摘要
目的:为医疗机构管理药品及药品说明书提供参考。方法:收集我院2012年12月使用中的相同成分与给药途径的国产和外资药品说明书34组,依据2010年版《中国药典·临床用药须知》对药品说明书"修改日期"项的修改次数和修改年份进行统计分析。结果:34组药品说明书中有口服剂型25组(包括心血管系统药物8组)、注射剂型9组,其中国产药品说明书修改次数达33次,外资药品说明书113次;2011-2012年发生修改的国产药品说明书有8种,外资药品说明书有17种。口服剂型中,修改次数≤1的国产药品说明书有18种,外资药品说明书有8种;国产药品说明书修改次数达26次,外资药品说明书76次;2011-2012年发生修改的国产药品说明书有5种,外资药品说明书有12种。心血管系统药物中,修改次数≤1的国产药品说明书有4种,外资药品说明书有1种;国产药品说明书修改次数达11次,外资药品说明书27次;2011-2012年发生修改的国产药品说明书有2种,外资药品说明书有6种。结论:外资药品说明书的修改明显比国产药品说明书频繁。
OBJECTIVE： To provide reference for the management of drugs and their package inserts in medical institutions. METHODS： 34 groups of package inserts of same ingredient and delivery way drugs produced by domestic or foreign companies were collected from our hospital in Dec. 2012. The modification times and date of ＂Modified Date＂ item in package inserts were an- alyzed statistically according to Clinical Drug Use Instruction Part of Chinese Pharmacopeia （2010 edition）. RESULTS： 34 groups of package inserts included 25 groups of oral dosage form （containing 8 groups of cardiovascular drugs） and 9 groups of injection; the package inserts of domestic preparation had been modified by 33 times, and those of foreign preparations had been modified by 113 times; 8 kinds of domestic preparations and 17 kinds of foreign preparations had been modified during 2011- 2012. Among oral dosage forms, 18 kinds of domestic preparations and 8 kinds of foreign preparations had been modified no more than 1 time; the package inserts of domestic preparation had been modified by 26 times, and those of foreign preparation had been modified by 76 times; 5 kinds of domestic preparations and 12 kinds of foreign preparations had been modified during 2011- 2012. Among car- diovascular drugs, 4 kinds of package inserts of domestic preparations and 1 kind of foreign preparations had been modified no more than 1 time; the package inserts of domestic preparation had been modified by 11 times, and those of foreign preparations had been modified by 27 times; 2 kinds of domestic preparations and 6 kinds of foreign preparations had been modified during 2011--2012. CONCLUSIONS： The package inserts of foreign drugs change more than those of domestics.
出处
《中国药房》
CAS
CSCD
2014年第1期94-96,共3页
China Pharmacy
关键词
药品说明书
国产
外资
修改日期
差异
Drug package insert
Domestic
Foreign
Modified date
Difference
