5.4.2 Monitoring safety

Even though the shorter all-oral bedaquiline-containing regimen is well tolerated, the safety profile of some medicines used concomitantly may present its own concerns. Thus, for instance, concomitant use of clofazimine, bedaquiline and high-dose moxifloxacin – all of which prolong the QT interval – may make it more important to monitor for additive cardiotoxicity (using ECG) for these drug combinations than it is for other drug combinations. Any adverse events for patients on treatment need to be reported primarily to the national agency responsible for pharmacovigilance, within the framework of aDSM (19). A functional aDSM system is required at the time of starting patients on the shorter all-oral bedaquilinecontaining MDR/RR-TB regimen. Two key elements need to be in place so that the essential safety data are collected for all patients from the moment that they are started on treatment: preparations for the collection of data in paper or electronic format and staff properly trained to collect these data.

All details of the patient’s diagnosis, DST, treatment, adverse effects and outcomes must be recorded in accordance with good practice. In addition, routine monitoring or regular surveys should be performed to assess for emerging bedaquiline resistance.

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