In this issue...
Directly Observed Therapy as Standard of Care
Contact Investigation Guidelines
Additional Investigation Guidelines
General Guidelines for Children < Age 4, HIV-positive Individuals and Other Immunosuppressed Contacts
Directly Observed Therapy as Standard of Care
In carrying out its mission to protect the citizens of the Commonwealth from the spread of tuberculosis (TB), one of the most important responsibilities of the health department is to ensure that persons with active TB disease are treated with an appropriate combination of medicines until such persons are successfully cured. Unlike many other diseases, incomplete or inaccurate treatment of TB can lead to more serious consequences (e.g. emergence of drug resistance) than a lack of treatment. The health department, therefore, has a vested interest in ensuring that TB patients remain fully adherent to their prescribed course of therapy.
Directly Observed Therapy (DOT) is the observation of the patient as s/he swallows prescribed medications. A number of observational studies, and at least one meta-analysis study in the U.S., strongly suggest that DOT, coupled with individualized case management offer the best chances for successful cure of the individual patient, and for establishing and maintaining control of TB in our communities.
Thus, DOT is a preferred, core management strategy and should be considered in all TB cases, regardless of the source of medical care. In 1998, Directly Observed Therapy (DOT) was established by VDH-DTC as the "Standard of Care" for all cases of pulmonary TB. Although private providers may choose to decline to order DOT, it should always be offered; and, a health department TB professional should be certain that the private provider understands the advantages of DOT and the consequences of nonadherence. While use of DOT in cases of extra-pulmonary or clinically defined TB would be desirable, limited resources may preclude universal implementation. In certain situations, the use of DOT should be considered mandatory. These include the following situations where the risk and/or consequences of nonadherence are grave:
In these situations, local health officers are strongly encouraged to exercise their statutory authority, under the Code of Virginia §32.1-50.1, to review TB treatment plans and mandate the use of DOT. The requirement for DOT in these situations can be waived only with an explicit order and written justification from a licensed physician, and approval by the local health officer. The written justification should include an acknowledgement by the treating physician that s/he is accepting full responsibility for ensuring adherence to recommended therapy, and for any TB transmission in the community that may result from treatment nonadherence.
DTC has received several troublesome complaints (reports) from private physicians concerning provision of DOT services. According to these reports, personnel from various local health departments across the Commonwealth have declined to offer DOT services to pulmonary TB cases, even when the private physicians had specifically requested DOT. In some of these instances, health department staff have advised physicians that DOT was unnecessary. Such advice is in direct conflict with stated VDH-DTC guidelines and cannot be justified. In addition, these mixed messages greatly undermine our collective efforts over the last several years to promote DOT as the standard of care in the medical community and to educate community partners on the importance of ensuring adherence.
It is likely that in most of the above instances, the inability to provide DOT as requested was a result of staffing shortages. These circumstances should be shared with the provider so that a mutually acceptable means of ensuring adherence can be developed. If there are instances when a local health department is unable to provide DOT services for an individual with pulmonary TB or a member of a high-risk group (described above), please notify DTC immediately. This information will enable DTC to offer assistance to ensure that DOT is available.
The Division of Tuberculosis Control (DTC) has prepared the following chart, as well as some general recommendations, to assist in the initiation of contact investigations and follow-up for selected categories of contacts, and to offer recommendations for the initiation of preventive therapy during the "window period." We hope this information is useful in your efforts to control tuberculosis in the Commonwealth.
Classification |
TB Lab Results |
Investigation Level Required |
Pulmonary TB Suspect |
Smear positive, Culture Pending |
1. Do not wait for culture results |
Smear negative, Culture pending |
1. Defer investigation until results of culture received |
|
Pulmonary TB Case |
Smear positive, culture positive |
1. Proceed with concentric circle contact investigation. Evaluate household and other close contacts. Expansion of investigation based on results of screening. |
Smear negative, culture positive |
1. Contact investigation usually not indicated. |
|
Extrapulmonary TB |
Smear neg/pos, Culture positive |
1. Collect on cluster of sputa to rule out pulmonary involvement, unless this has already been done. |
Clinical Pulmonary Case |
Smear negative, culture negative |
1. Contact investigation usually not indicated. |
Additional Investigation Guidelines
›All contacts with positive TST results should be evaluated by chest x-ray.
›Symptomatic contacts should have sputum examination and further examination as warranted.
›All contacts placed on treatment for LTBI need evaluation to rule-out TB disease prior to initiating any treatment (i.e. symptom screen, TST, CXR).
›CXR results for all contacts must be recent, i.e. obtained since the initiation of the investigation or at least after contact was broken. If contact was broken and the CXR is over 3 months old, the film must be repeated prior to the initiation of any preventive treatment.
›Contacts who are known to have a previously positive TST should be evaluated for symptoms. No further follow-up is indicated for asymptomatic individuals. For those with symptoms compatible with active disease, the individual should receive a full evaluation as a TB suspect. The exception to this would be HIV positive contacts. HIV positive individuals should receive a symptom review and chest x-ray regardless of duration of TST-positivity or history of prior treatment for LTBI.
General Guidelines for Children < Age 4, HIV-positive Individuals and Other Immunosuppressed Contacts
›Children, infants, HIV-positive individuals, and other immunocompromised individuals who are contacts to smear positive confirmed or suspected pulmonary TB cases should immediately be evaluated by symptom screen, TST, a physical exam by RCC, PMD or CHCN, and chest x-ray regardless of TST result.
›The CXR must be recent, i.e. taking since the initiation of the investigation or at least after contact was broken. If contact was broken and the CXR is over 3 months old, the film must be repeated prior to the initiation of any preventive treatment. If contact was not broken, the film must be repeated prior to initiation of any preventive treatment.
›These contacts should be started on treatment for LTBI, regardless of TST result, as soon as active TB has been excluded by confirming the absence of symptoms and verification that the chest radiograph is normal. If the initial TST was negative, the TST should be repeated 3 months after contact was broken. If the repeat test is negative, treatment and follow-up can be discontinued for asymptomatic individuals. If the repeat test is positive, treatment should be continued for the full recommended preventive course.
›For infants under 6 months of age, treatment for LTBI should be continued until such time as a repeat TST can be accomplished after age 6 months and 12 weeks have elapsed since last exposure to the infectious patient.