Étude des initiations de traitement par isotrétinoïne par voie orale en France entre 2014 et 2021 : évolution et respect des indications et du programme de prévention des grossesses
Background
Acne is a chronic inflammatory disease that frequently affects teenagers and young adults of both sexes. It is the eighth most common skin disease worldwide, affecting 640 million people, 85% of whom are teenagers. Isotretinoin was granted marketing authorization (AMM) in France in 1984 for the treatment of severe acne. Recommendations for the management of acne were updated in June 2015 by the French Society of Dermatology (SFD). They recommended the use of oral isotretinoin as a first-line treatment for very severe grade 5 acne, and as a second-line treatment after oral antibiotic therapy and topical therapy for moderate and severe acne (grades 3 and 4). Also, since the introduction of the pregnancy prevention program (PPG) in 1997 due to the teratogenic risk associated with the use of isotretinoin, several pharmacovigilance and pharmaco-epidemiological studies have shown a non-negligible number of pregnancies exposed to isotretinoin, and insufficient compliance with recommendations, particularly concerning the performance of pregnancy tests. Thus, in May 2015, the French National Agency for the Safety of Medicines and Health Products (ANSM) restricted the initial prescription of isotretinoin to dermatologists, but prescription renewals could be carried out by any doctor. In December 2018 and January 2019, safety information on teratogenicity was again distributed by ANSM to healthcare professionals, and additional risk reduction measures (MARR) and associated documents were updated.
Objectifs
The aims of the present study were i) to describe the use of oral isotretinoin over the period 2014-2021 and ii) to assess the effect of the ANSM measure restricting initial prescribing to dermatologists in 2015, the updated MARRs in 2019 and the updated SFD recommendations in 2015 on compliance with recommendations for use.
Résultats clés
→ Entre 2014 et 2021 parmi l’ensemble des cures, 41% des cures ne respectaient pas le PPG à l’initiation, 29% des dispensations ne respectaient pas le PPG pendant les cures et 90% des cures ne respectaient pas le PPG en fin de cure.
→ La mise à jour des MARR par l’ANSM en 2019 n’a pas eu d’effet significatif sur le respect strict du PPG à l’initiation et en fin de cure, et était associée à une diminution du respect strict du PPG pendant les cures.
Rapport d’étude Accéder à l’articleConference presentations
Oral communications
- Congrès de la Société Française de Pharmacologie et de Thérapeutique (SFPT) (12-14 juin 2023, Limoges, France)
Respect du programme de prévention des grossesses parmi les femmes âgées de 11 à 50 ans ayant initié un traitement par isotrétinoïne orale
Havet A, Bouvard C, Moskal A, Chanelière M, Massardier J, Lebrun-Vignes B, Jonville-Bera A-P, Payet C, Viprey M
- International Conference on Pharmacoepidemiology (ICPE) (23-27 août 2023, Halifax Canada)
Determinants of non-compliance with the pregnancy prevention program among women initiating oral isotretinoin therapy: a cohort study from the French nationwide claims database
Havet A, Bouvard C, Moskal A, Chanelière M, Massardier J, Lebrun-Vignes B, Jonville-Bera A-P, Payet C, Viprey M
- Congrès de la Société Française de Pharmacologie et de Thérapeutique (SFPT) (12-14 juin 2023, Limoges, France)
Respect de l’utilisation de l’isotrétinoïne orale avec les recommandations de prescription et de délivrance entre 2014 et 2021 en France
Bouvard C, Havet A, Moskal A, Chanelière M, Massardier J, Lebrun-Vignes B, Jonville-Bera A-P, Payet C, Viprey M
Communications affichées
- International Conference on Pharmacoepidemiology (ICPE) (23-27 août 2023, Halifax Canada)
Compliance of oral isotretinoin use with prescription and delivery guidelines between 2014 and 2021 in France
Bouvard C, Havet A, Moskal A, Chanelière M, Massardier J, Lebrun-Vignes B, Jonville-Bera A-P, Payet C, Viprey M