Slide 1
Slide 1 of 57
Talking Points
This presentation may include
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- This presentation may include information that is not on FDA-required product labels.
- NOTE TO SPEAKER: Please disclose any financial relationship(s) you have with industry.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 2
Slide 2 of 57
Talking Points
This presentation has been
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- This presentation has been peer reviewed.
Disclosure Text
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 3
Slide 3 of 57
Talking Points
Generous support for today’s
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Generous support for today’s webinar has been provided by The National Campaign to Prevent Teen and Unplanned Pregnancy and their Bedsider program. Bedsider is a new online birth control support network designed to provide targeted information to women between the ages of 18 and 29. I encourage you to check it out at www.Bedsider.org and refer your patients there for a wealth of resources on EC and other methods.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 4
Slide 4 of 57
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- By the end of this presentation, participants should be able to:
- Describe emergency contraception (EC) options available in the United States
- Respond to patients’ concerns about the safety and efficacy of emergency contraceptive pills (ECPs)
- Discuss the mechanism of action of ECPs to reduce confusion
Disclosure Text
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 5
Slide 5 of 57
Talking Points
Emergency contraception (EC)
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Emergency contraception (EC) is a therapy for women who have had unprotected sexual intercourse, including sexual assault, and want to avoid pregnancy.
- The two most common reasons for seeking EC are failure of a barrier method (usually condoms) and failure to use any contraceptive method.
- EC pills are unique; they are the only method used easily postcoitally to prevent pregnancy.
References
- Finer LB, Zolna. Unintended pregnancy in the United States: incidence and disparities. Contraception. 2011, in press.
- ACOG Practice Bulletin No. 112: Emergency Contraception. Obstet Gynecol. 2010; 115:1100-9.
- Coeytaux F, Wells ES, Westley E. Emergency contraception: have we come full circle? Contraception 2009;80(1):1-3.
- Trussell J, Schwarz EB. Emergency Contraception. In Hatcher RA, Trussell, J Nelson AL, Cates W, Kowal D, Policar M (eds). Contraceptive Technology: Twentieth Revised Edition. Ardent Media: New York NY, 2011. Pp.113—145.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 6
Slide 6 of 57
Talking Points
Question 1: Approximately
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Question 1: Approximately what percent of US pregnancies are unintended?
- 10%
- 35%
- 50%
- 65%
- Contraceptive methods with high efficacy rates have been available for several decades.
- Still, half of all pregnancies in the United States are unintended—either mistimed or unwanted.
- EC has the potential to reduce a woman’s chance of unintended pregnancy after an episode of unprotected intercourse
References
- Finer LB, Zolna. Unintended pregnancy in the United States: incidence and disparities. Contraception. 2011, in press.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 7
Slide 7 of 57
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 8
Slide 8 of 57
Talking Points
EC options available in the
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- EC options available in the US today:
- Plan B One-Step
- Next Choice (generic) and Levonorgesterel are dedicated (FDA-approved) ECPs containing 1.5mg levonorgestrel
- ella is a dedicated (FDA-approved) ECP containing 30mg ulipristal acetate
References
- Trussell J, Raymond EG. Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy. November 2011. Available at http://ec.princeton.edu/questions/ec-review.pdf.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 9
Slide 9 of 57
Talking Points
Plan B One-Step was approved
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Plan B One-Step was approved by the FDA in July 2009 and has replaced the previous two-pill Plan B product.
- Although the package label directions state to take the pill within 72 hours after intercourse, studies have shown that progestin-only ECPs can still be effective up to 120 hours after intercourse.
- Several large studies have shown that progestin-only ECPs are more effective the sooner they are taken after unprotected sex.
- May be cheaper with an Rx, but cost from $30-$60 OTC
- ECPs can be obtained for a reduced rate (or free) at Planned Parenthood or other family planning clinics that use a sliding scale to determine charges for those who are low income or don’t have insurance coverage.
References
- Arowojolu AO, Okewole IA, Adekunle AO. Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians. Contraception 2002;66:269-273.
- How to get emergency contraception? How much do emergency contraceptive pills cost? Available at http://ec.princeton.edu/questions/eccost.html. Accessed November 10, 2011.
- Ngai SW, Fan S, Li S, et al. A randomized trial to compare 24h versus 12h double dose regimen of levonorgestrel for emergency contraception. Hum Reprod 2004;20:307-311.
- Piaggio G, von Hertzen H, Grimes DA, et al. Timing of emergency contraception with levonorgestrel or the Yuzpe regimen. Lancet 1999;353:721.
- von Hertzen H, Piaggio G, Ding J, et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomized trial. Lancet 2002;360:1803-1810.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 10
Slide 10 of 57
Talking Points
Next Choice is a generic
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Next Choice is a generic product and was approved by the FDA in June 2009. It is therefore, generally 10%-20% cheaper than the brand name Plan B
- Although the package label directs women to take the 2 pills 12 hours apart, studies have shown that both pills can be taken at the same time with no reduction in effectiveness nor increase in side effects.
- Taking both pills at once is easier for women and enhances compliance.
- Although the package label directions state to take the first pill within 72 hours after intercourse, studies have shown that progestin-only ECPs can still be effective up to 120 hours after intercourse.
- However, several large studies have shown that progestin-only ECPs are more effective the sooner they are taken after unprotected sex.
References
- Arowojolu AO, Okewole IA, Adekunle AO. Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians. Contraception 2002;66:269-273.
- How to get emergency contraception? How much do emergency contraceptive pills cost? Available at http://ec.princeton.edu/questions/eccost.html. Accessed November 10, 2011.
- Reproductive Health Technologies Project. FDA approved emergency contraceptive products currently on the US market. August 2011. Available at http://www.rhtp.org/contraception/emergency/documents/FDAApprovedEmergencyContraceptiveChartAugust2011-PRINTABLE.pdf. Accessed November 4, 2011.
- Ngai SW, Fan S, Li S, et al. A randomized trial to compare 24h versus 12h double dose regimen of levonorgestrel for emergency contraception. Hum Reprod 2004;20:307-311.
- Piaggio G, von Hertzen H, Grimes DA, et al. Timing of emergency contraception with levonorgestrel or the Yuzpe regimen. Lancet 1999;353:721.
- von Hertzen H, Piaggio G, Ding J, et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomized trial. Lancet 2002;360:1803-1810.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 11
Slide 11 of 57
Talking Points
Ella was approved by the FDA
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Ella was approved by the FDA in August 2010 and is labeled for use up to 120 hours after unprotected intercourse.
- Ella is the only EC product labeled for use in the 73-120 hours after sex window.
- While the effectiveness of progestin-only pills declines with delay in treatment, the effectiveness of ella does not (up to 120 hours).
- Has been shown to be more effective for obese women.
- Ella is available online through Kwikmed for $77 including shipping fee.
- ECPs can be obtained for a reduced rate (or free) at Planned Parenthood or other family planning clinics that use a sliding scale to determine charges for those who are low income or don’t have insurance coverage.
References
- Glasier A, Cameron ST, Blithe D, et al. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception 2011;84(4):363-7.
- Moreau C, Trussell J. Results from pooled phase III studies of ulipristal acetate for emergency contraception. Contraception 2011;84:308.
- How to get emergency contraception? How much do emergency contraceptive pills cost? Available at http://ec.princeton.edu/questions/eccost.html. Accessed November 10, 2011.
- Reproductive Health Technologies Project. FDA approved emergency contraceptive products currently on the US market. August 2011. Available at http://www.rhtp.org/contraception/emergency/documents/FDAApprovedEmergencyContraceptiveChartAugust2011-PRINTABLE.pdf. Accessed November 4, 2011.
Disclosure Text
Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 12
Slide 12 of 57
Talking Points
Most effective EC method
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Most effective EC method available in the US today remains under utilized
- Emergency Copper-T IUD insertion placed within 5 days after unprotected sex
- WHO guidelines allow IUDs to be inserted up to day 12 of the cycle with no restrictions and at any other time in the cycle if it is reasonably certain that she is not pregnant.
- Provides at least 12 years of highly effective contraception
References
- Selected practice recommendations for contraceptive use. Second Edition. Geneva: World Health Organization. 2004.
- Trussell J, Raymond EG. Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy. November 2011. Available at http://ec.princeton.edu/questions/ec-review.pdf.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 13
Slide 13 of 57
Talking Points
EC options available in the
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- EC options available in the US today:
- Emergency use of oral contraceptive pills containing estrogen and progestin
- 2 doses of pills (# of pills varies by brand)
- 1st dose within 120 hours after unprotected sex; 2nd dose 12 hours later
- See this chart (http://ec.princeton.edu/questions/dose.html#dose) for a list of combined OC regimens
- Dedicated ECP products have now largely replaced this older combined hormone pill Yuzpe method as they are more effective and cause fewer side effects.
- Therefore, this method should only be considered if dedicated products or Copper-T IUD are not available.
References
- Trussell J, Raymond EG. Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy. November 2011. Available at http://ec.princeton.edu/questions/ec-review.pdf.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 14
Slide 14 of 57
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 15
Slide 15 of 57
Talking Points
ECP efficacy conveys the
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- ECP efficacy conveys the reduction in pregnancy risk after a single coital act
- Plan B package (LNg regimen): 88%
- Published literature:
- LNg regimen: 52% - 100%
- Yuzpe regimen: 56% - 89%
References
- Trussell J, Raymond EG. Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy. November 2011. Available at http://ec.princeton.edu/questions/ec-review.pdf.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 16
Slide 16 of 57
Talking Points
The methodology used to
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- The methodology used to calculate these numbers is sometimes different.
- In a group of ECP users, compare:
- observed number of pregnancies
- expected number of pregnancies (number that would have occurred without ECPs)
- Challenge: Calculate the reduction due to the ECPs
References
- Trussell J, Raymond EG. Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy. November 2011. Available at http://ec.princeton.edu/questions/ec-review.pdf.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 17
Slide 17 of 57
Talking Points
WHO 1998 trial of LNg vs.
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- WHO 1998 trial of LNg vs. Yuzpe regimen
- 1001 women using LNG regimen
- Pregnancies observed: 11
- Pregnancies expected without EC: 75.3
- Pregnancies prevented: 75.3 - 11 = 64.3
- Efficacy: 64.3 = 85%
75.3
References
- Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998;352:428-33
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 18
Slide 18 of 57
Talking Points
Determine the day of the
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Determine the day of the menstrual cycle when the coital act occurred
- Estimate that day relative to day of ovulation
- Use published probabilities of pregnancy by cycle day to estimate expected pregnancies
References
- Trussell J, Raymond EG. Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy. November 2011. Available at http://ec.princeton.edu/questions/ec-review.pdf.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 19
Slide 19 of 57
Talking Points
As you see here different
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- As you see here different studies have produced slightly different rates of pregnancy at each cycle day.
- Depending on which study you use to determine the # of “expected pregnancies” you will reach a different estimate of EC effectiveness for a given # of observed pregnancies
References
- Schwartz D, Mayaux MJ, Martin-Boyce A, et al. Donor insemination: conception rate according to cycle day in a series of 821 cycles with a single insemination. Fertility and Sterility 1979; 31(2):226-9.
- Schwartz D, MacDonald PDM, and Heuchel V. Fecundability, coital frequency, and the viability of ova. Population Studies 1980;34(2):397-400.
- Colombo B and Masarotto G. Daily fecundability: first results from a new data base. Demographic Research 2000;3(5). Available at http://www.demographic-research.org/Volumes/Vol3/5.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 20
Slide 20 of 57
Talking Points
Women in the studies wanted
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Women in the studies wanted to be pregnant
- ECP users wanted NOT to be pregnant.
- Possible differences in:
- Amount and type (broken condom, withdrawal?) of unprotected sex?
- Fecundity?
- Accuracy of data?
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 21
Slide 21 of 57
Talking Points
One study found that in 25 of
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- One study found that in 25 of 69 women seeking EC, no sperm were present in the vagina
- When sperm were present, the number was much lower than in women trying to conceive
References
- Espinos-Gomez JJ, Senosiain R, Mata A, et al. What is the seminal exposition among women requiring emergency contraception? A prospective, observational comparative study. Eur J Obstet Gynecol Reprod Bio 2007;131:57-60.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 22
Slide 22 of 57
Talking Points
Another study found that 99
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Another study found that 99 women were between days -5 and +1 when the day of ovulation was estimated as usual cycle length minus 13
- Hormonal data indicated that only 51 of these 99 (56%) were in fact between days -5 and +1
References
- Espinos JJ, Rodriguez-Espinosa J, Senosiain R, et al. The role of matching menstrual data with hormonal measurements in evaluating effectiveness of postcoital contraception. Contraception 1999;60:243-7.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 23
Slide 23 of 57
Talking Points
Estimates of expected
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Estimates of expected pregnancies are almost certainly too high
- Therefore estimates of effectiveness are too high
- What one can examine is the rate of pregnancy among those using emergency contraception.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 24
Slide 24 of 57
Talking Points
This graphic shows the
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- This graphic shows the number of pregnancies that would be expected among 1000 women who had an episode of unprotected sexual intercourse.
- Green: nothing used
- Yellow: a Yuzpe regiment (combined hormonal option) used (which is no longer recommended as it has higher rates of side effects)
- Pink: levonorgesterol used
- Red: ella or ulipristal used
- Blue: Copper IUD in place
References
- Trussell J, Raymond EG. Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy. November 2011. Available at http://ec.princeton.edu/questions/ec-review.pdf.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 25
Slide 25 of 57
Talking Points
Failure rates from pooled
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Failure rates from pooled data from two randomized trials of LNg versus Yuzpe (combined EE+LNg)
- Yuzpe 3.3%
- LNg 1.7%
- p<0.01
References
- Raymond E, Taylor D, Trussell J, Steiner MJ. Minimum effectiveness of the levonorgestrel regimen of emergency contraception. Contraception 2004;69:79-81.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 26
Slide 26 of 57
Talking Points
Unless these other factors
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Unless these other factors were controlled, UPA was not superior to LNg.
- multivariable analyses after controlled for BMI, time from sex to ovulation, expected probability of conception, repeated sex, study
References
- Glasier AF, Cameron ST, Fine PM, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet. 2010;375:555-62.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 27
Slide 27 of 57
Talking Points
The reason seems to be that
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- The reason seems to be that ulipristal acetate is more effective than levonorgestrel in postponing imminent ovulation.
- Randomized trial of UPA vs. LNg
References
- Glasier AF, Cameron ST, Fine PM, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet. 2010;375:555-62.
- Trussell J and Schwarz EB. Emergency Contraception. In Hatcher RA, Trussell, J Nelson AL, Cates W, Kowal D, Policar M (eds). Contraceptive Technology: Twentieth Revised Edition. Ardent Media: New York NY, 2011. Pp.113—145.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 28
Slide 28 of 57
Talking Points
UPA works closer to the time
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- UPA works closer to the time ovulation would occur, usually when follicle size is about 18-22 mm
References
- Croxatto HB, Brache V, Pavez M, et al. Pituitary-ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75-mg dose given on the days preceding ovulation. Contraception. 2004;70:442-50.
- Brache V, Cochon L, Jesam C, et al. Immediate preovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod. 2010;25:2256-63.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 29
Slide 29 of 57
Talking Points
No follicular rupture within
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- No follicular rupture within 5 days of ulipristal
- 100% women treated before onset of the LH surge
- 79% of women treated after the onset of the LH surge but before the LH peak
- 8% of women treated after the LH peak
References
- Brache V, Cochon L, Jesam C, et al. Immediate preovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod. 2010;25:2256-63.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 30
Slide 30 of 57
Talking Points
There is no statistically
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- There is no statistically significant effect of treatment delay on pregnancy rates (p = 0.91 ).
References
- Moreau C, Trussell J. Results from pooled phase III studies of ulipristal acetate for emergency contraception. Contraception. 2011;84(3):308.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 31
Slide 31 of 57
Talking Points
By comparison to the UPA
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- By comparison to the UPA study data showing no statistically significant effect of treatment delay on pregnancy rates, there is markedly lower efficacy for levonorgestrel with delay of treatment after unprotected intercourse.
- A recent analysis of four WHO trials demonstrated that odds ratios for pregnancy in the second, third and fourth day with respect to the first day were not significantly different from 1 at the 5% level of significance. On the fifth day, the odds ratio of pregnancy compared to the first day was almost 6. Delaying levonorgestrel administration until the fifth day after unprotected intercourse increases the risk of pregnancy over five times compared with administration within 24 hours. It is uncertain whether levonorgestrel administration on the fifth day still offers any protection against unwanted pregnancy.
References
- Piaggio G, Kapp N, von Hertzen H. Effect on pregnancy rates of the delay in the administration of levonorgestrel for emergency contraception: a combined analysis of four WHO trials. Contraception. 2011;84:35-9.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 32
Slide 32 of 57
Talking Points
LNG showed a rapid decrease
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- LNG showed a rapid decrease of efficacy with increasing BMI, reaching the point where it appeared no different from pregnancy rates expected among women not using ECPs at a BMI of 26 kg/m2 compared with 35 kg/m2 for UPA.
- NO decrease in effectiveness of IUD
References
- Glasier A, Cameron ST, Blithe D, et al. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011;84:363-7.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 33
Slide 33 of 57
Talking Points
When women had repeated acts
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- When women had repeated acts of unprotected intercourse their risk of pregnancy increases, even if they use ECPs
- An IUD provides women the best protection because all future episodes of intercourse will be protected
- Some have worried that because UPA delays rather than inhibits ovulation, women who have taken UPA might be at greater risk of pregnancy after subsequent unprotected intercourse than women who tookLNg. However, this is not supported by the evidence.
References
- Glasier A, Cameron ST, Blithe D, et al. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011;84:363-7.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 34
Slide 34 of 57
Talking Points
The literature includes 42
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- The literature includes 42 studies on the use of IUDs for EC published between 1979 to 2011. Of these, 29 were published in Chinese and 13 in English.
- In total, these studies document the experience of over 7,000 women, and show that very few women became pregnant after having an emergency IUD placed
- A copper-T IUD can provide very effective protection against pregnancy for at least 10 years after insertion. It avoids the problem caused by further acts of unprotected intercourse after treatment in the treatment cycle
- A striking finding is that all of the pregnancies in the English-language literature occurred in one study conducted in Egypt in 1987. [Askalani 1987] In this study, four pregnancies occurred among 200 women, for a 2% failure rate (95% CI=0.69-5.03%). Even more striking is the fact that this study is the only placebo-controlled contraceptive study that we are aware of. Three hundred women who had engaged in unprotected intercourse around the time of ovulation (and so had a relatively high probability of pregnancy) were randomized to either postcoital insertion of a Cu-T 200 or no treatment. The pregnancy rates were 2% among the treatment group and 22% in the expectant management group. The failure rate in the treatment arm of this study is surprisingly high, and significantly higher than the rate in all other countries combined ( p = 0.0001); in contrast, the results among the five countries excluding Egypt are homogeneous (p=1). If the true failure rate in Egypt were the same as in the other five countries (0.000878), then the chance of observing four or more pregnancies is vanishingly small, about 1 in 30,000 (p=0.00004). This high failure rate can possibly be explained by the fact that women were specifically selected if they had had intercourse around the time of ovulation, but in any event Egypt is a clear outlier. If the unusual results from the Egypt study were excluded, the overall failure rate would be 0.09% (95% CI=0.04-0.19%); this is our preferred estimate.
References
- Cleland K, Hoaping Z, Goldstruck N, et al. The efficacy of IUDs for emergency contraception: a systematic review of 35 years of experience. 2011. Under review.
- Askalani AH, Al-Senity AM, Al-Agizy HM, et al. Evaluation of copper T-200 as a post-coital contraceptive. Egyptian Journal of Obstetrics and Gynaecology 1987;13:63–6.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 35
Slide 35 of 57
Talking Points
ECPs do work!
Even though
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- ECPs do work!
- Even though effectiveness cannot be precisely estimated, ECPs offer a proven and safe method to prevent pregnancy after unprotected intercourse.
- More effective than nothing
- IUD is most effective option, especially for women who are obese or who have repeated acts of unprotected intercourse
References
- Trussell J, Ellertson C, von Hertzen H, et al. Estimating the effectiveness of emergency contraceptive pills. Contraception. 2003;67:259-65.
- Raymond E, Taylor D, Trussell J, et al. Minimum effectiveness of the levonorgestrel regimen of emergency contraception. Contraception 2004;69:79-81.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 36
Slide 36 of 57
Talking Points
IUDs are recommended by the
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- IUDs are recommended by the American College of Obstetricians and Gynecologists as first choice contraceptives for teens, and can be easily placed for nulliparous women
- IUDs do not increase risk of STI or PID and have no adverse effect on future fertility
References
- ACOG Committee Opinion No. 392: Intrauterine Device and Adolescents. Obstet Gynecol. 2007;110:1493-5
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 37
Slide 37 of 57
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 38
Slide 38 of 57
Talking Points
ECPs may theoretically
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- ECPs may theoretically prevent pregnancy through several mechanisms.
- The most likely mechanism of action is the inhibition or delay of ovulation.
- Preventing the sperm and egg from meeting. This may occur by either, trapping of sperm in cervical mucus or inhibition of tubal transport of egg or sperm. There is little evidence of this occurring.
- Prevention of implantation by disrupting the uterine lining. There is no direct evidence of this occurring.
- There has been little specific human research on post-fertilization effects of ECPs and such effects cannot be studied because there is no test for fertilization itself.
- ECPs do not interrupt an established pregnancy or harm a developing embryo.
References
- Davidoff F, Trussell J. Plan B and the politics of doubt. J Am Med Assoc 2006;296:1775-8.
- Mechanism of Action: How do levonorgestrel-only emergency contraceptive pills (LNG ECPs) prevent pregnancy? New York: International Consortium for Emergency Contraception (ICEC) and International Federation of Gynecology & Obstetrics (FIGO). March 2011.
- Trussell J, Raymond EG. Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy. November 2011. Available at http://ec.princeton.edu/questions/ec-review.pdf.
- Gemzell-Danielsson K. Mechanism of action of emergency contraception. Contraception. 2010;82:404-9.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 39
Slide 39 of 57
Talking Points
We know that LNg ECPs can
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- We know that LNg ECPs can inhibit or delay ovulation, but do not always do so even when given before ovulation. Inhibiting ovulation may be the only mechanism of action.
References
- Croxatto HB, Brache V, Pavez M, et al. Pituitary-ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75-mg dose given on the days preceding ovulation. Contraception 2004;70:442-450.
- do Nascimento JA, Seppala M, Perdigao A, et al. In vivo assessment of the human sperm acrosome reaction and the expression of glycodelin-A in human endometrium after levonorgestrel emergency contraceptive pill administration. Hum Reprod 2007;22:2190-5.
- Durand M, del Carmen Cravioto M, Raymond EG, et al. On the mechanisms of action of short-term levonorgestrel administration in emergency contraception. Contraception 2001;64:227-234.
- Hapangama D, Glasier AF, Baird DT. The effects of peri-ovulatory administration of levonorgestrel on the menstrual cycle. Contraception 2001;63:123-129.
- Marions L, Cekan SZ, Bygdeman M, et al. Effect of emergency contraception with levonorgestrel or mifepristone on ovarian function. Contraception 2004;69:373-377.
- Marions L, Hultenby K, Lindell I, et al. Emergency contraception with mifepristone and levonorgestrel: mechanism of action. Obstet Gynecol 2002;100:65-71.
- Munuce MJ, Nascimento JAA, Rosano G, et al. Doses of levonorgestrel comparable to that delivered by the levonorgestrel-releasing intrauterine system can modify the in vitro expression of zona binding sites of human spermatozoa. Contraception 2006;73:97-101.
- Okewole IA, Arowojolu AO, Odusoga OL, et al. Effect of single administration of levonorgestrel on the menstrual cycle. Contraception 2007;75:372-7.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 40
Slide 40 of 57
Talking Points
We know that UPA ECPs can
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- We know that UPA ECPs can inhibit or delay ovulation, but do not always do so even when given before ovulation. Inhibiting ovulation may be the only mechanism of action.
References
- Brache V, Cochon L, Jesam C, et al. Immediate preovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod. 2010;25:2256-63.
- Stratton P, Levens ED, Hartog B, et al. Endometrial effects of a single early luteal dose of the selective progesterone receptor modulator CDB-2914. Fertil Steril. 2010;93:2035-41.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 41
Slide 41 of 57
Talking Points
The evidence strongly
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- The evidence strongly suggests that EC works primarily by stopping or delaying ovulation.
- It cannot be proved that ECPs have no postfertilization effect
- The best available evidence is consistent with the hypothesis that ECPs’ ability to prevent pregnancy can be fully accounted for by mechanisms that do not involve interference with post-fertilization events
References
- Davidoff F, Trussell J. Plan B and the politics of doubt. J Am Med Assoc 2006;296:1775-8.
- Novikova N, Weisberg E, Stanczyk FZ, et al. Effectiveness of levonorgestrel emergency contraception given before or after ovulation – a pilot study. Contraception 2007: 75: 112-118.
- Mechanism of Action: How do levonorgestrel-only emergency contraceptive pills (LNG ECPs) prevent pregnancy? New York: International Consortium for Emergency Contraception (ICEC) and International Federation of Gynecology & Obstetrics (FIGO). March 2011.
- Brache V, Cochon L, Jesam C, et al. Immediate preovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod. 2010;25:2256-63.
- Stratton P, Levens ED, Hartog B, et al. Endometrial effects of a single early luteal dose of the selective progesterone receptor modulator CDB-2914. Fertil Steril. 2010 ;93:2035-41.
- Gemzell-Danielsson K. Mechanism of action of emergency contraception. Contraception. 2010;82:404-9.
- Trussell J, Raymond EG. Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy. November 2011. Available at http://ec.princeton.edu/questions/ec-review.pdf.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 42
Slide 42 of 57
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 43
Slide 43 of 57
Talking Points
Question 2: Is there a limit
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Question 2: Is there a limit to how many times you can safely prescribe ECPs for the same person?
A. Yes
B. No
C. Unsure
- There is no limit to how many times you can use ECPs.
References
- http://www.bpas.org/bpaswoman/ec-how-it-works
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 44
Slide 44 of 57
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- There are no medical contraindications to use of ECPs at any age, except pregnancy; if a woman is already pregnant, treatment is ineffective but will not harm a pregnancy.
- The U.S. Medical Eligibility Criteria for Contraceptive Use does not include ulipristal acetate yet.
- In the U.S., the labeling for Plan B One-Step, Next Choice and ella includes only one contraindication – known or suspected pregnancy.
- The advantages of ECP use generally outweigh the risks even for women who have one of more contraindications to the ongoing use of estrogen-containing contraceptives, such as vascular disease, migraine with aura, or severe liver disease.
- For such women, the use of ulipristal acetate or progestin-only ECPs or IUDs are all safe.
- There are no restrictions on the use of progestin-only ECPs or IUDs by breastfeeding women. It is not known if UPA is excreted in human milk, so use of ella by breastfeeding women is not recommended.
- Likelihood of serious harm is low for moderate repeat use
- Repeated use of ECPs is safer than pregnancy
- No increased risk of birth defects
- ECPs do not increase the chance that a pregnancy following ECP use will be ectopic. In fact, ECPs lower the risk of ectopic pregnancy by preventing pregnancy in the first place.
- ECPs safety does not change with age (ie no more risk if <17yo)
- There are no medical contraindications to emergency insertion of a copper-releasing IUD except pregnancy and a high risk of STIs (which can be simultaneously treated) at the time of insertion.
References
- Trussell J, Raymond EG. Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy. November 2011. Available at http://ec.princeton.edu/questions/ec-review.pdf.
- Trussell J, Schwarz EB. Emergency Contraception. In Hatcher RA, Trussell, J Nelson AL, Cates W, Kowal D, Policar M (eds). Contraceptive Technology: Twentieth Revised Edition. Ardent Media: New York NY, 2011. Pp.113—145.
- Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR 2010;59:(No. RR-4):1-85.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 45
Slide 45 of 57
Talking Points
ECP side effects are not
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- ECP side effects are not serious.
- Side effects include nausea and vomiting, abdominal pain, breast tenderness, headache, dizziness, and fatigue.
- Side effects subside within a day or two after treatment is completed.
- LNG and UPA ECPs have a lower incidence of nausea and vomiting than combined ECPs.
- Women may experience a shorter or longer menstrual cycle depending when in the cycle the ECPs are taken.
References
- Trussell J, Raymond EG. Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy. November 2011. Available at http://ec.princeton.edu/questions/ec-review.pdf.
- Glasier AF, Cameron ST, Fine PM, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet. 2010;375:555-62.
- Creinin MD, Schlaff W, Archer DF, et al. Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Obstet Gynecol. 2006;108:1089-97.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 46
Slide 46 of 57
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 47
Slide 47 of 57
Talking Points
Question 3: In your opinion,
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Question 3: In your opinion, what effect will increased availability of ECPs have on adolescent risk-taking behaviors?
A. Increase
B. Decrease
C. No change
D. Undecided
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 48
Slide 48 of 57
Talking Points
Studies have been conducted
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Studies have been conducted around the world to examine whether ECPs impact risk-taking behavior.
References
- Glasier A, Baird D. The effects of self-administering emergency contraception. N Engl J Med 1998;339:1-4.
- Raine T, Harper C, Leon K, et al. Emergency contraception: advance provision in a young, high-risk clinic population. Obstet Gynecol 2000;96:1-7.
- Jackson RA, Schwarz EB, Freedman L, et al. Advance supply of emergency contraception: effect on use and usual contraception?a randomized trial. Obstet Gynecol 2003;102:8-16.
- Gold MA, Wolford JE, Smith KA, et al. The effects of advance provision of emergency contraception on Adolescent women’s sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol 2004;17:87-96.
- Lo SS, Fan SYS, Ho PC, et al. Effect of advanced provision of emergency contraception on women’s contraceptive behavior: a randomized controlled trial. Hum Reprod 2004;19:2404-2410.
- Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial. JAMA 2005;293:54-62.
- Hu X, Cheng L, Hua X, et al. Advanced provision of emergency contraception to postnatal women in China makes no difference in abortion rates: a randomized controlled trial. Contraception 2005;72:111-116.
- Raymond EG, Stewart F, Weaver M, et al. Impact of increased access to emergency contraceptive pills: a randomized controlled trial. Obstet Gynecol 2006;108:1098-1106
- Belzer M, Sanchez K, Olson J, et al. Advance supply of emergency contraception: a randomized trial in adolescent mothers. J Pediatr Adolesc Gynecol 2005; 18(5):347-54.
- Trussell J, Raymond E, Stewart FH. Re: Advance supply of emergency contraception. J Pediatr Adolesc Gynecol 2006;19(3):251.
- Walsh TL, Frezieres RG. Patterns of emergency contraception use by age and ethnicity from a randomized trial comparing advance provision and information only. Contraception. 2006; 74(2):110-7
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 49
Slide 49 of 57
Talking Points
In these studies, women were
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- In these studies, women were randomized to receive either:
- (1) counseling and access to ECPs on demand, or
- (2) ECPs in advance for later use should the need arise.
References
- Glasier A, Baird D. The effects of self-administering emergency contraception. N Engl J Med 1998;339:1-4.
- Raine T, Harper C, Leon K, et al. Emergency contraception: advance provision in a young, high-risk clinic population. Obstet Gynecol 2000;96:1-7.
- Jackson RA, Schwarz EB, Freedman L, et al. Advance supply of emergency contraception: effect on use and usual contraception?a randomized trial. Obstet Gynecol 2003;102:8-16.
- Gold MA, Wolford JE, Smith KA, et al. The effects of advance provision of emergency contraception on Adolescent women’s sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol 2004;17:87-96.
- Lo SS, Fan SYS, Ho PC, et al. Effect of advanced provision of emergency contraception on women’s contraceptive behavior: a randomized controlled trial. Hum Reprod 2004;19:2404-2410.
- Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial. JAMA 2005;293:54-62.
- Hu X, Cheng L, Hua X, et al. Advanced provision of emergency contraception to postnatal women in China makes no difference in abortion rates: a randomized controlled trial. Contraception 2005;72:111-116.
- Raymond EG, Stewart F, Weaver M, et al. Impact of increased access to emergency contraceptive pills: a randomized controlled trial. Obstet Gynecol 2006;108:1098-1106
- Belzer M, Sanchez K, Olson J, et al. Advance supply of emergency contraception: a randomized trial in adolescent mothers. J Pediatr Adolesc Gynecol 2005; 18(5):347-54.
- Trussell J, Raymond E, Stewart FH. Re: Advance supply of emergency contraception. J Pediatr Adolesc Gynecol 2006;19(3):251.
- Walsh TL, Frezieres RG. Patterns of emergency contraception use by age and ethnicity from a randomized trial comparing advance provision and information only. Contraception. 2006; 74(2):110-7
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 50
Slide 50 of 57
Talking Points
Women who received ECPs in
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Women who received ECPs in advance were not more likely to:
- Use ECPs repeatedly
- Have unprotected sex
- Change to less effective contraception
- Use contraception less consistently
- Acquire an STI (in the three studies that measured STIs)
- However, reanalysis of one of the randomized trials suggests that easier access to ECPs may have increased the frequency of coital acts with the potential to lead to pregnancy.
- Easier access also led to greater substitution of ECPs for condoms or another contraceptive
References
- Glasier A, Baird D. The effects of self-administering emergency contraception. N Engl J Med 1998;339:1-4.
- Raine T, Harper C, Leon K, et al. Emergency contraception: advance provision in a young, high-risk clinic population. Obstet Gynecol 2000;96:1-7.
- Jackson RA, Schwarz EB, Freedman L, et al. Advance supply of emergency contraception: effect on use and usual contraception?a randomized trial. Obstet Gynecol 2003;102:8-16.
- Gold MA, Wolford JE, Smith KA, et al. The effects of advance provision of emergency contraception on Adolescent women’s sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol 2004;17:87-96.
- Lo SS, Fan SYS, Ho PC, et al. Effect of advanced provision of emergency contraception on women’s contraceptive behavior: a randomized controlled trial. Hum Reprod 2004;19:2404-2410.
- Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial. JAMA 2005;293:54-62.
- Hu X, Cheng L, Hua X, et al. Advanced provision of emergency contraception to postnatal women in China makes no difference in abortion rates: a randomized controlled trial. Contraception 2005;72:111-116.
- Raymond EG, Stewart F, Weaver M, et al. Impact of increased access to emergency contraceptive pills: a randomized controlled trial. Obstet Gynecol 2006;108:1098-1106
- Belzer M, Sanchez K, Olson J, et al. Advance supply of emergency contraception: a randomized trial in adolescent mothers. J Pediatr Adolesc Gynecol 2005; 18(5):347-54.
- Trussell J, Raymond E, Stewart FH. Re: Advance supply of emergency contraception. J Pediatr Adolesc Gynecol 2006;19(3):251.
- Walsh TL, Frezieres RG. Patterns of emergency contraception use by age and ethnicity from a randomized trial comparing advance provision and information only. Contraception. 2006; 74(2):110-7
- Raymond EG, Weaver MA. Effect of an emergency contraceptive pill intervention on pregnancy risk behavior. Contraception 2008;77:333-6.
- Weaver MA, Raymond EG, Baecher L. Attitude and behavior effects in a randomized trial of increased access to emergency contraception. Obstet Gynecol 2009;113:107-16.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 51
Slide 51 of 57
Talking Points
IUDs are more effective than
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- IUDs are more effective than ECPs at preventing pregnancy, but the emergency insertion of an IUD is only possible if one overcomes barriers such as cost and access to a trained provider for insertion.
References
- Polis CB, Schaffer K, Blanchard K, et al. Advance provision of emergency contraception for pregnancy prevention. Cochrane Database Syst Rev 2010, Issue 2.
- Raymond EG, Trussell J, Polis C. Population effect of increased access to emergency contraceptive pills: a systematic review. Obstet Gynecol 2007;109:181-188.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 52
Slide 52 of 57
Talking Points
14 studies measured the
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- 14 studies measured the impact of lECPs on pregnancy rates (advance provision versus going to as clinic when the need arose)
- In none of the eight did advance provision of ECPs reduce pregnancy rates
- However, only three studies were powered to detect a decrease in pregnancy rates
- It is important to remember that this is the effect at the population level and not at the individual level.
References
- Polis CB, Schaffer K, Blanchard K, et al. Advance provision of emergency contraception for pregnancy prevention. Cochrane Database Syst Rev 2010, Issue 3.
- Raymond EG, Trussell J, Polis C. Population effect of increased access to emergency contraceptive pills: a systematic review. Obstet Gynecol 2007;109:181-188.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 53
Slide 53 of 57
Talking Points
In San Francisco almost half
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- In San Francisco almost half of the women in the advance provision group who had unprotected intercourse did not use ECPs
- In Nevada/NC, 57 of the 74 pregnancies in the advance provision group occurred to women who did not use ECPs in that cycle
- These studies were conducted with progestin-only ECPs.
References
- Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial. JAMA 2005;293:54-62.
- Raymond EG, Stewart F, Weaver M, et al. Impact of increased access to emergency contraceptive pills: a randomized controlled trial. Obstet Gynecol 2006;108:1098-1106
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 54
Slide 54 of 57
Talking Points
In Scotland:
About 1 in 5
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- In Scotland:
- About 1 in 5 women aged 16-29 got ECPs in advance to take home
- About half of these used ECPs at least once
- Results
- 78% of women with advance supplies who got pregnant did not use ECPs.
- Women most at risk probably did not get ECPs
- No effect on abortion rates was observed
References
- Glasier A, Fairhurst K, Wyke S, et al. Advanced provision of emergency contraception does not reduce abortion rates. Contraception 2004;69:361-366
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 55
Slide 55 of 57
Talking Points
While we have excellent
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- While we have excellent evidence that ECPs work, the lack of reduction in pregnancies demonstrated consistently across several studies teaches us several lessons:
- Women underestimate their risk of pregnancy
- More education is needed
- OTC access is necessary – but not sufficient – for solving this problem
- ECPs are not used frequently enough!
- Major public health impact is unlikely
References
- Polis CB, Schaffer K, Blanchard K, et al. Advance provision of emergency contraception for pregnancy prevention. Cochrane Database Syst Rev 2010, Issue 2.
- Raymond EG, Trussell J, Polis C. Population effect of increased access to emergency contraceptive pills: a systematic review. Obstet Gynecol 2007;109:181-88.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 56
Slide 56 of 57
Talking Points
Both Plan B One-Step and the
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Both Plan B One-Step and the generic Next Choice products are FDA-approved to be sold without a prescription to women and men 17 and older in the United States.
- A government-issued ID is required for proof of age to purchase Plan B OTC.
- Women age 16 and younger still need a prescription from a health care professional. In pharmacy access states, that prescription can be written by a pharmacist.
- “Pharmacy access” means specially trained pharmacists can decide if EC is medically appropriate for the woman requesting it and can prescribe or dispense ECPs under protocol.
- States that currently have pharmacy access in place: AK, CA, HI, NH, NM, MA, ME, VT, and WA.
- OTC availability of EC pills has dramatically increased women’s access.
- Pharmacy access reduces barriers by
- Not requiring appointments
- Being open evening, weekends and holidays
- Offering OTC EC to men who meet the age requirement
- Prescribing EC to undocumented women immigrants, women Medicaid clients who otherwise can’t afford OTC ECPs, and women needing a prescription for their private insurance to cover the cost of ECPs.
References
- Food and Drug Administration. Plan B One-Step Approval Letter. 2009. Available at http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021998s000ltr.pdf. Accessed November 14, 2011.
- Next Choice Consumer Information. Available at http://pi.watson.com/data_stream.asp?product_group=1648&p=ppi&language=E. Accessed November 14, 2011.
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE
Slide 57
Slide 57 of 57
Talking Points
Bedsider.org (Bedsider) is a
VIEW MORE
Source: Association of Reproductive Health Professionals
Peer Review Date: 12/14/2011
Notes Talking Points
- Bedsider.org (Bedsider) is a free support network for birth control for women 18-29 operated by The National Campaign to Prevent Teen and Unplanned Pregnancy.
- The EC Hotline and Website are operated by the Office of Population Research at Princeton University and by the Association of Reproductive Health Professionals.
- These resources are not connected with any companies that manufacture or sell emergency contraceptives.
- The EC Hotline and Website were developed to increase women's knowledge about and timely access to EC.
- ARHP’s EC fact sheet for clinicians has been recently updated.
- A recently published book on the history of EC in the U.S. The Morning After: The History of Emergency Contraception in the United States – available from Rutgers University Press
Disclosure Text Original content for this slide submitted by ARHP’s Clinical Advisory Committee for New Approaches to Unintended Pregnancy Prevention in December 2011. This project is funded through an educational grant from Watson Pharma, Inc. This slide is available at www.arhp.org/core.
Creative Commons
HIDE