# Presentation: 143563

## EMERGENCY CONTRACEPTION

- “Beyond Coca-Cola”
- - ECPs & IUDs
- Barb Orcutt, CNM  2/2004

## In the US, EC could potentially prevent up to 1.7 million unintended pregnancies and 800,000 abortions each year

## A PILOT PROJECT -

- in the state of Washington
- a pilot project for 16 months
- allowed easier access to EC by providing it directly through 130 participating pharmacies
- prevented an estimated 700 unintended pregnancies and 350 abortions

## DID YOU KNOW -

- 3.04 million unintended pregnancies in 1994
- 48% of all pregnancies were unintended
- 47% of unintended pregnancies ended in abortion, 40% in birth, 13% in miscarriage

## 53% of the women with unplanned pregnancies were using contraception

48% of women aged 15-44 have had an unplanned pregnancy

60% of women aged 35-39 have had an unplanned pregnancy

- 48% of women aged 15-44 have had an unplanned pregnancy
- 60% of women aged 35-39 have had an unplanned pregnancy

## ANYONE CAN FORGET HER OCPS!

## HISTORY of EC -

- "First immediately after ejaculation let the two come apart and let the woman arise roughly, squeeze and blow her nose seven times and call out in a loud voice. She should jump violently backwards seven to nine times."
- Abu Bakr Muhammad ibin Zakariya' al-Razi
- 						      (865 AD-925 AD)

## HISTORY of EC -

- Hormonal methods originated in mid-1920s with discovery that estrogenic ovarian extracts have anti-fertility effect
- High-dose estrogen (DES or EE) post-coitally as a treatment for rape survivors in the 1960s

## HISTORY of EC -

- How about a post-coital
- 		Coca-Cola douche!
- (The New England Journal of Medicine published a study on that one as late as the 1980s.)

## 
Yuzpe’s original article – 1974

Dosage was two doses of two Ovral tablets, 12 hours apart
within 72 hours of unprotected intercourse
Effectiveness believed to be about 95%
Problems = nausea, time frame

- Yuzpe’s original article – 1974
- Dosage was two doses of two Ovral tablets, 12 hours apart
- within 72 hours of unprotected intercourse
- Effectiveness believed to be about 95%
- Problems = nausea, time frame

- CURRENT EC -

## Other Regimens –	2 doses, 12 hrs apart

**Ogestrel – 2 white pills per dose**
- Levora – 4 white pills **per dose**
- LoOvral – 4 white pills **per dose**
- Levlen – 4 light orange pills **per dose**
- TriLevlen – 4 yellow pills **per dose**

## Copper IUDs also are EC- first reported in 1976

- Advantages:
- Decreases risk of pregnancy by 99% if used within 5 days of unprotected intercourse
- Can be left in place for ongoing effective contraception for up to 10 years
- Disadvantage
- Not a good option for women who are at risk for STDs – pre-RX?

## ANTIPROGESTINS

- Different action from its use in medical abortion, same dose
- A single 600mg dose of Mifepristone (RU-486) within 72 hrs after unprotected intercourse is highly effective
- Fewer side-effects than Yuzpe
- 10mg dose may be equally effective

## PLAN B® -

- Levonorgestrel 0.75mg per dose (1 pill), x 2 doses, packaged as EC
- Approved by FDA in 1999, Rx only
- More effective than Yuzpe regimen of combination OCs
- Less nausea, fewer side-effects
- As of April 2003, more than 3 million doses sold

## PLAN B®

- OTC “behind the counter” in 5 states – WA, CA, AK, HI, NM
- Dec. 2003 – FDA advisory committee endorsed OTC sale
- Feb. 2004 – strong political pressure to reject OTC sales
- FDA decision pended until May

## How do ECPs work?

- Emergency contraceptives work _before_ implantation and not after a woman is already pregnant

## EC Does Not Cause  Abortion -

- “Pregnancy” is medically defined as the implantation of a fertilized egg in the lining of a woman's uterus

## PLAN B® –MECHANISM OF ACTION

- The exact mechanism of action may vary from woman to woman and may depend on the day of the menstrual cycle on which treatment is started
- (DO NOT try to calculate by her menstrual cycle how likely it is or isn’t that she might get pregnant – just get it to her as soon as possible no matter where she is in her cycle)

## Levonorgestrel, the active ingredient in Plan B®, is believed to act principally by interfering with the process of ovulation
It may inhibit tubal transport of the egg or sperm
It may also interfere with fertilization or implantation

- It may inhibit tubal transport of the egg or sperm
- It may also interfere with fertilization or implantation

## 
the sooner ECPs are taken, the more likely they are to alter ovulation, and less likely to inhibit implantation after fertilization
PROVIDE ECP IN ADVANCE!

- the _sooner_ ECPs are taken, the _more_ likely they are to alter ovulation, and _less_ likely to inhibit implantation after fertilization
- PROVIDE ECP IN ADVANCE!

- IF YOU CARE ABOUT DISRUPTING A FERTILIZED EGG --

## EFFECTIVENESS

- Recent studies indicate that BOTH types of pills (combination OCPs as well as Plan B) are effective when the first dose is started up to 5 days (120 hours) after unprotected intercourse

## EFFECTIVENESS

- However, a recent large study by the World Health Organization found effectiveness declined significantly with increasing delay between unprotected intercourse and the initiation of treatment

## EFFECTIVENESS –  PLAN B® INFORMATION

- Early treatment is significantly more effective. For emergency contraception generally, each 12 hours of delay in the start of treatment reduces efficacy by 50%

## EFFECTIVENESS – PLAN B® INFORMATION

- Plan B® prevents 95% of expected pregnancies when taken in the first 24 hours after a single act of unprotected intercourse, reducing the crude pregnancy rate from about 8% with no treatment, down to 0.4%

## EFFECTIVENESS – PLAN B® INFORMATION

- If treatment is delayed 25-48 hours, efficacy declines to 85%, and if treatment is delayed beyond 48 hours, efficacy declines to 61%

## But - one observational study cited by ACOG found that differences in success rates for women taking EC within either 72 hours or 120 hours of intercourse were not statistically significant 

## EFFECTIVENESS??

- Clinical trials demonstrated a higher pregnancy rate in Chinese populations with both Plan B® and the combination Yuzpe regimen
- It is unknown as to exactly what the effectiveness may be in our patient populations

## Dosage Adjustments

- Recent studies indicate that BOTH doses of PLAN B can be taken at the same time with no decrease in efficacy
- At least consider the timing of the second dose – earlier than 12 hours is OK

## Dosage Adjustments

- Efficacy of emergency contraceptive pills may be reduced in women also taking _Dilantin_ or other **enzyme inducers**
- No official recommendations exist for this situation
- Informal - patients should double the amount of hormone in the first of the two ECP doses

## Dosage Adjustments

- If taking _St. John's Wort_ –
- ECPs _may_ not work quite as well as they would otherwise
- - but might still work well _enough_
- Some advise to increase the number of pills in each dose by 50%

## Dosage Adjustments

- If doubling or increasing doses, consider ordering Meclizine
- 25-50 mg before the first dose of ECPs

## CONTRAINDICATIONS

- The only _absolute_ contraindication is PREGNANCY
- Plan B® will have no effect
- _No_ evidence that there is any harm to a fetus

## CONTRAINDICATIONS

- Women with undiagnosed abnormal genital bleeding probably should not use emergency contraception

## CONTRAINDICATIONS

- Women should not use Plan B® if they might be hypersensitive to any component of the product
- Women who should not use OCPs as a _regular_ method are generally safe using occasional EC

## Will women stop using other forms of contraception if EC becomes too easily available?

## Studies have shown that  women given ECPs in advance do not abandon other more reliable BCMs

## Why don’t they?	

- ANY other BCM is more effective than ECPs!
- ECPs are more expensive than most other BCMs!
- ECPs contain a higher dose of hormones than ongoing BCPs
- Nausea & cycle irregularity might deter routine use

## OFFER ANOTHER METHOD!

- Given that EC is less effective than ANY other ongoing contraception, offer another method while you’re counseling your patient
- Condoms and other barrier methods can be provided immediately

## OFFER ANOTHER METHOD!

- Oral contraceptives and IUDs may be initiated immediately following Plan B® treatment or after the next menses
- If waiting until the next menses, impress upon the woman that she should have no unprotected intercourse while waiting!

## OFFER ANOTHER METHOD!

- If oral contraceptives are initiated before the next menses, a follow-up pregnancy test is recommended, since the OCPs will change the bleeding pattern and make it difficult to tell if a woman is pregnant or not

## PLAN B®

- About 58 percent of users will have their next menses on time or a few days early or late
- If no menses by 3 weeks, should get a pregnancy test

## Will men be less likely to use condoms?	

- ECPs don’t protect against STDs
- Condom use is critical for those at risk of STD
- Men & women may feel more comfortable using condoms if they know EC is available if a condom slips or breaks
- PLAN B has a note in the instructions about STD screening

## What we know -

- A Kaiser study found that 100% of obstetrician/gynecologists believe that ECPs are safe and effective

## What we do -

- - only 10% of OB/Gyns routinely discuss EC with patients
- - only 24% prescribe ECPs more than 5 x a year

## ACOG – Feb. 2002

- “Clinicians should proactively talk to their patients of reproductive age about ECPs and _offer advance prescriptions_ for ECPs during routine gynecologic office visits....”
- Remind women to check expiration dates if bought ahead

## RESOURCES & FAQs

- _[www.uptodateonline.com](http://www.uptodateonline.com/)_
- _[http://www.plannedparenthood.org/library/BIRTHCONTROL](http://www.plannedparenthood.org/library/BIRTHCONTROL)_
- _[www.NOT-2-LATE.com](http://www.not-2-late.com/)_
- _[www.backupyourbirthcontrol.org](http://www.backupyourbirthcontrol.org/)_
- 1-888-NOT2LATE

## Thanks for your attention – HAPPY TRAILS!