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ASHP Again Endorses Intermediate Drug Category

Mar 01, 2008

ASHP reiterated its sup­port for the creation of a “behind-the-counter” class of medications during testi­mony at a Food and Drug Admin­istration (FDA) public meeting in November. William A. Zellmer, MPH, ASHP deputy executive vice president (pictured at right), told administration officials that patients would benefit both from the increased availability of medica­tions in an intermediate category and accompanying access to phar­macists as medication experts.

The classification “would give the public greater access to medications that have potential for yielding immense gains in health status,” Zellmer said. “And it would tap the expertise of pharmacists…health profession­als who are well-prepared to help people make the best use of medicines in this category.”

Although pharmacy organizations strongly supported the “behind-the-counter” class for medications at the meeting, other speakers at the meeting voiced a broad range of other opinions on the classification change.

Recommending an Evidence-Based Approach

Longstanding ASHP policy, which calls for establishing an intermediate class of drugs, recommends that regulators use an evidence-based approach to select appropriate products. Under this system, pharmacists would assess diseases or conditions and recommend appropriate medications. Medications in this class should have a high margin of safety and a history of being on the market and used safely and appropriately by patients.

Although ASHP opposed the reclassification of statin as a nonprescription drug, it would be a good candidate for inclu­sion in an intermediate category, according to Zellmer.

In December, two FDA advisory committees recom­mended that the administration not approve over-the-counter (OTC) status for lovastatin 20 mg (Mevacor). Merck & Co., Inc., applied for the status change.

During the joint meeting of the FDA’s advisory com­mittees on nonprescription drugs and endocrinologic and metabolic drugs, ASHP again voiced its opposition to OTC status for statin. Cynthia Reilly, B.S., Pharm., ASHP director of clinical standards and quality, testified that the proposed formu­lation and product use wasn’t consistent with treatment guidelines for hyperlipidemia.

Opening the Door for Adverse Drug Events

ASHP believes assigning an OTC status to statin would force patients to self-assess for this complex therapy, which could open the door to more adverse drug events, she said.

“The wider use encouraged by OTC status will include statin use by individuals with multiple disease states and those taking potentially interacting medications,” Reilly told the committees.

Zellmer said that the fact that the FDA held a public meeting on this topic “signals a milestone in the administration’s interest in the idea of an intermediate category and a maturation of the concept.”

In the end, the FDA followed the recommendation of its two advisory committees and rejected Merck’s application.

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