1. Clopidogrel Audit Vikas Jasoria December 2006

2. What is it? Clopidogrel is a thienopyridine antiplatelet drug which reduces platelet aggregation by inhibiting the binding of adenosine phosphate to its platelet receptor Clopidogrel is a thienopyridine antiplatelet drug which reduces platelet aggregation by inhibiting the binding of adenosine phosphate to its platelet receptor IN SIMPLE TERMS IN SIMPLE TERMS Anti-platelet which works in a different way to aspirin Anti-platelet which works in a different way to aspirin

3. Why Clopidogrel? Increasing prescriptions Increasing prescriptions 2003: 2003: 2.1m prescriptions costing £87m 2.1m prescriptions costing £87m Increase of > 50% since 2002 Increase of > 50% since 2002 Length of course often not specified Length of course often not specified Patients on Clopidogrel indefinitely when may not need to be the case Patients on Clopidogrel indefinitely when may not need to be the case

4. Why Clopidogrel? Prescribers incentive scheme 2006/2007 Prescribers incentive scheme 2006/2007

5. In real terms….. 28 tablets cost £ 35.31 28 tablets cost £ 35.31 £ 423.72 per patient per year (aspirin £ 10.44) £ 423.72 per patient per year (aspirin £ 10.44) £ 413.28 per year saving per patient!!!!!! £ 413.28 per year saving per patient!!!!!! Stop giving BIG PHARMA money……. Stop giving BIG PHARMA money……. Use money for other health services…… Use money for other health services……

6. The Evidence Primary Prevention Primary Prevention CHARISMA trial CHARISMA trial Clopidogrel plus aspirin is no more effective than aspirin alone in preventing major cardiovascular events Clopidogrel plus aspirin is no more effective than aspirin alone in preventing major cardiovascular events

7. The Evidence Antithrombotic Trialists Collaboration (BMJ2002;324:71) Antithrombotic Trialists Collaboration (BMJ2002;324:71) Clopidogrel is an effective alternative if cannot take aspirin Clopidogrel is an effective alternative if cannot take aspirin

8. The Evidence Post MI/ACS: Post MI/ACS: CLARITY trial (NEJM2005:352;1179) & COMMIT study (Lancet2005:366;1667) CLARITY trial (NEJM2005:352;1179) & COMMIT study (Lancet2005:366;1667) Addition of clopidogrel to aspirin improves outcomes (Decreased mortality and CV complications) Addition of clopidogrel to aspirin improves outcomes (Decreased mortality and CV complications) No additional risk of bleeding when used in combination 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 Clopidogrel and aspirin should be used in standard treatment post MI, at least in short term

9. The Evidence NICE (NSTEMI): NICE (NSTEMI): Continue up to 12 months after most recent acute episode ACS Continue up to 12 months after most recent acute episode ACS Prescribers incentive scheme: Prescribers incentive scheme: Clopidogrel licenced for use in MI (STEMI) up to 35 days after the event Clopidogrel licenced for use in MI (STEMI) up to 35 days after the event  For cardiac event:  For cardiac event: No patient should be on clopidogrel for secondary prevention for > 1 year No patient should be on clopidogrel for secondary prevention for > 1 year

10. The Evidence JBS-2 2005 Guideline: JBS-2 2005 Guideline: IF ASPIRIN NOT TOLERATED: IF ASPIRIN NOT TOLERATED: Prescribe clopidogrel 75mg od for Prescribe clopidogrel 75mg od for Vascular disease Vascular disease Diabetes Diabetes Asymptomatic whose 10 year risk > 20% Asymptomatic whose 10 year risk > 20%

11. Indications – NO CVD & Aspirin intolerant Over 50 and > 20% Framingham 10 yr risk Over 50 and > 20% Framingham 10 yr risk Diabetics Diabetics Age 50 years or over Age 50 years or over Diabetes > 10 years Diabetes > 10 years Taking treatment for hypertension Taking treatment for hypertension Evidence of target organ damage Evidence of target organ damage All people with target organ damage from hypertension All people with target organ damage from hypertension AF AF

12. Indications – CVD & Aspirin intolerant CVD? CVD? With aspirin: With aspirin: Myocardial infarction, angina Myocardial infarction, angina If aspirin intolerant: If aspirin intolerant: Non-haemorrhagic cerebrovascular disease (not in AF) Non-haemorrhagic cerebrovascular disease (not in AF) Peripheral vascular disease Peripheral vascular disease Atherosclerotic renovascular disease Atherosclerotic renovascular disease

13. Criteria & Standards Patients on clopidogrel should have a valid clinical indication recorded Patients on clopidogrel should have a valid clinical indication recorded Standard: 90% Standard: 90% Patients prescribed clopidogrel as monotherapy should have documented contra-indication or intolerance of aspirin: Patients prescribed clopidogrel as monotherapy should have documented contra-indication or intolerance of aspirin: Standard: 90% Standard: 90% Patients on clopidogrel for ACS or MI are on clopidogrel for < 12 months after most recent acute cardiac episode Patients on clopidogrel for ACS or MI are on clopidogrel for < 12 months after most recent acute cardiac episode Standard: 90% Standard: 90%

14. Method Patients prescribed clopidogrel over last 90 days from 8 th November 2006 Patients prescribed clopidogrel over last 90 days from 8 th November 2006 Computer & paper notes (where indicated) Computer & paper notes (where indicated) Correspondence letters Correspondence letters Excel Spreadsheet Excel Spreadsheet  TIME CONSUMING !!!!!

15. RESULTS

18. Standard Met NO(NEARLY!!!)

19. Discussion Clinical indications? Clinical indications? “post hypotensive episode/migraine” “post hypotensive episode/migraine” Registered newly and was on clopidogrel before – no documentation as to why Registered newly and was on clopidogrel before – no documentation as to why ? Post valve replacement and warfarin intolerant ? Post valve replacement and warfarin intolerant Also on aspirin 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” 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 No intolerance of aspirin noted

20. Discussion ?Swapping to clopidogrel because of need for NSAID and aspirin ?Swapping to clopidogrel because of need for NSAID and aspirin Started aspirin and clopidogrel 2002 after more TIAs. Started aspirin and clopidogrel 2002 after more TIAs. Advised by neuro then to cut out aspirin slowly and continue clopidogrel Advised by neuro then to cut out aspirin slowly and continue clopidogrel No intolerance of aspirin noted No intolerance of aspirin noted Evidence changes with time… we need to keep up Evidence changes with time… we need to keep up

21. FIX IT! Documentation, documentation, documentation Documentation, documentation, documentation Computer popup needed everytime Clopidogrel prescribed Computer popup needed everytime Clopidogrel prescribed “Is there a valid clinical indication documented in the notes” “Is there a valid clinical indication documented in the notes” Consider cost/benefit of patient requests for Clopidogrel when not indicated Consider cost/benefit of patient requests for Clopidogrel when not indicated Is it worth it? Is it worth it? Need to get a better history from new patients Need to get a better history from new patients Stop prescribing repeats and ask patients to come in for 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 Contacting individual GPs with their patients that need to be addressed

23. Standard Met NO

24. Discussion CVA/TIA who are on both aspirin and clopidogrel CVA/TIA who are on both aspirin and clopidogrel Old vs. new evidence Old vs. new evidence If aspirin is stopped then reason in notes needs to be more clearly documented 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 Patient awaiting angio after trop negative CP ?likely diagnosis stable angina but not aspirin intolerant

25. FIX IT! Contact individual GPs Contact individual GPs If no intolerance of aspirin then stop Clopidogrel and change to aspirin If no intolerance of aspirin then stop Clopidogrel and change to aspirin ? Write to patients ? ? Write to patients ?

27. Standard Met NO (NEARLY!!!)

28. NOTE!!!! Excluded in results those that had cardiac event and stenting Excluded in results those that had cardiac event and stenting Controversial as to length of treatment of clopidogrel post stent Controversial as to length of treatment of clopidogrel post stent Numbers are low! Numbers are low!

29. Discussion Patient had NSTEMI November 2005 on discharge summary says "review in clinc" but no evidence of formal review note Patient had NSTEMI November 2005 on discharge summary says "review in clinc" but no evidence of formal review note

30. FIX IT! Contact GP involved Contact GP involved Consider stopping clopidogrel as > 1 year post MI Consider stopping clopidogrel as > 1 year post MI Set computer reminder to prompt if > 1 year post most recent cardiac event Set computer reminder to prompt if > 1 year post most recent cardiac event

31. CONCLUSIONS

32. Conclusions Old evidence vs. New evidence Old evidence vs. New evidence MEDICATION REVIEWS IMPORTANT MEDICATION REVIEWS IMPORTANT Documentation, documentation…….. Documentation, documentation…….. Not far from standards in 2/3 Not far from standards in 2/3 Need to address Clopidogrel monotherapy group Need to address Clopidogrel monotherapy group Solutions involve contacting individuals and making changes Solutions involve contacting individuals and making changes Difficult audit – which one for submission if any? Difficult audit – which one for submission if any? Re-audit in April 2007 Re-audit in April 2007

33. Thank You