EAHP EU Monitor - 29 October 2015

The EAHP EU Monitor is a regular round up of news relevant to hospital pharmacy in Europe.

You can subscribe to receive the EAHP EU Monitor by email here. 


Access to the patient medical record among the top challenges for European hospital pharmacy

The European Association of Hospital Pharmacists (EAHP) has published new research revealing the common difficulty faced by hospital pharmacists across Europe in being able to enter medicines used onto the patient's medical record on admission. The profession also faces systemic problems in being able to contribute to the transfer of information about medicines when patients move between and within healthcare settings.

The findings are published in the results of a pan-European survey of hospital pharmacies that sought to gain a better understanding of perceptions, and the status of implementation, of the 44 European Statements of Hospital Pharmacy.

More information here. 

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Round up of latest Falsified Medicines Directive news

The 25th August 2015 edition of the EAHP EU Monitor reported on the long awaited publication of the European Commission's 'Delegated Act' which sets out the detailed requirements of medicines authentification procedures expected to be met by both community and hospital pharmacies by the end of 2018. Some additional developments for hospital pharmacist awareness are reported below.

EDQM announce formal collaboration with the European Medicines Verification Organisation

The European Directorate for the Quality of Medicines & HealthCare (EDQM), an agency of the Council of Europe, has announced a new relationship with the European Medicines Verification Organisation (EMVO). EDQM will in future conduct periodic conformity assessments of the European Medicines Verification System ("EMVS") and its governance. The European Medicines Verification System is the product of the EMVO, a designed solution by 5 European medicines supply chain organisations (EFPIA, EGA, GIRP, EAEPC, PGEU) to meet the verification and authentification requirements of the 2011 Falsified Medicines Directive. It provides a centralised "blueprint" model that each country can adopt under the governance of "national medicines verification organisations" (NMVOs), which are currently in the process of construction.

EDQM's new role with the system provides a form of external audit for the overall EMVO system "to determine whether the EMVO European Hub and blueprint systems are designed, managed and operated in accordance with the standards described in the "Delegated Act on the Unique Identifier".

The announcement appears to bring to an end the previous concept of a second European medicines verification system to be operated under EDQM's governance called E-tact, that would have competed with EMVO's system. This leaves the European Medicines Verification System as the only well developed system for implementation of the Falsified Medicines Directive's verification and authentification requirements.

More information here and here.

Next steps

EAHP will now continue discussions with all relevant stakeholders in respect to how the challenges for FMD implementation for hospitals can best be overcome, including with the European Medicines Verification Organisation (EMVO) and its constituent member organisations, the EMVO's preferred system providers (Aegate, SolidSoft, Arvato), and all other relevant stakeholder organisations.

On the basis of these discussions, EAHP will seek to provide advice to its member organisations to the best of its ability. However, as much of the implementation activity will be nationally-specific EAHP's member organisations are also encouraged to give priority to this topic and ensure hospital pharmacy representation in national implementation dialogue (e.g. with relevant Government units, and the national medicines verification organisations that are in the process of formation).

The Falsified Medicines Directive will also be a priority topic at the EAHP Members Meeting in Vienna, March 2016, and the EAHP General Assembly in Prague, June 2016.

Aegate Ltd publish EJHP article on Good Authentification Practice (GAP)

The European Journal of Hospital Pharmacy has published an open access article examining the future challenges to be faced by hospitals across Europe in meeting the authentification requirements of the 2011 Falsified Medicines Directive. The article outlines research findings from piloting activity conducted by Aegate Ltd in a UK NHS Teaching Hospital, and sets out some suggested "Good Authentification Practice" (GAP) guidelines.

Amongst the 12 key points of Good Authentification Practice (GAP) are:

  • each individual hospital must decide on the optimum point for medicines authentication; 
  • robotic authentication should be favoured over manual where possible using 2D data matrix scanners; and, 
  • medicines identified as falsified or recalled should be quarantined for the inspection of suitably qualified professionals to investigate.

More information here.

Aegate Ltd are one of the three preferred providers selected by the European Medicines Verification Organisation for implementing national level verification systems. The other preferred providers are Arvato Systems and SolidSoft Reply. More information here.

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Health related components of Horizon 2020 Work Programme 2016-17 announced, with funding submission deadlines

The European Commission has published the Horizon 2020 2016-2017 work programme for the Societal Challenge 1 (SC1) related to Health Demographic Change and Wellbeing, focusing on personalised health and care, with an overall funding budget of €934 million. Horizon 2020 is the EU framework programme for research and innovation with nearly €80 billion of funding available over 7 years (2014 to 2020).

In the next two years health-related research priorities of the Horizon 2020 programme will include:

  • personalised medicine,
  • rare diseases,
  • human bio-monitoring,
  • mental health,
  • comparative effectiveness research,
  • advanced technologies,
  • e/m-health,
  • robotics,
  • patient empowerment,
  • active and healthy aging,
  • data security,
  • big data,
  • valorisation, and
  • antimicrobial resistance.

The calls for proposals for the 2016 topics have been published on the participants' portal. Deadlines vary from end of January to April 2016, depending on the topic.

Full version of the health related Horizon 2020 2016-2017 work programme here.

The UK's NHS European Office has published a useful guide to health organisations considering involvement in Horizon 2020 projects available here.

A range of further explanatory information for health sector organisations has been published by the European Commission's Directorate General for Research and Innovation, which oversees the H2020 programme. Available here.

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EJHP - November 2015 edition now online!

The November 2015 edition of the European Journal of Hospital Pharmacy includes articles on:

• Evidence based skills and practice for the future of pharmacy;
• Potential benefit of repeated MDI inhalation technique counselling for patients with asthma;
• The impact of clinical pharmacist support on patients receiving multi-drug therapy for coronary heart disease in China: a long-term follow-up study;
• Evaluation of chemical contamination of surfaces during the preparation of chemotherapies in 24 hospital pharmacies; and,
• Medicines wastage evaluation and prescription management in homecare medicines in Nottingham University Hospitals NHS Trust.

Full edition here