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A research agenda for moving early medical pregnancy termination over the counter
Author(s) -
Kapp N,
Grossman D,
Jackson E,
Castleman L,
Brahmi D
Publication year - 2017
Publication title -
bjog: an international journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.157
H-Index - 164
eISSN - 1471-0528
pISSN - 1470-0328
DOI - 10.1111/1471-0528.14646
Subject(s) - misoprostol , mifepristone , over the counter , medical abortion , pregnancy , food and drug administration , comprehension , medicine , regimen , gestation , obstetrics , psychology , abortion , medical emergency , pharmacology , computer science , medical prescription , surgery , genetics , biology , programming language
Given the overall safety profile and increasing availability of medical pregnancy termination drugs, we asked: would the mifepristone–misoprostol regimen for medical termination at ≤10 weeks of gestation meet US Food and Drug Administration regulatory criteria for over‐the‐counter ( OTC ) approval, and if not, what are the present research gaps? We conducted a literature review of consumer behaviours necessary for a successful OTC application for medical termination at ≤10 weeks of gestation and identified crucial research gaps. If we were to embark on a development programme for OTC or more generally, self‐use of medical termination, the critical elements missing are the label comprehension, self‐selection and actual use studies. Tweetable abstract Considering medical pregnancy termination through the over‐the‐counter regulatory lens clarifies critical evidence gaps.