Pharmacy Times, Volume 0, 0

Hospital pharmacy leaders have urged the FDA to developimproved postmarketing safety regulation for prescription drugsand to address concerns about problems caused by confusinglynamed pharmaceuticals.

The suggestions, made by officials of the American Society ofHealth-System Pharmacists (ASHP), were delivered to FDA officialswho are currently reviewing the federal Prescription DrugUser Fee Act (PDUFA). That law comes up for reauthorization thisyear. In urging the FDA to use the reauthorization process as anopportunity to improve PDUFA, the ASHP leaders also urged theagency to "develop models of patient care that bring actual medicationuse into better alignment with medication-safety information."

In the area of premarket risk assessment for new drugs indevelopment, the group called on the FDA to work with manufacturersand health care professionals to design more flexible andeffective systems for determining these risks. Simultaneously, theASHP officials suggested the elimination of current statutoryrestrictions that prevent PDUFA fees from being used to assesssafety issues postapproval. Specifically, the group suggested thatthe FDA "conduct research on maximizing the public health benefitsassociated with collecting and reporting adverse eventsthroughout a product's life cycle."

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