Reporting of Adverse Events and Serious Adverse Events

Serious Adverse Events (SAE) needs to be reported to the nearest ADR monitoring centre (AMC) and Central TB Division (CTD) within 24 hours.  Any death of a patient occurring during treatment, regardless of causality, must be reported as an SAE.

 aDSM-treatment review form to be filled whenever the DR-TB patient develops any SAE 

• The primary responsibility of filling up the aDSM forms will be with the nodal officer of the DR-TB centre with the help of a senior medical officer (SMO) or medical officer (MO) designated.
• It is essential that Nikshay data entry are being done on regular basis by statistical assistant at the NDR-TBC and senior DR-TB TB-HIV supervisor at the DDR-TBC centre.
• Forms should be maintained in hard copies until the ADR module is active in Nikshay.

Once relevant forms of aDSM are filled in Nikshay, information is directly communicated to the pharmaco-vigilance programme of India (PvPI) through the Vigiflow=connecting bridge for signal generation.