction

F C R F C R

Bleeding, overdose,underdose or failure totake dose.

Patient has appointmentbut long time periodbetween discharge andclinic appointment.

Secondary care

Risk to patient that dosing is incorrect dueto delay between clinical review duringanticoagulant induction therapy.

Patient may be required to return tohospital ward for blood test and dosing –ad hoc arrangement ‘on duty’ staff whomay not know or expect the patient arerequired to manage care on an interimbasis. Patient’s care record may no longerbe on the ward. Patient may not attenddue to confusion over arrangements.

Frequent anticoagulantclinics to minimise thetime betweendischarge from hospitaland clinical review.

6 B H Proposed saferpractice solutions1, 2, 5, 6, and 8.

4 B M

Bleeding, overdose,underdose or failure totake dose.

Failure to arrangeappointment with theoutpatient anticoagulantservice.

Primary care


Less complex, less urgent need fortreatment group of patients beingreferred to anticoagulant service. Usuallydiagnosis AF.

Sometimes referral forms used, at othertimes letters.

Patients can arrive to anticoagulantservice with no forms due to GP error orpatient error.

Diagnostic information but no drugdetails provided.

Electronic record keeping better thanpaper records but GP systems havedifferent layouts – (standard pro formawould improve record keeping).

Consider standard pro forma.

Lack of orientation; systems exist butjuniors not aware/ informed of systems.

Date for next (first) appointment is sentdirect to patient.

Patient fails to attend first clinicappointment as unaware of need; eithernot communicated prior to discharge ormethod of communication post-discharge fails.

Anticoagulant serviceensures full informationbefore takingresponsibility forpatient (possible delayin treatment).

Assess to GP records.

Clinic in GP surgery.

Involvement of patient.

4 A L Proposed saferpractice solutions1, 2, 5 and 6.

3 A L


Prescribing/dosing




Riskswith allaction


Prescribe wrong dose or no dose ofanticoagulant.

Secondary care - inpatients

Mis-communication of intended dose ofanticoagulant.

Prescribing in tablets rather than mg.

Dose does not appear on prescription but held separately e.g. back of prescriptionor other form.

6 B H Proposed saferpractice solutions1, 2, 11 and 14.

5 B M

Poor dosing decisions based on INR andother factors.

Lab results matched to incorrect patient.

Omission of doses as written up on a daily basis.

6 B H Proposed saferpractice solutions1, 2, 3, 4, 5 and14.

5 B M

No tests – induction doses (higher) initiated– baseline?

Lack of standardisation for use of loadingdose vs build up from low dose.

Daily dosing and testinglocal policy (Fennerty).

Lack of adverseincidents linked toinduction prescriptions.

5 B M Proposed saferpractice solutions1, 2, 3, 4 and 5.

4 B M


Prescribe wrong dose orno dose of anticoagulant.

Unfractioned heparin prescribed inunits/hour administered in ml/hour.(Prescribed by junior medical staff).

Issues over test results and dosing forsodium heparin.

Low molecular weight (LMW) heparinmg/kg or unit/kg or ml – and the weightmay not be available and incorrectlyestimated. Sometimes prescribed total doseper patient.

Sometimes prescribed as mg/kg.

Many different types of LMW heparin –wrong dose.

Different dose/frequency of some LMWheparin for different indications.

Units misinterpreted as dose zeros causingdose errors of factors of 10.

Heparin and warfarinprescriptionsgenerated/held togetherfor therapeutic review.

Inspection ofprescription bypharmacy.

Local dosing guidelines.

Dose in more than onelocation; preventativeor causal factor?

Use British Society ofHaematology/hospitalguidelines.

Standardisation withinindividual hospitals/units cardiology vs rest.

Special prescribingforms for heparinproducts in somehospitals .

6 B H Proposed saferpractice solutions1, 2, 3, 4, 5, 11,12 and 14.

4 B M






Prescribing/dosing




Riskswith allaction


Repeat prescribeanticoagulant.

Inappropriate prescriptionfor supply.

Failure to check the following:• continued appropriateness; • recent INR;• safe INR;• recent or planned appointment with

anticoagulant;• are the tablets to be prescribed

appropriate for the dose?• appropriate quantity requested.

Locality standard for using 0.5mg, 1mg,3mg, 5mg tablets.

Part of the normal repeat prescriptionrequests for other medicines.

Six monthly medicationreview.

GP managed servicewhere results fromhospital.

Near-patient system.

5 B M Proposed saferpractice solutions2, 9, 10 and 11.

4 B M


Dosing.

Primary care – where patientmanaged by GP anticoagulant serviceresults from hospital

Telephone service – instruct patient onnew dose.

Patient updates dose in yellow book.

Repeat prescriptions causes and process asabove.


5 B M

Bleeding, overdose.

Patient is discharged onloading dose.

Secondary care

Loading dose may be continued in error.Poor inpatient documentation.

Unclear, incomplete or wrong completionof yellow book, e.g. loading dosesrecorded in yellow book, delay inappointment for anticoagulant clinic, nofurther doses recorded in yellow book,patient assumes that they are to continuewith previous dose until seen in theanticoagulant clinic.

Lack of awareness of regime byjunior doctor.

No formal preventativemeasures.

Relies on individualmembers of themultidisciplinary teamchecking that yellowbook has beencompleted fully andaccurately and thatdosing instruction areappropriate until seenin anticoagulant clinic.

6 B H Proposed saferpractice solutions1, 2, 5, 6 and 8.

5 B M


Prescribing/dosing




Riskswith allaction

F C R F C RBleeding or other adversedrug reaction as aconsequence of a drug-drug interaction.

Co-prescribing in absenceof knowledge ofprescription of warfarin orother drugs.

Secondary care – inpatients

Two separate hospital inpatientprescription forms for anticoagulants andother drugs being prescribed, i.e.prescription information in two or moreplaces, not together.

Hospital prescribers have to remember toprescribe the anticoagulant(s) on the maininpatient prescription form withoutincluding details of dose and prescribe theanticoagulant(s) a second and subsequenttimes on an anticoagulant chart wheredetails of the daily dose are included.

More than one prescriber not aware ofwarfarin prescription.

Primary care

Less of an issue – GP prescribing systemsalert prescriber.

Out-of-hours /house calls where no GPsystem available.

Less of an issue duringinduction but riskincreased later;although dose dependsupon other drugsconcurrently prescribedwith warfarin.

Ward pharmacyservices.

Education ofprescribers.

Local documentation/software systems.

Decisions recorded soprescribing actionsunderstood asintentional.

Use of IT prescriptionssystems to alert tocontraindications.

Community pharmacysystem alert tointeraction if they go tothe same communitypharmacy.

6 A M Proposed saferpractice solutions1, 2, 5 and14.

5 A L

“As directed” directions applied.

Primary care and hospital outpatients

Prescription for discharge and repeatsupplies of warfarin ‘as directed’. Adosage check made by the doctor writingprescription. Separation of responsibilities– those prescribing ‘supply’ ofanticoagulants to those ‘dosing’anticoagulants.

Once discharged from hospital the yellowbook is the only information source thatprovides information about the dosage.The yellow book is not regarded as aprescription but rather ‘supplementaryclinical information’.

The information in the yellow book is notchecked by a pharmacist or nurse – as it isnot regarded as a prescription. Lack ofsource of other information to confirmdose for patient or professionals.

Use of otherinformation source tocheck dose.

Use “as directed”within yellow book todirect patient toinformation.

In some cases yellowbook checked at time ofrepeat prescription.

6 B H Proposed saferpractice solutions1, 2, 5, 6 and 10.

5 B M






Prescribing/dosing




Riskswith allaction

F C R F C R

Miscommunicating dose(does not include near-patient testing).

Anticoagulant service, GP services,pharmacy services

Blood sample – telephone or postal dose service.Many steps involved. Communication to and from non-healthcare staff.

Information not sent or miscommunication –lost in post. Telephone a message to anintermediary and the message not passedon.

Do not receive information. Wrong selection of patient.For telephone service – patients expected torecord new dose in yellow book.For postal service – updated yellow booksent and not received.Urgent modification required – telephone.

5 B M Proposed saferpractice solutions 8 and 10.

4 B M

Miscommunicating dose(does not include near-patient testing).

Postal issuesLost in post.Delay in receiving letter.Internal distribution delay in care settings.Understanding of written information.Legibility.Failure to read and change dosing practice.Unqualified care staff may not able tochange doses.

6 A M Proposed saferpractice solutions 8 and 10.

5 A M

Telephone issuesTelephone after hours.Difficulty in reaching patient.For telephone service – patients expected torecord new dose in yellow book.


5 A M

Face-to-facePoor communication and understanding ofinstructions and failure to record new dosein yellow book by health professional.

4 A L Proposed saferpractice solutions1and 2.

4 A L


Prescribing/dosing




Riskswith allaction

F C R F C RMiscommunicating dose– near-patient testing.


Face-to-face.

New record made in yellow book by healthprofessional/check understanding.

Near-patient testing may involve districtnurse in patient home – dose delayed after test.

4 A L No change. 4 A L

Bleeding or thrombosis.

Incorrect dose induction.

Secondary care

Inexperienced staff.Senior staff using their own protocols.

Different guidelines – confusing.Poor compliance with guidelines.

No measurement of baseline INR.

Patients are discharged before they havecompleted induction dose – must comeback to hospital for INR

Education and trainingaudit.

6 A M Proposed saferpractice solutions1, 2, 3, 5 and 14.

5 A L


Incorrect dose induction.

Primary care

GP sends patient to hospital anticoagulantservice with request to please start thispatient on warfarin as per inductionguideline on AF.


Inappropriatemaintenance dosecalculation/adjustment.


Empirical dosing method.Algorithms not used appropriately.Multi-tasking/inexperience.No standard method – different styles.

6 B H Proposed saferpractice solutions1, 2, 3, 4, 5 and14.

5 B M






Prescribing/dosing




Riskswith allaction

F C R F C RDose adjustment forsurgery/dentistry.

Different guidelines.BDA endorsed guidelines unknown orunused.Dentists require different INR beforeoperating.

Unclear guidelines/requirements forsurgery.

Major/minor/ investigations/cardioversion/endoscopy.

Operations are delayed and cancelled.

Attend hospital for blood test. If INR levelokay, proceed; if not, surgery delayed.

6 B H Proposed saferpractice solutions1, 2 and 3.

5 B M

Bleeding or other adversedrug reaction as aconsequence.

Unconsidered co-prescribing of non-steroidal anti-inflammatoryagents (NSAI).


Lack of knowledge, time, professionaljudgement.

Lack of use of cytoprotective.

Lack of awareness.

Patients self prescribing/taking over thecounter supplies of nonsteroidals.

No system safeguards.

Clinical experience.

GP computer systemalerts – too sensitive –not always effective.

6 B H Proposed saferpractice solutions1, 2, 5 and 7.

5 B M

Bleeding or other adversedrug reaction as aconsequence.

Unconsidered co-prescribing ofaspirin/antiplatelets.


Lack of knowledge, time, professional judgement.

Lack of use of cytoprotective.

Lack of awareness.

Failure to stop aspirin as intended whenwarfarin started.

No system safeguards.

Clinical experience.

Treatment plan statinguse of aspirin.


Pharmacist review of prescription.


4 B M


Prescribing/dosing




Riskswith allaction

F C R F C RBleeding or other adversedrug reaction as aconsequence.

Unconsidered co-prescribing of otherinteractive drugs.


Lack of knowledge, time, professional judgement.

Lack of awareness.

Assumption that the anticoagulant servicewill adjust warfarin dose to cope with theinteracting drug.

Failure of the prescriber to inform theanticoagulant service of the interactionwhen new drug started and also wheninteracting drug is stopped, e.g. amiodarone.

Irregular consumption by patient of co-prescribed medicines.


Pharmacist review ofprescription.


4 B M

Over or underdosing.

Patient managed carehome monitoring.

Primary care

Self testing with dose advice from healthprofessional.Self determined dose.Incorrect dose used.Appropriate and convenient for some patients.May be costly if overused.Patients have to buy their own test machine

Appropriate patientselection.


Over or underdosing.

Anticoagulant serviceprovided by communitypharmacy.

Primary care

Referral from GP.

Temporary residents.

No requirement to dispense all prescriptionsfor patients.

Rely on information from GP, patient andother community pharmacies.

Dedicated time.

Dedicated staff.

Dedicated communitypharmacy for alldispensing andanticoagulant services.

Share info via NHSspine.

4 A L Proposed saferpractice solutions 1and 2.

4 A L






Prepare/dispense/supply




Riskswith allaction


Supply of wrong strengthof anticoagulant byhealth professional.

Secondary care

Doses written as number of colour of tablets.

Product of previous dose choice [error].

Misinterpretation of dose on theprescription – dispensing error.

Unrestricted access to supplies ofanticoagulants as ward stock; no check ofproduct used by a pharmacist.

Supply of wrong strength from pharmacyfor ward stock (selection error by pharmacy staff).

Use or supply to patient of wrong strengthanticoagulant (selection error by nursing staff).

Confusing labelling and packaging ofmedicine products, poor storage, poorprocedures.

Local standardisationon one strength oftablet.

Use of differentiatedlabelling andpackaging.

Risk assess storage area.


3 B M

Overdose/underdoseduring preparation.

Secondary care

Heparin – supplied as concentrate thatrequired dilution 5,000units/ml,10,000units/ml, 20,000units/ml.

LMW heparin based on weight.Miscalculation error.Use of wrong body weight measurement.Incorrect physical syringe measurement of dose.

Incorrect dilution / volume of dilutent.

6 B H Proposed saferpractice solutions 2 and 12.

4 B M






Riskswith allaction

F C R F C R


Failure to reinforcecounselling.

Secondary care

Prescribed as “use as directed”; failure tocheck yellow book; yellow book notavailable at point of supply.

Lack of linkage between supply and reviewof dose; pharmacy dose not seen; yellowbook induction dose may be maintained.

Absence of INR results /out-of-hours serviceprovision; supply made before dose agreed.

Change in working practices may result inpatients being discharged before INR isavailable; discharge medication suppliedbut patient must contact ward to find outdose once at home – may not beundertaken/may not understand/carers notaware

System inflexibility to meet patient needssafely; who is responsible for dosinginformation?

Move towards supply from ward stock where yellowbook information is available.


4 B M


Supply of wrong drug/strength of anticoagulantby health professional.

Primary care

Hand written prescription – legibility.

Selection errors.

Problems confusion with 0.5mg and 5mg.

National standard forwarfarin strengths.

Use of colour anddesign of labelling andpackaging.

3 A L Proposed saferpractice solutions2 and 11.

3 A L










Riskswith allaction


Inappropriate supply ofanticoagulant.

Routine check of INR, dose or clinicattendance may not be a part of the repeatprescription process.

Failure to check the following:•continued appropriateness; •recent INR;•safe INR;•recent or planned appointment with

anticoagulant;•are the tablets to be prescribed

appropriate for the dose?•appropriate quantity requested.

Locality standard for using 0.5mg, 1mg,3mg, 5mg tablets.

Part of the normal repeat prescriptionrequests for other medicines.

6 B H Proposed saferpractice solutions2, 9 and 11.

5 B M

Dispensinganticoagulants inmonitored dosingsystems.

Single product card.

Problems of dose adjustment in monitoreddose system.

Preparation weeks or a month in advance inthe pharmacy.

Returned box from care home for re-dispensing.

Delay or omission of doses.

Multiple product dosette.

Problems of dose adjustment in multipleproduct dosette.

Delay or omission dose changes.


4 A L




Administer dose




Riskswith allaction

F C R F C R

Bleeding, overdose,dose duplicationunderdose – thrombosis.

Administer the wrongdose of anticoagulant.

Secondary care

Lack of effective systems to checkadministration problems – includesinformation on administration chart.Patient receives wrong drug.

SOPs.Training of clinical staff,carers and patients.Standard prescriptionform.Missing informationhighlighted/obtained bynursing staff.Pharmacy surveillance. Local decisions to useone form of LMWH.Minimise use of sodiumheparin.Syringes specific to doses/heparins.Skill base reduced due todecrease use ofunfractionated heparinproducts.

5 A M Proposed saferpractice solutions 1, 2 and 5.

4 A L

Primary care

Warfarin.Poor communication to patients by healthprofessionals.

Confusion over dose to be taken – not onmedicine label – verbal or yellow bookinformation.

Confusion over mg/tablet dosing. Poor record keeping in yellow book.Record keeping – possibility of doseomission or dose duplication.

Human error – administer wrong drug.Lack of specialist medicines training for staff.

Training.

SOPs.

Medication review.

Training.


4 B M

Care home

Pharmacy/home generated drugadministration chart – transcription errorfrom yellow book.Poorly designed inflexible system.High potential for confusion and error.Charts may say “as directed” – care staffhave to check with the yellow book or someother record for the dose.Dose advice sent to home by fax.Over mg/tablet dosing. Poor record keeping in yellow book.

SOPs.

Medication review.

Poorly designedinflexible system.

5 B M Proposed saferpractice solutions 2, 8, 10, 11 and13.

4 B M




Administer dose




Riskswith allaction

F C R F C R

Bleeding, overdose,underdose – thrombosis –during preparation.

Administer the wrongdose of heparin.


Heparin.Sodium calculation errors.Dosing by units per hour or mls per hour.Infusion pump programming error, canula block.Failure to monitor results in wrong dose administration.Poorly designed system.High potential for confusion and error.

Not available as wardstock in some hospitals.

Standardise productsand strengths availableas ward stock.

Pharmacist review ofprescription.

Double checks onpreparation of infusion.

5 B M Proposed saferpractice solutions 1, 2, 12 and 14.

3 B M

Misselection and use ofLMW heparin.

Community nursesLMWH; select correct dose for body weight.Prophylaxis and treatment doses confused.Different heparins for different indications.Confused mg/kilo prescribed.No double check on pre-filled syringe.

Standardise productsand strengths available.


4 B M

Misselection and use ofLMW heparin.

Incorrect selection, volume calculation,dose measurement.

Standardise productsand strengths used.

SOP.

Training.

1 B L Proposed saferpractice solutions 2 and 14.

1 B L

Dose omitted. Secondary care

The daily dose not prescribed and so doseadministration omitted. Due to :

Lack of availability of INR result to adjustdose before administration. Blood samplestaken in hospital during morning – resultssent back to ward in the afternoon.

INR result available but failure of juniormedical staff to prescribe new dose. Due tooversight, time pressures, lack of clarityover responsibility.

The anticoagulant prescription isoverlooked by nursing staff responsible foradministering medicines due to oversight,time pressures, lack of clarity overresponsibility for this role.

Warfarin dose not prominently displayedon regular drug chart, separate chart.Theanticoagulant dose cannot beadministered as the medicine/drug chart isnot available on the ward.

Nursing and pharmacistsensuring doseprescribed.

Pharmacy review ofomission on drug chart.

5 A M Proposed saferpractice solutions1, 2, 5 and 14.

3 A L


Risk assessment of anticoagulant therapy Risk assessment grid

21National Patient Safety Agency January 2006 ©

Administer dose




Riskswith allaction

F C R F C RThrombosis.

Dose omitted.

Primary care

Warfarin doses are administered in theevening in hospitals for logistic reasons. Thisconvention is continued when the patient isin the community – and this time for drugadministration may not be suitable for thepatient at home or for carer use.

Patient forgets.

Patient wishes to drink alcohol,

Out of supplies – availability of heparin products.

6 A M Proposed saferpractice solutions 2, 10 and 11.

4 A L

Thrombosis.

Dose omitted.

Residential care

Warfarin doses are administered in theevening in hospitals for logistic reasons. Thisconvention is continued when the patient isin the community – and this time for drugadministration may not be suitable for thepatient at home or for carer use.

Patient forgets.

Patient wishes to drink alcohol,

Out of supplies – availability of heparin products.

4 A L Proposed saferpractice solutions 2 and 10.

4 A L


Wrong/previous doseadministered.

Secondary care

Dose restarted post operatively but administration not linked to previous records.

Lack of reference to, or access to, historicalinformation to re-introduce anticoagulationtherapy.

Picked up by ward staffbefore discharge byeveryday checks or GP,patient, carer.

5 A M Proposed saferpractice solutions 1, 2, 3 and 14.

4 A L




Monitor treatment




Riskswith allaction

F C R F C R


Failure to attend INR clinic.


Poor communication to patients by healthprofessionals, confusion overneed/frequency to attend for regular INRtesting.

Inconvenience of attending anticoagulantclinic /inability to attend(transport/willingness/still inhospital/treatment stopped)/lack ofunderstanding for attendance.

Failure to audit and follow-up DNA’s.

GP services may not have a automatedsystems for DNA’s.

Community phlebotomyservices.

Near-patient testingservices.

Rely on anticoagulantservice to follow-up.

Escalate letters to patient– then to GP if multipleDNA’s.

6 A M Proposed saferpractice solutions 1, 2, 6, 8 and 10.

5 A L

Bleeding, overdose,underdose – dose omission.

Sampling problems;phlebotomist takes bloodfrom wrong patient,wrongly labelled, samplelost, label lost or defaced.


Wrong anticoagulant administered topatient.

Dose omitted due to no INR result.

Wrong test is requested.

Underfilled sample bottle.

Haemolysed sample.

SOPs.

Training.Bar coding and othertechnologies.Audit.

Undertake near-patienttesting.


4 A L

Blood tests for domicillarypatients.

Delays or no INR test.

Primary care

Inability to get venus blood – weekend problems.

Inexperienced staff – ill patients.

Capillary blood sample used.


4 B M



Monitor treatment




Riskswith allaction

F C R F C R


Problems and errors with laboratorymeasurement.

Calibration/qualityassurance (QA) ofequipment and results.


Wrongly calibrated machine.

Problems with analyser equipment andreagents.

Failure to maintain laboratory equipment.

Use of out of date reagents.

Failure to enrol and act on quality control system.

Up-to-date SOPs.

Education and trainingof laboratory staff.

Internal and external qualityassurance systems.

2 B L No change. 2 B L


Problems and errors withnear patient testingequipment.


Inadequate education and training of staffand patients using this equipment.Inadequate SOP’s.

Wrongly calibrated machine.

Problems with equipment and reagents.

Failure to maintain near-patient testing equipment.

Use of out-of-date reagents.

Failure to enrol and act on quality control system.

(Significant numbers of users not enrolledwith external QA systems).

More problems with district nursemeasurement in patients homes. Smallnumber of patients and poor training.

Testing of individual patients in GP clinic orcommunity pharmacies, clinics.

Small batches of patients in clinics.

SOPs.

Education and trainingof laboratory staff.

Internal and external qualityassurance systems.

Immediate repeat test.

5 A L Proposed saferpractice solutions 2 and 3.

4 A L





Monitor treatment




Riskswith allaction

F C R F C R


Problems with testreporting system.


Transcription errors/poor hand writing.

Patient identity errors.

From autoanalyser to laboratory reporting system.

From laboratory reporting system to GP system.

From autoanalyser to anticoagulant dosingsystem to yellow book.

From autoanalyser to anticoagulant dosingsystem to yellow book.

From laboratory reporting system to care record.

Delays in reporting results from laboratoryto clinician.

Clinical/admin staffidentify problem andsend for retest.


4 A L


Failure to modify dose,monitoring and counsel patient.

Poor systems of communication betweenanticoagulant clinic and patient – poor useof telephone, postal communication.

Patients/carer not at home.

Telephone communication to the confused patient where the carersupervises medication.

Incorrect telephone number.

Staff unable to make contact.

Language difficulties.

Access to staff easier in residential care.

Patient fails to carry out communicatedaction and update yellow book accurately.

Social care carers are not permitted toadjust dosage.

Education and trainingof patients and carers.

Suitable patient selection– able to use telephonecommunication.

Get patient to say thenew dose back.

Send yellow book backto patient.

Postal service.

Telephone service.

Six month check as asafeguard.

5 B M Proposed saferpractice solutions 1, 2, 8, 9, 10 and11.

4 B L



Monitor treatment




Riskswith allaction

F C R F C R

Thrombosis.

Discontinue too early.

Prophylaxis

Discontinue too early because ofadherence to protocol without clinicalassessment e.g. ongoing thrombotic risk.

Evidence accumulating for requirement of more prolonged prophylaxis, e.g. one month post THR balance cost/easeof administration.

Treatment

Discontinue too early because ofadherence to protocol without clinicalassessment.

Discontinue too early – therapeutic INR for24 hours not yet achieved.

Infusion pump failure/blocked i.v. access.

Failure to discontinue/ recognise patient onanticoagulant when new bleeding eventhas occurred – unfamiliar patient/on callstaff, lack of drug chart.

Awareness of need tooverlap heparin with oralanticoagulant for 48hours after initialattainment oftherapeutic range of INR.

6 A M Proposed saferpractice solutions 1, 2, 3, 5 and 14.

5 A M

Failure to discontinuewarfarin.

Failure to discontinue/recognise patient onanticoagulant when new bleeding eventhas occurred – unfamiliar patient/on callstaff, lack of drug chart.

5 B M Proposed saferpractice solutions 1, 2, 3 and 5.

4 B M

Failure to discontinueheparin.

Failure to discontinue heparin. Finite prescription ondrug chart.

Medical /nursing staff awareness.

5 B M Proposed saferpractice solutions 1, 2, 3, 5 and 14.

4 B M



26 National Patient Safety Agency January 2006 ©


Monitor treatment




Riskswith allaction

F C R F C R

Bleeding, overdosage,underdosage, or failure totake dose.

Failure to issue yellowbook or writteninformation.

Incomplete or unclear, orincorrect information inyellow book.

Separation of duties. Prescriber may informpatients of their new treatment at the sametime as they prescribe the anticoagulant,and assume some other member of themultidisciplinary team will communicatewith the patient and issue a yellow bookand advise on attending an anticoagulantclinic.

Lack of time, or poor documentationsystem.

Lack of stock of yellow book.

Counselling may be disassociated withsupply of yellow book. Lack of clarity overwhen the yellow book should be issued.

Some trusts do not use yellow book – useseparate information leaflets andindividually printed dosage instructionforms from the anticoagulant service.

In some trusts the yellow book is used asthe referral document for anticoagulantclinic. In this case failure to issue the yellow book may have a greater clinical consequence.

Lack of education of staff.Different arrangements in differenthospitals/wards.Done less well outside DVT service.Heparin – no yellow book or written information.Heparin and warfarin – mention of heparinmay be in yellow book.

No formal preventmeasures.

Relies on individualmembers of themultidisciplinary teamchecking that a yellowbook has been issued,written information iscomplete and accurate.

The yellow bookprovides the minimuminformation aboutanticoagulant therapyand current dosage anda written reminder forpatients and carers thatthey must attendanticoagulant clinicsregularly, have theirblood tested, and dose adjusted.

Supply book with drugs– on discharge but noton ward – varies forweekend discharge.

Information completedby the anticoagulantservice/GP/Community.

Start the use of yellowbook at time ‘0’ used insome hospitals.

Also record inpatientdosing used in some hospitals.

5 A L Proposed saferpractice solutions 1, 2, 5, 8 and 10.

4 A L




Communication with patient: use of yellow book/patient held information




Riskswith allaction

F C R F C R

Bleeding, overdosage,underdosage, or failure totake dose.

Failure to communicatetreatment.

Patient knowledgeincomplete – passiverecipients ormisunderstanding of whyon anticoagulant.

Prescriber may inform patients of their newtreatment at the same time as theyprescribe the anticoagulant, and assumesome other member of themultidisciplinary team will communicatewith the patient about their anticoagulanttreatment, issue a yellow book and advisethe patient concerning attending ananticoagulant clinic or GP clinic.

Patient does not recall information. Nodocumentary evidence of counselling ortest of patient understanding. Failure toobtain feedback from patient.

Patient not aware of symptoms to watchout for. Communication is frequently a oneway transfer of information. There is nochecking of understanding.

The communication needs of carers andsocial care (when the patient is inresidential care) are not usually considered.

Lack of time, or poor documentationsystem.

The communication is undertaken withoutthe presence supply of yellow book.

Yellow book may be supplied without anyverbal counselling.

Assumption that nurses/junior medics haveknowledge and skills to counsel.

Junior medical staff new shift patterns – lack of continuity or availability to counselpatients.

Yellow book update needed – accurate andappropriate (incl. language) informationfor patients needs.

No formal preventativemeasures.

Relies on individualmembers of themultidisciplinary teamchecking that patient hasbeen adequatelycounselled about their therapy.

Patients may not retainvery much informationwhen beingcommunicated with inhospital. Clinicians referpatient to anticoagulantclinic where patientunderstanding may beassessed – informationprovided or re-iterated.

What is important is toensure they know thatthey must attendanticoagulant clinicsregularly, have theirblood tested, and doseadjusted. Additionaltreatmentcommunication can beundertaken as part ofthe anticoagulant clinicservice.

GP/practice staffreinforcement ofeducation.

5 A M Proposed saferpractice solutions1,2, 5 and 8.

4 A L


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