FDA Proposal Gives Pharmacists Too Much Power, Docs Argue

CHICAGO – Physicians are concerned regarding a recent government proposal to create a new class of drugs that would fall somewhere between those that need a doctor’s prescription, and those that can be bought over the counter.

The proposal, which the Food and Drug Administration (FDA) calls a “new paradigm,” would allow some drugs that currently require a prescription to be made available over the counter (OTC) under certain conditions, such as after a consultation with a pharmacist. In February, the FDA published a notice about the proposal, calling for public input about its feasibility.

At a meeting of the American Medical Association (AMA) here this week, doctors expressed concern about giving pharmacists the authority to prescribe drugs that currently require a doctor’s prescription, such as cholesterol-lowering medications.

However, FDA officials and pharmacists countered that the proposal could increase patients’ ability to get drugs when needed, and said that drugs like statins would always require a prescription before being dispensed.

“We’re looking to redirect patients back into the health care system, [and] improve access,” to drugs, said Marcie A. Bough, senior director of government affairs at the American Pharmacists Association, who spoke here Sunday, addressing the goal of the FDA’s proposal. Pharmacists are not looking to break up patient care, or take patients away from their doctors, Bough said.

The AMA will vote this week whether to adopt a policy opposing the FDA’s proposal.

Proposed new paradigm

In the FDA’s proposal, some prescription drugs, such as emergency asthma medications or drugs for migraine headaches, could be made available without a prescription, under “conditions of safe use.”

“The conditions of use could include requiring pharmacist intervention to ensure appropriate nonprescription use,” the agency said in the document.

Perhaps a source of contention around the issue was an example the FDA provided of one such “condition” of use.

“Some diseases or conditions might require confirmation of a diagnosis or routine monitoring using a diagnostic test (e.g., a blood test for cholesterol levels or liver function) that could be available in a pharmacy. A pharmacist, or consumer, could then use the results to determine whether use of a certain drug product is appropriate,” the document says.

In an AMA committee meeting yesterday, Dr. Robert Orford, an assistant professor of medicine at the Mayo Clinic in Arizona, said: “While pharmacists are valued members of the patient care team, they do not have the statutory authority to prescribe drugs.”

“Pharmacists’ training is not even close to the comprehensive systematic training of physicians,” Orford said.

Orford authored a resolution that the AMA will vote on, stating the group’s opposition to federal legislation that would allow pharmacists to dispense or refill prescription drugs without a new prescription.

Misunderstandings

Janelle Derbis, of the FDA’s Office of Special Health Issues, said the FDA is concerned the AMA’s resolution does not accurately represent the agency’s intent in its proposal.

“FDA is not proposing to change who can prescribe and or dispense prescription drugs,” Derbis said. “Rather, the FDA is proposing to explore a flexibility in allowing certain OTC products to be dispensed with conditions of safe use.”

For example, Derbis said, the new class of drugs might include albuterol inhalers used to treat wheezing and difficult breathing in asthma patients. Currently, asthma patients who have used up or lost their inhalers and experience an asthma attack must go to the emergency room. If albuterol inhalers were reclassified so that they could be dispensed over the counter, patients could instead go to a pharmacy, Derbis said.

In addition, patients with chronic diseases who are already on medications for their condition might be able to go to the pharmacy for refills, instead of to the doctor every time, Derbis said.

“This is just another way of making sure people are getting access to medications,” said Karen Riley, of the FDA’s office of public affairs, who noted that people might stop taking their medications if they can’t make it to the doctor.

In order for a drug to be classified in the new category, called “OTC with conditions of safe use,” manufacturers would have to submit their drugs for review to the FDA, which would make a decision, Debris said.

The FDA is currently reviewing the input it received at a public meeting about the issue in March.

Physicians at the meeting were also concerned that insurance companies may not cover drugs placed in the proposed new class. In a separate resolution, they argued “patients with chronic medical conditions benefit from annual visits to the physician.”

This second resolution does not directly oppose the FDA’s ideas for a new drug category. Instead, the resolution urges the AMA to express its concerns to the FDA and continue to monitor the issue.

The AMA is set to vote on the resolutions over the next few days.

Pass it on: Doctors have concerns over the FDA’s proposal to create a new class of over-the-counter drugs.

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