Recommended action / Suggested evidence / Assessment / Comment/further action required
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
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.
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.
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.
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.
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.
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.
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
identifying patients lost
to follow-up). / Results from anticoagulant clinic(s) over 12 months.
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
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 / Number of reports
Prescribing
Dispensing/medicine preparation
Administration
Monitoring
Total
Type of incident / Number of reports
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
Signature of Drugs and Therapeutics Committee Chair:
Name of Drugs and Therapeutics Committee Chair:
Date: Next review date:
NPSA audit checklist for anticoagulant therapy Word file available at
March 2007
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