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Pharmakovigilance: An active role for rare disease patients

EURORDIS encourages patients to take an active role in managing their disease. 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. 

EURORDIS' new Pharmacovigilance section emphasises the importance of reporting any problems a patient experiences with their medicine – whether a prescription drug or an over-the-counter treatment. 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.

It is also explained 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 (www.adrreports.eu) 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, available in seven languages, has already received praise from the European Medicines Agency. EURORDIS hopes that by helping patients learn how to report adverse effects, medicines for rare diseases will become safer and more effective. 

Pills Spilled Around A Pill Bottle

Image courtesy of renjith krishnan / FreeDigitalPhotos.net