NACDS tells Congress its concern about track-and-trace programs

February 7, 2012

The National Association of Chain Drug Stores (NACDS) expressed its concerns about proposed mandatory prescription track-and-trace programs in comments to a Congressional advisory panel recently.

The National Association of Chain Drug Stores (NACDS) expressed its concerns about proposed mandatory prescription track-and-trace programs in comments to a Congressional advisory panel recently.

NACDS submitted written comments ahead of a February 1 Congressional hearing on the reauthorization of the Prescription Drug User Fee Act (PDUFA).

Chain pharmacies have already taken a leadership role to improve the safety of the U.S. drug supply, according to NACDS. For example, chain drug stores have supported state-level legislation to require enhanced wholesale distributor licensure requirements and pedigrees for medicines sold outside normal distribution channels.

“Chain pharmacy remains committed to working with Congress on the security of the U.S. drug distribution supply chain. However, we remain concerned with mandates to track and trace prescription drugs due to disruptions, complexities, and the substantial resources that would be required. These would occur at a time when the healthcare system is seeking to reduce costs,” the NACDS reported in its comments.

NACDS also said that community pharmacists’ concerns about the FDA’s Risk Evaluation and Mitigation (REMS) program should be taken into consideration. While NACDS supports PDUFA’s goals to standardize the REMS program, pharmacies and other relevant healthcare providers should be included on an expert panel of REMS’ reviewers.

“Although pharmacies are not directly responsible to FDA for the design, implementation, and success of REMS, pharmacies are subject to the elements of REMS in order to meet the needs of patients,” the NACDS commented.