Literature DB >> 31933288

Evaluation of Physician Knowledge of the Key Safety Information for Aflibercept in Canada: Evaluation of Risk-Minimization Measures.

Laurie J Zografos1, Elizabeth Andrews2, Dan L Wolin2, Brian Calingaert2, Eric K Davenport2, Kelly A Hollis2, Nada Djokanovic3, Vito S Racanelli3, Paul Petraro4,5, Zdravko P Vassilev4.   

Abstract

BACKGROUND: As part of the risk-management plan (RMP) for aflibercept, materials have been developed to educate physicians in Canada on the key safety information and safe use for aflibercept.
OBJECTIVE: The objectives of this study were to assess whether physicians in Canada received and reviewed the aflibercept educational materials (i.e. vial preparation instruction card, intravitreal injection procedure video, and product monograph) and to evaluate their knowledge of key safety information.
METHODS: Retinal specialists and ophthalmologists who prescribe and/or administer aflibercept were recruited to complete a survey. Physicians could complete and return a paper questionnaire by mail or complete the questionnaire online via a study website.
RESULTS: Of the 308 physicians invited to participate in the survey, 95 (31%) completed the questionnaire. Nearly all physicians (98%) reported receiving at least one of the educational materials. The proportion of correct responses to individual questions on storage and preparation of aflibercept ranged from 54 to 98%. Physician knowledge was high on the recommended dose of aflibercept (91%), dose preparation (91-96% on individual items), and dosing guidelines (75-95% on individual items). Most physicians knew the contraindications for aflibercept (89%) and that aflibercept should not be used in pregnancy unless clearly indicated by medical need in which benefits outweigh risks (60%); 21% responded more conservatively that aflibercept should never be used in pregnancy. Knowledge was high for most questions about injection procedures (91-99% on individual items); however, fewer physicians (24%) correctly reported that the eye should be covered with a sterile drape. Knowledge was high for possible side effects (89-100% on individual items) and actions to take in relation to the potential for increased intraocular pressure (86-93% on individual items).
CONCLUSION: Nearly all physicians (98%) reported having received the product monograph, and most (82%) reported having received the vial preparation instruction card; nearly half (46%) reported having received the intravitreal injection procedure video. Physicians' knowledge of the most important topics was high. Knowledge varied for topics that are less frequently encountered (e.g. use in women of childbearing potential) and for recommendations that are not standard medical practice in Canada (e.g. use of sterile drape).

Entities:  

Mesh:

Substances:

Year:  2019        PMID: 31933288     DOI: 10.1007/s40290-019-00278-z

Source DB:  PubMed          Journal:  Pharmaceut Med        ISSN: 1178-2595


  13 in total

Review 1.  Ranibizumab therapy for neovascular age-related macular degeneration.

Authors:  James C Folk; Edwin M Stone
Journal:  N Engl J Med       Date:  2010-10-21       Impact factor: 91.245

Review 2.  Age-related macular degeneration.

Authors:  Rama D Jager; William F Mieler; Joan W Miller
Journal:  N Engl J Med       Date:  2008-06-12       Impact factor: 91.245

3.  Survey of intravitreal injection techniques and treatment protocols among retina specialists in Canada.

Authors:  Lin Xing; Stephen J Dorrepaal; Jeffrey Gale
Journal:  Can J Ophthalmol       Date:  2014-06       Impact factor: 1.882

Review 4.  Anti-VEGF compounds in the treatment of neovascular age related macular degeneration.

Authors:  C Campa; S P Harding
Journal:  Curr Drug Targets       Date:  2011-02       Impact factor: 3.465

Review 5.  Anti-vascular endothelial growth factor therapy for diabetic macular edema.

Authors:  David S Boyer; J Jill Hopkins; Jonathan Sorof; Jason S Ehrlich
Journal:  Ther Adv Endocrinol Metab       Date:  2013-12       Impact factor: 3.565

6.  Safety implications of vascular endothelial growth factor blockade for subjects receiving intravitreal anti-vascular endothelial growth factor therapies.

Authors:  Karl Csaky; Diana V Do
Journal:  Am J Ophthalmol       Date:  2009-08-26       Impact factor: 5.258

Review 7.  Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for neovascular age-related macular degeneration.

Authors:  S S Vedula; M G Krzystolik
Journal:  Cochrane Database Syst Rev       Date:  2008-04-16

Review 8.  Safety and efficacy of intravitreal anti-VEGF injections for age-related macular degeneration.

Authors:  V Swetha E Jeganathan; Nitin Verma
Journal:  Curr Opin Ophthalmol       Date:  2009-05       Impact factor: 3.761

9.  Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study.

Authors:  Wally Landsberg; Imad Al-Dakkak; Antonia Coppin-Renz; Uli Geis; Timothy Peters-Strickland; Emiel van Heumen; Mirza Rahman
Journal:  Drug Saf       Date:  2018-08       Impact factor: 5.606

10.  Evaluation of Risk-Minimization Activities for Cyproterone Acetate 2 mg/Ethinylestradiol 35 µg: A Cross-Sectional Physician Survey.

Authors:  Kimberly H Davis; Alex Asiimwe; Laurie J Zografos; David J McSorley; Elizabeth B Andrews
Journal:  Pharmaceut Med       Date:  2017-08-28
View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.