Prendre la pharmacovigilance au sérieux

Les dangers sanitaires – réacteurs nucléaires, armes à feu, et aliments contaminés – nous menacent tous, c'est pourquoi les gouvernements jouent un rôle actif pour les limiter, par le biais de réglementations souvent couronnées de succès. Pourtant, la situation est très différente lorsqu'il s'agit de l'innocuité des médicaments délivrés sur ordonnance. En fait, pour le régulateur, la pharmacovigilance est le parent pauvre de la protection publique.

La portée du problème est pourtant énorme. Rien qu'aux États-Unis, on estime que chaque année les effets secondaires sont responsables de la mort de 100 000 patients. Si ces chiffres sont avérés, cela signifie que les décès provoqués par des médicaments se classent quatrième ou cinquième principale cause de mortalité (selon les estimations sur la mortalité utilisées). En outre, les coûts hospitaliers annuels directs imputables aux effets indésirables se chiffreraient en milliards de dollars, et tout cela sans parler des souffrances causées par les effets secondaires qui ne mènent pas à l'hospitalisation (ou à la mort).

Les difficultés à déterminer les causes et les effets doivent être prises en compte. Il est parfois ardu de savoir si le décès ou l'hospitalisation d'un patient est imputable à un médicament particulier, à la maladie traitée ou à l'association des deux. Ce phénomène ne fait que souligner la nécessité d'assurer l'innocuité des médicaments.

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