Thursday, February 04, 2016

OpenMedicine drive towards tangible outcomes – a triple win for Europe

The openMedicine Expert Council met for its 2nd meeting on Jan. 21 to 22, 2016 at the CEN – CENELEC Management Centre in Brussels, Belgium. It was very well attended by more than 30 experts from Europe and the USA. They represented medicinal productsstandardisation, and regulatory bodies, the European Commission, and the core project team.
Based on and guided by first year project results, the experts
  • intensely discussed critical issues and challenges brought forward both by council members and the openMedicine team
  • debated options for standards and their impact on prescriptions, their dispensation at community pharmacies in another country, patient summaries and drug databases
  • contributed suggestions on providing ultimately a set of recommendations for EU member states as well as an implementation roadmap on how to assure the univocal cross border identification of medicines for human use wherever needed.

Enabling the delivery of safe and efficient cross-border healthcare is a policy priority of the European Union. The openMedicine project contributes to this by solving an urgent problem of portability of ePrescriptions across Europe. The main challenge is the univocal identification of medicinal products to be dispensed by a community pharmacist in case of a cross-border (e)Prescription and dispensation. The project also addresses the different regulations regarding substitution of a prescribed medicine at the point of dispensation, considering that a pharmacist has to comply to the respective national rules, which often differ from those in the country where the prescription was issued.
Expert discussions clearly identified that the project is producing concrete results which are poised to deliver a very tangible triple win for Europe – for its citizens, patients and clinical professionals, its regulatory agencies and pharmaceutical industry; as well as for member states’ healthcare systems:
  • Clinical domain: The globally univocal identification of pharmaceutical and medicinal products will allow for easy and consistent recording and exchanging of information on medicines in electronic health records (EHRs), (e)Prescriptions, dispensation reports, patient summaries etc. This will positively impact on patient safety, e.g. by reducing adverse drug events, benefit physicians and nurses by streamlining clinical care, supporting researchers undertaking clinical studies.
  • Regulatory and medicinal products domain: Project work is undertaken and coordinated with the European Medicines Agency (EMA), national regulatory agencies, producers of drug dictionaries and others involved in the wider pharmaceutical field. They will benefit from more consistent and higher quality data on medicinal products, easer registration and authorisation processes, more reliable exchange of data.
  • Member states’ health systems: Finally, the concrete implementation and wide diffusion of the data model(s), identifying attributes and semantic coding of data elements proposed by openMedicine in cooperation with standards development organisations (SDOs) ( , regulatory agencies and representatives from national health systems will strongly support the safety and continuity of care within member states and across borders, particularly in application fields like ePrescriptions, patient summaries, dispensation reporting, or analysis of such data for public health purposes.
As a next step, the project is preparing a trans-Atlantic meeting, together with the USA Federal Drug Agency (FDA), at its premises in Washington, DC. It is expected that it will be attended also by representatives of regulatory agencies from other continents and WHO-UMC. It is planned to undertake a first proof of concept to generate aglobally univocal identification code for pharmaceutical products. The next Expert Council Meeting is planned for October of this year in London at the European Medicines Agency (EMA).

“It was a very encouraging meeting in Brussels, which demonstrated the excellent progress the team has made since the first expert council  last June.  It feels as if an important milestone has been reached, so the focus can move from “what is the answer” to “how do we prepare for implementation.”Jeremy Thorp
Director of Business Architecture
Health and Social Care Information Centre, Department of Health, UK

“It was excellent to see the progress that is being made in openMedicine towards supporting cross border prescribing, by using the developing IDMP database from the regulatory agencies as a high quality and coherent source of medicinal product information to patient care.  National medicinal product terminologies will be able to support their own business needs and support cross border use cases by implementing in harmony with the firm foundations of IDMP, so that in the future “cross border medication management” will be an accepted reality, increasing safety and quality for patients.”Julie M James
Blue Wave Informatics LLP

“As Convenor of ISO TC 215’s working group developing and maintaining the IDMP standards, I am enthusiastic about openMedicine’s progresses. These are going to show the right and sustainable direction for the identification of medicinal products in clinical settings, such as retail pharmacies, hospitals and nursing homes. IDMP impacts related standards for prescription, dispensation, etc. which in a couple of months from now will be made available to implementers. That global approach includes supply chain processes and is providing enhanced patient safety in Europe and in the world.”Christian Hay
GS1 Global Office

“The Pharmacy HIT Collaborative is honored to participate in the openMedicine project.  Over the years the US has worked hard to achieve a standard level of uniformity of prescribed products and we hope the US work can help the project reach a global consensus resulting in the electronic delivery of appropriate medicine.  The openMedicine project’s focus on standardized prescription medication identification is the first step to standardized global clinical medication-related terms.  Sharing standardized data across borders is essential component of safe health.”Rachelle “Shelly” Spiro, RPh, FASCP
Pharmacy Health Information Technology  Collaborative
Washington, DC, USA