摘要
目的:了解非处方药(OTC)说明书中特殊人群用药说明项的标注现状,为进一步规范OTC说明书提供参考。方法:选取市场流通的OTC说明书97份,根据《化学药品非处方药说明书规范细则》和《中成药非处方药说明书规范细则》对说明书的特殊人群用药说明项进行检查,对存在问题的说明书进行统计、分析。结果:97份OTC说明书中,儿童、老年人、孕妇、哺乳期妇女用药说明项缺项率分别为2.06%、70.10%、39.18%、64.95%。结论:目前市场上OTC说明书关于特殊人群的用药说明存在问题较严重,质量亟待提高。
OBJECTIVE： To probe into special group medication in package inserts of over-the-count （OTC） drugs to lay a foundation for the further standardization of package inserts of OTC drugs. METHODS： 97 package inserts of OTC drugs sampled from current market were investigated and analyzed in term of special group medication according to Package Inserts Regulations for OTC Chemical Drugs and Package Inserts Regulations for OTC Chinese Patent Medicine. The existing problems were analyzed statistically. RESULTS： Of 97 package inserts of OTC drugs, the rate of missing medication for child was 2.06%, for the old 70.10%, for pregnant 39.18% and for lactation woman 64.95%. CONCLUSION： Problems can be found in package inserts of OTC drugs about special group medication, and the quality of package inserts of OTC drugs should be further improved.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第24期2225-2227,共3页
China Pharmacy
