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FDA Hears Pros, Cons of Pharmacist-to-Patient Drug Sales
Date:11/14/2007

'Behind-the-counter' dispensing would bypass doctors for some prescriptions

WEDNESDAY, Nov. 14 (HealthDay News) -- During a day-long public hearing Wednesday on whether to allow certain drugs to be sold by pharmacists without a prescription, U.S. Food and Drug Administration officials listened to arguments for and against the proposal by representatives of various medical and public interest groups.

But at the day's end, the FDA officials said they weren't ready to make a decision on whether to create a new class of drugs that pharmacists could sell "behind-the-counter." And, they wouldn't speculate on a timetable for such a decision.

"Today we benefited from a wide ranging discussion of views from a variety of stakeholders in the health-care arena about whether increased use of behind-the-counter access could benefit patients and public health," Randall Lutter, the FDA's deputy commissioner for policy, said during a late afternoon teleconference.

Right now, the agency is interested in gathering views from the public on whether behind-the-counter (BTC) drug sales could be beneficial to consumers, Lutter said. "We will review the comments we got today and the comments that we receive in writing to our open public docket, and then we will evaluate appropriate next steps," he said. "We haven't decided what the next step might be."

If the proposal were to be enacted, 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.

Lutter said greater consumer involvement in health care is driving the FDA's decision to consider "behind-the-counter" drugs. "Our interest is driven by an increased trend toward consumer involvement and consumer and patient empowerment in their own decisions and responsibilities that they take for health care," he said. "That is really manifested by the Internet and the changes it has brought about."

Among those supporting the idea of "behind-the-counter" drugs is the National Community Pharmacists Association (NCPA).

"NCPA strongly supports BTC because it will increase patient access, reduce health-care costs, increase interaction between the patient and pharmacists and have an overall positive impact on health care," Steve Giroux, NCPA president, said in a prepared statement. "Transitioning some drugs to BTC status will offer patients a readily available, cost-effective means for treatment, reducing the severity of illnesses and increasing workforce productivity by decreasing sick time."

Another industry association also supports the BTC drug sales, but for a different reason.

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

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.

Dr. Daniel A. Hussar, Remington professor of pharmacy at the University of the Sciences in Philadelphia's College of Pharmacy, expressed support for the proposal.

"The involvement of the pharmacist in counseling patients will be of great value in assuring the effective and safe use of these medications," Hussar said in a prepared statement. "Also, this role will enhance the recognition of pharmacists as sources of useful information regarding other medications and health-care issues."

Hussar said he has developed a list of medications he believes could be made available BTC. This list includes: varenicline (Chantix), a smoking-cessation drug; epinephrine, used to treat serious allergic reactions; oseltamivir (Tamiflu), for influenza infection; and statins, for high cholesterol.

However, one doctor believes pharmacists aren't qualified to sell medications, particularly statins.

"What is going to be provided to the pharmacists to give the appropriate dose of the appropriate statin and what criteria is going to be followed," said Dr. Howard Weintraub, co-director of the New York University Medical Center lipid treatment program, who was not at the hearing. "Unless the pharmacist is empowered to order blood tests and interpret them, they will not be able to prescribe the correct drug at the right dose."

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

More information

For more on prescription drugs, visit the FDA.



SOURCES: Howard Weintraub, M.D., co-director of the New York University Medical Center lipid treatment program, New York City; Joseph Cranston, director of Science, Research, and Technology, American Medical Association; James Appleby, chief operating officer, American Pharmacists Association, Washington, D.C.; Daniel A. Hussar, Ph.D., Remington professor of pharmacy at USP's Philadelphia College of Pharmacy; Nov. 14, 2007, teleconference with Randall Lutter, Ph.D., deputy commissioner for policy, U.S. Food and Drug Administration


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