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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.

Substantial investment in digital solutions for improved health services has occurred in recent years in Africa. Digital Health provides for proven, beneficial applications in many different areas of health systems. It supports the transformation of healthcare delivery, and its potential is seemingly boundless. However, the deployed systems are in silos, and interoperability and integration are largely missing. There is no timely information for easy and quick decision making; there is no ability to track service levels across the whole health sector. What is missing is an integrated information system across all healthcare facilities nationwide. Such a Digital Health Ecosystem, the holistic application of information and communications technologies, services and applications, will support health systems and improve healthcare delivery, coordination and integration across providers. Based on global experience in resource-constraint contexts, core steps necessary to develop and implement such an ecosystem are explored, and four fundamental building blocks and their elements are developed. The results presented are succinctly integrated into six statements on lessons learned and recommendations. [ABSTRACT FROM AUTHOR]

Intermediate results from an ongoing health technology assessment exercise of a simulation model of paediatric cardiomyopathy are reported. Comprehensive data on paediatric cardiomyopathy/heart failure, treatment options, incidence and prevalence, prognoses for different outcomes to be expected were collected. Based on this knowledge, a detailed clinical pathway model was developed and validated against the clinical workflow in a tertiary paediatric care hospital. It combines three disease stages and various treatment options with estimates of the probabilities of a child moving from one stage to another. To reflect the complexity of initial decision taking by clinicians, a three-stage Markov model was combined with a decision tree approach - a Markov decision process. A Markov Chain simulation tool was applied to compare estimates of transition probabilities and cost data of present standard of care treatment options for a cohort of children over ten years with expected improvements from using a clinical decision support tool based on the disease model under development. Early results indicate a slight increase of overall costs resulting from the extra cost of using such a tool in spite of some savings to be expected from improved care. However, the intangible benefits in life years saved of severely ill children and the improvement in QoL to be expected for moderately ill ones should more than compensate for this. [ABSTRACT FROM AUTHOR]

To better enable cross-border healthcare delivery, particularly the exchange of ePrescriptions, this global undertaking advances the unique identification of medicinal products (MPs) and patient safety in cross-border settings. Major stakeholders harmonise their respective efforts to deliver * common data models for prescribed MPs * a common vocabulary for unambiguous definition, description, and identification of MPs * rules to harmonise practices of therapeutic and economic substitution * a global roadmap for post-project actions and implementations Based on earlier activities of standard development organisations (SDOs), use case scenarios are developed, where the identification of an MP is an issue, including pharmacological and pharmacokinetic attributes, clinical indications, and risks to be considered. Next, the univocal identification of MPs is addressed, for standard pre-packed ones as well as for special cases like MPs with multi-components, biologics, or special packaging. Impacts will be considerable for global healthcare services and systems as well as - through simplifying and speeding up the registration of new products and afterwards pharmacovigilance - for national and international regulatory agencies, the MPs industry, and, in particular, patients. [ABSTRACT FROM AUTHOR]

Driven by the diverse needs for exchanging patient, other healthcare and health system data with the aim to improve the overall quality and efficiency of healthcare provision, regions and countries globally have been developing electronic platforms to gather and exchange such data. Based on an initial sample of more than 50 potential cases, eight such platforms were analysed in detail. This covered issues like core public health policy goals pursued, and major patient and other healthcare data access and exchange characteristics driving the platforms surveyed. This allows for arriving at an initial, pragmatic typology of such platforms. It provides for a better understanding of the main objective(s) and the major thrust of the underlying national (or district-related) health policy to develop and implement such infrastructures. [ABSTRACT FROM AUTHOR]