Active TB drug safety monitoring and management (aDSM)
Overview
Active tuberculosis (TB) drug safety monitoring and management (aDSM) is a key component for the use of new and repurposed TB drugs.
Since 2015, WHO recommends that aDSM accompanies the use of new and repurposed TB drugs, particularly in the context of drug-resistant TB (DR-TB) management. Information on the extent of aDSM in many countries remains limited, with a lack of national guidelines for aDSM. In many settings, aDSM is considered to be sub-optimal, despite widespread use of more recently licenced TB drugs such as bedaquiline, delamanid, linezolid and clofazimine.
TDR (the Special Programme for Research and Training in Tropical Diseases), in partnership with the Access and Delivery Partnership (ADP), the WHO Global TB programme, and key stakeholders in national TB programmes (NTP), set out to improve the capacity for aDSM in high-burden settings through implementation research activities on the ground. These activities include tackling barriers to aDSM as well as developing standardized tools such as training materials, teaching and supervision of health care workers and their managers. This work aims to build capacity towards optimising aDSM practices and reporting in a sustainable manner.
Our work
Understanding and addressing barriers to TB safety monitoring in Africa
Professor Dissou Affolabi (WARN-CARN-TB secretariat) and Dr Albert Kuate (NTP Cameroon) at the annual meeting of NTP coordinators in Cotonou, Benin, on 25-26 February 2021.
In 2021 implementation research was conducted through the West and Central African Networks for TB control (WARN/CARN-TB) to assess countries’ capacities and identify gaps and barriers to implementing WHO’s aDSM recommendations. A survey of 27 National Tuberculosis Programmes (NTPs) participating in the networks demonstrated that only about half of the countries implemented aDSM at the time. Specific barriers and needs to overcome these challenges were identified, such as training on pharmacovigilance and technical support to implement a monitoring system, to allow countries to improve TB patients’ safety going forward.
Findings from the survey were used as the basis for a hybrid workshop on the implementation of TB drug safety monitoring in the region, coordinated by the secretariat of the WARN/CARN-TB in Benin. The workshop further facilitated South-South collaboration and sharing, thorough the attendance of representatives from the NTP of Indonesia (also an ADP focus country with relevant aDSM activities).
As a result of the implementation research activities through the WARN/CARN-TB networks, a joint action plan was developed, which stipulated for each NTP to develop a country-specific aDSM implementation plan.
These activities in support of aDSM were particularly relevant since countries of West and Central Africa were in the process of introducing TB drugs for an all-oral shorter treatment regimen as recommended by WHO. TDR, the WHO Global TB Programme and technical partners subsequently developed ShORRT (Short, all-Oral Regimens For Rifampicin-resistant Tuberculosis), an operational research package to assess the effectiveness, safety, feasibility, acceptability, cost and impact of the use of such drug regimens for adults and children with drug-resistant TB.
News
Featured publications
In 2022, a generic guideline and standard procedure for effective implementation of aDSM was developed by a WARN-CARN TB working group (REF generic guideline to upload). In addition to this aDSM generic guideline and procedure of implementation guide, a training pack was developed to aid specific audiences - health care workers, NTP managers and pharmacovigilance managerial staff - towards successful implementation of aDSM.
The training pack is based on WHO Global TB Programme training materials developed in 2016. This covers background and aDSM overview, basic components of aDSM and sessions on implementing aDSM in approximately 25 presentations and interactive sessions. The training pack is accompanied by a training guide to serve as a resource document in organizing and delivering the training. Trainers will usually be country focal points with experience in aDSM or pharmacists. Most recently, the training pack and guide were translated into French, to facilitate the dissemination of aDSM in francophone countries.
For the health care workers
1.1. Structure and training objectives for this course & key references
1.2. Key definitions
2.1. Clinical monitoring of adverse events and management of adverse drug reactions
2.2. Train staff on the collection of data
2.3. National and international reporting of adverse events: mechanisms, routes and resources
2.4. Records management and quality assurance of data
3.1. Indicators of aDSM implementation and programme management
For the managers
1.1. Structure and training objectives for this course & key references
1.2. Key definitions
2.1i. Create a national coordinating mechanism for aDSM
2.1ii. Develop a plan for aDSM
2.1iii. Define management and supervision roles and responsibilities
2.1iv .Create standard data collection materials
2.1v. Train staff on the collection of data
2.1vi. Define schedules and routes for data collection and reporting
2.1vii.Consolidate aDSM data electronically
2.2. National and international reporting of adverse events: mechanisms, routes and resources
2.3. Indicators of aDSM implementation and programme management
3.1. Records Management & Quality Assurance of Data
3.2. Causality assessment: scales and methods
3.3. Introduction to signal detection
3.4. Overview on risk communication and new knowledge integration
3.5. Role of national and international technical and funding partners in the implementation of aDSM
Pour les soignants
1.1. Structure et objectifs de formation pour ce cours & références clés
1.2. Définitions clés
2.1. Surveillance clinique des effets indésirables et gestion des évènement indésirables aux médicaments
2.2. Formation du personnel à la collecte de données
2.4. Enregistrement et assurance de la qualité des données
3.1. Indicateurs de la mise en œuvre de l'aDSM et de la gestion du programme
Pour les managers
1.1. Structure et objectifs de formation pour ce cours & références clés
1.2. Définitions clés
2.1i. Créer un mécanisme national de coordination pour l'aDSM
2.1ii. Élaborer un plan pour l’aDSM
2.1iii. Définir les rôles et les responsabilités en matière de gestion et de supervision aDSM
2.1iv. Créer des supports de collecte de données standard
2.1v. Former le personnel à la collecte de données
2.1vi. Définir les calendriers et les circuits de collecte et de notification des données
2.1vii. Consolider les données aDSM par voie électronique
2.1viii. Développer les capacités de détection des signaux et d'évaluation de la causalité
2.3. Indicateurs de la mise en œuvre de l'aDSM et de la gestion du programme
3.1. Enregistrement et assurance de la qualité des données
3.2. Évaluation de la causalité : échelles et méthodes
3.3. Introduction à la détection des signaux
3.4. Vue globale de la communication sur les risques et de l'intégration des nouvelles connaissances