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TB Clinical Guidelines: Revision Highlights March 2014 AIR TRAVEL & TB CONTROL With respect to non-ambulance air travel of patients diagnosed with or suspected as having active Mycobacterium tuberculosis, the following is recommended: Non-ambulance air travel of patients with active pulmonary TB is not permitted until: 1. Smear-positive, culture-positive cases: i. Three consecutive smear negative sputa have been collected after the initiation of effective therapy and ii. Two weeks of directly observed therapy has been completed and iii. There is evidence of clinical improvement. Smear-negative, culture-positive cases: i. Two weeks of directly observed therapy has been completed and ii. There is evidence of clinical improvement. 2. Patients being investigated for but not diagnosed with active TB may fly if: i. Suspicion for active TB is low and smear-negative sputum, or ii. At the discretion of the TB physician. 3. Patients are prohibited from flying if: i. Suspicion for active TB is moderate to high and 3 smear-negative sputum, unless ii. Cultures are final and negative or following completion of two weeks of directly observed drug therapy and evidence of clinical improvement. Patients whose specimens are found to be positive are categorized as having active pulmonary TB until conditions in point 1 are satisfied. 4. Patients with extra-pulmonary TB are not considered infectious and are safe to fly as usual. Any open lesion should be covered by a health care worker with a suitable dressing. 5. Patients with latent TB (prior positive TST) with no respiratory symptoms and not being investigated for active TB are non-infectious and safe to fly. 6. Patients with latent TB (prior positive TST) with new respiratory symptoms should undergo a medical evaluation prior to being cleared for non-ambulance air travel. 7. Patients with negative or unknown TST result and respiratory symptoms are outside the domain of TB Prevention and Control SK and should engage in non-ambulance air travel at the discretion of the physician most affiliated with the patient. Any patient diagnosed with or suspected as having active TB in serious or critical condition requiring a level of care greater than what is locally available can be transported via air ambulance if in accordance with air ambulance’s own policy. In this case, patients should wear a surgical mask and all staff and crew should wear N95 masks when it is safe to do so (from a flight safety perspective). TB Clinical Guidelines: Revision Highlights, March 2014 Page 1 of 5 AIRBORNE PRECAUTIONS AND AIRBORNE INFECTION ISOLATION ROOMS (AIIR) Airborne precautions are required for all patients/clients/residents with suspected or confirmed respiratory TB disease, including those with smear-negative, culture-positive TB. Exception: For the pediatric population, airborne precautions are generally not required; however, the decision will be based on clinical judgment and the clinical presentation of the child. Patient Placement: An AIIR is required for all patients/clients/residents with suspected or confirmed respiratory TB disease admitted to acute care or long term care or corrections. If an AIIR is not available, transfer to another facility with an AIIR if possible. If transfer is not possible, the patient/client/resident should be placed in a private room with the door closed and an air purifier/scrubber (with ultraviolet light included) placed in the room. If an air purifier is not available then a private room with door closed is required. Staff should wear a N95 respirator when in the AIIR. Patient/clients/residents should wear a regular (surgical) mask when outside the AIIR. Suspect TB – precautions may be discontinued if: Three consecutive sputum smears are negative for AFB, UNLESS TB is still strongly suspected AND no other diagnosis has been made. Confirmed smear-negative, culture-positive TB – precautions may be discontinued if: 1. Minimum 2 weeks effective drug therapy completed, AND 2. Clinical improvement. May be discharged to home isolation if: 1. Clinical improvement, AND 2. No drug resistant TB, AND 3. No other contraindications for home isolation. Confirmed smear-positive, culture-positive TB – precautions may be discontinued if: 1. Minimum 2 weeks effective drug therapy completed, AND 2. Clinical improvement, AND 3. 3 consecutive negative sputum smears for AFB (collect sputum following two weeks of drug therapy). May be discharged to home isolation if: 1. Clinical improvement, AND 2. No drug resistant TB, AND 3. No other contraindications for home isolation. Home Isolation: Conditions for home isolation are as outlined in figure 2 of chapter 15 (page 19) in the Canadian TB Standards. Consider admission to acute care service for infectious period if patient/client/resident non-compliant with home isolation. Respirator Fit Testing for staff to be completed in accordance with local regional policy. TB Clinical Guidelines: Revision Highlights, March 2014 Page 2 of 5 CONTACT INVESTIGATIONS A contact investigation is required for all sputum smear-positive and smear-negative respiratory TB cases. Contacts will be categorized as high, medium or low priority. High priority contacts include those with the most exposure and at greatest risk of developing active TB if infected. High priority contacts include: • Household contacts, including those exposed as household members in congregate settings (e.g., roommates) • Close non-household contacts or casual contacts who are at high risk of progression of latent TB infection to active TB (e.g., immunologically vulnerable individuals such as children less than five years of age, individuals with HIV, silicosis, transplant, those receiving dialysis, etc.) Close non-household contacts are individuals with regular, extensive contact with the case and share the same breathing space daily or almost daily but do not sleep in the same household. Close non-household contacts may include caregivers, extended family, close friends, classmates, coworkers, etc. • Contacts exposed (without wearing appropriate personal protective equipment) during aerosol-generating medical procedures such as bronchoscopy, autopsy and sputum induction. Medium priority contacts include close non-household contacts that are not at high risk of progression of latent TB infection to active TB (i.e., not immunologically vulnerable). Medium priority contacts include individuals with daily or almost daily exposure. Low priority contacts include casual contacts with less exposure to the case such as extended family that only spend time with the case occasionally. An initial and eight week post-exposure assessment should be completed for high priority contacts. Medium and low priority contacts only require an eight week post-exposure assessment. Assessment should include a TST, if previously negative, symptom assessment and confirmation of risk factors. Smear-positive TB contact investigations: Assessment of contacts should include high and medium priority contacts and extend back three months from the date contact was broken (isolation initiated) or the date of the first positive specimen collection, whichever date extends further back. Individuals exposed to the active case during the period between specimen collection and initiation of isolation should be included as contacts. Smear-negative TB contact investigations: Assessment of contacts should include high priority contacts only and extend back four weeks from the date contact was broken (isolation initiated) or the date of the first positive specimen collection, whichever date extends further back. Individuals exposed to the active case during the period between specimen collection and initiation of isolation should be included as contacts. The contact investigation may be extended to include medium priority contacts as deemed necessary by the TB physician. TB Clinical Guidelines: Revision Highlights, March 2014 Page 3 of 5 HIV TESTING Screening for HIV in patients with suspected TB Screen all persons being evaluated for latent or active TB 13 years of age or older. Testing of patients younger than 13 is at the discretion of the physician. Document consent in the health record; signed consent is not required. HIV ELISA Ab test or 4th generation combined Ab-Ag test required. Screening for TB in those with HIV Suspected active TB in those with HIV Notify local physician, other specialist or TB Prevention and Control SK if high risk: • Chest x-ray (CXR) • Sputum (AFB and TB culture): collect 3 specimens 8 hours apart in a 24 hour period with at least one early-morning specimen • Labs: CBC, electrolytes, urea, creatinine, ESR or CRP, AST, ALT, ALP, GGT, bilirubin • If coughing or CXR abnormal, isolate the patient until criteria for discontinuing airborne precautions is met or reviewed with TB Prevention and Control SK. The individual should stay at home as much as possible, wear a surgical mask if leaving home, and avoid children less than five years of age. Screening for Latent TB in HIV positive persons that are not Contacts Individuals diagnosed with HIV should be screened for latent TB infection within one month of HIV diagnosis. A tuberculin skin test should be performed within 1-2 months of the HIV diagnosis unless the individual is not well (CD4 < 200). • TST ≥ to 5 mm is positive, refer to TB Prevention and Control SK • TST < 5 mm, do not refer to TB Prevention and Control SK unless patient is a contact • CD4 > 200, repeat TST annually for high risk clients • CD4 < 200, repeat when CD counts improved to > 200 on HIV therapy Screening for Latent TB in HIV positive persons that are Contacts Refer all patients to TB Prevention and Control SK regardless of CD4 count or TST result. All patients are eligible for prompt initiation of prophylaxis. INTERFERON GAMMA RELEASE ASSAY Not currently available in Saskatchewan; discussions pending. SPUTUM SPECIMENS Three specimens to be collected eight hours apart in a 24 hour period with at least one early morning specimen. TB Clinical Guidelines: Revision Highlights, March 2014 Page 4 of 5 TREATMENT Directly observed therapy remains the standard for medication administration and delivery. Admission to acute care may be considered under the following conditions: • If the patient is on methadone and there is an increased risk of withdrawal • To investigate and/or treat symptoms such as fever, life-threatening hemoptysis, malaise/cachexia • To establish an acceptable therapeutic regimen in patients with significant drug-related adverse events or with known/suspected drug resistance • For drug desensitization • For management of medical conditions that complicate TB care such as congestive heart failure, HIV infection, or respiratory failure • To provide airborne isolation, if unable to effectively provide on an outpatient basis • Involuntary admission to provide treatment when other measures such as DOT are unsuccessful. ACTIVE TB The goal of active TB treatment is for the patient to receive 100 percent of prescribed medication doses. Medication Start date Therapy will be initiated the week of diagnosis provided a minimum of two doses can be delivered in the week. If unable to administer two doses, therapy will be started on the Monday of the following week. Exception: Therapy will start as soon as the medications are available in congregate settings such as acute care. Intensive or Initial phase In general, four drugs (Isoniazid, Rifampin, Ethambutol, and Pyrazinamide) will be administered five days a week (Monday – Friday) for two months. Daily administration may be utilized on a case by case basis at the discretion of the TB physician. If compliance is ≤ 80% at the time of the first medication audit, consideration may be given to changing five days a week therapy to daily administration (i.e., 7 days a week). Ethambutol may be discontinued prior to the end of the intensive phase if the patient is fully susceptible to all first line drugs; Isoniazid, Rifampin, and Pyrazinamide will continue for the full two months. Continuation phase In general, two drugs (Isoniazid and Rifampin) will be administered three times a week for a period of four months. The continuation phase may be extended to seven months or longer in the presence of specific patient conditions. LATENT TB In general, the treatment regime will consist of twice a week administration of Rifampin and Isoniazid for four months. Regimes will vary for specific patient conditions such as HIV co-infection. Treatment may be extended to six months or nine months on a case by case basis. Certain regimes may be administered once daily or three times a week. Patients who wish to receive self-administered therapy for latent TB should receive daily therapy rather than intermittent therapy. Treatment may be stopped if the patient is non-adherent. TB Clinical Guidelines: Revision Highlights, March 2014 Page 5 of 5