调查注意力缺陷/多动症药物审批的差异：比较药物标签的跨国文件分析。

IF 2.7 3区医学 Q2 PSYCHIATRY

Journal of Attention Disorders Pub Date : 2024-09-01 Epub Date: 2024-02-07 DOI:10.1177/10870547231224088

Laila Tanana, Asam Latif, Prasad S Nishtala, Timothy F Chen

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引用次数: 0

摘要

研究目的本研究旨在比较五个国家批准治疗儿童注意力缺陷/多动症（ADHD）药物的情况：方法：利用英国、澳大利亚、新西兰、加拿大和美国五个国家的注意力缺陷多动障碍（ADHD）药物标签完成了文件分析。方法：利用英国、澳大利亚、新西兰、加拿大和美国五个国家的多动症药物标签完成了文件分析，比较了儿科多动症药物的现有配方和批准信息：结果：在所研究的国家中，美国批准的药物和剂型数量最多（10 种批准药物的 29 种剂型）。在多个国家的药品标签中发现了获批年龄和剂量的差异以及剂量信息的缺失：结论：ADHD 药物标签中批准信息的差异以及各国药物剂型供应的不同表明，各国对 ADHD 的管理存在差异。需要对药物标签进行更新，并进一步研究产生差异的原因和对实践的影响。

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

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.

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来源期刊

Journal of Attention Disorders PSYCHIATRY-

CiteScore

7.60

自引率

6.70%

发文量

审稿时长

6-12 weeks

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.