School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
School of Health Sciences, Faculty of Medicine and Health Sciences, School of Health Sciences, University of Nottingham, Nottingham, United Kingdom.
J Child Adolesc Psychopharmacol. 2021 May;31(4):294-309. doi: 10.1089/cap.2020.0154. Epub 2021 Feb 18.
To determine the differences in information between prescribing guidelines and drug labeling, as well as to compare the approval of psychotropic medicines for major depression in pediatric patients ("pediatric depression") across countries. The recommendations of The Maudsley Prescribing Guidelines in Psychiatry (MPGP) for the treatment of pediatric depression (<18 years) were compared against the regulatory-approved drug-labeling documents from the United Kingdom, Australia, New Zealand, Canada, and the United States. The use of medicines outside of their regulatory approval is defined as off-label use, so differences between the drug labeling and MPGP were characterized according to unapproved age, indication, dosage, or route of administration. Information in the drug labeling was also compared across countries. MPGP provides recommendations for 6 medicines for the treatment of pediatric depression, for which, 30 drug labeling were retrieved. Three of 30 drug labeling were consistent with MPGP recommendations (fluoxetine in the United Kingdom, fluoxetine and escitalopram in the United States). Differences in information between MPGP and the drug labeling were identified in 26 of 30 drug labeling analyzed, most often due to age (24/26) followed by indication (2/26). No differences pertaining to dosage or route of administration information were identified. The number of approved psychotropic medicines varied across the studied countries and we found cross-country discrepancies in information in the drug labeling. Significant differences in information exists between MPGP and the drug labeling for psychotropic medicines for pediatric depression, due to unapproved ages or indications. Additionally, approval information in the drug labeling are not consistent across countries. Further research into reasons for variability and impact on practice may be warranted.
为了确定处方指南和药品标签之间的信息差异，并比较不同国家对儿童抑郁症（“儿童抑郁症”）的精神类药物的批准情况。将《莫兹利精神病学处方指南》（MPGP）治疗儿童抑郁症（<18 岁）的建议与英国、澳大利亚、新西兰、加拿大和美国的监管批准的药品标签文件进行了比较。药品标签外的使用被定义为标签外使用，因此根据未经批准的年龄、适应证、剂量或给药途径来描述药品标签和 MPGP 之间的差异。还比较了各国药品标签中的信息。MPGP 为治疗儿童抑郁症推荐了 6 种药物，共检索到 30 种药品标签。在这 30 种药品标签中，有 3 种（英国的氟西汀、美国的氟西汀和依地普仑）与 MPGP 的建议一致。在所分析的 30 种药品标签中，有 26 种药品标签与 MPGP 之间存在信息差异，最常见的是年龄差异（24/26），其次是适应证差异（2/26）。没有发现剂量或给药途径信息的差异。研究国家批准的精神类药物数量不同，我们发现药品标签中的信息在各国之间存在差异。由于未批准的年龄或适应证，MPGP 和药品标签之间的精神类药物治疗儿童抑郁症的信息存在显著差异。此外，药品标签中的批准信息在各国之间并不一致。进一步研究引起差异的原因和对实践的影响可能是必要的。
