4.2.2 Area 2 – Regulatory approval and importation of products
Step 2.1 – Complete national regulatory processes
Step 2.1 – Complete national regulatory processes
Step 1.1 – Establish a TWG, and define roles and responsibilities
The decision by a ministry of health to initiate or expand TB infection testing requires preparedness of medical services. Many of the people who may be eligible for TPT will need to be able to access this important intervention. This means that referral pathways and health services must be planned or reorganized to ensure that all individuals among target populations are tested promptly and linked to appropriate treatment based on the test results. This is best accomplished by adopting a patient-centred approach that considers the individual’s needs and perspectives.
Clinical outcomes and pharmacokinetics of first-line drugs (rifampicin, isoniazid, ethambutol and pyrazinamide) in children (aged <18 years) treated for drug-susceptible tuberculosis: systematic review and meta-analysis.
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DS-TB: drug-susceptible TB; FDC: fixed-dose combination; TB: tuberculosis.
Effective communication skills are described in Section 4.2. These need to be practised by health-care providers before they can share the information outlined above as part of health education and counselling.
1. Factual information about TB as a disease and its treatment
Information about TB and its treatment should be explained to the patient. This includes:
To date, the criteria for a positive TBST have been established by the manufacturers. These criteria are based on clinical data in relatively small numbers of patients. In addition, all of the studies to date evaluating accuracy of these tests have used cross-sectional designs. Data from prospective observational or experimental studies may result in modification of these criteria in the future.
Table 3.2. Criteria for a positive TBST