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Table 3 ADR reporting for adverse events in patients on anti-tuberculosis treatmenta

From: Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis

Country Form(s) used for reporting: Authority to which primary ADR report is submitted aDSM expert committee Reporting to PIDMa database Reporting to global aDSM databaseb Reporting to GDFc
TB- Specific form Yellow card form GDF Form
Eswatini Xd X   NMRA NAe MoH (NPVU) NTP not done
Ethiopia Xf X Xg NMRA NAh EFDA not done not done
Nigeria X X Xg NTP X NAFDAC not done NTP
Tanzania Xi Xi Xg NTP and NMRAi X TMDA not done TMDA
  1. aAbbreviations: ADR adverse drug reaction, aDSM active drug safety monitoring and management, EFDA Ethiopian Food and Drug Administration, GDF Global Drug Facility, MoH Ministry of Health, NA not available, NAFDAC National Agency for Food and Drug Administration and Control, NMRA national medicines regulatory authority, NPVU national pharmacovigilance unit, NTP national tuberculosis program, PIDM Programme for International Drug Monitoring, PV pharmacovigilance, TMDA Tanzania Medicine and Medical Devices Authority, TB tuberculosis
  2. b WHO and TDR (Special Programme for Research and Training in Tropical Diseases; https://www.who.int/tdr/news/2016/global-database-adsm/en/) host the global aDSM database.
  3. c Countries receiving bedaquiline under the USAID donation programme had to send reports of serious adverse events to the GDF (www.stoptb.org/gdf/)
  4. dAt the time of assessment (June 2018), different forms were used: a TB-specific form in sentinel sites, a project-specific form for TB patients used in one site, and Yellow card forms for aDSM. After harmonization, there are now two data collection forms, one for spontaneous reporting on any adverse event, and one for active pharmacovigilance (aDSM data for MDR-TB and dolutegravir containing regimens from selected facilities)
  5. eA National Patient safety Management and Monitoring committee assesses all types of ADRs from all types of medicines.
  6. fAdverse events of special interest can be entered into an Excel sheet by the TIC’s DR-TB clinicians or nurses (called line listing in the system). This sheet is monthly sent by email to EFDA (with a copy to the focal person of NTP). Serious adverse events are reported through the Yellow card form
  7. g Filled and submitted by the NTP.
  8. hThere is a clinical review committee at the NTP and a safety advisory committee at EFDA
  9. iTB related ADRs should be reported both using the aDSM form and the Yellow Card form