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No. 3, 2013

Dear Colleague:

As you should already be aware, Dr. Ken Castro, Director, Division of Tuberculosis Elimination (DTBE), has accepted a request from the leadership of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) to serve as Acting Director of the Division of HIV/AIDS Prevention (DHAP), until a permanent Director for DHAP is found. This is the result of Dr. Jonathan Mermin, former Director of DHAP, being selected as the new Director of NCHHSTP. Dr. Castro agreed to work in this capacity on a time-limited basis, and started on August 19. In addition, Phil Talboy, DTBE Deputy Director, is on a temporary detail to the Field Services Office, Office of State, Tribal, Local, and Territorial Support (OSTLTS), until January 2014 to help DTBE and other divisions in NCHHSTP re-build the crucial Public Health Advisor pipeline of the future. In the interim, I have agreed to serve as Acting Director, DTBE. While I am serving in this capacity, Dr. John Jereb, Field Services and Evaluation Branch (FSEB) medical officer, has agreed to serve as the DTBE Acting Associate Director for Science. Kathryn Koski is serving as Acting Deputy Director, and Lee Ann Ramsey is serving as Acting Associate Director for Management and Operations, DTBE. Dr. Castro and I both appreciate your support of these individuals as they carry out these important duties.

In April 2013, DTBE issued a notification via the CDC Health Alert Network (HAN) regarding nationwide shortages of Tubersol and Aplisol, the only U.S. Food and Drug Administration–approved purified protein derivative (PPD) solutions for use in performing tuberculin skin tests (TSTs). In September 2013, DTBE issued an updated health alert. This stated that "although supplies were restored in early June 2013, Tubersol is in shortage again until at least the middle of October 2013. At the current time, the 5 tuberculin unit/0.1 mL, 5 mL (50-test) multiple dose vials are unavailable. The 5 tuberculin unit/0.1 mL, 1 mL (10-test) multiple dose vials are in limited supply."

CDC recommends any of three general approaches for addressing the shortages of tuberculin skin test antigens:

  1. Substitute IGRA blood tests for TSTs.
  2. Substitute APLISOL for TUBERSOL for skin testing if APLISOL is available.
  3. Allocate TSTs to priority usages, such as TB contact investigations, as determined by public health authorities.

Some surveillance programs for TB infection control rely on routine serial TSTs. Switching products or methods might make serial changes in test results difficult to interpret. The apparent conversions of results from negative to positive or reversions from positive to negative could be caused by inherent inter-product or inter-method discordance. In settings with a low likelihood of TB exposure, the deferment of routine serial testing should be considered in consultation with public health and occupational health authorities.

Please see the official health update at http://emergency.cdc.gov/HAN/han00355.asp for further details and discussion of the recommendations above.

Updates about the shortages of tuberculin skin test solutions are posted by the FDA Center for Biologics Evaluation and Research at http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm351921.htm.

As one additional update, Sanofi Pasteur reports that the supply of Tubersol has improved and will steadily improve for the remainder of the year. Existing Sanofi Pasteur customers can purchase directly from Sanofi Pasteur by visiting VaccineShoppe.com® or by calling 1-800-VACCINE (1-800-822-2463). In addition, limited quantities of Tubersol Diagnostic Antigen are available through the wholesaler/ distributer channel. Customers who normally order through this channel should work with their preferred wholesaler/distributor to better understand Tubersol Diagnostic Antigen quantities that may be available to them. If you are a new customer or have inquiries regarding the availability of Tubersol Diagnostic Antigen, you should contact Sanofi Pasteur at 1-800-VACCINE (1-800-822-2463), or your wholesaler/distributor.

On July 19, a number of DTBE staff members were recognized at the NCHHSTP Honor Awards Ceremony. Please see the article in this issue about the awards won by our staff for their important work.

Philip LoBue, MD, FACP, FCCP
Acting Director
Division of Tuberculosis Elimination
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

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