Restrictive access to clopidogrel and mortality following coronary stent implantation.
BACKGROUND
In Canada, access to clopidogrel is restricted by most provincial drug insurance plans in order to contain costs. Until April 2007, the Régie de l'assurance maladie du Québec (RAMQ) Prescription Drug Insurance Plan reviewed special access forms before approving reimbursement for clopidogrel prescriptions. We investigated the impact of this restrictive process on patient's filling of prescriptions and on all-cause mortality following coronary stenting.


METHODS
We analyzed prescriptions filled and all-cause mortality in the year following a percutaneous coronary intervention among patients who underwent stent implantation between January 2000 and September 2004. We obtained administrative data from the RAMQ databases. We included patients who filled at least 1 prescription for a nonrestricted cardiovascular drug after hospital discharge. We used Cox proportional models to compare mortality rates as a function of delayed or absent outpatient clopidogrel therapy.


RESULTS
Of 13,663 patients, 1571 (11.5%) did not fill any clopidogrel prescription despite filling at least 1 nonrestricted cardiovascular drug prescription after a percutaneous coronary intervention, and 1174 (8.6%) patients filled their clopidogrel prescription with a delay of at least 1 day (median delay 5 days) after filling the nonrestricted cardiovascular drug prescription. After controlling for pertinent covariables, not filling a clopidogrel prescription (hazard ratio [HR] 1.70, 95% confidence interval [CI] 1.35-2.15) and filling with a delay (HR 1.34, 95% CI 1.01-1.80) were associated with a significant increase in all-cause mortality.


CONCLUSIONS
Restricted access to clopidogrel was associated with about 20% of patients either not receiving clopidogrel or receiving therapy after a delay. Delay or absence of clopidogrel therapy increased the risk of all-cause mortality after percutaneous coronary intervention with stenting.
Sheehy
Odile
O
Pharmaco-economics and pharmaco-epidemiology unit, Centre Hospitalier de l'Université de Montréal Research Centre, Université de Montréal, Montréal, Que.
LeLorier
Jacques
J
Rinfret
Stéphane
S
D000368:Aged; D002170:Canada / Q000453:epidemiology; D002423:Cause of Death / Q000639:trends; D000077144:Clopidogrel; D001026:Coronary Artery Bypass / Q000295:instrumentation*; D003324:Coronary Artery Disease / Q000401:mortality / Q000601:surgery*; D023903:Coronary Restenosis / Q000188:drug therapy / Q000401:mortality*; D016527:Drug Costs; D011307:Drug Prescriptions / Q000191:economics*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007356:Insurance, Pharmaceutical Services / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010975:Platelet Aggregation Inhibitors / Q000191:economics / Q000627:therapeutic use; D012189:Retrospective Studies; D015607:Stents; D015996:Survival Rate / Q000639:trends; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D013997:Time Factors
D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine