PMID- 30686706
OWN - NLM
STAT- MEDLINE
DCOM- 20200911
LR  - 20201011
IS  - 1938-131X (Electronic)
IS  - 1553-7250 (Print)
IS  - 1553-7250 (Linking)
VI  - 45
IP  - 5
DP  - 2019 May
TI  - Gaps in Ambulatory Patient Safety for Immunosuppressive Specialty Medications.
PG  - 348-357
LID - S1553-7250(18)30309-X [pii]
LID - 10.1016/j.jcjq.2018.12.003 [doi]
AB  - 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.
CI  - Copyright (c) 2018 Elsevier Inc. All rights reserved.
FAU - Patterson, Sarah
AU  - Patterson S
AD  - Department of Medicine, Division of Rheumatology, University of California, San 
      Francisco. Electronic address: Sarah.Patterson@ucsf.edu.
FAU - Schmajuk, Gabriela
AU  - Schmajuk G
AD  - Department of Medicine, University of California, San Francisco, and the 
      Department of Veterans Affairs Medical Center, San Francisco, USA.
FAU - Evans, Michael
AU  - Evans M
AD  - Department of Medicine, Division of Rheumatology, University of California, San 
      Francisco.
FAU - Aggarwal, Ishita
AU  - Aggarwal I
AD  - Department of Medicine, Division of Rheumatology, University of California, San 
      Francisco.
FAU - Izadi, Zara
AU  - Izadi Z
AD  - Department of Epidemiology and Biostatistics, University of California, San 
      Francisco.
FAU - Gianfrancesco, Milena
AU  - Gianfrancesco M
AD  - Department of Medicine, Division of Rheumatology, University of California, San 
      Francisco.
FAU - Yazdany, Jinoos
AU  - Yazdany J
AD  - Department of Medicine, Division of Rheumatology, University of California, San 
      Francisco.
LA  - eng
GR  - K24 AR074534/AR/NIAMS NIH HHS/United States
GR  - P30 AR070155/AR/NIAMS NIH HHS/United States
GR  - R01 HS024412/HS/AHRQ HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20190125
PL  - Netherlands
TA  - Jt Comm J Qual Patient Saf
JT  - Joint Commission journal on quality and patient safety
JID - 101238023
RN  - 0 (Immunosuppressive Agents)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - *Ambulatory Care
MH  - Databases, Factual
MH  - Electronic Health Records
MH  - Female
MH  - Humans
MH  - *Immunosuppressive Agents
MH  - Male
MH  - Middle Aged
MH  - Patient Safety/*standards
MH  - Young Adult
PMC - PMC7433663
MID - NIHMS1610735
EDAT- 2019/01/29 06:00
MHDA- 2020/09/12 06:00
PMCR- 2020/08/18
CRDT- 2019/01/29 06:00
PHST- 2018/06/14 00:00 [received]
PHST- 2018/12/06 00:00 [revised]
PHST- 2018/12/10 00:00 [accepted]
PHST- 2019/01/29 06:00 [pubmed]
PHST- 2020/09/12 06:00 [medline]
PHST- 2019/01/29 06:00 [entrez]
PHST- 2020/08/18 00:00 [pmc-release]
AID - S1553-7250(18)30309-X [pii]
AID - 10.1016/j.jcjq.2018.12.003 [doi]
PST - ppublish
SO  - Jt Comm J Qual Patient Saf. 2019 May;45(5):348-357. doi: 
      10.1016/j.jcjq.2018.12.003. Epub 2019 Jan 25.