Emergency Contraception: A Practitioner's Guide
Many doctors have expressed a desire to learn more about ella®, the new emergency contraceptive product that came on the market in the U.S. at the end of 2010. What is it? How does it work? How is it different from other forms of emergency contraception?
To help answer these and other questions about EC, PRCH has fully revised our publication “Emergency Contraception: A Practitioner’s Guide.” Included in the guide is information about this new medication as well as a comprehensive review of other EC options. Read or download the guide below. With this guide, PRCH aims to provide physicians with the necessary tools to offer EC to patients who need it.
EMERGENCY CONTRACEPTION A Practitioner’s Guide
Emergency Contraceptive Pills
Emergency contraceptive pills (ECPs) are a safe, effective way to prevent pregnancy after unprotected intercourse, including rape, sexual assault, or contraceptive failure, such as a torn condom or missed pills. ECPs currently available consist of either single-dose or two-dose regimens of progestin-only oral contraceptives. For two-dose regimens, the FDA label recommends the first dose to be taken within 72 hours after unprotected intercourse, followed by a second dose about 12 hours later.1 Recent studies have shown that both doses of progestin-only pills can be taken at once with the same effectiveness and no increase in side effects.2,3 Studies also show that ECPs can be effective up to 120 hours after unprotected intercourse.3,4 However, ECPs are most effective when taken in the first 12 hours after intercourse,4 and women are urged to take the pills as soon as possible after sex.
• Plan B® One-Step: This product contains progestin in a single 1.5 mg dose of levonorgestrel. Plan B® One-Step replaced the original Plan B® on the market, which consisted of two tablets, each containing of 0.75 mg of levonorgestrel. Aside from the dosing, Plan B® One-Step is the same as the original Plan B®, and therefore the manufacture has chosen to discontinue the original product. • NextChoice: This generic product is equivalent to the original Plan B® product in terms of the medication it contains, the recommended timing and route of administration, safety, and efficacy.
• Marketed Birth Control Pills: More than 20 brands of regular combined oral contraceptives and one brand of progestin-only oral contraceptives may be used. For updated information, visit http://ec.princeton.edu/questions/dose.html#dose.
Though it is possible to ascertain how many pregnancies occur in a given population after ECP use, it is much harder to assess how many pregnancies were prevented. Therefore, exact efficacy rates are difficult to determine. Research demonstrates, however, that ECPs can substantially reduce the chance of pregnancy after one episode of unprotected sex and that they are more effective the sooner they are taken.5,6,7
Mechanism of Action:
ECPs are contraceptive agents that have been shown to work by delaying or inhibiting ovulation and may work by inhibiting fertilization or preventing implantation. Pregnancy is defined as
starting at implantation. If the woman is already pregnant, ECPs will not disrupt or harm the pregnancy.8
ECPs and the “Abortion Pill”:
ECPs should not be confused with mifepristone, or the “abortion pill” (previously called RU486). ECPs prevent pregnancy and will not work if a woman is already pregnant. In the U.S., mifepristone, marketed under the brand name MifeprexTM, is used to terminate a pregnancy by inducing a medical miscarriage.
Side Effects and Contraindications of ECPs:
• Nausea/Vomiting: Some women may experience nausea and vomiting. These symptoms are more common with combined ECPs than with progestin-only pills. Taking an antinausea medicine one hour prior to the first dose of the ECPs reduces the risk of nausea.9 If vomiting occurs within two hours after the woman has taken the first dose, some clinicians may advise a repeat dose. In cases when vomiting makes oral administration impossible, the repeat dose may be administered vaginally (inserted high in the vagina).10 • Other Side Effects: Other side effects may include short-term fatigue, headache, dizziness, breast tenderness, or a change in the timing of the next period. • Contraindications: There are no medical contraindications to ECPs.11 ECP use can be considered even for women who have medical conditions that make them poor candidates for combined oral contraceptives, and the progestin-only ECP provides an excellent alternative that contains no estrogen. A woman should avoid using the pills if she is already pregnant, but ECPs will not end a pregnancy and do not cause birth defects.
Basic ECP Information and Follow-Up Care
Supportive, nonjudgmental approaches are best for providing information and for encouraging women to voice concerns and ask questions. Clinicians should give instructions and information on potential side effects to women who choose to take ECPs. Training staff, including receptionists, in ECP protocols will facilitate women’s access to the pills. A pelvic exam, pregnancy test, or office visit is not necessary; healthcare professionals can safely provide ECPs over the phone. When prescribing by phone, clinicians should review the patient’s menstrual history and determine when unprotected acts of intercourse occurred, in order to assess the likelihood that the patient is already pregnant. However, suspected pregnancy should not rule out the use of ECPs.
A woman can begin using any hormonal contraceptive immediately after ECP use, or she can use a barrier method until her next period begins. If menses do not occur within three weeks of EC use, a pregnancy test is indicated.
Access to ECPs:
Over-the-Counter Availability: All dedicated ECPs (Plan B® One-Step and NextChoice) are available without a prescription to anyone aged 17 or older. Because dedicated ECPs are offered in both prescription and non-prescription forms using the same packaging, they are kept behind the counter at pharmacies and clinics. In order to obtain dedicated ECP products without a prescription, patients must present proof of age through an ID issued by any government. When counseling patients, providers should be aware that this creates an additional burden for undocumented women and women without proper identification. Health clinics may also dispense Plan B® One-Step or NextChoice without a prescription if there is a healthcare professional on site. Although patients 17 and older don’t require a prescription to obtain ECPs, health care providers must play a vitally important role in educating all patients about emergency contraception and improving women’s access to the medication. Physicians should: Educate everyone about emergency contraception Write prescriptions for women younger than 17 Write prescriptions for women 17+ for insurance coverage Provide emergency contraceptive pills, in the office, to everyone
Prescribing ECPs: Women ages 17 and younger are able to obtain ECPs with a prescription throughout the U.S. and without a prescription in states with direct pharmacy access (see below). Any physician, physician assistant, nurse practitioner, or nurse midwife with prescribing privileges can prescribe ECPs just like any other prescription medication. Because some insurance plans may not cover ECPs if patients purchase it without a prescription, clinicians may wish to provide patients with written prescriptions for insurance purposes. Patients should check with their insurance provider about coverage for ECPs. Prescriptions may also make it easier for women to obtain Plan B if they do not have a government issued ID available, they are embarrassed to ask the pharmacist at the counter for Plan B without a doctor’s prescription, or they want to avoid additional questions from pharmacists about their intended use of Plan B. In many states, Medicaid only covers ECPs for enrolled women with a prescription. Advance Prescription: Physicians for Reproductive Choice and Health strongly supports the advance prescription of emergency contraception to women during their routine gynecologic and primary care visits. This offers an important opportunity for patient education about ECPs. Because of the time-sensitive nature of this method, prescriptions given in advance will improve patient access and options. Advanced prescriptions are an especially important option for rural women, for whom long travel distances may preclude timely access to ECPs through pharmacies. The American Medical Association, 12 American College of Obstetricians and
Gynecologists,13 American Academy of Pediatrics,14 Society for Adolescent Medicine,15 and the American Academy of Family Physicians16 all support advance prescriptions for ECPs. Providing to Minors: The FDA restricts individuals 16 and younger from obtaining ECPs without a prescription. According to the Society for Adolescent Medicine, 15 no scientific evidence exists to support requiring prescriptions for minors. Pharmacy Access: Women of any age can obtain EC directly from some pharmacists without a prescription in ten states: Alaska, California, Hawaii, Maine, Massachusetts, Montana, New Hampshire, New Mexico, Vermont, and Washington State. In these states, minors have access to ECPs without a prescription. See www.ec-help.org/PharmacyLocations.asp or www.not-2late.com to find participating pharmacies. Crisis Management: Healthcare providers should be aware of the possibility that a woman requesting ECPs may be a victim of sexual assault, should screen patients as appropriate, and should know how to provide compassionate and sensitive care, counseling, and referrals. Survivors of sexual assault who are seen in an emergency setting should be offered ECPs as pregnancy prevention. Dispensing ECPs: Pharmacies and health clinics may dispense dedicated ECP products without a prescription if there is a healthcare provider on site. Clinicians are urged to dispense ECPs and/or oral contraceptives directly to their patients at their office. A provider can directly dispense dedicated ECP products anywhere she or he has prescribing authority for those under 17 years old with no restrictions for those 17 years and over. Evidence shows that the patients are more likely to take ECPs17 and take them sooner18 if they receive them in advance.19 Stock: Not all pharmacies stock Plan B® One-Step or Next Choice. Since ECPs are more effective the sooner they are taken, clinicians should keep a list of the pharmacies near them that stock dedicated ECP products and encourage others to begin stocking it. Clinicians may also stock ECPs at their practices. This is another reason to provide advance prescriptions of ECPs. Referral Services: A list of local providers can be obtained by visiting www.not-2-late.com. Both the hotline and website are free and operate 24 hours a day. 1. Plan B package insert. Pomona, NY: Duramed Pharmaceuticals Inc.; 2004. 2. Arowojulu AO, Okewole IA, Adekunle AO. Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians. Contraception 2002;66:269-73. 3. von Hertzen H, Piaggio G, Ding J, Chen J, Song S, Bártfai G, Ng E, GemzellDanielsson K, Oyunbileg A, Wu S, Cheng W, Lüdicke F, Pretnar-Daroved A, Kirkman R, Mittal S, Khomassuridze A, Apter D, Peregoudov A. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomized trial. Lancet 2002;360:1803-10. 4. Ellertson C, Evans M, Ferden S, Leadbetter C, Spears A, Johnstone K, Trussell J. Extending the time limit for starting the Yuzpe regimen of emergency contraception to 120 hours. Obstet Gynecol 2003;101:11168-71.
5. Task Force on Postovulatory Methods of Fertility Regulation. Randomized controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998;352:428-433. 6. Trussell J, Ellertson C, von Hertzen H, Bigrigg A, Webb A, Evans M, Ferden S, Leadbetter C. Estimating the effectiveness of emergency contraceptive pills. Contraception 2003;67:259-65. 7. Raymond E, Taylor D, Trussell J, Steiner MJ. Minimum effectiveness of the levonorgestrel regimen of emergency contraception. Contraception 2004;69:79-81. 8. Trussell J, Jordan B. Mechanism of Action of Emergency Contraception Pills. Contraception 2006;74:87-89. 9. Raymond EG, Creinin MD, Barnhart KT, Lovvorn AE, Rountree W, Trussell J. Meclizine for prevention of nausea associated with emergency contraceptive pills: a randomized trial. Obstet Gynecol 2000; 95:271-277. 10. International Consortium for Emergency Contraception. Emergency Contraceptive Pills: Medical and Service Delivery Guidelines, 2nd edition. New York: International Consortium for Emergency Contraception, 2004. http://www.cecinfo.org/publications/PDFs/resources/MedicalServiceDeliveryGuideline s_Eng.pdf. Accessed May 23, 2008. 11. Medical Eligibility Criteria for Contraceptive Use. Third Edition. Geneva: World Health Organization, 2004. 12. American Medical Association. Access to emergency contraception. Policy of the House of Delegates, H-75.985; 2002. Available at: http://www.amaassn.org/apps/pf_new/pf_online?f_n=browse&doc=policyfiles/HnE/H-75.985.HTM. Accessed May 24, 2008. 13. American College of Obstetricians and Gynecologists. Emergency Contraception. ACOG Practice Bulletin, Number 69. Washington DC: The American College of Obstetrics and Gynecologists, December 2005. Obstet Gynecol 2005;106:1443-1451. 14. American Academy of Pediatrics, Committee on Adolescence. Emergency contraception. Pediatrics 2005;116:1026-1035 15. Gold MA, Sucato GS, Conard LA, Hillard PJ, Society for Adolescent Medicine. Provision of emergency contraception to adolescents: position paper of the Society for Adolescent Medicine. J Adolesc Health 2004;35:67–70. 16. Weismiller DG. Emergency contraception. Am Fam Physician. 2004;70:707-714. 17. Raine T, Harper C, Leon K, Darney P. Emergency Contraception: advanced provision in a young, high-risk clinic population. Obstet Gynecol 2000;96:1-7. 18. Gold MA, Wolford JE, Smith KA, Parker AM. The effects of advance provision of emergency contraception on adolescent women’s sexual and contraceptive behaviors. J Pediatr Adolesc Gynecol 2004;17:87-96. 19. Cheng L, Gulmezoglu AM, Piaggio G, Ezcurra E, Van Look PFA. Interventions for emergency contraception. Cochrane Database Syst Rev 2008;Issue 2.
Table 1. Oral contraceptives that can be used for emergency contraception in the United States
Brand Company Pills per Dose Ethinyl Estradiol per Dose (µg) Levonorgestrel per Dose (mg)c
Progestin-only pills: Take one dose Plan-B Ovrette Barr/Duramed Wyeth-Ayerst 2 white pills 40 yellow pills 0 0 1.5 1.5
Combined progestin and estrogen pills: Take two doses 12 hours apart Alesse Aviane Cryselle Enpresse Jolessa Lessina Levlen Levlite Levora Lo/Ovral Low-Ogestrel Lutera Nordette Ogestrel Ovral Portia Quasense Seasonale Seasonique Tri-Levlen Triphasil Trivora Wyeth-Ayerst Barr/Duramed Barr/Duramed Barr/Duramed Barr/Duramed Barr/Duramed Berlex Berlex Watson Wyeth-Ayerst Watson Watson Wyeth-Ayerst Watson Wyeth-Ayerst Barr/Duramed Watson Barr/Duramed Barr/Duramed Berlex Wyeth-Ayerst Watson 5 pink pills 5 orange pills 4 white pills 4 orange pills 4 pink pills 5 pink pills 4 light-orange pills 5 pink pills 4 white pills 4 white pills 4 white pills 5 white pills 4 light-orange pills 2 white pills 2 white pills 4 pink pills 4 white pills 4 pink pills 4 light-blue-green pills 4 yellow pills 4 yellow pills 4 pink pills 100 100 120 120 120 100 120 100 120 120 120 100 120 100 100 120 120 120 120 120 120 120 0.50 0.50 0.60 0.50 0.60 0.50 0.60 0.50 0.60 0.60 0.60 0.50 0.60 0.50 0.50 0.60 0.60 0.60 0.60 0.50 0.50 0.50
Resources for Providers and Patients www.backupyourbirthcontrol.org: Offers basic facts about EC; mainly intended for the general public with a section for providers www.go2ec.org: Provides information on EC access for providers and patientsNational Sexual Assault Hotline, 1-800-656-HOPE: Provides victims of sexual assault with free, confidential, around-the-clock services www.not-2-late.com: Provide answers to the most common questions about EC Endnote on the Copper IUD This card focuses primarily on emergency contraceptive pills. Copper-bearing IUDs can be inserted up to eight days after unprotected intercourse as an alternate method of emergency contraception.13 Developed in Collaboration with: Reproductive Health Technologies Project Susie Baldwin, MD, MPH, Los Angeles County Department of Public Health Christa Christakis, ACOG District 2 Diana Cowan, ACOG District 9 Carrie Cwiak, MD, MPH, Emory University Phil Darney, MD, Center for Reproductive Health Research and Policy, UCSF David Grimes, MD, University of North Carolina James Trussell, PhD, Princeton University Carolyn Westhoff, MD, Columbia University © 2010 Physicians for Reproductive Choice and Health
Physicians for Reproductive Choice and Health is a doctor-led national advocacy organization. We use evidence-based medicine to promote sound reproductive health policies. We believe in reproductive choice for everyone. Our network unites the medical community and concerned supporters. Together we work to improve access to comprehensive reproductive health care, including contraception and abortion.
PRCH does not accept contributions or sponsorships from corporations and does not engage in the endorsement or promotion of any specific emergency contraceptive or oral contraceptive product.
For more information about PRCH, visit www.prch.org. To learn more about the PRCH network of pro-choice physicians and supporters or make a financial contribution to PRCH, please call 646-366-1890, x24, or email firstname.lastname@example.org.
Published under a Creative Commons License By attribution, non-commercial
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