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  • Title: Should oral contraceptives be sold over-the-counter?
    Author: Stone SC.
    Journal: Am J Gynecol Health; 1993; 7(2):27-32. PubMed ID: 12319537.
    Abstract:
    The US Food and Drug Administration (FDA) is considering reclassifying oral contraceptives (OCs) as an over-the-counter (OTC) drug. Family planning providers do not agree on whether making OCs an OTC drug would hurt or benefit US women. Since OC use currently requires a physician's approval, some providers believe that OCs are geographically, economically, and often culturally inaccessible to many women. Others feel that OTC status would result in incorrect use and an increase in unplanned pregnancies. Some argue that giving OCs OTC status would increase access to adolescents and low-income women, and therefore reduce unwanted pregnancies. Yet, Medicaid pays for OCs but not OTCs. Low-income women already have access to OCs at reduced rates at family planning clinics. If OCs achieve OTC status, FDA needs to come up with a way for pharmacies, other sales outlets, and labels to provide the instructions and counseling about nuisance and serious side effects once supplied by clinicians. This would be difficult because instructions are extensive and complex. The fact that 1 in 8 people in the US is illiterate makes it hard to provide adequate instructions on labels. Consequences of improper use are substantial: unwanted pregnancy, psychological stress, health risks from an abortion, risk of mortality from childbirth. Women might stop having the routine gynecological examinations now required for the prescription, so clinicians would not be able to screen for contraindications, sexually transmitted diseases (STDs), and AIDS or provide advice about condom use to prevent STDs and AIDS. This effect would adversely affect public health. Industry is concerned about increased liability if women do not use OCs correctly. Industry is largely staying out of the debate, however. Others are concerned that OTC OCs would cost more to market. A pilot model program is needed to determine whether reclassification would improve access and long-term maintenance on OCs. More research is needed before FDA grants OCs OTC status.
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