| ACIP moved hepatitis B vaccination of infants born to uninfected mothers from a universal birth dose to shared clinical decision-making in December 2025, with further modification by HHS in January 2026. The Pediatric Pharmacy Association recommends continuing the universal birth dose strategy.1 |
| Lumbar puncture analgesia in neonates requires both a systemic and a local agent given concurrently, about 45 minutes before the procedure. Oral sucrose is not adequate for moderately painful procedures. |
| The FDA cleared Dexcom's Stelo Glucose Biosensor System, the first over-the-counter continuous glucose monitor for children 2 years and older who do not use insulin. The same device was approved for adults in March 2024.2 |
Newborns infected with hepatitis B have a 90% risk of developing chronic infection compared with 5% in adults, and CDC data indicate that 25% of those infected in early life die prematurely from a hepatitis B-related complication such as liver disease or liver cancer. Perinatal transmission is the major route, but horizontal transmission accounted for 46-68% of pediatric cases before universal vaccination, a risk amplified by an estimated 50% of infected individuals in the United States being unaware of their status.
Universal infant vaccination reduced the rate of pediatric hepatitis B disease from 0.7-0.9 per 100,000 between 1986 and 1990 to 0.1 per 100,000 by 2000. Maternal screening remains incomplete, with only 84-86% of pregnant women tested between 2015 and 2020, and many diagnostic tests fail to detect escape mutant strains. The American Academy of Pediatrics and American Academy of Family Physicians immunization schedules have not changed, and no new safety concerns or changes to the vaccine's efficacy assessment have been identified.1
Limitation: This is a position paper drawing on observational and historical data; clinicians should consult the full document and the cited primary sources for evidence grading.
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Clinical Implication
The shared clinical decision-making pathway adds parallel workflows and increases the likelihood of missed doses. Institutions should confirm that birth-dose order sets and parent education materials reflect that the AAP and AAFP schedules are unchanged and that pharmacists can conduct these vaccine conversations with caregivers.
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Lumbar puncture is a moderately painful invasive procedure. Inadequate analgesia produces neonatal stress responses that may alter cerebrospinal fluid dynamics and reduce diagnostic value. Effective pain prevention requires both systemic and a local pharmacologic agents given concurrently, approximately 45 minutes before the procedure. Oral sucrose is not appropriate for moderately painful procedures.
| Agent | Dose | Role |
|---|---|---|
| Fentanyl | 0.5 to 3 mcg/kg IV | Systemic analgesia |
| Dexmedetomidine | 1 mcg/kg IV | Systemic analgesia (alternative) |
| Lidocaine 1% preservative-free | Infiltrate, max 0.8 mL | Local infiltration |
| EMLA cream | Topical | Local adjunct |
A systemic agent is paired with local infiltration, with topical EMLA cream as an optional adjunct. The combined regimen is administered about 45 minutes before the procedure to allow onset.
| Bottom line: Pair a systemic agent (fentanyl or dexmedetomidine) with local lidocaine infiltration and topical EMLA cream, given about 45 minutes before lumbar puncture. Oral sucrose is not adequate for this indication. |
Dexcom Stelo Glucose Biosensor System Cleared Over the Counter for Children 2 Years and Older Who Do Not Use Insulin
On June 12, the FDA cleared the Dexcom Stelo Glucose Biosensor System, the first over-the-counter continuous glucose monitor for children, indicated for people 2 years and older who do not use insulin. The same device was approved for adults in March 2024. The wearable sensor pairs with a smartphone app that displays glucose measurements and trends every 15 minutes, with each sensor lasting up to 15 days, though wear time may be shorter in pediatric users.2
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What This Means in Practice
The system is not for people who use insulin, is not designed to alert for problematic hypoglycemia, and is not for patients on dialysis. Children should use it under adult supervision, families with a history of disordered eating should consult a provider first, and medication changes should not be made on device output alone.
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- Girotto JE, Fly JH, Warminski S, Forster J, Oz T. Why the birth dose matters for hepatitis B vaccination. J Pediatr Pharmacol Ther. 2026;31(1):102-105.
- FDA clears first over-the-counter continuous glucose monitor for children. US Food and Drug Administration. June 12, 2026. Accessed June 22, 2026. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor-children
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