Investigating Variations in Medicine Approvals for Attention-Deficit/Hyperactivity Disorder: A Cross-Country Document Analysis Comparing Drug Labeling.
Laila Tanana, Asam Latif, Prasad S Nishtala, Timothy F Chen
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引用次数: 0
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.
期刊介绍：
Journal of Attention Disorders (JAD) focuses on basic and applied science concerning attention and related functions in children, adolescents, and adults. JAD publishes articles on diagnosis, comorbidity, neuropsychological functioning, psychopharmacology, and psychosocial issues. The journal also addresses practice, policy, and theory, as well as review articles, commentaries, in-depth analyses, empirical research articles, and case presentations or program evaluations.
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