Résumé
This thesis focuses on oral isotretinoin, a drug used to treat severe acne, with an emphasis on risk minimization strategies to prevent its serious adverse effects, including teratogenic and psychiatric risks. The pharmacological characteristics of isotretinoin and the associated risks are presented first. It then describes the risk reduction measures in place, such as the pregnancy prevention plan and prescription restrictions to ensure safe use of the drug. This thesis will also explore the importance of medical information in detecting pharmacovigilance cases with or without adverse effects. It will describe the role of medical information both as an entry point for information to the health authorities, and as an exit point for ensuring that patients and healthcare professionals adhere to the correct use of healthcare products. The pharmacovigilance system and the management of safety signals will be developed. This thesis describes the need for close collaboration between the various healthcare players to improve the safety of patients treated with isotretinoin and maintain a positive benefit/risk balance.