Department of Pharmacy Practice and Science, School of Pharmacy, University of Maryland, Baltimore, MD 21201, USA.
Pharmacotherapy. 2010 Aug;30(8):776-86. doi: 10.1592/phco.30.8.776.
To characterize renal function parameters reported in United States Food and Drug Administration-approved prescribing information (package inserts), to compare dosage recommendations for patients with impaired renal function between prescribing information and tertiary drug dosing references, and to evaluate renal function quantification methods most commonly used by clinical pharmacists to develop dosage regimens.
Retrospective analysis and Web-based survey.
Prescribing information for all new molecular entities (NMEs) approved from 1998-2007 in which dosing recommendations were proposed for patients with impaired renal function, drug monographs from four tertiary drug dosing references (Micromedex, Lexi-Comp, Epocrates Rx, and American Hospital Formulary Service [AHFS] Drug Information) for all identified NMEs, and a Web-based survey of 204 nephrology and critical care pharmacy practitioners.
A total of 44 NMEs included renal dosing recommendations in their prescribing information. For all 44 NMEs, prescribing information was reviewed to determine methods to quantify renal function, units of measure reported, and use of chronic kidney disease terminology. The most common index of renal function was creatinine clearance; the Cockcroft-Gault equation was specified in the prescribing information of 11 NMEs. Standardization for body weight was inconsistent, with prescribing information for four NMEs reporting renal function in ml/minute/1.73 m(2). The prescribing information or tertiary sources did not mention use of estimated glomerular filtration rate (eGFR) or the Modification of Diet in Renal Disease Study (MDRD) equation. Epocrates Rx provided the most abbreviated renal dosing information, whereas AHFS Drug Information was the most comprehensive, and Lexi-Comp includes a renal function calculator. Nearly all (86%) clinical pharmacists indicated that automated eGFR is reported at their institutions, although they do not use these predictions for dosing in patients with impaired renal function, and their approaches to renal function estimation varied widely.
Reporting of renal function methods and dosing recommendations for patients with impaired renal function requires standardization in order to ensure optimal dosing. Pharmacy clinicians do not substitute eGFR in place of creatinine clearance for renal dosing, which is consistent with current prescribing information. Studies are needed that will evaluate the validity of using eGFR to predict drug clearance and thereby generate dosage recommendations.
描述美国食品和药物管理局批准的说明书（包装插页）中报告的肾功能参数，比较说明书和三级药物剂量参考资料中肾功能损害患者的剂量建议，并评估临床药师最常用来制定剂量方案的肾功能量化方法。
回顾性分析和基于网络的调查。
1998-2007 年批准的所有新分子实体（NME）的说明书，其中提出了肾功能损害患者的剂量建议，来自四个三级药物剂量参考资料（Micromedex、Lexi-Comp、Epocrates Rx 和美国医院处方集服务[AHFS]药物信息）的所有鉴定 NME 的药物专论，以及对 204 名肾病学和重症监护药房从业者的基于网络的调查。
共有 44 种 NME 在说明书中包含了肾脏剂量建议。对于所有 44 种 NME，均审查了说明书，以确定肾功能量化方法、报告的度量单位以及慢性肾脏病术语的使用。最常见的肾功能指标是肌酐清除率；11 种 NME 的说明书中指定了 Cockcroft-Gault 方程。体重的标准化不一致，4 种 NME 的说明书报告了肾功能的 ml/min/1.73 m(2)。说明书或三级来源均未提及使用估计肾小球滤过率（eGFR）或肾脏病饮食改良研究（MDRD）方程。Epocrates Rx 提供了最简短的肾脏剂量信息，而 AHFS Drug Information 则最全面，Lexi-Comp 包含一个肾功能计算器。近 90%（86%）的临床药师表示，他们所在机构报告了自动 eGFR，但他们并未将这些预测用于肾功能损害患者的剂量，并且他们的肾功能估计方法差异很大。
为了确保最佳剂量，有必要规范说明书中报告的肾功能方法和肾功能损害患者的剂量建议。药房临床医生并未将 eGFR 替代肌酐清除率用于肾脏剂量，这与现行说明书一致。需要开展研究，评估使用 eGFR 预测药物清除率并由此生成剂量建议的有效性。
