National Coordinating Mechanism for Active Tuberculosis Drug Safety Monitoring and Management

Training package on active tuberculosis drug safety monitoring and management (aDSM) 2023

2.1i. Create a national coordinating mechanism for aDSM

Learning objective By the end of this presentation, the participant is expected to be able to Describe the main steps needed to establish an appropriate structure to coordinate aDSM at national level

Key steps in aDSM implementation Create a national coordinating mechanism for aDSM Develop a plan for aDSM Define management and supervision roles and responsibilities Create standard data collection tools Train staff on the collection of data Define schedules and routes for data collection and reporting Consolidate aDSM data electronically Develop capacity for signal detection and causality assessment

National coordinating mechanism for aDSM (1) The national authority responsible for drug-safety and TB treatment (e.g. Ministry of Health) has a responsibility to ensure the good coordination of activities needed to put in place aDSM The authority needs to put in place the regulatory and other enabling measures necessary to establish aDSM This is expected to entail consultations, development of regulations, possibly issue or revision of contracts

National coordinating mechanism for aDSM (2) The coordinating structure should have adequate expertise and hierarchical standing to allow it to perform its duties The coordinating mechanism should have access to experts from relevant disciplines, such as drug safety, therapeutics, pharmacy, regulation, surveillance, with inputs from other domains e.g. logistics, finance, communication, patients The duties of the national coordinating mechanism can be vested upon an existing structure, with an extension of its duties e.g. the MDR-TB consilium

National coordinating mechanism for aDSM (3) Amongst the first things that the coordinating group needs to do is to : ensure that the two minimum elements (data collection and staff trained in their collection) are in place develop a plan (with human resource needs) and have it approved In time the coordinating group can be assigned a steering/advisory role, e.g. overseeing monitoring and supervision supporting clinicians to manage SAEs reviewing causality assessment for SAEs communications of new findings programmatic evaluation and policy change

National coordinating mechanism for aDSM (4) relative intensity of required work over first year (expected) Q1 Q2 Q3 Q4 Processes ++ + Define cohort ++++ +++ +++ +++ Do serial clinical & lab tests ++ Create expert group ++ Create protocol ++ + + + Manage & supervise +++ + +/- Train staff ++ Create data collection material ++ + Create e-database ++ ++ ++ ++ Collect & enter data +/- +/- + Identify signals and data analysis

National Coordination Mechanism for the aDSM (5) National pharmaconvigilance programme (NPV) National TB programme (NTP) Drug safety monitoring (aDSM Component) TB-MR treatment facility Reporting as required by local regulations Further analysis for signal detection/causality assessment and communication Cohort-based follow-up of patients with questionnaires to elicit symptoms; and routine tests for TB drug safety monitoring Delivery of treatment Management of adverse reactions Recording of all SAEs in a national aDSM database (regularly transferred into the global database) Signal detection/causality assessment by the NTP (if capacity is limited by national pharmacovigilance system (NPV)) Support for signal detection and causality assessment Inform update of treatment policy and patient care practice (as per PMDT guidance) Inform updates of country and global drug safety profile New evidence

Conclusions A national coordinating mechanism will have the overall responsibility for the implementation and successful conduction of aDSM in TB treatment services The responsibilities of this mechanism could be assigned to an existing, high-level committee (e.g. MDR-TB consilium) The initial priorities are to establish the methods and routes for data collection The role of the aDSM coordinating mechanism may evolve over time as key milestones are reached

Acknowledgements The development of the aDSM training material was funded by TDR as part of the Access and Delivery Partnership (ADP) with funding from the Government of Japan. These training materials were put together in 2016 the WHO Task Force on aDSM with technical partners KNCV Tuberculosis Foundation, Management Sciences for Health (SIAPS), MSF, WHO GTB, and TDR. The materials were updated in 2022-23 by Mahamadou Bassirou Souleymane (TDR consultant) with Marie-Eve Raguenaud (TDR), Branwen J Hennig (TDR), and Corinne Merle (TDR), and reviewed by Linh Nhat Nguyen (WHO/GTB), Medea Gegia (WHO/GTB), and Fuad Mirzayev (WHO/GTB). We thank all members of the WARN/CARN-TB working group on aDSM who contributed to the development of the aDSM generic guidelines as well as the secretariat, particularly Dr Christ Houessinon: Disadidi Ambrioso, Esse Marius, Adomou Jamal Rouamba Ruffine, Haro Sougrimani, Koumbem Boureima, Nsanzerugeze Jos lyne, Tollo Tollo Daniel Alphonse D sir , Mpaba Minkat Th ophile Mistral, Julie Abessolo, Ursule IDOKO, Tijan Baldeh , Wandifa Samateh, Tida S Kinteh, Alieu Wurie, Mardemn Yeasuen, Benjamin K. Quenneh, Cheick Oumar Bah, Kane El Hadj Malick, Aw Idriss, Mamoudou Hama Rachida, Gagara I. M. Assiatou, Katamb Balkissa, Seiyabatou ElhSaidou, Liombo Anastasie, Lunganyu Junior, Kitambala Sentime, Lula Yves , Habimana-Mucyo Yves, Migambi Patrick, dos Santos Brigite, Castro V nia, Wadson Cruz, Gueye Aminata, Mukeh Fahnbulleh, Bailor Samuel, Manjo Lamin, Saleh Mahareb Abdoulaye, Haroun Saleh Naima, Mouhoudine Yerima, Kpelafia Silifa