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U.S. Department of Health and Human Services


Core Curriculum on Tuberculosis, 2000

Chapter 7
Treatment of TB Disease


Nonadherence to TB treatment is a major problem in TB control. Of cases reported in the United States for 1994, 14% of patients who were started on treatment had not completed a full course by 1998. 1 Inadequate treatment can lead to relapse, continued transmission, and the development of drug resistance.

Most health departments have public health nurses or community outreach workers who can work with patients and clinicians to help patients adhere to a prescribed regimen. Whenever possible, a worker who has the same cultural and linguistic background as the patient should be assigned to help develop an individualized treatment adherence plan.

Patient Education
All patients should be educated about TB, the dosing of medications, the possible adverse reactions of the medications, and the importance of taking their medication. Health care workers must take the time to explain clearly to patients when the medication should be taken, how much, and how often, especially if the patient is not receiving directly observed therapy (DOT). Written instructions should also be provided.

Case Management
One strategy that may be used to ensure that patients complete TB treatment is case management. There are three elements of case management: assignment of responsibility, systematic regular review, and plans to address barriers to adherence. In case management, a health department employee (case manager) is assigned primary responsibility for the management of specific patients and is held accountable for ensuring that each of those patients is educated about TB and its treatment, that therapy is continuous, and that contacts are examined. Some specific responsibilities may be assigned to other persons (e.g., clinic supervisors, outreach workers, health educators, and social workers).

Directly Observed Therapy
A component of case management that helps to ensure that patients adhere to therapy is directly observed therapy (DOT). DOT means that a health care worker or another designated person watches the patient swallow each dose of TB medication. DOT ensures an accurate account of how much medication the patient really took. DOT should be considered for all patients because clinicians are often inaccurate in predicting which patients will adhere to medication regimens on their own. 2 However, it takes good case management in concert with DOT to really make DOT programs effective.

In many areas, patients are routinely given DOT. 3 DOT has been shown to be cost-effective when intermittent regimens are used. 4,5 Furthermore, DOT can significantly reduce the frequency of the development of drug resistance and of treatment failure or relapse after the end of treatment. 6,7 Nearly all the treatment regimens for drug-susceptible TB can be given intermittently if they are directly observed; using intermittent regimens reduces the total number of doses a patient must take, as well as the total number of encounters with the health care provider or outreach worker, making these regimens more cost-effective. Multidrug-resistant TB (MDR TB) should always be treated with a daily regimen and under direct observation. There are no intermittent regimens for treatment of MDR TB.

It is important that DOT be carried out at times and in locations that are as convenient as possible for the individual patient. Therapy may be directly observed in a medical office or clinic setting, but can also be observed by an outreach worker in the field (i.e., the patientís home, place of employment, school, or other mutually agreed-upon place). In some situations, staff of correctional facilities or of drug treatment programs, home health care workers, maternal and child health staff, or designated community members may provide DOT.

Incentives and enablers should be used to enhance adherence to therapy. This may be as simple as offering a cup of coffee and talking with a patient who is waiting in the clinic or as complex as providing food and housing for a homeless patient. Establishing a relationship with the patient and addressing barriers to adherence is the core of a successful DOT program.

Health care professionals, including private practitioners, who note that a particular TB patient has demonstrated the inability or unwillingness to adhere to a prescribed treatment regimen should consult the health department. The TB control program in the health department should assist in evaluating the patient for causes of nonadherence and should provide additional services, such as the services of outreach workers, to enable the patient to complete the recommended therapy. If these efforts are unsuccessful, the health department should take appropriate action, such as seeking court-ordered DOT or, if all other measures fail, the detention of a patient who is unwilling or unable to complete treatment and who is infectious, at risk of becoming infectious, or at risk for drug-resistant TB.

Self-Administered Therapy
When therapy is self-administered, the use of fixed-dose combination capsules or tablets may enhance patient adherence and reduce the risk of inappropriate monotherapy. Therefore, it may prevent the development of acquired drug resistance. For this reason, the use of such fixed-dose combinations is strongly encouraged for adults prescribed a self-administered regimen. In the United States, the Food and Drug Administration has licensed fixed-dose combinations of isoniazid and rifampin (Rifamate) and of isoniazid, rifampin, and pyrazinamide (Rifater). Clinicians should become familiar with the management of TB using these fixed-dose combination drugs. In addition, incentives and enablers should be used to enhance adherence to therapy.

Patients should be asked routinely about adherence at follow-up visits. Pill counts should be taken routinely, and urine tests can be used periodically to check for the presence of drug metabolites. In addition, the response to treatment (bacteriologic conversion to negative) should be monitored closely for all patients. If the patientís sputum remains positive after 2 months of treatment, the patient should be reevaluated and DOT should be considered for the remainder of treatment.


Released October 2008
Centers for Disease Control and Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination -

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