Victoria C Ziesenitz1,2, Maryann Mazer-Amirshahi3,4, Mark S Zocchi5, Erin R Fox6,7, Larissa S May8. 1. Department of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel, Switzerland ziesenitz.md@gmail.com. 2. Department of Pediatric Cardiology, University Children's Hospital, Heidelberg, Germany ziesenitz.md@gmail.com. 3. Department of Emergency Medicine, MedStar Washington Hospital Center, Washington, DC. 4. Georgetown University School of Medicine, Washington, DC. 5. Center for Healthcare Innovation and Policy Research, George Washington University, Washington, DC. 6. Drug Information Service, University of Utah Health Care, Salt Lake City, UT. 7. College of Pharmacy, University of Utah, Salt Lake City, UT. 8. Department of Emergency Medicine, University of California Davis, Sacramento, CA.
Abstract
PURPOSE: Trends in shortages of vaccines and immune globulin products from 2001 through 2015 in the United States are described. METHODS: Drug shortage data from January 2001 through December 2015 were obtained from the University of Utah Drug Information Service. Shortage data for vaccines and immune globulins were analyzed, focusing on the type of product, reason for shortage, shortage duration, shortages requiring vaccine deferral, and whether the drug was a single-source product. Inclusion of the product into the pediatric vaccination schedule was also noted. RESULTS: Of the 2,080 reported drug shortages, 59 (2.8%) were for vaccines and immune globulin products. Of those, 2 shortages (3%) remained active at the end of the study period. The median shortage duration was 16.8 months. The most common products on shortage were viral vaccines (58%), especially hepatitis A, hepatitis B, rabies, and varicella vaccines (4 shortages each). A vaccine deferral was required for 21 shortages (36%), and single-source products were on shortage 30 times (51%). The most common reason for shortage was manufacturing problems (51%), followed by supply-and-demand issues (7%). Thirty shortages (51%) were for products on the pediatric schedule, with a median duration of 21.7 months. CONCLUSION: Drug shortages of vaccines and immune globulin products accounted for only 2.8% of reported drug shortages within a 15-year period, but about half of these shortages involved products on the pediatric vaccination schedule, which may have significant public health implications.
PURPOSE: Trends in shortages of vaccines and immune globulin products from 2001 through 2015 in the United States are described. METHODS: Drug shortage data from January 2001 through December 2015 were obtained from the University of Utah Drug Information Service. Shortage data for vaccines and immune globulins were analyzed, focusing on the type of product, reason for shortage, shortage duration, shortages requiring vaccine deferral, and whether the drug was a single-source product. Inclusion of the product into the pediatric vaccination schedule was also noted. RESULTS: Of the 2,080 reported drug shortages, 59 (2.8%) were for vaccines and immune globulin products. Of those, 2 shortages (3%) remained active at the end of the study period. The median shortage duration was 16.8 months. The most common products on shortage were viral vaccines (58%), especially hepatitis A, hepatitis B, rabies, and varicella vaccines (4 shortages each). A vaccine deferral was required for 21 shortages (36%), and single-source products were on shortage 30 times (51%). The most common reason for shortage was manufacturing problems (51%), followed by supply-and-demand issues (7%). Thirty shortages (51%) were for products on the pediatric schedule, with a median duration of 21.7 months. CONCLUSION: Drug shortages of vaccines and immune globulin products accounted for only 2.8% of reported drug shortages within a 15-year period, but about half of these shortages involved products on the pediatric vaccination schedule, which may have significant public health implications.
Authors: Monir Ejemel; Todd G Smith; Lauren Greenberg; William C Carson; David Lowe; Yong Yang; Felix R Jackson; Clint N Morgan; Brock E Martin; Chantal Kling; Christina L Hutson; Nadia Gallardo-Romero; James A Ellison; Susan Moore; Adam Buzby; John Sullivan-Bolyai; Mark Klempner; Yang Wang Journal: Sci Rep Date: 2022-06-07 Impact factor: 4.996
Authors: Mark A Matson; Eran Schenker; Michal Stein; Vladislava Zamfirova; Huy-Binh Nguyen; Garrett E Bergman Journal: Hum Vaccin Immunother Date: 2019-09-24 Impact factor: 3.452