Postmarketing Spontaneous Pharmacovigilance Reporting Systems

Pharmacovigilance reporting systems provide the infrastructure that enables health professionals and consumers to alert health authorities and drug manufacturers when a suspected adverse drug reaction occurs. Postmarketing spontaneous reports are a recognized tool that empowers concerned stakeholders to trigger a signal detection process that can result in appropriate regulatory action when needed to protect the public from unnecessary risks or harms. Compared to the cost of large formal studies utilizing clinical trials or healthcare databases, postmarketing spontaneous reporting systems are generally less expensive, and offer unique advantages in real-time postmarketing safety monitoring capabilities. Individuals are encouraged to report suspected adverse drug reactions or adverse events to health authorities or drug manufacturers for compilation, analysis, and effective action. This chapter describes some basic features of pharmacovigilance systems around the world.