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Hormonal Contraception: Updates for 2020

EVE ESPEY MD MPH

UNIVERSITY OF NEW MEXICO

Disclosure of Financial Relationships

Eve Espey

Has no relationships with any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on,

patients.

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Objectives

•Understand current national trends in use of hormonal contraceptives

•Describe use of the US Medical Eligibility Criteria to determine candidates for hormonal contraception in a range of patients

•Explain opinions and attitudes about pharmacy access and over-the-counter access to hormonal contraceptives

Simplified objectives

- Please consider:◦ Saying positive things about contraception

◦ Prescribing hormonal contraceptives

◦ Advocate for OTC access to hormonal contraceptives

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Unintended pregnancy in the US

1 YEAR: 6.7 MILLION PREGNANCIES

Finer, Zolna. Contraception. 2011

Unintended 49%

Unintended birth

Induced abortion

Pregnancy

loss

Intended: 51%

51% 23%

21%

5%

Good (now old-ish) news!

Finer NEJM, 2016

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US abortion rate at lowest level since Roe v. Wade

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What has made a difference?- Better and more

consistent use of contraceptives

- Long acting reversible contraceptives (LARC) use

- Increased abstinence

The small proportion of women who do not use contraceptives

Not

using

11%

Using

89%

Using

53%

Not

using

47%

Women at risk of

unintended pregnancy

Women experiencing

unintended pregnancies

. . . account for roughly half of all unintended pregnancies

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Changes in method use over 10 years

Kaiser Family Foundation 2016

REDUCE UNINTENDED PREGNANCY

EMPOWER WOMEN TO MAKE THE DECISION THAT IS BEST FOR THEM

Goal of contraception

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Did you want to get pregnant?

Yes

No

All of the above

✔YesNo Maybe?

Reproductive Healthcare Disparities

30 postpartum women with Medicaid ◦ 63% African-American, 27% Hispanic

Counseling experiences:◦ Feeling ignored or impersonal counseling

◦ Undertones of coercion if their method choice differed from provider’s recommendation

◦ Racial discrimination

Yee 2011

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U.S. Contraceptive Use

23% 25%

13%

11% 7%4% 2%

2%

% of women at risk of unintended pregnancy by method type

Guttmacher, 2018 (2014 Data)

% women using methods by race/ethnicityD A N I E L S , N C H S D ATA B R I E F, D E C E M B E R 2 0 1 8

% women using methods by race/ethnicity

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% women using methods by educationD A N I E L S , N C H S D ATA B R I E F, D E C E M B E R 2 0 1 8

Bedsider.org

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US Medical Eligibility Criteria

- CDC guidance on contraceptive practice

- Ongoing systematic reviews

- Evidence-based candidate selection and best practices

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Can a teen use

an IUD?

Can a woman

with diabetes

use the pill?

Can a woman on

seizure meds use the

patch?

Can a

breastfeeding

woman use

the shot?

MEC: Who?

US MEC Categories

US Medical Eligibility Criteria

(US MEC)

• Category 1: No restriction for the use of the contraceptive method

• Category 2: Advantages generally outweigh the theoretical or proven risks

• Category 3: Theoretical or proven risks usually outweigh the advantages

• Category 4: Unacceptable health risk if the contraceptive method is used

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US MEC Categories

Category 1

Use!

Category 3

Don’t use!

Category 2

Use!

Category 4

Don’t use!

US MEC Box 2

Breast cancerHepatocellular adenoma and malignant liver tumors (hepatoma)

Complicated valvular heart disease Peripartum cardiomyopathy

Cystic fibrosis Schistosomiasis with fibrosis of the liver

Diabetes: insulin dependent; with nephropathy/ retinopathy/neuropathy or other vascular disease; or of >20 years’ duration

Severe (decompensated) cirrhosis

Endometrial or ovarian cancer Sickle cell disease

EpilepsySolid organ transplantation within the past 2 years

Hypertension (systolic > 160 mm Hg or diastolic > 100 mm Hg)

Stroke

History of bariatric surgery within past 2 years Systemic lupus erythematosus

HIV: not clinically well or not receiving anti-retroviral therapy

Thrombogenic mutations

Ischemic heart disease Tuberculosis

Gestational trophoblastic disease

Some conditions associated with adverse outcomes as a result of unintended pregnancy

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US MEC app—it’s free!

Case: Sylvia

34 year old presents for a prescription for birth control pills – she also had a recent medication change and tells you how excited she is about her new boyfriend.

BP 130/78 Height 5’2” Weight 140 pounds

PMH: ◦ Smokes 12 cigarettes a day

◦ Migraines without aura

◦ Her doctor started her on HCTZ for hypertension 6 months ago

◦ Regular menstrual cycles x 5-7 days

◦ Moderate - heavy bleeding, mild dysmenorrhea

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Birth control pills: The basicsMost commonly used reversible contraceptive

Typical failure rate: 8-10%

Combination pills◦ Estrogen and progestin

Progestin-only pills◦ Breastfeeding

◦ Contraindications to estrogen

Effectiveness: The difference between “perfect use” and “typical use”

Hatcher R, et al. Contraceptive Technology. 2004.

% estimates of unplanned pregnancy in the first year of use

PILL Injectable Copper T

8

3

0.80.3 0.3 0.6

Typical Perfect

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What do you need to prescribe pills?

Age

HTN, DM, cardiovascular risk factors

Smoking

Personal h/o VTE: DVT/PE

Migraine with aura

Blood pressure

HISTORY PHYSICAL EXAM

More…Combination pills ◦ A combination of estrogen and progestin

◦ Low dose: 35 micrograms of ethinyl estradiol or less

◦ Confusing array of progestins

◦ Norethindrone (Ortho-Novum 1/35)

◦ Levonorgestrel (Seasonique)

◦ Desogestrol , Norgestimate (Sprintec)

◦ Drosperinone (Yaz)

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Sprintec

- 35 mcg EE and .25 mg norgestimate

- Generic list at Wal-Mart, Target and Smiths

- $9 for 1 month, $24 for 3 months

- Note: Continuation 50% at one year

Combination pills

BENEFITS

- Effectiveness

- Cycle control

- Acne improvement

- Decrease in risk of uterine and ovarian cancer

RISKS

Slight increase in DVT

Increased MI/Stroke in women ◦ Over 35 who smoke

◦ With migraine/aura

◦ With cardiovascular risk factors like HTN

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DVT risk with combined hormonal contraceptives

Shulman LP. J Reprod Med. 2003. Chang J. In: Surveillance Summaries. 2003.

Beige, 20 cm2 patch that sticks to the skin and releases 1.59 mg norelgestromin and 35 mcg EE daily

New patch applied once a week for 3 weeks, followed by 1 week off

The pill… in transdermal patch form: Xulane

Good Rx = $112

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15 mcg EE

1.2 mg

etonogestrelRing in 3

weeks and out

for 1 week

Same safety/ efficacy

profile as pills

The pill… in Vaginal Ring form

Good RX = $170

Back to Sylvia:Headaches and contraceptives

CONDITION CHC POP DMPA Implants LNG-IUD Cu-IUD

A. Non-migrainousheadache

1 1 1 1 1 1

B. Migraine headache

i. Without aura 2 1 1 1 1 1

ii. With aura 4 1 1 1 1 1

* Clarification: Classification depends on accurate diagnosis of those severe headaches that are

migrainous and those headaches that are not

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Smoking and contraceptives

Condition COC/P/R POP DMPA Implants Cu-IUD LNG-IUD

Smoking

a. Age <35 2 1 1 1 1 1

b. Age≥35

i. <15 cigarettes/day 3 1 1 1 1 1

II.≥15 cigarettes/day 4 1 1 1 1 1

http://www.cdc.gov/mmwr/pdf/rr/rr5904.pdf

Hypertension and Contraceptives

CONDITION COC/P/R POP DMPA IMPLANTIUDS

LNG-IUD Cu-IUD

Adequately Controlled BP

3 1 2 1 1 1

Elevated BP1. Systolic 140–159

mm Hg ordiastolic 90–99 mm Hg

3 1 2 1 1 1

2. Systolic ≥160 mm Hg or diastolic ≥100 mm Hg

4 2 3 2 2 1

3. History of high blood pressure during pregnancy (current BP is normal)

2 1 1 1 1 1

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Using the U.S. MEC App

Case: Sylvia

-You prescribe the progestin-only pill (the mini-pill) –Micronor (Lyza) - $9

-As Sylvia is leaving she mentions,

-“By the way, we had sex last night and the condom broke…”

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Oral Emergency ContraceptionULIPRISTAL ACETATE (ELLA)

- Selective progesterone receptor modulator

- Effective up to 5 days after unprotected sex

- Delays ovulation up to/after LH surge

- Requires Rx

LEVONORGESTREL (PLAN B)

- Progesterone

- Effective up to 5 days after unprotected sex, more effective if taken earlier

- Delays ovulation up to LH surge

OTC

Glasier AF. Lancet 2010;375:555-62.

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Emergency Contraception

Ella - $42

Plan B - $30Pregnancy rate is

less than .1%

Pregnancy rate is

9% to 2.1%

Pregnancy rate is

.6% to 3.1%

Cleland Clin Obstet Gynecol 2014

Give emergency contraception regardless of weight!

- “No woman should be refused or discouraged from using EC based on her weight.”

- LNG EC is often the most accessible option for many women but may be less effective at higher weights.

- Regardless of weight, the most effective form of EC is the copper IUD, followed by ulipristal acetate.

ASEC: EC efficacy and weight statement, May 2016

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Emergency Contraception: Dispelling Myths

The morning after pill is not the abortion pill

EC does not cause an abortion

EC does not harm an existing pregnancy

EC does not affect future fertility

EC does not increase risky sexual behavior

EC may prevent unwanted pregnancy and abortion

Long-Acting Reversible Contraception (LARC)

Mirena (LNG IUS)• 99% effective• 20 mcg

levonorgestrel/day• Up to 5 years (7

years)

Liletta (IUD)• 99% effective• 18.6 mcg

levonorgestrel/day• Up to 3-4 years

Skyla • 99% effective• 14 mcg

levonorgestrel/day• Up to 3 years

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Long-Acting Reversible Contraception (LARC)

Kyleena• 99% effective• 17.5 mcg• levonorgestrel/day• Up to 5 years

Copper T IUD• 99% effective• Copper ions• Up to 10 years

Hormone IUD: $900

Copper IUD: $800

IUDs

IUD FDA use (yrs)

FailureRate

Content LNG (mg)

Advantages Disadvantages

Paragard 10 .8% None No hormone Heavy bleeding and cramping

Kyleena 5 .2% 19.5 Smaller frameand insertion

tube

Initial irregular bleeding

Liletta 3 .2% 52 Less bleeding Initial irregular bleeding

Mirena 5 .2% 52 Less bleeding Initial irregular bleeding

Skyla 3 .4% 13.5 Smaller frameand insertion

tube

Irregular bleeding, low

rate of amenorrhea

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Nexplanon®

◦ 4 cm etonogestrel implant

◦ Highly effective for 3-5 years

◦ Perfect and typical failure rate 0.1%

◦ THE MOST EFFECTIVE REVERSIBLE

CONTRACEPTIVE

◦ Continuation rate 70-80%, discreet

◦ $800

◦ Expensive

◦ Provider controlled

Contraceptive CHOICE project• Prospective cohort of 10,000

women 14-45• Method provided at no cost• Standardized counseling with

script to inform about LARC

Secura, et al. The Contraceptive CHOICE Project: reducing barriers to long

Acting reversible contraception. Am J Obstet Gyn Aug 2010

O’neil-Callahan, et al. Twenty-four-month continuation of reversible

Contraception. Obstet Gynecol Nov 2013

Winner, et al. Effectiveness of long-acting reversible contraception.

NEJM May 2012

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Baseline Chosen Method

%

LNG-IUS 46.0

Copper IUD 11.9

Implant 16.9

DMPA 6.9

Pills 9.4

Ring 7.0

Patch 1.8

Other <1.0

75%

Peipert Obstet & Gynecol 2012

12-Month Continuation RatesMethod Continuation Rate (%)

LNG-IUS 87.5

Copper IUD 84.1

Implant 83.3

Any LARC 86.2

DMPA 56.2

OCPs 55.0

Ring 54.2

Patch 49.5

Non-LARC 54.7

Peipert Obstet Gynecol 2011

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Results - CHOICE

Somewhat or very satisfied

◦ IUDs - 80%

◦Pills/patch/ring – 54%

Risk of failure 20 times higher with pills/patch/ring than with LARC

Peipert, OB-GYN, 2012

Preventing Unintended Pregnancies by Providing No-cost Contraception

•Clinically and statistically significant reduction • Abortion rates

• 4.4-7.5 abortions/1,000 in study pop vs. 13.4-17/1,000 in St. Louis region vs. 19.6/1,000 in US

• Teen birth rates• 6.3/1,000 vs. US rate 34.1/1,000

•1 abortion prevented for every 108 women given free contraceptive

Peipert, OB-GYN, 2012

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Candidates for LARC use

Dispelling myths about IUDs- IUDs don’t cause PID or infertility

◦ Nulliparous women are good candidates for the IUD

◦ Teenagers are good candidates for the IUD

- IUDs don’t cause ectopic pregnancy

- IUDs are not abortifacients

- IUDs do not make women have more and/or riskier sex

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Injectable: Depo-provera

Perfect Use: 0.3%Typical Use: 3%

Injected in deltoid or gluteus muscle every

3 months

150 mg of DMPA

Weight gain?

Irregular bleeding

Delay in return to fertility

Reduced bone mineral density

Disadvantages

Price: $20 - $700…

Side Effects

-1st several months: unpredictable bleeding/spotting

-After 1 year: 40-50% amenorrhea

-20-25% discontinue due to bleeding issues

-Reversible reduction in BMD

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How to

determine a

woman is not

pregnant?

What follow-up

is needed after

IUD

placement?

When can you

rely on the

pill?

SPR: How?

US Selected Practice Recommendations for Contraceptive Use, 2016Recommendations for common, yet sometimes controversial or complex, issues regarding initiation and use of specific contraceptive methods

◦ How to tell if a women is not pregnant

◦ Recommended examinations and test before contraceptive initiation

◦ When can you rely on a contraceptive method?

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When to rely on the progestin-only pill?

What’s new in permanent contraception?Filshie clip

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Bilateral salpingectomy for sterilizationPRO

- Decreases risk of ovarian cancer, potentially by 50%

-No increase in complications

- Likely more effective, RCTs needed

CON

- Decreases risk of ovarian cancer, likely by 25%

- May takes longer

- Potential impairment of ovarian blood supply

- Lack of long-term population level data on outcomes

Creinin and Zite, Obstet Gynecol 2014ACOG CO 620 2015SGO CO 2013

Hysteroscopic sterilization: Essure: it’s gone…

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!! Hormonal contraceptives OTC !!

OTC access◦Prescription access is a barrier

◦Patients want it

◦ It’s safe – pregnancy can be dangerous

◦Professional organizations support it

Global OC prescription requirements

Grindlay et al., 2013

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The future?- Longer acting injectables

- Biodegradable implants

- Non-surgical permanent sterilization

- Male contraceptive??!!

Summary

- Contraception promotes healthy women, families and communities

- Use the US MEC and SPR app!

- Consider prescribing hormonal contraception to patients who want it and refer for LARCs

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OCs meet FDA criteria for switch to OTCFDA CRITERIA

Drug without toxicity if overdosed

Drug not addictive

Users self-diagnose need

Users can understand instructions

Users can safely take the medication without a clinician’s screening

ORAL CONTRACEPTIVES

True

True

True

True

True: Evidence that women can self-screen for contraindications

Women pass self-screen test 96% of the time

Patient vs. provider checklist

Contraindications◦Combined pill – 4.6% ◦Progestin-only pill – 3.1%

Agreement: 96%

Shotorbani 2006

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Women accurately self-screen

Self-screen vs. provider checklist

Of women with a contraindication, only 7% did not accurately self-identify

High agreement with providers

Grossman 2008

Contraindications are uncommon

Prospective study

1010 women desiring combined oral contraceptives

Only 2.4% had a true contraindication

Xu et al, CHOICE, 2016

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Prescription access isn’t perfect

Shortridge and Miller, Contraception, 2007

No screening--including by an OB-GYN--is perfect

6% of current pill users who obtained pills by prescription had a contraindication

Pregnancy is dangerous!Significantly higher than most of the dangers of contraindications

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