Has the time come for a third class of drugs?

Imagine this scenario. You hold a cholesterol screening clinic at your pharmacy. In walks a middle-aged woman who couldn't go to a physician because she doesn't have insurance. You perform a blood test and find that her cholesterol level is dangerously high. You explain the benefits of taking cholesterol-lowering medication and making lifestyle changes. You prescribe a behind-the-counter (BTC) cholesterol-lowering drug, advise the patient how to take it, and discuss potential side effects and drug interactions. You charge the patient for the screening, consultation, and the medicine. After the consult, the patient makes an appointment to return for a follow-up so that you can monitor her drug therapy.

This scenario may be played out in pharmacies nationwide if the Food & Drug Administration approves a third, or behind-the-counter (BTC), class of drugs. Once opposed, the FDA is now exploring the idea of making certain drugs available BTC at the pharmacy without a prescription, but only after intervention of a pharmacist before dispensing. FDA posted an announcement in the October 4, 2007, Federal Register; then held a public meeting on November 14, 2007, to elicit comments.

Elevating the role of the R.Ph.

Michael D. Hogue, Pharm.D., assistant professor of pharmacy practice at the McWhorter School of Pharmacy Samford University, echoed Giroux's sentiments about the benefit to patients of increased access. "There are far too many people who are uninsured or underinsured who simply can't afford to seek care from a physician on a regular basis. I don't think a BTC category exempts a patient from having to see their physician, but it offers us an opportunity to reduce the number of physician office visits that are necessary and hopefully to remove that access barrier to the pharmaceuticals."

William Zellmer, deputy executive VP of the American Society of Health-System Pharmacists (ASHP), anticipates that a BTC class would elevate pharmacists' clinical role and improve patients' health. He argued that by making certain prescription medications more widely accessible, public health issues such as hypertension and hypercholesterolemia may improve. "Because these drugs are available by prescription only from a physician, there seems to be a certain segment of the population who are not using these medications, and yet there are some safety concerns surrounding the medication which makes us hesitant to make them OTC. The idea would be to create an intermediate class of medications, where the prospect for making them OTC could be evaluated, and while this evaluation is going on, these medications would be available from pharmacists," Zellmer explained.

ASHP has recommended to FDA that the agency launch some demonstration projects around the country to assess a couple of models, including payment for pharmacist services. "If that were done, we would strongly advocate that outpatient pharmacy departments in hospitals be part of those experiments, because in many respects pharmacies in an institutional environment are used to practicing in this environment," said Zellmer.

BTC ruffles some feathers

While many associations applaud the FDA's desire to study the public health implications of making certain drugs available BTC, several groups are adamantly opposed or have some serious concerns about it.

In a statement to FDA, Joseph W. Cranston, Ph.D., the American Medical Association's director of science, research, and technology, said, "The AMA supports the present classification of drugs as prescription and OTC and opposes the establishment of a new, BTC category. When a drug product is considered unsafe without supervision, a physician should be responsible for supervising the use of that drug. There is little scientific evidence to support the need for a third class of drugs, and many questions about the impact of this class remain unanswered. The AMA is concerned that a third class of drugs could have a negative impact on patient access to some drugs, reflect an increase in costs, and potentially harm patients. This has the potential to put patient health in jeopardy by taking a vital step out of physician diagnosis and treatment of patients."