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FDA proposal on "safe use" drugs draws strong debate

A recent FDA proposal to add a third category of "safe use" drugs in addition to prescription and nonprescription offerings has clearly pitted different medical groups against each other.

In what it calls a "new paradigm," the FDA is suggesting that certain drugs normally requiring a prescription become available without one. In other words, the agency states, a pharmacist would be allowed to freely dispense them.

That proposal has drawn strong criticism from the American Academy of Family Physicians (AAFP), which contends that it could "seriously compromise" a patient's care and result in serious medication errors and other medical harm.

"This proposed new paradigm would allow patients to receive powerful prescription drugs without the input of a physician," noted AAFP chairman Roland Goertz, MD, in a recent letter to the FDA.

The FDA counters that its proposal would apply only to a limited number of drugs -- such as EpiPens and glucagon, used in life-threatening conditions and sometimes needed quickly by users -- and would have several salutary effects for the medical industry in general.

Included among those, say FDA officials, would be the following: better access overall to doctors by sicker patients, since fewer routine visits would be required by patients seeking "safe use" medications; easier and quicker access to drugs deemed safe through pharmacies; and a reduction in health care costs systemically, given the reduced burdens associated with fewer physician visits.

The American Medical Association also opposes any new drug classification. The American Pharmacists Association, unsurprisingly, favors the FDA proposal,

Source: MedPage Today, "AAFP says no to 'safe use' class of drugs," Emily P. Walker, May 1, 2012

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