Self-screening for contraindications to oral contraceptive use: Evidence for the safety of over-the-counter provision

Combined oral contraceptives (COCs) are a very safe and effective family planning method. While women in many countries can purchase COCs over-the-counter, in the US a prescription is required, creating a barrier to contraceptive access. Even with clinician screening, it is estimated that 6% of COC users in the US are contraindicated for use. We aimed to determine how well a convenience sample of women from the general population could self-screen for contraindications to COCs using a checklist. 1,271 women 18-49 years old were recruited at shopping malls in El Paso, Texas, and asked to use a checklist to determine the presence of level 3 or 4 contraindications to COCs according to the WHO Medical Eligibility Criteria. Women were then interviewed by a blinded nurse practitioner who also measured blood pressure. The sensitivity of the checklist to detect true contraindications was 84.5% (95% CI: 80.9%-87.6%) and specificity 88.4% (85.9%-90.5%). 6.0% (4.6%-7.3%) of women incorrectly thought they were not contraindicated when they truly were, largely due to unrecognized hypertension of > 140/90 mmHg. Using a cut-off of 160/100 mmHg (WHO category 4 contraindication), 1.8% (1.1%-2.6%) incorrectly thought they were not contraindicated. In regression analysis, younger women, Spanish-speakers and non-contraceptive-users were significantly more likely to correctly self-screen than older women, English-only-speakers and hormonal-users (p<0.05). Self-screening with a checklist would not result in more contraindicated women using COCs than the current clinician-screening system. Over-the-counter provision of COCs would be safe, especially for younger women and if independent blood pressure screening were encouraged.