The Safety Effects of Child-Resistant Packaging for Oral Prescription Drugs

Abstract

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. (JAMA. 1996;275:1661-1665)