1. 1. Structure and training objectives for this course & key references
Multi-partner training package on active TB drug safety monitoring and management (aDSM)
July 2016

2. Contributors to this training package
The slide set in this training module was put together in July 2016 by representatives of four technical partners on the WHO Task Force on aDSM:
KNCV Tuberculosis Foundation
Management Sciences for Health (SIAPS)
Médecins sans Frontières
World Health Organization / Global TB Programme
Special Programme for Research and Training in Tropical Diseases at WHO Headquarters (TDR)
ahead of the launch of the global aDSM database

3. Learning objectives (1) By the end of the training modules, the participant is expected to be able to…
Identify the key concepts and definitions of aDSM
Describe how to implement and manage aDSM within a TB programme
Understand how to detect adverse events in the course of the clinical monitoring of TB treatment
ctd…/

4. Learning objectives (2) By the end of the training modules, the participant is expected to be able to…
ctd…/
Explain how adverse drug reactions are clinically managed
Record adverse events and ensure quality of data records
Understand key concepts of causality assessment, signal detection and safety risk management

5. Structure of this training package (1)
1. Background, Overview, Objectives
1. Training objectives for this course & key references
2. Active TB drug-safety monitoring : rationale and mechanisms in the context of TB & MDR-TB treatment

6. Structure of this training package (2)
2. The basics of active TB drug safety monitoring and management (aDSM)
3. Key definitions
4. Clinical monitoring of AEs and management of adverse drug reactions
5. National and international reporting of adverse events: mechanisms, routes and resources
6. Record management and quality assurance of data
7. Causality assessment: scales & methods
8. Signal detection introduction
9. Indicators of aDSM implementation and programme management
10. Overview on risk communication and new knowledge integration

7. Structure of this training package (3)
3. Implementing aDSM
11. The 8 key elements for the implementation of aDSM in a national TB programme
i. Create a national coordinating mechanism for aDSM
ii. Develop a plan for aDSM
iii. Define management and supervision roles and responsibilities
iv. Create standard data collection materials
v. Train staff on the collection of data
vi. Define schedules and routes for data collection and reporting
vii. Consolidate aDSM data electronically
viii. Develop capacity for signal detection and causality assessment
12. Role of national and international technical and funding partners in the implementation of aDSM

8. Key references

11. WHO guidance on treatment & management
of drug-resistant TB,
2016

12. 2012
Historically, the first WHO publication specifically focused on the pharmacovigilance of TB medications.
Describes spontaneous and active pharmacovigilance; signal detection, causality assessment between an event and a drug, making decisions and communicating findings

13. 2013
Standardization of definitions and reporting parameters has permitted uniformity in the reporting of performance indicators of national TB programmes for many years

14. 2013
2014

15. August 2014
(update early 2016)
pp339ff

17. 2015
“active and systematic clinical and laboratory assessment of patients on treatment with new TB drugs, novel MDR-TB regimens or XDR-TB regimens to detect, manage and report suspected or confirmed drug toxicities”
apps.who.int/iris/bitstream/10665/204465/1/WHO_HTM_TB_ _eng.pdf

18. WHO/HTM/TB/
Adopting electronic recording and reporting is not simply about choosing a piece of software: it is also about changing how people work. This is not a simple undertaking.
This document indicates key questions to be considered and illustrates what the questions, options and recommendations mean in practice by drawing on examples of recent experience from a variety of countries. It is useful for those planning to introduce electronic recording and reporting systems for TB care and control, or to enhance existing systems
whqlibdoc.who.int/publications/2012/ _eng.pdf
Workshop for 18 high-priority countries of the WHO European Region on recording and reporting of drug resistant tuberculosis

19. WHO/HTM/TB/
This book presents the practicalities of standard and advanced analysis of programme TB surveillance data. The same approaches could have an application for in-depth analysis of aDSM data.
apps.who.int/iris/bitstream/10665/129942/1/ _eng.pdf

21. Mann’s Pharmacovigilance, 3rd Edition
Mann’s Pharmacovigilance, 3rd Edition. Published 2014 by John Wiley & Sons, Ltd.