What is it about?
In recent years, new treatments for difficult-to-treat (multidrug-resistant) forms of tuberculosis have become available that are more effective to treat these forms of tuberculosis than the old treatments. However, their safety profiles are not yet fully clear. Therefore, a close watch on adverse events that may occur in patients treated with these new treatments is needed; this is called active drug safety monitoring and management (aDSM). We reviewed the literature to find papers reporting their aDSM results. We found only data for one country. In this review, we therefore added data from countries that we have supported in setting up their aDSM. Although there are some beneficial effects of aDSM, like more awareness about the occurrence, detection and management of adverse events, it is difficult to implement as in most countries, the authorities responsible for surveillance of adverse events have little capacity and there are weak links with the national tuberculosis programmes.
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Why is it important?
To be able to detect potential drug-related hazards timely, a strong drug safety monitoring programme needs to be available. However, many countries currently don't have the infrastructure in place, nor is there sufficient awareness among health care workers that monitoring is important to minimize the number of patients suffering from preventable drug side effects. In this paper, we highlight this. We also report enablers as well as barriers for setting up pharmacovigilance systems.
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This page is a summary of: Integration of drug safety monitoring in tuberculosis treatment programmes: country experiences, European Respiratory Review, September 2019, European Respiratory Society (ERS), DOI: 10.1183/16000617.0115-2018.
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PAVIA is an EU-funded project to strengthen pharmacovigilance in 4 sub-Saharan African countries.
Introduction of active tuberculosis drug-safety monitoring and management (aDSM) for new drugs and regimens
With recent developments in drug-resistant TB (DR-TB) treatment, particularly the approval for use of the new drugs bedaquiline and delamanid ahead of the completion of Phase III trials, there is a need for early and systematic detection, management, recording, and reporting of any adverse events that may occur in patients who are prescribed these medications. This technical guidance document introduces the concept of aDSM for new drugs and regimens used in the treatment of drug-resistant TB patients, outlines the definitions related to aDSM, the agreed essential activities, and the key steps in implementing aDSM in patients on treatment.
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