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安大略省13年间品牌名与通用名口服双膦酸盐药物的使用模式:一项描述性研究。

Patterns of use for brand-name versus generic oral bisphosphonate drugs in Ontario over a 13-year period: a descriptive study.

作者信息

Fraser Lisa-Ann, Albaum Jordan M, Tadrous Mina, Burden Andrea M, Shariff Salimah Z, Cadarette Suzanne M

机构信息

Department of Medicine, University of Western Ontario, London, Ont.

Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ont.

出版信息

CMAJ Open. 2015 Jan 13;3(1):E91-6. doi: 10.9778/cmajo.2014-0090. eCollection 2015 Jan-Mar.

Abstract

BACKGROUND

Bisphosphonates are the first-line therapy for the treatment of osteoporosis. In the province of Ontario, the Ontario Drug Benefit Program funds medications for patients aged 65 years and older. The Ontario Drug Benefit Program has a generic substitution policy that requires lower-cost generic drugs to be dispensed when they are available. However, there is controversy surrounding the efficacy and tolerability of generic bisphosphonates. The objective of this study was to describe patterns in the use of brand-name versus generic formulations when dispensing oral bisphosphonate over a 13-year period.

METHODS

We identified all osteoporotic preparations for alendronate and risedronate that were dispensed through the Ontario Drug Benefit Program from 2001 to 2014. We stratified our sample into community-dwelling residents and residents in long-term care facilities. The number of prescriptions dispensed per month were plotted to illustrate trends over time.

RESULTS

We found a rapid switch from brand-name to generic bisphosphonate equivalents immediately after the generic became available on the Ontario Drug Benefit formulary, with generics accounting for > 88% of dispensed drug within 2 months. We also observed a reduction in the number of generic drugs dispensed each time a new brand-name alternative (e.g., monthly risedronate, weekly alendronate plus vitamin D) was introduced to the formulary. The dispensing trends were similar in the community and long-term care settings.

INTERPRETATION

The Ontario Drug Benefit Program generic substitution policy resulted in rapid uptake of generic oral bisphosphonates among seniors in Ontario. However, there was a switch away from generic medications to new brand-name alternatives whenever they were introduced to the formulary. Therefore, some patients continued to use brand-name bisphosphonate despite the availability of generic options.

摘要

背景

双膦酸盐是治疗骨质疏松症的一线疗法。在安大略省,安大略药物福利计划为65岁及以上的患者提供药物资助。安大略药物福利计划有一项通用名替代政策,要求在有成本较低的通用名药物时予以配药。然而,通用名双膦酸盐的疗效和耐受性存在争议。本研究的目的是描述在13年期间发放口服双膦酸盐时品牌名制剂与通用名制剂的使用模式。

方法

我们确定了2001年至2014年通过安大略药物福利计划发放的所有阿仑膦酸盐和利塞膦酸盐的骨质疏松症制剂。我们将样本分为社区居住居民和长期护理机构居民。绘制每月发放的处方数量以说明随时间的趋势。

结果

我们发现,通用名双膦酸盐在安大略药物福利处方集上可用后,立即迅速从品牌名制剂转向通用名等效物,通用名药物在2个月内占发放药物的88%以上。我们还观察到,每当有新的品牌名替代药物(如每月一次的利塞膦酸盐、每周一次的阿仑膦酸盐加维生素D)被引入处方集时,发放的通用名药物数量就会减少。社区和长期护理环境中的发放趋势相似。

解读

安大略药物福利计划的通用名替代政策导致安大略省老年人迅速采用通用名口服双膦酸盐。然而,每当有新的品牌名替代药物被引入处方集时,就会出现从通用名药物转向新品牌名替代药物的情况。因此,尽管有通用名选择,一些患者仍继续使用品牌名双膦酸盐。

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A reappraisal of generic bisphosphonates in osteoporosis.重新评价骨质疏松症中的通用双膦酸盐。
Osteoporos Int. 2012 Jan;23(1):213-21. doi: 10.1007/s00198-011-1796-6. Epub 2011 Sep 28.
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Comparative gastrointestinal safety of weekly oral bisphosphonates.每周口服双膦酸盐的胃肠道安全性比较。
Osteoporos Int. 2009 Oct;20(10):1735-47. doi: 10.1007/s00198-009-0871-8. Epub 2009 Mar 6.

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