pharmacovigilance

Full Definition

Systematic monitoring and evaluation of adverse effects and safety issues with medications after they reach the market. In psychopharmacology, pharmacovigilance is particularly important due to the complex side effect profiles of psychiatric medications and their potential for serious adverse events. This includes monitoring for rare but serious effects like tardive dyskinesia, metabolic complications, and suicide risk. Pharmacovigilance activities include adverse event reporting, safety database analysis, and risk evaluation and mitigation strategies (REMS).

Usage

Usage note: Refers specifically to post-marketing safety monitoring, not pre-approval clinical trials.

In Context

• "Pharmacovigilance data revealed an increased risk of metabolic side effects with this antipsychotic." — Safety report
• "The pharmacovigilance system detected a previously unreported drug interaction." — Regulatory document