眼科外用药说明书中儿童用药内容的分析

目的调查我院眼科外用药品说明书中儿童用药项的标注情况，分析儿童眼科用药现状，为临床医师、生产厂家及有关管理机构提供参考。方法依据《中华人民共和国药品管理法》、《药品说明书和标签管理规定》、绸敞上方药说明书规范细则》、《化学药品和治疗用生物制品说明书规范细则》，对我院眼科外用药的24种药品说明书进行了儿童用药内容的分析。结果24种眼科外用药中，标注儿童用药的为22种，未标注儿童用药的为2种。24种眼科外用药在标注药代动力学上除1种中成药滴眼剂未注明、1种尚不明确以外，其余均为健康成年人。结论我院目前儿童眼科外用药说明书中存在儿童用药内容不完整与用语含糊等现象，易引起用药安全隐患，应当引起各方面的重视，进一步加强与完善。

Analysis of the Instructions for Children of Ophthalmic Drugs for External Use

Objective To analyze the instructions for children of ophthalmic drugs for external use in our hospital. And provide reference for clinical physicians, manufacturers and related management institutions. Methods According to the ＂drug administration law＂, ＂the drugs specification and tag management regulation＂, ＂Standard rule of specification of OTC drug ＂, ＂Standard detailed rule of specification of chemical drug and biological product for treatment＂, we have analyzed the children instructions of 24 species of ophthalmic drugs for external use. Results There are 22 species which contain the children instructions, 2 species contain nothing for children. Except one kind of traditional Chinese medicine eye drops has nothing in ＂pharmacokinetic＂ item of specification and another is not clear. All of other ＂pharmacokinetic＂ data is based on health adult. Conclusion The instructions for children of ophthalmic drugs for external use in our hospital is not complete, and expression is ambiguous, etc. It should be paid more attention and the related standards should be developed.