Active Drug Safety Monitoring (aDSM) is a proactive effort made to elicit adverse events from patients by directly asking the patient, screening records, and checking laboratory and clinical tests. All adverse events are captured systematically at all patient visits (during treatment initiation, treatment review and extra visits).
Vestibular toxicity is one of the Adverse Drug Reactions (ADRs) that results in damage of the balance structure in the inner ear leading to loss of balance for the patient.
Suspected agent(s): Amikacin (Am), Cycloserine (Cs), Fluoroquinolones (FQs), Isoniazid (H), Ethionamide (Eto), Linezolid (Lzd)
Suggested Management Strategies
Serious Adverse Drug Reaction (ADR), such as peripheral neuropathy, may occur during Drug-resistant TB (DR-TB) treatment.
Suspected agent(s): Linezolid (Lzd), Cycloserine (Cs), Isoniazid (H), Amikacin (Am), Fluoroquinolone (FQ), rarely Ethionamide (Eto), Ethambutol (E)
Suggested Management Strategies
Hepatitis is a common adverse drug reaction caused by some Drug-resistance TB (DR-TB) drugs. It is monitored by measuring the Alanine transaminase (ALT) and Aspartate aminotransferase (AST) levels.
If there is jaundice (yellowing of the skin or eyes), field-level health care workers must immediately refer the patient to the nearest higher health centres - District/ Nodal DR-TB Centre/ Sub-district or district hospital, medical college hospitals, etc.
Hypersensitivity reactions like rashes, allergies and anaphylactic reactions are common Adverse Drug Reactions (ADRs) to any of the second-line anti-TB drugs.
These ADRs are often reported by patients themselves.
Milder forms of this ADR present with a localised rash that is not associated with mucus membranes. In such cases, patients can be reassured and managed symptomatically at home or at the Peripheral Health Institution (PHI).
QT prolongation is a condition in which repolarization of the heart after a heartbeat is affected.
It results in an increased risk of an irregular heartbeat which can result in shortness of breath or chest pain, fainting, seizures or cardiac arrest.
If patients experience such signs or symptoms, health workers need to refer such patients to the nearest health facility where Electrocardiogram (ECG) can be done and further management initiated.
Replacement of component(s) drug(s) is required in conditions like adverse drug reaction, poor tolerance, contraindication and resistance detected on baseline Liquid Culture (LC) Drug Susceptibility Testing (DST).
The replacement sequence of drugs is prepared according to their efficacy, no demonstrable resistance, prior use, side-effect profile and background resistance to replacement drug in the country.
The total duration of a longer oral Multidrug/ Extensively drug-resistant TB (M/XDR-TB) regimen is 18–20 months.
All women of childbearing age who are awaiting results of the Culture and Drug Susceptibility Test (C&DST), as well as those receiving Drug-resistant TB (DR-TB) treatment, should be advised and counselled intensively to use birth control measures because of the potential risk to both the mother and the foetus.
Apart from clinical evaluation, the patients need to be closely assessed by various laboratory parameters to monitor the improvement on treatment, drug-induced adverse events or co-morbidities to enable timely interventions to address these and improve the probability of treatment success, survival and quality of life.