Zografos LJ, Calingaert B, Davenport EK, Vassilev ZP, Wolin DL, Andrews E. Evaluation of patient knowledge of safety and safe use information for aflibercept in Europe. Poster presented at the 34th ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 26, 2018. Prague, Czech Republic. [abstract] Pharmacoepidemiol Drug Saf. 2018 Aug; 27(S2):520. doi: 10.1002/pds.4629

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 information for aflibercept and distributed them to ophthalmology practices to increase awareness and understanding.

OBJECTIVES: To measure whether patients received the aflibercept patient booklet, patient information leaflet, and audio CD and evaluate their knowledge of the key safety information.

METHODS: An observational, cross‐sectional study was conducted in the United Kingdom, Germany, France, Spain, and Italy. A diverse sample of ophthalmology practices was recruited among known aflibercept prescribers identified by Bayer. Geographic location was evaluated to ensure diversity. Physicians invited patients who had received an aflibercept injection in the last 6 months to complete an interviewer‐administered questionnaire. Data analyses were descriptive.

RESULTS: Of the 851 eligible patients, 776 were interested, 774 consented, and 773 were included in the analysis (completed at least one knowledge question in full). Thirty‐eight percent of patients reported receipt of the aflibercept patient booklet; 23% the aflibercept audio CD; and 35% the aflibercept patient information leaflet. Patients' knowledge of health conditions to discuss with a doctor before an aflibercept injection was high, from 85% (95% CI, 82%‐ 87%) to 92% (95% CI, 90%‐94%) on 8 of 9 items. Knowledge was lower, 52% (95% CI, 48%‐55%), on the one item related to pregnancy and breastfeeding, likely because this condition is less salient in the aflibercept patient population given the patients' ages (99% of patients in the study were >46 years). Knowledge about possible side effects varied by item, with the highest correct response proportion (74% [95% CI, 70%‐77%]) for “eye pain” and the lowest (42% [95% CI, 39%‐46%]) for “detachment of the gel‐like substance inside the eye from the retina.” Most patients (78% [95% CI, 75%‐81%]) knew they should speak to their health care provider immediately if they think they might be having a side effect from their aflibercept injection.

CONCLUSIONS: Levels of patient knowledge were as expected, with highest knowledge on less complex concepts (eg, conditions to discuss with the physician and easily identified side effects) and lower knowledge on more complex concepts and issues less salient to the patient population (eg, more complex side effects and issues pertaining to women of childbearing potential).

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