Balkhi Bander, Seoane-Vazquez Enrique, Rodriguez-Monguio Rosa
Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Department of Biomedical and Pharmaceutical Sciences, Chapman University, Irvine, CA, USA.
Saudi Pharm J. 2018 Feb;26(2):238-243. doi: 10.1016/j.jsps.2017.12.005. Epub 2017 Dec 8.
In October 2010, the US Food and Drug Administration (FDA) issued a safety communication regarding the risks of atypical fractures of the femur, with bisphosphonates drugs. This study evaluated the impact of the bisphosphonates FDA safety communication on the utilization of osteoporosis medications in Medicaid programs.
Osteoporosis drugs utilization data from the July 2006 to June 2014 were extracted from the national Summary Files from the Medicaid State Drug Utilization Data maintained by the Centers for Medicare & Medicaid Services (CMS). We performed an interrupted time series analyses to evaluate trends in utilization of osteoporosis drugs before and after the 2010 FDA safety commination.
Time-series analyses of osteoporosis drug utilization in Medicaid program revealed a significant downward trend associated with the 2010 FDA bisphosphonates safety communication. Before the FDA safety communication was issued, the utilization rate was slightly decreased between 2006 and 2010. In the year following the FDA safety communication the bisphosphonate DDDs per 1000 beneficiaries of fell 22% yearly until the end of study period.
The 2010 FDA bisphosphonates safety communication appeared to have influenced Osteoporosis utilization in Medicaid recipients. The 2010 FDA bisphosphonates safety communication was associated with a significant reduction in the utilization of bisphosphonates in the Medicaid program.
2010年10月，美国食品药品监督管理局（FDA）发布了一份关于双膦酸盐药物导致股骨非典型骨折风险的安全通报。本研究评估了FDA双膦酸盐安全通报对医疗补助计划中骨质疏松症药物使用情况的影响。
从医疗保险和医疗补助服务中心（CMS）维护的医疗补助州药物使用数据的国家汇总文件中提取2006年7月至2014年6月的骨质疏松症药物使用数据。我们进行了中断时间序列分析，以评估2010年FDA安全通报前后骨质疏松症药物的使用趋势。
医疗补助计划中骨质疏松症药物使用情况的时间序列分析显示，与2010年FDA双膦酸盐安全通报相关的显著下降趋势。在FDA安全通报发布之前，2006年至2010年期间使用率略有下降。在FDA安全通报发布后的一年里，每1000名受益人的双膦酸盐限定日剂量（DDD）每年下降22%，直至研究期结束。
2010年FDA双膦酸盐安全通报似乎影响了医疗补助接受者中骨质疏松症药物的使用。2010年FDA双膦酸盐安全通报与医疗补助计划中双膦酸盐使用的显著减少有关。
