Evidence map›Paper›PMID 34180161›Full record

ArticleNeuropsychopharmacology reports2021

Medications for attention-deficit/hyperactivity disorder in Japan: A retrospective cohort study of label compliance.

Daniel Fife, Erica A Voss, Jill Hardin, Hany Rofael, Ira D Solomon, Patrick B Ryan, Paul Stang

Abstract read
In one paragraph

Article in Neuropsychopharmacology reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
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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

7 authors.

Daniel FifeDepartment of Epidemiology, Janssen Research & Development, LLC, Titusville, NJ, USA.
Erica A VossDepartment of Epidemiology, Janssen Research & Development, LLC, Titusville, NJ, USA.
Jill HardinDepartment of Epidemiology, Janssen Research & Development, LLC, Titusville, NJ, USA.
Hany RofaelEstablished Products, Janssen Research & Development, LLC, Titusville, NJ, USA.
Ira D SolomonEstablished Products, Janssen Research & Development, LLC, Titusville, NJ, USA.
Patrick B RyanDepartment of Epidemiology, Janssen Research & Development, LLC, Titusville, NJ, USA.
Paul StangDepartment of Epidemiology, Janssen Research & Development, LLC, Titusville, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo assess label compliance in prescription of medications approved for treatment of attention-deficit/hyperactivity disorder (ADHD) in Japan at the time of this study: methylphenidate (MPH), atomoxetine, and guanfacine.

methodsRetrospective descriptive study was conducted in prevalent-user cohorts from the Japan Medical Data Center database. Patients who were prescribed a study drug between January 1, 2013 and September 30, 2018 and were in the database for ≥30 days were included. A prescription was considered compliant if all 4 criteria were satisfied: appropriate age, daily dose not exceeding the approved maximum, no contraindicated concurrent medications, and no contraindicated conditions.

resultsAmong 17 418 patients who were prescribed a study drug during 2013-2018, 73% were male and 53% were children (aged <18 years). Fewer than 2% of prescriptions were for patients outside the approved age, 10%-13% of patients in the atomoxetine and MPH cohorts received ≥1 prescription exceeding maximum approved dose, no patients were co-prescribed a contraindicated medication, and 16%-18% of patients in the MPH cohorts had ≥1 contraindicated condition. During their first 500 days of use, for approximately 73%-86% of patients, all prescriptions were compliant with all label requirements.

conclusionsAmong patients exposed to ADHD medications in Japan during 2013-2018, nearly all prescriptions for these medications were label-compliant for age. For >85% of patients, all prescriptions were label-compliant for dose, and for approximately 80%, all prescriptions were label-compliant for contraindicated conditions. We did not find evidence of widespread abuse or noncompliant use of prescribed ADHD medications.

Indexed as

Attention Deficit Disorder with HyperactivityCentral Nervous System StimulantsMethylphenidatePharmaceutical PreparationsAtomoxetine HydrochlorideChildHumansJapanMaleRetrospective StudiesAtomoxetine HydrochlorideCentral Nervous System StimulantsMethylphenidatePharmaceutical PreparationsatomoxetineguanfacineJMDClabel compliancemethylphenidate

Identifiers

PMID34180161
PMCPMC8411317

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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.