Please use this identifier to cite or link to this item: https://hdl.handle.net/1959.11/28198
Title: Off-label use of misoprostol in gynaecology
Contributor(s): Turner, J V  (author)orcid ; Agatonovic-Kustrn, S (author); Ward, H R G (author)
Publication Date: 2015-12-28
Open Access: Yes
Handle Link: https://hdl.handle.net/1959.11/28198
Open Access Link: https://www.fvvo.be/archive/volume-7/number-4/
Abstract: Clinical use of drugs is approved for specified clinical indication, route of administration, dose and population group. Off-label prescribing of a registered medicine occurs outside of these parameters and may be justified by pharmacology and physiology, as well as sufficient evidence from published clinical trials and reviews. Misoprostol and mifepristone in combination have recently been registered in Australia for medical termination of pregnancy in women of child-bearing age. There is good clinical evidence for efficacy and safety of misoprostol in uterine evacuation in both miscarriage and termination of pregnancy. The pharmacological effects of misoprostol on the uterus and clinical outcomes in both early miscarriage and abortion are comparable. Medical management of miscarriage with misoprostol in Australia is performed off-label. A woman presenting with first trimester miscarriage must be clearly informed that use of misoprostol in her case is for a non-approved indication. This raises the issue of inequity in her management compared with that of first trimester medical abortion, including being treated off-label and the potential cost of non-subsidised medication. The clinician must also be careful to use an evidence-based protocol that would withstand medicolegal challenge in the case of an adverse outcome.
Publication Type: Journal Article
Source of Publication: Facts, Views & Vision in ObGyn, 7(4), p. 261-264
Publisher: Universa Press
Place of Publication: Belgium
ISSN: 2684-4230
2032-0418
Fields of Research (FoR) 2008: 110399 Clinical Sciences not elsewhere classified
111502 Clinical Pharmacology and Therapeutics
Fields of Research (FoR) 2020: 320299 Clinical sciences not elsewhere classified
321402 Clinical pharmacology and therapeutics
Socio-Economic Objective (SEO) 2008: 920114 Reproductive System and Disorders
920206 Health Inequalities
Socio-Economic Objective (SEO) 2020: 200204 Health inequalities
Peer Reviewed: Yes
HERDC Category Description: C1 Refereed Article in a Scholarly Journal
Appears in Collections:Journal Article
School of Rural Medicine

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