Original Article
Pharmacy based surveillance for identifying missing tuberculosis cases: A mixed methods study from South India

https://doi.org/10.1016/j.ijtb.2020.09.017Get rights and content

Highlights

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    Only 11% and 6% of the pharmacies in the selected districts had submitted the data on anti-TB drug sales during 2018.

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    72% and 52% TB patients in selected districts were identified as previously 'un-notified' TB patients on validation.

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    These patients contributed to 20% and 29% of the total TB cases notified as a part of this pharmacy-based-surveillance process.

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    Enablers for pharmacy-based-surveillance: importance of notification, availability of resources, repeated trainings/workshops and inter-agency partnerships.

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    Barriers to pharmacy-based-surveillance: Patient's perceived threat to confidentiality, cumbersome recording and reporting process, high workload.

Abstract

Background

No Indian studies have assessed the implementation of recent policy on pharmacy based surveillance and its contribution in TB notification. So, this study was conducted with objectives to describe: a) pharmacy based TB surveillance and TB notification, and b) experiences of pharmacy based surveillance implementation from the programme managers and pharmacists perspective.

Methods

A mixed methods study—quantitative (cross-sectional) and qualitative (in-depth interviews) in two selected districts Dharmapuri and Salem districts of Tamil Nadu State, India.

Results

In 2018, 45 (11%) of 397 pharmacies in Dharmapuri and 90 (6%) of 1457 pharmacies in Salem districts reported sale of anti-TB drugs to 1307 and 1673 persons respectively. Upon validation through direct patient contact 942 (72%) persons in Dharmapuri and 863 (52%) persons were identified as previously ‘un-notified’ TB patients. These patients constituted 20% and 29% of the total TB cases notified in Dharmapuri and Salem respectively. The enablers for implementing this activity were: understanding the importance of notification, availability of resources (manpower, computers) to record, report and validate the patient data, repeated trainings and partnerships. The barriers were: patients' hesitancy to share their details to pharmacists (confidentiality), cumbersome recording and reporting process, difficulties in recording patient details during high workload busy business hours.

Conclusion

This process contributed about one-fourth of the TB patients notified in these districts. Its implementation needs to be strengthened and should be scaled up in other parts of the country.

Introduction

India contributes a quarter of global tuberculosis (TB) burden with an estimated annual incidence of 2.8 million patients. However, in 2017, only 1.9 million patients were notified—about0.9 million were'missing’,1 the missing TB cases are presumed to be either undiagnosed or diagnosed and treated in the vast private sector but not notified to the public health authorities. Detection, notification and providing quality assured TB services to the missing TB patients is an essential step to End TB by 2025 in the country.2,3 Hence several efforts are being made to engage the vast private health sector in the country and get the information on TB patients diagnosed and treated by them.4

Private pharmacies play an important role in providing TB treatment in India as it is the point of anti-TB drug sale for TB patients diagnosed and treated in the private sector.5,6 An analysis of the sale of anti-TB drugs in the country indicated that the quantum of anti-TB drugs sold is huge and could possibly be used to treat 65–117% of new incident TB cases.7 Therefore, it was strongly felt that engaging pharmacies could help in obtaining information on the TB patients diagnosed and treated in the private sector. To this effect the Government of India released a Gazette Order on March 16, 2018 making notification of TB patients by private practitioners, laboratories and pharmacies mandatory.8 Accordingly to the Gazette Order, all pharmacies are expected to share the details of patients and their providers for whom they have sold the anti-TB drugs in a structured format on a monthly basis. Thereafter, these patients are contacted and verified by public health authorities or their authorized representatives. This process is called as “Pharmacy based surveillance”. This will help public health authorities to deliver quality assured anti-TB services as well as get a relatively more accurate measure of the disease burden in the country.9

This pharmacy based surveillance is similar to the inventory or record linkage studies reported from other countries.10, 11, 12 Previous studies in India have assessed ways to engage the pharmacies in TB control activities,5,13, 14, 15 however none of the studies have assessed the pharmacy based surveillance implementation in national TB programme and its contribution in TB notification. In this study, conducted in two districts of the South Indian State of Tamil Nadu, we describe: a) pharmacy based TB surveillance and TB notification, and b) experiences of pharmacy based surveillance implementation from the perspectives of programme managers and pharmacists.

Section snippets

Study design

This was a mixed methods study with quantitative (cross-sectional study) and qualitative component (in-depth interviews with pharmacists and TB programme managers) in a concurrent design.16

General

Tamil Nadu is a southern state in India implementing the Government of India's National Tuberculosis Elimination Programme (earlier named Revised National TB Control Programme, RNTCP- during the study implementation period) for the last 20 years. The two districts where the study was conducted were: a)

Pharmacy based TB surveillance and TB notification

A total of 45 (11%) of 397 existing pharmacies in Dharmapuri and 90 (6%) of 1457 pharmacies in Salem submitted their Schedule H1/Annexure III reports during January to December 2018. According to information obtained from Sales report and Wholesale distributors, 140,731 and 94,605 anti-TB (ATT) tablets were sold in Dharmapuri and Salem respectively (Fig. 1).

In Dhamapuri district, as per these reports, a total of 1307 patients had purchased ATT in Dharmapuri district. On validation by RNTCP

Discussion

This is the first study describing the implementation of pharmacy based surveillance system in the country and the number of TB notifications resulting from itunder routine programmatic conditions. Previous study had highlighted the high volume of anti-TB drug sales and an indirect estimate of the patients receiving treatment in private sector,7 and this study describes the process of surveillance-validation-notification of pharmacy data under RNTCP.

The major strength of the study was that it

Conclusion

This study on pharmacy surveillance gave important insights about the status of implementation, the contribution of this surveillance system to the overall TB notification numbers, enablers and barriers for implementing this activity at the field level. We recommend that the implementation of this surveillance system must be further strengthened. This will help in eliminating TB in India by providing information on the magnitude of TB cases diagnosed and treated in the private sector and

Funding

The training course under which this research was conducted was funded by, The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Conflicts of interest

The authors have none to declare.

Acknowledgement

This research was conducted as a part of the ‘National Operational Research Training Course 2018–19'organised by Project Axshya, funded by The Global Fund and implemented by The International Union Against Tuberculosis and Lung Diseases (The Union), South-East Asia Regional Office, New Delhi, India. The training course was conducted in collaboration with Revised National Tuberculosis Control Program, Ministry of Health and Family Welfare, Government of India and National Institute for TB and

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