FDA eyes "behind the counter" drug category with greater clinical role for pharmacists

Pharmacists argue it will increase access to health care, but physicians say it could endanger patients.

By Victoria Stagg Elliott, AMNews staff. Dec. 17, 2007.

The Food and Drug Administration is contemplating the establishment of a class of medications that would be available only after counseling from a pharmacist but without a physician's prescription. Physicians widely oppose the development, arguing that it could disrupt continuity of care and put patients at risk.

"We're concerned about patient safety," said Rebecca J. Patchin, MD, an American Medical Association trustee. "If a medication requires oversight, it should be available by prescription, and a physician should be involved in prescribing it and monitoring the patient." The AMA testified in opposition to this action at the FDA's Nov. 14 hearing on the subject.

Known as "behind the counter," this category exists in many other countries in various forms. The FDA is considering the possibility for the fourth time since the 1970s because agency officials feel the emergence of the Internet means that consumers are more informed than ever and the time may be right to make this change in the United States.

"Given that new technology, it seems like an appropriate time to ask now whether or not there are ways of improving public health through increased access by behind-the-counter availability," said Randall Lutter, PhD, the FDA Deputy Commissioner for Policy.

It is unknown what drugs might fall into the BTC category or how dispensing them might work, although two examples currently exist. Emergency contraception is behind the counter because of the need for age verification. Over-the-counter medicines with pseudoephedrine also are handled in this manner in an effort to reduce their diversion to the manufacture of methamphetamine. These two examples, however, are not what pharmacists, who tend to support this step, have in mind.