Characterization of the safety notes of pharmaceutical products issued by two regulatory authorities from Latin America

Pharmaceutical product safety notes (PPSNs) are regulatory communications that disseminate updated information on the risks of pharmaceutical products (PPs). This study characterized the PPSNs issued by the Direccion General de Medicamentos, Insumos y Drogas (Peru) and the Instituto de Salud Publica de Chile (ISP) between 2014 and 2023. A retrospective analysis of PPSNs published on their websites was conducted. Those describing adverse drug reactions (ADRs) were included. Data were extracted on the type of ADRs, regulatory actions, sources of evidence, and reasons for issuance. Of 746 PPSNs identified, 153 met the criteria (100 Peru, 53 Chile), with a monthly average of 0.83 and 0.44, respectively. Differences in content and PPs were observed. Both agencies based their PPSNs mainly on alerts from the U.S. Food and Drug Administration. The most frequent action was the modification of the technical data sheet; the ISP additionally implemented monitoring and restrictions. In conclusion, PPSNs depend on external alerts, which evidences the need to strengthen local pharmacovigilance and evaluate their impact on the safety of PPs.