I recently read a newspaper articlethat described a consumer-use studyconducted to determine the feasibilityof making lovastatin (Mevacor) anOTC product. The Merck-sponsoredstudy concluded that lovastatin couldbe safely and effectively used by consumerswith the aid of a self-managementsystem developed by the manufacturer.The FDA, however, disagreedwith the conclusions drawn from thedata and denied approval of lovastatinOTC status. What bothered me aboutthe article was a reference to the designof the study, which used nurses asstudy investigators who "assumed therole"of pharmacists!
I searched out the article by Melin etal from the American Journal of Cardiology(November 15, 2004) to try tounderstand the study design andreview the trial results. I was particularlyinterested in why nurses were used inlieu of pharmacists. I was even moreappalled to learn that nurse investigatorswere explicitly instructed not to volunteerany information or perform an eligibilityassessment that could assist theconsumer as they contemplated initiatingtherapy. They were allowed to usescripted responses if patients (studyparticipants) asked questions.
Although the consumers wererequired to know their baseline high-densitylipoprotein, low-densitylipoprotein (LDL), and triglyceride levels,no efforts were made to ensureaccurate recollection by the patient. Onrequest, consumers could purchasea cholesterol test.
Then I got it! The study wasdesigned to evaluate a layperson'spotential for self-treatmentwithout any help. To me,this is an affront to the pharmacist'srole and value inimproving health.
The authors suggested that>23 million Americans comprisethe intermediate-riskpopulation for coronary heartdisease and that 62% of thispopulation remains untreated.Clearly there is an important unmetneed here. The statistics reflect littleawareness on the part of consumersregarding the impact of abnormal cholesterollevels, much less the lifestylechanges needed to help ameliorate theproblem. Pharmacists know that toomany people decline counseling, aremarginally compliant, and communicateinconsistently or poorly withtheir providers.
Lovastatin seems to be a perfect drugto be designated as a "limited-distribution"drug that could be safely andeffectively managed by pharmacists.Cholesterol screening could be offeredto determine baseline cholesterol levelsand treatment monitors. Pharmacistsare accomplished patient counselorswhen given the time and patient interest.Pharmacists could notify thepatients'physician about laboratorytest results and the drug-dose regimeninitiated by them. Education couldinclude improving lifestyle behaviorsand monitoring for possible sideeffects. Periodic reassessments wouldenable dosage refinement or suggestthe need to see a physician.
This relatively safe and effectivedrug could serve as a trial of the effectivenessof pharmacists as integralproviders of patient care, whose valuehas been underestimated and underutilized.Imagine the impact of aggregatednational results that reflectedthat pharmacists initiated therapy for75% of the moderate-risk patients,which in turn resulted in effectivelowering of LDL!
Perhaps Merck and other manufacturersshould consider partnering withpharmacists to improve health, by supportingpharmacists who manage limited-distribution drugs. We pharmacistsare ready for this responsibility.