Adverse Drug Reactions in Children—A Systematic Review

Adverse drug reactions in children are an important public health problem. We have undertaken a systematic review of observational studies in children in three settings: causing admission to hospital, occurring during hospital stay and occurring in the community. We were particularly interested in understanding how ADRs might be better detected, assessed and avoided

Adhésion médicamenteuse des patients ayant initié un traitement par isotrétinoïne orale.

International audienc

Adhésion médicamenteuse des patients ayant initié un traitement par isotrétinoïne orale.

International audienc

Effet de la pandémie COVID-19 sur l’utilisation de l’isotrétinoïne orale, les modalités de prescription et le respect du Programme de Prévention des Grossesses entre 2019 et 2022.

International audienc

Compliance with the pregnancy prevention program among women initiating isotretinoin treatment between 2014 and 2021: A nationwide cohort study on the French Health Data System ( SNDS )

International audienceAbstract Background Despite the French pregnancy prevention program (PPP), a considerable number of pregnancies are potentially exposed to oral isotretinoin. New measures were taken by the French Medicines Agency, including the restriction of initial isotretinoin prescriptions to dermatology specialists in May 2015 and a new information campaign on teratogenicity in January 2019. Objectives The aims were to: describe, between 2014 and 2021, compliance with PPP recommendations: isotretinoin use as a second‐line treatment, first prescription by a dermatology specialist, monthly prescription renewal and pregnancy testing (PT); assess the effect of the 2015 and 2019 measures on PT compliance; and identify the determinants of PT noncompliance. Methods A retrospective cohort study was conducted among women aged 11–50 years initiating isotretinoin between 2014 and 2021 using the French Health Data System. PT compliance corresponded to pregnancy test completion and specific delays between prescription and dispensation. Time series analyses were performed to evaluate the effect of the 2015 and 2019 measures on PT compliance, and log‐binomial and Poisson multivariate regression models were used to identify the determinants of PT noncompliance. Results Isotretinoin was prescribed as a second‐line treatment in 64% of initiations, mainly by dermatology specialists (92%). A new monthly prescription was observed in 98% of dispensations. PT compliance reached 61%, 72% and 25% at initiation, renewals and end of treatment, respectively. The 2015 measure was associated with better PT compliance at initiation and renewals. The 2019 measure had no significant effect on PT compliance at the initiation or end of treatment but was associated with a decrease in PT compliance at renewals. Age, low socioeconomic level, initiation by a nondermatology specialist and during summer were associated with PT noncompliance. Conclusions Understanding factors associated with PT noncompliance could help to target specific subpopulations of women treated with isotretinoin