GMS Medizinische Informatik, Biometrie und Epidemiologie (Dec 2017)
The univocal identification and safe dispensation of medicinal products across Europe – challenges and solution proposal
Abstract
Problem: The Smart Open Services for European Patients (epSOS) the exchange of electronic Patient Summaries and ePrescriptions between selected member states of the European Union (EU). This project basically solved the ‘communication’ or message transfer problem. However, it encountered a serious ‘delivery’ problem: the safe dispensation of a medicinal product noted in a prescription from a given country by a retail pharmacist in another country. The reason for this was that the specified medicine could in many instances not univocally be identified – the same name may identify a product with a different active ingredient, or the product with identical composition may carry a different name in the other country. If the prescribed medicine had not been authorised for marketing in the other country, information on its attributes may not be available. This rendered dispensation by the pharmacist impossible, even where substitution would, in principle, be allowed and possible.Objectives: This paper reports on the goal, activities and achievements of the openMedicine project towards development of a digital solution and its implementation to meet this identification and the resulting delivery challenge. European-wide and cross-Atlantic endeavours to enhance pharmacovigilance by being able to match adverse event reports filed under different drug names which provide, however, for the same active ingredient(s) were developed upon. And the need for and benefits of being able to trace for clinical purposes, e.g. the longer-term treatment with the same active ingredient, even when the name of the prescribed medicine changed several times, were explored.Methodological approach: The openMedicine project was funded by the European Commission (EC) on behalf of member states to analyse this European-wide problem. Work benefitted from the epSOS project and work by the European Medicines Agency (EMA), the USA Federal Drug Agency (FDA), and standard development organisations (SDOs). Reviews of white and grey literature, reports, regulatory documents, standards and other documents were undertaken. An online survey of 160 experts in all EU member states contributed empirical evidence. Work gained from discussions within an Expert Council representing core players and stakeholders in Europe and North America, and regional workshops across the EU and at the FDA. They also contributed towards validation of results.Results: The fragmentation of national markets for medicinal products lies at the root of the identification problem. About 600,000 different products are marketed across the Union, but even in a large country like Germany only ca. 50,000 are readily available. The great flexibility of marketing authorisation holders to provide different names for the same or equivalent products in different countries adds to this identification challenge, and naming issues related to legacy products complicate it further. – Options to identify medicinal products in a prescription are analysed, like noting a package code, the brand name of the product, the specification of an active substance only, or of a subset of similar products, from which the pharmacist has to choose. The EU-wide adoption of the International Standards Organisation’s (ISO) Identification of Medicinal Products (IDMP) suite of standards, as already under way by EMA and FDA for pharmacovigilance purposes, is proposed. Through globally agreed coding of packages, medicinal as well as pharmaceutical products, substances, dose forms, and other identifying attributes as needed, the identification as well as partly the ‘delivery’ problem can be solved. This will require linking to a central data base maintained by EMA, and the synchronisation of national as well as commercial medicinal and pharmaceutical product data bases with it. The full solution of the delivery problem will, however, also depend on the introduction – in countries where this is not yet allowed – and the relaxation respectively harmonisation of national substitution rules. Of course, if no equivalent product is available, delivery will fail – or require import from another country. Conclusions: Implementing digital infrastructures facilitating the univocal identification of medicinal products in regulatory and clinical contexts will generate long-term benefits for patient safety, pharmacovigilance, and positive socio-economic impacts for all key players. Harmonising the identification of medicines in regulatory processes as well as clinical documents is well on its way, but a European approach towards common processes for validation of contents, error mitigation, of linking from central hubs to national and regional levels, updates and mappings to other systems will require intensified cooperation of all stakeholders in years to come.
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