1. 11 iii. Define management and supervision roles and responsibilities
Multi-partner training package on active TB drug safety monitoring and management (aDSM)
July 2016

2. 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

3. Objective of the presentation By the end of this presentation, the participant is expected to be able to:
Describe the roles and responsibilities in the management and coordination of aDSM at the
Health facility level
National level
Global level

4. Roles and responsibilities Health facility level (1)
Main activities are the
Detection of AEs
Management of AEs
Recording of AEs
Transfer of data on AEs to the next administrative level (e.g. national level)

5. Roles and responsibilities Health facility level (2)
Several staff positions or entities have different responsibilities with respect to aDSM:
Clinicians, nurses, community health workers
conduct clinical monitoring
early detection and management of AEs
collect aDSM data during baseline, treatment initiation and subsequent clinical visits
record AEs
Clinical Experts
Advise the treating clinicians on potential relationships between the drug or regimen and the adverse event

6. Roles and responsibilities Health facility level (3)
Data entry staff
Check completeness and consistency of data collected
Notify the clinical expert team of any problems with the quality, completeness or timeliness of the aDSM data collected
Submitting entered data to the national aDSM database at regular intervals, according to national regulations
Data manager
Data storage and quality
Timely data transfer to the national level
Regular feedback to the clinicians collecting aDSM data

7. Roles and responsibilities National level (1)
The main agencies involved in aDSM at national level are the national TB programme (NTP) and the pharmacovigilance structure (NPV). The tasks in aDSM are divided between them according to local conditions
NPV can provide guidance to the NTP on aDSM activities. If a NPV does not exist, one or more staff from other disease programs (e.g. HIV or malaria) who have the right expertise could advise the NTP on aDSM activities
The NTP is usually the initiator of aDSM activities for the TB programme

8. Roles and responsibilities National level (2)
The national TB programme
organizing a national aDSM coordinating mechanism (see Module 11.i)
secures funding for the implementation of different elements of aDSM
develops Standard Operating Procedures
ensures all staff involved in aDSM receives appropriate training

9. Roles and responsibilities National level (2)
The national TB programme
ensures that electronic means to consolidate the aDSM data are available – newly created or modified existing system - and functioning adequately at the start of aDSM activities
Can be adapted for health facilities
Collecting data according to the plan
Managing and supervising all aspects of aDSM data collection
Reporting validated data to supranational level

10. Roles and responsibilities National level (3)
The national TB programme, possibly with NPV
Assesses causality
Signal detection
Data analysis and provision of feedback to health centers and clinicians
Communication of new knowledge to health care professionals and public (see Module 10)

11. Roles and responsibilities Global level
WHO and TDR will maintain a global aDSM database
This database will accommodate SAEs and other AEs for TB patients on aDSM
The global aDSM database will be used to help detect signals and inform future updates of global policies on the use of anti-TB drugs and novel regimens
This process is distinct from the existing mechanism for the global coordination of individual case safety reports (spontaneous reports) from NPVs

12. Conclusions
Roles and responsibilities for aDSM are discussed at three main levels: health facility, national and global
The health facility needs to be equipped to monitor patients and manage the adverse reactions
At national level the roles and responsibilities are split between national TB programmes and the pharmacovigilance structure
The global level is dealing with the global aDSM reports, signal detection, acquisition and use of new knowledge for policy updates