Using a Pharmacy-Based Surveillance System to Improve Standards for TB Care in Kerala, India.

Introduction: Eleven anti-TB drugs were included in the Government of India's Schedule H1 drug regulations in 2014. The National Strategic Plan for TB Elimination in India 2017-2025 recognized the opportunity to strengthen the TB surveillance system and improve the quality of TB care by implementing the Schedule H1 regulation. However, there were no documented systematic large-scale efforts to use Schedule H1 regulation to support TB surveillance or improve the quality of care. We aimed to document the process of implementation of the Schedule H1 regulation to enhance the quality of TB care and strengthen the TB surveillance system in Kerala, India.

Methods: We conducted 33 in-depth interviews of the drugs control department enforcement officers, chemist shop owners, private-sector doctors, leaders of professional medical associations, and program managers and key staff of the TB Elimination Program in Kerala. Major themes identified were the process of implementation of Schedule H1 and how the National TB Elimination Program used the information. Findings from the qualitative interviews were corroborated with the quantitative information from the annual program performance reports and anti-TB drug sales data.

Results: The TB Elimination Program of Kerala used the information from the Schedule H1 drug register to identify the missing TB cases and strengthen TB notification, identify providers for engagement and extend support to them for ensuring standards of TB care, and provide feedback to providers regarding prescription practices. Stakeholders felt that implementation of Schedule H1 surveillance has helped to improve TB patient notifications from the private sector, build better public-private partnerships, and improve the quality of TB diagnosis and treatment in Kerala.

Conclusion: Pharmacy-based drug sales data collected either through regulatory or non-regulatory methods have immense potential to support TB elimination programs.