FDA panel hears arguments in BTC debate

WASHINGTON Pharmacists representing several pharmacy organizations all advocated the creation of a third class of drugs Wednesday morning before a panel of Food and Drug Administration executives chairing a meeting to consider what issues ought to be addressed in considering a behind-the-counter class of drugs.

Opposed to a third class of drugs were the American Medical Association and the Consumer Healthcare Products Association.

Increased access to comprehensive patient medical records was one need identified by pharmacy if pharmacists were to be intimately involved in the dispensing of a BTC class of drugs.

Much of pharmacy’s support of BTC was centered on the increased access to medication that a BTC class of drugs would create. For example, vaccines could be administered by pharmacists in some 46 states, testified Michael Hogue, speaking for the Institute for Public Health and Pharmacy, but those pharmacists cannot prescribe those vaccines. A BTC class of drugs that included vaccinations would therefore increase access to those vaccines and convenience to the consumer.

Some of the pharmacy organizations expressed a concern that over-the-counter medicines might be inappropriately moved to BPC, limiting access. BTC should be a clinical encounter as opposed to a “policed” dispensing of certain medicines, noted Ed Webb, speaking on behalf of the American College of Clinical Pharmacy, setting the stage for an argument that those clinical consultations ought to be reimbursed, whether by third-party payers or by the patients themselves. That consultation is of some considerable value—increasing compliance and thereby decreasing future hospital expenditures—and should be reimbursed as such.

The American Medical Association was also concerned over the potential reimbursement of those clinical consultations with pharmacists, worrying that managed care might incentivize patients to pursue a cheaper BPC treatment regimen before consulting their general practitioner, a factor that may delay treatment of an undiagnosed condition.

Along those lines, AMA challenged the notion that the pharmacists would even be capable of adequately consulting with their patients on BTC medicines on account of their expertise and training in medicines and lack of expertise and training in the diagnosis of disease. “When a drug is not safe for use without supervision,” AMA’s Joseph Cranston said, “then a physician … should be responsible for the administration of that drug.”

The relationship between a patient’s pharmacists and a patient’s physician ought to be collaborative rather than adversarial, countered Bill Soller of the UCSF School of Pharmacy. “The pharmacist is a coach” in the healthcare paradigm, he said. “This [role] is something doctors should support, rather than oppose.”

AMA also stated emphatically that the whole question of a BTC class of drugs was moot without a change in the Federal Food, Drug and Cosmetic Act. “It is somewhat perplexing to the AMA that the FDA is even holding this meeting,” Cranston said.

CHPA stated its belief that a BTC class of drugs might, in fact, restrict access and increase costs—the current OTC market system helps keep costs down through competition, reported CHPA’s David Spangler. The switch of cough-cold products in the 1970s and 1980s resulted in 100,000 fewer doctor visits per year by the end of the 1980s, Spangler said. When nicotine-replacement therapies switched, use of those products increased three- to fourfold, he added.

And if a BTC class of drugs were created, CHPA charged, that class may both become the default channel into which prescription-only drugs may switch and the channel into which any OTCs with a hint of controversy may be pushed. Indeed, Maria Sulli of the St. John’s University College of Pharmacy suggested that kids’ cough-cold medicines, indicated for children under the age of 6, may be ideal candidates for BTC placement.

Eileen Harley, speaking on behalf of the Food Marketing Institute, advised the FDA panel that the creation of a BTC class of drugs would necessitate considerable capital costs throughout retail pharmacy. Retail pharmacy would need to expand their pharmacy shelf space to incorporate this new class of drugs and, in many cases, would also need to reorganize the overall pharmacy layout in order to incorporate private screening areas where pharmacists could consult with their patients.

The National Association of Chain Drug Stores and the National Pharmacists Association are scheduled to testify before the panel Wednesday afternoon.