Los Angeles County
Department of Public Health
Tuberculosis Control Program
2615 S. Grand Avenue, Room 507
Los Angeles, CA 90007
Phone: (213) 744-6160
Fax: (213) 749-0926
Email: tb@ph.lacounty.gov

Standards for Directly Observed Therapy (DOT)

• All patients with active or suspected tuberculosis should be considered for DOT whether a clear indication exists or not.
• DOT is defined as delivery of every dose of medication by a Health Care Worker (HCW) who observes and documents that the patient actually ingests or is injected with the medication.
• Delivery alone to the patient without observation and documentation is not DOT.
• Generally, patient circumstances will guide whether the medication is to be administered at the Chest Clinic or at another location such as the client’s home.
• Trained community workers and other HCWs are generally expected to deliver DOT.
• Patients on DOT should be on intermittent therapy when at all possible. Exceptions to this include daily therapy requirements during the initial induction period and treatment of MDR-TB. It is intended that daily DOT should be furnished for 7 days a week and non-injectable medications should be provided to the patient for self-administration on weekends and holidays.

ABSOLUTE INDICATORS

• The following patient characteristics are considered absolute indicators for Directly Observed Therapy. If it is decided not to place the patient on DOT, the reasons must be documented in the chart.
  • HIV co-infection
  • History of previous tuberculosis disease
  • Homelessness
  • History of criminal incarceration
  • Psychiatric disorder
  • Cognitive dysfunction
  • Controlled & illicit substance misuse or history of misuse
  • History of non-adherence to medication regimens
  • Cultures showing resistance to one or more anti-TB drugs
  • Persistently positive specimen smears or cultures
  • Failure to respond to therapy or relapse of tuberculosis
  • History of leaving medical facility against medical advice

MISSED DOT

• The following are procedures for missed Directly Observed Therapy:
  • Triggers for PHN Case Manager Notification
    • 2X weekly DOT: One or more missed dose(s).
    • 3X weekly DOT: Two or more missed doses.
    • Daily DOT: Two or more missed doses.
    • MDR: One or more missed dose(s), notify MDR-TB Unit at TB Control.
  • Make-up Time Parameters
    • 2X weekly DOT: One or more missed doses per week will result in a one to one weekly extension of therapy.
    • 3X weekly DOT: Two or more missed doses per week will result in a one to one weekly extension of therapy.
    • Daily DOT: Two or more missed doses per week will result in a one to one weekly extension for the induction period of starting medication.
    • MDR DOT: Call TB Control MDR-TB Unit.

Missed Clinic Visits

• Any patient on DOT who misses a scheduled clinic appointment must be returned to clinic within one week for clinical assessment.
• Any further delinquencies without good reason will result in the holding of DOT and a clinician assessment for plan of action including the issuing of an order for examination or isolation where appropriate.

Acceptable Intermittent Therapy Schedules

• For patients with Mycobacterium tuberculosis drug-sensitive isolates.
• The clinician shall determine the appropriate regimen depending upon individual patient assessment and need.
• Therapy may need to be prolonged for certain patients (e.g., those with HIV, extensive disease, etc.).
• Acceptable Intermittent Schedules
  1. For drug-sensitive TB: INH, rifampin, PZA, and ethambutol daily for 8 weeks followed by INH and rifampin twice weekly for 16 weeks.
  2. For drug-sensitive TB: INH, rifampin, PZA, and ethambutol daily for 2 weeks followed by INH, rifampin, PZA, and ethambutol twice weekly for 6 weeks followed by INH and rifampin twice weekly for 16 weeks.
  3. INH, rifampin, PZA, and ethambutol three times weekly for 6 months. (For drug-sensitive TB, ethambutol may be discontinued, and PZA may be discontinued after 2 months.)

Adult Dosing Schedule
Drug	Daily	2X Weekly	3X Weekly
Isoniazid (INH)	5 mg/kg Max 300mg	15 mg/kg Max 900mg	15 mg/kg Max 900mg
Rifampin (RM)	10 mg/kg Max 600mg	10 mg/kg Max 600mg	10 mg/kg Max 600mg
Pyrazinamide (PZA)	20-25 mg/kg Max 2 g	40-50 mg/kg Max 4 g	30-35 mg/kg Max 3 g
Ethambutol (EMB)	15 mg/kg	40-50 mg/kg	25-30 mg/kg

INH and rifampin can also be given in the form of Rifamate®

INH, rifampin, and PZA can also be given as Rifater®

Child Dosing Schedule - (See Chapter 4 of the TB Control Manual).