EAHP EU Monitor 18 December 2012


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

You can subscribe to the EAHP EU Monitor here.


European Hospital and Community Pharmacists issue joint statement on future pharmacist roles

The two organisations representing community and hospital pharmacists in Europe have come together to make a declaration on the development of the pharmacy profession.

The joint statement by the Pharmaceutical Group of the European Union (PGEU) and the European Association of Hospital Pharmacists (EAHP) represents a call to action to national governments to, firstly, enable pharmacists to increase their role in optimising patient use of medicines, and, secondly, to improve the systems supporting multi-professional care across Europe.

EAHP and PGEU believe that pharmacists, as experts in medicines, should be at the heart of national strategies to ensure best outcomes for patients. This includes pharmacists educating patients about the optimal use of their medicines, and helping to ensure that potential polypharmacy problems, which can arise when a patient takes multiple medications, are satisfactorily resolved and reconciled.

The development of these roles for pharmacists is especially relevant in view of Europe’s ageing population, combined with the pressures on public spending that are likely for the foreseeable future. In this sense, it has never been more important to ensure national spending on medicines achieves intended outcomes in a cost-effective manner.

Pharmacists, in both community and hospital settings, are uniquely placed to facilitate this, so long as health policy makers recognise the opportunity and make the necessary commitments to its achievement.

Finally, the joint statement also highlights the need for multi-professional approaches to healthcare delivery to ensure integrated and seamless patient care. This includes improving systems for communication between health sectors when a patient transfers between hospital and community (and vice-versa), especially in relation to situations where changes are made to a patient’s medication.

PGEU and EAHP call for commitment from Governments to achieving multi-professional care, and for the integration of the multi-professional team concept within health professional education curriculums.

Speaking on the publication of the statement, Dr. Roberto Frontini, EAHP President said:

“The joint statement by EAHP and PGEU represents our shared goals in maximising the benefits the health service derives from pharmacists’ expertise in medicines. More than ever before decision makers in the health sector must ask and answer important questions about improving value and the outcomes achieved for patients. The pharmacist’s positive role in ensuring optimal use of medicines by patients is therefore a central consideration to successfully meeting the challenges of today and tomorrow.”

Ms Isabelle Adenot, PGEU President said:

“While patients receive primary care as well as hospital-based care, European pharmacists practice in both settings and share the challenge of improving the rational use of medicines. Having a common roadmap can help them to progress. This is the purpose of our joint statement.”

Statement here.


European Parliament vote for more transparency on medicines pricing and for a single EU patent

Members of the European Parliament have voted on a range of medicine and health related topics including the transparency of medicines pricing decisions and the need for a single EU patent to support innovation in sectors such as pharmaceuticals.

On Tuesday 18th December, the Parliament’s Health Committee (ENVI) voted to support European Commission proposals that would impose more precise time limits on Member States on pricing and reimbursement of medicines. The Committee’s rapporteur for the subject file, Antonyia Parvanova (ALDE, Bulgaria) explained the vote in support of stricter deadlines by pointing to the need for deadlines “not only to avoid unfair practices and market barriers but also to ensure an effective access to affordable medicines for millions of patients.”

In particular, the Commission’s proposals sets out a 60-day time limit for countries to decide on the pricing and reimbursement of generic medicines, in order to speed up their availability. To add weight to the time limit, the legislative proposal also requires Member States to provide mediation or remedial measures for an applicant in cases where there are unjustified delays in including medicines in public health insurance systems.

The Transparency proposal goes further by also requiring Member States to publish the list of the medicinal products covered by their public health insurance system and their prices, at least once a year.

More information here.

A Single EU Patent

Meanwhile, 30 years of wrangling between countries of the EU about the creation of a single EU patent were almost brought to an end when the European Parliament gave approval  to a combined package of proposals to enable one patent regime across countries. However, for the moment, Spain and Italy will remain outside the regime.

The changes are expected to assist the introduction of new medicines as pharmaceutical companies will now have opportunities to register innovations with one EU authority, cutting time and costs on the current process of registering a patent with every EU country.

More information here.

Parliamentary approval to Health Committee antimicrobial proposals

Finally, the European Parliament gave approval to the Health Committee’s November report on combatting the antimicrobial challenge (featured in the EAHP EU Monitor 12 November 2012).

The report calls for:

  • The establishment of an effective European network of national surveillance systems to facilitate clear, comparable, transparent and timely reference data on antimicrobial drug usage, based on the fragmented range of existing networks
  • The compilation by the Commission of a best practice list with regards to professional training courses relating to antimicrobial awareness
  • Enhanced cooperation between the FDA in America, and the European Medicines Agency, in relation to approaches that will facilitate antimicrobial drug development and regulation

More information about the report here.


EMA make breast cancer, schizophrenia and bipolar medicine recommendations

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has issued new recommendations in relation to a number of medicines.

The Committee has issued a positive opinion on Perjeta (pertuzumab) in combination with Roche's blockbuster Herceptin (trastuzumab) and docetaxel in patients with HER2-positive metastatic or locally recurrent unresectable breast cancer (mBC). The recommendation supports an indication for people with this specific type of cancer who have not received prior anti-HER2 therapy or chemotherapy.

The Committee also gave approval for Alexza Pharmaceuticals' Adasuve (loxapine) for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. The CHMP has recommended that the treatment should be administered only in hospital under the supervision of a healthcare professional.

Approval for label extensions were also given to:

  • Otsuka’s schizophrenia drug Abilify (aripiprazole);
  • Novartis' Ilaris (canakinumab) for the treatment of cryopyrin-associated periodic syndromes (CAPS); and,
  • Intercell's Japanese encephalitis vaccine Ixiaro.

More information here. 


EJHP: safe handling and use of hazardous medicines

On the online first edition of the EJHP, a new research article investigates methods to evaluate occupational risks and to recommend protective measures in relation to hazardous medicines.

The article gives detail on the development of a standardized evaluation algorithm and how risks of exposure were evaluated, including screening methods for toxicity.

Read the full article here.