Monday, December 10, 2007

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

From the American Medical News:
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. ...more

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