Table 1—

The International Standards for Tuberculosis Care

Standards for diagnosis
 Standard 1All persons with otherwise unexplained productive cough lasting ≥2–3 weeks should be evaluated for TB
 Standard 2All patients (adults, adolescents and children who are capable of producing sputum) suspected of having pulmonary TB should have at least two, and preferably three, sputum specimens obtained for microscopic examination. When possible, at least one early morning specimen should be obtained
 Standard 3For all patients (adults, adolescents and children) suspected of having extrapulmonary TB, appropriate specimens from the suspected sites of involvement should be obtained for microscopy and, where facilities and resources are available, for culture and histopathological examination
 Standard 4All persons with chest radiographic findings suggestive of TB should have sputum specimens submitted for microbiological examination
 Standard 5The diagnosis of sputum smear-negative pulmonary TB should be based on the following criteria: at least three negative sputum smears (including at least one early morning specimen); chest radiography findings consistent with TB; and lack of response to a trial of broad-spectrum antimicrobial agents. (Since fluoroquinolones are active against M. tuberculosis complex, and thus may cause transient improvement in persons with TB, they should be avoided). For such patients, if facilities are available, sputum cultures should be obtained. In persons with known or suspected HIV infection, the diagnostic evaluation should be expedited
 Standard 6The diagnosis of intrathoracic (i.e. pulmonary, pleural, and mediastinal or hilar lymph node) TB in symptomatic children with negative sputum smears should be based on the finding of chest radiographic abnormalities consistent with TB and either a history of exposure to an infectious case or evidence of TB infection (positive tuberculin skin test or interferon gamma release assay). For such patients, if facilities for culture are available, sputum specimens should be obtained (by expectoration, gastric washings, or induced sputum) for culture
Standards for treatment
 Standard 7Any practitioner treating a patient for TB is assuming an important public health responsibility. To fulfil this responsibility, the practitioner must not only prescribe an appropriate regimen, but also be capable of assessing the adherence of the patient to the regimen and addressing poor adherence when it occurs. By so doing, the provider will be able to ensure adherence to the regimen until treatment is completed
 Standard 8All patients (including those with HIV infection) who have not been treated previously should receive an internationally accepted first-line treatment regimen using drugs of known bioavailability. The initial phase should consist of 2 months of isoniazid, rifampicin, pyrazinamide and ethambutol. The preferred continuation phase consists of isoniazid and rifampicin given for 4 months. Isoniazid and ethambutol given for 6 months is an alternative continuation-phase regimen that may be used when adherence cannot be assessed, but it is associated with a higher rate of failure and relapse, especially in patients with HIV infection. The doses of anti-TB drugs used should conform to international recommendations. Fixed-dose combinations of two (isoniazid and rifampicin), three (isoniazid, rifampicin (or rifampin) and pyrazinamide), and four (isoniazid, rifampicin, pyrazinamide and ethambutol) drugs are highly recommended, especially when medication ingestion is not observed
 Standard 9To foster and assess adherence, a patient-centred 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 sex sensitive and age specific 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 and be mutually acceptable to the patient and the provider. Such measures may include direct observation of medication ingestion (DOT) by a treatment supporter who is acceptable and accountable to the patient and to the health system
 Standard 10All patients should be monitored for response to therapy, best judged in patients with pulmonary TB by follow-up sputum microscopy (two specimens) at least at the time of completion of the initial phase of treatment (2 months), at 5 months and at the end of treatment. Patients who have positive smears during the 5th month of treatment should be considered as treatment failures and have therapy modified appropriately (see standards 14 and 15). In patients with extrapulmonary TB and in children, the response to treatment is best assessed clinically. Follow-up radiographic examinations are usually unnecessary and may be misleading
 Standard 11A written record of all medications given, bacteriological response and adverse reactions should be maintained for all patients
 Standard 12In areas with a high prevalence of HIV infection in the general population and where TB and HIV infection are likely to co-exist, HIV counselling and testing are indicated for all TB patients as part of their routine management. In areas with lower prevalence rates of HIV, HIV counselling and testing are indicated for TB patients with symptoms and/or signs of HIV-related conditions and in TB patients having a history suggestive of high risk of HIV exposure
 Standard 13All patients with TB and HIV infection should be evaluated to determine if antiretroviral therapy is indicated during the course of treatment for TB. Appropriate arrangements for access to antiretroviral drugs should be made for patients who meet indications for treatment. Given the complexity of co-administration of anti-TB treatment and antiretroviral therapy, consultation with a physician who is expert in this area is recommended before initiation of concurrent treatment for tuberculosis and HIV infection, regardless of which disease appeared first. However, initiation of treatment for TB should not be delayed. Patients with TB and HIV infection should also receive cotrimoxazole as prophylaxis for other infections
 Standard 14An assessment of the likelihood of drug resistance, based on history of prior treatment, exposure to a possible source case having drug-resistant organisms, and the community prevalence of drug resistance should be obtained for all patients. Patients who fail treatment and chronic cases should always be assessed for possible drug resistance. For patients in whom drug resistance is considered to be likely, culture and drug susceptibility testing for isoniazid, rifampicin and ethambutol should be performed promptly
 Standard 15Patients with TB caused by drug-resistant (especially MDR) organisms should be treated with specialised regimens containing second-line anti-TB drugs. At least four drugs to which the organisms are known or presumed to be susceptible should be used, and treatment should be given for ≥18 months. Patient-centred measures are required to ensure adherence. Consultation with a provider experienced in treatment of patients with MDR-TB should be obtained
Standards for public health responsibilities
 Standard 16All providers of care for patients with TB should ensure that persons (especially children aged <5 yrs and persons with HIV infection) who are in close contact with patients who have infectious TB are evaluated and managed in line with international recommendations. Children aged <5 yrs and persons with HIV infection who have been in contact with an infectious case should be evaluated for both latent infection with M. tuberculosis and for active TB
 Standard 17All providers must report both new and retreatment TB cases and their treatment outcomes to local public health authorities, in conformance with applicable legal requirements and policies
  • TB: tuberculosis; DOT: directly observed therapy; MDR: multidrug resistant.