Preventing Medication Overdoses in Pediatric Patients Under the Age of 5

School of Nursing, Louisiana State University Health New Orleans

NURS4379: Nursing Leadership in the Health Care System

July 15, 2022

As the use of over the counter and prescription medications increases, the potential for improper usage also increases. Medication dosing for children is age or weight-based, leaving them more vulnerable to overdoses (Center for Disease Control [CDC], 2020). Overdoses are the leading cause of medication-related problems in children under five years of age causing tens of thousands of Emergency Department (ED) visits annually in the US (Office of Disease Prevention and Health Promotion, 2021). The National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance System (NEISS-CADES) is a system created by the Consumer Product Safety Commission to collect data on consumer product-related injuries throughout US Emergency Departments (ED). 100 hospitals are used as a sample set to represent the approximately 5,000 EDs in the US.

Annually, an estimated one out of every 150 two-year-old children is treated in a US ED for unintentional overdose (United States Consumer Product Safety Commission [CPSC], n.d.). For children under 5, over 90% of overdoses are unsupervised ingestions and 5% medication errors from caregivers (CDC, 2020). From 2018-2019, approximately 21.3 ED visits for medication overdoses per 10,000 children under 5 were reported (Office of Disease Prevention and Health Promotion, 2021). This prompted Healthy People to set a target goal to reduce the incidence to 16.6 per 10,000 children by 2030.

Healthy People was created in 1979 as an initiative of the Office of Disease Prevention and Health Promotion which is a branch of the US Department of Health and Human Services. The goal of the initiative is to promote, evaluate, and strengthen efforts to improve the health and well-being of all people in the country over the next decade. To achieve this goal, measurable, data-driven objectives are set to focus on topics presenting as healthcare priorities. In 2020, over 355 new objectives were launched to address current health-related challenges. This paper will focus on the Healthy People 2030 identified objective to “reduce emergency department visits for medication overdoses in children under five years” (Office of Disease Prevention and Health Promotion, 2021). NEISS-CADES (n.d.) recognized contributing causes of overdoses in this population as dosing instructions using teaspoons instead of milliliters, lack of safety devices on containers, and lack of education on safe medication storage and usage. Methods to reduce medication overdoses in young children will be proposed and their efficacy evaluated.

Review of Literature

Medication overdoses in children are a persistent problem in healthcare. For the purpose of this paper, only unintentional factors leading to overdose in young children will be included. Literature reviewed focused specifically on causes prompting ED visits and associated interventions to prevent future episodes. The two main causes of unintentional overdoses in children were noted to be accidental exposure through child self-ingestion and unintentional dosing errors by caretakers.

Self-Ingestions by Children

Child-Resistant Packaging

According to the CDC (2020), over 90% of cases of unintentional overdoses in children under 6 are from self-exposures. The Poison Prevention Packaging Act of 1970 (PPPA) mandated child-resistant caps on nearly all over-the-counter medications. Although child-resistant packaging has significantly decreased self-ingestions in children, the issue persists (Budnitz et al., 2020). One factor contributing to ingestions was the removal of medication from the original child-resistant packaging, thus bypassing the safety feature (Budnitz et al., 2020; Tadros et al., 2016). Families may have members with limited abilities to open child-resistant packaging prompting the removal. Some use medication reminder boxes when on a complicated regimen for ease of daily use. Others do not close bottles promptly after taking medication. All provide opportunities for exposure to young children.

Flow Restricting Valves

Flow restricting valves are devices that may be added to bottles in addition to the child-resistant cap. These limit the passive flow of medication when the bottle is squeezed, shaken, or turned upside down. Paul et al. (2019) performed an observational study on acetaminophen overdoses in children under six. Flow restrictors were added to pediatric acetaminophen bottles in 2011 but not ibuprofen. The study reviewed overdoses from one year prior to the implementation to five years after. Results showed a statistically significant reduction in the number and severity of acetaminophen overdoses. Budnitz et al. (2020) reported after the 2011 acetaminophen flow restricting cap implementation, “both the number of calls to poison centers for unintentional acetaminophen exposures and the amount of acetaminophen ingested declined from 2012 to 2015”. Lovegrove et al. (2019) stated the calls to poison control centers involving bottles with flow restricting valves were “significantly less likely to involve meaningful doses”. Additionally, in a randomized trial, “only 6% of preschool children were able to empty bottles and no children under three-and-a-half years removed 5 mls.”

Unit-Dose Packaging

Lovegrove et al. (2015) acknowledged the efficacy of flow restricting valves. However, the valves are only placed on pediatric liquid medications. Due to the bulk of pediatric overdoses attributed to child self-ingestions, adult medications must also be considered. Single-dose packaging allows the child-resistant packaging to remain in place until each dose is needed. A recent study revealed significantly higher calls to poison control centers for buprenorphine/naloxone tablet ingestions from multidose bottles compared with unit-dose packaging. In 2010, the FDA approved the buprenorphine film which is only unit-dosed child-resistant packaging. Buprenorphine exposures in children under six declined 35.7% from 2011 to 2013 despite a doubling in sales volumes lending further credit to the efficacy of unit-dose packaging (Post et al., 2018).

Dosing Errors by Caregivers

According to Wang et al. (2020), over 93% of dosing errors by caregivers are due to the wrong volume administered. A major root cause for dosing errors was identified as confusion on dosing instructions leading to inappropriate volume or frequency of doses, specifically when no clear written instructions are available on the medication, such as in children under two or off-label uses that require instructions by a healthcare worker (Brass et al., 2018; Crawford et al., 2017). Another identified contributing factor was inappropriate or no measuring device utilized (Brass et al., 2018; Budnitz et al., 2020; Wang et al., 2020). Differences in same product concentrations was identified as contributing to dosing errors by caretakers (Brass et al., 2018; Wang et al., 2020). Errors from these areas led to the issuing of recommendations by the American Academy of Pediatrics, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Council for Prescription Drug Programs, to standardize concentrations, standardize milliliters as the unit of measure for dosing, and include a measuring device with medications in 2011 (Wang et al., 2020).

Education

All prevention measures reviewed can be improved through caregiver education (Tadros et al., 2016). Proper use of child-resistant packaging and purchasing bottles containing or requesting flow-restricting valves from pharmacists for liquid medications, or solid medications sold in unit-dosed packaging add an additional safety feature. Child-safety devices are only mandated on most over-the-counter medications, but many ingestions are unintentional and may involve adult or prescription medications (Tadros et al., 2016). To complement safety features, proper securement and storage of medications, such as highlighted in the CDC’s Up and Away campaign, decrease children’s access to medications (CDC, 2020, Up and Away Campaign section). Proper written instructions for caregivers by healthcare workers on utilization of appropriate measuring devices and dosing volumes is essential, especially when deviating from instructions on the packaging or when no clear instructions are available. Additionally, households with members who use/abuse drugs place children at an additional risk of access to improperly stored/dropped medication, improper dosing, and access to opioid medications that can have life-threatening effects (Tadros et al., 2016). Education for these family members should remain a priority.

Change Theory

Kurt Lewin’s Field Theory uses the model of unfreezing, moving, and refreezing to examine a situation and bring about change. This theory uses the principle of driving forces and restraining forces. Driving forces are those factors which facilitate change and restraining forces are those which “maintain the status quo” or inhibit a change from occurring (Kearney-Nunnery, 2020). The first step within this theory is unfreezing. During unfreezing, a problem and its driving and restraining forces are identified, which will create disequilibrium (Kearney-Nunnery, 2020). Next, the moving phase occurs, and a plan is created to produce the change. The last step is refreezing in which a new equilibrium has been achieved through the completion of the plan created in the previous step. Refreezing focuses “on maintaining the goal achieved and highlighting the present benefits over past practices” (Kearney-Nunnery, 2020). Lewin’s Field Theory will be used as a guide to produce the change of decreasing pediatric medication overdoses in children under five years of age. This theory was chosen for its simplistic and straight-forward approach to producing change.

The first step is unfreezing. The problem that has been identified as needing a change is an increase in emergency department visits for pediatric overdoses. To begin the process of change, the restraining and driving forces will be identified. Restraining forces for this problem are improper medication packaging, medication dosing errors, and unsafe storage of medications. Additional restraining forces include insufficient knowledge of caregivers on proper medication practices and insufficient education of safe practices provided to healthcare workers. The driving forces identified are the desire to decrease pediatric overdoses and educational tools that will be used to spread knowledge and awareness.

Next is the moving phase. During this step change will be implemented in the form of providing education. Current institutional protocols will be examined, and a system-wide training protocol will be created. The protocol will provide education to nurses on proper techniques to educate caregivers of safe medication practices and proper documentation of caregiver education.

The final phase of refreezing will occur when the goal of decreasing overdoses is achieved, and a new equilibrium is formed. Once the goal is achieved, the implemented provider and caregiver education plan will become the new status quo. Education should continue to maintain the new equilibrium.

Proposed Plan

Utilization of Proper Dosing Measurements and Tools

Pediatric dosages are either based on age or weight. Over-the-counter pediatric medications include the proper dosing device and should be used when possible. Special dosing situations, such as weights outside of labeled dosing parameters, off-label uses of adult medications for pediatrics, dose modifications for renal/hepatic insufficiencies, or for children under two where instructions read “Ask a doctor” should be clearly addressed by the care providers. In Louisiana Children’s Medical Center’s (LCMC) outpatient clinic, there is currently no specific medication dosing education given regarding dosing volume or devices.

Over-the-Counter Preparations

For children under five, during each well-visit to the clinic, nurses will review the proper over-the-counter dosing information on the most used medications based on the individual needs of each child. Acetaminophen dosing will always be reviewed unless contraindicated. Ibuprofen and diphenhydramine instructions will be given when age appropriate, six months and two years respectively. Cough and cold medications should not be administered to children under four, and nurses will review symptom treatment plans instead. If the included dosing device is appropriate, a review on its usage will be included as part of the standard education. Proper medication dosing should be given in writing at the end of each well-visit on a card including the patient’s current age and weight. Medication instruction handouts, with label pictures to complement verbal education, will be distributed. If proper dosing requires a device not included with the purchased medication, the necessary device should be given and reviewed. In fact, according to Brass et al (2018), approximately 69% of 106,884 accidental overdose exposures were related to caregivers incorrectly dosing due to healthcare professionals being the primary source of dosing information. Therefore, both manufacturers and facilities should provide updated instructions and protocols on how to guide caregivers when children fall outside the typical range of less than six months of age or under two years of age period rather than relying on individual provider experience and preferences for pediatric dosing.

Prescription Medications

Prescription medications such as antibiotics and steroids, may be required for specific illnesses seen upon well-visits. Children under five being seen in specialty clinics for illnesses requiring specific medications, such as seizure or antihypertensive medications, will have thorough medication administration instruction as part of the initial visit when the medication is prescribed. Proper dosing in milliliters as well as oral syringe dosing demonstration, as appropriate, will be reviewed. Follow-up education will be ongoing during the patient’s treatment course including new instructions, handouts, and oral syringes given with dosing adjustments as necessary.

Medication Storage

Children should never have access to medications. Any medication, from vitamins to opioids, should be stored out of reach and out of sight of children (CDC, 2020). The CDC’s Up and Away Campaign outlines steps to take to ensure medications are properly stored. All medications should be stored in a place where a child cannot see or reach the medications (CDC, 2020). This location may be different in each home but can include upper kitchen cabinets or medicine cabinets on the wall of a bathroom. Using child-proofing mechanisms on these locations when applicable can add an additional barrier to medication access by children. Medications should not be stored in lower cabinets, drawers, nightstands, dressers, or left out on the kitchen or bathroom counter. Medications should be promptly secured in their safe location after each medication use (CDC, 2020). It can be tempting to leave a medication on the counter if it requires frequent use, but medications should never be left out in the open for any reason. Additionally, bottle caps should be completely closed and secured before storage (CDC, 2020). Although a container may have a child-proof cap, care must be taken to ensure it is turned until a click is heard. Medications in pill form should always remain in the original container and never be left loose or transferred into a separate container without a child-proof lid. Children should be educated on medication safety so they are aware that medication can be dangerous. Any guests visiting the home should also be instructed not to leave any medications they may have in sight or in reach of children (CDC, 2020).

Family Education

All verbal education will be complemented and reinforced with written instructions. Handouts given on over-the-counter medications will be available on the LCMC website and parents will be educated on how to access online handouts in the event the patient’s forms are lost. Additional resources such as recorded videos on proper measuring techniques and selection of correct measuring device size will be available on the website for parents to access later. Instructions on how to access MyChart, LCMC’s online patient portal, will be reviewed with families. MyChart can be utilized to access the most current patient’s weight if the parents do not have access to a scale. Additionally, individual medication dosing instructions given to parents for prescriptions or over-the-counter medications that require oral syringes will be uploaded into the patient’s MyChart. Parents will be instructed to communicate with the on-call service prior to giving any medications not reviewed during the visit, if any additional questions present, or if more clarification is required. The on-call number is in MyChart, the LCMC website, and will be included on all written handouts given to the families.

Staff Education

Staff training will be required before project implementation. Nurses will be educated on the most common over-the-counter medications used for children under five and the included dosing devices. Samples will be available for nurses to have hands on practice and to use for parent education and demonstration. Central supply will provide oral syringes to be dispensed to parents with new prescriptions. Instructions for staff and parents will include using the smallest syringe available to give the proper dose. Nurses will be educated and show parents how to properly draw up medication doses, wash and reuse syringes, and to return to the pharmacy or clinic to replace as needed.

Documentation

Training modules specific to nursing regarding new medication education practices for families will be assigned through the Learning Center by the Nursing Education Department. Individual clinic managers will be responsible for assuring 100% staff compliance in completing assigned modules. Nurses will be given 2 weeks to complete the modules before go-live of the new practice.

The new medication education practice will be added to the education record in EPIC. Nurses will be instructed to document the verbal education, demonstration, and written instructions/handouts given. Parent understanding will also be documented through repeat verbalization by parent of accurate dosing instructions and return demonstration using sample standard dosing device or syringe as applicable. Check-off boxes will be provided in the education record for ease of documentation by the nurse.

Conclusion

In order to meet the 2030 Healthy People objective of “reducing emergency department visits for medication overdoses in children under 5 years” (Office of Disease Prevention and Health Promotion, 2021) and reduce the incidence of accidental pediatric overdoses causing emergency department visits, the following changes are recommended: parents should be educated on proper storage, usage, and closure of containers, the importance of using accurate dosing and measurement tools, and following a single set of dosing instructions per medication.

LCMC outpatient clinics are the best setting for implementing and integrating these educational opportunities. Parents and guardians can receive real-time instructions and practice teach-back with healthcare professionals while present for acute illness or wellness visits, and they can access carefully created and curated informational brochures regarding accidental pediatric overdose safety risks, precautions, and preventions. Facilities can also arrange for community-based workshops to target a broader audience. Larger changes can be made at an LCMC system level to ensure any custom-formulary liquid medications come packaged in child-proof containers, include easy-to-read labels of concentration and an appropriately sized and labeled measuring device. While changes to packaging and instructions are important, the biggest impact will occur from ensuring parents and guardians are knowledgeable about the risks present when administering medications at home and how to avoid these risks.

References

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