Davis K, Asiimwe A, Zografos L, McSorley D. Evaluation of risk minimisation activities for cyproterone acetate 2 mg/ethinylestradiol 35 μg. Poster presented at the 32nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE); August 27, 2016. Dublin, Ireland. [abstract] Pharmacoepidemiol Drug Saf. 2016 Aug; 25(Suppl 3):309-10.


BACKGROUND: Cyproterone acetate 2 mg/ethinylestradiol 35 μg (CPA/EE), an estrogen/progestogen drug indicated for dermatologic conditions shares thromboembolism risk with combined hormonal contraceptives. A "Dear health care professional" letter, patient information card, and prescriber checklist were distributed to physicians to increase awareness of this risk.

OBJECTIVES: To measure physician knowledge of thromboembolism risk by specialty and ascertain whether physicians received educational materials.

METHODS: This cross-sectional, study was conducted in Austria, the Czech Republic, France, the Netherlands, and Spain. Recent prescribers of CPA/EE were recruited to complete a phone or web survey. Physician specialty was considered when selecting the sample based on country-specific prescribing patterns. Frequency and percentage of correct responses were calculated for 14 knowledge questions.

RESULTS: The targeted 500 responses were achieved (9% [N = 559] of invited physicians), with 44.7% OB/GYNs, 33.6% GPs, and 21.6% dermatologists. 47.8% reported receiving at least one of the educational materials, and 73.5% to 79.3% of those reported the materials were helpful. Knowledge was highest (greater than or equal to 80%) for (1) symptoms of possible deep vein thrombosis, pulmonary embolism, and cerebrovascular accident; (2) most important risk factors for thrombosis; and (3) use in smokers. Knowledge ranged from moderate to high (greater than or equal to 61%) for approved indication and risky time periods/special situations. It varied for contraindications, symptoms of myocardial infarction, other risk factors for thrombosis, instructions related to immobilisation and selected concomitant medical conditions. Knowledge was less than or equal to 60% regarding prescribing CPA/EE for acne only after failure of topical therapy or systemic antibiotics. It did not vary by receipt of educational materials or physician specialty for most questions.

CONCLUSIONS: Knowledge of thromboembolism risk was generally high. Knowledge varied for topics that were more complex or less frequently encountered in which physicians might consult additional references. The relatively low knowledge about prescribing after failure of other acne treatments was unexpected.

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