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This audit evaluates the usage and cost-effectiveness of the antiplatelet drug clopidogrel in comparison to aspirin, based on 2006 data and clinical evidence. It assesses prescribing trends, guidelines, and patient indications for clopidogrel, emphasizing the need for proper documentation and adherence to standards.
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Clopidogrel Audit Vikas Jasoria December 2006
What is it? • Clopidogrel is a thienopyridine antiplatelet drug which reduces platelet aggregation by inhibiting the binding of adenosine phosphate to its platelet receptor • IN SIMPLE TERMS • Anti-platelet which works in a different way to aspirin
Why Clopidogrel? • Increasing prescriptions • 2003: • 2.1m prescriptions costing £87m • Increase of > 50% since 2002 • Length of course often not specified • Patients on Clopidogrel indefinitely when may not need to be the case
Why Clopidogrel? • Prescribers incentive scheme 2006/2007
In real terms….. • 28 tablets cost £ 35.31 • £ 423.72 per patient per year (aspirin £ 10.44) • £ 413.28 per year saving per patient!!!!!! • Stop giving BIG PHARMA money……. • Use money for other health services……
The Evidence • Primary Prevention • CHARISMA trial • Clopidogrel plus aspirin is no more effective than aspirin alone in preventing major cardiovascular events
The Evidence • Antithrombotic Trialists Collaboration (BMJ2002;324:71) • Clopidogrel is an effective alternative if cannot take aspirin
The Evidence • Post MI/ACS: • CLARITY trial (NEJM2005:352;1179) & COMMIT study (Lancet2005:366;1667) • Addition of clopidogrel to aspirin improves outcomes (Decreased mortality and CV complications) • No additional risk of bleeding when used in combination • Clopidogrel and aspirin should be used in standard treatment post MI, at least in short term
The Evidence • NICE (NSTEMI): • Continue up to 12 months after most recent acute episode ACS • Prescribers incentive scheme: • Clopidogrel licenced for use in MI (STEMI) up to 35 days after the event • For cardiac event: • No patient should be on clopidogrel for secondary prevention for > 1 year
The Evidence • JBS-2 2005 Guideline: • IF ASPIRIN NOT TOLERATED: • Prescribe clopidogrel 75mg od for • Vascular disease • Diabetes • Asymptomatic whose 10 year risk > 20%
Indications – NO CVD & Aspirin intolerant • Over 50 and > 20% Framingham 10 yr risk • Diabetics • Age 50 years or over • Diabetes > 10 years • Taking treatment for hypertension • Evidence of target organ damage • All people with target organ damage from hypertension • AF
Indications – CVD & Aspirin intolerant • CVD? • With aspirin: • Myocardial infarction, angina • If aspirin intolerant: • Non-haemorrhagic cerebrovascular disease (not in AF) • Peripheral vascular disease • Atherosclerotic renovascular disease
Criteria & Standards • Patients on clopidogrel should have a valid clinical indication recorded • Standard: 90% • Patients prescribed clopidogrel as monotherapy should have documented contra-indication or intolerance of aspirin: • Standard: 90% • Patients on clopidogrel for ACS or MI are on clopidogrel for < 12 months after most recent acute cardiac episode • Standard: 90%
Method • Patients prescribed clopidogrel over last 90 days from 8th November 2006 • Computer & paper notes (where indicated) • Correspondence letters • Excel Spreadsheet TIME CONSUMING !!!!!
Standard Met NO (NEARLY!!!)
Discussion • Clinical indications? • “post hypotensive episode/migraine” • Registered newly and was on clopidogrel before – no documentation as to why • ? Post valve replacement and warfarin intolerant • Also on aspirin • January 2003: “Very keen to try clopidogrel for 1 month, has read about it in the paper”; “No more chest pain since starting clopidogrel” • No intolerance of aspirin noted
Discussion • ?Swapping to clopidogrel because of need for NSAID and aspirin • Started aspirin and clopidogrel 2002 after more TIAs. • Advised by neuro then to cut out aspirin slowly and continue clopidogrel • No intolerance of aspirin noted • Evidence changes with time… we need to keep up
FIX IT! • Documentation, documentation, documentation • Computer popup needed everytime Clopidogrel prescribed • “Is there a valid clinical indication documented in the notes” • Consider cost/benefit of patient requests for Clopidogrel when not indicated • Is it worth it? • Need to get a better history from new patients • Stop prescribing repeats and ask patients to come in for medication review if needed • Contacting individual GPs with their patients that need to be addressed
Standard Met NO
Discussion • CVA/TIA who are on both aspirin and clopidogrel • Old vs. new evidence • If aspirin is stopped then reason in notes needs to be more clearly documented • Patient awaiting angio after trop negative CP ?likely diagnosis stable angina but not aspirin intolerant
FIX IT! • Contact individual GPs • If no intolerance of aspirin then stop Clopidogrel and change to aspirin • ? Write to patients ?
Standard Met NO (NEARLY!!!)
NOTE!!!! • Excluded in results those that had cardiac event and stenting • Controversial as to length of treatment of clopidogrel post stent • Numbers are low!
Discussion • Patient had NSTEMI November 2005 on discharge summary says "review in clinc" but no evidence of formal review note
FIX IT! • Contact GP involved • Consider stopping clopidogrel as > 1 year post MI • Set computer reminder to prompt if > 1 year post most recent cardiac event
Conclusions • Old evidence vs. New evidence • MEDICATION REVIEWS IMPORTANT • Documentation, documentation…….. • Not far from standards in 2/3 • Need to address Clopidogrel monotherapy group • Solutions involve contacting individuals and making changes • Difficult audit – which one for submission if any? • Re-audit in April 2007