lawcePharmacists' Role When Plan A Fails: Patient Considerations in the Dispute Over Plan B and Emergency Contraception

Release Date: October 1, 2011

Expiration Date: October 31, 2013

FACULTY:

Kelly Cabral, BS, PharmD Candidate 2013
University of Connecticut School of Pharmacy
Storrs, Connecticut

Gerald Gianutsos, PhD, JD, RPh
Associate Professor of Pharmacology
University of Connecticut School of Pharmacy
Storrs, Connecticut

FACULTY DISCLOSURE STATEMENTS:

Ms. Cabral and Dr. Gianutsos have no actual or potential conflict of interest in relation to this activity.

Postgraduate Healthcare Education, LLC does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity 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 objective analysis of scientific data.

ACCREDITATION STATEMENT:

Pharmacy
acpePostgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
UAN: 0430-0000-11-029-H03-P
Credits: 2.0 hours (0.20 ceu)
Type of Activity: Knowledge

TARGET AUDIENCE:

This accredited activity is targeted to pharmacists. Estimated time to complete this activity is 120 minutes.

Exam processing and other inquiries to:
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DISCLAIMER:

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients' conditions and possible contraindications or dangers in use, review of any applicable manufacturer's product information, and comparison with recommendations of other authorities.

GOAL:

To provide an overview of the media portrayal of emergency contraception (i.e., Plan B) in regard to OTC appropriateness, indications for use, mechanism of action, and pharmacy conscientious objection clauses and to discuss the associated controversy's effect on patient care.

OBJECTIVES:

After completing this activity, the participant should be able to:

  1. Analyze conflicting media reports on emergency contraception and summarize scientific studies that can provide clarity for patients.
  2. Recognize the alternative definitions of pregnancy that contribute to the ethical debate regarding emergency contraception.
  3. Describe pharmacy conscientious objection clauses and their interstate variability.
  4. Compare and contrast arguments made by proponents and opponents of increased access to emergency contraception.
  5. Describe Plan B’s appropriate use and its role as emergency contraception..

Since the 1998 release of Preven, the first dedicated emergency contraceptive product,1 emergency contraception has made headlines and generated controversy in both the public and professional spheres. Emergency contraception empowers women to prevent pregnancy after unprotected sex, with newer products (ulipristal acetate) effective when taken up to 5 days after the event. Emergency contraception options in the United States include estrogen and progestin combinations, progestin-only products, ulipristal acetate products, and copper-T intrauterine devices (IUDs).1TABLE 1 lists currently available oral emergency contraceptives. Yet much of the debate has focused on the brand-name product Plan B and its successor, Plan B One-Step. In the 12 years since its approval, the progestin-only Plan B has served as a public symbol for emergency contraception. Media coverage of the product's struggle for OTC approval— and the subsequent legal and ethical clashes over its distribution—have left many patients confused and hesitant as to whether this drug is appropriate and safe for public use.

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As trusted health care professionals, pharmacists have a responsibility to serve their patients and to empathize with their unique health situations and concerns. However, emergency contraceptives such as Plan B have implications beyond traditional medical issues. Rather, emergency contraceptives are associated with ethical, religious, and political conflicts that can affect both patients and pharmacists. Pharmacists are left in a unique position where they must balance their duty to act as an agent for their patients with their own moral or religious convictions. The media's report of pharmacists who conscientiously object to the dispensing of Plan B blurs the lines of professional obligations, and can make patients question whether their pharmacist is acting as a nonjudgmental health care provider. Pharmacists must be prepared to clarify and correct media reports on Plan B legislation and on the pharmacist conscientious objection clause in order to maintain an open and trusting relationship with the patients they serve.

FDA Advisory Committee:
The Lightning Rod for the Media

The media furor over Plan B peaked following pivotal events in 2004, when the product's manufacturer, Barr Pharmaceuticals, resubmitted an application to the FDA to classify Plan B as a nonprescription product. A similar request made by Plan B's original manufacturer, Women's Capital, had been previously denied.2-4 Though a 2003 FDA advisory committee voted 23-4 in favor of the switch, the FDA made a controversial move and ignored the committee's recommendation. Denying the motion, the FDA cited concerns listed in a "minority report" written by advisory committee member W. David Hager, MD, which called for more studies to be done on the potential use of OTC Plan B by young girls.5 The official rationale for the FDA's denial therefore suggested concerns about the drug's impact on risky sexual behavior in America's youth.

However, according to an FDA scientist questioned under oath, the public's best interest was not the primary point of concern. In a sworn deposition, Florence Houn, MD, alluded to political agendas taking precedence over scientific evidence in regard to the FDA's treatment of Plan B. In her statement, Dr. Houn implicated then FDA Deputy Commissioner Janet Woodcock, MD (now director of the Center for Drug Evaluation and Research), as stating that the original Plan B OTC application was rejected "to appease the [Bush] administration's constituents."2 The New York Times also reported that the Government Accountability Office had discovered that "top agency officials had decided to reject the initial Plan B application months before a scientific review was complete."6 These news bulletins suggest that political pressure from the conservative White House may have played heavily into the FDA's decision to reject Plan B's application for nonprescription status.

Media reports at the time also implied that the administration's decision process had little to do with an assessment of the drug's safety and efficacy. In a CBS News edition of 60 Minutes that aired in 2005, reporter Lesley Stahl presented information that would lead the average viewer to conclude that the safety of Plan B was indisputable. No evidence connecting Plan B with strokes, heart attacks, deaths, misuse, or abuse was reported by the FDA.5 Moreover, the aforementioned Dr. Hager had proclaimed the drug "totally safe."5 If a nonprescription status for Plan B truly did not pose a significant health risk to patients, it was therefore logical for viewers to question the rationale for denial.

The argument that increased accessibility to Plan B would lead to a spike in sexually transmitted diseases (STDs) by promoting risky sexual behavior has been shown to have little scientific weight. In fact, the FDA's advisory committee had access to 40 studies that concluded that Plan B does not lead to an increase in irresponsible sexual behavior or STDs.5 Furthermore, when Barr Pharmaceuticals rewrote the application with a 16-year-old age cutoff,3 the application still met with resistance. Though it would seem that the age restriction would have alleviated fears regarding the use of the drug in young teenage girls, the decision on Plan B was postponed.5 Plan B was finally approved for OTC purchase by both women and men 18 years and older in August 2006, and the age restriction was decreased to 17 years in 2009.6,7 SIDEBAR 1 provides additional information on regulations regarding the sale of OTC Plan B.

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CBS's 60 Minutes piece further provoked viewers by presenting religion as a contributing factor to the FDA's decision. Though Dr. Hager, the writer of the minority report, adamantly denied an association between his report and his religious beliefs, a clip of him speaking at a Christian college suggested otherwise. Dr. Hager is shown addressing the crowd, proclaiming, "I argued it from a scientific perspective. And God took that information and He used it through this minority report to influence a decision. You don't have to wave your bible to have an effect as a Christian in the public arena."5 Dr. Hager's speech and his publicized antiabortion stance called into question whether his report encroached upon the boundaries set up for separation between church and state.

With the media pointing to politics and religion as potential confounders of the FDA's scientific decisionmaking process, it is reasonable that the public might lose trust in the administration's integrity. The FDA champions itself as a scientific institution focused on improving the health and safety of American citizens. However, when that aim is compromised by political obligations, the public has little incentive to believe that its best interests are at heart. This mistrust can extend to all health care professionals. Patients allow their physicians and pharmacists to help them make health decisions because they believe that health care professionals will use the best possible scientific evidence to guide treatment. The media's portrayal of scientists favoring politics over facts serves to erode the public's confidence in the health care system as a whole.

Pharmacy Conscientious Objection Clause

Pharmacy conscience clauses came about as a result of the Supreme Court ruling in the Roe v. Wade case of 1973.8 The court's decision made it illegal for state laws to prohibit abortion. In response, many states enacted health care professional "refusal" or "conscience" clauses in order to excuse those individuals who would not perform abortions on the basis of their ethical, moral, or religious convictions. In the intervening years, pharmacists have since expanded the scope of conscience clauses to include refusal to dispense emergency contraception.9 The American Pharmacists Association (APhA) supports the rights of pharmacists to refuse to dispense emergency contraception such as Plan B, but recommends that the objecting pharmacist "step away" rather than "in the way" of such a transaction.10

While it is necessary to protect a pharmacist's personal beliefs, pharmacy conscience clauses may interfere with patient care. APhA's suggestion that the patient should not be made aware that the pharmacist is stepping away would be ideal; however, it is not necessarily practical.10 If there is only one pharmacist working at a particular pharmacy, it is not feasible for that individual to refuse service without the patient being informed. The only way in which this could be accomplished would be to provide false information to the patient, such as claiming that the item is out of stock. Yet, such an action would be a violation of the pharmacist's Code of Ethics.10 Furthermore, Plan B is a medication where the patient would benefit from counseling (SIDEBAR 2). For example, patients must be made aware of the appropriate time frame in which to take the medication, and be informed that emergency contraception should not be used repeatedly as a primary birth control method. Therefore, it is inappropriate for a technician to sell the OTC drug if the pharmacist is not willing to provide a consultation.

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The practice of "refuse and refer" is even more of a consideration in rural areas or for patients with limited access to transportation. Plan B is a time-sensitive drug that must be taken within 72 hours of unprotected sex; therefore, the efficacy of the treatment will be significantly reduced if the patient has to travel great distances to find a pharmacy willing to dispense the medication.

Media reporting of pharmacy conscience clause legislation can leave the public confused and frustrated. As of 2011, 11 states possess legislation allowing refusal to fill (TABLE 2), whereas Illinois has rules in place mandating pharmacies to dispense contraception.9 State-to-state variability only constitutes half the issue; back-and-forth legislation within a state can also be difficult for the lay public to follow. For example, Washington State has experienced turmoil over its regulations regarding Plan B. In 2007, rules were put in place that required a pharmacist to dispense Plan B unless another pharmacist was available in person or via telephone to dispense it. Yet, lawsuits waged by pharmacists and pharmacy owners in opposition to this ruling forced the state board to reconsider its policy. Indeed, in 2010 the Washington Board of Pharmacy abandoned its 2007 decision and enacted a new process called "facilitated referral," in which pharmacies can refuse to dispense Plan B but must refer patients to another pharmacy that will dispense it.11,12 This new ruling may be discouraging for proponents of women's rights, especially given that the reason for the change seems to have been based partly on financial concerns. As Washington Board of Pharmacy member Dan Connolly explained, "We can't afford more lawsuits…If we don't change the current rule, this board is going to always be in litigation."12

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An important question patients might ask after seeing this coverage is: Where will pharmacists draw the line? If pharmacists are allowed to refuse to dispense Plan B, what will stop them from refusing to dispense other drugs of a sensitive nature? Some pharmacists may not be comfortable dispensing Suboxone (a drug used to treat opiate addiction) or needles to known drug addicts, but that does not necessarily mean they should have the authority to refuse these products. In fact, a complaint was recently filed against a pharmacist in Nampa, Idaho, who was reported to have rudely declined to fill a prescription for methergine, a drug sometimes used to control postabortion bleeding.13 When considering which situations should allow conscience clauses to be invoked, it may be reasonable to wonder if individuals of different religions or sexualities could possibly be discriminated against if too broad a scope were allowed.

The Ethical Debate

A common source of confusion in the ethical debate over Plan B is the difference between Plan B and the "abortion pill," RU-486. It is important to establish that Plan B does not contain mifepristone, the active ingredient of RU-486, nor does it act via a similar mechanism. Plan B, which originally contained 0.75 mg of levonorgestrel in each of two tablets and now contains 1.5 mg in one tablet (Plan B One-Step),1 instead shares an active ingredient with many "regular" birth control pills—progestin. This fact serves as a point of controversy: If two medications have the same active ingredient, why is one considered "birth control" and the other a potential abortifacient? The answer to that question lies in one's personal interpretation of pregnancy and, to some degree, one's interpretation of scientific results on Plan B's mechanism of action.

The mechanism of action of Plan B is contingent upon its endocrine effects. Levonorgestrel, its active ingredient, is classified as a synthetic progestin hormone and is believed to act via a negative feedback mechanism on the hypothalamic-pituitary axis. When taken in the late follicular phase of a woman's ovarian cycle, levonorgestrel hinders the release of follicle stimulating hormone (FSH) and luteinizing hormone (LH). Without the traditional LH and FSH peaks that occur during a normal menstrual cycle, prevention of follicular development in the ovary and eventual follicular involution will result. This leads to an anovulatory cycle.14,15

According to the FDA, the National Institutes of Health, and the American College of Obstetricians and Gynecologists, pregnancy begins with implantation of a fertilized egg.16 As such, Plan B's hindrance of ovulation does not interfere with an established pregnancy. Rather, it decreases the likelihood of a woman becoming pregnant. Yet, while a report published in Contraception in November 2010 concluded that Plan B works only by delaying or preventing ovulation,17 other studies have predicted that Plan B could "inhibit implantation of a fertilized egg in the endometrium."16 This possibility is significant to some religious groups who contest the FDA's definition of pregnancy, arguing that pregnancy begins upon fertilization rather than implantation.5 To those in agreement with this latter definition of pregnancy, any drug that prevents or hinders implantation of a fertilized egg would be considered an abortifacient. Since studies exploring the mechanism of action of levonorgestrel contraceptives have yielded varied results as to whether implantation is affected, pro-life proponents have deemed scientific inquiries inconclusive on the matter.16

Reproductive physiologist Horacio B. Croxatto, MD, of the Chilean Institute for Reproductive Medicine, Santiago, Chile, argues that implantation is not affected by levonorgestrel emergency contraceptives. From a consolidation of his studies on the effects of levonorgestrel on the reproductive cycle of female rats, monkeys, and humans, he concluded that Plan B acts by interfering with ovulation rather than postfertilization events.18-21 If Dr. Croxatto's conclusions were to be verified in such a way as to dispel residual doubts about Plan B's mechanism of action, the argument that Plan B was an abortifacient would be null and void. Yet, this type of consensus appears unlikely.

In an academic review updated in June 2011, James Trussel, PhD, and Elizabeth G. Raymond, MD, state that emergency contraceptives and all "regular hormonal contraceptives such as the birth control pill, the implant Implanon, the vaginal ring NuvaRing, the Evra patch, and the injectable Depo-Provera, and even breastfeeding…may at times inhibit implantation of a fertilized egg in the endometrium."16 This statement fuels the fire of the "Plan B is abortion" argument, by validating the belief that levonorgestrel can inhibit implantation. However, it also extends this possibility to all other forms of birth control. If this is indeed the case, then those who object to the sale of Plan B could theoretically object just as stridently to the sale of regular birth control options. To protest against Plan B while dispensing traditional oral contraceptives would seem to go against Drs. Trussel and Raymond's proposal that the two work via the exact same mechanism.

Patients reading the above contradictory reports may find themselves hesitant to pick a side of the Plan B debate. Not only must patients choose at which point they believe pregnancy begins, but they must wade through conflicting evidence on the drug's mechanism of action. Furthermore, patients who are themselves apathetic to the abortion issue may lose faith in pharmacists whose objections to Plan B are based on such inconclusive evidence.

Patients who note the shared active ingredient and mechanism of action between Plan B and traditional oral contraceptive options are likely to wonder why women cannot simply take a higher dose of regular birth control pills to have the same effect. The truth is, they can, and guidelines have been developed explicitly for this purpose. Women and Infants Hospital in Providence, Rhode Island, and the Office of Population Research at Princeton University offer conversion tables of many major birth control pills that can be taken at emergency contraceptive doses, a summary of which can be found in TABLE 3.16,22 Taking combined estrogen and progestin pills in this manner has been historically known as the Yuzpe regimen, named after the Canadian physician who first provided empirical evidence for the efficacy of high-dose contraceptives for emergency contraception as an off-label use.16 However, it is generally recommended to take a progestinonly pill such as Plan B for emergency contraception rather than a high dose of the combined progestin and estrogen pills normally taken as daily birth control. This is because progestin-only emergency contraception has greater efficacy than estrogen and progestin pills, reducing the chance of becoming pregnant after unprotected sex by 88% rather than 75% with the combination pill. Additionally, progestin-only pills are less likely to cause the side effects of nausea and vomiting that can occur with high doses of the combination pill. Though at a lower risk for nausea and vomiting, patients taking Plan B should still be informed of the potential for these side effects as well as for headache, dizziness, fatigue, breast tenderness, lower abdominal pain, unexpected bleeding and slight alterations in time of next menstruation.1

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The Practical Debate

The ethical dilemma is not the only factor that influences opinions regarding whether Plan B should be dispensed. In fact, some patients and practitioners remain wholly indifferent to the raging controversy over implantation and abortion. Rather, these individuals choose to weigh in on the issue from a practical standpoint.

Arguments against OTC Plan B are rooted in considerations of physician supervision and STD acquisition rates. Critics are apprehensive that increased access to the drug discourages women from seeing their gynecologists or primary care physicians.5 Since there is no need to seek medical attention before taking the drug, some individuals are worried that other consequences of unprotected sex, such as STDs, may go undetected. Furthermore, there are claims that women will be more sexually promiscuous if they know that the option for emergency contraception exists.7 An increase in unprotected sex secondary to diminished fear of pregnancy has also been believed to drive up rates of STD acquisition.

However, these concerns have been largely dispelled. OTC Plan B has gained the support of the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Medical Association.5 The approval of these associations conveys that physicians are not concerned about Plan B reducing the frequency with which women seek care for reproductive health. Furthermore, it is not practical to expect women to schedule a physician visit immediately after unprotected sex, as they may need access to emergency contraception on nights or weekends when physician's offices are typically closed. The assertion that access to Plan B will increase unprotected sex and STDs has also been disproved. A 2005 study conducted by the Center for Reproductive Health Research and Policy at the University of California, San Francisco concluded that easier access to emergency contraceptives does not make a woman more likely to engage in unprotected sex, nor does it predispose her to discontinue other contraception methods.25

Among their defenses, proponents of Plan B cite cost-effectiveness, abortion rate declines, and the household as the proper place for contraception discussions and decisions. Paramount to their stance is the notion that Plan B could save significant health care dollars for both state Medicaid programs and private insurers. According to the Comptroller's Office report "Emergency Contraception in New York State," the state could save $452 million annually by making emergency contraception such as Plan B more accessible.26 For these kinds of cost savings to be achieved, education on the availability of emergency contraception would also be necessary, as only 55.9% of sexually active New York City high school females and 40.1% of high school males were aware of emergency contraception in 2007.27 Prevention of teen pregnancy is financially beneficial, as "teens who have children are less likely to finish high school, have lower earning potential, are more likely to depend upon public welfare assistance and are more likely to have larger families, thus increasing the financial burden on the mother and society."28

Another contributory factor to cost savings is the number of abortions avoided due to emergency contraception use. Though this argument is colored by whether one believes that emergency contraceptives like Plan B are abortifacients, the medical definition of abortion will suffice for the purposes of this discussion. In an analysis done by the Alan Guttmacher Institute, it was found that emergency contraception was responsible for preventing 51,000 abortions in 2000, a year after Plan B was released onto the market.29 In view of the statistic that emergency contraception is tied to 46% of the total decline in abortions from 1994 to 2000,29 it is valid to propose that better access to emergency contraceptives would result in further decreases in abortion rates. Advocates for Plan B's nonprescription status further contend that decisions on sexual activity and contraception should be left to the discretion of a family unit. Susan F. Wood, PhD, former head of the FDA's Office of Women's Health, made a convincing appeal in regard to this stance. When questioned as to whether it is appropriate to allow teenagers access to Plan B, Dr. Wood replied, "Have we asked that question about other contraceptive methods? Are we going to label [sic], take condoms behind the counter? Make them prescription? I don't think we should…I think most Americans would like to leave those decisions as private decisions, and decisions within the family."5 If it is appropriate to have condoms widely available for sale and often distributed freely among high school and college students, it follows that it must also be appropriate for women to have access to alternative contraceptive methods. Indeed, the reason contraceptive methods such as condoms are promoted so emphatically is that health care workers have determined it is better to equip teenagers with the tools they need to protect themselves than to hope that they will choose to abstain sexually.

Effects on Patient Care

The dissension about Plan B can have significant effects on patient care. In the community, patients may feel ashamed, embarrassed, or condemned for their use of emergency contraception. Women who have previously taken emergency contraception may feel regretful if they later read a news report that likens Plan B to an abortion pill. If patients are denied their right to consultation regarding Plan B, essential information regarding its appropriate use as a backup method may not be communicated. The uninformed patient may not understand that Plan B does not provide protection against STDs and remains inferior in efficacy and cost to traditional birth control methods. In the hospital, patient care can also be compromised because of biases against Plan B. A survey done of Connecticut hospitals in 2006 found that only four out of 10 victims of sexual assault were even informed of the option for emergency contraception.30 This finding is likely influenced by the fact that many Catholic hospitals do not support treatment with emergency contraceptives, although the U.S. Conference of Catholic Bishops does authorize their compassionate use.30 Further perpetuating this lapse in patient care is the omission of emergency contraceptives from a sexual assault treatment protocol written by the Department of Justice in 2005,31 despite the fact that the American Medical Association endorses Plan B's value in this patient population.30

Conclusion

Patients are ultimately the ones most affected by the turmoil surrounding Plan B, and pharmacists must be prepared to address patient concerns. Pharmacist-provided patient education is essential in light of conflicting media reports. Though the coverage on Plan B is relatively all encompassing, it can be daunting for patients to evaluate all sides of the issue. With the debate so staunchly divided, media reports often take either a steadfastly conservative or liberal tone. Patients can misinterpret differences in opinion between news reports as evidence of inaccuracy. Case in point is the controversy over whether Plan B causes abortion. A medically based article may clearly state that Plan B is not the abortion pill, whereas a faith-based article may condemn use of the drug as immoral. It is challenging for a patient to reconcile these two views without the unbiased support of a pharmacist. Though pharmacists are entitled to their own beliefs, the profession should espouse that all pharmacists present a complete and accurate summary of all available facts to their patients. Severing the patient–pharmacist relationship because of a difference in opinion on emergency contraception would compromise everything that the profession stands for: promoting patient care, fostering patient satisfaction, and advocating for the profession of pharmacy.

REFERENCES

  1. Office of Population Research at Princeton University and Association of Reproductive Health Professionals. The Emergency Contraception Website. http://ec.princeton.edu/. Accessed September 10, 2011.
  2. FDA scientist was told nonprescription Plan B application would be rejected ‘to appease the administration's constituents,' deposition says. Kaiser Network. August 4, 2006. www.kaisernetwork.org/daily_reports/ rep_index.cfm?DR_ID=38921. Accessed March 2, 2011.
  3. Center for Reproductive Rights. Emergency contraception timeline. May 26, 2011. http://reproductiverights.org/en/emergency-contraceptiontimeline. Accessed June 8, 2011.
  4. Rovner J. Timeline: the debate over Plan B. National Public Radio. August 28, 2006. www.npr.org/ templates/story/story.php?storyId=5725514. Accessed July 8, 2011.
  5. Schorn D. The debate over Plan B. CBS News. 60 Minutes. November 27, 2005. www.cbsnews.com/ stories/2005/11/22/60minutes/main1068924_page3. shtml?tag=contentMain;contentBody. Accessed July 6, 2011.
  6. Harris G. FDA approves broader access to next day pill. NY Times. August 25, 2006. www.nytimes.com/ 2006/08/25/health/25fda.html?pagewanted=2&ref= planbcontraceptive. Accessed March 2, 2011.
  7. Associated Press. FDA approves Plan B for 17-yearolds. Fox News. April 22, 2009. www.foxnews.com/ politics/2009/04/22/fda-approves-plan-b-year-olds/. Accessed March 2, 2011.
  8. Roe v. Wade, 401 U.S. 113 (1973).
  9. National Conference of State Legislatures. Pharmacy conscience clauses: laws and information. Updated February 2011. www.ncsl.org/default.aspx?tabid=14380. Accessed September 10, 2011.
  10. American Pharmacists Association. Government Affairs Issue Brief: Federal Conscience Clause.March 2009. www.pharmacist.com/AM/Template. cfm?Section=Home2&TEMPLATE=/CM/ContentDisplay.cfm&CONTENTID=15688. Accessed March 2, 2011.
  11. Pharmacy board takes another run at Plan B rule. News Tribune. July 15, 2010. www.thenewstribune.com/ 2010/07/15/1264410/pharmacy-board-takes-anotherrun.html. Accessed July 9, 2011.
  12. Schrader J. Board of pharmacy OKs rule allowing for ‘conscientious' refusals. News Tribune. November 5, 2010. www.thenewstribune.com/2010/11/05/1410620/ board-oks-drug-referrals.html#storylink=mirelated. Accessed March 2, 2011.
  13. Strauss S. Planned Parenthood files complaint against Nampa pharmacist. Idaho Press-Tribune. January 12, 2011. www.idahopress.com/news/ article_528847ac-1e9f-11e0-8247-001cc4c03286.html. Accessed March 2, 2011.
  14. Tirelli A, Cagnacci A, Volpe A. Levonorgestrel administration in emergency contraception: bleeding pattern and pituitary-ovarian function. Contraception. 2008;77:328-332.
  15. Lexi-Comp Online [Internet database]. Hudson, OH: Lexi-Comp, Inc; 2011. www.lexi.com. Accessed July 8, 2011.
  16. Trussel J, Raymond EG. Emergency contraception: a last chance to prevent unintended pregnancy. March 2011. http://ec.princeton.edu/questions/ec-review.pdf. Accessed September 10, 2011.
  17. Gemzell-Danielsson K. Mechanism of action of emergency contraception. Contraception. 2010;82: 404-409.
  18. Duclayan G. Emergency contraception's mode of action clarified. Population Briefs. 2005;11(2):3. www.popcouncil.org/pdfs/popbriefs/pbmay05.pdf. Accessed March 2, 2011.
  19. Croxatto HB, Brache V, Pavez M, et al. Pituitaryovarian 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.
  20. Ortiz ME, Ortiz RE, Fuentes MA, et al. Post-coital administration of levonorgestrel does not interfere with post-fertilization events in the new-world monkey Cebus apella. Hum Reprod. 2004;19:1352-1356.
  21. Muller AL, Llados CM, Croxatto HB. Postcoital treatment with levonorgestrel does not disrupt postfertilization events in the rat. Contraception. 2003;67: 415-419.
  22. Emergency contraception provider information. Providence, RI: Women and Infants Hospital. December 2009. www.womenandinfants.org/documents/ CoE_Provider_12_09.pdf. Accessed July 8, 2011.
  23. Drug Facts and Comparisons 4.0 [Internet database]. St. Louis, MO: Wolters Kluwer Health, Inc; 2008.http://online.factsandcomparisons.com/index.aspx. Accessed July 8, 2011.
  24. Mendez M. Emergency contraception: a review of current oral options. West J Med. 2002;176:188-191.
  25. 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.
  26. Sherman MM. Emergency contraception in New York state: fewer unintended pregnancies and lower health care costs. Office of the State Comptroller. November 2003. http://ec.princeton.edu/ news/emergencycontraceptionreport.pdf. Accessed September 10, 2011.
  27. Table 5.5 percentage of NYC public HS students who have heard of emergency contraceptive pills, YRBS 2007. http://home2.nyc.gov/html/doh/downloads/excel/ms/ms-teen-preg-table5-5.xls. Accessed September 10, 2011.
  28. Johnson R, Nshom M, Nye AM, Cohall AT. There's always Plan B: adolescent knowledge, attitudes and intention to use emergency contraception. Contraception. 2010;81:128-132.
  29. Wind R. Emergency contraception (EC) played key role in abortion rate declines. News release. Guttmacher Institute. December 17, 2002. www.guttmacher.org/media/nr/2002/12/17/nr_340602. html. Accessed March 2, 2011.
  30. Compassion for rape victims. NY Times. February 4, 2007. www.nytimes.com/2007/02/04/opinion/ CThospitals.html?_r=1&ref=planbcontraceptive. Accessed March 2, 2011.
  31. Advocacy groups criticize federal government for omitting EC information from DOJ rape survivor treatment guidelines. Kaiser Health News. January 7, 2005. www.kaisernetwork.org/daily_reports/rep_index. cfm?hint=2&DR_ID=27517. Accessed March 2, 2011.
  32. ella. Watson Pharma, Inc. www.ella-rx.com. Accessed September 2, 2011.
  33. Next Choice. Watson Pharma, Inc. http://mynextchoice.com. Accessed September 2, 2011.
  34. Plan B One-Step. Teva Women's Health, Inc. www.planbonestep.com. Accessed September 2, 2011.

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