Off-label drug use in an adult intensive care unit of a Brazilian hospital

Abstract The objective of this study was to determine the prevalence and describe the factors associated with off-label drug use in an adult intensive care unit (ICU) of a Brazilian hospital. An analytical, cross-sectional, prospective study was conducted in the adult ICU population from March 2018 to May 2018. Off-label use of medication was classified by indication, dosage, route of administration, type and volume of diluent, and duration of administration. Most patients were female (57.89%), non-elderly (56.14%), and had a mean age of 54.44 ± 17.15 years. The prevalence of off-label drug use was 70.31%, but was not associated with the clinical severity of the patients. A statistically significant association was observed between label use of drugs and prescribing potentially inappropriate medicines (PIM). The most common reasons for off-label drug use were therapeutic indication (19.58%) and volume of diluent (23.30%). Drug administration by enteral tubes accounted for the largest number of off-label uses due to route of administration (90.85%). There was a higher prevalence of off-label use of systemic antimicrobials (14.44%) and norepinephrine (9.28%). Our study provided a broad characterization of off-label drug use in an adult ICU and showed why it is important for health professionals to evaluate the specific risks and benefits of this practice.

摘要 本研究旨在明确某巴西医院成人重症监护病房（intensive care unit, ICU）中药物超说明书使用（off-label drug use）的患病率，并描述其相关影响因素。本研究于2018年3月至2018年5月针对该成人ICU人群开展了一项分析性横断面前瞻性研究。药物超说明书使用依据治疗适应证、给药剂量、给药途径、稀释剂类型与体积以及给药时长进行分类判定。纳入研究的患者中，女性占比57.89%，非老年患者占比56.14%，平均年龄为54.44 ± 17.15岁。药物超说明书使用的总患病率为70.31%，但该现象与患者的临床严重程度无显著关联。研究观察到，规范用药与处方潜在不适当用药（potentially inappropriate medicines, PIM）之间存在具有统计学意义的显著关联。药物超说明书使用最常见的两类原因为治疗适应证（19.58%）与稀释剂体积（23.30%）。因给药途径导致的超说明书使用中，经肠内导管给药占比最高，达90.85%。全身用抗菌药物（14.44%）与去甲肾上腺素（9.28%）的超说明书使用患病率更高。本研究全面刻画了成人ICU内药物超说明书使用的特征，并证实了医疗专业人员评估该诊疗实践的特定风险与获益的重要性。