Retrospective study on the pattern of off-label use of misoprostol in Tabuk, Saudi Arabia

Abstract

Introduction: Off-label drug use (OLDU) refers to the prescription of a currently available and marketed medication for a use that has never been approved by the Food and Drug Administration (FDA). Misoprostol is one of the drugs which is used off-label. This drug, authorized for the treatment or prevention of peptic ulcers and other stomach disorders, is commonly used off-label for inducing labor or intrauterine device insertion. This research focuses on identifying the percentage of morbidity and mortality by off-label use of misoprostol; classifying the most common off-label misoprostol use in Tabuk hospitals; and determining the availability of policy and procedures behind prescribing the off-label misoprostol. Materials and Methods: Retrospective observational study was carried out. Data were collected from patients’ files for those admitted to the maternity wards in Tabuk Hospitals from March 2019 until September 2019. Results: Approximately 53% of cases were diagnosed with missed abortion. The mean time for abortion after administering misoprostol was 20.7 ± 28.2h. About 76% of women had an indication of bleeding. Guidelines were not followed with respect to dosage regimen. The mean of hospital stay was 3 days. There were no significant complications associated with the administration of misoprostol. Conclusion: There is no policy and procedure available in the hospital regarding off-label use of misoprostol. Moreover, physicians have low adherence to the guideline in terms of dosage, interval, and route of administration for each indication in obstetrics and gynecology.

Keywords

• induction of abortion
• miscarriage
• misoprostol
• off-label use
• postpartum hemorrhage