<   back

UNICOM

unicom

Up-scaling the global univocal identification of medicines

 

Project description

UNICOM aims to be a game-changer for patient safety around medication. It does so by leveraging 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.

ISO IDMP answers to longstanding challenges for semantic interoperability in the medicinal products domain across Europe and globally. E.g., UNICOM will facilitate 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 also impedes further progress in international digital health service provision. This may, e.g., prevent people moving across Europe from hassle free access to the necessary medicine. 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, adverse effects reporting etc. awkward and ineffective. 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 develops the communication strategy of the project and manages dissemination actions in team with the project coordination and other project partners.

In addition – and synergistic with the dissemination – EHTEL supports the stakeholder dialogue.

  • To this aim, EHTEL will be joining forces with fellow project partners and external stakeholder organisations to enable the dialogue of the project with end user associations e.g. of clinicians and pharmacists, fellow stakeholder organisations in digital health and other projects and initiatives.
  • Moreover, EHTEL’s own task forces and member networks like the EHTEL/ELO Network of National and Regional Competence Centres will enable EHTEL to be instrumental in providing liaison platforms for the project.

 

Perspective and next steps

UNICOM is funded by the European Union for 48 months until end of year 2023.
 
The consortium brings together 26 National Competent Authorities for Medical Products (11 partners, 15 affiliated), National eHealth Centres, Standard Development Organisations (SDOs), Health-IT vendors and producers of pharmaceutical dictionaries. Clinicians, patients, and other relevant stakeholders are involved through their associations.  
 
To be successful, the project relies on presenting and reflecting its proceedings and achievements to all actors involved in the medication process and their ecosystems.
 
 

EU222
This project is funded by the European Union (EU) Horizon 2020 program
under Grant number No. 875299.

 
 

Participating Members