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Table 5 Handling of ADR reports received by the NMRAa

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

Country Acknowledgementof receipt report Individualfeedbackreport Aggregatedfeedback reports Causality assessmentand signal detection Joint causalityassessmentNMRA/NTP
Eswatini Not consistently No Yes No No
Ethiopia Yes No Yes Yesb Yesd
Nigeria Yes No Yes Yes No
Tanzania Yes No Yes Yes Yesc
  1. aAbbreviations used in this table: ADR adverse drug reaction, NMRA national medicines regulatory authority, NTP, national tuberculosis program
  2. bOnly 10 reports were subjected to a formal causality assessment during the past calendar year, based on an assessment of case severity, and community/public health programme concerns. Most of these concerned AEFIs and adverse events among TB patients on new medicines
  3. cCausality assessment is currently done by the National aDSM committee during quarterly meetings. Recently, it was agreed between NTP and TMDA that TMDA will take the lead in causality assessment and be represented in all National aDSM Committee meetings. NTP is responsible for organizing the meetings
  4. dCausality assessment for adverse event reports from DR-TB patients through the aDSM scheme is done during clinical review meetings. Those adverse events that have fatal outcomes are prioritized. The National Clinical Review Committee consists of staff members from the Medical Faculty of Addis Ababa University with different specializations as well as DR-TB specialized clinicians from the two DR-TB centres of excellence (St Peter’s and ALERT hospital), representatives of the NTP and partner organisations, and a representative of EFDA. NTP is responsible for organizing these meetings. Whenever needed, email consultations are organized, but the Committee sometimes also physically meets. If needed, the Clinical Review Committee can visit the TIC to verify the information in the ADR report and collect additional information