1. 11 i. Create a national coordinating mechanism for aDSM
Multi-partner training package on active TB drug safety monitoring and management (aDSM)
July 2016

2. 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

3. 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

4. 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

5. 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)

6. 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

7. 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

9. 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