AdolescentReproductive &SexualHealthEducationProject
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
Emergency Contraception
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)?
Emergency Contraception
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
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
Emergency 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
Emergency Contraception
PRCH 2012
Indications for EC
Emergency Contraception
PRCH 2012
Inconsistent contraceptive use
Incorrect contraceptive use
Unplanned intercourse
Human Error
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
Methods of EC
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
ella®
FDA approved in August 2010
Single tablet of 30 mg ulipristal acetate
Only available by prescription
Brand NameUlipristal Acetate EC
Emergency Contraception
PRCH 2012
Original PlanB®
Now discontinued Two doses
ella®
Single dose
Summary: FDA Approved Dedicated EC
Products
Emergency Contraception
PRCH 2012
Plan B OneStep®
Single dose
NextChoiceTM Generic Two doses
Summary: FDA Approved Dedicated EC
Products
Emergency Contraception
PRCH 2012
Yuzpe method Combined oral contraceptive pills
(OCPs) containing combined ethinyl estradiol and either norgestrel or levonorgestrel
Combined Oral Contraceptives as ECPs
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
Regimens Efficacy
Clinical Components of EC
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
Each packet includes
A single course of treatment
Ulipristal Acetate Regimen
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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?
Emergency Contraception
PRCH 2012
Studies in animals: Levonorgestrel administered in doses that inhibit ovulation has no post-fertilization effect
Does Levonorgestrel-Only EC Prevent Implantation?
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
Adolescent Access to EC: Challenges &
Opportunities
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
Patient Level
Provider Level
Health Systems and Public Policy Level
Challenges and Opportunities
Emergency Contraception
PRCH 2012
Patient Level
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
Provider Level
Emergency Contraception
PRCH 2012
Of pediatricians with adolescent patients: 20% report prescribing EC 24% report counseling adolescents about EC
Many Providers Do Not Discuss EC with Young
Patients
Emergency Contraception
PRCH 2012
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
Emergency Contraception
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
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
Emergency Contraception
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
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
Emergency Contraception
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
Facilitating Use in Practice
Emergency Contraception
PRCH 2012
Facilitating Use in Practice
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
Emergency Contraception
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
Emergency Contraception
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
Emergency Contraception
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
Emergency Contraception
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
Emergency Contraception
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
Emergency Contraception
PRCH 2012
Health Systems and Public Policy Level
Emergency Contraception
PRCH 2012
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
Emergency Contraception
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
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?
Emergency Contraception
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
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)
Emergency Contraception
PRCH 2012
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
Emergency Contraception
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
Emergency Contraception
PRCH 2012
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
Emergency Contraception
PRCH 2012
Please Complete Your Evaluations Now
Emergency Contraception
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
Emergency Contraception
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
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