Mr. Eckel is professor and director of the Office of Practice Development and Education at the School of Pharmacy, University of North Carolina at Chapel Hill.
After years of debate, could we finally see the emergence of a new category of behind-thecounter (BTC) drugs?
The idea of a drug category that would be available to patients with pharmacist advice but without a prescription is gaining support. Notably, the FDA's position has shifted. For years, the agency maintained that it lacked the authority to designate drugs for BTC access without legislative changes. The agency's 2006 decision to assign BTC status to levonorgestrel (Plan B) suggested just the opposite, however, and the FDA's recent hearings reflect its interest in applying BTC status more broadly.
BTC systems have been operating successfully for years in several countries, including the United Kingdom and Canada. Medications already being offered abroad on this basis include some of those being discussed for potential BTC status here, such as drugs for chronic conditions like high cholesterol.
In this country, a BTC category could benefit patients by providing easier access to some drugs, along with the medical guidance needed to ensure safety. It also could benefit our profession, not least by helping us expand our role as medication advisers.
Of course, BTC remains controversial. An argument still exists about whether patients need expert counseling to help them manage chronic conditions, or whether they should simply be able to obtain drugs over the counter.
I feel that the pharmacist's role with BTC medications could be viewed as confirming a patient's self-diagnosis—ruling out the possibility that the diagnosis is incorrect— and then providing a treatment plan to address the patient's condition.
The Asheville Project has confirmed that pharmacist intervention can be extremely effective at improving outcomes for various chronic disease states. This could substantially cut the nation's health care costs, because chronic diseases account for many billions of dollars in health care spending every year, and much of the cost is due to inappropriate treatment of those diseases.
Another question about the introduction of a BTC category is whether all pharmacists are ready to step into this new role. Clearly, we are well-trained and adequately prepared to counsel patients. Many of us are so preoccupied with filling prescriptions, however, that we have not yet adjusted to the idea of advisory roles that involve higher visibility and greater interaction with the public. To make this transition feasible, we need to push for adequate reimbursement for the time we spend counseling patients.
Establishment of a BTC category could help us provide the right drugs to millions of people suffering from chronic diseases. We should support efforts to make this a reality.
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