Postmarketing Spontaneous Pharmacovigilance Reporting Systems

The analysis of a complex adverse event (AE)/adverse drug reactions (ADRs) can involve the fields of medicine, pharmacology, epidemiology, statistics, pharmacy, toxicology, and others. There are several methods of clinical postmarketing safety assessment. This chapter focuses on spontaneous pharmacovigilance reporting systems. The individual case report is the fundamental unit of a postmarketing pharmacovigilance reporting system. The use of social media for pharmacovigilance presents both opportunities and challenges, and is an area of active research. The national pharmacovigilance center is part of the drug regulatory authority; in some, the monitoring is carried out jointly by the drug regulatory authority/Ministry of Health and an independent institution. The review of individual case safety reports of AEs/ADRs is a complex process. There are a variety of specific algorithms that have been applied to safety signal detection in AE/ADR databases. The quality of the report is critical for an informative and meaningful review of the individual case safety report.