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


1 Department of Pharmacy Practice, Faculty of Pharmacy, University of Tabuk, Tabuk, Saudi Arabia
2 Director of Pharmaceutical Care Administration in Tabuk Region, Tabuk, Saudi Arabia
3 Board Certified Pharmacotherapy Specialist, Pharmacy Director and Head of DIC, Umluj General Hospital, Tabuk, Saudi Arabia
4 King Khalid Hospital, Tabuk, Saudi Arabia

Correspondence Address:
Kousalya Prabahar,
Department of Pharmacy Practice, Faculty of Pharmacy, University of Tabuk, Tabuk.
Saudi Arabia
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jpbs.JPBS_368_20

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.


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    -  Alharthi NM
    -  Alsaeed MS
    -  Alsharif MO
    -  Almalki MG
    -  Alshehri WS
    -  Prabahar K
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