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EMERGENCY CONTRACEPTION: AN UPDATEand better facilitate timely administration. Although ECis indicated for use after unprotected intercourse, consumersdo not need to wait to purchase it until after theyhave experienced a contraceptive emergency.Pharmacists who are available to consumers withquestions about EC will have an opportunity to makereferrals to community resources. Pharmacists are inan excellent position to serve as a resource for consumersand provide information about other methodsof contraception that, when used before or during intercourse,are more effective than EC in preventing unintendedpregnancies. Pharmacists should have availablethe name, address, and phone number for local referralservices when the consumer’s contraceptive needscannot be met in the pharmacy. This may include consumerslacking proof of age needed to purchase ECwithout a prescription, girls under the age of 17, consumersunable to pay for EC, or those who want tobe examined for STIs. In the event that the pharmacydoes not have EC in stock, the pharmacy staff shouldbe prepared to provide consumers with contact informationfor a nearby pharmacy, after verifying the productis in stock, to avoid delays in starting therapy.Pharmacists should be aware that some women seekingEC may be victims of sexual assault. If a womandiscloses violence to the pharmacist, whether in thecontext of purchasing EC or first aid supplies such asbandages, offering access to a private phone andreferral information for support services is indicated.Every pharmacist should also have national and localdomestic and sexual violence service agency contactinformation readily available for consumers.Pharmacy Access ProgramsIn states with pharmacy access programs, women seekingEC who are unable to show proof of age or whoneed a prescription for insurance purposes may beable to have a prescription for EC initiated by a pharmacist.Direct access from a pharmacist is currentlypermitted in nine states: Alaska, California, Hawaii,Maine, Massachusetts, New Mexico, New Hampshire,Vermont, and Washington. 31 States permittingpharmacists to initiate prescriptions have specificrequirements for pharmacist participation that mayinclude training and/or collaborative protocol arrangements.In some states with pharmacy access it maybe permitted to provide other prescription oral contraceptiveproducts for use as EC under certain circumstances,such as when levonorgestrel-only productsare unavailable (TABLE 5).Pharmacy access programs are not available to malesunder age 17 seeking EC because only the person takingthe medication can receive a prescription fromthe pharmacist. If EC products are out of stock orotherwise unavailable, there are alternative regimenssuch as oral contraceptive combinations that can beprovided by the pharmacist under some access programs.These regimens have more side effects and maybe less effective; however, if there are no other options(such as referral to a nearby pharmacy or clinic) theymay serve as a backup option. 8,25,32Summary and ConclusionsLevonorgestrel-only EC is safe and effective for preventingunintended pregnancy after intercourse.The OTC sale to consumers at least 17 years of ageis a major step toward improving access and removingbarriers to the use of EC in the U.S. The timesensitivenature of EC means that ready access towomen is an essential component of successful use.Pharmacists serve a critical role in expanding accessto EC and are relied upon for up-to-date informationregarding the safety and efficacy of EC. The role ofthe pharmacist includes: providing information andcounseling to consumers seeking EC, maintaining anadequate supply of EC at all times, and in states wherecollaborative practice allows pharmacists to provideEC directly to those under age 17, becoming an ECdirectprovider. By understanding the appropriate useand distribution of EC products, pharmacists can significantlyreduce barriers preventing consumers fromusing these products.REFERENCES1. FDA. Plan B (levonorgestrel 0.75 mg) [Letter FDA to Sponsor]. August26, 2005. www.fda.gov/bbs/topics/news/2005/duramed_ ltr.html. AccessedSeptember 2009.2. FDA. Plan B (levonorgestrel 0.75 mg) [Approval letter]. August 24,2006. www.fda.gov/cder/foi/nda/2006/021045s011_Plan_B_APPROV.pdf.Accessed September 2009.3. FDA. Plan B One-Step (levonorgestrel 1.5 mg) [Approval letter]. July10, 2009. www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021998s000ltr.pdf. Accessed September 2009.4. Finer LB, Henshaw SK. Disparities in the rates of unintended pregnancyin the United States 1994-2001. Perspect Sex Reprod Health. 2006;38:90-96.5. Plan B One-Step (levonorgestrel 1.5 mg tablets) package insert. Pomona,New York: Duramed Pharmaceuticals, Inc. July 2009.6. Trussell J, Schwarz EB, Guthrie K, Raymond E. No such thing as aneasy (or EC) fix. Contraception. 2008;78:351-354.7. Cheng L, Gulmezoglu AM, Piaggio G, et al. Interventions for emergencycontraception. Cochrane Database Syst Rev. 2008;(2):CD001324.8. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists,Number 69, December 2005. Emergency oral contraception.Obstet Gynecol. 2005;106:1443-1452.9. Task Force on Postovulatory Methods of Fertility Regulation. Randomisedcontrolled trial of levonorgestrel versus the Yuzpe regimen of combinedoral contraceptives for emergency contraception. Lancet.1998;352:428-433.10. Turner A, Ellertson C. How safe is emergency contraception? DrugSafety. 2002;25;695-706.11. Minutes of the FDA Joint Advisory Committee Meeting December 16,2003. www.fda.gov/ohrms/dockets/ac/03/transcripts/4015T1.htm. AccessedSeptember 2009.12. Abuabara K, Becker D, Ellertson C, Blanchard K, et al. As often asneeded: appropriate use of emergency contraceptive pills. Contraception.2004:69:339-342.13. Ellertson C, Webb A, Blanchard K, et al. Modifying the Yuzpe regimenof emergency contraception: a multicenter randomized controlled trail.Obstet Gynecol. 2003;101:1160-1167.76U.S. Pharmacist • November 2009 • www.uspharmacist.com
EMERGENCY CONTRACEPTION: AN UPDATE14. Creinin MD, Schlaff W, Archer DF, et al. Progesterone receptor modulatorfor emergency contraception. A randomized controlled trial. ObstetGynecol. 2006;108:1089-1097.15. Croxatto HB. Emergency contraception pills: how do they work? IPPFMed Bull. 2002;36:1-2.16. Gemzell-Danielsson K, Marions L. Mechanisms of action of mifepristoneand levonorgestrel when used for emergency contraception. HumReprod Update. 2004;10:341-348.17. Croxatto HB, Brache V, Pavez M, et al. Pituitary-ovarian function followingthe standard levonorgestrel emergency-contraception dose or a single0.75 mg dose given on the days preceding ovulation. Contraception.2004;70:442-450.18. Durand M, del Carmen Cravioto M, Raymond EG, et al. On the mechanismsof action of short-term levonorgestrel administration in emergencycontraception. Contraception. 2001;64:227-234.19. Davidoff F, Trussell J. Plan B and the politics of doubt. JAMA.2006;296:1775-1778.20. Baird DT. Emergency contraception: how does it work? Reprod BiomedOnline. 2009;18(suppl 1):32-36.21. Trussell J, Hedley A, Raymond E. Ectopic pregnancy following use ofprogestin-only ECPs. J Fam Plann Reprod Health Care. 2003;29:249.22. International Consortium for Emergency Contraception and the InternationalFederation of Gynecology & Obstetrics. How do levonorgestrelonlyemergency contraceptive pills work to prevent pregnancy? October2008. www.cecinfo.org. Accessed September 2009.23. WHO Fact Sheet 244. Emergency contraception. Revised October2005. www.who.int/mediacentre/factsheets/fs244/en/ index.html. AccessedOctober 2009.24. Piaggio G, Von Hertzen H, Grimes DA, Van Look PF. Timing of emergencycontraception with levonorgestrel or the Yuzpe regimen. Lancet.1999;353:721.25. Ellertson C, Evans M, Ferden S, et al. Extending the time limit for startingthe Yuzpe regimen of emergency contraception to 120 hours. ObstetGynecol. 2003;101:1168-1171.26. Rodrigues I, Grou F, Joly J. Effectiveness of emergency contraceptive pillsbetween 72 and 120 hours after unprotected sexual intercourse. Am J ObstetGynecol. 2001;184:531-537.27. Von Hertzen H, Piaggio G, Ding J, et al. Low dose mifepristone and tworegimens of levonorgestrel for emergency contraception: a WHO multicentrerandomized trial. Lancet. 2002;360:1803-1810.28. Arowojulu AO, Okewolw IA, Adekunle AO. Comparative evaluation ofthe effectiveness and safety of two regimens of levonorgestrel for emergencycontraception in Nigerians. Contraception. 2002;66:269-273.29. Hamoda H, Ashok PW, Stalder C, et al. A randomized trial of mifepristone(10 mg) and levonorgestrel for emergency contraception. Obstet Gynecol.2004;104:1307-1313.30. Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency contraceptionthrough pharmacies and effect on unintended pregnancy and STIs:a randomized controlled trial. JAMA. 2005;293:54-62.31. GO2EC. Comparison of EC pharmacy access states. Models for EC pharmacies.www.go2ec.org/ModelsForECPharmacies.htm. Accessed September2009.32. International Consortium for Emergency Contraception. Emergency ContraceptivePills: Medical and Service Delivery Guidelines. 2nd ed. Washington,DC; 2004. www.cecinfo.org/publications/PDFs/resources/MedicalServiceDliveryGuidelines_Eng.pdf. Accessed September 2009.■ Disclosure Statements:Kathleen H. Besinque, PharmD, MSEd, has no real or apparent conflicts ofinterest in relation to this program.U.S. Pharmacist does not view the existence of relationships as an implicationof bias or that the value of the material is decreased. The content of theactivity was planned to be balanced, objective, and scientifically rigorous.Occasionally, authors may express opinions that represent their own viewpoint.Conclusions drawn by participants should be derived from objectiveanalysis of scientific data.■ Disclaimer:Participants have an implied responsibility to use the newly acquired informationto enhance patient outcomes and their own professional development. Theinformation presented in this activity is not meant to serve as a guideline forpatient management. Any procedures, medications, or other courses of diagnosisor treatment discussed or suggested in this activity should not be used by clinicianswithout evaluation of their patients’ conditions and possible contraindicationsor dangers in use, review of any applicable manufacturer’s productinformation, and comparison with recommendations of other authorities.EXAMINATIONSelect one correct answer for each question and recordyour responses on the examination answer sheet. Mail itto U.S. Pharmacist, address shown on the answer sheet(photocopies are acceptable). Please allow four weeks forprocessing. Alternatively, this exam can be taken online atwww.uspharmacist.com. Please contact CE Customer Serviceat (800) 825-4696 or cecustomerservice@jobson.comwith any questions.2 CE CreditsEmergency Contraception:An Update of Clinical andRegulatory Changes1. Which of the following statements accuratelydescribes emergency contraception (EC) withlevonorgestrel?A. A hormonal method of contraception afterintercourseB. A method of contraception that hasbeen studied since the 1970sC. A safe and effective method for preventingunintended pregnancyD.All of the above2. Which of the following describes whenEC is indicated?A. After a condom fails (dislodges/breaks) duringintercourseB. After a sexual encounter when a woman hasmissed one or more doses of her oralcontraceptiveC. When a contraceptive method was not usedduring intercourseD.All of the above3. Clinical studies have demonstrated thatlevonorgestrel-based emergency contraceptivesprevent pregnancy by which of the followingmechanisms?A. Inhibition or delay of ovulationB. Disruption of an implanted embryoC. Changes to endometrial lining of the uterusD.All of the above77U.S. Pharmacist • November 2009 • www.uspharmacist.com
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