Administrative control in pharmacovigilance: achievements and challenges in the Nicaraguan Social Security Institute, Nicaragua 2024.

Abstract

The achievements and challenges in the administrative control of pharmacovigilance activities in health units of the Nicaraguan Social Security Institute (INSS) during 2024 were evaluated. A quantitative, descriptive, and cross-sectional study was conducted in ten health units, applying a structured questionnaire to 46 healthcare professionals, an observation guide for administrative processes, and a vaccination site evaluation checklist based on ICH E2E and Q9 guidelines. The findings indicated significant progress in administrative control: all units met the deadlines for reporting adverse events, effectively used the NotiFACEDRA platform, and demonstrated a high level of compliance with Ministry of Health Regulation 063. Additionally, 90% of the units maintained adequate records of adverse events. However, challenges were identified, such as the absence of systematic audits, lack of performance indicators, and limited feedback between management levels. It is concluded that INSS has achieved meaningful progress in consolidating an efficient and regulation-aligned pharmacovigilance system, laying the groundwork for strengthening the quality of administrative processes focused on patient safety.