Parshuram Christopher S, Ng Geraldine Y T, Ho Tommy K L, Klein Julia, Moore Aideen M, Bohn Desmond, Koren Gideon
Department of Critical Care Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada.
Crit Care Med. 2003 Oct;31(10):2483-7. doi: 10.1097/01.CCM.0000089638.83803.B2.
We sought to test the assumption that the measured concentrations of medication infusions are within pharmaceutical standards (+/-10% of intended concentrations) and whether, at the time the infusion was mixed, the professional background of persons preparing the infusion or the unit for which the infusion was prepared were related to the observed variation.
DESIGN, SETTING, AND PARTICIPANTS: This prospective, observational study was conducted in the neonatal and pediatric intensive care units of a university-affiliated tertiary pediatric center. Morphine infusions prepared for clinical use were randomly sampled over a 7-month period. Those with no error between labeled and ordered concentration were further analyzed. High-performance liquid chromatography was used to determine the concentration of morphine infusions. The primary outcome was a difference of >10% between ordered and measured concentrations.
The measured concentration of 65% of the 232 infusions was >10% different from the ordered concentration (95% confidence interval, 58-71%). The concentrations of 6% of infusions represented two-fold errors (95% confidence interval, 3-9%). The difference was normally distributed around zero, suggesting a cumulative effect of random errors, rather than a systematic bias. The time that the infusion was prepared, the professional background of the persons preparing the infusion, and the unit for which the infusion was mixed were not significant predictors of discrepancy (p =.74, analysis of variance).
The concentration of two thirds of infusions prepared for clinical use was outside accepted industry standards. These findings are likely to be broadly representative of intravenous drug administration in hospitalized children and pediatric pharmacokinetic studies. Further study of the causes and clinical impact is required.
我们试图检验以下假设，即所测药物输注浓度是否在药品标准范围内（预期浓度的±10%），以及在输注混合时，准备输注的人员的专业背景或准备输注的科室是否与观察到的差异有关。
设计、设置和参与者：这项前瞻性观察性研究在一所大学附属三级儿科中心的新生儿和儿科重症监护病房进行。在7个月的时间里，随机抽取临床使用的吗啡输注样本。对标签浓度和医嘱浓度之间无误差的样本进行进一步分析。采用高效液相色谱法测定吗啡输注液的浓度。主要结局是医嘱浓度与实测浓度之间的差异>10%。
232例输注液中，65%的实测浓度与医嘱浓度相差>10%（95%置信区间，58 - 71%）。6%的输注液浓度存在两倍的误差（95%置信区间，3 - 9%）。差异围绕零呈正态分布，提示是随机误差的累积效应，而非系统偏差。准备输注的时间、准备输注的人员的专业背景以及混合输注液的科室并非差异的显著预测因素（方差分析，p = 0.74）。
为临床使用准备的三分之二的输注液浓度超出了公认的行业标准。这些发现可能广泛代表住院儿童静脉给药情况及儿科药代动力学研究。需要进一步研究其原因及临床影响。
