Community Research and Development Information Service - CORDIS

H2020

openMedicine Report Summary

Project ID: 643796
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - openMedicine (openMedicine)

Reporting period: 2015-01-01 to 2015-12-31

Summary of the context and overall objectives of the project

Context:
Enabling the delivery of safe and efficient cross-border healthcare is a policy priority of the European Union. Towards this end, member states of the European Union are taking down borders among member states to electronically exchange patient summaries and ePrescriptions. In this context, the overall goal of openMedicine is to contribute towards and enhance the safety and continuity of cross-border (and also national level) treatment through interoperable ePrescriptions, and to develop concrete solutions to remaining challenges. Whereas the epSOS project basically solved the electronic “communication” or message transfer problem, it encountered a serious “delivery” problem: the univocal identification of the medicinal product, which was noted in a prescription from a given country, by a pharmacist dispensing it in another country (initially across the Union, but eventually globally). S/he must be able to select from the pharmaceutical products available in that country the product that perfectly matches the prescribed pharmaceutical product for safe dispensation to the patient. Or, if and where substitution is permitted or even required, a similar product in line with national regulations.

Objectives:
openMedince addresses both the identification and the substitution challenge. The project aims to reach a global consensus in order to univocally identify and describe unambiguously a medicine, resulting in the authorised delivery of the appropriate medicinal product. In detail, this concerns developing
• common data models for prescribed medicines
• a common vocabulary for unambiguous definition, description, and identification of medicines
• rules to harmonise practices of substitution
• a roadmap for post-project actions and implementations.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Work performed:
During its initial 12 month period, openMedicine identified and intensively discussed prior results and assets relevant for its work, and based on this developed concepts, structures and elements for
• a common data model - based and expanding upon the standards used by epSOS and the ISO/IDMP standards - for univocally identifying in a prescription prescribed medicinal products
• a vocabulary for data fields mandatory for the unambiguous definition, description, and identification of medicinal/pharmaceutical products throughout Europe, including identification of semanticd assets related to this
• the identification and handling of different concepts and practices of generic and therapeutic substitution of medicines at the point of dispensation across member states

Work involved not only the whole project team, but also more than 20 members of the openMedicine Expert Council, which met once in June 2015 at the European Medicines Agency (EMA) in London, and colleagues from North America (USA, Canada). This council assembles experts from industry, national healthcare systems and competent authorities, research organisations, representatives of stakeholder associations as well as individual experts, all of whom are also available for individual exchange with the project team for work items for which they have indicated a specific interest and competence, and for the quality review of deliverables. To assure reaching the results foreseen and global impact, close cooperation and coordination of activities with the European Medicines Agency (EMA) and the US Federal Drug Administration (FDA) have been established.

Main results:
The main achievements so far include:
• a proposal for an openMedicine infostructure (a standards based structure for the univocal identification of medicinal and pharmaceutical products) and standards to be applied or further developed, based on a thorough review of epSOS experience and new complementary use cases where the univocal identification of medicines is mandatory, and a data model
• an analysis and proposal for a comprehensive set of openMedicine identifying and descriptive attributes for pre-packed branded medicinal products
• a framework and structure to analyse substitution challenges at the point of dispensation across member states, the development of a complex questionnaire to survey experts across all member states on national practice and rules, and the implementation of the survey
• establishment of a communication infrastructure for and one meeting of the Expert Council at EMA London facilities
• realisation of an openMedicine website with a variety of relevant resources, news items and references to EC, EMA and other documents relevant in the policy context of the project

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

openMedicine is well on its way to indeed deliver practical solutions ready to be implemented by international (like EMA or FDA) and national member state regulatory bodies on two key issues of cross-border prescription services: the univocal identification of medicinal products globally, and clear rules of how to deal with the issue of substitution when presenting a prescription in another MS. The concrete solutions to create these impacts concern
• common data models for prescribed medicinal products
• identification of a common vocabulary for unambiguous definition, description, and identification of medicinal/pharmaceutical products
• rules for the cross-border handling of different practices of economic substitution in Europe
• a practical roadmaps for post-project implementation of the solutions elaborated.
Furthermore, through the involvement of US experts and an expert workshop at the FDA, impact will also be assured on the intentions of the MoU signed between the US Department of Health and Human Services (HHS) and the EC on trans-Atlantic eHealth cooperation.

Benefits will be generated for
• Patients – safer (cross-border) healthcare, better access to prescribed medicines abroad
• Clinicians – improved reliability of medication records, better comprehension of foreign patient data
• Pharmacists – more reliable identification of medicines specified in a (cross-border) prescription, improved substitution guidance
• Pharmacovigilance – improved identification of medicinal products in question
• Pharmaceutical industry – easier registration of new medicinal products
• Further actors [national & international regulators (e.g. EMA, FDA); national/ regional/local information systems; clinical trials]

Related information

Record Number: 190226 / Last updated on: 2016-11-09