Project Description


The World Health Organization (WHO) recommends that countries introducing new drugs and novel treatment regimens for multidrug-resistant tuberculosis (MDRTB) should develop and implement a system for active pharmacovigilance (PV) allowing for detection, reporting, and management of adverse drug reactions (ADRs).

In May 2018, the TB CARE II team organized a workshop as part of the USAID/Janssen Pharmaceuticals Bedaquiline Donation Program’s TA to strengthen the capacity of countries introducing NDs and STRs to monitor patient safety and report adverse events using the WHO aDSM framework. The workshop streamlined the implementation of aDSM for new drugs and shorter treatment regimens into TB care standards.

The workshop:

  • Engaged TB stakeholders from select countries on the need and rationale for stronger PV systems to ensure patient safety and appropriate utilization of ND and STR.
  • Discussed the potential of introducing WHO-recommended aDSM framework in countries as part of their ND/STR introduction.
  • Identified opportunities for effective collaboration and joint implementation of aDSM activities between NDRA, NTPs, and National PV Centers. 
  • Present and share experiences/lessons learned from countries that have implemented aDSM as part of the introduction of ND/STR implementation for MDR TB care.
  • Developed country roadmaps and actions for aDSM implementation at a country level.