| 冯爽,刘影,耿胜男,李阳杰.备案制背景下医疗机构中药制剂存在的问题与建议[J].中国药事,2021,35(5):581-585 |
| 备案制背景下医疗机构中药制剂存在的问题与建议 |
| Problems and Suggestions of Traditional Chinese Medicine Preparations in Medical Institutions in the Context of Filing System |
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| DOI：10.16153/j.1002-7777.2021.05.013 |
| 中文关键词: 医疗机构 中药制剂 备案制 影响 |
| 英文关键词: medical institution traditional Chinese medicine preparation filing system influence |
| 基金项目: |
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| 中文摘要: |
| 目的：通过对医疗机构中药制剂在备案实施过程中存在的问题进行分析，探讨解决相关问题的办法，为监管实施部门提供参考。方法：通过定性分析法，结合笔者工作经历，分析备案制为医疗机构中药制剂带来的积极影响以及目前存在的问题，并提出相关建议。结果：备案制为医疗机构中药制剂带来了新的发展机遇，但同时产生了一些新的问题。结论：新政策实施后，全国医疗机构申报中药制剂的积极性增加，新备案中药制剂种类三年来持续增加；但监管难度增大、经典制剂无法共享等问题限制了医院中药制剂的发展应用。备案制值得大力推广，但仍需要药品监管部门以及医疗机构共同努力，解决存在的问题，促进中医药的发展。 |
| 英文摘要: |
| Objective: To analyze the problems existing in the process of filing and implementation of Traditional Chinese Medicine (TCM) preparations in medical institutions, and to explore solutions to the relevant problems, in order to provide references for the supervision and implementation departments. Method: Through qualitative analysis combined with the author's work experience, the paper analyzed the positive impact on the filing system in medical institutions for traditional Chinese medicine preparations, as well as the existing problems and provided relevant suggestions. Results: The filing system has brought new opportunities for the development of TCM preparations in medical institutions, though some new problems have arisen at the same time. Conclusion: After the implementation of the new policy, the enthusiasm of medical institutions nationwide to declare TCM preparations has increased, and the number of new Chinese medicine preparations has increased continuously for three years; however, problems such as increasing difficulty in supervision and inability to share classical preparations limit the development and application of TCM preparations in hospitals. The record keeping system deserves vigorous promotion, but it is still necessary for drug regulators and medical institutions to work together in order to solve the existing problems and promote the development of TCM. |
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