# Enhancing Medication Safety in Children with Polypharmacy Using Parent-Reported Symptom Assessments

> **NIH NIH K23** · UNIVERSITY OF COLORADO DENVER · 2020 · $165,143

## Abstract

PROJECT SUMMARY/ABSTRACT
An increasing number of children with medical complexity are exposed to polypharmacy in the ambulatory
setting and take multiple high-risk medications daily. Polypharmacy can lead to serious adverse drug events
(ADEs). The most vulnerable children with medical complexity exhibit a multitude of symptoms and have
impairments that make the self-report of ADEs unfeasible, severely limiting the conduct of clinical trials and
post-marketing drug surveillance studies to detect ADEs. Dr. James Feinstein’s overarching hypothesis is
that repeated parent-reported symptom assessments (PRSA) before and after medication changes will provide
clinically pertinent information, improve ADE signal detection, and enhance medication safety. This patient-
oriented mentored career development award is designed to support the transition of James Feinstein, MD,
MPH, an Assistant Professor of Pediatrics at the University of Colorado, into an independent clinician-scientist
and to achieve his long-term career goal of becoming a national leader in pediatric polypharmacy and
medication safety research. His short-term career goals are to (1) study factors involved in the escalation of
polypharmacy and (2) implement a prospective PRSA system to guide and monitor pharmaceutical care for
high-risk children. Dr. Feinstein will complete additional didactic and experiential training in 3 key areas
necessary for his success: (1) pharmacoepidemiology and pharmacovigilance; (2) quantitative longitudinal
data analysis; and (3) the design and conduct of prospective cohort studies. The University of Colorado
Anschutz Medical Campus provides a unique research environment to conduct pediatric polypharmacy
research, supported by collaborative research partnerships between the Adult and Child Consortium for
Health Outcomes Research and Delivery Science (ACCORDS), The Skaggs School of Pharmacy and
Pharmaceutical Sciences, and the Children’s Hospital Colorado Special Care Clinic for children with medical
complexity. Dr. Feinstein’s renowned team of research mentors, Dr. Allison Kempe (health services
research), Dr. Robert Valuck (pharmacoepidemiology), Dr. Chris Feudtner (children with complex chronic
conditions), and Dr. Diane Fairclough (biostatistics), will guide completion of the proposed training and
research plan. To achieve his short-term career goals, Dr. Feinstein proposes three research projects that will
contribute to the implementation of a PRSA system to evaluate children with polypharmacy for medication-
related issues. The specific aims are to conduct: (1) a retrospective cohort study to quantify annual
polypharmacy and factors associated with escalation of polypharmacy; (2) a cross-sectional evaluation of
symptoms in children with polypharmacy using PRSAs to advance our understanding of signal-to-noise and
signal detection challenges; and (3) a prospective cohort study to assess whether using PRSAs prior to and
after medication changes detects known ADE...

## Key facts

- **NIH application ID:** 9988908
- **Project number:** 5K23HD091295-04
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** James A Feinstein
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $165,143
- **Award type:** 5
- **Project period:** 2017-08-01 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9988908

## Citation

> US National Institutes of Health, RePORTER application 9988908, Enhancing Medication Safety in Children with Polypharmacy Using Parent-Reported Symptom Assessments (5K23HD091295-04). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/9988908. Licensed CC0.

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