Health Alert
RECOMMENDATIONS FOR DRUG ALLOCATION, TUBERCULOSIS PREVENTION THROUGH TREATMENT OF LATENT INFECTIONS AND PATIENT CARE DURING ISONIAZID SHORTAGES

Background

Shortages of isoniazid (INH), a cornerstone drug for treating tuberculosis disease (TB) and latent tuberculosis infection (LTBI), first reported in late 2012, are continuing and causing the need to prioritize use of INH. Only two active companies currently supply INH in the United States, and supplies have been very limited. Medication orders that were expected in February 2013 have now been pushed back to March 2013.

Delaware’s Division of Public Health (DPH) is in the process of gathering data on the numbers of active and latent TB patients currently under treatment by DPH, and determining the availability of INH statewide. A database search of pharmaceutical warehouses serving Delaware on Monday, January 28, 2013 found no available INH in stock.

Recommendations

1. During the shortage, use of INH should be limited to:
   1. Patients who have active TB disease
   2. Individuals with LTBI who were diagnosed during contact investigations from an active case
   3. Those who have begun a course of treatment with INH and are not appropriate for treatment with an alternate medication
   4. Those patients with LTBI who face the greatest likelihood of TB disease (such as those with significant immunosuppression), or for whom the risk of severe illness is high, such as children under five years of age.
2. Individuals with LTBI who do not meet above criteria should either be treated with an alternative regimen (such as rifampin) or treatment of LTBI deferred till INH is again available in sufficient amounts.  Providers should develop a strategy for recalling patients not eligible for INH at this time once it again becomes available.
3. Health care providers are encouraged to call the Center for Disease Control’s Regional TB Training and Consultation center (New Jersey Global TB Institute) for guidance regarding specific patient scenarios at 1-800-482-3627. Consultation is free.

Additional Information

• The Centers for Disease Control has produced a fact sheet on the four FDA approved regimens for treatment for LTBI at:  http://www.cdc.gov/tb/publications/factsheets/treatment/LTBItreatmentoptions.htm
• The Centers for Disease Control and Prevention (CDC) published a notice regarding this shortage in the December 21, 2012, Morbidity and Mortality Weekly Report (MMWR) at:  http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6150a4.htm). This report outlined national plans for restoring INH supplies and published guidance to assist clinicians in making treatment decisions when INH is unavailable.

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