WHO publication: Active tuberculosis drug-safety monitoring and management (aDSM)

The World Health Organization (WHO) has recently released a consensus document after a meeting on the essential elements for monitoring the safety of anti-TB drugs (aDSM) in Geneva in July 2015.

The idea of the document is to help clarify what countries should do to that effect. The goal of aDSM is to "reduce risks from drug-related harms in patients on second-line treatment for drug-resistant TB and to generate standardised aDSM data to inform future policy updates on the use of such medicines."

The document says that aDSM applies to:

• MDR-TB and XDR-TB patients treated with new medicines, such as bedaquiline or delamanid;

• MDR-TB patients enrolled on treatment with novel regimens, such as those much shorter than currently recommended by WHO;

• All other XDR-TB patients on second-line treatment (as these regimens often include multiple repurposed drugs);

• Once these groups of patients are covered, aDSM can be extended to other patients on treatment with conventional MDR-TB regimens, depending on the resources available

Several WHO documents (including the PMDT Handbook, the interim policy guidance on bedaquiline and delamanid, and the bedaquiline implementation guide) will be updated in the near future, and an updated list of Frequently-asked questions on aDSM will also be disseminated soon.

To download the document, click here.