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Unit-dose packaging of iron supplements and reduction of iron poisoning in young children
1Department of Pediatrics, University of Manitoba Children's Hospital, Winnipeg. mtenenbein@hsc.mb.ca
Insights
Unit-dose packaging for iron supplements significantly reduced iron poisoning calls and deaths in young children. This regulation effectively prevents accidental iron ingestion and fatalities in children under six.
Area of Science:
- Pediatric Toxicology
- Public Health Policy
- Drug Safety Packaging
Background:
- Iron poisoning is a leading cause of fatal unintentional poisonings in young children.
- A US Food and Drug Administration (FDA) regulation mandated unit-dose packaging for iron supplements in 1997.
Purpose of the Study:
- To evaluate the impact of the unit-dose packaging regulation on iron ingestion incidents.
- To assess the effect of this regulation on iron poisoning-related deaths in children under six years old.
Main Methods:
- A pre-intervention and post-intervention study design was employed.
- Data on iron ingestion and poisoning deaths in children under six were collected for 10 years pre-regulation and 5 years post-regulation.
- Information was sourced from the American Association of Poison Control Centers annual reports.
Main Results:
- Calls regarding iron ingestion in children under six decreased from 2.99 to 1.91 per 1000 calls (OR, 1.29; P<.001).
- Deaths due to iron poisoning in this age group dropped significantly from 29 to 1 (OR, 13.56; P = .03).
Conclusions:
- The unit-dose packaging regulation for iron supplements demonstrably decreased non-intentional ingestion and mortality in young children.
- This intervention is validated as an effective strategy for preventing iron poisoning and related deaths.
- Unit-dose packaging should be considered for other high-risk medications to prevent overdose morbidity and mortality.
Background:
Iron poisoning is a major cause of unintentional poisoning death in young children. The US Food and Drug Administration proclaimed a regulation for unit-dose packaging of iron supplements in 1997.
Objective:
To determine whether the requirement for unit-dose packaging of iron supplements decreases the incidence of iron ingestion and the incidence of deaths due to iron poisoning in children younger than 6 years.
Methods:
This is a preintervention-postintervention study of the US federally mandated requirement for unit-dose packaging of iron supplements. The 10 years prior to the intervention were compared with the 5 years after its promulgation. The incidences of iron ingestion and of iron poisoning deaths for children younger than 6 years were obtained from the annual reports of the American Association of Poison Control Centers (Washington, DC).
Results:
The average number of iron ingestion calls per 1000 of all calls to poison control centers regarding children younger than 6 years decreased from 2.99 per 1000 to 1.91 per 1000 (odds ratio, 1.29 [95% confidence interval, 1.27-1.32]; P<.001). The number of deaths decreased from 29 to 1 (odds ratio, 13.56 [95% confidence interval, 1.85-99.52]; P = .03).
Conclusions:
These are the first data that show a decrease in the incidence of nonintentional ingestion of a specific drug by young children and a decrease in mortality from poisoning by this drug after the introduction of unit-dose packaging. There was a decrease in the incidence of iron ingestion and a dramatic decrease in the number of deaths due to iron poisoning. This validates unit-dose packaging as an effective strategy for the prevention of iron poisoning and iron poisoning deaths in young children. This highly effective intervention should be considered for other medications with a high hazard for morbidity and mortality when taken as an overdose.
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