Pharmacy Contraceptive Access: Successes, Dilemmas and Unmet Needs

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Pharmacy Contraceptive Access Successes,
Dilemmas and Unmet Needs

• Don Downing
• Institute for Innovative Pharmacy Practice
• University of Washington School of Pharmacy
• dondown_at_u.washington.edu

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Program Outline

• Background and History of Pharmacist-initiated EC
• Mechanism of Action Review
• OTC Plan B issues
• Referrals, refusals and community resources
• Case Studies

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Why is Emergency Contraception Needed?

• In the U.S., there are 3 million unintended
  pregnancies each year
• That is nearly ½ of ALL pregnancies (48)
• 50 of unintended pregnancies lead to ABs
• 48 of women aged 15-44 have had an unintended
  pregnancy
• Emergency contraception has the potential to
  reduce unintended pregnancies

Source Henshaw 1998, Trussell et al. 1997
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Methods of Emergency Contraception

• Emergency Contraceptive Pills (ECP)
• Short-course, high dose regimens of
• estrogen/progestin combos (Yuzpe)
• progestin only pills (Plan B)
• taken ASAP within 120 hours of unprotected
  intercourse to prevent pregnancy

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Combination oral contraceptives
Ethinyl estradiol 0.1 mg DL-norgestrel 1.0
mg TWO (2) doses 12 hours apart

• Ovral 2 white tablets
• Lo-Ovral 4 white tablets
• Nordette 4 light orange tablets
• Levlen 4 light orange tablets
• Alesse 5 pink tablets
• Trilevlen 4 yellow tablets
• Triphasil 4 yellow tablets
• Others

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Pharmacy Contraceptive Successes

• WA State EC Study 1997-99
• Goals train pharmacists, enroll 250 women over
  18 months, determine if women/pharmacists approve
• Outcome 11,969 women enrolled pharmacists
  became largest EC provider in WA state thousands
  of pt. referrals
• CA, AK, MA, ME, NH, VT, NM, HI followed
• WA Study 2001-06 Direct Access Study
• Women started on pills, patch, ring by pharmacist
• To be published in 2007
• CA to expand this research
• Pharmacists become enrollment site for states
  Medicaid Waiver family planning program
• OTC Plan B will be available by mid-November

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Mechanism of Action Effect on ovulation,
fertilization implantationsimilar evidence for
each of the following

• Doubling up when oral contraceptive pills
  (OCPs) missed
• OCPs, minipills and Depo-Provera
• The contraceptive effect of breast feeding

ACOG 1998 Kennedy and Trussell. Contraceptive
Technology 17th Revised Edition 1998
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ECP Mechanism of Action

• Clinical studies have shown that ECP can inhibit
  or delay ovulation if taken early enough in cycle
• Biologic plausibility regarding inhibition of
  fertilization
• Thickening of cervical mucous
• Changes in uterine environment immobilize sperm
• Evidence regarding endometrial alterations
  equivocal
• Not clear that changes observed would inhibit
  implantation
• Croxatto studies point to no effect after
  ovulation
• Growing evidence does not support
  post-fertilization effect

Source Swahn et al., 1996 Ling et al., 1979
Rowlands et al., 1986 Ling et al., 1983 Kubba
et al., 1986 Taskin et al., 1994. HB Croxatto
et al Contraception 70 (2004) 442-450 Trussel et
al JAMA Oct 11, 2006
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ECP Mechanism of Action

• Levonorgestrel (LNG)
• Lowers LH surges levels
• Delays LH surge
• Suppresses LH surge
• Even if follicle ruptures, fertilization is
  impaired if LH timing or level is changed
• These events occur in 79-86 of women taking LNG
  before LH surge (same as rate of effectiveness of
  Plan B)

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ECP Mechanism of Action

• Levonorgestrel (LNG)
• No evidence of effectiveness if follicle is 18mm
• No evidence of effectiveness greater than placebo
  during or after LH surge
• No evidence of endometrial changes leading to
  prevention of implantation
• Single does (0.75mg) as effective as 2 doses
• 2 doses better at preventing delayed ovulation
• Full effectiveness can be fully accounted for by
  known pre-fertilization effects (Davidoff F,
  Trussell J, 296 1775-78 JAMA, Oct 11, 2006)

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International Consortium for Emergency
Contraception July 2003

• Repeat Use
• Women should use ECPs as often as needed.
• However, counseling should include
• ECPs less effective at preventing pregnancy than
  other hormonal contraceptive methods
• Women choosing to take ECPs should start the
  method as early as possible after unprotected
  sex,
• ECPs dont protect against STIs and that barrier
  methods should be used if at risk

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OTC Plan B
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OTC Plan B ProtocolScenario 1

• Consumer comes to pharmacy, asks for EC
• Upon informing her/him that EC is available,
  staff person asks for Gov.-issued I.D. verifies
  purchaser is 18 years old
• Consumer is under 18 years of age
• What can you do to help this person?

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OTC Plan B ProtocolScenario 2

• Consumer comes to pharmacy, asks for EC
• Upon informing her/him that EC is available,
  staff person asks for Gov.-issued I.D. consumer
  says he/she doesnt have any
• What can you do?
• What if patient appears to be 40 years old?

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OTC Plan B ProtocolScenario 3

• Consumer comes to pharmacy, asks for EC
• Asks if Medicaid covers it. Does it?
• Asks if their private insurance plan covers it
• Asks if he can buy it for his girlfriend

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Dilemmas

• Not as effective as other contraceptives for
  regular use
• Does not protect against STDs
• Expense of ECP (covered in many cases)
• Confidentiality
• Need for on-going contraception
• Need to use EVERY time a contraceptive method
  fails or is not used

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Dilemmas

• Does pharmacy stock EC?
• Pharmacists liability
• Clinical Issues
• Adolescent use of EC an opportunity
• Women who use EC several times
• Pharmacist-choice
• Counsel consumers on 2 pills stat and 120 hr
  window?

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OTC Plan B Dilemmas

• Will insurance cover OTC product? If Rxd?
• What I.D. is necessary?
• What if consumer looks obviously over 18 but has
  no I.D.?
• How many can be purchased at a time?
• Is it legal to sell to one person knowing that it
  will be used by someone else?
• How much do your staff know about EC?

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OTC Plan B Dilemmas

• Can a man buy it?
• Do I need to keep a signature registry like
  pseudoephedrine products and photo I.D.?
• What if store/pharmacy have differential hrs?
• How will patients get the information they need
  about EC, on-going HC, needed resources?
• Can I use current Plan B as OTC product?

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Unmet needs

• Women need convenient access to on-going hormonal
  contraception
• Price of Plan B creates access barriers
• Screening for sexually transmitted infections
• Critical mass of pharmacists providing
  contraception
• Balance of pharmacist right of conscience and
  patient rights to non-discrimination access

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Patient Education Materials Available for
Download

• www.path.org
• Patient Education Materials in 13 Languages
• www.GO2ec.org (for providers)
• Not-2-Late website and phone (for consumers)
• http//ec.princeton.edu/ or www.not-2-late.com
• 888-NOT-2-LATE