FDA May Allow Pharmacists to Dispense Some Drugs Without a Doctor's Prescription

he U.S. Food and Drug Administration (FDA) is considering adopting a new drug classification that would allow some medications to be sold from behind the counter (BTC)--requiring only a pharmacist's approval instead of a doctor's prescription. It's a move some say could increase consumer choice and lower costs.

FDA representatives met with pharmacists and consumers on November 14 to discuss the idea. "This has been raised several times over the past several years," said Ilisa Bernstein, FDA's director of pharmacy affairs. "The time was right to have a meeting to bring everyone together to discuss it more fully."

Bernstein said the meeting was appropriate because the health care landscape has changed over the past decade and pharmacists are much better trained to be part of a team of health care professionals than they once were.

"Patients are taking a more proactive role in their health care decisions and are more informed because of the Internet and other media," Bernstein explained. "We are particularly interested in whether BTC might improve patient access to safe and effective drug products. If a patient won't or can't go to their doctor because of time or money concerns, is there a health benefit if they can get safe and effective medicines by going to the pharmacy and consulting with their pharmacist?"

Listening Meeting

More than 30 groups representing consumers, pharmacists, pharmaceutical companies, and doctors attended the meeting. A public comment period remained open until December 1.

BTC classification of medication could help patients who can't see a doctor or don't have sufficient insurance, Bernstein said. The classification would most likely apply to some drugs with strong safety records, but FDA has not yet decided which drugs to include.

Bernstein could not say when, if at all, the idea may become a reality in pharmacies across the country.

"At this point, we have more questions than answers," Bernstein said. "This is more of a listening meeting."

Many pharmaceutical and medical associations are still reviewing information and will make recommendations about the value and implementation of BTC medications at the meeting.

Changing Status

Carmita Coleman, executive director of the Student National Pharmaceutical Association and assistant dean of student affairs at San Antonio's University of the Incarnate Word's School of Pharmacy, said the concept of BTC drugs isn't novel.

Many states already have a similar process, Coleman said, for dispensing drugs such as emergency contraceptives. Similarly, other countries, including Australia, Canada, and New Zealand, offer a BTC drug status, according to the FDA docket detailing the meeting.

However, because of the uniqueness of the U.S. health care system, hearing about BTC drugs' impact on other countries was informative but not necessarily applicable, Bernstein said.

"Our system is very different, our practice of pharmacy and medicine is different, and payment for health care is very different," Bernstein explained.

Some presenters at the November 14 meeting discussed how drug prices fall when they move from prescription-only to over-the-counter status.

"Whether they would [likewise fall] if they became BTC is unclear, but there's some indication they would," Bernstein said.

Evaluating Patients

Coleman said each state has standards for pharmacists and the drugs they can dispense without a prescription.

"We're really already doing this," Coleman said. "We give adequate consultation for over-the-counter medications. We have people who come to our counters on a daily basis asking for medications that can help them."

The difference, Coleman explained, is FDA could regulate BTC drugs on a more national level if the rule change passes. If so, she said, the next step to consider is implementation. Pharmacists could better serve patients if given more access to their medical records, Coleman said.

The drug reclassification could help restructure the way Americans approach their medicine, said Mitch Rothholz, chief of staff of the American Pharmacists Association, an industry group based in Washington, DC.

Trained pharmacists could educate patients, help them evaluate risks and benefits, and ensure the medication safely treats their conditions, Rothholz explained.

"[BTC status drugs] would be another tool in the armament of available options to the patient," Rothholz said.

Considering Possibilities

Cynthia Reilly, director of clinical standards and quality at the American Society of Health-System Pharmacists (ASHSP), an association of pharmacists based in Bethesda, Maryland, said pharmacists' easy accessibility could benefit many consumers, especially in rural communities.

BTC drugs' success would depend on continuous communication between the pharmacist and the patient, Reilly said. Pharmacists must be able to view patients' records and monitor their responses.

"It's not simply a 'go to the pharmacy, pick it up, and you're done' approach for these medications," Reilly said.

A new classification could change the way pharmacies approach the distribution of medicines. Chrissy Kopple, vice president of media relations for the National Association of Chain Drug Stores (NACDS), said government affairs and policy experts are still researching the possibilities.

NACDS wants to discuss how the medications would be tracked, how they would be documented, and how patients' records could be kept current, Kopple said.