Behind-The-Counter Rx Drug Classification

Armen Hareyan's picture


Two newspapers recently featured articles on FDA'sconsideration of a new category of drugs known as "behind the counter."The agency is seeking comments on the "public health benefit of drugsbeing available without prescription but only after intervention by apharmacist," according to a notice published last month in the FederalRegister. BTC drugs -- a status that could be applied to some drugscurrently available only with a prescription -- would not require aprescription from a doctor, but pharmacists would have to verify thatcustomers meet certain criteria before selling a drug and also wouldinstruct customers on proper use of the drug (Kaiser Daily Health Policy Report, 10/4). Summaries appear below.

  • Baltimore Sun: The Sunon Thursday examined how the "drugstore has long held two options forthe sick: medications made available only with a doctor's prescriptionor less potent drugs sold over the counter." Pharmacists have lobbiedfor FDA to create a BTC class of drugs, which would "add to theever-expanding role of a profession long frustrated with beingperceived as mere pill dispensers who are expert at counting by five,"according to the Sun. The Sun notes thatpharmacists offer two advantages: they "have the time" and "areaccessible in ways doctors can never be, located right down the street,in the supermarket, in the drugstore, where patients are already goingseveral times a week." However, physicians "see safety issues as theywatch their own roles diminished," according to the Sun.In addition, both physicians and pharmacists worry that if drugs aregiven BTC status, health insurance no longer will cover themedications. According to Kristina Lunner, vice president of governmentaffairs for the American Pharmacists Association,the best drugs for BTC status would treat conditions that patients canself-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 statuscomes from physicians "concerned about a loss of control" and from OTCdrug manufacturers "who fear profits could disappear if products end uphidden behind the counter," Newhouse/Plain Dealer reports. The American Medical Associationbelieves that BTC status is unnecessary and that the lack of physicianoversight 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 Groupat Public Citizen, said that "[m]any questions still remain," adding,"Will pharmacists have the training and the time to explain the drugsand side effects to patients? Who will pay for that training? Will thisthird class pull more from drugs currently sold over the counter orfrom those requiring a prescription?" (Cohen, Newhouse/Cleveland Plain Dealer, 10/31).

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