title: Compliance with risk management plan recommendations on laboratory monitoring of antitumor necrosis factor-α therapy in clinical practice.
abstract: OBJECTIVE
  A risk management plan (RMP) was introduced to monitor the association between initiation of antitumor necrosis factor-α (anti-TNF-α) therapy and tuberculosis (TB) and viral hepatitis infections. The aim of this study was to assess adherence and predictors of laboratory-testing rates among patients treated with anti-TNF-α therapy.
  
  
  METHODS
  Data on patients receiving anti-TNF-α therapy between January 1, 2005, and November 31, 2013, were retrieved from a large medical organization in Taiwan. Newly-treated patients were categorized into pre- and post-RMP groups. Laboratory testing for TB and hepatitis B and C was ascertained and the proportion of new users receiving the test was compared between the pre- and post-RMP groups. Patient characteristics and concomitant medications used were investigated using multivariate logistic regression to determine the impact of each factor on laboratory testing.
  
  
  RESULTS
  Among 1128 new users, the initial testing rate of chest X-ray (CXR) for latent TB infection increased from 60.26% before RMP to 76.38% after RMP implementation; hepatitis B surface antigen (HBsAg) increased from 31.13% to 51.42%; and hepatitis C virus antibody (HCVAb) increased from 32.2% to 54.10%. CXR was significantly associated with age >60 years, higher Quan-Charlson comorbidity index score, psoriasis, and use of prednisolone (≥7.5 mg/d). Patients aged 40-60 years and with prednisolone doses of ≥7.5 mg/d and history of cancer were more likely to receive HBsAg or HCVAb tests than their counterparts.
  
  
  CONCLUSIONS
  The rate of laboratory test monitoring for anti-TNF-α therapy increased after RMP implementation. A strategy that integrates efforts from patient's education, health profession, and regulatory agencies is needed to improve safety screening and access to laboratory resources for the at-risk group of patients.
authors.affiliation: School of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan.
authors.forename: Meng-Ju
authors.initials: MJ
authors.lastname: Chan
authors.affiliation: School of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Pharmacy, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan.
authors.forename: Yaw-Bin
authors.initials: YB
authors.lastname: Huang
authors.affiliation: School of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan.
authors.forename: Yen-Hsia
authors.initials: YH
authors.lastname: Wen
authors.affiliation: Department of Public Health and Center of Excellence for Environmental Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
authors.forename: Hung-Yi
authors.initials: HY
authors.lastname: Chuang
authors.affiliation: Department of Pediatrics, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, College of Medicine, Kaohsiung, Taiwan.
authors.forename: You-Lin
authors.initials: YL
authors.lastname: Tain
authors.affiliation: Department of Pharmacy, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.
authors.forename: Yu-Ching Lily
authors.initials: YC
authors.lastname: Wang
authors.affiliation: School of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Pharmacy, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan. Electronic address: chien_ning_hsu@hotmail.com.
authors.forename: Chien-Ning
authors.initials: CN
authors.lastname: Hsu
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D016903:Drug Monitoring; D005260:Female; D019983:Guideline Adherence; D006509:Hepatitis B / Q000175:diagnosis; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006526:Hepatitis C / Q000175:diagnosis; D006801:Humans; D055985:Latent Tuberculosis / Q000175:diagnosis; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D012308:Risk Management; D013624:Taiwan; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D006514:Hepatitis B Surface Antigens; D014409:Tumor Necrosis Factor-alpha
keywords: antitumor necrosis factor-α; infection; pharmacovigilance; risk management plan; tuberculosis; viral hepatitis