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8/21/2003

ASHP's Manasse Appointed to FDA Advisory Committee

Donna Young

Henri R. Manasse Jr., executive vice president of the American Society of Health-System Pharmacists (ASHP), was appointed in July by FDA Commissioner Mark B. McClellan to serve a four-year term on the agency’s Drug Safety and Risk Management Advisory Committee.Manasse

The 13-member committee advises McClellan about the agency’s responsibilities of ensuring safe and effective drugs for human use.

Gary C. Stein, ASHP’s director of federal regulatory affairs, said the committee’s importance has increased in several areas of FDA regulation, including the safety of specific drugs, restricted drug distribution programs for high-risk drugs, the agency’s overall risk management program for prescription drugs, and the provision of written prescription drug information to consumers.

Manasse said his first public meeting as a member of the committee is scheduled for September 18 in Silver Spring, Maryland, where members plan to discuss medication errors related to the labeling and packaging of various drug products in low-density polyethylene plastic vials.

The next day, the committee will discuss drugs that have sound-alike and look-alike names, he noted.

Manasse said he hopes to bring patient safety and risk management issues to the forefront of the committee’s agenda and is looking forward to discussing the construction of risk management elements for new generations of drug products, particularly genome-based and biotechnology drug products.

Another issue Manasse wants to bring to the committee’s attention is longitudinal postmarketing surveillance for drugs products such as hydroxymethylglutaryl–coenzyme A reductase inhibitors.

“What would be the impact on individuals and populations being on these drugs for 30 years?” he asked. “We have little experience” in studying those drugs.

Because many drugs are complex, Manasse said, patients need to be more active in risk management. There is a large gap, he declared, between a pharmacist’s knowledge of drug products and what most patients know about drugs.

“We should begin to think about how we can make patients better partners,” he said.

Manasse also serves on several other boards and committees, including the National Patient Safety Foundation’s board and executive committee and the American Hospital Association’s Quest for Quality Award Selection Committee. He is chair of the Joint Commission on Accreditation of Healthcare Organization’s Sentinel Event Advisory Group.