The Global TB Programme and the Special Programme for Research and Training in Tropical Diseases at the World Health Organization launch a global database for active TB drug safety monitoring and management (aDSM). Countries are now invited to contribute data to the global database.
Liverpool ¦ 24 October 2016 - The Global TB Programme and the Special Programme for Research and Training in Tropical Diseases (TDR) at the World Health Organization (WHO) are pleased to announce the launch of a global database for active TB drug safety monitoring and management (aDSM). Countries are now invited to contribute data to the global database.
WHO issued policies on the use of bedaquiline and delamanid in TB treatment in 2013 and 2014 respectively, and on the use of a standardised, shorter treatment regimen for multidrug-resistant TB (MDR-TB) in 2016. Active monitoring and management of adverse events is one of the conditions set for the use of these drugs or for novel MDR-TB regimens.
Active TB drug safety monitoring and management (aDSM) defines the active and systematic clinical and laboratory assessment of patients on treatment with new TB drugs or novel MDR-TB regimens to detect, manage and report suspected or confirmed drug toxicities (1). Earlier in 2016, the WHO Global TB Programme released a Framework for the Implementation of aDSM (2), representing a consensus position on how this can be applied in the context of national TB programmes and national pharmacovigilance centres.
Apart from safeguarding patient health, aDSM is also geared to improve the evidence base for global policy on new and repurposed medicines. For this to happen the adverse event data collected by national authorities need to be shared to permit global monitoring and data pooling. This approach is also useful to detect previously unrecognised or poorly documented adverse events. Countries can report their data securely to this database under a special agreement covering their use and publication. The data will be analysed periodically for signals of previously unknown or poorly documented drug-related harms. The global aDSM database is located at and maintained by the Luxembourg Institute of Health under the auspices of WHO.
National authorities are invited to share these data with WHO. Details on how to participate in this collaborative effort can be obtained by an email request to aDSMfirstname.lastname@example.org.
Background materials to help health care providers mount aDSM and prepare their data are being developed by partners taking part in this effort and will shortly be available via the TDR website.
Please refer to the "Frequently Asked Questions" on aDSM for more details: www.who.int/entity/tb/areas-of-work/drug-resistant-tb/treatment/faq_adsm_2016.pdf
- WHO | Active TB drug-safety monitoring and management (aDSM). WHO website: http://www.who.int/tb/areas-of-work/drug-resistant-tb/treatment/pharmacovigilance/en/
- Active tuberculosis drug-safety monitoring and management (aDSM): Framework for implementation. (WHO/HTM/TB/2015.28). Geneva, World Health Organization; 2015. Available from: http://apps.who.int/iris/bitstream/10665/204465/1/WHO_HTM_TB_2015.28_eng.pdf
Source: WHO Global TB Program NewsFlash