Base Technical Content in text and simple images.
Attribution definitions for causality assessment are divided into five categories and are as follows:
Adverse Event (AE) that is not related to the use of the drug.
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.
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:
Treatment with Isoniazid (H) mono/ poly Drug-resistant Tb (DR-TB) regimen needs special considerations in certain special situations.
Pregnancy and Lactation
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:
Isoniazid (H) mono/ poly Drug-resistant TB (DR-TB) regimen has the following regimen, duration and dosage of drugs.
Regimen: (6 or 9) Lfx R E Z
Dosage
Pre-treatment evaluation for any TB patient must include a thorough clinical evaluation by a doctor with:
No additional investigations (except the basic evaluations mentioned above) are required for Isoniazid (H) mono/ poly Drug-resistant TB (DR-TB) patients unless clinically indicated.
The table below showcases the adverse drug events that may be caused by drugs used for longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB) regimen. In these situations, replacement drugs are used instead of these drugs.
|
ADVERSE DRUG EVENTS |
DRUGS |
|---|---|
|
QT prolongation |
Longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB) regimen can be given to patients with Extrapulmonary (EP) disease. Drug adjustments may be required, depending on the specific location of the disease.
Treatment of Multidrug-resistant (MDR)/ Rifampicin-resistant TB (RR-TB) meningitis is best guided by Drug Susceptibility Testing (DST) of the infecting strain and by the ability of TB medicines to cross the blood-brain barrier.
Pre-treatment evaluation for patients on a longer oral Multi/ Extensively Drug-resistant TB (M/XDR-TB) regimen requires both clinical evaluation and laboratory-based evaluation as given below.
Clinical Evaluation
Laboratory-based Evaluation