Performance of active drug safety monitoring and management for pharmacovigilance strengthening in Ethiopia, experience from a multidrug-resistant tuberculosis management program: a cross-sectional study

Objective The study aimed to assess the performance of active drug safety monitoring and management (aDSM) in the context of multidrug-resistant and rifampicin-resistant tuberculosis (MDR/RR-TB) treatment programmes to generate insights that could support potential scale-up efforts to strengthen the pharmacovigilance (PV) system in Ethiopia and beyond. Design A cross-sectional study design was employed. The records of patients with MDR/RR-TB enrolled and treated at selected hospitals during April 2018 through February 2023 were reviewed. Data were collected using a structured data extraction form, and Research electronic Data Capture (REDCap) was used for data entry and management. The data were analysed using SPSS version 25, employing descriptive statistics. Setting The study was carried out at ten (10) public hospitals in Ethiopia. Participants A total of 1377 patients with MDR/RR-TB were included from 10 hospitals. Results Out of the 1377 patients, the majority (59.3%) were males, and 39.9% were new to anti-TB treatment. Deviations from the schedule or missed safety monitoring and other investigations were observed. No records were available for monitoring adverse events (AEs) in 94 (6.8%) of the patients during their treatment follow-up. Overall, 455 (33.0%) patients experienced at least one AE during the treatment period. A total of 774 AE records were identified, of which 134 (17.3%) and 225 (29.1%) were serious adverse events (SAEs) and adverse events of special interest (AESI), respectively. Only 135 (17.4%) of all identified AEs were reported to the PV Centre, of which 70 (51.9%) and 48 (35.6%) were AESI and SAE, respectively. However, the trend of AE detection and reporting showed improvement over the surveyed aDSM implementation period. Conclusion Despite the implementation of aDSM, AE detection and reporting remained suboptimal in the MDR/RR-TB treatment cohort. Therefore, routine aDSM needs to be strengthened and consistently implemented to improve the national pharmacovigilance system and enhance patient safety monitoring and management.