Clinical trials are an essential proving ground for new pharmaceutical products, with tens of thousands of studies in progress at any one time, spread across thousands of research sites and hundreds of biopharmaceutical sponsors. Advances in research are leading to exciting new possibilities and, with the mapping of the human genome enabling a new era of increasingly personalized medicine, clinical trials are becoming more specialized and complex than ever.
As research expands, a need for consistency and accuracy in operational systems becomes more acute. For example, to date, thousands of investigational products are identified and named differently by each pharmaceutical sponsor; there is no standard method in use. Some of the largest research centers are involved with numerous clinical trials at one time – at the Dana-Farber Cancer Institute (Dana-Farber) in Boston, there are about 750 active drug studies typically under way simultaneously. A lack of standardized product identification and processes presents significant challenges for the industry, and potential safety issues for patients.
SUPPLY CHAIN LOGISTICS
When investigational products arrive at a research facility, the pharmacist or clinical research coordinator assumes responsibility for maintaining vigilant control over the chain of custody, inventory, and record-keeping. Products arriving with different documentation and serialization methods must be manually logged into the receiving site’s system.
Today, healthcare institutions are moving away from paper-based tracking systems in favor of electronic inventory systems for tracking products. For Dana-Farber, this means that when an investigational product is received, a unique, internally generated barcode is created and affixed to each dispensable unit. Information on the shipping documentation must still be entered into the system manually.
A BETTER WAY
Dana-Farber worked with GS1 Healthcare US®, a collaborative industry group that seeks to solve supply chain and business process challenges through the adoption of GS1 Standards, and pharmaceutical research sponsors Amgen, MSD, Eli Lilly and Company (Eli Lilly) and Pfizer to explore potential ways to simplify the clinical research processes and make them more efficient.
For approved drugs, the U.S. FDA’s Drug Supply Chain Security Act (DSCSA) now requires pharmaceutical companies to be marked with a National Drug Code (NDC), Serial Number, Lot Number, and Expiration Date in both machine-readable and human-readable format.
As a result, pharmaceutical companies are already working on adapting their operational processes for approved medications, using GS1 Standards for unique product identification, to comply. Amgen, MSD, Eli Lilly and Pfizer quickly realized that expanding the use of standardized barcodes to include identification of investigational products would enable more efficient processes at institutions already using electronic inventory systems, such as Dana-Farber.
The companies further agreed that it would not be necessary to create a new standard. Instead, they decided to advocate for adoption of existing global GS1 System of Standards to identify investigational products and for sharing information throughout the clinical research supply chain. This would allow pharmaceutical companies to leverage the significant investments they are already making to implement GS1 Standards for commercially available prescription drugs
With clinical research facilities working with multiple companies and running numerous studies, it’s conceivable that a research pharmacy could need to use a different scanner for each supplier’s products. Yet the types of data being tracked in clinical research, including lot number, vial number, and expiry dates, are the very same data points that are contained in GS1 Standards. Incorporating the data into the GS1 Standard format makes perfect sense, and would eliminate confusion and inefficiencies by streamlining implementation tools and processes.
The advantages of using the GS1 System of Standards—item level accuracy, operational efficiency, business process familiarity, and improved patient safety—benefit the entire medical community and their patients. Amgen, MSD, Eli Lilly and Pfizer are encouraging the industry to adopt the same standards to consistently identify commercial and investigational drugs.
PUTTING GS1 STANDARDS INTO PRACTICE
The GS1 Global Trade Item Number®, or GTIN®, is a GS1 product identification standard that uniquely identifies a product and information about that product (e.g., manufacturer of the product). Part of the 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 contained in a barcode and applied to the product’s packaging. Pharmaceutical sponsors could begin by identifying each container of investigational product with a GTIN and serial number encoded in a 2-dimensional GS1 DataMatrix barcode. Then, members of the clinical research team, or others in the supply chain, could easily identify a specific container of an investigational product and access information about it by reading the container’s barcode with a simple scan. One scanner would work for all suppliers’ products.
For commercial products in the U.S., the National Drug Code (NDC) is utilized for the Item Reference. For investigational products, since there is no NDC assigned, pharmaceutical sponsors would need to determine what to use as an Item Reference and how to manage this within their systems. For blinded dispensable units, the Item Reference could be a Packaging Control Number or other equivalent number.
Based on their collaborative analysis and experience, Amgen, Eli Lilly, MSD and Pfizer advise other pharmaceutical companies to leverage their experience in implementing GS1 Standards for approved drugs and apply what they have learned to their investigational products. They will need to take steps to implement the changes in packaging and Enterprise Resource Planning (ERP) systems to create and manage GTINs with the 2-dimensional GS1 DataMatrix barcodes.
Transitioning to GS1 Standards will take time, yet a commitment to start and move in that direction is needed. As foundational standards are put into place, the industry can then work together to utilize the information-sharing power enabled by these standards. The foundational infrastructure of GS1 Standards is needed to support the expansive clinical research that is enabling unprecedented medical discoveries today and in the future.
For more information on GS1 Standards in healthcare, visit www.gs1us.org/industries/healthcare.