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The Division of Public Health (DPH) is issuing this health alert regarding an impending shortage of APLISOL® (JHP Pharmaceuticals, LLC).
In June the Centers for Disease Control and Prevention (CDC) informed health care providers of an impending shortage of APLISOL®, one of two brands of tuberculin purified protein derivative (PPD) used in the U.S. for tuberculin skin tests (TST). According to the CDC, the shortage is expected to last three to 10 months.
This notice alerts health care providers and facilities who test for tuberculosis (TB) and provides guidance on how to manage the shortage.
Two types of immunological methods (tuberculin skin tests (TSTs) and interferon-gamma release assay [IGRA] blood tests) are used for detecting Mycobacterium tuberculosis infection. TSTs and IGRAs are used for the diagnosis of latent TB infection (LTBI) and can aid in the diagnosis of TB disease, though additional evaluation and testing is necessary to distinguish between LTBI and TB disease and to determine the appropriate treatment.
Two FDA-approved PPD tuberculin antigen products are available in the U.S. for use in performing TSTs: APLISOL® and TUBERSOL® (Sanofi Pasteur Limited).
"Although overall test concordance is high, switching between PPD skin test products or TSTs and IGRAs in serial testing might result in apparent conversions from negative to positive or reversions from positive to negative that might be attributable to inherent interproduct or intermethod discordance rather than change in M. tuberculosis infection status. Clinicians should assess test results based on the person’s likelihood of infection and risk for progression to TB disease, if infected1," according to the CDC.
As a result of this shortage, supplies of TUBERSOL® may also run out.
When the CDC announced the shortage, they also provided recommendations to providers on how to manage for the duration. Chief among them were to prioritize the allocation of TSTs to conserve PPD stock and to substitute with IGRAs to test for TB.
In Delaware, regulations for the following types of long-term care facilities specifically require the two-step TST in order to satisfy testing requirements:
Recognizing this, for the duration of the APLISOL® shortage, the Division of Health Care Quality (DHCQ) will not enforce the TST requirement and will allow use of the IGRA as an acceptable alternative for TB testing of new employees and residents in these facilities. This does not suspend any testing requirements but allows for use of an alternative testing method in the facilities listed above. All other facility-specific relevant regulations already allow for the use of the IGRA.
At this time, Delaware is not authorizing deferment of testing.
DPH has been advised by the Centers for Medicare and Medicaid Services (CMS) that physicians may call their provider advice line to see about negotiating reimbursement for the TB blood test on a case-by-case basis.
As of May 2019, per CDC recommendations, annual TB testing of health care personnel is not recommended unless there is a known exposure, or evidence of ongoing transmission.
As a reminder, a chest X-ray is not an appropriate first line diagnostic tool for TB, and for adults, should only be obtained if the individual has already tested positive with a TST or IGRA.
If you have any further questions or concerns, contact the Delaware Division of Public Health TB Program central office at 302-744-1053 or email the TB Program manager, Crystal Vicidomini, MSN/MBA, RN (Crystal.Vicidomini@delaware.gov).
1Nationwide Shortage of Tuberculin Skin Test Antigens: CDC Recommendations for Patient Care and Public Health Practice. MMWR Morb Mortal Wkly Rep 2019;68:552–553. DOI: http://dx.doi.org/10.15585/mmwr.mm6824a4
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