HealthManagement, Volume 5 / Issue 3-4 / 2010
Pharmacists and patients welcomed the new proposal for a directive on Pharmacovigilance at an event held on Wednesday 15 September 2010 at the European Parliament as an opportunity for pharmacists and patients to work more effectively together to improve medication safety.
The new directive was adopted by the European Parliament on 21 September and is expected to enter into force by the end of 2010 or in early 2011.
At the meeting, organised jointly by the Pharmaceutical Group of the EU (PGEU) and the European Patients’ Forum (EPF) and sponsored by the Pharmacovigilance Rapporteur, Mrs Linda McAvan MEP, an audience of interested stakeholders heard the views of pharmacists’ and patients’ representatives, regulators (including the European Medicines Agency and the MHRA1), academics (the Netherlands Pharmacovigilance Centre Lareb), the European Commission and the pharmaceutical industry.
All speakers welcomed the new directive as a major step forward towards achieving a better balance between benefits and risks of medicines. In particular, speakers stressed the importance of effective reporting of adverse drug reactions. The new directive proposes a stronger reporting framework for pharmacists and health professionals, and introduces direct reporting by patients. The data gathered from such reports will be used to monitor risks posed by medicines once they have been approved and become available to patients.
PGEU President Mr Filip Babylon said “I believe the new Directive is a significant step in creating a basis for effective collaboration between pharmacists and patients in the area of medication safety.” EPF President Mr Anders Olauson said “We welcome the proposals regarding direct patient reporting and giving patients wider access to safety data, as this contributes to patients’ empowerment and greater patient safety. These efforts should be seen as integral to the wider EU debate on patient empowerment and health literacy, with the aim of enhancing the safety and quality of care for all patients across the European Union.”
For more information, please visit: www.eu-patient.eu
