by Nathalie Kapp, Daniel Grossman, Emily Jackson, Laura Castleman, Dalia Brahmi
BJOG: An International Journal of Obstetrics & Gynaecology, 27 April 2017
Given the overall safety and increasing availability of medical abortion, would mifepristone+ misoprostol at ≤10 weeks of pregnancy meet US Food and Drug Administration regulatory criteria for over-the-counter (OTC) approval? We conducted a literature review of consumer behaviours necessary to make OTC availability successful, and identified crucial research gaps. The critical missing elements were comprehension of the label (and directions for use), self-selection for use (based on being ≤10 weeks pregnant), and outcome of actual self-use.
A label comprehension study would require testing to achieve acceptable comprehension of the indication for use, instructions on how to use the medication, contraindications to use (including who should not use) and when to seek care from a medical professional. A self-selection study would need to determine whether women can use the label to determine on their own if the medication is appropriate for them; this depends primarily on accuracy in determining length of pregnancy (≤10 weeks for home use), based on first day of the last menstrual period (LMP). There are also ongoing studies of women using LMP-based calculators in the developing world…
The results of actual-use studies would indicate how women translate the label information into correct or incorrect use of the medicines, self-management of the process, and awareness of side effects and complications, including when to seek medical care.
Serious complications following medical termination are uncommon in clinical studies. Ongoing pregnancy occurs <1% of the time with mifepristone+misoprostol at ≤10 weeks of gestation. There is ongoing investigation into how best to identify length of pregnancy, e.g. by use of semi-quantitative or low-sensitivity urine pregnancy tests. The critical step for safely self-using medical abortion pills is understanding when to seek medical care, both for signs and symptoms of ongoing pregnancy and for complications such as prolonged, heavy bleeding and infection. Studies will need to document that women are able to do so. Ideally, services should include trained providers.
As non-traditional access to medical abortion expands, the research agenda to improve and establish safe self-use has clear priorities. It needs to include development of an understandable label or product information which includes indication, eligibility, contraindications, how to use and when to seek medical advice. This label/product information should provide data on the expected outcomes and complications following self-use in a setting where such access is on the horizon. Although there may be political opposition to moving medical abortion pills over the counter, such a change could result in significant improvements in access to early termination and deserves to be rigorously studied.
PHOTO: Graham Turner