EAHP EU Monitor 12 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.

EAHP launch survey on medicines shortages impact on patient care

As part of its ongoing work to highlight the urgency of current problems hospitals are experiencing with medicines shortages, EAHP has launched a new survey to better understand the impacts shortages have in relation to care to the patient.

The short survey of seven questions seeks to find out whether hospital pharmacists consider the medicines shortage problem is getting worse or getting better, whether shortages have negative impacts on patient care, what hospital pharmacists believe are the principal causes of shortages and what they believe would be the most useful solutions to enact.

Hospital Pharmacists are asked to make responses by the end of January 2013.

Survey here

A previous EAHP survey, launched in September 2012, remains open for responses, and looks to understand the prevalence and nature of the shortage problem across Europe.

September 2012 Survey here

Commission publish action plan on “A digital future for healthcare”

The European Commission has unveiled an Action Plan “to address barriers to the full use of digital solutions in Europe's healthcare systems”.

The Commission believes that “while patients and health professionals are enthusiastically using telehealth solutions and millions of Europeans have downloaded smartphone apps to keep track of their health and wellbeing, digital healthcare has yet to reap its great potential to improve healthcare and generate efficiency savings.”

Therefore, in order to address this challenge, the Commission’s Action Plan aims to:

  •  clarify areas of legal uncertainty;
  •  improve interoperability between systems;
  • increase awareness and skills among patients and healthcare professionals;
  • put patients at the centre with initiatives related to personal health management and supporting research into personalised medicine;
  • ensure free legal advice for start-up eHealth businesses.

The Action Plan notes that despite the economic crisis, the global telemedicine market grew from $9.8 billion in 2010 to $11.6 billion in 2011, while the global mHealth market is set to grow to €17.5 billion a year by 2017.

The Commission also commits to issue a mHealth (Mobile Health) Green Paper by 2014 addressing quality and transparency issues.

The legal status of telemedicine is also a particular focus of an accompanying Staff Working Paper, which gives a legal overview of how current EU legislation applies to this area. It addresses such questions as:

  • Does a healthcare professional involved in cross-border telemedicine need to be licensed/registered in the Member State of the patient?
  • How should health data be processed?
  • Will a given service be reimbursable?
  • What is the liability regime applicable in case of legal action?

More information here.

Short video here.


EMA issue call for interest in clinical trial data advisory groups

The European Medicines Agency is inviting persons with an interest in the publishing formats and rules of engagement for access to clinical trial data to express an interesting in joining 5 special advisory groups by Friday 21 December.

The call follows an earlier workshop held in November 2012 as the EMA prepares to enact a policy of proactive publication of clinical trial data. The groups are seen as a key means for the Agency to have developed dialogue with stakeholders in 5 key areas:

1.    Protecting patient confidentiality

2.    Clinical-trial-data formats

3.    Rules of engagement (conditions stakeholders may need to meet in order to download data)

4.    Good analysis practice (EMA may recommend guidelines in this area to data requestors)

5.    Legal aspects (understanding when data may be commercially sensitive)

Please email richard [dot] price [at] eahp [dot] eu if you are a hospital pharmacist with an interest and experience in relation to clinical trial activity, and would like to be considered as an EAHP nominee to any of the 5 advisory groups.

Most of the advisory group activity will be conducted by virtual methods (e.g. email and teleconference).

The bulk of the advisory group activity is intended to be conducted between January and April 2013.

More information about the call for participation here.

Report of the November 2012 Clinical Trial Data workshop here


EJHP: Editor Philip Wiffin on Evidence-based medicine

In the latest edition of the EJHP, new Editor-in-Chief Philip Wiffin writes on the evolution and use of the Evidence-based Medicine (EBM) concept.

This article looks at the background and definitions of EBM together with an outline of the tools that can support EBM in practice. In particular the role of systematic reviews and the utility of forest plots, L'Abbe plots and numbers needed to treat are presented.

See the full edition here.