“Behind-the-counter” drugs could become the newest category of medications.

Americans currently can get their medications with a prescription or over the counter. For behind-the-counter (BTC) drugs, patients would not need a doctor’s prescription. But this isn’t as furtive as it sounds: Patients would have to be counseled by a pharmacist before buying BTC medicines.

The idea, now under consideration by the U.S. Food and Drug Administration, is controversial. Pharmacists generally welcome it, doctors oppose it, and consumer advocates express mixed opinions.

The FDA started the ball rolling in November at a public meeting to hear views from representatives of all three groups.  “We believe pharmacists, already one of the most trusted and accessible health care providers and experts in appropriate use of medication, are uniquely qualified to take on this new role,” said Mary Ann Wagner, a senior vice president of the National Association of Chain Drug Stores.

Joseph Cranston, director of science, research and technology at the American Medical Association disagreed. “While pharmacists are very knowledgeable about drugs,” he said, “they lack the necessary education and experience in patient evaluation, clinical diagnosis and prescribing for individual patients to make the … decisions that physicians do on a routine basis every day.” In the AMA’s view, he added, BTC drugs “will be detrimental to the health of many individuals and for the public.”

Only two types of medicines are currently sold from behind the counter. One is the emergency contraceptive Plan B, which under FDA rules is kept behind the counter to ensure that women under age 18 cannot obtain it without a prescription. The other is a group of cold medicines that contain pseudoephedrine, which can be used to make crystal methamphetamine, an illegal drug.     

But if a whole new category of BTC medicines is introduced, pharmacists could talk to patients who hadn’t received a doctor’s diagnosis and then make their own decisions about dispensing medication.    

This raises several issues. Which drugs would be classified as BTC, and why? Where would the lines be drawn between prescribed drugs and BTC drugs or between BTC and over-the-counter drugs?  Would pharmacists need special training to counsel patients effectively?  What fees could they charge for these extra responsibilities?

For consumers, there are potentially pluses and minuses. Rebecca Burkholder of the National Consumers League said at the FDA hearing that her group had always favored a BTC category, “but we do have numerous concerns about how such a system will work safely and effectively.”

On the plus side, Burkholder said, a BTC category could, for example, “expand the range of conditions that patients can self-treat without spending time or money on a doctor’s visit.” But, she warned, “Quality pharmacy consultation would be critical to ensuring that the medication is taken safely and appropriately.”

Canada, Australia and several European nations have had BTC systems in place for years. The most recent full review of 10 of these systems, conducted in 1995 by the U.S. General Accounting Office (now the Government Accountability Office), concluded that “their value has yet to be demonstrated” and showed that the required counseling by pharmacists was often inadequate.

But compared with these countries, the United States is unique in having 47 million people without health insurance. Proponents say a BTC system would significantly increase these people’s access to medicines. On the other hand, it isn’t clear whether insurers would cover BTC products—which could mean that people with health insurance would pay more for them. Under current law, the Medicare Part D program can cover only prescribed drugs.

An FDA spokesman said it’s also not clear when a decision on allowing BTC products will be made or whether it requires congressional approval. For now, the agency is reviewing comments from experts and the public.