What You Need to Know About GS1 Standards for IRT
Hans Von Steiger, Group Leader, Clinical Supply Chain Management, Pfizer
What you need to know about GS1 Standards for IRT
Hans von Steiger, Group Leader of Clinical Supply Chain Management at Pfizer, spoke at the Interactive Response Technologies (IRT) conference in October 2023 in Boston.
His presentation focused on the use of GS1 standards and how its implementation across the clinical supply chain can enhance patient safety and streamline business processes. Steiger also explained ways in which global standards for clinical trials impact IRT.
How GS1 Standards Work
The session began with an introduction to GS1, a neutral, nonprofit organization that supports companies globally in the standardization of barcodes. The organization has 112 offices across the world, with 1.5 million companies currently using GS1 standards, and 100 million products carrying its barcodes. Steiger said there is a “critical mass” of GS1 barcodes in the commercial industry, but pharmaceutical and clinical supply markets are behind in their use.
Steiger also discussed the intricacies of the barcodes, which consist of numeric identifiers of data fields with specific definitions. The content of data fields is indicated by the Application Identifier (AI), a universal indicator of specific information that is recognized across an industry. For example, expiration dates, batch/lot numbers, and more. This is a great example of how product information can be used by clinical supply teams to standardise information, according to Steiger.
Similarly, Electronic Data Interchange (EDI) standards allow different systems to communicate with each other. Pfizer has its own system that uses EDI to communicate shipping requests, which then requires other companies to develop interfaces to receive these messages. Steiger argued that institutions, such as hospitals, lack the resources to develop several interfaces for different pharmaceutical companies. To mitigate this issue, standardized XML tags are used for electronic communications between trading parties when handling shipments. To simplify the process of EDI, information is shared in different ways. Steiger shared an example of this: the 13-digit Global Location Numbers that are used to identify parties instead of addresses. This data is quicker and easier for computers to process, thus streamlining the business process.
Development of the GS1 Clinical Trial Standards Team
Steiger explained the origins of the GS1 Clinical Trials Standards Team, an industry-led group with 110 representatives and 57 clinical trial organizations. Starting in March 2019, the team issued the GS1 standard for the identification of investigational products in clinical trials. This related to the use of GS1-compliant barcodes on pharmaceutical products. In October 2020, two components of the EDI standard were issued, including the GS1 pharmaceutical clinical trial electronic messaging standards. This was followed by the XML messaging standard in April 2020, which was described by Steiger as the “more technical” guidebook.
The session detailed the vision behind GS1 standards, which is to simplify the clinical supply and distribution processes. Typically, the distribution model used by pharmaceutical companies to manage shipments receives information from IRT. The goal is to move away from this, and rather enable IRT systems to communicate directly with clinical sites through clinical pharmacy inventory management systems.
Steiger emphasized that IRT vendors will benefit from the interoperability provided by GS1 standards. On a smaller scale, mobile apps can be used at clinical sites for inventory management. If there is a label barcode standard across pharma, product identification and flow of information is much simpler – all enabled through scanning using a mobile app.
Some large pharmaceutical companies, such as Pfizer and Sanofi, are supporting the adoption of GS1 standards despite their concerns for the usability of these label barcodes. Steiger concluded the presentation by sharing the need to get solution providers on board, including IRT vendors. He said that the power of standards can have a positive impact from clinical site managers to big pharma and service providers.
