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Biomedical subjects

Elizabeth G Raymond

Publications and source records attributed to Elizabeth G Raymond.

3 recordsLinked to original sources

"Actual use" study of emergency contraceptive pills provided in a simulated over-the-counter manner.

OBJECTIVE: To evaluate use of an emergency contraceptive pill product dispensed under simulated over-the-counter conditions. Secondary objectives were to assess repeat use, pregnancy, and adverse events. METHODS: The study was conducted at family planning clinics and pharmacies in the United States. During enrollment, these facilities did not provide unsolicited counseling about or evaluations for emergency contraceptive pills. Women who requested emergency contraception were asked to examine a package that was modified for over-the-counter use. A package (levonorgestrel, two 0.75-mg tablets) was provided to each woman who met study criteria and indicated that she wished to receive one. Each subject paid the amount normally charged by the facility for emergency contraceptive pills. Subjects were contacted 1 and 4 weeks later and asked about use of the product, side effects, and pregnancy. RESULTS: Of 665 women screened for the study, 585 received at least one package, and 540 reported having used the product. Of classifiable first uses, 1.3% (97.5% confidence interval [CI] 0.5%, 3%) were contraindicated and 28% (97.5% CI 23%, 32%) were incorrect by strict primary definitions of these inappropriate use patterns, based on the label instructions. Only 6.6% (97.5% CI 4.3%, 9.5%) of classifiable first uses were incorrect by a reasonable alternate definition. Ten subjects received the product more than once, and ten were found to be pregnant during the study. The pattern of adverse events was consistent with findings of previous studies. CONCLUSION: Most women used emergency contraceptive pills appropriately without provider evaluation and counseling.

Adolescent↗

Emergency contraception.

Emergency contraception is used to prevent pregnancy after a coital act not adequately protected by a regular method of contraception. In contrast to early medical abortion, emergency contraception prevents a pregnancy from starting and does not disrupt an established pregnancy. The most commonly used approaches consist of two oral doses of contraceptive steroids. The levonorgestrel-only regimen (levonorgestrel, 0.75 mg, repeated in 12 hours) appears to be more effective and better tolerated than the Yuzpe regimen (ethinyl estradiol, 100 microg, and levonorgestrel, 0.5 mg, repeated in 12 hours). In the largest randomized, controlled trial to date, levonorgestrel prevented about 85% of pregnancies that would have occurred without its use. Hormonal emergency contraception has no known medical contraindications, although it is not indicated for suspected or confirmed pregnancy. However, if hormonal emergency contraception is inadvertently taken in early pregnancy, neither the woman nor the fetus will be harmed. Nausea and vomiting associated with the Yuzpe regimen can be reduced by prophylactic use of meclizine. A strong medical and legal case exists for making hormonal emergency contraception available over the counter, as has happened in countries other than the United States. Easier access to and wider use of emergency contraception could dramatically lower the high rates of unintended pregnancy and induced abortion in the United States.

Age Factors↗

Comprehension of a prototype over-the-counter label for an emergency contraceptive pill product.

OBJECTIVE: This study was designed to evaluate comprehension of a prototype over-the-counter package label for an emergency contraceptive pill product. METHODS: Interviews were conducted with 663 women in malls and family planning clinics in eight United States cities. The sample included many young and minority women and women of low literacy. After looking at the package, subjects were asked 30 questions that addressed 11 communication objectives about indications, contraindications, instructions, side effects, and management of serious complications. Most questions asked whether or not use of the product would be appropriate in a described situation. RESULTS: Seven of the 11 communication objectives were each understood by more than 85% of subjects. Most women in the study understood the most important objectives: that the product is indicated for prevention of pregnancy after unprotected sex (93%), that the first pill should be taken within 72 hours or as soon as possible after intercourse (97%), that the product should not be used by women who are already pregnant (98%), and that the product does not prevent sexually transmitted diseases or human immunodeficiency virus/acquired immune deficiency syndrome (94%). More-literate women were more likely to understand the objectives than less-literate women. CONCLUSION: These results indicate that by reading the prototype label, most women could understand key information necessary for safe and effective use of this product.

Adolescent↗