This presentation contains materials obtained from Linda Prine MD, Mark A. Goedecker, MD, Mark Deutchman MD and Laura Stein MD

Objectives

 Role of the rural physician in contraception  Assessing the patient’s desire and need for contraception  Non-Hormonal contraception  Hormonal contraception  Emergency contraception  Male sterilization  Female sterilization  IUD video and lab

Role of the rural physician in contraception

 Office practice: individual patient visits  Consultant to health department  Information to concerned community members  Parents  Schools  Religious groups  News media  Overall: improve access to contraceptive information and direct services  Opportunity for health promotion and life skills counseling

Assessing the patient’s desire and need for contraception

 Full-time vs sporadic  Long term vs short term  STI protection   Sexuality concerns Others………………

Background: Importance of Contraception Unintended pregnancy

Unintended, occur earlier than desired - 29% Unintended, occur after desired family size reached - 20% Intended - 51%

Approximately 6.4 million pregnancies per year

Nonuse all year - 8% Inconsistent use - 27% Consistent, long-acting method use - 50% At-risk gap use - 15% 28 million U.S. women at risk for unintended pregnancy

Unintended pregnancy rate by race/ethnicity/income 180 160 140

Unintended pregnancies per 1,000 women

120 100 80 60 40 20 0 Below poverty level Above poverty level all white latina black

What are the lifetime considerations of unintended pregnancy ?

How many can you think of?

Effectiveness Group No Method Family Planning Method Typical-Use Rate Perfect-Use Rate of Pregnancy of Pregnancy

No method Male latex condoms Diaphragm 85% 14% 20% 85% 3% 6 Cervical cap

Less effective

Female condoms Spermicide 20%-40% 21% 26% 9%-26% 5% 6% Withdrawal Fertility Awareness 19% 20% 4% 1%-9%

Effectiveness Group Effective Family Planning Method Typical-Use Rate of Pregnancy Perfect-Use Rate of Pregnancy

Birth control pills Transdermal patch 8% Unknown (8%) 0.1%-0.5% 0.3%-0.8% Vaginal ring Unknown (8%) 0.1%-0.5%

Effectiveness Group Highly Effective (for all users) Family Planning Method Typical-Use Rate of Pregnancy Perfect-Use Rate of Pregnancy

Male and female sterilization 0.2%-0.5% 0.1%-0.5% Implants 0.1% 0.1% Hormone shot Intrauterine devices 0.3% 0.8%-2% 0.3% 0.6%-1.5%

Hormonal Contraception

 Combination estrogen/progesterone pills  Sequential estrogen/progesterone  Biphasic  Triphasic  Progesterone only  Pills, Injection and subcutaneous capsule  Extended cycle  Transdermal patches  Vaginal ring  Hormone-containing IUD

How do Oral Contraceptives Work?

 Suppress, but not eliminate ovulation (Decrease FSH and LH by pituitary suppression)  Thin the endometrium  Thicken cervical mucous

Hormonal Contraceptives

What is needed before prescribing pills?

Medical history REQUIRED Pap smear Pelvic/breast exam STI testing Hemoglobin NOT REQUIRED Blood pressure RECOMMENDED

Estrogens in OCP’s

  Most pills use ethinyl estradiol (EE) as their estrogen (50 µg mestranol = 35 µg EE) Doses range from 20 µg – 50 µg, but most are 20 µg – 35 µg  Lower dose estrogens have the benefits of less bloating and breast tenderness but may increase the rate of breakthrough bleeding especially in obese patients

“Older” vs. “Newer” Progestins

 Newer:  Less androgenic (minimizes side effects such as acne, hirsutism, nausea, and lipid changes)  Increase progestational effects  Levonorgestrel is the most androgenic available in US  First, second, third, and fourth generation progestins  Estranes and gonanes

“Newer” Progestins

  Minimal androgenic effects

Norgestimate

 Increases HDL and decreases LDL 

Desogestrel (etonogestrel)

 Possible increase risk in venous thromboembolism (VTE) (Jick S et al. Contraception 2006:73:566-70. SORT B) 

Drospirenone

 Antimineralocorticoid activity   Theoretically could cause hyperkalemia Essentially no androgenic activity

Monophasics vs. Biphasics vs. Triphasics

 There is insufficient data that biphasic or triphasic combined oral contraceptive pills are better than monophasic pills (effectiveness, bleeding patterns, or discontinuation rates) SORT B Cochrane Database of Systematic Reviews 2007 Van Vliet HAAM, Grimes DA, Lopez LM, Schulz KF, Helmerhorst FM. Triphasic versus monophasic oral contraceptives for contraception Van Vliet HAAM, Grimes DA, Helmerhorst FM, Schulz KF. Biphasic versus monophasic oral contraceptives for contraception

Choosing the Right Pill

 Low androgenic activity is desirable in most if not all  If patient weighs more than 160 pounds consider higher estrogen and progestin activity  Low dose estrogen if:   History of nausea, edema or hypertension in pregnancy Uterine fibroids    Fibrocystic breasts Heavy menses Migraines

Choosing the Right Pill

 Low progesterone if:  History of preeclampsia, excessive weight gain, tiredness, or varicose veins during pregnancy,  Depression  Excessive premenstrual  If history of polycystic ovaries, high progestational and low androgenic

• • • •

Estrogen contraindications:

Migraine with aura Uncontrolled hypertension Postpartum < 6 weeks History of DVT Smoking: NOT a contraindication in women/teens under age 35

Femcon Fe

®

 The new name for Ovcon Fe chewable  Chewable spearmint flavored tablet  EE 35 µg, norethindrone 0.4 mg (21 days)  Placebo contains 75 mg ferrous fumarate 

ADVANTAGE: For

those who cannot swallow pills (and need fresh breath)

Yaz 24/4

®

 Same ingredients as Yasmin but…  EE 20 µg (instead of 30 µg)  3 mg of drospirenone  24 days of active medication and 4 days of placebo (as compared to the usual 21/7) 

ADVANTAGE:

 Has an FDA indication for premenstrual dysphoric disorder (the only hormonal contraceptive with this)  Shorter periods

Loestrin 24 Fe

®

    24 days of hormones (similar to Yaz 24/4 EE 20 µg, Norethindrone 1 mg Placebo pills contain iron

ADVANTAGE:

 Periods last less than 3 days  More pronounced suppression of follicular development

®

)

Extended Cycle Regimens

Extended Cycle Contraceptives

 Seasonale

®

, Seasonique

®

, Lybrel

®

 Oral contraceptives taken continuously for more than 28 days compare favorably to traditional cyclic oral contraceptives (bleeding, discontinuation rates, and reported satisfaction) SORT A Edelman AB, Gallo MF, Jense JT, Nichols MD, Schulz KF, Grimes DA. Continuous Or extended cycle versus cyclic use of combined oral contraceptives for contraception.

The Cochrane Database of Systematic Reviews 2007 Issue 2

Seasonique ®

  Like Seasonale

®

:  EE 30 µg, levonorgestrel 0.15 mg for 12 weeks But…  13 th week contains EE 10 µg (instead of placebo) 

ADVANTAGES:

 Low dose EE may reduce hormone withdrawal symptoms (migraines and dysmenorrhea)  May cause less breakthrough bleeding then with Seasonale (main reason women stop Seasonale)

Lybrel ®

     Taken in a continuous 365-day regimen EE 20 µg and levonorgestrel 0.09 mg 28 pills in a pack FDA approved and will be released July 2007

ADVANTAGE:

 No menstrual bleeding  During the 13 pill pack:    59% of women achieve amenorrhea 20% of women have spotting only 21% of women required sanitary protection due to breakthrough bleeding • http://www.drugs.com/newdrugs/fda-approves-lybrel-first-low combination-oral-contraceptive-offering-women-opportunity-period-free 491.html?printable=1

Contraindications to Combined Oral Contraceptives

   Unexplained VTE or VTE associated with pregnancy or exogenous estrogen use (unless on anticoagulants) Women age 35 and older who smoke Poorly controlled diabetes or diabetes with complications such retinopathy, nephropathy, or other vascular complications Level A Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin No. 73. American College of Obstetricians and Gynecologists. Obstet Gynecol 2006: 107:1453-72.

Contraindications to Combined Oral Contraceptives

 OCP’s should be stopped one week prior to surgery or heparin prophylaxis should be considered  Women with CAD, CHF, or cerebral vascular disease  Use caution in obese women over the age of 35  Poorly controlled HTN (or complications)  Patients with Factor V Leiden gene mutation or prothrombin gene mutations Level B Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin No. 73. American College of Obstetricians and Gynecologists. Obstet Gynecol 2006: 107:1453-72.

Patients Who it is OK to Use OCP’s

 Benign breast disease or family history of breast cancer  Mild lupus with no antiphospholipid antibodies Level A Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin No. 73. American College of Obstetricians and Gynecologists. Obstet Gynecol 2006: 107:1453-72.

Patients Who it is OK to Use OCP’s

 Healthy, non-smoking women can continue their OCP’s until age 50-55  Well-controlled HTN <35 who do not smoke and are healthy  Well-controlled DM <35 who do not smoke and are healthy  Women with migraines who are healthy, do not smoke, and have no focal neurologic signs  Women with depressive disorders Level B Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin No. 73. American College of Obstetricians and Gynecologists. Obstet Gynecol 2006: 107:1453-72.

• • • • • 1 patch weekly for 3 weeks, then one week off Same efficacy & contraindications as OCs OK to shower, swim, exercise with patch on Failures in trials were in women over 198 pounds, but still rare Higher risk of clots? Conflicting studies… Gallo MF, et al.

Cochrane Reviews.

2003, Issue 1. Art. No. CD003552.

Jick S, et al.

Contraception

73 (2006)

Ortho Evra

®

Transdermal Contraceptive Patch

 EE 20 µg/d and norelgestromin 0.15 mg/d  One patch weekly for three consecutive weeks followed by one patch-free week  Mean serum concentrations are not affected by heat, humidity, exercise or cold-water immersion  Contraceptive failure is higher in women with body weight >90 kg

Ortho Evra

®

Transdermal Contraceptive Patch

 Possible increased risk of venous thromboembolism (VTE)  This is due to the increased serum concentration  Peak serum estrogen concentration is 25% less than the peak level with the pill (30 µg)   But women with the patch are exposed to 60% more estrogen than taking the pill NuvaRing – 3.4 times less estrogen exposure than patch and 2.1 less than the pill Thacker H, Falcone T, Atreja A, Jain A, Harris CM. How should we advise patients about the contraceptive patch given the FDA warning? Cleveland Clinic Journal of Medicine 2006: 73(1): 45-47.

The Patch and VTE

 Two-fold increase in the risk of VTE versus norgestimate-containing oral contraceptives with 35 µg of EE  Overall, the number needed to harm (NNH) was 4,444 (AMI, VTE, stroke)  There is a five-fold increase in risk of VTE in pregnancy  There is no increased risk for acute myocardial infarction or stroke Cole J, Norman H, Doherty M, Walker A. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Obstet Gynecol 2007: 109(2):339-46.

Injectable Contraceptives

  Only one currently available is Depo-Provera

®

Lunelle

®

was withdrawn from the US due to lack of demand and a recall (half-filled syringes)

Depo-Provera

®

  Medroxyprogesterone 150 mg given

IM

13 weeks New Depo-subQ Provera 104

®

every 11  Given every 12-14 weeks  Can be administered by the patient in the thigh or abdomen  Side effects are similar  Slow return to fertility (14 weeks to 9 months)  Irregular bleeding  Short-term loss of bone mineral density

Depo-Provera

®

and Osteoporosis

 FDA has required a black-box warning since 2004  “only use as long-term birth control method(>2 years) if other methods inadequate” 

It has not been associated with postmenopausal osteoporosis or fractures

 Society for Adolescent Medicine, ACOG and WHO have recommended continuing Depo after appropriately counseling

• Active for at least 3 weeks • Lowest estrogen dose: 15 mcg / day • Same efficacy and contraindications as OCs • May remove for up to 3 hours • QuickStart same as with OCs

NuvaRing

®

 EE 15 µg/day and etonogestrel 0.12mg/day  Inserted into vagina and left in for three weeks  Removed for one week  Can be re-inserted if it has been out for less than three hours (rinse with cold or warm water, not hot)  8/10 partners do not feel the ring during intercourse (can removed prior to intercourse) http://www.nuvaring.com/HCP/PrescribingNuvaRing/StartingYourPatients/index.asp

• • • • • • Highly effective and rapidly reversible Discreet Not user-dependent Contain no estrogen Can be used during lactation Active hormone: etonogestrel (68 mg) Reinprayoon.

Contraception

2000 Diaz.

Contraception

2000

Causes spotting Requires certified clinician visits for insertion and removal

Implantable Contraceptives

 Norplant

®

was on the US market from 1991-2002  Six rods containing levonorgestrel  Several class action law suits over:  Failure to disclose side effects (irregular bleeding)  Difficulty removing rods

Implantable Contraceptives

 IMPLANON™ released August 2006  One rod containing etonogestrel  Can be left in for up to three years  Only providers who have completed a “comprehensive practical training session” can insert IMPLANON™ (sponsored by Organon)  www.implanon-usa.com

IMPLANON™

 Mean insertion time 1.3 minutes (range 1-15 minutes)  Mean removal time 3.8 minutes (range 1-60 minutes)  4 cm long and 2 mm in diameter

Take at once, up to 5 days after unprotected sex.

Lowers risk of pregnancy by 58-89%

Levonorgestrel EC: Mechanism of Action

Inhibits ovulation Does NOT cause abortion

Ulipristal acetate: a new emergency contraceptive option

Decreases risk of unintended pregnancy by about 90% Maintains nearly full efficacy up to 5 days after unprotected intercourse

• IUDs can be used safely by nulligravid women and teens!

• IUDs DO NOT raise risk of PID.

• IUDs DO NOT raise risk of infertility.

• IUDs DO NOT raise risk of ectopic pregnancy.

• IUDs DO NOT cause abortion.

• OK to insert IUD at any point in the menstrual cycle.

• OK to insert immediately post-partum or following surgical abortion • OK to test for STIs at time of insertion (& treat infections with IUD in place)

Lost Your IUD?

(Can’t feel the string? Look with ultrasound !) Sagittal view Transverse view

Male Sterilization: Vasectomy

Vasectomy Methods 1

Dassow P , Bennett J. Vasectomy: An Update Am Fam Physician 2006;74:2069-74, 2076.

Vasectomy Methods 2

Dassow P , Bennett J. Vasectomy: An Update Am Fam Physician 2006;74:2069-74, 2076.

Vasectomy Methods 3

Dassow P , Bennett J. Vasectomy: An Update Am Fam Physician 2006;74:2069-74, 2076.

Female Sterilization

 

Tubal Ligation Tubal occlusion (Essure

®

)

Pomeroy technique

©2001

Parkland technique

©2001

Open

Filshie Clip

®

Closed Later Early ©2001

Filshie Clip ® Application

Essure ®

Hysteroscopically-placed tubal occlusion device Requires hysterosalpingogram in 3 months Hysteroscopic Placement Coil in place

Hysterosalpingogram

Fallopian tubes open A=Right, C= left B= uterus D= balloon tip catheter Tubes blocked

Counseling to Enhance Adherence

 LISTEN to her ideas about the best method.

 EXPLORE lifestyle issues that may impact adherence.

 ENCOURAGE her to call you with problems/concerns.

60 50 40 47 51 36 34 30 20 10 0 Very satisfied w/ provider Not very satisfied w/ provider Usually see same clinician Do not usually see same clinician Percent of pill users who missed one or more pills during the past three months

% of at-risk women experiencing contraceptive non-use in the past year

DE-LINK pap smears from birth control prescriptions.

ROUTINELY prescribe 1-year supply with 3 packs at a time.

Use Quickstart.

Ask about contraceptive needs at all types of visits.

Emphasize high-efficacy methods, but honor women’s choice whenever possible.

• • Hatcher et al, Contraceptive Technology 2007 Managing Contraception – book online @ • • • • • www.managingcontraception.org

• Medical Eligibility Criteria for Contraceptive Use 2010 by WHO www.who.int/reproductive-health • Association of Reproductive Health Professionals www.arhp.org

Alan Guttmacher Institute Planned Parenthood www.Not-2-Late.com

www.agi-usa.org

www.plannedparenthood.org

The Cochrane Collaboration www.cochrane.org

Reproductive Health Access Project www.reproductiveaccess.org