ABSTRACT
Objectives
To develop a model to estimate the possible impact of use of an over-the-counter (OTC)
progestin-only pill (POP) on the number of unintended pregnancies in the United States.
Study design
Using typical use failure rates (7% for POPs), we compared the expected number of
unintended pregnancies for two theoretical cohorts of 100,000 women: one which purchased
and used an OTC POP exclusively for contraception, the other using contraceptive methods
at proportions obtained from an actual-use clinical trial simulating OTC use of norgestrel
0.075 mg (including 35% using no method and only 19% using hormonal contraception
or long-acting contraceptives). Sensitivity analyses were conducted using alternative
model inputs such as different failure rates for OTC POPs and varied alternative contraceptive
method mix.
Results
An estimated 37,624 unintended pregnancies would occur annually if 100,000 women continued
their usual contraceptive method as used at baseline in the actual use trial. This
would be reduced by 81% to 7,000 pregnancies with the exclusive use of an OTC POP
– a net reduction of 30,624 unintended pregnancies annually. While the number of unintended
pregnancies prevented varied as the model parameters were modified (ranging from 1,461
to 34,124), a net benefit of OTC POP use was observed over a wide range of input values.
Conclusions
Using data from a real-world contraception user profile, our model suggests that use
of an OTC POP could reduce the overall number of unintended pregnancies in the United
States. This conclusion remains true across a wide range of modeled scenarios.
Implications
The estimates suggested by this model are supportive of an OTC switch for a POP.
Keywords
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Article info
Publication history
Published online: October 15, 2022
Accepted:
October 11,
2022
Received in revised form:
October 10,
2022
Received:
August 18,
2022
Footnotes
Conflicts of interest: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: I Laurora and H Guillard are employees of HRA Pharma. S Sober, A Karapet, E Brass and A Glasier serve as consultants to HRA Pharma.
Funding: This work was fully funded by Laboratoire HRA Pharma.
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