11 i. Create a national coordinating mechanism for aDSM Multi-partner training package on active TB drug safety monitoring and management (aDSM) July 2016

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 materials 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) Processes Q1 Q2 Q3 Q4 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

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