Counterfeit drugs are a growing problem globally. They pose severe risks, potentially containing incorrect, insufficient, or absent active ingredients. They can also include toxic substances, often due to unsanitary manufacturing conditions.

According to the World Health Organization, one in ten medical products in low and middle-income countries is counterfeit. This data reflects the urgent need for a secure and transparent pharma supply chain.

The Emergence of the Drug Supply Chain Security Act
According to the Partnership for Safe Medicines, the United States is widely acknowledged as having one of the most secure pharma supply chains in the world, yet counterfeit pharmaceuticals remain a persistent threat. So when the U.S. government introduced the Drug Supply Chain Security Act (DSCSA), it was meant to tackle the counterfeit threat by strengthening the security of the regulated pharma supply chain within the U.S.

The DSCSA requires supply chain participants to be authorized trading partners and to transact only with other authorized entities. It also mandates a transaction document, similar to a pedigree, that tracks products through the supply chain and must be retained for a specified period.

Adopting Serialization in the Pharma Supply Chain
Serialization represents the DSCSA's fundamental element—applying individual product identifiers at the unit level. Each identifier includes the product's national drug code (NDC), serial number, lot number, and expiration date.

For years, pharma products were tracked only by batch or lot numbers, making traceability challenging. If a product recall or issue arose, tracing could only happen at the batch level, even though units from that batch were often distributed across multiple supply chain partners. Serialization addresses this by enabling unit-level tracking, providing precise visibility into each product's origin and destination. This approach allows for a more surgical track-and-trace process, which is essential for effective quality assurance in healthcare.

While serialization is crucial, it's just one part of a complete security strategy. By combining it with enhanced packaging features like holographic labels and rigorous transport security measures such as GPS tracking, you can create a more robust and secure logistics network for your temperature-controlled products.

Support with DSCSA Implementation
Third-party logistics providers are working with supply chain partners and customers to ensure the services they provide are compatible with the DSCSA's requirements.

At UPS Healthcare, our comprehensive cold chain management ensures precise handling of temperature-sensitive products, while UPS® Premier offers advanced tracking with real-time visibility and prioritization for critical shipments. Our dedicated serialization services and transactional documentation systems facilitate seamless interoperability, instilling confidence in your supply chain.

Find out how UPS Healthcare solutions can help you meet your DSCSA requirements and strengthen the security of your pharma supply chain in the fight against counterfeit drugs.

Note: This article was originally published on June 28, 2021.

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