Summary Report: Lessons from roll-out of MDR-TB services

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Lessons from the roll out of Multidrug

Resistant Tuberculosis (MDR-TB) services

Online consultation and

key informant interviews

conducted by CNS on

MDR-TB related services

in high burden countries October-November 2012

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The writers of Citizen News Service (CNS) come from affected communities who

have something to say on issues they feel for, or are affected by, in their daily lives,

and give a voice to those who are seldom heard. CNS syndicates content generated

in English and other vernacular languages to a range of media channels and

forums under Creative Commons (CC) attribution license.

CNS also provides media and communication related services to health and

development agencies globally. Lung Week (12-17 November 2012) CNS: www.citizen-news.org CNS: This content is shared under the Creative Commons License Attribution 3.0 Unported (CC BY 3.0) license

Citizen News Service (CNS)

CNS: C-2211, C-block crossing, Indira Nagar, Lucknow-226016. India

M: +91-98390-73355 | E: [email protected] | W: www.citizen-news.org

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Citizen News Service – CNS, a partner of the Stop TB Partnership, along with other partners such as National Partnership for TB Care and Control in India, Rural Youth Advocate for Health and Development in Nigeria, National Council of People Living with HIV in India (NCPI+), International Treatment Preparedness Coalition (ITPC) India, Global Health Advocates (GHA), Sneha Foundation Varanasi, Asha Parivar, Vote For Health campaign and National Alliance of People’s Movements (NAPM) and the Global Stop-TB eForum had hosted the online consultation and key informant interviews on issues related to multidrug-resistant tuberculosis (MDR-TB). Shobha Shukla, Rahul Dwivedi and Bobby Ramakant from CNS provided support to manage the process. OBJECTIVE The objective of this initiative was to document community perspectives and learn lessons on what worked and what didn’t in rolling out MDR-TB services in different countries/ contexts. These lessons are very important, especially experiences of affected communities, we believe, and must not be missed. These lessons should inform the ongoing and future planned roll-out (and scale up) of MDR-TB services at all levels. GUIDING QUESTIONS were: * Please share your experiences and perspectives of what works and what doesn’t work in your local settings where MDR-TB related services are available? * What are the key lessons from this experience, that must be taken into account before scaling up the MDR-TB services any further for enhanced public health outcomes? BACKGROUND There were about 650,000 cases of multidrug-resistant tuberculosis (MDR-TB) present in the world in 2010. Annually, about 440,000 fall ill with MDR-TB and 150,000 die due to this form of TB. India has an estimated annual incidence of 99,000 cases of MDR-TB (which is second only to China with about 100,000 cases). Out of these only 3610

About the e-consultation and

key informant interviews

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cases had been initiated on category IV treatment till 2010 under the DOTS Plus program. TARGETS Scaling up MDR-TB control and treatment services is critical to achieving the goal of zero TB deaths (and HIV deaths) and new infections, the MDR-TB related targets of the revised Global Plan to Stop TB (2011-2015) and national TB programmes such as the Revised National TB Control Programme (RNTCP - DOTS Plus targets). LEARN BEFORE WE SCALE UP We can only effectively scale up the roll out of MDR-TB services, if we learn well from the experience of rolling out MDR-TB services in the past years, in different settings and for different key populations and contexts. RATIONALE Despite about half a million new MDR-TB cases every year, MDR-TB related services have been limited to very fortunate few with large number of people who need care remaining unreached. Unless required measures are urgently taken to reduce new MDR-TB infection rate, and standard MDR-TB related care is made available and accessible to all those who are in need, a humungous pandemic will continue to brew. It is acutely important to learn lessons on what worked and what didn’t in rolling out MDR-TB services which currently reach a very small fraction of people who need care for MDR-TB. These lessons must inform the ongoing roll-out and accelerate scale up of MDR-TB services in different countries and contexts, to enhance positive public health outcomes. TIMELINE: The online consultation was open for three weeks (Wednesday, 17th October 2012 to Wednesday, 7th November 2012), after which this SUMMARY REPORT was published by CNS and partners. HOW DID MEMBERS PARTICIPATED? Members had their say by: - Joining the new Stop-TB eForum by sending an email to: [email protected] or [email protected] - Becoming an organizational PARTNER of this online consultation - to be a partner organization, send an email to: [email protected] - EMAILING us their comments, perspectives and experiences at: [email protected] - Going online at CNS blog: www.citizen-news.org and publishing their comments real time! - Skype-ing us and we recorded their statement (skype id: bobbyramakant ). - Tweet-ing us! By using #tag: #MDRTB - Having their say on our CNS Facebook page! - Calling us and recording their statement! (+91-98390-73355)

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WHAT WILL HAPPEN TO THIS SUMMARY REPORT? The summary of this online consultation fed into the issue brief which the onsite CNS team at the 43rd Union World Conference on Lung Health (Kuala Lumpur, Malaysia) is using to provide issue-based coverage. The CNS team members and partners also raised key issues highlighted by this consultation process at this conference in appropriate sessions. The summary report is also being distributed at this conference, and also will be disseminated to national TB programmes of 27 high burden MDR-TB countries identified by the Stop TB Partnership by end of 2012, and through other channels such as Stop-TB eForum, CNS syndicate, other networks and social media platforms. REFERENCE DOCUMENTS Stop TB Strategy Global Plan to Stop TB: 2011-2015 WHO Global Tuberculosis Control Report 2012 WHO Global Tuberculosis Control Report 2011 Whole Is Greater Than Sum Of Its Parts: CNS report 2011 RNTCP Annual TB Report 2011 MDR-TB Planning Toolkit (WHO and PATH) 2012 Hearing the unheard voices: Saving children from tuberculosis (CNS Report 2012)

Well-ventilated, clean TB ward at Pulmonary Medicine Department, King George’s Medical University, Lucknow | July 2012

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[All issues highlighted below were raised by about 300 participants who participated in the e-consultation on the

Global Stop-TB eForum and other social media platforms (blogs, twitter, Facebook pages/ groups, emails, phone or skype) or

were interviewed as a key informant by CNS]

he spread of MDR-TB is a grave public health risk that needs to be taken very Tseriously. TB control is still not a public health movement in high burden TB countries such as India and the general public is perhaps not adequately aware of the magnitude of the TB epidemic in the country. The media, NGOs, politicians, and even doctors remain largely insensitive to the issue. Also much more work needs to be done to raise recognition of the linkages between TB and other health or development initiatives – and bring those stakeholders on-board. There are too many shortfalls in implementation of DOTS programme, and pace of India’s national TB programme (formally called Revised National TB Control Programme – RNTCP) seems to be slow. The quality and strength of medicines dispensed at DOTS centres is also suspected to be poor as reported in some cases. India has a large private health sector and ways and means to control it effectively have not been made. The TB programme managers in high burden TB countries such as India must utilize the full potential of the electronic media in reaching out to the public. This tool has largely remained untapped. Treatment for MDR-TB in public health sector of India is few and far between and treatment in private sector is so costly that it is unaffordable for most patients. Regulating treatment modalities in private sector remains a huge challenge.

EXPERTS’ SPEAK: Professor (Dr) Surya Kant, Head of Pulmonary Medicine department, King George’s Medical University (KGMU) and Vice President, Indian Chest Society: Most of the times, it is doctors who are responsible for creating multidrug-resistance in society. It is the responsibility of the doctors' community to educate and motivate the patient so that they do not default from treatment. Patients should be told about the consequences of defaulting from the treatment. Professor (Dr) Anthony Harries, Senior Adviser, International Union Against Tuberculosis and Lung Disease (The Union): Sputum culture to test for drug resistance

SUMMARY

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should be done at the beginning of TB treatment and not when the first-line of treatment fails—as is normally done in the global TB Control programmes in Africa, India and China. So the correct diagnosis is far too delayed, and by then a lot of patients are already dead and/ or the infection has been transmitted to many others. Dr Y Ganesh, India: One of the ways to control MDR-TB and bring down numbers of new infections of MDR-TB is to strengthen the DOTS programme. Unless the leaks in DOTS are plugged it will be difficult to control MDR-TB. Dr Dennis Falzon, specialist with the Stop TB programme at WHO: (Source article written by Malia Politzer in July 2012, published in Live Mint, online at: http://www.livemint.com/Politics/bsWjPBLT7E6xbIVlbylkiJ/Fighting-drugresistant-TB-chinks-in-Indias-armour.html : Drug-resistant tuberculosis is a man-made phenomenon. It is due primarily to improper treatment of TB. If TB is treated improperly or inconsistently, drug-resistant strains emerge—once they emerge, they can spread to other people. Dr Muherman Harun, Indonesia: For culture tests it takes 2 months, and another 2 - 4 weeks for sensitivity tests. Now the patients have to collect the results by themselves, previously it was coordinated by the main centre. The patient has to visit the centre at least four times before MDR-TB status is confirmed - first time for presentation of sputum; second time to get sputum smear result; third time for culture test result; fourth or more visits to get the ultimate sensitivity tests results. In order to diagnose and begin treatment of MDR-TB early - we must have decent and reliable bacteriological labs and the cost of bacterial examination should be free or low. The number of tests should be increased according to the number of TB drugs used. The sensible doctor should do culture and sensitivity tests at the start of treatment if confronted by serious, or previously treated, lung TB. Depending on the size and nature of the lung lesion and severity of disease, he/she should decide whether 1 or 3 sputum smears are examined and whether or not sensitivity tests are needed. Treatment should be started only if all drugs are available throughout the treatment period. MDR patients cough a lot, are emaciated, thoroughly demoralised and have lost interest in life. Patients and family should be consistently motivated. It must be regularly emphasized to healthcare workers that every patient has a human dignity, which we should respect, irrespective of religion, conviction, gender, socioeconomic status culture and education.

SUMMARY OF EXPERTS’ OPINION: The doctors interviewed were of

the opinion that DOTS programme should be strengthened and revamped in order to control MDR-TB and that drug sensitivity tests need to be done at start of TB treatment. They also felt that proper counselling of TB patients and their family was a must to ensure that they complete the

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treatment and not leave it on and off, as this often leads to drug resistance. They also felt the need for more bacteriological labs and the cost of bacterial examination should be free or low to make them easily accessible to patients. Also as MDR patients are demoralised lot and have lost interest in life, they and their family should be consistently motivated. It must be regularly emphasized to healthcare workers that every patient has a human dignity, which we should respect.

PATIENTS’ SPEAK U Bishwanath, India—I completed my TB treatment in Ballia district successfully two years back. Got a recurrence last year and did treatment in private first, then when it didn't work, went to the government DOTS Centre. The treatment didn't work so went to Varanasi, and then to Lucknow and now hoping that this treatment for drug-resistant TB works. Why is there no DST lab in my area? Why have I to travel hundreds of kilometres and waste months feeling sick in confusion whether the treatment will work or not? Why cannot doctors find out first whether a medicine will work on me or not? Santosh Kumar, a migrant from Bihar has been undergoing treatment for MDR-TB since March-April, 2012. As there are NO government DOTS-Plus centres that provide free MDR-TB medication near his village, he has moved from his parents’ home to Delhi 1000km away with his family (wife and two children) for his treatment as he could not afford the private medication in Bihar. (Source--Written by Malia Politzer in July 2012, online at: http://www.livemint.com/Politics/bsWjPBLT7E6xbIVlbylkiJ/Fighting-drugresistant-TB-chinks-in-Indias-armour.html) Mahendra Patwar, MDR-TB patient from Delhi has been battling TB for nearly eight years. First diagnosed with the disease at 20, Patwar was prescribed daily treatment for six months, and declared cured. But three-and-a-half years later, he started coughing and losing weight again. This time he was given treatment for eight months. Two years later his TB returned and he was again on medicines for 4 months. Finally diagnosed with MDR-TB, Patwar began MDR-TB treatment several months ago, involving a daily regimen of pills and an injection. Due to the severe side effects—nausea, loss of appetite, ringing in his ears and severe joint pains—Patwar has been unable to work. He rarely misses his daily dose which he gets at the Shastri Park chest clinic in north-east Delhi. But despite his commitment to treatment, the efficacy is only about 50%, according to S.K Arora, Delhi's State TB control officer. 32 years old Payal Bhattacharya, a lymph node MDR-TB patient from Delhi has been on tuberculosis medication for more than two years now. She also suffers from an extremely rare genetic disorder known as VHL syndrome which results in the

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formation of multiple benign or malignant tumours in different body organs. She was first diagnosed with TB in 2009. After 3 months of treatment she was found to be resistant to the 1st line drugs of rifampicin and combutol. An 8 months regimen of Streptomycin injections along with other drugs has not given relief. She has completed two years of MDR TB treatment at AIIMS, New Delhi, but still not cured. She suffers from severe side effects of drugs—extreme body pain, seizers, difficulty in walking, skin pigmentation. She says that there is need for better drugs with lesser side effects. She also wants the government to do something concrete (and not just pay lip service) to ameliorate the lot of TB patients in India. MDR TB Patients need financial and emotional support. Treatment for MDR TB in public sector is largely unavailable and is too costly in the private sector. The following MDR TB patients are supported by St.Stephens Hospital with Home based care and are on treatment under the RNTCP DOTS PLUS program in Delhi:-- 17 years old Karim (Ajit Nagar); 23 years old Om Prakash (Nandnagri); 43 years old Gopal (Ashok Nagar); 36 years old Gajraj (Shahdara); 35 years old Nizamuddin (Tikona Park)-- The nearest DST Lab is 8-10km away from their homes. Patients came to this centre from other government healthcare facility, private doctors, and some of them come on their own too. Patients have to visit the centre around 6-7 times before their MDR TB status is confirmed and it takes about a month’s time for the culture test results to be known. They wished that investigations should take lesser time and there should not be repetitive visits. They would be happy if there were no long lines at the centres and reports were made available quickly without facing any problem, so that treatment is not delayed. They also felt that healthcare providers do not consider MDR-TB patients as equal partners with dignity. He wants healthcare providers to behave nicely with patients and give them respect. He wants healthcare providers to be more respectful to the patients, talk politely and not get angry or misbehave with them. They should also explain about the medicines and their side effects to them. Anonymous---I am receiving MDR-TB treatment in Zambia and had to go to the lab two times. The lab is 145 km away from my place and it took about 14 days for the results to come. My question is why cannot we complain about problems (side effects) to doctors - it is not waste of time of doctors as side effects are one reason why people may interrupt treatment. Also why are patients of MDR-TB not counseled and briefed clearly on side-effects? Who can do this better than someone undergoing MDR-TB treatment or has finished MDR-TB treatment? Le T Thu, Viet Nam---I am thankful to Hanoi Hospital for Lung survived MDR-TB. I began treatment in 2011. My question is - why treatment has to be so difficult, with

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severe side-effects that don't allow me to work normally, and so long up to or more than 2 years?

SUMMARY OF PATIENTS’SPEAK: There was a general lament of the inaccessibility to DST Labs as they are very few in number and located far off from most of them. Also a lot of time is wasted before MDR TB is confirmed and this delay can become crucial and a matter of life and death. Those getting treated in the private sector found it very difficult to meet the high cost of treatment. They wished that investigations should take lesser time and reports were made available quickly so that treatment is not delayed. They wished that investigations should take lesser time and there should not be repetitive visits. They also felt that healthcare providers do not consider MDR-TB patients as equal partners with dignity and wanted them to behave nicely with patients and give them respect. Patients also wanted to be counselled more and better informed about side effects of medicines at health centres and also at the community level with the help of ex MDR TB patients.

CIVIL SOCIETY SPEAK Peter N Owiti, Kenya, Wote Youth Development Projects Makueni, Kenya-- There is no drug-sensitivity testing (DST) laboratory (lab) in my area/region. The nearest DST lab is 72 kilometres from my place. It usually takes about eight weeks for the DST test results to be known. With the G-Xpert which is 72 km away it takes 2 days. The patient has to visit the centre four times before his/her MDR-TB positive status is confirmed. In areas where there is no G-Xpert it takes as long as nine months for diagnosis and treatment of MDR TB to begin. With the introduction of G-Expert the time is short for diagnosis but the commencement of treatment still takes long because of the other tests (like Liver function test and the thyroid function test). These tests are not available at the government facilities and the patients not only pay in private clinics but also have to travel long distances to seek that service. As they look for which asset to sell to pay for the tests, the mycobacterium eats their lungs. Yes it is more difficult to diagnose extra pulmonary MDR-TB. I do not think healthcare providers consider MDR-TB patients as equal partners with dignity. Healthcare workers and nurses dealing with TB are deployed from other departments and take this as a punishment posting. This should not happen. Let TB healthcare workers be trained specifically for TB and retained. Let us employ them through competency and interest and then retain them.

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Collection and transportation of specimens must be made efficient and results conveyed to the patients by phone to avoid many trips to the facility. Preliminary tests used are too expensive and the cost is being borne by the patients. Amir Siddiqui, Pakistan--There is no DST lab in my area. The nearest DST lab is at least 250 km away. Even healthcare providers keep doing hit and trial treatment instead of confirming first whether there is drug resistance or not. Drug sensitivity testing profiling must be done BEFORE a patient is put on treatment - and time delays have to be worked upon to make the DST quick and efficient, and as close as possible to TB clinics. MDR-TB patient is supposed to feel grateful for the treatment she/ he is receiving, and under the weight of this supposed gratitude the patient is not expected to complain about side effects. The reality is grim as side effects, even if the doctor thinks these are 'routine', are very severe and debilitating at times. We surely need to address this equation and since MDR-TB patient has to receive care on daily basis for a longer duration, they must be more engaged in the programme itself. Owen Mulenga, Zambia---In Kafue district 45km south of Lusaka, Zambia, we don't have drug-sensitivity laboratory and the nearest lab is 70 km away in Chelstone. Mostly it takes 2 visits for a patient to be confirmed his/ her MDR-TB status. Because MDR-TB lab is the government institution most patients are referred from the government health facilities and a few from private doctors. It is very difficult to diagnose MDR-TB here because we only have one MDR-TB lab which is always under pressure of work due to the large number of clinics it serves. Also, drug sensitivity tests are done only after a patient has undergone 6 month of DOTS for normal TB treatment and still TB bacilli are present in second sputum. Then it is recommended for MDR-TB test to be done, samples are taken to the MDR-TB lab in Chelstone lab and the results take a week and some days to come. So a lot of time is wasted before MDR TB treatment can begin. The behaviour of healthcare providers towards MDR-TB patients is not very good mostly because of the setup of our health centres which are poorly ventilated and there is lack of proper infection-control/safety tools for healthcare providers for them not to be infected with the disease which is very contagious. The change which is needed in order for MDR-TB to be diagnosed early is to establish MDR-TB labs in many districts in the province so that MDR-TB can be diagnosed even before the patient is put on DOTS of normal pulmonary TB and not after the 1st line treatment fails, as then it may be too late for the patient.

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SUMMARY OF CIVIL SOCIETY OPINION: Drug sensitivity testing profiling must be done BEFORE a patient is put on treatment and time delays have to be worked upon to make the DST must be made quick and efficient to avoid time delays. There should be more DST Labs close to TB clinics. Doctors should counsel MDR-TB patients properly regarding the severe and debilitating side effects of drugs. As MDR-TB patients have to receive care on daily basis for a longer duration, they must be more engaged in the programme itself. Healthcare workers should be specially trained to treat the patients with dignity.

There should be strict surveillance of the medicines given at DOTS centres (refer to case of Radha’s mother and the news story of Pushpa Narayan

about ‘empty capsules’). Also healthcare workers and doctors should be provided with proper infection control tools to protect themselves from the TB bacilli.

DRUG TOXICITY AND MDR-TB TREATMENT Dr Nerges Mistry, Director and trustee, The Foundation for Medical Research, Mumbai, India, shared the chart on MDR-TB drug toxicity.

Drug Frequent side effects

Occasional side effects

Rare side effects

CYCLOSERINE Neurological and psychiatric disturbances, including headaches, irritability, sleep disturbances, aggression, and tremors, gum inflammation, pale skin, depression, confusion, dizziness, restlessness, anxiety, nightmares, severe headache, drowsiness

Visual changes; skin rash; numbness, tingling or burning in hands and feet; jaundice; eye pain

Seizures, suicidal thoughts

KANAMYCIN Pain at injection site, renal failure (usually reversible)

vestibular and auditory damage-usually irreversible; genetic

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predisposition possible (check family for aminoglycoside ototoxicity), nephrotoxicity (dose-related to cumulative and peak concentrations, increased risk with renal insufficiency, often irreversible), peripheral neuropathy, rash

OFLOXACIN Generally well- tolerated

GI intolerance; CNS-headache, malaise, insomnia, restlessness, and dizziness

allergic reactions; diarrhea; photosensitivity; increased LFTs; tendon rupture; peripheral neuropathy

LEVOFLOXACIN Generally well- tolerated

GI intolerance; CNS-headache, malaise, insomnia, restlessness, dizziness, allergic reactions, diarrhoea, photosensitivity

tendon rupture; QT prolongation; peripheral neuropathy

ETHIONAMIDE Severe GI intolerance (nausea, vomiting, diarrhea, abdominal pain, excessive salivation, metallic taste, stomatitis, anorexia and weight loss). Adverse gastrointestinal effects appear to be dose related, with approximately 50% of patients unable to tolerate 1 gm as a single dose. Gastrointestinal effects may be minimized by decreasing dosage, by changing the time of

Allergic reactions; Psychotic disturbances (including mental depression), drowsiness, dizziness, restlessness, headache, and postural hypotension. Neurotoxicity (administration of pyridoxine has been recommended to prevent or relieve neurotoxic effects); transient increases in serum bilirubin; reversible hepatitis (2%) with jaundice (1-3%); gynecomastia; menstrual irregularity,

reports of peripheral neuritis, optic neuritis, diplopia, blurred vision, and a pellagra-like syndrome, reactions including rash, photosensitivity, thrombocytopenia and purpura

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drug administration, or by the concurrent administration of an anti-emetic agent

arthralgias, leucopenia, hypothyroidism especially when combined with PAS

PARA AMINO SALICYLIC ACID

GI intolerance (anorexia and diarrhea); hypothyroidism (increased risk with concomitant use of ethionamide)

hepatitis (0.3-0.5%); allergic reactions; thyroid enlargement; malabsorption syndrome; increased prothrombin time; fever

REFERENCES: RNTCP, DOTS plus guidelines, CTBD, DGHS

MDR-TB patients

need to be

engaged at every

level of MDR-TB

programming as

equal partners,

and with dignity

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GLOBAL TARGETS

WHERE WE ARE

WHERE WE SHOULD BE

Achievement

2011 2011 goal 2015 goal

Number of people whose TB was detected and treated

5.8 million 6.1 million 6.9 million

Percent of previously treated TB patients tested for MDR-TB

6% 40% 100%

Number of people treated for MDR-TB following WHO guidelines

60 000 130 000 270 000

Percent of HIV-positive TB patients receiving antiretroviral therapy

48% 82% 100%

Percent of TB patients tested for HIV

40% 100% 100%

Data derives from the 2012 World Health Organization Global Tuberculosis Report, www.who.int/tb www.who.int/tb

NOTE: This table (and image below) is part of the snapshot of the global TB pandemic and gaps in funding which was published by the Stop TB Partnership and WHO. It is available online at: http://www.stoptb.org/assets/documents/news/TB_CurableA4folded.pdf

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