PROTECT Initiative: Using a Healthy People 2030 Objective to Advance Children’s Medication Safety

Reducing emergency department (ED) visits for medication overdoses among children under 5 years of age is a national public health priority. The Healthy People 2030 objective MPS-01 tracks this important issue. The baseline for this Healthy People 2030 objective is 25.6 estimated ED visits per 10,000 children under 5 years of age, which was observed during 2016-2017, and the target rate to be achieved by the end of the decade is 16.6 ED visits per 10,000 children under 5 years of age — an additional 35 percent reduction.

Medication overdoses are a significant public health problem and often lead to emergency treatment and sometimes hospitalization. Young children are especially vulnerable to unintentional overdoses, but overdoses can be prevented.

The PRevention of Overdoses and Treatment Errors in Children Taskforce (PROTECT) Initiative is a Centers for Disease Control and Prevention (CDC)-led public-private partnership that uses a collaborative, data-driven approach to reduce harm from unintentional medication overdoses in children. PROTECT brings together public health agencies, private sector companies, healthcare professional organizations, consumer/patient advocates, and academic experts to develop strategies to keep children safe. 

“The Healthy People 2030 objective to reduce pediatric medication overdoses has helped the PROTECT Initiative drive national prevention efforts — and, with those efforts, we look forward to achieving the target well before the end of the decade,” says Dr. Michael Bell, deputy director of CDC’s Division of Healthcare Quality Promotion.

Translating National Data Into Action to Keep Children Safe

PROTECT Initiative activities are guided by national data on ED visits for unintentional medication overdoses among young children. Data from the National Electronic Injury Surveillance System — Cooperative Adverse Drug Event Surveillance (NEISS-CADES) project estimate that each year in the United States:

• Approximately 35,000 ED visits result from unintentional medication overdoses among children under the age of 5 years
• 1 out of every 250 2-year-olds is treated in an ED for an unintentional medication overdose
• Over 90 percent of ED visits for unintentional medication overdoses among children under 5 years of age involve children who get into medicine on their own without caregiver oversight
• Approximately 5 percent of ED visits for unintentional medication overdoses among children under 5 years of age are due to medication errors

Recent NEISS-CADES data show considerable improvement in unintentional medication overdoses  compared to the 2016-2017 baseline. The 2020–2021 NEISS-CADES estimate is 18.0 ED visits for unintentional medication overdoses per 10,000 children under age 5, which is very close to the Healthy People 2030 target.

PROTECT’s 3-Pronged Approach

During the early 2000s, ED visits and hospitalizations for unsupervised medication exposures among young children increased by approximately 30 percent to a peak of 76,000 visits in 2010. In response, efforts to reduce pediatric medication overdoses were initiated, including CDC’s PROTECT Initiative. Since 2008, the PROTECT partnership has used a 3-pronged approach to keep children safe from unintentional medication overdoses:

1. Packaging Improvements to prevent or minimize exposure to medications when young children find and try to ingest medications on their own (unsupervised exposures)
2. Error Prevention through standardization of medication labels and dosing devices (such as dosing cups and oral syringes)
3. Education on Safe Medication Use and Storage through the Up and Away and Out of Sight campaign to remind parents, grandparents, and other caregivers about the importance of safe medication storage, how to store medications safely around young children, and what to do in case of emergency

PROTECT’s collaborative approach has led to specific improvements in each of the 3 activity areas. PROTECT activities have demonstrated that enhanced safety packaging can prevent unsupervised medication ingestions, or at least limit the amount of medication that young children can access on their own. PROTECT participants have developed and refined the concept of pediatric exposure-limiting packaging, assessed the efficacy of specific innovative packaging designs in limiting access by young children, and encouraged the adoption of innovative safety packaging. In the 2010s, voluntary addition of flow restrictors (adapters designed to limit the flow of liquid out of the bottle) on over-the-counter pediatric liquid products containing acetaminophen, including cough and cold medications (CCM); voluntary withdrawal of infant CCM products; and labeling warning against CCM use in children under 4 years of age coincided with reductions in ED visits and poison center calls for unintentional overdoses by young children.

Clearly and consistently showing volumetric measures (e.g. mL) on liquid medication packaging, labels, and dosing devices could minimize errors when measuring and giving doses. PROTECT partners have led several activities to encourage the use of mL when prescribing, dispensing, and communicating with patients and caregivers about oral liquid medications. They have also led activities to improve labeling on medication bottles and dosing devices and have participated in related activities led by partner organizations. In addition, CDC, the Consumer Healthcare Products Association Educational Foundation, and a broad range of PROTECT partners collaborated to develop the Up and Away and Out of Sight campaign, which is centered around several simple, data-driven actions that parents, grandparents, and other caregivers can take to prevent medication overdoses in children by using safe medication storage practices.  

PROTECT Initiative efforts to reduce unintentional medication overdoses by young children are informed by the data and adjusted as needed to respond to new or emerging trends. 

“To build on our initial success,” adds Dr. Bell, “we will need to maintain our multifaceted approach and collaborations with diverse public and private sector partners to sustain gains and drive additional progress in protecting children from overdose harms in the coming decade.