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  1. AU="Wolin, Dan L"
  2. AU="Zhang, Tenan"
  3. AU="Piedrafita, Lídia"
  4. AU="Nandy, Ananya"
  5. AU="Bansemer, Sven"
  6. AU="Kochetov, O"
  7. AU="Liu, Fen"

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  1. Article ; Online: Evaluation of Physician Knowledge of Safety and Safe Use Information for Intravitreal Aflibercept Injection in Europe: A Second Survey of Physicians Following Dissemination of Updated Risk-Minimization Materials.

    Zografos, Laurie J / Andrews, Elizabeth / Wolin, Dan L / Calingaert, Brian / Davenport, Eric K / Michel, Alexander / Latocha, Margarete / Schmidt-Ott, Ursula Maria / Lovic, Nejra / Brunck, Lynne R / Johnson, Kristian T / Suzart-Woischnik, Kiliana

    Pharmaceutical medicine

    2023  Volume 38, Issue 1, Page(s) 63–73

    Abstract: Background: Materials have been distributed in the European Union to inform physicians on the safe use of intravitreal aflibercept (IVT-AFL) as part of the risk-minimization plan for IVT-AFL.: Objective: We aimed to measure physician knowledge and ... ...

    Abstract Background: Materials have been distributed in the European Union to inform physicians on the safe use of intravitreal aflibercept (IVT-AFL) as part of the risk-minimization plan for IVT-AFL.
    Objective: We aimed to measure physician knowledge and understanding of key safety information for IVT-AFL.
    Methods: The current study was a follow-up cross-sectional survey ('wave 2') to an earlier survey ('wave 1') examining the effectiveness of the IVT-AFL educational materials by assessing physician knowledge of the key safety information. Based on wave 1 results, the educational materials were revised to focus more on items of key concern (e.g., use in women of childbearing potential, procedural information); physicians in France, Germany, Italy, Spain, and the UK completed a questionnaire to evaluate their knowledge of key safety information in the revised educational materials.
    Results: Among 454 physician respondents (of 4715 invited; response rate 9.6%), most reported having received the IVT-AFL Summary of Product Characteristics (SmPC; 89%) and Prescriber Guide (82%). More than half reported receiving the Injection Procedure Video (54%) and Patient Booklet (65%). The highest percentage of correct answers was observed for questions concerning procedural steps, the most important risks, and safe use as emphasized by the educational materials and the SmPC.
    Conclusion: Physician knowledge and understanding of safe use of IVT-AFL, including for questions that prompted revisions to the educational materials, suggests the need to reconsider methods for developing educational materials to follow best practices (e.g., focusing on only key messages and pretesting with end users).
    MeSH term(s) Humans ; Female ; Cross-Sectional Studies ; Europe ; Physicians ; Surveys and Questionnaires ; Recombinant Fusion Proteins ; Receptors, Vascular Endothelial Growth Factor
    Chemical Substances aflibercept (15C2VL427D) ; Recombinant Fusion Proteins ; Receptors, Vascular Endothelial Growth Factor (EC 2.7.10.1)
    Language English
    Publishing date 2023-12-05
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 2415165-8
    ISSN 1179-1993 ; 1178-2595
    ISSN (online) 1179-1993
    ISSN 1178-2595
    DOI 10.1007/s40290-023-00506-7
    Database MEDical Literature Analysis and Retrieval System OnLINE

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

    Zografos, Laurie J / Andrews, Elizabeth / Wolin, Dan L / Calingaert, Brian / Davenport, Eric K / Hollis, Kelly A / Djokanovic, Nada / Racanelli, Vito S / Petraro, Paul / Vassilev, Zdravko P

    Pharmaceutical medicine

    2020  Volume 33, Issue 3, Page(s) 235–246

    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 ... ...

    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).
    MeSH term(s) Angiogenesis Inhibitors/administration & dosage ; Angiogenesis Inhibitors/adverse effects ; Canada ; Clinical Competence/statistics & numerical data ; Cross-Sectional Studies ; Female ; Health Education/methods ; Humans ; Intravitreal Injections ; Male ; Ophthalmologists ; Practice Patterns, Physicians' ; Receptors, Vascular Endothelial Growth Factor/administration & dosage ; Recombinant Fusion Proteins/administration & dosage ; Recombinant Fusion Proteins/adverse effects ; Risk Management ; Surveys and Questionnaires
    Chemical Substances Angiogenesis Inhibitors ; Recombinant Fusion Proteins ; aflibercept (15C2VL427D) ; Receptors, Vascular Endothelial Growth Factor (EC 2.7.10.1)
    Language English
    Publishing date 2020-01-13
    Publishing country New Zealand
    Document type Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 2415165-8
    ISSN 1179-1993 ; 1178-2595
    ISSN (online) 1179-1993
    ISSN 1178-2595
    DOI 10.1007/s40290-019-00278-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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