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Dear Colleague Letters										Related Pages
										June 7, 2019
Dear Colleagues:
TB Medication
CDC is anticipating a nationwide shortage of Aplisol beginning in June 2019 and potentially lasting for 10 months. Attached for your reference is a copy of the official CDC Health Advisory Notice that was issued yesterday, June 6 to ensure rapid and broad awareness of this shortage.
We have provided colleagues in the CDC Info call center with scripts to help answer inquiries from the public; specifically, if a clinician calls for advice, it will include guidance to contact their state or local TB control programs to better understand how their jurisdiction is responding to the shortage.
FDA has informed us that they will post updates on Aplisol availability to their website as information becomes available from the manufacturer.
Sincerely,
/Philip LoBue/
Philip LoBue, MD, FACP, FCCP Director
Division of Tuberculosis Elimination
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Centers for Disease Control and Prevention
Centers for Disease Control and Prevention

**This is an official**CDC HEALTH ADVISORY
Distributed via the CDC Health Alert Network
June 6, 2019, 1130 ET (11:30 AM ET)
CDCHAN-00420
Nationwide Shortage of Tuberculin Skin Test Antigens:
CDC Recommendations for Patient Care and Public Health Practice
**Summary**
The Centers for Disease Control and Prevention (CDC) is expecting a 3 to 10 month nationwide shortage of APLISOL®, a product of Par Pharmaceuticals. APLISOL® is one of two purified-protein derivative (PPD) tuberculin antigens that are licensed by the United States Food and Drug Administration (FDA) for use in performing tuberculin skin tests. The manufacturer notified CDC that they anticipate a supply interruption of APLISOL® 5 mL (50 tests) beginning in June 2019, followed by a supply interruption of APLISOL® 1 mL (10 tests) in November 2019. The expected shortage of APLISOL® 1 mL (10 tests) could occur before November 2019, if demand increases before then. The 3-10 month timeframe for the nationwide shortage is the manufacturer’s current estimate and is subject to change.
To monitor the status of this supply interruption, visit FDA’s “Center for Biologics Evaluation and Research (CBER)-Regulated Products: Current Shortages” webpage: https://www.fda.gov/vaccines- blood-biologics/safety-availability-biologics/cber-regulated-products-current-shortages.
**Background**
Two types of immunological methods are used for detecting *Mycobacterium tuberculosis*infection: tuberculin skin tests (TSTs) and interferon-gamma release assay (IGRA) blood tests. TSTs and IGRAs are used for diagnosing latent TB infection and may aid in diagnosing TB disease. Additional evaluation and testing is necessary to distinguish between latent TB infection and TB disease, and to determine the correct treatment (1). When findings, such as chest radiography and mycobacterial cultures, are sufficient for confirming or excluding the TB diagnosis, the results from a TST or an IGRA blood test might not be needed (1). Most TB cases in the United States are diagnosed with a set of findings including results from one of these tests.
Two FDA-approved PPD tuberculin antigens are available in the United States for use in performing TSTs: TUBERSOL® and APLISOL®. In controlled studies, the concordance between the two products is high (2).
When TB disease is strongly suspected, specific treatment should be started regardless of results from TST or an IGRA blood test (3,4).
**Recommendations**
CDC recommends three general approaches to prevent a decrease in TB testing capability because of the expected shortage of APLISOL®.
Substitute IGRA blood tests for TSTs. Clinicians who use the IGRA blood tests should be aware that the criteria for test interpretation are different from the criteria for interpreting TSTs (3).
Substitute TUBERSOL® for APLISOL® for skin testing. In cross-sectional studies, the two skin test products give similar results for most patients.
Prioritize allocation of TSTs, in consultation with state and local public health authorities. Prioritization might require the deferment of testing some persons. CDC recommends testing only for persons who are at risk of TB (5-7). High-risk groups for TB infection include:
People who are recent contacts exposed to persons with TB disease;
People born in or who frequently travel to countries where TB disease is common;
People who currently or used to live in large group settings, such as homeless shelters or correctional facilities;
People with weaker immune systems, such as those with certain health conditions or taking certain medications that may alter immunity; and
Children, especially those under age 5, if they are in one of the risk groups notedWhile overall test concordance is high, switching between PPD skin test products or between TSTs and blood tests in serial testing may cause apparent conversions of results from negative to positive or reversions from positive to negative. This may be due to inherent inter-product or inter-method discordance, rather than change in *M. tuberculosis*infection status (3,8). Clinicians should assess test results based on the person’s likelihood of infection and risk of progression to TB disease, if infected (1).
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. Annual TB testing of health care personnel is not recommended unless there is a known exposure or ongoing transmission (8).
**References**
Lewinsohn, David M., et al. “Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention clinical practice guidelines: diagnosis of tuberculosis in adults and children.” Clinical Infectious Diseases 64.2 (2017): e1-e33.https://academic.oup.com/cid/article/64/2/e1/2629583
Villarino ME, Burman W, Wang Y, et Comparable specificity of 2 commercial tuberculin reagents in persons at low risk for tuberculous infection. JAMA. 1999;281(2):169–171.http://dx.doi.org/10.1001/jama.281.2.169
Centers for Disease Control and Prevention. Updated guidelines for using interferon gamma release assays to detect Mycobacterium tuberculosis infection — United States, 2010. MMWR 2010;59(RR- 5): 1-25. http://www.cdc.gov/mmwr/PDF/rr/rr5905.pdf
Nahid, Payam, et al. “Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America clinical practice guidelines: treatment of drug- susceptible tuberculosis.” Clinical Infectious Diseases 63.7 (2016): e147-e195.https://academic.oup.com/cid/article/63/7/e147/2196792
Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis MMWR 2000;49(RR-6): 1-51. http://www.cdc.gov/mmwr/PDF/rr/rr4906.pdf
Centers for Disease Control and Prevention. Guidelines for the investigation of contacts of persons with infectious tuberculosis; recommendations from the National Tuberculosis Controllers Association and CDC, and Guidelines for using the QuantiFERON®-TB Gold test for detecting Mycobacterium tuberculosis infection, United States. MMWR 2005;54(No. RR-15): 1-47.https://www.cdc.gov/mmwr/pdf/rr/rr5415.pdf
US Preventive Services Task Force. Screening for latent tuberculosis infection in adults: US Preventive Services Task Force recommendation statement. JAMA. 2016;316(9):962–969. DOI:http://dx.doi.org/10.1001/jama.2016.11046
Sosa LE, Njie GJ, Lobato MN, et al. Tuberculosis screening, testing, and treatment of U.S. health care personnel: recommendations from the National Tuberculosis Controllers Association and CDC, 2019. MMWR Morb Mortal Wkly Rep 2019;68:439–443. DOI:http://dx.doi.org/10.15585/mmwr.mm6819a3*The Centers for Disease Control and Prevention (CDC) protects people’s health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.*
Categories of Health Alert Network messages:
Health Alert Requires immediate action or attention; highest level of importance
Health Advisory May not require immediate action; provides important information for a specific incident or situation Health Update Unlikely to require immediate action; provides updated information regarding an incident or situation HAN Info Service Does not require immediate action; provides general public health information
##This message was distributed to state and local health officers, state and local epidemiologists, state and local laboratory directors, public information officers, HAN coordinators, and clinician organizations##
							
					
						Page last reviewed:  June 7, 2019					Content source: 	Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention homeTuberculosisBasic TB Factsplus iconHow TB SpreadsLatent TB Infection and TB DiseaseSigns & SymptomsTB Risk FactorsExposure to TBTB PreventionVaccinesTB & HIV CoinfectionTB and DiabetesTB TermsPersonal StoriesTesting & Diagnosisplus iconWho Should be TestedTesting for TB InfectionTesting in BCG-Vaccinated PersonsTB Screening and Testing of Health Care PersonnelTesting During PregnancyDiagnosing latent TB infection and TB diseaseTreatmentplus iconDeciding When to Treat Latent TB InfectionTreatment Regimens for Latent TB Infection (LTBI)Treatment for TB DiseaseAdverse EventsTB Treatment of Persons Living with HIVTB Treatment and PregnancyTB Treatment for ChildrenFrequently Asked QuestionsDrug-Resistant TBResearchplus iconTB Epidemiologic Studies Consortiumplus iconResearch ProjectsPublicationsTB Trials Consortiumplus iconStudy DescriptionsBackgroundBehavioral & Social Science ResearchHealth Care Settingsplus iconTB Infection Control in Health Care SettingsResources for TB Screening and Testing of Health Care Personnelplus iconFrequently Asked QuestionsTB in Specific Populationsplus iconHealth DisparitiesAsian PersonsBlack or African American PersonsHispanic or Latino PersonsChildrenPregnancyCorrectional FacilitiesPeople Experiencing HomelessnessInternational TravelersLaboratory Informationplus iconDrug Susceptibility TestingFalse-Positive Investigation ToolkitInterim Laboratory Biosafety Guidance for XDR  tuberculosis strainsModel Performance Evaluation Program (MPEP)Rapid Molecular Testing to Detect Drug-Resistant TB in the USplus iconExecutive SummaryIntroductionBackground on Tests for Molecular Detection of DRGeneral Considerations and Principles for a Molecular DR Testing ServicePossible Scenarios and Scope of Testing for a Molecular DR Testing ServiceResearch NeedsGeneral Recommendations of the Expert PanelCommunication Plan for the ReportRecommendationsReferencesPanel Members and CDC ParticipantsAppendix 1Appendix 2Appendix 3The Uses of Nucleic Acid Amplification Tests for the Diagnosis of TBplus iconGeneral ConsiderationsGeneral Recommendations of the Expert PanelRecommendations to ACET, CDC, DTBEData & Statisticsplus iconTB Incidence in the United StatesReported TB in the US, 2022 Surveillance Reportplus iconNational DataReporting Area DataRisk FactorsDemographicsTB Treatment and Case OutcomesDrug-Resistant TBMolecular SurveillanceTuberculosis in the United States, 2022 (Slide Set)Archived Surveillance Reports and Slide Sets2021 State and City ReportArchived State and City ReportsProfessional Resources & Toolsplus iconTools for Healthcare ProvidersResources for TB Programsplus iconStrengthening Civil Surgeons’ Capacity to Improve LTBI Surveillance and Outcomes Among Status AdjustersNotice of Funding Opportunity (NOFO)Program EvaluationTB Centers of ExcellenceTB Elimination AllianceTB Genotypingplus iconConventional TB GenotypingWhole Genome SequencingTB GIMSAnalytic ToolsLatent Tuberculosis Infection ResourcesPublications & Productsplus iconPatient and Public MaterialsFact SheetsGuidelinesplus iconControl & EliminationDrug-Resistant TBInfection Control & PreventionLaboratory & GenotypingTB & HIVTB in Specific PopulationsTesting & DiagnosisTreatmentVaccines & ImmunizationsArchived TB GuidelinesGuides & Toolkitsplus iconAggregate ReportsCDC TB Surveillance TrainingCore CurriculumEffective TB Interviewing for Contact InvestigationEthnographic GuidesFalse-Positive Investigation ToolkitForging Partnerships to Eliminate TuberculosisGuide to Application of GenotypingLTBI: A Guide for Primary Health Care ProvidersMantoux Tuberculin Skin Testing ProductsReport of Verified Case of Tuberculosis (RVCT)Self-Study ModulesTB Contact Investigation Interviewing Skills CourseTB eDOT ToolkitUnderstanding the TB Cohort Review ProcessNewslettersplus iconTB Notes, No. 4, 2023TB Notes, No. 3, 2023TB Notes. No. 2, 2023TB Notes. No. 1, 2023TB Notes, No. 4, 2022TB Notes, No. 3, 2022TB Notes, No. 2, 2022TB Notes, No. 1, 2022TB Notes, No. 4, 2021TB Notes, No. 3, 2021TB Notes, No. 2, 2021TB Notes, No. 1, 2021Pamphlets, Brochures, Bookletsplus iconQuestions and AnswersPatient Education SeriesTuberculosis - Get the FactsTuberculosis - The Connection between TB and HIV12-Dose Regimen for Latent TB Infection-Patient Education BrochurePostersplus iconMantoux Tuberculin Skin Test Wall ChartWorld TB DayThink TBStop TBTake on TBReports & Articlesplus iconDTBE Authored Journal ArticlesTuberculosis Laboratory Aggregate ReportsSlide Setsplus iconIntroduction to TuberculosisEpidemiology of Tuberculosis Among Non-U.S.​–Born Persons in the United States, 1993–2016Self-Study Modules on Tuberculosis, 1-5 Slide SetsThe Tuberculosis (TB) in Correctional Settingsplus iconFacilitator GuideIntroduction to TB GenotypingEpidemiology of Tuberculosis in Correctional Facilities, United States, 1993-2017Prevention and Control of Tuberculosis in Correctional and Detention FacilitiesGuidelines for Preventing the Transmission of M. TB in Health care SettingsInvestigation of Contacts of Persons with Infectious TBEpidemiology of Pediatric Tuberculosis in the United StatesTargeted Tuberculosis Testing and Treatment of Latent Tuberculosis InfectionElectronic Tools & ResourcesWeb-Based Courses & Webinarsplus iconTB 101 for Health Care WorkersContent SyndicationInfographicsplus iconSocial Media GraphicsCustomizable Take on TB Infographic with InstructionsEventsWorld TB Dayplus iconU.S. TB ChampionsHistoryFeaturesplus iconTB Risk FactorsTreating Latent TB Infection with Short-Course RegimensWorld Tuberculosis (TB) Day 2021World Tuberculosis (TB) Day 2020Linksplus iconState TB Control OfficesAbout Usplus iconMission Statement and Activitiesplus iconDTBE Strategic PlanNational TB Program ObjectivesOrganization ChartAdvisory Groupsplus iconFederal TB Task Force To receive email updates about this page, enter your email address: Email Address			What's this?				Submit


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