Published On May 3, 2008
BUYING A PACK OF CIGARETTES TAKES JUST PROOF OF AGE and less than $10. But breaking the nicotine habit with, say, the drug varenicline requires a doctor’s prescription. That’s “an unacceptable irony,” says professor Daniel Hussar of the Philadelphia College of Pharmacy, which is why he and many of his colleagues support the creation of a third drug category.
There are two classes of drugs today: those available on pharmacy and grocery shelves and those physicians prescribe. The proposed third category—known as “behind the counter,” or BTC—would be prescribed by pharmacists.
Here’s how it might work: Patients with easily diagnosable conditions (such as nicotine addiction) would describe their symptoms to a pharmacist, who would then conduct a clinical evaluation, which might include drawing blood and reviewing a patient’s relevant medical records. After prescribing medications, pharmacists would be responsible for monitoring their effects. (They would likely receive training in drug administration before being licensed to do so.) The types of drugs most frequently mentioned for inclusion in this category are antismoking products, epinephrine auto-injectors (for people at risk of dangerous allergic reactions) and statins (for those with high cholesterol).
The proposal has opened a rift as physicians, the American Medical Association and over-the-counter drugmakers face off against the American Pharmacist Association and the American Society of Health-System Pharmacists. “When a drug is considered unsafe without supervision, a physician should be supervising its use,” says Joseph Cranston, the AMA’s director of science, research and technology. A third class of drugs, he says, would remove the “vital step” of physician treatment. He notes that it could also force consumers to pay higher costs if insurers refuse to cover medications that are not prescribed by doctors.
William Zellmer, deputy executive vice president of the ASHP, counters that the new category would be limited to medications with high ratios of benefit to risk. In the past, Zellmer says, making certain drugs widely available by removing them from the prescription-only category has had a clear public health benefit. When a prescription was no longer required for several nicotine-replacement products, their use spiked, increasing as much as 200% in the first year following their switch to OTC status. Varenicline, a relatively new drug, would be a candidate for BTC status because it lacks an adequate track record and some users have experienced problematic side effects.
Many pharmacists think the BTC category would also improve general health by lowering barriers to helpful medications. That’s because, industry experts say, pharmacies are often the entry point into the health care system for people who can’t—or won’t—see a physician for economic or sociological reasons (such as illiteracy or a fear of doctors).
Great Britain and Germany are among the nations that have created a BTC category, but the pros and cons are still being debated. A Canadian government official told the FDA during testimony in November that Canada has generally embraced the designation. No further hearings are planned, but the FDA “remains interested,” spokeswoman Karen Mahoney says.