Emergency contraception: Update for pharmacists
Publication date: 2010
www.pharmacytoday.org48 Pharmacy Today • june 2010 Reviews emergency contraception: Update for pharmacists Linda Dominguez, Donald F. Downing, Beth Jordan, Deborah Kurnik, eleanor B. schwarz, James Trussell, and elizabeth westley Linda dominguez, rN-c, NP, is a nurse prac- titioner, Southwest Women’s Health, Albu- querque, NM. donald F. downing, BPharm, is Clinical Professor, School of Pharmacy, University of Washington, Seattle. Beth Jor- dan, md, is Medical Director, Association of Reproductive Health Professionals, Wash- ington, DC. deborah Kurnik, mBa, is an in- dependent medical writer, Silver Spring, MD. Eleanor B. Schwarz, md, mS, is Assis- tant Investigator, Magee-Womens Research Institute, Pittsburgh, PA, and Assistant Pro- fessor, University of Pittsburgh, Pittsburgh, PA. James Trussell, BPhil, Phd, is Director, Office of Population Research, and Professor of Economics and Public Affairs, Princeton University, Princeton, NJ. Elizabeth Westley, mPh, is Senior Manager of Global Consor- tiums, Family Care International, New York. correspondence: Association of Reproduc- tive Health Professionals, 1901 L St. NW, Suite 300, Washington, DC 20036. Fax 202- 466-3826. E-mail: firstname.lastname@example.org acknowledgments: To Dr. Trussell and Eliza- beth G. Raymond, MD, MPH, Associate Med- ical Director, Family Health International, for developing considerable original content. The American Pharmacists Association and the Association of Reproductive Health Pro- fessionals have collaborated for the purpose of developing and providing this continuing pharmacy education activity. Abstract Objective: To provide pharmacists with updated information on emergency con- traception (EC). Data sources: Searches of PubMed were conducted using one or more of the following terms: emergency contraception, EC, Next Choice, Plan B One-Step, unin- tended pregnancy, morning-after pill, and pharmacists. References and related ar- ticles from relevant articles were searched to retrieve additional articles. In addition, Google was used to identify national organizations that are dedicated to EC, and the websites of these organizations were searched for additional information. Data extraction: By the authors. Data synthesis: About one-half of the 6-million pregnancies per year in the Unit- ed States are unintended. EC has the potential to reduce a woman’s risk of unintend- ed pregnancy. Pharmacists have become a critical link between EC and the women who need it. In the previous decade, the regulatory status for EC drugs has shifted from prescription only to OTC for those 18 years of age or older and now to OTC for those 17 years or older. Although the changes and dual status have improved access to EC, they have also created confusion among patients, clinicians, and pharmacists. Conclusion: EC is a safe and effective method of preventing unintended preg- nancy after unprotected intercourse. Pharmacists are in a unique position to assist patients in need of EC. As frontline providers, they have the opportunity to offer sup- port on many levels, including counseling individual patients, helping inform the com- munity about EC, and becoming advocates for improved access to EC for low-income women and those younger than 17 years of age. Keywords: Emergency contraception, unintended pregnancy, morning-after pill, risk taking, barriers to access, over the counter. Pharmacy Today. 2010(Jun);50(6):48–60. Learning objectives At the completion of this activity, the pharmacist will be able to: ■ Describe progestin-only emergency contraception (EC) products, regi- mens, and access issues to ensure more consistent usage by patients. ■ Outline and discuss mechanism of action of EC with patients as a means of dispelling myths surrounding these products. ■ Respond to patients’ concerns about the safety and efficacy of EC prod- ucts using FDA guidelines. ■ Provide evidence-based EC informa- tion and appropriate counseling and care to patients to ensure improved patient health care outcomes. Accreditation Information Provider: American Pharmacists Association Target audience: Pharmacists Release date: June 1, 2010 Expiration date: June 1, 2013 Fee: There is no fee associated with this activity for members of the American Pharmacists Association. There is a $15 fee for nonmembers. The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of CPE. The ACPE Universal Activity Number assigned to the program by the accredited provider is 202-999-10-148-H01-P. Disclosure: Ms. Dominguez has received an honorarium for serving as a consultant and speaker for Teva/Barr, Wyeth, and Schering Plough. The other authors, Association of Reproductive Health Professionals staff, and APhA’s editorial staff declare no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. Funding: This activity is supported by an educational grant from Duramed Research, Inc., a subsidiary of Teva Pharmaceuticals. ACPE number: 202-999-10-148-H01-P CPE credit hours: 2.0 hours (0.2 CEUs) ACPE activity type: Knowledge-based www.pharmacist.com june 2010 • Pharmacy Today 49 EMERGENCY CONTRACEPTION UPDATE Reviews Unintended pregnancy continues to be a major public health issue in the United States. About one-half of the 6-million pregnancies in the United States each year are unintended.1 The majority of women in their child- bearing years (15–44 years of age) use some form of con- traception, but more than one-half of all unintended preg- nancies occur when these women experience contracep- tive failure. The remaining pregnancies occur in women not using any contraceptive method.2 Therefore, efforts to increase use of contraceptives for those experiencing method failure or those not using any method could poten- tially decrease the rate of unintended pregnancy (Figure 1). Emergency contraception (EC) has the potential to re- duce women’s risk of unintended pregnancy, and EC medi- cations are the only contraceptive method that can easily be used postcoitally to prevent pregnancy.3 EC is a therapy for women who have had unprotected sexual intercourse, including sexual assault and known or suspected contra- ceptive failure, 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 contra- ceptive method.4 Even women who do not desire pregnancy may prac- tice contraception poorly or not use a birth control method. This contradiction can be explained by a number of factors, including women’s ambivalence about potential pregnancy; experiences with contraceptive methods; partner influenc- es; lifestyle factors such as travel, work, and relationships; and interactions with contraceptive care providers. These factors influence gaps in contraceptive use, which heighten the risk of unintended pregnancy.5 The need for EC and ready access to it may be more critical when women and families are faced with finan- cial hardship. In the best of economic times, the poorest women are more likely to face unintended pregnancy. The Guttmacher Institute recently collected data on the effect of recession on women’s family-planning decisions. In the current recession environment of increasing unemploy- ment, lower incomes, and concerns about health insurance and access to care, one in four women have delayed a gy- necologic or birth control visit to save money and one in four women are having a harder time paying for birth con- trol. Many are stretching their monthly medication supply, changing to a less expensive (and perhaps less effective) method, or not using a contraceptive.6 EC products (ECPs) are available without a prescrip- tion behind pharmacy counters for purchase by women and men 17 years of age or older in the United States. In the previous decade, the regulatory status for ECPs has evolved from prescription only to OTC for those 18 years or older and now to OTC for those 17 years or older. Al- though the changes and dual status (prescription only or OTC based on age) have certainly improved access to EC, they have also created confusion among patients, clini- cians, and pharmacists. eC methods Emergency contraceptives available in the United States include ECPs and the Copper T intrauterine device.4,7,8 This article will cover information about ECPs. At a Glance Synopsis: PubMed and other sources were searched to provide pharmacists with updated infor- mation on emergency contraception (EC). Approxi- mately 50% of the 6-million pregnancies per year in the United States are unintended, and EC has the potential to reduce the risk of unintended pregnancy. Although regulatory changes and dual status (prescription only or OTC based on age) have improved access to EC, they have also created confusion among patients, clini- cians, and pharmacists. As frontline providers, phar- macists are uniquely positioned to assist patients with EC, including counseling individual patients, helping inform the community about EC, and becoming advo- cates for improved access to EC for low-income women and those younger than 17 years of age. Analysis: Evidence has shown that unless ECPs are used more frequently and when needed, a major public health impact will not be realized. Because direct-to-patient advertising for ECPs is scarce, many women do not know that ECPs are effective, safe, and readily available in pharmacies. Lack of information from health care providers further limits awareness and knowledge of EC and its availability; in a 2002 sur- vey, only 3% of women reported discussing EC with a health care provider in the previous year. Although EC has not reduced unintended pregnancy at the popula- tion level, predictions by EC opponents that easier ac- cess to OTC EC would lead women to have more unpro- tected sex and more abortions have been unrealized as well. Figure 1. Annual pattern of pregnancies in the United States: Intended versus unintended pregnancies (6.3 million pregnancies total) Source: Reference 1. Intended Birth Abortion Miscarriage Unintended www.pharmacytoday.org50 Pharmacy Today • june 2010 Reviews EMERGENCY CONTRACEPTION UPDATE eCPs Table 1 shows the two types of ECPs that are available in the United States: combined ECPs containing both es- trogen and progestin (Yuzpe method) and progestin-only ECPs. Combined ECPs contain the hormones estrogen and progestin. The specific agents that have been studied ex- tensively in clinical trials of ECPs are the estrogen ethinyl estradiol and the progestins levonorgestrel and norgestrel. A specially packaged combined ECP (Preven—Barr Labo- ratories) was approved by FDA in 1998 but withdrawn from the market in 2004 based on data showing that progestin- only EC was more effective. Combining estrogen and pro- gestin hormones in this manner is also called the Yuzpe method, after the Canadian physician who first described the regimen. Progestin-only ECPs have largely replaced combined ECPs because they are more effective and cause fewer adverse effects. Although ECPs are commonly known as “morning-after pills,” the term is misleading; ECPs may be initiated sooner than the name implies or much later than the morning after. ECPs are most effective when taken immediately after unprotected intercourse. Efficacy de- clines as time elapses between sex and drug administra- tion. ECPs are approved by FDA for use up to 72 hours after intercourse. They are reasonably effective for up to 120 hours and perhaps longer.9 However, patients should remember that progestin-only ECPs are more effective the sooner they are taken after unprotected sex.10–13 The products currently approved by FDA for use in the United States contain the progestin levonorgestrel. Two progestin-only products are currently available in the Unit- ed States: ■ Next Choice (Watson; two 0.75-mg tablets), approved Table 1. Oral contraceptives approved for EC in the United States Brand Manufacturer Tablets per dosea Ethinyl estradiol per dose (μg) Levonorgestrel per dose (mg)b Progestin-only dedicated EC (take one dose)c Plan B One-Step Teva 1 white tablet 100 1.5 Next Choice Watson 2 peach tablets 100 1.5 Combined progestin and estrogen tablets (take two doses 12 hours apart) Aviane Teva 5 orange tablets 100 0.50 Cryselle Teva 4 white tablets 120 0.60 Enpresse Teva 4 orange tablets 120 0.50 Jolessa Teva 4 pink tablets 120 0.60 Lessina Teva 5 pink tablets 100 0.50 Levora Watson 4 white tablets 120 0.60 Lo/Ovral Akrimax 4 white tablets 120 0.60 LoSeasonique Teva 5 orange tablets 100 0.50 Low-Ogestrel Watson 4 white tablets 120 0.60 Lutera Watson 5 white tablets 100 0.50 Lybrel Wyeth 6 yellow tablets 120 0.54 Nordette Teva 4 light-orange tablets 120 0.60 Ogestrel Watson 2 white tablets 100 0.50 Portia Teva 4 pink tablets 120 0.60 Quasense Watson 4 white tablets 120 0.60 Seasonale Teva 4 pink tablets 120 0.60 Seasonique Teva 4 light–blue-green tablets 120 0.60 Sronyx Watson 5 white tablets 100 0.50 Trivora Watson 4 pink tablets 120 0.50 Abbreviation used: EC, emergency contraception. aPlan B One-Step and Next Choice are the only dedicated products specifically marketed for EC in the United States. Aviane, Cryselle, Enpresse, Jolessa, Lessina, Levora, Lo/Ovral, LoSeasonique, Low-Ogestrel, Lutera, Lybrel, Nordette, Ogestrel, Portia, Quasense, Seasonale, Seasonique, Sronyx, and Trivora have been declared safe and effective for use as EC products (ECPs) by FDA. Outside the United States, more than 100 ECPs are specifically packaged, labeled, and marketed. Levonorgestrel-only ECPs are available either OTC or from a pharmacist without having to see a clinician in 60 countries. Plan B One-Step and Next Choice are available OTC to women and men 17 years or older in the United States. bThe label for Plan B One-Step indicates taking the tablet within 72 hours after unprotected intercourse. Research has shown that all brands listed here are effective when used within 120 hours after unprotected sex. The label for Next Choice directs to take one tablet within 72 hours after unprotected intercourse and another tablet 12 hours later. Research has shown that that both tablets can be taken at the same time with no decrease in efficacy or increase in adverse effects and that they are effective when used within 120 hours after unprotected sex. cThe progestin in Cryselle, Lo/Ovral, Low-Ogestrel, and Ogestrel is norgestrel, which contains two isomers, only one of which (levonorgestrel) is bioactive; the amount of norgestrel in each tablet is twice the amount of levonorgestrel. Source: Reference 9. www.pharmacist.com june 2010 • Pharmacy Today 51 EMERGENCY CONTRACEPTION UPDATE Reviews by FDA in June 2009, is the branded generic of its two- tablet predecessor, Plan B (Duramed; first approved by FDA in July 1999). ■ Plan B One-Step (Duramed; single 1.5-mg tablet), ap- proved by FDA in July 2009. The original treatment schedule was one 0.75-mg dose within 72 hours after unprotected intercourse and a sec- ond 0.75-mg dose 12 hours later. The 72-hour marker is listed on the label for both of the currently marketed ECPs. However, subsequent studies have shown that a single 1.5-mg dose is as effective as two 0.75-mg doses 12 hours apart.10,11 A single 1.5-mg dose is now considered the ev- idence-based standard, and it can be effective up to 120 hours after unprotected intercourse. This dosing regimen is easier for women and enhances adherence. When ECPs specifically indicated for EC are not avail- able, certain other oral contraceptives can be used in specified combinations for EC. The regimen is one dose fol- lowed by a second dose 12 hours later, where each dose consists of up to six tablets, depending on the brand. Cur- rently, 19 brands of combined oral contraceptives are ap- proved in the United States for use as EC. effectiveness The published literature on progestin-only EC (Next Choice and Plan B One-Step) estimates a range of effectiveness between 52% and 94% in reducing pregnancy risk based on nine studies of nearly 10,500 women.10–12,14–19 The ef- fectiveness listed on the Plan B One-Step package is 89%. Data clearly show that the progestin-only EC regimen is more effective than the Yuzpe method. Both Yuzpe and progestin-only regimens are more effective than using no method of contraception.20 The published literature on combined progestin–estro- gen EC estimates a range of effectiveness between 56% and 89% in reducing pregnancy risk. A meta-analysis of eight studies concluded that the effectiveness of the com- bined regimen is 74%.21 Most published efficacy data likely overestimate the effectiveness of ECPs. For EC, efficacy was demonstrated initially in noncomparative observational studies; thereaf- ter, use of a placebo was believed to be unethical. There- fore, the chance that pregnancy would occur in the absence of EC is estimated indirectly using published data on the probability of pregnancy on each day of the menstrual cy- cle.22,23 This estimate is compared with the actual number of pregnancies observed after treatment in observational treatment trials. Effectiveness is calculated as 1 – (O/E), where O and E are the observed and expected number of pregnancies, respectively.9 Calculation of effectiveness involves many assump- tions that are difficult to validate. Accurate estimates of efficacy depend on accurate recording of timing of inter- course and cycle day (to estimate timing of ovulation).9 One study comparing self-report of cycle day with urinary pregnanediol concentrations demonstrated that more than 30% of women presenting for ECPs had inaccurately dated their menstrual cycles, believing themselves to be in the fertile phase of their cycle when they were not. In the same study, 60% reported more than one act of intercourse in the cycle, indicating that pregnancies attributed to ECP failure might actually be the result of unprotected inter- course earlier in the cycle.24 Another study found that 99 women were between days –5 and +1 when the day of ovu- lation (day 0) was estimated as usual cycle length minus 13 days. However, hormonal data indicated that only 51 of these 99 (56%) were between days –5 and +1.25 In another study, cervical smears showed that more than one-third of women requesting ECPs had no sperm present in the va- gina and that those with sperm present had fewer sperm than women attempting to become pregnant.26 For a vari- ety of reasons, many women do not accurately understand when they are at risk for pregnancy. The efficacy of progestin-only EC may be enhanced by adding a nonsteroidal anti-inflammatory agent that is specific for a cyclooxygenase-2 (COX-2) inhibitor. A pilot study of 41 women found that adding a COX-2 inhibitor (meloxicam 15 mg) to levonorgestrel 1.5 mg significantly increased the proportion of cycles with no follicular rup- ture or ovulatory dysfunction (88% vs. 66%, P = 0.012). Adding a COX-2 inhibitor can disturb the ovulatory process after the onset of the luteinizing hormone surge.27 Generic meloxicam is covered by many community pharmacy ge- neric plans. A trial regarding optimal dosing is under way. Mechanism of action ECPs may theoretically prevent pregnancy through several mechanisms. The most likely mechanism of action is the inhibition or delay of ovulation. Several clinical studies have shown that combined ECPs containing the estrogen ethinyl estradiol and the progestin levonorgestrel can inhibit or delay ovulation.28–31 Although early studies indicated that alterations in the en- dometrium after treatment with the regimen might impair Case study 1 Woman who has missed oral contraceptive doses A woman comes to the pharmacy counter and tells you that she has missed the first three doses of her birth control medication and wonders if she needs emergency contraception (EC). ■ Ask the woman if she has a few moments to talk privately. ■ Ask her whether she has had unprotected sex within the previous 120 hours. If she has, offer to provide her with EC products. If she has had sex without using a condom, you might inform her to con- sider a follow-up visit with her primary provider for an examination for sexually transmitted diseases. ■ If she has insurance coverage and you practice in one of nine states that allow pharmacist-initiated prescription of EC, you can pre- scribe EC and generate an insurance claim. ■ If the woman has time, ask her if she’s satisfied with her current form of ongoing contraception and if she commonly misses doses. Suggest other forms of ongoing contraception, provide her with in- formation about other methods, and make a referral if needed. www.pharmacytoday.org52 Pharmacy Today • june 2010 Reviews EMERGENCY CONTRACEPTION UPDATE receptivity to implantation of a fertilized egg, more recent studies have found no such effects on the endometrium.32,33 Additional possible mechanisms include interference with corpus luteum function; thickening of the cervical mucus resulting in trapping of sperm; alterations in the tubal transport of sperm, egg, or embryo; and direct inhibition of fertilization.7,34–36 No clinical data exist regarding the last three possibilities. Treatment with levonorgestrel-only ECPs as soon as possible after unprotected sex has been shown to impair the ovulatory process and luteal function. Levonorgestrel- only ECPs can inhibit ovulation but do not always do so, even when given before ovulation.37–42 Inhibiting ovulation may be the only mechanism of action for levonorgestrel- only ECPs. Recent studies have found no effect on the en- dometrium.42–44 In one study, levonorgestrel 1.5 mg had no effect on the quality of cervical mucus or on the penetra- tion of spermatozoa in the uterine cavity.43 Animal studies demonstrated that levonorgestrel ad- ministered in doses that inhibited ovulation had no postfer- tilization effect that impaired fertility.36,45,46 Whether these results can be extrapolated to humans is unknown. Based on those animal studies and their own studies in women, Novikova et al.47 argued that most, if not all, of the contra- ceptive effect of both combined and progestin-only ECPs can be explained by inhibited or dysfunctional ovulation. This question of postfertilization effect may never be an- swered unequivocally because no test exists for fertiliza- tion itself, only tests for pregnancy. Thus, although prov- ing that ECPs have no postfertilization effect in humans is not possible, the best available evidence indicates that levonorgestrel does not interfere with any postfertilization events. ECPs do not interrupt an established pregnancy, which medical authorities such as FDA, the National Institutes of Health,48 and the American College of Obstetricians and Gynecologists49 define as beginning with implantation. Based on these considerations, ECPs are not abortifa- cients.50,51 safety Millions of women have used EC safely and effectively. The benefits of using ECPs outweigh the risks in all situations.52 Almost every woman who needs ECPs can use them safe- ly, even those with contraindications to the routine use of combined hormonal contraceptives. Women with previous ectopic pregnancy, cardiovascular disease, migraines, and liver disease may use ECPs. In fact, research has shown that pregnancy poses a greater threat to women with medi- cal problems such as thromboembolic and liver disease than a 1-day dose of estrogen and/or progestin.53 Women who are breastfeeding may safely use ECPs. They may experience a transient change in their milk sup- ply. No risk of serious harm for moderate repeat use of ECPs appears to exist, and repeated use of ECPs is safer than pregnancy.9 The risk of birth defects does not increase if pregnancies occur after use of ECPs. Postmarketing sur- veillance since 1999 has shown no increase in the risk of ectopic pregnancies and no reports of overdose, overuse, or abuse.54 The safety of ECPs does not change with age; there- fore, they carry no added risks for those younger than 17 years.55 Possible ECP adverse effects include nausea and vom- iting, abdominal pain, breast tenderness, headache, dizzi- ness, and fatigue. These effects usually do not occur for more than a few days after treatment, and they generally resolve within 24 hours.9 Considerably fewer adverse ef- fects occur with progestin-only ECPs compared with com- bination products. Combination ECPs can cause nausea in up to 50% of women and vomiting in up to 20%.12,56 Women may experience a shorter or longer menstrual cycle de- pending on when ECPs are taken.57,58 impact of eC on risk taking One of the concerns expressed about making EC available OTC was that easy access would encourage women, partic- ularly adolescents, to increase risky sexual behavior and reduce their routine use of regular methods of contracep- tion. Reported evidence from studies conducted around the world demonstrated that making ECPs more widely avail- able does not increase risk taking or adversely affect regu- lar contraceptive use.59–69 In studies of ECP use and risk taking, women were randomized to receive either counsel- ing and ECPs on demand or ECPs in advance for later use. Reanalysis of one of the randomized trials suggested that easier access to ECPs may have increased the frequency of unprotected coital acts.70 Women in the increased-access group were significantly more likely to report that they had ever used EC because they did not want to use condoms or another contraceptive method.71 impact of eC on unintended pregnancy: Population level No published study has demonstrated that increasing ac- cess to ECPs reduces pregnancy or abortion rates at the population level,72–74 although one demonstration project75 and three clinical trials68,69,73 were specifically designed to Case study 2 Man wants to purchase EC for girlfriend A man comes to the pharmacy counter and wants to know if you will sell him emergency contraception (EC) products for his girlfriend. ■ Tell him that you would be happy to provide him with EC if he is eli- gible. ■ Ask for his identification to verify that he is old enough (at least 17 years) to buy OTC EC. ■ If he is old enough, sell him the EC. ■ If he is not old enough but his girlfriend is, let him know that she can purchase the EC herself. Alternatively, someone else who is old enough to purchase EC without a prescription may purchase the products. www.pharmacist.com june 2010 • Pharmacy Today 53 EMERGENCY CONTRACEPTION UPDATE Reviews address this issue. One explanation for this result is that even when provided with ECPs in advance of need, most women use ECPs too rarely after risky incidents to result in a substantial population effect. In a trial conducted in San Francisco, 45% of women in the advance-provision group who had unprotected in- tercourse during the study period did not use ECPs.68 In a Chinese trial, 30 women in the advance-provision group (n = 746) did not use ECPs in the cycle in which they be- came pregnant.69 In a Nevada/North Carolina trial, 33% of women in the advance-provision group had unprotected in- tercourse at least once without using ECPs and 57 did not use ECPs in the cycle in which they became pregnant.73 In a demonstration project, 27 women with advance supplies of EC who became pregnant never used ECPs.75 In a Nevada/North Carolina trial, increased access to EC had a greater impact on use of ECPs among women who were at lower baseline risk of pregnancy.76 This may explain in part why increased access to EC has increased use of EC with- out measurable effect on pregnancy rates in clinical trials. Thus, although considerable evidence shows that le- vonorgestrel ECPs are effective, several lessons can be learned from the lack of reduction in pregnancies. Women often underestimate their risk of pregnancy, and education is needed to encourage women to use ECPs every time they are needed. OTC access is necessary but probably will not reduce unintended pregnancies sufficiently. Unless ECPs are used more frequently and when needed, a major public health impact is unlikely.72 Although the effect of EC on unintended pregnancy rates for the overall population remains to be shown, EC is most certainly of benefit to individual women seeking to prevent an unintended pregnancy after unprotected inter- course has occurred. Women who recognize their pregnan- cy risk are likely to seek EC if they are aware of it, and EC is easily accessible. While the population effect promise of EC has been largely unrealized, so have predictions of disaster. Abor- tion opponents said easier access to Plan B would lead women to have more unprotected sex and more abortions. No evidence suggests that either outcome has occurred. Barriers to eC access and use Timely access to EC is essential. Access has improved con- siderably since FDA approved OTC status for progestin-on- ly emergency contraceptives for anyone 17 years or older. However, barriers to EC access and use continue to exist and are brought about by politics, lack of awareness, lack of clinician discussion of EC and its availability, and other issues. Political barriers The fact that many emergency departments do not provide EC services to women who have been raped is a tragic ex- ample of neglected preventive health care.77,78 One 2005 survey found that 55% of Catholic and 42% of non-Catholic U.S. hospitals did not dispense EC in emergency depart- ments.77 The Department of Justice makes no mention of EC in the 130-page A National Protocol for Sexual As- sault Medical Forensic Examinations that was published in September 2004.79,80 Despite these obstacles, efforts are under way to reduce barriers to EC access in emergency departments. As of 2009, 15 states and the District of Co- lumbia had laws requiring emergency departments to pro- vide information about or access to EC to sexual assault survivors.81 Additionally, the Department of Defense Pharmacy & Therapeutics Committee removed the levonorgestrel ECP from the Basic Core Formulary (BCF; medications that must be stocked at every full-service Military Treatment Facility [MTF]) in May 2002, only 1 month after the drug had been added to the BCF,82 because of complaints from conservative members of Congress.83 Whether the drug is stocked is left to the discretion of each MTF. Levonorgestrel ECPs were not available to all American soldiers serving overseas, which was of particular concern for women who were raped or faced an unintended pregnancy, until Next Choice was added to the BCF on February 3, 2010.84 Lack of marketing and awareness Direct-to-patient advertising for ECPs is scarce.9 Conse- quently, many women do not know that ECPs are effective, safe, and readily available in pharmacies.9 Lack of discussion with a health care provider According to data from the 2002 National Survey of Family Growth, only 3% of women reported that a health care pro- vider had discussed EC with them in the previous year.9,85 Lack of information from a trusted health care provider further limits women’s awareness and knowledge of EC and its availability. Other barriers Access to EC remains limited for certain patient popula- tions, such as female patients younger than 17 years, wom- en with low income, and women without proper identifica- tion, including undocumented residents.57,86 Most Medicaid Case study 3 Young female wants EC after she was raped A young-looking female tells you that she needs emergency contracep- tion (EC). She tells you that she’s been raped and that she is 15 years old. ■ You can prescribe EC if you practice in one of nine states that allow pharmacist-initiated prescription of EC. If she doesn’t have money to purchase EC, check your pharmacy’s policy about “charity care” for these kinds of situations. ■ If you can, provide her with EC, then talk with her and coordinate a referral to a local Title X clinic/Planned Parenthood clinic or emer- gency department to provide her with postrape care. Consider having a pharmacy staff person escort the girl to the referral site. ■ If you are not able to directly provide her with EC, you should consider contacting a local Title X clinic/Planned Parenthood clinic or emer- gency department for EC and postrape care. ■ In most states, this situation would mandate a report to a child protec- tion service. www.pharmacytoday.org54 Pharmacy Today • june 2010 Reviews EMERGENCY CONTRACEPTION UPDATE beneficiaries and others seeking insurance coverage for EC still require a prescription. At an average retail price of about $45, the cost of ECPs is prohibitive for many indi- viduals, including college students. Health care providers can help women in these difficult situations by keeping a referral list of other family-planning clinics that use a slid- ing scale to determine charges for those who are low in- come or do not have insurance coverage. ECPs can often be obtained from these clinics for a reduced rate or for free. OTC availability and regulatory status Both Plan B One-Step and the generic Next Choice two- tablet product are approved by FDA for sale without a prescription to women and men aged 17 years or older in the United States. A government-issued identification is re- quired for proof of age to purchase Plan B without a pre- scription.87,88 Although most women can obtain progestin-only ECPs without a prescription, female patients aged 16 years or younger still need a prescription from a health care pro- vider. The EC OTC status for patients 17 years or older and prescription-only status for female patients younger than 17 years or women without proper identification (so-called dual-label status of these products) necessitates keep- ing ECPs behind the counter in pharmacies. FDA wanted patients to have access to a knowledgeable health care provider who could answer questions patients might have when purchasing ECPs. Therefore, the products may be shipped to and stocked only by pharmacies or clinics and are not available at general retail locations that do not em- ploy a licensed health care provider. In pharmacy-access states, specially trained pharma- cists can decide whether EC is medically appropriate for the woman requesting it and can prescribe ECPs to female patients of any age, including those who do not have gov- ernment-issued identification for proof of age. Currently, the states with pharmacy access to EC are Alaska, Califor- nia, Hawaii, New Hampshire, New Mexico, Massachusetts, Maine, Vermont, and Washington.89 The American Academy of Pediatrics, American Col- lege of Obstetricians and Gynecologists, and Society for Adolescent Medicine have all supported the availability and use of EC in teens.57 Studies show that adolescents are capable of using ECPs correctly and safely and that access to EC is not associated with increased rates of unprotected intercourse, decreased use of condoms, or higher rates of pregnancy or sexually transmitted infections.57,90,91 If not in a pharmacy-access state, pharmacists can help female pa- tients younger than 17 years obtain ECPs by offering a list of local clinicians and clinics that provide prescriptions for ECPs. Access to ECPs for adult patients has been increased by their OTC availability. Pharmacies also lower access barriers by not requiring appointments; being open eve- nings, weekends, and holidays; and offering OTC EC to both women and men who meet the age requirement. Of important note, patients seeking EC are not subject to the same requirements as patients seeking pseudoephed- rine and other potential methamphetamine precursors; pur- chasers of EC do not need to sign a registry in the pharmacy, and no limits exist for the maximum quantity that can be purchased. Similar to the sale of OTC nicotine products, the sale of EC is limited only by the age of the purchaser, with no requirement for record keeping of purchases. Pharmacist consultation Because of their dual-label status, OTC ECPs are kept be- hind pharmacy counters. This placement provides pharma- cists with an opportunity to play a crucial role in providing advice and information to patients about EC. OTC sale to patients 17 years of age or older improves access to EC by removing the delay associated with obtaining a prescription for this time-sensitive medication, thereby increasing use of this safe and reliable method for preventing an unplanned pregnancy. Pharmacists have become a critical link be- tween EC and women who need it. Dispensing and selling eCPs Practices may vary by pharmacy and state; however, phar- macists are only required to verify the age of the OTC EC purchaser. If the individual is aged 17 years or older, the ECPs can be sold, and no other screening or counseling is required. If a woman has public or private insurance cover- age of prescription EC, then pharmacists in pharmacy-ac- cess states can prescribe EC to ensure insurance coverage even though the woman is eligible for OTC EC based on her age. In some instances, counseling may be viewed as intru- sive or an additional barrier to access to OTC EC. The phar- macist must determine whether such services are desired by the purchaser. Prescription EC counseling is mandated by federal and state laws. Table 2. Action items for pharmacists regarding EC Stock and dispense EC. Make sure all of your pharmacy’s employees, particularly those who answer the telephones, know that you provide EC. Routinely discuss EC with appropriate patients (e.g., new users of oral contraceptives, condom users). Provide ECPs in advance to patients when possible. Determine your state’s requirements for prescribing ECPs to pa- tients 16 years of age or younger. In states with pharmacy access to EC, prescribe ECPs for female patients younger than 17 years. In other states, suggest that patients younger than 17 years obtain a prescription from their health care provider for use if ECPs are needed. Advertise the availability of EC in your pharmacy. List your pharmacy in directories of pharmacies carrying EC. Have an area available where you can discuss EC with patients confidentially. Abbreviations used: EC, emergency contraception; ECP, emergency contraception product. www.pharmacist.com june 2010 • Pharmacy Today 55 EMERGENCY CONTRACEPTION UPDATE Reviews If the patient is interested and has the time and the pharmacist has a private area in which to counsel, the pharmacist may provide the patient with a short summary of key issues, including ongoing contraceptive options, and offer further counseling. Pharmacists should be aware that some patients may feel stressed or embarrassed when in- quiring about EC. Additional considerations for pharmacists Pharmacists may offer EC to appropriate patients (e.g., condom users, parenting teens, those taking oral contra- ceptives) in advance of need. Having EC on hand may help these individuals take it sooner after an incident of unpro- tected intercourse. In pharmacy-access states, pharmacists provide pa- tient assessment, consultation, and EC prescribing.92 Poli- cies about paying pharmacists for this type of service vary among states and insurance companies. As EC has evolved, pharmacists in many states have been actively engaged in making it available to more wom- en (Table 2). In pharmacy-access states, this often has been achieved through the development of collaborative practice agreements permitting pharmacists to prescribe ECPs.93 Experts in pharmacy provision of EC urge all phar- macists to join their colleagues in providing this important component of women’s health care. Conclusion EC is a safe and effective method of preventing unintended pregnancy after unprotected intercourse. The EC environ- ment has changed considerably during the previous decade with the regulatory status for ECPs in the United States shifting from prescription only to OTC for those 18 years of age or older and now to OTC for those 17 years or older. 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