Our Mission
The Pediatric Therapeutics and Regulatory Science Initiative aims to advance the development and evidence-based use of therapeutics for pediatric patients in the United States and globally. Based at Harvard Medical School and Boston Children's Hospital, the Initiative seeks to inform regulatory policy and improve safe and effective use of drugs and devices in children through research and collaboration with regulators, policymakers, and industry.
1968
“By an odd and unfortunate twist of fate, infants and children are becoming ‘therapeutic or pharmaceutical orphans.’”
- HARRY SHIRKEY, MD; JOURNAL OF PEDIATRICS
TODAY
Recent research
The Initiative's research has been published in NEJM, JAMA, JAMA Pediatrics, Lancet Child & Adolescent Health, PLOS Medicine, and Pediatrics, among others. For more information on our current and past work, see Our Research.
One current project includes →
High rates of opioid use among adolescents
In several recent publications, we assess opioid prescribing and the high risk of misuse of opioid medications among adolescents and young adults. Our findings indicate that physicians continue to prescribe opioids at high rates to adolescents receiving care in emergency departments and other ambulatory care settings. In fact, for certain common conditions, such as dental disorders or clavicle fractures, rates of opioid prescribing exceed 40%. However, it is also important to note the role of diversion in the misuse of these medications—among adolescents and young adults misusing opioids, over a third obtain them from friends and family.
US states have enacted a number of laws to decrease the amount of opioid medications prescribed and distributed. In our most recent analysis, using national data on opioid poisonings, we demonstrate that these state-level policies may reduce reduce opioid poisoning, misuse, and overdoses in children and adolescents.
Where our work has appeared
