“Side effects--part of the package”: A mixed methods approach to study adverse events among patients being programmatically treated for DR-TB in Gujarat, India

Abstract

BackgroundHigh rates of Adverse Events (AEs) during treatment is one of the leading causes of unsuccessful treatment outcomes among patients with drug resistant tuberculosis (DR-TB). However, information related to AEs is not systematically collected and managed under programmatic setting. The present study assessed the a) incidence and pattern of adverse events in first three months of DR-TB treatment initiation; b) treatment seeking behaviour for AE management; and c) explore the challenges in seeking treatment and reporting AEs.MethodsThis mixed methods study included all patients diagnosed and initiated on treatment under RNTCP during July-September 2018 at Ahmedabad DR-TB centre. The patients were interviewed telephonically and assessed for all AEs experienced by them. In-depth interviews and key-informant interviews were conducted among patients, DOTS supervisors and programme staffs (treatment supervisors, medical officer and district program manager). Results: Total 207 AEs were reported by the 74 DR-TB patients. All patients experienced at least one AE during initial treatment period. Incidence rate of AEs (experienced) was 3.11 (1st month-4.6, 2nd month-2.7, 3rd month-2.02) per 100 person days. Of the 207 AEs, gastro-intestinal (59, 28.3%), ophthalmic (32, 15.4%) and otolaryngology (25, 11.9%) system related AEs were commonly experienced. Treatment was not sought in two-fifths of the AEs. Themes and sub-themes related to challenges in treatment seeking or reporting of AEs were 1) Patient related-Misconceptions, accessibility and affordability of management, lack of counselling support, stigma and discrimination, and past treatment experience; 2) Health system related- lack of guidelines and training for AE management, 3) Poor coordination between hospital and tuberculosis centre. Conclusion: The incidence of AEs was high among patients with DR-TB in the first three months of treatment and treatment seeking/reporting was low. Adequate health education and counselling of the patient and orientation of the health systems are the need of the hour. An efficient real-time reporting and management of AE should be developed and tested for effective DR-TB control.

Facilitators and barriers in implementation of active TB drug safety monitoring and management (aDSM) in programmatic management of drug resistance TB in Dar es Salaam region

“…Less than half the numbers of clinicians and DOT-nurses were found to have been trained on aDSM component. This means very few health care workers had awareness on adverse events management, recording and reporting; a finding coherent with a study conducted in Namibia [15].Similar findings were seen in a study done India where it was reported that lack of training in AE management resulted in health care workers not knowing what, when or why they should report the adverse events occurring to the patients they attended [14]. The low number of trained staff in these findings could be attributed by the limited funds allocated for pharmacovigilance activities and high staff turnover among departments in the health facilities.…”

“…These results are similar to a study done in Tanzania where implementation of aDSM was found to be difficult since most health facilities either lacked the necessary toxicity monitoring equipment like ECG, or had been faulty or HCWs were unable to operate it [13]. Another similar study conducted in India, on adverse events among patients being programmatically treated, found that guidelines, SOPs and aDSM forms were available at the treatment centre; however some toxicity monitoring tests were not done due to absence of machines for the respective tests [14]. With facilitation of toxicity monitoring tests being far from adequate, the program should increase number of functional laboratories at least one laboratory in each district; rather than having just the Muhimbili national laboratory to serve all health facilities in Dar es Salaam region.…”