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探索社区药剂师对仿制药的看法:来自马来西亚的全国性研究。

Exploring community pharmacists' views on generic medicines: a nationwide study from Malaysia.

机构信息

Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Minden, Penang, Malaysia.

出版信息

Int J Clin Pharm. 2011 Feb;33(1):124-31. doi: 10.1007/s11096-010-9470-1. Epub 2011 Jan 13.

Abstract

OBJECTIVE

To evaluate the Malaysian community pharmacists' views on generic medicines.

SETTING

A sample of 1419 Malaysian community pharmacies with resident pharmacists.

METHOD

A cross-sectional nationwide survey using a self-completed mailing questionnaire.

MAIN OUTCOME MEASURE

Pharmacists' views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence.

RESULTS

Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia.

CONCLUSION

The Malaysian pharmacists' have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.

摘要

目的

评估马来西亚社区药剂师对仿制药的看法。

背景

对有驻店药剂师的 1419 家马来西亚社区药店进行抽样调查。

方法

采用横断面全国性邮寄问卷调查。

主要观察指标

药剂师对仿制药的看法,包括疗效、安全性、质量和生物等效性等问题。

结果

共收到 219 家药店(应答率 15.4%)的回复。仅有 50.2%的被调查药剂师认为所有被批准为仿制药的产品都可以被认为与原研药具有治疗等效性。约 76%的受访者表示,窄治疗指数药物的仿制药替代是不适当的。大多数药剂师(84.5%)理解仿制药必须含有相同剂量的活性成分,且必须与原研品牌具有相同的剂型(71.7%)。约 21%的受访者认为仿制药的质量不如原研药。大多数药剂师(61.6%)不同意仿制药比原研品牌产生更多的副作用。在对仿制药的看法上,毕业于马来西亚大学、双联课程和海外大学的药剂师没有显著差异。此外,受访者似乎难以确定马来西亚市场上销售的仿制药的生物等效性状态。

结论

马来西亚药剂师对马来西亚仿制药的制造和/或审批系统缺乏信息和/或信任。这个问题应该由药剂师教育者和相关政府机构来解决。

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