DataSheet1_Prevalence of use of on-label and off-label psychotropics in the Greek pediatric population.docx

With a global increased use of psychotropics in pediatrics, their off-label use is a concern due to uncertainty and risk. Data on psychotropics use in the Greek pediatric population do not exist to date. We analyzed retrospective data from the nationwide pharmacy claim database, to estimate the prevalence of psychotropics in pediatrics focusing on off-label use (March 2016-October 2019). In total 63,782 pediatric subjects had at least one identified psychotropic prescription. The prevalence of psychotropics use was 5.1–14.6/1,000 pediatric inhabitants. When excluding 42,508 subjects who received only short-time hydroxyzine, the prevalence was 3.1–6.5/1,000 pediatric inhabitants; adolescents and boys had higher exposures. An in-depth analysis of 21,274 subjects accounting for 222,307 psychotropic dispensations, showed antiepileptics as the most frequent psychotropics, consistently with the finding on epilepsy being the most frequent diagnosis; diazepam was the single drug with the highest exposure in almost all ages. 14% of subjects have received at least one medicine with no pediatric information in the labelling, corresponding to 5.5% of dispensed psychotropics. 7.6% of all dispensed psychotropics were used in a non-authorized age range with quetiapine being the most frequent psychotropic as off-label age range; antipsychotics and antidepressants were first as off-label for non-authorized indication. Data from Greece show that a relevant number of patients are prescribed psychotropics, with 1 in 7 being under off-label use. Due to the limitations inherent to pharmacy claims databases, further research using clinical data for a longer follow-up period could confirm and identify trends in psychotropics use in Greece.

在全球范围内精神活性药物在儿科领域的使用日益增多之际，其超适应症使用引起了广泛关注，原因在于其不确定性和潜在风险。截至目前，关于希腊儿科人群精神活性药物使用的数据尚不存在。本研究通过对全国药店索赔数据库的回顾性数据分析，旨在估算儿科领域精神活性药物的使用普遍性，并重点关注其超适应症使用情况（时间范围：2016年3月至2019年10月）。总计63,782名儿科患者至少有一次被识别出的精神活性药物处方。精神活性药物的使用普遍性为5.1-14.6/1,000名儿科居民。当排除仅接受短时羟嗪治疗的42,508名患者后，普遍性为3.1-6.5/1,000名儿科居民；青少年和男童的暴露程度较高。对21,274名患者的深入分析，涉及222,307次精神活性药物配给，结果显示抗癫痫药是使用频率最高的精神活性药物，这与癫痫病为最常见的诊断结果相一致；地西泮在几乎所有年龄段中均具有最高的暴露程度。14%的患者至少接受过一种在标签上缺乏儿科信息的药物，相当于所有配发的精神活性药物的5.5%。7.6%的所有配发精神活性药物在非授权的年龄范围内被使用，其中喹硫平是最常见的非授权年龄范围的精神活性药物；抗精神病药和抗抑郁药首先被用于非授权的指征。希腊的数据表明，相当数量的患者被开具了精神活性药物处方，其中每7名患者中就有1名处于超适应症使用状态。鉴于药店索赔数据库固有的局限性，进一步的研究，采用临床数据并延长随访期，有助于证实并识别希腊精神活性药物使用趋势。