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.

随着全球范围内精神药物在儿科领域的广泛应用，其非适应症使用引起了广泛关注，这主要源于其不确定性和潜在风险。截至目前，关于希腊儿科人群中精神药物使用的数据尚不存在。本研究通过分析全国药店索赔数据库的回顾性数据，旨在估计儿科领域精神药物的使用普及率，尤其关注其非适应症使用情况（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精神药物处方。精神药物的使用普及率为5.1-14.6/1,000名儿科居民。在排除仅接受短时羟嗪治疗的42,508名患者后，普及率降至3.1-6.5/1,000名儿科居民；青少年和男性患者的暴露率较高。对21,274名患者的深入分析，涉及222,307次精神药物配给，发现抗癫痫药是最常见的精神药物，这与癫痫病作为最常见的诊断结果相符；地西泮在几乎所有年龄段都是暴露率最高的单一药物。14%的患者至少接受过一种在标签上缺乏儿科信息的药物，相当于配发的精神药物中占5.5%。7.6%的所有配发精神药物被用于非授权的年龄范围内，喹硫平是最常见的在非授权年龄范围内使用的非适应症精神药物；抗精神病药和抗抑郁药首次被用于非授权的适应症。希腊的数据显示，相当数量的患者被处方精神药物，其中1/7的患者处于非适应症使用状态。鉴于药店索赔数据库固有的局限性，采用临床数据进行更长期跟踪的研究有助于进一步确认和识别希腊精神药物使用趋势。