FDA Explores Idea of 'Behind-the-Counter' Drugs

The FDA is exploring the public health benefit of allowing certain drugs now available only by prescription to be dispensed -- with pharmacist oversight -- from "behind the counter," or BTC. The agency will hear public comment on the issue at a Nov. 14 meeting in Washington.

According to an online notice from the FDA, some groups have stated that "Because pharmacists have the training and knowledge to provide certain interventions, they may be able to ensure that patients meet the conditions for use and educate patients on appropriate use of the drug product."

The FDA noted that pharmacist groups have argued that BTC access to drugs could help uninsured patients gain access to certain drugs now available only by prescription. The agency also pointed out that variations of BTC drug regulations are in effect in a number of countries, including Australia, Canada, France, New Zealand, the United Kingdom, Germany and Italy. In those countries, said the FDA, the pharmacist typically is required to ensure that the patient meets certain criteria before dispensing and to "provide education on proper use and monitoring."

Steven Crawford, M.D., of Oklahoma City, chair of the AAFP Commission on Governmental Advocacy, confirmed that the BTC drug issue is on the agenda for the commission's Nov. 18 meeting and said that the AAFP plans to submit written comments to the FDA.

The deadline for public comment is Nov. 28.

Crawford pointed out that the FDA periodically moves certain types of drugs from prescription to over-the-counter, or OTC, status. H2 blockers and vaginal yeast infection medications fall into that category, he said. "Many years ago, Tylenol was originally a prescription drug that went OTC."

However, Crawford has safety concerns about making certain drugs available to patients without a prescription, including cholesterol-lowering statins -- known as HMG-CoA reductase inhibitors -- or antimicrobial drugs, such as those used to treat herpes simplex virus infections.

"The challenge in the BTC proposal is that if there's enough concern that a drug needs to be put behind the counter -- and particularly with drugs that need laboratory monitoring, like statins -- are we then going to have the pharmacist doing lab work and interpreting lab work?" asked Crawford.

"Statins are a chronic long-term therapy, and a physician should be involved in the decisions about the institution of that therapy, the modification of that therapy and other issues related to cardiovascular risk reduction," said Crawford. "Most people don't have just high cholesterol; they also have potential elevated blood pressure, diabetes, plus all other kinds of health issues. I can't imagine a pharmacist doing a Pap smear at the pharmacy or a rectal exam for male prostate cancer screening."

Crawford said that as a member of the Academy and as the governmental advocacy commission chair, he's focused on the big picture -- namely, the patient-centered medical home.

"I'm concerned about the consequences," said Crawford. "BTC distribution of drugs used to treat chronic conditions -- such as hypercholesteremia -- could harm AAFP's goal of ensuring that patients have a strong patient-centered medical home."

In its online notice, the FDA noted that it is seeking public input on a lengthy list of specific issues related to BTC dispensing, including

AAFP members can participate in the BTC discussion by providing their written comments to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments also can be submitted electronically.

Transcripts of the public meeting will be available online about the middle of December.