A research agenda for moving early medical pregnancy termination over the counter

نویسندگان

  • N Kapp
  • D Grossman
  • E Jackson
  • L Castleman
  • D Brahmi
چکیده

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.

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عنوان ژورنال:

دوره 124  شماره 

صفحات  -

تاریخ انتشار 2017