Assessment of the Post-Marketing “Drug Ineffective” Reports Received by the Saudi Vigilance System

Abstract

Aim: Drug Ineffective (DI) reports are Adverse Drug Events (ADE) important for post-marketing surveillance (PMS).  Currently drug safety information from the DI reports received by the Saudi Food and Drug Authority (SFDA) via the Saudi Vigilance System (SVS) is undetermined. The study aims to describe the DI reports received by the SVS from different stakeholders. Methods: DI reports received by the SVS between January 2020 to December 2021 were retrieved and characterized based on patients’ demographics, reporter type and suspected drug type and group in comparison to non-DI reports. Potential determinants of the DI reports were screened to estimate odds ratios (OR) and the 95% confidence intervals (CI) for these reports. Results: The total number of DI reports was 1885.  Adults constituted the major age group (67.6 %), and male gender dominated most DI reports (80.2%) compared to equal percentages of males and females in non-DI reports. Most of the DI reports were reported by pharmacists (68.9%), and the most frequently reported drugs associated with DI and non-DI reports were Metformin (16.3%) and Atorvastatin (5.30%) respectively. Adjustment of potential confounding variables showed that gender (AOR = 2.285, 95% CI = 1.921–2.719) and age (AOR = 1.005, 95% CI = 1.002– 1.007) were significantly associated with the DI reports. Conclusion: DI reports were frequently associated with adult male patients, and were more frequently reported by pharmacists. Most of the DI reports did not indicate the seriousness criteria, and the most frequently reported drug associated with DI reports was Metformin.