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

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

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

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)

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

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

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

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

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

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)

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

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