Literature DB >> 31933286

Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: Evaluation of Risk-Minimization Measures.

Laurie J Zografos1, Elizabeth Andrews2, Daniel L Wolin2, Brian Calingaert2, Eric K Davenport2, Kelly A Hollis2, Ursula Maria Schmidt-Ott3, Paul Petraro4,5, Zdravko P Vassilev4.   

Abstract

BACKGROUND: As part of the risk-management plan for aflibercept in the European Union, materials have been developed to educate physicians and patients in Europe on the safe use of aflibercept.
OBJECTIVES: The objectives of this study were to measure receipt of the educational materials and to evaluate understanding of key safety information for aflibercept.
METHODS: An observational cross-sectional study among physicians and patients with recent aflibercept experience in France, Germany, Italy, Spain, and the UK was conducted. Eligible physicians and patients completed a brief questionnaire regarding their knowledge of key safety information.
RESULTS: Among the 8424 physicians invited to participate in the survey, 428 physicians were eligible, completed the questionnaire, and were included in this analysis. Most physicians reported having received the aflibercept summary of product characteristics (87%) and prescriber guide (77%); approximately half reported receiving the injection procedure video (50%) and patient booklet (54%). Physician knowledge of the most important topics (i.e., side effects; preparing patients for aflibercept injection) was high. Physician knowledge of dosing was high for neovascular (wet) age-related macular degeneration and lower for less commonly prescribed indications. Most physicians knew the contraindications for aflibercept and recognized possible side effects. Among the 874 patients approached about participation in the study, 773 patients were eligible, completed the questionnaire, and were included in the analysis. Patients' reported receipt was relatively low for the aflibercept patient booklet (38%) and the audio CD (23%). Patient knowledge of the health conditions to discuss with a doctor prior to injection was generally high; knowledge about possible side effects varied. Most patients knew that they should speak to a physician immediately if they experienced a possible side effect of aflibercept.
CONCLUSION: Most physicians reported receiving the summary of product characteristics, prescriber guide, and patient booklet; half reported receiving the intravitreal injection procedure video. Patient receipt of the educational material was variable. Observed patterns of knowledge indicated the greatest knowledge of the most important risks emphasized in the educational material and lower knowledge of more complex or less salient aspects of safe use.

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Year:  2019        PMID: 31933286     DOI: 10.1007/s40290-019-00279-y

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


  8 in total

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Authors:  Robert S Brody; Charles L Liss; Heather Wray; Ramon Iovin; Carmen Michaylira; Anushini Muthutantri; Philip Damstetter; Catherine Datto; Leigh Jefferies
Journal:  Int Clin Psychopharmacol       Date:  2016-01       Impact factor: 1.659

2.  Why are response rates in clinician surveys declining?

Authors:  Ellen R Wiebe; Janusz Kaczorowski; Jacqueline MacKay
Journal:  Can Fam Physician       Date:  2012-04       Impact factor: 3.275

Review 3.  Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation.

Authors:  Anjan Kumar Banerjee; Inge M Zomerdijk; Stella Wooder; Simon Ingate; Stephen J Mayall
Journal:  Drug Saf       Date:  2014-01       Impact factor: 5.606

4.  Patient understanding of drug risks: an evaluation of medication guide assessments.

Authors:  Caitlin Knox; Christian Hampp; Mary Willy; Almut G Winterstein; Gerald Dal Pan
Journal:  Pharmacoepidemiol Drug Saf       Date:  2015-03-23       Impact factor: 2.890

5.  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 6.  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

7.  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

8.  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
  8 in total
  2 in total

1.  Pharmacists' perception of educational material to improve patient safety: A cross-sectional study on practices and awareness in Germany.

Authors:  André Said; Leonard Freudewald; Natalie Parrau; Matthias Ganso; Martin Schulz
Journal:  Medicine (Baltimore)       Date:  2021-03-19       Impact factor: 1.817

2.  Effectiveness of risk minimisation measures for valproate: A cross-sectional survey among physicians in Europe.

Authors:  Massoud Toussi; Bardoulat Isabelle; Stephanie Tcherny-Lessenot; Hanka de Voogd; Vasilis Dimos; Sigal Kaplan
Journal:  Pharmacoepidemiol Drug Saf       Date:  2020-11-20       Impact factor: 2.890

  2 in total

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