Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Pharmacoepidemiol Drug Saf. 2019 Apr;28(4):536-543. doi: 10.1002/pds.4760. Epub 2019 Mar 7.
In late 2012, South Korea revised the Pharmaceutical Affairs Act to make selected medications including acetaminophen, ibuprofen, and cold medications available in nonpharmacy outlets, including the 24-hour convenient stores (CVS). The objective of this study was to identify whether the characteristics and trend of self-poisonings associated with these medications were altered after the legislative change.
A retrospective study was performed using national data from the Emergency Department (ED)-based Injury In-depth Surveillance database. The patients diagnosed with poisoning were sorted from 2011 to 2016 and included in the study. As the Act was implemented from 2013, the demographic characteristics and clinical outcomes were compared before and after January 2013. A piecewise regression analysis was performed to determine the association between the monthly use of acetaminophen, medication for cold, and nonsteroidal anti-inflammatory drugs (NSAIDs) and the incidence of total poisonings before and after the January 2013.
Among 1 536 277 patients included in the database, 17 523 patients diagnosed with poisoning were enrolled. After the legislative change, the etiology of poisoning did not change, although the frequency of hospitalization from ED was significantly increased. The monthly trend for poisoning due to acetaminophen, cold medications, and NSAIDs showed no significant slope change between before and after the legislative change. The proportional use of acetaminophen and cold medications was significantly decreased, while that of NSAIDs was unchanged before and after the legislative change.
The change in the Pharmaceutical Affairs Act was not associated with any change in the monthly frequency of medication-related poisoning.
2012 年末，韩国修订了《药品管理法》，将包括对乙酰氨基酚、布洛芬和感冒药在内的部分药物可在非药店网点（包括 24 小时便利店）购买。本研究旨在确定立法变更后与这些药物相关的自我中毒的特征和趋势是否发生变化。
本研究采用基于急诊（ED）的伤害深入监测数据库的全国性数据进行回顾性研究。将 2011 年至 2016 年期间被诊断为中毒的患者进行分类，并纳入研究。由于该法案于 2013 年实施，因此比较了 2013 年 1 月之前和之后的人口统计学特征和临床结果。进行分段回归分析以确定每月使用对乙酰氨基酚、感冒药和非甾体抗炎药（NSAIDs）与 2013 年 1 月之前和之后总中毒发生率之间的关联。
在数据库纳入的 1 536 277 名患者中，有 17 523 名患者被诊断为中毒。立法变更后，中毒的病因没有改变，尽管从 ED 住院的频率明显增加。由于对乙酰氨基酚、感冒药和 NSAIDs 引起的中毒的每月趋势在立法变更前后没有明显的斜率变化。对乙酰氨基酚和感冒药的使用比例在立法变更前后显著下降，而 NSAIDs 的使用比例在立法变更前后保持不变。
《药品管理法》的变更与与药物相关的中毒的每月发生频率的变化无关。
