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Jt Comm J Qual Patient Saf. 2019 May;45(5):348-357. doi: 10.1016/j.jcjq.2018.12.003. Epub 2019 Jan 25.

Gaps in Ambulatory Patient Safety for Immunosuppressive Specialty Medications.

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Department of Medicine, Division of Rheumatology, University of California, San Francisco. Electronic address:
Department of Medicine, University of California, San Francisco, and the Department of Veterans Affairs Medical Center, San Francisco, USA.
Department of Medicine, Division of Rheumatology, University of California, San Francisco.
Department of Epidemiology and Biostatistics, University of California, San Francisco.



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.


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