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我院46份皮肤外用药品说明书中儿童用药标注情况分析
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| 篇名： | 我院46份皮肤外用药品说明书中儿童用药标注情况分析 |
| TITLE： | |
| 摘要： | 目的：了解我院皮肤外用药品说明书中儿童用药标注存在的问题并提出建议。方法：收集我院门诊药房2018年1－12月皮肤外用药品说明书46份，对药品说明书中儿童用药、儿童注意事项、儿童用法用量、儿童药动学的标注情况进行统计，并按国产、进口、合资制药企业类型，西药、中成药分类以及标识内容的明确性等内容进行汇总分析。结果：46份药品说明书中，来自西药37份，中成药9份；涉及国产企业31家，进口企业9家，合资企业6家。国产药品儿童用药、儿童注意事项、儿童用法用量、儿童药动学标注率分别为38.7％、58.1％、29.0％、0，进口药品标注率分别为88.9％、55.6％、44.4％、33.3％，合资药品标注率分别为33.3％、83.3％、16.7％、0；西药标注率分别为59.5％、62.2％、32.4％、8.1％，中成药标注率分别为0、55.6％、22.2％、0；有明确的儿童用法用量的有5份（10.9％），用法用量涉及儿童的有12份（26.1％），提醒儿童在医师/成人监护下使用的有12份（26.1％），儿童用药尚不明确、儿童用药安全性尚未确立的有11份（23.9％），提示儿童慎用、禁用的有1份（2.2％），未涉及儿童用药说明的有3份（6.5％），置于儿童不能触及的地方存放的有2份（4.3％）。结论：我院皮肤外用药品说明书中存在儿童用药标注率差异较大、儿童用药项标注的内容模糊不清和缺乏药动学数据、药品说明书前后内容不一致且使用专业术语致患者不易理解等问题。建议可从药品监管部门加强药品说明书的监督管理、加大儿童专用药品的研发力度、提高制药企业对儿童用药的关注度并规范药品说明书修订以及推进儿童临床试验、提高患者及使用者安全用药意识等方面，来提高药品说明书中儿童用药标注的规范性、严谨性、指导性。 |
| ABSTRACT： | OBJECTIVE： To investigate the labelling problems of pediatric medication in the package inserts of skin external drugs in our hospital， and to put forward the suggestions. METHODS： A total of 46 package inserts for skin external medicine were collected from outpatient pharmacy of our hospital during Jan.-Dec. in 2018. Information on pediatric medication， precautions for pediatric medication， pediatric usage and dosage， and pediatric pharmacokinetic labelling in those package inserts was analyzed and summarized according to the types of domestic， imported and joint enterprises， classification of western medicine and Chinese patent medicine and labelling clarity， etc. RESULTS： Among 46 package inserts， 37 western medicines and 9 Chinese patent medicines were included； 31 domestic enterprises， 9 import enterprises and 6 joint ventures were involved. The ratio of pediatric medication， precautions （for pediatric medication）， pediatric usage and dosage， and pediatric pharmacokinetics labelling were 38.7％， 58.1％， 29.0％ and 0 for domestic drugs； 88.9％， 55.6％， 44.4％ and 33.3％ for imported drugs； 33.3％， 83.3％， 16.7％ and 0 for joint venture drugs； 59.5％， 62.2％， 32.4％ and 8.1％ for western medicine； 0， 55.6％， 22.2％ and 0 for Chinese patent medicine. 5 （10.9％） drug package inserts clearly indicated the usage and dosage of children； 12 （26.1％） drug package inserts were clearly labeled for the usage and dosage involving children； 12 （26.1％） drug package inserts were clearly marked to remind children to use under the supervision of doctors and adults； 11 （23.9％） drug package inserts clearly indicated that pediatric medication was not clear and the safety of pediatric medication was not yet established； 1 （2.2％） package insert clearly indicated that children should be cautious and forbidden； 3 （6.5％） package inserts did not involve package insert for pediatric medication； 2 （4.3％） package inserts clearly indicated that the drugs were stored in places not accessible to children. CONCLUSIONS： There are some problems in the package inserts of skin external drugs in our hospital， such as the marked rate of pediatric medication is quite different； the contents of the labels of pediatric medication are ambiguous and pharmacokinetic data is absent； the contents of the package inserts are inconsistent and the patients are not easy to understand professional terms. The standardization， strictness and guidance of drug package inserts for children can be improved by strengthening the supervision and management of drug package inserts by drug regulatory authorities， increasing the research and development of children’s special drugs， increasing the attention of pharmaceutical enterprises to pediatric medication， paying the attention to the revision of standard package inserts， advancing the clinical trials of children， and raising the awareness of safe drug use of patients and users. |
| 期刊： | 2019年第30卷第8期 |
| 作者： | 张琳，胡利华 |
| AUTHORS： | ZHANG Lin，HU Lihua |
| 关键字： | 皮肤外用药品；药品说明书；儿童用药；标注 |
| KEYWORDS： | Skin external drugs； Drug package inserts； Pediatric medication； Labelling |
| 阅读数： | 462 次 |
| 本月下载数： | 14 次 |
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