Enhancing Pediatric Adverse Drug Reaction Documentation in the Electronic Medical Record

Abstract

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.

Methods for Detecting Pediatric Adverse Drug Reactions From the Electronic Medical Record

“…As shown in many previous studies, voluntary reporting of ADRs is low in the absence of an active pharmacovigilance program 3,5,6,8,10 . In 2019, only 21 ADRs were reported in the Riley Hospital for Children electronic medication safety tracking system.…”

“…Both Riley Hospital for Children and Children's Mercy Hospital are similarly sized (∼350 beds) freestanding children's hospitals; therefore, the number of ADRs would be expected to be similar. In an 8‐year period from 2010 to 2018, 3065 total ADRs, or approximately 383 ADRs per year, were reported at Children's Mercy Hospital 8 . As previously noted, triggers related to the allergy profile and selected ICD codes accounted for 75% of the Children's Mercy Hospital ADRs.…”

“…Following Riley Hospital for Children institutional review board exempt approval, triggers used by Children's Mercy Hospital (Table 1) to identify potential ADRs were applied retrospectively at Riley Hospital for Children from January 1 to December 31, 2019. In a recent publication by Children's Mercy Hospital, 37% of all ADRs were detected by an automated daily report that pulls any allergy/ADR that had newly been entered into a patient's ADR profile, 15% were identified by an automated daily report that pulled any patient that has an active order on his/her medication administration record, but the same or similar medication in the allergy/ADR profile, 22% were identified by a report generated through EMR utilizing the below billing codes (Table 2), 15% were independently identified by the drug safety service pharmacist, and <3% were identified by diphenhydramine orders, ADR referrals directly to the pharmacovigilance program, or the sedation report 8 . Because the majority of Children's Mercy Hospital ADRs were identified by allergy/ADR lists and ICD codes, these triggers were used at Riley Hospital for Children to generate lists of possible ADRs for manual EMR review to collect data and confirm the validity of the ADR trigger.…”

“…ADRs frequently occur, but are often not reported 2 . The presence of a pharmacovigilance service has been shown to greatly increase timely documentation of ADRs within the medical record 3–8 . Currently Riley Hospital for Children, Indianapolis, Indiana, a 350‐bed freestanding children's hospital that has approximately 22 000 admissions or observations and 51 000 emergency room visits annually does not have a prospective pharmacovigilance program.…”

“…Children's Mercy Hospital, Kansas City, Missouri, a freestanding children's hospital of similar size, has an active prospective pharmacovigilance program in which ADRs are identified by several hospital‐specific daily reports and International Classification of Disease (ICD) codes 9 . These ADRs are then reviewed by a pharmacist and entered into the electronic medical record (EMR) 8,10 . The aim of this pilot study was to apply triggers used at Children's Mercy Hospital to retrospectively detect ADRs at Riley Hospital for Children and determine if these methods could be replicated to provide the basis for a new prospective pharmacovigilance program.…”