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.


Pharmacovigilance is important and can detect issues with drugs early, so that disasters as with thalidomide do not happen again at a similarly large scale. However, currently it is given low priority in many developing countries, because systems and staff are overburdened. More budget and urgency should be given to pharmacovigilance. I think that building up pharmacovigilance systems (including those for drug-resistant TB) should be driven by the individual country's need. Yet, all side effects that are relevant to be reported globally should be reported through one single system. Currently, with different global databases, there is a risk that these become scattered over databases, making it hard to pick up signals of potential harmful effects of drugs.

Edine Tiemersma
KNCV Tuberculosis Foundation

Read the Original

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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