Published Online: Sunday, April 1, 2007

Hospital pharmacy leaders have urged the FDA to develop improved postmarketing safety regulation for prescription drugs and to address concerns about problems caused by confusingly named pharmaceuticals.

The suggestions, made by officials of the American Society of Health-System Pharmacists (ASHP), were delivered to FDA officials who are currently reviewing the federal Prescription Drug User Fee Act (PDUFA). That law comes up for reauthorization this year. In urging the FDA to use the reauthorization process as an opportunity to improve PDUFA, the ASHP leaders also urged the agency to "develop models of patient care that bring actual medication use into better alignment with medication-safety information."

In the area of premarket risk assessment for new drugs in development, the group called on the FDA to work with manufacturers and health care professionals to design more flexible and effective systems for determining these risks. Simultaneously, the ASHP officials suggested the elimination of current statutory restrictions that prevent PDUFA fees from being used to assess safety issues postapproval. Specifically, the group suggested that the FDA "conduct research on maximizing the public health benefits associated with collecting and reporting adverse events throughout a product's life cycle."

Hospital pharmacists also recommended new FDA guidance on the naming and labeling of drugs to reduce the risk of medication mix-ups due to sound-alike names. "We urge the inclusion of pharmacists as part of the agency's consultation in developing this guidance," said the ASHP officials.

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