AAFP Says No to Safe Use Class of Drugs

AAFP Says No to 'Safe Use' Class of DrugsBy Emily P. Walker, Washington Correspondent, MedPage Today Published: May 01, 2012

WASHINGTON -- The American Academy of Family Physicians (AAFP) has voiced its opposition to an FDA proposal that would allow pharmacists to dispense some drugs without a prescription.

Currently, the FDA approves drugs either as prescription or nonprescription, but the agency is considering adding a third class of drugs called "safe use" drugs, which would be regulated much as over-the-counter drugs are now, but with extra controls.

"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 an April 30 letter to FDA Commissioner Margaret Hamburg.

In a notice published in February, the FDA said it is considering a "new paradigm" where drugs that would normally require a prescription could be available without one if they met certain "conditions of safe use."

Those conditions could include restricting them to sale behind the counter at a pharmacy, or requiring an initial prescription but allowing refills at the patient's request.

Examples cited by Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, might be EpiPens or glucagon -- both of which are prescribed for possibly life-threatening conditions and which patients can easily find themselves without when they're needed.

Moving some prescription drugs into safe use status could allow patients to skip visits to the doctor, which the AAFP opposes.

"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.

In March, the FDA held a public meeting on its proposed plan and heard from stakeholders such as the AAFP, the AMA, which is also opposed to the safe use category, and the American Pharmacists Association (APhA), which is in favor of adding this third category of drugs.

Thomas Menighan, CEO of the APhA, said creating a safe use category could greatly improve access to drugs because pharmacists are the most easily accessed healthcare provider for many patients.

In addition to improving access for patients, reducing routine doctor's visits could free up physicians to spend more time with sicker patients, "reduce the burdens on the already overburdened healthcare system, and reduce healthcare costs," the February FDA notice read.

When nicotine replacement therapy changed from requiring a prescription to being over-the-counter, tens of thousands of people quit smoking, which represented a $2 billion annual "societal benefit," Scott Melville, CEO of the Consumer Healthcare Products Association, a trade group for over-the-counter drugmakers, said during the FDA's public meeting.

In addition, making heartburn medicines available without a prescription saves the healthcare system $757 million each year, according to Melville.

In order for the FDA to consider switching a drug from prescription to nonprescription, it must meet certain criteria, including that it must not be addictive; it must not have significant toxicity if overdosed; and users must be able to self-diagnose conditions for appropriate use and be able to safely take the medication without a physician's screening.

Presumably some of those same requirements would apply to drugs moved from prescription status to the new safe use status.

During the March public meeting, an ob/gyn argued that birth control pills -- especially progestin-only pills -- meet those criteria and should be available without a prescription.

The FDA is seeking comments on the proposal.

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My take? We have more drug training than physicians. It's all about the $.