FDA Proposal to Allow Pharmacists to Prescribe Some Drugs Sparks Swift Rebuke From AAFP

An FDA plan to create a third drug category that would allow pharmacists to dispense drugs for nonprescription use that previously would have required a physician's prescription has generated a letter of opposition from the AAFP, which points out that the proposal could endanger patients and harm patients' relationships with their physicians.

In a Feb. 28 Federal Register (4-page PDF; About PDFs) notice, the agency asked for input on a proposal that would allow pharmacists to dispense certain prescription drugs that meet safe use criteria without a physician's prescription.

In response, the AAFP sent a letter to FDA Commissioner Margaret Hamburg, M.D. AAFP Board Chair Roland Goertz, M.D., M.B.A., of Waco, Texas, points out in the April 30 letter that the proposed new paradigm would result in patients receiving powerful prescription drugs without input from their physicians. "It is the AAFP's policy to oppose regulations and legislation that would allow pharmacists to dispense medication beyond the expiration of the original prescription for reasons other than emergency purposes," Goertz says.

In the letter, Goertz recognizes the important role pharmacists play in the health care system, noting that 250 million people walk into a pharmacy every week. "As such, pharmacists play an essential role in providing direction to patients seeking advice on nonprescription and OTC medications," says Goertz. "In instances where a patient is seeking information in the absence of direction from a physician, the pharmacy professional is the logical source to provide that information."

As a consequence, there are areas of "professional activity where, by good practice and law, the pharmacist practices independently," Goertz says. "However, other areas exist where that expertise is best exercised in an environment with physician supervision. (Although) pharmacy professionals should not prescribe drugs or alter a prescription written by a physician, they have valuable contributions to make as part of a patient's medical team, especially in a predetermined collaborative practice arrangement."

However, says Goertz, the FDA's proposal creates a problematic issue regarding the appropriate relationship between patients, physicians and pharmacy professionals.

"Only licensed doctors of medicine, osteopathy, dentistry and podiatry have the statutory authority to prescribe drugs," says Goertz. "Allowing the pharmacist authority to dispense medication without consulting with the patient's physician first could seriously compromise the physician's ability to coordinate the care of multiple problems of many patients."

Pharmacy professionals and physicians need to work in a collaborative environment and use their combined expertise to "optimize the therapeutic effect of pharmaceutical agents in patient care to achieve the desired outcomes while maintaining overall efficiency," says Goertz.