Laboratory for Mother and Child Health, Department of Public Health - Istituto di Ricerche Farmacologiche Mario Negri IRCSS, Via Giuseppe La Masa 19, 20156, Milan, Italy.
Eur J Clin Pharmacol. 2019 Jun;75(6):769-776. doi: 10.1007/s00228-019-02641-0. Epub 2019 Feb 7.
Drug use in the pediatric population still often features off-label prescriptions, particularly for psychotropic drugs. We reviewed the registration status, scientific evidence, and recommendations from the guidelines for antipsychotics used for psychiatric disorders in children.
Antipsychotic drugs marketed in Italy, the United Kingdom (UK) and United States (US) were identified with the ATC Classification System. The licensing status and Summary of Product Characteristics (SPC) were taken from the national formularies. We analyzed reviews and guidelines on antipsychotics use in children and adolescents in the MEDLINE, EMBASE, and PsycINFO databases.
Out of 67 drugs, 19 were marketed with a pediatric license in at least one country: three in all the selected countries, and only paliperidone with the same indications. Haloperidol was the only antipsychotic authorized for autism in Italy and the UK, and as well as risperidone and aripiprazole in the US. Aripiprazole and paliperidone were licensed in all three countries for schizophrenia. Aripiprazole was licensed for bipolar disorders in all three countries. Haloperidol was licensed for Tourette syndrome in Italy and the UK, and pimozide and aripiprazole in the US. We retrieved 21 pertinent reviews and 13 guidelines for the management of neuropsychiatric disorders in pediatrics. There was a complete overlap between the authorized therapeutic indications and the available scientific evidence for autism in the US, for conduct disorders and bipolar disorders in the UK, and for Tourette syndrome and tics in the UK and Italy.
These results highlight the different regulatory processes that deny to many children and adolescents the most appropriate and rational antipsychotic therapy.
儿科人群中的药物使用仍常常涉及超适应证处方，尤其是精神药物。我们回顾了用于儿童精神障碍的抗精神病药物的注册状况、科学证据和指南推荐。
通过 ATC 分类系统确定了在意大利、英国和美国上市的抗精神病药物。从国家处方集获取了许可状态和产品特性摘要（SPC）。我们分析了 MEDLINE、EMBASE 和 PsycINFO 数据库中关于儿童和青少年抗精神病药物使用的综述和指南。
在 67 种药物中，有 19 种在至少一个国家获得了儿科许可：三种在所有选定的国家都有，只有帕利哌酮具有相同的适应证。氟哌啶醇是意大利和英国唯一获准用于自闭症的抗精神病药物，也是美国获准用于自闭症的利培酮和阿立哌唑。阿立哌唑和帕利哌酮在这三个国家都获得了精神分裂症的许可。阿立哌唑在这三个国家都获得了双相情感障碍的许可。氟哌啶醇在意大利和英国获准用于抽动秽语综合征，而匹莫齐特和阿立哌唑在美国获准用于该疾病。我们检索到了 21 篇相关综述和 13 篇儿科神经精神障碍管理指南。在美国，自闭症的授权治疗适应证与可用的科学证据完全一致；在英国，品行障碍和双相情感障碍的情况相同；在英国和意大利，抽动秽语综合征和抽动的情况相同。
这些结果突出了不同的监管程序，这些程序使许多儿童和青少年无法获得最合适和合理的抗精神病药物治疗。
