Strasbourg, France, and London, United Kingdom -- SNOMED International and the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, have signed an agreement governing the creation, maintenance and distribution of a map between both organisations’ terminologies. The agreement came into effect in September 2022.
SNOMED CT is a comprehensive, multilingual healthcare terminology created for use by healthcare professionals to capture the care of individuals in an electronic health record and facilitate sharing, decision support and analytics, to support safe and effective health information exchange.
The EDQM Standard Terms database contains a set of concepts used in defining and describing medicinal products, including the pharmaceutical dose form (i.e. the dosage form), route or method of administration, and certain important packaging items such as the container, closure and administration device. They are designed for use in marketing authorisation applications, medicinal product labelling (including the summary of product characteristics) and in electronic communications about medicines, as well as for related purposes such as adverse event reporting (pharmacovigilance) and clinical trials.
The agreement resulted from the need identified by SNOMED International’s Drug Extension User Support Group to align EDQM Standard Terms and SNOMED CT dose forms to serve specific use cases. It will focus on putting in place mechanisms for the release, maintenance and updating of the mapping between the lists of controlled terms in the EDQM Standard Terms database and the equivalent lists in SNOMED CT.
The alpha release of the EDQM Standard Terms to SNOMED CT map package for dose forms was made available by SNOMED International in early January 2023. A spreadsheet format has also been made available for those who want to review the map. Feedback received from the alpha release will be incorporated into the Production release of the map package in Q2 of 2023, followed by annual releases.
Both organisations will review the conditions of the agreement every five years. They will also ensure that the quality of the map being created under the agreement meets the needs of stakeholders, and will put in place plans to distribute, maintain and update it. Additionally, any new content that is needed to create the map will be included in regular SNOMED CT International Edition releases and made available by both parties. As the work develops, both organisations may also propose future collaborative activities based on emerging requirements in the European Union or elsewhere.
“We are excited about the opportunities this agreement enables to link information required for drug regulation using EDQM Standard Terms database with information captured as part of care using SNOMED CT,” said SNOMED International CEO Don Sweete. “Such an approach is a giant step in the right direction – toward seamless interoperability – and it promises enormous benefits to patient safety and healthcare delivery.”
Petra Doerr, EDQM Director, stated on this occasion, “The EDQM is committed to providing quality standards for the safe use of medicines. Communicating information about medicinal products in a harmonised and understandable way is an important part of this.” She further affirmed that this mapping exercise is an important step toward improving communication between stakeholders, and complements the global implementation of the IDMP (Identification of Medicinal Products) project.
About the EDQM
The EDQM is a directorate of the Council of Europe, an international organisation working to promote human rights, democracy and the rule of law on the European continent and beyond. The EDQM works to protect public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use, which are recognised as a scientific benchmark and applied worldwide.
About SNOMED International
SNOMED International is a not-for-profit organisation that owns and develops SNOMED CT, the world's most comprehensive healthcare terminology product. We play an essential role in improving the health of humankind by determining standards for a codified language that represents groups of clinical terms. This enables healthcare information to be exchanged globally for the benefit of patients and other stakeholders. We are committed to the rigorous evolution of our products and services, to deliver continuous innovation for the global healthcare community. SNOMED International is the trading name of the International Health Terminology Standards Development Organisation. www.snomed.org
EDQM, Conseil de l’Europe