Active TB drug-safety monitoring and management (aDSM) is pivotal to ensure the safety of patients with drug-resistant TB who need treatments with new drugs. Since 2015, WHO has recommended that safety monitoring accompanies the use of new TB drugs such as bedaquiline and delamanid. However, information on the extent of safety monitoring in countries remains limited.
TDR (the Special Programme for Research and Training in Tropical Diseases), in partnership with the Access and Delivery Partnership (ADP) , has carried out implementation research activities in order to shed light on the situation and to support West and Central African countries in their efforts to improve TB patients’ safety.
A questionnaire to assess countries’ capacities and identify gaps and barriers to implementing aDSM recommendations was developed in collaboration with the WHO Global TB Programme. The questionnaire was circulated across the West and Central African Networks for TB control (WARN-TB and CARN-TB) and completed by the coordinators and the staff of the 27 National Tuberculosis Programmes (NTPs) participating in the networks.
“Now that NTPs in our region have access to new TB drugs for treating MDR-TB (multidrug-resistant TB) patients it is important that we have a clear understanding of the level of implementation of aDSM in the region and the gaps,” said Professor Dissou Affolabi, head of the National TB Programme of Benin and head of the executive secretariat of the WARN-TB and CARN-TB networks.
Findings from the survey revealed that among the 27 countries of WARN-TB and CARN-TB, only 14 NTPs have started implementing active TB drug safety monitoring and management. The survey highlights specific barriers and needs, such as training on pharmacovigilance and technical support to implement the monitoring system.
The annual meeting of NTP coordinators organized by the secretariat of the WARN-TB and CARN-TB networks presented an opportunity to hold a workshop on the implementation of TB drug-safety monitoring in the region to discuss these results. In light of the COVID-19 pandemic, this event took place on 26 February 2021 in Cotonou, Benin, and relied on a mix of virtual and physical participation with strict control measures. This hybrid set-up allowed all 27 coordinators of NTPs of the West and Central Africa region and all partners to participate in the discussions.
South-South sharing and collaboration
Representatives from the NTP of Indonesia, an ADP focus country, also attended the workshop. Dr Endang Lukitosari and Dr Retno Kusumadewi shared their extensive experience with active TB drug safety monitoring and management, first implemented in 2015 and expanded to 295 treatment centres for drug-resistant TB patients.
“It was a nice experience and opportunity to share the experience of NTP Indonesia on aDSM implementation with the WARN-TB & CARN-TB countries,” said Dr Lukitosari of Indonesia’s NTP. “We are not in the same continent, but we share the same concerns and face the same challenges!”
The workshop created an environment of learning through sharing of experiences and presented a successful example of South-South collaboration, which will be pursued in the coming year. NTPs that have implemented active TB drug-safety monitoring and management will share country guides, written procedures, and training materials within the network. The WARN-TB and CARN-TB networks have already integrated in their action plan for 2021 the objective for each NTP to develop a country-specific aDSM implementation plan by December 2021.
These activities in support of aDSM are particularly relevant as all countries of West and Central Africa are planning to introduce this year new TB drugs for an all-oral shorter treatment regimen as recommended by the WHO and for which TDR has developed the ShORRT research package.
For more information, please contact Dr Corinne Merle.
1 ADP works with low- and middle-income countries to ensure life-saving medicines and health technologies reach the people who need them. The Partnership is supported by the Government of Japan and led by the United Nations Development Programme, in collaboration with the World Health Organization, the Special Programme for Research and Training in Tropical Diseases and PATH.