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


CONCLUSIONS
Considering medical pregnancy termination through the over-the-counter regulatory lens clarifies critical evidence gaps.
Ipas, Chapel Hill, NC, USA.
N
N
Kapp
Advancing New Standards in Reproductive Health (ANSIRH), Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, Oakland, CA, USA.
D
D
Grossman
Independent Consultant, Los Angeles, CA, USA.
E
E
Jackson
Ipas, Chapel Hill, NC, USA.
L
L
Castleman
Ipas, Chapel Hill, NC, USA.
D
D
Brahmi
D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage*; D000021:Abortifacient Agents, Steroidal / Q000008:administration & dosage*; D000028:Abortion, Induced / Q000941:ethics / Q000379:methods*; D017277:Drug Approval; D004359:Drug Therapy, Combination; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D015735:Mifepristone / Q000008:administration & dosage*; D016595:Misoprostol / Q000008:administration & dosage*; D004366:Nonprescription Drugs; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D014481:United States; D014486:United States Food and Drug Administration
D000020:Abortifacient Agents, Nonsteroidal; D000021:Abortifacient Agents, Steroidal; D004366:Nonprescription Drugs; D016595:Misoprostol; D015735:Mifepristone
First trimester; medical termination of pregnancy; mifepristone; misoprostol; over-the-counter; pregnancy termination