Abstract

In the United States today $40.7 billion is spent annually on nonsurgical contraception as well as the costs due to method failures. There are 60 million women of childbearing age (15-44 years) in the U.S.; of those an estimated 39 million use some form of contraception. Almost half of the 6 million pregnancies per year in the U.S. are unintended costing $22.5 billion annually. This is a huge market and many health care administrators look at it with the intention of locating savings. One possible avenue is moving oral contraceptives (OC) to over-the-counter (OTC) status. This would negate the need for many physician visits and consumers could purchase extremely effective contraceptive means without having to visit a medical doctor. Many women do not have access to physicians and due to financial constraints cannot afford to visit a physician. Some teenagers do not want their parents to know they are sexually active. The decline in the teenage pregnancy rate from 1991 to 1996 Was largely related to condom use and adoption of injectable and implant contraception. However the need for a physicians prescription is a potential access barrier to OCs for many young women age 25 and younger. The pregnancy rate remains highest for women in their early twenties. The overall unintended pregnancy rate still remains unacceptably high. There are three major criteria provided by law for a drug to be moved from prescription to OTC status: safety efficacy and proper labeling. Within the scope of these criteria the drug should be nonaddictive; it should be for a self-diagnosable condition; it should have low potential ham in case of incorrect use; it should have mild side effects that can be largely self-diagnosable; and the labeling should be written in a comprehensive way to enable unsupervised use. (excerpt)

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