Integrating Regulatory Guidance, Evidence Evaluation, and Informatics to Advance Pediatric Medication Safety
This webinar will address the critical gap in pediatric medication safety: the disconnect between federal regulatory guidance and institutional implementation. Despite the Pediatric Research Equity Act (PREA) requiring pediatric studies for new drugs, up to 64% of medications still lack pediatric labeling 5 years post-approval, and 50-80% of pediatric medications are prescribed off-label without adequate safety data. This evidence gap is a leading contributor to medication errors and adverse drug events (ADEs) in children.
Target Audience
- Pharmacists
Learning Objectives
At the conclusion of this activity, pharmacists should be able to:
- Apply a stepwise evidence evaluation framework to assess medications lacking FDA-approved pediatric labeling for formulary and standardization decisions.
- Design a structured decision-making workflow for reviewing new evidence and incorporating it into formulary review, order sets, and EHR clinical decision support.
- Establish a sustainable process for monitoring FDA pediatric labeling updates and triggering institutional reviews.
Cara Christopher, PharmD, MPH
PGY2 Resident Pharmacist
Robert Wood Johnson University Hospital
Planners
Jessica Lise, PharmD, BCPPS
Pediatric Clinical Pharmacist Specialist
Robert Wood Johnson University Hospital
Mital Desai, PharmD
Director, Pharmacy Network
Vizient, Inc.
Lauren McCree, MBA
Networks Manager
Vizient, Inc.
Samantha Gordon, MS
CE Programs Manager
Vizient, Inc.
Marilu Kelly, MSN, RN, NPD-BC, CHCP
Director, Continuing Education
Vizient, Inc.
Joint Accreditation Statement
In support of improving patient care, Vizient, Inc. is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
Available Credit
- 1.00 ACPE Pharmacist
- 1.00 General CE - Attendance
- If the "Register/Take Course" tab is displayed instead of the "Obtain Credit" tab, you must first login to proceed with the credit claim process.
- This activity requires learners to confirm their attendance using an activity code. An Access Denied error message indicates that your attendance was not recorded via SMS text or QR code scanning.
Required Hardware/software
The Vizient CE Learner Portal is compatible with most modern web browsers (such as Firefox, Google Chrome, Microsoft Edge, Apple Safari) and can also be accessed with mobile devices.

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