Evaluation of a Newly Developed Post Marketing Surveillance Method to Verify the Efficacy and Safety of Rx-to-OTC Switch Drugs
Evaluation of a Newly Developed Post Marketing Surveillance Method to Verify the Efficacy and Safety of Rx-to-OTC Switch Drugs
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评估新开发的上市后监测方法以验证 Rx-to-OTC 转换药物的有效性和安全性
DOI：
10.11256/jjdi.19.121
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
M. Shiragami
中科院分区：
文献类型：
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作者：
Rie Nakajima;F. Oki;M. Shiragami
背景资料：我们报告了盐酸非索非那定片（AllegraFX）的健康检查表调查结果，该调查使用了基于先前报告的Loxonin（R）S调查结果开发的新健康检查表。此外，我们检查的实用程序的健康检查表的调查结果进行比较AllegraFX与上市后的监督（特别调查）由制药公司生产的drug.Methods：新的健康检查表调查AllegraFX进行了41家药店。结果：AllegraFX的健康检查表调查涉及190名购买者，其中143人（75.3%）完成了第二次访问调查。在健康检查表调查中，AllegraFX的有效率为88.4%。在特别调查中报告的两例病例的16种症状中，10种也是通过健康检查表调查发现的。六个症状被检测到的健康检查表调查，但没有在专项surveillance.Conclusion报告：虽然进行了一个短的调查期间，在一个小的样本量，健康检查表调查取得了类似的结果，在确定不良事件方面的专项调查，表明使用健康检查表的调查可以获得的结果与现有的PMS协议，具有相当低的劳动力。
Background: We report the results of the health check sheet survey on fexofenadine hydrochloride tablet (AllegraFX), conducted using a new health check sheet developed based on the results of the previously reported Loxonin (R) S survey. In addition, we examined the utility of the health check sheet by comparing the results of the survey on AllegraFX with the post marketing surveillance (special survey) conducted by the pharmaceutical company manufacturing the drug.Methods: The new health check sheet survey for AllegraFX was conducted in 41 pharmacies. Efficacy, safety, and patient adherence were analyzed.Results: The health check sheet survey for AllegraFX involved 190 purchasers, 143 (75.3%) of whom completed the second visit survey. The efficacy rate for AllegraFX was 88.4% in the health check sheet survey. Of the 16 symptoms reported over two cases in the special survey, 10 were also detected by the health check sheet survey. Six symptoms were detected by the health check sheet survey but were not reported in the special survey.Conclusion: Although conducted for a short survey period and in a small sample size, the health check sheet survey achieved results similar to the special survey in terms of identifying adverse events, indicating that a survey using the health check sheet can obtain results comparable to existing PMS protocols, with considerably lower labor.