aDSM review form

The aDSM treatment review form is a schedule to be filled out:

i) When any adverse event is reported by a patient on a newer drug containing a DR-TB regimen 

ii) When a Serious Adverse Event (SAE) of the Division of Allergy and Infectious Diseases (DAIDS) grade 3 or 4 is reported by patients on other DR-TB treatment

This form is to be filled out by the health facility managing the SAE and the following information needs to be covered:

• Patient details (name, age, sex, weight, height, Ni-kshay id, PMDT no.)
• TB-related details - Type of TB, type of drug resistance, and previous history of treatment
• Pregnancy and lactation-related details (if applicable)
• Adverse Drug Reaction (ADR) details – Course of events, timing and suspected cause of ADR, DAIDS grading of the Adverse Event (AE), date of onset and resolution of ADR
• Seriousness of the AE (life-threatening, requires hospitalisation, permanent disability, congenital anomaly, conditions where the intervention is required to prevent permanent impairment/ damage, death)
• Outcome of the adverse event
• Causality with the anti-TB medicines the patient was consuming and actions taken by the clinician in case of suspected adverse event linked to a drug
• Any other relevant clinical information

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Figure: aDSM Treatment Review Form; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, India, 2017.

Importance of aDSM Review Form

• Although all AEs are to be clinically managed, aDSM treatment review form focuses mainly on the serious AEs and is an integral component of the Programmatic Management of Drug-resistant TB (PMDT).
• This form helps to carefully monitor and document the drug-related harms attributed to the recent developments in DR-TB treatment, particularly the approval for use of new medicines ahead of the completion of phase III trials, increased use of repurposed drugs for Extensively Drug-resistant TB (XDR-TB) treatment and the development of novel second-line anti-TB regimens, some of which may not have been described yet.
• This also helps clinicians to take corrective actions and help improve the health and safety of patients.

Resources

• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, India, 2021.
• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, India, 2017.
• Active Tuberculosis Drug-safety Monitoring and Management (aDSM) - Framework for Implementation. WHO End TB Strategy, 2015. 

Assessment