Over the past 10-15 years, over-the-counter access to emergency contraception has been a highly debated issue, both scientifically and politically. The FDA first approved plan B, or levonorgestrel, in 1999 for the use in emergency contraception up to 72 hours after unprotected intercourse. The use of this product would help to reduce the occurrence of unintended pregnancies in the United States, which is much higher than other similarly developed nations. When first introduced to the market, it was available by prescription only. However after continual deliberation and petitioning by the drug manufacturers the FDA approved the Plan B One-Step in 2009 to be dispensed via ...view middle of the document...
Unintended pregnancies are a prominent issue in the United States, with a rate of 52/1000 women between the ages 15-44 years old, accounting for approximately 49% of pregnancies. The rates have been found to be significantly higher than other developed countries. The availability of emergency contraception is of particular interest as more four out of five teen pregnancies are unintended, most of which result in abortion. Thus, with the new accessibility of the drug unintended pregnancies may be expected to decrease throughout all age groups.
Primary Literature Review
When considering the implications and controversy that surrounds this new ruling, there a three factors that need to be addressed. One must consider the safety and efficacy of the drug in younger populations, the ability of younger females to comprehend proper usage of the medication, and the impact of increased availability of the drug on decreasing unintended pregnancies in the United States.
When addressing the safety and efficacy of the drug, as it was previously mentioned, there have been multiple studies conducted in women from ages 13 to 45 years old. Of particular interest were studies conducted involving females from ages 12-16. These are of interest as the average age for menarche is 12.4 years and 90% of women have menstruated by the age of 13.8 years. One study conducted in 2004 in San Francisco, California addressed two of the issues at hand. The study consisted of 52 healthy females aged 12-16 years old who had reached menarche. The study looked to evaluate the occurrence of side effects, access proper usage of the product, and evaluate the impact on the individual’s menstrual cycle after the administration of two 0.75 mg levonorgestrel tablets. After data was collected, it was determined that 51/52 participants (98%) had taken the second dose as directed, while 49/52 participants (94%) did not have any issues with following the directions. No serious side effects were noted however common side effects such as nausea (p=0.001), headache (p=0.004), fatigue (p=0.002), and diarrhea (p=0.002) did occur and were noticeably more likely to occur in the first week. Other side effects such as vomiting, dizziness, and breast tenderness did occur but reports did not occur more in the first week. As for the participant’s menstrual cycle, the measured last menstrual period before administration averaged 5.0 days across the group and was found to last 5.3 days after the treatment (P= 0.146); thus no significant difference was observed in duration of menses. The majority (62.5%) of patients had their menses return within a week of the expected date, with 8% occurring later than 7 days and 29% occurring early.
Studies have also been conducted to further analyze label comprehension in younger adolescents (as young as 12 years old). Sufficient data is limited due to the low percentage of women engaging in sexual...