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Periodic Reporting for period 2 - openMedicine (openMedicine)

Reporting period: 2016-01-01 to 2016-12-31

Enabling the delivery of safe and efficient cross-border healthcare is a policy priority of the European Union. The overall goal of openMedicine was to enhance the safety and continuity of cross-border (and also national level) healthcare through interoperable ePrescriptions. Whereas the epSOS project solved the electronic “communication” or message transfer problem, it encountered a serious “delivery” problem: the univocal identification of a medicinal product noted in a prescription from a given country by a pharmacist dispensing it in another country. S/he must be able to select from the medicinal products available in that country the one that matches the prescribed product for safe dispensation to the patient. Or, if substitution is permitted, a similar product in line with national regulations.

openMedince addressed both the identification and the substitution challenge. This concerned developing respectively identifying
• a common data model for prescribed medicines
• a common vocabulary for unambiguous definition, description, and identification of medicines
• prevailing national rules and practices of substitution
• a roadmap for post-project actions and implementations
and to contribute towards
• the intentions of the MoU signed between the US Department of Health and Human Services (HHS) and the EC on trans-Atlantic eHealth cooperation.

Harmonising the identification of medicines in regulatory processes, in ePrescriptions, eDispensation reports as well as in clinical messages, records and decision support systems remains a European challenge. It impacts on pharmacovigilance, the tracing of data across the life cycle of a medicinal product, the aggregation of information for public health purposes and many other health domains. And it promises a substantial European added value.

Across the Union, differences in names of medicinal products and active substances, variations in strength and box size prevail, and the availability of a specific medicinal product varies across member states. This situation necessitates substitution of the prescribed product at thre point of dispensation in many instances if a patient is to be timely served in a pharmacy. The EU-wide implementation of ISO IDMP standards as under way by EMA for pharmacovigilance is a route to mitigate many of these problems. To fundamentally increase the probability, e.g. that a cross-border ePrescription can indeed be dispensed in another member state, it is mandatory to have the pharmaceutical product identification number (PhPID) available respectively automatically included from national sources or a central EMA data base, in order to identify medicinal products locally available which are equivalent to the one identified in the prescription. This also applies mutatis mutandis to other clinical or regulatory records and contexts.

In the medium term, it will be mandatory to link the EMA IDMP (SPOR) DB with national drug DBs (or use NCPeH procedures) to have identifiers and identifying attributes automatically included into software systems which have to make use of such input for prescribing and other clinical systems. This will also improve and harmonise reporting of adverse drug events and pharmacovigilance.

Work should also concern an assessment of impacts based on benefits and costs to be anticipated. Such an assessment should not only concern regulatory impacts, impacts on setting global standards and best practice, and impact on clinical data quality and interoperability, but also spill-over effects to pharmaceutical companies, data base producers and competitive advantage of European companies.
Work performed:
Based and expanding upon epSOS results, new use cases, and reviewing ISO/IDMP standards, the work performed identified a common structure, data elements and semantic assets (vocabulary) for the unambiguous definition, description, and identification of medicinal products (MPs) throughout Europe. Detailed exchanges with and contributions to the eHealth Network activities on revised Guidelines led to concrete solution proposals for rendering cross-border eHealth services (ePrescriptions, ePatient Summaries) safer and more efficient.

Four Expert Council Meetings were organised, twice at the premises of EMA in London, at CEN premises in Brussels, and with FDA at their premises in Washington, D.C.

Across all member states, a survey was undertaken to gather information on and to analyse the handling of concepts and practices of substitution of medicinal products at the point of dispensation.

A set of high level recommendations and a roadmap for post-project actions were discussed, validated and agreed.

Key results of openMedicine:
• A common data model for prescribed medicinal products (a common structure, data elements and semantic assets (vocabulary) for the unambiguous definition, description, and identification of medicinal products)
• Contributions to the activities of the eHealth Network and the revised Guidelines for ePatient Summaries and ePrescriptions.
• Submission of options to member states developing cross-border eHealth services in the context of the “Connecting Europe Facility” framework. In close cooperation with the EMA, intermediate solutions for univocally identifying medicinal products in cross-border contexts, particularly for ePrescribing services, were submitted
• Four Expert Council Meetings with representatives of all major player and stakeholder groups from both sides of the Atlantic, two at the premises of EMA in London, one at CEN facilities in Brussels, and one at the US Federal Drug Administration (FDA) in Washington, DC.
• An empirical surveyed across all member states on substitution of medicinal products at the point of dispensation.
• A set of high level, critical recommendations and a roadmap for post-project actions and implementations.

Results were widely disseminated to key players, stakeholders, thought leaders and multipliers through Expert Council meetings, regional workshops all across the Union; presentations at conferences and standardisation bodies; publications; and a comprehensive website.
Progress beyond the state of the art:
openMedicine has substantially contributed towards the univocal identification of medicinal products. Solutions based on the ISO IDMP (identification of medicinal products) suite of standards are ready to be implemented by international (like EMA or FDA) and national (member state) regulatory bodies, by producers of medicinal products data bases, and by providers of clinical or pharmacy software. They will facilitate cross-border ePrescription services like those under implementation in the context of the Connecting Europe Facility (CEF).

Benefits, impacts:
OpenMedicine work will generate long-term benefits for
• Patients: safer (cross-border) healthcare, better access to prescribed medicines abroad
• Clinicians: improved reliability, and easier understanding and comprehension of medication records
• Pharmacists: more reliable identification of medicines specified in a (cross-border) prescription, improved substitution guidance
• Pharmacovigilance: faster alignment of reports on adverse drug events (ADEs) related to medicinal products with the same active ingredient(s)
• Pharmaceutical industry: more efficient submission of information necessary for marketing authorisation of new medicinal products.
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