Compliance of oral isotretinoin use with prescription and delivery guidelines between 2014 and 2021 in France.
Résumé
Introduction
Due to adverse effects of isotretinoin, prescription and dispensation guidelines recommended to use it as a second-line treatment, to renew the prescription for each dispensation and to perform laboratory monitoring. In June 2015, a decision of regulatory authorities restricted treatment initiation to dermatology specialist.
To evaluate the compliance of oral isotretinoin use to national guidelines between 2014 and 2021 in France.
Methods
A retrospective cohort study was conducted using data from the National Health Data System and included all new users of oral isotretinoin between 2014 and 2021 Initiation corresponded to the first dispensation of isotretinoin with no prior dispensation for at least 12 months. Four outcomes were assessed the initial rescription by dermatology specialist, the second line prescription after systemic antibiotic and/or topical therapy, the renewal of prescription for each dispensation, and carrying out lipid and hepatic enzymes laboratory monitoring. The effect of the
decision of June 2015 on the direct ( and prolonged ( changes in proportion of treatment initiated by dermatology specialist was assessed using a monthly interrupted time series analyze (ARIMA model). We expressed the results of this model as change in proportion 95 confidence intervals 95 CI) and p-value (p).
Results
We included 552,221 patients (mean age: 24 years sex ratio: 0.95). The percentage of
treatment initiated by a specialist increased from 88% to 92% after June 2015. Time series analysis showed a significant immediate increase (2.93%, 95% CI 1.71% to 4.15%, p < 0.01) but no significant change in trend over time (0.08%, 95% CI -0.23% to 0.09%, p= 0.39). Within 12 months before initiation, 63% of patients received at least one dispensation of systemic antibiotic therapy and 42% received at least one dispensation of systemic antibiotic and topical therapy. In average, 86% of dispensations had a new prescription. 80% of patients had lipid and hepatic enzymes monitoring before treatment initiation and 41% during treatment.
Conclusion
Guidelines on initial prescriber and renewal of prescription were mostly respected while compliance to guidelines on second line prescriptions and biological monitoring was inadequate.
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