Direct adverse event reporting by patients: medicines agencies must listen

The EU Parliament underlined the advantages of patient involvement in the pharmacovigilance system. Members requested that the new texts encourage patients to report all adverse events potentially due to their treatments, both to their doctor/pharmacist and to pharmacovigilance bodies (i.e. medicines agencies).

During the Council's preparatory work, some countries were opposed to the idea that patients should be able to report adverse events directly to medicines agencies. It is true that registration and analysis of such notifications would entail extra work. It is also true that a handful of highly anxious patients report effects that are either negligible or unrelated to their treatments. It remains that patients must be able to report directly to a pharmacovigilance body, not least because some may have lost confidence in their doctor or pharmacist, while others may wish to notify both a health care professional and their medicines agency. This is one way of ensuring that patients feel more engaged in rational and safe drug use. And health authorities have a duty to listen to the public they serve.

The amendment voted by Parliament must be inserted, in its entirety, into the last sentence of article 20, even if it means that some national medicines agencies will have to acquire additional means to deal with direct patient notifications.

The Medicines in Europe Forum trusts that the many drug scandals in recent years will lead Member States to adopt a more responsible attitude in this area.

©La revue Prescrire for the Medicines in Europe Forum 1 March 2003