PV in the EU: Can the Doctor See You Now?

  • by: Peter Pitts |
  • 04/06/2017
European, national, and regional authorities should invest in awareness-raising campaigns to increase public knowledge about medicinal safety and adverse drug reaction (ADR) reporting.
This is one of the main findings of the study “Pharmacovigilance in the European Union: Practical implementation across Member States” from the University of Duisburg-Essen which assesses the functioning of EU pharmacovigilance legislation.
The report focuses on adverse drug reaction (ADR) reporting of biologicals in six EU Member States - the UK, Finland, France, Poland, Portugal, and Germany. Since the 1990s, legislation at the EU level has strengthened medicinal safety in general, and particularly the reporting of ADRs. However, transposition problems remain in some EU Member States when it comes to medicinal safety.
ADRs account for 5% of all hospital admissions, cause around 200,000 deaths per year in the EU, and cost roughly €80 billion.
Almost 85% of EU rules are not transposed on time, and occasionally come with a delay of more than two years. Although patients are given a strong role within the new EU pharmacovigilance legislation, they lack awareness, and this leads to ADRs going unreported.
The report argues that ADR reporting should be viewed as a key responsibility for healthcare professionals and not as a failure or lead to reputational damage. They should also be properly trained and targeted by awareness-raising campaigns to ensure they are aware of the importance of medicinal safety to public health and feel comfortable in reporting ADRs without fear of liability and/or failure.
Patients also have a critical role to play, and Member States should enable patients to report ADRs online, and connectivity of IT systems between general practitioners, hospitals, pharmacies, and the national competent authority should be improved.
A key solution identified by the report is to put in place awareness raising programmes aimed at both patients and healthcare professionals to increase knowledge about medicinal safety and highlight the role it can play to ensure public health.
The report will be shared with EU Member States, the EU Institutions, and key stakeholders, with the aim of ensuring the recommendations are taken up by governments, and that the EU legislation can be properly implemented across Europe.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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