Plan B One-Step

Plan B One-Step emergency contraception is a new 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 will be replacing the old Plan B.”

Plan B One-Step can be used by women to prevent an unintended pregnancy after unprotected sex or contraceptive failure with just one pill that can be taken right away.

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.

The new Plan B works in much the same way that hormonal birth control does.

• How Plan B One-Step (and Hormonal Contarception) Work to Prevent Pregnancy

Emergency contraception is often mistakenly confused with the early abortion pill, RU486 (also referred to as M&M, Mifeprex, RU486, 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.

How to Obtain Plan B One-Step:

If you are younger than 17 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.

As a precaution, those girls under 17 can ask their doctor about obtaining a prescription for Plan B One-Step to have ahead of time -- just in case an emergency occurs. This way, you will already have a prescription to be filled immediately and will not need to wait to get a medical appointment.

You must go to the pharmacy counter and ask to purchase Plan B One-Step (since it will be kept behind the counter). If you don’t feel comfortable asking for it out loud, you can print out a Patient Request Card so you can make a private purchase. Just hand it to the pharmacist with your ID, and you won’t have to say a word.

The new Plan B One-Step will also be dispensed in the same packaging, regardless of whether it is obtained OTC or by prescription.

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:

• Alaska
• California
• Hawaii
• Maine
• Massachusetts
• New Hampshire
• New Mexico
• Vermont
• Washington

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.

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 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:

STD Protection:

Pharmacist Compliance with Emergency Contraception:

_Sources:

_{Teva Pharmaceuticals. Complete Prescribing Information. Accessed: July 13, 2009. http://www.planbonestep.com/pdf/PlanBOneStepFullProductInformation.pdf}