HHS Announces a Standard Clinical Definition for Opioid Withdrawal in Infants

Major step towards improving standards of care for infants prenatally exposed to opioids, part of the HHS Overdose Prevention Strategy

The U.S. Department of Health and Human Services (HHS) together with leading clinicians, researchers, and policy experts led the development of a standard clinical definition for opioid withdrawal in infants to help improve care.  It is accompanied with a set of foundational principles that outlines bioethical uses for the definition, distinctly centering around identifying clinical and supportive care needs of mothers and their infants, using an evidence-based, compassionate, and equitable approach.

Across the U.S., the number of mothers with opioid-related diagnoses documented at delivery increased approximately 130% from 2010 to 2017, according to a 2021 report. Yet infants born with opioid exposure and withdrawal often lack consistent diagnosis and care. 

“As a pediatrician, I have seen the need for a standard clinical definition for opioid withdrawal in neonates, and am excited to see this step in improving care for infants and their families as part of the HHS Overdose Prevention Strategy,” said HHS Assistant Secretary for Health ADM Rachel Levine. “I look forward to working across all health sectors to get this definition adopted into clinical practice.”

This announcement builds on a recent study published by HHS researchers in a January 2022 issue of MMWR that highlights data collection challenges, including lack of a standard clinical definition, and infrastructural gaps in states with mandated public health reporting of withdrawal from prenatal substance exposures. Such challenges can influence comprehensive state-level strategies to treat opioid use disorder for pregnant and postpartum women as well as treatment for their infants.

Lacking a standard clinical definition for the past 45+ years has been a historical gap in the care of mothers and infants affected by opioid exposure, and created inconsistencies in diagnosing infants. This has resulted in multiple challenges including medical coding, public health surveillance, research, public health policy and program development.

The new standard clinical definition for diagnosis includes prenatal exposure and specific evidence-based clinical signs such as excessive crying, fragmented sleep, tremors, increased muscle tone, and gastrointestinal disfunction. It can be applied in the context of neonatal abstinence syndrome (NAS) or neonatal opioid withdrawal syndrome (NOWS), terminologies typically used to describe withdrawal due to prenatal substance exposure in infants. The definition also includes bioethical principles emphasizing that it is not meant to prove or imply harm, nor should it be used to assess child social welfare risk or status.

This is a major step forward towards improving standards of care for infants prenatally exposed to opioids, part of the HHS Overdose Prevention Strategy, through:

• Diagnosis: Providing a consistent way to diagnose infants, which will lead to better infant care;
• Data: Informing medical coding practices to improve health care data collection for infants affected by opioid exposure;
• Programs: Informing surveillance practices, helping to understand the short- and long-term needs of affected communities, which will lead to better programs, and better resources to help both mother and infant;
• Research: Informing and optimizing research study design by having a consistent way to define opioid withdrawal in infants, which will lead to better research data to develop and guide better treatments;
• Health Equity: Accompanying bioethical principles that inform clinical use of the definition aim to reduce stigma and protect mothers and infants so they get the care they need without fear of reprisal.

The new standard clinical definition of opioid withdrawal in neonates is published in The Journal of Pediatrics: https://doi.org/10.1016/j.jpeds.2021.12.021.