UNICOM
Up-scaling the global univocal identification of medicines
At a glance:
Project description
UNICOM aimed to be a gamechanger for patient safety around medication. It leveraged the ISO IDMP family of internationally agreed standards for univocal identification of medicines along their whole life cycle – for regulatory purposes, in healthcare, pharmacovigilance, and medical research.
The ISO IDMP offers answers to longstanding challenges for semantic interoperability in the medicinal products domain across Europe and globally.
UNICOM facilitated the implementation of ISO IDMP standards and related terminologies in the emerging cross-border ePrescription and eDispensation services between participating EU member states healthcare services (eHealth Digital Services Infrastructure – eHDSI).
Why the project?
The lack of univocal identification of drugs across borders and internationally is a challenge to patient safety and efficient pharmacovigilance. It impedes progress in international digital health service provision. This may prevent people who are moving across Europe from getting hassle-free access to necessary medicines. Moreover, it renders the whole data process chain of applying for marketing authorisation for a new drug in several countries, permission to market it in various member states, assembly of national medicinal product dictionaries, prescribing and dispensation, and adverse effects reporting.
This is due to various obstacles like:
- The same name may identify a medicinal product with a different active ingredient in another country, or a product with identical composition may carry a different name elsewhere. This then renders dispensation impossible, even where substitution by a pharmacist is legally allowed.
- Similarly, pharmacovigilance reporting will be considerably improved once medicinal products, including their active substance, can be uniquely identified by drug agencies around the globe thus safeguarding universal patient safety.
- The same will hold for clinical information on drugs patients have taken recorded in medication histories (stored within Electronic Health Records) or being used within eOrdering/ePrescribing as well as Clinical Decision Support Systems.
EHTEL's role
EHTEL developed the communication strategy of the project and managed dissemination activities by teaming up with the project coordinatior and other project partners.
EHTEL also supported stakeholder dialogue.
- EHTEL joined forces with fellow project partners and external stakeholder organisations to enable the project to dialogue with end user associations consisting of clinicians and pharmacists, fellow stakeholder organisations in digital health, and other projects and initiatives.
- EHTEL’s own task forces and member networks enabled the association to provide 'liaison platforms' for the project.
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