Pediatric Pharmacy Association Develops First-of-its-Kind List of Drugs to Avoid for Children

Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List

For almost 30 years, the Beers Criteria, a list of potentially inappropriate drugs for use in patients 65 years and older, has guided safe medication prescribing in older adults. Until recently, no similar document has existed to improve the prescribing standard of care in pediatric patients. In 2017, the Pediatric Pharmacy Association (PPA) commissioned an expert group of pediatric pharmacists to compile a list of drugs, both prescription and over-the-counter, that should be avoided in the pediatric population. The list of identified medications associated with a high risk of adverse drug reactions (ADRs) will be a tool used to evaluate and enhance the quality of care and identify research needs in the pediatric population.

The World Health Organization (WHO) defines ADRs as “any noxious and unintended response to a drug that occurs in man at doses normally used for prophylaxis, treatment of diagnosis of disease, or the modification of physiological function.” Despite many attempts to quantify, the rate of ADRs in the pediatric population has been difficult to discern. Factors confounding researchers include the prevalent off-label use of medications and the altered pharmacokinetics. Investigators find that 50% of medications in the United States are not labeled for use in children, forcing practitioners to prescribe unvalidated and potentially dangerous dosing regimens. Further complicating safe dosing are the maturational changes in body compositions and organ function that occur throughout adolescence. The absorption, distribution, metabolism, and excretion of the same drug occurs differently in 2-year-old versus a teenager.

With the pediatric populations’ unique risk factors for ADRs in mind, the panel researched and identified potentially inappropriate medications for use in the pediatric population. The researchers defined the list as “medications or medication classes that should generally be avoided in persons younger than 18 years because they pose an unnecessary high risk for children and a safer alternative is available.” Utilizing the strength of their recommendation, quality of evidence in the literature, and the severity of potential adverse effect, the panel labeled medications either “avoid” or “caution use.”

Systematic search of PubMed, Lexi-Drugs, FDA communications, and expert opinion resulted in inclusion of 67 drugs and 10 excipients on the KIDs List. Thirty-nine (39) drugs/excipients were listed as “avoid” and 23 as “use with caution.” Frequent classes of medications included were anti-infectives, antipsychotics, dopamine antagonists, and gastrointestinal agents. The authors further provided specific recommendations for each drug to account for the unique risks of each stage of adolescence.

The authors intend for health care professionals in acute and ambulatory care settings to use the list as an evidence-based guide to improve the safety of medication use in pediatric patients. Investigators also warned that the list is not a substitute for practitioner’s clinical judgement or other resources, such as the WHO Model List of Essential Medicines for Children.

Investigators excluded aspirin, fluoroquinolones, antidepressants, and cough preparations from the KIDs List. While these medications present safety concerns in pediatrics, in some instances their benefit outweighs the risk. Following extensive review, the expert panel excluded medications in the table below based on a lack of sufficient evidence of the pediatric risks.

Medications and Classes Excluded from the KIDs List
Products/Class Reason for Exclusion
OTC Pediatric cough and cold preparations Safety issues linked to overdoses. The panel found no toxicity issues when recommended doses were utilized.
Fluoroquinolones Evidence of the historical recommendation to avoid use was not found to be robust. The benefits in certain populations (cUTI, Cystic Fibrosis, CAP) outweigh the potential risk.
Aspirin* Recent literature has contested the association with Reye’s syndrome. Benefits outweighs risk in certain populations – Kawasaki disease, post ischemic stroke, and cardiac surgery patients.
Antidepressants FDA issued a black box warning on the entire class of antidepressants, indicating their association with increased risk of suicidality and suicidal ideation in children. The panel felt the evidence of clinical benefit was too strong to include the entire class of medications on the KIDs List.

*Aspirin was included on the list with a weak recommendation to use with caution in children with suspicion of viral illness (influenza and varicella).

The impact of the KIDs List will depend upon its adoption by pediatric and general healthcare practitioners. The fastest path to usage in clinical decision-making and safe prescribing will involve inclusion in drug information resources, electronic health records, and e-prescribing systems. Much like the Beer’s Criteria, medications placed on the KIDs List should have pediatric safety warnings added to their drug information pages. Lexicomp, for example, has updated the drug information for all KIDs List medications to reflect the recommendations made by the panel. Integration of the KIDs list across all drug compendia will increase impact on prescribing patterns and pediatric patient safety.

The panel stated they expect significant feedback, and they intend to update the KIDs List when a critical mass of new information is received. Throughout their research, the authors continually cited a paucity of evidence and lack of sufficient drug safety data in the pediatric population. While the current version of the KIDs List represents a starting point for safe medication use in the pediatric population, continued research and data collection is more important than ever.

The entire alphabetical list can be found at the following address: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7134587/pdf/i1551-6776-25-3-175.pdf

 

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):175-191. doi:10.5863/1551-6776-25.3.175

KIDs List

 

 

 

 

 

 

 

Posted September 2020

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