'Have we missed reporting adverse drug reactions under Revised National TB Control Programme?' - A mixed method study in Bengaluru, India

Abstract

Objective: Prompt identification, reporting and management of ADRs during anti tuberculosis treatment can ensure better compliance and treatment outcomes. The study was conducted to identify the gaps and associated factors in reporting of ADRs under RNTCP; assess knowledge, attitude and practice of RNTCP staff regarding pharmacovigilance programme and explore the barriers in reporting of ADRs from provider's perspective.

Methods: Mixed method research with sequential explanatory design was carried out in Tuberculosis Units of RNTCP administrative district of Bangalore city during July to December 2017. Quantitative study was carried out among 222 patients on intensive phase of Category I and Category II DOTS to study the incidence, severity and causality of ADRs; and records of these patients were analysed for gaps in reporting. Knowledge, attitude and practice (KAP) regarding recording and reporting aspect of pharmacovigilance programme was assessed among RNTCP staff. As part of the qualitative study, focus group discussion was carried out among RNTCP staff to study barriers for reporting ADRs from the provider's perspective.

Results: Record analysis at the time of recruitment showed documentation of ADRs in only five patients. Subsequent analysis of patient records during the middle and end of the intensive phase (IP) did not show documentation of any ADRs. Simultaneously interviews with patients revealed 116 (52.2%), 72 (32.4%) and 53 (23.8%) patients reported one or more symptoms of ADRs. The commonest ADR symptom reported were fatigability and gastrointestinal symptoms followed by musculoskeletal symptoms. KAP among 25 RNTCP staff showed that 96% of them felt reporting of ADRs was necessary and 92% reported the ADRs to their seniors, however 12% were scared to report. The main reason expressed for non-reporting was 'managing ADRs is more important than reporting' (52%). Also, 32% felt the need for retraining of staff on reporting and documentation. Barriers to reporting of ADRs were both health-system related like insufficient training and inadequate guidelines provided to RNTCP staff and patient-related factors like lack of awareness and reluctance to report ADRs.

Conclusion: Successful implementation of RNTCP and achievement of TB elimination requires provision of adequate information regarding ADRs to patients and intense follow-up and probing at each contact by programme staff to effectively manage ADRs.

Keywords: Adverse drug reactions; India; Pharmacovigilance; RNTCP; Tuberculosis.