Patient safety alert 18
Actions that can make anticoagulant therapy safer
Audit checklist
Date:
Name of organisation:
Audit checklist prepared by:
1. Review of training and competence
Recommended action
Suggested evidence
Assessment
Ensure all staff caring for patients
on anticoagulant therapy have the
necessary work competences to
undertake their duties safely.
Copy of:
• training programme for
foundation year doctors and
others;
• system of clinical
supervision, where senior
staff oversee and assess
work competences of less
experienced staff;
• training records and
competence assessment for
healthcare professionals
involved in anticoagulation.
Compliance
or
non-compliance
NPSA audit checklist for anticoagulant therapy
March 2007
Comment/further action required
Word file available at www.npsa.nhs.uk/health/alerts
1
2. Procedures and clinical protocols
Recommended action
Suggested evidence
Healthcare organisations should have written
procedures and clinical protocols for the safe use of
oral and injectable anticoagulant therapy.
These procedures should include guidance
on the following:
Copy of:
• procedures;
• clinical protocols;
• date of Drugs and
Therapeutics
Committee
approval;
• review date.
Compliance
(Yes/No)
Comment/further action required
Risk assessing the benefits vs the risks of
anticoagulant therapy for individual patients.
Providing information to the patient before
anticoagulant therapy is commenced, prior to
hospital discharge, on first visit to the anticoagulant
clinic and when necessary throughout the course of
the treatment.
How to safely initiate anticoagulant loading doses,
including the use of low dose loading for patients
with atrial fibrillation.
How to monitor anticoagulation and adjust dosage
to achieve target INR range.
Safe systems for documenting results
and treatment.
NPSA audit checklist for anticoagulant therapy
March 2007
Word file available at www.npsa.nhs.uk/health/alerts
2
Recommended action
Suggested evidence
Compliance
(Yes/No)
Comment/further action required
Effective communication systems when clinical
responsibility for anticoagulant therapy is being
transferred, e.g. on discharge from hospital.
That safe practice is promoted with prescribers and
pharmacists to check that patient’s INR is being
monitored regularly and that the INR level is safe
before issuing or dispensing repeat prescriptions
for oral anticoagulants.
That safe practice is promoted with prescribers
co-prescribing one or more clinically significant
interacting medicines for patients already on oral
anticoagulants, to make arrangements for
additional INR blood tests, and inform the
anticoagulant service that an interacting medicine
has been prescribed. To promote safe practice that
those dispensing clinically significant interacting
medicines for those patients check that these
additional safety precautions have been taken.
That dental practitioners manage patients on
anticoagulants according to evidence-based
therapeutic guidelines.
Annual clinical review of patients on
oral anticoagulants.
How patients should have their anticoagulant
therapy discontinued.
NPSA audit checklist for anticoagulant therapy
March 2007
Word file available at www.npsa.nhs.uk/health/alerts
3
Recommended action
Suggested evidence
Compliance
(Yes/No)
Comment/further action required
That all strengths of warfarin tablets should be
used to best meet the needs of individual patients.
Not all patients will need all strengths of tablets.
That oral anticoagulant doses should be expressed
as mg and not as number of tablets.
Dosage recommendations should:
• use the least number of tablets each day;
• use constant daily dosing and not alternate day
dosing;
• not require the use of half tablets. Patients find
it difficult to break tablets and instead, when
necessary, would rather use 0.5mg tablets.
Where infusions of sodium heparin are used, a
standard, ready-to-use presentation of 1000 units
in 1ml is used. Changes in daily dose should be
made by adjusting the rate of administration.
Ward stock locations
and purchasing
records of heparin
>1000unit/ml
products
Promotion of the use of written safe practice
procedures for the use of anticoagulants in care
homes, including the safe practice recommendation
for written confirmation of dose changes from
prescribers, and the minimised use of monitored
dosage systems for anticoagulants.
NPSA audit checklist for anticoagulant therapy
March 2007
Word file available at www.npsa.nhs.uk/health/alerts
4
3. Audit of safety indicators
Recommended indicator
Suggested evidence
Audit result
Comment/further action required
Safety indicators for patients starting oral anticoagulant treatment
Percentage of patients following
loading protocol.
Results of prospective
observational audit of
prescription charts over
one month.
Percentage of patients
developing INR > 5.0.
Results from monitoring
service over 12 months.
Percentage of patients in
therapeutic range at discharge.
Results of prospective
observational audit of
prescription charts over
one month.
Percentage (incidence) of
patients suffering a major bleed
in first month of therapy and
percentage suffering major bleed
with INR above therapeutic
range.
Results from hospital
admissions and clinical data
over 12 months.
Percentage of new referrals to
anticoagulant service (hospital or
community based) with
incomplete information.
Results from anticoagulant
clinic(s) over 12 months.
Percentage of patients that were
not issued with patient-held
information and written dosage
instructions at start of therapy.
Results from anticoagulant
clinic(s) over 12 months.
NPSA audit checklist for anticoagulant therapy
March 2007
Word file available at www.npsa.nhs.uk/health/alerts
5
Recommended indicator
Suggested evidence
Percentage of patients that were
discharged from hospital without
an appointment for next INR
measurement or for consultation
with appropriate healthcare
professional to review and
discuss treatment plan, benefits,
risks and patient education.
Results from anticoagulant
clinic(s) over 12 months.
Audit result
Comment/further action required
Safety indicators for patients established on oral anticoagulant treatment
Proportion of patient-time in
range or percentage of INRs.
Results from monitoring
service over 12 months.
Percentage of INRs > 5.0.
Results from monitoring
service over 12 months.
Percentage of INRs > 8.0.
Results from monitoring
service over 12 months.
Percentage of INRs > 1.0 INR
unit below target (e.g.
percentage of INRs < 1.5 for
patients with target INR of 2.5).
Results from monitoring
service over 12 months.
Percentage of patients suffering
adverse outcomes, categorised
by type, e.g. major bleed.
Results from hospital
admissions data over 12
months.
Percentage of patients lost to
follow-up (and risk assessment
of process management for
Results from anticoagulant
clinic(s) over 12 months.
NPSA audit checklist for anticoagulant therapy
March 2007
Word file available at www.npsa.nhs.uk/health/alerts
6
Recommended indicator
Suggested evidence
Audit result
Comment/further action required
identifying patients lost
to follow-up).
Percentage of patients with
unknown diagnosis, target INR
or stop date.
Results from anticoagulant
clinic(s) over 12 months.
Percentage of patients with
inappropriate target INR for
diagnosis, high and low.
Results from anticoagulant
clinic(s) over 12 months.
Percentage of patients
without written patient
educational information.
Results from anticoagulant
clinic(s) over 12 months.
Percentage of patients without
appropriate written clinical
information, e.g. diagnosis,
target INR, last dosing record.
Results from anticoagulant
clinic(s) over 12 months
NPSA audit checklist for anticoagulant therapy
March 2007
Word file available at www.npsa.nhs.uk/health/alerts
7
4. Review of patient safety incident data involving anticoagulants for preceding 12 months
Clinical outcome
Death
Severe (permanent harm)
Moderate (significant, but not permanent harm, requiring increase in treatment)
Low (temporary harm, requiring extra observation or minor treatment)
No harm
Total
Type of report
Prescribing
Dispensing/medicine preparation
Administration
Monitoring
Total
Type of incident
Wrong dose
Wrong frequency
Omitted medicine/dose
Wrong drug
Wrong quantity
Mismatching of patient and their medicine
Wrong/transposed/omitted medicine label
Wrong/omitted/passed expiry date
Wrong storage
Wrong route
Contraindication
Patient allergic to treatment
Wrong formulation
Wrong method of preparation/supply
Adverse drug reaction – when used as intended
Wrong or omitted verbal patient directions
Other
Total
NPSA audit checklist for anticoagulant therapy
March 2007
Number of reports
Number of reports
Number of reports
Word file available at www.npsa.nhs.uk/health/alerts
8
5. Overall comments and actions recommended by Drugs and Therapeutics Committee
Comments:
Action:
Signature of Drugs and Therapeutics Committee Chair:
Name of Drugs and Therapeutics Committee Chair:
Date:
Next review date:
NPSA audit checklist for anticoagulant therapy
March 2007
Word file available at www.npsa.nhs.uk/health/alerts
9