Off-label use of misoprostol for labor induction: a nation-wide survey in Switzerland

Abstract

ObjectiveOff-label use of drugs is frequent in obstetrical practice. No data however are available about nation-wide off-label use in obstetrics regarding frequency and patient information. The objective of our study was to assess the clinical practice of off-label use of misoprostol for labor induction. Study designWe performed a prospective nation-wide survey study by means of a validated questionnaire in three languages in Switzerland. All registered obstetricians/gynaecologists in Switzerland were included. Of 1100 subjects, 725 (66%) answered the questionnaire; 69 subjects were excluded because they were not actively practicing OB/GYN, resulting in a total of 656 questionnaires included in the analysis. ResultsA total of 512 out of 656 obstetricians/gynaecologists (78%) use misoprostol for labor induction. The most frequent administration route of misoprostol is intravaginal (86%), in a single dose of 50μg (94%), at a dose interval range from 4 to 6h (85%). Among the users of misoprostol, 314 (61%) answered that they do not inform their patients about the off-label use of the medication. Among the non-users of misoprostol, the main reason for non-use is absent license for obstetric indications (48%) and non-availability (14%). If misoprostol were to be licensed for this indication, and commercially available, 69% of current non-users would use it. Non-users of misoprotol use prostaglandin E2 vaginal gel, ovules or slow-release vaginal insert, and oxytocin for labor induction. ConclusionMisoprostol is the single most commonly used drug for labor induction in Switzerland, although it is not licensed and although there are effective, licensed alternative drugs available. A minority of practitioners inform the patients about the off-label use.