Though numbers vary widely depending on country of origin, the World Health Organization estimates that between 1 and 10 percent of drugs sold around the world today are counterfeits.
Additionally, around 50 percent of medicines purchased over the internet from illegal sites without a published physical address have been found to be counterfeit. This has broad implications for the pharmaceutical industry, not the least of which is patient safety.
Pharmaceutical manufacturing and packaging companies are grappling with compliance challenges as more countries implement serialization and tracking regulations in an effort to ensure the safety and quality of prescription drugs being sold within their borders and to facilitate quick and thorough recalls or alerts.
In the United States, the Drug Supply Chain Security Act (DSCSA) signed by President Obama in 2013 demands error-free serialization and tracking of pharmaceutical products throughout the entire supply chain. The intent is to collect data to illustrate the who, what, when, where and why of any interaction with a container of medicine from the time it is manufactured until it lands in a consumer’s hands.
From the consumer point of view, these regulations will enhance product safety. You can feel more confident that the medicine you purchased originated from and flowed through a legitimate chain of custody. Consumers will be better protected against substandard, falsely-labeled or counterfeit medical products. In addition, when a problem arises, subsequent recalls will be more comprehensive and methodical. The specific locations of affected medicines will be more quickly known and notified.
Implications for the pharmaceutical industry
Complying with serialization regulations in a considered, forward-thinking way is a demanding task due to evolving guidance and regulation definitions from the Food and Drug Administration (FDA.) Contract manufacturers, contract packagers, distributors and pharmacies need to continually examine their compliance status, take note of upcoming deadlines, and formulate future plans.
Compliance requirements for the DSCSA are being phased in incrementally through 2023. The regulations will increase in complexity as time goes on, culminating with full item-level traceability from the individual bottle, syringe, carton, etc., back to the initial manufacturer. According to the FDA, the auditable serialization data will encompass billions of transactions that must be captured in a “secure, computer-generated, time-stamped electronic record” and should be stored in accordance with current good manufacturing process (cGMP) standards.
Currently, all pharmaceutical manufacturers, repackagers, wholesale distributors and dispensers (such as pharmacies) must be appropriately licensed and registered. Second, these trading partners must also have systems in place to correctly exchange product lot information to enable tracing of each product’s transactions in the supply chain. The third requirement is that these supply chain participants must be able to respond to verification requests or product alerts, and to investigate and quarantine suspected products as well as notify any trading partners of illegitimate products found.
In November 2017, pharmaceutical manufacturers will be expected to comply with item-serialization requirements, and requirements on repackagers will follow in 2018. Wholesaler and logistics companies will begin with lot-level traceability in 2019, with pharmacies and other dispensers affected in 2020. Finally, in 2023, all these entities will need to communicate with each other and with regulatory bodies regarding the supply chain history of each saleable pharmaceutical package.
For pharmaceutical companies, serialization affects operations in an extreme way. Virtually every area of the company will be touched. While the IT challenge of data management and software integration is obvious, other impacts are not immediately seen. Examples of areas affected by these changes include manufacturing equipment, packaging artwork, legal agreements, standard operating procedure (SOP) documentation, logistics resources, and government relations.
When evaluating options, organizations should make sure their solutions have the ability to grow with the business and adapt to the requirements coming in the next few years. To avoid missteps and wasted resources, it’s essential to take a holistic view of the implications of this regulatory change. Successful companies typically involve a cross-functional team of internal business function experts in detailed vendor interviews and implementation of the serialization process. Learning from experienced peers can also provide valuable insight.
With the goal of helping pharmaceutical companies learn from their peers and other experts about how to comply with the DSCSA, Bell and Howell is hosting a free Traceability and Serialization Forum in Durham on Nov. 17.
Editor's Note: This blog post was originally published in the Triangle Business Journal on Oct. 28, 2016.