EAHP EU Monitor 05 November 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.


Have you experienced difficulty in gaining recognition for your hospital pharmacy qualification in another country?

The European Association of Hospital Pharmacists is seeking case studies from individuals across Europe who have experienced personal difficulties in having their hospital pharmacy qualification recognised in another country.

In advance of votes to be taken in the European Parliament before the end of the year on the review of the Directive on the Mutual Recognition of Professional Qualifications, EAHP would like to highlight to Members of the Parliament, the real life difficulties hospital pharmacists can experience in gaining recognition in another country for their qualifications.

If you have personal experience of your hospital pharmacy qualification not being recognised in another country please contact the EAHP policy team (po[at]eahp[dot]eu) to give your story.

The intention is to provide your account in an anonymous fashion to demonstrate to Members of the European Parliament the real life impact that occurs as a result of the fact that the current Directive for the Mutual Recognition of Professional Qualifications contains no mechanism for recognising specialisms of pharmacy across borders.

EAHP is campaigning to reform the Directive to provide new opportunities for pan-European recognition of the hospital pharmacy qualification. Several MEPs have tabled amendments to assist the campaign with votes to be taken in the coming weeks.


European Medicines Agency launches pharmacovigilance review of diclofenac-containing medicines 

The European Medicines Agency has announced it is commencing a review of diclofenac-containing medicines to assess their cardiovascular safety.

Diclofenac is a widely used non-selective non-steroidal anti-inflammatory drug (NSAID), a type of medicine used to relieve pain and inflammation. A recent review of scientific studies by the Agency’s Committee for Medicinal Products for Human Use (CHMP) assessed the latest data on the risk of cardiovascular side effects (such as heart attack or stroke) with non-selective NSAIDs. It concluded that the latest available data provide further evidence on the known risk with these medicines. Overall, the studies consistently indicate a small increase in risk with diclofenac compared with other non-selective NSAIDs, similar to the risks of COX-2 inhibitors (another class of painkillers).

The review will cover diclofenac-containing medicines formulated for systemic use (such as those taken by mouth or injection). The European Medicines Agency will evaluate the impact of the latest information on the benefit-risk balance of diclofenac and consider the need to update the existing treatment advice with regard to cardiovascular risk.

The review of diclofenac has been initiated at the request of the UK medicines agency, under Article 31 of Directive 2001/83/EC.

The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.

More information here: http://www.emea.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Diclofenac-containing_medicines/human_referral_prac_000009.jsp&mid=WC0b01ac05805c516f

Pharma industry suggest proposals to resolve medicines supply threat in Greece


EFPIA, the principal trade association for pharmaceutical companies in Europe, has made a proposal to cap the total amount the government of Greece pays for its medicines in a bid to resolve a crisis that is jeopardizing the supply of drugs to hospitals and patients.

According to reports from Reuters news agency, EFPIA has suggested that in exchange for a ceiling on outpatient pharmaceutical expenditure of 2.88 billion euros in 2012, the government in Greece should then commit to pay all outstanding debts and prevent further arrears from building up.
The move follows growing concerns about the situation in Greece, where the government last month took the highly unusual step of suspending all drug exports from the country in an attempt to prevent shortages.

Other pharmaceutical stability agreements have already been agreed in Portugal, Ireland and Belgium, and it is thought the model could be extended to other European countries in future.

More information here: http://uk.reuters.com/article/2012/11/05/us-greece-pharmaceuticals-idUKBRE8A40AL20121105


EJHP: EAHP Survey 2010 on Production and Quality Assurance


The latest EJHP article analysing the results of the EAHP 2010 survey of hospital pharmacy practice across Europe was published this week. The article focuses on production and quality assurance issues.

Contributed by Dr. Roberto Frontini, Universitätsklinikum Leipzig, and President of the EAHP, the article looks at such issues as:
• The trends in numbers of hospitals producing sterile as well as non-sterile medicines;
• The implementation of quality control and good manufacturing practice (GMP) across Europe; and,
• The extent to which hospital pharmacies seek external certification for quality control and GMP practice.


The full article is available here: http://ejhp.bmj.com/content/early/2012/11/02/ejhpharm-2012-000243.full