Clopidogrel AuditClopidogrel Audit

Vikas JasoriaVikas Jasoria

December 2006December 2006

What is it?What is it?

Clopidogrel is a thienopyridine Clopidogrel is a thienopyridine antiplatelet drug which reduces antiplatelet drug which reduces platelet aggregation by inhibiting the platelet aggregation by inhibiting the binding of adenosine phosphate to its binding of adenosine phosphate to its platelet receptor platelet receptor

IN SIMPLE TERMSIN SIMPLE TERMS Anti-platelet which works in a different Anti-platelet which works in a different

way to aspirinway to aspirin

Why Clopidogrel?Why Clopidogrel?

Increasing prescriptionsIncreasing prescriptions 2003:2003:

2.1m prescriptions costing 2.1m prescriptions costing ££87m87m Increase of > 50% since 2002Increase of > 50% since 2002

Length of course often not specifiedLength of course often not specified Patients on Clopidogrel indefinitely when Patients on Clopidogrel indefinitely when

may not need to be the casemay not need to be the case

Why Clopidogrel?Why Clopidogrel?

Prescribers Prescribers incentive scheme incentive scheme 2006/20072006/2007

In real terms…..In real terms…..

28 tablets cost 28 tablets cost £ 35.31£ 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……

The EvidenceThe Evidence

Primary PreventionPrimary Prevention CHARISMA trialCHARISMA trial

Clopidogrel plus aspirin is no more effective Clopidogrel plus aspirin is no more effective than aspirin alone in preventing major than aspirin alone in preventing major cardiovascular events cardiovascular events

The EvidenceThe Evidence

Antithrombotic Antithrombotic Trialists Trialists Collaboration Collaboration (BMJ2002;324:71)(BMJ2002;324:71)

Clopidogrel is an Clopidogrel is an effective alternative effective alternative if cannot take aspirinif cannot take aspirin

The EvidenceThe Evidence Post MI/ACS: Post MI/ACS:

CLARITY trial (NEJM2005:352;1179) & COMMIT CLARITY trial (NEJM2005:352;1179) & COMMIT study (Lancet2005:366;1667)study (Lancet2005:366;1667)

Addition of clopidogrel to aspirin improves outcomes Addition of clopidogrel to aspirin improves outcomes (Decreased mortality and CV complications)(Decreased mortality and CV complications)

No additional risk of bleeding when used in No additional risk of bleeding when used in combinationcombination

Clopidogrel and aspirin should be used in Clopidogrel and aspirin should be used in standard treatment post MI, at least in short standard treatment post MI, at least in short termterm

The EvidenceThe Evidence NICE (NSTEMI):NICE (NSTEMI):

Continue up to 12 months after most recent Continue up to 12 months after most recent acute episode ACSacute episode ACS

Prescribers incentive scheme:Prescribers incentive scheme: Clopidogrel licenced for use in MI (STEMI) up Clopidogrel licenced for use in MI (STEMI) up

to 35 days after the eventto 35 days after the event For cardiac event:For cardiac event:

No patient should be on clopidogrel for No patient should be on clopidogrel for secondary prevention for > 1 yearsecondary prevention for > 1 year

The EvidenceThe Evidence

JBS-2 2005 Guideline:JBS-2 2005 Guideline: IF ASPIRIN NOT TOLERATED:IF ASPIRIN NOT TOLERATED: Prescribe clopidogrel 75mg od forPrescribe clopidogrel 75mg od for

Vascular diseaseVascular disease DiabetesDiabetes Asymptomatic whose 10 year risk > 20%Asymptomatic whose 10 year risk > 20%

Indications – NO CVD & Aspirin Indications – NO CVD & Aspirin intolerantintolerant

Over 50 and > 20% Framingham 10 yr riskOver 50 and > 20% Framingham 10 yr risk DiabeticsDiabetics

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 All people with target organ damage from hypertension hypertension

AFAF

Indications – CVD & Aspirin Indications – CVD & Aspirin intolerantintolerant

CVD?CVD? With aspirin:With aspirin:

Myocardial infarction, anginaMyocardial infarction, angina If aspirin intolerant:If aspirin intolerant:

Non-haemorrhagic cerebrovascular disease Non-haemorrhagic cerebrovascular disease (not in AF)(not in AF)

Peripheral vascular diseasePeripheral vascular disease Atherosclerotic renovascular disease Atherosclerotic renovascular disease

Criteria & StandardsCriteria & Standards Patients on clopidogrel should have a valid Patients on clopidogrel should have a valid

clinical indication recordedclinical indication recorded Standard: 90%Standard: 90%

Patients prescribed clopidogrel as Patients prescribed clopidogrel as monotherapy should have documented monotherapy should have documented contra-indication or intolerance of aspirin: contra-indication or intolerance of aspirin: Standard: 90%Standard: 90%

Patients on clopidogrel for ACS or MI are Patients on clopidogrel for ACS or MI are on clopidogrel for < 12 months after most on clopidogrel for < 12 months after most recent acute cardiac episoderecent acute cardiac episode Standard: 90%Standard: 90%

MethodMethod

Patients prescribed clopidogrel over Patients prescribed clopidogrel over last 90 days from 8last 90 days from 8thth November 2006 November 2006

Computer & paper notes (where Computer & paper notes (where indicated)indicated)

Correspondence lettersCorrespondence letters Excel Spreadsheet Excel Spreadsheet

TIME CONSUMING !!!!!

RESULTSRESULTS

Valid Clinical Indication Recorded

Yes, 44, 85%

No, 8, 15%

List of Clinical Indications

6

9

1115

7

4

PVD

CVA/TIA

Post Stenting

MI/STEMI

Angina

High CVS risk

Standard MetStandard Met

NONO

(NEARLY!!!)(NEARLY!!!)

DiscussionDiscussion Clinical indications?Clinical indications?

““post hypotensive episode/migraine”post hypotensive episode/migraine” Registered newly and was on clopidogrel Registered newly and was on clopidogrel

before – no documentation as to whybefore – no documentation as to why ? Post valve replacement and warfarin ? Post valve replacement and warfarin

intolerantintolerant Also on aspirinAlso on aspirin

January 2003: “Very keen to try clopidogrel for January 2003: “Very keen to try clopidogrel for 1 month, has read about it in the paper”; “No 1 month, has read about it in the paper”; “No more chest pain since starting clopidogrel”more chest pain since starting clopidogrel”

No intolerance of aspirin notedNo intolerance of aspirin noted

DiscussionDiscussion

?Swapping to clopidogrel because of need ?Swapping to clopidogrel because of need for NSAID and aspirinfor NSAID and aspirin

Started aspirin and clopidogrel 2002 after Started aspirin and clopidogrel 2002 after more TIAs.more TIAs. Advised by neuro then to cut out aspirin slowly Advised by neuro then to cut out aspirin slowly

and continue clopidogreland continue clopidogrel No intolerance of aspirin notedNo intolerance of aspirin noted

Evidence changes with time… we need to Evidence changes with time… we need to keep upkeep up

FIX IT!FIX IT!

Documentation, documentation, documentationDocumentation, documentation, documentation Computer popup needed everytime Clopidogrel Computer popup needed everytime Clopidogrel

prescribedprescribed ““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 Consider cost/benefit of patient requests for Clopidogrel when not indicatedClopidogrel when not indicated Is it worth it?Is it worth it?

Need to get a better history from new patientsNeed 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 neededmedication review if needed

Contacting individual GPs with their patients that Contacting individual GPs with their patients that need to be addressedneed to be addressed

If Clopidogrel Monotherapy Then Intolerance to Aspirin Noted?

Yes , 15, 60%

No, 10, 40%

Standard MetStandard Met

NONO

DiscussionDiscussion CVA/TIA who are on both aspirin and CVA/TIA who are on both aspirin and

clopidogrelclopidogrel Old vs. new evidenceOld vs. new evidence

If aspirin is stopped then reason in notes If aspirin is stopped then reason in notes needs to be more clearly documentedneeds to be more clearly documented

Patient awaiting angio after trop negative Patient awaiting angio after trop negative CP ?likely diagnosis stable angina but not CP ?likely diagnosis stable angina but not aspirin intolerantaspirin intolerant

FIX IT!FIX IT!

Contact individual GPsContact individual GPs If no intolerance of aspirin then stop If no intolerance of aspirin then stop

Clopidogrel and change to aspirinClopidogrel and change to aspirin ? Write to patients ?? Write to patients ?

If cardiac event then on clopidogrel for > 1 year

Yes, 1, 13%

No, 7, 87%

Yes No

Standard MetStandard Met

NO NO (NEARLY!!!)(NEARLY!!!)

NOTE!!!!NOTE!!!!

Excluded in results those that had Excluded in results those that had cardiac event and stentingcardiac event and stenting Controversial as to length of treatment Controversial as to length of treatment

of clopidogrel post stentof clopidogrel post stent Numbers are low!Numbers are low!

DiscussionDiscussion

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

FIX IT!FIX IT!

Contact GP involvedContact GP involved Consider stopping clopidogrel as > 1 Consider stopping clopidogrel as > 1

year post MIyear post MI Set computer reminder to prompt if Set computer reminder to prompt if

> 1 year post most recent cardiac > 1 year post most recent cardiac eventevent

CONCLUSIONSCONCLUSIONS

ConclusionsConclusions

Old evidence vs. New evidenceOld evidence vs. New evidence MEDICATION REVIEWS IMPORTANTMEDICATION REVIEWS IMPORTANT

Documentation, documentation……..Documentation, documentation…….. Not far from standards in 2/3Not far from standards in 2/3

Need to address Clopidogrel monotherapy groupNeed to address Clopidogrel monotherapy group Solutions involve contacting individuals and Solutions involve contacting individuals and

making changesmaking changes Difficult audit – which one for submission if Difficult audit – which one for submission if

any?any? Re-audit in April 2007Re-audit in April 2007

Thank YouThank You