ABSTRACT
Objective To provide references for rational use of Chinese patent medicine (CPM). Methods The package inserts of 143 CPM which were prescribed in our hospital were set as subjects, and the contents were analyzed according to pregnancy contraindication stated in Chinese Pharmacopoeia (2015 edition). Results Among the 143 CPM, there were 74 CPM which had the contraindication labels. Only 17 CPM contained prohibited compositions and 33 CPM contained caution compositions. There were 21 CPM which had no prohibited compositions and 3 CPM had prescription confidentiality. But the contraindication labels of only 25 CPM matched with their compositions. The rest did not match with their compositions. Conclusion Some package inserts of CPM about pregnancy contraindication exist content missing and description irregularities. The drug regulatory departments should further strength the supervision and management, and improve the quality of package inserts.
ABSTRACT
OBJECTIVE:To provide reference for drug consultation of Chinese patent medicine(CPM)in pregnancy. METH-ODS:Package inserts of CPM in our hospital during Jan.-Jun. 2016 were collected. Referring to the prohibited,contraindicated and caution materials and decoction pieces in Chinese Pharmacopoeia(part 1,2015 edition),based onnoteitem in Chinese Pharma-copoeia and Clinical Application Guidelines(2010 edition),problems existing in pregnancy contraindication labeling of package in-serts were compared and analyzed. RESULTS:There were 99 kinds of prohibited,contraindicated and caution materials and decoc-tion pieces in Chinese Pharmacopoeia. There were 210 package inserts of CPM except for the special medicine for children,in which 32 contained prohibited materials,61 contained caution materials,only 21 were in line with the contained materials. Among the package inserts of 93 CPM containing prohibited or caution materials,27 were included in Chinese Pharmacopoeia,13 in Clini-cal Application Guidelines only,17 in both,but only 6 had the same contraindication labeling. Among the package inserts of 32 CPM containing prohibited materials,6 were explicitly labeled prohibited,17 labeled contraindicated or caution,and 9 labeled none. Among the package inserts of 61 CPM containing caution materials,29 were labeled prohibited or contraindicated,15 la-beled caution,and 17 labeled none. Among the package inserts of 117 CPM containing no prohibited,contraindicated or caution materials,8 were labeled contraindicated in pregnancy,and 18 labeled prohibited in pregnancy. CONCLUSIONS:The pregnancy contraindications of most CPM are not normative,showing poor consistency with Chinese Pharmacopoeia or Clinical Application Guidelines. Except for providing drug consultation by complying with Chinese Pharmacopoeia,Clinical Application Guidelines and package insert,pharmacists can judge the CPM without labeled pregnancy contraindication by analyzing its classification of con-tained materials. Using TCM does not indicate safety drug use,in addition,some CPM contain western medicine ingredients. There-fore,pharmacists should conduct medication education for patients who used CPM in pregnancy. Considering the new and severe adverse reactions of TCM injections are more,its adverse reactions exist unpredictability,so that pregnant patients should be sug-gested to avoid using TCM injections by pharmacists.
ABSTRACT
The efficacy and safety of application of traditional Chinese medicines (TCMs) during the pregnancy is a hotspot among scholars. However, the traditional pregnancy contraindication content has certain historical limitations, and cannot meet the needs of the current pregnant women for rational drug use. We need to refine and interpret it with modern medical science. In this paper, we summarized the ancient and modern knowledge about pregnancy contradiction and tried to establish a grading safety system, based on the actual clinical practices and thte medication grading concept of western medicines. Specifically speaking, in this paper, we compared the connotations of forbidden/contradiction and cautious use, and focused on the safe herbs that included in the prescriptions for dietary therapy. Meanwhile, in this paper, we summarized the core content of the famous theories of ″You Gu Wu Yun (pregnancy disease)″ and ″Shuai Qi Da Ban Er Zhi (therapy during pregnancy)″, and studied the dangerous and unknown risk of TCMs during pregnancy. At last, a five-grade safety system of TCMs applied on the pregnant women was established, including forbidden, contraindicated, cautious, uncertain and available medicines. We classified medicines with the embryotoxicity (e.g. teratogenic, mutagenic, ageneisa), the traditional toxicity (e.g. abortion), the fierce herbal property (e.g. removing blood stasis, promoting Qi circulation) and reliable edible medicinal herbs. We also place an ″uncertain″ category based on objective reality. Meanwhile, 33 sample TCMs were preliminarily determined. This paper proposed the preference and ideas for the rational herbal use in pregnancy.
ABSTRACT
Objective To provide references for clinical rational use of Chinese patent medicine. Methods Totally 387 specifications of Chinese patent medicine in our hospital were analyzed, and were judged by pregnancy contraindication according to China Pharmacopeia (2010 edition). Results The 387 Chinese patent medicines involved 32 prohibited pregnancy ingredients, 1 taboo ingredient. In 89 Chinese patent medicines contraind prohibited ingredients, 33 marked prohibited ingredients, 18 marked contraindicated ingredients, 14 marked cautious ingredients, and 24 marked without-contraindication ingredients. 68 Chinese patent medicines contained pregnancy contraindication labels but without prohibited ingredients. Conclusion A unified standard of pregnancy contraindication should be established;researches on pregnancy contraindication should be strengthened;medicine specifications should be standardized and perfected.