国家药品集中采购政策背景下中选药临床换药率分析

Analysis of Clinical Dressing Rate of Selected Medicine under the Background of the National Drug Centralized Procurement Policy

目的拟通过对改革前后1年(2018年3月28日~2020年3月27日)国产仿制中选药与非中选原研药临床换药情况进行分析,以评估通过一致性评价的仿制药在临床中的使用是否符合预期。方法针对在改革前后1年使用13种药品的患者进行国产仿制中选药与非中选原研药换药情况,利用EXCEL对数据进行分类统计。结果改革1年前后,使用13种“4+7”中选药对应的通用品的患者大部分专一使用国产仿制中选药或非中选原研药,出现国产仿制中选药或非中选原研药交换使用的患者比例较小,为5.78%~20.78%。对换药人群进一步分析发现,绝大多数患者都为非中选原研换国产仿制中选,比例为75.00%~94.85%,且60.53%~85.96%患者会使用2次及以上中选药。“非中选原研换中选,再换非中选原研”的患者仅占中选与非中选原研交换人数的2.29%~18.31%,平均为11.85%。另外,中选换原研的患者比例仅占中选与非中选原研交换人数的0.00%~20.31%,平均为5.52%。结论临床医生或患者愿意尝试使用国产仿制中选药,且大多数在使用一次后,愿意继续使用国产仿制中选药,较少患者会再换回非中选原研药。以上均侧面证明经过一致性评价的药品其使用效果也受到临床认可。

OBJECTIVE To analyze the clinical change of domestic generic selected medicines and non-selected original medicines in the first year before and after the reform(March 28,2018-March 27,2020),to evaluate whether the use of pharmaceuticals through the consistency evaluation in the clinic is as expected.METHODS The patients who used 13 kinds of selected drugs in one year before and after the reform werecollected to analyze the situation ofdomestic generic selected medicine and non-selected original medicine replacement.And EXCEL were used to classify the statistics.RESULTS Around one year after the reform,most patients who used the 13 kinds of“4+7”selected medicines were all used to domestic generic selected medicine exclusively or non-selected originalmedicines.The proportion of patients with domestic generic selected medicine or non-selected original medicine used interchangeably was small,at 5.78%-20.78%.A further analysis of the drug-changing population found that the vast majority of patients changed non-selected original medicine into domestic generic selected medicine,with a ratio of 75.00%-94.85%,and 60.53%-85.96%of patients used selected medicine twice or more.Moreover,the patients of“non-selected original medicine exchanged,then re-selected non-selected original medicine”accounted for only 2.29%-18.31%in the number of exchanges between non-selected original medicine and selected medicine,with an average of 11.85%.In addition,the proportion of patients who were selected for the original study was only 0.00%-20.31%in the number of exchanges between the selected medicine and the non-selected original medicine,with an average of 5.52%.CONCLUSION The results show that doctors or patients are try to use domestic generic selected medicines,and most of them are willing to continue to use domestic generic selected medicines after one use.Few patients will switch back to non-selected original medicines.The above all prove that the use effect of the drug after consistency evaluation is also recognizedclinically.