(78) Will The Implementation of ISO/CEN Standards for Global Identification of Medicinal Products (IDMP) Make Any Difference for Pharmaco-Epidemiology?

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1123

Presenting Author(s)

Robert H. Vander Stichele, MD
– University of Ghent Med School, University of Ghent, Belgium, Gent, Oost-Vlaanderen, Belgium

Co-Author(s)

Miriam C. Sturkenboom, PharmD, PhD, FISPE
– prof. dr., University Medical Center Utrecht, Utrecht, Utrecht, Netherlands
Carlos Duran
– Julius Center for Health Sciences and Primary Care, Department of Data Science & Biostatistics, University Medical Center Utrecht, the Netherlands, Netherlands
Luc Nicolas
– European Health Telematics Association, Belgium
Dipak Kalra
– Ghent Univerisity, Department of fundamental and applied Medical Sciences, Unit of Clinical Pharmacology, Gent, West-Vlaanderen 9000, Belgium

Background: The suite of 5 IS0/CEN standards for identification of medicinal products (IDMP) is a major standardisation effort that exists since 2012, but has barely been implemented, despite several European supporting projects and incompleted attempts to create a European database of Medicinal Products. This time, however, a firm cooperation has originated between FDA, EMA, and the WHO Uppsala Monitoring Centre for Pharmacovigilance, supported by the European UNICOM project. Expert teams have cleansed the terminologies for substance in regulatory authorities. In addition, the International Harmonisation Council (IHC) has advocated the global use of the European Directorate for the Quality of Medicine (EDQM) terminology for identifying dose forms, with a multilingual set of 34 languages.

Objectives: A procedure has been tested to standardize the expression of strength of single and combination products. Algorithms are tested to produce on the basis of these 3 elements (substance, dose form, strength) a global number for any medicinal product anywhere in the world, so that the product becomes recognisable anywhere in the world.

Methods: Several examples of standardisation and aggregation of substance and dose form data will be presented, as well as examples of the production of a global Pharmaceutical Product Identifier (PhPID). Examples of applications in clinical care for health care providers and patients will be provided.

Results: Global terminologies and ontologies for substance and dose form hold the promise to connect descriptive identification of medicinal products with international drug classification, unleashing the power of big data, rendering the common data models of drugs more robust. This could foster the world-wide collection of adverse event reports, and allow more sophisticated pharmaco-epidemiological data, drilling down to granular substance and brand level. A better understanding of the variety in therapeutic arsenals in the different nations will deepen the comprehension of variation in drug consumption.
Furthermore, increased semantic interoperability may facilitate the the dissemination of evidence-based efficacy and safety information in computerised decision support for healthcare providers and patients, and in. These systems will become more cost-effective, as the connection with the many drug dictionaries in the world (often several in each country) becomes less laborious.

Conclusions: Global identification of medicinal products (IDMP) holds the promise of helping prescriptions, medical records, and evidence cross the borders of nations, to contribute to global health, and to facilitate pharmaco-epidemiology on an even larger scale.