Tuberculosis: The Good, The Bad and The Unfinished!

Tuberculosis (TB) has been with humans since time immemorial.

We have been trying to get rid of TB since centuries.

Have we done enough? Of course not! TB is still the leading cause of death.

What can be done to eliminate TB?

This could be a wrong question to ask. We must ask ourselves, what have we done till date and what more can be done to prevent huge loss to mankind from TB. This article gives an account of what has been done so far (the good!); where did we go wrong (the bad!); and what must be done (the unfinished!) to decrease the burden of TB, in India.

Let’s start with the progress made thus far, or the “good”. India has come a long way from starting a National TB Program in 1962 (mainly for hospitalizing treatment) to rolling out Revised National TB Program (RNTP) in 1993 and Revised National TB Control Program (RNTCP) in 1997 to achieving its nationwide coverage by 2006.  The national programs imbibed the WHO’s Direct Observed Therapy Shortcourse (DOTS) Strategy in 1994, DOTS Plus strategy in 1998. Programmatic Management of Drug Resistant TB (PMDT) was started in 2007; achieved a nationwide coverage by 2013 and rolled out Bedaquiline under RNTCP through conditional access in 2016.

Central TB Division (CTD) collaborated with National Information Centre (NIC) in 2012 to develop Nikshaya, a web based solution to monitor TB patients. RNTCP launched Standards of TB Care in India (STCI) in 2014. Cartridge based nucleic acid amplification test (CBNAAT) like GeneXpert has already been launched at Anti-Retroviral Therapy (ART) sites in 2014. We have now come up with our indigenous TrueNat for the drug sensitivity testing at near point of care facility. India is moving forward to roll out Universal Drug Sensitivity Test (DST) for every newly diagnosed TB case from now onwards. TB case notification was made mandatory by May 2012 but it is only by this week that the Union Health Ministry has made it a criminal offence punishable with a jail term of 6 months to two years for clinical establishments, pharmacies, chemists and druggists to not notify TB cases and also an incentive of 1000 INR for anyone who notifies a potential TB case. National TB Institute, Bangalore has launched first nationwide anti-TB drug resistance survey of India in 2014.

The week of March 12th will be remembered as a stepping stone to India’s fight against TB. TB was declared a public health emergency by World Health Organization in 1993. Our Prime Minister emphasised the fact that even after 25 years of such a declaration, we are not able to decrease the disease burden. This calls for a change in action plan. India seems ready to tackle TB issue in mission mode by introducing an ambitious target of TB elimination by 2025, 5 year ahead of the global target. In this regard, the launch of National Strategic Plan 2017-2025 is applauded. It has got political and financial commitment form Government of India. India became signatory of Global TB Caucus in 2017. The mission mode continues with the establishment of India TB Research Consortium (ITRC), an Indian Council of Medical Research (ICMR) initiative to bring together all major national and international stakeholders to develop new tools for TB elimination, drawing parallelism with Open Source Drug Discovery (OSDD) platform.

Apart from these government efforts, India has enormous sector of national and international NGOs doing brilliant work in this sector. IPAQT, an initiative of non-profit stakeholder and supported by Clinton Health Access Initiative (CHAI) and over 100 private sector labs/hospitals with a pan India presence to provide WHO approved tests at lower costs. CHAI is also leading the Zero TB Cities project in Chennai along with TB Reach. The project will try to create an “island of elimination”. 99DOTS, funded by Gates Foundation, is a low-cost and accessible patient medication package in secondary envelopes adding dosage instruction, and a series of hidden numbers behind the pills to help track the compliance of TB medication. Other interesting examples of TB treatment compliances are the Freedom TB initiative by ZMQ Technologies and eCompliance initiative (with Microsoft) of Operation ASHA.

The Private Provider Interface Agency (PPIA) model by PATH strengthens the capacity of private practitioners serving people in slum areas to ensure early, accurate diagnosis of TB (including drug-resistant forms), effective case management, and successful treatment. PPIA operates as a part of Mumbai Mission for TB Control (MMTBC) and has led to improving situation in Maharashtra. Government of India, The Union and World Vision India together launched project Axshya in 300 districts, across 21 states, through 8 sub-recipient partners. The focus is to facilitate universal access to TB care especially for the vulnerable and marginalised communities. A standardized patient study by QUTUB project has given newer insights on the care seeking behaviour of the patients and care delivery modes of the providers.

This was the “good” of the story; let’s move on to the “bad” of the story. India still misses out on the 1 million tuberculosis suspects who are never diagnosed of TB. They are not screened on the radar of RNTCP. They might be going to private players, getting symptomatic relief, however remaining a carrier all this while and incurring high out of pocket expenditure on treatment. India accounts for a very large public sector healthcare. We have not been able to tap this potential for overcoming tuberculosis burden. Why we say bring the patients to public sector, why can’t we equip the private players to treat them in the standard way? This is a fatal flaw in India’s strategy against TB. Let the patient choose where to go. An approach like this would require many strings of the RNTCP program to be pulled, but its time!

The problem of drug and its supply chain management is also common in TB sector. Out of stock drugs at the DOTS centres forces discontinuation of the medication and leads to risk of degraded quality of the drugs being supplied. We must learn from the AIDS/HIV story on how NACO was able to monitor the drug shortage. The accurate diagnostics at the point of care facility is also a major problem leading to both wrongly diagnosed and under diagnosed pool of TB suspects which invariable leads to spread of infection. 

India’s TB control pioneers P.V. Benjamin and Frimodt-Moller introduced the mass BCG vaccination in the hope that it would protect against infection by TB bacilli. However it primarily protects only the 0-5 age group of population. As was evident in the last Global Forum on TB Vaccines at Delhi in Feb, 2018; there is a dire need to find the TB vaccine for a better tomorrow. Resources need to be channelled in this direction to see fruitful results. Similarly there is a need to find newer drugs for shorter treatment regimen to decrease the medication burden on TB patients.

Let’s come to the “unfinished” part of the story. We need to get back to design board to redesign the strategy to control TB! It needs a patient centric approach instead of a provider centric approach. It has been now know that over the fifteen year time period even though over a billion dollar has been spent of new mechanisms for tackling TB in India, only a negligible improvement has been seen on the economic loss due to TB. There is a need for complete assessment of the impact of TB, not simply to inform policy-makers of the burden of disease but also to provide the basis for targeted interventions in TB control. An extensive involvement of Information and Communication Technology (ICT) is the need of the hour. From case detection, diagnosis confirmation, treatment initiation to treatment compliance; all these aspects demand concrete attention in silos and a whole umbrella approach for strengthening the continuum of TB care.

An Information Education Advocacy and Communication (IEAC) component to target the sites where the prevalence of the disease is more; to prompt the masses to call as the single call will provide them tangible benefits from the dreaded disease with counselling. A Command and Control Centre component acting as a hub to receive the calls and schedule appointment of the beneficiaries with the doctor is another feature. The triage of leading questions will help in identifying the disease case. This provision is needed as it will reduce the load on the diagnostic facilities and help the Centre to tag the suspecting patient and not lose him or her from the care radar. Provision of integrated case management software in the command and control centre with modules for integrating mapped DOTS centres to register and track movement of registered beneficiaries; provision of directory service; documentation for each unique ID post conformation; and liking of financial benefits to the TB patients must be a key feature. A strong clinical component to be manned by tertiary care centre and DOTS centres with provision of sputum microscopy, CBNAAT like TrueNat testing and GeneXpert; diagnosis of tuberculosis (also Drug Sensitive or Drug Resistant Tuberculosis); integration of private care providers (RMPs, private labs, chemists) into the tuberculosis care cascade to improve the clinical outcome for the patients. The approach must have a capacity building, performance monitoring and quality improvement component for training modules for the existing workforce in the tuberculosis care cascade; to lay out the standard operating procedures and manuals for the staff and defining of key performance indicators of the programs, process diagrams and role and responsibilities of the staff in the various component of the proposed scheme, in accordance with the guidelines from RNTCP.

We ask ourselves, are we willing to this? After the political and financial commitment, we need to get to the ground and start rolling and END TB!!!

NOTE

This blog has been dedicated on world TB day with an aspiration to give hope to millions of TB patients in India and across the world. The blog has been prepared in collaboration with Dr. Deepika Sharma of ACCESS Health, New Delhi, India.

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