FDA Mulls Direct Pharmacist-to-Patient Drug Sales

TUESDAY Nov. 13, 2007 -- Experts at the U.S. Food and Drug Administration are meeting Wednesday to hear arguments on whether or not pharmacists might someday bypass doctors and directly provide consumers with certain drugs that now require a prescription.

If this plan were to go ahead, it would create a new class of drugs that could be sold by pharmacists "behind-the-counter." Such drugs might include birth control pills, cholesterol drugs and migraine medicine, experts said. Their sales would require that patients discuss these purchases with the pharmacist first.

"We believe having certain drugs behind the counter, but available only after a consultation with a pharmacist, could significantly increase patient access," Ilisa Bernstein, the FDA's director of pharmacy affairs, told the Los Angeles Times.

Wednesday's hearing marks another chapter in the behind-the-counter saga. In 2005, the agency rejected a proposal to allow the cholesterol-lowering drug Mevacor to be sold without a prescription. At the time, however, some of the FDA's scientific advisers said it might be possible for pharmacists to sell the drug if they could help select which customers bought the pills.

But the issue finds arguments both pro and con.

Several industry groups support the proposal.

"The whole notion of having some medications behind the counter is a wonderful way to improve medication use and advance patient care," said James Appleby, chief operating officer of the American Pharmacists Association.

He sees the proposal as a way for druggists to be reimbursed by the health insurance industry for dispensing advice and medications to consumers.

"If behind-the-counter medications are going to be a true health-care experience, the American Pharmacists Association would envision a situation in which insurers and third-party payers would pay pharmacists, much the way they pay physicians for physician visits," Appleby said.

But the country's largest organization representing physicians, the American Medical Association, does not endorse the plan.

"We are opposed to it for a variety of reasons," said Joseph Cranston, AMA's director of Science, Research, and Technology. "First of all, we don't think FDA has the legal authority to establish it without legislation."

His group also does not believe there's even a need for this new form of dispensing medicine, Cranston said.

"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.

Posted: November 2007


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