Supply Chain Security
Securing the Supply Chain
Millions of prescriptions are processed every year in the U.S. Keeping track of these legal medications is a challenging task. Increasing numbers of illegally imported medicines and counterfeit drugs add to the full scope of the growing challenge. Considering the real health consequences that can arise from stolen, counterfeit, or otherwise illegal medications, it’s vital that we continue to improve the security of the nation’s pharmaceutical supply.
Along the pharmaceutical supply chain, opportunities arise for drug theft or diversion, or the introduction of counterfeit drugs. Addressing these areas of weakness in the supply chain with a comprehensive solution will help ensure the integrity of the U.S. pharmaceutical market.
To help keep track of the millions of medications, the pharmaceutical industry supports the development of track-and-trace systems. These electronic systems use encoded data to quickly provide a drug product’s vital information. Track-and-trace systems can include product information such as the drug’s strength and expiration date, lot number, and serial number.
In 2012, PhRMA supported the adoption of The Pharmaceutical Traceability Enhancement Code (RxTec). Introduced by the Pharmaceutical Distribution Security Alliance (PDSA), RxTec struck a critical balance between the security needs of the pharmaceutical supply chain and the financial and technological hurdles of adopting security measures.
RxTec’s tracing requirements were designed to phase in over a period of years, requiring changes from pharmaceutical manufacturers, repackagers, wholesale distributors, and dispensers. Under the program, each unit of medication would be tagged with a scannable code, linking the medication to a specific lot. Individual lots will be traceable to the previous and next owners.
Benefits of the RxTec system
Federal adoption of the RxTec system would:
- Deter the introduction of counterfeit drugs into our market, since these drugs would lack the proper identification
- Assist authorities in identifying stolen or counterfeit drugs
- Make product recalls easier to carry out
- Create a single standard of pharmaceutical tracing to replace a costly patchwork of sometimes onerous state regulations
- Increase the safety of the U.S. pharmaceutical market
- Impose industry requirements that are achievable both financially and technologically
Legislation is still needed
The RxTec code was not included as part of the Food and Drug Administration Safety and Innovation Act of 2012. As part of his response to the legislation, PhRMA president and CEO, John J. Castellani, stated: “It is important to highlight a critical issue that was not resolved in this legislation–‘downstream’ supply chain security. Protecting American patients from counterfeit and adulterated medicines is a public policy priority for PhRMA, Congress, FDA, and a multitude of stakeholders, and we commend Congress’s efforts to address this issue. We strongly encourage Congress to continue working to pass legislation that establishes a national uniform system to protect our drug distribution system, from manufacturers to dispensers, this year. We stand ready to support and actively engage in any legislative process to achieve this goal.”