PII-113 - PHARMACOTHERAPY RESEARCH LANDSCAPE AND KNOWLEDGE GAP FOR OPIOIDS AMONG THE MATERNAL AND PEDIATRIC POPULATIONS

A. shendre¹, X. Liu², A. Goodwin¹, S. Oteng¹, J. Deypalubos¹, S. Zhang¹, J. Liu¹, L. Wang², S. Quinney^3,4, L. Li⁵; ¹Ohio State University, Columbus, OH, United States, ²The Ohio State University, Columbus, OH, USA, ³Division of Clinical Pharmacology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA, ⁴Department of OB/GYN, Indiana University School of Medicine, Indianapolis, IN, USA, ⁵The Ohio State University, Columbus, OH, United States.

Background: The misuse of opioids has surged in the past decade, with nearly half of users being female. Although lower among pregnant women, trends mirror the general population, with opioid misuse reported as high as 21.2% in the CDC Pregnancy Risk Assessment Monitoring System (PRAMS) survey. This review assesses the pharmacotherapy landscape and knowledge gaps for opioid use in maternal and pediatric populations.

Methods: We searched PubMed for studies on opioid use in maternal and pediatric populations, focusing on 27 opioid drugs. The review included English-language articles on pharmacokinetics (PK), pharmacoepidemiology (PE), and clinical trials (CTs). Data from eligible studies were synthesized to identify evidence gaps. Additionally, MarketScan claims data and FDA drug labels were analyzed to highlight discrepancies between opioid usage and available scientific evidence.

Results: Morphine, fentanyl, methadone, and buprenorphine are the most researched opioids in PK, PE, and CT literature for maternal and pediatric populations. However, claims data show oxycodone, hydrocodone, and codeine as the most prescribed opioids in these groups. Eight drugs lack FDA labels for any formulation, and of the 19 with FDA labels, seven have no reportable human data. Hydrocodone and codeine are among those with no human data in FDA labels.

In the maternal population, 9, 12, and 7 opioids have not been studied in PK, CT, and PE, respectively. Similarly, 7, 17, and 6 opioids lack studies in these categories for pediatric populations. PK studies often focus on labor, delivery, and lactation, with neonatal data included. Pregnancy research is mainly in PE studies, while PK and CT data are limited. Research on children aged 1-12 is more evenly distributed across study types, while adolescents are primarily studied in PE. Drug concentration is the most reported parameter in PK studies, and neonatal opioid withdrawal syndrome (NOWS) is a key focus in PE. Side effects are frequently reported in both PE and CT studies.

Conclusion: There is a significant gap between the most prescribed opioids and those most extensively studied. The absence of human data in FDA labels highlights the need for further studies, particularly in pregnant and lactating women, with real world data addressing the data source gap for these subpopulations.