Active tuberculosis drug-safety monitoring and management (aDSM): Framework for implementation
The WHO Global TB Programme convened key technical and funding agencies at a meeting in Geneva, Switzerland on 28-29 July 2015 to discuss essential requirements for the implementation of active pharmacovigilance and proper management of adverse drug reactions when introducing new anti-TB medicines or novel MDR-TB regimens. This document reflects the agreement achieved during this meeting and in subsequent discussions. Other WHO documents – particularly the PMDT Handbook, the policy implementation package for new TB drug introduction, frequently asked questions and the associated documents - are also being updated accordingly.
The 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. The aDSM approach also offers options for the implementation of drug safety activities based on capacity and availability of resources at country level which will help facilitate the introduction of new TB drugs and novel regimens. The adaptation of aDSM helps the TB community speak the same language while implementing the required drug-safety activities, contribute to ensuring patient safety as well as updating policies for the treatment of drug-resistant TB.