Tyson Stuelpe 

The start of 2024 brings pharmacy operators and pharmaceutical distributors additional time to accurately identify, track, and verify the condition of prescription drugs as they move through the last miles of the supply chain for delivery to dispensers and end users.

Enforcement of the package-level product tracing requirements enacted under the Drug Supply Chain Security Act (DSCSA ) has been delayed until November 27, 2024, by the FDA. One reason for the deadline change: only about 35% of manufacturers are sending serialization data to trading partners.

The postponement provides pharmacy operators and distributors another opportunity to resolve technical and operational issues. If the compliance deadline had not been extended, industry groups warned that supply chain disruptions could adversely impact patients’ access to needed medications. They also said pharmacy operators and small dispensers (with fewer than 25 employees) could not meet DSCSA requirements by the 2023 deadline.

Under the DSCSA law, wholesale distributors, re-packagers, dispensers, and other third-party logistics providers must implement interoperable and electronic tracing of prescription products at the package level. Pharmacy operators need visibility into databases that store documentation of DSCSA compliance by partners throughout the supply chain.

Compliance can make it easier to identify and remove risky prescription products (contaminated, counterfeit, damaged, or stolen) and protect the health and safety of patients and consumers.

While many pharmacy operators and their distributors have implemented the necessary hardware and software and systems and are compliant with DSCSA, other pharmacy operators need more time to resolve the following critical issues:

 — Collaborating with distributors can ensure that all pharmaceutical products in inventory have unique identifiers and are traceable throughout the supply chain through electronic records.

 — Implementing and maintaining systems with manufacturers and distributors for collecting, managing, and sharing electronic pharmaceutical product information in ways that meet DSCSA requirements.

 — Ensuring that pharmaceutical operators have digital systems that can effectively communicate and share information with systems used by distributors and other partners in the supply chain, including wholesalers and manufacturers.

 — Establishing and executing procedures to verify the authenticity of pharmaceutical products when pharmacy and dispensing. Pharmacy operators will also need processes to handle suspect or illegitimate products.

 — Providing ongoing training for pharmacy employees about DSCSA requirements and proper usage of traceability and authentication systems.

 — Keeping pace with technological advancements and upgrading systems as needed to meet evolving DSCSA standards.

Ensuring that drugs rendered unsellable due to conductions, including recalls, damage, temperature excursion or expiry, are removed from inventory.

The impact of DSCSA compliance on pharmacy operators will be enormous, but proven condition monitor technology solutions can be quickly and affordably implemented to help meet the November 27 deadline.

Changes in temperature, vibration and shock can all damage pharmaceutical products in transit, during re-packing, in storage, and through the final delivery to dispensers and end users. Without reliable indicators and electronic reporting of conditions throughout the supply chain, it’s impossible to know what happened to pharmaceutical products.

Temperature excursion is one of the most important factors that could render the drug unfit for distribution; it also would generate credible concern that the medication can result in serious adverse health consequences or death to humans.

 Pharmacy operators and distributors can take control of condition monitoring to help ensure DSCSA compliance.

For example, during transit or storage, temperature indicators can help you know which packages experienced temperature excursions, and which were handled properly. Because these indicators are temperature-over-time indicators, they will activate once a specified temperature threshold has been exceeded over a specified length of exposure. That makes it possible to know whether a product remains safe and effective or should be replaced.

There are cost-effective solutions available to monitor temperature-sensitive products during transportation, which offer irreversible evidence of a cold- or hot-temperature excursion.

The reporting occurs in real-time, enabling pharmacy operators and distributors to take immediate action to remove a damaged drug from inventory. Temperature indicators are ideal for use on containers after pharmaceutical products have been repackaged for shipping in small lots from distribution centers or central pharmacies to retail locations within a pharmacy collective or to the points of care within a healthcare system.

Identifying vibration and shock can be accomplished with impact indicators, which are single-use devices that determine whether fragile products have been dropped during transit or in storage.

There is no doubt that pharmacy operators and distributors have a lot of work ahead in 2024 to comply with DSCSA requirements. There’s also a significant opportunity for pharmacy operators and distributors to reduce other risks.

An estimated 25% to 30% of pharmaceutical products get spoiled during shipment. Cold or hot temperatures outside specified ranges are to blame, so are shocks and vibrations beyond what compounds and finished medications are designed to tolerate. Steps taken to minimize this spoilage can also lower costs for pharmacy operators, dispensers, and patients.

The DSCSA has been the law of the land since 2013 with deadlines staggered throughout the past decade. Pharmacy operators are among those responsible for DSCSA compliance, but they are not in this alone. Stakeholders can work closely with industry associations, manufacturers and distributors, and technology suppliers to fulfill responsibilities under DSCSA. The place to start: Demand that they provide thorough pharmaceutical product tracing, verification, and reporting.

By Nov. 27, stakeholders will need to confidently know and prove what happened to the pharmaceutical products in their pharmacy inventory. This can effectively be accomplished by insisting supply-chain partners provide reliable electronic documentation.

Investing in digital data management systems compatible with those used by manufacturers and distributors.

Implementing technologies to monitor and document the condition of pharmaceutical products during storage, delivery, and dispensing.

Providing the staffing and training necessary for organizations to understand the DSCSA regulations and how to successfully implement and maintain compliance systems.

Remember, you have up until a few days before Thanksgiving to meet DSCSA requirements. Count on compliance, logistics, and cold-chain experts to get you to the finish line.

Tyson Stuelpe is vice president of Product Management at 

1. Martha M. Rumore and Jesse C. Dresser, “With DSCSA Compliance Delay, Certain Requirements Still Require Action Now,” Pharmacy Times, November 10, 2023, pharmacytimes.com

/view/with-dscsa-compliance-delay-certain-requirements-still-require-action-now.

2. Food and Drug Administration, “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry,” March 2023, 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/definitions-suspect-product-and-illegitimate-product-verification-obligations-under-drug-supply

Articles

Under the DSCSA law, wholesale distributors, re-packagers, dispensers, and other third-party logistics providers must implement interoperable and electronic tracing of prescription products at the package level.