Bacille Calmette-Guérin Supply Disruption Emphasizes the Importance of Stewardship

Alejandro Abello; Patrick A. Kenney

doi:10.1055/s-0039-1692693

Revista Urología Colombiana / Colombian Urology Journal, Inhaltsverzeichnis

CC BY-NC-ND 4.0 · Revista Urología Colombiana / Colombian Urology Journal 2019; 28(03): 191-192
DOI: 10.1055/s-0039-1692693

Editorial

Sociedad Colombiana de Urología. Publicado por Thieme Revinter Publicações Ltda Rio de Janeiro, Brazil

Bacille Calmette-Guérin Supply Disruption Emphasizes the Importance of Stewardship

Alejandro Abello

¹Department of Urology, Yale School of Medicine/Yale-New Haven Hospital, New Haven, CT, United States

,

Patrick A. Kenney

¹Department of Urology, Yale School of Medicine/Yale-New Haven Hospital, New Haven, CT, United States

References
1 Morales A, Eidinger D, Bruce AW. Intracavitary Bacillus Calmette-Guerin in the treatment of superficial bladder tumors. J Urol 1976; 116 (02) 180-183
2 Sylvester RJ, van der MEIJDEN AP, Lamm DL. Intravesical bacillus Calmette-Guerin reduces the risk of progression in patients with superficial bladder cancer: a meta-analysis of the published results of randomized clinical trials. J Urol 2002; 168 (05) 1964-1970
3 Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin 2019; 69 (01) 7-34
4 Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018; 68 (06) 394-424
5 Khanna A, Yerram N, Zhu H, Kim S, Abouassaly R. Utilization of Bacillus Calmette-Guerin for Nonmuscle Invasive Bladder Cancer in an Era of Bacillus Calmette-Guerin Supply Shortages. Urology 2019; 124: 120-126
6 Messing EM. The BCG Shortage. Bladder Cancer 2017; 3 (03) 227-228
7 Mostafid AH, Palou Redorta J, Sylvester R, Witjes JA. Therapeutic options in high-risk non-muscle-invasive bladder cancer during the current worldwide shortage of bacille Calmette-Guérin. Eur Urol 2015; 67 (03) 359-360
8 NOTIFICATION OF SUPPLY ALLOCATION: TICE® BCG BCG LIVE (for intravesical use) [press release]. January, 2019 2019
9 National Comprehensive Cancer Network. NCCN Clincial Practice Guidelines in Oncology. Bladder Cancer 2018
10 Messing EM, Tangen CM, Lerner SP. , et al. Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on Tumor Recurrence: SWOG S0337 Randomized Clinical Trial. JAMA 2018; 319 (18) 1880-1888
11 Han RF, Pan JG. Can intravesical bacillus Calmette-Guérin reduce recurrence in patients with superficial bladder cancer? A meta-analysis of randomized trials. Urology 2006; 67 (06) 1216-1223
12 Oddens J, Brausi M, Sylvester R. , et al. Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guérin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance. Eur Urol 2013; 63 (03) 462-472
13 Lightfoot AJ, Breyer BN, Rosevear HM, Erickson BA, Konety BR, O'Donnell MA. Multi-institutional analysis of sequential intravesical gemcitabine and mitomycin C chemotherapy for non-muscle invasive bladder cancer. Urol Oncol 2014; 32 (01) 35 e15-39
14 Important Message About the BCG Shortage [press release]. auanet.org, February 19, 2019
15 Svatek RS, Tangen C, Delacroix S, Lowrance W, Lerner SP. Background and Update for S1602 "A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-naïve High-grade Non-muscle-invasive Bladder Cancer. Eur Urol Focus 2018; 4 (04) 522-524
16 Food and Drug Administration. Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions; Public Meeting; Request for Comments 83 FR 45640. (2018–19612):45640–45642
17 Food and Drug Administration. Latest News on Sterigenics and Other Sterilization Facility Closures. 2019
18 Tang CS. Robust strategies for mitigating supply chain disruptions. International Journal of Logistics Research and Applications. 2006; 9 (01) 33-45