DR-TB Coordinator

The Ni-kshay Online Portal under National Tuberculosis (TB) Elimination Program (NTEP) has a provision for generating TB treatment outcome reports which should be downloaded periodically to understand the TB treatment adherence and response to TB treatment provided to the patients.

Following are the steps to download and review the treatment outcome report from Ni-kshay.

Step 1: Open the Nikshay Reports page.

Step 2: Under Notification Reports, click Outcome Reports.

The World Health Organisation (WHO) recommends Tuberculosis Preventive Treatment (TPT) among contacts exposed to Multidrug-resistant TB (MDR-TB) with Fluoroquinolone (FQ)-sensitive, or Isoniazid (H)-resistant with Rifampicin (R) sensitive DR-TB patients.

Points to be Considered Before TPT Initiation

The current TB treatment strategy is based on a patient-centred approach to treatment and alleviation of patients' suffering that has been restricted mostly to its physical aspects. However, difficulties faced by patients and families affected by life-threatening diseases span across physical, psychological, social and spiritual aspects. Therefore, a more holistic approach to patient treatment requires broadening to a patient-centric care approach with palliative care services.

Palliative care would be necessary for the care of:

There are two main interim treatment outcomes that can occur during Drug-resistant TB (DR-TB) treatment. These are:

Bacteriological Conversion: This occurs after bacteriological confirmation of TB in at least two consecutive cultures (applicable for DR-TB and Drug-sensitive (DS-TB)) or smears (applicable for DS-TB only), taken on different occasions, at least 7 days apart, are found to be negative.

Adverse Drug Reactions (ADRs) have been graded based on their severity. The figure below provides criteria for the assessment of the severity grade of ADRs.

Figure: Criteria for Severity Grade Assessment of ADRs

The World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) system has been developed as a practical tool for the assessment of case reports. 

The table below lists the various causality categories and their assessment criteria that have been developed under this system.

Attribution definitions for causality assessment are divided into five categories and are as follows:

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• Not related​

Adverse Event (AE) that is not related to the use of the drug.​

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• Doubtful ​

AE for which an alternative explanation is more likely, e.g., concomitant drug(s), concomitant disease(s) or the relationship in time suggests that a causal relationship is unlikely.​

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There are three methods for reporting pharmacovigilance activities (see figure below).

Figure: Three Methods for Reporting Pharmacovigilance Activities

he potential adverse drug events that can occur when using drugs in the H mono/ poly DR-TB regimen are tabulated below:

Different conditions may demand the replacement of Isoniazid (H) mono/ poly Drug-resistant TB (DR-TB) and shorter oral Bedaquiline (Bdq)-containing Multidrug-resistant (MDR)/ Rifampicin-resistant (RR) -TB regimens.

Replacement Sequence of Drugs in H Mono/ Poly DR-TB Regimen

Drugs of the H mono/ poly DR-TB regimen will be replaced in case of: