Bykov Katsiaryna, Gagne Joshua J, Wang Bo, Choudhry Niteesh K
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA (K.B., J.J.G., B.W., N.K.C.).
Departments of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA (J.J.G.).
Circ Cardiovasc Qual Outcomes. 2018 Oct;11(10):e004096. doi: 10.1161/CIRCOUTCOMES.117.004096.
Shortages of chronic medications are an increasingly common problem, yet little is known about their impact on drug utilization and clinical outcomes. We evaluated the population-level impact of metoprolol extended release shortage that occurred in the United States in 2009 to 2010.
We conducted a population-based, time series analysis of 38 914 patients (mean age, 60 years; 69% men) discharged after hospitalization for myocardial infarction (MI) between January 2006 and November 2012 in a large commercial insurance database. The shortage period was defined as February 2009 to June 2010. Data before September 2008 was defined as preshortage period and data after June 2010 as postshortage period. Outcomes were proportion of patients who filled any long- or short-acting β-blocker within 30 days of discharge, adherence to β-blockers within the first year of therapy among patients who initiated β-blockers, and rates of 1-year rehospitalization for MI or unstable angina. Post-MI statin utilization and adherence were evaluated as control outcomes. During the preshortage period, 70% of patient filled a β-blocker, mean monthly adherence was 76%, and the average monthly rate of rehospitalization was 6.5 events per 100 person-years, as compared with β-blocker use of 62%, average adherence of 70%, and rehospitalization rate of 5.6 events per 100 person-years during the shortage. After accounting for the baseline (preshortage) trends, the shortage was associated with significant monthly reductions in postdischarge β-blocker use (-0.57% of patients [95% CI, -0.90 to -0.24] per month) and an immediate decrease in adherence (-4.58% days covered [95% CI, -6.12 to -3.04]). No negative impact on rates of rehospitalization, post-MI statin utilization, or statin adherence was observed. β-Blocker utilization began to increase after the resolution of the shortage.
The nationwide metoprolol extended release shortage in the United States was associated with fewer patients receiving any long- or short-acting β-blocker post-MI and lower adherence to β-blocker therapy for those who did receive it, but did not appear to appreciably affect clinical outcomes at the population level.
慢性药物短缺是一个日益普遍的问题，但关于其对药物使用和临床结局的影响却知之甚少。我们评估了2009年至2010年在美国发生的美托洛尔缓释制剂短缺对总体人群的影响。
我们对一个大型商业保险数据库中2006年1月至2012年11月因心肌梗死（MI）住院后出院的38914例患者（平均年龄60岁；69%为男性）进行了基于人群的时间序列分析。短缺期定义为2009年2月至2010年6月。2008年9月之前的数据定义为短缺前时期，2010年6月之后的数据定义为短缺后时期。结局指标包括出院后30天内服用任何长效或短效β受体阻滞剂的患者比例、开始使用β受体阻滞剂的患者在治疗第一年对β受体阻滞剂的依从性，以及MI或不稳定型心绞痛1年再住院率。MI后他汀类药物的使用和依从性作为对照结局进行评估。在短缺前时期，70%的患者服用β受体阻滞剂，平均每月依从性为76%，平均每月再住院率为每100人年6.5次；相比之下，短缺期间β受体阻滞剂的使用率为62%，平均依从性为70%，再住院率为每100人年5.6次。在考虑基线（短缺前）趋势后，短缺与出院后β受体阻滞剂使用的每月显著减少（每月-0.57%的患者[95%CI，-0.90至-0.24]）以及依从性立即下降（覆盖天数-4.58%[95%CI，-6.12至-3.04]）相关。未观察到对再住院率、MI后他汀类药物使用或他汀类药物依从性的负面影响。短缺解决后，β受体阻滞剂的使用开始增加。
美国全国范围内的美托洛尔缓释制剂短缺与MI后接受任何长效或短效β受体阻滞剂的患者减少以及接受治疗的患者对β受体阻滞剂治疗的依从性降低有关，但在总体人群水平上似乎并未明显影响临床结局。
