Pediatric Pharmacovigilance: Enhancing Adverse Drug Reaction Reporting in a Tertiary Care Children's Hospital

Therapeutic Innovation & Regulatory Science
Jennifer L GoldmanJennifer Lowry

Abstract

Adverse drug reactions (ADRs) are notoriously underreported within health care facilities. In 2009-2010, ADRs were detected in only 0.5% of patients at the authors' institution, a pediatric hospital in the Midwestern United States. Additionally, historical ADRs were often inaccurately or incompletely documented in the medical record. An integrative Drug Safety Service (DSS) was implemented to improve the detection and accurate documentation of ADRs. The DSS incorporated standardized ADR terminology, computerized triggers to identify ADRs, and a simplified voluntary reporting system within the facility. The DSS staff provided extensive hospital staff education on ADR reporting and the role of the DSS. The primary aim of this report was to assess the impact of the DSS on the number of ADRs reported at the authors' institution. The secondary aims were to evaluate the mechanisms by which patients with ADRs were identified and to assess the accuracy of ADR documentation after implementation of the DSS. A significant increase was observed (slope, 6.01; P < .001) in ADR detection after implementation of the DSS, with a greater than 4-fold increase from 10 cases per 10,000 admissions before initiation to 41 cases per 10,000 admissions ...Continue Reading

References

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Citations

Dec 12, 2018·Infection Control and Hospital Epidemiology : the Official Journal of the Society of Hospital Epidemiologists of America·David F ButlerJennifer L Goldman
May 21, 2020·Pharmacoepidemiology and Drug Safety·Malahat KhaliliAli Akbar Haghdoost
Sep 18, 2016·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Stella StergiopoulosKenneth A Getz
Aug 11, 2020·Journal of Clinical Pharmacology·Emma M TillmanJennifer L Goldman
Jul 17, 2019·Journal of Clinical Pharmacology·Diana YuJennifer Goldman
Nov 23, 2017·Journal of the Pediatric Infectious Diseases Society·Julie N BeckJennifer L Goldman

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