Introduction The use of oral retinoids during pregnancy is associated with teratogenic effects and malformations in newborn babies. The European Medicine Agency (EMA) provided recommendations regarding the restrictive use of oral retinoids during pregnancy in 2003, and updated these recommendations in 2018 by introducing a pregnancy prevention program (PPP). This study aimed to investigate the awareness of oral retinoid teratogenicity and the adherence to the PPP by physicians, pharmacists and patients in Denmark.
Method. As part of the EMA initiated multi-country survey, web-based questionnaires were distributed among Danish dermatologists and general practitioners, community pharmacists, and women of childbearing age, who were not pregnant and were using or had used oral retinoids within the past five years.
Results. A total of 62 physicians, 96 pharmacists, and 50 oral retinoid using women responded to the questionnaires; 95%, 100%, and 98%, respectively, were aware of the teratogenic risks of oral retinoids. For physicians, the most applied PPP measures were the usage of the patient (44%) and the healthcare professional (19%) guides, while the least applied measure was signing medication risk form (3%). The majority of the physicians discontinued oral retinoids in women who wanted to become pregnant (90%). Performing pregnancy tests and monthly follow-ups with women using oral retinoids were practiced by appr. two thirds of the physicians. Among the pharmacists, the warning sign on the outer medication package was the most used measure (45%), the other measures showed a use of 12.0% or lower; 79% of the pharmacists often or always provided information about the importance of effective contraception when dispensing oral retinoids, and 74% advised women to contact their prescriber if they suspected being pregnant. Among the women, a majority (90%) had read the patient information leaflet included in the medication package and 72% discussed the use of contraception with their healthcare provider, while risk awareness forms and patient cards were seen by only few.
Conclusion. The study showed that in Denmark physicians, pharmacists and medicine users are aware about the teratogenic effects of oral retinoids. Adherence to pregnancy prevention measures varied considerably for different measures, indicating a lack of access or unwillingness to use the measures that require patients’ signatures. Feasibility and accessibility of the PPP measures need to be improved to help increase their adherence and improve the safety of oral retinoid prescribing, dispensing, and use.