Evidence map›Paper›PMID 37695707›Full record

ArticleHealthcare policy = Politiques de sante2023

Reforming Paediatric Drug Regulations in Canada: A Clinical and an Access Imperative.

Charlotte Moore Hepburn, Allison A Chang, Deborah M Levy

Abstract read
In one paragraph

Article in Healthcare policy = Politiques de sante, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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.

Charlotte Moore HepburnAssociate Professor Division of Paediatric Medicine The Hospital for Sick Children Adjunct Professor Institute of Health Policy, Management and Evaluation University of Toronto Toronto, ON.
Allison A ChangCandidate Department of Social Work King's University College University of Western Ontario London, ON.
Deborah M LevyAssociate Professor Department of Paediatrics Temerty Faculty of Medicine University of Toronto Clinical Director Division of Rheumatology The Hospital for Sick Children Toronto, ON.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Children deserve the same high standards for drug safety, efficacy and access as adults. Unfortunately, Canada lags behind leading international regulators in implementing reforms to ensure access to paediatric medications. Paediatric regulations, also known as paediatric rules in the US, include a mandate to submit paediatric data in all new drug applications when paediatric use can be anticipated. Absent paediatric regulations, many medications with paediatric-specific indications in other countries remain "off-label" for Canadian children. In addition to concerns related to off-label drug safety, the absence of paediatric indications prohibits appropriate paediatric-specific health technology assessments and limits the evidence-based listing of paediatric medications on public and private formularies.

Indexed as

Drug and Narcotic ControlOff-Label UseAdultCanadaChildHumans

Identifiers

PMID37695707
PMCPMC10519333

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.