185412 Safety and effectiveness of OCs: Making the case for an OTC switch

Monday, October 27, 2008: 3:30 PM

Kelly Blanchard, MSC , Ibis Reproductive Health, Cambridge, MA
Daniel Grossman, MD , Ibis Reproductive Health, San Francisco, CA
Requiring a prescription for oral contraceptive pills (OCs) may be a significant barrier to access for many women. The time, cost and inconvenience of a physician visit (if the woman has access to a provider) may prevent some women from choosing OCs or from continuing use once started. The prescription requirement may also lead women and providers to believe OCs are less safe than they are. Moving OCs over-the-counter (OTC) could reduce barriers to access, and increase use of the method.

Clinical data indicate that OTC access to OCs is likely safe. Contraindications are few and self-reported, except for hypertension which could be self-assessed or measured by a pharmacist. Data from recent studies show that women can self-screen for contraindications as accurately as trained providers, and requiring provider intervention does not prevent contraindicated women from using OCs. Evidence indicates that for women at all ages who do not smoke, taking OCs is significantly safer than pregnancy. The prevalence of contraindications among women, and especially among young women, in the US is extremely low.

This presentation will review data on the safety and effectiveness of OCs, addressing whether these data support a switch to OTC access based on FDA guidelines. We will also discuss recent research on non-contraceptive benefits of OC use and the potential public health benefits of OTC access, focusing on unintended pregnancy and other reproductive health outcomes, and present a research agenda to fill in existing gaps and build the case for moving OCs OTC.

Learning Objectives:
1. Describe the safety and effectiveness of oral contraceptives, and compare adverse events to adverse events experienced during pregnancy. 2. Articulate the FDA criteria for over the counter access distribution of drugs. 3. Describe research that would be needed to support providing oral contraceptives over the counter.

Keywords: Contraception, Access and Services

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am currently the President of Ibis Reproductive Health, and completed an MSC degree at the Harvard School of Public Health in 1997. At Ibis and with my colleague Dan Grossman, we convene the Working Group on Moving OCs OTC, which brings together researchers, clinicians, advocates, policy makers and industry to discuss the evidence for and help support an inclusize process to assess whether moving OCs OTC will improve women's access to contraception in the US. Dan Grossman and I have also published, in AJPH, a review of current contraceptive labeling that highlights where labeling does not reflect the best evidence, and notes that current clinical evidence largely supports OTC access for OCs.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.