The safety effects of child-resistant packaging for oral prescription drugs - Two decades of experience
The safety effects of child-resistant packaging for oral prescription drugs - Two decades of experience
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DOI：
10.1001/jama.275.21.1661
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发表时间：
1996-06-05
影响因子：
120.7
通讯作者：
Rodgers, GB
中科院分区：
文献类型：
--
作者：
Rodgers, GB
目的：评估儿童防护包装在降低5岁以下儿童因意外摄入口服处方药死亡率方面的有效性。
设计：构建1964年至1992年期间5岁以下儿童因意外摄入口服处方药的年死亡率。采用多元时间序列回归模型评估儿童防护包装在干预后时期（1974年至1992年）对儿童死亡率的影响。该分析控制了口服处方药消费量随时间的变化以及长期安全趋势。
地点：美国。
研究对象：5岁以下儿童。
主要观察指标：与使用儿童防护包装相关的儿童死亡率的估计降低值。
结果：在控制协变量后，使用儿童防护包装与5岁以下儿童每百万人口中口服处方药相关死亡率每年降低1.40例（95%置信区间，0.85 - 1.95）相关。这表明从1974年（口服处方药开始受儿童防护包装要求约束的年份）到1992年，儿童死亡人数减少了约460例——与未实施儿童防护要求所预计的水平相比，死亡率降低了约45%。
结论：儿童防护包装降低了儿童因意外摄入口服处方药的死亡率。
Objective.-To evaluate the effectiveness of child-resistant packaging in reducing the mortality rate for children younger than 5 years from the unintentional ingestion of oral prescription drugs.Design.-Annual mortality rates for children younger than 5 years associated with the unintentional ingestion of oral prescription drugs are constructed for 1964 through 1992. The effect of child-resistant packaging on the child mortality rate during the postintervention period (1974 through 1992) is evaluated with a multivariate time series regression model. The analysis controls for changes in the consumption of oral prescription drugs over time and for long-term safety trends.Setting.-United States.Subjects.-Children younger than 5 years.Main Outcome Measure.-Estimated reductions in the child mortality rate associated with the use of child-resistant packaging.Results.-After controlling for covariates, the use of child-resistant packaging was associated with an annual reduction in the oral prescription drug-related mortality rate of 1.40 (95% confidence interval, 0.85-1.95) deaths per million children younger than 5 years. This suggests a reduction of about 460 child deaths from 1974, the year oral prescription drugs became subject to child-resistant packaging requirements, through 1992-a mortality rate reduction of about 45% from levels projected without the child-resistant requirements.Conclusion.-Child-resistant packaging reduces child mortality from the unintentional ingestion of oral prescription drugs.