1. The Latest in Contraception: Pearls for Busy Primary Care Providers
Women’s Health in Primary Care
Orlando, Florida
March 16, 2011
Norma Jo Waxman MD
Assoc Professor of Family and Community Medicine
University of California San Francisco

2. Disclosures Norma Jo Waxman MD
No pharmaceutical support or other commercial disclosures

3. Objectives: After this talk you will be able to:
Describe why pelvic exams and lab tests are not necessary prior to prescribing hormonal contraception.
Integrate the use of the "Quick Start" method of initiating contraception into their practice.
Encourage more efficacious and long-acting methods of contraception
Update practice protocols to increase contraceptive use and decrease unintended pregnancy in their office.
) Discuss changes in prescription protocols and the relative efficacy of available forms of contraception 2) Identify candidates for and explain the safety of long acting reversible contraception (LARC)   3) Utilize the WHO Medical Eligibility Criteria to inform the prescribing of contraceptives

4. Outline Unintended pregnancy Barriers to contraceptive access and use
Contraceptive methods updates
Continuous cycle combined hormonal
Evidence based IUD use
New Progestin Implant
New Sterilization techniques

5. 6.3 Million Pregnancies in the U.S.
25 % Unintended
Despite Method Used2
51% Intended 1.
Almost 50 percent of pregnancies in the United States are unintended and about half of these end in elective abortion.1 The proportion of unintended pregnancies is high not only among adolescents but also among older women—over 40 percent in those aged 35 to 39.1
earlier than desired (29%) or after
women have reached their desired family
size (20%).1 by age 45, more than half of U.S.
women have had one or more unintended
pregnancies.3
Urban Poor rates even higher
availability of as many safe and effective contraceptive methods as possible.
Clearly there is an unmet need for highly effective contraceptive methods that are “forgettable,” for which the default option is pregnancy prevention. Examples of such methods include intrauterine contraception, hormonal implants, and surgical and transcervical sterilization. With these methods, action is required to discontinue or reverse protection but not to continue it.
References
1. Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect. 1998;30(1):24-9, 46.
2. Rosenberg MJ, Waugh MS, Long S. Unintended pregnancies and use, misuse and discontinuation of oral contraceptives. J Reprod Med. 1995;40(5):
3. Potter L, Oakley D, de Leon-Wong E, Canamar R. Measuring compliance among oral contraceptive users. Fam Plann Perspect. 1996;28(4):154-8.
54% of women having abortions used a contraceptive method during the month they became pregnant. 76% of pill users and 49% of condom users reported using the methods inconsistently, while 13% of pill users and 14% of condom users reported correct use. 2
2.Jones RK, Darroch JE and Henshaw SK, Contraceptive use among U.S. women having abortions in , Perspectives on Sexual and Reproductive Health, 2002, 34(6):
Unintended Pregnancy and Contraception:
Among women who are at risk of an unintended pregnancy, 89% are currently using a method of contraception.
Nevertheless, almost half of all pregnancies are unintended.
A birth is classified as unintended if the mother says that, at the time of conception, she wanted to have the child later or wanted to have no more children. For the purposes of these statistics, all pregnancies ending in abortion were assumed to have been unintended.
Half of unintended pregnancies occur among the 11% of women at risk who were not using a contraception method during the month they became pregnant.
48% of women who have unintended pregnancies were using a contraceptive method during the month they became pregnant, although often not correctly every time.
Unintended pregnancy is most likely to occur among women 18-24, unmarried women, black and Hispanic women, and women with low incomes.
23 % Unintended
No Contraception
Finer et al, 2006
Jones RK, et al Perspectives on Sexual and Reproductive Health, 2002

6. Half of women at risk are not fully protected from unintended pregnancy
Over a one-year period, half of women at risk of unintended pregnancy are adequately protected through consistent and correct contraceptive use. However, nearly one in four (more than six million women) are at high risk for becoming unintentionally pregnant because they experience a gap in contraceptive use: Eight percent use no contraceptive all year, and 15% have a gap in use of one month or longer. An additional 27% are at elevated risk for unintended pregnancy because they use their contraceptive method inconsistently or incorrectly.

7. The Profound Impacts of Unintended Pregnancy
Increased domestic violence1
Increased maternal drug and alcohol use
Among teens:
Decreased high school completion
Increased likelihood of life in poverty
Intro slide (may not use-nj to deliver)
In the life of a woman, few experiences have as profound and potentially devastating an impact as an unintended pregnancy.
Unintended pregnancy leads to higher levels of domestic violence, life in poverty, and substance abuse
In the teen population, an unintended pregnancy decreases the likelihood of high school completion, and puts the woman at risk of a life in poverty, with it’s associated consequences.
References:
1. Pallitto, et al. Is Intimate Partner Violence Associated with Unintended Pregnancy? A Review of the Literature
Christina C. Pallitto. Trauma, Violence, & Abuse, Vol. 6, No. 3,
1. Pallitto, et al. Trauma, Violence, & Abuse, 2005.

8. The Profound Impacts of Unintended Pregnancy
Delayed prenatal care
Higher rates of fetal drug and alcohol exposure
Higher rates of low birth weight and infant mortality
Higher rates of developmental deficits
Higher rates of child abuse and life in poverty
Intro slide-may not use
The potentially devastating effects of an unintended pregnancy extends to the health of the fetus, should the woman decide to continue the pregnancy. Unintended pregnancy is associated with delayed prenatal care, higher rates of fetal drug and alcohol exposure, low birth weight, higher rates of infant mortality, developmental deficits and child abuse. Additionally, considering the increased chance that the child will be raised in poverty, the potential ramifications are staggering.

9. Jane 27 year-old taking combined OCPS Missed two periods
Urine Hcg is positive
Jane tells you that she ran out of birth control pills last month, and that she tried to call the office to get an appointment, but the receptionist told her she was overdue for a pap smear and couldn’t get a refill. Today was the first day she could get an appointment with you.

10. What is required before starting contraception?
Pelvic exam
Up to date Pap test
Breast Exam
STI testing
Pregnancy test
None of the above

11. NOT REQUIRED! And the evidence says…. Medical History: Required
BP: Helpful
Breast exam, Pelvic exam, Pap, Hemoglobin, pregnancy test, STI testing:
NOT REQUIRED!
This applies to young teenagers who may be embarrassed or afraid, and is particularly helpful in new patient visits.
References:
Stewart F, et al. Clinical breast and pelvic examination requirements for hormonal contraception: Current practice vs evidence. JAMA. 2001;285:
Stewart F, et al. Clinical breast and pelvic examination requirements for hormonal contraception: Current practice vs evidence. JAMA. 2001;285:

12. When in her menstrual cycle can she start contraception?
The first day of her period
The Sunday after the first day of her cycle
Any time in the month
All of the above

13. “Quick Start”
“Quick Start” – start pill1,2 ( patch3, shot, ring4, ) on day of visit- any time of the month.
EC if unprotected sex in last 5 days
Back up method for first week
Urine HCG if no withdrawal bleed at end of cycle, or 2 weeks after DMPA injection
Reassure- exposure of embryo to OC not teratogenic
Westhoff et al Contraception Westhoff et al Fertil Steril Murthy AS,
et al. Contraception Westhoff CW, et al. Obstet Gynecol. 2005

14. What methods of contraception are most effective?
Despite high theoretical effectiveness, typical use results in much lower effectiveness
Long- term methods that require low to no user maintenance/ intervention have the smallest disparity between typical and perfect use effectiveness

16. Effectiveness Rates Typical Use Perfect Use Implanon 0.05 IUD
Mirena (LNg releasing)
ParaGard (copperT)
0.2
0.8
0.6
Male Sterilization
0.15
0.10
Female Sterilization
0.5
Depo-Provera q3months
Combined Hormonal methods
(Pill, Patch and Vaginal Ring)
3.0
8.0
0.3
For methods that require the user to remember daily or do something at the time of intercourse, the most important determinant of success is consistent and correct use.
Methods that require less of the user, such as IUD, Depo Provera, Norplant and Sterilization are minimally influenced by consistent use; they also have higher inherent efficacy.
Source:
Hatcher, RA et al; Contraceptive Technology 18th Edition, New York, Ardent: 2004.

17. Effectiveness Rates Typical Use Perfect Use Cap -- nullip 16 9
Sponge -- nullip
Diaphragm 6
Female Condom 21 5
Withdrawal 27 4
Male Condom 15 2
For methods that require the user to remember daily or do something at the time of intercourse, the most important determinant of success is consistent and correct use.
Methods that require less of the user, such as IUD, Depo Provera, Norplant and Sterilization are minimally influenced by consistent use; they also have higher inherent efficacy.
Source:
Hatcher, RA et al; Contraceptive Technology 17th Edition, New York, Ardent: 1998.
Hatcher, RA et al; Contraceptive Technology 18th Edition,: 2007

19. Access Issues and Unintended Pregnancy
Jane tells you that her insurance permitted her to obtain only one pack of pills each month, and she was late in getting her pack last month because of working until after the pharmacy was closed.

20. How many refills can I give her?
One month?
3 months
13 cycles
What if you have never seen her?
Can you refill a new patient’s contraception until you could see her?
YES, it is safe to continue her medication

21. Dispensing 12 months of contraception increases continuation & lowers costs
UCSF Bixby Center evaluated 2003 claims for 82,319 women dispensed OCPs via Fam PACT Outcomes:
Women who received 13 cycles more likely to be receiving pills in 2004 than women who received 1 or 3 cycles.
Women dispensed 13 cycles more likely to receive Pap & Chlamydia tests; less likely to have pregnancy test
Fam PACT saved $99/ year on women who received 13 cycles
The tendency to discontinue use when required to make multiple visits to refill prescriptions may be even greater in other health care settings
Number of Oral Contraceptive Pill Packages Dispensed, Method Continuation,
and Costs. Obstetrics & Gynecology. 108(5): , November 2006.
Foster, D et al. Obstetrics & Gynecology 108(5): , November 2006.

22. How can we help patients with access and adherence
Help patients obtain method of choice
Eliminate practice barriers
Review and offer all options
Posters and handouts in exam rooms
Anticipate side effects and forgetting
set expectations: improves continuation1,2
Explain Medical Benefits
Patient Centered approach very important
Women choose diffent methods throughout their reproductive life cycle.
Multiple studies have shown increase of adherence and continuation with education of side effects.
Mexican study show very significant increase in correct use of Depo with education about SEs
1. Lei Z, Contraception, Canto-DeCetina, Contraception 2001

23. Systemic Barriers
Trouble with refills - can’t get through on phone, not called in to pharmacy quickly enough, formulary changes, only one month at a time covered by insurance…
Patients can’t contact provider about side effects, stops taking the method…
Provider links refills to BP check or pap test
Time constraints lead to incomplete contraceptive counseling
Provider not comfortable with full range of products
Others?

24. PDR, Product Labeling & Inserts
Labeling change biased towards adding warnings vs. removal of incorrect information1
New indication or removal of safety information requires two well-controlled studies
FDA approval not required to add warning
Liability concerns lead to unwarranted Black Box warnings
1. Grossman D, et al. Am J Public Health. 2006;96(5):791-9

25. PDR, Product Labeling & Inserts
PDR often outdated and incorrect1
Package inserts cause irrational fear of rare health risks & decrease use of contraception2
“Throw the package insert away”
1. Mullen et al Ann Emerg Med Feb 1997;29: Grubb G. J Biosoc Sci. 1987;19:313–321

26. Use absolute vs. relative risk
“Of every 1 million OC users, 4 develop heart attack each year compared with 2 nonusers.”
“OC use increases risk of heart attack 1.5 fold.”
Talking Points
Use absolute risk
Use absolute risk instead of or in addition to relative risk.
For conditions with a low rate in the baseline population, relative risk alone may exaggerate the hazard.
SAY “Of every 1 million OC users, about 4.2 develop heart attack each year. About 1.7 nonusers have heart attacks each year.” (Age 30-34, nonsmoker)
NOT “OC use increases risk of heart attack 1.5 fold”
References
Gigerenzer G, Edwards A. Simple tools for understanding risks: from innumeracy to insight. BMJ. 2003;327:741-4.
Farley TMM, Collins J, Schlesselman JJ. Hormonal contraception and risk of cardiovascular disease: an international perspective. Contraception. 1998;57:
Sloman, SA, Over D, Slovak L, Stibel, JM. Frequency illusions and other fallacies. Organizational Behavior and Human Decision Processes. 2003;91:
- - -
Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006.
Gigerenzer G, Edwards A. BMJ
Farley TMM, Collins J, Schlesselman JJ. Contraception
Sloman SA. Organizational Behavior and Human Decision Processes

27. Patient Centered History
Do you plan to become pregnant in the next year?
Ask about accidental pregnancy? How would it effect her life?
Explore tolerance of side effects:
spotting, headaches, weight gain, nausea
Is she comfortable touching her vagina?
How heavy &/or painful are her periods?
What method(s) has she used in the past?
What contraception did she come for today?

28. Do women need a “break” or “holiday” from contraception?
NO! they get pregnant
Is it safe to not have periods?
Dispel myths around “need to bleed”
Reassure our patients that amenorrhea on progestin is safe vs. amenorrhea off hormones

29. Extended Cycle Advantages
Traditional prescription historic only
Increase of efficacy
47% of women have follicle ready to ovulate by day 7 of placebo week1
24/3 pills found to have higher efficacy then 21/72
Symptoms w/ OC worse during withdrawal bleed
Cyclic vs. extended cycle: less headaches, tiredness, bloating, menstrual pain 3,4
Treats anemia, dysmenorrhea, heavy bleeding, PMS, menstrual migraines, endometriosis, PCOS
Although many women prefer to cycle monthly since it feels more natural, there’s no…
Skipping periods actually improves efficacy and decreases blood loss (anemia)
Dinger J, Minh TD, Buttmann N, Bardenheuer K. Effectiveness of oral contraceptive pills in a large US cohort comparing progestogen and regimen. Obstet Gynecol 2011;117(1):33-40
Obstet Gynecol Jan;117(1):33-40.
Effectiveness of oral contraceptive pills in a large U.S. cohort comparing progestogen and regimen.
Dinger J, Minh TD, Buttmann N, Bardenheuer K.
ZEG, Berlin Center for Epidemiology and Health Research, Berlin, Germany.
Abstract
OBJECTIVE: To estimate real-life effectiveness of oral contraceptive pills by progestogen, length of pill-free interval, and body mass index while focusing on the effect of progestogens with a long half-life and on 24-day oral contraceptive pills regimens.
METHODS: Outcome data from 52,218 U.S. participants in the International Active Surveillance of Women Taking Oral Contraceptives—a large, prospective, controlled, noninterventional, long-term cohort study with active surveillance of the study participants—were used to analyze contraceptive failure in association with oral contraceptive pills use. Low loss to follow-up is ensured by a comprehensive follow-up procedure. Contraceptive failure rates are described by Pearl Index and life-table analysis. Inferential statistics for contraceptive failure are based on Cox regression models.
RESULTS: Analyses are based on 1,634 unintended pregnancies during 73,269 woman-years of oral contraceptive pills exposure. Life-table estimates of contraceptive failure for a 24-day regimen of drospirenone and ethinyl estradiol and 21-day regimens of other progestogens were 2.1% and 3.5% after the first study year, and 4.7% and 6.7% after the third year. The adjusted hazard ratio was 0.7 (95% confidence interval 0.6–0.8). Direct comparisons of the 24-day and 21-day regimens of drospirenone and norethisterone, respectively, showed also lower contraceptive failure rates for 24-day regimens. Contraceptive failure rates adjusted for age, parity and educational level showed a slight increase with higher body mass index.
CONCLUSION: The 24-day oral contraceptive regimens containing a progestogen with a long half-life show higher contraceptive effectiveness under routine medical conditions compared with conventional 21-day regimens. Obesity seems to be associated with a slight reduction of contraceptive effectiveness.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT
LEVEL OF EVIDENCE: II
This is a report from a large cohort, the International Active Surveillance of Women Taking Oral Contraceptives, funded by Bayer Schering Pharma, Berlin, the manufacturer of a drosperinone-containing OC formulation with 24 days of active pills followed by 4 days of marker pills. This report includes 52,218 US women and 99,382 woman-years of observation. Participants were asked to complete mailed questionnaires biannually for up to 5 years. The study began enrollment in 2005, the mean age at enrollment was 26.3 years, and the loss to follow-up was 7.1%. Predefined confounders included age, body mass index, smoking, parity, and education. There were 1634 unintended pregnancies of which 229 (14%) were unassociated with conditions of noncompliance; the remainder reported conditions such as forgetting pills, the use of antibiotics, and episodes of diarrhea or vomiting. Contraceptive failure rates for drosperinone-24, drosperinine-21, and all other OCs were 2.1%, 2.8%, and 3.5%, respectively, after 1 year, and 4.7%, 5.4%, and 6.7%, repectively, after 3 years. Specific comparisons showed hazard ratios (HRs) favoring drosperinone-containing regimens and 24-day regimens as follows: HR = 0.8 for drosperinone-24 vs drosperinone-21; HR = 0.7 for drosperinone-24 vs norethisterone-24; HR = 0.7 for drosperinone-21 vs norethisterone-21; and HR = 0.8 for norethisterone-24 vs norethisterone-21. Safety issues were not addressed in this report.
1. Baerwald, Contraception, Dinger et al Obstet Gynecol 2011;117(1): Edelman et al Cochrane Review Sulak

30. Extended cycle: Is Something Building Up Inside?
Endometrial biopsy data – no hyperplasia1
Tricycle regimen, short hormone-free, cont.
1 year continuous: 11% weakly proliferative
Ultrasound data - thin endometrial stripe in study of continuous x 6 months 2
Traditional use decreases risk of endometrial cancer
1. Bachman, Contraception, 2004; Johnson, Contraception, Foidart, Contraception, 2006; Anderson, Contraception, 2003; Kwiecien, Contraception, 2003.

31. Lifetime Number of Menstrual Cycles50
100
150
200
250
300
350
400
450
Prehistoric
160
Colonial America
Modern
500
Number of Cycles
As a result of the evolution of civilization, women today have a higher number of total natural menstrual cycles during their reproductive years than their ancestors.
Compared with a typical contemporary woman who may experience about 450 natural menstrual cycles over her reproductive life, hunter/gatherer women had many more pregnancies and breast-fed each of their children for up to 3 years. Consequently, they would have experienced about 160 menstrual cycles over their lifetime.
In general, foraging women experienced later menarche, earlier childbearing, higher parity, more prolonged breastfeeding and earlier death compared with contemporary women—all of which contribute to a higher lifetime number of menstrual cycles.
References:
Eaton SB, Pike MC, Short RV, et al. Women’s reproductive cancers in evolutionary context. Quart Rev Biol. 1994;69:
Coutinho EM. Is Menstruation Obsolete? New York. Oxford University Press, Inc.
1999.
Adapted from Coutinho EM. Is Menstruation Obsolete? 1999.
Eaton SB, et al. Quart Rev Biol. 1994;69:

32. Continuous Cycle Dedicated Products
Lybrel ™
20 mcg EE/ 90 mcg LNG
Daily continuous use, no placebo, for a year
Seasonale ™ (generic version now available)
30 mcg EE/ 150 mcg LNG
84 active pills/ 7 placebo pills
large-scale, controlled study1 to test the efficacy and safety of an extended-cycle oral contraceptive in women up to age 40.
electronic diary to record pill-taking and spotting/bleeding.
The diaries were programmed to alarm in the event that more than 24 hours lapsed between diary entries. The electronic diaries utilized by the women in this study provided a detailed snapshot of compliance and cycle control.
Because of the nature of the regimens, the two OCs were given in an open-label design.
The study1 found that the 91-day OC regimen is effective in preventing pregnancy.
Pearl Index calculations based on method failure were 0.60 for the 91-day OC regimen and 1.78 for the 28-day OC regimen.
Four pregnancies occurred in women years of age during 809 completed 91-day cycles (0.9%), representing an overall use-efficacy pregnancy rate of 1.98 per 100 women-years of use. Three of the 226 women using the 28-day regimen (1.3%) became pregnant.
The clinical trial protocol did not contain exclusion criteria for body weight; the average BMI of study subjects (~26 kg/m2) was in the overweight range.
No patient weighing more than 90 kg became pregnant.
Endometrial biopsies were performed on a subset of patients in the 84/ day regimen group to assess the effect of levonorgestrel 150 µg/ethinyl estradiol 30 µg on the endometrium.
A total of 456 women received the 84/7-day regimen* and 226 women received the 21/7-day regimen† (utilizing the same hormonal components).
*SEASONALE® (levonorgestrel/ethinyl estradiol tablets) 0.15 mg/0.03 mg.
†Nordette® (levonorgestrel 150 g/ethinyl estradiol 30 g).
1. Anderson FD, Hait H, the Seasonale-301 Study Group. A multicenter,
randomized study of an extended cycle oral contraceptive. Contraception.
2003;68:89-96.

33. Continuous Cycle Dedicated Products
Seasonique ™
30 mcg EE/ 150 mcg LNG
84 active pills/ 7 pills 10mcg EE
LoSeasonique ™
20 mcg EE/ 100 mcg LNG
84 active pills/ 7pills 10mcg EE
large-scale, controlled study1 to test the efficacy and safety of an extended-cycle oral contraceptive in women up to age 40.
electronic diary to record pill-taking and spotting/bleeding.
The diaries were programmed to alarm in the event that more than 24 hours lapsed between diary entries. The electronic diaries utilized by the women in this study provided a detailed snapshot of compliance and cycle control.
Because of the nature of the regimens, the two OCs were given in an open-label design.
The study1 found that the 91-day OC regimen is effective in preventing pregnancy.
Pearl Index calculations based on method failure were 0.60 for the 91-day OC regimen and 1.78 for the 28-day OC regimen.
Four pregnancies occurred in women years of age during 809 completed 91-day cycles (0.9%), representing an overall use-efficacy pregnancy rate of 1.98 per 100 women-years of use. Three of the 226 women using the 28-day regimen (1.3%) became pregnant.
The clinical trial protocol did not contain exclusion criteria for body weight; the average BMI of study subjects (~26 kg/m2) was in the overweight range.
No patient weighing more than 90 kg became pregnant.
Endometrial biopsies were performed on a subset of patients in the 84/ day regimen group to assess the effect of levonorgestrel 150 µg/ethinyl estradiol 30 µg on the endometrium.
A total of 456 women received the 84/7-day regimen* and 226 women received the 21/7-day regimen† (utilizing the same hormonal components).
*SEASONALE® (levonorgestrel/ethinyl estradiol tablets) 0.15 mg/0.03 mg.
†Nordette® (levonorgestrel 150 g/ethinyl estradiol 30 g).
1. Anderson FD, Hait H, the Seasonale-301 Study Group. A multicenter,
randomized study of an extended cycle oral contraceptive. Contraception.
2003;68:89-96.

34. Extended Cycle Dedicated Products
2- 4 days of placebo rather than 7
Suppresses follicular growth seen during placebo week
Similar breakthrough bleeding
Loestrin 24 Fe ™
20 mcg EE/ 1 mg NET
24 days active, 3 days of Fe
Mircette ™ (Kariva generic)
20 mcg EE/ 150 mcg DSG
21 days active, 2 days placebo, 5 days 10 mcg EE
Yaz ™
20 mcg EE/ 3 mg DRSP
24 active pills/ 3 placebo pills
Mishell, Contraception 71, 2005p304-5 .

35. Lawonda
29 yo G5P2Tab3
Currently using oral contraception (OCs), but admits to frequently forgetting to take her pill
Wants to try patch because her friends like it
What do we know about adherence and OCs?
What are the side effects of the patch we need to talk to her about?

36. Adherence with Oral Contraception: What Women Do!
Percent of Women (%)
For many women, oral contraceptives are an excellent choice for pregnancy prevention. But the misuse or discontinuation of oral contraceptives—a method for which effectiveness is dependent on the degree to which it is used correctly and consistently—leads to over 1 million unwanted or mistimed pregnancies each year in the United States.2 One study found that 30 percent to 51 percent of women missed taking their oral contraceptives at least three days per month.
Potter et al., Fam Plann Perspect 1996; 28:
103 women in a 2/3 university health setting and 1/3 public health setting. 93% >high school edu, 74% white and 93% unmarried
Active Pills Missed
Potter L et al, Fam Plann Perspect

37. It is hard to take the pill
Nationally nearly half (47%) of pill users miss 1 or more pills per cycle (Rosenberg, 1999)
The third most common reason for missing a pill is “No new pill pack,” cited in 10% of the instances of missed pills. (JD Smith et al., 2005)
1 in 7 women seeking abortion in US report using pills in the month they conceived. (RK Jones et al, 2002)

38. Weekly: Contraceptive Patch (Evra)
Apply weekly x 3, then 1 wk off
EE: 20 mcg/ Norgestimate
Place on arm, trunk, buttock
Same contraindications as OCs. Typical use efficacy may be > than OCs1
Decreased efficacy, not contraindicated in women >198 lbs2
Breast discomfort and spotting > > than OC in cycles 1 & 23
Average levels of circulating estrogen 60% higher though peak levels are lower compared to OCs
Sonnenberg et al, Am J Obstet Gynecol , 2. Zieman M, Fertil & Steril, 2002
3. Audet, et al. JAMA. 2001;285:

39. EE Exposure with CHC AUC (area under curve) ng.h/mL Patch 37.7 + 5.6
OC*
Ring
* 30 mcg EE/150 mcg LNG
van den Heuvel,
Contraception :168

40. Ortho Evra and risk of Venous Thromboembolism (VTE)
Retrospective case-control studies from claims data
Jick et al, 2006 Nested case-control design based on information from PharMetrics; 59K patch, 147K OC users
did not show increased risk of VTE : OR .9 (CI 0.5–1.6) and OR 1.1 (CI 0.6–2.1) with 2006 data, when compared to OCs containing 35mcg ethinylestradiol (EE) and norgestimate
Cole’s discussion –
The study population consisted of 340,377 women who received at least one dispensing of the norelgestromin/ethinyl estradiol transdermal contraceptive system (98,790 women) or a norgestimate-containing OC (256,981 women) between April 1, 2002, and December 31, These women contributed 49,048 woman-years of transdermal contraceptive system exposure and 202,344 woman-years of norgestimate-containing OC exposure during the observation period. The median age of the women was 25 years.
There was a more than two-fold risk of venous thromboembolism in association with transdermal contraceptive system exposure compared with norgestimate-containing OC exposure (adjusted incidence rate ratio 2.2, 95% confidence interval [CI] 1.3–3.8). For AMI, transdermal contraceptive system exposure was associated with an incidence rate ratio of 1.8 (95% CI 0.5–6.8) based on only three events in transdermal contraceptive system users and seven in norgestimate-containing OC users. No ischemic stroke events occurred among transdermal contraceptive system users.
chance variation
Jick didn’t do chart review to confirm, just med treatment claim, so could have missed cases of dvt
Accepted only new use of study drug, maybe some selected out by previous problems with ocs “survivor cohort effect”
Either way, need to discuss risk,
DISCUSSION
Current users of the norelgestromin/ethinyl estradiol transdermal contraceptive system experienced a more than two-fold increased risk of venous thromboembolism, compared with norgestimate-containing OC users. The risk attributable to use of the transdermal contraceptive system was 22.5 per 100,000 woman-years, whereas the number needed to harm was 4,444. The result was not ascribable to confounding by differential use of the transdermal system in women predisposed to venous thromboembolism. Among women who did not possess transient exogenous risk factors for venous thromboembolism, transdermal contraceptive system use was associated with an increased risk of venous thromboembolism, compared with norgestimate-containing OC use (OR 2.4, 95% CI 1.1–5.5).
The incidence rate of venous thromboembolism associated with norgestimate-containing OC use was 18.3 per 100,000 woman-years and is consistent with published estimates of venous thromboembolism rates among users of oral contraceptives containing second-generation progestins of levonorgestrel and norgestrel. These range from 16 to 36 per 100,000 woman-years.8–10 The observed incidence rate of venous thromboembolism associated with transdermal contraceptive system use at 40.8 per 100,000 woman-years is similar to Jick et al's 6 reported rate of venous thromboembolism associated with transdermal contraceptive system use, at 52 per 100,000 woman years. However, our observation of a 2.4-fold increased risk of venous thromboembolism associated with transdermal contraceptive system use differs from Jick et al's reported odds ratio of 0.9. This difference could be ascribable to chance variation, because we note overlapping confidence intervals of our 2.4 odds ratio for venous thromboembolism (95% CI 1.1–5.5) compared with Jick et al's reported odds ratio (95% CI 0.5–1.6). There were also important differences between the two studies. Jick et al did not confirm outcomes by chart review, but rather relied on insurance claims for care and drug dispensing. The high proportion of venous thromboembolism cases that were pulmonary embolism in the Jick study (38 pulmonary embolism out of 68 venous thromboembolism, or 68%) suggests that many cases of deep vein thrombosis may have been missed. In addition, Jick et al accepted only new use of the study drug as a valid exposure. Although this seems reasonable at first blush, it means that prior norgestimate users were excluded from the norgestimate group but were allowed into the transdermal contraceptive system group. Because of its recent introduction, the transdermal contraceptive system could not be in the prior use category for the norgestimate users. This asymmetry meant that the transdermal contraceptive system–exposed patients could well have been more experienced users of hormonal contraception. Because venous thromboembolism risk predominates early in use, this differential history could well have depressed the apparent risk in transdermal contraceptive system users. The phenomenon is known as a survivor cohort effect. The transdermal contraceptive system users in Jick et al's study could have preferentially “survived” prior norgestimate use, whereas there was no comparable filter on the norgestimate users.
No strokes occurred among transdermal contraceptive system users, and rates of acute myocardial infarction events were low, based on three events among transdermal contraceptive system users and seven among users of norgestimate-containing OCs. Although the incidence rate ratio for AMI associated with transdermal contraceptive system use compared with norgestimate-containing OC use was elevated (1.8), the estimate is consistent with a wide range of both protective and causative levels of association (the 95% CI of the relative risk ranges from 0.5 to 6.8). The result is therefore inconclusive.
The purpose of the nested case-control analysis was to investigate the possibility of residual confounding from the cohort analysis by variables identifiable in the medical and prescription claims data. In performing this investigation, our assumption was that covariates directly identifiable in the database could be confounding the observed association. Further, they could be correlated with other variables not directly identifiable in the database, such as prescriber preference for the transdermal contraceptive system to high-risk women, if it was perceived to be less risky than alternative contraceptive forms. Among all cases and controls, none of the covariates fulfilled a 10% “change-in-estimate” criterion. After case-control matching on year of birth and usage pattern, the odds ratios were similar to the incidence rate ratios, providing further reassurance that residual confounding by the matching factors did not bias the cohort analysis.
As with any epidemiologic study conducted within the context of an automated medical and pharmacy insurance claims database, drug exposure is never entirely certain. Although there is evidence in the claims of women receiving a prescription drug at an outpatient pharmacy, we are unable to verify that women actually used the medication. Our assumption in this study was that drugs were used beginning on the date they were dispensed. If a woman did not actually use her medication, however, exposure misclassification would result. Women with no exposure to the transdermal contraceptive system or norgestimate-containing OCs would have been classified as exposed, introducing a bias of the observed odds ratio toward the null if this phenomenon occurred differentially. Under these conditions, after correcting for differential exposure misclassification, we would expect the odds ratios to be further away from the null than originally observed.
Our study did not account for the possibility of exposure due to professional samples of the transdermal contraceptive system or norgestimate-containing OCs dispensed to women at a physician's office or clinic. Because professional samples are not submitted for reimbursement by UnitedHealthcare, evidence of their use is not present in the automated database. Therefore, we may have under-ascertained the true number of woman-years of exposure. The precise changes in the effect estimates would be related to differential rates of thrombotic events among users of professional samples compared with users who filled prescriptions for the transdermal contraceptive system or norgestimate-containing OCs at outpatient pharmacies.
Women included in this study had commercial insurance coverage through UnitedHealthcare either as a direct employment benefit or as a benefit through a spouse or as a dependent. UnitedHealthcare prescription coverage is an open formulary, with patient copayments corresponding to a tiered structure with generics in the lowest tier and brands in higher tiers. During the study period, the transdermal contraceptive system and norgestimate-containing OCs were in the same copayment tier. Therefore, economic factors should not have influenced a woman's or prescriber's selection of either method of contraception. However, because these data were from a commercial health insurance plan, the women included in this study could have better access to health services compared with women without insurance or to women with other forms of insurance. In this respect, the women included in this study are not representative of those eligible for government-sponsored health programs such as Medicaid. The ability to assess heterogeneity of the effect for women with such health insurance coverage may be limited.
In conclusion, we observed a more than two-fold increase in the risk of venous thromboembolism associated with exposure to the norelgestromin/ethinyl estradiol transdermal contraceptive system in comparison with users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol. Outcomes of acute myocardial infarction and ischemic stroke occurred too rarely to ascertain precise measures of association.
Jick SS et al. Contraception 2006;73: and Contraception 2007;76:4-7

41. Ortho Evra and risk of Venous Thromboembolism (VTE)
Retrospective case-control studies from claims data
Cole et al, United Health Care claims data and chart reviews; 99K patch 257K OC users
did show odds ratio 2.4 (CI ) for VTE among patch users compared to OCs with 35 mcg EE and norgestimate
Bias: new patch users vs. new and prior OC user
Cole’s discussion –
The study population consisted of 340,377 women who received at least one dispensing of the norelgestromin/ethinyl estradiol transdermal contraceptive system (98,790 women) or a norgestimate-containing OC (256,981 women) between April 1, 2002, and December 31, These women contributed 49,048 woman-years of transdermal contraceptive system exposure and 202,344 woman-years of norgestimate-containing OC exposure during the observation period. The median age of the women was 25 years.
There was a more than two-fold risk of venous thromboembolism in association with transdermal contraceptive system exposure compared with norgestimate-containing OC exposure (adjusted incidence rate ratio 2.2, 95% confidence interval [CI] 1.3–3.8). For AMI, transdermal contraceptive system exposure was associated with an incidence rate ratio of 1.8 (95% CI 0.5–6.8) based on only three events in transdermal contraceptive system users and seven in norgestimate-containing OC users. No ischemic stroke events occurred among transdermal contraceptive system users.
chance variation
Jick didn’t do chart review to confirm, just med treatment claim, so could have missed cases of dvt
Accepted only new use of study drug, maybe some selected out by previous problems with ocs “survivor cohort effect”
Either way, need to discuss risk,
DISCUSSION
Current users of the norelgestromin/ethinyl estradiol transdermal contraceptive system experienced a more than two-fold increased risk of venous thromboembolism, compared with norgestimate-containing OC users. The risk attributable to use of the transdermal contraceptive system was 22.5 per 100,000 woman-years, whereas the number needed to harm was 4,444. The result was not ascribable to confounding by differential use of the transdermal system in women predisposed to venous thromboembolism. Among women who did not possess transient exogenous risk factors for venous thromboembolism, transdermal contraceptive system use was associated with an increased risk of venous thromboembolism, compared with norgestimate-containing OC use (OR 2.4, 95% CI 1.1–5.5).
The incidence rate of venous thromboembolism associated with norgestimate-containing OC use was 18.3 per 100,000 woman-years and is consistent with published estimates of venous thromboembolism rates among users of oral contraceptives containing second-generation progestins of levonorgestrel and norgestrel. These range from 16 to 36 per 100,000 woman-years.8–10 The observed incidence rate of venous thromboembolism associated with transdermal contraceptive system use at 40.8 per 100,000 woman-years is similar to Jick et al's 6 reported rate of venous thromboembolism associated with transdermal contraceptive system use, at 52 per 100,000 woman years. However, our observation of a 2.4-fold increased risk of venous thromboembolism associated with transdermal contraceptive system use differs from Jick et al's reported odds ratio of 0.9. This difference could be ascribable to chance variation, because we note overlapping confidence intervals of our 2.4 odds ratio for venous thromboembolism (95% CI 1.1–5.5) compared with Jick et al's reported odds ratio (95% CI 0.5–1.6). There were also important differences between the two studies. Jick et al did not confirm outcomes by chart review, but rather relied on insurance claims for care and drug dispensing. The high proportion of venous thromboembolism cases that were pulmonary embolism in the Jick study (38 pulmonary embolism out of 68 venous thromboembolism, or 68%) suggests that many cases of deep vein thrombosis may have been missed. In addition, Jick et al accepted only new use of the study drug as a valid exposure. Although this seems reasonable at first blush, it means that prior norgestimate users were excluded from the norgestimate group but were allowed into the transdermal contraceptive system group. Because of its recent introduction, the transdermal contraceptive system could not be in the prior use category for the norgestimate users. This asymmetry meant that the transdermal contraceptive system–exposed patients could well have been more experienced users of hormonal contraception. Because venous thromboembolism risk predominates early in use, this differential history could well have depressed the apparent risk in transdermal contraceptive system users. The phenomenon is known as a survivor cohort effect. The transdermal contraceptive system users in Jick et al's study could have preferentially “survived” prior norgestimate use, whereas there was no comparable filter on the norgestimate users.
No strokes occurred among transdermal contraceptive system users, and rates of acute myocardial infarction events were low, based on three events among transdermal contraceptive system users and seven among users of norgestimate-containing OCs. Although the incidence rate ratio for AMI associated with transdermal contraceptive system use compared with norgestimate-containing OC use was elevated (1.8), the estimate is consistent with a wide range of both protective and causative levels of association (the 95% CI of the relative risk ranges from 0.5 to 6.8). The result is therefore inconclusive.
The purpose of the nested case-control analysis was to investigate the possibility of residual confounding from the cohort analysis by variables identifiable in the medical and prescription claims data. In performing this investigation, our assumption was that covariates directly identifiable in the database could be confounding the observed association. Further, they could be correlated with other variables not directly identifiable in the database, such as prescriber preference for the transdermal contraceptive system to high-risk women, if it was perceived to be less risky than alternative contraceptive forms. Among all cases and controls, none of the covariates fulfilled a 10% “change-in-estimate” criterion. After case-control matching on year of birth and usage pattern, the odds ratios were similar to the incidence rate ratios, providing further reassurance that residual confounding by the matching factors did not bias the cohort analysis.
As with any epidemiologic study conducted within the context of an automated medical and pharmacy insurance claims database, drug exposure is never entirely certain. Although there is evidence in the claims of women receiving a prescription drug at an outpatient pharmacy, we are unable to verify that women actually used the medication. Our assumption in this study was that drugs were used beginning on the date they were dispensed. If a woman did not actually use her medication, however, exposure misclassification would result. Women with no exposure to the transdermal contraceptive system or norgestimate-containing OCs would have been classified as exposed, introducing a bias of the observed odds ratio toward the null if this phenomenon occurred differentially. Under these conditions, after correcting for differential exposure misclassification, we would expect the odds ratios to be further away from the null than originally observed.
Our study did not account for the possibility of exposure due to professional samples of the transdermal contraceptive system or norgestimate-containing OCs dispensed to women at a physician's office or clinic. Because professional samples are not submitted for reimbursement by UnitedHealthcare, evidence of their use is not present in the automated database. Therefore, we may have under-ascertained the true number of woman-years of exposure. The precise changes in the effect estimates would be related to differential rates of thrombotic events among users of professional samples compared with users who filled prescriptions for the transdermal contraceptive system or norgestimate-containing OCs at outpatient pharmacies.
Women included in this study had commercial insurance coverage through UnitedHealthcare either as a direct employment benefit or as a benefit through a spouse or as a dependent. UnitedHealthcare prescription coverage is an open formulary, with patient copayments corresponding to a tiered structure with generics in the lowest tier and brands in higher tiers. During the study period, the transdermal contraceptive system and norgestimate-containing OCs were in the same copayment tier. Therefore, economic factors should not have influenced a woman's or prescriber's selection of either method of contraception. However, because these data were from a commercial health insurance plan, the women included in this study could have better access to health services compared with women without insurance or to women with other forms of insurance. In this respect, the women included in this study are not representative of those eligible for government-sponsored health programs such as Medicaid. The ability to assess heterogeneity of the effect for women with such health insurance coverage may be limited.
In conclusion, we observed a more than two-fold increase in the risk of venous thromboembolism associated with exposure to the norelgestromin/ethinyl estradiol transdermal contraceptive system in comparison with users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol. Outcomes of acute myocardial infarction and ischemic stroke occurred too rarely to ascertain precise measures of association.
Cole JA et al. Obstet Gynecol 2007;109:

42. Monthly: Vaginal Contraceptive Ring Nuvaring™ 15 mcg EE & 120 mcg desogestrel
Easily placed and removed
Rarely noticed during sex
Higher acceptability and compliance than pills
Less spotting compared to pills
constant serum estrogen levels
Obesity doesn’t affect efficacy
No liver first-pass metabolism
etonogestrel: 120 microgm/day ~1500 pg/ml the biologically active metabolite of desogestrel; Eng is also used in implanon & pills in other countries
ethinyl estradiol: 15 microgm/day ~20 pg/ml
N.V. Organon has developed a combined contraceptive vaginal ring, NuvaRing®. It contains the progestagen etonogestrel and the estrogen ethinylestradiol.
NuvaRing is a flexible, soft, transparent ring made of evatane, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. One ring is to be used for one cycle which consists of a 3–week period of continuous ring use followed by a ring-free period of one week.
Each ring releases 15 g ethinylestradiol and 120 g etonogestrel per day over the 3 week period of use.

43. Vaginal Contraceptive Ring: Off label, Extended cycle regimens
The Ring is effective for up to 35 days1
Continuous cycling, increases breakthrough bleeding2
“Calendar month” use 1-27th of month, then off for rest of month
1. Mulders & Dieben, Fertil Steril 2001;75: Miller, et al. 2005

44. Q 3 months: Progestin-Only Injection: Depo Medroxyprogesterone Acetate (DMPA -IM 150mg q12wk)
Irregular bleeding is expected
and Amenorrhea is normal:
50% at 1 year, 80% at 5 years
May decrease seizure frequency and sickle crisis
Part responsible for decrease in teen birth & abortion
Advantages for teens: privacy, adherence, efficacy, decreased PID risk
Advise Calcium & Vit D, and weight bearing exercise
Pages 129, 132, 134.
Weight gain can be progressive: average of 5.4 pounds in first year of use and 16.5 pounds after 5 years.
Weight loss strategies include: Eat less, exercise more, and drink water daily.
If these strategies do not work, she may consider switching to a different contraceptive method.

45. DMPA-IM 150 & Black Box Warning
Loss of BMD happens in first 2 years
Pregnancy and nursing cause similar or > bone loss than DMPA1
In teens, bone loss reversed within 12 months of discontinuation, and ultimate BMD may be higher in the former users of DMPA 2,6
No increased incidence of osteoporosis or fractures w/ DMPA in >30yrs of worldwide use3
No role for BMD evaluation or treatment with bisphosphonates4
Experts feel “FDA's recent additional labeling for DMPA is unnecessary and should be revised or rescinded” 5
Berenson, A.B., et al., /Effects of hormonal contraception on bone mineral density after 24 months of use./ Obstet Gynecol, *103*(5 Pt 1): p
Cromer, B.A., et al., /Depot medroxyprogesterone acetate, oral contraceptives and bone mineral density in a cohort of adolescent girls./ J Adolesc Health, *35*(6): p
Gbolade, B., et al., /Bone density in long term users of depot medroxyprogesterone acetate./ Br J Obstet Gynaecol, *105*(7): p
Lara-Torre, E., et al., /Bone mineral density in adolescent females using depot medroxyprogesterone acetate./ J Pediatr Adolesc Gynecol, *17*(1): p
Lloyd, T., et al., /Adolescent Caucasian mothers have reduced adult hip bone density./ Fertil Steril, *77*(1): p
Orr-Walker, B.J., et al., /The effect of past use of the injectable contraceptive depot medroxyprogesterone acetate on bone mineral density in normal post-menopausal women./ Clin Endocrinol (Oxf), *49*(5): p
Scholes, D., et al., /Change in bone mineral density among adolescent women using and discontinuing depot medroxyprogesterone acetate contraception./ Arch Pediatr Adolesc Med, *159*(2): p
Scholes, D., et al., /Bone mineral density in women using depot medroxyprogesterone acetate for contraception./ Obstet Gynecol, *93*(2): p
Taneepanichskul, S., et al., /Bone mineral density in long-term depot medroxyprogesterone acetate acceptors./ Contraception, *56*(1): p. 1-3.
Merki-Feld, G.S., M. Neff, and P.J. Keller, /A prospective study on the effects of depot medroxyprogesterone acetate on trabecular and cortical bone after attainment of peak bone mass./ Bjog, *107*(7): p
Sowers, M.F., et al., /Bone loss in adolescent and adult pregnant women./ Obstet Gynecol, *96*(2): p
Longitudinal study of depot medroxyprogesterone acetate (Depo-Provera®) effects on bone health in adolescents: study design, population characteristics and baseline bone mineral density Contraception, Volume 77, Issue 4, April 2008, Pages Christine C. Johnson, Ronald T. Burkman, Melanie A. Gold, Robert T. Brown, Zeev Harel, Ann Bruner, Margaret Stager, Laura K. Bachrach, S. Paige Hertweck, Anita L. Nelson, Dorothy A. Nelson, Susan M. Coupey, Alison McLeod, Henry G. Bone
2. Recovery of bone mineral density in adolescents following the use of depot medroxyprogesterone acetate contraceptive injections Contraception, Volume 81, Issue 4, April 2010, Pages Zeev Harel, Christine Cole Johnson, Melanie A. Gold, Barbara Cromer, Edward Peterson, Ronald Burkman, Margaret Stager, Robert Brown, Ann Bruner, Susan Coupey, Paige Hertweck, Henry Bone, Kevin Wolter, Anita Nelson, Sharon Marshall, Laura K. Bachrach
Change in Bone Mineral Density Among Adolescent Women Using and Discontinuing Depot Medroxyprogesterone Acetate Contraception Delia Scholes, PhD; Andrea Z. LaCroix, PhD; Laura E. Ichikawa, MS; William E. Barlow, PhD; Susan M. Ott, MD
Arch Pediatr Adolesc Med. 2005;159:
Background  Several studies report an association between depot medroxyprogesterone acetate (DMPA) injectable contraception and decreased bone mineral density. Adolescents, who are still gaining bone, may be particularly affected, but there has been little study of the association in adolescent users and none following discontinuation.
Objective  To evaluate bone mineral density changes in adolescents using and discontinuing use of DMPA contraception.
Design  A population-based prospective cohort study.
Participants  One hundred seventy adolescent women, aged 14 to 18 years; 80 baseline DMPA users and 90 age-similar, unexposed comparison women. Sixty-one participants discontinued DMPA use during follow-up.
Main Outcome Measure  Bone mineral density, measured every 6 months for 24 to 36 months at the hip, spine, and whole body, comparing mean bone mineral density changes in DMPA users and discontinuers with nonusers.
Results  Among DMPA users, bone mineral density declined significantly relative to nonusers at the hip and spine but not the whole body. Annualized mean percentage changes, adjusted for covariates, were hip, –1.81% vs –0.19%; P<.001; spine, –0.97% vs 1.32%; P<.001, and whole body, 0.73% vs 0.88%; P = .78 for DMPA users vs nonusers, respectively. New users lost bone mineral density more rapidly than prevalent users. Discontinuers experienced significantly increased bone mineral density relative to nonusers at all anatomical sites; annualized mean percentage changes were hip, 1.34% vs –0.19%; P = .004; spine, 2.86% vs 1.32%; P = .004; and whole body, 3.56% vs 0.88%; P<.001.
Conclusions  Use of DMPA contraception in adolescents was associated with significant continuous losses of bone mineral density at the hip and spine. However, significant gains postdiscontinuation provide evidence that the loss of bone mass is apparently reversed.
1. Sowers Obstet Gynecol, 2000;96: Scholes Arch Pedatir Adol Med 2005;159: Westhoff C Contraception. 2003;68: ACOG Bulletin Kaunitz Contraception 2005;72: Harel et al Contraception, 2010;81:

46. Long Acting Reversible Contraception
What about new LARC evidence?
Long Acting Reversible Contraception
Long over-due
Acceptable
Reliable
Contraception

47. Why are IUDs So Underused in the US?
[Insert Lecture Name Here]
Why are IUDs So Underused in the US?
Lack of awareness of method and anxiety around insertion among patients
Dearth of trained, willing clinicians to insert
Misconceptions regarding difficulty of insertion
Negative publicity, fear of litigation
Upfront cost and insurance issues
Non evidence based office protocols decrease access
Despite being most cost-effective methods, high up front cost and inconsistent insurance coverage
Talking Points
The majority of residents responding to a 1995 survey of program directors and chief residents at 244 family medicine residency programs in the United States reported they had no clinical experience in IUD insertion and removal.
31% of chief residents and 22% of program directors reported no oral instruction about IUDs.
43% of chief residents at family practice programs received no training in IUD insertion; 41% received no removal training.
A mailed survey of 811 practicing ob/gyns (all ACOG members) shows that ob/gyns insert few IUDs because of myths about IUD safety and fear of litigation.
Other reasons for the under-use of IUDs in the US include:
Negative publicity about older methods
Misconceptions among providers & public
Fear of litigation
Upfront cost for patient and provider
Lack of awareness of method among women
References
Stanwood, NL, Garrett JM, Konrad TR. Obstetrician-gynecologists and the intrauterine device: a survey of attitudes and practice. Obstet Gynecol. 2002;99:
Steinauer JE, DePineres T, Robert AM, et al. Training family practice residents in abortion and other reproductive health care: a nationwide survey. Fam Plann Perspectives 1997;29:222-7.
Weir E. Preventing pregnancy: a fresh look at the IUD. CMAJ. 2003;169(6):585.
- - -
Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007.
Weir E. CMAJ Stanwood NL, et al. Obstet Gynecol
Steinauer JE, et al. Fam Plann Perspect. 1997
Asker C, et al. J Fam Plann Reprod Health Care
Slide 47

48. Intrauterine Contraception (IUDs)
Most Common Reversible Contraception Worldwide
Copper T 380A (ParaGard)
Effective 12 years and No hormones
Increased blood loss and cramping with regular periods
Levonorgestrel releasing system (Mirena)
Effective 5 (maybe 7) years
Irregular spotting & bleeding
Amenorrhea 20% at1yr 80% 5yr
Many non-contraceptive benefits
Negative US perception b/c Dalkon Shield. Caused plummet of US use (10% of women used IUD mid-70’s)
Many formats internationally not availbe in the US. In particular the “slim copper T “ for nulliporus woman
In 1995, IUDs were used by 11.9% of women worldwide, but by only 0.8% of US women (down from almost 10% of US women in the mid-70’s)1
160 woman worldwide use IUD, 15% of world.
60% of woman in vietnam

49. Evidence based shift of eligible candidates
CuT380A-ParaGard Label Change 2005
Mirena package insert outdated (grrr); can use Evidence Based indications off-label
Expanded patient profile
Nulliparous women
History of ectopic pregnancy
Past history of PID or STI
More than one partner
Contraindications
Acute cervicitis or PID, or high personal risk for cervicitis or PID

50. LARC is safe when other hormonal methods are contraindicated
WHO Medical Eligibility for Initiating Contraception
Condition
Copper IUD
LNG-IUS
Implant
Breastfeeding (>6 weeks postpartum) 1
Smoking
Hypertension
<159 / <99
>160 / >100 2
+ Vascular disease
Migraines
Diabetes mellitus
Liver disease
Cirrhosis
2/3
Tumors 3
Active hepatitis
The side-effect profiles of LARC methods are significantly different from combined oral contraceptives. The copper T is hormone-free and has no hormone-related side effects. The LNG-IUS and implant are progestin-only, although their FDA labels include warnings against generic hormonal side effects, including ones attributed to estrogen only (such as headache, back ache, decreased libido and hypertension). All LARC methods are a good alternative for women with contraindications to estrogen use. This includes women who smoke, women who have migraines, diabetes, cardiovascular or liver disease.
Notes on medical eligibility criteria categories:
Implant is not recommended for women less than 6 weeks postpartum.
Timing of postpartum IUD insertion is complicated and addressed in a later slide.
Smoking does not effect eligibility for LARC methods regardless of age or the number of cigarettes consumed per day.
Migraines do not effect eligibility for LARC methods regardless of age or presence or absence of aura.
Mild cirrhosis is classified as a 2 for the progestin LARC methods; severe cirrhosis is a 3.
Women carrying viral hepatitis that is not active may safely use any form of LARC (1).
WHO Medical Eligibility Criteria for Contraceptive Use. In Family Planning 50 50

51. Do IUDs cause STIs and PID?
Transient PID risk of 1/1000 likely due to infection or contamination at insertion 1,2
Okay to screen for STI and insert IUD at same visit3
Some protocols moving to “may, not must” screening for STIs (Family Pact and Planned Parenthood)
Okay to treat STI and PID with IUD in place3
Do not remove unless treatment failure
Dose and duration does not change
Don’t remove for Actinomycosis
Prophylactic antibiotics not necessary4
Grimes, D Lancet 2001; 7358:6-7, 2. Grimes, D Lancet 2000; 356:1013-9
3. WHO Grimes Cochrane Database 2001, revised 2003

52. What about the risk of PID & infertility?
The evidence shows:
IUDs DO NOT increase risk of infertility or STI1,2
PID risk with cervicitis similar with & w/o IUD1
Tubal infertility linked to presence of Chlamydia antibodies, but NOT history of IUD
Grimes, D. Lancet 2000; 356:
Systematic review found no significant effect of IUD use on infection and infertility
Risk of developing PID with asymptomatic cervicitis similar with and without an IUD
2. Hubacher D, et al. NEJM 2001; 345:561-7
Tubal infertility is linked to presence of antibodies to Chlamydia but NOT to a history of IUD use
Case control study of 1895 women
Compared 1311 infertile nulliparous women with 584 primigravid controls
3. Medical eligibility criteria for contraceptive use. 3nd edition, Geneva: WHO, 2004
Grimes, D Lancet 2001; 7358:6-7, 2. Grimes, D Lancet 2000; 356:1013-9
1. Grimes, D. Lancet 2000; 356: Grimes, D Lancet 2000; 356: Hubacher D, et al. NEJM 2001; 345:561-7.

53. IUD Myths Debunked IUDs DO NOT cause Abortion:
LNG IUDs thicken cervical mucus, suppress endometrium, & have some anovulatory effect
Copper IUDs act as a spermicide
IUDs DO NOT increase risk of ectopic pregnancy
recommended in women w/ H/O ectopic-
WHO Class 1
Rapid return to fertility after IUD removal
A substantive amendment to this systematic review was last made on 08 December Cochrane reviews are regularly checked and updated if necessary.
Background: Concern about the risk of upper genital tract infection (pelvic inflammatory disease) often limits use of the IUD, a highly effective contraceptive. Prophylactic antibiotic administration around the time of induced abortion significantly reduces the risk of postoperative endometritis.(Sawaya, 1996) Since the risk of IUD-related infection is limited to the first few weeks to months after insertion,(Lee, 1983; Farley, 1992) contamination of the endometrial cavity at the time of insertion(Mishell, 1966) appears to be the mechanism, rather than the IUD or string itself. Thus, antibiotic administration before IUD insertion might reduce the risk of upper genital tract infection from passive introduction of bacteria at insertion.
Objectives: To assess the effectiveness of prophylactic antibiotic administration before intrauterine device (IUD) insertion in reducing IUD-related complications (pelvic inflammatory disease; complaints leading to an unscheduled visit) and discontinuations within three months of insertion.
Search strategy: We used computer searches of MEDLINE, POPLINE, and EMBASE. We also reviewed lists of references in original research and in review articles. We reviewed the reference lists of all trial reports. We wrote to experts on several continents to identify unpublished trials.
Selection criteria: We included randomized controlled trials using any antibiotic compared with a placebo.
Data collection and analysis: Data extraction: Two independent reviewers abstracted data. We made telephone calls to investigators when necessary to provide additional information. We assessed the validity of each study using methods suggested in the Cochrane Handbook. Data synthesis: We generated 2x2 tables for the principal outcome measures. The Peto modified Mantel-Haenszel technique was used to calculate odds ratios and assessed statistical heterogeneity between studies.
Main results: The odds ratios for pelvic inflammatory disease associated with use of prophylactic doxycycline or azithromycin compared with placebo or no treatment was 0.89 (95%CI ). Use of prophylaxis was associated with a small reduction in unscheduled vists to the provider (OR 0.82; 95% CI ). Use of doxycycline or azithromycin had little effect on the likelihood of removal of the IUD within 90 days of insertion (OR 1.05; 95% CI ). No statistically significant heterogeneity between study results was detected.
Authors' conclusions: Use of either doxycycline 200 mg or azithromycin 500 mg by mouth before IUD insertion confers little benefit. While the reduction in unscheduled visits to the provider was marginally significant, the cost-effectiveness of routine prophylaxis remains questionable. A uniform finding in these trials was the low risk of IUD-associated infection, with or without use of antibiotic prophylaxis.
Citation: Grimes DA, Schulz FK. Antibiotic prophylaxis for intrauterine contraceptive device insertion. The Cochrane Database of Systematic Reviews 2001, Issue 2. Art. No.: CD DOI: / CD
Hubacher NEJM 2001;108: , Grimes Cochrane Database Andersson Contraception 1994;49 4. Medical eligibility criteria for contraceptive use. 3nd edition, Geneva: WHO, 2004

54. More IUD Myths Debunked
Insert at any point in the menstrual cycle1
Rapid return to fertility after removal
May insert both devices immediately post-1st trimester abortion and 4 weeks post-partum
Safe in woman with HIV and AIDs stable on ARVs- WHO class 2;
no increased risk of infection or viral shedding3,4,5
Medical eligibility criteria for contraceptive use. 3nd edition, Geneva: WHO, 2004.
Grimes D, et al, Immediate post-partum insertion of intruterine devices, Cochrane 2003 (1)
Hubacher D et al. Use of copper IUDs and the risk of infertility among nulligravid women NEJM, 2001, 108;304-14
4. Grimes DA, Schulz KF. Antibiotic prophylaxis for intrauterine contraceptive device insertion. Cochrane Database Syst Rev. 2001;(1):CD
5. Selected practice recommendations for contraceptive Use, 2nd edition, Geneva: WHO 2005
1.Medical eligibility criteria for contraceptive use WHO, Hubacher NEJM Sinei et al, Lancet Morrison et al, BJOG Richardson et al, AIDS 1999

55. IUDs in Young and Nulliparous Women
Safe and effective in nulliparous women and women <20yrs old with low risk of PID- WHO class 21-4
Higher continuation rates than with OCs in teens1
Progestin IUS great choice with menorrhagia and/or dysmenorrhea
IUD expulsion, bleeding, and pain slightly more likely among nulliparous women2-5
IUDs: For Nulliparous Women
IUDs are appropriate for many nulliparous women who are at low risk for STDs.
Use of IUDs for nulligravid women with low risk of PID is as safe and reliable as among parous women.1-3
The levonorgestrel-releasing IUDs may be more appropriate for nulliparous women with menorrhagia and/or dysmenorrhea.
IUD expulsion, bleeding, and pain are slightly more likely among nulliparous women than among women who have had children.2-5 Correct insertion, with the IUD placed up to the fundus, is thought to reduce the likelihood of expulsion.4
Sources:
Suhonen S, Haukkama M, Jackobsson T. Clinical performance of a levonorgestrel-releasing intrauterine system and oral contraceptives in young nulliparous women: a comparison study. Contraception. 2004;69:
Nelson AL. The intrauterine contraceptive device. Obstet Gynecol Clin North Am. 2000;27:
Dardano KL, Burkman RT. The intrauterine contraceptive device: an often-forgotten and maligned method of contraception. Am J Obstet Gynecol.1999;181:1-5;
Li C-FI, Lee SNN, Pun TC. A pilot study of the acceptability of levonorgestrel-releasing intrauterine device by young, single, nulliparous Chinese females following surgical abortion. Contraception 2004;69:
Treiman, K., L. Liskin, A. Kols, and W. Rinehart. "IUDs—An Update." Population Reports, Series B, no. 6 (December 1995). Available from Population Information Program, Johns Hopkins University, 327 St. Paul Street, Baltimore, MD Treiman K, et al. Population Reports
Suhonen S. Contraception 2004;69: Nelson AL. Obstet Gynecol Clin North Am. 2000;27: Dardano KL, Burkman RT. Am J Obstet Gynecol. 1999;181: Li C. Contraception 2004;69: Treiman K, et al. Population Reports

56. LARC methods are the most cost-effective methods of contraception
LARC methods have high up-front costs, but are very cost-effective over their lifespan for both patients and providers. Compared to all other contraceptive methods, IUDs are the most cost-effective after 1 year of use in the UK, and 1-2 years in the US. This graph is based on the Trussell analysis, which concluded: “Because of the similarity in effectiveness among the copper-T IUD, vasectomy and the LNG-20 IUS, the results were very cost-sensitive, particularly between IUD and IUS devices. Only a small change in costs altered the cost-effectiveness rankings, and for all practical purposes, the IUD and IUS could be considered to have equivalent cost effectiveness. These results are likely to vary across health plans depending on the negotiated discount rates.” Medicaid, 115 waivers for family planning services, and patient assistance programs can lower the cost of the device for low-income women.
Chiou CF et al. Contraception Mavranezouli I et al. Human Reprod Trussell J et al. Contraception 56 56

57. Copper IUD: Most Effective Form of Emergency Contraception
Pregnancy Rate after Copper IUD for Emergency Contraception %
Insertion of Copper IUD
up to 5 days after unprotected sex or
up to 5-7 days after suspected ovulation
Trussell et al. American Journal of Obstetrics and Gynecology. (2004) 190; S30-8

58. Progesterone Implant: Implanon™
4cm flexible rod (etonogestrel)
Highest Efficacy and continuance
Lasts 3 years & Rapid return to fertility
Inhibits ovulation and thickens cervical mucous
Minor procedure to insert and remove
Contraceptive Implant: Implanon
Implanon is the newest contraceptive implant system that has completed worldwide phase III clinical trials, however is not yet available in the United States. It is a single rod, etonogestrel-releasing system that contains 68 mg of 3-keto-desogestrel, with a membrane of ethylene vinyl acetate. The initial release rate of etonogestrel is g/day, and declines to about 40 g/day at 12 months, to 34 g/day by 24 months, and to g/day by 36 months. Inhibition of ovulation is the primary mechanism of action and occurs within one day of insertion. Effective contraception lasts for three years.
References:
Croxatto HB. Clinical profile of Implanon: a single rod etonogestrel contraceptive implant. Eur J Contracept Reprod Health Care. 2000;(5supp2):21-28.
Huber J, Wenzl R. Pharmacokinetics of Implanon. An integrated analysis. Contraception. 1998;58(6 Suppl):85S-90S.
Le J, Tsourounis C. Implanon: a critical review. Ann Pharmacother. 2001;35(3):
POSTED: September 25, 2002
REVIEWED: September 25, 2002
Glasier A, Contraception Zheng SR, et al. Contraception. 1999;60:1-8. Meckstroth & Darney P, Obstet Gynecol Clin North Am, Croxatto HB, et al. Hum Reprod. 1999;14:

59. Implant and Vaginal Bleeding
Bleeding pattern unpredictable but less bleeding than cycling women
Continuous progestin prevents EM hyperplasia; endometrial biopsy unnecessary for this purpose
Management options
Counseling and reassurance
Estradiol 1-2 mg PO QD for days, or
OCs, given for 2-3 cycles, or
Ibuprofen mg TID for 7-days

60. Sterilization Comparisons
Hysteroscopic
Sterilization
Tubal Ligation
Vasectomy
Incisions
None
1-2
Typical anesthesia
Local or
IV Sedation
General
Local
Peritoneal entry No
Yes
Resume activities
1-2 days
4.4 days
2 days
Effectiveness rate
E: 5 yrs
A: 3 yrs
98.82%
@ 4 yrs
98.87%
@ 5 yrs
Jamieson DJ, Costello C, Trussell J, Hillis SD, Marchbanks PA, Peterson HB; US Collaborative Review of Sterilization Working Group.Related Articles, Links
The risk of pregnancy after vasectomy. Obstet Gynecol May;103(5 Pt 1): Erratum in: Obstet Gynecol Jul;104(1):200. PMID: [PubMed - indexed for MEDLINE] 2:
Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J.
Related Articles, Links
The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol Apr;174(4):1161-8; discussion PMID: [PubMed - indexed for MEDLINE]
E: Essure® A=Adiana® 60

61. Hysteroscopic Sterilization
Essure Procedure®
Micro-insert placed in proximal portion of fallopian tubes…expands upon release and permanently anchored in the tube
Adiana Permanent Contraception®
Radiofrequency burn in the proximal portion of each tube lumen, then rice-grain sized silicon matrix inserted
Subsequent benign local tissue in-growth over a 3-month period…scarring blocks fallopian tube 61

62. Hysteroscopic Sterilization: Candidates
Women who prefer this approach to laparoscopy
Especially, for women with …
Obesity (BMI of > 45)
Abdominal mesh that prevents laparoscopy
Permanent colostomy
Multiple abdominal/pelvic surgeries (adhesions)
Use of anticoagulation medications
Medical problems that contraindicate general anesthesia

63. Optimizing Contraceptive Use
Separate contraceptive prescription from health screening
Simplify renewal process and maximize refills
Participate in resolving insurance/ pharmacy issues
Use US MEC Guidelines to screen for contraindications
Describe all forms of contraception and non-contraceptive benefits- put risks in perspective
Encourage more efficacious methods like LARC
Patient Centered approach very important
Women choose diffent methods throughout their reproductive life cycle.
Multiple studies have shown increase of adherence and continuation with education of side effects.
Mexican study show very significant increase in correct use of Depo with education about SEs

64. Managing Contraception – book online @(
Association of Reproductive Health Professionals (ARHP) (
The Guttmacher Institute-
www. contraceptiononline.org
Reproductive Health Access Project
A Clinical Guide for Contraception Speroff and Darney