《国家基本药物目录》(2012年版)儿童用药超说明书使用现状分析

Analysis of the Pediatric Off-label Use of Medicines in 2012 Edition of National Essential Medicine List

目的通过调查研究我国《国家基本药物目录》(2012年版)化学药品和生物制品药品儿童用药超说明书使用现状,分析超说明书用药产生的原因,提出解决儿童用药超说明书使用的建议。方法采用问卷调查法在全国10家三甲儿童医院进行超说明书用药调查,调查结果采用Excel 2007软件进行数据计算和统计分析。结果《国家基本药物目录》(2012年版)儿童用药超说明书使用涉及20个类别药品、22个剂型,占全部药品类别的80%;无儿童用法用量(62.95%)是导致的超说明书用药主要原因;超说明书用药的类型主要表现在超适应证用药(85.94%)和超给药途径用药(66.96%),而有药理作用无适应证占超适应证用药的占45.63%;超说明书用药中34.60%的依据来源于《中国国家处方集(化学药品和生物制品卷·儿童版)》及中华人民共和国药典《临床用药须知》(2010年版);超说明书用药的品种通过Micromedex数据库检索,59.36%的药品FDA与非FDA推荐有适应证,其中27.10%有儿童用法用量。结论《国家基本药物目录》(2012年版)儿童用药超说明书使用普遍存在,亟待采取有效措施解决儿童用药超说明书使用问题。

OBJECTIVE To investigate and study the 2012 edition of National Essential Medicine List chemical medicines and biological products off-label drug use in pediatrics, analyze the causes of off-label use of medications, provide the suggestion for off-la- bel drug use in pediatrics. METHODS To adopt questionnaire survey in different regions of the 10 third-grade class-A children＇s hospital off-label use of medications in 2012 edition of National Essential Medicine List chemical medicines and biological products of 309 types which excluded obstetrics and gynecology medication, family planning administration and national immunization programs with vaccine from 317 types. Excel 2007 software is used for data calculation and statistical analysis. RESULTS ①20 categories, 22 dosage forms, which accounted for 80% of all drug categories are involved in off-label use of medications in 2012 edition of National Essential Medicine List. ②Lack of children＇s dosage （62. 95% ） is mainly responsible for off-label of drugs. Off-label use of medica- tions mainly manifest in off-labeling with pediatric indications （ 85.94% ） , of which labeling with pharmacological action without indi- cation （45.63%） is the main type, and off-labeling with route of medication （66. 96% ）. ③ 2013 edition of Chinese National Formu- lary（ Chemical and Biological Products for Children）and 2010 edition of Chinese Pharmacopoeia of Clinical Medication Information are the main evidence for off-label drug use, account for 34. 60% of the total number of cases.④ 147 types of medicines which involved in off-label use are searched in a database named Micromedex. Indications have been approved by the the US Food and Drug Adminis- tration （FDA） or not which labeling with children＇s dosage account for 27. 10% of the total number of indications. CONCLUSION Off-label drug use in the 2012 edition of National Essential Medicine List is an important public health issue for children. It reflects the lack of labeling with pediatric information. It is suggested that joint efforts should be paid by departments concerned and more support be provided to further improve the policy for children＇s medication.