| 刘明玉,张四喜,宋燕青.新生儿科住院患者超说明书用药分析[J].中国药事,2018,32(3):404-411 |
| 新生儿科住院患者超说明书用药分析 |
| Analysis of Off-label Drug Use of Inpatients of Neonatology Department |
| 投稿时间：2017-07-19 |
| DOI：10.16153/j.1002-7777.2018.03.019 |
| 中文关键词: 超说明书用药 新生儿科 住院患儿 用药分析 |
| 英文关键词: off-label drug use neonatology department inpatients medication analysis |
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| 中文摘要: |
| 目的：调查吉林大学第一医院2014年10月-2015年9月新生儿科300例住院患者超说明书用药情况，为开展新生儿科药学服务，促进新生儿合理用药提供依据。方法：调取我院新生儿科2014年10月-2015年9月期间共4225名住院患者，随机抽取300名病例，根据药品说明书及相关文献，判断医嘱是否存在超说明书用药，对患儿基本信息、药物使用情况及超说明书用药情况进行统计与分析。结果：抽取的300名新生儿病例，共纳入5793条医嘱，涉及145种药品。按患儿人数、用药医嘱条数进行统计，超说明书用药发生率分别为99.7%、59.2%。超说明书用药类型主要包括未提及新生儿用药信息（68.5%）、超剂量（24.5%）、超适用人群（3.1%）、超禁忌证（1.91%）、超频次（1.1%）、超适应证（0.93%）。结论：我院新生儿住院患者超说明书用药现象较常见，一方面反映了药品说明书中新生儿用药信息严重缺乏，针对新生儿的药品太少，应当引起相关部门的重视；另一方面提示医师要严格把握说明书规定的适应证、用法用量、禁忌证，减少超说明书用药，保障新生儿安全用药和规避医师职业风险。 |
| 英文摘要: |
| Objective: To survey the situation of off-label drug use of 300 inpatients in the neonatology department of the First Hospital of Jilin University from October, 2014 to September, 2015 in order to provide references for carrying out pharmacy service and improving the rational drug use in the neonatology department. Methods: 300 were randomly selected from a total of 4225 inpatients in the neonatology department from October, 2014 to September, 2015. Whether off-label drug use existed in the prescriptions was determined by the package inserts and related documents. The basic information of patients, usage of drugs and off-label drug use were analyzed. Results: There were 5793 prescriptions and 145 drugs in total. The rate of off-label drug use was 99.7% and 59.2% respectively according to the number of inpatients and the number of prescriptions. The kinds of off-label drug use consisted of neonatal drug information without being mentioned (68.5%), overdose (24.5%), super applicable population (3.1%), over contraindications (1.91%), over frequency (1.1%) and over indications (0.93%). Conclusion: Off-label drug use in the neonatology department of our hospital was common, indicating serious lack of neonatal medication information in the package inserts. On the other hand, doctors should be reminded to strictly follow the indications, usage and contraindications stipulated in the package inserts so as to reduce the off-label drug use, to ensure the medication safety of newborns and to avoid occupational risks of doctors. |
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