EAHP EU Monitor 28 September 2012

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

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



Two weeks left to submit abstract posters for Paris Congress! 


EAHP would like to remind hospital pharmacists that the deadline for submitting abstract posters for the 2013 Congress in Paris is fast approaching – Monday 15th October.

The Abstract Poster Walk is a highlight of EAHP’s Congress, displaying concise information about:
• hospital pharmacy practice innovation;
• the introduction and assessment of new technologies;
• new understandings about pharmacotherapy issues; and
• the key findings of many other evaluative exercises from hospital pharmacies across Europe and beyond.

Any hospital pharmacist may submit an abstract to the EAHP’s Scientific Committee who will then consider its inclusion in the Congress poster display.

Accepted abstracts will be published in the official Abstract Book issued to all Congress attendees, will be available to view via the EAHP website following the Congress, and will be included in the Congress edition of the European Journal of Hospital Pharmacy (EJHP).

Every year, at the conclusion of the EAHP Congress, 1st, 2nd and 3rd place prizes are awarded to the 3 abstracts that have most impressed Judges with regards to aspects like originality, scientific quality and practical applicability.

Full information on submitting an abstract is available here: http://www.eahp.eu/congresses/abstract




New pan-European proposals for medical device regulation 


The European Commission has published its proposals for the future regulation of medical devices with the aim of improving assessment procedures, access to information and traceability procedures.

In relation to healthcare professionals, it is the Commission’s expressed hope that the proposals will enable better provision of information on the benefits of particular devices to patients as well as residual risks. This will be provided by an extension of the existing database on medical devices (Eudamed), with access to non-confidential data provided to patients, healthcare professionals and the public at large. The Commission hope this will help healthcare professionals in making the best use of medical equipment in their treatment and care of patients.

Other key aspects of the Commission proposals are:

Medical Device Assessment procedures

Criticism has been made that of the up to 80 notified bodies across Europe empowered to assess devices and issue a pan-European CE mark, not all are maintaining the same standards and rigour in their assessment processes. The Commission’s proposals will enable stronger supervision of independent assessment bodies by national authorities, with new details to be given on how notified bodies must carry out their evaluations before and after market release (eg the documents to be provided, the scope of verification, the obligation to carry out unannounced on-the-spot inspections, checks of samples). The Commission’s proposal will also create stricter requirements for clinical evidence to support assessments of medical devices. It is hoped that these measures will ensure more equal control conditions for devices across Europe.

New rules for high risk devices

The Commission proposals introduce a new “scrutiny procedure” for very risky products (Class III). Under this procedure, notified bodies – which authorise the placing on the market of devices qualifying for the CE label – will be obliged to inform a pan-European Medical Device Coordination Group when they receive a new request for market authorisation for a risky device. The coordination group, made up of national experts, will have 15 days to decide whether further evaluation is needed and may issue comments on the preliminary investigation conducted by the notified body within 90 days.

Inspection of device manufacturers

The Commission’s proposals will also issue more powers and obligations for device assessment bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections and sample testing.


The Commission’s proposals will introduce a Unique Device Identification system to enhance post-market safety of medical devices, to help to reduce medical errors and to fight against counterfeiting. The difficulty in trying to trace medical devices was a problem exposed by the PIP breast implant scandal.

In vitro medical devices

A separate proposal has also been put forward by the European Commission in relation to the regulation of in vitro diagnostic medical devices (IVDs), such as blood tests. It is proposed to extend existing regulations in this area to genetic tests and companion diagnostics, which will be classified as in vitro diagnostic medical devices.

Throughout 2013 the proposals will be reviewed by the European Parliament and the Council of Ministers with a target date for adoption in 2014, and implementation in 2019.

EAHP will be scrutinising the proposals in more detail over the coming weeks and will work with partners to ensure the Commission’s suggestions in areas such as the information access for hospital pharmacists, stand up to scrutiny and are fully future-proofed.

More information here: http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm



EDQM calls on Governments to introduce pharmaceutical care indicators 


The European Directorate for Quality Medicines (EDQM) has published a report which sets out a series of proposals to European Governments on how to achieve more responsible medication use, including recommending global pharmaceutical care indicators.

Published on 25th September, the report is titled “Pharmaceutical care: Policies and Practices for a Safer and More Responsible and Cost-effective Health System” and was jointly prepared by: Dr David Cousins, Head of Safe Medication Practice at the National Patient Safety Agency, UK; Mr Nico Kijlstra, Vice-Chairman of the European Committee on Pharmaceuticals and Pharmaceutical Care, Council of Europe; and, Dr Sabine Walser of the EDQM.

Amongst its key recommendations are for every country, globally, to introduce generally applicable quality indicators for pharmaceutical care “to provide themselves with valid information for policy-making and to set professional standards and best practices in the field”.

To that end, the report suggests 4 basic indicators for pharmaceutical care:

1. Number of pharmaceutical care interventions delivered per standardised denominator, such as 1000 prescriptions dispensed or 1000 patients

2. Number of patients counselled about their medicines per standardised denominator, such as 1000 prescriptions dispensed or 1000 patients

3. Number of formal written feed-back responses from patients during treatment per 1000 prescriptions or 1000 patients about patients' specific medication-related literacy, concerns, life-quality needs/expectations, and satisfaction.

4. Number of adverse drug event reports (to include both adverse drug reactions and medication errors) per year.

Also contained within the report are an interesting mixture of statistics relating to hospital pharmacy, including references to studies suggesting that medicine administration errors are the most frequent type of medication error in hospital in the hospital setting and that prescribing errors affect up to 7% of medication orders, 2% of patient days and 50% of hospital admissions.

The report identifies a remaining problem in the great variation in the rate of reporting prescribing errors and the lack of a standardised scale of severity for measuring harm to patients by prescribing error.

The report will be formally launched at a Summit of European Health Ministers in Amsterdam on 3rd October.

More information here: http://www.edqm.eu/medias/fichiers/summit_promoting_responsible_use_of_medicines.pdf


EJHP: The debate about hospital pharmacy preparation


On the online first section of the EJHP website Swiss hospital pharmacist Professor Helena Jenzer provides a summary of the lively debate at EAHP’s 2012 Milan Congress on the future of hospital pharmacy preparation.

The debate at the Congress was entitled: “Survival of hospital pharmacy preparations—standards for quality and safety, where to go?’ and heard from 3 main speakers:
• Henk Scheepers, senior inspector from the Dutch Ministry of Health, Welfare and Sports, delegate to the European Directorate for the Quality of Medicines (EDQM);
• Vagn Handlos, member of the EAHP Board and former EAHP Director of Education, Science and Research; and
• Irene Krämer from the Pharmacy Department, Mainz University Medical Centre.

Each gave their views on challenges presented to hospital pharmacy preparation, and the impact of the 2011 resolution by the European Directorate of Quality Medicines (EDQM) in relation to achieving standards of Good Manufacturing Practise (GMP).

The full report of the discussion is available here: http://ejhp.bmj.com/content/early/2012/09/17/ejhpharm-2012-000195.full