Active TB Drug Safety Monitoring and Management (aDSM) global database: Outcome of the assessment and future of data reporting
6 July 2021, Geneva | A global database set up by WHO’s Global Tuberculosis Programme in collaboration with the Special Programme for Research and Training in Tropical Diseases (TDR) has been collating data on Active TB Drug Safety Monitoring and Management (aDSM) since 2016, to monitor the safety of patients who receive MDR-TB treatment with new medicines (e.g. bedaquiline, delamanid), repurposed medicines (e.g. linezolid, clofazimine) or new regimens, which don't have a well-established safety profile. The aDSM framework has been promoted by WHO and stakeholders since 2015 for monitoring safety for patients who receive MDR-TB treatment with medicines of interest and successfully implemented in many countries for ensuring safety of patients while rolling of the newly recommended MDR-TB treatment regimens.
A comprehensive assessment of the aDSM database was convened by
WHO's team on Pharmacovigilance, and the Global TB Programme in
collaboration with TDR in 2020, in order to better understand
the benefit and risk profiles of four TB medicines bedaquiline,
delamanid, clofazimine and linezolid for their use in treatment
of MDR-TB. The aim of the assessment was to identify for these
four TB drugs any new potential "signals" and any new emerging
safety concerns.
Analysis of the safety data from aDSM database was supplemented
by additional safety data provided by the public portal of
Eudravigilance and the WHO Global Individual Case Safety Report
database (VigiBase). The outcomes of the assessment were
reviewed by the
WHO Advisory Committee on Safety of Medical Products
(ACSoMP)
in its 17th meeting on 27-29 October 2020. The main finding of
the assessment, reviewed and agreed by the committee, confirmed
the current safety profiles of the four reviewed TB drugs and no
regulatory action (i.e. labelling change) is considered
necessary at present regarding the TB drugs of interest.
However, the assessment also pointed out some “potential
signals of emerging risks” in relation to these medicines
and therefore, the committee recommended the continuation of
active monitoring following the WHO aDSM framework by countries.
Following the outcomes of the assessment, the data in the Global
aDSM database will be archived and securely stored by
WHO’s Global Tuberculosis Programme. To strengthen
country-based monitoring and pharmacovigilance systems in line
with committee recommendations, WHO will continue to support
national TB programmes in the implementation of the aDSM
framework and to use VigiBase for individual case safety
reporting, the usual route used by the national
pharmacovigilance authorities.
* 2020 recommendations of the WHO Advisory Committee on Safety of Medical Products (ACSoMP)
Source:
WHO
