A Comparative Study of Active and Passive Adverse Drug Reaction Monitoring Methods in Category I Tuberculosis Patients at a Tertiary Care Hospital in India

Adverse Drug Reactions (ADRs) are common with drug treatment. They can be collected by active and passive
methods. The aim of the study was to compare active and passive ADR monitoring methods in terms of yield and lag period in category
I tuberculosis patients.
Materials & Methods: A prospective observational analytical study was done in a directly observed therapy short-course (DOTS)
center and pharmacovigilance center of SMS hospital, Jaipur, Rajasthan, India from 1.1.2019 to 31.12.2019. A total of 303 category I
tubercular patients on DOTS were divided into groups A (150) and B (153). Group A (active) patients were interviewed personally or
telephonically for ADRs on 0,3,7,15,30, 90,180 days of therapy as per pre-structured & pre-validated questionnaire. Group B (passive)
patients were asked to report ADRs themselves to pharmacovigilance center directly or through a drop box. Collected ADRs were
compared statistically using software Minitab 14, Pennsylvania, USA.
Results: The yield of ADRs in active method was 4.5 times higher than the passive method. GIT related ADRs were similar in both
groups, cutaneous were higher in active and CNS concerned were higher in passive method. However, consistency of ADR reporting
was more in passive method. Mean lag period between onset and reporting of ADRs by active and passive methods were 5.72 and 22.4
days, respectively.
Conclusion: Active method initially and numerically facilitates ADR reporting together with decreased lag period but passive method
gives consistent yield in chronic diseases like TB, hence, an integrated approach to identify and manage ADRs will be most beneficial
for patients.