Druggists seeking enlarged care role

FDA considers behind-the-counter medical authority

November 01, 2007|By Stephanie Desmon | Stephanie Desmon,Sun Reporter

The drugstore has long held two options for the sick: medications made available only with a doctor's prescription or less potent drugs sold over the counter.

Now the Food and Drug Administration is considering a third class of drugs: "behind-the-counter" medications that would be available without a prescription, but only after consultation with a pharmacist. Birth-control pills, cholesterol-lowering medicine and weight-loss drugs, available now by prescription, might be candidates.

"We're looking at improving access to safe and effective drugs," said Ilisa Bernstein, the FDA's director of pharmacy affairs.

Pharmacists have lobbied for this authority, which would add to the ever-expanding role of a profession long frustrated with being perceived as mere pill dispensers who are expert at counting by five.

Pharmacists have begun to counsel patients on managing their chronic diseases, going beyond talk of drugs to advice on diet and exercise. They can now give flu shots. Under a recent change to Medicare, they advise some patients who take a laundry list of drugs. They can tell you if the herbal remedy you have pulled off the shelf will interact with your blood-pressure medication.

In this increasingly busy world, where getting in to see a doctor seems ever more difficult, pharmacists offer two advantages. They have time. And they are accessible in ways doctors can never be, located right down the street, in the supermarket, in the drugstore, where patients are already going several times a week.

"Certainly a pharmacist is more qualified than giving you a bottle and saying, `Give me $10,'" said Butch Henderson, a Harford County pharmacist. "The pharmacist is the one who is most trained on medications, and we can sit down and take the time with patients. The average doctor has seven minutes with a patient. They just don't have time."

Schools of pharmacy have been pushing for more roles for their graduates for more than a decade. Many have changed their curricula to include more clinical training and more instruction on how to interact with patients and counsel them in ways not seen since the druggist was the only medical professional in town.

But not everyone supports handing over more responsibilities to pharmacists. Doctors see safety issues as they watch their own roles diminished.

"The bottom line is, it's a bad idea," said Dr. Martin P. Wasserman, a former state health secretary and current executive director of MedChi, the state's largest physician organization. "This is the slippery slope I don't think our policies ought to encourage."

How a behind-the-counter class of medication would work has yet to be worked out. FDA officials are holding a meeting Nov. 14 to solicit views. A decision could take months or longer.

The impetus for this proposal arose in 2005, when Merck & Co. asked the FDA to move its prescription cholesterol-lowering drug Mevacor over the counter. The proposal was rejected, but several FDA advisory committee members said they would have considered placing it behind the counter, if such an option had been available.

Some over-the-counter drugs are technically sold behind the counter, but the pharmacists' function is limited in those examples. Cold and allergy medicines containing pseudoephedrine, an ingredient that can be used to make the illegal stimulant methamphetamine, require a photo ID for purchase. To obtain the emergency contraceptive Plan B, a woman must prove she is at least 18 years old.

The new class of drugs would require pharmacist input far beyond checking an ID. The best candidates would be medications for conditions that patients can self-diagnose and that pose minimal risk but would benefit from some clinical oversight, said Kristina Lunner, vice president of government affairs for the American Pharmacists Association.

One concern revolves around health insurance. Currently, policies may cover prescription drugs, but not those sold over the counter. Some pharmacists and physicians worry that insurers would no longer cover medications that formerly had to be prescribed.

The University of Maryland's School of Pharmacy began a pilot program last year in Western Maryland to help diabetes patients better manage their disease. Called P3, it is modeled on a successful initiative in North Carolina that resulted in improved health for patients, decreases in health care costs for doctor visits and hospitalizations, and fewer employee sick days.

Diabetics receive a year's worth of one-on-one counseling sessions with pharmacists who teach them about their disease, oversee their medication and talk through any health issues they might have. Employers pay for the cost of the program and employees are encouraged to sign up with the promise of a year's worth of co-pays for medication and diabetes-care equipment.

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