Building Capacity for Active Tuberculosis Drug Safety Monitoring and Management

Training package on active tuberculosis drug safety
monitoring and management (aDSM)
2023
 
 
 
2.1viii. Develop capacity for signal detection
and causality assessment
 
Key steps in aDSM implementation
 
 
Learning objective
By the end of this presentation, the participant is expected to…
 
Understand how to build capacity in-country to undertake
causality assessment and contribute to signal detection
 
Reported information on a 
possible
 causal relationship between
an AE and a TB medicine
The relationship was 
previously unknown 
or incompletely
documented (e.g. 
a new aspect of a known association
)
Signal detection is based on analyses of multiple data points
 
Definition of signal
 
Introduction
 
Building capacity will need a dual investment in
human resource development, and
facilities (location, equipment, consumables, infrastructure…)
Needed to undertake 
causality assessment 
and 
signal detection
within the health care services
 
The aDSM plan needs to make provision for these coordinated
activities and budget for them
 
Human resource development (1)
training staff
 
Based on the roles and responsibilities of the staff who will be
carrying out the aDSM (see module 2.1iii), a training plan is drawn
up with objectives and training material
Appropriate experts will be needed to prepare for and undertake
the training
These experts may be present in the country (e.g.
pharmacovigilance centre); if not the expertise may be accessed
through technical partners
 
Human resource development (2)
training as a trainer
 
Familiarize yourself with the content of 
all
 modules
Delegate the technical modules if not your specialty e.g. AE clinical
management can be delegated to a medical doctor, key definitions to
a specialist from the national pharmacovigilance structure
Select commonplace examples from your context, for instance it is
better to use scenarios of TB cases with HIV co-infection if you work in
Central Africa region
Leave space for questions and discussions
 
Facilities (1)
conducive environment
 
In order to undertake causality assessment and signal detection, the
environment - 
(location, equipment, consumables, infrastructure etc.
-> 
needs to be conducive for the workers to undertake the required
tests (clinical and special tests) among target patients and to report
the associated data appropriately
If staff are trained to undertake causality assessment they need to be
able to access special diagnostic facilities (e.g. have ECGs and
calculation of the corrected QT interval)
Beyond the first training, the staff need to have mentoring and access
to specialist opinion to resolve any difficulties which they may have
 
Facilities (2)
support to signal detection
 
While causality assessment is primarily an activity which needs to
happen at local level, for signal detection the pooling of data across
different cohorts is expected given that new signals may be relatively
uncommon.
The primary rationale underpinning the creation of a global aDSM database is
to unite safety reports from TB patients on treatment in different countries
For staff from an individual country or subnational centre to
participate effectively in the global database they will need to adhere
to the reporting specifications and also to receive feedback on the
relevance of their contribution to global knowledge
 
Conclusions
 
Developing capacity for signal detection and causality assessment
requires investment in the training and support of national staff
The skills needed for staff to be able to establish causal links and
determine the probability of an association are rooted in
epidemiology and in drug safety
In addition to training, the staff would need to count upon support
from expert staff to answer to any difficulties which they may
experience
The facilities available - including equipment, consumables, and
infrastructure - also need to be conducive to the required practice
Acknowledgements
The development of the aDSM training material was funded by TDR as part of the Access and Delivery Partnership (ADP)
with funding from the Government of Japan.
These training materials were put together in 2016 the WHO Task Force on aDSM
 with technical 
partners KNCV
Tuberculosis Foundation, Management Sciences for Health (SIAPS)
, MSF, WHO GTB, and TDR.
The materials were updated in 2022-23 by Mahamadou Bassirou Souleymane (TDR consultant) with Marie-Eve Raguenaud
(TDR), Branwen J Hennig (TDR), and Corinne Merle (TDR), and reviewed by Linh Nhat Nguyen (WHO/GTB), Medea Gegia
(WHO/GTB), and Fuad Mirzayev (WHO/GTB).
We thank all members of the WARN/CARN-TB working group on aDSM who contributed to the development of the aDSM
generic guidelines as well as the secretariat, particularly Dr Christ Houessinon
: 
Disadidi Ambrioso, Esse Marius, Adomou
Jamal Rouamba Ruffine, Haro Sougrimani, Koumbem Boureima, Nsanzerugeze Josélyne, Tollo Tollo Daniel Alphonse
Désiré, Mpaba Minkat Théophile Mistral, Julie Abessolo, Ursule IDOKO, Tijan Baldeh , Wandifa Samateh, Tida S Kinteh,
Alieu Wurie, Mardemn Yeasuen, Benjamin K. Quenneh, Cheick Oumar Bah, Kane El Hadj Malick, Aw Idriss, Mamoudou
Hama Rachida, Gagara I. M. Assiatou, Katambé Balkissa, Seiyabatou Elh Saidou, Liombo Anastasie, Lunganyu Junior,
Kitambala Sentime, Lula Yves , Habimana-Mucyo Yves, Migambi Patrick, dos Santos Brigite, Castro Vânia, Wadson Cruz,
Gueye Aminata, Mukeh Fahnbulleh, Bailor Samuel, Manjo Lamin, Saleh Mahareb Abdoulaye, Haroun Saleh Naima,
Mouhoudine Yerima, Kpelafia Silifa
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This training package focuses on developing capacity for signal detection and causality assessment in the management of active tuberculosis drug safety. Key steps include creating a national coordinating mechanism, defining roles and responsibilities, training staff, and consolidating data electronically. The learning objective is to understand how to undertake causality assessment and contribute to signal detection. Human resource development is emphasized through training plans and accessing expertise when needed.


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  1. Training package on active tuberculosis drug safety monitoring and management (aDSM) 2023

  2. 2.1viii. Develop capacity for signal detection and causality assessment

  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. Learning objective By the end of this presentation, the participant is expected to Understand how to build capacity in-country to undertake causality assessment and contribute to signal detection

  5. Definition of signal Reported information on a possible causal relationship between an AE and a TB medicine The relationship was previously unknown or incompletely documented (e.g. a new aspect of a known association) Signal detection is based on analyses of multiple data points

  6. Introduction Building capacity will need a dual investment in human resource development, and facilities (location, equipment, consumables, infrastructure ) Needed to undertake causality assessment and signal detection within the health care services The aDSM plan needs to make provision for these coordinated activities and budget for them

  7. Human resource development (1) training staff Based on the roles and responsibilities of the staff who will be carrying out the aDSM (see module 2.1iii), a training plan is drawn up with objectives and training material Appropriate experts will be needed to prepare for and undertake the training These experts may be present in the country (e.g. pharmacovigilance centre); if not the expertise may be accessed through technical partners

  8. Human resource development (2) training as a trainer Familiarize yourself with the content of all modules Delegate the technical modules if not your specialty e.g. AE clinical management can be delegated to a medical doctor, key definitions to a specialist from the national pharmacovigilance structure Select commonplace examples from your context, for instance it is better to use scenarios of TB cases with HIV co-infection if you work in Central Africa region Leave space for questions and discussions

  9. Facilities (1) conducive environment In order to undertake causality assessment and signal detection, the environment - (location, equipment, consumables, infrastructure etc. -> needs to be conducive for the workers to undertake the required tests (clinical and special tests) among target patients and to report the associated data appropriately If staff are trained to undertake causality assessment they need to be able to access special diagnostic facilities (e.g. have ECGs and calculation of the corrected QT interval) Beyond the first training, the staff need to have mentoring and access to specialist opinion to resolve any difficulties which they may have

  10. Facilities (2) support to signal detection While causality assessment is primarily an activity which needs to happen at local level, for signal detection the pooling of data across different cohorts is expected given that new signals may be relatively uncommon. The primary rationale underpinning the creation of a global aDSM database is to unite safety reports from TB patients on treatment in different countries For staff from an individual country or subnational centre to participate effectively in the global database they will need to adhere to the reporting specifications and also to receive feedback on the relevance of their contribution to global knowledge

  11. Conclusions Developing capacity for signal detection and causality assessment requires investment in the training and support of national staff The skills needed for staff to be able to establish causal links and determine the probability of an association are rooted in epidemiology and in drug safety In addition to training, the staff would need to count upon support from expert staff to answer to any difficulties which they may experience The facilities available - including equipment, consumables, and infrastructure - also need to be conducive to the required practice

  12. Acknowledgements The development of the aDSM training material was funded by TDR as part of the Access and Delivery Partnership (ADP) with funding from the Government of Japan. These training materials were put together in 2016 the WHO Task Force on aDSM with technical partners KNCV Tuberculosis Foundation, Management Sciences for Health (SIAPS), MSF, WHO GTB, and TDR. The materials were updated in 2022-23 by Mahamadou Bassirou Souleymane (TDR consultant) with Marie-Eve Raguenaud (TDR), Branwen J Hennig (TDR), and Corinne Merle (TDR), and reviewed by Linh Nhat Nguyen (WHO/GTB), Medea Gegia (WHO/GTB), and Fuad Mirzayev (WHO/GTB). We thank all members of the WARN/CARN-TB working group on aDSM who contributed to the development of the aDSM generic guidelines as well as the secretariat, particularly Dr Christ Houessinon: Disadidi Ambrioso, Esse Marius, Adomou Jamal Rouamba Ruffine, Haro Sougrimani, Koumbem Boureima, Nsanzerugeze Jos lyne, Tollo Tollo Daniel Alphonse D sir , Mpaba Minkat Th ophile Mistral, Julie Abessolo, Ursule IDOKO, Tijan Baldeh , Wandifa Samateh, Tida S Kinteh, Alieu Wurie, Mardemn Yeasuen, Benjamin K. Quenneh, Cheick Oumar Bah, Kane El Hadj Malick, Aw Idriss, Mamoudou Hama Rachida, Gagara I. M. Assiatou, Katamb Balkissa, Seiyabatou ElhSaidou, Liombo Anastasie, Lunganyu Junior, Kitambala Sentime, Lula Yves , Habimana-Mucyo Yves, Migambi Patrick, dos Santos Brigite, Castro V nia, Wadson Cruz, Gueye Aminata, Mukeh Fahnbulleh, Bailor Samuel, Manjo Lamin, Saleh Mahareb Abdoulaye, Haroun Saleh Naima, Mouhoudine Yerima, Kpelafia Silifa

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