The Drug Supply Chain Security Act (DSCSA), enacted in 2013 by the U.S. Food and Drug Administration (FDA), aims to usher in significant changes in the pharmaceutical industry to ensure the integrity and security of the pharmaceutical supply chain and protect consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs.
In order to achieve this, the DSCSA set forth technological requirements for ensuring the tracing of pharmaceutical products amongst all trading partners, including pharmacists (both hospital and community). Scheduled originally to go live on November 27, 2023, the FDA recently made an important decision in postponing the enforcement of the DSCSA by one year to allow for stabilization and maturation of systems in hospitals and pharmacies.
New compliance deadline – November 27, 2024; What does this mean for hospital pharmacists?
Hospital pharmacists play a crucial role in the pharmaceutical supply chain as the face of neighborhood healthcare. The delay allows hospital pharmacies another year to prepare and adapt their individual hospital systems to comply with the requirements. But although this brings a sense of relief, it also brings some challenges, as balancing patient care while establishing a comprehensive system is a complex task.
One of the primary concerns is the cost of implementing the necessary systems to comply with the DSCSA requirements. As hospitals work on budgets, pharmacists will need to make strategic investments in software and systems to not only satisfy the technological requirements, but also uphold the quality of patient care. This means that certain medications may take extra time to acquire due to allocating funds to establish a new hospital pharmacy system. However, the compliance date delay allows time for hospital pharmacists to determine what they can do with their present and future budget and plan strategically.
Not only that, but the hospital pharmacy must ensure that adequate staff is available to resolve any potential technological issues and maintain the new system. As hospital pharmacists are responsible for the program, they must ensure staffing is available to continue to provide patient care while also having enough resources to resolve potential technological issues. The additional time announced allows hospital pharmacy staff to ensure they are able to resolve any potential technical issues in their newly integrated system while also maintaining the current care of their patients.
Another concern is the critical aspect of ensuring uninterrupted patient access to prescription medications during the technological integration. As updates within hospital systems require time to initiate and integrate, the potential risk of delaying lifesaving medications for hospital patients poses serious risk for both patients and the institution. Any delays during the integration of the hospital’s system can also potentially slow down or obstruct patient care processes, such as order verification or reviewing patients’ profiles. The delayed enforcement provides additional time for trading partners to adjust their systems without disrupting important patient care needs.
In conclusion, the delayed implementation of the DSCSA provides hospital pharmacists and other trading partners in the pharmaceutical supply chain with additional time to prepare and comply. The FDA’s decision to postpone the enforcement until November 2024 acknowledges the need for further development and refinement of systems and processes. This needed time will ensure a robust supply chain security while maintaining patient access to medications. By extending the timeline, this also opens doors for collaboration, advocacy, and education efforts to support a smooth transition to your newly implemented system.
