This publication is a five-part series on “Best Practices in Programmatic Management of Drug-resistant Tuberculosis (PMDT) in India” that

Citizen News Service – CNS did with support from Lilly MDR TB Partnership in India during January-June 2013. The views expressed in these articles are those of the commentators, and the persons interviewed by CNS. Editor: Shobha Shukla – CNS Email: shobha@citizen-news.org

July 2013
DISCLAIMER: This report has been generated in consonance with CNS and Lilly MDR-TB
Partnership, a Corporate Responsibility initiative of Eli Lilly and Co. (India) Pvt. Ltd. after a survey and a detailed research to generate recommendations on Management of Drug Resistant Tuberculosis across India. This report so generated focuses on best practices in PMDT at selected sites in India. The recommendations and the information of the infrastructure shall in no way be construed as promotion of specifically covered institutions. This report shall in no way be considered a substitute to any personalized advice of Health Care Providers on the disease state of an individual. The interviews of Nurses, support staff or HCPs are only limited to suggestions and the best practices of various institutes and hence in no way intended to harm image of any institution that does not have practices that are alike. The expression of opinion or view point are general in nature and any reference to any person, living or dead, is coincidental and with no intent to harm any personal interest. The report conceived after survey and research and public disclosure of the same has been done based on the consent of respective stakeholders including but not limited to picture/ images of Patients, Nurses and HCPs. This report has been generated in Public interest and for the wellbeing of the society.

Citizen News Service - CNS
C-2211, C-block crossing, Indira Nagar, Lucknow-226016. India
M: +91-98390-73355 | E: editor@citizen-news.org | W: www.citizen-news.org

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Introduction Part I: Infection control Part II: Counselling Part III: Diagnostics and laboratory services Part IV: Treatment and care

What did we find at PMDT sites we visited? Recommendations What did we find at PMDT sites we visited? Recommendations RNTCP approved diagnostic tests in India Flow of specimen from periphery to C-DST laboratory Costing of unit test at a laboratory What did we find at PMDT sites we visited? Recommendations What did we find at PMDT sites we visited? Recommendations
When he vomited blood one day A pain in chest Persistent low grade-fever & cough Listen to me as I do not want anyone to go through what I am experiencing Adhering to treatment, but lost hearing power irreparably TB rebounds, with drug resistance From private to PMDT: Journey of a priest from TB to MDR-TB “I wish if there was a vaccine to control its spread…” Deserted by family, divorced by wife, PMDT become his new family With family’s support, he is determined to complete the treatment Aspiring for size zero, acquires TB Instead of heralding social change, she turned positive for TB Surviving bravely despite TB, diabetes, other health concerns He never thought he can ever get TB! Misdiagnosed as typhoid but had TB TB is not only a poor person’s disease! Going to college with treatment alongside After a whirlwind search for cure, found relief at PMDT site in Delhi Blew up more than cost of MDR-TB treatment in private sector Deserted by husband’s family, she needs an oxygen cylinder to breathe MDR-TB survivor also bravely battles against a rare genetic disease We can stop TB: With a little bit of love and a pinch of will power

Part V: Personal stories of MDR-TB/ XDR-TB patients and MDR-TB survivors

4 10 21 24 47 50 53 54 55 71 75 93 96 97 98 99 101 102 103 104 105 107 109 110 112 114 115 117 118 119 120 121 123 126 129 133 134 135 137 139

Annexure Annexure Annexure Annexure

I II III IV

Annexure V Annexure VI

Patients’ Charter for Tuberculosis Care What PMDT Guidelines say on infection control? What PMDT Guidelines say on counselling? What PMDT Guidelines say on diagnostics and laboratory services? What PMDT Guidelines say on treatment and care? What PMDT Guidelines say on treatment outcome definitions?

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Despite challenges of health systems and the biggest TB disease burden globally, India has certainly come a long way forward in its response to providing access to standard WHO recommended anti-TB treatment through Directly Observed Treatment Shortcourse (DOTS) to more than 14.2 million (1.42 crores) people across the country. Despite successes TB continues to remain one of the key public health priorities in India. Drug-resistant TB is one of the concerns and India envisions providing universal access to quality diagnostics and treatment services for all patients with drugresistant TB in next five years. CNS with support from Lilly MDR TB Partnership in India embarked upon this mission to document best practices and lessons learnt from some select sites of Programmatic Management of Drug-resistant Tuberculosis (PMDT) in India. We conducted close to 200 key informant interviews with key stakeholders – cured patients of multidrugresistant TB (MDR-TB), MDR-TB patients currently on treatment and their family members, extensively drug-resistant TB (XDR-TB) patients, nurses, doctors, laboratory technicians, microbiologists, PMDT site nodal officers, state and district TB officers, among other stakeholders. We took photographs too of PMDT related services. All interviews and photographs were taken after due consent in English or local vernacular languages. CNS analyzed the evidence thus generated and is coming up with specific recommendations to help achieve universal access to quality diagnostics and treatment in PMDT across the country. CNS has produced five-part series of “Best Practices in PMDT in India” on following specific themes:

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Infection control Counselling Diagnostics and laboratory services Treatment and care Personal stories of people with drug-resistant TB and MDR-TB survivors

We are very grateful to the (current and cured) patients of drug-resistant TB, their family members, care providers and other key stakeholders who consented to be interviewed and helped us learn vital lessons. Our sincere thanks also to: Dr KS Sachdeva, Central TB Division; Dr Jayant Banavaliker, former Director, RBIPMT; and Sunita Prasad, Lilly MDR TB Partnership India for their constant support and guidance.

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THE INITIATIVE
The initiative “Documenting best practices and lessons learnt in rolling out MDR-TB services in India” began with the following goals: • Documenting best practices and lessons learnt in rolling out prevention, treatment, care and support services related to multidrug-tuberculosis (MDR-TB) in 14 government and private/ non-government sites in 6 Indian cities (see below). • Drafting priority recommendations for achieving MDR-TB related targets set by the Revised National Tuberculosis Control Programme (RNTCP) of the Government of India by 2015. These recommendations will be based upon key informant interviews and focused group discussions with people receiving MDR-TB services, care-providers, and other key experts. • Analysing the qualitative data collected and producing an advocacy document to help RNTCP achieve its targets related to MDR-TB by 2015 or earlier. • Publishing and syndicating article series based upon the interviews on the above MDR-TB sites through CNS and other networks (such as Stop-TB eForum) • Producing a photo essay documenting a range of issues related to MDR-TB services. • Disseminating advocacy document and key learning and recommendations at a national media workshop in Delhi. • Organizing public exhibitions of the photo essay through projection.

METHODOLOGY
With informal discussions with Dr KS Sachdeva, Additional Director General, Central TB Division, and Ms Sunita Prasad, Lilly MDR TB Partnership and PPP Focal Point of Partnership for TB Care and Control in India, CNS selected PMDT sites that had significant number of people seeking treatment and care for drug-resistant TB, and were functional since past few years (except one new PMDT site that was a year old). We also selected national reference laboratories (NRLs) and state’s intermediate reference laboratories (IRLs) along with a private diagnostic laboratory of repute. Innovative approaches such as home-based care models or other centres that were doing inspiring work to enhance positive outcomes of PMDT sites were also included. We covered 14 sites in 6 cities (see table below) during January – March 2013 and conducted over 200 key informant interviews. Apart from these sites, we also interviewed cured MDR-TB patients in Delhi and Gujarat. These interviews were transcribed, translated and qualitative data analysed to produce a 5-part series on infection control, counselling, diagnostics and laboratory services, treatment and personal testimonies of MDR-TB and XDR-TB patients (including cured patients). All photographs and key informant interviews were conducted after seeking due consent. Consent forms were available in English, Gujarati, Bengali and Hindi. We credit CNS team members who worked hard on this initiative: Shobha Shukla (editor), Mukta Srivastava, Rahul Dwivedi and Bobby Ramakant.

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S.no.

Site All India Institute of Medical Sciences (AIIMS) Delhi Calcutta Rescue Centre, Kolkata, West Bengal Civil Hospital, BJ Medical College, Ahmedabad, Gujarat Dr Dang’s Lab, Delhi K S Roy Hospital, Kolkata, West Bengal King George’s Medical University
(KGMU), Lucknow, UP

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Facilities (laboratory, treatment and care) Intermediate Reference Laboratory (IRL) and treatment and care Counselling, DOTS and support to PMDT site in Kolkata (KS Roy Hospital) Intermediate Reference Laboratory (IRL) and treatment and care Diagnostics and Laboratory services (private) Treatment and care Intermediate Reference Laboratory (IRL) and treatment and care National Reference Laboratory (IRL) and treatment and care

Diagnostic tests - Solid culture, Liquid culture, LPA routinely used - Xpert MTB/RIF for research purposes

2 3

- Solid culture, Liquid culture, LPA routinely used - Solid culture, Liquid culture, LPA routinely used - Solid culture, Liquid culture, LPA routinely used - Solid culture, Liquid culture, LPA routinely used - Xpert MTB/RIF for research purposes Xpert MTB/RIF routinely used

4 5 6 7

8 9

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Lala Ram Sarup (LRS) Institute of Tuberculosis and Respiratory Diseases, Delhi Lok Nayak Hospital, Delhi Murshidabad District TB Hospital, Murshidabad, West Bengal National JALMA Institute for Leprosy and Other Mycobacterial Diseases, Agra, UP New Delhi TB Centre, Delhi Rajan Babu Institute of Pulmonary Medicine and TB (RBIPMT), Delhi St Stephen’s Hospital’s Homebased care of MDRTB patients, Delhi Vallabhbhai Patel Chest Institute, Delhi

Xpert MTB/RIF available, Treatment and care Treatment and care (new PMDT site) National Reference Laboratory (IRL) and treatment and care

- Solid culture, Liquid culture, LPA routinely used - Xpert MTB/RIF, DNA Chip, DNA Sequencer, Mass Spectroscopy using electron microscope, for research purposes

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Intermediate Reference Laboratory (IRL) and DOTS Treatment and care

- Solid culture, Liquid culture, LPA routinely used

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Counselling and home-based care services to patients enrolled in PMDT sites in Lok Nayak Hospital and RBIPMT Delhi

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New upcoming PMDT site

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S.no.

Site All India Institute of Medical Sciences (AIIMS) Delhi Calcutta Rescue Centre, Kolkata, West Bengal Civil Hospital, BJ Medical College, Ahmedabad, Gujarat Dr Dang’s Lab, Delhi K S Roy Hospital, Kolkata, West Bengal King George’s Medical University (KGMU), Lucknow, UP Lala Ram Sarup (LRS) Institute of Tuberculosis and Respiratory Diseases, Delhi Lok Nayak Hospital, Delhi Murshidabad District TB Hospital, Murshidabad, West Bengal National JALMA Institute for Leprosy and Other Mycobacterial Diseases, Agra, UP New Delhi TB Centre, Delhi Rajan Babu Institute of Pulmonary Medicine and TB (RBIPMT), Delhi St Stephen’s Hospital’s Home-based care of MDRTB patients, Delhi Vallabhbhai Patel Chest Institute, Delhi

1 2 3 4 5 6 7 8 9 10 11 12 13

Facilities (laboratory, treatment and care) Intermediate Reference Laboratory (IRL) and treatment and care Counselling, DOTS and support to PMDT site in Kolkata (KS Roy Hospital) Intermediate Reference Laboratory (IRL) and treatment and care Diagnostics and Laboratory services (private) Treatment and care Intermediate Reference Laboratory (IRL) and treatment and care National Reference Laboratory (IRL) and treatment and care Xpert MTB/RIF available, Treatment and care Treatment and care (new PMDT site) National Reference Laboratory (IRL) and treatment and care Intermediate Reference Laboratory (IRL) and DOTS Treatment and care Counselling and home-based care services to patients enrolled in PMDT sites in Lok Nayak Hospital and RBIPMT Delhi New upcoming PMDT site

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WAY FORWARD

We aim to disseminate these 5-part series of advocacy documents in a media workshop in Delhi in June 2013, send them to the key people at all the sites we covered across the country and last but not the least to Central TB Division requesting them to consider incorporating the recommendations on infection control, counselling, diagnostics and laboratory services and treatment and care services in PMDT in India. Some of the recommendations are also for strengthening or establishing linkages with other programmes or departments of the government and we will aim to deliver these to appropriate agencies. We also aim to exhibit the photo essay at different opportunities and also share it with the sites for non-commercial use such as patient or community education. We believe that these 5-part series of advocacy documents and photo essay might also be of use to new and upcoming PMDT sites, private centres or other supporting initiatives by NGOs and PPP approaches. We will make these materials available for them as well.

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Infection control
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All India Institute of Medical Sciences (AIIMS), Delhi
The PMDT site of AIIMS was located away from other departments and buildings in the campus towards one end. The OutPatients’ Department (OPD) area was very well ventilated, with high roofs, diffused sunlight and well-spaced seating arrangement for patients and attendants. There were lot of TBrelated information, education and communication (IEC) material in Hindi and English displayed in the OPD area using powerful illustrations and simple texts to highlight the importance of basic principles of DOTS – including importance of infection control, early diagnosis, treatment adherence, among others. Sputum collection area was also away from the main thoroughfares, and person giving sputum was supposed to give sputum sample in an open, empty, segregated and cross-ventilated side corridor. We found resident and senior doctors at AIIMS Chest Clinic OPD and laboratory areas were wearing N95 masks. The healthcare workers were wearing surgical masks. Doctors and other healthcare providers were also encouraging patients to wear masks at every opportunity such as at drug dispensing sites, OPDs, and other patient contact points.

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DR KAMAL VERMA, Department of Medicine, AIIMS, who was attending to patients at DOTS Referral Centre when we met him, said “All of us doctors dealing with TB patients have to wear N95 masks.” DR SK SHARMA, Professor and Head of the department of Medicine, AIIMS, stressed that “Basic sanitation and hygiene methods like cough and spitting etiquettes, not urinating in public, among others, must be taught in school not only with the perspective of TB but for broader benefits of practicing basic infection control in our daily lives. I would like to say that merely making rules will not help unless we implement them also.”

Dr SK Sharma, HOD Medicine, AIIMS

Resident and senior doctors at AIIMS Chest Clinic OPD and laboratory areas were wearing N95 masks. Doctors and other healthcare providers were also encouraging patients to wear masks at every opportunity such as at drug dispensing sites, OPDs, and other patient contact points.

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Civil Hospital, BJ Medical College, Ahmedabad, Gujarat

We found that the indoor ward for patients of drug-resistant TB was very well crossventilated, with well-spaced beds, enough natural sunlight, and clean floors. This ward was away from other areas of the building and wash rooms were separated by a corridor. DR AMAR SHAH, WHO consultant for RNTCP for the state of Gujarat (at BJMC, Ahmedabad) said: “For infection control we follow certain measures at all our drug-resistant TB sites. There is maximum ventilation in the wards. We make sure to have area equivalent to at least 20% of the floor area, to have open air space and cross-ventilation. Our healthcare staff monitors proper and regular air exchange. Each patient is provided with sputum cups and surgical masks.” DR RM LEUVA, District TB Officer (DTO), Ahmedabad Municipal Corporation district, lamented that “Spitting is a very common but bad habit in us Indians. When we go abroad then we do not spit, because of the fine which we have to pay. But once back in India we start spitting again. This must stop.”

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DR PURVI from the Ahmedabad PMDT site said that, “We counsel all our patients and also tell them about infection control methods to be practiced at home. We give them a spittoon to spit into. We also ask them to wet mop the floors with 5% phenol, as we do here in the wards, or kerosene mixed water. We ask them to cover their spit with mud.” A patient re-admitted in the MDR-TB ward due to some breathing problem said that she follows all the infection control methods explained by the doctors/nurses to be practiced at home.

There is maximum ventilation in the wards. We make sure to have area equivalent to at least 20% of the floor area, to have open air space and cross-ventilation. Our healthcare staff monitors proper and regular air exchange. Each patient is provided with sputum cups and surgical masks
King George’s Medical University (KGMU), Lucknow
DR SURYA KANT, Professor and Head, Department of Pulmonary Medicine said that Patients should follow the practice for proper sputum disposal and for covering of mouth during coughing and speaking.

KS Roy Hospital, Kolkata
The OPD area was very well crossventilated. The wards were very airy, cross-ventilated and sunlit. The iron beds were at distance of 6 feet from each other, and the doors and windows occupied more than 20% of the total floor area of the wards. There were separate wards (and building) for male and female drug resistant TB patients and a separate waiting room in a building across the wards for patients’ attendants. DR VR PRADHAN, Superintendent, KS Roy Hospital, told us that, “Infection control is a very important part of controlling the spread of the disease and we strictly follow all the air borne infection control
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methods. Broadly speaking they are about cough etiquette, sputum disposal system, sputum disinfection system, biomedical waste management, counselling on not spitting etc, and they must be followed everywhere-- in and outside the wards; in the OPD; in the laboratories, in communities among other places. Sputum disposal is in lid-covered sputum cups and these cups are kept overnight in 5% phenol solution before being washed and ready for use again. Wet mopping of floor with phenyl disinfectant is done. The ward master is in charge of cleaning the wards. Biomedical waste disposal is in place. As per RNTCP guidelines washing soap should have 70% alcohol. But as this is not available, we use carbolic soap instead. We also take adequate steps for prevention of infection among healthcare providers. They are told to keep their faces away from the patients, use surgical masks, do proper hand washing and use swabs. They are actually trained and they teach themselves how to take care of the infection from the patients. We continuously counsel our staff on infection control methods.” MS BANSRI MONDAL, Nursing Superintendent said that, “When the patients are admitted here for treatment initiation, we instruct them about infection control methods which they have to follow at home, but we do not know if they are actually following them. So the community healthcaregiver must actually do regular home visits to check among other things that infection control measures are in place. We have to use other means also to further stress upon good practices of infection control through

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advertisements and health education.”

Lok Nayak Hospital, Delhi
When we went to the Hospital in February 2013, the indoor wards had been temporarily closed for renovation work. So patients who needed to be admitted were being accommodated in Rajan Babu Institute of Pulmonary Medicine and Tuberculosis. We found that the OPD was located in a very big hall with separate large and open cubicles for

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doctors, equipped with exhaust fans and proper ventilation. We reached there at 9 am and the work was already in full swing. The place was spick and span and all the outdoor sputum positive patients who had come to take their medicines or show themselves to a doctor were wearing masks. The patients I spoke to said that they had been given clear instructions by the doctors on infection control methods to be practiced at home, like using a separate room and toilet and wearing a mask.

LRS Institute of TB and Respiratory Diseases, Delhi
This Institute is the only one in the entire country to have model wards for drug resistant TB patients. They consist of 24 cubicles, completely isolated from each other, which can house 24 patients—one in each cubicle—who can be monitored 24 hours a day through a screen monitor placed in the nursing station outside the ward. They have state of art infection control devices in place like negative pressure and air filters. Whatever the patient coughs never comes out of the ward, but always goes up where it is filtered out by the air filters.

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DR NEETA SINGLA, PMDT Nodal Officer at LRS, informed that, “These special wards were made to see the feasibility of these model wards in India but we found that these model wards are not feasible in India (which has a huge patient load of drugresistant TB), because of the high costs involved in their construction and daily maintenance. But since we have made them we are maintaining them as free wards.” When I sought permission to interview some patient in the model ward, I had to wear an N95 mask before entering the negative pressure special wards. The hospital also has the normal 40 bedded ward for patients of drug resistant TB where all infection control measures were found to be in place—sunlit ward, well- spaced beds, proper cross ventilation, exhaust fans, sputum disposal cups with each patient, among others. All the patients were wearing masks.

Rajan Babu Institute of Pulmonary Medicine and Tuberculosis (RBIPMT), Delhi
We were really impressed by the vast area of the institute. DR ANUJ BHATNAGAR, PMDT Nodal Officer at RBIPMT, told us that this place is spread over an area of 70 acres and was used as a TB hospital since 1935, due to its location which was outside the city in those days. We found that except for one new building which was multi-storied, the rest were all single-storied and designed in a manner to offer natural

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ventilation in and outside the wards. Dr Bhatnagar informed that when the guidelines for airborne infection control were being formulated by RNTCP they visited this place. They found that whereas recommended air exchange is 12 per hour, here in the wards it was 29, just because of natural ventilation. We saw that there were separate wards for male and female drug resistant patients. At the time of our visit in an afternoon of February 2013, 50 out of the 53 beds in the male ward were occupied —17 by XDR-TB patients. The wards, equipped with ceiling fans, were well cross-ventilated with a lot of sunshine streaming in the ward. The wide corridors were fitted with a wire mesh. All the patients were wearing masks and their beds were well spaced from each other. Some of the indoor and outdoor patients, who we spoke to, said that they had been instructed about proper disposal of their sputum at home to avoid infection. In the hospital we found adequate waste disposal system with different coloured bins for different types of waste material as per PMDT guidelines. The sputum sample collection room was away from the OPD and wards but located in a naturally ventilated open area. A chart giving clear instructions on AFB Smear Staining was pinned on the wall of the room.

Recommended air exchange is 12 per hour, here in the wards it was 29, just because of natural ventilation…

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  

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Quality counselling of those people with presumptive drug-resistant TB and their family members by healthcare providers and cured patients on infection control (in home, community and healthcare settings) among other aspects of PMDT will go a long way in ensuring success and positive outcome of PMDT in India. Infection control counselling and literacy of healthcare staff at all PMDT sites will also help improve PMDT outcomes. Uninterrupted supplies of N95 and/or surgical masks, sputum cups with lids, disinfectants, among others, are also important for PMDT success. Hands-on training of patients (and their family members or care providers) in sputum disposal, cleaning of sputum cups, proper wet mopping of floors with 5% phenol or kerosene mixed water, hand washing, wearing proper masks, washing of masks, among other measures, should be provided in a patientfriendly manner. There should be adequate facilities for hand washing and good maintenance and cleaning in the wards with uninterrupted supplies (such as soap, etc). Adequate ventilation (natural and/or assisted) at all times is important. Exhaust fans should be functional where natural ventilation is an issue. The PMDT guideline of adequate space between 2 adjacent beds, at least 6 feet, should be strictly adhered to. Cough hygiene should be promoted through signage and practice ensured through patients and staff training. Reinforcement of cough hygiene should be done at every opportunity of patient contact. Cough hygiene should be integrated in general health education and awareness missions for overarching public health benefits. Spitting should be strictly discouraged in all healthcare settings, and communities. Awareness and practice of infection control measures in home-settings was inadequate – perhaps that is why in many cases we found more than one family member was infected with drug-resistant TB. Mechanisms to monitor and help strengthen infection control in community and home settings will help pronounce the gains of PMDT. Patients, especially women who often spend most of their time indoors, should be encouraged to expose themselves more to sunshine and fresh air. Special infection control education to protect transmission of all forms of TB (and other infections) to children should be provided to patients and all family members. Similar messaging should also be incorporated in other health education campaigns for broader gains. For example, patients should be discouraged on bringing children to hospitals or drug dispensing sites, and family members should be educated and sensitized to support such infection control measures. Attendants of indoor patients in PMDT wards should be educated on infection control measures and related practices.
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“Infection prevention and control measures aim
to ensure the protection of those who might be vulnerable to acquiring an infection both in the general community and while receiving care due to health problems, in a range of settings. The basic principle of infection prevention and control is hygiene.” Source: World Health Organization (WHO)

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All India Institute of Medical Sciences (AIIMS), Delhi
Dr Shalini (in the MDR-TB Ward): “Very good communication between patient and referral centre, referral centre to diagnostic centre and diagnostic centre to the chest clinic is extremely important. It is important to have contact numbers of TB patients’ to track them, especially in case of migrant population, as they form major category of people who opt out of treatment. The health workers must also be more proactive and visit and follow up the patients properly. Education also plays an important role. Kerala with highest literacy rate has least number of MDR-TB patients.”

Very good communication between patient and referral centre, referral centre to diagnostic centre and diagnostic centre to the chest clinic is extremely important

Civil Hospital, BJ Medical College, Ahmedabad, Gujarat
Dr Amar Shah, Consultant for RNTCP for the state of Gujarat: “From the patients’ perspective, we need counsellors in management of MDR-TB not only at the state but also at peripheral level to ensure adherence; otherwise after 6 months once the patients start feeling better there is likelihood of their not adhering to treatment. Family involvement is important. So this positive energy is needed by the patients. We need trained counsellors at macro and micro levels. We need one counsellor at the DR-TB centres, where the patient gets admitted, to counsel not only the patient but also his or her family members and other care providers, especially for drug side-effects and to look for behavioural changes like depression and suicidal tendencies. We need counsellors at district and peripheral levels also. So expert and continuous counselling is needed at all 3 levels. The RNTCP sanctioned the posts of counsellors in 2011. So now we have stopped taking the help of NGOs in the area of counselling as it a part of the programme. Now we have diverted their help to other areas like helping with TB programme among prisoners. We have also started a programme where the counsellors are appointed for TB patients in the prisons.

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Eli Lilly was earlier supporting us in 7 districts. They were having counsellors at district level who would visit each diagnosed patient and have a profile for each patient on the basis of which we provided support to needy patients. Eli Lilly was supporting in proper follow-ups of patients. Now we do not need counsellors from Eli Lilly but they still help in pulmonary (through lung exercises for example) and occupational rehabilitation. They help in providing sewing machines for the female patients and other things like cycles to help them.” Dr Leuva, DTO Ahmedabad Municipal Corporation (AMC):

Eli Lilly was supporting in proper follow-ups of patients. Now we do not need counsellors from Eli Lilly but they still help in pulmonary (through lung exercises for example) and occupational rehabilitation. They help in providing sewing machines for the female patients and other things like cycles to help them

“Initial counselling is most important. We must counsel the presumptive MDR-TB
patients beforehand. They must be told that the treatment is of long duration and may involve complications and hence hospital admittance. We must also communicate with the family members. There should be prompt follow ups. For example, as I came to know that a patient of mine met with a fracture then I made a follow up within next 24 hours. I assured him that he will get the medicine and injections at home for it. So, social communication is very important and there must be a good doctor- patient relationship. I always make sure that the patient gets proper follow ups, even when I am not available. I always make sure that there is some other person available for follow-ups in my absence. Face to face communication always proves to be successful. I even call the patients to meet me, wherever mutually convenient (and not necessarily in a clinic setting), to counsel them in case they do not want me to come to their house. My staff also coordinates accordingly and counsels patients outside their homes if necessary. I would like to recall one incident. I still remember my first patient of MDR-TB: Leela Ben. She was a vegetable vendor. A private doctor had his clinic nearby and he really helped and counselled her. The doctor went to his clinic every day, even on holidays, to give the medicine to her. He was from private setup but he ensured patients adhered to complete treatment and coordinated very well with us. I feel very

satisfied even if I am able to save one patient. All my past patients still are in contact with me and we share a very good relationship.”

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Dr Pranav Patel, microbiologist in charge of IRL at BJMC: “We counsel the patient to ensure that we get good quality sputum sample for test. We request the patient to give sputum sample avoiding blood as it hampers the overall result. If the sputum is good then we can obtain the result just in 3 days, otherwise the sample with blood would have to go through the process of culture and it would take a much longer time. We sensitize the healthcare providers to collect the best sputum sample avoiding even a single food particle in it. The correct method for the patient to give sputum sample is after doing gargling. Between 2009 and 2012 out of a total 35,000 samples, we got only 76 samples with blood. By improving quality of samples we have got 97% correct results.”

Dr Chhaya: “Patients are already fed up of taking drugs by the time they are diagnosed with MDR-TB. When they are told that they have to be on treatment for another 24-27 months, they are really dejected. So in case of MDR-TB patients counselling should begin right from day zero when the sputum is sent for culture sensitivity. We tell all the facts very clearly to the patients: if you have MDR-TB then you will need treatment for 24-27 months; you will have to take daily injections also, except on Sundays, for at least 6 months and after that you will take only oral drugs; in between you will be giving sputum for culture examination; if you take your drugs regularly you will be cured—there is no doubt about it. When MDRTB patients are admitted in the ward they have to be counselled again. Then when they go back to their home, the DOTS provider, along with Medical Officer (MO) and DTO should counsel them regularly. If this is done properly there will be no treatment adherence problem.

We counsel the patient to ensure that we get good quality sputum sample for test. We request the patient to give sputum sample avoiding blood as it hampers the overall result. If the sputum is good then we can obtain the result just in 3 days, otherwise the sample with blood would have to go through the process of culture and it would take a much longer time. We sensitize the healthcare providers to collect the best sputum sample avoiding even a single food particle in it.

We also give the phone numbers of all our healthcare providers to the patients. We tell them that they are free to call anyone of us at any odd time and we will be there

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to solve their problem. And they do call and we do attend to them. We counsel them repeatedly. We have developed counselling tools even in local language for the patients, for the DOTS providers and for the supervisors. Doctors are the best counsellors. At the time of treatment initiation we make patients aware of the probable side-effects of medicines in a gentle way: if you have yellow urine, or giddiness or any other problem, then please let us know on phone. We do not tell anything bluntly as that is going to affect there adherence to treatment. We train our DOTS providers to observe the patient for any side-effects like jaundice and behavioural changes.

Patients are already fed up of taking drugs by the time they are diagnosed with MDR-TB. When they are told that they have to be on treatment for another 24-27 months, they are really dejected. So in case of MDR-TB patients counselling should begin right from day zero when the sputum is sent for culture sensitivity

Cyclocerine is the worst drug in terms of side-effects which gives rise to psychological problems like suicidal tendency and acute depression. We have patients who have tried to commit suicide. Other side effects like joint pain, nausea etc are minor ones. With the help of Eli Lilly we have tried to rehabilitate patients by giving them cycles, sewing machines, lorries to sell vegetables, etc.”

Calcutta Rescue Centre, Kolkata
Dr Aloknanda Ghosh, Deputy Chief Executive Officer, Health and Operations: “Counselling and awareness is very important. We do have counsellors—we have our health education consultant over here and we also have health educators in the Calcutta Rescue staff who give health education at the beginning of treatment and when the patients come to take medicines. So at every opportunity patients get the health education.” Ms Bobita Chakarbarty, Nursing Supervisor: “When patients hear for the first time that they have MDR-TB they get a shock. That is the time I counsel them and talk to their family. Talking to the family of the patient is very important to make them understand about TB. They must be given health education about MDR-TB in the interest of the patient completing treatment. So I counsel both—the patient as well as the family. Many of our TB patients are also HIV positive and some have diabetes. So many of the patients have to take medicines for more than one disease and they feel they have to take too many medicines. My biggest problem is patients with alcoholism. They are the ones who are at a much

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higher risk of not adhering to treatment. With other patients we do not have much problem about treatment adherence. One of my patients is a young girl who is now in the continuation phase (CP) of treatment and comes here every day to take her medicines. Sometime ago she developed some psychological problems: sitting all day at home with nobody talking to her. So I advised her family to send her to school again. But she is very shy and thought that she is Group counselling session facilitated by Bobita Chakarbarty overage for her class. I told her that age is never a bar for studies. I even counselled her family for it and now she is very happy going to school again and talking to her friends. She started going in January 2013 only when she was infection free. From the school she comes here to take medicine. Earlier she would cry all the time but now she is back to normal and very happy.” A female patient: “The Doctor has counselled me on some preventive measures and for this I have my separate bed at home, I have separate utensils to eat my food and a separate water bottle. I do not eat with my siblings. Even in school I keep a handkerchief on my mouth while talking or sneezing and I want to tell all other people that we must take proper medicines and on time and also that we should never miss even a single dose. Bobita didi helped me a lot by just talking and listening to me. She forced and convinced me to join school again which has made me very happy.”

Even in school I keep a handkerchief on my mouth while talking or sneezing and I want to tell all other people that we must take proper medicines and on time and also that we should never miss even a single dose. Bobita didi helped me a lot by just talking and listening to me. She convinced me to join school again which has made me very happy

Another female patient: “I have been counselled by the doctor to put on the mask whenever I open my mouth to speak or else cover my mouth with a handkerchief when I go out for better infection control or as a preventive measure. I have been coming every day to

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Calcutta Rescue Centre since past 9 months to take my medicines. This centre is very good and the staff is very understanding and caring.”

King George’s Medical University (KGMU), Lucknow
Dr Surya Kant, Professor and Head, Department of Pulmonary Medicine: “I believe religious and faith-based leaders have an important role to play as counsellors. They need to be educated and told that they need to create awareness in the society. They should be asked to tell people that TB is curable and it can be cured by regular and proper treatment. Irregular and inadequate treatment is another major challenge. Once the patient becomes symptom-free within 4-6 weeks he/she tends to stop the treatment. So, doctor-patient communication is needed. Counsellors should be appointed at the tuberculosis centres and they should regularly counsel patients for treatment adherence. Doctors can only prescribe drugs and it is not possible for them to monitor patients daily. So, a special force of volunteers and health workers need to be created to do this important task.

There is enough evidence linking tobacco smoking with TB, so incorporating tobacco cessation and education services to strengthen counselling will have far reaching results on public health

We need to raise awareness about overarching benefits of daily adequate sunlight exposure which should also be a part of TB control policy. Also balanced diet is very important to support patients who are on treatment. There is enough evidence linking tobacco smoking with TB, so incorporating tobacco cessation and education services to strengthen counselling will have far reaching results on public health. We run a tobacco cessation clinic at our site. Counselling must address issues related to tobacco and other forms of addictions including alcohol. ”

KS Roy Hospital, Kolkata
Dr VR Pradhan, Superintendent: “Counselling is very important because patients have a tendency to defer and leave treatment midway mostly because of the toxic side-effects of the drugs. Counselling should start from the time the sputum sample is sent for testing. It should not be left for later after diagnosis has been made. Once patient is diagnosed with MDR-TB then next stage of counselling should be done at district level. There should be counselling before diagnosis and after diagnosis; before treatment initiation and after initiation; and in the continuation of treatment for two years. We need this counselling, which we have arranged for in this centre. Close contact with the patients is important so that they do not leave us midway without completing treatment. When the patients
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come at PMDT site counselling should be given to both- the attendants as well as the patients. Counselling should be face to face and group counselling is better. If there is any complication, like drug toxicity or disease complication, that should be taken care of very quickly. There is one TB-HIV counsellor posted in the district. There is There is need for counsellors much more need for counsellors much more in the districts, because in the districts, because patients stay patients stay there and are on there and are on drugs for two years. drugs for two years. Counselling should also be like a training for Counselling should also be like a training the patients-- how to stay in for the patients-- how to stay in the the ward; how to stay in their house; how to spit; how to ward; how to stay in their house; how to dispose the sputum—all this spit; how to dispose the sputum should be part of counselling too. In the patient’s house there may be no ventilation like we have here in the hospital—there may be just one door and no windows. So counselling is important for two reasons- for adherence to treatment and for air borne infection control.” Bansri Mondal, Nursing Superintendent: “Counselling is the first and foremost thing for MDR-TB patients because it is mostly the basic DOTS patients who get MDR-TB. So actually the DOTS patients should have regular counselling along with regular medicine supply. If this is the regular practice then we are less likely to have a patient become drug-resistant. So we have to take care of counselling even at basic DOTS stage so that patients get cured of drug susceptible TB successfully. A lot of stigma is still there, especially in case of female patients. Stigma is created

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by society and families. Just 15 days back we had a patient from A lot of stigma is still there, Midnapore district in West Bengal especially in case of female who told that her husband had left her because she had MDR-TB. patients. Stigma is created by Our role to address this stigma is society and families. Just 15 limited inside the hospital. I think much more needs to be days back we had a patient done at the grassroots level with from Midnapore district in the help of social workers, NGOs, counsellors and the politicians. West Bengal who told that her The poor patients are very busy husband had left her because to earn their bread and butter. So when they start the medicine she had MDR-TB. Our role to in the initial phase and start address this stigma is limited feeling better they stop taking medicines and go to their work inside the hospital. I think not realizing that it is for their own betterment that they should much more needs to be done continue treatment. So there is need for continuous counselling and supporting the family - if the only earning member is suffering from TB, he or she is not able to work and the family suffers. It may just not be enough to counsel them to take medicines regularly. There should be some way of providing them with food and shelter also. It is my personal view that if their socioeconomic condition is not improved, if they cannot meet their basic needs then you cannot expect them to complete the treatment. We can set up RNTCP programmes but unless we ensure they address problems faced by patients, outcomes will be limited. We must make patients feel good and confident by counselling them properly.” MDR-TB Patient: “I am very happy here. The sisters (nurses) are doing much more than my family could ever have done. All the responsibilities which should have been taken by my family members are being taken by the sisters (nurses), caregivers and doctors of this hospital. I am very grateful to all the hospital staff. We should believe the nurses and doctors, and other healthcare givers, listen to them and follow what they tell about what to do and what not to do and adhere to the treatment schedule. This is going to benefit us after all. Another MDR-TB Patient: “I am very happy with the kind and loving attitude of the nursing staff here. They are all very affectionate. I feel fitter here than at home. The sisters (nurses) are very good. They always ask about my wellbeing. Please pray for my recovery.”

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Ms Sayantani Bose, Social Counsellor, CARE India (She is supported by Eli Lilly through CARE India and counsels PMDT patients at KS Roy Hospital, Kolkata)

“We cannot help the patient with any physical problems (arising
out of medication) as these problems are dealt by the doctors and the nurses. But the counsellor can play a major role when the patient undergoes mental problems and needs some social support. The patients start from CAT-1 and then goes to CAT-2 and then to CAT-4. So, it is a long period that they have to undergo treatment for MDR-TB. We come across many cases of frustration because every time the patients are told that they will get cured soon. Even in CAT-1 they are assured of the fact that they will be cured. The same thing is conveyed in CAT-2 also although it may not happen and then it may lead to MDR-TB and so, frustration occurs. So, we help these patients in such cases. We give mental strength to the patient which is very important. There are stigmas associated with the disease and we help patients to overcome them. COUNSELLING OF FAMILY MEMBERS Counselling of family members is one of the important tasks. We can counsel the patient but patient may not always be in that state of mind. So, at first point of contact we try to counsel the family members also. We tell We come across them the kind of support that should be provided to the many cases of patient. Family members also undergo the phase of frustration due to their relative undergoing years of frustration because treatment. Counselling is also important because some of the every time the patients might go to the private sector leaving the RNTCP. patients are told They are frustrated with the fact that they are not getting relieved in the government sector. So in order to reassure that they will get them of the government facilities and their fruitful results, cured soon. Even in counselling plays a major role. NUTRITION Regarding nutrition and counselling I, advice the patient to be on a proper balanced diet. In nutritional counselling it is important to remember the diabetes and tuberculosis association-- like a patient living with diabetes should not take too much quantity of food at one time. They should eat smaller amounts at regular and frequent intervals. I have learnt this thing from the doctors who are staying in the hospital. I also learnt from them on how to give nutritional tips to the patient and now I give them. There are some myths associated with nutrition. People think that they should not take food which is sour in taste. They also think that costly food like meat fish and eggs are more nutritious.

CAT 1 they are assured of the fact that they will be cured. The same thing is conveyed in CAT 2 also although it may not happen and then it may lead to MDR TB and so, frustration occurs.

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But all this is not correct. I tell them that a balanced diet consisting of pulses, rice and vegetables is the perfect diet. I advise my patients from staying away from cold and stale food. I also advise them to drink 6-7 glasses of water a day. The point in treatment literacy that I would like to mention is about treatment duration and also I tell them the interval of the culture- the time period in which the culture needs to be sent for the further processing. I also tell that it is also the responsibility of the patient to ensure the sputum is sent for culture in time, otherwise it would unnecessarily make treatment longer-- Instead of six months it might lead to a period of 9 months of injections. Although, the centre contacts the patient but it is also the responsibility of the patient to get back to their respective centre and get their sputum culture done at the right time. I also tell them that duration of treatment is longer for MDR-TB than their earlier TB but they will have to complete it. I advise the patients to complete the process of eating medicines within 30 to 40 minutes and take a gap of five minutes between two pills in order to avoid the problem of vomiting. I also advise them to take medicines on an empty stomach. The injection should be completed within one hour of taking the medicine.

INFECTION CONTROL COUNSELLING I advise the patients to always wear masks in the initial period of six months. They should keep 2 masks in use regularly. One can be washed and dried in sunlight while the other is in use and this process should be continued till six months. When the culture becomes negative then the patient does not need to wear the mask all the time -just needs to wear it during sneezing and coughing and then it is up to the patient to use the mask later on. But in the initial 6 months it is really important. The other important point is that the patient must stay away from children. Proper disposal of sputum is important. The sputum should be kept in a container with phenol. I would also like to mention that some people wrongly believe that one can get TB through use of utensils/ clothes of the patient, but TB is an air borne infection. The most important thing is keeping doors and windows open for cross ventilation. WOMEN AND TB It is generally seen that if a woman is having TB then she is being looked after by her parents, brother, sister or anyone but not in-laws or husband. I would also like to

I tell them the interval of the culture- the time period in which the culture needs to be sent for the further processing. I also tell that it is also the responsibility of the patient to ensure the sputum is sent for culture in time, otherwise it would unnecessarily make treatment longer-Instead of six months it might lead to a period of 9 months of injections. Although, the centre contacts the patient but it is also the responsibility of the patient to get back to their respective centre and get their sputum culture done at the right time.

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mention a unique case wherein a woman requested me to keep her admitted in the hospital so that she could escape from the hard work imposed by her inlaws. The lady said to me ‘Didi please get me admitted and keep me in the hospital otherwise my mother-in-law will make me do hard work.’ I spoke to her husband and mother-in-law and after the things got well and she came up with a negative strain, the mother-in-law was convinced and she took her daughter-in-law back home. But then I came across a counsellor who told me that another lady was struggling with the same problem of family issues and was prevented by her mother-in-law from even touching her 3 years old son because of her TB. This counsellor wanted to talk to the motherin-law for counselling her but mother-in-law refused. CURED PATIENTS I also bring cured patients in the counselling sessions. We organize a patient provider meeting in the TU (tuberculosis unit) where patients are free to share their problems with the medical officer and the medical officer addresses those problems. I deliberately include one or two cured TB patients in these meetings who share their experiences of various stages of TB treatment they have undergone. They also talk about the difficulties faced and the way they had overcome them. This inspires and motivates other patients to complete treatment. It is not only the cured TB patients that I bring in counselling session for motivating others but I also bring those who have left treatment in between, or have interrupted their treatment, to share their views and many of them are now back into the treatment and are feeling much better.

a woman requested me to keep her admitted in the hospital so that she could escape from the hard work imposed by her inlaws. The lady said to me ‘Didi please get me admitted and keep me in the hospital otherwise my mother-in-law will make me do hard work.’ I spoke to her husband and mother-in-law and after the things got well and she came up with a negative strain, the mother-in-law was convinced and she took her daughter-in-law back home. But then I came across a counsellor who told me that another lady was struggling with the same problem of family issues and was prevented by her mother-in-law from even touching her 3 years old son because of her TB

COUNSELLING AT DIFFERENT LEVELS I am counselling at the KS Roy TB hospital. I counsel the patients from the time they get admitted for treatment initiation at the DR-TB site. I also counsel the patients when they get discharged and then I also continue with the follow up process either through the STO, PMDT, or may be in some cases, directly. Many patients give their mobile number, so I contact them over phone. In many cases the patients tell that they do not want to take the medicines and they feel better by not taking medicines. In that case I visit the patients’ house and counsel them directly. I am supported by Lilly MDR TB Partnership through CARE India which has partnered with the RNTCP.

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SELF-MOTIVATION counsellor for so many In order to boost morale I tell patients that it is a patients and the number long duration treatment and I agree with them that it is painful to take these medicines. I talk to is increasing day by day. It them and show empathy. I think that helps the is very difficult for one patients. The RNTCP is providing only the drugs. I single counsellor to think if the assurance and mental support is helpful then I must do that and I have also seen address problem of all patients following our suggestions as they now patients so it is very have faith in me. So, it also inspires me. important that counselling Regarding my family initially I did face some problem from my husband’s side. He questioned should not be seen me that why do I work only for TB and that too separate and it should be for MDR-TB. When I consulted the doctors they integrated at all levels told me that the TB germs are present everywhere and we need not worry. This information which I got from knowledgeable persons was enough to convince my husband and now I do not have any problem. WAY FORWARD Usually there is a single counsellor for so many patients and the number is increasing day by day. It is very difficult for one single counsellor to address problem of all patients so it is very important that counselling should not be seen separate and it should be integrated at all levels. We may start with the staff of the hospital as they may also have misconceptions.” Dr Bandita SenGupta, Project Manager, CARE India “DOTS provider is the first point of contact with the MDR-TB patient and will be staying with him for 2 years to complete the treatment so he or she can be the best counsellor. Generally in RNTCP, when a patient is diagnosed with MDR-TB they call the DOTS provider and just teach the provider how to help with the treatment card. Nothing else is conveyed to them. So we identify 10-15 DOTS providers and organize quality training sessions for them. We have not seen any such module on the website of RNTCP. In West Bengal we have developed a booklet in Bengali language as a guide for DOTS Plus providers. It mainly focuses on the points on how to be a good counsellor, apart from giving basic information on MDR-TB. We use these booklets during training sessions too. RNTCP is also using the same booklet. Earlier when MDR-TB patients were admitted in the hospital for at least 1 month for treatment initiation, life would become very monotonous for them away from home. So we used to provide them with some
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recreational media such as games like carom-board, ludo, chess, among others. Right now we have 5 counsellors supported by Eli Lilly. The program has evolved over two years and many changes have been incorporated since the time it was initiated. Initially there was concept of counsellors at PMDT sites but now the focus is also on the district level. The counsellors are taken for this project. When the project was started, there were 2 counsellors including Sayantani and another person at the PMDT site in Jalpaigudi district. Later in consultation with the RNTCP, three more counsellors were appointed who are based at the district level in Howrah, Murshidabad and Bardhaman. So now the counselling services are also decentralized.”

Right now we have 5 counsellors supported by Eli Lilly. When the project was started, there were 2 counsellors including Sayantani and another person at the PMDT site in Jalpaigudi district. Later in consultation with the RNTCP, three more counsellors were appointed who are based at the district level in Howrah, Murshidabad and Bardhaman

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Lok Nayak Hospital, Delhi
Dr Ashwani Khanna, PMDT Nodal Officer, Lok Nayak Hospital: “As a matter of fact I myself counsel my patients. We have 3 medical officers here and I prefer to counsel all the patients personally and in case the junior residents have counselled them, we confirm from the patients about what they were told and then we put a stamp on their prescription and sign it just to make sure that she/he was counselled. I am very sure that if we counsel them from the very beginning then we do not need a DOTS provider to counsel them later. We must tell them the facts that it is a fully curable disease if they take the medicines regularly and complete the treatment. We tell them that we are there to help you and very often the default rates go down because of this. In my opinion counselling is more effective if started early at the commencement of treatment. If it is done later, the patient may already be feeling better and would not be that receptive. So if you tell them at the very beginning that they will start feeling better after one month but that treatment would last for 24 months which will cure the disease completely and prevent reoccurrence of disease, then response will be better. It is very important to counsel the family members along with the patients.

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Good counselling in the DOTS programme itself is very important. Here we counsel each and every patient put on DOTS to prevent them from leaving treatment midway and encourage them to take their drugs regularly. In case of MDR-TB patients we make it a point to treat them properly and fully and also screen their contacts. We are doing this in the programme but good advertising and publicity is also needed.

It always feels very good when your patient of MDR-TB gets cured after 2 years of treatment and comes with a smile on his face. It gives us happiness when we tell them that you are alright and cured and then we get an immense sense of satisfaction.”

Good counselling in the DOTS programme itself is very important. Here we counsel each and every patient put on DOTS to prevent them from leaving treatment midway and encourage them to take their drugs regularly. In case of MDR-TB patients we make it a point to treat them properly and fully and also screen their contacts.

LRS Institute of TB and Respiratory Diseases, Delhi
Dr Neeta Singla, Nodal Officer for managing MDR-TB: “Counselling can take the patient through the entire treatment. There are some NGOs who are helping in the programme in some parts of Delhi, and there the treatment non-adherence rate is much less (7-10%) than what we have here (20%): the main reason being that they have some NGOs doing the counselling, giving patients emotional support and some physical support in the sense that they take patient to the hospital if required and so these small steps help in a big way. Constant counselling at every centre will help. We also have counselling tools for all healthcare staff - the medical officer at the peripheral unit, district TB officer, the medical officer of the MDR-TB centre or wherever the patient comes and seeks help. We all are being given training to give counselling at whatever level we are, apart from the counsellors hired specifically for that purpose. The RNTCP is now planning to have counsellors to counsel all the MDR-TB patients. Under the RNTCP within about a year’s time we will have counsellors who would he lp patients because that is very important. We have learnt from different programmes, like the AIDS programme, that the role of counsellors is very important.

Counselling can take the patient through the entire treatment. There are some NGOs who are helping in the programme in some parts of Delhi, and there the treatment non-adherence rate is much less (7-10%) than what we have here (20%)
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Almost 70% to 80% of the patients have some adverse drug reactions and so they need some kind of emotional support. Community support is also important. TB is a disease where you require support from all. When we go for home visits they ask us to call them wherever we want but we should not come to their place as they do not want anybody to know about it, due to stigma associated with the disease. But there are also examples where community has been very supportive - like we get some patients where the neighbour is running around with some papers that we need to help this patient. But we also have examples where landlords have chucked their tenants out once they came to know about them having MDR-TB.”

Murshidabad Medical College and Hospital, West Bengal
Dr Kajal Krishna Banik, Medical Superintendent: “Human resource is a continuous demand of the programme. But at the same time I am confident that it is not possible to provide one healthcare provider to each and every individual patient. It is not possible in a resource constrained country like ours. But if human resource is increased at all levels then definitely the services would be easily rendered to all the patients who are in need of it.

New Delhi TB Centre
Dr Jayant Banavaliker, Chairman, New Delhi TB Centre & former Director, RBIPMT: “I feel that if a patient is adequately counselled and if the doctors talk to the patient, one will never have this problem of non-adherence to treatment. Unfortunately, we do not counsel the patient properly. So after taking treatment for some time the patient starts feeling better and thinks that there is no need of taking anti-TB drugs anymore. Patients need to be counselled on side-effects of anti-TB medicines which is another reason for non-adherence. I believe that the patient should be treated like a VIP. If you give a patient hearing to the patient and then counsel him it would result in better treatment adherence. I know that there is a big load on doctors but that does not mean that they should not attend to the patient properly. It is necessary to attend to the patient and counsel him well. Health education and treatment literacy is important not only for the medical staff but also for the patients. Patients have an important role to play in successful completion of treatment. Counselling is also important to keep the morale of the patient high.”

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Rajan Babu Institute of Pulmonary Medicine & TB, Delhi
Dr Saral, MDR-TB Ward: “It is most important to ensure treatment adherence. The duration of treatment is very long and there are many medicines to take with severe side-effects. If we are able to convince the patients to take the medicine then outcome is positive. Basically we have to counsel the patient. We have to ensure that they are taking the medicine. We try to remove the complaints as much as possible. Rate of non-adherence to treatment is low here. They do have minor complaints of side-effects but we keep on counselling and motivating the patients and address their issues as far as possible within the programme. Nutrition has to be good too. A proper normal diet is sufficient. If the patients are poor, we support their diet as long as they are admitted here. If they eat what they usually used to eat then also it is sufficient.” Dr Ngilang, district TB officer and CMO in charge of chest clinic: “Counselling and continuous motivation of MDR-TB patients is very important. We ensure that our DOTS providers are doing this and we make them accountable for any patient who is not able to adhere to treatment. In cases where the patient does not turn up any day we make sure that the DOTS provider goes to his/her house the same day and the patient gets counselled and brought back to the programme as far as possible. It is our objective and responsibility to make sure that the patient completes the treatment from the first drug to the last and does not develop resistance. So, constant motivation is important.”

St Stephen’s Hospital Home-based care facility, Delhi
Dr Joyce Vagela, public health specialist, Community Health Department: “This centre is basically a community health department of St Stephens’s hospital, Delhi. Home-based care model is for MDR-TB patients. It is a home-based care model for counselling the MDR-

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TB patients. It came up in collaboration with Eli Lilly in August 2009. They get their treatment from some government PMDT site. Our role is to counsel them and help them in completing their two years treatment. Most of them have already been on a long duration of treatment (Cat-1 and Cat-2) and are already dejected. Once they come to know of their MDR-TB status and that they have to be on treatment for another 24 months, it breaks them completely. So we like to take patients early on just when they are about to begin treatment, as that is the most crucial time. We are in contact with Dr Ashwani Khanna, the PMDT nodal officer at Lok Nayak Hospital—and the list of patients comes from there. Then accordingly we select the patients on the basis of our feasibility of visiting them —those who live nearby and are connected to nearby DOTS centres. In the first phase of our project we had two members in our team — one male and one female — who were trained as per the 2005 module of DOTS Plus workers’ training. Sarthak helped in giving some training on psychological issues as well. So they are fully equipped to understand and empathize with the patients. The home care team is also fully trained as home attendants. If the patient is admitted in RBIPMT, they take from there itself. In the Intensive Phase the home visit is once every 15 days (12 visits in 6 months) and in continuation phase it is once every 45 days (another 12 visits). So generally there are 24 visits per patient in the entire treatment phase. We have a 17 page questionnaire (prepared with the help of experts) which is filled in the first visit after taking the patient’s consent. Thereafter there is one page to be filled on every home visit.

Home-based care model is for MDR-TB patients. It came up in collaboration with Eli Lilly in August 2009 for counselling the MDR-TB patients. They get their treatment from some government PMDT site. Our role is to counsel them and help them in completing their two years treatment.

The first visit is very long when all the family history of disease as well as other information is sought. We tell them about the side-effects that can occur and also ask in detail if they are facing any of them. We have found that over 40% patients have joint pains, 20% have nausea and vomiting, 15% suffer from anxiety. Besides these, there are numerous other side effects, including weakness. The patients have the

The first visit is very long when all the family history of disease as well as other information is sought. We tell them about the side-effects that can occur and also ask in detail if they are facing any of them. We have found that over 40% patients have joint pains, 20% have nausea and vomiting, 15% suffer from anxiety. Besides these, there are numerous other side effects, including weakness.
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phone numbers of our team members and they can call them any time. If the patient needs medical attendance, the team member informs me and I inform Dr Khanna (Lok Nayak Hospital) and/or Dr Anuj Bhatnagar (RBIPMT) and the patient is sent there and attended to, even out of turn. This works very well as the two doctors are very quick to respond and help. We do nursing care of the patients at home also. In the first phase of our project we had some funds to support their nutrition as proper nutrition is a big problem especially in the IP phase, as there is not enough money in the house for balanced diet. But now we do not have funds for that. But we do counsel them on having cheap food options. Sometimes it requires a lot of persuasion for them to go to the centre every day for their medicines. We take a real interest in their problems and give them love and care. They also feel very encouraged. Some times their family members are scared to take care of them for fear of contracting the disease. So we counsel them as well. We tell them about infection control methods to be followed at home to prevent spread of the disease—cover the mouths of patients, cough hygiene, sputum disposal methods (burying it or heating it on fire and then disposing it). Taking care of the adverse side effects of medicines plays a very big role in restoring patients’ confidence and ensuring treatment adherence. In the 1st phase of our project we took 101 patients of MDR-TB, out of which 69% are cured and another 2% completed the treatment (they have yet to get their final report). So 71% in all completed their treatment. The second phase of our project started in September 2012 in which we have nearly 200 patients, and as some of them complete their treatment we will take more patients. We have a very good coordination with the government. This is all due to our very dedicated team members who make a very good rapport with the patients. Seeing our work, Dr Ashwani has given us some special cases to handle (patients who have left treatment midway repeatedly or those patients who are addicted). There are over 50 children between 11 to 20 years of age who have MDR-TB and have had to leave their studies in between. They have to be counselled in a special way to be able to resume their studies.”

Some times their family members are scared to take care of them for fear of contracting the disease. So we counsel them as well. We tell them about infection control methods to be followed at home to prevent spread of the disease—cover the mouths of patients, cough hygiene, sputum disposal methods (burying it or heating it on fire and then disposing it). Taking care of the adverse side effects of medicines plays a very big role in restoring patients’ confidence and ensuring treatment adherence. In the 1st phase of our project we took 101 patients of MDR-TB, out of which 69% are cured and another 2% completed the treatment (they have yet to get their final report). So 71% in all completed their treatment

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Noor Mohammad, Project Team Leader of We also refer the Counselling Team: “Our motive is to help the patients continue and patients to the doctor complete their MDR-TB treatment. I have seen that immediately if they once the IP phase is over, men tend to become more face major side-effects careless about their treatment once they start going out to work. Women, on the other hand, remain like ringing in the ears careful throughout, perhaps because they have the or breathing problem. fear of being thrown out of the family if not treated or because of their children. In that sense women If they have minor side are more aware and conscious about treatment effects like joint pain adherence. In IP phase both understand equally, but not later when they start feeling better. Women are then we try to help more stigmatised than men due to their TB. We them out by giving counsel the family members also. Very often it is the apathy of family and community that can kill the them a massage patient, rather than the disease itself. Of course precautions have to be taken by all for infection control—but they should not ostracize or discard or humiliate the patient. We tell them about all this. As it is, an MDR-TB patient is forced to lead a very secluded life apart from dealing with severe side effects. So, emotional support of family members is vital. I feel very good to counsel them. I really listen to these persons and it feels good as there is no one to listen to them. So I feel that I must talk to them patiently because there is nowhere else these people can express their grief. I learnt from them that whatever may be the problem we must have the courage to fight with it. So, I consider myself very lucky to get a chance to work for them. Even if I get a call in the night from any of them I am available. Right now I am making a movie on cured MDRTB and TB patients after interviewing them to spread the message that TB is curable. The members of our team talk to patients about the problems that they are facing (like the side effects of medicines) and after listening to their problems try to find a solution. We just listen to them patiently and try to help them in every possible way. We also give them small tips—how to massage the swelling at the place of injection, how to cope with pain/strain in the waist region, how to do dressing of a wound-- and if the patient is
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completely on bed then we encourage him to start walking. We also encourage them to take low cost proper and nutritious diet—take jaggery instead of pomegranate for iron intake. We ask them to eat small portions several times, in case of loss of appetite. We tell the patients that the better their diet the sooner they will recover. As they are taking 13 to 14 tablets in a day this becomes very necessary. We tell them that if there is a competition between 2 persons, and one of them is stronger, the winner would only be the stronger person and not the weak one.

We also give them small tips—how to massage the swelling at the place of injection, how to cope with pain/strain in the waist region, how to do dressing of a wound-- and if the patient is completely on bed then we encourage him to start walking. We also encourage them to take low cost proper and nutritious diet—take jaggery instead of pomegranate for iron intake. We ask them to eat small portions several times, in case of loss of appetite

We also refer the patients to the doctor immediately if they face major side-effects like ringing in the ears or breathing problem. If they have minor side effects like joint pain then we try to help them out by giving them a massage. My team members are very dedicated. They know that the disease is a very risky one and anybody who works in close proximity of the patients can catch it but they are not scared. If we see any patient sitting lonely then we go talk to that person so that he can speak his heart out and feel better. We ask people to continue with their studies and tell them that it is not necessary to go to school to get education; they can get it through open schools. We tell patients about any scheme that has benefit for them. It gives us a great feeling when some patient gets cured. We ask these cured patients to tell other people that how they got well after bearing so many problems and how our team members helped them in overcoming those problems. We never wear masks when we talk to them so that they do not feel discriminated. But we encourage them to use masks. Once we come out of one house we sanitise our hands before visiting the next one.” Dr Amod Kumar, Head, Community Health Department: “It is very important that the patient is given assurance at home with the entire family being there so that the counsellor can eliminate all kinds of fear of all the family members, and create hope and solidarity with the patient and family. Also it is not possible at the clinic level for one person to counsel several patients in crowded conditions. So, we
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Darkness cannot drive out darkness; only light can do that. Hate cannot drive out hate; only love can do that.
- Martin Luther King, Jr.

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thought of this programme to actually go to the home of the patients and the patients themselves came forward to support it. The next challenge was to find out people who were willing to go to home of patients with MDR-TB as it is infectious. But fortunately we got very dedicated people who were willing to come forward and help such patients despite knowing all the dangers. Then we had to train them because counselling of MDR-TB patients is a big challenge and can be done by a trained counsellor only. We have an organization called Sarthak-- they develop special modules and train our home care providers. Gradually we realized that many of the patients were economically bankrupt, so their nutrition was a major concern. So, we requested Lilly MDR-TB Partnership to support supplementary nutrition for MDR-TB Patients. The team at the St Stephen’s Community Health Department put together a special package consisting of high protein and low cost nutrition. We also tried to get some resources, through government programmes or individual donors to help the affected families become financially independent. For example, we helped one family to set up shop; we helped another family to set up fax machine repair workshop. So, home care workers not only give them knowledge but they also give them hope that there is somebody to care for them. It is a mutually enriching experience. Counsellors also feel very happy despite knowing all the dangers.”

Gradually we realized that many of the patients were economically bankrupt, so their nutrition was a major concern. So, we requested Lilly MDR-TB Partnership to support supplementary nutrition for MDR-TB Patients. The team at the St Stephen’s Community Health Department put together a special package consisting of high protein and low cost nutrition. We also tried to get some resources, through government programmes or individual donors to help the affected families become financially independent. For example, we helped one family to set up shop; we helped another family to set up fax machine repair workshop. So, home care workers not only give them knowledge but they also give them HOPE that there is somebody to care for them

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 

 

Recognition of importance of counselling at different levels of TB care and control has certainly grown over the past years and has given positive outcomes. PMDT services has integrated multilevel counselling but number of counsellors, quality of counselling, training needs, engaging cured MDR-TB patients more effectively as equal partners with dignity, are some of the areas to further strengthen counselling and enhance positive programme outcomes. As India envisions to achieve universal access to TB care and control in next five years, it also includes universal access to quality counselling and support at different levels. As post of counsellors has already been sanctioned by the government, recruitments should be made at the earliest across the country, proper quality training in counselling should be provided on a range of issues related to drug-resistant TB care and control, and financial compensation to counsellors should be given on time every month. We learnt from our interviews with care providers, MDR-TB and XDR-TB patients who are currently seeking care from PMDT sites, and cured MDR-TB patients that there were issues that can perhaps be better addressed through quality counselling. For example, diagnostics (such as giving quality sputum samples, explaining why culture and DST results will take few weeks or months, among others) and treatment literacy, adverse side-effects of drugs and their management, contextual nutritional needs, issues related to diabetes and TB co-morbidity, infection control in patients’ unique context in household and community settings, addressing stigma and discrimination (if any) by engaging family members and other people (such as school staff or work place colleagues) in counselling sessions, tobacco cessation and alcohol de-addiction needs (may be providing referral services), among others. There should be sincere efforts in terms of messaging and communication campaigns, to normalize wearing of masks by patients as well as care providers. The stigma associated with wearing of masks must be addressed. Many of the married women seeking care from PMDT sites we interviewed were not getting support from their husbands and were rather supported by their parents. The counselling needs with female patients are unique and need much greater attention. There should be enough female counsellors to meet the unique counselling needs of women who come to seek TB care. Counselling for women by women should address issues related to pregnancy, child care and infection control, stigma and discrimination, nutrition, among others. Partner or husband and other family members should also be counselled adequately, especially to address stigma and discrimination issues, and encouraged to support the woman on treatment where appropriate. Regular home-based counselling to address specific issues during the entire treatment and care of patients (and their family members) in PMDT has shown to give positive results. More NGOs and private public partnership (PPP) models should be utilized to strengthen home-based care including counselling support. Cured MDR-TB patients we interviewed were instrumental in bringing back patients who had left treatment midway in PMDT. Cured patients must be supported in PMDT (even financially) to play a key role in counselling where appropriate. PMDT team members at all levels should be engaged in counselling as appropriate.

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Diagnostic test for drugresistant TB SOLID CULTURE (using solid egg-based LowensteinJensen (LJ) media) * The turnaround time for C-DST results by Solid Culture is around 84 days * BSL-III laboratory is must if ‘tube’ will be opened for DST - Phenotypic method

Advantages - Mycobacterial culture and identification of M. tuberculosis provide a definitive diagnosis of TB, significantly increases the number of cases found (often by 30-50%), and can detect cases earlier (often before they become infectious). Culture also provides the necessary isolates for conventional DST. - Solid culture methods are less expensive than liquid culture systems

Disadvantages - Culture is much more complex and expensive than microscopy to perform, requiring facilities for media preparation, specimen processing, and growth of organisms, specific laboratory equipment, skilled laboratory technicians, and appropriate biosafety conditions. - Results are invariably delayed due to the slow growth of mycobacteria. - DST methods are suitable for use at central/national reference laboratory level only, given the need for appropriate laboratory infrastructure (particularly biosafety) and the technical complexity of available technologies/methods.

Limitations - Specimens have to be decontaminated prior to being cultured to prevent overgrowth by other microorganisms. All decontamination methods are to some extent also harmful to mycobacteria, and culture is therefore not 100% sensitive. Good laboratory practices maintain a delicate balance between yield of mycobacteria and contamination by other microorganisms - The accuracy of DST varies with the drug tested. Phenotypic DST is very reliable for isoniazid (H), rifampicin (R), and streptomycin (S), and somewhat less reliable for other drugs such as ethambutol (E) - Specimens have to be decontaminated prior to being cultured to prevent overgrowth by

LIQUID CULTURE (endorsed by WHO in 2007) - The turnaround

- Mycobacterial culture and - Culture is much more identification of M. complex and expensive tuberculosis provide a than microscopy to definitive diagnosis of TB, perform, requiring facilities significantly increases the for media preparation, number of cases found specimen processing, and (often by 30-50%), and can growth of | organisms, Best Practices in PMDT in India July 2013

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time for C-DST results by Liquid Culture (MGIT) is around 42 days - BSL-III laboratory required - Phenotypic method

detect cases earlier (often before they become infectious). Culture also provides the necessary isolates for conventional DST. - Liquid culture increases the case yield by 10% over solid media, and automated systems reduce the diagnostic delay to days rather than weeks.

specific laboratory equipment, skilled laboratory technicians, and appropriate biosafety conditions. - Liquid systems are, however, more prone to contamination and the manipulation of large volumes of infectious material mandates appropriate and adequate biosafety measures. - DST methods are suitable for use at central/national reference laboratory level only, given the need for appropriate laboratory infrastructure (particularly biosafety) and the technical complexity of available technologies/methods.

other microorganisms. All decontamination methods are to some extent also harmful to mycobacteria, and culture is therefore not 100% sensitive. Good laboratory practices maintain a delicate balance between yield of mycobacteria and contamination by other microorganisms - The accuracy of DST varies with the drug tested. Phenotypic DST is very reliable for isoniazid (H), rifampicin (R), and streptomycin (S), and somewhat less reliable for other drugs such as ethambutol (E) - LPAs are suitable for implementation at central/national reference laboratory level, with potential for decentralisation to regional level if appropriate infrastructure can be ensured. - Conventional culture (solid or liquid) is still

MOLECULAR LINE PROBE ASSAY (LPA) (was endorsed by WHO in 2008) - The turnaround time for C-DST results by LPA is around 72 hours - BSL-II laboratory required

- Genotypic methods have considerable advantages for scaling-up programmatic management of drug-resistant and HIVassociated TB, in particular with regard to speed, standardised testing, potential for high throughput, and reduced biosafety needs. - Molecular/genotypic tests are much faster than phenotypic tests, as molecular tests don’t require growth of the

- LPAs do not eliminate the need for conventional culture and DST capability. Currently available LPAs are registered for use only on smear-positive sputum specimens - M. tuberculosis isolates grown from smear-negative specimens by conventional culture methods.

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- Genotypic method

organism, and M. tuberculosis is notoriously slow growing.

required to monitor treatment response (culture conversion) of DRTB patients. - Molecular/ genotypic DST is highly reliable for rifampicin, but has limited sensitivity for detection of isoniazid resistance - Xpert MTB/RIF requires uninterrupted and stable electrical power supply and yearly calibration of the cartridge modules. The positive predictive value of Xpert MTB/RIF is low in settings where rifampicin resistance is rare and results need to be confirmed by phenotypic DST or LPA. - Conventional culture (solid or liquid) is required to monitor treatment response (culture conversion) of DRTB patients.

Xpert MTB/TIF (endorsed by WHO in December 2010) - The turnaround time for C-DST results by Xpert MTB/RIF is around 2 hours. - BSL-II or BSLIII not required (suitable for all levels of laboratories) - Genotypic method

- Genotypic methods have considerable advantages for scaling-up programmatic management of drug-resistant and HIVassociated TB, in particular with regard to speed, standardised testing, potential for high throughput, and reduced biosafety needs. - Xpert MTB/RIF detects both TB and rifampicin resistance in a single test. Rifampicin resistance is a good and reliable proxy for MDR-TB in high burden settings - Molecular/genotypic tests are much faster than phenotypic tests, as molecular tests don’t require growth of the organism, and M. tuberculosis is notoriously slow growing.

- Capacity of one device is limited to 20 specimens per day. Higher-volume settings may require more than one device - detects rifampicin resistance only, although clinical treatment can commence as per guidelines, culture DST needs to be done

- Xpert MTB/RIF is highly reliable for rifampicin resistance only Source: WHO Information Note on TB Diagnostics and Laboratory Services, online at: http://www.who.int/tb/dots/lab.pdf

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Source: PMDT Guidelines in India, May 2012

MDR-TB DIAGNOSTIC TECHNOLOGY CHOICE 1. Molecular DST (e.g. LPA DST) 2. Liquid culture isolation and LPA DST 3. Solid culture isolation and LPA DST 4. Liquid culture isolation and Liquid DST 5. Solid culture isolation and Solid DST
(Source: PMDT Guidelines in India, 2012)
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Component of unit cost figure of a laboratory procedure
Source: “TB diagnostic tests: how do we figure out their costs?” by Sohn H et al (2009)

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We visited two National Reference Laboratories (NRLs): Lala Ram Swarup Institute of Tuberculosis and Respiratory Diseases New Delhi and National JALMA Institute of Leprosy and Other Mycobacterial Diseases (ICMR), Agra; and three state-level Intermediate Reference Laboratories (IRLs): All India Institute of Medical Sciences (AIIMS) New Delhi; Civil Hospital, BJ Medical College Ahmedabad; and New Delhi TB Centre. We also visited one private laboratory of repute: Dr Dang’s Lab in Delhi.

NRL at National JALMA Institute of Leprosy and Other Mycobacterial Diseases (ICMR), Agra
Dr D S Chauhan: Senior Research Officer, Microbiology and Molecular Biology: “It would be best to test for drug resistance at the start of TB treatment itself. LPA In a single strip of LPA we have the probe for two main drugs, rifampicin and isoniazid. If the patient is resistant to any of these, the bacteria will wind on that strip. So within 72 hours we can find out if it is resistant or sensitive to these drugs. It would take 3 months to get the same result by conventional culture methods. At present molecular testing can be done only for two drugs: rifampicin and isoniazid. For other drugs we do the conventional culture testing. But scientists are now working to put another strip in LPA which has the probe for another drug also. XPERT MTB/RIF It can detect resistance to rifampicin only. We have had some cases where the patient is sensitive to rifampicin but resistant to isoniazid. Such cases are more likely to come from rural areas and especially in patients who are tobacco users. At some point of time they might have been given streptomycin or isoniazid without proper evaluation to cure their cough or cold. There is more mono-resistance in smokers, ‘gutkha’ eaters or users of other forms of tobacco. In Ghatampur village of Kanpur district, we have a unit and this region has incidence of

It would be best to test for drug resistance at the start of TB treatment itself…

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tobacco use. Rifampicin is usually given here as an antibiotic by ‘quacks’ in rural as well as urban areas to cure common ailments other than TB. This can lead to disastrous consequences if they ever happen to develop TB. So it is often the fault of the treating doctor which spreads drug-resistant TB due to a wrong regimen or a wrong prescription.

We have had some cases where the patient is sensitive to rifampicin but resistant to isoniazid

BIOSAFETY LEVEL III (BSL-III) LABORATORY AT JALMA This room has entry through fingerprint and card reader to prevent unauthorized entry. There is a double door autoclave to let the infectious material go from one end and then the cleaned one exits from the other end. The system is maintained as such to prevent all bacteria from entering it. All students need to pass an examination on good laboratory practices relevant to BSL-III laboratories, to get authorized to enter this laboratory. There is also monitoring system to monitor the people who enter the laboratory; the period for which they stayed in the laboratory; whether they wore apron and mask and followed other protocols — all this is recorded with the help of software. The main laboratory has negative pressure throughout. There are filters attached to filter out the bacteria. Sputum is centrifuged and then instantly put for culture in the prepared media where it is incubated at 37 degrees Celsius as it is the optimum temperature at which the bacteria would grow. At higher temperatures the bacteria will get killed. Liquid culture is done for patients who are serious and whose report needs to get processed in short time duration of 15 days. This is for confirmation that culture is positive. After processing the results can be seen on the computer screen, which I can access even from my home. EMERGENCY SHOWER It can be used in case of emergency, in case if some reagent falls down and casualty occurs during testing. Meanwhile the person changes, takes a shower and informs via the intercom.

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DIAGNOSTICS FOR RESEARCH PURPOSES AT JALMA (or difficult to treat cases) DNA CHIP FOR TB: In our laboratory we print the DNA chip for TB patients. As soon as the TB bacteria takes the drug, it effluxes it out (efflux mechanism), and does not digest the drug given to it to kill it. For the first time in India we at JALMA created a DNA chip which shows which genes are responsible for the efflux so that we can block those genes to let the bacteria to take the drug properly. We have made a DNA chip of 4 genes which were responsible for the drug efflux. We got a 20 years patent for this in 2010. MOLECULAR FINGERPRINTING There is a difference between relapse and reinfection. This can be found by molecular fingerprinting. Suppose in one strain I can see 4 fingerprints and after relapse again I get the same number then it means that patient has not been cured as yet. But if I get 2 fingerprints then it is a case of reinfection with another strain of TB. DNA SEQUENCER The DNA sequencer gives confirmation of whether it is a real MTB through sequencing. DNA sequencing is done when the patient does not respond to treatment. The reason for not responding can be either the person is having drug-resistant TB or does not have TB at all (it could be some other bacteria). In case if we do not find the sequence for bacteria we tell the doctor. Such cases are very rare—around 1%. MASS SPECTROSCOPY, ELECTRON MICROSCOPY JALMA does ‘protein work’ too because functional units of genes are protein. They use mass spectroscopy instrument. There is also provision of a robotic system to manage the large number of samples. The protein from the gel is picked up by these robotic entities and then the protein in the sample is digested. There is the gel from the susceptible and as well as from the

There is a difference between relapse and reinfection. This can be found by molecular fingerprinting.

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resistant bacteria. The susceptible bacterium is killed by the drugs, while the resistant bacterium is not We try to evaluate killed by the drugs. As proteins are the functional units they play an important role in the phenotypic changes. whether a change So we run two sample gels: the susceptible and in protein resistant - and then we compare the result with the help of spectrum. We do get some changes in the two expression plays types of bacteria. We have observed that 70-80% of any role in making the proteins are common. We try to evaluate whether a change in protein expression plays any role in making it resistant it resistant. We are also looking for some novel protein that can act as a novel marker for resistance. If we get that protein we can evaluate the patient as a case of MDR-TB. We also use the electron microscope to study the structure of bacteria and also the efficacy of drugs.”

IRL at Civil Hospital, BJ Medical College, Ahmedabad, Gujarat
Dr Amar Shah, WHO Consultant to PMDT Gujarat: “If any patient on Cat-1 does not respond to treatment within 2 months we screen them for MDR-TB. Again all retreatment (Cat- 2) cases on entry itself are screened for MDR-TB now. All TB-HIV patients are screened. So there is no backlog. We are now heading towards diagnosing even a fresh case of TB for resistance.” Dr Pranav Patel, Microbiologist-in-charge, IRL, BJMC, Ahmedabad: “Ours is the first IRL in India which has received second-line DST accreditation. SPUTUM QUALITY Quality of sputum sample is very important to get a correct and quick diagnosis. After getting 35,000 sputum samples, between 2009 and 2012, we rejected only 76 samples (as they were samples with blood). The samples with blood do not go through the LPA because the blood contains PCR inhibitors. These samples would have to go through the process of culture testing which would take around one and a half months to get the result. Otherwise if the samples were good quality without blood, then LPA can test and give the result in 2-3 days. So to avoid delay in diagnosis we counsel the patients to give good quality sputum sample without blood and any food particle in it. We also sensitize the healthcare providers to collect the best sputum sample. RNTCP guidelines also recommend that patients should be told the correct method of giving
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sputum samples which include: gargling few times, cleaning the mouth properly and ensuring food particles or blood may not come in the sample. SPUTUM TRANSPORT MODEL We pioneered the sputum transport model in India. The sputum is transported from the district level in thermocol boxes having pre-freezed base. Then we put on the box the name of the patient and the criteria: A, B or C; and the district and PHC to which the patient belongs. The DMC i.e. designated microscopy centre and primary microscopic centre gives us the sample and then we prepare the annexure 1 format which goes in the collection box and the samples are sent to IRL where they are kept under ideal conditions. Transportation of samples is not a problem in Gujarat. Sample remains okay for 24 to 36 hours after collection. But we get it by courier within much shorter time of 18-20 hours. The boxes must

We pioneered the sputum transport model in India. The sputum is transported from the district level in thermocol boxes having pre-freezed base at minus 20 degrees Celsius at the district level. Then we put on the box the name of the patient and the criteria: A, B or C; and the district and PHC to which the patient belongs

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be kept at district level for 48 hours at 20 degrees Celsius. The temperature is maintained so as to keep the sample solidified otherwise it will melt within 2 hours. We have proper storage facility at all district levels. All our senior supervisors, laboratory technicians and staff at district level are trained for collecting the sputum and transporting it properly. The model for keeping samples at low temperature is now approved by central TB division (CTD). LIQUID CULTURE We get the liquid media directly from Becton, Dickinson and Company (BD) as we have no guidelines in the RNTCP for preparation of liquid media. We have to prevent media contamination because if that is contaminated we again have to go through the process of collecting sample and processing it. We have the bio safety cabinet here to prevent contamination in media as well as in the sample. LPA Gujarat is the pioneer of LPA. LPA takes 34 hours. We have also devised methods for direct sputum microscopy and to receive samples from the Central TB Division (CTD). So they are sending 2 samples. We do the direct microscopy for the samples and if they are smear positive then we need to process a single sample for higher tests such as LPA. But a year ago, we had to process both the samples. So in this way we have reduced the workload as well as requirement of the machinery. PCR We have the thermocycler for the amplification. In this instrument 10-12 samples can be processed in on ego. GT Blot is used to get the amplified product. During treatment, MDR-TB patients have to send their sputum samples 11 times for follow up. On the basis of our data for the last 3 years (2009, 2010, 2011) of 70008000 patients they have made the policy that for each patient only 1 sample needs to be given every time (instead of two as was being done earlier). We are also doing another operational research in which we process only one sample for all smear negative patients. Before that we were taking 3 samples to diagnose TB. But

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thereafter, the programme decided to do it with 2 samples and now we have made an attempt to do it with a single sample. We have done this to decrease the loads of IRLs. We collect the samples and slides from various places and then process them under the direct microscopy under strict quality control just to ensure that there are no false negatives. We do this every month for quality control.

IRL at New Delhi TB Centre
Dr Hanif: “We upgraded out existing laboratory to BSL-3 level about three years ago (in 2010). We follow all RNTCP guidelines strictly and standards of good laboratory practices, such as ensuring proper air circulation per hour among other parameters so that infection is not transmitted to others and laboratory can function properly. XPERT MTB/RIF RNTCP has approved of Xpert MTB/RIF but is still debating about their operational feasibility—whether to place them at district level, or at microscopy centres, or at state level. At one time this machine can process only 4 samples in 2 hours. So in one day we can process a maximum of 16 samples. In LPA we can process 40-50 samples in a two days cycle. We do liquid culture here also which takes 2 Bio Safety Level II (BSL-2) to 3 weeks.” laboratories do not have Dr Vidyanidhi: “Bio Safety Level II (BSL-2) laboratories do not have negative pressure. But for the sample preparation, sample procedure, and extraction of DNA, the environment requires negative pressure which is available in BSL-3 laboratory. We have to have strict infection control so as not to contaminate the sample.

We have a dedicated material transport vehicle. The samples are put on it and our technical staff transports them to the receiving window outside. As per the BioSafety Level Laboratory Guidelines, the sample and the reagents have to move in one direction only, through power flow in that particular closed chamber. So the infection is also controlled. The environment is cleaned through ultraviolet (UV) rays. ”

negative pressure. But for the sample preparation, sample procedure, and extraction of DNA, the environment requires negative pressure which is available in BSL-3 laboratory. We have to have strict infection control so as not to contaminate the sample

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LPA Once we process the sample then we extract the DNA and then this DNA is processed by LPA. In BSL-2 laboratory we have 3 separated chambers for LPA: one each for mixing, amplification, and hybridization. BSL-3 In the changing room, we wear all personal protection (PP) equipment (such as a new N95 mask, shoe protection, a special apron, goggles in some cases, etc) in sequential order. We have to check the mask compatibility and integrity too. No air should come in from the sides of the mask to ensure that it is properly placed on the face. There should be no leakage. We can use one N95 mask for a maximum of 8 hours. Normally we work for 4 hours in the laboratory in one day and so we can use the same mask for two days. One N95 mask costs around INR 400 (USD 8) in the open market but we get it at a lower price. There is a special interlocking device for opening and closing of entrance door of the BSL-3 laboratory. We can also check the number of people who have been in the laboratory earlier. We have to maintain optimum temperature and pressure. If we want to open one door, we have to close the other door first. If we open both doors at the same time, then negative pressure will get dis-balanced. That is why we have
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interlocking system in laboratory. As per WHO recommended guidelines, minus 35 to minus 50 Pascal pressure must be maintained. As per the guidelines, every nook and corner of the BSL-3 laboratory is regularly fumigated with water and formaldehyde. Once the sample is decontaminated and processed it is then segregated and brought to the other 2 biosafety cabinets—one part goes for LPA (after DNA extraction) and the other for liquid culture. We have liquid culture facility where we use the machine referred to as Becton Dickinson (BD)’s MGIT. Once MDR-TB is diagnosed, then patient’s samples are sent for testing periodically during intensive phase (IP) and continuation phase (CP) of treatment to see if they are still positive or not. We are also testing smear negative cases through liquid culture. Previously we used to perform solid culture which took longer time. With liquid culture we get the result in less than 15 days (maybe 9-10 days). Once processing and testing of samples is

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completed then we will send our samples through this negative power flow. They are kept in exit transport behind which we have to have proper infection control. ”

LRS Institute For TB and Respiratory Diseases, Delhi
Dr Ajay: “The culture medium has to be sterilized in the incubator in the media preparation room because they are air-containing media and we cannot autoclave them. LIQUID CULTURE AND LPA Only two people are allowed at a time inside a BSL-3 laboratory. The first step is to prepare to go inside the BSL-3 laboratory where sample cleaning and DNA extraction among other processes is done. Once the DNA extraction has taken place in BSL-3 laboratory, rest of the procedures of LPA are done in BSL-2 laboratory. BSL-2 laboratory is divided into 3 sterile rooms; one each for mixing, amplification, and hybridization. Thermocycler is used to amplify the DNA after mixing the extracted DNA with requisite chemical reagents. Once it gets amplified in the desired number then we can analyze and give the final result. The whole process takes 2 to 3 days. This is molecular testing referred to as LPA. According to the RNTCP’s PMDT guidelines, all sputumsmear positive samples are tested using LPA for mycobacterium and also for isoniazid and rifampicin resistance. However if the sputum is smear negative then it will go for the liquid culture and if liquid culture is positive then we will do the LPA. XPERT MTB/RIF We have the Xpert MTB/RIF but it is still under PMDT’s evaluation so it is not being used for testing routine patient samples. We have done our own evaluation process and are currently using the machine for research purposes as of now.”

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All India Institute of Medical Sciences (AIIMS), Delhi
Dr Ragini: LPA “We are using a Hain company’s kit for LPA which is called anti-TB GenoType MDR-TB Plus 2002. LPA strips are based on the molecular detection of the mutation in the gene. Sputum samples of Category -1 and 2 patients who are not responding to treatment are tested with LPA. LPA can test for resistance to two drugs in our laboratory: Rifampicin and Isoniazid. The strip has wideband patterns. I will show you one example of MDR-TB. Here you can see this is resistant for Rifampicin as well as Isoniazid. In this there is a missing wide type 8 band, and we got a mutation here. So we can say this patient is resistant to Rifampicin. This is a molecular based rapid technique and within two days we are able to diagnose whether the patient has MDR-TB or not. If at four months to six months follow-up the sputum is still culture positive, then we suspect it to be a case of XDR-TB. Then the culture sample goes for the second line testing at LRS which is our National Reference Laboratory. This facility is not available at any IRL in Delhi. Here at AIIMS we are trying to get this facility too. LIQUID CULTURE We use liquid culture to test for sensitivity to four drugs: Rifampicin, Isoniazid, Streptomycin and Ethambutol. Either we can do liquid culture after LPA results or we can do both tests together alongside each other.

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XPERT MTB/RIF We have Xpert MTB/RIF in our laboratory and we can test samples if so indicated, results of which come within 2 hours. SOLID CULTURE Solid culture is still our golden standard and perhaps we may never be able to replace it with any other modern technique at least in the present context. In solid culture we are able to differentiate between the colony morphology, colour and pigmentation of the bacteria, but in liquid culture we are not able to differentiate between all these parameters. We can do testing by solid culture for first line for these four drugs and for the second line drugs also. Very soon we are planning to do second line DST by the solid culture and by liquid culture also.” Mr Rajnarayan, microbiologist: “We are using home-made media for solid culture for DST. We make our media for solid culture and also have negative pressure facility for inoculation. Our laboratory

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participates annually for the professional testing with the NRL at LRS and for the last two years our accuracy has been 95% - 98%. We incubate the media here too. Wearing of N95 mask is mandatory in our laboratory. Right now we are doing DST using solid culture for first line drugs. For rifampicin we are using 1% proportional method (For Rifampicin we are taking 40 microgram per ml and for isoniazid 29 microgram per ml). We send the test reports through email and/or SMS to the respective DTOs. ”

Dr Dang’s Lab
Dr Navin Dang: “We are very particular about the quality of reagent. The quality of reagent and sample is important for getting good results. This is the major thing that lacks in most of the laboratories. We calibrate our cold rooms once every 2-3 months. Quality control team maintains the temperature of the cold rooms daily. The temperature inside the room is below zero. We have a protocol for keeping the samples for some period. We keep the samples stored here as they might be required for some repeat tests or for some other test in near future. The samples are always taken by the doctors. Every sample comes with a barcode. Apart from maintaining quality another specialty of our laboratory is that we have all our machines in duplicate. This is done to manage the sample load so that if there is any breakdown the work does not suffer and the reports are given on time. Before we start a machine the first thing that we do is quality control. So, all the samples go through quality control and after all the parameters are qualified we run quality control for both the machines. The machines are calibrated as per the schedules. The parameters are calibrated as such. We follow

The quality of reagent and sample is important for getting good results. This is the major thing that lacks in most of the laboratories.

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the quality control parameters very strictly as on world class basis. All the instructions are followed by all the staff members. Another unique thing that we have is the cooling centrifuge. As it becomes extremely cold in winters and hot in summers in India, samples may be affected in a normal centrifuge. But here the centrifuge works at a particular optimum temperature irrespective of the outside temperature. We have an automated system for coagulation. We are very particular about the safety of staff.

All samples are routinely tested through microscopy apart from other advanced tests. It has to be validated by doctors and only then it is authenticated. Every sputum sample goes through pathologists’ eyes before it gets validated. Every sample has to be stained.

MICROSCOPY All samples are routinely tested through microscopy apart from other advanced tests. It has to be validated by doctors and only then it is authenticated. Every sputum sample goes through pathologists’ eyes before it gets validated. Every sample has to be stained. The slides are numbered properly thereafter. The system automatically reads the sample barcode-wise. Our microbiology laboratory is segregated from other laboratories as it is considered the most infectious area. We have a separate area for TB testing also. The media is prepared here and then autoclaving is also done here. The incubator is also here. We are yet to start using the LPA. There is a spill kit to be used in case of emergencies. We follow special waste management techniques. For instance we cover our dustbins with different colors of plastics like yellow is for discarding samples, red is for infected samples. We also have certain waste management agencies involved.”

King George’s Medical University (KGMU), Lucknow
Dr Surya Kant, Professor and Head, Department of Pulmonary Medicine: “In my opinion sputum culture should be done at that instant only when patient comes for simple TB testing.”

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Laboratory strengthening has been one of the major pillars of PMDT in India. The mechanisms of NRLs and IRLs are in place, training capacity and re-training of laboratory team members are in place, conventional and new molecular standard diagnostic tests are being scaled up, and laboratory strengthening processes is surely gifting TB care and control with better diagnostic competence across the country. This process needs to continue as it is surely one of the basic pillars of TB care and control: early and accurate diagnosis. Political will and financial investment should be optimally scaled up to help expedite this strengthening of diagnostic and laboratory capacities across India. Quality sputum collection was one of the key issues highlighted in our interviews with PMDT laboratory team members. Adequate counselling of entire TB staff and volunteers on the correct way of giving sputum sample should be given. Strengthening of sputum transport systems should be expedited to timely bring quality sputum samples to the appropriate laboratories across the country. The standard sputum packaging model endorsed by PMDT in India should be adhered to and staff trained and monitored to follow these guidelines as it is very important for early and accurate case finding. Uninterrupted laboratory supplies including masks and other infection control requirements must be ensured at all laboratories across the country. It is important to counsel laboratory staff on importance of bio-safety level (BSL) guidelines and protocols and reinforce counselling at every opportunity. Laboratories must ensure that all their staff and team members are strictly adhering to all guidelines, good laboratory practices, and infection control protocols. Regular adequate supplies of gloves, N95 masks, protective aprons, shoe covers, goggles (where necessary), quality reagents, sputum cups, among others, must be ensured.
Ban on TB serological tests should be strictly enforced across the country. Entire laboratory staff is already being trained in conventional and new diagnostic techniques. The quality of these trainings and reinforcement of key messages should be upheld. NRLs are already playing an admirable role of doubly making sure the reports of IRLs are validated from time-to-time. These practices should continue as NRLs and IRLs both have unique roles to play. Laboratory fumigation, UV ray cleaning, regular air exchanges, quality checks of different diagnostic machines, temperature and pressure control as needed, uninterrupted power supply, and all other protocols should be strictly upheld. Patients and their family members should be adequately counselled by TB care and control staff on diagnostics and laboratory services in India. For example, it needs to be explained as effectively as possible on importance of DST and time required tests will take to keep the patient in the programme, and not dissuade him to seek care from alternative sources. Communication between laboratory services and relevant STOs and DTOs, DTOs and DOTS centres, and DOTS centres and providers should be as efficient as possible for early case finding.

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“Laboratory strengthening did not have a prominent profile in
that plan [Global Plan to Stop TB, 2006-2015]. In 2008, the Global Laboratory Initiative (GLI) was created as a new Working Group, to give a much higher profile to the crucial need to strengthen laboratories, which are essential for the diagnosis of all forms of TB. An update of the plan [2011-2015] allows a higher profile to be given to laboratory strengthening”
Source: Global Plan to Stop TB: 2011-2015

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All India Institute of Medical Sciences (AIIMS), Delhi
Dr Kamal Verma, Department of Medicine: “At AIIMS, PMDT started in 2009 and it is one of the 4 PMDT sites which Delhi has currently. There are four chest clinics attached to this centre: Motinagar, NDMC, Nehru Nagar, and Deen Dayal Upadhyay (DDU). TREATMENT PROCEDURE Ideally it should take at least 2 weeks to put an MDR-TB patient on Cat- 4 treatment once the sputum sample is collected and sent for tests. When a patient from say any area of Delhi is diagnosed with MDR-TB, he/she then goes to the nearest DOTS clinic and from there is sent to the respective chest clinic. The DTO at the chest clinic fills an RNTCP form called Annexure 5 and sends the patient to our PMDT site with the form and culture report. Now we have to pre-evaluate the patient before starting treatment to rule out other medical conditions if any, like HIV, thyroid (as MDR-TB drugs cause hypo-thyroidism as a possible side-effect), and diabetes among others. We also do ECG and chest X-Ray of the patient. All these investigations are done free of cost. We have to take the patient’s consent for starting treatment. After doing pre-evaluation of the patients we prepare a PMDT Treatment Card and send the patients to Rajan Babu Institute of Pulmonary Medicine and TB (RBIPMT) for treatment initiation. There they are admitted for a minimum of 7 days to check if they can tolerate the drugs and do not have adverse drug reactions (1%-2% patients are not able to tolerate kanamycin injection reactions). Then the patient is discharged with 7 days medicine for transit We also have a regimen period and RBIPMT sends us an email too. After receiving the email, we inform that particular for the migrant chest clinic to arrange for the patient’s population. We provide medication. If any problem occurs with the patient during follow up —culture is positive again -- then he/she is sent by the MO for culture test here. The MO or a doctor here fills up the Annexure 2 referral form. When the sputum report comes from the AIIMS laboratory an email is sent from the laboratory itself to the chest clinic whether the patient is positive or negative. If found positive the laboratory sends another filled form to us and we pre-evaluate the patient. After pre-evaluation we send the patient to RBIPMT, and also inform them by email that a patient has been sent. After three days we find out

them with a postcard. So they go and give it to the nearest DOTS site and thus we come to know that the person is registered there as the postcard is sent to the STO. If the post card is not received then the tracing for the patient starts at the earliest

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telephonically from them if the patient has reached or not. In case the patient does not reach the hospital then we inform the DOTS site from where he/she was referred. The personnel there try to trace and convince the patient to take treatment in order to prevent further transmission.

The patients who come here are generally referred from DOTS centres. But we also have patients who are coming directly to our OPD. Once we diagnose them they are referred to their nearest DOTS centre. After the patient visits that DOTS centre, the necessary papers are made and after the patient takes them from there we trace the patient to confirm whether he/she had gone to that place or not. We get patients from Haryana, Punjab, Jharkhand and many other states as well.

Nutritional diet plays a key role in combating MDR-TB and also ensuring treatment adherence. It is important for TB patients to eat good nutrition in order to develop strong immunity to fight the disease and tolerate the toxic side-effects of medicines. The history of most of our TB patients (including those from upper strata) shows that they are poor eaters and do not take a proper diet at proper time.

We also have a regimen for the migrant population. We provide them with a postcard. So they go and give it to the nearest DOTS site and thus we come to know that the person is registered there as the postcard is sent to the STO. If the post card is not received then the tracing for the patient starts at the earliest. Nutritional diet plays a key role in combating MDR-TB and also ensuring treatment adherence. It is important for TB patients to eat good nutrition in order to develop strong immunity to fight the disease and tolerate the toxic side-effects of medicines. The history of most of our TB patients (including those from upper strata) shows that they are poor eaters and do not take a proper diet at proper time. We find that there is greater problem of Extra Pulmonary TB (EPTB) in urban population. Even after a lot of motivation, some of the patients tend to run away from treatment due to the long course and side-effects of medicines. Tracing patients who leave the treatment in between is a big problem, especially in case of migrants.” Smoking and alcoholism are two main Dr Shalini (in the MDR-TB clinic): “Smoking and alcoholism are two main problems likely to be in men which often affect their treatment adherence. Women are likely to adhere better to

problems likely to be in men which often affect their treatment adherence. Women are likely to adhere better to treatment but they suffer more because of the unhygienic conditions in which they are likely to be living, especially in rural areas where hygiene is not paid much attention

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treatment but they suffer more because of the unhygienic conditions in which they are likely to be living, especially in rural areas where hygiene is not paid much attention. Some of our EPTB female patients from rural areas do not pay attention to basic hygiene. So this could be a factor, though we do not have any data on it. The other problem that women face, especially in rural areas and urban slums, is that they stay indoors for most of the time within poorly ventilated houses with a lot of cook stove smoke pollution, whereas men do go out in fresh air and spend less time in cramped homes. Women hide their problems too and the husbands have no time to inquire about the spouses’ health. The patients must be provided with some nutritional/monetary support, especially those who are daily wage earners. Patient education and awareness is also very important.”

The other problem that women face, especially in rural areas and urban slums, is that they stay indoors for most of the time within poorly ventilated houses with a lot of cook stove smoke pollution, whereas men do go out in fresh air and spend less time in cramped homes. Women hide their problems too and the husbands have no time to inquire about the spouses’ health

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Calcutta Rescue Centre, Kolkata, West Bengal
Dr Aloknanda Ghosh, Deputy Chief Executive Officer, Health and Operations: “This centre has been treating MDR-TB patients since 1995. As per 2011 data our treatment success (cure) rate is 61%. This is not an indoor hospital, so patients are not admitted here. These outpatients come mainly to the morning clinic where we treat very poor patients from Kolkata and rural West Bengal. From the PMDT we are supporting two government aided TB programmes--one in Kolkata (KS Roy Hospital, Kolkata) and other in rural West Bengal. Also, patients who are not enrolled under the government setup are referred to us.
Bobita with a MDR-TB patient’s medicine

We treat all patients free of cost, so there is an eligibility criterion for them to become eligible for seeking treatment here. Before putting a patient on treatment, we do house visit of the patient, and if we find that they really cannot afford their own treatment then only we put them on treatment. Regarding treatment adherence we do follow a strict protocol. We take written consent from the patient as well as from the patient’s family and from the superintendent of KS Roy Hospital that unless they complete the treatment they will not be discharged from the hospital. They get supervised treatment from the nurses over there and we send the medicines. Sometimes, due to scarcity of beds, the patients admitted in the hospital are discharged when they become sputum negative. We do ask the patients’ family to bring them later to the local DOTS centre so that some medical officer or any DOTS provider or any responsible family member who is literate, can take the responsibility of supervising the drug. When they give consent then only we start the treatment. Sometimes due to cyclocerine toxicity patients develop psychological problems and some of them leave the treatment. But these are very few in number. Treatment nonadherence rate is 3% at our centre. Patients referred from KS Roy Hospital do not come here every day for their medicines but take it from the hospital only as we provide the medicines every 2 to 4 weeks to this hospital. Nutrition is a problem too but as such if we find a malnourished patient in MDR-TB then he/she is supported by our centre.”

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Civil Hospital, BJ Medical College, Ahmedabad, Gujarat
Dr Amar Shah, consultant for RNTCP for the state of Gujarat: “Patients from 13 districts are coming here for treatment initiation. We have two senior doctors along with 8 to 9 resident doctors for these patients. They take care of the patients 24 hours. Very many patients are coming from private to government set up. As per guidelines we have annexures 1 and 2 in the referral form. If the patient has some adverse drug problem then he/she is sent here with same referral form. We fast track the patients in the OPD—if they come with annexure 1 we know it is for pretreatment evaluation of MDR-TB. We do LFT, RFT, thyroid function test, blood investigations, X-Ray. Then after 2 days we start Cat-4 treatment. We observe the patient for 3-4 days. If patient is not facing any problems we discharge him/her with some documents like PMDT Treatment Card for the patient, Discharge Card for hospital, and i-card among others. We telephonically inform the district centre to which the patient is going so that his/her treatment begins upon reaching there. But now we are decentralizing the system and starting this pre-treatment evaluation at district level also. Many patients were finding it inconvenient to come to our centre for treatment initiation. Also, many Gujarat developed the model for investigations can be done at district level itself and very few cases require making patient-wise monthly drug hospitalization. The practice now is that the boxes. Now this model has been patient gets all pre-treatment investigations approved in 2012 by CTD to be done at district level itself and then the used throughout the country. The scanned copy of the results is sent to the DRreason for one month boxes is TB committee. A committee is also formed at that all MDR-TB drugs are the district level comprising the civil superintendent and physicians. So we can temperature (<25 degrees Celsius) interact with them either through phone or and humidity (<60%) sensitive. email. Thus patients who hesitate to come However, efficacy of drugs is here can seek treatment in their own district maintained for a period of 6 under the supervision of the district staff.

PMDT DRUG BOXES
We prepare one month drug boxes for the MDRTB patients. Such type of arrangement was piloted for the first time in Gujarat. Gujarat developed the model for making patient-wise boxes. Now this model has been approved in 2012 by CTD to be used throughout the country. The reason for one month boxes is that all MDR-TB drugs are temperature (<25 degrees Celsius) and humidity (<60%) sensitive.

months even if they are exposed to sunlight and humid conditions. We wanted to ensure that they remain under ideal conditions as far as possible. So at the state level we have the state-of-art drug store (at BJMC) with temperature and humidity controls. We have also upgraded all the 30 district centres with AC and humidity control monitors.

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However, efficacy of drugs is maintained for a period of 6 months even if they are exposed to sunlight and humid conditions. We wanted to ensure that they remain under ideal conditions as far as possible. So at the state level we have the state-of-art drug store (at BJMC) with temperature and humidity controls. We have also upgraded all the 30 district centres with AC and humidity control monitors. But we do not have these optimal drug storage facilities at the peripheral level of PHCs and sub centres. So from the district level, only 1 month boxes are issued to the DOTS providers at peripheral level. So storage becomes easier. We have designed special 14 grooved boxes (patient of highest weight band requires 14 tablets). This can be used even by uneducated peripheral DOTS providers, who just have to give one tablet from each of the compartments—there is no need to count the appropriate number of tablets to be given for that particular weight band. We have type A, B and C boxes: Type A for patients in Continuation Phase (CP); type B for patients in Intensive Phase (IP) when kanamycin is also added. So just by knowing the type of boxes with the DOTS provider we come to know patient’s profile that whether he is in IP or CP. In IP patient has to take injections. If patient is not tolerating any of the drugs then we have provision of replacing kanamycin with PAS, as per guidelines, which comes in the box

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type C. so it is clear that all patients will be given type A, and if they are in IP, injection will be added. Now the treatment non-adherence rate is 5%-10%.

PRIVATE PUBLIC PARTNERSHIP (PPP)
In Gujarat we already have the involvement of private doctors in TB treatment. So patients who do not want to come to government can go to private doctors. We leave their drug boxes there and they can get the medicine. This is working very well in certain cities like Rajkot and Ahmedabad. The IMA president and secretary are proactive at the state level for its proper implementation. In this the private doctor will follow RNTCP guidelines and the patient would not be forced to come to the government hospital. So the DOTS provider could be a private doctor of the patient’s choice. The private doctors are happy in the sense that though they are not earning more money, they are earning the goodwill of the patients who are getting proper and free treatment of MDR-TB and moreover that patient is bringing more general patients to the doctor. We try to convince doctors from private setup that we are not trying to steal their patients-- rather we want to support them for a common cause. We do not want to shift the patients from the private to public. We know that 80% of people in India are seeking help in private medical sector and so we cannot reach everyone without their support. We have involved homeopathic and ayurvedic doctors as well. All private doctors are also free to use our diagnostic facilities free of charge for testing MDR-TB. The only condition is that they do not charge their patients for all this.

FIGHTING STIGMA THROUGH INNOVATIONS
There is stigma in the society. If the child gets TB the parents try to hide it from others, especially if it is a girl child. So at times in cases of female patients we provide the family some ideas on how women can come to receive medicines by respecting confidentiality and without letting the others come to know about it. For taking TB medicines we tell the woman to make excuses of going to temple or somewhere else and in this way she is accompanied by her husband to the DOTS plus centre, without the entire family and neighbours coming to know about it. Many such innovative things are going on at grass roots level to ensure treatment compliance.”

Treatment adherence issues are due to several reasons. Firstly, it is the long duration of treatment. Secondly, it is alcohol. Once the patients recover they start feeling that there is no need to take precautions anymore. There must be proper communication between all the healthcare workers, and coordination between staff is also required to ensure patients’ faith in the set up. If the patients’ adverse drug reactions are attended to, they do not lose faith in the system and feel satisfied that the healthcare workers do care about them. It is all about building mutual trust

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Dr Leuva, DTO Ahmedabad Municipal Corporation (AMC): “In my long experience of treating MDR-TB patients I found that there are treatment adherence issues due to several reasons. Firstly, it is the long duration of treatment. Secondly, it is alcohol. Once the patients recover they start feeling that there is no need to take precautions anymore. There must be proper communication between all the healthcare workers, and coordination between staff is also required to ensure patients’ faith in the set up. If the patients’ adverse drug reactions are attended to, they do not lose faith in the system and feel satisfied that the healthcare workers do care about them. It is all about building mutual trust.” Dr Rajesh N Solanki, PMDT Nodal Officer, Gujarat: “The basic problem for treatment adherence is that our patients are malnourished. Our data shows that nearly 80% people in our state have low BMI. The sputum culture reversal and treatment failure is basically an outcome of low BMI. If patients’ nutrition would improve then definitely treatment adherence would also improve. Another reason is adverse drug reactions. All the second line drugs are very toxic with serious side-effects. To overcome this problem proper counselling and management at field level is required. We are working on it since past 2 years and we are supported by ELi Lilly where Dr PK Chhaya himself works as a coordinator and we have observed that many patients with protein adequate nutrition have continued with treatment and shown very good outcomes.” Dr PK Chhaya: “There is 75%-85% treatment adherence at this centre. Of course it is easier said than done. The MDR-TB patient is already emaciated—with only bones and no muscles. So if the DOTS provider is not very adept with giving injections, problems will arise as nearly 200 injections are to be taken. We train and instruct our DOTS providers how to give injections. After giving the injection we tell the provider to slowly rub the area where it was given for at least one minute—recite the Hanuman Chalisa. If this is done, then patients will

The basic problem for treatment adherence is that our patients are malnourished. Our data shows that nearly 80% people in our state have low BMI. The sputum culture reversal and treatment failure is basically an outcome of low BMI. If patients’ nutrition would improve then definitely treatment adherence would also improve. Another reason is adverse drug reactions. All the second line drugs are very toxic with serious side-effects. To overcome this problem proper counselling and management at field level is required. We are working on it since past 2 years & we are supported by ELi Lilly

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have no problem of pain or of swelling. In our state, not a single patient out of 2500 patients, has had injection sepsis.

We also provide nutritional support to some patients which acts like an allurement for them to continue treatment.”

We train and instruct our DOTS providers how to give injections. After giving the injection we tell the provider to slowly rub the area where it was given for at least one minute— recite the Hanuman Chalisa. If this is done, then patients will have no problem of pain or of swelling. In our state, not a single patient out of 2500 patients has had injection sepsis.

DRUG STORE AT BJMC AHMEDABAD
The Gujarat state drug store pharmacist Ms Ragini: “Here we make the drug boxes for one month for 30 districts of Gujarat. We just make the patients’ boxes and send them to the respective districts. This model is an innovation of Gujarat and endorsed by RNTCP for the entire country. Note: The doctor shows that each medicine box has 14 partitions, and one tablet from each partition has to be given by the DOTS provider to the patient. One month supply is packed in each box per patient. The boxes are also made and labeled here. The authorized company sends the drugs here and then from those drugs 11 types of one monthly boxes are repacked-- 5 regimens corresponding to the 5 weight bands, and in each regimen IP and CP. The last one is type C—that is PAS—which has no colour code because irrespective of the weight band we use the drug accordingly. Right now, we get the supply in sachets so there are 60 sachets to make one type C. Thus a total of 24 boxes—18 blue coloured type A boxes (for CP) and 6 pink coloured type B boxes (for IP) cumulatively make the full course of the patient. Boxes are designed in such a way that the 14 grooves/partitions accommodate the maximum configuration of the doses (14 tablets at a time) which is for highest weight band of above 70 kg. If 8
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grooves are filled then those 8 have to be taken by the patient daily. All the details like daily doses are written there. So, there is no need of calculation. It does not matter whether the patient is on IP or CP. He/she just has to take one tablet from each of the filled groves. The horizontal bar decides the weight band. The 5 weight bands are <16kg, 1625kg, 26-45kg, 46-70kg and >70kg.

60% of the patients lie in the 26-45 kg band and very few patients—just about 5%-- are above 70 kg. These drugs require certain kind of storage ambience. As far as this centre is concerned it is well equipped with the temperature management and humidity measurement equipment. According to guidelines if medicines are exposed continuously for more than 6 months to extreme temperatures they cannot be used. There are four DR-TB Centres or PMDT sites in Gujarat as well as 30 districts, all of which are equipped with temperature control methods and so they receive 6 months’ supply of drugs in this format only. At our place we have a buffer stock. The norm is that monthly consumption multiplied by 7 has to be there for the district and multiplied by 2 for the PHC.”

Drugs like Quinolones are being misused for treating other diseases also, like pneumonia and other pulmonary infections which mimic TB. Moxifloxacin is another anti-TB drug which is misused… Only qualified doctors in the private sector who have been trained in TB management should be authorized to prescribe standard quality-assured medicines to MDR-TB patients

King George’s Medical University (KGMU), Lucknow, UP
Dr Surya Kant, Professor and Head, Department of Pulmonary Medicine: “Drug resistance develops when complete standard treatment regimens are unavailable to patients. Drugs like Quinolones are being misused for treating other diseases also, like pneumonia and other pulmonary infections which mimic TB. Moxifloxacin is another anti-TB drug which is misused. I would suggest that the authority to prescribe anti-TB drugs should be given only to trained and certified medical doctors. Only qualified doctors in the private sector who have been trained in TB management should be authorized to prescribe standard quality-assured medicines to MDR-TB patients.”

KS Roy Hospital, Kolkata, West Bengal
Dr VR Pradhan, Superintendent: “All patients of MDR-TB who are treated here are on re-treatment under criterion A. Sputum samples are sent by the DTO to the IRL where diagnostics are done. After diagnosis is done the patients come here for start of treatment. But now all patients need not come to this hospital/PMDT site to start treatment. The concerned DTO can do pre-treatment evaluation and send all the papers to the site here and if our DOTS
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plus committee agrees for the start of treatment, the DTO can start treatment there itself. Those who are sent here by the DTO for initiation of treatment stay for a maximum of two weeks. After registration and initiation of treatment at this centre, if they feel ok they we discharge them as per guidelines of RNTCP through DTO for follow up. Then they go to their own district for continuation of treatment under the DTO who is in charge of the district. The DTO arranges for medicines and healthcare provider at the nearest DOTS centre for the patient, close to the patient’s house. The patient has to go there every day for medicines as well as injections for the first 6-9 months (except Sundays). Patients have helpline phone numbers of DOTS office. If there is any problem they can take help from me. For treatment adherence we will have to remain in very close contact with the patients.

Initially there was a problem for women to come under the purview of MDR-TB treatment for fear of rejection by their families. But now once they are diagnosed with MDR-TB we counsel the families to take care of the patient. If they refuse to do so then we provide food to them along with the drugs. So now the problem is being gradually overcome

Initially there was a problem for women to come under the purview of MDR-TB treatment for fear of rejection by their families. But now once they are diagnosed with MDR-TB we counsel the families to take care of the patient. If they refuse to do so then we provide food to them along with the drugs. So now the problem is being gradually overcome.”

Lok Nayak Hospital, Delhi
Dr Ashwani Khanna, PMDT nodal officer: “We treat DR-TB patients who are from within Delhi and those patients who are diagnosed with DR-TB but do not belong to Delhi are referred to wherever they belong. We are catering to 9 chest clinics, so we have patients from 9 districts (out of the 26 districts in Delhi) coming here. Rich people hardly come, but we do have patients from the middle class. We have 3 or 4 patients of extra pulmonary MDR-TB as recently we have started diagnosing EPTB. Our treatment success rate is a little over 50%-60%. We have a monthly evaluation of data at our centre. We conduct monthly meetings with all the 9 chest clinics allotted to us in which all the problems which patients are

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facing are discussed. We manage the complete data of the patient as to what would be the follow up; who will be doing it; if patient is presumed to have MDR-TB then whether the sputum sample will be tested using Cartridge Based Nucleic Acid Amplification Tests (such as Xpert MTB/RIF, available in Lok Nayak Hospital) or sent to IRL for LPA or Culture testing and DST. Such details are managed here in a proper record form. Treatment adherence is a problem that we face today as the drugs have lots of side effects and so patients do leave in between. Most of these are the ones who had left treatment midway earlier too. Then there are people who use excessive alcohol, who are also at high risk of leaving treatment midway. The long duration of treatment and the compulsion of coming every day to the centre to take drugs could be other reasons for non-adherence to treatment. Alcoholism and drug addiction are major problems with some people. I think females are more treatment adherent.” A doctor in the OPD explains the working system: “All those who come here are diagnosed. And then they are referred back to from where they came to start treatment there. These are the referral forms in which all information of the patient (including the name, diagnosis, date of start of treatment) is filled in triplicate. The white slip stays with us; the pink one is posted to the respective DOTS centre and yellow one is given to the patient along with a post card which has the same details and which the patient has to repost to us after getting it signed from the DOTS centre. So, we have the feedback for everybody from any part of the country who had been put on treatment at this centre. Then we enter these details here and send an email to their centre. Each form is filled in triplicate. Thus through post cards, letters and emails we make sure that the patient has been put on treatment. At the end of every month we do data analysis.”

The long duration of treatment and the compulsion of coming every day to the centre to take drugs could be other reasons for non-adherence to treatment. Alcoholism and drug addiction are major problems with some people. I think females are more treatment adherent

LRS Institute of TB and Respiratory Diseases, Delhi
Dr Rohit Sarin, Director: “As a tertiary care institution, we treat all cases of MDR-TB who come to us whether within the programme or outside the programme. After the clinicians here diagnose the patients they refer the patients to their respective centres (where the programme
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exists) for subsequent treatment and follow ups. But where PMDT does not exist as of today, our clinician deals with it at their own level and try to monitor the patients as best as possible. So we have lot many patients coming to us from different parts of the country who are outside the government programme. We have around 550 patients under the programme and another 250 patients from outside the government programme. We have one single district where we do direct care where our workers supervise every dose. Then we have about one third of Delhi (6 districts), where we are doing hospitalized management and adverse drug reaction management as and when required.” Dr Neeta Singla, PMDT Nodal Officer: “Treatment adherence is a bigger issue with men, may be because women are more responsible towards their treatment. They know that their disease is going to affect other people. More of nonadherence to treatment is happening with men. Alcoholism, drug abuse and tobacco consumption all these problems are much more with the men, so, they tend to leave treatment midway. But women patients have to face greater stigma. They do not get family support or emotional support. Their nutritional status is also not good. They are also often dependent on others to bring them to the centre for follow up tests or if there are adverse reactions to look into. Hence their follow ups get delayed. Very often they do not tell about adverse drug reactions like Treatment adherence is a bigger issue with depression or psychological disturbances. The family also men, may be because women are more thinks that it is all part of responsible towards their treatment. the disease and there is Alcoholism, drug abuse and tobacco nothing to worry about. These side-effects must be consumption all these problems are much brought to the attention of more with the men, so, they tend to leave healthcare workers including treatment midway. But women patients the DOTS providers. Personally, I feel that if I know how important it is for me to take medicines then let me have the medicines with me and I will be more adherent to treatment. Coming to the centre daily for medicines could be a reason for non-adherence. But then again if the medicine is given for home,

have to face greater stigma. They often do not get family support or emotional support. Their nutritional status is also not good. They are also often dependent on others to bring them to the centre for follow up tests or if there are adverse reactions to look into. Hence their follow ups get delayed. Very often they do not tell about adverse drug reactions like depression or psychological disturbances

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it is likely that the patient would not take it, more so because of its severe sideeffects.”

Murshidabad Medical College and Hospital, West Bengal
Dr Kajal Krishna Banik, Medical Superintendent: “We are admitting cases after doing rigid evaluation jointly by all the departments and members of the DR-TB centre. For 5 to 7 days we admit patients to put them on treatment and then ask the DOTS providers to follow up at their residence. We do have some patients who refuse treatments, although their number is very small. This is mainly due to the long term treatment with so many drugs and drug toxicities. But our team members try to sort it out with knowledge and motivation and hopefully after some time we will be able to bring all the infected cases into the treatment fold.”

New Delhi TB Centre
Dr KK Chopra, Director: “Delhi was the first state in India, after Kerala, which started treatment for drug-resistant TB patients throughout the state. We started with 5 or 7 districts and within three months we spread it throughout the state. PMDT was started in a safe manner because of limited laboratory capacity, which was available in some big institutes but not everywhere in India in the beginning, when the programme was launched. So the states where there was good laboratory capacity (like in Delhi), PMDT gained strength. In our centre we have got culture and DST facility. Second important thing is that in addition to the laboratory capacity, we need infrastructure also because we need to give daily DOTS to our MDR-TB patients, and we need to augment our activities in DOTS centres. Patients have to be followed up for a minimum of 24 months, and then there is a follow up sputum-culture examination which is done every three months. Another thing which is required is training of the doctors. They have to be trained for PMDT so that they can give proper treatment schedule, monitor any side-effects and keep records. So there are two aspects: one is establishing laboratory capacity, and the other is preparation and development of human resources in the districts such as trainings. We also need to ensure that adequate infrastructure is in place and
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standard protocols of good practices are being strictly adhered to. For example, we need to ensure that the PMDT site has sufficient laboratories, rooms, drugs storage, and other requisite facilities. Another aspect is drugs: we have to match our drugs boxes with the number of cases which are diagnosed, because if we diagnose the patient we have to give treatment. Before PMDT begins in any state, first we see if a laboratory is established there or not. Next step is for the state to ensure that the district is prepared in terms of trained human resources and other facilities. Then a central team visits to validate their preparedness for PMDT. The Central Team will also evaluate if DOTS is fully implemented with good results-- only then PMDT will begin. PMDT is going ahead in a phased manner and at present more than 90% districts (there are 640 districts in India) have rolled out PMDT services and our target is that soon the whole country will be covered by PMDT services to gear up for universal access by 2015. We found that out of the 30% patient we lose (patients with presumptive MDR-TB who were not put on MDR-TB treatment) about 8%-9% patients died during those three months, because they were presumed to have MDR-TB but were not put on treatment as they were waiting for diagnostic reports. Another set of 8%-9% patients lost faith, because they knew they were not responding to the treatment and we were giving them the same treatment during the time taken to confirm the diagnosis and start MDR-TB treatment. So they went away to the private sector to get treatment. Some of the patients were also lost to follow up as we were not able to hold them back. In many places like Delhi there is a big population of migrants who might have gone back to their native places. Regarding treatment, we give free drugs. As for infrastructure, we already have DOTS centres. The only thing is that we have to augment and train our DOTS providers regarding MDR-TB treatment (which is prolonged and the drugs are toxic). Another challenge was that initially we were getting low treatment success rates of about 50%-60% in PMDT because perhaps patients were opting out of treatment due to severe side-effects of the toxic second line drugs. Now, we are training our DOTS

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providers and doctors for early identification and management of side-effects, because if we identify the side-effects early we can manage them early on, and we will not lose the patients. If we do not identify and manage them timely, the patient is more likely to leave treatment midway. This can be done through more interaction with the patients. We have designed a very simple questionnaire for our DOTS providers. They ask the patients whether they have got itching, swelling in the body, vomiting or other sideeffects. If there is, we immediately refer the patient to the doctor for management of side-effects and encourage the patient to continue treatment. ”

Rajan Babu Institute of Pulmonary Medicine & TB, Delhi
Dr Anuj Bhatnagar, PMDT nodal officer: “TB medicines work best when taken together in one go (and not split in morning, evening, afternoon doses) and they need not necessarily be taken on an empty stomach. This hospital is the only one where we have around 150-200 beds, especially for MDR and XDR-TB patients. In Delhi indoor admission facility is available here and in LRS Institute for TB and Respiratory Diseases. But the maximum load of indoor patients is here as even patients of AIIMS and Lok Nayak Hospital are admitted here. Apart from that we have logistic criteria wherein the patients come with lots of papers/ forms. So we discuss each case with our committee on starting the treatment. The person diagnosed with DR-TB is admitted here for a minimum of 7 days to carry out all the investigations and to observe if the patient is able to tolerate the treatment or not. After that we counsel the patient and the family and tell them the reason why he/she has to be admitted here. I tell the patient clearly that if he/she takes the treatment there are very high chances of getting cured. We have observed that the patients who complete the treatment have attained the success cure rate of 92%-95%. So treatment adherence and catching the disease early is the most important thing here. If the patients come late for treatment after extensive destruction of lungs has already occurred then they take time to respond. And even if the patient gets cured then there are other comorbidities that reduce his/her quality of life. One new thing that we have started here is the follow up—once a patient is started on treatment and sent back to his/her place there are different checks and balances. I give a phone call to the respective district TB centre that we have received your

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patient. We register and admit the patient and tell the district TB centre about his/her weight band and ask them to arrange for medicines as the patient would be discharged from here after 7 days. Meanwhile the patient and the family are counselled. When the patient is discharged with 7 days of medicine for transit, I make another call or send an email informing the district centre. When the patient reaches there, the medicines have already been arranged. Also every Saturday I have my OPD for patients’ follow up if they need any help regarding the side-effects of drugs. We are giving all supporting medicines as well as protein supplements to them if need be. There are some NGOs who help us with this. We also have a separate segment of programme where in we treat the patients who are not referred to us from DOTS centres. This is called lateral entry into the programme. We have an OPD for such patients on every Tuesday and Friday. Now the number of such patients is falling as number of districts under PMDT has increased. Whenever we get any patient from outside we do the diagnosis and mail the records to the concerned district TB officer, the state TB officer, a copy to my state TB officer and a copy to CTD. The patient then starts medicines at his/her place only.

During the course of treatment there is monthly follow up. Each patient has a DOTS plus card with his/her name, address, the date of last admission on PMDT site and the date he/she was put on IP and/or CP. If the sputum culture converts (becomes negative) within 4 months of treatment then it is counted as a good response. If the sputum culture is positive even after 4 months of continuous treatment for MDR-TB then as per the programme guidelines, the patient is tested for XDR-TB. This norm is strictly followed. The report of this test takes very long. Field studies are going on for faster second line testing but they have not been validated as yet, although WHO has said that second line LPA is quite reliable and the report comes in 7 days. We also ask the patients to bring their relatives to this centre to get tested. The programme also says that sputum samples of contacts of MDR-TB patients should be sent for testing. We have had 20 families with more than one MDR-TB patient. In one family there was a young patient (who died eventually of XDR-TB) who first took treatment in private sector. Then his brother, sister and both parents also got MDRTB. His brother is admitted here and sister is also on treatment. We need to make

The programme also says that sputum samples of contacts of MDR-TB patients should be sent for testing. We have had 20 families with more than one MDR-TB patient. In one family there was a young patient (who died eventually of XDRTB) who first took treatment in private sector. Then his brother, sister and both parents also got MDRTB. His brother is admitted here and sister is also on treatment. We need to make sure that the follow ups of the relatives are also done. It is also our internal policy here that we follow up all cured patients for 2 years

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sure that the follow ups of the relatives are also done. It is also our internal policy here that we follow up all cured patients for 2 years. The patient will develop resistance if treated with only one drug. If we can control basic TB at the start with a proper therapy no resistance would develop. Even today more than 91 combinations of medicines are used in the private sector which is a big problem as it simply multiplies the resistance in the community. ” Dr Rashmi, Medical Officer, PMDT: “The main impediment in treatment adherence is lack of information on part of the patients. The symptoms subside but the treatment has to continue for 2 long years. These medicines initially cause a lot of problems—vomiting, acidity, and joint pain among others, despite which adherence has to be there. As the patient improves the importance of completing the treatment has to be explained on each visit. Then again, malnourishment is another problem.” Dr Ngilang, district TB officer and CMO in charge of chest clinic: “Some patients find it very difficult to adhere. Long duration of treatment, alcoholism, migration from one place to another, and stigma attached with the disease are some of the reasons that lead to non-adherence.”

St Stephen’s Hospital’s home-based care facility, Delhi
Dr Joyce Vagela, public health specialist, Community Health Department:

“Taking care of the adverse side effects of medicines plays
a very big role in restoring patients’ confidence and ensuring treatment adherence. We have found that over 40% patients have joint pains, 20% have nausea and vomiting, 15% suffer from anxiety. Besides these, there are numerous other side effects, including weakness. Sometimes it requires a lot goading for them to go to the centre every day for their medicines. Proper nutrition is a big problem especially in the IP phase, as there is not enough money in the house for balanced diet.”

Taking care of the adverse side effects of medicines plays a very big role in restoring patients’ confidence and ensuring treatment adherence. We have found that over 40% patients have joint pains, 20% have nausea and vomiting, 15% suffer from anxiety. Besides these, there are numerous other side effects, including weakness
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 

Despite TB being a notifiable disease in India since May 2012, all private healthcare providers treating TB are not notifying it still. This information is critical to inform the programme and help further improve its response to TB care and control. All professional associations related to TB care and control, law enforcing agencies, media, among others, should be effectively engaged. Engaging pharmacies in DOTS is a positive way ahead for India’s programme and must be expedited with all required safeguards and cautions. Irrational use of anti-TB drugs needs to be regulated. Uninterrupted supplies of standard quality-assured anti-TB drugs should be made available to private and public sector where TB is being treated strictly as per guidelines. TB treatment must not be started without confirmed diagnosis of TB and drug sensitivity testing (DST) if required, from RNTCP accredited laboratory. Even in private sector there is a need to ensure that TB treatment is not put without confirmed diagnosis from accredited laboratories. RNTCP is already considering private laboratories where good practices are adhered to with proper checks. Quality counselling at every level of TB care must be provided, and cured TB patients be engaged where possible to enhance treatment outcomes. Counselling and proper management of side-effects as reported by the patient must be ensured. Stigma is a barrier to access existing TB care services. TB-related stigma in the community and internalized stigma in those seeking care, must be effectively addressed through myriad channels and innovative evidence-based mechanisms. Cured patients have a unique role in this regard. Nutrition was identified as one of the factors impacting treatment outcome. Good nutrition has a broader positive impact on health and appropriate linkages be established of RNTCP with nutrition and food security programmes including the Right To Food Bill currently in parliament. Other innovative mechanisms supported by private public partnership (PPP) to support nutritional needs of patients under PMDT should be explored, established and strengthened. Holding the patient in the programme during the wait for diagnostic results is important. The patient and other family members should be effectively counselled on why diagnostic results take time, and why treatment must not be initiated without confirmed results. Restoring the faith of the patient and family members in the RNTCP is crucial to retain patients all through the treatment and care. Supporting patients of drug-resistant TB in strengthening their income generation activities or helping rehabilitate them is a key to sustaining positive outcomes of PMDT. PPP offers good examples where cured MDR-TB patients were supported by private sector such as Eli Lilly to find sustainable ways to earn their livelihood. Such mechanisms should be explored and fully utilized to complement PMDT. Gender sensitive approaches should be more integrated in PMDT to help support TB care needs of women and other genders.

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Living with drug-resistant
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Note: These stories highlight the personal experiences of people who were diagnosed with drug resistant TB. The names of all patients have been changed to respect their freedom of anonymity, given the huge social (and internalized) stigma connected with the disease, and associated with other factors such as poverty or HIV.

When he vomited blood one day…
48 years old Deepak, a driver in the police department, was leading a happy normal life with his wife and 3 children, when suddenly he vomited blood one day, way back in 1997. The doctor diagnosed him with pulmonary TB on the basis of a chest X-Ray and put him on a 6 month ATT under DOTS. Deepak was presumably cured and remained okay for a year and a half. Meanwhile he had been transferred from Ramgarh to Uttar Kashi. But then his problem recurred and he vomited blood again. He was put on treatment once again in this new town, but he admitted to not being very regular with his medicines this time and even missed some doses due to his own carelessness, even as he was transferred once again from Uttar Kashi to Srinagar. He would stay healthy for some time and then again become sick. He then took medicines for 9 months from a private doctor and felt completely cured although financially devastated-- he had to spend around INR 30,000 on his treatment in the private sector, but then at that time the government TB programme was not offering treatment for MDR-TB. After remaining healthy for several years, Deepak took ill once again in February 2012. This time he went to a DOTS centre in New Delhi (where he was posted) and was put on medication. Simultaneously his sputum was sent for culture, the report of which came in April 2012, confirming MDR-TB. The DOTS centre then referred him to AIIMS on 12th of April 2012. The doctors at AIIMS sent him to Rajan Babu Institute of Pulmonary Medicine and TB (RBIPMT) for pre-treatment evaluation and treatment initiation (AIIMS does not have indoor admission facility for TB patients, but has a liaison with RB TB Hospital to admit patients there). He stayed
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there for one week and after that he has been going daily to hid DOTS centre to take the medicines in front of the DOTS provider. The day I met him in the OPD of AIIMS Deepak had come for his three monthly follow-up. He told me excitedly that he had been testing negative from the fourth month of treatment onwards and was now in the continuation phase of treatment. The ordeal of daily injections was over and he was well on the path of recovery. As a matter of precaution, Deepak stayed in his department’s hospital away from his wife and 3 children till his sputum culture report was negative. Now he wears a mask at home and practices all infection control methods.

Deepak has since become a TB advocate and if he comes across persons suffering from persistent cough and fever he urges them to go to a DOTS center for a free checkup and treatment there. His message for other TB patients: treatment in the Government setup is free and very reliable. This is a boon for poor people like me and we should make use of the government facility if we happen to contract the disease. The medicines for TB are very expensive in the private market. I spent around INR 30,000 (approximately USD 600) while seeking treatment in the private sector and yet was not cured—rather I developed a worse form of TB. One must take the medicines regularly, eat nutritious food and stay away from alcohol and cigarettes [all forms of tobacco].”

The day I met him in the OPD of AIIMS Deepak had come for his three monthly follow-up. He told me excitedly that he had been testing negative from the fourth month of treatment onwards and was now in the continuation phase of treatment. The ordeal of daily injections was over and he was well on the path of recovery

A pain in chest…
Dinesh works as a cook in Delhi. His family comprising his mother, wife, one son and two daughters live in his native village in Almora—a hilly region in North India. About a year ago, (around May 2012) he complained of pain in his chest. He showed himself in AIIMS and was diagnosed with TB. He was put on Cat 1 treatment under DOTS. But when the sputum report was positive even after 5 months, the doctors suspected drug resistance. Dinesh was lucky to be in Delhi and luckier to be seeking treatment from AIIMS- a tertiary care hospital with very good diagnostic facilities. The Line Probe Assay confirmed resistance to isoniazid and he was immediately put on MDR-TB treatment regimen in October 2012. When I met him in February 2013 in the OPD of AIIMS, he had completed almost 5 months of medication from the DOTS plus site of AIIMS. His one report had already come negative and the next one was to come in a week’s time. Of late Dinesh had

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been feeling giddy and weak (side effect He was relieved that his daily of drugs) but he is determined to injections would stop in a month’s complete his full 2 years treatment time and he would expectedly (treatment non-adherence is a problematic issue with MDR-TB patients). move on to the continuation phase He was relieved that his daily injections of medication. Dinesh confessed to would stop in a month’s time and he being an avid ‘bidi’ (tobacco rolled would expectedly move on to the continuation phase of medication. Dinesh in a leaf) smoker earlier but said confessed to being an avid ‘bidi’ (tobacco that now he is totally off tobacco rolled in a leaf) smoker earlier but said and is careful about his diet that now he is totally off tobacco and is careful about his diet. He still wears a mask to his work place but not always when at his living place which he shares with others.

Persistent low grade-fever & cough…
40 years old Rukmini lives close to the Civil Hospital of BJ Medical College in Ahmedabad. She used to sell fruits to supplement her daily wage earner husband’s meager income till tuberculosis struck her in 2010. She has a 17 year old daughter and an elder son who is married. Rukmini is illiterate but she managed to educate her children up to elementary level.

Unfortunately, Rukmini’s daughter contracted MDR-TB through her mother and has been on MDR-TB treatment in the same hospital since the last 6 months. The attending doctor told me that, “Direct MDR-TB transmission through contact is common. So if a family member of such a patient has MDR-TB we test for MDR-TB in the beginning itself and if diagnosed put him/her directly on Cat-4 treatment

“Three years ago, in 2010, I started having persistent low grade fever and cough. There was never enough money in the house, so I took treatment intermittently in the private sector, as and when I had money. But one and a half years ago my condition worsened. I was breathless all the time and could not even walk properly. So I eventually came to this government hospital (BJ Medical College) where I was admitted for 3 months for TB treatment but was eventually diagnosed with MDR-TB. My family is very supportive despite the infectious nature of the disease. My husband always accompanies me to the hospital.” Unfortunately, Rukmini’s daughter contracted MDR-TB through her mother and has been on MDR-TB treatment in the same hospital since the last 6 months. The

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attending doctor told me that, “Direct MDR-TB transmission through contact is common. So if a family member of such a patient has MDR-TB we test for MDR-TB in the beginning itself and if diagnosed put him/her directly on Cat-4 treatment.” When I met Rukmini in February 2013 she was admitted in the MDR-TB Ward of Civil Hospital of BJ Medical College, Ahmedabad for breathing problems. TB had perhaps caused irreversible damage to her lungs. Although she has already tested negative she is in and out of the hospital because of breathlessness. Still she feels that there has been a vast improvement in her condition as compared to when she began her treatment.

“When I came to this hospital one year ago, I was bedridden. I could not walk without help and could not even drink water. Now I have become mobile once again and the credit for this goes to the doctors and nurses of this hospital, especially Dr Kusum Shah under whom I was admitted initially for 3 months. They have given me a new lease of life. They have really counseled me well and I follow all their instructions regarding infection control methods at home —I spit in a spittoon given by the hospital, I bury my spit in mud, I keep my house very clean. I hope I will soon be able to go back to my work of selling fruits and not remain a financial burden on my loving husband.” The attending doctor, Dr Purvi, was all praises for Rukmini as she has been a very good patient and has diligently followed all the instructions given to her by the doctors.

When I came to this hospital one year ago, I was bedridden. I could not walk without help and could not even drink water. Now I have become mobile once again and the credit for this goes to the doctors and nurses of this hospital

Rukmini’s message for other TB patients: We should not take treatment in the private sector. The MDR-TB drugs which are given free at the government centres are very good and all patients must take them. Nobody must stop the treatment in between.

We should not take treatment in the private sector. The MDR-TB drugs which are given free at the government centres are very good and all patients must take them. Nobody must stop the treatment in between.

Listen to me as I do not want anyone to go through what I am experiencing…
A tailor by profession, 28 years old Rakesh comes from a well to do family of rural Gujarat. His village near Palanpur in Banaskanta district is about 150km from Ahmedabad. I met him on February 19, 2013 in the MDR-TB ward of Civil Hospital at

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BJ Medical College, Ahmedabad. He had been re-admitted there that very day due to severe swelling in his legs. Rakesh had been on MDR-TB treatment (Cat 4) for the past one year. Narrating his story, Rakesh spoke with bitterness about his bad experiences with the private set up while seeking treatment. He was also critical about the social stigma connected with the disease that led to delay in his seeking proper diagnosis and treatment of MDR-TB in a good government hospital. Three years ago, in 2010, his persistent cough led Rakesh to a private TB physician who put him on ATT. His cough vanished after six months of treatment and he felt fit and fine again. But his state of wellbeing was short lived. After 6-7 months he started coughing again. This time he went to a PHC close to his village. “The health worker there asked me to bring some people from my village who would give the guarantee that I would complete a 6 months’ treatment course. I did that and took medicines religiously for 4 months. But instead of improving, my condition worsened. My father and I begged the healthcare workers at the PHC to please test me again and send my sputum for culture. But they insisted on my completing the 6 months course first. In desperation I left that treatment and again went to the same private doctor from whom I had taken treatment earlier. I took medicines for another one and a half year, including injections, spending INR 6000 per month on my treatment. Yet there was no improvement in my condition. My doctor said that now the cost of medicines will increase to 15,000 per month. Although I had no money problem but this was really beyond my pocket. He was kind enough to give me the address of Dr RN Solanki, PMDT Nodal Office, BJMC, Ahmedabad, Gujarat, and so I came to this hospital for the first time in February 2012. I stayed in the hospital for 3 days and then went back to my village. Earlier also I had been on Cat-4 treatment in the private. This time I was given 11 medicines and one injection per day. I did not suffer any He spoke with bitterness side-effects and continued with the medicines. about his bad experiences After 6 months I had to go to Rajasthan for with the private set up some work. It was very hot there and one day I vomited blood. I had carried my medicines and while seeking treatment. my medical file with me. I showed myself to He was also critical about the government doctor there and he advised the social stigma me to take rest. I came back to my village and took complete rest for two months but again I connected with the vomited blood. This was repeated again after disease that led to delay a few months. I had not missed a single dose in his seeking proper of medicine but my health had broken down completely.” diagnosis and treatment According to Dr Purvi the swelling in his legs was due to some adverse drug reaction and also due to some other co-morbid condition

of MDR-TB in a good government hospital

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which he might be having. She informed that the patient has been going through the phase of reversion and conversion. His culture report came negative after 3, 4 and 5 months, then positive after 6 months, and then again negative in the 7th and 9th month. This is not uncommon and at times when Kanamycin is stopped the sputum does test positive, after being negative in the intensive phase. “My father and brother were very reluctant to bring me to this hospital for a checkup , despite the doctor at the PHC asking them to do so. They are uneducated and think that if a case is referred to this big hospital, it means it is a gone case. They think that only very serious patients who are on death bed (with no hope of cure) are advised to go to a tertiary hospital like this. They feared that I was being referred here as I was about to die. They finally agreed because of my insistence and so I came here today with my brother and my wife. I love my wife and my 5 year old son. She is not educated but takes very good care of me.” He joked that his beautiful and chubby wife cannot get TB as she is fat, but if she were thin she might be at risk. His message to other TB patients: People in the villages still think that TB is incurable and is a death sentence. They also feel that government hospitals are no good. Even I used to think that as treatment in private sector is expensive so it ought to be better than that in a government hospital. This ignorance must be removed. We must face the disease bravely and not be afraid or get dejected. If you are scared you will die, if you are brave you will survive.
(Rakesh told me that this was the first time he had dared to narrate all this to a complete stranger like me, with a view to share his story with others as he did not want anyone else to suffer the same fate as he did out of ignorance and fear).

Adhering to treatment, but lost hearing power irreparably…
I met 19 year old Reena at the MDR-TB drug dispensing counter of RB TB hospital, New Delhi, where she had come to take her daily dose of MDR-TB medication. Her hearing power had been

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impaired irreversibly due to side effect of medicines. So I communicated with her through pen and paper and she replied orally. Reena began her TB treatment from this hospital, six years ago in 2007. She had been suffering from shortness of breath along with chest pain and was told that there is water in her lungs. Six months of medication cured her of her problem and she got well. But after three years she was sent to look after her married sister who was suffering from TB (the sister died eventually). She contracted the disease again from her. Reena was in class 9 at that time but was forced to leave her studies because of her illness. Her teacher asked her not to come to school. She had reached the continuation phase of her treatment and was on the path of recovery.

Her MDR-TB treatment started in this hospital in July 2011and she was put on continuation phase in March 2012. Dr Anuj Bhatnagar informed that she has been testing negative after 3 months of treatment, which is an ideal response. She has taken the treatment well and has high chances of a complete cure, more so because she is young.

Six months of medication cured her of her problem and she got well. But after three years she was sent to look after her married sister who was suffering from TB (the sister died eventually). She contracted the disease again from her. Reena was in class 9 at that time but was forced to leave her studies because of her illness. Her teacher asked her not to come to school. She had reached the continuation phase of her treatment and was on the path of recovery

Reena said, “I am now feeling much better. Earlier I was not able to walk properly and I lost a lot of hair—I almost turned bald. Now I just have hearing problem otherwise I am okay. My two married sisters died of TB, but I want to live and lead a normal TB free life. I love to watch old movies and eat meat, fish and eggs. I would go back to my studies once I am okay.”

TB rebounds, with drug resistance…
Anil belongs to a family of dairy farmers and owns a dairy shop in Delhi. He lives with his wife, a 5 year old daughter, his parents, two brothers and their wives and one unmarried brother. I met him at the MDR-TB drug dispensing counter of Rajan Babu Institute of Pulmonary Medicine and TB (RBIPMT), where he has been on treatment since November 2012, and is now in the continuation phase. In 2010, when Anil was 30 years old, he suffered from persistent cough. He sought treatment from a private doctor who diagnosed TB and put him on an 8 month long course of ATT. He spent INR 70,000 (approximately USD 1400) on his medication but was presumably cured. He stayed well for the next two years. Then one day in 2012

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he started coughing again and he had a nagging doubt in his mind if the TB had returned. This time he thought of seeking treatment in the government setup as his earlier private treatment had resulted only in temporary cure. So this time he acted wiser and showed himself for a checkup in RBIPMT - one of Delhi’s best health facilities for TB treatment. The diagnosis confirmed MDR-TB and he was put on treatment in November 2012. When I spoke to him in February 2013, he looked healthy and sounded very optimistic. He praised the doctors who had been treating him and said that he was steadily feeling better and better. His general health had improved-- just within two months of starting medication his weight had increased by 9 kg-from a measly 41 kg to 50 kg. He does have some pain in his legs, which he hopes will vanish with time. He said—“I have to get well and I will get well.”

He has now become a TB advocate in his own way and guides patients to a government facility for diagnosis and treatment. His message for other TB patients is: “Please do not waste money
on costly and improper treatment in the private sector. A government hospital is the best place where the problem will not only be diagnosed completely but a proper and lasting solution (treatment) will also be provided by the doctors”

Anil religiously follows the doctor’s advice on all the precautions he has been asked to take. He has got all his family members tested for TB and fortunately none of them have the disease. At home he always spits in a cup of hot water and disposes off his sputum by burying it in mud. He thinks that non vegetarian diet is more nutritious, so he has started eating meat and eggs for more nourishment. But this he has to do outside his house as his family is strictly vegetarian. Anil has now become a TB advocate in his own way and guides patients to a government facility for diagnosis and treatment. His message for other TB patients: Please do not waste money on costly and improper treatment in the private sector. A government hospital is the best place where the problem will not only be diagnosed completely but a proper and lasting solution (treatment) will also be provided by the doctors.

From private to PMDT: Journey of a priest from TB to MDR-TB
The teenage son (studying in class 9) of a patient had come to take the daily dose of MDR-TB medicine for his father who was paralyzed as he had suffered a brain

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haemorrhage. He told me, “My father is a priest. We live in a village on the outskirts of Delhi, where he was diagnosed with TB some years ago. He was put on treatment under a private doctor but did not get cured. Then we moved to Gurgaon (city very close to Delhi), where we shifted from one private doctor to another but to no avail. We were even told that he does not have TB at all. Then one of our neighbours, who works in this hospital (RBIPMT) advised us to come here. We got him tested and MDRTB was confirmed. His treatment started in May 2012. At that time he was very sick so he was admitted in this hospital for 5 months. Now his TB is better but he is suffering from many side effects and currently he is totally incapacitated because of a paralytic stroke. So the doctors have permitted me to come here every day to carry his medicines home. Today I brought his sputum sample also for follow up culture.”

“I wish if there was a vaccine to control its spread…”
It was a humbling experience to meet Ajay, a middle aged graduate from Muzzafarnagar, UP. Ajay was one of the rare cases of XDR-TB who had tested negative (but still under treatment) and was recovering in the MDR-TB Ward of RB TB Hospital, Delhi. He was very keen to share his experiences with the rest of the world. Here is his story in his own words: “I faced the problem for the first time in 2004 and then I took treatment for 9 months from a private hospital. The doctor said that I was okay, but there was still no improvement in my coughing. So I kept on taking medicines from here and there. I would stay well for a while and then the cough would return. I became very sick again in 2006. My friends and relatives advised me to go to Delhi. Here also I took treatment for 9 months again in a private hospital, but I did not get much relief. Then somebody told me about another doctor under whom I took medicines for 14 months. But I was not improving. I felt that my death was imminent. Then an acquaintance directed me to a doctor in Meerut and I was again on medication for 10 months. Never did I miss my dose even for a single day. But by now I had lost all hope. I asked the doctor as to how many more days I would be alive? Then on a well-wisher’s advice I came to this hospital (RBIPMT). I clearly remember the date—it was 15th June 2012. Dr Anuj Bhatnagar sent my sputum for testing at AIIMS. This was the first time in so many years of medication that somebody thought that sputum culture Dr Anuj Bhatnagar sent my was necessary. The report came after sputum for testing at AIIMS. three and a half months. Meanwhile I This was the first time in so had been admitted at LRS TB Hospital in Mehrauli. Then my report came in many years of medication that September, 2012 and thereafter my somebody thought that sputum treatment for XDR-TB began on 4th culture was necessary. October 2012. Since then I am admitted here and have been on this
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treatment for over 4 months. I am feeling a lot better now.” “The government of India is doing a commendable job by providing such good facilities to TB patients in Delhi. I wish these amazing diagnostic and treatment facilities are also made available in villages and far flung places where private doctors are fleecing patients like. I can say from my personal experience that families are being ruined financially while seeking treatment from private doctors, especially in small towns and villages. I have seen people spending INR 5 lakhs from their pockets on this without getting cured. The private sector only drains out money from our pockets but has nothing to offer in return. People do not have much knowledge about this disease which is spreading at an alarming rate as it is infectious. I wish there was some vaccine to control its spread.” Ajay’s message: I would like to spread the message that government is taking a lot of initiative for TB care and control. But very often the money provided for this work is not used properly, especially in a state like UP which has been riddled with corruption scams. The media should also pay some more attention to this problem and spread awareness in common public. If I stay alive I will become an advocate for TB control and spread awareness about it in society.

Deserted by his family, divorced by wife, PMDT staffers become his new family…
Anirban Mukherjee is from Kolkata. An only child, he is 32 years old and educated till Class 10. He was already married and had a daughter when he was first diagnosed with TB in 2002. At that time he was working as a marketing manager in the mess of a students’ hostel in Dhanbad. He first took treatment in the private sector but then came

My sputum which was sent to DMC for testing (while I was working in Dhanbad) came out positive again at the end of 2011. So in 2012 I was back in the same hospital with XDR-TB

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to the DOTS centre where he took Cat 1 medicines for 5 months. According to him, he was told by the caregiver there that he was TB free so he discontinued the treatment. Two months later he had a relapse. The cold, cough and fever returned. “I came to K S Roy Hospital, Kolkata in 2007 and was put on Cat2 treatment. But even after 9 months of regular medication my sputum was triple positive. So I was declared Cat2 failure. My sputum was sent to IRL for culture and the result showed that I had MDR-TB. I started MDRTB treatment under PMDT in February 2010. I was on treatment for 27 months, but at the end of it my sputum again tested positive. Eventually I got cured, went back to my community and back to my job in Dhanbad. But again there was a relapse. My sputum which was sent to DMC for testing (while I was working in Dhanbad) came out positive again at the end of 2011. So in 2012 I was back in the same hospital with XDR-TB.” Meanwhile his wife had divorced him in 2008 because of his TB and taken her away her daughter with her. His employer turned him out of his job and his landlord threw him out of his house. His mother too refused to take him back. He was now homeless and a destitute. So he returned to the same hospital and the Superintendent at KS Roy Hospital admitted him on compassionate grounds. He has been there at this centre since then—for over 1 year and 2 months. The sister in charge of the MDR-TB ward told that he would remain here as long as his treatment continues. No one else in his family has ever had TB. He never smoked nor ate gutkha/paan masala but used to take alcohol occasionally. Now his own people have left him. Abandoned by family, it is strangers who are taking care of him and attending on him. Yet there was a glow of happiness and gratitude on Anirban’s face. He said, “I am very happy staying in the ward here. The sisters (nurses) are doing much more than my family could ever have done. They are very dedicated in their work. All the responsibilities which should have been taken by my family members are being done by the sisters the care givers and doctors of this hospital. They are helping me in whatever way they can. They are closest to my heart. I am too happy to stay in the hospital. I have no feelings for my real family, but I am very grateful to all the hospital staff.”

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Anirban’s message to other TB patients: We should have faith in the sisters and doctors, and other healthcare givers and listen to them and follow all the instructions given by them on infection control. We should also strictly follow the treatment schedule and then we will be cured.

With family’s support, he is determined to complete the treatment
Abdul comes from 24 Paraganas district of West Bengal, which is located very close to Kolkata. Although he is illiterate, Abdul is an expert in zari embroidery work. Married in 2010, Abdul was leading a happy life with his parents, wife and two children (a son and a daughter) when he came down with persistent cough, fever and cold in June 2012. He went to Baruipur district hospital and they gave him some medicines. When his condition did not improve they did an X-Ray and also tested his sputum. The test results came in 5 days and confirmed TB. Abdul was devastated. He was just 26 years old and no one else in his family had ever had the dreaded disease.

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But he was not given medicines from there as the hospital did not fall in the same district as his home town. He was referred to a TB centre close to his place of residence and there his medicines started. He was put on CAT 1 treatment. “Every alternate day (Monday, Wednesday and Friday) I would cycle to the drug dispensing centre situated at the village panchayat , which was not very far from my home, and eat my medicine there. I ate the medicines for 17 days. Then I had severe vomiting and could not even digest my medicines—I would vomit them out. So I went to the main TB centre which directly gave medicines. They stopped my medicines and gave me some other combination of 4 medicines. These medicines helped me and could regain some of my lost strength. My cough also vanished. My appetite returned. I felt much better. Then they asked me to be on CAT 1 again. They said if it suits you then you will get well quickly. They gave me two strips of medicines. But after taking two doses, I started vomiting again. So they decided to change my medication. They also sent my sputum for culture and when the report came I was told that there was some problem and I would have to be admitted in Jadavpur hospital (KS Roy Hospital). So I came here yesterday (23rd January, 2013) and my medication for MDR-TB will begin now. Today morning I was having a lot of shivering. The doctors have said that they will relieve me after 7 days.

I am determined to complete my medication and not leave in between. My family members are with me and they have no stigma. My brothers live separately. I will pay full attention to all the instructions about infection control and other things which the nurses will tell me

I am determined to complete my medication and not leave in between. My family members are with me and they have no stigma. My brothers live separately. I will pay full attention to all the instructions about infection control and other things which the nurses will tell me.” (The sister-in-charge said that Abdul was diagnosed with MDR-TB last year in 2012. He was sent here recently and is now on CAT 4 treatment). Abdul admitted to being a smoker but then he left smoking three years ago, when he got married, at the insistence of his wife. He said that he was very happy with the
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kind and loving attitude of the nursing staff of the hospital. “They are all very affectionate and always ask about my wellbeing. I feel fitter here than at home.” His message to other TB patients: All patients should practice infection control methods and use masks. This I tell my family members also and ask them to keep away from me. My parents are not following strict infection control protocol at home. But I always use a mask and cover my mouth when I am coughing. Please pray for my recovery.

Aspiring for size zero, acquires TB…
17 years old Rehana is a petit and very soft spoken 17 years old girl studying in Class 11. She lives with her parents (her father has a shop selling readymade garments), three brothers and a sister in Baratalla in Kolkata. Like other girls of her age she was very calorie conscious; went on a strict diet control to remain extra slim at the cost of her general body immunity, which went down too along with her weight. She fell ill around 20th August 2012 with severe cough. She was shown to a private doctor and her treatment started on 29th August. She ate the medicines for whatever period of time they were prescribed. (Neither she nor her mother were able to recall the exact duration of the treatment). She had to take over 80 injections as well. To make matters worse, her liver was also affected and she got an attack of jaundice. She continued with the same doctor but her condition did not improve. She would feel nauseas and vomit all the time. Eventually the doctor said that as the medicines were not improving her condition, she should be taken to a government hospital. Her parents, in the absence of any proper knowledge about TB, took her to a government facility in Baratalla where her sputum tested negative. From there they were directed to Aamtala hospital where the sputum test result was positive for MDR-TB. She was then sent to K S Roy Hospital in Jadavpur.

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When I met her in the MDR-TB ward of the hospital on January 24, 2013 I found her a very pale and frail looking girl. She had already spent two weeks in the hospital and her medication had begun just 5 days ago. The nurse told us that as her condition had deteriorated after admission, she was being allowed to stay in the ward till she felt better, although normally MDR-TB patients are hospitalized for not more than 7 days for treatment initiation. Rehana said that she was already feeling a lot better than before. Some cough was still there but her appetite had returned. Her mother, who was attending on her, complained that, “Rehana has always been a poor eater and never cared for her health. She started dieting when she had put on some weight. So she started eating very little. Maybe this is one of the reasons for her to get the disease as her body immunity must have become low. She never listened to me. My house is in a mess. I have another 12 year old daughter who is looking after the house and has stopped going to school as there is no one else to do the family chores. I am staying here in the hospital day and night. No one else in our family has ever had TB.” I wished Rehana good luck and told her that she should go back to studies once she is cured, and look after herself well and eat well. That brought a smile to her pale face and she promised to do so.

I have another 12 year old daughter who is looking after the house and has stopped going to school as there is no one else to do the family chores. I am staying here in the hospital day and night. No one else in our family has ever had TB

Instead of heralding social change, she turned positive for TB...
21 years old Neelam Das is a graduate and aspires to work in the police or the railway department, or else become a teacher as teachers can bring a positive change in the lives of students. Her father works in the blood bank of SSKM Hospital, more commonly known as Presidency General Hospital or PG Hospital Kolkata and the family lives in the PG Quarters inside the hospital campus. Neelam’s problems began in January 2012 when she had a slight cough accompanied with a persistent high fever. The doctor at PG Hospital

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said that there was accumulation of cough in the chest and medicines would make it okay. She completed a 9 month course of ATT despite undergoing severe nausea and vomiting during the course of treatment. But at the end of the treatment there was no relief. So her sputum was sent for culture on 8th October 2012 and the culture report came after three months on 8th January, 2013, confirming diagnosis of MDRTB. She was admitted in KS Roy Hospital, Kolkata on 10th January for pre-treatment evaluation and initiation of MDR-TB treatment. Her medication started on 19th January and she was to be discharged on 28th—4 days after I met her on 24th January. No one else in Neelam’s family, including her two younger brothers, has ever suffered from TB. But all of them, including her college friends have been very cooperative and stood by her side during her illness. Neelam’s mother, however, who was attending on her, complained that, “Neelam is a poor eater and that could be the

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reason for low immunity level of body. She would go on an empty stomach to college. Now since the day she has started eating medicines she does not eat as she is scared that she may vomit out the medicines. The sisters have asked her to eat well and drink 6 litres of water every day.”

Neelam said that she felt nauseous after taking medicines in the morning but felt better by evening. However she promised that once she goes home she would follow all the instructions given by the nurses regarding diet and infection control. She was very appreciative of the nursing staff of the hospital and said that they were changing the lives of patients for better.

Neelam told me that she loves to read and study. Even earlier, while on treatment, she managed to appear for her exams despite high fever. She is determined to pursue her post-graduation once she is cured.

Neelam told me that she loves to read and study. Even earlier, while on treatment, she managed to appear for her exams despite high fever. She is determined to pursue her post-graduation once she is cured. (The nurse in the ward said that for some unknown reasons the incidence of TB is very high in the PG Quarters area which she called a den of tuberculosis.)

Surviving bravely despite TB, diabetes, other health concerns…
Krishna Dalal is a housewife and has studied till Class 10. Her husband works as a peon in Calcutta University. She has a 14 years old son and a 10 years old daughter. Nobody else in the family has TB—they have all been tested for TB and are free from the disease. “I was diagnosed for the first time in 2007 with early symptoms of fever and cough. I then took treatment from a private doctor for one year and got cured and then my medication stopped. I have also had diabetes since 2006. I was okay for two years, but in 2010 my fever and cough reappeared. This time I went to a DOTS clinic and then I took medicines from there for 8 months and was okay. But my culture report was again and again coming incorrect due to some problem or the other or my bad luck. Finally my medication for MDR-TB started in April 2012 and it has since been 9 months that I am taking those medicines. There were several problems related to my TB diagnosis, either there was some

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problem in quality of sputum or sending of sputum, or in the diagnosis. I really do not know. But now (February, 2013) my report has turned negative for MDR-TB. I have also started feeling much better. Earlier I was totally unable to do my domestic chores but now I have started with some small work at home. I still have minor problems of side effects of medicines but they are less than before.”

There were several problems related to my TB diagnosis, either there was some problem in quality of sputum or sending of sputum, or in the diagnosis

“I have been asked by the doctor at Calcutta Rescue Centre to wear a mask whenever I open my mouth to speak or else cover my mouth with a handkerchief when I go out, as a preventive measure for infection control. I have been coming every day to Calcutta Rescue Centre to take my medicines for the past 9 months and the place is not so far from my home. I have taken injections as well for 6 months. When my report came negative, injections and pyrazinamide were stopped but other medication is continuing. I have been told that the treatment will last for 2 years. This centre is very good and the staff here is very understanding and caring.” Krishna’s message to other TB patients: Cure for this disease is possible. However one needs to have patience, and although one might face many problems in the beginning by way of side effects of medicines, but in the end all will be fine. Slowly the patient recovers from the disease if he or she takes proper and continuous medication as prescribed. So one must have patience and take medicines regularly. (Babita, the nurse in charge at Calcutta Rescue Centre, Kolkata told:--Krishna is a patient from our Ward 3. Hers is a sad story as twice she took TB treatment in private and twice Cat 2 treatment in the government set up before her MDRTB was diagnosed. She is very faithful towards taking medicine. Her family and she are educated and the family is very supportive. In 2006 she took Cat 1 medicine from a private doctor for 8 months. When she came to our centre I saw her prescription and found that she was neither given proper medicines nor the proper doses. Her body weight was nearly 80 kg but rifampicin and INH dose given was not appropriate to this weight. I suspected that she must have become drug resistant. She was very upset that time. But then she took Cat 2 medicines from our centre and became negative. I was very happy and thought that my earlier presumption about MDR-TB was wrong. But after one year she returned with the same problem. So I requested the government doctor to send her sputum for culture. But at that time there were problems of sputum cups not being available in government set up, so there was more delay. Then I requested my DTO Dr Singh and with his help her sputum was sent for culture and she tested positive for MDR-TB. Only then could she be put on proper treatment and now she has tested negative and is in the continuation phase.)

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He never thought he can ever get TB!
It has been two and a half years (from 2010) that Mukesh has been staying in the MDR-TB indoor ward of KS Roy Hospital, Kolkata. About 5 years ago he suffered from stomach ache, body ache and loss of appetite. He did not realize even the wildest of his dreams that this could be due to TB. Even his private doctor treated him for stomach problem. But there was no relief and his health kept on deteriorating. He became very weak and now there was persistent cough accompanied with high fever. So he was advised to get tested in the medical college. His sputum examination revealed that he was suffering from TB. So he was put on Cat1 treatment for 6 months, at the end of which his report was still positive. Then with support from Calcutta Rescue Centre, he was put on Cat2 treatment at KS Roy Hospital for another 6 months, at the end of which his sputum still tested positive. The culture report confirmed MDR-TB. So he was told that he would have to get admitted in the hospital and would be given medicines there. When I spoke to him in February 2013, he had been on MDR-TB treatment for nearly 23 months and his treatment was about to get over in March 2013. His culture reports were consistently coming out to be negative and only the final culture report was awaited.

Mukesh is 34 years old and is a resident of Howrah in Kolkata. He used to give private tuitions to students from nursery to class 4. I have my mother, a brother and brother’s wife in the family apart from me. He is a non-smoker and nobody else in his family (consisting of his mother, brother and brother’s wife) is suffering from TB. His family has stood by him and they come to meet him in the hospital.

I faced a lot of difficulties due to severe side effects of medicines. My whole body would feel as if on fire; there was severe body pain and I would feel tired and weak, as if there was no energy left in my body. I feel better now

Mukesh said that, “I faced a lot of difficulties due to severe side effects of medicines. My whole body would feel as if on fire; there was severe body pain and I would feel

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tired and weak, as if there was no energy left in my body. I feel better now but still do not feel quite up to the mark.” Mukesh’s message to other TB patients: Never miss any dose of drug and take the medicines properly if you want to get cured. (Calcutta Rescue Centre has a tie up with KS Roy Hospital. They have 2 staff members who visit K S Roy Hospital every Friday and cater to all the patients of Calcutta Rescue Centre admitted there and also provide medicines to some other patients admitted there—those who are outside the DOTS plus programme).

Misdiagnosed as typhoid but had TB…
This is the story of Nusrat--I am 19 years of age and I have in my family my mother, father, 4 brothers and one younger sister. My father is a labourer. This disease happened to me in 2009 when I was in class 7. I was then diagnosed with typhoid. But despite taking treatment for it the high fever continued. So I went for a complete checkup and was diagnosed with TB. I took treatment for 9 months from a private doctor. But there was no improvement in my condition—rather it worsened. I vomited a lot, had high fever and lost weight. One day I spitted out blood from mouth which really scared me and I stopped eating the medicines. My mother took me to our village in Amethi near Lucknow during school vacations. But there my condition became worse. I was so weak that I could not get up from bed. I returned to Kolkata and showed myself at Calcutta Rescue Centre. Thus I was put on Cat-2 treatment for TB in 2010. I had to take injections too. But when the treatment was completed I again fell ill. So I was on Cat-2 regimen again in 2011. Still I did not improve and my reports came out positive. Then my sputum was finally sent for culture and the report came after 4 months and I was diagnosed with MDR-TB. So since 16th February 2012 I have been taking medicines for MDR-TB from Calcutta Rescue Centre. Now I am feeling much better and I walk to this centre alone every day after attending school to take my medicines. I had to discontinue my studies because of my

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illness and lost two years. But now on the insistence of Babita didi I have recently taken admission in class 9. I am really happy to be back to my friends and teachers. The doctor has asked me to take some preventive measures at home which I follow religiously-- I have my separate bed at home; I have separate utensils to eat my food and a separate water bottle. I do not eat with my siblings. Even in school I keep a handkerchief on my mouth while talking or sneezing. Nusrat’s message to other TB patients: I want to tell all other people that they m ust take proper medicines and on time and should never miss even a single dose. They should adhere to their treatment and complete it and not leave it in between. (Babita, the nurse in charge at Calcutta Rescue Centre, Kolkata told —Nusrat took medicines from some private doctor for about a year in 2009 and came to Calcutta Rescue in July 2010 for Cat2 treatment. As her body weight was very low (about 22kg) she was given pediatric doses and also given streptomycin injections. Thereafter her reports came negative and she was cured by March 2011. But just one month later, on 27th April 2011, she came back with the same problems (low grade fever and cough). Her sputum tested positive again. Then she was put on Cat2 for relapse. But by now she had already taken Cat 2 treatment twice—once in private and then in government. Yet she was not responding. So finally her sputum was sent to the government hospital for culture and after 4 months the report confirmed MDR-TB and she was then put on Cat4 treatment. As per our rules she was admitted it K S Roy Hospital for fifteen days for observation and took medicines from there. Thereafter she has been on MDR-TB treatment for over a year now (it was February 2013). The results of the culture and smear are now coming negative and she is slowly getting better. She is now in the continuation phase and comes here alone every day to take her medicines. Her mother used to come with her when she was getting injections, but now she comes alone. Sometime ago she developed some psychological problems-- sitting all day at home with nobody talking to her. So I advised her family to send her to school again as she was now infection free. She thought that she had become overage for her class. But then I counseled her and her family and told her that age is never a bar for studies. So she rejoined her school in January, 2013 and is now very happy going to school and talking to her friends. Her school does not know about her TB status. From the school she comes here to take her medicines. Earlier she would cry all the time but now she is back to being a normal and happy girl). When I spoke to Nusrat in February 2013, she sounded very optimistic and full of hope. Going back to school had perhaps worked wonders for her mental health. She was happy to be with her friends once again and no longer treated as an outcast. There was no trace of dejection and depression in her talks. In fact she promised to meet me on her next visit to her grandparents’ house in Amethi.

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TB is not only a poor person’s disease!
I met Bhaskar in the MDR-TB OPD of Lok Nayak Hospital, New Delhi, on an early February morning in 2013. He seemed to be well educated and spoke in fluent English. He admitted to being a smoker in the past but had since given up smoking. But he was not convinced that smoking could have been a reason for his getting afflicted with TB. He had got his wife and only child tested for TB in July 2012 and their report was negative. He said he would send them for testing again this summer. Bhaskar had the usual symptoms of cough and fever in 2012 when he went to a private doctor who diagnosed him with TB on the basis of a chest X-Ray. The doctor said that it would take him 8-9 months to get cured. So Bhaskar did not take his disease seriously and started his medication under his doctor. He never thought it necessary to go to a government centre. But even after completing 6 months of treatment there was no visible improvement in his condition. Alarmed at this he showed himself at this hospital where he was diagnosed with MDR-TB. He had been on MDR-TB treatment at Lok Nayak Hospital since April 2012. Bhaskar has faced lot many problems during the course of his treatment. Earlier he suffered from excessive weight loss and faced other problems too like stomach ache, vomiting, and nausea. When I met him he sounded very dejected, especially because of the toxic side effects of medicines. He lamented, “If there is something which I cannot just digest is why these 2 painful years of medicines—were the medicines not good enough? Right now also I am suffering from many side effects of medicines. I feel very restless at night after taking my medicines. I feel okay in the latter part of the day, but I cannot sleep properly at night, and next morning I have to go to my job. So it becomes very tiring for me, although I am a bit relaxed than before. Earlier, when I was taking painful injections, it was worse. Whatever anyone told me to do in the last 2 years I have done that. I only hope that now I will get better.” “I am taking all precautions as told by the doctors here. I have been told to use a separate room and toilet. In the initial period I used to wear a mask but not now. As much as I can I take all precautions. I am ready to do things that are required at the moment even if by little force as I really want to get cured.” “I do not know if smoking was responsible for my TB. If everyone stops smoking then India will become the poorest country of the world due to loss of revenue. But anyways, I have quit smoking and it is okay with me. And I am not tempted to take to

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tobacco again.” [Editor’s note: As per a study conducted by Indian Council of Medical Research (ICMR), India loses more money on treating tobacco related causes than the revenue from tobacco industry.]

Going to college with treatment alongside...
Rafiq belongs to Haryana and is currently studying in the second year of B.A. in Jamia Millia University, Delhi. His father is a driver and he is the second eldest amongst 9 siblings—7 brothers and 2 sisters. He probably contracted TB probably 3 years ago in 2010 when he was studying at Nadwa College in Lucknow. It started with cold and cough. He showed himself in a government hospital in Lucknow and was diagnosed with TB. So he went back home and began his treatment in some government hospital in Haryana. But as he was not getting well he thought the treatment did not suit him, and he left it midway without completing the 6 month regimen. He then turned to a private doctor and was under his treatment for 2 years, spending INR 3000 per month on his medicines. But he was not getting any better. As he was now living in Delhi, he eventually showed himself at Lok Nayak Hospital where he was diagnosed with MDR-TB. His medication for MDR-TB began on 26th September, 2012 and when I met him in February 2013 he was in the fifth month of his treatment. Rafiq said that, “I am feeling much better with the treatment provided here, although after taking injections and medicines I do feel restless at times. This centre opens at 9 am, so I come here to take the medicines and injections and then go to college, as my classes start from 10 am. I have taken a room here in Delhi and stay alone. I do not cook my own food but eat in a hotel as I have to take proper diet to bear the side effects of drugs. I do not take anything like cigarettes or alcohol. The doctor here has not asked me to eat anything in particular, but people have advised me to eat more non vegetarian food as it gives more energy. No other person in my family has TB and none of them have been tested for this disease. I have mostly stayed away from home, so it is unlikely that they will get the infection from me.”

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After a whirlwind search for cure, found relief at PMDT site in Delhi

In the MDR-TB OPD of Lok Nayak TB Hospital I came across the harried father of a 19 years old girl who had reached Delhi that very morning of February, 2013 and then had immediately come to the hospital. His daughter’s case had been referred from SGPGI Lucknow to this hospital. His heart rending tale of woes was a living testimony of a callous and irresponsible private sector and a careless government sector. He was carrying a fat load of her past prescriptions gathered as the hapless father went from one doctor to another; from one treatment to another; while her TB got worse by the day. The duo belonged to MP where the girl first took ill in September 2010. She had constant fever and cough. Her sputum was tested and X-Ray was also taken. She took treatment under a private doctor for 8 months. She was okay for 4 months and then the problems recurred. This time the father took her to a government hospital in Chhatarpur where she was again put on a 9 months regimen. But the medicines had to

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be bought from the private market as the government doctor was treating her as a private patient (the father said that this was quite the norm at his native place. Here she was given kanamycin 750 mg injections for 3 months on alternate days, but not streptomycin. Yet there was no relief. For two years she was treated in MP but did not improve even one bit. The patient as well her parents were all fed up with the long drawn out treatment without any visible relief. Then on a relative’s advice she was shown in SGPGI Lucknow in June 2012. There she was given 60 streptomycin injections. Kanamycin was also started again. As per her SGPGI prescriptions she had been on 2nd line drugs since 1st November 2012. For the last three months she had had no fever or cough and for the first time after 2010 she was feeling better. But probably the right treatment came to her a bit too late-- one of her lungs had been damaged almost completely and she was also suffering from a total loss of appetite. So she had been referred to this hospital. (The attending doctor in the OPD went through all her past prescriptions very rigorously and concluded that she although she had been given kanamycin earlier by the doctor in MP, but other second line drugs were not given. So she developed resistance. The SGPGI doctors followed the protocol. Their tests revealed MDR-TB and they treated her accordingly. But they were not able to get the desired response. So now they doubted that she is resistant to second line drugs also—which means that it could be a case of XDR-TB. The doctor also said that as per the rules, if XDR-TB is diagnosed, this hospital would not be able to provide free drugs to this outstation patient, although they would give other support. Drugs from the private market would cost around INR 5 lakhs, for the whole course of treatment. However, he said that they we would try to register her under some project or the other which go on in RB TB Hospital and LRS Hospital, and if she is lucky she would get free treatment under them. But there was no guarantee of this).

Blew up more than cost of MDR-TB treatment in private sector…
I have my mother, an elder brother and 3 sisters in my family. No other person is suffering from TB in my family. 21 years old Saral belongs to Bihar. He started facing problems 4 years ago when he was studying in school. He would feel very weak and also coughed a lot. But he ignored these tell-tale signs and gradually his health worsened. Then he went to Mumbai to visit his cousins where he showed himself to a private doctor who told him that a lot of phlegm had accumulated in the chest. He prescribed medicines to be taken for two months and also

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advised bed rest. After taking medicines for 1 week Saral returned to Bihar. His problems aggravated there and so again he went to a private doctor there. He was under this treatment for nearly 8 months. In the beginning he did get some relief, but then again the problems recurred (at this stage the patient was feeling it difficult to speak, so I spoke to his brother outside the ward). Brother of the patient –“Initially we spent a lot of money (over INR two lakhs) on private doctors’ treatment in Darbhanga, Bihar, with no positive outcomes. Then some people of the village told us about this LRS Institute and so we brought him here as already a person from our own village had taken treatment here and got well. Saral has now been on treatment at LRS Institute for the past one and a half years and since the time he is taking treatment he is feeling much better. The patient had started working also as he felt better. But then again his condition started worsening and so he was admitted here a few days ago. The doctor has said that they have now replaced the old drugs with more powerful ones. He is facing some problems in urination and so he will remain here for another 2-3 days and would be relieved after that and the medicine would continue till the doctor says. By God’s grace all is going well now. Now he has the confidence that he will get well soon but had he known about this place earlier then treatment would have started early too. In the villages, those persons who know even a little about TB, apply their own knowledge and ask to shift the patient to so or so place.” The brother and mother of Saral were all praises for the doctors and the staff who are very efficient and nice. They said that he was just a bag of bones when he came to this hospital and now his health has improved because of the good care that he has been given. The advice of patient’s brother to other people: it is important to meet the right doctor and contact qualified persons for seeking proper treatment. They should not listen to every person who has some advice to offer. Instead they should apply their own sense, otherwise nothing other than simple time waste would come in hand. The nurse informed that perhaps the family is not realizing that XDR-TB is very difficult to treat. Of course right now they are very happy that since they brought the patient here, he has improved tremendously.

Deserted by husband’s family, in her father’s care: she needs an oxygen cylinder to breathe…
I met 18 years old Rinki in Febraury 2013 in the Model MDR-TB Ward 8 of LRS Institute, Delhi. (There are 24 such state of the art wards in this hospital which are one of their kind in India and are equipped with the most advanced infection control gadgets). She

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was breathing through an oxygen cylinder fitted in her ward. Rinki had completed 18 months of her MDR-TB treatment at LRS Institute in February 2013. She had tested negative and was in the continuation phase of medication. However TB had taken its toll by way of damaging her lungs, making her dependent on an oxygen cylinder to breathe. When she does not use the oxygen cylinder she suffers from intense body pain and feels very uncomfortable as she gasps for breath. The oxygen cylinder seems to have become her lifeline now as TB has ravaged her lungs. Rinki comes from a very poor family and could study till class 6 only. She was married at a very young age, but was thrown out of her in-laws house when she contracted TB. A native of Bihar, Rinki lives with her parents and brother in a slum of Delhi. Her brother is a roadside vendor and the sole bread winner. Her father, who stays with her in the hospital from 4 pm till 10am, is a patient of hypertension. He used to ply a rickshaw but now his health does not permit him to do that. Rinki’s mother is also sick with many gastric ailments. Rinki was put on TB treatment in 2009 when she was 14 years old. She completed 6 months therapy at LRS Institute and then tested negative. She remained okay for 6 months. Meanwhile she was married off by her parents (despite being so young and recuperating from a debilitating disease). But after some time her problem of cough and fever recurred and she was ill again. This time she was put on a 10 month treatment course. But her in-laws did not pay much attention and there was carelessness in taking medicines regularly. This disruption in treatment further deteriorated her condition. She was admitted in LRS Institute for 4 months, and then she became better and was discharged. After 1 month she was sick again. This whole cycle repeated once again. She was eventually diagnosed with MDR-TB one and half years ago. Since then she has been on MDR-TB treatment for the last 18 months. Now she is negative and in the continuation phase of treatment. But her lungs are damaged, so she needs an oxygen cylinder to breathe. When she is out of the hospital she needs a cylinder which costs 300 per day which her poor parents can ill afford. So she just keeps flitting in and out of the hospital where mercifully she is able to get free admittance. But the hospital administration
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has its own logistic problems. They find it difficult to keep a patient in the ward for an indefinite period of time, although they are doing their best to help her. Rinki repeatedly told me that she felt very guilty for putting her parents to so much of trouble because of her seemingly never ending illness. No one else has TB in her family. Her father has resigned himself to his fate. He said that, “Perhaps taking TB medicine is like spraying insecticide in the body. If any germ remains, TB recurs —else why did my daughter get it over and over again?” The Sister-in-charge of the ward said that although Rinki had become negative, but as soon as she goes home after getting discharged she starts facing problems of oxygen shortage and then she returns as they are too poor to afford an oxygen cylinder continuously. Her condition will improve gradually but for that she regularly needs nutritious and protein rich diet and fresh fruits which the family is perhaps unable to afford. Once her MDR-TB medication is over she would be prescribed some lung exercises to improve her lung condition.

MDR-TB survivor also bravely battles against a rare genetic disease
She is a brave woman who is a living example of the oft-quoted adage - 'When the going gets tough, the tough gets going...' Read her story in her own words -a real-life experience, full of grit, courage and determination, to continue living and spreading light despite seemingly insurmountable challenges.

“I have been suffering from a rare genetic
disorder called Von Hippel Lindau (VHL) Syndrome since my early childhood. This disorder results in excess blood flow due to hypoxia inducible factor (HIF) resulting in repeated tumor growths in different organs of my body. VHL is a lifetime disease. Patients need to be constantly checked and treated/operated for the tumors and cysts that develop at various sites in the central nervous system and visceral organs throughout their lifetime. Because of the complexities associated with management of the various types of tumours in this disease, treatment is multidisciplinary.

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Very often timely aggressive surgical intervention is the only cure. As a VHL liver
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transplant patient, I have undergone and 9 surgeries one brain tumor removal, besides grappling with MDR-TB which was diagnosed in 2010. I developed MDR-TB. Manifestation of my latent TB happened under immune compromised situation, confirmed by a radiological conference facilitated by Dr Randeep Guleria at All India Institute of Medical Sciences (AIIMS). I developed pulmonary, bone and lymph involvement, to such an extent that it gnaws my bones and I walk with help of a fourtoed stick. The latest CT study of my chest reveals multiple nodules, many of them calcified, and also fibroatelectatic lesions in both lung fields. The appearance is consistent with chronic tubercular lesions. Compared with previous CT chest studies of 2010 and 2011, there is relative regression of the lung parenchymal lesions. CT study of head reveals an enhancement in right cavernous sinus as well as right convexity. In view of the size of lesion and my age (33years), radiosurgery-- cyber knife—has been suggested by doctors at Medanta Medicity Hospital. My father’s sudden demise in 2010 has left me and my mother in a penniless situation, and my younger brother is now the sole earning member of the family. We are left with nothing to carry on my treatment. We are homeless, being evicted by landlords as and when they feel I am contagious because of my TB. At present I am living in a crummy rented place with narrow stairs, without ventilation, which is having adverse effects on my lung lesions, bone TB and hypoxia related VHL tumours which are growing fast. Initial support was provided by my friends and well-wishers but they and my brother can no longer pull the economy of my diseases together.” Note: Presently as of 1 May 2013, she is struggling to raise resources enough to meet her healthcare financial expenses for a range of conditions.

We are homeless, being evicted by landlords as and when they feel I am contagious because of my TB. At present I am living in a crummy rented place with narrow stairs, without ventilation, which is having adverse effects on my lung lesions, bone TB and hypoxia related VHL tumours which are growing fast

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We can stop TB: With a little bit of love and a pinch of will power...
This is the story of Munnawar Khan Pathan, a 49 years auto rickshaw driver of Ahmedabad who has successfully battled multidrug-resistant TB (MDR-TB) through his will power and the loving efforts of his doctor Dr R M Leuva. His is an example of how a caring and committed doctor can help an MDR-TB patient to complete the two years long ordeal of toxic medication and get fully cured. Last month, in February 2013, I was in Ahmedabad, talking to a healthy and beaming Munnawar, little realising that he had been through terrible times before eventually conquering MDR-TB. Although I had spoken to many patients afflicted with this serious form of the disease, this was the first time I was face to face with a cured MDR-TB patient. Munawwar’s ordeal began in 2006 when he was diagnosed with TB for the first t ime. “At that time I used to eat gutkha, smoke cigarettes and bidi. Firstly I showed myself in the Ahmedabad Municipality TB Centre but my condition did not improve. I was also not very regular with my treatment and would go on and off medicines. In 2008 I sought treatment in the private sector, but my condition deteriorated. But God is great. He came to me in the garb of Leuva Sahib (who had treated me earlier). Dr Leuva stopped me one day while I was driving my auto rickshaw and asked me to meet him in the hospital as he wanted to talk to me. I felt very happy and proud that such a reputed doctor had called me personally. So I went to him and he gave me the confidence that I will be cured of my TB. My medicines for MDR-TB started in October 2009. On Dr Leuva’s insistence I gave up smoking bidi, cigarette, and eating gutkha, and started taking my medicines religiously. I had to stay in the hospital for 19 days. I had to take 13 tablets every day. I always ate them together in one go and also took injections for 6 months. While on treatment I once fractured my leg and was admitted to a nearby hospital for about 4 months. During that time Leuva sahib would come personally to give me injections. So my treatment was not disrupted.” “Now I have been completely cured since 2011. I owe all my good health to Dr Leuva. It is only because of him that I am standing perfectly well on my feet today along with

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my family members and driving my vehicle as well. I am so indebted to him that even if would call me at midnight I would go readily to offer any help I can.” Explained Dr Leuva, “Munawwar had been a Cat 1 treatment failure earlier and hence a presumptive MDR-TB patient. I was there in the same government hospital where Munawwar had sought treatment earlier and I knew he had been defaulting on treatment. At that time there was no government programme to treat MDR-TB. So he had shifted to the private sector and was on kanamycin under the private doctors. When government programme for MDR-TB treatment started in Gujarat, I remembered him and thought to bring him to the government clinic so that he could get free treatment. I knew that he sometimes came to this particular spot. So I would stand there every day waiting for him as I did not have his home address. I finally found him one day, and asked him to come to the hospital. Initially he did not want to take the treatment as he had no faith in the government programme. Moreover it took 4 months for the test report to come and confirm the diagnosis of MDR-TB. Even after the diagnosis it took a lot of effort to make him agree to begin treatment. While on treatment he once fractured his leg and was confined to bed. I ensured to give him his daily dose of injections during this period by doing home visits as a special case. Today he is standing in front of you—fit and fine.” Munawwar has since become a TB advocate and his mission is to spread awareness about TB in the general population. I found his auto rickshaw decorated with several hoardings with informative messages on TB and advertisements about the government TB programme. Now whenever Munnawar sees any patient suffering from TB then he goes to the patient and tells him/ her that once he also had the same problem and now he is doing well after taking treatment. He always keeps the hospital card in his pocket to show others how he got well and from where he took his treatment. He has brought many patients to the programme who had either left treatment midway or were hesitant to begin treatment. “If I find any person suffering from TB, I try to share their suffering and problem and bring them free of cost in my auto to this DOTS centre. This is the only way I can show my gratitude for all that Leuva sahib did for me. I have brought many patients here. Sometimes the patient gets angry on me but I do not mind it as deep inside my heart I

“If I find any person suffering from TB, I try to share their suffering and problem and bring them free of cost in my auto to this DOTS centre. This is the only way I can show my gratitude for all that Leuva sahib did for me. I have brought many patients here. Sometimes the patient gets angry on me but I do not mind it as deep inside my heart I know how painful the whole process is. My work is only to make them understand because a person gets irritated while on treatment as I have gone through all this myself
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know how painful the whole process is. My work is only to make them understand because a person gets irritated while on treatment as I have gone through all this myself. I also tell the people suffering from TB that there is no need to seek such costly treatment in the private sector. I too wasted so much of my money in taking medicine from the private doctors but it did no good,” confided Munawwar. Dr Nevin Wilson, Regional Director of the South-East Asia Office, International Union Against Tuberculosis And Lung Disease (The Union), rightly believes that, “Patients and communities are central to TB control. Patients must be empowered to act positively for their own good through full knowledge of their illness and the risks involved in not completing treatment. They also require support to complete a full course of treatment. This support has to be continuous and includes the regular provision of medication; counselling to understand the side effects of medication and the need to persist with complete treatment.” Seeing is believing, and, coming across a grateful patient advocate and a devoted (yet very humble) doctor, restored my faith in our combined ability to control the menace of all forms of TB—sensitive and resistant. There are many more such healthcare professionals and advocates doing inspiring work in our midst. We just need to help them multiply their efforts, in whatever way we can, to fulfill our mission of a TB free world.

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The Patients’ Charter for Tuberculosis Care (the Charter) outlines the rights and responsibilities of people with tuberculosis (TB). It empowers people with the disease and their communities through knowledge of the disease. Initiated and developed by patients from around the world, the Charter makes the relationship with health-care providers a mutually beneficial one. The Charter sets out the ways in which patients, communities, health-care providers, both private and public, and governments can work together as partners in a positive and open relationship, to improve standards of TB care and enhance the effectiveness of the healthcare process. It allows all parties to be held more accountable to each other, fostering mutual interaction and a “positive partnership”. Developed in tandem with the International Standards for Tuberculosis Care (1) to promote a “patient-centred” approach, the Charter adheres to the principles on health and human rights of the United Nations, UNESCO, WHO and the Council of Europe, as well as other local and national charters and conventions (2). The Charter embodies the principle of Greater Involvement of People with TB (GIPT). This affirms that the empowerment of people with the disease is the catalyst for effective collaboration with health-care providers and authorities and is essential to victory in the fight to stop TB. The Charter, the first global “patient-powered” standard for care, is a cooperative tool, forged from a common cause, for the entire TB community.

PATIENTS’ RIGHTS
1. CARE a. The right to free and equitable access to TB care, from diagnosis to completion of treatment, regardless of resources, race, gender, age, language, legal status, religious beliefs, sexual orientation, culture or health status. b. The right to receive medical advice and treatment that fully meets the new International Standards for Tuberculosis Care, centring on patient needs, including those of patients with MDR-TB or TB-HIV co-infection, and preventive treatment for young children and others considered to be at high risk. c. The right to benefit from proactive health sector community outreach, education and prevention campaigns as part of comprehensive health-care programmes. 2. DIGNITY a. The right to be treated with respect and dignity, including the delivery of services, without stigma, prejudice or discrimination by health-care providers and authorities. b. The right to high-quality health care in a dignifi ed environment, with moral support from family, friends and the community. 3. INFORMATION a. The right to information about the availability of health-care services for TB, and the responsibilities, engagements and direct or indirect costs involved.

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b. The right to receive a timely, concise and clear description of the medical condition, with diagnosis, prognosis (an opinion as to the likely future course of the illness) and treatment proposed, with communication of common risks and appropriate alternatives. c. The right to know the names and dosages of any medications or interventions to be prescribed, its normal actions and potential side-effects and its possible impact on other conditions or treatments. d. The right of access to medical information relating to the patient’s condition and treatment and to a copy of the medical records if requested by the patient or a person authorized by the patient. e. The right to meet, share experiences with peers and other patients and to voluntary counselling at any time from diagnosis to completion of treatment. 4. CHOICE a. The right to a second medical opinion, with access to past medical records. b. The right to accept or refuse surgical interventions if chemotherapy is possible and to be informed of the likely medical and statutory consequences within the context of a communicable disease. c. The right to choose whether or not to take part in research programmes without compromising care. 5. CONFIDENCE a. The right to respect for personal privacy, dignity, religious beliefs and culture. b. The right to confidentiality relating to the medical condition, with information released to other authorities contingent upon the patient’s consent. 6. JUSTICE a. The right to make a complaint through channels provided for this purpose by the health authority and to have any complaint dealt with promptly and fairly. b. The right to appeal to a higher authority if the above is not respected and to be informed in writing of the outcome. 7. ORGANIZATION a. The right to join, or to establish, organizations of people with or affected by TB, and to seek support for the development of these clubs and community-based associations through health-care providers, authorities and civil society. b. The right to participate as “stakeholders” in the development, implementation, monitoring and evaluation of TB policies and programmes with local, national and international health authorities. 8. SECURITY

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a. The right to job security after diagnosis or appropriate rehabilitation upon completion of treatment. b. The right to nutritional security or food supplements if needed to meet treatment requirements.

PATIENTS’ RESPONSIBILITIES
1. Share information a. The responsibility to provide as much information as possible to health-care providers about present health, past illnesses, any allergies and any other relevant details. b. The responsibility to provide information to health-care providers about contacts with immediate family, friends and others who may be vulnerable to TB or who may have been infected. 2. Follow treatment a. The responsibility to follow the prescribed and agreed treatment regimen and to conscientiously comply with the instructions given to protect the patient’s health and that of others. b. The responsibility to inform health-care providers of any difficulties or problems in following treatment, or if any part of the treatment is not clearly understood. 3. Contribute to community health a. The responsibility to contribute to community well-being by encouraging others to seek medical advice if they exhibit symptoms of TB. b. The responsibility to show consideration for the rights of other patients and healthcare providers, understanding that this is the dignified basis and respectful foundation of the TB community. 4. Solidarity a. The moral responsibility to show solidarity with other patients, marching together towards cure. b. The moral responsibility to share information and knowledge gained during treatment, and to share this expertise with others in the community, making empowerment contagious. c. The moral responsibility to join in efforts to make the community free of TB. Help turn these words into realities. Support the drive towards implementation in the community.

Source: Patients’ Charter for Tuberculosis Care © 2006 World Care Council

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Source: Guidelines for PMDT in India: May 2012

Summary of recommendations for Airborne Infection Control in M/XDRTB WARDS Key Recommendations:  Located away from the other wards, with adequate facilities for hand washing and good maintenance and cleaning.  Adequate ventilation (natural and/or assisted ventilated) to ensure >12 Air Changes per Hour (ACH) at all times.  Adequate space between 2 adjacent beds, at least 6 feet  Cough hygiene should be promoted through signage and practice ensured through patients and staff training, ongoing reinforcement by staff  Adequate sputum disposal, with individual container with lid, containing 5% phenol, for collection of sputum  All staff should be trained on standard precautions, airborne infection control precautions, and the proper use of personal respiratory protection. A selection of different sizes of re-usable N95 particulate respirators should be made available for optional use by staff.

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Source: Guidelines for PMDT in India: May 2012

It is crucial that patients with Rifampicin resistance be referred for treatment as soon as possible. If Rifampicin resistance – with or without INH resistance – is confirmed, the DTO will trace the patient, with help of the Medical Officer – TB control (MO-TC) and Senior Treatment Supervisor (STS) and bring them to the DTC where they will be counselled by the DTO. Counselling should include (1) information on the lab results, and the reliability of lab results from RNTCP certified C-DST laboratories, (2) the need for additional treatment, (3) the importance of rapid initiation of treatment, (4) the services RNTCP offers for PMDT, (5) what patients should do next, and (6) infection control precautions that are necessary, and reassurance to the family against panic or unnecessary stigmatization of the patient. After counselling, the patient is referred to the concerned DR-TB Centre with their DST result and PMDT referral for treatment form All MDR-TB cases will be offered referral for HIV counselling and testing at the nearest centre if the HIV status is not known or the HIV test is found negative with results more than 6 months old Patients should receive counselling on: 1) the nature and duration of treatment, 2) need for regular treatment, 3) possible side effects of these drugs and 4) the consequences of irregular treatment or pre-mature cessation of treatment. It is advisable to involve close family members during the counselling, since family support is an essential component in the management. Patients should be advised to report any side effects experienced by them. Female patients should receive special counselling on family planning. PROVIDING COUNSELLING TO PATIENT AND FAMILY MEMBERS Providing counselling and health education to the MDR-TB patients and their family members about the disease and about the necessity of taking regular and adequate treatment is of utmost importance. Health education and counselling is provided to all patients and family members at different levels of health care, right from one at the periphery to those at the DR-TB Centre facility. It is started at the initial point of contact and carried on a continuous basis at all visits by the patient to a health facility. The counselling and motivation is required to be done not only of the patient but also of the family members.
SOCIAL AND EMOTIONAL SUPPORT Having MDR-TB can be an emotionally devastating experience for patients and their families - there may be stigma attached to the disease and this may interfere with adherence to therapy. In addition, the long nature of MDR-TB therapy combined with the medications’ adverse effects may contribute to depression, anxiety and further difficulty with treatment adherence. The provision of emotional support to patients may improve chances of adhering with therapy. This support may be provided formally in the form of support groups or one-on-one counselling with trained providers. Informal support can also be provided by physicians, nurses, community workers or volunteers, and family members. Ideally a multidisciplinary team, comprising of a social worker, nurse, health educators, companions, and doctors, should be set up to act as a “support to adherence” team to the patient. Linking up these cases with the available social welfare schemes through active engagement with the civil society partners and NGOs is another option the programme officer must explore to promote treatment adherence. Best Practices in PMDT in India | July 2013

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Source: Guidelines for PMDT in India: May 2012 One of the five components of PMDT in India: Diagnosis of MDR-TB through quality-assured culture and drug susceptibility testing (DST): - Proper triage of patients for C-DST testing and management under PMDT - Co-ordination with National and Supra-National Reference Laboratories Laboratory services required for introduction of PMDT Optimal management of MDR-TB requires both mycobacterial and clinical laboratory services. At a minimum, the State level Intermediate Reference Laboratory (IRL) or any other RNTCP-certified Culture & DST laboratory should provide: - Diagnostic culture on solid and/or liquid media, - Confirmation of resistance to rifampicin by either molecular tests (Line probe assay or other RNTCP-approved technology); - Confirmation of the species as M. tuberculosis or non- tuberculous mycobacteria (NTM); and - testing for susceptibility to at least isoniazid and rifampicin by solid or liquid culture. Definition of accreditation and certification: Laboratory Accreditation means third-party certification by an authorized agency using internationally approved standards for evaluating the competence of laboratories to perform specific type(s) of testing and is a formal recognition of competent laboratories. It includes all aspects of the laboratory including physical infrastructure, biosafety, competencies of staff, processes, procedures and quality system elements (QSE) enumerated in the system i.e (ISO, CAP, NABL etc). Certification is a process by which a specific procedure being performed in the laboratory i.e DST in TB labs is being quality assured by means such as standard EQA system (retesting and panel testing) by a higher level laboratory to ensure quality of that service. A patient is confirmed to have MDR or XDR TB only when the results are from a RNTCP quality-assured Culture & DST Laboratory and by a RNTCP-endorsed testing method. It is to be noted that rifampicin resistance is quite rare without isoniazid resistance. The great majority of DST results with rifampicin resistance will also be isoniazid resistance, i.e. MDR TB. Therefore RNTCP has taken the programmatic decision that patients who have any Rifampicin resistance, should also be managed as if they are an MDR-TB case, even if they do not formally qualify as an MDR-TB case as per the above definition. Therefore programme and clinical actions will be driven primarily by rifampicin DST results. METHODS FOR DRUG SUSCEPTIBILITY TESTING Presently, 3 technologies are available for diagnosis of MDR TB viz. the conventional solid egg-based Lowenstein-Jensen (LJ) media, the liquid culture (MGIT), and the rapid molecular assays such as Line Probe Assay (LPA) and similar Nucleic Acid Amplification Tests like Xpert MTB/Rif. Conventional DST evaluates if M. tuberculosis grows in the presence of drug-containing media, and is also known as phenotypic DST. Molecular DST evaluates for the presence of genetic mutations that are highly associated with phenotypic resistance, and is also known as genotypic DST. The differences between the tests should be understood. Phenotypic DST is available for more drugs, and is considered very reliable for isoniazid (H), rifampicin (R), and streptomycin (S), and somewhat less reliable for other drugs such as ethambutol (E). Molecular/genotypic DST is highly reliable for rifampicin, but has limited sensitivity for detection of isoniazid resistance. Results from any RNTCP-approved tests are considered equivalent, and can be the basis of clinical action, though in some settings additional testing will be done. Molecular/genotypic tests are much faster than phenotypic tests, as molecular tests don’t require growth of the organism, and M. tuberculosis is notoriously slow growing. The turnaround time for C-DST results by Solid LJ media is around 84 days, by Liquid Culture (MGIT) is around 42 days, by LPA is around 72 hours and by CB-NAAT is around 2 hours. Best Practices in PMDT in India | July 2013 DST for Ofloxacin (O) and Kanamycin (Km) and Pyrazinamide (Z) will be introduced and gradually scaled up to all RNTCPcertified C-DST Laboratory in the near future.

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MDR DIAGNOSTIC TECHNOLOGY CHOICE 1. Molecular DST (e.g. LPA DST) 2. Liquid culture isolation and LPA DST 3. Solid culture isolation and LPA DST 4. Liquid culture isolation and Liquid DST 5. Solid culture isolation and Solid DST SPECIMEN COLLECTION An often-overlooked problem is that of obtaining adequate good quality specimens at the peripheral laboratories. Unless specimens are collected with care and promptly transported to the laboratory under temperature control, diagnosis may be missed, and the patient could miss the chance to be detected and put on the correct treatment. A good sputum specimen may literally make the difference between life and death, and allow containment of the disease and prevent spread to others in the family and community. The Laboratory technician needs to explain the process of collecting “a good quality sputum specimen” and avoid using vernacular terminologies that convey the meaning as saliva instead of sputum. In addition though the general guideline for collection of sputa is one spot and one morning, this does not preclude from collecting 2 spot specimens that need to be collected with a gap of at least one hour (60 minutes) if the patient is coming from a long distance or there is a likelihood that the patient may default to give a second specimen. A good sputum specimen consists of recently discharged material from the bronchial tree, with minimum amounts of oral or nasopharyngeal material. Satisfactory quality implies the presence of mucoid or mucopurulent material. Ideally, a sputum specimen should have a volume of 3-5ml. The patient must be advised to collect the specimen in a sterile container (falcon tube) after through rinsing of the oral cavity with clean water. Specimens should be transported to the laboratory as soon as possible after collection. If delay is unavoidable, the specimens should be refrigerated up to 1 week to inhibit the growth of unwanted micro-organisms. SPECIMEN TRANSPORTATION TO CULTURE-DST LABORATORIES Fresh sputum samples will need to be transported from the DMC to the RNTCP-certified CDST laboratory in cold chain within 72 hours. Ideally an agency (courier / speed post) with a pan district presence should be identified for this purpose. Two innovative models for specimen collection and transport using fresh samples in falcon tubes to be transported in cold chain using gel packs and their technical specifications have been developed by Gujarat (from peripheral DMCs) and Andhra Pradesh (from high burden DMCs at TUs/DTCs). The following points are critical for the collection of fresh sputum samples at DMCs: - The falcon tubes and the 3 layer packing materials like thermocol box, ice gel pack (prefreezed at -20 degree for 48 hours), request for C-DST forms, polythene bags, tissue paper roll as absorbent, parafilm tapes, brown tape for packaging box, permanent marker pen, labels, bio-hazard sticker, scissors, spirit swab etc. should be supplied to the DMCs for collection of sputum through the DTO. - The falcon tubes should carry a label indicating the date of collection of the samples and the patient’s details like name, date of sample collection, name of DMC/DTC, Lab. No:- XYZ, specimen A or B - The Lab technicians (LT) at DMCs should be trained to carefully pack the sputum samples in the cold box to avoid spillage of the samples. - The LT of DMC issuing the falcon tubes to the patients should also give clear instructions to the patients on correct technique of collection of the sputum. Also the date of issue of the falcon tubes to the patient should be recorded. - The LT of the DMC should ensure that the request for C-DST form is packed in a separate plastic zip pouch and placed in the cold box before sealing the lid of the box. Also, the biohazard symbol should be pasted on the external side of the cold box along with the label indicating the postal address of the RNTCP-certified C-DST Lab assigned. - The LT of the DMC should promptly inform the sample transport agency like a courier / speed post service, speed post or a human carrier to collect and transport the samples Best Practices in PMDT in India | July 2013 As per the national guidelines for Biomedical waste management the containers used for transporting sputum samples to the RNTCP-certified laboratory should be labelled with a “BIO-HAZARD” sticker.

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Source: Guidelines for PMDT in India: May 2012

CRITERIA FOR PRESUMPTIVE CASES OF MDR-TB Criteria A –

Criteria B – in addition to Criteria A:

Criteria C – in addition to Criteria B -ve previously treated pulmonary TB cases at diagnosis, HIV TB co-infected cases at diagnosis A patient who is a presumptive case of MDR-TB, should be referred by the respective medical officer – peripheral health institute (MO-PHI) to the nearby DMC that has been developed for sample collection for CDST at the earliest i.e. as soon as the sputum results are available. If the diagnosis is based on Line Probe Assay (LPA), the patient’s results will be available within 48 hours and the decision of starting the patient on the appropriate regimen can be taken after results are available. PRE-TREATMENT EVALUATION The patient should be hospitalised (at the DR-TB Centre) for pre-treatment evaluation and treatment initiation. Pre-treatment evaluation should include a thorough clinical evaluation by a physician, chest radiograph, and relevant haematological and bio-chemical tests. Since the drugs used for the treatment of MDR-TB are known to produce adverse effects, a proper pre-treatment evaluation is essential to identify patients who are at increased risk of developing such adverse effects. A thorough clinical examination should be done during the pre-treatment evaluation. The pre-treatment evaluation will include the following:
1. Detailed history (including screening for mental illness, drug/alcohol abuse etc.) 2. Weight 3. Height 4. Complete Blood Count with platelets count 5. Blood sugar to screen for Diabetes Mellitus 6. Liver Function Tests 7. Blood Urea and S. Creatinine to assess the Kidney function 8. TSH levels to assess the thyroid function 9. Urine examination – Routine and Microscopic 10. Pregnancy test (for all women in the child bearing age group) 11. Chest X-Ray

All MDR-TB cases will be offered referral for HIV counselling and testing. GROUPING OF ANTI-TB DRUGS
Group 1: First-line oral anti-TB agents: Isoniazid (H); Rifampicin (R); Ethambutol (E); Pyrazinamide (Z) Group 2: Injectable anti-TB agents: Streptomycin (S); Kanamycin (Km); Amikacin (Am); Capreomycin (Cm); Viomycin (Vm) Group 3: Fluoroquinolones: Ciprofloxacin (Cfx); Ofloxacin (Ofx); Levofloxacin (Lvx); Moxifloxacin (Mfx); Gatifloxacin (Gfx) Group 4: Oral second-line anti-TB agents: Ethionamide (Eto); Prothionamide (Pto); Cycloserine (Cs); Terizadone (Trd); para-aminosalicylic acid (PAS) Group 5: Agents with unclear efficacy (not recommended by WHO for routine use in MDR-TB patients): Clofazimine (Cfz); Linezolid (Lzd); Amoxicillin/Clavulanate (Amx/Clv); thioacetazone (Thz); imipenem/cilastatin (Ipm/Cln); highBest Practices in PMDT in India | July 2013 dose isoniazid (high-dose H); Clarithromycin (Clr)

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ENABLERS AND INCENTIVES MDR-TB treatment can be successful with high overall rates of adherence when adequate support measures are provided. These measures include enablers and incentives for delivery of DOT to ensure adherence to treatment and may include the following: rsement of travel expenses to patient and attendants for visits to DTC and designated DR-TB Centre education on MDR-TB treatment; ctions; -salaried DOT providers INDOOR ADMISSION The patient will be admitted in the designated DR-TB Centre in-door facility for at least seven days post-treatment initiation. This period of admission will allow for investigations to be undertaken; olerance of the Regimen for MDR-TB; families; the services in the respective district where the patient resides (including identification and training of a local DOT provider and family treatment supporter); The hospital should provide comfortable living conditions, adequate food, proper ventilation and sufficient activities to keep the patients occupied. Further admission may be necessary during ambulatory treatment for management of severe adverse drug reactions, complications, to assess need and fitness for surgical intervention; social reasons, etc. After admission at the DR-TB Centre for at least seven days post-treatment initiation, the patient can be discharged to the residence district with up to a maximum of one week’s supply of drugs, arrangements for injections in transit, and a copy of the treatment card and referral form. The respective DTO should be informed by the attending physician of the patient’s planned discharge 3 days prior to the actual date of discharge, by means of the RNTCP PMDT referral for treatment form which can be sent by email.

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Source: Guidelines for PMDT in India: May 2012

M/XDR TB TREATMENT OUTCOME DEFINITIONS Standardised treatment outcome definitions are to be used following treatment of an MDR-TB case. These definitions apply to patients with rifampicin resistance (who are taken to be MDR-TB for management purposes), and XDR-TB cases as well: : A patient who has completed treatment and has been consistently culture negative (with at least 5 consecutive negative results in the last 12 to 15 months). If one follow-up positive culture is reported during the last three quarters, patient will still be considered cured provided this positive culture is followed by at least 3 consecutive negative cultures, taken at least 30 days apart, provided that there is clinical evidence of improvement. : A patient who has completed treatment according to guidelines but does not meet the definition for cure or treatment failure due to lack of bacteriological results. : Treatment will be considered to have failed if two or more of the five cultures recorded in the final 12-15 months are positive, or if any of the final three cultures are positive. : A patient who dies

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