What Plan B One-Step Is:
Plan B One-Step emergency contraception is a drug application approved by the FDA on July 13, 2009. Plan B One-Step consists of just one oral pill (levonorgestrel tablet, 1.5 mg). The original Plan B (and its generic equivalent, Next Choice) include two emergency contraceptive pills to be taken 12 hours apart or at the same time. According to Denise Bradley, company spokesperson, “Plan B One-Step has replaced the old Plan B.”
Many physicians, such as Ashlesha Patel, MD, MPH, Division Director of Family Planning Services at John H. Stroger Jr. Hospital in Chicago, prefer one-pill dosing for their patients. One-step formulations allow patients “to act more quickly, while providing a high level of safety and efficacy” explains Dr. Patel.
- In July 2012, the FDA approved a generic equivalent to Plan B One-Step: Next Choice One Dose
How Plan B One-Step Works:
Plan B One-Step works in most of the ways that hormonal birth control does. With that being said, there is some dispute about the exact ways that Plan B One-Step works. This disagreement stems over the issue of whether or not Plan B One-Step prevents implantation of a fertilized egg to occur. Although the FDA has included, on the product labeling, that this as one of the ways that Plan B One-Steps works, the medical community as well as current research claims that this emergency contraceptive has no impact on implantation.
What Plan B One-Step is Not:
Emergency contraception is often mistakenly confused with the early abortion pill, RU486 (also referred to as M&M, Mifeprex, mifepristone or medical abortion). These two medications serve two different purposes and work completely different from one another.
Plan B One-Step is not an abortion pill. It is also not effective if taken after a woman is already pregnant. The new Plan B will not terminate an existing pregnancy. According to Teva Pharmaceuticals, the manufacturer of Plan B One-Step, there is no evidence that Plan B One-Step harms a pregnant woman or a developing fetus.
Teva Pharmaceuticals also advises that Plan B One-Step should not be used as a substitute for routine contraception use.Tummino v. Hamburg, the judge ordered the FDA to allow Plan B One-Step to be sold over-the-counter with no age restrictions. The FDA has yet to change it's policy to be in compliance with the court order. However, on April 30, 2013, the FDA did make the announcement that Plan B One-Step would now be available over-the-counter (without a prescription) to those 15 years of age and older. When you purchase Plan B One-Step, the cashier will require you to show a valid government-issued, proof-of-age identification. The FDA instructed new labeling on Plan B One=Step to read, "not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified."
Women over the age of 14 may still need a prescription for Plan B One-Step:
- In order for insurance coverage, so you may want to check on what your insurance policy’s requirements are before you find yourself in the position of needing emergency contraception.
- If you do not have proper, government-issued identification.
If you are younger than 15 years old, Plan B One-Step can be obtained via a prescription from your doctor. A physical examination should not required prior to prescribing Plan B One-Step.
Plan B One-Step is no longer required to be kept behind the pharmacy counter. It should be located in your store's family planning aisle/section. The FDA is still, however, requiring that Next Choice, the 2 tablet, generic form of the old Plan B as well as Plan B One-Step's one tablet generic equivalent Next Choice One Dose be kept behind the pharmacy counter and available without a prescription for those aged 17 and older. So this means that the new FDA regulations ONLY apply to Plan B One-Step.
Plan B One-Step will also be dispensed in the same packaging, regardless of whether it is obtained OTC or by prescription.
Recognizing the importance of access to emergency contraception, legislation has been passed that allows specially trained pharmacists in pharmacy-access states to prescribe Plan B One-Step when medically appropriate to female patients of any age, including those who do not have government-issued identification for proof of age. The requirements for pharmacy access and certification are regulated from state to state. Currently, nine U.S. states have pharmacy-access policies that allow women of any age to obtain Plan B One-Step from participating pharmacists at select pharmacies without a prescription. These states include:
- New Hampshire
- New Mexico
When to Use Plan B One-Step:
To reduce the risk of an unplanned pregnancy, Plan B One-Step should be taken as soon as possible within 72 hours (3 days) of unprotected sex or contraceptive failure. The sooner Plan B One-Step is taken, the more effective it'll be. Plan B One-Step can also be used any time during your menstrual cycle. If you vomit within 2 hours of taking the pill, you should immediately contact your doctor to discuss whether to take another pill.
Note: In general, emergency contraception can be used up to 5 days after unprotected sex. So it may still be useful to take Plan B One-Step for up to 120 hours after unprotected sex.
Side Effects of Plan B One-Step:
When used as directed, Plan B One-Step is safe for most women. The most common side effects in the clinical trial for women receiving Plan B One-Step included:
- Heavier menstrual bleeding (30.9%)
- Nausea (13.7%)
- Lower abdominal pain (13.3%)
- Fatigue (13.3%)
- Headache (10.3%)
- Dizziness (9.6%)
- Breast tenderness (8.2%)
- Delay of menses (more than 7 days) (4.5%)
After taking Plan B One-Step, you could likely experience changes in your period. In some cases, your next period may be heavier or lighter, or earlier or later.
- It is important to consult a doctor if your scheduled period is more than 1 week late, as this may indicate that pregnancy could have occurred.
If you are experiencing severe abdominal pain 3 to 5 weeks after taking Plan B One-Step, there could be the possibility that you have an ectopic pregnancy, so you should seek immediate medical attention -- in general, ectopic pregnancies account for approximately 2% of all reported pregnancies. Yet, up to 10% of pregnancies reported in studies of routine use of progestin-only contraceptives are ectopic.
Plan B One-Step Effectiveness:Plan B One-Step is most effective the sooner it is started. When taken as directed (within 72 hours of unprotected sex or contraceptive failure), Plan B One-Step is about 89% effective in reducing the chance of pregnancy. About 7 out of 8 women who would have gotten pregnant will not become pregnant after taking Plan B One-Step.
Plan B One-Step will not continue to prevent pregnancy during the rest of a woman’s cycle. The manufacturer states that “a rapid return of fertility is likely following treatment with Plan B One-Step for emergency contraception,” so additional contraceptive methods should be continued or started as soon as possible following use of the new Plan B to ensure ongoing prevention of pregnancy.
Plan B One-Step Costs:The cost of one package of Plan B One-Step can range anywhere from about $35 to $60... with the average cost being around $45. Currently, the manufacturer of Plan B One-Step is offering a printable coupon:
STD Protection:Plan B One-Step offers no protection against sexually transmitted infections or HIV.
Pharmacist Compliance with Emergency Contraception:U.S. retail pharmacists have been overwhelmingly compliant with Plan B dispensing guidelines. For example, just one year after the Plan B OTC approval, 95% were comfortable selling/dispensing this emergency contraceptive. With that being said, it is important to be aware that certain states have adopted refusal/conscience clauses. These laws allow pharmacists the right to refuse to perform certain services based on a violation of personal beliefs or values. Currently, the following six states have passed laws that explicitly permit a pharmacist to refuse to dispense emergency contraception drugs:
- South Dakota
FDA. (April 30, 2013). FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older. Accessed 5/1/13
Teva Pharmaceuticals. Complete Prescribing Information. Accessed: July 13, 2009. http://www.planbonestep.com/pdf/PlanBOneStepFullProductInformation.pdf