May 16, 2012

'Safe Use' Drug Idea: Pharmacists, Yay; Physicians, Nay

Washington, D.C.In the United Kingdom and Australia, some medications are classified as neither prescription nor OTC, but drugs that require the oversight of a pharmacist before patients can gain access to them. A similar system is even being tested in this country after the Arkansas state legislature decided that pseudoephedrine should be dispensed at the discretion of pharmacists.

Yet, consideration by the FDA of adding a third, "safe use" class of drugs has created a firestorm of opposition from physician groups. The most recent volley came from the American Academy of Family Physicians (AAFP).

"The AAFP recognizes the important role of pharmacists in the provision of high quality healthcare; however, this proposed new paradigm would allow patients to receive powerful prescription drugs without the input of a physician," Roland Goertz, MD, chairman of AAFP board, wrote in a recent letter to FDA Commissioner Margaret Hamburg.

The FDA published a notice in February that it is considering a "new paradigm" to allow drugs normally requiring a prescription to be available without one if they meet certain "safe use" conditions. One possible condition would be restricting them to sale behind the counter at a pharmacy, giving pharmacists more authority in dispensing them. Another would be allowing refills without a doctor's approval.

Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said examples might be EpiPens or glucagon.

The comment period ended for the public hearing on May 7, but FDA did not announce the next steps in the process.

The American Pharmacists Association (APhA), is strongly in favor of adding the third category of drugs, but physician groups are up in arms, partly because of concerns that patients would visit their doctors less often.

"Only licensed doctors of medicine, osteopathy, dentistry, and podiatry have the statutory authority to prescribe drugs...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," Goertz wrote in the letter to Hamburg. The American Medical Association also has expressed its opposition.

At a March public meeting on the proposed plan, Thomas Menighan, CEO of the APhA, pointed out that pharmacists are the most available health care provider for many patients and that cutting down on doctor's visits could benefit the nation's health care system by reducing costs.

Menighan said APhA "sees this as a significant and important opportunity for pharmacists to improve public health, and increase access, much as we've done with immunizations."

Another speaker at the meeting, Scott Melville, CEO of the Consumer Healthcare Products Association, the OTC trade group, noted that when nicotine-replacement therapy no longer required a prescription, more Americans quit smoking and created a $2 billion annual "societal benefit." He also said that OTC heartburn medicines save the health care system $757 million each year.

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