PROBLEM: Pediatric patients are vulnerable to higher rates of adverse drug events for a variety of reasons, including frequent off-label drug usage, individualized dose calculations, and age-related differences in drug disposition and effect. While children's hospitals often have pediatric-specific safeguards built throughout the medication-use process, most pediatric patients are treated in general hospitals, emergency departments (EDs), and other healthcare facilities. Practitioners who are completing the medication reconciliation must determine if the drugs the pediatric patient has been taking at home require modifications in the care plan. Practitioners who are not specialized in pediatrics may be unfamiliar with a medication’s use, maximum dose, contraindications, side effects, recommended monitoring parameters, or other safety concerns that could cause harm.
To create a standard of care for the safe use of medications in pediatric patients, the Pediatric Pharmacy Association (PPA) commissioned a group of pediatric pharmacists to evaluate the literature and compile a list of potentially inappropriate drugs for pediatric patients. The PPA KIDs List of Key Potentially Inappropriate Drugs in Pediatrics was published in the Journal of Pediatric Pharmacology and Therapeutics in 2020 and became the first list of drugs that should be “avoided” or “used with caution” in all or a subset of pediatric patients.1 It is akin to the well-known Beers Criteria for older adults, but it’s for pediatric patients. ISMP served as a reviewer for the project. The KIDs List Collaborators were recognized with an ISMP Cheers award in 2021 for their passion to improve the safe use of medications in pediatric patients and inspire future medication safety research in children.
In 2025, twelve pediatric pharmacists reviewed and updated the KIDs List. For each potentially inappropriate medication, they evaluated primary, secondary, and tertiary literature; US Food and Drug Administration (FDA) pediatric safety communications; the UpToDate Lexidrug database; and product information. ISMP served as a reviewer for the updated list. After critical analysis and reorganization, the second edition of the KIDs List contains 39 medications and/or drug classes (refer to Table 1 in the journal article) and 10 excipients (refer to Table 2 in the journal article). There were several major updates, including those described below.2
Examples of Updates from 2020
- The first edition in 2020 provided recommendations based on age categories (e.g., newborn, infant, preschool child, child, adolescent). However, in the second edition, as no specific breakpoints between these groups consistently correlated with the available evidence, the panel opted to report specific ages (e.g., less than one year old) to avoid or use caution with the drug rather than age categories.
- Addition of the following drugs:
- Angiotensin receptor blockers (caution in less than 1 month of age due to risk of renal tubular dysgenesis)
- Mirabegron (caution in less than 3 years of age due to risk of increased blood pressure)
- Molnupiravir (caution in 18 years of age and younger due to risk of bone and cartilage toxicity)
- Montelukast (caution in 18 years of age and younger due to risk of sleep disturbances)
- Ribavirin oral inhalation (caution in less than 2 years of age due to risk of sudden respiratory deterioration)
- Codeine and traMADol recommendations updated to reflect the latest FDA guidance (risk of respiratory failure and death)
- Revision of guanylate cyclase-c agonists recommendation based on updates to the package insert, which shows a risk of death from dehydration in patients less than 2 years of age (linaclotide) and 18 years and younger (plecanatide)
- DAPTOmycin was removed due to emerging case series describing safety
- Ivermectin (oral) was removed due to emerging case reports and series describing safe use in specific disease states in patients less than 15 kg
- Expansion of the tetracycline class with stratification of quality based on evidence regarding tooth discoloration
- Significant revision of DOPamine antagonists based on emerging evidence, along with reorganization as first-generation antipsychotics, second-generation antipsychotics, and other DOPamine antagonists
- Midazolam quality of evidence changed from high to low after reappraisal of cited evidence
- Revision of ethanol/ethyl alcohol, polysorbate 80, and propylene glycol recommendations due to emerging evidence/guidance
The KIDs List is a remarkable step forward for pediatric medication safety. To reduce harm, organizations and practitioners must understand how to operationalize this guidance in the clinical setting.
SAFE PRACTICE RECOMMENDATIONS: We encourage organizations that treat pediatric patients to review the updated KIDs List and implement safeguards into systems and processes by considering the following recommendations.
Complete a gap analysis. Review the updated KIDs List and conduct a gap analysis of drugs used within your organization. Evaluate whether the drug (or a drug with the excipient) is available on the organization’s formulary and if any restrictions are needed based on the risk and recommendations provided. Recognize that pediatric patients may present to a variety of settings with a home medication list that includes a KIDs List drug that is not on the organization's formulary. If it is a nonformulary product with high usage, consider whether the drug is appropriate for formulary addition, so that system safeguards can be optimized.
Safeguard medication reconciliation. If the practitioner completing a pediatric patient’s medication history determines that the child is taking a drug on the KIDs List and it has an applicable warning (e.g., avoid use in their particular age range), they must escalate this to the prescriber responsible for completing medication reconciliation. The prescriber responsible for completing medication reconciliation should then evaluate why the patient is taking the drug. Consider whether an alternative drug or formulation is appropriate and/or if additional monitoring should be done.
Evaluate order sentences. Review if there are order sentences and/or order sets available in the electronic health record (EHR) for the medications on the KIDs List. Consider if changes are needed, such as indication-based sentences with dosing guidance based on the child’s age/weight, or additional monitoring parameters. Include discharge orders, order sets, and prescriptions in the review to assess if improvements are necessary.
Use dose range checking. Test your EHR settings to determine if it will generate a dose range checking (DRC) alert based on the KIDs List recommendations. For example, if a prescriber orders loperamide for a child less than 3 years old for acute infectious diarrhea, does the EHR warn the prescriber and/or pharmacist that this could result in ileus or lethargy? Ensure alerts are meaningful and easy to understand so practitioners can act upon them.
Enhance clinical decision support. Consider whether additional changes to clinical decision support (CDS) should be implemented (e.g., hard stop, contraindication warning). For example, if a prescriber orders a sodium phosphate solution enema rectally for a child less than 2 years old, what type of alert is generated? Is the warning a soft stop that can be easily overridden, or is it a hard stop that indicates this may result in electrolyte abnormalities, acute kidney injury, arrhythmia, and death?
Review ADCs. Evaluate if any medications on the KIDs List are stored in automated dispensing cabinets (ADCs) and determine if any formulations should be removed. Determine whether practitioners have access to KIDs List drugs via override, and if it should be removed.
Optimize drug libraries. Based on the EHR build (e.g., order sets, DRC, hard stops), align the smart pump drug library for applicable drugs on the KIDs List. Set soft dosing limits in the drug library that reflect the maximum expected dose and rate prescribed as well as a buffer for pediatric patients who may require more or less than the typical default doses and rates. Set hard dosing limits as a forcing function to prevent catastrophic errors, while considering patients who may clinically require atypical doses, to prevent end users from needing to program the infusion without engaging the dose error reduction system (DERS).
Determine a risk-mitigation plan. Use the information gathered from the gap analysis to create a comprehensive risk-mitigation plan. Understanding that there are quite a few medications and excipients on this comprehensive list, determine where the organization is most vulnerable, focusing on those drugs that present the highest risk to your patient population.
Educate practitioners. While practitioners may be more familiar with the Beers Criteria for older adults, they may be less familiar or even unaware that the KIDs List exists as a valuable safety resource. Educate practitioners about the KIDs List during orientation, annual competency assessments, huddles, staff meetings, and/or as a topic for grand rounds. Discuss how to safely use drugs on the KIDs List and what actions have been taken to protect pediatric patients from harm.
Collaborate with outpatient practitioners. Reach out to local outpatient pharmacies, compounding pharmacies, clinics, doctors' offices, urgent care locations, and EDs to spread awareness of the KIDs List. Share system changes that your organization has made to protect pediatric patients and encourage similar enhancements in their systems.
Monitor. Monitor patients for adverse drug events, including those involving drugs on the KIDs List, and evaluate if additional system changes are needed. Regularly review order sets, DRC settings, alerts generated through CDS and DERS, and corresponding actions taken. Frequent bypassing of dose limits or system warnings should prompt a review of their appropriateness.
Collaborate with vendors. Work with technology vendors to discuss the capability of the CDS for drugs and excipients on the KIDs List and provide feedback for upcoming enhancements.
Report errors. Report errors and close calls with medications, including those on the KIDs List, internally and to ISMP.
References
1. Meyers RS, Thackray J, Matson KL, et al. Key potentially inappropriate drugs in pediatrics: the KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-91.
2. McPherson C, Meyers RS, Thackray J, et al. Pediatric Pharmacy Association 2025 KIDs List of key potentially inappropriate drugs in pediatrics. J Pediatr Pharmacol Ther. 2025;30(4):422-39.
Suggested citation:
Institute for Safe Medication Practices (ISMP). Safeguard pediatric patients – act upon the 2025 KIDs list. ISMP Medication Safety Alert! Acute Care. 2025;30(18):1-3.
