Postmarketing Spontaneous Pharmacovigilance Reporting Systems

Only 50 years ago the thalidomide tragedy served as a wake-up call to clinicians and health authorities worldwide and showed the need for effective systems to detect and seek to prevent such unforeseen consequences of therapeutic drug use. Today, increasingly sophisticated methods are employed in this effort, often referred to as pharmacovigilance. Much more needs to be done. 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.