|Year : 2015 | Volume
| Issue : 1 | Page : 6-11
Standards for tuberculosis care in India, a road map to universal access in quality tuberculosis care
Anil J Purty, Zile Singh, Joy Bazroy, Ramesh C Chauhan, N Murugan
Department of Community Medicine, Pondicherry Institute of Medical Sciences, Puducherry, India
|Date of Submission||29-Jul-2015|
|Date of Acceptance||19-Oct-2015|
|Date of Web Publication||09-Nov-2015|
|Date of Print Publicaton||09-Nov-2015|
Anil J Purty
Department of Community Medicine, Pondicherry Institute of Medical Sciences, Puducherry - 605 014
Source of Support: None, Conflict of Interest: None
Tuberculosis (TB) remains one of the world's deadliest communicable diseases. In 2013, an estimated 9.0 million people developed TB, and 1.5 million died from the disease. The International Standards for TB Care (ISTC) were formulated to develop uniform guidelines for ensuring the delivery of widely accepted level of care by all healthcare workers in managing TB patients or those suspected to have TB. In India, the quality of care for TB patients receive varies considerably and often is not in accordance with the international standards. In this article, we provide an overview of the recent standards for TB care in India (STCI). These standards were developed after a national level consultation meeting involving over 120 national and international experts, these have been supported by the World Health Organization guidelines pertaining to TB care and are duly approved by the Central TB Division, Ministry of Health and Family Welfare, Government of India. The STCI has outlined 26 standards (diagnosis: 1–6; treatment: 7–11; public health: 12–21; social inclusion: 22–26) for effective prevention and control of TB in India. These standards need to be widely disseminated to all stakeholders to ensure universal access in quality TB care is available to all patients. The community health providers (both private and public), and governments should work as partners with a view to improve TB care and enhance the effectiveness of the healthcare process so that the ISTC is objectively implemented in day-to-day practice.
Keywords: International standards, standards for tuberculosis care in India, tuberculosis, universal access
|How to cite this article:|
Purty AJ, Singh Z, Bazroy J, Chauhan RC, Murugan N. Standards for tuberculosis care in India, a road map to universal access in quality tuberculosis care. J Curr Res Sci Med 2015;1:6-11
|How to cite this URL:|
Purty AJ, Singh Z, Bazroy J, Chauhan RC, Murugan N. Standards for tuberculosis care in India, a road map to universal access in quality tuberculosis care. J Curr Res Sci Med [serial online] 2015 [cited 2019 Nov 21];1:6-11. Available from: http://www.jcrsmed.org/text.asp?2015/1/1/6/168918
| Introduction|| |
Tuberculosis (TB) remains one of the world's deadliest communicable diseases. In 2013, an estimated 9.0 million people developed TB, and 1.5 million died from the disease, 360,000 of whom were HIV-positive. As per the World Health Organization (WHO) global TB report 2014, more than half (56%) of these deaths occurred among TB patients in the South-East Asia and Western Pacific Regions. India alone accounted for 24% of the global TB cases, making India the world's highest TB burden country. TB is slowly declining each year, and it is estimated that 37 million lives were saved between 2000 and 2013 through effective diagnosis and treatment. However, given that most deaths from TB are preventable, the death toll from the disease is still unacceptably high and efforts to combat it must be accelerated as per the goal of the "Strategic vision of TB control" in India until 2015 through the Revised National TB Control Programme (RNTCP), which is to decrease mortality and morbidity due to TB and cut transmission of infection until TB ceases to be a major public health problem in India.
Studies in India have reported that patients often begin seeking care in the informal private sector, then seek care from qualified practitioners, and eventually end up in the RNTCP for free treatment.,,, A systematic review of 23 studies has shown that, on an average, TB is diagnosed in India after a delay of about 2 months, and three providers are seen before they are finally diagnosed and put on TB treatment. Prescription studies have shown in the past and continue to show widespread use of irrational drug regimens.,, Diagnostic practices in the private sector in India remain suboptimal and heavily reliant on unreliable blood tests for TB.,,, Thus, quality of TB care in India is variable and often not aligned with international standards ,, and one of the first steps in improving the quality of TB care is to set standards.
| International Standards of Tuberculosis Care|| |
All patients with TB should receive the same quality of care, based on the best evidence available. The best practices for TB are enshrined in the International Standards of TB Care (ISTC), which was first published in 2006, second edition in 2009 the most recent, the third edition was released on World TB day 2014. ISTC has inspired several country-specific adaptations, including the European Union Standards of TB Care  and also the Standards for TB Care in India (STCI).
| Standards for Tuberculosis Care in India|| |
The first edition of the STCI that is described here is the result of a long process that culminated in a 3-day national workshop organized by the Central TB Division at New Delhi in December 2012 with the technical assistance with technical assistance from WHO Country Office for India. About 120 experts from national and international level including various public health administrators, program managers, representatives from various professional associations (Indian Medical Association, Association of Physicians of India, College of Physicians Association of India, Indian Association of Paediatricians, Federation of Obstetricians and Gynaecologists Congress of India, Family Physician Association of India, etc.), academicians and specialists from public and private sectors (pulmonologists, physicians, surgeons, pediatricians, gynecologists, orthopedic surgeons, microbiologists, public health specialist, etc.), donors, technical and implementation partners, pharmaceutical companies, and pharmacists. As an output of the workshop, 26 standards with India specific evidence was developed-viz. diagnosis 1–6, treatment 7–11, public health 12–2,1 and social inclusion 22–26 which is a new standard that goes beyond the (ISTC) 2009. After the statement of each standard, a brief summary of the international and national evidence are described along with the references to literature. These standards are intended to be used to enhance quality and mutually acceptable engagement with the private and other sectors in India to enhance TB care. Thus, this is an important tool for achieving the goal of universal access to quality TB care.
Standard 1 testing and screening for pulmonary tuberculosis
Any person with symptoms and signs suggestive of TB including cough >2 weeks, fever >2 weeks, significant weight loss, hemoptysis, 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. 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 healthcare workers, prisoners, slum dwellers, and certain occupational groups such as miners.
Standard 2 diagnostic technology
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 acid-fast bacillus) for microbiological confirmation. Where available, chest X-ray should be used as a screening tool to increase the sensitivity of the diagnostic algorithm. Serological tests are banned and not recommended for diagnosing TB. Tuberculin skin test (TST) and interferon gamma release assay are not recommended for the diagnosis of active TB. Standardized TST may be used as a complimentary test in children. Cartridge-based nucleic acid amplification test (CB-NAAT) is the preferred first diagnostic test in children and PLHIV. Effective mechanism should be developed to validate newer diagnostic tests.
Standard 3 testing for extrapulmonary tuberculosis
For all patients (adults, adolescents and children) with presumptive extrapulmonary TB, appropriate specimens from the presumed sites of involvement must be obtained for microscopy/culture and drug sensitivity testing (DST)/CB-NAAT/molecular test/histopathological examination.
Standard 4 diagnosis of HIV coinfection in tuberculosis patients and drug-resistant tuberculosis
All diagnosed TB patients should be offered HIV counseling and testing prompt and appropriate evaluation should be undertaken for patients with presumptive Multidrug-resistant (MDR)-TB or rifampicin (R) resistance in TB patients who have failed treatment with first-line drugs, pediatric 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 coinfection 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 TB patients prior to start of treatment. 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 tuberculosis
Presumptive TB patients without microbiological confirmation (smear microscopy, culture, and molecular diagnosis), but with strong clinical and other evidence (e.g. X-ray, fine needle aspiration cytology, and histopathology) may be diagnosed as "Probable TB" and should be treated. For patients with presumptive TB found to be negative on the rapid molecular test, an attempt should be made to obtain culture on an appropriate specimen.
Standard 6 pediatric tuberculosis
In all children with presumptive intrathoracic 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. 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 TB case, evidence of TB infection (positive TST), and clinical findings suggestive of TB. For children with presumptive extrapulmonary TB, appropriate specimens from the presumed sites of involvement should be obtained for the rapid molecular test, microscopy, culture and DST, and histopathological examination.
Standard 7 treatments with first-line regimen
Treatment of new tuberculosis patients
All new patients should receive an internationally accepted first-line treatment regimen for new patients. The initial phase should consist of 2 months of isoniazid (H), rifampicin (R), pyrazinamide (Z), and ethambutol (E). The continuation phase should consist of three drugs (isoniazid, rifampicin, and ethambutol) given for at least 4 months.
Extension of continuation phase
The duration of continuation phase may be extended by 3–6 months in special situations like bone and joint TB, spinal TB with neurological involvement, and neuro-TB.
The patients should be given dosages of the drugs depending upon body weight in weight bands. 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. All patients should be given daily regimen under direct observation. However, the country program 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 pediatric and HIV-infected TB patients should be given daily regimen under direct observation. FDCs of four drugs (isoniazid, rifampicin, pyrazinamide, and ethambutol), and three drugs (isoniazid, rifampicin, and ethambutol) and two drugs (isoniazid and rifampicin) are recommended. 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
Response to therapy in patients with pulmonary TB, 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. The extension of the intensive phase is not recommended. 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. Response to treatment in extrapulmonary TB: In patients with extrapulmonary TB, the treatment response is best assessed clinically. The help of radiological and other relevant investigations may also be taken. 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. After completion of treatment, the patients should be followed up with clinical and/or sputum examination at the end of 6 months and 12 months.
Standard 9 drug resistant tuberculosis management
Patients with TB 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-TB drugs 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 hospitalization is recommended. 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 p-aminosalicylic acid if cycloserine cannot be used. 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 4–6 weeks. All patients of MDR/XDR-TB should be evaluated for surgery at the initiation of treatment and/or during follow-up. Until 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 MDR-TB (i.e., not previously treated for MDR-TB) with recommended intensive phase of treatment being 6–9 months The total duration may be modified according to the patient's response to therapy. Consultation with a specialist experienced in the treatment of patients with MDR/XDR-TB should be obtained, whenever possible. 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. The use of sputum culture (one sample) is recommended for monitoring of patients with MDR-TB during treatment. 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.
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, and imipenem to which the organisms are known or presumed to be susceptible. 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 tuberculosis with HIV infection and other comorbid conditions
TB patients living with HIV should receive the same duration of TB treatment with daily regimen as HIV-negative TB patients. Antiretroviral therapy must be offered to all patients with HIV and TB, as well as drug-resistant TB requiring second-line anti-TB drugs, irrespective of CD4 cell count, as early as possible (within the first 8 weeks) following initiation of anti-TB treatment. Appropriate arrangements for access to antiretroviral drugs should be made for patients. However, initiation of treatment for TB should not be delayed. Patients with TB and HIV infection should also receive co-trimoxazole as prophylaxis for other infections. 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 should be offered for 6 months or longer.
Standard 11 treatment 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. Supervision and support should be individualized and should draw on the full range of recommended interventions and available support services, including patient counseling and education. 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. Such measures may include identification and training of a treatment supporter (for TB and, if appropriate, for HIV, diabetes mellitus, etc.) who is acceptable, accessible, and accountable to the patient and to the health system. Optimal use of ICT should be done to promote treatment literacy and adherence.
Standard 12 public health responsibility
Any practitioner treating a patient for TB is assuming an important public health responsibility to prevent on-going transmission of the infection and the development of drug resistance. To fulfill 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 nongovernmental organizations to assess the adherence of the patient and to address poor adherence when it occurs.
Standard 13 notification of tuberculosis cases
All health establishments must report all TB cases and their treatment outcomes to public health authorities (District Nodal Officer for Notification). Proper feedback need to be ensured to all healthcare providers who refer cases to a public health system on the outcome of the patients which they had referred.
Standard 14 maintain records for all tuberculosis patients
A written record of all medications given, bacteriologic response, adverse reactions, and the clinical outcome should be maintained for all patients.
Standard 15 contact investigation
All providers of care for patients with TB 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 the search of any active TB case in the household of the child must be undertaken.
Standard 16 isoniazid prophylactic therapy
Children who are <16 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 healthcare facility infection control strategy.
Standard 18 quality assurance systems for diagnostic tests
All healthcare providers should ensure that all diagnostic tests used for diagnosis of TB are quality assured. Quality assurance (QA) for anti-TB drugs. QA system should ensure that all anti-TB drugs used in the country are subjected to stringent QA mechanisms at all levels.
Standard 19 Panchayati Raj Institutions
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
Every TB symptomatic should be properly counseled by the healthcare provider. TB patients and their family members should get proper counseling and health education at every contact with the healthcare system.
Standard 21 death audit among tuberculosis patients
Death among TB patients should be audited by a competent authority.
Standard 22 information on tuberculosis prevention and care seeking
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
All patients, especially those in vulnerable population groups, accessing a provider where TB services are available should be offered free or affordable quality assured diagnostic and treatment services which should be provided at locations and times so as to minimize work day or school disruptions and maximize access.
Standard 24 respect, confidentiality, and sensitivity
All people seeking or receiving care for TB should be received with dignity and managed with promptness, confidentiality, and gender sensitivity. Ensure that infection control procedures do not stigmatize TB patients.
Standard 25 care and support through social welfare programs
Patient support system should endeavor to derive synergies between various social welfare support systems to mitigate out of pocket expenses such as transport and wage loss incurred by people affected by TB for the purpose of diagnosis and treatment.
Standard 26 addressing counseling and other needs
Persons affected by TB should be counseled at every opportunity, to address information gaps and to enable informed decision making. Counseling should address issues such as treatment adherence, adverse drug reactions, prognosis and physical, financial, psychosocial, and nutritional needs.
| Conclusion|| |
The above mentioned STCI emphasize on individual patient care and public health principles of disease control. These will assist the healthcare providers in adopting a scientifically approved strategy in the management of all TB patients in the country. The next step logical would be to develop at the national level another handbook for using the STCI, as the handbook for using ISTC presents suggestions and guidance, based mainly on country-level experiences the delivery of high-quality care by all practitioners providing TB services. The patients charter for TB care by the ISTC, which describes the ways in which patients, the community, health providers (both private and public), and governments can work as partners in a positive and open relationship with a view to improving TB care and enhancing the effectiveness of the healthcare process needs to be objectively implemented in day-to-day practice.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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