OBJECTIVE: Off-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 DESIGN: We 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. RESULTS: A 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. CONCLUSION: Misoprostol 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.
OBJECTIVE: Off-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 DESIGN: We 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. RESULTS: A 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. CONCLUSION:Misoprostol 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.
Authors: P Tsikouras; Z Koukouli; B Manav; M Soilemetzidis; A Liberis; R Csorba; G Trypsianis; G Galazios Journal: Geburtshilfe Frauenheilkd Date: 2016-07 Impact factor: 2.915
Authors: David M Haas; Joanne Daggy; Kathleen M Flannery; Meredith L Dorr; Carrie Bonsack; Surya S Bhamidipalli; Rebecca C Pierson; Anthony Lathrop; Rachel Towns; Nicole Ngo; Annette Head; Sarah Morgan; Sara K Quinney Journal: Am J Obstet Gynecol Date: 2019-05-07 Impact factor: 8.661