HSCA Files Comments on DSCSA With FDA

The Healthcare Supply Chain Association has filed comments with the U.S. Food and Drug Administration on interoperability standards for prescription drug transactions.

The FDA requested the comments as part of the Drug Supply Chain Security Act, Title II of the Drug Quality and Security Act signed into law on Nov. 27 by President Barack Obama.

DSCSA outlines steps to build an electronic, interoperable system to identify and trace the distribution of certain prescription drugs in the United States.

In its comments, the HSCA advocates eliminating paper format systems of gathering data in favor of electronic, interoperable systems that enable easier exchange of data and business transactions.

"We strongly maintain that paper systems need to be replaced with innovative electronic systems and tools that allow for usable, interoperable, seamless exchange of secure data from disparate sources and that data identifiers need to be standardized," said the HSCA.

Additionally, HSCA encourages the FDA to coordinate and collaborate with the Office of the National Coordinator for Health IT to develop stage 3 meaningful use objectives incorporating unique device identifiers into the electronic health record, helping create an interoperable EHR.

"HSCA maintains that capture of both UDI and appropriate pharmaceutical product information within EHRs would result in several benefits to patient care, including establishing improved recall resolution, enhanced care coordination and a definitive source of information for both patients and providers," HSCA said. "Including this information would also create new and important opportunities to perform comparative research and effectiveness."

Overall, HSCA sees overall benefits to the DSCSA, including improved detection of illegitimate drugs, better tracking through the supply chain and increased interoperability through standardization.

"We believe that implementation of the DSCSA holds the promise of linking all appropriate aspects of the healthcare supply chain and ultimately positively connecting to patient care," HSCA concluded.

More Articles on Hospital Supply Chains:

The More Things Change, the More They Stay the Same: Dealing With Drug Shortages
The Zimmer-Biomet Merger: 5 Things for Hospitals to Know
FDA Requires Epidural Corticosteroid Label Changes to Warn of Potential Neurological Adverse Events

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