Contraceptive Counseling Tool - American Academy of Family

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					                                                                                        ACTIVITY DISCLAIMER

      Contraception Management:                                                         The material presented at this activity is being made available by the American Academy of Family Physicians for educational purposes
                                                                                        only. This material is not intended to represent the only, nor necessarily best, method or procedure appropriate for the medical situations
                                                                                        discussed but, rather, is intended to present an approach, view, statement or opinion of the faculty that may be helpful to others who face
                                                                                        similar situations.

     Empowering TODAY's Women!                                                          The AAFP disclaims any and all liability for injury or other damages resulting to any individual attending this program and for all claims
                                                                                        that may arise out of the use of the techniques demonstrated therein by such individuals, whether these claims shall be asserted by a
                                                                                        physician or any other person. Every effort has been made to ensure the accuracy of the data presented at these activities. Physicians
                                                                                        may care to check specific details such as drug doses and contraindications, etc. in standard sources prior to clinical application. These
                                                                                        materials have been produced solely for the education of attendees. Any use of content or the name of the speaker or AAFP is prohibited
                                                                                        without written consent of the AAFP.

                                                                                        Supported in part by a grant to the AAFP from Merck & Co., Inc.

                   David Weismiller, M.D., FAAFP
                   Americo Fraboni, M.D., FAAFP                                         FACULTY DISCLOSURE

                                                                                        The AAFP has selected all faculty appearing in this program. It is the policy of the AAFP that all CME planning committees, faculty,
                                                                                        authors, editors, and staff disclose relationships with commercial entities upon nomination or invitation of participation. Disclosure
                                                                                        documents are reviewed for potential conflicts of interest and, if identified, they are resolved prior to confirmation of participation. Only
                                                                                        those participants who had no conflict of interest or who agreed to an identified resolution process prior to their participation were involved
                                                                                        in this CME activity.
                                                                                        David Weismiller, MD, FAAFP, returned a disclosure indicating that he has no affiliation or financial interest in any organization(s).

                                                                                        Americo D Fraboni, MD, FAAFP, returned a disclosure indicating that he has no affiliation or financial interest in any organization(s).
            CME #231 Thursday, 9:00-10:00 p.m. Location: Room 403

            CME #230 Thursday, 1:30-2:30 p.m. Location: Room 403

                 Learning Objectives/
                  Search References
• Counsel patients on natural family planning.                                      •     All methods can fail
• Counsel patients on effective birth control
  methods, including emergency contraception.                                       •     Two methods are better than one
• Counsel patients with unintended pregnancies
  on the available resources.                                                       •     Methods used wrong fail more
                                                                                    •     Always need a backup plan
 Medline via Ovid, Cochrane Database of
 Systematic Reviews; National Guideline                                             •     No plan offers an 85% chance of getting
 Clearing House, Institute for Clinical                                                   pregnant
 Systems Improvement, AFP

   Contraceptive Counseling Tool                                                          Contraceptive Counseling Tool
Association of Reproductive Health Professionals. Clinical Proceedings: Periodic
Well-Woman Visit: Individualized Contraceptive Care. Washington, DC; April 2004
                                                                                   6. For user-controlled methods, how often did you
1. What are your contraceptive goals? Do you ever
                                                                                      forget to use the method?
   plan to get pregnant? When?
                                                                                   7. Are there any methods you have heard about and
2. Are you currently having sex with ♂ partner?
                                                                                      would like to try?
3. Have you tried any contraceptive methods? If so,
   which one(s)?                                                                   8. How important is spontaneity of use?
4. What did you like/dislike about the method(s)?                                  9. Is protection from STIs important considering your
5. Are you a good pill taker?                                                         life situation?
                                                                                   10. Is cost an issue? Does your health insurance plan
                                                                                       cover any contraceptive method?
     Contraceptive Options
     • Irreversible                    • Reversible
        – Tubal ligation*                 – Oral contraceptives*
                                             • Combined pills*
        – Vasectomy                          • Progestin-only pills
     • Abstinence                         – Other hormonal
        – Reasonable,                        •   Implant
          acceptable option;                 •   Injections
          particularly in                    •   Vaginal ring
          younger patients                   •   Patch
                                          – Intrauterine Devices
                                          – Barrier methods
                                             • Male condom*
  * Three most commonly used in US        – Natural Family
    Pregnancy poses a greater risk          Planning
than any contraceptive method

                Informed Consent
 •   Benefits                                                           Health Benefits
                                                                        Use in Chronic Disease
 •   Risks
                                                                        Extended Cycle
 •   Alternatives                                                       Depo Provera and Bone
                                                                        Emergency Contraception
 •   Inquiries
 •   Decision to change acceptable
 •   Explanation                                                        CONTRACEPTION
 •   Documentation

        Combined Contraceptives                                       Combined Contraceptives
• Pills                               • Estrogen                       • Inhibits ovulation at pituitary and
     – Monophasic                       – Ethinyl Estradiol              hypothalamus
     – Multiphasic                    • Progestin                      • 25-year mortality from all causes same for
• Ring                                                                   OCP users vs. non-users
                                                                                   » Narod et al NEJM, 1998.
• Patch                                                                • Estrogen
     – Highly efficacious in
       women < 90kg
                                                                         – Ethinyl estradiol
     – Safety Warning (FDA)                                            • Progestins
        • ~ 60% more estrogen per                                        – Drosperinone – no risk of hyperkalemia
          cycle than 35 mcg pill
                                                                                   » Contraception 2008;78:377
        • > 3x risk of VTE compared
          to combined OCP
  Descending order of androgenic potency

                               Progestins                                                   What generation of Progestin to
        First                   Second                   Third                Fourth
   “Original pills”   •   Levonorgestrel          •   Norgestimate      •   Drosperinone
                                                                                              • 2nd generation – higher androgenic
                            •Alesse                     •Ortho Cyclen         •Yasmin           component
                            •Levlite                    •Ortho                •Yas
                            •Nordette                   Tricyclen       Anti-androgenic       • 3rd generation
                            •Levlen               •   Desogestrel
                      •   Norgestrel                    •Mircette                                  – Less androgenic, less metabolic effects on
                            •LoOvral                    •Desogen                                     CHO and lipids
                            •Triphasil                  •Orthocept
                            •Trilevlen                                                             – Do the new oral contraceptives (3rd generation)
                      •   Norethindrone acetate                                                      increase the risk of thrombosis as compared
                      •   Norethindrone
                                                                                                     with older products?
                            •Orthonovum 1/35                                                            • Kemmeren et al. Third generation oral contraceptives and risk of
                            •Ovcon 35                                                                     venous thrombosis: meta-analysis. BMJ 2001;323:131-134
                      •   Ethynodiol diacetate
                            •Demulen 1/35

Kemmeren et al., 2001
    Meta-analysis assessing risk of VTE                                                                      Combined Contraceptives
                (Case-control and Cohort studies)
   • Odds of developing VTE – with a third generation OCP
     was 70% higher than with second generation product                                           • Less risk of ectopic pregnancy
      – Odds ratio 1.7 (95% CI 1.4-2.0)
   • Risk seems to be higher with first-time users                                                • Increases bone mass
      – Odds Ratio 3.1 (95% CI 2.0-4.6)                                                                • Reduces risk of postmenopausal hip fractures
   • EXCESS RISK IS SMALL                                                                         • Relieves dysmenorrhea
      – 1.5 per 10,000 women per year
      – Additional risk of death is exceedingly small 1                                           • Improves symptoms of PCOS
         additional death in 25,000 women taking these                                                 • High estrogen/progestin ratio
         products over 10 years
   • Question – with the availability of many equally-                                            • Low-dose pills useful for management of
     useful choices, often less expensive, is the risk worth                                        perimenopause

                Combined Contraceptives                                                     Stewart et. Al. Systematic Review*
                                                                                             • Consensus statement reviewing and summarizing
  • Iron deficiency anemia                                                                     relevant medical literature and policy statements
  • Fibrocystic breast disease                                                               • No evidence supporting necessity of CBE (clinical
  • Functional ovarian cysts (use high estrogen                                                breast exam) and pelvic examination
    content) /fibroids
                                                                                             • The available evidence supports prescribing
  • Pelvic inflammatory disease                                                                hormonal contraception based only on:
     – Cervical mucus/reduced menstrual blood flow                                                – Blood pressure measurement
     – Less retrograde menstruation                                                               – Review of medical history
  • Ovarian and endometrial cancers                                                          • A real change in management for many clinicians
          • Protective effects persists up to 20years after
  • Endometriosis (use strong progestin component)                                         *Stewart FH, Harper CC, Ellertson CE, et. al. Clinical breast and pelvic
                                                                                           examination requirements for hormonal contraception: current
                                                                                           practice vs evidence. JAMA. 2001;285(17):2232-9.
                                                          Combined Contraceptives
            Medical History                               Side effects (Excess)
                                                          • Estrogen              • Progestin
• Chronic diseases            • Previous
  – Hypertension                                            – N/V                    – Acne
  – DM                                                      – Bloating/edema            • (Ortho Tricyclen
                                methods, successes                                        approved for
  – Hyperlipidemia              and failures                – Hypertension                treatment)
  – Migraine                                                – Migraine HA
                              • VTE                                                  – Increased appetite
  – Immune deficiency                                       – Breast tenderness
    states                    • Tobacco use                                          – Hypertension
  – Cancer                                                  – Decreased libido       – Fatigue
• Gynecologic history                                       – Weight gain            – Depression
  – Infections                                              – Heavy bleeding         – Hirsutism
                                                            – Leukorrhea             – Vaginal yeast infection

Combined Contraceptives                                   Estrogen and Progestins in OCPS
Side effects (Deficiency)                                                  Cochrane 2005
• Estrogen                     • Progesterone                 • Low dose estrogen (20 mcg) cause
  – Spotting/breakthrough         – Amenorrhea
                                                                more irregular bleeding than > 20 mcg
  – Amenorrhea                    – Late breakthrough         • Monophasic pills recommended as the
  – Vaginal dryness                 or heavy bleeding           first choice for women starting OCPs

  Extended-Cycle Contraception                                 Extended Active Pill Cycle
                                                                        Safety and Efficacy
  • Women desire less frequent periods
      – 1970s – researchers established women               • Sulak et al. Am J Obstet Gynecol
        wanted to control the timing of their menstrual       2002;186:1142-1149.
        cycles                                                 – Active-pill cycle 6-12 weeks followed by a 7-day
                                                                 pill-free interval
      – 1999 Dutch study – Most women would                    – Substantial alleviation of menstrual-related
        choose to menstruate less than once per                  complaints: mastalgia, bloating, headache,
        month                                                    menstrual pain, FATIGUE
      – 2002 Harris Poll – 1 in 4 respondents               • No difference in safety or effectiveness
        considered menstruation to have a negative            between cyclic and continuous or extended-
                                                              cycle combined contraceptives
        impact on important aspects of their lives
        • 44% preferred to never menstruate
                                                           Extended and Continuous
             Clinical Practice
 • Modify standard use of monophasic OCs             • Compared to conventional regimens, shorter or
                                                       fewer hormone-free intervals theoretically might
 • Use active pills continuously for 84 days
                                                       further decrease the risk of ovulation and
   followed by 1 week of inactive pills                unintended pregnancy
 • Withdrawal bleed ~ 4 times per year               • Willis et al. Contraception 2006;74:100
                                                         – Regimen with shorter hormone-free intervals
                                                           suppressed ovarian hormone production more
                                                           effectively than those with traditional 7-day interval.

                     Options                         Extended vs. 28-day cycle OCPS
                                                     Cochrane 2005
• 24 days followed by 4 days of inert tablets
  – Yaz and Loestrin 24 FE
                                                      • Similar pregnancy rates, safety profiles,
• 91-day cycle with only 4 withdrawal bleeds per
  year                                                • Some discontinuation rates for bleeding
  – e.g., Seasonique, Seasonale                         problems
• 365-day cycle                                           – Only 16% of women will be amenorrheic in
  – Lybrel (Wyeth) – FDA-approved continuous cycle          the first three months
    combination oral contraceptive
                                                      • Less headaches, genital irritation,
  – Cost /year $684.32
                                                        fatigue, bloating, dysmenorrhea

Extended vs. 28-day cycle OCPS                       Long-term safety of an
Cochrane 2005                                        extended-regimen OC
                                                     Davis MG, Reape KZ, and Halt Howard. A look at the long-term safety of an
                                                     extended-regimen OC. The Journal of Family Practice. 2010;59(5):E9-E13.
 • Similar pregnancy rates, safety profiles,
   compliance                                        • Evaluated the safety of a 91-day extended-
                                                       regimen OC containing 150 mcg
 • Some discontinuation rates for bleeding             levonorgestrel/30mcg ethinyl estradiol (EE) for
   problems                                            84 days, followed by 7 days of 10 mcg EE
    – Only 16% of women will be amenorrheic in       • Adverse event profile of the 91-day extended-
      the first three months                           regimen OC over 4 years was similar to that
 • Less headaches, genital irritation,                 seen in the 1-year clinical trial, with no expected
   fatigue, bloating, dysmenorrhea                     adverse events
Progestin-only methods more
appropriate than combined
ACOG 2006                                                        • Good choice for chronic medical problems
                                                                    – Decreases crisis in sickle cell disease
• Smoking or obesity AND over age 35 [SOR B, A; respectively]    • No effect on BP; risk of VTE, CVA, MI
• Hypertension with vascular disease or > age35 [SOR B]            [SOR: B]
• Lupus with vascular disease, nephritis [SOR A]
• Migraine with focal aura [SOR B]
                                                                 • Side effects:
• Current or personal history of VTE associated with pregnancy      – Weight gain, amenorrhea, hair loss, bone loss
  or estrogen unless on anticoagulation [SOR A]                  • Loss of bone density
• Coronary artery/Cerebrovascular disease [SOR C]                   – Should be used for > 2 y only if other methods
                                                                      are inadequate [SOR: B]
                                                                    – No current recs for BMD measurements

    What does the evidence say?                                   Bone loss prevention…
     • Reduction of bone mineral density (in 7                    • WHO recommends using DMPA with
       cross-sectional studies and 5                                caution in women
       prospective cohort studies) was 2-6%                          – < 18
          – Did not result in osteopenia                             – > 45
     • Bone loss is regained even in young                           – On chronic steroid therapy
       users (Scholes et al. 2005)                                   – > 2 years IF at high risk for osteoporosis
     • No trial had fracture as an outcome                        • ↑ dietary calcium + vitamin D may be
                                                                    partially protective

    Candidates for DMPA Use                                             Natural Family Planning
     •   Postpartum Contraception                                         Pluses                       Minuses
     •   Smokers > 35                                            • No adverse drug effects     • No non-contraceptive
                                                                 • No medication or device       benefits of some other
     •   Lactating                                                 cost; cannot “run out” of     methods
     •   Women who can tolerate a period of                        method                      • Requires periodic
                                                                 • Immediately reversible        abstinence
         infertility after DMPA is discontinued
                                                                 • Acceptable to all major     • Requires intensive
         – 70% conceive by 12 months                               religions                     education
         – By 24 months, rates similar to other                  • Expands couples’
           methods                                                 communication and forms
                                                                   of sexual expression
                                                                                                              Failure Rate
                                                                                     Method         Typical use         Perfect use

                                                                    LAM           Combined OCP
                                                                                   Tubal Ligation
                                                                                                                                      Three critical criteria
                           Lactational Amenorrhea Method                           Male condom

    • Highly effective temporary family                                           • Must meet all three criteria before using as
      planning method for BF women in the                                           protection against pregnancy
                                                                                       – Less than six months postpartum
      first months after delivery                                                      – Amenorrheic
        – Natural protection against pregnancy for                                     – Fully breastfeeding (without use of supplements)
          up to 6 months pp                                                       • If/when one of the three conditions change – begin
               • 2% risk of pregnancy                                               another FP method
                                                                                       – also, use another method if 2% risk of pregnancy is too
        – Provides time to choose more
                                                                                         high for woman
          permanent method

                                                                                               So how does choice impact
Contraceptive use during lactation                                                                     lactation?
                                                                                   LAM                             IUD                            Combined
  • All family planning choices are available                                                                          Copper            Pills   pill
    to the postpartum lactating woman                                             Periodic                         Sterilization         Injectables
                                                                                  Abstinence/                                     Implants        Ring
  • Choice and clinical ramifications merit
                                                                                  NFP Methods                                     Levonorgestrel Injectable
    additional counseling                                                                                                        IUD
                                                                                   Barrier Methods

                                                                                  No known                        Little to no        Some reports of Expected to
                                                                                  impact on                       known               negative impact have
                                                                                  lactation                       impact on           on lactation    negative
                                                                                                                  lactation                           impact on

     WHO Medical Eligibility Criteria                                                                              Abstinence
Duration of     Progestin- Progestin- Progestin-   Combined Combined Low dose
BF method       only pills only       only         injectable patch or combined
                           depots     implants/    contracep ring
                                      IUD          -tives                          • Convey to adolescents that this is expected, be
< 6 weeks PP                                                                         realistic
                   3           3          3           4         4         4        • Abstinence teaching programs have some
> 6 w to < 6
m PP                                                                               • Encouragement to practice abstinence can be a
(primarily         1           1          1           3         3         3          powerful tool to enhance empowerment for self
> 6 m PP
                   1           1          1           2         2         2        • Advantages: no STDs, no cost, no pregnancy
                                                                                   • Disadvantages: difficult to maintain
1 – No restriction
2 – Generally use
3 – Not usually recommended
4 – Not to be used
                                                                                                                                        Long-Acting Reversible
                              Sexual Abstinence
                                                                                                                                        Contraceptive Methods
       • Educational programs that teach BOTH                                                                        • Methods                                                               • Barriers
         abstinence and contraception                                                                                        – Implant                                                               – Lack of health care
             – Delay onset of sexual activity and reduce                                                                     – Intrauterine Device                                                     provide knowledge or
               number of sexual partners                                                                             • Fewer than 5% of
                                                                                                                                                                                                     – Low Patient
                    • Ancheta et al. J Pediatr Adolesc Gynecol 2005;18.                                                women in the US                                                                 Awareness
       • “Pledge” to remain abstinent: 50% honor                                                                       report ever using
                                                                                                                                                                                                     – High upfront costs
         pledge 12 months later                                                                                        intrauterine
                                                                                                                       contraception or an
             – STIs same whether pledgers or non-pledgers                                                              implant *
                    • Rosenbaum et al. Am J Public Health. 2006;96                                              *Chandra A, Martinez GM, Mosher WD, Abma JC, Jones J. Fertility, family planning, and reproductive health of
                                                                                                                U.S. women: data from the 2002 National Survey of Family Growth. Vital Health Stat 23 2005;(25):1-60.

      Strategies to reduce barriers and                                                                                     Intrauterine Contraceptives
      increase use of implants and IUDS                                                                                    Marketed in the United States
      • Encourage implants and IUDS for all
        appropriate candidates – including
        nulliparous women and adolescents
      • Adopt same-day insertion protocols                                                                                 Levonorgestrel-Releasing                                                        Copper-Releasing
                                                                                                                               Intrauterine System                                                    Intrauterine Contraceptive
            – Screening for Chlamydia, gonorrhea, and                                                                         (LNG-IUS, Mirena®)                                                          (ParaGard® T380A)
              cervical dysplasia SHOULD NOT be required                                                                     Releases 20 µg of levonorgestrel                                         Polyethylene device with 380 mm3
                                                                                                                            every 24 hrs                                                             of exposed copper
              before implant or IUD insertion but may be
                                                                                                                            Duration of use: 5 years                                                 Duration of use: 10 years
              obtained on the day of insertion, if indicated                                                                0.1% of women experience an                                              0.6% of women experience an
                                                                                                                            unintended pregnancy within the                                          unintended pregnancy within the
ACOG Committee Opinion No. 450. Increasing use of Contraceptive Implants and                                                first year of typical use                                                first year of typical use
       Intrauterine Devices to Reduce Unintended Pregnancy. Obstet Gynecol.
                                                                                                                Kulier R, et al. Cochrane Database Syst Rev. 2006;3:CD005347; Trussel J. Contraception. 2004;70:89-96;
                                                    2009;114(6): 1434-1438.                                     Lahteenmaki P, et al. Steroids. 2000;65:693-697; Sivin I, et al. Contraception. 1991;44:473-
                                                                                                                480; Peterson HB, et al. Am J Obstet Gynecol. 1996;174:1161-1168.

               Intrauterine Contraceptives                                                                                    Common MYTHS About
                           Mechanisms of Action                                                                          Intrauterine Contraceptives (IUDs)
                                                                                                                   • IUDs are abortifacients
                                                                                                                   • IUDs cause ectopic pregnancies and, therefore,
                                                                                                                     cannot be used in women with a history of ectopic
                                                                                  Barr Pharmaceuticals, Inc.

              Levonorgestrel-Releasing                                        Copper-Releasing
             Intrauterine System (LNG-IUS,                               Intrauterine Contraceptive
                                                                                                                   • IUDs cause pelvic inflammatory disease (PID)
                        Mirena®)                                             (ParaGard® T380A)                     • IUDs need to be removed to treat PID
                  Inhibits fertilization                                   Inhibits fertilization                  • IUDs cannot be used in nulliparous women
                  Thickens cervical mucous                                 Releases copper ions (Cu2+) that        • IUDs cause infertility
                  Inhibits sperm function                                  reduce sperm motility
                                                                           May disrupt the normal division of      • IUDs have to be removed if actinomyces-like
                  Thins and suppresses the
                                                                           oocytes and the formation of              organisms are observed in a Pap smear
                                                                           fertilizable ova                     Hubacher D, et al. N Engl J Med. 2001;345:561-567; Stanwood NL, et al. Obstet Gynecol. 2002;99:275-280;
                                                                                                                Forrest JD. Obstet Gynecol Surv. 1996;51(12 suppl):S30-34; Lippes J. Am J Obstet Gynecol. 1999;180(2 Pt 1):265-269;
 Jonsson B, et al. Contraception. 1991;43:447-458; Videla-Rivero L, et al. Contraception.                       Andersson K, et al. Contraception. 1994;49:56-72; Duenas JL, et al. Contraception. 1996;53:23-24; Otero-Flores JB, et al.
 1987;36:217-226; Kulier R, et al. Cochrane Database Syst Rev. 2006;3: CD005347.                                Contraception. 2003;67:273-276; Penney G,et al. J Fam Plann Reprod Health Care. 2004;30:29-41.; Weiss E, Moore K.
                                                                                                                Contraception. 2003;68:359-364
      Patient Education and Consent                                                                  Patient Education and Consent
    • Failure Rate                                                                                                                    Advantages
          – ParaGard                     0.6-0.8%                                                 IUD                       Long term, no patient                   Rare uterine perforation;
                                                                                                                            compliance required; rapid              risk of infection with
          – Levonorgestrel               0.1%                                                                               return of fertility after               insertion
                                                                                                  Paragard T380-A           FDA approved for up to10 Irregular/heavy bleeding
                                                        Failure Rate                                                        years; (shown to be           and dysmenorrhea
                         Method             Typical use           Perfect use                                               effective for up to 12 years)
                     Combined OCP                8%                    0.3%                       Mirena (LNG-IUs) Decreased bleeding and                           Irregular bleeding initially,
                      Tubal Ligation             0.3%                  0.3%                                        dysmenorrhea;                                    followed by amenorrhea
                      Male condom                15%                   2%                                          FDA approved for up to 5                         (reported in about 20% of
                      Depo-Provera               3%                    0.3%                                        years; (shown to be                              users after 1 year of use);
                                                                                                                   effective for up to 7 years)                     ovarian cysts

                    Billing and Coding
  Contraception   Code     Cost of     Billing amount     Other Billing        Billing Charge
                                                                                                              New Guidelines for IUDs
                           Device             for         Requirements        with Insertion or
                                       Contraceptive                          Administration
 Mirena           J7302 $468.71        $708.00          Bill w/ IUD           $1,076.00              Organization Recommendation
                                                        58300/$368.00                                ACOG 2007                Asymptomatic women may use an IUD
 Paragard         J7300 $392.00        $431.00          Bill w/ IUD           $799.00                                         within 3 months of treated pelvic
 T380-A                                                 insertion                                                             infection or septic abortion
                                                                                                     ACOG 2007                All adolescents should be screened for
  ICD-9-CM Diagnostic Codes:                                                                                                  GC and Chlamydia prior to insertion
  V25.1 Encounter for contraceptive management; insertion of intrauterine
         contraceptive device                                                                        Cochrane                 No benefit from doxycycline or
  V25.42 Intrauterine contraceptive device; checking, reinsertion, or removal of                     2007                     azithromycin prior to insertion
         intrauterine device
  V72.42 Screening pregnancy test (+)
  V72.41 Screening pregnancy test (-)

e.g., Average retail price of Seasonale® for 1 year $580

              Implantable Hormonal                                                                        Contraceptive Implant Efficacy
             Devices ( July 18, 2006)                                                                                        Mechanisms of Action
                                                                                                   • Suppresses ovulation
                                                                                                      – Occurs within 1 day of insertion
                                                                                                      – Ovulation in <5% of users after 30
                                                                   Organon USA Inc.
                                                                                                        months of use
    • Single rod, subdermal implantation.
                                                                                                   • Increases viscosity of the cervical mucous
    • 68 mg of etonogestrel – period of up to three years
          – Heavier women may need a new implant every two years
    • Since 1998 – 2.5 million women (30 countries)
    • Side Effects: Irregular bleeding
          – HA, acne, dysmenorrhea, emotional lability                                            Bennink, HJ. Eur J Contracept Reprod Health Care. 2000;5 Suppl
                                                                                                  2:12-20; Le J, Tsourounis C. Ann Pharmacother. 2001;35:329-336.
          – NO significant side effect on BMD or lipid metabolism
                                                                                                                                                                         * DMPA for comparison
       Common Myths About Contraceptive
          Implants Among Clinicians                                                                                          Coding and Billing
                                                                                            Contraception                Code       Cost of   Billing amount    Other Billing    Billing Charge
  • Insertion and removal is time-consuming and difficult to                                                                        Device           for        Requirements    with Insertion or
    learn – Not true!                                                                                                                         Contraceptive                     Administration
     – Time to insert is 1.1 minutes                                                       Implanon                    J7307 $566.93          $914.00          Bill w/ Insertion $1,215.00
     – Time to remove is 2.6 minutes                                                                                                                           Capsule
  • Implants are associated with a higher risk of ectopic
                                                                                           Depo Injection              J1055 $23.17           $85.50 per       Bill w/          $128.50 per
    pregnancy – Not true!                                                                  (DMPA)* q 12                      per              dose; $342.00    administration   dose; $514.00
     – No pregnancies were reported during 5,629 woman-                                    weeks                             dose;            per year         90772/$43.00     per year
       years of use                                                                                                          per year
     – The baseline ectopic pregnancy rate in the United                                     ICD-9-CM Diagnostic Codes:
       States is 1.97%                                                                       V25.9 Implanon, unspecified birth control
                                                                                             V72.42 Screening pregnancy test (+)
 Mascarenhas L. Eur J Contracept Reprod Health Care. 2000;5 Suppl 2:29-34;                   V72.41 Screening pregnancy test (-)
 Glasier A. Contraception. 2002;65:29-37; Centers for Disease Control and
 Prevention. MMWR Morb Mortal Wkly Rep. 1995;44:46-48.

 Postcoital Treatments for                                                                             Single Dose Levonorgestrel?
 Preventing Pregnancy                                                                                    Von Hertzen H, Piaggio G, Ding J, et al. Low dose mifepristone and two
                                                                                                            regimens of 58 for emergency contraception: a WHO multicentre
                                                                                                                   randomized trial. Lancet 2002;360:1803-10.
 Recommended within 120 hours
• Option
         Combination OCPs
                                                                                                      • World Health Organization - RCT
           • Taken in 2 doses 12 hours apart
                                                                                                             – Levonorgestrel dose does not need to be
• Option – Progestin only
         Plan B (Levonorgestrel)                                                                               split, but that a single dose of 1.5 mg can be
           • 1 tablet 12 hours apart                                                                           used.
         Plan B One-Step (June 2009)
         Overette                                                                                            – The use of a single dose simplifies the use
           • 20 tablets in two doses 12 hours apart
           • Failure rate - ~2%
                                                                                                               of levonorgestrel for EC without an increase
     – Nausea and Vomiting – more common with combination OCPs                                                 in side effects.
              If vomiting occurs after 60 minutes, additional dosing may not be required
              Prophylactic antiemetic
• Option – Copper IUD
         Failure rate - < 1%
         Cost and concerns regarding infection
    Note: Data does not suggest that use of OCPs can interrupt                             Photo Courtesy of Teva Pharmaceuticals
          an already established pregnancy

ELLA™ (ulipristal acetate)
FDA Approved 13 August 2010                                                                  Emergency Contraception (EC)
                                                                                                  • Prevent fertilization by inhibition of
• Progesterone agonist/antagonist whose likely main effect
  is to inhibit or delay ovulation.
    – Since May 2009, the prescription product has been available in                              • Use after implantation does not interrupt
      Europe under the brand name ellaOne.
• Prescription-only product, single dose taken orally within
                                                                                                    an established pregnancy
                                                                                                                                » Grimes et al. Ann Intern Med 2002:137
  120 hours (five days)
• Side effects most frequently observed with ella in the
  clinical trials include: headache, nausea, abdominal pain,
  pain/discomfort during menstruation (dysmenorrhea),
  fatigue, and dizziness. Profile of side effects similar to
  that of FDA-approved levonorgestrel emergency
   EC Indications                                                                              Providing EC is now the
                                                                                             Medico-Legal Standard of Care
   ACOG - 2005
   • Inadequately protected or unprotected                                          • EC is the accepted standard of care
     intercourse who do not desire pregnancy                                            (ACOG Practice Pattern)
                                                                                       – FDA notice in Federal Register on ECPs (2/97) declared 6
     (SOR A)                                                                             (now 13) brands of regular OCs to be safe and effective
                                                                                         for use for emergency contraception
   • No evidence that EC is unsafe for women
                                                                                       – FDA explicitly approved Plan B as dedicated products, but
     with contraindications to OCPs or for those                                         FDA still recognizes 13 brands of regular combined OCs
     with medical conditions                                                             to be safe and effective for use for emergency
   • Should be offered up to 120 hours after                                        • Consider liability for failure to provide EC
     unprotected intercourse (SOR B)                                      
                                                                                                                                    ACOG 2005
                                                                                                                                    CRLP 1999

                                                                                           Pregnancies in the United States
                                                                                                            (Approximately 6.3 Million Annually)

        Options with an Unintended

                                                                                               % of pregnancies



        •Continue the pregnancy
        •Continue the pregnancy followed by adoption                                                              0%
        •Elective Termination                                                                                           Intended        Unintended
                                  •Medical                                          Source: Henshaw, 1998
                                                                                         (1994 data)

     Outcomes of Unintended Pregnancies
                                        (Approximately 3.0 Million Annually)          Incidence of Elective Termination

                                  60%                                               • In 2000, 1.31 million pregnancies were
                                                                                      terminated by abortion in the United States.
         % of unintended pregs.

                                  50%                        40%
                                  40%                                               • Some 2.1% of all women aged 15–44 had
                                  30%                                                 an abortion in 2000.
                                  20%                                      13%      • Abortion is one of the most common
                                                                                      surgical procedures in the United States.

                                         Abortions        Births     Miscarriages

Source: Henshaw, 1998
    (1994 data)                                                                      Source: Finer and Henshaw, 2003
                          Abortion Rates in Western
                           Industrialized Countries

                                  25               21.3      22.2

                                                                                                                              Reasons for Elective Termination
      Rate per 1,000

                                  20                                             16.5    16.4     15.6

                                  10                                                                           7.6

                                                 United    Australia Sweden Denmark Canada      England Germany Holland
                                                 States                                         & Wales

Source: Henshaw et al., 1999
        (1996 data)

                               Most Important Reason Given for
                              Terminating an Unwanted Pregnancy

  Inadequate finances                                                                                    21%
  Not ready for responsibility                                                                           21%
  Woman’s life would be changed too much                                                                 16%
  Problems with relationship; unmarried                                                                  12%                   Safety of Elective Termination
  Too young; not mature enough                                                                           11%
  Children are grown; woman has all she wants                                                             8%
  Fetus has possible health problem                                                                       3%
  Woman has health problem                                                                                3%
  Pregnancy caused by rape, incest                                                                        1%
  Other                                                                                                   4%

  Average number of reasons given                                                                         3.7

  Source: Torres and Forrest, 1988; (1987 data)

                                                          Deaths per 100,000                                                           Abortion Risks in Perspective
                                                          Abortions or Births
                                                                                                                                                                     Chance of death
                                                                                                                              Risk from terminating pregnancy:       per year:
                                                                                                                                   Before 9 weeks                       1 in 500,000
                                            14                                           12.7
                                                                                                                                   Between 9 and 10 weeks               1 in 300,000
                       Deaths per 100,000

                                            12                                                                                     Between 13 and 15 weeks              1 in 60,000
                                            10                                                                                     After 20 weeks                       1 in 8,000
                                             8                                                                   6.6
                                                                                                                              Risk to persons who participate in:
                                                                                   3.7                                             Motorcycling                         1 in 1,000
                                                                           1.8                                                     Automobile driving                   1 in 5,900
                                             2       0.2     0.3    0.6                                  0.6                       Power- boating                       1 in 5,900
                                             0                                                                                     Playing football                     1 in 25,000
                                                   <9              11-12         16-20                         Births
                                                                                                                              Risk to women aged 15–44 from:
                                                          Abortions by gestation
                                                                                                                                   Having sexual intercourse (PID)      1 in 50,000
                                                                                                                                   Using tampons                        1 in 350,000
    Source: Gold 1990
    (1981–1985 data)                                                                                                          Source: Gold, 1990; Trussell, 1998
                                                                                                          Method           Advantages                                   Disadvantages
                                                                                                          Medication       •Used early during pregnancy                 •Often requires at least two clinic visits
                                                                                                                           •Resembles a natural miscarriage             •Takes days, sometimes weeks to
            Who Has Abortions, Why and                                                                                     •Often considered more private
                                                                                                                           •Usually avoids aspiration
                                                                                                                                                                        •Efficacy decreases at later

               When in Pregnancy:                                                                                          intervention (2-5% will need one)
                                                                                                                           •Anesthesia not required
                                                                                                                                                                        gestational ages
                                                                                                                                                                        •Women may see blood clots and the
                                                                                                                           •High success rates (for combined            products of conception
                                                                                                                           regimens)                                    •Mifepristone and/or methotrexate

 • Women having abortions are                                                                                                                                           may not be available
                                                                                                                                                                        •Mifepristone can be expensive
   predominantly young, single, from minority                                                             Aspiration       •High success rate (>99%)
                                                                                                                           •May require only one clinic visit
                                                                                                                                                                        •Involves an invasive procedure
                                                                                                                                                                        •May not be available very early in
   groups and low-income.                                                                                                  •Procedure completed within                  pregnancy
                                                                                                                           minutes                                      •Often considered to be “less private”
 • Most women have multiple reasons for                                                                                    •Sedation is available                       •Quality of facilities may vary
   choosing to have an abortion.                                                                        Surgical (Aspiration)
 • Almost 90% of abortions occur in the first                                                           Medication
   trimester.                                                                                           FIRST TRIMESTER TERMINATION (<13 WEEKS)

     Safety of Surgical (Aspiration)                                                                                          Medication Abortion
                                                                                                            Alternative to first-trimester (<13 weeks) aspiration
                                                                                                                                Comparing Medication Abortion Regimens
 •   Abortion is one of the safest surgical                                                            Regimen         Advantages                            Disadvantages                       FDA Approved

     procedures for women in the United                                                                Mifepristone/   •High efficacy (~95%)                 •Mifepristone is often expensive;
                                                                                                                                                                                                 YES (9/2000)
     States.                                                                                           misoprostil     •Can be used through 63 days’
                                                                                                                                                             not available in many countries
                                                                                                                                                             •Cannot be used to treat ectopic
                                                                                                                       •Abortion typically occurs within     pregnancies
 •   Laws criminalizing abortion make                                                                                  hours of misoprostil administration
                                                                                                       Methotrexate/   •High efficacy (90-95%)               Abortion can occur over 4 week      NO; there is an
     abortions unsafe but do not eliminate                                                             misoprostil     •Can be used through 56 days’
                                                                                                                                                             May cause fetal anomalies in
                                                                                                                                                                                                 protocol physicians
     them. In developing countries, where                                                                              •Generally less expensive than
                                                                                                                                                             continued pregnancies
                                                                                                                                                             Efficacy decreases after 49 day’s
                                                                                                                                                                                                 are legally permitted
                                                                                                                                                                                                 to use

     abortion is often illegal or highly restricted,                                                                   •Treats ectopic pregnancies           gestation

     abortion mortality rates are hundreds of                                                          Misoprostil-
                                                                                                                       •Can be used through 63 days’
                                                                                                                                                             •Efficacy is variable (65-90%)
                                                                                                                                                             •Regimen is currently under

                                                                                                                       •Widely available worldwide           investigation
     times higher than rates in developed                                                                              •Often VERY inexpensive               •Cannot be used to treat ectopic
                                                                                                                       •Stable at room temperature           pregnancies

Commonly used mifepristone/misoprostil
            regimens                                                                                            The Provision of and Access to
                                                                                                                      Abortion Services:
                                 US FDA Regimen                   Evidence-Based Regimen*
Mifepristone Dosage              600 mg (Day 1)                   200 mg (Day 1)

Misoprostil Dosage               400μg, PO                        400ug, PO or 800μg, PV                  •   Most abortions occur in abortion clinics.
Gestational Limit                <49 days                         <49 days for PO misoprostil
                                                                                                          •   A steady decline in providers in the last two
                                                                  <63 days for PV misoprostil                 decades has left the majority of counties in
Location of                      At medical office/clinic         At medical office/clinic or at              the United States with no provider.
misoprostil                                                       home
administration                                                                                            •   Many of the difficulties in providing and
Timing of misoprostil
                                 Day 3                            Day 2, 3, or 4
                                                                                                              obtaining access to abortion would
Timing if initial follow-        Day 14                           Day 4 to 14                                 disappear if the procedure were integrated
up examination                                                                                                with other health care services.
Number of clinic visits Three or more                             Two or more
* Number of studies have shown that alternatives to the FDA approved protocol are safe and effective
     Counseling and Informed
                                                                Adolescents and ECPs
• Provide information and support that women            • Adolescents’ right to confidentiality with
  need to complete all aspects of the procedure           regard to reproductive health care is
  – Pregnancy termination alternatives                    protected by law in some states. Some
  – What the woman should expect during aspiration or     states have laws requiring parenteral
    medication termination
                                                          involvement in a minor’s abortion decision.
  – Review possible side effects and complications
                                                          ECPs are not abortificients and these laws
  – Identify reasons for which the woman should seek
    additional assistance or follow-up                    do not apply to ECPs
• Provide accurate information in an unbiased and       •
  non-judgmental manner

                                                        •   All methods can fail
                                                        •   Two methods are better than one
               Summary                                  •   Methods used wrong fail more
                                                        •   Always need a backup plan
                                                        •   No plan offers an 85% chance of getting
                                         (Control of Fertility/Infertility)

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Schwartz SM, Petitti DB, Soscovick DS, Longstreth WT Jr, Sidney S, Raghunathan TE, et al. Stroke and use of low-
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Web Sites:
Planned parenthood:
The Alan Guttmacher Institute: http://
The JAMA Contraception Information Center:

Weismiller, MD, ScM and Fraboni, MD – AAFP Assembly 2010

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