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Editorial


It’s been a long voyage for Plan B, but patience and persistence won

We can expect many more questions from patients, and continue advance prescribing for women under 18

October 2006 · Vol. 18, No. 10

Well, they finally made the right decision! After almost 3 years of attempting to sail directly into a gusty wind, against a strong current, with a heavy anchor deployed, the administrators at the FDA decided to be rational, reverse course, and approve Plan B for over-the-counter sales to women 18 years of age or older. This new course has made headway in women’s access to the full range of reproductive health services. The efforts of many of our readers, the American College of Obstetricians and Gynecologists, the American Medical Association, and many reproductive rights advocates led to this progress.

Prescribing and counseling

Over-the-counter availability of Plan B will probably increase its use. We should continue to educate our patients about its availability, and we can expect to field many more questions from patients. For example:

What are the contraindications?

According to the World Health Organization, there is no contraindication to Plan B for women who are breastfeeding or who have a history of ectopic pregnancy, cardiovascular or liver disease, or migraine. Logically, Plan B is contraindicated if the patient is known to be pregnant or if the patient is allergic to the medication.

The excellent safety profile of Plan B is a strong reason for its status as an over-the-counter medication.

Can the 2 levonorgestrel pills be taken at the same time?

The Plan B blister package contains 2 pills of 0.75 mg of levonorgestrel. The FDA approval for Plan B indicates that 1 pill should be taken immediately and 1 pill in 12 hours.

The alternative—taking both pills together—appears to be effective.1 If the patient vomits within 1 hour of taking a pill, she should be prescribed another pill and given an antiemetic prophylactically.

Can the second pill be taken 24 hours after the first pill?

It appears to be safe and effective to take the second pill 24 hours after the first pill.2

How long after the sexual exposure can the pills be taken?

There appears to be a roughly linear relationship between the efficacy of emergency contraceptive and the length of time from intercourse.3,4 For example, the risk of pregnancy is about 0.5% if emergency contraception is taken within 12 hours, and increases to about 4% if taken 61 to 72 hours after exposure.4 The FDA approved Plan B to be taken up to 72 hours after exposure, but it appears to be effective up to 120 hours after exposure. Overall, Plan B is estimated to prevent about 85% of pregnancies compared with placebo.

Can multiple courses of Plan B be used in the same cycle?

It appears that it is safe and effective to use a second course of Plan B in the same cycle if another exposure occurs.

When can the patient expect the onset of menses?

About 85% of women who take Plan B will have their next period within 1 week before or after their next expected menses. About 15% of women who use Plan B have a delay in their menses of more than 7 days.3 Pregnancy should be considered a possibility in these women.

Is there an increased risk of ectopic pregnancy?

Plan B does not increase the absolute risk of an ectopic pregnancy.5 However, when women become pregnant after taking Plan B, an ectopic pregnancy should be considered as a possibility.

What is the impact of Plan B on a preexisting pregnancy?

There is little information about the impact of Plan B on a preexisting pregnancy. Given the fact that progestin-containing contraceptives taken during pregnancy have minimal effects on the pregnancy, Plan B would probably have minimal effects on a pregnancy.5

Advance prescribing

Nine states (Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont, Washington) currently allow specially trained pharmacists to initiate prescriptions for Plan B under collaborative drug therapy protocols. Clinicians in these states can continue to sign collaborative agreements with pharmacists to increase access for women not eligible to receive Plan B over-the-counter, including women under age 18 and women without ID.

Over the next few years, it is likely that the FDA will revisit the availability of over-the-counter Plan B for women less than 18 years of age and adjust the age restriction downward.

Until that time, clinicians can continue to provide prescriptions of Plan B in advance to women under age 18.

REFERENCES

1. von Hertzen H, Piaggio G, Ding J, et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomized trial. Lancet. 2002;360:1803-1810.

2. Ngai SW, Fan S, Li S, et al. A randomized trial to compare 24 h versus 12 h double dose regimen of levonorgestrel for emergency contraception. Hum Reprod. 2005;20:307-311.

3. Task Force on Postovulatory Methods of Fertility Regulation. Randomized controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet. 1998;352:428-433.

4. Piaggio G, von Hertzen H, Grimes DA, Van Look PF. Timing of emergency contraception with levonorgestrel or the Yuzpe regimen. Lancet. 1999;353:721.-

5. ACOG Practice Bulletin. Emergency contraception. Obstet Gynecol. 2005;106:1443-1452.

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