The Dallas Morning News recently had an article about an FDA proposal to create a new category of drugs — “Behind the Counter” medications. These would be drugs that now require a prescription, but in the future would require only that you talk with you pharmacist before you can buy them. Is this a good idea? I have mixed feelings. It would save some hassle, but should we always trust the new night-shift pharmacist in a chain store to make the right decision about our medical needs? Here are excerpts from the article:
For years, consumers either showed up at the drugstore with a doctor’s prescription or settled for less powerful medications sold over the counter.
Now the U.S. Food and Drug Administration is considering creating a class of medicines dubbed “behind the counter.” It would let consumers buy routine medicines that could include birth control pills, cholesterol drugs and migraine medicine without a prescription – as long as they discuss it with a pharmacist first.
Pharmacists and drug companies like the idea; doctors think it’s dangerous. If approved, the new drug classification could go into effect as early as next year.
“We believe having certain drugs behind the counter but available only after a consultation with a pharmacist could significantly increase patient access,” said Ilisa Bernstein, the FDA’s director of pharmacy affairs.
But doctors are on alert. Dr. Anmol Mahal, a gastroenterologist and president of the California Medical Association, said the federal agency’s proposal is ill-conceived and unsafe for consumers.
“Patients are not clinicians,” he said. “Allowing people to self-diagnose and self-treat is not in their best interest.”
Currently, only a handful of drugs are available behind the counter without a prescription. Best-known is the morning-after birth control pill that was banned for over-the-counter sale in the U.S. until last year. Women under the age of 18 still need a prescription for the drug.
Over-the-counter drugs typically sell for less than prescription medicines but often at much higher volumes, potentially making them more profitable for manufacturers in certain cases.
Much will depend on which behind-the-counter drugs that insurers decide to cover. Most insurance plans cover prescription drugs but not over-the-counter medicines. Insurers say they are researching the FDA’s proposal.
John Tilley, who owns four pharmacies in Downey, Calif., and serves as the president of the National Community Pharmacists Association, sees the FDA’s proposal as a “win-win” for patients.
Pharmacists are trained to consult about routine medical information, he said, and are often more accessible and spend far more time with customers than do their doctors. He said greater access to medications might help patients without health insurance who otherwise might not be getting care.
“It’s not like people would be getting these medications from a vending machine,” he said. “This would include an adequate level of care.”
Critics of looser oversight of the nation’s drug supply were less optimistic.
Dr. Mahal of the California Medical Association said he was concerned that patients would buy medication and then lack supervision to ensure their treatment was safe and effective.
Ms. Bernstein of the FDA said the agency had several questions about how such a proposal would work in practice – including how it could affect patient safety and whether it actually would improve access to medications.
“We’re still in research mode,” she said.
