Pharmacists must prepare for full enforcement of the Drug Supply Chain Security Act
(DSCSA) in order to avoid significant penalties associated with noncompliance.
First enacted in November 2013, the DSCSA compels drug manufacturers, wholesale distributors, dispensers, and other players in the pharmaceutical supply chain to comply with track-and-trace requirements developed by the Food and Drug Administration (FDA) to identify counterfeit, diverted, or stolen products.
The DSCSA’s product tracing requirements involve transaction information such as the name, strength, dosage form, lot number, and container size of a product; comprehensive transaction history of each time the product changed ownership; and transaction statements that serve as an attestation by each trading partner every time ownership is transferred.
“This system will enhance [the FDA’s] ability to help protect consumers from exposure to drugs that may be…harmful” and “will improve detection and removal of potentially dangerous drugs from the drug supply chain to protect US consumers,” the FDA stated.
Pharmacies were originally slated to be penalized for noncompliance with DSCSA product tracing obligations
beginning July 1, 2015, but the FDA has since delayed
this enforcement until November 1, 2015.
At the National Association of Chain Drug Stores (NACDS) 2015 Total Store Expo, Sandi Michael, director of the Franciscan Missionaries of Our Lady Health System in Louisiana, told session attendees that DSCSA requirements support the idea of the “right drug, for the right patient, at the right time.”
Ahead of the November 1 deadline, “there are a couple of things that pharmacists should know…nuances you haven’t thought about,” HD Smith vice president of supply chain integrity Julie Kuhn told NACDS session attendees.
Among these nuances is the fact that pharmacies as dispensers “have to be sure that trading partners are authorized, have licenses, and that these licenses haven’t expired,” explained Johnson & Johnson director of end-to-end traceability Tom Pizzuto.
This will require open communication networks
within and among organizations throughout the drug supply chain, he said.
One of the more onerous DSCSA requirements for pharmacies is being able to provide lot-level product tracing information for 6 years following the transaction. To meet this requirement, pharmacies should begin to develop a methodology to collect and store the transaction data that they are obligated to collect, Pizzuto advised.
“Work with your wholesale distributor to get connected and make sure you know how to access your data,” he said. “Reach out to your management and secure the support of your leadership, because you’ll need to bring in other departments across your company to fully implement” the necessary standards.
“Start today,” Pizzuto urged.