OBJECTIVE: To compare and analyze the ADR in Chinese Pharmacopoeia (2010 edition) (ChPD) and non-pharmacopoeia quality standard drugs (NChPD) and its standard. METHODS: In respective study, ADR reports and drug utilization data in our hospital from 2012 to 2014 were collected and divided into ChPD group and NChPD group, the index differences were analyzed. RESULTS: The percentages of reported ADR to product regulation [(0.27±0.10)%] and to drug use frequency [(0.15±0.06)%] in ChPD group were significantly lower than NChPD group [(0.62±0.08)%、(0.32±0.07)%], with statistical significance (P<0.05). Compared with the percentage of general reported ADR to drug use frequency in NChPD group [(0.44±0.12)%], there was no significant difference in ChPD group [(0.23±0.09)%] (P>0.05); the percentage of new severe reported ADR to drug use frequency in ChPD group [(0.04±0.01)%] was significantly lower than NChPD group [(0.27±0.05)%], with statistical significance (P<0.05). And there were no significant differences in indexes in different years (P>0.05). CONCLUSIONS: Drug quality standards should be payed more attention, from the perspective of which to reduce the incidence of adverse drug reactions. While the drugs introduced to hospital should be strictly controlled and timely adjust the drug structure; the pharmacopoeia standard drugs should be generalized among doctors to reduce ChPD drug reactions and ensure the drug safety.
关键词
药品质量标准中国药典不良反应相关性
Keywords
Drug quality standardChinese PharmacopoeiaAdverse drug reactionCorrelation