Back to: Global IDMP Implementation – Getting Closer to the Goal
🔔 Note: Stop playback at 12:19 to complete this lesson.
Presenter
Ron Fitzmartin, PhD, MBA
Senior Advisor
Data Standards Branch
Office of Regulatory Operations
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Abstract
This presentation discusses the significant strides being made toward global IDMP implementation, an ambitious goal in healthcare. IDMP is a suite of five ISO standards released in 2012, designed to standardize the identification of medicinal products and their substances across different countries and regulations, minimizing risks of miscommunication and errors. It provides standardized identifiers like the Medicinal Product Identifier (MPID), Pharmaceutical Product ID (PhPID), and a substance identifier, along with covering dose forms, routes of administration, strengths, and units of measurement. Key benefits of IDMP include enhanced safety and pharmacovigilance through accurate product tracking and faster adverse event reporting, improved management of medicinal product shortages by identifying alternative products, facilitation of global cross-border healthcare by ensuring accurate medication histories, and achieving interoperability between different healthcare systems through a common language for data exchange. The Global IDMP Working Group (GIDWG), established in 2021, leads this effort, focusing on projects like mapping substance and dose form identifiers, standardizing strength representation, and developing a consensus-based operating model for the global PhPID. The GIDWG also conducts rigorous end-to-end testing to assess the readiness of the global PhPID service, covering technical and operational aspects, and has already processed a dataset representing over 2,000 medicinal products to harmonize information and generate global PhPIDs.