Department of Pharmacy, Uppsala University, Uppsala, Sweden.
Infection Medicine, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Int J Antimicrob Agents. 2024 Jan;63(1):107032. doi: 10.1016/j.ijantimicag.2023.107032. Epub 2023 Nov 11.
To illustrate the impact of errors in documented dose administration time on therapeutic drug monitoring (TDM)-based target attainment evaluation for vancomycin and meropenem, and to explore the influence of drug and patient characteristics, and TDM sampling strategies.
Bedside observations of errors in documented dose administration times were collected. Population pharmacokinetic simulations were performed for vancomycin and meropenem, evaluating different one- and two-sampling strategies for populations with estimated creatinine clearance (CLcr) of 30, 80 or 130 mL/min. The impact of errors was evaluated as the proportion of individuals incorrectly considered to have reached the target.
Of 143 observed dose administrations, 97% of doses were given within ±30 min of the documented time. For vancomycin, a +30 min error was predicted to result in a 0.1-3.9 percentage point increase of cases incorrectly evaluated as reaching area under the concentration-time curve during a 24-hour period (AUC)/minimum inhibitory concentration (MIC) >400, with the largest increase for patients with augmented renal clearance and peak and trough sampling. For meropenem, a +30 min error resulted in a 1.3-6.4 and 0-20 percentage point increase of cases incorrectly evaluated as reaching 100% T, and 50% T, respectively. Overall, mid-dose and trough sampling was most favourable for both antibiotics.
For vancomycin, simulations indicate that TDM-based target attainment evaluation is robust with respect to the observed errors in dose administration time of ±30 min; however, the errors had a potentially clinically important impact in patients with augmented renal clearance. For meropenem, extra measures to promote correct documentation are warranted when using TDM, as the impact of errors was evident even in patients with normal renal function.
说明记录的给药时间误差对万古霉素和美罗培南基于治疗药物监测(TDM)的目标达成评估的影响,并探讨药物和患者特征以及 TDM 采样策略的影响。
收集记录的给药时间误差的床边观察结果。对万古霉素和美罗培南进行群体药代动力学模拟,评估估计肌酐清除率(CLcr)为 30、80 或 130 mL/min 的人群的不同单采样和双采样策略。通过评估错误比例,将错误对目标达成的影响评估为错误判断个体达标比例。
在观察到的 143 次给药中,97%的剂量在记录时间的±30 分钟内给予。对于万古霉素,预测+30 分钟的误差会导致在 24 小时期间 AUC/MIC>400 的个体错误评估比例增加 0.1-3.9 个百分点,其中增加最大的是增强肾清除率和峰谷采样的患者。对于美罗培南,+30 分钟的误差会导致错误评估为达到 100%T 和 50%T 的病例分别增加 1.3-6.4 和 0-20 个百分点。总体而言,两种抗生素的中剂量和谷浓度采样最有利。
对于万古霉素,模拟结果表明,基于 TDM 的目标达成评估对给药时间的观察误差±30 分钟具有稳健性;然而,在增强肾清除率的患者中,这些误差具有潜在的临床重要影响。对于美罗培南,即使在肾功能正常的患者中,误差的影响也很明显,因此在使用 TDM 时需要采取额外措施来促进正确记录。