I thought using the above initials might get most of you who don’t necessarily need emergency contraception (EC) to pay attention. OTC obviously stands for over-the-counter.
The April issue of the journal Obstetrics and Gynecology included an evaluation of proper use of an over-the counter single tablet emergency contraceptive called Plan B One-Step which was given to females aged 11-17 who requested emergency contraception at reproductive clinics. (I have to say that even I was appalled that 11 and 12 year olds were sexually active….but the authors pointed out that in actuality no 11- or 12 year olds were enrolled in the study, although statistics tell us that approximately 3% of teens initiate sexual activity before age 13.) The authors simply wanted to see if very young women would and could read the instructions and use the pill appropriately without interacting with providers.
A total of 345 females were enrolled in 5 cities, 279 were younger than 17. This product was then given to participants who were eligible. They were then contacted 1,4, and 8 weeks later to assess use, pregnancy and adverse events.
As many of you know, the Plan B One-Step (one tablet of 1.5 mg levonorgestrel, a type of progestin that is in many birth control pills) has been granted approval by the FDA to be marketed as emergency contraception without a prescription for females aged 17 and older. It is restricted and can be given by prescription only for females aged 16 and younger. (And this decision created a huge political and gender based battle.) But despite the recommendations by major medical associations, physicians and women’s groups, the FDA insisted that additional data was needed demonstrating that females aged 17 and younger understood the “key concepts needed for safe and effective use for this product to be sold over-the-counter.”
This study pretty much answers this concern. The participants had to agree and use the emergency contraceptive only after reading the information on the front and back panels without any assistance from the study staff or health care providers, as well as understand when and how to take it and the possible consequences. Parental consent was waived because minors can receive contraceptive services without parental consent in the states where the study was conducted. The study participants were considered appropriate (and understood that they were) if they responded yes to one of 4 questions that they were asked and they don’t want to get pregnant: Did they have sex but didn’t use a condom? Did the condom break? Did they not use their birth control pills correctly? Did they have sex without any form of birth control? And they were not eligible for the study if they thought they were pregnant or indeed were, they had unprotected sex more than 3 days before they requested the EC or they simply wanted to use EC every time instead of birth control.
Among the 298 participants who used this single pill, 274 (92.9%) used it correctly as labeled. Selection and correct use was not associated with age. Fifty-seven participants (18.8%) used additional emergency contraception over the study period. (So repeat use was not common). Only seven (2.3%) who used Plan B One-Step became pregnant and there were no unusual adverse events. The conclusions in the article were a sort of “see we told you so” to the FDA. “Restricting young females’ use of a single tablet emergency contraceptive by prescription only is not warranted, because females younger than 17 years can use it in a manner consistent with over-the-counter access.” I couldn’t have said it better myself!