Contraceptive Methods _ Emergency Contraception – Emergency

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					      Contraceptive Methods &
      Emergency Contraception –
      Hormonal Methods

Karen Gunning, Pharm.D BCPS
Spring 2008
University of Utah College of Pharmacy
         y              g            y
Acknowledgement: slides adapted from the AACP
Women’s Health Curriculum – Laura Hanson, Pharm.D.
  d Shareen El Ibi
and Sh                 Pharm.D.
            El-Ibiary, Ph    D
Objectives:
Obj ti
                                   contraception
Describe the different methods of contraception,
and be able to discuss the advantages and
disadvantages of each with a patient.
Understand the mechanism of action of each of the
contraceptive methods.
Specify what adverse effects are specifically
S     if h t d           ff t           ifi ll
associated with estrogens and progestins
List the relative and absolute contraindications to
oral contraceptive therapy.
                                y      p
Understand what situations may compromise oral
contraceptive efficacy and develop a management
plan for such situations.
Objectives:
Obj ti
Given             patient,
Gi en a specific patient be able to select an oral
contraceptive to initiate therapy.
Given a patient with a specific adverse
reaction/complaint with oral contraceptives, be able
to develop a plan for further oral contraceptive use.
Be able to counsel a patient regarding each
contraceptive method, including how to use, what
         p              ,       g             ,
to expect, efficacy with perfect and with usual use,
and be able to select, with the patient, the most
appropriate method.
             yp
Perfect and Typical Use
Hormonal Methods
Oral C t     ti
O l Contraceptives
18 million users in U.S.
 • 4 million new users each year
 • 80% of all women will use OCs
Average length of use = 4.8 months
A          l   th f      48      th
40 - 60 % of new users d/c in the 1st year
 • 69% who d/c choose less effective method
         don t
 • 19% don’t choose a method!
Consequences
 1 million unintended pregnancies/year in OC users
  • 61% due to discontinuation
  • 24% due to poor compliance
  • 15% in patients who say they are “compliant”
 Reasons for poor compliance/discontinuation:
  • Bleeding/spotting
  • Inconsistent use due to failure to take at same time
    each day, missed days and lack of understanding of
    how to take if pills are missed
Compliance/Adherence
C   li    /Adh
OC compliance related to:
 • Education, motivation, side effects, quality of
       l ti   hi   ith health          id
     relationship with h lth care providers
Highest rates of OC discontinuation occur at 2
months
Counseling is the largest single area for
p             p
potential improvement in p               p
                             patient compliance with
OC’s
More than 50% of OC users miss three or more
  ill
pills PER MONTH!
Improving OC C
I     i          li
             Compliance
Provider                  Patient
  Clear instructions        Establish pill taking
  Explain side effects      routine
                            Read information
  Help patient identify
  backup                    Know what to do if dose
                            missed
  Provide written info
                                   p      y
                            Backup always available
  A il bl f f t
  Available for future        “Dual Contraception”
  questions
             p
Oral contraceptives
          g
 Advantages
 – No impact on future fertility, decreased
   cramps/blood loss, decreased incidence of
   ovarian and endometrial cancer, ovarian
   cysts, ectopic pregnancy, and benign
   b     t disease. I
   breast di                      t in
                    Improvement i acne and  d
   hirsutism. Can be used as ER
   contraception
 Disadvantages
               compliant,
 – Have to be compliant no STD protection
                p
   Oral Contraceptives:
   Mechanism of Action
    95% f the time – mechanism is suppression of ovulation
90 –95% of th ti        h i    i          i    f    l ti

   Progestin:                        Estrogen:
     Inhibits ovulation by             Prevent the development of
     inhibiting LH                     the dominant follicle by
                                       decreasing FSH secretion
     Thickens cervical mucous
                                       Inhibition of ovulation by
     Impair uterine/tubal motility
                                       inhibition of GNRH release
     Inhospitable endometrium          from hypothalamus        no
     for implantation                  FSH/LH surge
                                       Stabilizes endometrial
                                       lining
Oral Contraceptive Types
O lC t        ti T
 Monophasic
 Biphasic
 Triphasic
 Progestin Only (mini-pill)
 Stepped estrogen
 Shortened placebo period
 Extended regimen
 E     d d    i
Estrogen Components
E t      C       t
 Ethinyl estradiol (EE)    20 mcg, 30 mcg,
 35 mcg, 50 mcg
 Mestranol     only in Ortho Novum 1/50
 (50 mcg)
   Mestranol is metabolized to EE
   50 mcg mestranol = 35 mcg EE
   Enovid® (the first OC) contained 150 mcg
   mestranol
   g
Progestins:
Multiple pharmacologic effects
 Compared by
   Progestin activity
     Goal = high progestational efficacy
   Estrogen activity
     Progestins are metabolized to some degree to estrogens
     Goal = balance between estrogenic adverse effects and endometrial
     stability
   Androgen Activity
          p g                     y
     Most progestins are chemically related to 19-nor-testosterone
     Goal = low to avoid androgenic adverse effects
   Endometrial activity:
           y prevent breakthrough bleeding/spotting
     Ability to p              g          g p     g
     Depends on the estrogen/progestin ratio
 Cannot compare progestins mg to mg
Progestin C
P                t
      ti Components
                        generation
  Loosely organized by ‘generation’
  First generation:
     Norethindrone – the first modern progestin
       Relative progestational activity: 1.0
       Estrogenic activity: 1.0
             g            y
       Androgenic activity : 1.0
    Brevicon, Modicon (0.5/35)
    Ovcon(0.4/35, 1/50)
    Norinyl, Ortho-Novum 1/35
    N i l O th N
    Ortho-Novum 10/11 (0.5-1.0/35)
    Ortho Novum          (0.5 0.75 1.0/35)
    Ortho-Novum 7/7/7 (0.5-0.75-1.0/35)
    Tri-Norinyl (0.5-1.0-0.5/35)
    Nor QD (0.35)
Progestin Components:
Second Generation
 Norethindrone acetate             Ethynodiol diacetate
   Progestational Activity:          Progestational Activity:
   1.2                               1.4
   Estrogenic Activity: 1.5          Estrogenic Activity: 3.4
   Androgenic Activity: 1.6          Androgenic Activity: 0.6
      Loestrin 1/20                        Demulen 1/35
      Loestrin 1.5/30                      Demulen 1/50
      Estrostep (1/20 - 30 - 35)
Progestin Components:
Third Generation
Norgestrel                   Levonorgestrel
  Progestational Activity:    Progestational Activity:
  2.6                         5.3
  Estrogenic Activity: 0      Estrogenic Activity: 0
  Androgenic Activity: 4.2
                              Androgenic Activity: 8.3
     Lo Ovral (0.3/30)
     Lo-Ovral (0 3/30)
     Ovral (0.5/50)             Alesse (0.1/20)
     Ovrette (0.075)            Nordette, Seasonalle,
                                Levlen (0.15/30)
                                       (        )
                                Triphasil (0.05/30 -
                                0.075/40 - 0.125/30)
Progestin Components:
Fourth Generation
 Desogestrel
                             Norgestimate
   Progestational
   Activity: 9.0
          y                   Progestational Activity:
                              1.3
   Estrogenic Activity: 0
                              Estrogenic Activity: 0
   Androgenic Activity:
   3.4                        Androgenic Activity:
      Desogen (0.15/30)       1.9
      Ortho Cept
      Ortho-Cept (0.15/30)      Ortho-Cyclen (0.15/30)
      Mircette (0.15/20)        Ortho Tri-Cyclen
                                (0.18/35 - 0.25/35)
      Cyclessa (0.100 -
      0 125 - 0 150 / 25)
      0.125 0.150
Pharmacologic Effects of
Progestins Used in OC’s (approximate!)
                Progestin   Estrogen   Androgen
Desogestrel     ++++        0          +++
Levonorg.       ++++        0          ++++
Norgestrel      +++         0          +++
Ethynodiol      ++          +++        +
diacetate
Norgestimate    ++          0          ++
Norethindrone   ++          ++         ++
Acetate
Norethindrone   ++          ++         ++
Progestin Components:
“Other”
Drospirenone – a novel progestin
  Analog of spironolactone (a potassium sparing diuretic)
     Can increase serum potassium
     Monitor baseline and in 3 months
     Avoid other drugs that can increase potassium (ACEI inhibitors,
     spironolactone, angiotensin receptor blockers)
     Avoid in patients that may be at risk for hyperkalemia (renal
     dysfunction, adrenal dysfunction, hepatic dysfunction)
  Progestational activity: 1.5
  Androgenic activity: 0 (anti-androgenic?)
  Estrogenic activity: 0
  Yasmin™ (3.0/30)
  Yaz ™ (3.0/20)
Contraindications for
Combined Contraceptives
 World Health Organization (WHO) medical
 eligibility criteria
    p                    g
 Separated into four categories
1.   A condition for which there is no restriction for
     the use of the contraceptive method.
2.
2    A condition where the advantages of using the
     method generally outweigh the theoretical or
     proven risks.
3.         diti      h    th th     ti l            i k
     A condition where the theoretical or proven risks
     usually outweigh the advantages of using the
     method.
4.   A condition which represents an unacceptable
     health risk if the contraceptive method is used.
  Contraindications for Combined
  Contraceptives (Category 4)
                 6
Breastfeeding <6 wks                     Major surgery with prolonged
postpartum                               mobilization
Smoker ≥ 35 yrs                          Known thrombogenic
Multiple i k factors f CVD
M lti l risk f t     for                 mutations
BP >160/100                              Current and history of
Vascular disease                         ischemic heart disease
Current or history of                    Stroke (history of CVA)
DVT/PE
                                              p
                                         Complicated valvular heart
Complicated diabetes
                                         disease
Presence of liver tumors,
severe cirrhosis, or active              Migraine headache with
viral hepatitis                          aura
                                         Current breast cancer
http://www.who.int/reproductive-health/publications/MEC_3/summary_tables.html
        Serious Adverse Effects:
        ACHES
•   Abdominal pain
    •    Blood clot in liver or pelvis    •   Eye problems
    •    Gallbladder or benign liver
         tumor
                                              •   Stroke
•   Chest pain                                •   Vision changes
    •    Pulmonary embolism                   •   Blood clots in eyes
    •     yoca d a     a ct o and/or
         Myocardial infarction a d/o          •   Migraine with focal
         angina
                                                  neurologic symptoms
•   Headaches
    •    Stroke
                                          •   Severe leg pain
    •    High blood pressure                  •   Blood clot
    •    Migraine with focal neurologic
         symptoms
                 Case 1

     A 25 year-old female calls your
                            nausea.
pharmacy complaining of nausea Upon
review of her patient profile, you find that
 she started Demulen 1/35 (35 mcg EE   EE,
 1.0 mg ethynodiol diacetate) taking two
                       ago.
               weeks ago
      How would you handle this?
 Estrogenic Adverse Effects

Excess                   Deficiency
 Nausea                   Early or mid cycle
 Breast tenderness
                          bleeding/spotting
 Thromboembolic events
 Bloating                 Decreased flow
 Cervical mucorrhea       Dry vaginal mucosa
 M l
 Melasma
                          Amenorrhea
 Hypertension
 Headache
 H d h
Progestogenic Adverse Effects

“Excess”               “Deficiency”
  Increased appetite     Heavy flow
  Tiredness              Late breakthrough
  H
  Hypomenorrheah         bleeding (days 10 –
  Acne, oily scalp,      21)
  hirsutism
                 g
  Decreased length
  flow
Adverse effects of oral contraceptives:
Breakthrough bleeding, spotting and bleeding
  Breakthrough bleeding:
    Intermenstrual bleeding that requires a pad or
    tampon
  Spotting:
    Intermenstrual bleeding that does not require
    a pad or tampon
  These are th most common reasons for
  Th        the     t              f
  OC discontinuation
Breakthrough Bleeding:
Causes
 Variation in pt specific metabolism
 Missed pills
 Cigarette smoking
 Chlamydia infection
 Use of other meds or herbal products that alter
 estrogen/progestin levels
 Key: At the end of three cycles – rates of BTB
 are similar for nearly all OC preparations
Management of Side Effects:
Breakthrough Bleeding and Spotting
  If unexpected bleeding occurs, use additional
  contraception until bleeding completely ceases
           p                 (i.e.,
  Rule out potential causes ( , PID)  )
  Encourage continuation if first few cycles
  When switch is indicated:
    Increase estrogen dose:
                 g g           g            y
       If bleeding begins during first 14 days
       If absence of withdrawal menses
       If menses continues into active pill cycle
Management of Side Effects:
Breakthrough Bleeding and Spotting
  When switch is indicated:
   Change progestin:
       If bleeding begins after 14 days (of active med)
       Bleeding that occurs anytime in cycle
       Progestin should have higher progestational
        desogestrel) and/or androgenic activity
       (d          t l)
       (levonorgestrel)
    Increase both estrogen and progestin:
       If bleeding occurs midcycle
Oral Contraceptive Issues
O lC t        ti I
Weight gain
• Patient perception vs. objective documentation
• Cyclic weight gain can occur with fluid retention
Headaches
  Contraindicated ith i i
• C t i di t d with migraine with f        l
                                   ith focal
  neurologic symptoms
Oral C t     ti I
O l Contraceptive Issues
 Breast tenderness
    Typically relieved by decrease in estrogen
    (progestin?)
    (       ti ?)
 Nausea/Vomiting
          qhs,     pregnancy
    Dose qhs r/o pregnancy, change to 20 mcg EE pill
 Depression
                              p
    Not a contraindication to pill use
    Vitamin B6??
 Oral Contraceptive Risks
Breast Cancer (managing contraception pg 95)
  Largest study to date found no increased risk in current
  users, and a slight DECREASE (NS)in risk in those who had
  previously sed OC’s
  pre io sl used OC’s. Wingo et al Obstet Gynecol 2007;110:793-800.

Venous Thromboembolism (VTE)
  Deep venous thrombosis and/or pulmonary embolism
  Risk highest in the first year
    With no OC    4-8/100,000/year
                  4 8/100 000/
    Current use OC    10-30/100,000/year
    Pregnancy    60/100,000/year
  Progestin (?Desogestrel ?) - labeling
Oral C t     ti Ri k
O l Contraceptive Risks
 MI/Stroke
   No increase in healthy non-smokers < 35 years old
        OC s                      EE.
   with OC’s containing < 35 mcg EE
   Non smokers > 35 – MI: 88/million women/year
                                          y
   Smokers > 35 – MI: 396/million women/year
   The more cigarettes smoked, the higher the risk of MI
   OC use + uncontrolled hypertension or dyslipidemia
   or longstanding diabetes = increased risk of MI
   OC use + migraine with neurologic symptoms =
   increased risk of stroke
Oral C t     ti Ri k
O l Contraceptive Risks
 Other risks:
   Liver tumors
   Symptomatic gall bladder disease
   Dry eyes in those who wear contacts
   Chloasma
Non-Contraceptive Benefits
N C t        ti B     fit
Ovarian
O arian Cancer
  50% risk reduction with 5 years use of OC
         d ti      ith           f
  80% reduction with 10 years of use
  Extends for up to 30 years after d/c
Endometrial Cancer
  20% reduction with 1 year, 60% with 4 years
  Extends for up to 30 years after d/c
Non-Contraceptive Benefits
N C t        ti B     fit
Reduction in          pregnancy, anemia, acne,
Red ction in: ectopic pregnanc anemia acne
menstrual abnormalities
25% decrease in benign breast disease
Decreased colon cancer
Increased bone density (??)
I       db       d   it
   Greatest increase in BMD seen with >10 yrs use
Acne Benefits:
Effects of All OC’s on Androgenicity

    LH levels
   Ovarian testosterone production

   SHBG levels

    Free testosterone levels
Co b ed Co t acept es
Combined Contraceptives:
Drug Interactions
 Similar drug interactions reported for all
 dosage forms of combined contraceptives
 The l      th d       f t                  ti in
 Th lower the dose of estrogen or progestin i
 a contraceptive, the greater the risk that
 another medication could decrease its
 effectiveness
 My conservative thought:
 Back-up contraception should be used if a drug
 interaction that would decrease efficacy is
 possible
Drug interactionsDrugs which affect liver enzymes a) Rifampicin3Clarification: Although the
interaction of rifampicin or certain anticonvulsants with COCs is not harmful to women, it is likely to
reduce the effectiveness of COCs. Use of other contraceptives should be encouraged for women who
are long-term users of any of these drugs. Whether increasing the hormone dose of COCs is of benefit
          unclear
remains unclear. Evidence: Use of rifampicin and certain anticonvulsants decreased the contraceptive
effectiveness of COCs.212-237b) Certain anticonvulsants (phenytoin, carbamazepine, barbiturates,
primidone, topiramate, oxcarbazepine)3Antibiotics (excluding rifampicin) a) Griseofulvin2 b) Other
antibiotics3Evidence: The contraceptive effectiveness of COCs was not affected by coadministration
of most broad-spectrum antibiotics.238-290Antiretroviral therapy2Clarification: It is important to
note that antiretroviral drugs (ARV) have the potential to either decrease or increase the bioavailability
of steroid hormones in hormonal contraceptives. The limited data available (outlined in Annex 1)
suggest that potential drug interactions between many ARVs (particularly some non-nucleoside
reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs)) and hormonal contraceptives
                                                                                  ARVs.
may alter safety and effectiveness of both the hormonal contraceptives and the ARVs It is not known
whether the contraceptive effectiveness of progestogen-only injectable contraceptives (such as depot
medroxyprogesterone acetate and norethisterone enantate) would be compromised, as these methods
provide higher blood hormone levels than other progestogen-only hormonal contraceptives, as well as
than combined oral contraceptives. Studies are underway to evaluate potential interactions between
depot medroxyprogesterone acetate and selected PI and NNRTI drugs. Thus, if a woman on ARV
d     t    d            t          t t     d l t d         d        d     Th
treatment decides to initiate or continue hormonal contraceptive use, the consistent use of condoms is
recommended for preventing HIV transmission and may also compensate for any possible reduction in
the effectiveness of the hormonal contraceptive.
Co b ed Co t acept es
Combined Contraceptives:
Drug Interactions
 Hepatic enzyme inducers
   Agents most likely to cause breakdown of estrogen or
              phenobarbital phenytoin, topirimate,
   progestin: phenobarbital, phenytoin topirimate
   carbamazepine, oxcarbazepine, primidone
   Sodium valproate, ethosuximide, lamotrigine and
   vigabatrin do not effect contraceptive hormone levels
   Management
      Use      th
      U another method  th d
      Use different anticonvulsant
      Increase dose of contraceptive (not recommended)
                    p
  Combined Contraceptives:
  Drug Interactions
  Antibiotics
Recommendations by Council of Scientific Affairs to
  AMA
  Rifampin - significant risk of failure; counsel about the use
  of additional nonhormonal contraceptive methods during
  the course of rifampin therapy
  Other antibiotics - small risk of interactions; not possible
  to identify women who may be at risk of OC failure.
  Counsel about the additional use of nonhormonal
  contraception or alternate methods for:
       ‣ Those not comfortable with small risk of interaction
       ‣ Those with previous failures or who develop
       breakthrough bleeding during use of antibiotics
                                  Obstet Gynecol 2001;98:53-60
Combined Contraceptives:
Drug Interactions
 Protease inhibitors
   Can cause changes in mean AUC of estrogen
   Consider different contraceptive options
 St. John’s Wort
   Induces cytochrome P450 and could decrease
   effectiveness of oral contraceptives
 Increased ethinyl estradiol levels
   Reported with atorvastatin, ascorbic acid,
   acetaminophen, ketoconazole and itraconazole
Choice of OC’s...
 Ask three questions
 1. Should combined pills be avoided?
    Progestin only appropriate?
 2. Select based on cost, prior experience,
    and estrogen/progestin dose
 3.                            effects,
 3 If patient experiences side effects are
    they estrogen or progestin related?
    Adjust accordingly.
   Initial      Ch i
   I iti l Pill Choices
Initial ill h ld h                     d low androgen activity
I iti l pill should have < 35 mcg EE and l     d        ti it

      Demulen 1/35                Ortho-Cyclen
      Desogen                     Modicon
      Orthocept                   Loestrin
      Ovcon 35
Oral: Choosing a Pill
          Is she a candidate for a pill with estrogen?

              NO                            YES

Consider progestin-only               Choose combined pill
   or barrier methods:                       based on:
   Progestin-only pills                 Pt desires, benefits
      Depo-Provera                    # mcg EE, side effects
   Intrauterine device                   Availability, price
Condoms, Spermicides                    Prior pt experience
Diaphragm, Cervical cap
Oral: Starting Pills
O l St ti Pill
 Choose backup method
                g      pp p
 Start according to appropriate schedule
 (next slide)
          p      y
 Take 1 pill daily at the same time
   If taking 28 days, begin new pack immediately
   (last 7 days are inactive)
   If taking 21 days, stop taking pills for 1 week
   and then start new pack
Oral: Administration
When to start                        Back up contraception
First day of menses                  None needed
(preferred)
          y        g    y
Immediately, if pregnancy                        y
                                     Backup x 7days
excluded
First Sunday after next              Backup x 7days (if more
menses begins                        than 5 days since
                                     menstrual bleeding started)
Within 5 days after start of         None needed
menstrual bleeding

*Backup contraception for the first cycle is useful with all contraceptives
and is necessary for progestin-only oral contraceptives
Oral Contraceptives: Administration
Switching from
S it hi f             Start     i    di t l       th d has
                      St t COC immediately if method h
another hormonal      been used correctly. No backup needed.
method*
Switching from a      Start COC within 5 days of menstrual
non-hormonal          bleeding - no backup needed. Also can
method                start any time if not pregnant – backup x 7
                              y             p g             p
                      days
Switching from IUD    Start COC within 5 days of menstrual
                      bl di - no b k needed. Al can
                      bleeding      backup       d d Also
                      start any time if not pregnant – backup x 7
                      days
After emergency       Day after ECP – backup x 7 days. Sunday
contraception pills   start and first day start also possible.
(
(ECP) )
*If hormonal method was injection, start COCs when
repeat injection would have been given
Oral: Missed Doses
 Missed one pill
   Take missed pill ASAP. Take next pill as usual. No
   back       d d May ff ECPs.
   b k up needed. M offer ECP
 Missed two pills
   Take one of forgotten pills every 12 hours until
   caught up, then continue pack. Backup x 7 days.
   May offer ECPs.
 Missed more th t
 Mi   d                ill
             than two pills
   Offer ECPs. If taken, start OCPs next day and use
          p
   backup x 7days. y
   If ECPs not taken, skip missed pills and complete
   rest of pills in pack, but use barrier method until next
   menses.                          protection,
   menses Pills may not provide protection but will
   help control cycle.
       Hatcher RA, et al. A Pocket Guide to Managing Contraception. 2004.
                       g
Oral: Patient Counseling
 Counsel on 3 major areas
   What the contraceptive is for
   and how it works
   How to use the contraceptive
   What to expect

 ‘ACHES’
 Use of open ended questions
Oral Contraceptives:
Counseling New Starts
 Take at same time every day
         p
 No STD protection
 When to start
 Explain placebo presence (or absence!)
 Adverse effects
   Decrease over first three cycles
   ACHES
   Drug interactions
 Demonstrate how to use pillpack
Counseling:
Continuing Users
 Ask about OC use at each visit
 Compliance? (how often are doses
 missed?)
 What does she do if she misses a dose?
 Review ACHES
Pop Quiz!
  What lab value may need to be
  monitored for patients taking Yaz?
  Generic versus brand name oral
  G      i          b d            l
  contraceptives: is brand better?
  Is there something available for women
  that have difficulty swallowing pills?
  Are pills used in an extended manner
       ( ,
  safe (i.e., 3-4 consecutive months)? )
Choices for
Specific Patient Issues
  Headaches, nausea, breast tenderness
    Low dose estrogen, or stepped estrogen
  Androgenic Effects
    Decrease androgenic dose or increase
    estrogenic dose. Ethynodiol diacetate or
    norethindrone (not acetate)
Choices for
Specific Patient Issues

    p                 g
  Depression/Mood changes
   Decrease estrogen/progestin dose or both,
   Increase B6 intake ?

  Heavy Menses
   Increase progestin potency, decrease
   estrogen
“Newer” O l Contraceptives
“N    ” Oral C t     ti
Alesse/Levlite (20 mcg EE + 0.1mg levonorgestrel)
  Compliance important due to low progestin/estrogen doses
Estrostep (1mg norethindrone acetate + stepped
            20,30,35
estrogen - 20 30 35 mcg EE)
   “estrophasic” - ?
          (       g         g           g       y
Mircette (desogestrel 150 mcg, EE 20 mcg x 21 days, 2
days placebo, 5 days EE 10 mcg)
  Shortened hormonal free interval - ?
Yasmin (drospirinone 3 mg, EE 30 mcg)
Cyclessa (25 mcg EE + triphasic desogestrel)
Ortho Tri-Cyclen Lo (25 mcg EE + triphasic
      ti t )
norgestimate)
  Lowest EE doses for triphasic OC
Newest OC’
N    t OC’s
 Seasonale – Levonorgestrel 0.15/EE 30
 mcg – 84/7
 SEASONIQUE: levonorgestrel/EE 0.15 mg/0.03
mg & EE 0.01 mg – 84/7/0 – no placebo
Loestrin® 24 Fe: 1 mg norethindrone/20 mcg EE
75 mg ferrous fumarate (24 day active/4 FE)
    (drospirinone 3 mg, EE 20 mcg – 24/4)
Yaz (                                   / )
Lybrel (levonorgestrel 90 mcg/ EE 20 mcg) – 365
days/no placebo (28 day pack)
Progestin - O l Pills
P     ti    Only Pill
  Nor-QD
    Norethindrone
  Micronor
    Norethindrone
  Ovrette
    Norgestrel
  Important counseling point -- no placebo week!
         y                              yp
  Efficacy decreased vs. COCs with typical use
  Main effect is on cervical mucous changes ->
  less consistent ovulation inhibition than COCs
  Must be taken at same time each day
POPs: Initiation
 New start: may initiate anytime in cycle
 (p                             y          )
 (preferred is start on first day of menses).
 Use backup for at least 7 days.
 Post-partum: Immediately
 Post partum:
 (recommended to wait 6 weeks post
 delivery)
 Switching from other method:
 Immediately.
 Immediately Use of backup depends on
 previous method used.
Missed doses for progestin only
pills (POPs!)
 If more than 3 hours late taking a pill OR
 If misses 1 or more tablets

T k missed pill, th resume t ki pills at
Take i    d ill then       taking ill t
            regular time AND
   Use backup method x next 48 hours
Contraceptive Patch:
Evra™ (norelgestromin + ethinyl estradiol)
                         7 day patch x 3 weeks,
                         then no patch for 1 week
                         (not menses dependent)
                         Worn on lower abdomen or
                         buttocks
                         Provides 150 mcg
                         norelgestromin + 20 mcg
                         ethinyl estradiol daily
                         Norelgestromin is the
                         active metabolite of
                           o gest ate
                         norgestimate
        Contraceptive Patch:
          Appropriate Use
    Four-week cycle
    New patch applied each week for 3
    weeks, then 1 week patch-free
    Start new patch same day each week
                 CALENDAR

+
+
+
+
+
X
                            Ortho Evra Package Insert, 2003
Contraceptive Patch:
Evra™ (norelgestromin 150 mcg + ethinyl estradiol 20 mcg
       Clinical trial vs. Triphasil™
          Efficacy similar
          Compliance better with patch (88% vs. 79%)
          Higher rates of breakthrough
          bleeding/spotting in cycles 1 & 2 with patch,
          but similar after
          Breast discomfort, and dysmenorrhea more
          common in patch users in cycles 1 & 2

                       Audet et al JAMA 2001;285:2347-2354
        p
Contraceptive Patch: Initiation
 First day of menstrual bleeding (no
 backup      ithi   h       f t t f    l )
 b k if within 24 hours of start of cycle)
 Sunday start (backup x 7days)
 Anytime if not pregnant (backup x 7days)
 Switch from oral contraceptive
   Begin on 1st day of withdrawal bleeding or if
   later, then backup for 7 days
 Switch from depot medroxyprogesterone
   Start when next injection is due

                                      Ortho Evra PI, 2003
Contraceptive Patch:
Patient Instructions
Apply to clean, dry, intact healthy skin
  Buttock
  Abdomen
  Upper outer arm
   pp         (        g        )
  Upper torso (excluding breasts)
May shower, swim, workout, etc. with patch




                                    www.orthoevra.com
            p
    Contraceptive Patch:
    What To Do If Missed
  WEEK 1            WEEK 2 or WEEK 3                  WEEK 4


                    < 48 hrs        ≥ 48 hrs
• Apply as soon                                     •Remove when
as remembered                                       remembered
                  •Remove        •Remove
•Must use back-                                     •No back-up
up for 7 days     •Apply new     •Apply new         necessary
                  patch          patch; new cycle
•New “Day 1”                                        •Start next
and “Patch        •No back-up    •Must use back-    cycle on usual
Change Day”       necessary      up for 7 days      patch day
                  •Same “Patch   •New “Patch
                  Change Day”    Change Day”
                                                    Ortho Evra PI, 2003
         p
Contraceptive Patch:
Precautions

Women weighing more than 198 lbs (90 kg)
should be told that the patch may be less
                     p
effective and backup methods should be
considered. Some clinicians recommend using
a different method if a women is >198 lbs.
The Patch
Th P t h & VTE
 FDA revised labeling 11/05
  added a bolded warning that the
  patch exposes women to higher
  total amounts of estrogen than a
  typical oc containing 35 mcg EE
    60% higher AUC, lower peak
The Patch
Th P t h & VTE
         g
Revised again in 2006
  Alert to healthcare providers and
  patients of the results of two
  epidemiology studies and recommend
  that women with risk factors for venous
  thromboembolism di
  th     b     b li            the     f the
                     discuss th use of th
  patch with their healthcare provider
  since it may be associated with an
  increased risk of VTE in some women.
  2 studies – one did not show difference
  between patch/35 EE/norgestimate pill,
  one did show a difference
The Patch
Th P t h & VTE

 Revised again 1/18/08
  3rd study of vte/patch use – showed a 2x
  increased risk of VTE in patch users vs 30
  mcg EE/levonorgestrel
      g            g
                     p
Transdermal Contraceptive Patch:
Risk for Venous Thromboembolic Events*


           Relevant Studies                               Odds Ratio
                                                    (95% Confidence Interval)
     Jick SS, et al.,
                                                       0.9 (0.5–1.6)
     2006
     Cole JA, et al.,
                                                       2.4 (1.1–5.5)
     2007
 *Women should be counseled that all combined contraceptive
    products increase the risk of venous thromboembolic events;
         f h        d      h ld be discontinued if a patient
    use of these products should b di       i  d        i
    becomes immobilized.
Jick SS, et al. Contraception. 2006;73:223-228;
Cole JA, et al. Obstet Gynecol. 2007;109:339-346.
Contraceptive Patch:
Patient Counseling
  Similar to oral (expectations, ACHES)
  If patch-free interval >9 days, apply a new
      t h d        backup
  patch and use b k x 7 d     days
  No band-aids, tatoos or decals on top of patch
  S      th d
  Smooth edges d           ft     li ti
                   down after application
  Replacement patches available
  Time of day patch is changed does not matter
  Disposal: fold over patch, place in solid waste
  Cost is slightly higher than oral contraceptives
            p
Counterfeit patches
 February 4, 2004
         d Johnson & J h
 FDA and J h                           bli
                      Johnson warn public
 about counterfeit contraceptive patches
 b i sold on overseas i t
 being ld                       t   b it
                         internet websites
 http://www.fda.gov/bbs/topics/news/photo
 s/contraceptive/counterfeit.html




       Authentic       Counterfeit
Contraceptive Patch
C t      ti P t h
ADVANTAGES             DISADVANTAGES
• Efficacy             • Site reactions
• Compliance           • Patch detachment
• Adhesive             • Breast discomfort
  reliability          • Dysmenorrhea
•U            ll d
  User controlled      • Headache
• Readily reversible   • Nausea
Vaginal Ring




               www.nuvaring.com
Vaginal Ring: Appropriate Use
    Four-week cycle
    Ring inserted and kept in place for 3 wks
    The fourth week is a “ring-free” week
    New ring inserted one week after last ring
    removed
                  CALENDAR
+



X
      g        g
    Vaginal Ring: Initiation
•   No preceding hormonal contraceptive in past
    month
      Insert ring prior to Day 5 of menstrual cycle
      Use backup for 7 days (excluding diaphragm)
•   Switching from OC
      Insert ring within 7 days after last active OC
      No backup needed
•   Switching from progestin-only method
      Any day of month when switching from pill
      On the same day as IUD removal
      On the day when next injection would be due
      Use backup for 7 days (excluding diaphragm)
       Vaginal Ring: Insertion
1.              hands,
1 After washing hands remove ring from foil pouch
2. Choose comfortable position for ring insertion




                                          NuvaRing PI, 2001
         g        g
       Vaginal Ring: Insertion
3. Hold ring between thumb and index finger and
press sides of the ring together.
                      g g




4. G tl push folded ring iinto vagina. Th exact position
   Gently  h f ld d i       t     i    The    t    iti
of the ring is not important for it to work.




                                               NuvaRing PI, 2001
Vaginal Ring: Removal
                 g
 Remove the ring three weeks after
 insertion (same day, same time)
 Hook the index finger under the forward
 rim or by holding the rim between the
 index and middle finger and pulling it out
 Place the ring in the foil pouch or plastic
 bag and dispose out of reach of children
 or pets
                                 2-3
 Menstrual period will begin in 2 3 days
                                    NuvaRing PI, 2001
  g        g
Vaginal Ring: What to do if Missed
 Inadvertent removal, expulsion, or
    l    d i f       interval
 prolonged ring-free i t    l
   If < 3 hours, rinse with cool to lukewarm water
   and re-insert as soon as possible
   If > 3 hours, re-insert and use backup until ring
   has been used continuously for 7 days
                              y         y
 Prolonged use
                                               one
   If < 1 extra week, start new ring after the one-
   week ring free interval
   If > 1 extra week (4 weeks), rule out
   pregnancy, use backup until ring in for 7 days
                                         NuvaRing PI, 2001
Vaginal Ring: User Acceptability
  1950 women age 18-41 years
  13 cycles of use
    96% satisfied
    97% would recommend the ring
  Reasons for liking the ring
    • “Not having to remember anything” (45%)
    • “Ease of use” (27%)

                            Contraception 2003;67:187-94
Vaginal Ring: P
V i l Ri            ti
              Precautions
 Similar to oral and patch
 Women who are hesitant about touching
 their genitalia may not be good candidates
 Women who have difficulty inserting or
 removing ring may not be good
 candidates
Vaginal Ring:
Patient Counseling
  Similar to oral (expectations, ACHES)
         p                                  y
  Backup should be used for the first 7 days the
  ring is in place
  No special accuracy is required for placement
  Douching is discouraged, but topical therapies
  (antifungal agents, spermicides) are allowed
  May be worn with tampons
  Cost is similar to pack of oral contraceptives
Vaginal Ring

ADVANTAGES             DISADVANTAGES
• Efficacy             • Side effects similar
• Compliance             to other combined
• User controlled         eg e s
                         regimens
• Cycle control        • Vaginal discomfort
• Readily reversible   • Potential partner
                         awareness of ring
        y
• Privacy
 Depot M d
 D                  t
     t Medroxyprogesterone
                       Backup method
                       needed for 1st week
     Provera :
Depo Provera™:         post 1st shot or if
150 mg IM q 12 weeks   more than one week
                       late
                       First shot - within 5
                       days post menses
                       start then q 3 months
Depo SubQ Provera
Prefilled syringes only
   26 gauge 3/8 inch needle
104 mg sq every 12-14
wks
56% amenorrhea at 1 yr
Similar wt gain to IM
M di time t ovulation
Median ti    to     l ti
= 10 months
Administer in anterior
thigh or abdomen
Suspension = shake!
Depot
Medroxyprogesterone
 MOA:             o lation b s ppressing
 MOA Inhibits ovulation by suppressing LH
 surge, thickens cervical mucous, may alter
 endometrium
 Contraindications: breast cancer, liver disease,
 undx abnormal vaginal bleeding
  + : Compliance assured, no estrogen, light
    periods, decreased cramps
    p        ,                 p
  -- : Irregular cycles, weight gain, headache,
    spotting/btb, amenorrhea, delayed fertility, no
      p     g                         y       y
    STD protection, decreased bone density with
    long term use (black box!)
DMPA Injections: Initiation
                                 menses.
Preferred start: first 5 days of menses No
back up needed.
Alternative start: anytime in cycle if not
pregnant. Use backup x 7 days.
Postpartum: may give injection prior to
hospital discharge
               g      y                 y
Breast-feeding: may start immediately or wait
4-6 weeks
          g               y     p
Switching methods: anytime patient not
known to be pregnant. Use backup if
necessary.
DMPA Injections: Concerns about
Bone Mineral Density (BMD)
 Women who used DMPA for at least 5 years have
 significantly reduced BMD of lumbar spine and
   g         y                          p
 femoral neck, particularly after 15 years of use
 and if started before age 20.
 Effect is almost completely reversible, even after
 ≥4 yrs of DMPA use.
 All women placed on DMPA should be taking
 sufficient calcium and exercising regularly.
                                 g g       y

          Hatcher RA, et al. A Pocket Guide to Managing Contraception. 2004.
Depot
Medroxyprogesterone
 Irregular                    er
 Irreg lar bleeding/spotting very common in first
 6 months
 Conception may be delayed 6 – 12 months from
 last injection
 Can be used in breastfeeding women
 Amenorrhea up to 60% at one year
 Good option for women who cannot use
 estrogens
 Weight gain can be significant     2 – 6 lb
 increase is common
DMPA Injections:
Candidates for Use
Women who:
W      h
 Want intermediate- to long-term contraception
 Do t l                          ft
 D not plan pregnancy soon after DMPA
 discontinuation
      privacy, convenience,
 Want privacy convenience and high efficacy
 Want or need to avoid estrogen
 Use drugs that effect liver clearance
 Are exclusively breastfeeding >6 wks
 p p
 postpartum
 Consider bleeding to be a problem or nuisance
DMPA Injections: Patient
Counseling
Do not massage area where shot was given for
a few hours
Expect irregular bleeding/spotting in beginning –
decreases over time
                              1000 1200
Take calcium if not achieving 1000-1200 mg per
day through diet
Return in 11-13 weeks for next injection. Use
backup if ever more than 13 weeks.
If changing from DMPA to another method, start
method when next injection due
Another Implant Option:
3-keto-desogestrel Implant
(Implanon™)
  Single rod containing a different
             (3 keto desogestrel
  progestin (3-keto-desogestrel aka
  etnogestrel)
  Effective for three years
  Single-rod implant (4 cm in length and 2 mm
  in diameter) made of ethylene vinyl acetate
              )           y         y
  with 68 mg of etonogestrel
    Time to insert = 1.1 minutes
    Time to remove = 2.6 minutes
    Ti                 26 i
        p       p            y
Contraceptive Implant Efficacy:
Mechanisms of Action
 Suppresses ovulation
   Occurs within 1 day of insertion
   Ovulation in 5% f           ft
   O l ti i <5% of users after 30
   months of use
 Increases viscosity of the cervical
 mucous
Implants:
Weight Gain
 In clinical trials, the mean cumulative weight
 gain was:
   End of first year: +2.8 lbs.
   End of second year: +3.7 lbs.
   Caused discontinuation in 2.3% of patients
When to t t
Wh t start:
 If no hormonal contraceptive has been used in past
 month:
   Insert within 5 days of start of menses
 If switching from COC, insert in placebo week, or
             ring-free patch free
 during the ring free or patch-free period
 If switching from a progestin-only method:
                        progestin only
   Any day if using the progestin-only pill
   Same day as intrauterine device or implant removal
   On due date for next contraceptive injection
Implants
Contraindications: undiagnosed abnormal
vaginal bleeding, h/o breast cancer
 +: Last 5 years, compliance assured, light
           y      ,   p                 , g
   periods (eventually!), delayed fertility not a
   problem
 --: weight gain, unpredictable menses, heavy
   bleeding, amenorrhea, high initial cost, no
                i
   STD protection, d        i
                    depression, acne, d  drug
   interactions with phenytoin, carbamazepine,
   primidone,
   primidone rifampin
Implants:
Counseling
 Severe lower abdominal pain
      y g
 Heavy vaginal bleedingg
 Arm pain, bleeding or s/sx infection
 Expulsion of implant
 Delayed menses after long phase of
 regular periods
 Migraine headaches and/or blurred vision
 J.O.          o                          ob/gyn      pregnancy
 J O is a 29 y.o. female presents to her ob/g n s/p pregnanc
termination. States she feels like she is going to throw up
when she “takes them pills.” She is concerned about having
      kids.
more kid
 PMH: pregnancy termination x 2, 4/98-condom failure, 8/03-
OCP failure
 SH: No tobacco, 3 beers/week, 5 sexual partners in last year,
5 children
 Medication history: Occasional ibuprofen
                 y
 Otherwise healthy


      yp
What type of birth control does J.O. need?
What characteristics about J.O. lead you to this type of birth
control?
Methods f th Mill     i
M th d for the Millennium
Innovation guided by science, economics, politics,
legal issues, social, cultural and religious factors.
         g
   15 mcg EE doses/lower p g progestin doses
   Gels, cream, buccal, nasal
   Male methods
   Immunocontraception - HCG or LHRH vaccine
   Nestorone® metered-dose skin spray delivery
What is Emergency
Contraception?
 American College of Obstetrics and
 Gynecology definition:
 G      l   d fi iti

   “A therapy for women who have had
        p
     unprotected sexual intercourse,,
         including sexual assault.”

    ACOG Practice Bulletin. Int J Gyencol Obstet 2002;78:191-198
What i           ?
Wh t is pregnancy?
 NIH/FDA
   “Pregnancy encompasses the period of time from
   confirmation of implantation until expulsion or
   extraction of the fetus.”
 ACOG
   “Pregnancy is the state of a female after conception
   and until termination of the gestation.”
    Conception                              blastocyst.
   “Conception is the implantation of the blastocyst It is
   not synonymous with fertilization; synonym:
   implantation.”
 Personal b li f
 P      l beliefs
   Methods
EC M th d
 Yuzpe Regimen
 Levonorgestrel
   Recommended use within 72 hour of sexual
   intercourse,
   intercourse but may be up to 120 hours
 Copper IUD (up to 5 days after ovulation)
 Mifepristone ( ff label use, up t 5 d
 Mif i t       (off l b l        to days
 after sexual intercourse)

       www.contraceptiononline.org, assessed 8/30/04
When is Needed?
Wh i EC N d d?
Some examples:
  A condom breaks or slips off
  No birth control is used, including rape
  Two or more consecutive birth control pills are
    i
  missedd
  DMPA injection 2 or more weeks late
  IUD/Vaginal Ring slips out
  Contraceptive patch off longer than 24 hours
  Sexual assault
How MIGHT ECPs Work?

Inhibit ovulation
Trap sperm in thickened cervical mucus
Inhibit tubal transport of egg or sperm
Interfere with fertilization, early cell division,
or transport of embryo
Prevent implantation by disrupting the uterine
lining
                    Trussell and Raymond. Obstet Gynecol 1999;93:872
Yupze Regimen
Y     R i
 High dose estrogen (ethinyl estradiol 100
 mcg) + high dose progestin
 (levonorgestrel 1 mg)
 Used within 72 hours to prevent
 pregnancy
 Stops fertilization and implantation
 Does not harm fetus if already conceived
                   p
 Not an abortion pill
Yupze Regimen
Y     R i
Efficacy approximately 75% (range 63-79%)
Side effects:
  Nausea approximately 50 % due to estrogen
  component
  Vomiting approximately 20% due to estrogen
  component
  Heavy menses/breast tenderness

               www.contraceptiononline.org, assessed 8/30/04
Yupze Regimen
Y     R i
 Contraindications
   Known pregnancy
   Similar as those FDA labeling for OC
   products, but no data available
   p        ,
   History of clots, stroke, DVT, ischemic heart
   disease, migraines, liver tumors, breast
               g
   cancer


                    www.contraceptiononline.org, assessed 8/30/04
      Emergency Contraceptive Pills
      One dose within 72 hours, then one 12 hours later
• • Ovral         2 white tabs               100 mcg              0.50 mg LNG
 •   Alesse       5 pink tablets             100 mcg              0.50 mg LNG
 •   Nordette       light-
                  4 light-orange             120 mcg              0.60 mg LNG
 •   Levlen         light-
                  4 light-orange             120 mcg              0.60 mg LNG
 •   Levlite      5 pink tablets             100 mcg              0.50 mg LNG
 •   Lo/Ovral
     Lo/Ovral     4 white tablets            120 mcg              0 60 mg LNG
                                                                  0.60
 •   Triphasil    4 yellow tablets           120 mcg              0.60 mg LNG
 •   Tri-
     Tri-Levlen   4 yellow tablets           120 mcg              0 60 mg LNG
                                                                  0.60
 •   Ovrette      20 yellow tablets           0                   0.75 mg LNG
 •   Preven           g
                  2 light blue                     g
                                             100 mcg                    g
                                                                  0.50 mg LNG
 •   Plan B       1 white tablet             0                    0.75 mg LNG
                                                           1997;87(6):932-
                         Trussell J et al. Am J Pub Health 1997;87(6):932-937
Product Available
At-the-Counter in the U.S.
 Plan B (levonorgestrel 0.75 mg, 2 tablets in
 package)
    t t i US          dispense ECP without a
 6 states in U.S. can di              ith t
 prescription to anyone
    California
    Washington
    Maine
    New Mexico
    Hawaii
    Alaska
Emergency Contraception
Plan B
(levonorgestrel 0 75 mg, 2 t bl t i package)
(l         t l 0.75        tablets in  k   )
                          Only progestin, no
                             t
                          estrogen
                          Must be 18 or over
                          to     h
                          t purchase OTC
                          Rx only if < 18
Progestin-Only EC
P     ti O l
 Take 1 tablet within 72 hours of unprotected
 sexual intercourse
 Take second tablet 12 hours after first dose
 OR… can take both tablets at the same time
 Can use up to 120 hours after intercourse, but
 the longer the wait, the higher the risk of
 pregnancy
    g   y         p
Emergency Contraceptive Pills:
Management Concerns
• May take antiemetics 1 hour before first
  dose

• If patient vomits within 1 to 2 hours of first
  dose, need to repeat dose.


  Berardi RR, DeSimone EM, et al. Handbook of Non-Prescription Drugs:
  An Interactive Approach to Self-Care, 13th Ed., 2002.
Emergency Contraceptive Pills:
Management Concerns

 Menstrual changes in 10-15%
                      ntil next
 Need contraception until ne t menses
 If no menses in 3 weeks, see clinician
 immediately, could be pregnant
                                    g   y
 Increased incidence of ectopic pregnancy?
 not studied
Emergency Contraception
Patient Counseling
 Make certain that the patient does not want to
 get pregnant
 Explain that                  t     ti d
 E l i th t emergency contraception does not     t
 protect from STI’s
 Recommend an at home pregnancy test and
 medical follow up if the patient does not have a
 normal period with in 3 weeks
 Side effects include nausea and vomiting.
 Headaches, breast tenderness, and dizziness
 have been reported
Emergency Contraception
Patient Counseling
if a woman comes in for EC, take the
  opportunity to counsel on the following:
    pp      y                           g
   Contraception techniques and methods
   available
   Triage/refer any risk of sexually transmitted
   infections and encourage regular health
   examinations
Beginning Contraception after EC

Oral contraceptives, patches, and vaginal rings
        g                      p
     Regular start: use backup until next pperiod,
     then begin pills or patches or rings according
     to regular patient instructions
     Jump start: take ECP dose(s). Start a new
     pack of OCs or use a patch or ring the next
     day (use b k f fi t 7 d
     d (       backup for first days) )
Pharmacists Providing
Emergency Contraception
Washington State Pharmacists
  Formally endorsed by the Washington State Medical
  Association
  Formal training program and certification
  Washington Medicaid will pay for counseling, ECPs and
                                             $10
  antiemetics - predict annual savings up to $ million
  dollars
     p
7211 patient visits in 10 months
  Abortion rate in Washington State has dropped by 30%.
Patients highly satisfied with pharmacist counseling
                                    Belgium, Denmark,
Also available from pharmacists in: Belgium Denmark
France, Portugal, South Africa, Sweden, United Kingdom -

				
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