EAHP EU Monitor 22 May 2013


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 pharmacist organisations make joint call for action on medicines shortages

The representative organisations for European community, hospital and industrial pharmacists have issued a joint call for action by Governments, regulators and the European Commission to tackle the growing problem of medicines shortages.

More information here.


SPECIAL BRIEFING: EU Directive for the prevention of sharps injuries comes into force

May 2013 is the month by which time EU Member States are expected to have implemented the 2010 EU Directive on the prevention of sharps injuries. EAHP presents a briefing for hospital pharmacists on its key requirements.

The Directive applies to employers whose main activity is the management, organisation or provision of healthcare, whether Government-provided (e.g. public hospitals) or privately-provided (e.g. nursing homes). Hospital pharmacies therefore fall directly within the Directive’s scope.

1) Requirements on employers to conduct adequate risk reduction activity in relation to sharps injuries

The Directive requires healthcare employers to conduct activity to assess and mitigate against the risk of sharps injuries. Accordingly, the Directive requires all healthcare employers to have in place risk assessment procedures and that these procedures should include exposure determination and “understanding the importance of a well-resourced and organised working environment”. Furthermore, the procedures should take into account “technology, organisation of work, working conditions, level of qualifications, work related psycho-social factors and the influence of factors related to the working environment”.

Beyond this, the Directive provides a general expectation on employers to highlight different risks, give guidance on existing legislation, promote good practice and raise awareness about sharps injury issues.

2) The issue of syringe recapping

The original text of the Sharps Directive had set out a blanket ban on the practice of recapping syringes. However, following further consultation practical difficulties with such a ban were foreseen. Therefore a ‘clarification note’ was published to make clear that ‘The practice of recapping refers to needles without safety and protection mechanisms”. This has been interpreted to allow the limited continuation of recapping in so far as enabling pharmacists to carry out the necessary procedures to prepare medicines.
In addition to this, the Directive sets out a general expectation on employers to eliminate unnecessary use of sharps and to provide medical devices that incorporate safety-engineered protection mechanisms.

3) When a sharps injury occurs

The Directive puts in place a new duty on an individual employee who receive a sharps injury to notify the person responsible for safety and health in their workplace as soon as practicable.
At this point, the employer is required to take “immediate steps for the care of the injured worker, including the provision of post-exposure prophylaxis and the necessary medical tests where indicated for medical reasons, and appropriate health surveillance”. The employer must also investigate the causes and circumstances and record the incident. The worker must provide the relevant information at the appropriate time to complete the details of the accident or incident.

Directive text available here.


SPECIAL BRIEFING: Council of the EU and European Parliament confirm agreement reached on cross border health threats

The Council of the European Union has confirmed agreement has been reached with the European Parliament on the core components of a new EU decision on response procedures structures and roles in respect of serious cross border health threats.

In December 2011, the European Commission published proposals designed to improve the EU response mechanisms to cross border health threats, with experiences from the H1N1 pandemic in 2009 and the outbreak of E. coli STEC O104 in 2011 firmly in mind.

Having considered the Commission’s proposals, the Council of the EU has announced it has reached agreement with the European Parliament on many of the fundamental proposals, including:

• Expanding existing EU coordination mechanisms beyond simply communicable diseases, to “all health threats of biological, chemical, environmental and unknown origin”. This enables greater use of cross-border monitoring and alert mechanisms for a wider range of potential health threats;

• Introducing new requirements on member states to consult with each other on their preparedness and risk planning, including risk and crisis communication

• Providing the existing EU Health Security Committee, composed of member states and the European Commission, with formal legal status

• Creating a legal basis for a joint procurement procedure of medical countermeasures, in particular pandemic vaccines

• Introducing new possibilities for the European Commission to recognise a situation of public health emergency for the purposes of conditional marketing authorisations for medicinal products and for derogations of the terms of a marketing authorisation for a human influenza vaccine.

The final agreement on new EU processes for responding to cross border health threats is due to be agreed by the end of 2013.
Council of the European Union press release here.

EJHP: Results of EAHP 2010 survey of hospital pharmacy practice related to education and research 

The European Journal of Hospital Pharmacy recently published a summary of results from the EAHP 2010 survey relating to the areas of education and research.

The results cover a range of issues including: the extent of internally provided continuing education, hospital pharmacy relationships with pharmacy schools, and hospital pharmacist involvement in clinical research, drug evaluation and epidemiology studies.

Full article here.