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.

We retrospectively evaluated the effect of penicillin adverse drug reaction (ADR) labeling on surgical antibiotic prophylaxis. Cefazolin was administered in 86% of penicillin ADR-negative (−) and 28% penicillin ADR-positive (+) cases. Broad-spectrum antibiotic use was more common in ADR(+) cases and was more commonly associated with perioperative adverse drug events.

Adverse drug reactions (ADRs) often go unreported or are inaccurately documented in the electronic medical recorded (EMR), even when they are severe and life‐threatening. Incomplete reporting can lead to future prescribing challenges and ADR reoccurrence. The aim of this study was to evaluate the documentation of ADRs within the EMR and determine specific factors associated with appropriate and timely ADR documentation. Retrospective data were collected from a pediatric hospital system ADR reports from October 2010 to November 2018. Data included implicated medication, type, and severity of reaction, treatment location, the presence or absence of ADR documentation in the EMR alert profile within 24 hours of the ADR hospital or clinic encounter discharge, ADR identification method, and the presence or absence of pharmacovigilance oversight at the facility where the ADR was treated. A linear regression model was applied to identify factors contributing to optimal ADR documentation. A total of 3065 ADRs requiring medical care were identified. Of these, 961 ADRs (31%) did not have appropriate documentation added to the EMR alert profile prior to discharge. ADRs were documented in the EMR 87% of the time with the presence of pharmacovigilance oversight and only 61% without prospective pharmacovigilance (P < .01). Severity of ADR was not a predictor of ADR documentation in the EMR, yet the implicated medication and location of treatment did impact reporting. An active pharmacovigilance service significantly improved pediatric ADR documentation. Further work is needed to assure timely, accurate ADR documentation.

We performed a retrospective chart review on severe adverse drug reactions (ADRs) detected by a pharmacovigilance program at a free‐standing pediatric hospital from January 2011 through September 2014. The pharmacist‐led program identifies ADRs using electronic medical record triggers. A systematic approach was used to classify ADR type and severity and assure accurate documentation. Data collection included demographics, implicated medication, type of ADR, Naranjo probability scale, ADR‐associated International Classification of Diseases, 9th Revision E codes, 30‐day mortality, and health care visit cost. One hundred sixty‐six severe pediatric ADRs were included, occurring in 163 unique patients. Severe ADRs were commonly associated with antimicrobials (48%), antineoplastics (10%), and antiepileptics (10%). The majority of ADRs were classified by the Naranjo probability scale as probable (59%). One hundred fifty‐four patients were admitted to the hospital, with a median length of stay of 3 days; 22 of these patients required admission to the pediatric intensive care unit for a median of 3 days. The median estimated health care cost associated with severe ADRs was $4055.52. No deaths occurred. Nearly 40% of severe ADRs would have gone unidentified using ADR‐associated International Classification of Diseases, 9th Revision E codes alone. The impact of pediatric ADRs on the health care system is underestimated. Strategies such as active pharmacovigilance programs enhance the identification, characterization, and documentation of these otherwise unrecognized ADRs.