Today’s patients are aware of breakthrough treatments and the technological advancements that are raising the standard of care. They are not as privy to the complexities and challenges inherent in the flow and exchange of data related to their medications. In 2013, the Drug Supply Chain Security Act (DSCSA), outlined steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. Interoperability is achieved when sources of information within the health ecosystem find, exchange, use and share patient medication and product data securely across the complete spectrum of care.
Last month, Accenture completed research that revealed life sciences manufacturers, wholesalers and dispensers do not yet have a clear plan for exchanging this information in interoperable electronic-form, despite a 2023 deadline for the FDA’s DSCSA-mandated, unit-level traceability across the U.S. supply chain. So, in addition to gathering the facts, we recently invited supply chain traceability and serialization leaders to a workshop to share our findings and help them draft a comprehensive roadmap for the next four years.
In both our research and the workshop, I wasn’t surprised to see differences in perspectives depending on whether you were a manufacturer, wholesaler or dispenser. For example, all groups listed "data sharing" as a top three expected pain point for the path to 2023 compliance. But when it came to "change management" (inclusive of culture and employee mindset), manufactures ranked this as their number one expected pain point, whereas it dropped to 5th for dispensers. Wholesalers were the only group to include "capturing value beyond compliance" as a top-five pain-point.
As leaders navigate the next four years, the first step is to get over the fatigue. It’s time to focus on setting up a governance body, aligning on a vision and initiating standards. It will take consistent collaboration among all key stakeholders to build an interoperable system viable for all. I know the leaders we brought together are energized and optimistic about their path to compliance. Are you as confident?
Ultimately it all comes back to the patient. While the FDA requires increased visibility into the product’s supply chain through the phases of DSCSA, patients will soon require a more seamless view as well. Instead of focusing on potential challenges and limitations brought on by regulations, it’s time to appreciate the renewed trust and confidence that comes with increased patient visibility.
If you would like to learn more about our research or how to develop your roadmap to DSCSA 2023, please reach out to me.