(A-274) Characteristics of Drug Safety Alerts issued by two Latin American Drug Regulatory Agencies

Background: Drug Safety Alerts (DSAs) are crucial for enhancing drug safety by providing information on new signals and prompting regulatory and clinical actions to clinicians and patients.

Objectives: Our study aims to characterize DSAs issued by DIGEMID (Peru) and ISP (Chile) between 2014 and 2023.

Methods: We conducted a retrospective analysis of DSAs published on the official websites of DIGEMID and ISP. DSAs addressing identified or potential adverse drug reactions (ADRs) were included. We systematically extracted and evaluated their content to assess the nature of the ADRs, the regulatory actions taken, the sources of information, and the motivations behind their formulation.

Results: Of 746 DSAs identified, 153 met the inclusion criteria (100 from DIGEMID, 53 from ISP), with an average of two per month in Peru and one per month in Chile. The DSAs from both countries exhibited differences in content, particularly concerning ADRs and Anatomical Therapeutic Chemical codes. Both agencies primarily relied on alerts from other regulatory bodies, notably the FDA. The most common regulatory action was the modification of the Summary of Product Characteristics. At the same time, ISP implemented additional measures such as continuous monitoring, medication restrictions, and Risk Management plan requests.

Conclusions: These findings emphasize the importance of strengthening local pharmacovigilance systems to enhance spontaneous ADR reporting, which is essential for formulating DSAs. Further research is needed to assess the quality and impact of DSAs on improving drug safety.