Investigating Variations in Medicine Approvals for Attention-Deficit/Hyperactivity Disorder: A Cross-Country Document Analysis Comparing Drug Labeling

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  • Author(s): Laila Tanana (ORCID Laila Tanana (ORCID 0000-0003-1194-0180); Asam Latif; Prasad S. Nishtala; Timothy F. Chen
  • Language:
    English
  • Source:
    Journal of Attention Disorders. 2024 28(11):1437-1453.
  • Publication Date:
    2024
  • Document Type:
    Journal Articles
    Information Analyses
    Reports - Research
  • Additional Information
    • Availability:
      SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: [email protected]; Web site: https://sagepub.com
    • Peer Reviewed:
      Y
    • Source:
      17
    • Subject Terms:
      Medicine; Drug Therapy; Attention Deficit Hyperactivity Disorder; Merchandise Information; Pediatrics; Patients; Foreign Countries
    • Subject Terms:
      United Kingdom; Australia; New Zealand; Canada; United States
    • Accession Number:
      10.1177/10870547231224088
    • ISSN:
      1087-0547
      1557-1246
    • Abstract:
      Objective: This study aimed to compare the approval of medicines for attention deficit/hyperactivity disorder (ADHD) for pediatric patients across five countries. Method: A document analysis was completed, using the drug labeling for ADHD medicines from five countries; United Kingdom, Australia, New Zealand, Canada and United States (US). Comparisons of available formulations and approval information for ADHD medicine use in pediatric patients were made. Results: The US had the highest number of approved medicines and medicine forms across the studied countries (29 medicine forms for 10 approved medicines). Approved age and dosage variations across countries and missing dosage information were identified in several drug labeling. Conclusions: The discrepancies in approval information in ADHD medicine drug labeling and differing availability of medicine formulations across countries suggest variations in the management of ADHD across countries. The update of drug labeling and further research into reasons for variability and impact on practice are needed.
    • Abstract:
      As Provided
    • Publication Date:
      2024
    • Accession Number:
      EJ1435927