Zografos LJ, Andrews E, Calingaert B, Davenport EK, Wolin DL, Vassilev ZP. Evaluation of physician knowledge of safety and safe use information for aflibercept in Europe. Poster presented at the 34th Annual ICPE Conference; August 25, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug; 27(S2):207.


BACKGROUND: As part of the risk‐management plan for aflibercept (an intravitreal antineovascularisation agent with several indications), Bayer developed materials to educate physicians and patients on the key safety and safe use information for aflibercept and distributed them to ophthalmology practices to increase awareness and understanding.

OBJECTIVES: To measure whether physicians received the aflibercept prescriber guide (PG) and the injection procedure video and evaluate their knowledge of key safety information.

METHODS: An observational, cross‐sectional study was conducted in the UK, Germany, France, Spain, and Italy. Ophthalmologists who had prescribed and/or administered aflibercept in the past 6 months were recruited from a web panel to complete a survey. Data analyses were descriptive.

RESULTS: Of 459 eligible physicians, 445 consented and 428 completed the questionnaire and were included in the analysis. Eightyseven percent reported receipt of the summary of product characteristics (SmPC), 77% the PG, and 50% the intravitreal injection procedure video. Knowledge was high on storage and preparation (74%, 95% CI [70‐78%]) to 97%, 95% CI [95‐99%] for 5 of 6 items) and injection procedures (83%, 95% CI [80‐87%] to 96%, 95% CI [93‐ 97%] on 5 items). Knowledge of dosing requirements was highest for wet age‐related macular degeneration (28%, 95% CI [24‐33%] to 94%, 95% CI [91‐96%] on 4 items) and lower for newer or less commonly prescribed indications. The 28% knowledge level reflected more conservative interpretation of monitoring requirements (eg, 28% correctly responded “true” to there being no monitoring requirements between doses, while 68% responded “false”). Overall, knowledge of preparing patients for treatment was high (63%, 95% CI, [58‐68%] to 94%, 95% CI [91‐96%] on 3 items). Most physicians (82%, 95% CI [78‐85%]) identified all contraindications for use. Knowledge was also high for recognising signs and symptoms of possible side effects (78%, 95% CI [73‐81%] to 89%, 95% CI [85‐92%] on 4 items).

CONCLUSIONS:
Physicians' knowledge of most important topics was high (eg, side effects). Knowledge was lower for topics less frequently encountered (eg, use in women of childbearing potential) and for more complex aspects of safe use (eg, dosing and monitoring) for which we assume physicians would consult the label/PG rather than relying on recall. Reported receipt of the SmPC and PG was high, and the high level of knowledge suggests that the key safety information is available to physicians.

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