The pharmaceutical industry is knee-deep in transitioning to new product identification requirements for its commercial drugs, with a majority of companies still laboring to achieve compliance with Phase 2 of the 2013 Drug Supply Chain Security Act (DSCSA) before FDA enforcement begins next November. The good news is that adopting the required, standardized bar code format for all pharmaceutical products will introduce new efficiencies throughout the supply chain, streamlining operations and helping to improve patient safety.
Investigational drugs being used in clinical research are not currently included in this game-changing process evolution. Recently, a powerhouse of industry collaborators came together to examine the potential benefits of similar standards for identification of investigational drugs.
Four of the industry’s leading pharmaceutical manufacturers, Amgen, Eli Lilly and Company (Eli Lilly), MSD, and Pfizer, worked with GS1 Healthcare US, a collaborative industry group that seeks to solve supply chain and business process challenges through the adoption and use of GS1 Standards, and Dana Farber Cancer Institute (Dana-Farber) to investigate the supply-chain, inventory, and point-of-use issues associated with delivering these investigational drugs to researchers and, ultimately, to patients. Through their observations, systemic inefficiencies were identified that could be eased or eliminated with industry-wide adoption of the same GS1 Standards that are now being applied for FDA-approved pharmaceuticals.
Summarizing their analysis, the companies noted:
- The sheer number of clinical trials going on at any one time is in the tens of thousands.
- Many research facilities are conducting hundreds of these trials simultaneously.
- Every pharmaceutical manufacturer labels its investigational drugs differently.
- Inconsistencies in product labeling practices prevent interoperability across the supply chain, slowing down and complicating the inventory, tracking, and documentation of product usage at clinical sites.
- While manual data entry is prone to human error, it is commonly used in many institutions, due to disparities in bar code formats and scanning compatibility.
- Automated bar code scanning significantly reduces the risk of errors.
They concluded that standardizing the product identification format for investigational drugs can help accelerate and streamline operational efficiencies, with the same accuracy, efficiency, process familiarity, and safety benefits that DSCSA-compliant labeling will bring to the supply chain for commercialized drugs. Those benefits extend throughout the medical community, including to the patients themselves, whose safety can be improved as a result.
Additionally, the companies agree there’s no need to reinvent the wheel: the same GS1 Standards currently being used for commercial drugs will be just as effective in clinical research.
How it works
For FDA-approved drugs, a GS1 Global Trade Item Number (GTIN) is used to identify and provide information about various products. This GTIN includes the GS1 Company Prefix, which identifies the manufacturer, and the Item Reference, which uniquely identifies the product. When a serial number is added to the GTIN, it identifies the specific package that will be dispensed to the patient. The GTIN and serial number are encoded in a bar code that is applied to the product's packaging.
Using identification systems based on the common language of GS1 Standards, clinical research teams and other supply-chain members could easily identify a specific container of an investigational product and access information about it by reading the container's bar code via a simple scan. Using one scanner for all products, one system for tracking and tracing them, and one language for sharing information about them, the entire supply chain can simplify processes to run more smoothly.
Envisioning a path forward
Amgen, Eli Lilly, MSD, and Pfizer recommend companies leverage their experience implementing GS1 Standards for commercial drugs when they consider expanding their application for investigational products. They have joined together with Dana-Farber and GS1 US to advocate for adoption of the same GS1 Standards already working for commercial drugs to achieve system-wide efficiencies and benefits in the supply chain for clinical trials. By taking steps to create and manage GTINs and begin transitioning to GS1 Standards, pharmaceutical sponsors can work together to leverage the information-sharing power those standards enable.
For more information on GS1 Standards in healthcare, visit www.gs1us.org//industries/healthcare.
Greg Bylo currently serves as vice president, healthcare, GS1 US.