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Emergency Contraception and

Adolescents

Emergency Contraception

PRCH 2012

By the end of this presentation, participants will be able to: Discuss need for EC among

adolescents. Describe clinical components of EC. Understand the challenges and

opportunities for increasing EC use at the patient, provider, and health systems level.

Objectives


PRCH 2012

A safe and effective way of preventing pregnancy in cases of: Contraceptive failure. No contraceptive use. Unplanned or forced

intercourse. Some methods very effective up

to 120 hours after unprotected intercourse.

What Is Emergency Contraception (EC)?


PRCH 2012

The U.S. has one of the highest teen pregnancy rates in the industrialized world.

82% of teen pregnancies are unplanned.

Adolescents Need EC


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0 10 20 30 40 50 60 70 80 90

US 2006

US 2000

Romania

England

Canada

Norway

France

Spain

Netherlands

Japan

Teen Pregnancy Rates Worldwide

Teen Pregnancies per 1000 Population


PRCH 2012

Sexually active females ages 15–19 report: 21% used no method at first

intercourse 16% used no method at most recent

intercourse

13% of adolescents experience a contraceptive method failure during their first year of use

Unprotected Sex Happens


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9 8 5 13.9 3 9

16 15 18 20 20 19

3448

55 58 64722

3

4.12 4

764

4430 28 24

16

0%

20%

40%

60%

80%

100%

Before 19851985–1989 1990–1994 1995–1999 2000–2004 2005–2008

No Method

Other

Condom

Pill

Withdrawal

2006–2008 National Survey of Family Growth

Female Contraceptive Use at First Intercourse by Year of First Intercourse


PRCH 2012

54.9%

68.5%

18.7%13.1%

4.4% 1.7%0%

10%20%30%40%50%60%70%80%90%

100%

Females Males

Condom Use Birth Control Pills Injectables

Contraceptive Use, YRBS 2009

Percent of US High School Students Reporting Use of a Contraceptive Method at Last Intercourse

8.9% of students reported using both a condom and either birth control pills or injectable contraception


PRCH 2012

>50% of all rapes occur in young women under 18 years old.

For teens, 5.3% of rapes lead to a pregnancy.

Emergency contraception should be offered to all survivors of sexual assault.

Sexual Assault and EC


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Indications for EC


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Inconsistent contraceptive use

Incorrect contraceptive use

Unplanned intercourse

Human Error


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Patch off for 24 hours or more during patch-on weeks

More than two days late changing a patch

Late putting patch back on after patch-free week

Method Failure: Patch


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Taken out for more than three hours during ring-in weeks

Same ring left in more thanfive weeks in a row

Late putting ring back after ring-out week

Method Failure: Ring


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Condom breaks or slips Two or more missed active OCPs DMPA shot 14 or more weeks ago Expelled IUD Three or more hours late taking a

POP Diaphragm or cervical cap dislodges

Method Failure: Others


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Methods of EC


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Dedicated Product: Plan B One-Step®

FDA approved July 2009

Single tablet formulation 1.5 mg of levonorgestrel

Original Plan B®

Two tabs of 750 mcg levonorgestrel

Approved in 1999

Approved for OTC 18 and older in 2006

Both are now OTC for 17 and older

Brand Name Levonorgestrel ECPs


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Next ChoiceTM, a generic dedicated product approved June 2009 Two tabs of .75 mg levonorgestrel

For prescription use by women 16 and younger

OTC for women 17 and older

GenericLevonorgestrel EC


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ella®

FDA approved in August 2010

Single tablet of 30 mg ulipristal acetate

Only available by prescription

Brand NameUlipristal Acetate EC


PRCH 2012

Original PlanB®

Now discontinued Two doses

ella®

Single dose

Summary: FDA Approved Dedicated EC

Products


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Plan B OneStep®

Single dose

NextChoiceTM Generic Two doses

Summary: FDA Approved Dedicated EC

Products


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Yuzpe method Combined oral contraceptive pills

(OCPs) containing combined ethinyl estradiol and either norgestrel or levonorgestrel

Combined Oral Contraceptives as ECPs


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Insert within five days

Highly effective: Reduces risk of pregnancy by more than 99%

Rarely used for EC alone

Cannot use levonorgestrel IUD (Mirena) for EC

The Copper-T Intrauterine Device


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Regimens Efficacy

Clinical Components of EC


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Each packet includes:

A single course of treatment

For two dose regimens:

Both tablets may be taken at the same time (to increase compliance) with No reduction in effectiveness

No increase in side effects

Levonorgestrel-Only Regimen


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Each packet includes

A single course of treatment

Ulipristal Acetate Regimen


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Exact efficacy rates are difficult to determine Minimum efficacy for levonorgestrel

regimen is 49% Can substantially reduce the chance of

pregnancy after an episode of unprotected sex Most effective the sooner it is taken

LevonorgestrelEfficacy


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Levonorgestrel: How Long After the Morning

After?

p=.16

Von Hertzen H, et al. Lancet 2002;360:1803–1810

2002 WHO Trial of Levonorgestrel-Only EC Regimen Taken in Single Dose


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Two randomized clinical trials determined that the failure rate was around 2% Up to 120 hours after unprotected

intercourse Unlike levonorgestrel, it does not

decrease in efficacy between 72 and 120 hours

Ulipristal AcetateEfficacy


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Disrupts normal follicular development and maturation Results in ovulation or delayed ovulation

with deficient luteal function May also interfere with sperm

migration and function at all levels of the genital tract

Mechanism of Action of Levonorgestrel-Only EC


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Precise mechanism of action unknown

Thought to delay mid-cycle LH surge and thereby delay ovulation

May also interfere with sperm’s ability to reach and fertilize an egg, should ovulation occur

Mechanism of Action of Ulipristal Acetate EC


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LNG EC Two studies: No effect on the

endometrium One study: Taken before LH surge,

altered luteal phase secretory pattern of glycodelin in serum and the endometrium

Ulipristal acetate May depress endometrial enrichment,

thereby discouraging implantation More research needed to confirm No evidence of interrupting cells after

implantation

Does ECPrevent Implantation?


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Studies in animals: Levonorgestrel administered in doses that inhibit ovulation has no post-fertilization effect

Does Levonorgestrel-Only EC Prevent Implantation?


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Can inhibit or delay ovulation Older studies have shown

histologic or biochemical alterations in the endometrium

Recent studies found no such effects on the endometrium

Mechanism of Action: Combined ECPs


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Additional possible mechanisms: Dysfunctional ovulation Interference w/ corpus luteum

function Thickening of the cervical mucus* Alterations in tubal transport of

sperm, egg, or embryo* Direct inhibition of fertilization*

Mechanism of Action: Combined ECPs

*No clinical data exist regarding these mechanisms


PRCH 2012

Side Effects & Complications:Comparing Hormonal Methods

23%

11%

17%

51%

17%

29%

13%

5%

6%

Nausea

Dizziness

Fatigue

Ulipristal Acetate Yuzpe Levonorgestrel

Significant at p<0.01


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No deaths or serious complications have been causally linked to EC

No serious reactions have been reported

WHO Medical Eligibility Criteria

No situations in which risk of using EC outweigh benefits

EC Is Safe


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Known or suspected pregnancy

Only because it is INEFFECTIVE, not because it is harmful

Will NOT increase the risk of miscarriage

Hypersensitivity to any component of the product

Undiagnosed abnormal genital bleeding

Levonorgestrel ECContraindications


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Known or suspected pregnancy

Limited data suggests that ulipristal acetate will not affect an existing pregnancy

More research needs to be done to confirm

Ulipristal Acetate ECContraindications


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Adolescent Access to EC: Challenges &

Opportunities


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To utilize EC, young women (under 17) must: Be aware of the option. Locate a provider. Obtain a prescription. Find the money to pay for the pills. Fill prescription at a pharmacy that has

EC. Take pills at correct time.

Challenges and Opportunities


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Patient Level

Provider Level

Health Systems and Public Policy Level

Challenges and Opportunities


PRCH 2012

Patient Level


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28% of teen girls have heard of EC

40% of teens who know about EC understand that the pills should be taken after, not before, sex

Since ella® has recently been approved, awareness of this drug is expected to be much lower

Few Young Women Are Aware of EC


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Beliefs that EC functions as an abortifacient

Fear that the drug would harm fetus

Confusion over fertility cycle and timing

Patient Misconceptions Create Barriers to EC Use


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Perceived lack of confidentiality Lack of money and/or insurance Lack of transportation Inability to locate a healthcare

provider within the limited and effective timeframe

Belief that pelvic examination is mandatory

OTC exclusion of minors

Other Barriers


PRCH 2012

Provider Level


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Of pediatricians with adolescent patients: 20% report prescribing EC 24% report counseling adolescents about EC

Many Providers Do Not Discuss EC with Young

Patients


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As ella® becomes more widely available, physicians will need to learn about this option

A 2001 survey of pediatricians found: 72.9% were unable to identify any of the FDA-

approved methods of EC

Only 27.9% correctly identified the timing for initiation

31.6% felt comfortable prescribing EC

Providers Need More Training About EC


PRCH 2012

2001 survey of pediatricians found: 22% believed that providing EC

encourages adolescent risk-taking behavior

52.4% would restrict the number of times they would dispense EC to a patient

12% cited moral or religious reasons for not prescribing

17% were concerned about teratogenic effects

Provider Misconceptions Can Discourage Use


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No pelvic examination or pregnancy test required by ACOG or FDA

Pregnancy test prior to EC treatment is recommended only if: Other episodes of unprotected sex

occurred that cycle LMP (last menstrual period) was not

normal in duration, timing, or flow

Providers Can Remove Clinical Barriers to EC


PRCH 2012

Discuss EC with ALL patients Assess patient’s previous knowledge of

EC Discuss patient’s definition of

“unprotected sex”—when should patient fill/call in for prescription for EC

Frame scenarios according to patient’s current contraceptive plan, how it might fail, and how and when to use EC

To Facilitate Use, Providers Can


PRCH 2012

Providers must take into account patient’s: Knowledge of reproductive

physiology Ability to understand the regimen Moral perceptions of contraception Misconceptions about the drug’s

mechanism of action Barriers that may restrict access

Providers Can Facilitate Use


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Instruct patient on use: More effective the sooner it is taken Taking two pills at once (when

applicable) increases compliance and no increase in side effects

Call provider if there is no menstrual period within three weeks after taking EC

Providers Can Facilitate Use


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Taking EC once during the cycle does not protect women from pregnancy for the entire cycle.

Having unprotected sex after EC use can increase pregnancy risk.

To be effective, EC must be used each and every time a woman has unprotected sexual intercourse.

Counseling Key Points


PRCH 2012

Facilitating Use in Practice

Write: advanced prescription with multiple refills (12 recommended)

Discuss: condoms and assess for STI risk

Explain: EC is not an abortifacient, nor is it teratogenic


PRCH 2012

Train office staff on EC

Importance of timely appointments

Lack of required exam for prescriptions

LNG EC is OTC for patients 17 and older



PRCH 2012


List yourself as an EC provider on www.not-2-late.com

Compile list of pharmacists in area that dispense EC

Refer patients to www.not-2-late.com


PRCH 2012

Cost of EC may prohibit multiple use within a cycle (~$25–$50) Cost of ella® expected to be higher

During visit, discuss alternative and ongoing methods of contraception that are more effective and less expensive

Opportunities for Bridging Contraceptive

Services


PRCH 2012

Have you tried anything to prevent pregnancy in past?

Any problems with a previous method? Trouble remembering to take the

pill? Concerns over privacy with the

pill/patch? Difficulty using condoms

consistently? Cost barriers?

Counseling Teens About Contraception Method


PRCH 2012

Consider QuickStart initiation of an ongoing birth control method on day of EC administration Use backup method with ella® until next

menstrual period Patient should bleed in ~two weeks If administering DMPA:

Patient should return in two weeks for pregnancy test

InitiatingContraception:

Quickstart


PRCH 2012

Display posters and materials about EC

Work with teen patients to establish a “plan” in the event of contraceptive failure, including identifying: A pharmacy that will fill prescription A method of transportation to pharmacy A means of locating or borrowing funds

for pills

Provider Opportunities for Facilitating Use


PRCH 2012

If provider does not feel comfortable or competent counseling patient or writing prescription for EC:S/he must make a referral to someone who can

Refer patient to www.not-2-late.com

Provider Level: Ethical Obligations


PRCH 2012

Health Systems and Public Policy Level


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Path to OTC Access: August 2006

FDA announced that Plan B® will be available OTC to women 18 and

older

Minors still need to obtain a prescription (in states without

pharmacy access)

No medical or public health reason for limiting adolescents’ access to

LNG EC


PRCH 2012

2009 Court Decisions

65

US District Court rules: FDA must make Plan B available to women 17 and older within 30 days and reconsider the scientific evidence supporting any age limit on access to EC

Women 16 and younger still need a prescription to access EC

March 2009


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Generic Dedicated EC Product Approved

Generic dedicated LNG EC product, NextChoiceTM approved by the FDA to be available by prescription only

NextChoiceTM approved for OTC sales to women 17 and older

June 2009

August 2009


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Single-Dose Dedicated EC Product Approved

67

FDA approves Plan B OneStep® with a dual label

Women 16 and younger still need a prescription to access EC

July 2009

OneStep® begins to replace original Plan B in pharmacies


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Single-Dose Dedicated EC Product Approved

68

FDA approves ella®

ella® is a prescription-only product

August2010

Upon approval, new drugs are limited to prescription-only status for at least two years


PRCH 2012

Generics free to enter the market Until Aug 2012, Plan B® has market

exclusivity on single dose LNG products

FDA still under obligation to reconsider age restrictions

Data still supports increased access for minors

Marketing and distribution of ella®

What’s Next for EC?


PRCH 2012

In the early stages of its approval, providers and patients may not know about this EC option

Until use becomes common, may not be regularly stocked in pharmacies

Cost expected to be higher than that of levonorgestrel methods

Confusion over when to prescribe ella® versus when to recommend levonorgestrel

ella® Expected Challenges


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Does NOT increase risk taking behavior Does not decrease condom use Does not decrease contraceptive use Does not increase number of sexual

partners or increase risk for STIs

DOES increase use of EC Risks are reduced from episodes of

unprotected sex and/or contraceptive failure that occur

Advanced Provision & Pharmacy Access to

Minors


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Advanced Provision: No Increase in Risk Behavior

2004 study of young women randomized to:

Receive EC in advance

Receive instructions on how to get EC

Advance Rx: ~twice as much EC use as

control (15% vs. 8%)

No decrease in condom or

contraceptive use

No increase in unprotected sex

Advance Rx: used EC sooner than control

group (10 vs. 21 hrs)


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A 2005 study of 2117 young women Improved access group no more likely

to: Miss a pill Switch birth control methods Forgo using a condom

Frequency of intercourse, amount of unprotected sex, and number of sexual partners similar among the study groups

Pharmacy Access Does Not Increase Risk Behavior


PRCH 2012

While EC does NOT protect against STIs or HIV: 2005 study: Young women

obtaining EC from pharmacist were no more likely to get an STI

Product’s label clearly states that regimen does not protect against STIs or HIV

Addressing Concerns About STI Risk


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EC: safe and effective method of preventing pregnancy

Can prevent pregnancies when taken within indicated window

Should be readily available to all women, especially adolescents

Advanced provision and pharmacy access will not increase health risks for young women

Conclusions


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Please Complete Your Evaluations Now


PRCH 2012

Resources: www.prch.org—Physicians for Reproductive Choice and Health www.aap.org—The American Academy of Pediatrics www.acog.org—The American College of Obstetricians and

Gynecologists www.adolescenthealth.org—The Society for Adolescent Health and

Medicine http://www.aclu.org/reproductiverights—The Reproductive

Freedom Project of the American Civil Liberties Union www.advocatesforyouth.org—Advocates for Youth www.guttmacher.org—Guttmacher Institute www.cahl.org—Center for Adolescent Health and the Law www.gynob.emory.edu/centers/jfc.html—The Jane Fonda Center of

Emory University www.siecus.org—The Sexuality Information and Education Council

of the United States www.arhp.org—The Association of Reproductive Health

Professionals www.rhtp.org—Reproductive Health Technologies Project

Provider Resources

http://www.prch.org/

http://www.aap.org/

http://www.acog.org--/

http://www.adolescenthealth.org/

http://www.aclu.org/reproductiverights/

http://www.advocatesforyouth.org/

http://www.guttmacher.org/

http://www.cahl.org/

http://www.gynob.emory.edu/centers/jfc.html

http://www.siecus.org/

http://www.arhp.org/

http://www.rhtp.org/


PRCH 2012

PRCH’s Emergency Contraception: A Practitioner’s Guide

For information and a directory of EC providers, women can visit www.not-2-late.com

Managing Contraception: www.managingcontraception.com

Reproductive Health Technology Project EC Resources: www.rhtp.org/contraception/emergency/default.asp

Back Up Your Birth Control: Building Emergency Contraception Awareness Among Adolescents, A Tool Kit, Academy for Educational Development, www.aed.org/Publications/upload/ECtoolkit3283.pdf

National Sexual Assault Hotline 1-800-656-HOPE Provides victims of sexual assault with free, confidential, around-the-clock services

Provider Resources: Emergency

Contraception

http://www.not-2-late.com/

http://www.managingcontraception.com/

http://www.rhtp.org/contraception/emergency/default.asp

http://www.rhtp.org/contraception/emergency/default.asp

http://www.aed.org/Publications/upload/ECtoolkit3283.pdf

http://www.aed.org/Publications/upload/ECtoolkit3283.pdf

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