My name is Josh Rees. I’m Bell and Howell’s new Marketing Programs Manager. Until recently, I knew very little about the pharmaceutical industry and the impending 2023 DSCSA deadline. I had no idea about the challenges the industry is facing to ensure regulation compliance. However, I come from a small community in Ohio that has been devastated by the opioid epidemic. My mother has made a career working as a nurse in our local emergency room, where she has witnessed the impact first-hand. When I was asked by my company to attend the IQPC Pharmaceutical Traceability Forum in Arlington, VA, I took the opportunity to sit in on the conference sessions to learn about the industry’s goals, challenges and processes that are being used to ensure total compliance to the 2023 deadline.
The IQPC Pharmaceutical Traceability Forum is an interactive event that focuses on global serialization regulations and guidelines in the pharmaceutical industry. It provides a great venue for candid discussions about the challenges of implementing serialization and tracking technologies for pharmaceutical products throughout the entire supply chain. Some of the major challenges discussed in the sessions included how to ensure that inaccurate data transfers are caught and corrected, packaging & labeling mistakes, aggregation/de-aggregation, and how to find a serialized pedigree for saleable returns.
Because the industry is simultaneously creating the process for implementation AND the various solutions needed to ensure regulation compliance, it seems that nobody has an absolute “best practice” yet for solving these various challenges. Currently, the DSCSA guidelines primarily speak to the supply chain, but lack the guidance requirements for the dispensaries. At the end-of-the-day, both the FDA and the industry’s goal is to ensure patient safety.
Representatives from industry giants, to small/virtual manufacturers, came straight from a two-day FDA workshop where the FDA worked with solution providers to discuss what their views, system preferences and major pain points were.
From what I learned in these sessions, there is currently no real roadmap for regulation compliance in this industry. The 2023 deadline will provide a strong foundation and understanding of both the laws and (more importantly) the processes needed to provide comprehensive and accurate product traceability for the pharmaceutical supply chain.
The IQPC Forum afforded me the rare opportunity to witness members of a highly competitive industry sitting down at roundtables and discussing difficult topics. By sharing their individual trials and tribulations, the industry is working hand-in-hand to lay down the solid foundation needed to track their products throughout the entire supply chain, in the hopes of solving a major national crisis.