Skip to main content Back to Top

10/2/2003

ASHP Praises Interim FDA Report on Counterfeit Drug Measures

Cheryl Thompson

The American Society of Health-System Pharmacists (ASHP) supports many of the recommendations in the Food and Drug Administration (FDA) Counterfeit Drug Task Force’s Interim Report released Oct. 2, 2003. The report generally mirrors a new ASHP policy that calls for regulations restricting or prohibiting licensed drug distributors from purchasing prescription drugs from unlicensed entities.

ASHP policy supports a “transparent” national drug distribution system that accurately documents where a drug originates and the entire chain of custody from manufacturer to dispensing pharmacy.

“We look forward to working with the FDA Task Force in implementing these critical recommendations to protect the nation’s drug supply,” said Henri R. Manasse, Jr., Ph.D., Sc.D., ASHP executive vice president and CEO. He added that ASHP officials will stress the elements of its policy on improving the integrity of the national drug supply chain when they testify before the FDA Oct. 15.

The Society, which supports the FDA’s statement on the special due-diligence responsibilities pharmacists have when purchasing drug products, will issue guidance to its members about how to assess pharmaceutical suppliers.

ASHP also has promised FDA officials that it will provide rapid alerts to members and hospital pharmacy departments about counterfeit drug incidents, continuing the Society’s longstanding commitment to the FDA’s MEDWatch adverse-event reporting system.

ASHP remains extremely concerned about vulnerabilities in the pharmaceutical supply chain, particularly with respect to secondary distributors. While these entities may perform an important role in providing needed medications, ASHP believes that stronger state and federal oversight may be needed.

“Recent changes in the laws of certain states, such as Florida, have begun to address this problem,” said Manasse, adding a caution about the need for state regulation uniformity to maintain the integrity of the drug supply chain. ASHP also believes that possible unintended consequences—such as the creation of new barriers to distributing needed prescription drugs across state lines—should be assessed.

Additionally, ASHP will study and provide comments to the FDA on the issues of prescription product returns and the ability of health systems to repackage products into unit doses for safe patient use.

“We pledge our ongoing support to the FDA and state boards of pharmacy as they work to ensure the integrity of the U.S. medicine supply,” Manasse said.