Implementing semantic interoperability for medicinal products

UNICOM is a major new European Union (EU) digital health project on “Up-scaling the Global Univocal identification of Medicines” that started in December 2019.

Funded by the European Commission (EC) through its “Horizon 2020” Research and Innovation Programme, this action has a budget of € 21 million, with EC funding of € 19 million. It is undertaken by a consortium of 70 organisations across 18 European countries and the United States of America (USA) – either as beneficiaries or observers. Work is expected to last for 4 years.

UNICOM is about improved patient safety and better healthcare for all. The project focuses on implementing the International Standard Organisation’s (ISO) suite of IDMP (IDentification of Medicinal and pharmaceutical Products) standards. Work will involve further development, testing, implementation and diffusion of these standards for

  • regulatory purposes by National Medicinal Products Authorities and the European Medicines Agency (EMA),
  • global pharmacovigilance,
  • advancing cross-border digital health, particularly ePrescription, services,
  • better healthcare, public health, Big Data analytics, Artificial Intelligence applications.

Breaking down barriers hindering the free flow of detailed, interoperable drug information in the EU and across the Atlantic and thereby facilitating data sharing amongst health professionals and patients everywhere will benefit the safety and quality of healthcare. At the same time, it will benefit pharmaceutical companies applying for marketing authorisation of new products, providers of medicinal product dictionaries, clinical software producers including start-ups developing intelligent apps for patients, and last but not least patients and health professionals.

The UNICOM consortium includes 26 National Drug and eHealth Agencies, core Standard Development Organisations (SDOs), providers of cross-border ePrescription services in the context of the Connecting Europe Facility (CEF) eHealth services, clinicians, patients, and many other actors. A wide variety of relevant stakeholders are involved through their associations.

The univocal identification of medicinal products (and of the underlying pharmaceutical products) is a global challenge. This is due to various problems: e.g., 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. And if a medicine prescribed to a patient wanting to obtain it abroad has not been authorised for marketing in that other country, information on its attributes may not be available for its univocal identification, respectively of an equivalent medicine. This then renders dispensation impossible, even where substitution by a pharmacist is allowed.

Similarly, pharmacovigilance reporting will be considerably improved once medicinal products, including their active substance, can be uniquely identified around the globe and therefore such information easily be merged by the European Medicines Agency, the World Health Organisation’s (WHO) Uppsala Monitoring Centre (UMC) for pharmacovigilance, the USA Federal Drug Administration (FDA), national agencies and others.

The same will hold for clinical information on drugs patients have taken. Electronic Health Records (EHRs), eOrdering/ePrescribing or Clinical Decision Support Systems – all will become enabled such that the medicinal products taken by a patient or to be ordered for dispensation can be fully identified in any health situation and in any country which has adopted the IDMP standards and the codes, term lists etc. specified for their various data elements and attributes.

The many challenges still to be faced on this road will be tackled by a unique consortium assembling all relevant actors, with critical mass for impact, from the EU, Norway, the United Kingdom and the USA. After more than 10 years of development, the IDMP suite of standards is ready for implementation. Though some isolated implementation work has started, the time is now ripe for a more concerted effort towards large-scale implementation enabling the free flow of detailed, interoperable drug information. The project’s ambition centres on conversion of key regulatory and clinical processes to use IDMP as well as the agreed-upon dictionaries and codes for certain data elements, like active substance or dosage form. The medicinal products information value chain must be converted over its full length from data input to data repositories to data usage. Project work spans all three areas, focussing inter alia on one of the greatest challenge, the development and implementation of a European and national SPOR (substances, products, organisations, referentials) data bases, including establishing an authoritative EU Substance Reference System (EU-SRS) for regulatory and further usage by national authorities and the European Medicines Agency (EMA).

Coordination and management of this endeavour is led by empirica Communication & Technology Research Bonn, Germany.