CMAJ. 2011 Mar 8;183(4):E246-8. doi: 10.1503/cmaj.100467. Epub 2011 Jan 24.
Intravenous doses of medications require formulations that permit accurate preparation and administration. Current equipment does not permit accurate measurement of volumes less than 0.1 mL. In a study of four hypothetical standard pediatric patients, we found that 28 common medications required less than 0.1 mL of available formulation to prepare the dose. In a clinical study of actual use in a pediatric intensive care unit (ICU), 5245 (7.4%) of 71 218 intravenous doses required preparation from less than 0.1 mL of stock solution. For 28.5% of the 1531 ICU admissions, at least one dose was prepared from a volume of less than 0.1 mL. Our findings identify a substantial source of dosing error. Correction will require revision of preparation methods, regulatory requirements and manufacturing practices.
静脉内给药需要可实现精确配制和给药的剂型。目前的设备无法精确测量小于 0.1 毫升的体积。在对 4 名假设的标准儿科患者的研究中,我们发现,28 种常见药物所需的可用制剂不到 0.1 毫升即可配制出剂量。在儿科重症监护病房(ICU)实际使用的临床研究中,71218 个静脉内剂量中有 5245(7.4%)个需要从少于 0.1 毫升的储备液中进行配制。在 1531 名 ICU 入院患者中,28.5%的患者至少有一剂是从小于 0.1 毫升的体积中配制的。我们的研究结果确定了一个很大的剂量误差来源。纠正这一问题需要修改配制方法、监管要求和生产实践。