2001 - 2015年美国疫苗和免疫球蛋白产品短缺情况

U.S. vaccine and immune globulin product shortages, 2001-15.

作者信息

Ziesenitz Victoria C, Mazer-Amirshahi Maryann, Zocchi Mark S, Fox Erin R, May Larissa S

机构信息

Department of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel, Switzerland

Department of Pediatric Cardiology, University Children's Hospital, Heidelberg, Germany

出版信息

Am J Health Syst Pharm. 2017 Nov 15;74(22):1879-1886. doi: 10.2146/ajhp170066. Epub 2017 Oct 2.

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.

摘要

目的

描述2001年至2015年美国疫苗和免疫球蛋白产品短缺的趋势。

方法

从犹他大学药物信息服务中心获取2001年1月至2015年12月的药品短缺数据。对疫苗和免疫球蛋白的短缺数据进行分析,重点关注产品类型、短缺原因、短缺持续时间、需要推迟接种疫苗的短缺情况以及该药物是否为单源产品。还记录了该产品是否被纳入儿童疫苗接种计划。

结果

在报告的2080起药品短缺事件中,59起(2.8%)是关于疫苗和免疫球蛋白产品的。其中,2起短缺事件(3%)在研究期结束时仍处于短缺状态。短缺持续时间的中位数为16.8个月。短缺最常见的产品是病毒疫苗(58%),尤其是甲型肝炎、乙型肝炎、狂犬病和水痘疫苗(各有4起短缺事件)。21起短缺事件(36%)需要推迟接种疫苗,单源产品短缺30次(51%)。短缺最常见的原因是生产问题(51%),其次是供需问题(7%)。30起短缺事件(51%)涉及儿童疫苗接种计划中的产品,中位数持续时间为21.7个月。

结论

疫苗和免疫球蛋白产品的药品短缺在15年期间仅占报告的药品短缺的2.8%,但其中约一半的短缺涉及儿童疫苗接种计划中的产品,这可能对公共卫生有重大影响。

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