The safety effects of child-resistant packaging for oral prescription drugs. Two decades of experience.

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.