The European Medicinces Evaluation Agency (EMEA) has a working group on Pharmacovigilance. Emmanuel Trenado has been organising input on behalf of EPHA member organisations. He has drafted this introductory text on the question of pharmacovigilance. Comments welcome until the end of August 2003.
While you are having your breakfast, you hear on the radio that a certain medicine against cholesterol or against insomnia or pain has been taken off the market, that there have been some deaths, that the health authorities are aware of but have not yet divulged any information … This is not very reassuring for the patient who takes this medicine, or for the professionals who prescribe or dispense it!
These crises worry patients and generate confusion in doctors and pharmacists. They do not allow anyone to fully understand what the actual risk is, or what should be done to prevent other crises. They are detrimental to everyone involved, from the patient suffering from side effects to the pharmaceutical firm concerned.
Patients often bring to our attention the difficulties linked to adverse side effects of medicine. These effects are too often characterized as "secondary" yet they do grave damage to patients’ quality of life, and seriously compromise their health. Adverse events discourage patients; they impair adherence and even in the longer term they are responsible for abandonment of treatment.
