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.