Researchers Find Gaps in Safety Screening for Patients Taking New Specialty Drugs

AHRQ-funded researchers identified potential safety gaps related to new specialty drugs and are calling for more robust safety protocols to prevent medication-related adverse events for patients with inflammatory conditions. The study, published in The Joint Commission Journal on Quality and Patient Safety, found that only 26 percent of patients receiving new specialty drugs (such as biologics) were screened for tuberculosis and hepatitis B and C as is currently recommended to prevent reactivation of latent diseases. The researchers examined electronic health records of more than 2,000 patients at a large medical center; the patients were prescribed new specialty drugs such as adalimumab, etanercept, infliximab and ustekinumab for treatment of inflammatory joint, skin and/or gut conditions. These drugs, while generally safe and effective for treating inflammatory conditions, carry an increased risk of life-threatening infections, including tuberculosis and hepatitis. Access the abstract.

2019 Jan 24. pii: S1553-7250(18)30309-X. doi: 10.1016/j.jcjq.2018.12.003. [Epub ahead of print]

Gaps in Ambulatory Patient Safety for Immunosuppressive Specialty Medications.

Patterson S1, Schmajuk G2, Evans M3, Aggarwal I3, Izadi Z4, Gianfrancesco M3, Yazdany J3.

Author information

Abstract

OBJECTIVES:

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.

METHODS:

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.

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. Only 26% of patients were screened appropriately for all three infections. Screening patterns differed significantly according to treating specialty.

CONCLUSIONS:

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.