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Tuberculosis control needs a complete and patient-centric solution

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Madhukar Pai, Prashant Yadav and Ravi Anupindi,  McGill International TB Centre, Montreal & Stephen M. Ross School of Business, University of Michigan, Ann Arbor

Whether it is mobile phone service or vacation travel, good businesses know that success depends on providing a complete and customer-centric solution. Should patients with tuberculosis not be offered a complete solution that is patient-centered? After all, millions are affected and a large market at the base-of-the-pyramid (BoP) remains unserved.

A complete and patient-centric solution will not only include care that meets the International Standards for Tuberculosis Care, but also be delivered with dignity and compassion, grounded in the reality of patients’ lives as they navigate the long pathway from symptoms to cure. Such solution-based innovation requires a systems-thinking approach that must place patients at the center of design strategies, recognize their clinical and psycho-social needs, and be cost-effective.

Pai A patient with drug-resistant tuberculosis in India [Photo credit: Bijoyeta Das (www.bijoyetadas.com)]

Because tuberculosis requires long-term treatment and involves many actors in the value chain, there needs to be an entity which, with appropriate financial support from external agencies, can orchestrate a complete solution that is affordable and locally accessible for patients.

Are tuberculosis patients in high burden countries currently getting such a patient-centric solution? Let us consider India, which accounts for quarter of all tuberculosis cases in the world. Whether patients in India seek care in the public or the private sector, they struggle to get a complete solution.

While the Revised National Tuberculosis Control Programme (RNTCP) has done well to reach scale and provide free diagnosis and treatment for patients with drug-sensitive disease in the public sector, the programme falls short in making sure that all patients get screened for drug-resistance and in ensuring adequate therapy for all patients with multidrug-resistant (MDR-TB) and extensively drug-resistant tuberculosis. Of the estimated 64,000 cases of MDR-TB in 2012, only 17,373 cases were diagnosed under the RNTCP.

The diagnostic infrastructure in the public sector relies primarily on sputum smear microscopy that cannot detect drug resistance. It is only when patients fail to get better on standard treatment, or have recurrence of tuberculosis, that they get screened for MDR-TB, resulting in morbidity, continued transmission, and movement of patients from the public to the private sector.

Recognizing these problems, the RNTCP is actively scaling-up capacity to diagnose and treat MDR-TB. If adequately funded and successful, these initiatives should improve patient experience in the public sector.

But the stark reality of tuberculosis in India is that 50% of all cases are managed in the private sector, where the quality of tuberculosis care is suboptimal with inaccurate diagnosis, non-standard drug prescriptions, and limited effort to ensure treatment adherence. Also, private practitioners often do not screen for drug-resistance and empirical antibiotic abuse is rampant. All this means drug resistance can emerge or worsen, with poor outcomes. Lastly, out-of-pocket expenditure in the private sector can be catastrophic.

Are there examples of initiatives that address the above systemic problems? Operation ASHA is a non-governmental organization that extends the RNTCP model, and uses public sector diagnostics and drugs, to orchestrate a solution by establishing community-based treatment centers and ensuring adherence using local community providers and partners. It also leverages biometrics to increase efficiency and effectiveness. It relies on donors and the public sector for funding. This social enterprise model, however, does not offer a solution to patients who seek care in the private sector.

World Health Partners (WHP) is a donor-supported social marketing and social franchising model that delivers affordable reproductive and primary care (including tuberculosis) in underserved rural areas, by leveraging local entrepreneurs and informal providers, and by connecting them to the formal sector and specialists via telemedicine.

Initiative for Promoting Affordable, Quality TB tests (IPAQT), a coalition of more than 60 private laboratories, supported by non-profits like the Clinton Health Access Initiative, has increased the availability and affordability of WHO-endorsed tuberculosis tests. Although IPAQT is addressing the problem of suboptimal diagnosis, it does not cover treatment.

RNTCP recently announced “universal access to quality diagnosis and treatment for all tuberculosis patients in the community” as its goal in the new National Strategic Plan. Recognizing the need to leverage the private sector in developing a solution, the plan includes engagement of the private sector using “Public Private Interface Agencies” (PPIA) to enlist, sensitize, incentivize, and monitor diagnosis and treatment by private providers, to provide patient cost offsets such as subsidised diagnostics and free drugs to privately treated patients, and improve case notifications to the RNTCP. Ongoing PPIA pilot projects in Mumbai and Patna should inform policies for refinements and scale-up of this model.

Outside of India, Operation ASHA is now replicating its model in Cambodia. In Bangladesh, BRAC‘s tuberculosis program with shasthya shebikas has been successful in the public sector. This model is now creating linkages with private providers. In addition, they have created partnerships with garment industry owners in export processing zones that provide factory workers with better access to tuberculosis diagnosis and treatment utilizing BRAC’s infrastructure.

With donor support, Interactive Research and Development (IRD) and partners are expanding access to Xpert MTB/RIF (Cepheid Inc, CA), a WHO-endorsed test, in the private sector in Dhaka, Jakarta and Karachi, through mass verbal screening in private clinic waiting rooms, and referrals for computer-aided digital X-ray diagnosis. This model includes management of comorbid conditions such as diabetes and chronic obstructive pulmonary disease, to generate revenue for this social enterprise.

All these models are promising, but the goal of a complete, patient-centric solution is still elusive. Continued innovation in the development of scalable, sustainable and replicable business models to provide such solutions is critical.

To improve accessibility and affordability, many of the models will depend on community workers and coordinators, underscoring the need for well-designed strategies for their recruitment, training, incentivization, and performance management. Information and communications technologies will also be critical for success.

Solution-centric approaches have shown promise in several other BoP contexts, from affordable eye care to artificial limbs. By using product and process innovations, often with community champions, these models have shown that it is possible to serve the BoP market needs effectively and efficiently and with compassion and dignity. Individuals with tuberculosis deserve nothing less.

Note: This blog post is an edited version of a Comment that was published in the Lancet Global Health on 24th March 2014. The Lancet Global Health is an open access journal, and all material is published under Creative Commons licensing, with copyright retained by the authors.

The views are of the authors.

Written by JournalistsAgainstTB

March 24, 2014 at 7:56 am

Fixing India’s TB control policy

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Despite having a focused TB control programme for over five decades, India faces the ignominy of having the largest number of TB cases in the world. Non-compliance, confusion and poor implementation of government policies mark the failure of the system, both private and public, in providing quality treatment for TB to those who need it. Who will clean up the mess in the TB sector?

Dusk is falling on a day that has seen intermittent rains. Shanti Hospital in Bagalkot, Karnataka, is teeming with patients, many of who have travelled long distances to reach there. One of these is Mahboob Kushtagi (28). Married recently, he works as a supervisor in a granite company and earns about Rs 4000/- per month. He looks anxious and speaks haltingly; as if afraid that every word he utters will worsen his condition. “My travails began a year ago when I felt a swelling in my neck region which kept getting bigger,” he says. “Since then I have been to several doctors and have already spent Rs 20000/- on tests and medicines, not to count the work days I have lost. But I feel no better; in fact the swelling is much bigger now. I have lost weight and feel ill all the time.” Pointing to Dr Shafeeullahkhan Inamdar, a chest physician he has been directed to, he says tiredly, “I hope I get relief here. I don’t know where else to go for a cure.”

Dr Inamdar fills in the details, “His old records indicate that Mahboob was first treated for TB Lymphadenitis based on suspicion alone. The second doctor he went to conducted fine needle aspiration cytology (FNAC) on him. Though the results did not indicate evidence of it, he was again treated for the same condition. After a year he sought the opinion of an ayurvedic doctor who ran some scans and decided it was more prudent to refer him to me. I will do an excision biopsy and treat him based on the diagnosis.”
If her weight was the only indication of her age Ratnamala Melnada (53) would be eight years old. She weighs only 28 kgs and is a very sick person. Weakened to the extreme, she mumbles incoherently when asked questions. Her daughter replies on her behalf. Much of her past medical history is not clear; what is clear is that after recovering from an attack of TB more than 20 years ago, Ratnamala often took her old prescription to chemists and used anti-TB drugs to cure herself of normal coughs and colds. She is presently suffering from TB but is not responding to anti-TB medication. Her daughter swallows the lump in her throat and admits that if her mother were to die, she will be all alone in the world.

Mir Saheb (60) lives in an airless, dark, dank, two room tenement. His family of four other members including his one year old granddaughter lives with him. He sells ice cream and has to sometimes cycle 20 kms a day to make a decent living. He has recently been diagnosed with TB and put on the DOTS regimen. His granddaughter is very attached to him and he can be seen holding her and playing with her. But no family member has been counseled on the dangers that he poses to the little child. Nor has the child been put on prophylaxis treatment as recommended by the national TB control programme and in compliance with international standards of TB care.

If there is one thread that links these stories together, it is the failure of the system, both private and public in providing quality treatment for TB to those who need it. There are some tough questions that need immediate answers. Why was it so easy for Ratnamala to buy anti-TB drugs over the counter? Why is Mir Saheb’s little granddaughter so vulnerable and unprotected? Will Mahboob finally get the right treatment?
This story was researched from Bangalore, Bagalkot and Badami in Karnataka. It was difficult. While the latter two places at least provided answers, doctors and laboratories in Bangalore refused to take calls from this writer and in cases slammed phones on knowing who was calling.

Despite having a focused TB control programme for over five decades, India faces the ignominy of having the largest number of TB cases (26 per cent of the global total according to the Global TB Report 2013). Drug resistant strains of TB are on the increase and as per the same report India is estimated to have 64000 cases of MDR TB. In the year 2012, two important measures were introduced by the Government of India which could regulate the TB sector – the ban on serological tests for detection of TB and mandatory notification of TB cases being treated in the private sector. Compliance to both is poor, in fact nearly non-existent in the places researched for this story. Additionally, efforts to buy anti-TB drugs over the counter proved easier than buying cough lozenges in all three places. The real life instances quoted above also point to multiple problem areas such as lack of standardised practices, lack of accountability and rampant flouting of rules and norms.

It is a known fact that over 65 per cent of those who need anti-TB treatment in India go to private healthcare facilities. What quality of care do they receive? Dr Kiran Kalburgi who owns Kalburgi Nursing Home, Bagalkot says, “When I initiate a patient on anti-TB treatment, I have no mechanism to track whether s/he has completed the treatment. It is for the patient to complete the course of treatment. I have neither the inclination nor the time to follow-up on his/her progress.” Asked if he is not worried that the patient who drops out would be vulnerable to DR TB, he shrugs and is non-committal.

Speaking about the mandatory notification order, Kalburgi says, “I have not received any information about this. Even if I did, I would not be interested in notifying the government if it meant mountains of paperwork.” Kalburgi was not alone in his ignorance of the order. Very few doctors this writer spoke to knew about it. Inamdaar gives the situation another perspective, “Doctors in the private sector very commonly treat patients on suspicion alone. How will they notify when they have no evidence that they are treating confirmed cases of TB? Besides I have not seen any efforts by the government to sensitise doctors to the need to notify. The situation calls for much more than government orders (GOs) which remain on paper. It needs stricter enforcement.”

Pradeep Mane, Senior Treatment Supervisor, District Hospital, Bagalkot says, “We agree that the efforts to convey information about the mandatory notification have been inadequate. The response however is poor even in the few places we have conveyed the information. Doctors are reluctant to give us details fearing that there will be too much of documentation.”

Dr Nalini Krishnan, Director, REACH (Resource Group for Education and Advocacy for Community Health) points out, “We have belatedly put in regulations when the challenge of MDR TB is grave. RNTCP approaches private healthcare providers with a take it or leave it attitude. Notification of cases has to be facilitated with due consideration given to patient identity and confidentiality issues.” Krishnan observes that all is not well with the government system too, “We know that there is 17-20 per cent MDR-TB in re-treatment cases within the RNTCP itself which means that patients who have been on DOTS are coming back with drug resistance. This definitely raises questions about the quality of DOTS.”

Abhay Kumar, President, Indian Pharmacist Association (IPA) admits, “We know it is not healthy practice to dispense Schedule H drugs across the counter. But pharmacies in India are completely unregulated. We need stricter enforcement of the Drugs and Cosmetics Act. As per a survey we conducted in Mumbai, qualified pharmacists are almost never present in shops. There is almost always only a sales person dispensing drugs. The drug control department must be much more alert to such malpractices.”

Dr Gutta Suresh, National Coordinator for TB Control, IMA (Indian Medical Association) says, “Private practitioners are important players in the healthcare sector in India. It is evident that if the public health system was robust, there would be no demand for our services. We have supported mandatory notification, subject to certain conditions like protecting patient confidentiality. While it is early days yet, we know the weaknesses with regard to enforcement in India. The Drugs and Cosmetics Act which is more than 50 years old is yet to be enforced fully. So there are concerns about whether enforcement mechanisms are in place for this. Given the situation we need to be regarded as partners.”

So where does the buck stop? Who is to clean up the mess that the TB sector seems to be in? Most obviously the government. Madan Gopal I.A.S, Principal Secretary, Department of Health and Family Welfare, Government of Karnataka however says it a little differently, “The private sector in India is weakly regulated with specific reference to compliance to the quality parameters and adherence to legal provisions. Public interest is required to deal with TB and similar communicable diseases. Professional bodies such as IMA should take a lead in this. Availability of drugs without prescriptions is an issue not only for TB drugs but also other drugs. This calls for responsible business practices by the owners of pharmacies, better consumer awareness and punitive measures against those violating norms.”

Authorities from RNTCP, despite several efforts to get responses, remained silent and did not respond at all. While the debate goes on, point and counterpoints are raised, it is important to remember that Mahboob, Mir Saheb and Ratnamala are not ‘them’. They are ‘us’ and deserve better. Whether it takes coming together, punitive measures or any other, it is time now to get our act together. It might already be too late.

DISCLOSURES:
This story has been written under the aegis of the International Union Against Tuberculosis and Lung Disease (The Union)’s Media Fellowships for Reporting on TB.
The author can be contacted at bharathiksg@gmail.com

First published in http://issuu.com/indianexpressgroup/docs/pharma_onlinedec-1-15_1-54/45?e=5690019/5841113

Written by JournalistsAgainstTB

December 3, 2013 at 3:07 pm

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