Drugs’ adverse effects affect patients’ quality of life, increase the number and length of  hospital stays, and can even result in death. In most countries that have a pharmacovigilance system, gathering evidence of adverse effects is based on spontaneous reporting by healthcare professionals. The major drawback of this system is the under-reporting of adverse effects.

In some countries, there is, and has been for some time, a provision for patients to report adverse effects directly. Analysis of the data gathered by the Swedish pharmacovigilance system has shown that patients are more likely than are healthcare professionals to report changes in quality of life. The Dutch pharmacovigilance centre emphasises that patients report severe adverse effects more frequently.

Reports by patients sometimes draw attention to facts previously ignored by professionals. The vocabulary used by patients is different from that used by healthcare professionals, and so regrettably some of the information is ignored by medicines agencies.

Patients are capable of identifying more adverse effects and of making a strong link with the suspected drug.

Reports from patients complement those made by healthcare professionals. They help to identify unforeseen adverse effects, and to provide a fuller description of them.

In France, as of June 2011, patients can at last report adverse effects to their regional pharmacovigilance centres themselves.

©Prescrire 1 August 2011

Source: "Écouter les patients enrichit la pharmacovigilance" Rev Prescrire 2011; 31 (334): 590-592.

"Patient reporting improves pharmacovigilance" Prescrire Int 2008; 17 (98): 241-242. (Pdf, subscribers only)