Pharmacovigilance
The science of detecting, assessing, and preventing adverse drug reactions throughout a drug's commercial life. Systems include the FDA's MedWatch/FAERS, the EU's EudraVigilance, and the UK's Yellow Card Scheme. Pharmacovigilance is essential for monitoring widely used peptide drugs like GLP-1 receptor agonists.
Technical Context
Pharmacovigilance operates through: spontaneous reporting systems (MedWatch/FAERS in US, EudraVigilance in EU, Yellow Card in UK — healthcare professionals and patients voluntarily report suspected ADRs), post-marketing clinical trials (Phase IV studies and registries), active surveillance (sentinel systems mining electronic health records and claims databases), and literature monitoring (systematic review of published case reports and studies). Signal detection uses statistical methods: disproportionality analysis (proportional reporting ratio, reporting odds ratio, Bayesian methods — comparing observed vs expected reporting frequency), and temporal pattern analysis (time-to-onset distributions). Signal evaluation involves: case-by-case assessment, epidemiological studies, and benefit-risk re-evaluation. For widely prescribed peptide drugs like GLP-1 RAs (millions of patients exposed), pharmacovigilance is critical because rare adverse events (1:10,000 or rarer) may only become apparent with large-scale post-marketing exposure.