The European Union is moving fast towards the adoption of 5 ISO/CEN standards for the identification of medicinal products (IDMP). This would allow pan-European and global exchange of prescriptions and medication information on any medicinal product from any country. This adoption is supported by a large action program, called UNICOM, funded by the European Commission. More then 40 partners, including 11 National Drug Agencies participate in this project. The European Institute for Innovation through Health Data (i~HD) is a key partner. Researchers from i~HD have recently published a triad of publications on the identification of active substances and dose forms in medicinal products.
In a first publication, i~HD researchers compared aggregation levels for substance in virtual drug models represented by the WHO ATC-classification, RxNorm (US), SNOMED-CT, and the Belgian SAM Database. Grouper concepts for substances, and for two levels of aggregation of medicinal products were proposed. In a second publication, a thorough analysis was provided of the European EDQM terminology, selected as the global terminology to represent the dose form identification. This research was based on a mixture of qualitative and quantitate analyses of the characteristics and textual definitions of the 428 EDQM dose forms. Recommendations for minor improvements were made, and a small ontology of dose form was created, with 3 levels of aggregation, with each level supporting different use cases. In a third publication, this ontology was used to align the more granular EDQM dose forms from Europe with the more simple RxNorm dose forms from the US.
All this work will facilitate the implementation of the IDMP standards, and provide links between international drug classifications and the many national drug databases, allow for smart and fair substitution, and enable cross-border exchange of prescriptions and patients summaries.
Read the publications here:
- Vander Stichele R, Kalra D. Aggregations of Substance in Virtual Drug Models Based on ISO/CEN Standards for Identification of Medicinal Products (IDMP). Stud Health Technol Inform. 2022 May 25;294:377-381. doi: 10.3233/SHTI220478. PMID: 35612100.
- Natalie Karapetian, Robert Vander Stichele, Yuri Quintana, Alignment of two standard terminologies for dosage form: RxNorm from the National Library of Medicine for the United States and EDQM from the European Directorate for the Quality in Medicines and Healthcare for Europe. International Journal of Medical Informatics. 2022. 104826. ISSN 1386-5056
- Vander Stichele RH, Roumier J, van Nimwegen D. How Granular Can a Dose Form Be Described? Considering EDQM Standard Terms for a Global Terminology. Applied Sciences. 2022; 12(9):4337. https://doi.org/10.3390/app12094337
The UNICOM Innovation Action has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 875299.
The European Institute for Innovation through Health Data is a European, not-for-profit organisation facilitating optimal uses of health data through a series of complementary events.