Patterson Sarah, Schmajuk Gabriela, Evans Michael, Aggarwal Ishita, Izadi Zara, Gianfrancesco Milena, Yazdany Jinoos
Department of Medicine, Division of Rheumatology, University of California, San Francisco.
Department of Medicine, University of California, San Francisco, and the Department of Veterans Affairs Medical Center, San Francisco, USA.
Jt Comm J Qual Patient Saf. 2019 May;45(5):348-357. doi: 10.1016/j.jcjq.2018.12.003. Epub 2019 Jan 25.
New specialty drugs such as biologics are now available in record numbers, presenting increased safety risks for people with immune-mediated diseases. However, comprehensive assessments of patient safety for these drugs are lacking. We examined performance on key patient safety measures, such as screening for latent tuberculosis (LTBI), hepatitis B virus (HBV), and hepatitis C virus (HCV), for new users of a broad group of specialty medications.
Data were extracted via electronic health record data warehouses of a large university health system using structured queries, and extensive chart review was performed to confirm measure elements. We included all new users of immunosuppressive specialty drugs between 2013 and 2017. We assessed screening for LTBI, HBV, and HCV from 12 months before through 60 days after medication initiation, and calculated performance on a composite measure that required screening for all three infections. Multivariable logistic regression was used to assess differences in screening across specialties, adjusting for patient race, sex, age, and comorbidities.
Among 2027 patients, the most common drugs prescribed were adalimumab (32%), etanercept (24%), infliximab (19%), and ustekinumab (9%). Overall, 62% of patients were screened for LTBI, 42% for HBV, and 33% for HCV. Only 26% of patients were screened appropriately for all three infections. Screening patterns differed significantly according to treating specialty.
We found gaps in ambulatory safety for patients treated with immunosuppressive specialty drugs for diverse inflammatory conditions across all relevant treating specialties. More robust safety protocols are urgently needed to prevent serious patient safety events in this high-risk population.
如今，生物制剂等新型专科药物的数量达到了创纪录的水平，给免疫介导疾病患者带来了更高的安全风险。然而，目前缺乏对这些药物患者安全性的全面评估。我们研究了一大类专科药物新使用者在关键患者安全指标方面的表现，如潜伏性结核（LTBI）、乙型肝炎病毒（HBV）和丙型肝炎病毒（HCV）筛查。
通过结构化查询从大型大学健康系统的电子健康记录数据仓库中提取数据，并进行广泛的病历审查以确认指标要素。我们纳入了2013年至2017年间所有免疫抑制专科药物的新使用者。我们评估了从用药前12个月到用药后60天的LTBI、HBV和HCV筛查情况，并计算了对所有三种感染进行筛查的综合指标表现。采用多变量逻辑回归评估各专科筛查的差异，并对患者种族、性别、年龄和合并症进行校正。
在2027名患者中，最常开具的药物是阿达木单抗（32%）、依那西普（24%）、英夫利昔单抗（19%）和乌司奴单抗（9%）。总体而言，62%的患者接受了LTBI筛查，42%接受了HBV筛查，33%接受了HCV筛查。只有26%的患者对所有三种感染都进行了适当筛查。筛查模式因治疗专科不同而有显著差异。
我们发现，在所有相关治疗专科中，接受免疫抑制专科药物治疗的不同炎症性疾病患者的门诊安全性存在差距。迫切需要更有力的安全方案来预防这一高风险人群中的严重患者安全事件。
