Department of Medicine, Division of Geriatric Medicine, University of Massachusetts Medical School, Worcester, MA, USA.
Ann Pharmacother. 2011 Sep;45(9):1077-84. doi: 10.1345/aph.1Q158. Epub 2011 Aug 18.
Laboratory monitoring of medications is typically used to establish safety prior to drug initiation and to detect drug-related injury following initiation. It is unclear whether black box warnings (BBWs) as well as evidence- and consensus-based clinical guidelines increase the likelihood of appropriate monitoring.
To determine the proportion of patients newly initiated on selected cardiovascular medications with baseline assessment and follow-up laboratory monitoring and compare the prevalence of laboratory testing for drugs with and without BBWs and guidelines.
This cross-sectional study included patients aged 18 years or older from a large multispecialty group practice who were prescribed a cardiovascular medication (angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, amiodarone, digoxin, lipid-lowering agents, diuretics, and potassium supplements) between January 1 and July 31, 2008. The primary outcome measure was laboratory test ordering for baseline assessment and follow-up monitoring of newly initiated cardiovascular medications.
The number of new users of each study drug ranged from 49 to 1757 during the study period. Baseline laboratory test ordering across study drugs ranged from 37.4% to 94.8%, and follow-up laboratory test ordering ranged from 20.0% to 77.2%. Laboratory tests for drugs with baseline laboratory assessment recommendations in BBWs were more commonly ordered than for drugs without BBWs (86.4% vs 78.0%, p < 0.001). Drugs with follow-up monitoring recommendations in clinical guidelines had a lower prevalence of monitoring (33.1% vs 50.7%, p < 0.001).
Baseline assessment of cardiovascular medication monitoring is variable. Quality measurement of adherence to BBW recommendations may improve monitoring.
实验室监测药物通常用于在开始药物治疗前确保安全性，并在开始治疗后检测与药物相关的损伤。目前尚不清楚黑框警告（BBW）以及基于证据和共识的临床指南是否会增加适当监测的可能性。
确定在选定的心血管药物新开始治疗的患者中进行基线评估和随访实验室监测的比例，并比较有和没有 BBW 和指南的药物进行实验室检测的流行率。
这项横断面研究纳入了 2008 年 1 月 1 日至 7 月 31 日期间在一家大型多专科实践中接受心血管药物（血管紧张素转换酶抑制剂、血管紧张素 II 受体阻滞剂、胺碘酮、地高辛、降脂药、利尿剂和钾补充剂）治疗的年龄在 18 岁或以上的患者。主要结局指标是新开始的心血管药物的基线评估和随访监测的实验室检测订单。
在研究期间，每种研究药物的新使用者数量从 49 到 1757 不等。研究药物的基线实验室检测订单范围从 37.4%到 94.8%，随访实验室检测订单范围从 20.0%到 77.2%。有 BBW 中基线实验室评估建议的药物的实验室检测订单比没有 BBW 的药物更常见（86.4%对 78.0%，p<0.001）。有临床指南中后续监测建议的药物的监测流行率较低（33.1%对 50.7%，p<0.001）。
心血管药物监测的基线评估是可变的。对 BBW 建议的依从性进行质量测量可能会改善监测。
