References in the content below refer to the PBMEF Guide.
Definitions
Number of people on drug-resistant (DR) TB treatment (rifampicin-resistant [RR] and multidrug-resistant [MDR] TB and pre-extensively drug-resistant [pre-XDR] and extensively drug-resistant [XDR] TB) who developed at least one adverse drug reaction (ADR) to DR-TB treatment during the reporting period; this includes all people on treatment during the specified reporting period and is not related to a cohort.
An ADR (sometimes referred to as an “adverse event”) is any negative medical occurrence that may present in a person with TB during treatment with a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment. More information on monitoring of ADRs in DR-TB can be found here, and information on ADR grading can be found here (PDF, 626 KB).
Numerator
Denominator
Ref # |
TX_DR_ADR
(Previously RS-6) |
Tier Level |
Core Plus Indicator
|
Category |
Cure
|
Type |
Outcome
|
Unit of Measure |
Number of people
|
Data Type |
Integer
|
Disaggregations |
Age (<15, 15+)
Sex
Type of Adverse Reaction
|
Reporting Level |
All Core Plus indicators should be reported at the national level; data may also be collected subnationally for more granular monitoring.
|
Reporting Frequency |
This indicator should be reported on a semiannual basis at a minimum. More frequent monitoring on a quarterly basis is recommended.
|
The data sources are the basic management unit TB register, RR/MDR-TB register, and electronic management information systems at the health facility and district levels. This standard World Health Organization (WHO) indicator can also be calculated using the WHO Global TB Programme database variable: mdrtx_adverse_events.
Monitoring ADRs can help health programs with preventing and managing ADRs, relieve patient suffering, and improve treatment outcomes.
ADRs can lead to TB patients interrupting treatment before completion, and can thus contribute to avoidable morbidity, drug-resistance, treatment failure, reduced quality of life, or even death. Therefore, it is important that adverse reactions be monitored in TB patients undergoing treatment, especially those with DR-TB, who often take regimens combining new or repurposed medicines for which the safety profile is incomplete.
Systematically gathering this data assists with drug safety monitoring and the ability to detect, manage, and report suspected or confirmed drug toxicities.
Unlike other monitoring activities inherent to TB programs, TB programs have not consistently monitored adverse reactions to treatment in the past. Once monitoring of this aspect of TB treatment becomes mainstream, it is expected that its value will extend beyond the individual patient monitored to benefit other patients from improved knowledge of the medicines tracked as well as endowing programs with a robust mechanism to enable the introduction of future TB treatments at an accelerated pace.
Number of people on DR-TB treatment who developed an ADR can be analyzed as a trend showing whether adverse reactions for DR-TB patients are improving or getting worse over time. This data can be disaggregated by type of ADR to analyze which reactions are more common.
The data may also be analyzed by sex to see if males or females are disproportionately affected. In the example shown below, it appears that a much higher percent of males being treated for DR-TB experience adverse reactions than females (70.5% versus 56%, respectively).
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