Two newspapers recently featured articles on FDA`s consideration of a new category of drugs
known as "behind the counter." The agency is seeking comments on the "public health
benefit of drugs being available without prescription but only after intervention by a pharmacist," according to a notice published last month in the Federal Register. BTC drugs -- a status that could be applied to some drugs currently available only with a prescription -- would not require a prescription from a doctor, but pharmacists would have to verify that customers meet certain criteria before selling a drug
and also would instruct customers on proper use of the drug (Kaiser Daily Health Policy Report, 10/4). Summaries appear below.
Baltimore Sun: The Sun on Thursday examined how the "drugstore has long held two options for the sick: medications made available only with a doctor`s prescription or less potent drugs sold over the counter." Pharmacists have lobbied for FDA to create a BTC class of drugs, which would "add to the ever-expanding role of a profession long frustrated with being perceived as mere pill dispensers who are expert at counting by five," according to the Sun. The Sun notes that pharmacists offer two advantages: they "have the time" and "are accessible in ways doctors can never be, located right down the street, in the supermarket, in the drugstore
, where patients are already going several times a week." However, physicians "see safety issues as they watch their own roles diminished," according to the Sun. In addition, both physicians and pharmacists worry that if drugs are given BTC status, health insurance no longer will cover the medications. According to Kristina Lunner, vice president of government affairs for the American Pharmacists Association, the best drugs for BTC status would treat conditions that patients can self-diagnose and have minimal risk but require some clinical oversight (Desmon, Baltimore Sun, 11/1).
Newhouse/Cleveland Plain Dealer: The "loudest opposition" to granting some prescription drugs BTC status comes from physicians "concerned about a loss of control" and from OTC drug manufacturers "who fear profits could disappear if products end up hidden behind the counter," Newhouse/Plain Dealer reports. The American Medical
Association believes that BTC status is unnecessary and that the lack of physician oversight poses a safety risk. In addition, consumer advocates have "expressed skepticism such a system can work," according to Newhouse/Plain Dealer. Sidney Wolfe, director of the Health Research Group at Public Citizen, said that "[m]any questions still remain," adding, "Will pharmacists have the training and the time to explain the drugs and side effects to patients? Who will pay for that training? Will this third class pull more from drugs currently sold over the counter or from those requiring a prescription?" (Cohen, Newhouse/Cleveland Plain Dealer, 10/31).
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