Medscape Medical News (09.05.2013)
A CDC Health Alert Network advisory reported shortages of two tuberculin skin test (TST) antigens, Tubersol (Sanofi Pasteur) and Aplisol (JHP Pharmaceuticals). Both of the US Food and Drug Administration (FDA)-approved TSTs are purified-protein derivative tuberculin products. Fifty-dose Tubersol vials were completely unavailable, and there was a limited supply of 10-dose Tubersol vials. CDC expected Sanofi Pasteur would not replenish the Tubersol supply until mid-October at the earliest.
As a result of the Tubersol shortage, Aplisol, which gives results similar to Tubersol, was also in short supply in some US regions. JHP Pharmaceuticals was giving precedence to established Aplisol customers, but limiting the amount they could buy.
CDC announced a similar TST scarcity in April; Sanofi Pasteur resolved the shortage in early June. CDC recommended that public health agencies and private healthcare providers work around the TST shortages by substituting interferon-gamma release assay tests or Aplisol and by prioritizing the use of TSTs for direct contact investigations. Interferon-gamma release assay tests could be more expensive than TSTs and could yield “indeterminate or borderline results.”
The full advisory, “Recurrent Nationwide Shortage of Tuberculin Skin Test Antigen Solutions: CDC Recommendations for Patient Care and Public Health Practice,” was published online by CDC’s Emergency Preparedness and Response: Health Alert Network at http://emergency.cdc.gov/HAN/han00355.asp.
Updates from the FDA’s Center for Biologics Evaluations and Research are available at http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm351921.htm.