Streamlining for Safety: Navigating Changes and Trends in the Pharmaceutical Supply Chain Post-DSCSA

Valerie Bandy, PharmD

Drug Supply Chain Security Act (DSCSA) compliance requirements took effect on November 27, 2023. The clock is now ticking on a one-year stabilization period (November 2023-November 2024) during which trading partners must work to achieve fully interoperable, electronic tracing of drug products at the package level and verification of saleable returns.

With its aims to protect healthcare consumers against the dangers of counterfeit, contaminated, stolen or otherwise harmful drugs, the DSCSA represents a significant step forward in securing the pharmaceutical supply chain.

Defined as “dispensers” by the FDA, hospital pharmacies are expected to play a central role in facilitating DSCSA requirements. However, many hospital pharmacy leaders and staff members don’t understand what it takes to become “DSCSA-ready” to keep their patients safe.

Collaboration for compliance and efficiency

For a hospital pharmacy team to define steps they should take to support the DSCSA, and in turn protect the integrity of their supply chains and safety of their patients, it is helpful to start by understanding the broader work of their pharmaceutical trading partners.

Success of the DSCSA is highly dependent on the collaboration of all pharmaceutical supply chain stakeholders, including drug manufacturers, wholesalers, healthcare organizations and their pharmacy teams. Another key collaborator category encompasses the technology providers with enabling solutions for trading partners to provide, receive and maintain documentation about products and ownership electronically.

Communication of drug custody data from one trading partner to the next requires the integration of systems and data. Manufacturers and wholesalers have been working with technology solution providers to facilitate this level of comprehensive information.

The objective is to establish a digital history (aka e-pedigree) for prescription drug products in compliance with the DSCSA. This pedigree must accompany the delivery of drugs at a healthcare organization so that the pharmacy team can confirm the legitimacy of the drugs’ chain of custody.

Adapting pharmacy operations for DSCSA compliance

While pharmaceutical manufacturers and wholesalers are partnering with technology providers to align their systems and processes for DSCSA compliance, hospital pharmacy teams should also be working to meet the November 2024 DSCSA deadline with workflow adaptations of their own. For those teams still heavily reliant on disjointed legacy systems and manual processes for drug procurement and inventory management, achieving seamless electronic tracking and tracing of drugs can seem like an insurmountable task as the clock clicks down.

Hospital pharmacy teams with outdated supply chain processes will face challenges with key DSCSA requirement, including:

• Confirming that prescription drug products arrive with their transaction history (TH), transaction information (TI), transaction statements (TS), and package identifier (PI) to identify the prescription pharmaceutical product down to the package level.
• Storing product tracing information in a secure format for six years.
• Generating and providing product tracing documentation with the transaction when selling a prescription drug to a trading partner.

To overcome these challenges and support the patient safety objectives of the DSCSA, pharmacies are turning to end-to-end, digital supply chain management (SCM) solutions. With automated package level data capture, verification and tracking from time of drug product receipt through dispensing, pharmacy teams can document the information they need to satisfy DSCSA requirements.

When evaluating a SCM solution for the pharmacy supply chain, be sure to select one that integrates DSCSA software, to simplify and streamline compliance. Additionally, comprehensive pharmacy staff training on the chosen solution is critical to successful implementation and use.

Future trends in pharmaceutical supply chain management

Facing continued prescription drug cost increases, drug product shortages, and global supply chain disruptions, on top of demands for electronic tracking and tracing under the DSCSA, the future of pharmaceutical supply chain management will feature greater modernization, centralization, innovation, and a patient-first focus on safety.

Advancements in track-and-trace technologies will help bridge current gaps in pharmaceutical supply chain visibility and control that are fundamental to DSCSA success. Today, the transition from manually documenting the movement of drug products within a healthcare organization to automated data capture via barcode and RFID scanning supports greater accuracy and completeness in documentation. Automation also drives improved efficiency and productivity, which is critical at a time of ongoing pharmacy staff shortages.

To maintain drug supply continuity for patients, hospital pharmacy teams are also engaging in predictive analytics for better inventory control. The automation of supply chain processes and real-time digital data capture required for DSCSA compliance simultaneously supports advanced analytics by generating an accurate and complete data set. Analytics tools are only as good as the data feeding them. Data quality is becoming even more critical with the transition toward artificial intelligence (AI) for insights generation.

The evolution of pharmacy supply chain, with the integration of SCM solutions with electronic health record (EHR) systems, supports a patient-first focus by tracking and tracing drug products down to the individual patient. If a pharmacy team identifies an illegitimate drug in its supply chain, it can quickly determine whether the drug was dispensed, and to whom.

Enhancing patient safety through DSCSA

While some pharmaceutical supply chain stakeholders might view their work around the DSCSA as checking a regulatory compliance box, the patient safety implications of end-to-end, electronic tracing of drug products are significant.

The dangers of counterfeit drug products to public health are real; as evidenced by the FDA’s recent seizure of thousands of counterfeit Ozempic (semaglutide) injections from the legitimate U.S. drug supply chain.¹ When fully implemented, the DSCSA will allow pharmaceutical supply chain stakeholders to more quickly identify illicit drugs to keep them out of the hands of clinicians and patients.

• Receiving. When a manufacturer or wholesaler arrives at the hospital with a drug product delivery, the pharmacy team can quickly identify suspect products (e.g., missing required documentation) and quarantine them until their legitimacy has been validated. This quarantine process is a fundamental DSCSA requirement for hospitals.
• Storage. If suspect or recalled drugs have already been received into the healthcare organization’s pharmacy supply chain, the pharmacy team can quickly identify their storage location and remove them - in the consolidated pharmacy distribution center, automated dispensing machines, storage carousels, robotics, outpatient facilities, satellite pharmacies, etc.
• Dispensing. When electronic tracking and tracing of drugs is implemented down to the point of dispensing, the hospital’s SCM solution can alert the pharmacy team to suspect or recalled drugs with the scan of the product’s barcode, preventing administration of the drug to a patient.

DSCSA compliance is fundamental to the evolving landscape of pharmaceutical safety and integrity and the future of pharmaceutical supply chain management. Hospital pharmacies that implement technologies and processes to quickly identify and address risks throughout their supply chains and train their teams to be vigilant of the threats can protect their patients and prevent harm. They can also protect their healthcare organizations from the noncompliance and legal ramifications of dispensing illicit drugs.

The first step in DSCSA compliance is to become familiar with the Act and the responsibilities of hospitals as dispensers. From there the pharmacy team can assess its supply chain workflows, identify compliance gaps, and implement technology solutions to address them.

Hospital pharmacies that place the DSCSA at the core of their overall supply chain modernization and centralization efforts can not only achieve a patient-first focus on safety, but also gain visibility, efficiencies, and insights to improve overall operational and financial performance.

Reference

1. FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain, FDA, December 21, 2023, https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain

About the Author

Valerie Bandy, PharmD, is Senior Director of Pharmacy Solutions at Tecsys.