Environmental sustainability-an essential component of rational use of medicines.

Human-use medicines are introduced into surface water throughout their entire life cycle, from manufacturing and consumption to improper disposal, resulting in negative effects on aquatic flora and fauna. Sustainability approaches have addressed this issue, proposing frameworks like the One Health approach. A revised definition of the rational use of medicines has also been proposed, taking into account their environmental sustainability.

Gastrointestinal Perforations Associated With JAK Inhibitors: A Disproportionality Analysis of the FDA Adverse Event Reporting System.

Background: Gastrointestinal perforations have been reported in a small number of rheumatoid arthritis (RA) patients treated with Janus kinase (JAK) inhibitors in clinical trials. However, large-scale postmarketing data repositories are needed to further investigate this potentially rare but serious adverse event.

Methods: A retrospective, pharmacovigilance study of the FDA adverse event reporting system (July 2014 to September 2023) assessing the reporting of gastrointestinal perforations following JAK inhibitors compared to biological disease-modifying antirheumatic drugs (bDMARDs) in RA patients.

The reporting of disproportionality analysis in pharmacovigilance: spotlight on the READUS-PV guideline.

Disproportionality analyses are the most-commonly used study design used in the post-marketing phase to detect suspected adverse drug reactions in individual case safety reports. Recent years have witnessed an exponential increase in published articles on disproportionality analyses, thanks to publicly accessible databases. Unfortunately, this trend was accompanied by concerns on lack of transparency and misinterpretation of results, both generating unjustified alarm and diluting true signals into overwhelming noise.