References in the content below refer to the PBMEF Guide.
Definitions
Number of people on TB preventive treatment (TPT) who developed at least one adverse drug reaction (ADR) to treatment during the reporting period.
An ADR (often referred to as an “adverse event”) is any negative medical occurrence that presents in a person during TB preventive treatment with a World Health Organization (WHO) approved regimen that may or may not have a causal relationship with the prescribed treatment. More information on ADR and grading ADRs can be found here.
Numerator
Denominator
Ref # |
TPT_ADR
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Tier Level |
Project Level Indicators
|
Category |
Prevent
|
Type |
Outcome
|
Unit of Measure |
Number of people
|
Data Type |
Integer
|
Disaggregations |
Age (0–4, 5–14, 15+)
Sex
Type of Adverse Reaction
Severity
TPT Regimen
|
Reporting Level |
Project Level indicators are expected to be reported at the subnational level for subnational units where the partner is operating. National data may also be reported if available.
|
Reporting Frequency |
This indicator should be reported on an annual basis at a minimum. More frequent monitoring on a quarterly or monthly basis is recommended.
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The data sources are the TPT register or electronic management information systems at the health facility and district levels.
Monitoring ADRs can help health programs with preventing and managing ADRs, reduce patient suffering, and improve treatment outcomes.
ADRs can lead to people on TPT interrupting treatment before completion, resulting in ineffective preventive treatment. Therefore, it is important that adverse reactions be monitored in people taking TPT.
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, programs have not consistently monitored adverse reactions to TPT in the past. Once monitoring of this aspect of TPT becomes more common, 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 TPT treatments at an accelerated pace.
Number of TPT patients who developed an ADR to treatment can be analyzed as a trend showing whether adverse reactions for TPT patients are improving or getting worse over time.
This data can be disaggregated by type and severity of ADR to determine which adverse events are more likely to be associated with a specific TPT regimen.
The data may also be analyzed by sex to see if males or females are disproportionately affected.
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