Levels of monitoring in aDSM

Clinical description

In addition to drug safety monitoring, aDSM also incorporates a component that promotes the clinical management of all ADRs and AEs regardless of their seriousness. All AEs should National Tuberculosis Control Programme 125 be documented in the patient file as part of good clinical practice. In terms of reporting, the minimum requirement for aDSM is that all SAEs be registered and reported, regardless of their severity or whether they have been attributed to any of the medicines to which the patient is exposed. All detected adverse events (AEs) need to be managed clinically in a timely manner, and systematic clinical and laboratory assessments should be performed for early detection of drug toxicity and AEs.

aDSM packages according to the adverse event reported:

1. Core package: requiring monitoring for and reporting of all SAEs at each site initiating and managing patients on DR-TB treatment.

2. Intermediate package: includes SAEs as well as AEs of special interest.

3. Advanced package: includes all AEs of clinical significance.

The NTP will implement the core package of aDSM, that requires the reporting of only serious AEs (SAEs). Some treatment centers with additional resources may choose to monitor other AEs that are of clinical significance or of special interest to the programme, as part of an intermediate aDSM package. These are referred as sentinel sites, which will be designated and supported by the NTP.

Key steps to implementing aDSM There are eight key steps recommended by WHO for the programmatic implementation of aDSM:

1. Create a national coordinating mechanism for aDSM 2. Develop a plan for aDSM 3. Define management and supervision roles and responsibilities 4. Create standard data collection materials 5. Train staff for collection of data 6. Define schedules and routes for data collection and reporting 7. Consolidate aDSM data electronically 8. Causality assessment and signal detection Ideally, all eight steps should be in place before patients are enrolled on treatment with new drugs, new DR-TB regimens, or XDR-TB regimens. As this may not always be feasible, steps 1, 4 and 5 are essential ahead of any patient enrolment and implementation of “core package” of aDSM.

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