Compliance with risk management plan recommendations on laboratory monitoring of antitumor necrosis factor-α therapy in clinical practice
| Autor: | Yen-Hsia Wen, Chien-Ning Hsu, Yaw-Bin Huang, Yu-Ching Lily Wang, Meng-Ju Chan, You-Lin Tain, Hung-Yi Chuang |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
HBsAg Pathology 0302 clinical medicine 030212 general & internal medicine Medicine(all) lcsh:R5-920 Antibodies Monoclonal General Medicine Hepatitis B Middle Aged Hepatitis C tuberculosis Antirheumatic Agents Practice Guidelines as Topic Prednisolone Female Guideline Adherence Drug Monitoring Viral hepatitis lcsh:Medicine (General) medicine.drug Adult medicine.medical_specialty Tuberculosis Taiwan viral hepatitis 03 medical and health sciences Latent Tuberculosis Internal medicine Psoriasis Pharmacovigilance medicine Humans Retrospective Studies 030203 arthritis & rheumatology Risk Management Hepatitis B Surface Antigens business.industry Tumor Necrosis Factor-alpha risk management plan medicine.disease infection Logistic Models Concomitant pharmacovigilance Multivariate Analysis antitumor necrosis factor-α business |
| Zdroj: | Journal of the Formosan Medical Association, Vol 115, Iss 2, Pp 83-93 (2016) |
| ISSN: | 0929-6646 |
| Popis: | Background/Purpose 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. Conclusion 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. |
| Databáze: | OpenAIRE |
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