Abstract
The relationship between the Naranjo scaling system and pediatric adverse drug reactions (ADR) is poorly understood. We performed a retrospective review of 1,676 pediatric ADRs documented at our hospital from 2014–2018. We evaluated patient demographics, implicated medication, ADR severity, calculated Naranjo score, associated symptoms, and location within the hospital in which the ADR was documented. ADR severity was poorly correlated with Naranjo interpretation. Out of the 10 Naranjo scale questions, 4 had a response of “unknown” greater than 85% of the time. Cardiovascular and oncological/immunologic agents were more likely to have a probable or definite Naranjo interpretation compared to antimicrobials. Further strategies are needed to enhance the causality assessment of pediatric ADRs in clinical care.
Highlights
According to the World Health Organization, an adverse drug reaction (ADR) is “a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man” [1,2]
Even when ADRs are documented in the electronic medical record (EMR), the information often lacks the details required for medical providers to determine how to safely prescribe medications related to the implicated drug
70 ADRs failed to meet the remaining inclusion criteria: starting with patients older than 21 years of age (n = 6), those with missing Naranjo scores (n = 31), missing severity classification (n = 14), or failure to document if the reaction occurred within past 30 days (n = 7), classifications other than hypersensitivity reactions or side effects (n = 2), missing and unknown race (n = 10), resulting in a total of 1676 ADRs included in analysis
Summary
According to the World Health Organization, an adverse drug reaction (ADR) is “a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man” [1,2]. The frequent use of off-label medications along with developmental changes that occur in children from infancy to adolescence result in an elevated risk for ADRs [3,4]. Even when ADRs are documented in the electronic medical record (EMR), the information often lacks the details required for medical providers to determine how to safely prescribe medications related to the implicated drug. Doing so requires the determination of key factors such as ADR phenotype and severity, as many ADRs are tolerable side effects with low risk of recurrence while others can be severe and life threatening [6]. Without available clinical tests to confirm or negate if a drug caused a reaction, the medical provider is challenged on how to interpret a potential ADR
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