Investigation and analysis of pregnancy contraindication in package inserts of 205 Chinese patent medicines
Objective To analyze and discuss the specific situation of pregnancy contraindication labeling of Chinese patent medi-cines(CPM),and to provide reference for the rational and effective application of CPM by pregnant women.Methods Package inserts of CPM used in our hospital during January to June 2021 were collected.By referring to the pregnancy contraindicated mate-rials and decoction pieces in Chinese Pharmacopoeia(Volume 1,2020 edition),and according to the annotation of"note"item in Chinese Pharmacopoeia and Chinese Pharmacopoeia Guidelines for Clinical Drug Use(TCM Prescription Preparation Volume,2015 edition),problems existing in pregnancy contraindication instruction labeling of package inserts were compared and analyzed.Results Among 205 kinds of CPM,92 were included in Chinese Pharmacopeia,139 in the Guidelines for Clinical Drug Use,79 in both.Only 8 kinds of CPM's ingredients were completely consistent with the pregnancy contraindication in package inserts,Chinese Pharmacopeia and Guidelines for Clinical Drug Use(10.13％).Conclusion The pregnancy contraindications in most CPM are not standardized,showing poor consistency with Chinese Pharmacopeia or Guidelines for Clinical Drug Use.Drug regulatory authorities,marketing authorization holder(MAH),pharmaceutical production and marketing enterprises,and medical institu-tions are required to jointly promote the drug use information for women in pregnancy,and to ensure the rational use of drugs for pregnant patients.
Chinese patient medicinepackage insertsChinese PharmacopoeiaChinese Pharmacopeia Guidelines for Clinical Drug Usepregnancy contraindication
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万方数据
