STANDARDS FOR TB CARE IN INDIA- AN OVERVIEW

Dr. VIPIN VARKEY

Consultant Pulmonologist, DTC, Kozhikode

———-

Development of the Standards for TB Care in India (STCI) is the culmination of a series of discussions involving various stakeholders involved in TB control and review of literature. Central TB Division, Ministry of Health & Family Welfare, Government of India and WHO Country Office for India took the lead in the process. With its unique challenges, approximately one third of the world’s TB burden, and long history of dealing with a TB problem that appears to be resilient to the best efforts, it was felt that India should have its own standards that could be used as a benchmark by all providers managing TB patients within India. It is hoped that a set of standards recognized as appropriate for the specific challenges of India will spur observance to these standards by all care providers of India when managing a TB patient. As part of the development process, noted experts in the field of TB in India modified the international standards, following detailed review of India specific and India-relevant evidence. As an output of the workshop, 26 standards developed and the India-relevant evidence debated, and listed for each of the standards in this document. The standards thus evolved, are intended to be used to enhance quality and mutually acceptable engagement with the private and other sectors in India to enhance TB care. This is thus, an important tool for achieving the goal of universal access to quality TB care.

Introduction

India, the world’s second most populous country, accounts for a quarter of the world’s annual incidence of TB. Every year around two million people develop TB in India and 300,000 die of TB. Over 15 million patients have been treated and three million additional lives have been saved by the Revised National TB Control Programme (RNTCP) over the last decade. Cure rates have consistently been above 85% and the TB Millennium Development Goals are reachable. However, despite a comprehensive national TB control program guiding states for implementation of TB diagnosis and treatment there is still a long way to go. The decline in TB incidence has been slow, mortality remains unacceptably high and the emergence of drug-resistant TB has become a major public health concern. There are many challenges for TB control in India. Prompt, accurate diagnosis and effective treatment of TB are not only essential for good patient care, but they are also the key elements in the public health response to tuberculosis and the cornerstone of any initiative for tuberculosis control. The private sector holds a factual predominance of health care service delivery in India. There is very little information about the TB patient from the private sector available to the programme and little is known about their quality of treatment, including treatment outcomes. Engaging the private sector effectively is the single most important intervention required for India to achieve the overall goal of universal access to quality TB care. The vision of India’s national TB control programme is that the people suffering from TB receive the highest standards of care and support from healthcare providers of their choice. Also, the availability of new diagnostic tools and strategies for early TB diagnosis, emerging evidences on existing regimens and newer regimens, and the need for better patient support strategies including addressing social inclusiveness necessitated the development of Standards for TB Care in India. These standards represent the first what is expected from the Indian healthcare system.

STANDARD 1: TESTING AND SCREENING FOR PULMONARY TB

1.1 Testing:

• Any person with symptoms and signs suggestive of TB including cough >2 weeks, fever >2 weeks, significant weight loss, haemoptysis etc. and any abnormality in chest radiograph must be evaluated for TB.

• Children with persistent fever and/or cough >2 weeks, loss of weight / no weight gain, and/or contact with pulmonary TB cases must be evaluated for TB.

1.2 Screening:

• People living with HIV (PLHIV), malnourished, diabetics, cancer patients, patients on immunosuppressant or maintenance steroid therapy, should be regularly screened for signs and symptoms suggestive of TB.

• Enhanced case finding should be undertaken in high risk populations such as health care workers, prisoners, slum dwellers, and certain occupational groups such as miners.

STANDARD 2: DIAGNOSTIC TECHNOLOGY

2.1 Microbiological confirmation on sputum:

• All patients (adults, adolescents, and children who are capable of producing sputum) with presumptive pulmonary TB should undergo quality-assured sputum test for rapid diagnosis of TB (with at least two samples, including one early morning sample for sputum smear for AFB) for microbiological confirmation.

2.2 Chest X-ray as screening tool:

• Where available, chest X-ray should be used as a screening tool to increase the sensitivity of the diagnostic algorithm.

2.3 Serological tests:

• Serological tests are banned and not recommended for diagnosing tuberculosis.

2.4 Tuberculin Skin Test (TST) & Interferon Gamma Release Assay (IGRA)

• TST and IGRA are not recommended for the diagnosis of active tuberculosis. Standardised TST may be used as a complimentary test in children.

2.5 CB-NAAT (cartridge-based nucleic-acid amplification test) is the preferred first diagnostic test in children and PLHIV.

2.6 Validation of newer diagnostic tests:

• Effective mechanism should be developed to validate newer diagnostic tests.

STANDARD 3: TESTING FOR EXTRA-PULMONARY TB

3.1 Testing for extra-pulmonary TB

• For all patients (adults, adolescents and children) with presumptive extra-pulmonary TB, appropriate specimens from the presumed sites of involvement must be obtained for microscopy/culture/ CBNAAT/molecular test/histopathology examination and drug sensitivity testing (DST).

STANDARD 4: DIAGNOSIS OF HIV CO-INFECTION IN TB PATIENTS AND DRUG RESISTANT TB (DR-TB)

4.1 Diagnosis of HIV in TB patients:

• All diagnosed TB patients should be offered HIV counselling and testing.

4.2 Diagnosis of multi-drug resistant TB (MDR-TB):

• Prompt and appropriate evaluation should be undertaken for patients with presumptive MDR-TB or Rifampicin (R) resistance in TB patients who have failed treatment with first line drugs, paediatric nonresponders, TB patients who are contacts of MDR-TB (or R resistance), TB patients who are found positive on any follow-up sputum smear examination during treatment with first line drugs, diagnosed TB patients with prior history of anti-TB treatment, TB patients with HIV co-infection and all presumptive TB cases among PLHIV. All such patients must be tested for drug resistance with available technology, a rapid molecular DST (as the first choice) or liquid / solid culture-DST (at least for R and if possible for Isoniazid (H); Ofloxacin (O) and Kanamycin (K), if R-resistant/MDR).

• Wherever available DST should be offered to all diagnosed tuberculosis patients prior to start of treatment.

4.3 Diagnosis of Extensively Drug Resistant TB (XDR-TB):

• On detection of Rifampicin resistance alone or along with isoniazid resistance, patient must be offered sputum test for second line DST using RNTCP approved phenotypic or genotypic methods, wherever available.

STANDARD 5: PROBABLE TB

5.1 Probable TB

Presumptive TB : Patients with symptoms suggestive of TB without  microbiological confirmation (smear microscopy, culture and molecular diagnosis), but with strong clinical and other evidence (e.g. X-ray, Fine Needle Aspiration Cytology (FNAC, histopathology) may be diagnosed as “Probable TB” and should be treated.

• For patients with presumptive TB found to be negative on rapid molecular test, an attempt should be made to obtain culture on an appropriate specimen.

STANDARD 6: PAEDIATRIC TB

6.1 Diagnosis of paediatric TB patients:

• In all children with presumptive intra-thoracic TB, microbiological confirmation should be sought through examination of respiratory specimens (e.g. sputum by expectoration, gastric aspirate, gastric lavage, induced sputum, broncho-alveolar lavage or other appropriate specimens) with quality assured diagnostic test, preferably CB-NAAT, smear microscopy or culture.

6.2 Diagnosis of probable paediatric TB patients:

• In the event of negative or unavailable microbiological results, a diagnosis of probable TB in children should be based on the presence of abnormalities consistent with TB on radiography, a history of exposure to pulmonary tuberculosis case, evidence of TB infection (positive TST) and clinical findings suggestive of TB.

6.3 Diagnosis of extra-pulmonary paediatric TB patients:

• For children with presumptive extra-pulmonary TB, appropriate specimens from the presumed sites of involvement should be

obtained for rapid molecular test, microscopy, culture and DST, and histo-pathological examination.

STANDARD 7: TREATMENT WITH FIRST-LINE REGIMEN

7.1 Treatment of New TB patients:

• All new patients should receive an internationally accepted first-line treatment regimen for new patients. The initial phase should consist of two months of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), and E t h a m b u t o l ( E ) . T h e continuation phase should consist of three drugs (Isoniazid, Rifampicin and Ethambutol) given for at least four months.

7.2 Extension of continuation phase:

• The duration of continuation phase may be extended by three to six months in special situations like bone & joint TB, spinal TB with neurological involvement and neuro-tuberculosis.

7.3 Drug dosages:

• The patients should be given dosages of the drugs depending upon body weight in weight bands

7.4 Bio-availability of drugs:

• The bioavailability of the drug should be ensured for every batch, especially if fixed dose combinations. (FDCs) are used, by procuring and prescribing from a quality-assured source.

7.5 Dosage frequency:

• All patients should be given daily regimen under direct observation. However, the country programme may consider daily or intermittent regimen for treatment of TB depending on the available resources and operational considerations as both are effective provided all doses are directly observed.

• All paediatric and HIV infected TB patients should be given daily regimen under direct observation.

7.6 Drug formulations:

• Fixed dose combinations (FDCs) of four drugs (Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol), and three drugs (Isoniazid, Rifampicin and Ethambutol) and two drugs (Isoniazid and Rifampicin) are recommended.

7.7 Previously treated TB patients:

• After MDR-TB (or R resistance) is ruled out by a quality assured test, TB patients returning after lost to follow up or relapse from their first treatment course or new TB patients failing with first treatment course may receive the retreatment regimen containing first-line drugs: 2HREZS/1HREZ/5HRE

STANDARD 8: MONITORING TREATMENT RESPONSE

8.1 Follow up sputum microscopy:

• Response to therapy in patients with pulmonary tuberculosis, new as well as retreatment cases, should be monitored by follow-up sputum microscopy (one specimen) at the time of completion of the intensive phase of treatment and at the end of treatment.

8.2 Extension of intensive phase:

• The extension of the intensive phase is not recommended.

8.3 Offer DST in follow up sputum positive cases:

• If the sputum smear is positive in follow-up at any time during treatment, a rapid molecular DST (as the first choice) or culture-DST (at least for R and if possible for Isoniazid (H); Ofloxacin (O) and Kanamycin (K), if R-resistant/MDR) should be performed as laboratory facilities become available.

8.4 Response to treatment in extra-pulmonary TB:

• In patients with extra-pulmonary tuberculosis, the treatment response is best assessed clinically. The help of radiological and other relevant investigations may also be taken.

8.5 Response to treatment in children:

• In children, who are unable to produce sputum the response to treatment may be assessed clinically. The help of radiological and other relevant investigations may also be taken.

8.6 Long-term follow up:

• After completion of treatment the patients should be followed up with clinical and/or sputum examination at the end of six months and 12 months.

STANDARD 9: DRUG RESISTANT TB MANAGEMENT

9.1 Treatment of M/XDR-TB (or R resistant TB):

• Patients with tuberculosis caused by drug-resistant organisms (especially M/XDR or only R resistance or with O or K resistance), microbiologically confirmed by quality assured test, should be treated with specialized regimens containing quality assured second-line anti-tuberculosis drugs.

9.2 Model of care for drug resistant TB:

• Patients with MDR-TB should be treated using mainly ambulatory care rather than models of care based principally on hospitalization. If required, a short period of initial hospitalisation is recommended.

9.3 Regimen for MDR / R-Resistant TB cases:

• The regimen chosen for MDR-TB may be standardized and/or based on microbiologically confirmed drug susceptibility patterns. At least four drugs (second line) to which the organisms are susceptible, or presumed susceptible, should be used. Most importantly the regimen should include at least a later-generation Fluoroquinolone (such as high dose Levofloxacin) and a parenteral agent (such as Kanamycin or Amikacin), and may include Pyrazinamide, Ethambutol, Ethionamide (or Prothionamide), and either Cycloserine or PAS (Paminosalicylic acid) if Cycloserine cannot be used. 9.4 Regimen for MDR patients with Ofloxacin and/or Kanamycin resistance detected early:

• Treatment regimen may be suitably modified in case of Ofloxacin and/or Kanamycin resistance at the initiation of MDR-TB treatment or during early intensive phase, preferably not later than four to six weeks.

9.5 Surgery in MDR/XDR TB patients:

• All patients of MDR/XDR-TB should be evaluated for surgery at the initiation of treatment and/or during follow up.

9.6 Treatment Duration in MDR TB patients:

• Till newer effective drugs are available with proven efficacy with shorter duration of MDR-TB treatment; total treatment should be given for at least 24 months in patients newly diagnosed with MDRTB (i.e. not previously treated for MDR-TB) with recommended intensive phase of treatment being six to nine months. The total duration may be modified according to the patient’s response to therapy.

9.7 Specialist consultation in M/XDR TB patients:

• Consultation with a specialist experienced in treatment of patients with MDR/XDR tuberculosis should be obtained, whenever possible.

9.8 Ensuring adherence in M/XDR TB patients:

• Patient support systems, including direct observation of treatment, are required to ensure adherence. It should be ensured that the patient consumes all the doses of the drugs.

9.9 Single sample follow-up culture in M/XDR TB patients:

• The use of sputum culture (1 sample) is recommended for monitoring of patients with MDR-TB during treatment.

9.10 Second line DST during treatment of MDR TB:

• During the course of MDR TB treatment, if the sputum culture is found to be positive at 6 months or later, the most recent culture isolate should be subjected to DST for second-line drugs (at least O and K) to decide on further course of action. DST to other drugs namely Moxifloxacin, Amikacin and Capreomycin may also be done if laboratory facilities are available to guide treatment.

9.11 Regimen for MDR patients with Ofloxacin and/or Kanamycin resistance detected later:

• The patients with MDR-TB found to be resistant to at least Ofloxacin and/or Kanamycin during the later stage of MDR TB treatment must be treated with a suitable regimen for XDR TB using second line drugs including Group 5 drugs such as Amoxicillin Clavulanate, Clarithromycin, Clofazimine, Linezolid, Thioacetazone, Imipenem to which the organisms are known or presumed to be susceptible.

9.12 New drugs:

• New drugs need to be considered for inclusion in regimens whenever scientific evidence for their efficacy and safety becomes available as per the national policy for newer antimicrobials. Appropriate regulatory mechanisms for distribution control needs to be ensured.

STANDARD 10: ADDRESSING TB WITH HIV INFECTION AND OTHER COMORBID CONDITIONS

10.1 Treatment of HIV infected TB patients:

• TB patients living with HIV should receive the same duration of TB treatment with daily regimen as HIV negative TB patients.

10.2 Anti-retroviral & Co-trimoxazole prophylactic therapy in HIV infected TB patients:

• Antiretroviral therapy must be offered to all patients with HIV and TB as well as drug-resistant TB requiring second-line anti-tuberculosis drugs, irrespective of CD4 cell-count, as early as possible (within the first eight weeks) following initiation of anti-tuberculosis treatment. Appropriate arrangements for access to antiretroviral drugs should be made for patients. However, initiation of treatment for tuberculosis should not be delayed. Patients with TB and HIV infection should also receive Co-trimoxazole as prophylaxis for other infections.

10.3 Isoniazid preventive therapy in HIV patients without active TB:

• People living with HIV should be screened for TB using four symptom complex (current cough or, fever or weight loss or night sweats) at HIV care settings and those with any of these symptoms should be evaluated for ruling out active TB. All asymptomatic patients in whom active TB is ruled out, Isoniazid Preventive Therapy (IPT) should be offered for six months or longer.

STANDARD 11: TREATMENT ADHERENCE

11.1 Patient centered approach for adherence:

• Both to assess and foster adherence, a patient-centered approach to administration of drug treatment, based on the patient’s needs and mutual respect between the patient and the provider, should be developed for all patients.

11.2 Measures for treatment adherence:

• Supervision and support should be individualized and should draw on the full range of recommended interventions and available support services, including patient counselling and education. A central element of the patient centred strategy is the use of measures to assess and promote adherence to the treatment regimen and to address poor adherence when it occurs. These measures should be tailored to the individual patient’s circumstances based on details of the patient’s clinical and social history and be mutually acceptable to the patient and the provider.

11.3 Trained treatment supporter for treatment adherence:

• Such measures may include identification and training of a treatment supporter (for tuberculosis and, if appropriate, for HIV, Diabetes Mellitus etc.) who is acceptable, accessible and accountable to the patient and to the health system.

11.4 Use of Information Communication Technology (ICT) to promote treatment literacy and adherence:

• Optimal use of ICT should be done to promote treatment literacy and adherence

STANDARD 12: PUBLIC HEALTH RESPONSIBILITY

Any practitioner treating a patient for tuberculosis is assuming an important public health responsibility to prevent on-going transmission of the infection and the development of drug resistance.

• To fulfil this responsibility the practitioner must not only prescribe an appropriate regimen, but when necessary, also utilize local public health services / community health services, and other agencies including NGOs to assess the adherence of the patient and to address poor adherence when it occurs.

STANDARD 13: NOTIFICATION OF TB CASES

13.1 All health establishments must report all TB cases and their treatment outcomes to public health authorities (District Nodal Officer for Notification).

13.2 Proper feedback need to be ensured to all healthcare providers who refer cases to public health system on the outcome of the patients which they had referred.

TB is a notifiable disease in India as per the government order dated 7 May, 2012 and requires that all healthcare providers who have diagnosed a case of TB through microbiological testing or clinically diagnosed and/or started treatment for TB must report to the District Nodal Officer for Notification(1). Notification is a basic public health activity common to diseases of public health importance. With notification, public health authorities can identify TB patients and offer necessary public health care, supervise and support for the quality of treatment, and monitor disease trends. Ensuring notification of all TB cases is the most important step for a comprehensive TB surveillance system, which is required for effective TB control in the country. Cases are defined as anyone who has a microbiological (smear or culture) or approved molecular test proven disease or anyone who has a clinical syndrome consistent with active TB and is started on TB treatment. The requirement for reporting applies equally to government-run facilities and to private facilities. In both settings, it is the primary TB care provider or laboratory diagnostician’s responsibility to ensure that the required notification is completed (2). RNTCP has an electronic TB notification system (NIKSHAY) wherein all providers can register and notify cases –http://nikshay.gov.in

STANDARD 14: MAINTAIN RECORDS FOR ALL TB PATIENTS

14.1 A written record of all medications given, bacteriologic response, adverse reactions and clinical outcome should be maintained for all patients. Patient-level recording of details of diagnosis, treatment and outcome are the foundations of any effective public health surveillance system. Use of appropriate technology such as Nikshay should improve the quality and accessibility to a primary provider initiated record that is linked at every level from a primary clinic to the State Department of Health. In turn, it is the duty of the programme to monitor outcomes, both at primary level and aggregated into larger units, on a regular basis and reports the information that allow timely actions to improve services as needed. The Government of India through a gazette notification has made all anti-TB drugs under schedule H1. These drugs should not be dispensed without a valid prescription from a qualified practitioner. A copy of the prescription should be maintained and details of the patient to be recorded by the chemist and should be made available for verification by the responsible public health authorities.

STANDARD 15: CONTACT INVESTIGATION

• All providers of care for patients with tuberculosis should ensure all household contacts and other persons who are in close contact with TB patients are screened for TB

• In case of pediatric TB patients, reverse contact tracing for search of any active TB case in the household of the child must be undertaken.

STANDARD 16: ISONIAZID PROPHYLACTIC THERAPY

16.1  Children <6 years of age who are close contacts of a TB patient, after excluding active TB, should be treated with isoniazid for a minimum period of 6 months and should be closely monitored for TB symptoms.

STANDARD 17: AIRBORNE INFECTION CONTROL

• Airborne infection control should be an integral part of all health care facility infection control strategy.

STANDARD 18: QUALITY ASSURANCE (QA) SYSTEMS

18.1 Quality assurance for diagnostic tests:

• All healthcare providers should ensure that all diagnostic tests used for diagnosis of TB are quality assured.

18.2 Quality assurance for anti-TB drugs: Quality assurance system should ensure that all anti-TB drugs used in the country are subjected to stringent quality assurance mechanisms at all levels.

STANDARD 19: PANCHAYATI RAJ INSTITUTIONS

19.1 Panchayati Raj Institutions and elected representatives have an important role to share the public health responsibility for TB control with the healthcare providers, patients and the community.

STANDARD 20: HEALTH EDUCATION

20.1 Every TB symptomatic should be properly counselled by the healthcare provider.

• TB patients and their family members should get proper counselling and health education at every contact with healthcare system

STANDARD 21: DEATH AUDIT AMONG TB PATIENTS

• 21.1 Every death among TB patients should be audited by a competent authority.

STANDARD 22: INFORMATION ON TB PREVENTION AND CARE SEEKING

22.1 All individuals especially women, children, elderly, differently abled, other vulnerable groups and those at increased risk should receive information related to TB prevention and care seeking.

STANDARD 23: FREE AND QUALITY SERVICES

23.1 All patients, especially those in vulnerable population groups, should be offered free or affordable quality assured diagnostic and treatment services, which should be provided at locations and times so as to minimize workday or school disruptions and maximize access.

STANDARD 24: RESPECT, CONFIDENTIALITY AND SENSITIVITY

24.1 All people seeking or receiving care for TB should be received with dignity and managed with promptness, confidentiality and gender sensitivity. Public health responsibilities including notification, contact tracing, chemoprophylaxis, fast tracking, outcome monitoring etc. should be sensitive to respect and confidentiality of patients.

STANDARD 25: CARE AND SUPPORT THROUGH SOCIAL WELFARE PROGRAMMES

25.1 Healthcare providers should endeavour to derive synergies between various social welfare support systems such as RSBY, nutritional support programmes, national rural employment guarantee scheme etc. to mitigate out of pocket expenses such as transport and wage loss incurred by people affected by TB.

STANDARD 26: ADDRESSING COUNSELLING AND OTHER NEEDS

26.1 Persons affected by TB and their family members should be counselled at every opportunity, to address information gaps and to enable informed decision-making. Counseling should also address issues such as healthcare, physical, financial, psycho-social and nutritional needs.