Introduciotn

The Right To Refuse
Hail Abdullah
In recent years pharmacy counters have become a new front in the bitter battle over abortion. The refusal of some pharmacists to dispense emergency contraceptives (ECs) or abortaficient drugs all around the nation have been increasing. In Missouri, a pharmacist, citing personal moral grounds, refused to dispense an EC.1 In Texas, a pharmacist refused to dispense such a drug to a rape victim, and in Ohio, a pharmacist was fired from Kmart for obstructing access to emergency contraceptives and other birth control drugs.2,3 This has sparked a controversy of whether or not pharmacists should have the right to refuse to dispense ECs or abortive drugs based on their moral and religious beliefs. When a pharmacist is presented with a prescription for ECs or abortaficient drugs, which in the eye of pro-life pharmacists, are likely to kill an unborn baby, this pharmacist is left in a very difficult situation. The pharmacist can choose to refuse to dispense such medications and risk liability and disciplinary action or accommodate the patient and violate his or her moral and religious beliefs. To understand this issue better, we will look at some background information concerning the historical and present day use of emergency contraceptives. We will discuss the moral beliefs of some pharmacists regarding abortive drugs and ECs, and how such beliefs may conflict with the pharmacist's role as a drug provider and as a professional. The ethical and legal issues regarding the pharmacist's right to refuse to dispense based on personal beliefs will also be discussed. At the end a survey of pharmacy students will look at how religion, race, age, and gender shape people's opinion about this issue. In the 1960s, the Food and Drug Administration (FDA) approved the first oral contraceptive for marketing in the U.S.4 Since then, emergency hormonal contraception has been around through the off-label use of various types of oral contraceptives. For several decades, ECs have been prescribed for woman to reduce the risk of pregnancy after unprotected intercourse—in cases of contraceptive failures, unanticipated sexual activity, or sexual assault. Statistics show that in the early 1990s, one-third of EC prescriptions were used for rape survivors.5 Initially, high-dose estrogens were used as emergency contraceptives, but they had a five-day dosing regimen and severe adverse effects associated with them.6 Current forms of ECs include an estrogen-progestin combination (ethinyl estradiol with levonorgestrel), estrogen alone (ethinyl estradiol), and progestin alone (levonorgestrel). The FDA has approved 2 products to be used as emergency contraceptives—Preven and Plan B . Preven is an emergency contraceptive kit that includes four tablets containing 50 mcg ethinyl estradiol and 0.25 mg of levonorgestril, a home pregnancy test, and a patient information guide. The dosing regimen for Preven requires patients to take two tablets within 72 hours after unprotected intercourse, followed by the remaining two tablets 12 hours later.7 This product was discontinued in 2004 by the same company that manufactures Plan B (Barr Pharmaceuticals, Inc.) Plan B is a progestin-only product, which has been more effective and better tolerated than the combination product.8 When taken within 72 hours of unprotected intercourse, it has an 89% chance of preventing pregnancy. It operates in one of three ways: by preventing ovulation, interfering with fertilization, or interfering with implantation of fertilized egg in the uterine wall.9 B has become the only product in the market with an FDA indication for emergency contraception. In states such as Washington, Alaska, California, Hawaii, Maine, New Hampshire, and New Mexico, programs exist that allow woman to receive ECs from pharmacists without going to the doctor.10 In July of 2005, Massachusetts was set to become the eighth state to allow pharmacists to dispense ECs without a prescription, but Governor Mitt Romney chose to veto the bill, citing ECs as abortaficients.11 In these states, pharmacist's decision to refuse to dispense ECs will impact the life of some woman greatly. Barr Pharmaceuticals, Inc. have been trying to get Plan B to be available over the counter for woman who are 16 years of age or older since 2003. The FDA was supposed to issue a ruling on Barr Pharmaceuticals, Inc.'s subsequent application, but it has been delaying its decision on this matter. On August 26, 2005, the FDA has announced another delay of its decision on this matter citing concerns associated with difficulty in enforcing the over-the-counter age restrictions.12 While all hormonal products act primarily by inhibiting ovulation, abortaficients such as Mifeprex (mifepristone) cause termination of pregnancy after implantation of the fertilized egg to the uterine wall. Mifepristone is a glucocorticoid and progesterone receptor antagonist. It interrupts progesterone support to the endometrium and sensitizes the myometrium to prostaglandins. It increases the synthesis and decreases the metabolism of prostaglandins, causing menstrual bleeding, and placental function disruption.13 It can only be taken within 49 days of pregnancy. Pregnancy is dated from the first day of the last m in a presum occurring at mid-cycle. Patients taking mifepristone m 400 µg of misoprostol two unless a comp has already been confirmed . Currently mifepristone is available from doctors only, but pharmacists are usually the ones to dispense the misoprostol that go with it. If the FDA allows pharmacies to dispense mifepristone, then pharmacists will play an active role in drug-induced abortion. Other products that are use as abortaficients include methotrexate and high dose misoprostol early in pregnancy. For years, abortion has been a very important controversial subject in this country. Its importance can be seen during elections when candidates are pressured to clearly identify their position on this issue. People who are against abortion base their stance on moral and religious grounds. They strongly believe that ending the life of an unborn child is a sin. They recognize the sanctity of the unborn life that a pregnant woman would be bring, and that such life should not be destroyed at any stage of pregnancy. To take part in any action that leads to the loss of an unborn child after conception is equivalent to murder. Karen L. Brauer, president of Pharmacists for Life said "our group was founded with the idea of returning pharmacy to a healing-only-profession. What's been going on is the use of medication to stop human life. That violates the ideal of the Hippocratic oath that medical practitioners should do no harm.".14 Like Karen Brauer, some pharmacists don't view dispensing ECs or abortaficient drugs as part of the practice of medicine because such drugs do not prevent or heal, or manage the symptoms of a disease. These drugs cause the death of a human being. Pregnancy is not considered a disease, and therefore should not be stopped. While all people agree that pregnancy is not a disease, some believe that women should have the right to choose whether or not to have an abortion. Some rape survivors don't want to get pregnant after suffering a traumatic incident. They do not want to have something that reminds them of the awful event they had experienced. This is a very important point that pro-life pharmacist should be aware of. Everyone agrees that abortaficient drugs such as mifepristone cause abortion because they work after the fertilized egg has been implanted in the uterine wall. However, there is disagreement as to whether Plan B should be considered as an abortaficient drug. In this case a definition of pregnancy is necessary. While the most widely accepted definition of clinical pregnancy is implantation to delivery, pro-life groups including some pharmacists believe that life begins after conception.15 Some pharmacists believe that fertilization should be regarded as the beginning of life, and that ECs such as Plan B cause chemical abortion. Some experts argue that whether one believes that pregnancy begins with fertilization or implantation, emergency contraception use might not fit the concept of abortion because it is impossible to know whether conception has occurred when taking ECs.16 Some pharmacists also believe that dispensing such medications will be in violation of the ethical principle of non-maleficence. Those arguing for a pharmacist's right to refuse indicate that pharmacists are members of a profession that has its own code of ethics to which they all must abide by. Pharmacists serve a very important task in society by instructing patients on the appropriate use of medications and to ensure that the medications are safe and effective. Pharmacists use their clinical judgment when serving patients, which mean they can question a doctor's prescription if they deemed it inappropriate. Moreover, when pharmacists enter this profession, they are not required to forsake their moral and religious beliefs. Like physicians, nurses, and physician assistants, pharmacists should have the right to refuse to participate in abortion or other services that they believe violates their moral or religious convictions. Those who oppose the above view claim that pharmacists have a duty to serve their patients. The profession's code of ethics requires that "a pharmacist respects the autonomy and dignity of each patient" and "a pharmacist serves individual, community, and societal needs."17 Pharmacists are expected to put their patients' interest above their own. They claim that pharmacists willingly enter this profession and have a duty to dispense all prescriptions issued from a doctor without involving their moral values. Some pharmacists believe that if they are forced to do something that goes against their religious or moral beliefs, it would be a violation of their first amendment right. Others view the refusal of pharmacists to dispense ECs or abortaficient drugs as a step by pharmacists to impose their religious beliefs on their patients. It is also sometimes viewed as a violation of the pharmacist's codes of ethics, which states that "a pharmacist respects the autonomy and dignity of each patient".16 This would be true if the rights of pharmacists are ignored. If pharmacists are not supposed to use their clinical judgment when dispensing drugs and just follow the doctor's orders, then their autonomy is also violated. The patient's autonomy is violated when pharmacists refuse to dispense such medications base on moral grounds. This leads to the question of who is right. This is the dilemma that some pharmacists are faced with whenever they are presented with a prescription for ECs or abortaficient drugs. If the pharmacists dispense these medications they are fulfilling their professional duty toward their patients, but they are violating their moral convictions at the same time. If they refuse to dispense such medications, then they are interfering with their professional duty toward their patients. Sometimes pharmacists can be terminated by cause they refused to dispense such medications. An example of that is the current president of Pharmacists for Life, Karen Brauer, who in 1996 refused to fill Micronor , an oral contraceptive that maybe used as EC at a Kmart pharmacy. If pharmacists are not to refuse to dispense ECs or abortaficient drugs, do they have to stock such medications? If the answer is yes, then it is possible to say that all medical clinics should provide abortion services. This is not the case because laws exist that give physicians, nurses, and physician assistants the right to refuse participation in a procedure that conflicts with their moral or religious beliefs. Pharmacists believe that they should be protected as well. In a Drug Topics cover story, 82% of pharmacists surveyed believe that an owner-pharmacist has the right to deny an abortaficient based on the fact that the owner should have a right to decide what to stock and dispense to patients.18 People have different opinions as to what the right action should be, but there is no one easy answer to this issue. Time plays an important role in the efficacy of emergency contraceptives. A woman's likelihood of becoming pregnant increases the longer she waits to take an EC.19 When a pharmacist refuses to fill a prescription for an EC in an urban setting, a patient can take that prescription and go to another pharmacy. The same can not be said about women who live in rural areas since they may not have multiple pharmacies in their area. A poor woman may not have transportation or additional time or money to find a pharmacy that will dispense ECs.19 According to the American Pharmacist Association, a pharmacist who refuses services must make arrangements to ensure that patients get their medications.17 A woman who decides to take an EC has decided that she does not want to get pregnant. If she can not get an EC from a pharmacy because the pharmacist there does not want to dispense it to her, she might get pregnant and decide to have an abortion through a more risky procedure. Such actions might put the mother at greater risk for harm.16 Pro-life pharmacists will say that by not dispensing such drugs they are staying away from being involved in abortions, and so if someone else does it they are the ones committing the sin. Referring the patient to another pharmacy does not go well with some pharmacists because as one pharmacist put it "it is like saying I don't kill babies, but I know some one who does." By telling the patient where they can get their EC filled, the pharmacist is indirectly getting involved.14 Some people fear that if pharmacists have the right to refuse to fill prescriptions on moral, ethical, or religious beliefs, no one will know the extent to which pharmacists can use this right. A pharmacist might refuse to dispense antiretroviral drugs to an HIV-positive patient if the pharmacist thinks that the patient must have engaged in an immoral behavior.16 Similarly, a pharmacist who does not believe that HIV-positive mothers should get pregnant might not dispense a fertility drug to such a patient. The possibility of something like this can happen is very scant since all of the laws that have been passed to protect pharmacist's right to refuse have strict guideline as to when they can be applied. Many states pharmacy laws specify that it is the pharmacist's duty to refuse to dispense a drug if, in the pharmacist's professional judgment, the prescription does not seem to be valid or if filing the prescription could cause harm to the patient. What was not clear however is whether a pharmacist has the right to refuse to dispense based on personal moral or religious beliefs. Before 1998, no state board of pharmacy had adopted a conscious clause in the pharmacy laws. On March of that year, South Dakota became the first state to adopt a conscience clause, which protects a pharmacist who refuses to dispense a prescription because it can "cause an abortion, destroy an unborn child as defined by law, or cause the death of any person by any means of an assisted suicide, euthanasia, or mercy killing."20 This law sets these three criteria as a reason for refusal to dispense and this limits any improper use of this law by some pharmacists. Because of the intense debate that this controversial issue has created, many states are enacting laws to address whether pharmacists should have the right to refuse to dispense medications base on oral, ethical, or religious beliefs. As of April 2005, Georgia, Arkansas, and Mississippi, like South Dakota have adopted state laws to protect pharmacists who refuse to dispense ECs or abortive drugs based on moral or religious beliefs. Eight other states are considering similar measures.14,21 While some states are enacting laws that protect pharmacists' right to refuse, other states have done the opposite. On April1, 2005, the Governor of Illinois, Rod Blagojevich issued an emergency rule that ordered all pharmacists to dispense ECs or face consequences making Illinois the first state to enact such law.22 Although there have been numerous incidences in which pharmacists have refused to fill ECs and abortaficients, only one case has made it to court. This case involved a Kmart pharmacist, who in 2002 refused to fill a prescription for birth controls to a University of Wisconsin student, or transfer the prescription to another pharmacy. In this case, the administrative judge recommended that the pharmacist take ethics classes, make future employers aware of his beliefs, and pay the cost of the legal proceedings. 14 Legal protection of pharmacists' right to refuse is the goal of many pharmacists' organization including the American Pharmacists Association. Such laws would server two purposes: 1) Provide adequate protection against in the case that the pharmacist is sued by a patient or disciplined by employer: and 2) to prevent and discourage retaliation against the pharmacist. To understand how pharmacists' opinions are shaped by their religion, race, gender, and age, a survey of pharmacy students at Wayne State University and University of Michigan was conducted. The survey included 58 students in their second and third year of the Pharm. D program. The survey format is as follows: • Circle all that apply to you: 18-25 26-30 31-40 40-50 >50 Islam Judaism Hinduism Other Caucasian African American Arab American Hispanic American 5. Do you identify yourself as being a religious person? 7. Do you currently work as a pharmacy intern? Please read the following scenarios and answer the question. One hour before you are to close the pharmacy for Thanksgiving, a nervous 17 year old single woman walks into your pharmacy and presents you with a prescription for Plan B . She tells you that her doctor told her that she only has 24 hours for this drug to work, and that she want you to fill it as soon as possible. You know that all pharmacies in the area will closed the next day for Thanksgiving. 1. Do you believe that Plan B is an abortaficient? 2. Would you dispense Plan B ? 3. If your answer is No to question #1, would you refer the woman to another pharmacy where she can get Plan B ? 4. If you find out that the patient was raped, would that have changed you answer in question Please check all factors that influenced your decision in this Scenario, Religious beliefs Cultural background Professional Duty Others (please specify) _ AG, a 23 year-old woman comes to CBS pharmacy where you are the only pharmacist with a prescription for Misoprostol 500 mg. You know that a dose this high can only be used for one reason, to induce abortion. Fearing for the patient's safety, you approach the patient and asked if she is pregnant. She tells that she is pregnant, but she has decided she can't raise a baby on her own. 1. Would you dispense misoprostol knowing it will be used to induce abortion? 2. If you answered (N) to #1, then would you refer the patient to another pharmacy that would dispense such a drug? 3. If you find out that the patient was raped, would that have changed you answer in question Please check all factors that influenced your decision in this Scenario, Religious beliefs Cultural background Professional Duty Others (please specify) _ Do you believe that states should pass laws that protect a pharmacist's right to refuse to dispense ECs or abortaficient drugs if it violates their moral and religious beliefs? Disclaimer: This is a voluntary survey that is intended to be used in the Pharmacy Ethics and Professional Responsibility class. All information provided here will be kept Students' opinions about whether to dispense Plan B or not are illustrated in figure 1 below. These results are divided into subcategories based on religion, race, age, and gender. Religion and Plan B
Gender and Plan B
Abortaficient Drug Refer Patients to Gender and Plan B
Age and Plan B
(Figure 1) Plan B
When we look at the results of the survey we find that 20% of Catholic students and 25% of Muslim students consider Plan B an abortaficient drug and would refuse to dispense it because of religious and ethical beliefs compared to only about 8% of Protestant students. All of those who refused to dispense Plan B consider themselves religious, which shows that religion is a major factor that influences people's opinions about an issue like this. Not only did these students refuse to fill a prescription for Plan B , but they also would not refer the patient to another pharmacy that carries it even if the patient presenting the prescription is a rape victim. When race is considered, the proportion of students of Arab and Asian decent that refused to dispense Plan B appears to be greater than the proportion of Caucasian students. Although, 33% of all females surveyed considered Plan B to be an abortaficient drug, all of them chose to fill a prescription for Plan B . On the other hand 67% of males considered Plan B to be an abortaficient drug, and about half of those (33%) refused to fill a prescription for Plan B . Figure 2 below shows the survey results for questions in scenario # 2. The results are also divided into subcategories similar to those in Figure 1. When we look at data in figures 1 and 2, we can see that more students chose to refuse to dispense abortaficient drugs such as methotrexate or misoprostol compared to dispensing Plan B . Eighty percent of Muslim students, 67% of catholic students, 50% of Hindu students, and 36% of protestant students chose not to fill a prescription that will induce abortion. Although this is a high percentage, it appears that about half of those students who refused to fill it would refer a patient to another pharmacy that has it. About 50% of those that refused to fill it said that they would change their mind and dispense the abortaficient drugs if they find out that the patient is a rape victim. About seventy percent of females interviewed said that they would dispense an abortaficient drug compared to only 33% of males. With respect to race, it appears that more Arab-Americans and Asians would choose not fill a prescription for an abortaficient compared to Caucasians or African-Americans. Whether these results reflect pharmacist's opinion nationwide is unknown, but what they do show is that people's opinions about controversial issues such as this are influenced by factors such as religion, race and gender. Gender and Abortaficient
Religon and Abortaficient
Would Refer Patients to Race and Abortaficie nts
(Figure 2) Abortaficients
All students who refused to dispense Plan B or abortaficient drugs cited that their religious and ethical beliefs influenced their decision. On the other hand, students that decided to dispense these drugs cited professional duty, ethical beliefs, individual rights, and patients' autonomy as reasons for their decision to dispense Plan B . It is the pharmacist's professional duty to ensure that their patients receive the most optimal drug therapy, and to ensure that the patient's interests are placed ahead of their own. Like patients, pharmacists have rights too, and these rights should be acknowledged. A pharmacist who is presented with a prescription for ECs or abortaficient drugs should not be expected to dispense it if the pharmacist thinks it can lead to the destruction of a human life, a role that is completely the opposite of the pharmacist role as taking part in healing. Pharmacists like other healthcare professionals should be granted the right to refuse to dispense prescriptions that violate their moral and religious beliefs. It is also important for pharmacists to remember that responsibility to the patient must always be the top priority and that a right to withdraw must never be turned into a right to obstruct. When people consider this issue, they must examine the rights and obligations of both the pharmacist and the patient. One person's satisfaction must not come at anther person's expense. To make a decision about this issue, two possible solutions exist: an absolute right to refuse or no right to refuse. If pharmacists are given the right to refuse, this would respect the autonomy of pharmacists, but diminishes the professional obligation to serve patients. This would also limit the autonomy of the patient. If pharmacists are not given the right to refuse, this would force them to do things that violate their moral and religious rights. This is also problematic. Professional duty, ethical and religious beliefs, patient autonomy, and pharmacist's rights are all issues that play an important role in this controversy, and until a balance is created between them, this controversy will continue to exist. 1. Simon S. Pharmacist's new players in abortion debate. Los Angeles Times. March 2. Pharmacist refuses pill for victim. Chicago Tribune. February 11, 2004:C7. 3. Sweeney JF. May a pharmacist refused to fill a prescription? Plain Dealer. May 5, 4. Birth control. (Accessed on September 28, 2005 at http:www.orthotri- 5. Grossman, Richard A. &Bryan D. Grossman. (1994). "How Frequently Is Emergency Contraception Prescribed?" Family Planning Perspectives. 26(6), 240-1. 6. Thomas M. Postcoital contraception: contraception for the 21st century. Clin Ostet Gynecol. 2001;44:101-105. 7. American Pharmacists Association. Emergency Contraception: The pharmacist's Role. Washington DC; 2000. 8. Westhoff C. Emergency contraception. N Engl J Med. 2003;349:1830-1835. 9. Task Force on postovulatory methods of fertility regulation. Randomized controlled trials of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet. 1998;352:428-433. 10. Path--Program for appropriate technology in Health. Emergency Contraception Collaboration agreement Pilot Project. (accessed on October 10, 2005 at http:www.
12. The New York Times. U.S. Again Delays Decision on Sale of Next-Day Pill. (Accessed on November 15, 2005 at 13. Mifepristone. Clinical Pharmacology Web site. (Accessed on November 15, 2005 14. Stein, R. Pharmacists' Rights at Front Of New Debate: Because of Beliefs, Some Refuse To Fill Birth Control Prescriptions. (Accessed on November 23, 2005 at .) 15. National Institutes of Health. Regulation and Ethical Guidelines: Protection of human subjects. Title 45 CFR Part 46.202 (1983). (Accessed on November 23, 2005 at http:ohsr.od.nih.gov/guidelines/45cfr46.html#146202). 16. Cantor, J and Baum, K. The Limits of Conscientious Objection-May Pharmacists Refuse to Fill Prescription for Emergency Contraception? N Engl J Med. Nov 4, 2004:351(19);2008-2013. 17. American Pharmacists Association. Code of Ethics for Pharmacists: preamble. (Accessed on November 20, 2005, at .) 18. Ethical Hot Spots. Drug Topics 1997;Jan 20:442-55 19. Brody JE. The politics of emergency contraception. New York Times. August 24, 20. Pharmacy Laws.(Accessed on September 03, 2005, at 21. Tennessee Bill Protects Pro-Life Pharmacists on Abortion Drugs. (Access on November 21, 2005 available at 22. Illinois Governor Mandates Pharmacists Dispense Abortion Causing Morning- After Pills or Face Consequence. (accessed on November 23, 2005, at .

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