Every medication. Every physician order. Every patient. It’s all part of the intricate dance of pharmacy supply chain traceability that is now being mandated as part the November 2023 DSCSA compliance deadline. Now entering a one-year stabilization period, it has shifted from just a regulatory checkpoint to a fundamental change in how the industry approaches drug traceability and security. The DSCSA has set in motion a wave of innovation and adaptation, compelling stakeholders to rethink their strategies. It’s a big deal for every pharmacy leader because noncompliance carries hefty fines. And if past is prelude, some may pay attention only after the first penalties are levied; think back a decade ago when USP 797 violations led to 10-figure settlements for GlaxoSmithKline and Pfizer, or when noncompliance with HIPAA led to Cignet Health’s seven-figure civil money penalty.
However, it is clear from recent presentations, discussions and conversations at trade shows and conferences that there are many misconceptions about the DSCSA and pain points from the compliance efforts that have already taken place. As the industry navigates the post-deadline landscape, it is crucial to examine the impact of DSCSA, address persistent misconceptions and most importantly, explore solutions that bring us closer to achieving the DSCSA’s goal of ensuring patient safety by securing the pharmaceutical supply chain.
Persistent Myths
Compliance with the DSCSA is often misunderstood as a one-size-fits-all process that can be instantly implemented, whereas it is typically a phased integration, varying according to the size and operations of the entities involved. While some think certain entities are exempt from DSCSA, exemptions are specific and understanding them is key to compliance. For example, health systems’ responsibilities under DSCSA typically end upon drug receipt unless they sell to non-owned entities.
Another misconception is that DSCSA compliance is only the responsibility of drug manufacturers. In truth, all parties in the pharmaceutical supply chain, including repackagers, wholesalers, dispensers, and third-party logistics providers, have roles to play. Some stakeholders might think that DSCSA is solely a domestic regulation with no international implications. However, given the global nature of the pharmaceutical supply chain, DSCSA has significant implications for international stakeholders, especially those involved in importing or exporting drugs to or from the U.S
Beliefs that DSCSA compliance is solely about tracking and tracing drugs also exist, neglecting the importance of robust data security measures. Protecting data integrity is a serious aspect of compliance. Finally, others may overstate the cost of implementing serialization, assuming it to be a financial burden without considering the potential benefits, such as improved traceability and reduced counterfeiting risks, which protect the patient and contribute to the overall safety and security of the drug supply chain.
Ongoing Pain Points
The DSCSA’s implementation presents challenges, especially in meeting its stringent serialization and traceability requirements. These aspects can lead to considerable up-front costs for pharmaceutical manufacturers, distributors, and other supply chain entities. The complex nature of DSCSA regulations, including product tracing, verification and reporting, can be challenging particularly for smaller organizations with limited resources.
Discrepancies in state-level regulations further complicate compliance, particularly for businesses operating in multiple states. Integrating advanced serialization and traceability frameworks with existing supply chain systems demands significant effort and careful coordination; a process that can be both complex and lengthy.
With pharmaceutical supply chains extending globally, aligning DSCSA compliance within the U.S. focus with international regulatory frameworks is another critical challenge. The gradual shift towards full compliance may temporarily heighten risks like counterfeiting, especially for products that are not yet completely serialized.
Educating stakeholders about DSCSA’s intricacies, alongside the adoption of innovative technologies, is essential, as is ensuring robust data security in increasingly electronic systems. Smaller pharmaceutical players may experience disproportionate compliance costs, potentially affecting their financial health and industry competitiveness. Moreover, achieving consistent enforcement of DSCSA requirements is difficult, given the variability in regulatory approaches, which adds to the uncertainty for businesses.
Future Directions and Solutions
Despite these misconceptions and pain points, the DSCSA’s aim to enhance patient safety by securing the pharmaceutical supply chain must remain at the forefront. As we look ahead, the focus will be on centralizing pharmacy logistics, modernizing systems and strategically utilizing technology with a patient-first approach. This will ensure timely, affordable access to medications while maintaining regulatory compliance.
Centralized pharmacy distribution, enhanced with modern systems and automation, is crucial for the future of medication management and patient care. To address DSCSA challenges, a strategic and collaborative approach from all supply chain stakeholders is essential, with solutions to mitigate associated pain points. These solutions must address the following areas:
- Serialization Technology: Adopt scalable serialization technology integrated seamlessly into existing supply chain systems.
- Collaborative Supply Chain Efforts and Advocacy for Uniform Regulations: Enhance collaboration among stakeholders, including manufacturers and dispensers, to standardize information sharing and product verification processes harmonizing state-level drug supply chain security regulations.
- Centralized Data Management and Security: Implement secure and efficient systems for tracking and tracing products, emphasizing data integrity with implementation and regularly update robust cybersecurity protocols to protect serialized data.
- Global Standards Adoption with Phased Implementation: Align with international serialization and traceability standards for broader compliance with a step-by-step approach, communicating clear timelines to stakeholders.
- Regulatory Compliance Monitoring: Establish internal processes to monitor and adapt to regulatory changes.
- Advanced Technologies, Education and Training: Explore technologies like blockchain for improved traceability and real-time supply chain visibility and conduct comprehensive training for employees to understand DSCSA requirements to stay updated on changes.
By addressing these areas, stakeholders can do more than just comply with DSCSA; they can enhance the security and efficiency of the pharmaceutical supply chain. Collaboration, embracing modern technologies and proactive compliance strategies are the keys to success.
Dr. Valerie Bandy, PharmD, MBA
Dr. Valerie Bandy is a licensed and registered pharmacist with over 25 years of experience in pharmacy operations and compliance. She serves as Tecsys’ resident Drug Supply Chain Security Act (DSCSA) expert, with an extensive understanding of both its framework and execution best practices. Dr. Bandy has participated on task forces for the Texas State Board of Pharmacy, on committees and in officer roles at the local, state, and national level including TSHP (Texas Society of Health System Pharmacists), ASHP (American Society of Health System Pharmacists), MSHP, and other professional boards and foundations. She holds ASHP’s Leadership Academy training and serves as an ASHP Wellbeing and Resilience Ambassador. Prior to joining Tecsys, she was the director of Pharmacy at Wellstar’s Atlanta Medical Center in downtown Atlanta after leaving Trinity Health’s corporate office where she was the system director of Pharmacy. She also worked for five years on the Healthcare Provider Performance Improvement team under Strategy and Operations as a Specialist Master for Deloitte Consulting, LLP, and on the Healthcare Provider team at PriceWaterhouseCoopers. She holds experience in the full spectrums of pharmaceutical manufacturing, regulatory compliance, technology, billing, and operations industries. In her current role, she serves as a valuable source of innovative pharmacy operations insights amongst her peers within and outside of Tecsys.
