Evidence map›Paper›PMID 41390441›Full record

ReviewItalian journal of pediatrics2025

Beyond the label: ethical and clinical implications of off-label drug use in pediatric emergency care.

Marco Colombo, Anna Plebani, Massimo Agosti

Abstract readCase ReportsReview
In one paragraph

Review in Italian journal of pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Marco ColomboPediatric Emergency Department, Filippo del Ponte Hospital, ASST Sette Laghi, Varese, Italy. dott.marco.colombo@gmail.com.ORCID http://orcid.org/0000-0003-4947-519X
Anna PlebaniPediatric Emergency Department, Filippo del Ponte Hospital, ASST Sette Laghi, Varese, Italy.
Massimo AgostiDepartment of Medicine and Surgery, University of Insubria, Varese, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Off-label prescribing, the use of medications outside of approved indications, is a common practice in pediatric emergency medicine. This practice is driven by factors such as limited pediatric-specific clinical trial data, regulatory hurdles, and the urgent need to treat critically ill children. While off-label prescribing can be lifesaving, it raises significant ethical and legal concerns. This article explores the prevalence, challenges, and potential consequences of off-label drug use in pediatric emergency departments. A case study illustrates the complexities of off-label prescribing in a real-world clinical scenario. The discussion highlights the importance of balancing clinical needs with regulatory requirements and ethical considerations. Future research should focus on optimizing informed consent procedures, enhancing postmarketing surveillance, and developing evidence-based guidelines to ensure the safe and effective use of off-label medications in pediatric emergency care.

Indexed as

Emergency Service, HospitalOff-Label UseChildHumansAdverse drug reactionsClinical practiceDrug regulationDrug safetyEvidence-based medicineHealthcare policyInformed consentOff-label medicationsPediatric emergency medicinePediatric pharmacology

Identifiers

PMID41390441
PMCPMC12817774

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.