无菌调配：患者安全的临床、法律和监管影响。

Sterile compounding: clinical, legal, and regulatory implications for patient safety.

机构信息

Blue Cross Blue Shield of Michigan, 600 E. Lafayette Blvd., Mail Code 512C, Detroit, MI 48226-2998.

出版信息

J Manag Care Spec Pharm. 2014 Dec;20(12):1183-91. doi: 10.18553/jmcp.2014.20.12.1183.

DOI:10.18553/jmcp.2014.20.12.1183

PMID:25443512

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10441022/

Abstract

BACKGROUND

Poor compounding practices by the New England Compounding Center resulted in the 2012-2013 fungal infections outbreak. Contaminated injectable methylprednisolone led to the diagnosis of fungal infections in 751 patients and 64 deaths. In the United States, pharmacy compounding has traditionally been regulated by state boards of pharmacy rather than the FDA. To minimize safety risks related to pharmacy compounding, the Drug Quality and Security Act (DQSA) was signed into law November 27, 2013, to improve regulation of compounding pharmacies.

OBJECTIVES

To (a) review the literature regarding clinical, legal, and regulatory implications of pharmacy compounding for patient safety during the 2012-2013 fungal infections outbreak and (b) discuss strategies that managed care organizations (MCOs) can use to promote safe compounding practices.

METHODS

A literature search was conducted via PubMed for original articles on fungal infections related to drug compounding published October 2012 to March 2014. Specific search terms included "drug compounding and fungal infection" and "fungal meningitis outbreak." The FDA website was also utilized for material related to the Food, Drug, and Cosmetic Act and the DQSA.

RESULTS

Four articles met inclusion criteria. The 2012-2013 fungal infections outbreak was attributed to 3 lots of preservative-free methylprednisolone acetate, which comprised 17,675 vials distributed to 76 facilities across 23 states. Median incubation period (from time of last injection to initial diagnosis) was 47 days, ranging from 0 to 249 days. According to the FDA, a total of 30 recalls regarding compounded products were issued by pharmacies during March through December 2013.

CONCLUSIONS

Pharmacy compounding has the potential for significant safety risks. The purpose of the DQSA is to improve regulation of compounding pharmacies. Since registration as an outsourcing facility is voluntary, uncertainty still remains regarding advancement in safe compounding practices. MCOs can employ multiple strategies to ensure patient safety and promote appropriate drug therapy.

摘要

背景

新英格兰制药中心（New England Compounding Center）的药物配制操作不当，导致了 2012-2013 年真菌感染爆发。受污染的可注射甲基强的松龙导致 751 名患者和 64 人死亡。在美国，药品配制传统上由州药房委员会而不是 FDA 监管。为了最大限度地降低与药品配制相关的安全风险，2013 年 11 月 27 日签署了《药品质量和安全法案》（Drug Quality and Security Act，DQSA），以改善对配制药房的监管。

目的

（a）回顾 2012-2013 年真菌感染爆发期间与患者安全相关的药房配制的临床、法律和监管影响的文献；（b）讨论管理式医疗组织（Managed Care Organization，MCO）可以用来促进安全配制实践的策略。

方法

通过 PubMed 对 2012 年 10 月至 2014 年 3 月期间发表的关于与药物配制相关的真菌感染的原始文章进行了文献检索。具体的搜索词包括“药物配制和真菌感染”和“真菌性脑膜炎爆发”。还利用 FDA 网站获取了《食品、药品和化妆品法案》和《药品质量和安全法案》的相关材料。

结果

符合纳入标准的文章有 4 篇。2012-2013 年真菌感染爆发归因于 3 批不含防腐剂的醋酸甲基强的松龙，共有 17675 瓶，分发至 23 个州的 76 个设施。中位数潜伏期（从最后一次注射到最初诊断的时间）为 47 天，范围为 0 至 249 天。据 FDA 称，2013 年 3 月至 12 月期间，共有 30 家药房因配制产品召回而发布召回通知。