FDA Mulls Direct Pharmacist-to-Patient Drug Sales

"Most importantly, we are most concerned about the types of drugs that could be moved to this class, particularly for patients with chronic illnesses, where it is critical that there be diagnosis and management by a physician," he added.

Cranston believes the move toward behind-the-counter sales is fueled by the pharmacy and pharmaceutical industries, which he believes would see more sales -- especially of older drugs or drugs that have gone off patent.

There are several reasons that the FDA is considering the proposal. Among these is the assertion that the plan improves pharmacist interaction with patients and ensures safe and effective use of drugs requiring a prescription.

In addition, allowing certain drugs to be sold without a prescription might boost patient access to medications that are typically underused, especially by patients who don't have health insurance, experts said.

Variations of behind-the counter drug sales already exist in other countries, including Australia, Canada, France, New Zealand, the United Kingdom, Denmark, Germany, Italy, the Netherlands, Sweden, and Switzerland, according to the FDA.

The medications that these countries allow to be sold by pharmacists without a prescription are those that treat a self-diagnosed condition -- with the help of a pharmacist. Drugs with few side effects and with a low probability for overdose are also often included in behind-the-counter dispensing, the FDA noted.

Some countries require that the pharmacist ensure that the patient meets certain criteria before dispensing the drug, the agency said. Pharmacists are also asked to provide customers with education on the proper use of the drug and to monitor patient outcomes, according to the FDA.

A major consumer group sided with the AMA against behind-the-counter sales.

"The idea of behind-the-counter-drugs is not new," Dr. Sidney Wolfe, director of the Health Research Group at Washington, D.C.-based Public Citizen, said in a prepared statement. "The FDA has previously considered creating a third class of drugs -- an intermediate step between prescription medications and over-the-counter drugs -- but has not supported the idea, citing the need for more research. That need still exists today," he added.

One government study found that before such a program could be instituted, a number of questions needed to be answered, Wolfe noted. Those included questions as to the risks of inadequate counseling by pharmacists, cost, and the usefulness and logistics of adding this third layer of distribution.

"There's little evidence that these concerns have been addressed," Wolfe said. "Many questions still remain unanswered -- Will pharmacists have the training and the time to explain the drugs and side effects to patients? Who will pay for that training? Will this third class pull more from drugs currently sold over-the-counter or from those requiring a prescription? And will drug companies push to get their current prescription products into this class to avoid regulation?"

Finally, Wolfe said, "Will behind-the-counter availability effectively turn the drug store counter into a vending machine, free from doctors' oversight? The FDA needs to put more research behind the plan before it tells Congress it's OK to put more drugs behind the counter," he said.

But one New York City pharmacist believes those fears are overblown.

"It will be a great opportunity for patients to interact more with their pharmacists," said Catherine Tom-Revzon, a clinical pharmacy manager at the Children's Hospital at Montefiore Medical Center. "Pharmacists do have a wealth of knowledge to offer in regards to the proper use of medications and whether the drug that will be behind-the-counter will interact with the current medications that patients are on," she said.

In addition, Tom-Revzon believes the proposal will give pharmacists the ability to monitor the effectiveness of a medication and then change drugs and doses as needed. "It's a great opportunity for a pharmacist to work more closely with patients and prescribers," she said.

Some drugs may require that patients provide proof that the drug is needed, Tom-Revzon noted. Pharmacists may also ask patients for specific blood tests before selling a particular drug to be sure the drug is appropriate, she said. Pharmacists are trained to read such tests, Tom-Revzon noted.

More information

For more on drug regulation, visit the U.S. Food and Drug Administration.

SOURCES: Joseph Cranston, Ph.D., director, Science, Research, and Technology, American Medical Association, Chicago; James Appleby, COO, American Pharmacists Association, Washington, D.C.; Catherine Tom-Revzon, Pharm.D., clinical pharmacy manager, Children's Hospital, Montefiore Medical Center, New York City; Public Citizen, press statement;Los Angeles Times;