New EURORDIS Pharmacovigilance website section helps people living with a rare disease report problems with their medicines

People living with a rare disease are anything but passive. Patients, organisations, and families actively campaign to participate in all processes that improve conditions for rare disease patients. EURORDIS champions this activism and promotes initiatives that allow the rare disease community to take an active role. The latest endeavour is the new Pharmacovigilance section on the EURORDIS website.

“Pharmacovigilance” refers to the monitoring of medicines, particularly in the area of safety and side effects. New treatments are becoming increasingly available for rare diseases, and many of these may be tested on smaller patient cohorts than treatments for more common illnesses. Thus, even after a treatment has been tested and approved, it is crucial to continue tracking the benefits and risks patients experience while taking it and to be especially vigilant for side-effects that patients might experience. Here’s where you can help.

EURORDIS’ new Pharmacovigilance section, available in seven languages, emphasises the importance of reporting any problems a patient experiences with their medicine – whether a prescription drug or an over-the-counter treatment. Sharing experiences with the medicines taken to treat a rare disease is a way of showing solidarity. Letting other members of the community, including the manufacturers of treatments and the agencies responsible for regulating their use, know when an undesired side-effect is experienced helps to improve the medicines available. The new Pharmacovigilance section offers guidance on how to report an adverse effect. Members of the public can report a side effect themselves or ask their health professional to do so. Many patient organisations also offer assistance on reporting side effects. The new section provides a list of available rare disease help lines in Europe, where assistance with reporting an adverse effect can be found.

The new Pharmacovigilance section also explains how to check if other patients have reported a similar event. In April 2012, the European Medicines Agency starting making public the suspected adverse drug reaction reports filed by patients, consumers, health professionals or members of the biopharmaceutical industry and stored in the EudraVigilance database. The European Database of Suspected Adverse Drug Reaction Reports ( extracts data from EudraVigilance, allowing the public to view the adverse effects reported for different medicines. One can search for a specific medicine, and sort any existing data on reported side effects by type of reaction reported, age, gender, or geographic location.

The new section has already received praise from the European Medicines Agency. Dr Peter Arlett, Head of Pharmacovigilance and Risk Management, commented that, “Patients organisations have collaborated from the very beginning in the design, planning and implementation of this important piece of legislation. … This EURORDIS initiative will definitely help achieve the goals of the legislation by bringing it closer to patients. It will make it easier for patients to participate in activities which will improve the health of millions of people in Europe.”

We hope you like the new EURORDIS Pharmacovigilance website section as well. Let’s be “pharmaco-vigilant”!

Louise Taylor, Communications and Development Writer, EURORDIS

Page created: 27/03/2013
Page last updated: 26/03/2013
The voice of rare disease patients in EuropeEURORDIS The international voice of people living with rare diseasesRare Disease International Bringing together patients, families and experts to share experiences in a moderated multi-language forum. RareConnect The Rare Barometer Programme is a EURORDIS initiative that carries out surveys to transform rare disease patients' experiences into figures and facts that can be shared with decision-makers.Rare Barometer An international awareness raising campaign taking place on the last day of February each year, Rare Disease Day is a EURORDIS initiativeRare Disease Day Join the largest gathering of rare disease stakeholders across Europe, at the biennial European Conference on Rare Diseases and Orphan Products. ECRD is a EURORDIS initiativeEuropean Conference on Rare Diseases