带有黑框警告的美国食品药品监督管理局（FDA）批准的处方药的患病率及治疗分类

Prevalence and Therapeutic Classifications of FDA-Approved Prescription Drugs With Boxed Warnings.

作者信息

Cheng Christine M, DeLizza Colleen, Kapusnik-Uner Joan

机构信息

1 Disease Decision Support Group, First Databank Inc, South San Francisco, CA, USA.

2 School of Pharmacy, University of California, San Francisco, San Francisco, CA, USA.

出版信息

Ther Innov Regul Sci. 2014 Mar;48(2):165-172. doi: 10.1177/2168479013496091.

DOI:10.1177/2168479013496091

PMID:30227516

Abstract

PURPOSE

To characterize and determine the prevalence of drugs with boxed warnings (BXWs) based on a review of structured product labels (SPLs) available on the National Library of Medicine (NLM) DailyMed website.

METHODS

A cross-sectional review was conducted of SPLs with BXWs for human prescription drugs on the NLM DailyMed website in July 2012. The presence of a BXW in the DailyMed version of the SPL was validated by cross-referencing a corresponding label on the FDA website. The SPLs were organized into drug groups, and descriptive statistics were used to determine the proportion of SPLs and drug groups associated with a validated BXW. The top therapeutic classes of drugs with BXWs were determined as well as the percentage of the top 100 BXW-associated drugs used in US hospitals and retail settings in 2012.

RESULTS

Findings revealed that 35% (n = 4940/14,264) of drug labels on DailyMed and 35% (n = 650/1848) of the drug groups created were associated with a validated BXW. Central nervous system agents, antineoplastic agents, and cardiovascular drugs were the most common therapeutic classes. In 2012, 39% of the top 100 drugs were associated with a BXW.

摘要

目的

基于对美国国立医学图书馆（NLM）每日医学网站上结构化产品标签（SPL）的审查，对带有盒装警示（BXW）的药物进行特征描述并确定其流行率。

方法

2012年7月对NLM每日医学网站上带有BXW的人类处方药的SPL进行了横断面审查。通过参考FDA网站上的相应标签，验证了每日医学版SPL中BXW的存在。将SPL按药物类别进行组织，并使用描述性统计方法确定与经过验证的BXW相关的SPL和药物类别的比例。确定了带有BXW的药物的主要治疗类别以及2012年在美国医院和零售环境中使用的前100种与BXW相关的药物的百分比。