Active TB Drug Safety Monitoring [aDSM]

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).

Drug-resistant Tuberculosis (DR-TB) management requires a robust system of monitoring and reporting Adverse Drug Reaction (ADR)-related information to build guidelines for the safe use of drugs, newer drugs, a newer combination of drugs in the regimen, high dose formulations etc. Hence, aDSM is essential.  

The National Tuberculosis Elimination Programme (NTEP) in collaboration with PvPI (Pharmacovigilance Program of India) and with support from the World Health Organisation (WHO) India, developed the comprehensive aDSM system for monitoring the ADRs for all types of DR-TB patients.

• aDSM follows the patient pathway from registration to the treatment outcome. 
• For every patient, an aDSM treatment initiation form needs to be filled out. For all patients with Serious Adverse Events (SAE), the aDSM treatment review form needs to be filled out.
• The aDSM mechanism was initially used only at the Nodal DR-TB Centre (NDR-TBC) involved in Bedaquiline (Bdq - new drug) - containing regimens, but now this mechanism has been expanded to all DR-TB centres.
• A drug safety monitoring committee periodically monitors the occurrence of Adverse Events (AEs) or SAEs, including deaths of patients while on new drugs containing regimens for necessary signalling and guidance to the program on their safety and efficacy.
• aDSM reports should be uploaded in a timely manner on Nikshay.

 Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.   
• Ready Reckoner for Medical Officer - Adverse Drug Reactions Associated with Anti-TB Drugs Identification and Management, 2019.

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