Effectiveness of the golimumab educational program in ensuring healthcare professionals' awareness of risks described in the European risk management plan.
| Autor: | Felo L; Merck & Co., Inc., 351 N. Sumneytown Pike, P.O. Box 1000, Mailstop UG3C-54, N. Wales, PA 19454., Otero-Lobato M; Medical Affairs, Janssen Biologics BV, Leiden, The Netherlands., Geldhof A; Medical Affairs, Janssen Biologics BV, Leiden, The Netherlands., Noël W; Medical Affairs, Janssen Biologics BV, Leiden, The Netherlands. |
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| Jazyk: | angličtina |
| Zdroj: | Therapeutic advances in drug safety [Ther Adv Drug Saf] 2019 May 15; Vol. 10, pp. 2042098619847420. Date of Electronic Publication: 2019 May 15 (Print Publication: 2019). |
| DOI: | 10.1177/2042098619847420 |
| Abstrakt: | Background: The golimumab safety awareness study commenced in 2010 to measure, periodically, the awareness of golimumab prescriber healthcare professionals (HCPs) of specific risks associated with golimumab as well as awareness of the requirement to provide a patient alert card to each patient treated with golimumab, as described in the European golimumab educational program. The aim of this study was to measure the awareness of HCPs who prescribe or who intend to prescribe SIMPONI ® (golimumab) of the risks potentially related to golimumab and of the requirements for distributing the patient alert card, as described in the golimumab educational program. Methods: A structured, quantitative Web-based survey was conducted in 2010, 2012, 2014, and 2016 in eight European countries among HCPs who were at that time current or future prescribers of golimumab for patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, or ulcerative colitis. Results: The overall golimumab risk awareness was high for golimumab prescriber HCPs across the risk statement categories (median awareness in 2016 across categories: 91%). The awareness of the golimumab risks was generally slightly higher among rheumatologists (75-98%) and gastroenterologists (73-97%) than among dermatologists (67-94%). Overall, the awareness of the requirements for handing out the patient alert card to golimumab-treated patients remained steady or increased slightly in 2016 relative to the other surveys. Conclusions: The results of this study show that the awareness of risks associated with golimumab by golimumab prescriber HCPs is high. The information made available to golimumab prescriber HCPs appears to have been sufficient with respect to golimumab risk awareness education. Competing Interests: Conflict of interest statement: L. Felo is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and holds stock/stock options in the company. M. Otero-Lobato and A. Geldhof are employees of Janssen Biologics BV, Leiden, The Netherlands, and W. Noël is an employee of Janssen Cilag, Belgium; all three of these employees hold stock/stock options in Johnson & Johnson. All of the authors are responsible for the work described in this manuscript. All authors were involved in at least one of the following: (1) conception, design, acquisition, analysis, statistical analysis, or interpretation of data and (2) drafting the manuscript or revising it for important intellectual content. All authors provided final approval of the version to be published. |
| Databáze: | MEDLINE |
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