Non-compliance with pregnancy prevention recommendations for isotretinoin in Korea between 2019-2020

Abstract

Objective: Isotretinoin is commonly prescribed worldwide despite its notorious teratogenicity. A risk management program (RMP) was introduced in Korea to prevent isotretinoin use during pregnancy. Here, we evaluate the compliance of Korean women with the recommendations of the RMP.

Methods: This prospective cohort study was conducted between April 2019 and June 2020. Thirty-six and 82 patients received the prescription before and after the introduction of RMP, respectively.

Results: There was a significant difference in the total number of days for which isotretinoin was prescribed before and after the RMP was introduced (68.8±100.9 and 28.0±26.1 days, respectively). However, 1.43% (120/8,394) of the total patients contacted by the teratology information services were exposed to isotretinoin on an average.

Conclusion: The proportion of patients exposed to isotretinoin did not change, and there was no significant change in compliance, with the implementation of the RMP during the study period. Further studies are needed to evaluate the effectiveness of the RMP in the long term.

Keywords: Abortion, induced; Congenital abnormalities; Isotretinoin; Pregnancy; Risk management.

Fig. 1

The proportion of patients exposed to isotretinoin compared to the total patients in the study period.

Fig. 2

Trends regarding the knowledge of teratogenicity: written signature on the knowledge of teratogenicity, information of effective contraception, pregnancy test before therapy, and the drug being dispensed within seven days.