What is being done about TDR-TB in Mumbai?

“It is still possible for public health systems to take a pro-active step, as the Mumbai officials are now doing to stem the problem,” Dr Dewan told India Together. “TB Control in Mumbai can be transformed. The challenge is to ensure that all TB patients get the support they need and that would prevent the emergence of drug resistance strains."

Indeed, while health officials may want to downplay the notion that the TB cases Udwadia et al were totally drug resistant, they do at least appear to be taking the ‘threat’ of TDR-TB more seriously.

What is being done about the ‘TDR-TB cases identified in these reports?

Regarding the cases identified by Udwadia et al: the Central Team announced that the Revised National Tuberculosis Control Programme (RNTCP) Maharashtra would be adopting all these cases and offering them their entire course of treatment free of charge. [It is hoped that this treatment will at least include the medications devised by Udwadia et al, if the patients are indeed responding to treatment, but we have been un able to confirm this as of yet. Treatment for drug resistant TB in India is generally standardised, as access to second-line DST has been too limited to allow for individualised regimens).

Plans to isolate the ‘TDR-TB’ patients in a remote facility appear to have been put on hold for now. Shortly before the Central Team visit, an emergency plan had been approved to send the cases identified thus far to a 30 bed sanatorium facility in Jaysingpur, 400 kilometers (250 miles) south of Mumbai.

A number of experts and activists criticised isolation in a remote location as unnecessary and a kneejerk reaction — and potentially a violation of the patient’s human rights. Rather it was suggested that they would be better managed in the TB wards of their local hospital.

Others, such as Nerges Mistry, the director of the Foundation for Medical Research in Mumbai, voiced concerns in the Lancet about the lack of good infection control to prevent the spread of highly drug-resistant TB to staff and other patients.

Indeed, a more patient- and staff-centred approach would be to introduce good infection control in these facilities, given the fact that these cases probably represent the tip of the iceberg, in order to prevent the spread of difficult-to-treat TB strains that are probably already present but not yet detected in the facility — or deliver home-based care provided that infection control in the home can be established (and if not in the home, at least near to it).

(Some researchers believe that there are some circumstances where isolation in sanatoria might indeed be the best and most compassionate options for some patients, as long as certain criteria are in place, such as easy access for friends and family. This will be discussed in a future entry in the HATIP blog).

However, the Central Team advocated against isolation of these ‘TDR-TB’ cases, suggesting that treatment was greatly reducing their infectiousness — even though only some of the patients were smear-negative at the time of its visit. Of course, all of the cases probably spent at least some time infectious, so contact tracing for each of these patients and their families is underway.

What is being done to fight and prevent drug resistant TB in Mumbai?

After input from the Central Team, the Maharashtra state government, Brihanmumbai Municipal Corporation (BMC) and private hospitals came up with a plan to deal much more aggressively with drug-resistant TB in Mumbai. Several of these steps are described in a press release, though reports in the Times of India on 19 January and 20 January, and elsewhere in the Indian media have clarified a number of key points.[i]

1) Immediately and dramatically strengthening the TB control staff in Mumbai.

Each of Mumbai’s 24 wards are now designated as 24 RNTCP districts, each hiring its own district TB officer, coordinated by one senior TB officer for all of Mumbai. All 25 doctors hired as TB officers will be sent for training at Bengaluru's National TB Institute. They will be responsible for administration, and also follow up and monitoring of patients to ensure they do not drop out of treatment.

2) Dramatically strengthening the infrastructure to support the TB programme.

Each TB district will be supported with infrastructure including 24 district TB drug stores and one additional state level TB pharmacy. The TB programme will decentralise further so that that there will be a basis TB unit for every 200,000 people (rather than for every 500,000 people). Overall this will add 35 additional TB units, overseen by TB control officers, supported by 20 additional microscopy centres (and lab technicians to be hired immediately).

The number of TB beds at GTB hospital in Sewri will be increased from 45 to 90.

Three additional DOTS-Plus sites (for drug-resistant TB) will be established. Crucially, Mumbai’s public sector has lacked the laboratory infrastructure to identify and confirm the diagnosis of drug-resistant TB, so additional culture and second-line DST laboratories are to be established and accredited at GTB Hospital in Mumbai in the next five to six months, and at two private laboratories as soon as possible.

3) The programme will try to ensure case notification by implementing the notification system under the BMC Public Health Act for TB, which establishes with punitive measures for whenever healthcare providers fail to report TB cases (this should assist TB district officers keep track of patients going onto treatment.

Mandatory laboratory notification will be introduced for M/XDR TB from all public and private sector laboratories of Mumbai, with retesting and confirmation under RNTCP. 

4) Contract tracing will be performed for all patients diagnosed in Mumbai with M/XDR TB, and TB screening performed on all of their close contacts. A similar exercise will also be undertaken in other districts and municipal corporation areas in the state.

5) There will be universal access to MDR TB screening in Mumbai including those treated by the private sector (they no longer have to repeat a failed course of treatment in the public sector in order to qualify for DST).

6) And, last but not least, there will be universal access to treatment for patients diagnosed with drug-resistant TB in Mumbai, who will be treated free, with treatment support whether they have enrolled with RNTCP or not.

The high expense of second-line medication is one of the reasons why patients stop taking treatment and become even more resistant. While first-line treatment costs around US $45, treatment for drug resistant TB costs around $4000, while treatment for XDR-TB can cost at least 2 and a half times as much. Few Indians can afford appropriate M or XDR-TB treatment, but it has been decided, in Mumbai at least, that it would be more expensive not to treat it.

7) A publicity campaign will be launched widely in order to spread awareness of the availability of free diagnostic and treatment services for all types of TB.

Finally, according to a report in the Gulf News, a research project on the prevalence of TB in the congested slums of Dharavi will also be undertaken with technical assistance from the World Health Organisation.

Are these measures enough?

Whether these measures are enough will of course depend upon how well they are implemented — as well as whether estimates are accurate about how much drug-resistant TB there is in Mumbai.

There are some risks with implementation. Where and how people with drug-resistant TB are treated is an issue. Without addressing factors such as poor infection control, it is possible that bringing more people with drug-resistant TB into facilities could lead to its spread to other patients, and staff. This is less likely if treatment for drug resistant TB is ambulatory. Spreading drug resistance within a health facility has been the cause of other drug-resistant TB outbreaks (such as the initial XDR-TB outbreak in Tugela Ferry (Church of Scotland Hospital), KwaZulu-Natal, South Africa in 2005), and without good infection control, serious illness and  potential deaths among healthcare providers -  not to mention poor morale and staff retention - could undermine TB control efforts.

One issue HATIP is currently uncertain about is whether second-line TB treatment will be an empiric standardised regimen in Mumbai (second line is often standardised when there is inadequate access to second-line DST for individualised or optimised treatment) and if so, how well is it tailored to the local resistance patterns.

Constructing a standardised second line regimen that is effective in most of the TB cases in a population, can be difficult when people have very different treatment histories. According to the report in PLos Med, the poorly trained private practitioners in Mumbai prescribed a wide range of treatment regimens, and theirpatients, could have developed very different resistance profiles.

If that is the case, a standardised drug-resistant TB regimen may fail to adequately control the infections in many of the M/XDR-TB patients in Mumbai — and suboptimal treatment could thus lead to increased resistance.

On the other hand, when the resistance profiles in a population are relatively homogenous, a standardised empiric regimen that suits the population would be simpler and more cost-effective than performing all that DST testing, and procuring a wider array of anti-TB treatment medications. WHO recommends ongoing continuous resistance surveillance to inform these decisions.[ii]

In CID, Udwadia et al recommended that the public sector take over all treatment of drug-resistant TB. While the Global Plan to Stop TB recommends engaging all health care providers, is it wise to empower private practitioners to continue treating drug-resistant TB patients without first providing further training to make sure that treatment, care and support conforms to international standards? Or will enforcing the case notification system work well enough that district TB officers will be able to keep a close eye on all the people with M/XDR-TB treatment in their district?

Udwadia et al also suggested, as have others, that India needs to more tightly regulate access to TB medications. It is important to note that some TB drug resistance could be the result of inadvertent exposure to TB medications. Some second and third-line anti-TB drugs are also commonly used to treat other conditions. If a healthcare provider or pharmacist provides one of these medications, such as a fluoroquinolone without first screening the patient for TB or checking to see whether they are on TB treatment, it could foster drug resistance. WHO urges strict enforcement of regulations for the quality and dispensing of anti-TB drugs, particularly of the second-line drugs. Other steps, such as guidance to pharmacists and non-TB specialists might also help avoid such mishaps.

The initial steps being taken in Mumbai are primarily focused on traditional TB control programme elements but we have yet to see any mention of marginalised populations who tend to have a greater risk of drug-resistant TB and who can be difficult for the formal health sector to reach. Is the need to consider, reach out to, engage and address the needs of poor and vulnerable populations such as people living with HIV, the poor, low caste, migrants, and people who use drugs adequately addressed by the TB programme in Mumbai? Will universal access to M/XDR-TB diagnosis and treatment going to be extended to the prisons of Mumbai or will it be a blind spot - as in so many other settings?

One of the pillars of the Global Plan to Stop TB is that community engagement in the TB response is critical. For instance,  could accessing DR-TB treatment, even if free, jeopardise relationships, employment or housing because of TB-stigma; does it interfere with mobility or work? do people have to trade putting food on the table, for treatment?

Engagement with the various communities at risk can help identify these issues, lead to more effective outreach, support services, follow-up, contact tracing and so on. Empowered and informed patients and communities may also be able to influence national policy and help leverage more support for health systems and TB services. Service integration or collaboration with other health sectors is needed in order to guarantee that other essential care in these populations — such as HIV prevention, testing, treatment (especially early ART) and care, or substitution maintenance therapy for people who use drugs — is integrated at or effectively linked with TB service delivery points and vice versa.

Finally, and most glaringly, the reports describe these efforts as being Mumbai-specific. What about the rest of India?

As Dr Paul Nunn from WHO's Stop TB Department told The Lancet: “Until recently, care for MDR-TB was not available in the public sector in India. Thus those with MDR-TB were forced in to the private sector where availability of anti-TB drugs is effectively unregulated and care is uncoordinated and unsupervised…This problem was predictable, and indeed was predicted.”

It would be a fallacy to assume that serious TB drug resistance will only be limited to Mumbai and its slums when the conditions that lead to virtually untreatable TB exist in many other areas in India.

References

[1] Ministry of Health and Family Welfare. Central Team Submits Report on Drug Resistant Tuberculosis Mumbai Cases.  Centre Assures full Supply of DR-TB Drugs and Technical help. RNTCP Maharashtra to Adopt Identified Cases and Offer free Treatment. January 20, 2012.

[2] WHO. Guidelines for the programmatic management of drug resistant Tuberculosis. 2011 Update. Geneva, 2011.

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