Midwestern University College of Pharmacy-Glendale, Glendale, Arizona.
Sr Care Pharm. 2022 Nov 1;37(11):555-564. doi: 10.4140/TCP.n.2022.555.
Case reports of atypical fractures associated with bisphosphonates first appeared in the literature in 2005, with a larger number of reports published in 2007-2009. To describe reporting trends of bisphosphonate-associated atypical fractures relative to increasing awareness across medical and lay communities. Disproportionality analyses were performed to assess odds of reporting atypical fractures associated with oral bisphosphonates using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Reporting odds ratios (RORs) were assessed according to prespecified time periods (pre-awareness [1995-2006], growing-awareness [2007-2009], and post-warning [2010-2021]). There were 182 atypical fracture reports (n = 18 bisphosphonate-associated) during the pre-awareness period, 177 (n = 69 bisphosphonate-associated) during growing-awareness, and 6,170 (n = 3,150 bisphosphonate-associated) post-warning. Among reports by health care professionals, RORs for bisphosphonate-associated atypical fractures were 1.76, 13.49, and 12.16 across the three time periods. In comparison, RORs among all reporters (including consumers) increased from 1.50 to 7.95 to 18.93 across those three time periods. The highest proportion of reports during the pre-awareness period was for patients 51 to 65 years of age; however, patients 66 years of age and older comprised the largest proportion of reports in the growing-awareness and post-warning periods. Reporting patterns for atypical fractures associated with bisphosphonate therapy appear to correlate with increasing awareness among the medical and lay community. As medication experts, pharmacists play a key role in recognizing risk factors for atypical fractures, utilizing the FDA's system to support accurate event reporting, and promoting bisphosphonate deprescribing when clinically appropriate.
与双膦酸盐相关的非典型骨折的病例报告最早于 2005 年在文献中出现，2007-2009 年期间报告数量较多。本研究旨在描述与双膦酸盐相关的非典型骨折报告趋势，及其与医疗和非医疗群体认知度的相关性。使用美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据库，通过比例失衡分析评估与口服双膦酸盐相关的非典型骨折报告的可能性。根据预设的时间段（认知前[1995-2006]、认知增长[2007-2009]和警告后[2010-2021]）评估报告比值比（ROR）。在认知前时期报告了 182 例非典型骨折（n=18 例与双膦酸盐相关），在认知增长时期报告了 177 例（n=69 例与双膦酸盐相关），在警告后时期报告了 6170 例（n=3150 例与双膦酸盐相关）。在医疗保健专业人员的报告中，双膦酸盐相关非典型骨折的 ROR 分别为 1.76、13.49 和 12.16，跨越三个时间段。相比之下，在这三个时间段内，所有报告者（包括消费者）的 ROR 从 1.50 增加到 7.95 再增加到 18.93。认知前时期报告的患者年龄主要集中在 51-65 岁之间；然而，认知增长和警告后时期报告的患者中年龄在 66 岁及以上的比例最大。双膦酸盐治疗相关非典型骨折的报告模式似乎与医疗和非医疗群体的认知度增加相关。作为药物专家，药剂师在识别非典型骨折的风险因素、利用 FDA 系统支持准确的事件报告以及在临床适当的情况下促进双膦酸盐药物减量方面发挥着关键作用。
