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

Abstract

Aim: To 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.

Methods: Retrospective 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.

Results: Among 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.

Conclusions: Among 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.

Trial registration: ClinicalTrials.gov NCT04113551.

Keywords: JMDC; atomoxetine; guanfacine; label compliance; methylphenidate.

Conflict of interest statement

All authors are employees of Janssen Research & Development, LLC, and may own stock and/or stock options. The work on this study was part of their employment. The company manufactures Concerta®.

© 2021 Janssen Research & Development, LLC. Neuropsychopharmacology Reports published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Neuropsychopharmacology.

Figures

FIGURE 1
FIGURE 1
Patient disposition. †Not excluded were 3 patients who received MPH that was not specified as MPH‐C or MPH‐R; these patients also received atomoxetine. They were included in the ATO cohort but excluded from the MPH cohorts. ‡From January 1, 2013 to September 30, 2018. ATO, atomoxetine; GFC, guanfacine; JMDC, Japanese Medical Data Center; MPH, methylphenidate; MPH‐C/R, methylphenidate that is MPH‐C (Concerta®) or MPH‐R (Ritalin®)
FIGURE 2
FIGURE 2
Label compliance over time. Note: A patient was considered noncompliant when 1 or more of the 4 compliance criteria for the respective drugs (age, maximum daily dose, contraindicated medications, and contraindicated conditions [see Table S1]) were not satisfied. MPH‐C, methylphenidate (Concerta®); MPH‐R, methylphenidate (Ritalin®); MPH‐C + R, MPH‐C, and MPH‐R

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Source: PubMed

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