I recently read a newspaper article that described a consumer-use study conducted to determine the feasibility of making lovastatin (Mevacor) an OTC product. The Merck-sponsored study concluded that lovastatin could be safely and effectively used by consumers with the aid of a self-management system developed by the manufacturer. The FDA, however, disagreed with the conclusions drawn from the data and denied approval of lovastatin OTC status. What bothered me about the article was a reference to the design of the study, which used nurses as study investigators who "assumed the role"of pharmacists!
I searched out the article by Melin et al from the American Journal of Cardiology (November 15, 2004) to try to understand the study design and review the trial results. I was particularly interested in why nurses were used in lieu of pharmacists. I was even more appalled to learn that nurse investigators were explicitly instructed not to volunteer any information or perform an eligibility assessment that could assist the consumer as they contemplated initiating therapy. They were allowed to use scripted responses if patients (study participants) asked questions.
Although the consumers were required to know their baseline high-density lipoprotein, low-density lipoprotein (LDL), and triglyceride levels, no efforts were made to ensure accurate recollection by the patient. On request, consumers could purchase a cholesterol test.
Then I got it! The study was designed to evaluate a layperson's potential for self-treatment without any help. To me, this is an affront to the pharmacist's role and value in improving health.
The authors suggested that >23 million Americans comprise the intermediate-risk population for coronary heart disease and that 62% of this population remains untreated. Clearly there is an important unmet need here. The statistics reflect little awareness on the part of consumers regarding the impact of abnormal cholesterol levels, much less the lifestyle changes needed to help ameliorate the problem. Pharmacists know that too many people decline counseling, are marginally compliant, and communicate inconsistently or poorly with their providers.
Lovastatin seems to be a perfect drug to be designated as a "limited-distribution" drug that could be safely and effectively managed by pharmacists. Cholesterol screening could be offered to determine baseline cholesterol levels and treatment monitors. Pharmacists are accomplished patient counselors when given the time and patient interest. Pharmacists could notify the patients'physician about laboratory test results and the drug-dose regimen initiated by them. Education could include improving lifestyle behaviors and monitoring for possible side effects. Periodic reassessments would enable dosage refinement or suggest the need to see a physician.
This relatively safe and effective drug could serve as a trial of the effectiveness of pharmacists as integral providers of patient care, whose value has been underestimated and underutilized. Imagine the impact of aggregated national results that reflected that pharmacists initiated therapy for 75% of the moderate-risk patients, which in turn resulted in effective lowering of LDL!
Perhaps Merck and other manufacturers should consider partnering with pharmacists to improve health, by supporting pharmacists who manage limited- distribution drugs. We pharmacists are ready for this responsibility.