厦门长庚医院新药引进的评估方法及量化探讨
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摘要
目的:为医院新药引进工作提供评估方法,建立新药引进量化评分方法。方法:建立厦门长庚医院(以下简称"我院")《药品引进管理准则》,制定新药引进的评估方法及量化标准,评估实施效果,提出改进建议。结果:我院于2014年开始执行新准则,2014—2017年共接受新药申请371件,审议通过195件。其中,临床药师评估适合引进的新药,其最终审议通过率为78.8%;临床药师评估不适宜引进的新药,其最终审议不通过率为52.0%;因为滞料而被管制提新药申请的医师数量逐年减少,新准则起到了预期的管制效果。建议新药量化评分由品质分值和费用分值构成,根据体现疗效文献所发表期刊的等级、治疗类型、与现有药物对比、治疗效果、预估月用量、日均费用及医保给付状况等,设计具体分值,最终将品质分值与费用分值相除,所得数值越大,则表示该新药越适合我院,可优先考虑通过申请引进。结论:制定量化标准,可尽量减少主观性的影响,使新药引进评估工作更客观、合理和规范。
OBJECTIVE: To provide the assessment method and establish the quantitative scoring method for the introduction of new drugs. METHODS: "Guidelines for Drug Import and Management" in Xiamen Chang Gung Hospital(hereinafter referred to as "our hospital") was established, evaluation methods and quantitative standards for introduction of new drugs were formulated, the implementation effects were evaluates, and suggestions for improvement were put forward. RESULTS: Our hospital began to implement the new guidelines in 2014. In 2014-2017, a total of 371 new drug applications were accepted, and 195 were reviewed and approved. Among them, clinical pharmacists evaluated the new drugs suitable for introduction, and the final approval rate was 78.8%. The clinical pharmacist evaluated the new drug that was not suitable for introduction, and the final review failure rate was 52.0%. The number of physicians who have been applied for new drug withdrawals has been decreasing year by year due to stagnant materials, and the new guidelines achieved the desired regulatory effects. It is suggested that the new drug quantitative score should consist of quality scores and cost scores, be based on the grades of the journals published in the efficacy literature, the type of treatment, the comparison with existing drugs, the treatment effects, the estimated monthly dose, the average daily cost, and the medical insurance payment status, etc; the specific score was designed, and the final quality score was divided by the cost score. The larger the value, the more suitable the new drug is for our hospital, and the application for introduction can be given priority. CONCLUSIONS: The establishment of quantitative standards can minimize the influence of subjectivity and make the evaluation of introduction of new drugs more objective, reasonable and standardized.
OBJECTIVE: To provide the assessment method and establish the quantitative scoring method for the introduction of new drugs. METHODS: "Guidelines for Drug Import and Management" in Xiamen Chang Gung Hospital(hereinafter referred to as "our hospital") was established, evaluation methods and quantitative standards for introduction of new drugs were formulated, the implementation effects were evaluates, and suggestions for improvement were put forward. RESULTS: Our hospital began to implement the new guidelines in 2014. In 2014-2017, a total of 371 new drug applications were accepted, and 195 were reviewed and approved. Among them, clinical pharmacists evaluated the new drugs suitable for introduction, and the final approval rate was 78.8%. The clinical pharmacist evaluated the new drug that was not suitable for introduction, and the final review failure rate was 52.0%. The number of physicians who have been applied for new drug withdrawals has been decreasing year by year due to stagnant materials, and the new guidelines achieved the desired regulatory effects. It is suggested that the new drug quantitative score should consist of quality scores and cost scores, be based on the grades of the journals published in the efficacy literature, the type of treatment, the comparison with existing drugs, the treatment effects, the estimated monthly dose, the average daily cost, and the medical insurance payment status, etc; the specific score was designed, and the final quality score was divided by the cost score. The larger the value, the more suitable the new drug is for our hospital, and the application for introduction can be given priority. CONCLUSIONS: The establishment of quantitative standards can minimize the influence of subjectivity and make the evaluation of introduction of new drugs more objective, reasonable and standardized.
引文
[1] 卫生部,国家中医药管理局,总后勤部卫生部.关于印发《医疗机构药事管理规定》的通知[S].卫医政发[2011]11号.2011-01-30.
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[10] 朱玉洁,葛卫红,陈磊.国外新药引进评估方法简介[J].药品评价,2013,10(8):8-11.
[11] 朱玉洁,葛卫红,梁毅.我国医疗机构新药引进管理相关文献分析[J].中国药房,2012,23(5):464-466.
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[13] 韩爽,钟敏涛,李锦,等.我国辅助用药应用现状及管理对策初探[J].中国药学杂志,2016,51(8):678-682.
[2] 平杰,潘书权,王秀琴.医院新药引进流程中临床药师发挥的作用及其影响[J].中华全科医学,2014,12(11):1878-1879.
[3] 张钰宣,梅丹.国外医院处方集新药的遴选过程与标准介绍[J].中国医院药学杂志,2015,35(10):865-868.
[4] 孙祥生.浅谈我院新药引进的现状和管理办法[J].临床医药文献电子杂志,2016,3(51):10266-10267.
[5] 张虹.循证医学理论在我院药学工作中的实践应用[J].中国医药导报,2016,13(36):168-170.
[6] 李华,张朝利.运用循证药学原则完善医院新药引进工作[J].中国医药导报,2007,4(27):130-131.
[7] 彭晶晶.医院新药引进流程中临床药师发挥的作用[J].中国处方药,2015,13(11):45.
[8] 董玉华,陈嘉宁,张慕华,等.循证药学与模糊数学在医院新药引进中的综合运用[J].中国医院用药评价与分析,2015,15(7):990-992.
[9] 姚海,杨晓庆,黄益民,等.新药引进初评的量化探讨[J].中国药房,2006,17(2):107-108.
[10] 朱玉洁,葛卫红,陈磊.国外新药引进评估方法简介[J].药品评价,2013,10(8):8-11.
[11] 朱玉洁,葛卫红,梁毅.我国医疗机构新药引进管理相关文献分析[J].中国药房,2012,23(5):464-466.
[12] 杨安辉,陈建达,周丽芳.施行新药引进评分标准完善药事制度的探讨[J].海峡药学,2005,17(6):227-228.
[13] 韩爽,钟敏涛,李锦,等.我国辅助用药应用现状及管理对策初探[J].中国药学杂志,2016,51(8):678-682.