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Bacille Calmette-Guérin preparation and intravesical administration to patients with bladder cancer: Risks to healthcare personnel and patients, and mitigation strategies

Published online by Cambridge University Press:  11 December 2023

Ashley H. Marx Open the ORCID record for Ashley H. Marx [Opens in a new window] ,
Diana N. Nowicki Open the ORCID record for Diana N. Nowicki [Opens in a new window] ,
Rebecca B. Carlson Open the ORCID record for Rebecca B. Carlson [Opens in a new window] ,
Katherine M. Schultz ,
Emily Sickbert-Bennett  and
David J. Weber Open the ORCID record for David J. Weber [Opens in a new window]
Ashley H. Marx*
Affiliation:
Department of Pharmacy, University of North Carolina Medical Center; University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina
Diana N. Nowicki
Affiliation:
Department of Pharmacy, University of North Carolina Medical Center; University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina
Rebecca B. Carlson
Affiliation:
University of North Carolina Health Sciences Library, Chapel Hill, North Carolina
Katherine M. Schultz
Affiliation:
Department of Infection Prevention, UNC Medical Center; Chapel Hill, North Carolina
Emily Sickbert-Bennett
Affiliation:
Department of Infection Prevention, UNC Medical Center; Chapel Hill, North Carolina Department of Epidemiology, University of North Carolina School of Public Health; Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, North Carolina
David J. Weber
Affiliation:
Department of Infection Prevention, UNC Medical Center; Chapel Hill, North Carolina Department of Epidemiology, University of North Carolina School of Public Health; Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, North Carolina
*
Corresponding author: Ashley H. Marx; Email: ashley.marx@unchealth.unc.edu
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Abstract

Intravesical Bacillus Calmette-Guérin (BCG) is a standard therapy for non–muscle-invasive bladder cancer used in urology clinics and inpatient settings. We present a review of infection risks to patients receiving intravesical BCG, healthcare personnel who prepare and administer BCG, and other patients treated in facilities where BCG is prepared and administered. Knowledge of these risks and relevant regulations informs appropriate infection prevention measures.

Type
Review
Information
Infection Control & Hospital Epidemiology , Volume 45 , Issue 4 , April 2024 , pp. 520 - 525
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Copyright
© The Author(s), 2023. Published by Cambridge University Press on behalf of The Society for Healthcare Epidemiology of America

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Footnotes

a

Authors of equal contribution.

References

SEER*Explorer: an interactive website for SEER cancer statistics. Surveillance Research Program, National Cancer Institute. https://seer.cancer.gov/statistics-network/explorer/. Updated April 19, 2023. Accessed June 5, 2023.Google Scholar
Chang, SS, Boorjian, SA, Chou, R, et al. Diagnosis and treatment of non–muscle-invasive bladder cancer: American Urological Association/Society of Urologic Oncology guideline. J Urol 2016;196:1021.CrossRefGoogle Scholar
Babjuk, M, Burger, M, Capoun, O, et al. European Association of Urology guidelines on non–muscle-invasive bladder cancer (Ta, T1, and carcinoma in situ). Eur Urol 2022;81:75–94.CrossRefGoogle ScholarPubMed
NCCN clinical practice guidelines in oncology (NCCN guidelines) bladder cancer, version 2023 March. National Comprehensive Cancer Network website. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed June 9, 2023.Google Scholar
Lenis, AT, Lec, PM, Chamie, K. Bladder cancer: a review. JAMA 2020;324:1980–1991.CrossRefGoogle ScholarPubMed
Drug shortages, BCG live intravesical. American Society of Health-System Pharmacists website. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=519. Updated April 18, 2023. Accessed June 9, 2023.Google Scholar
Swanson, S, Sellinger, SB, Maddox-Smith, A, Harris, RG, Cookson, MS. BCG shortage info, September 2020 Member Communication and Recommendations. American Urological Association website. https://www.auanet.org/about-us/bcg-shortage-info. Published September 4, 2020. Accessed November 22, 2023.Google Scholar
Merck press release, March 13, 2019. Merck website. https://www.merck.com/news/merck-remains-committed-to-producing-tice-bcg-for-the-treatment-of-certain-forms-of-bladder-cancer/. Accessed March 13, 2023.Google Scholar
Lamm, DL. Efficacy and safety of Bacilli Calmette-Guérin immunotherapy in superficial bladder cancer. Clin Infect Dis 2000;31 suppl 3:S86–S90.CrossRefGoogle Scholar
Asín, MA P-J, Fernández-Ruiz, M, López-Medrano, F, et al. Bacillus Calmette-Guérin (BCG) infection following intravesical BCG administration as adjunctive therapy for bladder cancer: incidence, risk factors, and outcome in a single-institution series and review of the literature. Medicine (Baltimore) 2014;93:236–254.CrossRefGoogle Scholar
Kusakabe, T, Endo, K, Nakamura, I, et al. Bacille Calmette-Guérin (BCG) spondylitis with adjacent mycotic aortic aneurysm after intravesical BCG therapy: a case report and literature review. BMC Infect Dis 2018;18:290.CrossRefGoogle ScholarPubMed
Liaw, F, Tan, YY, Hendry, D. Systemic BCG-osis following intravesical BCG instillation for bladder carcinoma. Clin Case Rep 2017;5:1569–1572.CrossRefGoogle ScholarPubMed
Golub, V, Malhotra, P, Patel, S. Mycobacterial brain tuberculomas due to Bacille Calmette-Guérin intravesical chemotherapy for bladder cancer: a case report and literature review. Can J Infect Dis Med Microbiol 2011;22:104–106.CrossRefGoogle ScholarPubMed
Wadhwani, A, Moore, RD, Bakshi, D, Mirakhur, A. Mycotic aortic aneurysms postintravesical BCG treatment for early-stage bladder carcinoma. CVIR Endovasc 2018;1:28.CrossRefGoogle ScholarPubMed
Palmier, M, Monnot, A, Teniere, T, et al. Mycotic arterial aneurysm secondary to BCG intravesical instillation: a review. J Med Vasc 2022;47:94–105.Google ScholarPubMed
Gonzalez, OY, Musher, DM, Brar, I, et al. Spectrum of Bacille Calmette-Guérin (BCG) infection after intravesical BCG immunotherapy. Clin Infect Dis 2003;36:140–148.CrossRefGoogle ScholarPubMed
Atiyeh, BS, Wazzan, WC, Kaddoura, IL, Saghir, MB, Zaatari, AM, Hamdan, AM. Bacille Calmette-Guérin (BCG)-itis of the hand: a potential hazard for health workers. Ann Plast Surg 1996;36:325–329.CrossRefGoogle ScholarPubMed
Vigler, M, Mulett, H, Hausman, MR. Chronic Mycobacterium infection of first dorsal web space after accidental Bacilli Calmette-Guérin injection in a health worker: case report. J Hand Surg Am 2008;33A:1621–1624.CrossRefGoogle Scholar
Mundinger, GS, Douglas, KC, Higgins, JP. Acute mycobacterial flexor tenosynovitis following accidental Bacillus Calmette-Guérin inoculation in a healthcare worker: case report. J Hand Surg Am 2013;38:362–365.CrossRefGoogle Scholar
US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories, Sixth Edition. Washington, DC: Dept of Health and Human Services; 2020.Google Scholar
Waecker, NJ Jr, Stefanova, R, Cave, MD, Davis, CE, Dankner, WM. Nosocomial transmission of Mycobacterium bovis Bacille Calmette-Guerin to children receiving cancer therapy and to their health care providers. Clin Infect Dis 2000;30:356–362.CrossRefGoogle ScholarPubMed
CDC Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention. Menu of suggested provisions for state tuberculosis prevention and control laws. Centers for Disease Control and Prevention website. https://www.cdc.gov/tb/programs/laws/menu/caseid.htm. Reviewed September 1, 2012. Accessed June 7, 2023.Google Scholar
2020 Report of verified case of tuberculosis (RVCT) Instruction manual. Centers for Disease Control and Prevention website. https://www.cdc.gov/tb/programs/rvct/default.htm. Published August 2021. Accessed June 5, 2023.Google Scholar
Wansaula, Z, Wortham, JM, Mindra, G, et al. Bacillus Calmette-Guérin cases reported to the National Tuberculosis Surveillance System, United States, 2004–2015. Emerg Infect Dis 2019;25:451–456.CrossRefGoogle Scholar
Coppes, MJ, Oliveria, NF, Howes, M, Pusic, M, Gold, R, Richardson, SE. Mycobacterial brain abscess possibly due to Bacille Calmette-Guerin in an immunocompromised child. Clin Infect Dis 1992;14:662–665.CrossRefGoogle Scholar
Shope, TR, Garrett, AL,Waecker, NJ. Mycobacterium bovis spinal epidural abscess in a 6-year-old boy with leukemia. Pediatrics 1994;93:835–837.CrossRefGoogle Scholar
Stone, MM, Vannier, AM, Storch, SK, Nitta, AT, Zhang, Y. Brief report: meningitis due to iatrogenic BCG infection in two immunocompromised children. N Engl J Med 1995:333:561–563.CrossRefGoogle ScholarPubMed
Vos, MC, de Haas, PE, Verbrugh, HA, et al. Nosocomial Mycobacterium bovis—Bacille Calmette-Guérin infections due to contamination of chemotherapeutics: case finding and route of transmission. J Infect Dis 2003;188:1332–1335.CrossRefGoogle ScholarPubMed
Meije, Y, Martínez-Montauti, J, Caylà, JA, et al. Healthcare-associated Mycobacterium bovis—Bacille Calmette-Guérin (BCG) infection in cancer patients without prior BCG instillation. Clin Infect Dis 2017;65:1136–1143.CrossRefGoogle ScholarPubMed
Gupte, A, Matcha, A, Lauzardo, M. Mycobacterium bovis BCG spinal osteomyelitis in a patient with bladder cancer without a history of BCG instillation. BMJ Case Rep 2018;2018:bcr2018224462.CrossRefGoogle Scholar
Aqua, JK, Holdsworth, J, Burd, E, Jacob, JT, Ray, SM, Schetchter, MC. Mycobacterium bovis Bacillus Calmette-Guérin Cross-Contamination in the operating room: a case report. J Investig Med High Impact Case Rep 2021;9:23247096211066287.Google ScholarPubMed
TICE BCG. Package insert. Merck & Co., Inc.; 2021–2022.Google Scholar
NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. Centers for Disease Control and Prevention website. https://www.cdc.gov/niosh/docs/2016-161/default.html. Accessed November 17, 2023.Google Scholar
Gomella, LG. Is BCG a hazardous drug? Ask NIOSH, OSHA, and the USP. Can J Urol 2019;26:9687–9689.Google ScholarPubMed
American Urological Association and Society of Urologic Nurses and Associates (SUNA). Intravesical Administration of Therapeutic Medication for the Treatment of Bladder Cancer. American Urological Association website. https://www.auanet.org/about-us/policy-and-position-statements/intravesical-administration-of-therapeutic-medication. Published June 2020. Accessed June 13, 2023.Google Scholar
Hazardous drugs: draft NIOSH list of hazardous drugs in healthcare settings, 2020; procedures; and risk management information. Centers for Disease Control and Prevention website. https://www.cdc.gov/niosh/docket/review/docket233c/default.html. Accessed June 12, 2023.Google Scholar
Petrich, J, Marchese, D, Jenkins, C, Storey, M, Blind, J. Gene-replacement therapy: a primer for the health-system pharmacist. J Pharm Pract 2020;33:846–855.CrossRefGoogle ScholarPubMed
Penzien, C. Safe handling of biosafety drugs and live virus vaccines. Pharm Purch Prod Mag 2023;20(4):12.Google Scholar
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