Abstract
Introduction: Therapeutic ineffectiveness is a frequent drug-related problem that involves therapeutic failure, inefficacy or resistance, that includes both unintended and potentially harmful responses. Therapeutic peutic ineffectiveness reports can also contribute to identifying pharmaceutical defects of drugs. Many problems with medicinal products may not arise during the initial, pre-marketing testing phases, and may become apparent only after they are released into the market. The goal of many regulatory bodies is to monitor drugs through rigorous testing and post-marking reports. Objective: To evaluate the drug ineffectiveness reports received by the Saudi Vigilance System by: v Determining trends associated with time, gender, age, and the Anatomical Therapeutic Chemical (ATC) classification system in the therapeutic ineffectiveness reports. v Identify factors contributing to the reported therapeutic ineffectiveness. Methods: Design: Cross-sectional study was conducted to assess the post marketing experience of Drug Ineffectiveness (DI) reports received by the Saudi Vigilance System (SFDA spontaneous reporting system) from January 2018 to December 2021. Setting: The SFDA manages the Vigilance reporting System, which receives spontaneous reports from healthcare providers, Marketing Authorization Holders (MAHs), and patients directly. Outcomes: The study will be focus on which drugs are reported as being therapeutic ineffectiveness, what age group and gender chiefly report therapeutic ineffectiveness, and who is primarily reporting the therapeutic ineffectiveness (HCPs, MAHs, or patients). Results: A total of 2716 DI reports were included, in which the majority of them were reported from Health Care Providers (HCPs). Of all reports, 92% of the DI reports were classified as non-serious events and 8% of the DI reports were classified as serious events. Additionally, the study was found the percentage of males who experienced DI was higher than females. Conclusion: Reports of unexpected ineffectiveness can provide important information about Drug Ineffectiveness (DI). As such, unexpected or unexplained ineffectiveness can be potentially vital reportable event in pharmacovigilance. Additionally, Drug Ineffectiveness can occur as a result of different situations and can be contributed to different mechanisms. Therefore, an extensive research should be conducted to address inappropriate use, interactions or metabolic abnormalities and other factors that might contribute to Drug Ineffectiveness.