Tuberculosis (TB)

Active TB drug-safety monitoring and management (aDSM)

TB drug, hand, gloves, Russia
WHO/S. Volkov

Health programmes that systematically monitor patient safety are in a better position to prevent and manage adverse drug reactions (ADRs), relieve patient suffering and improve treatment outcomes. Likewise, TB programmes that actively pursue drug-safety monitoring and management are better prepared to introduce new anti-TB drugs and novel regimens. The prospects of new anti-TB drugs and use of novel regimens led WHO to release its first implementation manual for pharmacovigilance of anti-TB drugs in 2012. In 2013 and 2014, the WHO interim policies on bedaquiline and delamanid recommended active pharmacovigilance as one of the five conditions to be met when these drugs are used to treat MDR-TB patients.

The term "active TB drug-safety monitoring and management" (abbreviated as aDSM) describes a new TB programme component to provide for the active and systematic clinical and laboratory assessment of patients on treatment for XDR-TB, or with new TB drugs or novel MDR-TB regimens to detect, manage and report suspected or confirmed drug toxicities. The recording and reporting activities of aDSM primarily target the serious adverse events (SAEs) as a basic requirement. The appropriate and timely management of ADRs is an integral component of aDSM and patient care.

In 2016, WHO issued interim policy on the use of two new drugs, bedaquiline and delamanid in 2013 and 2014 respectively, and active TB drug-safety monitoring and management is one of the conditions set for the implementation of the new drugs. Since 2012 WHO’s Global TB Programme has been promoting active TB drug-safety monitoring and management for treatment of drug-resistant TB with shorter regimens.

Frequently asked questions about active TB drug-safety monitoring and management (aDSM)

These frequently asked questions (FAQs) summarize current WHO advice on the implementation of pharmacovigilance and management of drug safety in TB. These FAQs are to be read alongside the main documents dealing with active drug-safety monitoring and management produced by the WHO and its partners.

Active tuberculosis drug-safety monitoring and management (aDSM): Framework for implementation

This document outlines the essential requirements for active tuberculosis drug-safety monitoring and management (aDSM). It proposes key terms that are adapted to the specific context of active TB drug-safety monitoring. aDSM applies to patients on treatment with i) new anti-TB drugs; ii) novel MDR-TB regimens; or iii) XDR-TB regimens, in order to detect, manage and report suspected or confirmed drug toxicities. T

Data collection forms for aDSM

Global aDSM database

WHO global database for TB active drug safety monitoring home page

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