Pediatric Division, Assaf Harofeh Medical Center, Affiliated to Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Pediatric Intensive Care Unit, Assaf Harofeh Medical Center, Affiliated to Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Adv Ther. 2018 Jul;35(7):1122-1132. doi: 10.1007/s12325-018-0732-y. Epub 2018 Jun 15.
Many of the medications prescribed to children are off-label and/or unlicensed because pharmacologic evaluations have not been performed in this age group.
All drugs prescribed to patients admitted to the neonatal intensive care units (NICU) (n = 134) and pediatric intensive care units (PICU) (n = 56) during a 2-month observation period were recorded and classified according to patient age, drug license status, indicated use, and typical dosing, frequency and way of administration. Results were compared with prior data collected in 2002, from the same units.
In the NICU, among the 1064 prescriptions for 49 medications, 312 (29.2%) were licensed and 63 (5.9%) unlicensed, and 693 (64.8%) were off-label use. For the neonates, 23.9% and 96.3% received at least one unlicensed medication and one off-label medication, respectively. While the difference in off-label use between the two time periods was not statistically significant, unlicensed medications were less frequently prescribed in 2016 (5.9 versus 16.6%, p = 0.001). Regarding the PICU, among the 388 prescriptions for 75 medications, 205 (52%) were licensed and 13 (3.4%) unlicensed, and 170 (43.8%) were off-label. In contrast, in 2002, none of the medications prescribed were unlicensed (p = 0.001). The number of off-label medications (41%) and number of PICU patients receiving at least one unlicensed/off-label medication in these two time periods (88.7% versus 90.5% for 2016 and 2002, respectively) were similar.
The current study confirms the high prevalence of unlicensed and off-label drug use in a PICU and NICU setting. Compared with a similar study conducted in the same PICU in 2002, despite regulatory efforts conducted in this area, the prevalence of unlicensed medications was surprisingly higher.
许多给儿童开的药都是超说明书使用的和/或无许可证的，因为在这个年龄段还没有进行药理学评估。
在两个月的观察期内，记录并根据患者年龄、药物许可证状况、适应证用途以及典型剂量、频率和给药方式，对入住新生儿重症监护病房（NICU）（n=134）和儿科重症监护病房（PICU）（n=56）的所有患者的药物进行分类。结果与 2002 年同一单位收集的先前数据进行了比较。
在 NICU，在 49 种药物的 1064 种处方中，312 种（29.2%）有许可证，63 种（5.9%）无许可证，693 种（64.8%）为超说明书使用。对于新生儿，分别有 23.9%和 96.3%的患者至少使用了一种无许可证药物和一种超说明书药物。虽然两个时间段的超说明书使用率差异无统计学意义，但在 2016 年，无许可证药物的使用频率较低（5.9%比 16.6%，p=0.001）。在 PICU，在 75 种药物的 388 种处方中，205 种（52%）有许可证，13 种（3.4%）无许可证，170 种（43.8%）为超说明书使用。相比之下，在 2002 年，所开药物均有许可证（p=0.001）。在这两个时间段，超说明书药物的数量（41%）和至少使用一种无许可证/超说明书药物的 PICU 患者数量（2016 年为 88.7%，2002 年为 90.5%）相似。
本研究证实了在 PICU 和 NICU 环境中，无许可证和超说明书用药的高发生率。与 2002 年在同一 PICU 进行的一项类似研究相比，尽管在这一领域进行了监管努力，但无许可证药物的流行率出人意料地更高。
