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Abstract：
OBJECTIVE: To examine the current prevalence and cost of paediatric off-label drug prescriptions in Gansu, China, and the potential influencing factors.
METHODS: The prevalence of off-label prescriptions in paediatrics was evaluated according to the National Medical Products Administration drug instructions in the China Pharmaceutical Reference (China Pharmaceutical Reference, MCDEX) database. The evidence of the prescription was determined by existing clinical practice guidelines and the Thomson Grade in the Micromedex 2021 compendium. We used logistic regression to investigate the characteristics that influence paediatric off-label drug use after single-factor regression analysis.
METHODS: A multicentre cross-sectional study of outpatient paediatric prescriptions in 196 secondary and tertiary hospitals in Gansu Province, China, in March and September 2020.
RESULTS: We retrieved 104 029 paediatric prescriptions, of which 39 480 (38.0%) contained off-label use. The most common diseases treated by off-label drugs were respiratory system diseases (n=15 831, 40.1%). A quarter of off-label prescriptions had adequate evidence basis (n=10 130, 25.6%). Unapproved indications were the most common type of off-label drug use (n=25 891, 65.6%). A total of 1177 different drugs were prescribed off-label, with multienzyme tablets being the most common drug (n=1790, 3.5%). The total cost of the prescribed off-label drugs was ¥106 116/day. Off-label prescriptions were less frequent in tertiary than in secondary hospitals. Topical preparations were more commonly prescribed off-label than other types of drugs. Senior-level clinicians prescribed drugs off-label more often than intermediate and junior clinicians.
CONCLUSIONS: Off-label drug use is widespread in paediatric practice in China. Three-quarters of the prescriptions may potentially include inappropriate medication use, resulting in a daily economic burden of about ¥81 000 in 2020 in Gansu Province with 25 million inhabitants. The management of off-label drug use in paediatrics in China needs improvement.
METHODS: The prevalence of off-label prescriptions in paediatrics was evaluated according to the National Medical Products Administration drug instructions in the China Pharmaceutical Reference (China Pharmaceutical Reference, MCDEX) database. The evidence of the prescription was determined by existing clinical practice guidelines and the Thomson Grade in the Micromedex 2021 compendium. We used logistic regression to investigate the characteristics that influence paediatric off-label drug use after single-factor regression analysis.
METHODS: A multicentre cross-sectional study of outpatient paediatric prescriptions in 196 secondary and tertiary hospitals in Gansu Province, China, in March and September 2020.
RESULTS: We retrieved 104 029 paediatric prescriptions, of which 39 480 (38.0%) contained off-label use. The most common diseases treated by off-label drugs were respiratory system diseases (n=15 831, 40.1%). A quarter of off-label prescriptions had adequate evidence basis (n=10 130, 25.6%). Unapproved indications were the most common type of off-label drug use (n=25 891, 65.6%). A total of 1177 different drugs were prescribed off-label, with multienzyme tablets being the most common drug (n=1790, 3.5%). The total cost of the prescribed off-label drugs was ¥106 116/day. Off-label prescriptions were less frequent in tertiary than in secondary hospitals. Topical preparations were more commonly prescribed off-label than other types of drugs. Senior-level clinicians prescribed drugs off-label more often than intermediate and junior clinicians.
CONCLUSIONS: Off-label drug use is widespread in paediatric practice in China. Three-quarters of the prescriptions may potentially include inappropriate medication use, resulting in a daily economic burden of about ¥81 000 in 2020 in Gansu Province with 25 million inhabitants. The management of off-label drug use in paediatrics in China needs improvement.
摘要：
目的:了解甘肃省儿科超说明书用药的流行现状和费用,中国,以及潜在的影响因素。
方法：根据《中国药品参考》（中国药品参考，MCDEX)数据库。处方的证据由现有的临床实践指南和Micromedex2021汇编中的Thomson等级确定。单因素回归分析后，我们使用logistic回归分析影响儿科超说明书用药的特征。
方法:对甘肃省196家二级、三级医院门诊儿科处方进行多中心横断面研究,中国,2020年3月和9月。
结果：我们检索了104029张儿科处方，其中39480(38.0%)包含标签外使用。使用非说明书药物治疗的最常见疾病是呼吸系统疾病（n=15831，占40.1％）。四分之一的标签外处方有足够的证据基础(n=10130，25.6%)。未经批准的适应症是最常见的标签外药物使用类型（n=25891，65.6％）。总共有1177种不同的药物被处方在标签外，多酶片剂是最常见的药物（n=1790，3.5％）。处方外药物的总费用为日元106116/天。三级医院的处方处方频率低于二级医院。与其他类型的药物相比，外用制剂更常被处方。高级临床医生比中级和初级临床医生更经常地开处方。
结论：在中国儿科实践中，超说明书用药普遍存在。四分之三的处方可能包括不适当的药物使用，到2020年，甘肃省每天的经济负担约为81,000日元，人口为2500万。我国儿科超说明书用药管理有待改进
方法：根据《中国药品参考》（中国药品参考，MCDEX)数据库。处方的证据由现有的临床实践指南和Micromedex2021汇编中的Thomson等级确定。单因素回归分析后，我们使用logistic回归分析影响儿科超说明书用药的特征。
方法:对甘肃省196家二级、三级医院门诊儿科处方进行多中心横断面研究,中国,2020年3月和9月。
结果：我们检索了104029张儿科处方，其中39480(38.0%)包含标签外使用。使用非说明书药物治疗的最常见疾病是呼吸系统疾病（n=15831，占40.1％）。四分之一的标签外处方有足够的证据基础(n=10130，25.6%)。未经批准的适应症是最常见的标签外药物使用类型（n=25891，65.6％）。总共有1177种不同的药物被处方在标签外，多酶片剂是最常见的药物（n=1790，3.5％）。处方外药物的总费用为日元106116/天。三级医院的处方处方频率低于二级医院。与其他类型的药物相比，外用制剂更常被处方。高级临床医生比中级和初级临床医生更经常地开处方。
结论：在中国儿科实践中，超说明书用药普遍存在。四分之三的处方可能包括不适当的药物使用，到2020年，甘肃省每天的经济负担约为81,000日元，人口为2500万。我国儿科超说明书用药管理有待改进
