Periodic Reporting for period 1 - UNICOM (Up-scaling the global univocal identification of medicines)
Reporting period: 2019-12-01 to 2021-05-31
IDMP standards are to be used to describe and identify medicinal products, their ingredients as well as their packages in a coherent manner such that the information can be safely recorded, coded, and exchanged between regional, national, and international stakeholders. Receiving IDMP compliant data helps regulatory bodies by facilitating and substantially improving regulatory processes around authorising medical products and managing their full life cycle, in addition to rendering global pharmacovigilance and risk management procedures faster and more reliable. In the clinical domain, IDMP compliant data will support improving processes related to (cross-border) prescription exchange, dispensation reporting, or the reconciliation of medicinal products prescribed by independent healthcare professionals treating the same patient, amongst others.
The UNICOM project's main goal is to enhance and implement the ISO IDMP suite of standards for the univocal identification of medicinal products across participating Member States and all stakeholders engaged in the life-cycle data management of medicinal products. As a four-and-a-half year trans-Atlantic semantic interoperability project with a consortium of over forty European and American partners, UNICOM is well situated to provide the collaborative platform needed for such an ambitious goal. UNICOM integrates diverse perspectives and coordinates their activities by bringing together multiple stakeholders such as standard development organizations, national medicines authorities, pharmaceutical industry, national eHealth authorities, medicinal products database providers, cross-border healthcare services, healthcare professionals, patient advocacy groups, and others, into one European Innovation Action focused on IDMP implementation.
UNICOM´s objectives concerning the adoption of IDMP in eHealth services have been furthered through work on defining the business and functional requirements for IDMP implementation in the eHealth domain. This entailed an overview of key aspects of ePrescription, eDispensation, and Patient Summary activities to demonstrate how business value flows differ according to the different stakeholder perspectives. Active liaison between UNICOM and the Connecting Europe Facility eHealth Digital Service Infrastructure (CEF eHDSI) and European eHealth Network communities was established so as to align UNICOM work with these key bodies’ ambitions. In terms of the application of IDMP in big data for science, UNICOM has proposed a protocol and statistical analysis plan for subsequent proof of concept studies which include an overview of the common data models utilized by large research networks conducting such studies. Initial work on the link between IDMP implementation and data flows to pharmacotherapeutic groups, and the benefits for medical data in pharmacotherapeutic audits was also successfully started. Also, Medicinal Product Dictionaries (MPDs) as well as community prescribing and dispensing software systems that operate in EU member states were characterised. To assess UNICOM´s impact, an initial socioeconomic impact assessment and cost-benefit analysis framework was developed. The framework implementation will be use-case driven and incorporate multiple stakeholder perspectives.
The project management and scientific technical coordination offices were established to ensure that the underlying cross-project technical coordination processes were fully functional, including the submission of 32 deliverables. In addition to the publishing of regular news items and continued social media engagement, outreach efforts, in accordance with the project´s communication and exploitation strategy, included targeted events focused on different stakeholders including regular ‘’community of expertise’’ meetings with IDMP experts, consortium-wide meetings, best-practice sharing ISO IDMP workshops for non-participating National Medicines Authorities, an event focused on end-user engagement, and the first trans-Atlantic cooperation conference, amongst others.
More specifically, by the end of the project, UNICOM will have piloted IDMP compliant data feeds to and among National Competent Authorities for Medicinal Products, eHealth organisations, and medicinal product dictionary providers. ISO IDMP enhanced eHealth Pilot Services at national and cross border level with selected patients are planned to demonstrate the project´s impacts. Continued outreach to Member States outside the UNICOM consortium will push for IDMP implementation across the global medicinal product community.