Despite FDA’s recent one-year delay in DSCSA product identifier enforcement, the pharmaceutical industry continues to press forward with serialization strategies. But some companies may face consequences if they do not meet compliance deadlines.
That possibility surfaced in the Aug. 18, 2017 RxTrace.com blog, “How Long Until You Are Fully Serialized,” in which Dirk Rodgers writes about the final report of an IQPC survey conducted this past spring. He says one quarter of survey respondents said their companies wouldn’t be compliant for 18 to 24 months, to which Rodgers noted, “It means those companies are admitting that they are going to miss the deadlines in both the U.S. and the E.U.”
Not meeting the compliance deadlines is one thing, but what if serialization doesn’t ultimately result in a secure pharmaceutical supply chain?
That possibility came up in an article by Bob Miglani, Chief of Business Development at Applied DNA Sciences, a producer of DNA molecular tags that can be applied to authenticate raw materials and finished products (such as tablets) for pharmaceutical supply chain security.
The article, “What Philadelphia taught me about pharmaceutical serialization,” referenced a recent Pharmaceutical Traceability Forum in that city. In the story, Miglani made the following observations:
• Pharmaceutical serialization has become an industry on its own. He pointed to the growing number of conferences, suppliers and experts that focus specifically on pharmaceutical serialization implementation.
• Pharmaceutical serialization is not going to solve the pharmaceutical counterfeit problem. He said with serialization, would-be counterfeiters, “have access to the same GS1 rules as the ethical pharmaceutical industry! Bar codes might make it easier for counterfeiters to print convincing-looking labels. And while a person in the warehouse may not be able to tell the difference between a real bar code and one put on by the counterfeiters, the system hopefully [will] be able to catch it. This could be a big challenge.”
• Saleable returns might pile up with pharmaceutical serialization. He asked how wholesalers could deal with potential returns and how they could absolutely verify the authenticity of each package.
In summary, Miglani said, “Pharmaceutical serialization is certainly not ideal, but the role it will play in advancing pharmaceutical supply chain security is an important one. I believe that we cannot rely on serialization alone to help prevent or deter counterfeit pharmaceuticals into the marketplace. We can do better. We should continue to explore innovative solutions that, when combined with pharmaceutical serialization, offer a compelling way of tracking, tracing and eventually strengthening trust in the medicines we take each day.”
Established counterfeiting challenges
An online article from supplier TraceLink Inc., “Rise in Unsuccessful Serialization Implementations Prompts Pharmaceutical Companies to replace Competitive Offerings with TraceLink Solutions,” said pharmaceutical companies, “cite long implementation delays, gaps in country compliance coverage, repeated unsuccessful validation attempts, and high costs as primary factors leading to the decision to move away from other vendors in order to meet compliance deadlines under the U.S. Drug Supply Chain Act (DSCSA), EU Falsified Medicines Directive (FMD), and in other countries.”