Gaps in Ambulatory Patient Safety for Immunosuppressive Specialty Medications

摘要

Objectives: New specialty drugs such as biologics are now available in record numbers, presenting increased safety risks forpeople with immune-mediated diseases. However, comprehensive assessments of patient safety for these drugs are lacking.Weexamined 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.Methods: Data were extracted via electronic health record data warehouses of a large university health system using structuredqueries, and extensive chart review was performed to confirm measure elements.We included all new users of immunosuppressivespecialty drugs between 2013 and 2017. We assessed screening for LTBI, HBV, and HCV from 12 months beforethrough 60 days after medication initiation, and calculated performance on a composite measure that required screeningfor all three infections. Multivariable logistic regression was used to assess differences in screening across specialties, adjustingfor patient race, sex, age, and comorbidities.Results: 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. Only26% of patients were screened appropriately for all three infections. Screening patterns differed significantly according to treatingspecialty.Conclusions: We found gaps in ambulatory safety for patients treated with immunosuppressive specialty drugs for diverseinflammatory conditions across all relevant treating specialties. More robust safety protocols are urgently needed to preventserious patient safety events in this high-risk population.