Contraception in the medically complicated patient - ACOFP · that could be perceived as a real or...

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The American College of Osteopathic Family Physicians designates the lectures and workshops for Category 1-A credits on an hour-for-hour basis, pending approval by the AOA CCME, ACOFP is not responsible for the content.

ACOFP / AOA’s 122nd Annual Osteopathic Medical Conference & Exposition

OCTOBER 7 - 10PHILADELPHIA, PENNSYLVANIA29.5 Category 1-A CME credits anticipated

OMED 17®

Joint Session with ACOFP and ACOOG:Management of Complex Contraception

Sarita Sonalkar, MD, MPH

AAmmeerriiccaann CCoolllleeggee ooff OOsstteeooppaatthhiicc OObbsstteettrriicciiaannss && GGyynneeccoollooggiissttss

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10 August 2017

10/16/2017

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Sarita Sonalkar, MD MPHAssistant Professor

Division of Family Planning - PEACE

Department of Obstetrics and Gynecology

University of Pennsylvania

Contraception in the

medically complex patient

2

Disclosures

I am a consultant for World Health Organization

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Objectives

By the end of this lecture, attendees should be able to:

• Know the effects of hormonal contraception on women with certain

common medical conditions

• Use the CDC Medical Eligibility Criteria and Selected Practice

Recommendations for Contraceptive Use in practice

• Refine counseling and prescribing practices for contraception when

medication interactions are likely

4

U.S. Medical Eligibility Criteria for Contraceptive Use, 2016

Safe use of contraceptive methods by women and men

with certain characteristics or medical conditions

Target audience: health care providers

Purpose: to assist health care providers when they

counsel patients about contraceptive use and to serve as a

source of clinical guidance

Content: more than 1800 recommendations for over 120

conditions and subconditions

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5

Why is evidence-based guidance for contraceptive use

needed?

To base family planning practices on the best available

evidence

To address misconceptions regarding who can safely use

contraception

To remove unnecessary medical barriers

To improve access and quality of care in family planning

6

CDC Medical Eligibility Criteria for Contraceptive Use:

Categories

U.S. Medical Eligibility Criteria for Contraceptive Use, 2016.

1No restriction for the use of the contraceptive method

for a woman with that condition

2Advantages of using the method generally outweigh

the theoretical or proven risks

3

Theoretical or proven risks of the method usually

outweigh the advantages – not usually recommended

unless more appropriate methods are not available or

acceptable

4Unacceptable health risk if the contraceptive method

is used by a woman with that condition

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How safe is contraception?

Risk of death per year

From an automobile accident 1 in 5,000

From combined oral

contraception

Age 15-34 1 in 1,667,000

Age 35-44 1 in 33,000

From an early surgical abortion 1 in 1,000,000

From a laparoscopic tubal sterilization 1 in 66,700

From pregnancy 1 in 6,900

Hatcher, Contraceptive Technology, 20th Ed

8

Outline

Age

Tobacco Abuse

Hypertension

Migraine headaches

Thromboembolic events

Obesity

Medications

• Age

• Tobacco Abuse

• Hypertension

• Migraine headaches

• VTE

• Obesity

• Medications

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Case 1: Age

• Age

• Tobacco Abuse

• Hypertension


• VTE

• Obesity

• Medications

Anna, a 43 year old G1P1001 healthy woman, comes in

requesting contraception. She has completed childbearing,

has always used condoms, but recently had an unintended

pregnancy and miscarriage. Her teenage daughter recently

started on the combined oral contraceptive pill and Anna is

now interested in starting the pill as well.

10

Death from cardiovascular disease by age,

per 100,000, 2014

0.10.4

0.03

0.81.3

0.15

4.64.3

0.29

0

1

2

3

4

5

6

7

8

9

10

MI Stroke VTE

Age 15-24

25-34

35-44

• Age

• Tobacco Abuse

• Hypertension


• VTE

• Obesity

• Medications

CDC 2014 Vital Statistics,

https://www.cdc.gov/nchs/data/nvsr/nvsr65/nvsr65_04.pdf

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Annual cardiovascular mortality risk among COC non-users and users, per

100,000

COC non-user COC user

Age less than 35 0.59 0.65

Age 35 or older 3.18 6.21

Risk of death from cardiovascular disease is lower than the risk of death from a term pregnancy

12

Does age matter when it comes to contraception?

Mortality rates are low for women of reproductive age

Increased risk of cardiovascular disease with hormonal contraception

Mortality rates from cardiovascular events increase with age

• Age

• Tobacco Abuse

• Hypertension


• VTE

• Obesity

• Medications

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Combined pill, patch,

ring

Progestin-only pill

Injection Implant LNG-IUDCopper-

IUD

Age

<40=1 <18=1 <18=2 <18=1 <20=2 <20=2

>40=2 18-45=1 18-45=1 18-45=1 >20=1 >20=1

>45=1 >45=2 >45=1

CDC Recommendations

In healthy women, any age is category 1 or 2

• Age

• Tobacco Abuse

• Hypertension


• VTE

• Obesity

• Medications

14

Combined pill, patch,

ring

Progestin-only pill

Injection Implant LNG-IUDCopper-

IUD

Age

<40=1 <18=1 <18=2 <18=1 <20=2 <20=2

>40=2 18-45=1 18-45=1 18-45=1 >20=1 >20=1

>45=1 >45=2 >45=1

CDC Recommendations

• Age

• Tobacco Abuse

• Hypertension


• VTE

• Obesity

• Medications

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Case 2: Tobacco

Tatiana is a 37-year-old G4P2022. She has smoked half a pack

of cigarettes per day since she was 24. She has been on

combination oral contraceptives in the past and she would like

to restart them today. She is otherwise healthy.

Would you recommend COC?

• Age • Tobacco Abuse• Hypertension• Migraine headaches• VTE• Obesity• Medications

16WHO Lancet, 1997


Estimated incidence rate per 106 women-years, among European women

Non-users of

COCs

Users of COCs

Women under

age 35

Non-smokers 0.83 3.56

Smokers 7.78 42.7

Women 35 or

older


Smokers 88.4 486.4

Myocardial infarction risk: Smoking and COCs

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17WHO Lancet, 1997


Estimated incidence rate per 106 women-years, among European women

Non-users of

COCs

Users of COCs

Women under

age 35


Smokers 7.78 42.7

Women 35 or

older


Smokers 88.4 486.4

Myocardial infarction risk: Smoking and COCs

18

CDC Recommendations for cigarette smokers


Combined hormonal

contraception

Non-estrogen

contraception

Age greater than 35 2 1

Age 35 and older, less

than 15 cigarettes/day

3 1

Age 35 and older, 15 or

more cigarettes/day

4 1

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CDC Recommendations for cigarette smokers


Combined hormonal

contraception

Non-estrogen

contraception

Age greater than 35 2 1

Age 35 and older, less

than 15 cigarettes/day3 1

Age 35 and older, 15 or

more cigarettes/day

4 1

20

Case 3: Hypertension

Kia is a 32 yo G3P3 who has a

recent diagnosis of

hypertension. With her recent

weight loss and exercise

regimen she has been able to

get excellent blood pressure

control with a low dose of a

single antihypertensive agent.

Her blood pressure is 125/80

today.



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Effect of COC on blood pressure

COCs cause a mild increase in blood

pressure

• Systolic 7-8 mm Hg

•Diastolic 6 mm HG

Mechanism: Thought to involve the renin

angiotensin system

• Increase in plasma angiotensinogen, a renin

substrate

• Changes persist for 3-6 months after

stopping pills

Cardoso Int J Gynaecol Obstet, 1995

Narkiewicz Am J Hypertens, 1995


22WHO Lancet, 1997

MI risk: Hypertension and COCs


Non COC users

(odds ratios)

COC users

(odds ratios)

No Hypertension 1 (ref) 3.85

Hypertension 5.43 68.1

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23WHO Lancet, 1997

MI risk: Hypertension and COCs


Non COC users

(odds ratios)

COC users

(odds ratios)

No Hypertension 1 (ref) 3.85

Hypertension 5.43 68.1

24WHO Lancet, 1997

MI risk: Blood pressure checks and COCs


Non COC users All COC users

(odds ratio)

COC users who

had BP check

(odds ratio)

COC users who

did not have BP

check (OR)

1 (ref) 4.56 2.60 9.47

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CDC risk category

E + P P-only pill

P-implant

P-IUD

P-

injection

Cu-

IUD

During prior pregnancy only – now

resolved

2 1 1 1

Well controlled 3 1 2 1

Systolic 140-159 or diastolic 90-99 3 1 2 1

Systolic >160 or diastolic >100 4 2 3 1

With vascular disease 4 2 3 1

CDC MEC: Hypertension


26

CDC risk category

E + P P-only pill

P-implant

P-IUD

P-

injection

Cu-

IUD

During prior pregnancy only – now

resolved

2 1 1 1

Well controlled 3 1 2 1

Systolic 140-159 or diastolic 90-99 3 1 2 1

Systolic >160 or diastolic >100 4 2 3 1

With vascular disease 4 2 3 1

CDC MEC: Hypertension


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Case 3: Headaches

Lisa is a 23 year old medical student who has been on a low dose combined oral contraceptive pill. She states that she has had headaches before, but over the past few months she has noted an increase in frequency.

She is currently being worked up for her headaches but she does not report any aura-type symptoms.


28

Migraine headaches

Affect up to 28% of women of reproductive age

Migraine Prevalence in the U.S.

Lipton, et al, Neurology 2007

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What is a migraine?

Recurring HA with at least 5 attacks

Lasting 4-72 hours

At least 2 of the following - Unilateral location -

Pulsating quality - Moderate or severe pain intensity -

Aggravated by routine physical activity

At least one of the following - Nausea and/or vomiting

- Photophobia and phonophobia

Not attributed to another disorder


The International Classification of Headache Disorders, 3rd edition

30

What is an aura?

Associated with ischemic changes, and increases risk of

ischemic stroke

Develops gradually

Lasts 5-60 minutes

Aura precedes the headache by 5 to 60 minutes

Features

• Flickering colorless zig zag lines

• Scintillating scotomata

• Sensory disturbances, speech disturbances, motor weakness



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Not classified as aura

Nausea

Vomiting

Photophobia

Phonophobia

Visual blurring

Generalized visual spots



32

Migraine and stroke risk

Absolute risk of stroke in young women is

low (5-10 per 100,000 women–years)

OC use in women with migraines has

greater risk of stroke, especially if auras are

present

Attributable risk of stroke for pill users in

women with migraines

•8 per 100,000 at age 20

•80 per 100,000 at age 40

1Bousser, 2000; 2Etminan 2005; 3Curtis 2006; 4LaGuardia, 2005


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Odds ratios of ischemic stroke by history of migraine and

CHC use (ages 15-49)

Champaloux et al, AJOG 2017

Current CHC use Ischemic strokeAdjusted OR

No Migraine No Reference

Yes 1.39

Migraine without aura No 2.24

Yes 1.77

Migraine with aura No 2.65

Yes 6.08


34

CDC risk category Combination

methods

Progesterone

only pill

Progesterone

injectable

implant

IUD

Copper

IUD

I C I C I C

Non-migraine 1 2 1 1 1 1 1

Migraine < 35; no

aura

2 3 1 2 2 2 1

Migraine > 35; no

aura3 4 1 2 2 2 1

Migraine with aura,

any age4 4 2 3 2 3 1

I : Initiation of methodC: Continuation of method

CDC Recommendations: Migraine


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Case 4

22 year old G0 here for contraception counseling. She has

only used condoms in the past. She gives a family history of

her aunt having had “a blood clot in her leg.”


36

Estrogen and VTE

Estrogen increases coagulation factors – VII, VIII, X and fibrinogen

Risk of having an episode of VTE is highest during the 1st

year of use• Does not increase with continuous use

Population Relative Risk of VTE VTE incidence per

10,000/year

Young women: general

population

1 5-10

Oral contraceptives 2 10-20

FVL carrier 6-8 30-80

Pregnant women 12 60-120

FVL carrier and COC 10-15 50-100

FVL homozygous 80 400-800

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Women with hypercoagulable states

Syndromes

• Factor V Leiden mutation

• Prothrombin G2010 A mutation

• Protein S, Protein C and antithrombin deficiency

Women with familial thrombophilic syndromes

• have an increased risk of VTE when using combination

oral contraception

• present with VTE earlier during use than lower risk users


38

On the other hand…

98.85% of women who test positive will NOT

have a clinical VTE event

False positive tests: could be barrier to the use

of COCs, increasing risk of unintended

pregnancy

Screening for inherited thrombophilias is not

recommended


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CDC risk category E+P P-onlyP-IUD

C-IUD

History of DVT/PE 3/4 2 1

Acute DVT/PE 4 2 1

DVT/PE and established on anticoagulant therapy

3/4 2 1

Family history (first degree relatives) 2 1 1

CDC MEC: VTE

40

Case 5: Obesity

Jenny is a 36 year old female G4P4 with a BMI of 41. She has

undergone bariatric surgery and was referred to you from her

surgeon for a contraception consultation.


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Obesity

Nearly 1/3 of all Americans are obese

• 2/3 have BMI ≥ 25

Evidence does not generally show an association of BMI with change in effectiveness of hormonal contraceptives

•Quality of evidence is low

• For all patients, there is good evidence for shortening or eliminating the pill-free interval to improve efficacy

1Flegal, JAMA 2010


42

BMI n OR

<20 194 0.8

20-24 681 1.0

25-30 216 1.4

30-35 77 1.8

35+ 27 3.1

Estimated Absolute Annual Risk of VTE per 100,000 women using COC by BMI1,2

Trussell, Contraception 2008

VTE Risk and Obesity


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Bariatric Surgery

Weight loss: improved fertility

Malabsorptive procedures (Biliopancreatic diversion, jejunoileal

bypass, Roux-en-Y bypass)

•Decrease absorption of nutrients and calories by shortening the

small intestine

•Decreased efficacy of oral contraceptives

Restrictive procedures (laparoscopic banding, laparoscopic sleeve)

•Decrease storage capacity of the stomach

•Not associated with decreased efficacy of contraceptives


44

CDC risk categories COC Patch

and

Ring

POP Progesterone

injectable

implant

IUD

Copper

IUD

BMI > 30 kg/m2 2 2 1 1 1

Menarche to < 18

years

and > 30 kg/m2

2 2 1 1

*2 for DMPA

1

Restrictive procedures 1 1 1 1 1

Malabsorptive procedures: 3 1 3 1 1

CDC Recommendations: Obesity

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Medications

Contraceptive steroids are hepatically metabolized drugs• Cytochrome P450 3A4 has a role in metabolism

• Medications that induce this system may increase the rate of contraceptive metabolism

Efficacy can be affected in both contraception and concomitant medication • Antiepileptic drugs (AEDs)

• Antibiotics

• Antiretrovirals (ARTs)


46

Antiepileptic drugs (AEDs)

cytochrome 3A4 inducers cytochrome 3A4 noninducers

CarbamazepineFelbamateOxcarbazepinePhenobarbitalPhenytoinPrimidoneTopiramate

EthosuximideGabapentinLamotrigineLevetiracetamPregabalinTiagabineValproateZonisamide


http://www.bloodpressurereading.net/images/blood-pressure-medication.png

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Antiepileptic drugs (AEDs) and hormonal contraception

Certain anticonvulsants are category 3 for COC

Many common anticonvulsants are NOT

contraindicated

Patch and ring - limited studies

DMPA

• No increased risk of pregnancy

• Reduced seizure activity

LNG-IUS not compromised

Mattson et al, Neurology, 1984


48

Antibiotics and COC

Antiinfective agent that

decreases oral contraceptive

levels

• Rifampin

Antiinfective agents that do not decrease oral contraceptive levels◦ Ampicillin◦ Doxycycline◦ Fluconazole◦ Metronidazole◦ Miconazole◦ Quinolone antibiotics◦ Tetracycline

ACOG Practice Bulletin No 73, June 2006

In general, antibiotics do not alter the efficacy of COCs


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Antiretroviral medication

May either decrease or increase the bioavailability of steroid

hormones

May alter safety and efficacy of both drugs

• Particularly some ritonavir-boosted protease inhibitors

Recommend condoms along with COC

Use minimum formulation of 30mcg EE

Many medications lack good data: consult CDC MEC

Stringer et al., AIDS 2009


50

Etonogestrel pharmacokinetics are altered by efavirenz

Chappell et al, AIDS 2017


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Luteal activity in women using HAART and etonogestrel implant

Vieira, et al J Acquir Immune Defic 2014

Emerging data are quite convincing that concomitant use of efavirenz and the etonogestrel implant decreases the implant’s efficacy.

52

Additional considerations –beyond COC

Reasons to avoid hormonal contraception (progestin or estrogen)• Breast cancer

• Hepatic adenoma or malignancies

Reasons to avoid the IUD (progestin or copper)• Current uterine or cervical infections

• Initiation with uterine cancer, cervical cancer, pelvic tuberculosis

• Significant uterine distortion/uterine anomaly

• AIDS not controlled with HAART

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In review…

Reasons to consider progestin-only

methods or copper IUD

•Cigarette smoking in women older than 35 years

•Hypertension

•History of VTE or high risk for VTE•Coronary artery disease•Cerebrovascular disease•Migraine headaches in women with focal neurologic

signs

Recommend IUD instead of implant/OC for women on hepatic enzyme inducers

56

Please don’t forget: Pregnancy is especially risky for

women with medical conditions

Conditions associated with adverse health events as a result of

unintended pregnancy

Breast cancer Complicated valvular disease

Diabetes Endometrial or ovarian cancer

Epilepsy Hypertension

History of bariatric surgery HIV/AIDS

Ischemic heart disease Malignant gestational trophoblastic

disease

Malignant liver tumors Peripartum cardiomyopathy

Schistosomiasis Severe cirrhosis

Sickle cell disease Solid organ transplantation

Stroke Systemic Lupus erythematosus

Thrombogenic mutations Tuberculosis

Curtis, K. et al. Rev Endocr Metab Disord. 2011 (12) 119-25.

Need careful pregnancy prevention or planning• Should consider long-acting, highly

effective contraception, or • Facilitate careful multidisciplinary preconception

planning

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Take home points

Estrogen carries cardiovascular risks, but hormonal contraception is always safer than pregnancy

Most methods are appropriate for most women

IUDs and implants are safe in most clinical settings

Download the CDC MEC/SPR app!

Questions?

Thank you!

Contraception in the medically complicated patient - ACOFP · that could be perceived as a real or...

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