基于循证药学的儿科门诊超说明书用药调查

Investigation on the off-label drug use in pediatric outpatients based on evidence-based pharmacy

目的调查我院儿科门诊超说明书用药现状,为医院制定儿童超说明书用药规范提供依据。方法采用合理用药软件从本院儿科门诊2017年处方中随机抽取5%的处方,根据药品说明书的内容,判断用药医嘱是否存在超说明书用药,并统计超说明书用药发生率、类型、年龄分布、药物类别分布和医生分布等情况,同时采用循证药学的方法,对超说明书用药进行合理性评价。结果共抽取到儿科门诊处方4702张,包含12397条用药医嘱,涉及药物136种,其中处方、医嘱和药品超说明书用药的比例分别为72.27%、44.21%、69.85%;超说明书用药类型主要为超给药剂量(43.85%)和超适用人群(27.21%);超说明书用药年龄段排名最高为新生儿(63.64%),其次为婴幼儿(45.27%);超说明书用药发生率超过平均水平的药品种类由高到低依次为维生素和矿物质类用药(71.88%),糖类、盐类和酸碱平衡调节药(66.17%),解热镇痛抗炎药(65.87%),消化系统用药(56.61%),中成药(45.96%);超说明书用药医生职称排名:初级医师发生率最高(46.79%),主治医师发生率最低(40.73%);超说明书用药循证证据中,级别较高的一级证据主要来源于国内外医学和药学学术机构发布的指南,二级证据主要来源于《中国国家处方集(化学药品和生物制品卷·儿童版)》、中国药典《临床用药须知(2015年版)》和《新编药物学》等,两者合计占超说明书医嘱总数的33.68%,无循证依据可查的占47.36%。结论2017年我院门诊儿科超说明书用药情况较为普遍,超说明书用药循证证据级别普遍偏低,需要建立相关规范,保障儿童合理用药。

Objective To investigate the current situation of off-label drug use in pediatric outpatient department of our hospital, and to provide evidence for policy-making of off-label drug use in children. Methods By using the rational drug software,5% of the prescriptions in pediatric outpatient department in 2017 were randomly selected. Off-label prescription was determined according to the drug instructions, and the incidence rate, type, age distribution, drug category and doctor title distribution respectively. The evidence-based pharmacy method was used to evaluate the rationality of off-label drug use. Results A total of 4 702 prescriptions in pediatric outpatient department were collected, including 12 397 medication orders and involving 136 drugs,o f which the proportions of prescriptions,medical orders and drugs were 72. 27%, 44. 21% and 69. 85%, respectively. The primary types of off-label drug use were overdose ( 43. 85%) and over-applied population ( 27. 21%);the top age group was neonates ( 63. 64%),followed by infants ( 45. 27%);the category of drugs with a higher incidence were vitamins and minerals ( 71. 88%), sugars, salts and acid-base balance regulators ( 66. 17%), antipyretic analgesic and anti-inflammatory medicine ( 65. 87%),digestive system medication ( 56. 61%) and Chinese patent drug ( 45. 96%);the primary physicians had the highest proportion ( 46. 79%), and the attending physician had the lowest ( 40. 73%);in the evidence-based evidence, the first-level evidence mainly came from the guidelines issued by medical and pharmaceutical academic institutions at home and abroad, and the second-level evidence mainly came from the Chinese National Formulary ( Chemical and Biological Products for Children), the Chinese Pharmacopoeia“Notes on Clinical Use of Drugs ( 2015 Edition)”and“New Drugs”and other pharmacy monographs;the two together accounted for 33. 68%, and those without evidence-based evidence accounted for 47. 36%. Conclusion Off-label drug use in pediatric outpatient department of our hospital is common in 2017. The grade of evidence-based evidence is generally low, and it is necessary to establish relevant regulations to ensure the children's rational use of drugs.