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To dispense or not to dispense: a pharmacist’s right to refuse

To Dispense or Not To Dispense: A Pharmacist’s Right To Refuse
By: Jon Rys
It is 4:00 am. Stephanie J. has just left the hospital after suffering a terrifying ordeal. The night before, she was the victim of a sexual assault. On her way home she stops by a local community pharmacy to have a prescription filled for an emergency contraceptive. This medication will prevent her from becoming pregnant and carrying the baby of the assailant who raped her the previous night. She is distraught and exhausted. As she hands the prescription to the pharmacist, he politely explains to her that he will not fill the prescription. Stephanie is perplexed and asks the pharmacist what the problem is. She just received this prescription from the doctor and it is perfectly legal and prescribed appropriately. He tells her that filling this type of medication is against his moral values and he will not give her the medication. Stephanie begs and explains what a terrible evening she has had, and how she just wants to get this medication into her system as soon as possible. The pharmacist apologies and expresses concern. He tells her that she can take the prescription elsewhere. This is the only 24 hour pharmacy in town and Stephanie must go home disappointed and wait in fear for four hours until another pharmacy in This vignette presents an issue facing the practice of pharmacy and pharmacists across the country. Should pharmacists have the right to refuse to dispense medications based on moral grounds, or as a matter of conscientious objection? While this vignette focuses on emergency contraception, several other medications and situations present similar moral issues for pharmacists. These include abortifacients, oral contraceptives, medications used for physician assisted suicide, end of life doses, and pain management. Pharmacists must address these ethical dilemmas throughout their careers. Most pharmacists must deal with this on an every day basis. In order to procure an ethical decision on whether pharmacists should have the right to refuse, this quandary must be connected to some normative principles of ethics. The first principle to discuss is autonomy. According to the Stanford Encyclopedia of Philosophy, autonomy is, “An idea that is generally understood to refer to the capacity to be one's own person, to live one's life according to reasons and motives that are taken as one's own and not the product of manipulative or distorting external forces.”1 From the patient’s point of view, this principle can be applied to a pharmacist’s right to refuse by asking the question, “Should a pharmacist respect the autonomy of a patient to allow him/her to do what he/she wants with his/her own body?” The patient should be in control of his/her own life. The pharmacist should respect the wishes of the patient and fill the prescriptions as requested. From the conscientious objecting pharmacist’s point of view, the pharmacist has his/her own autonomy to act how he/she pleases. If a pharmacist feels dispensing a medication is amoral, then no external entity Another ethical normative principle to discuss is nonmaleficence. This is the theory that states, “first, do no harm.” A pharmacist would be in violation of nonmaleficence by administering any drug that will cause any harm. For example, administering an abortifacient will cause harm to the early developing fetus. Similarly, dispensing a high dose of a medication in physician assisted suicide will end a patient’s life and cause great harm. Along with the principle of nonmaleficence, is the principle of beneficence. Beneficence, simply put, tells us to do good. The predicament with this principle is in defining “good.” According to a patient who is suffering from terminal cancer and wants to end his/her life, the “good,” would be to respect his/her wish and dispense a lethal dose that has been prescribed. In doing this, however, the pharmacist would be violating the principle of nonmaleficence, by directly causing harm. The pharmacist, however, would be respecting the patient’s autonomy. In applying these normative principles of ethics, it is clear that the pharmacists’ right to refuse to dispense based on moral beliefs is clearly an ethical dilemma. It is now important to look at the medications and situations which are causing this predicament. Abortifacients are substances that induce abortion. There are several medications that are capable of and edications commonly used to induce abortion. Mifepristone (Mifeprex) inhibits the actions of progesterone at its receptors, resulting in the termination of pregnancy. It is FDA approved to cause abortion through 49 days of pregnancy. It is often used in combination with misoprostol (Cytotec), a prostaglandin E1 analogue, which causes uterine contractions and expulsion of the fertilized egg or fetus from the uterus. Misoprostol is not FDA approved for this purpose.2 High doses of estrogen cause a rapid shedding of the endometrium in the uterus, which significantly decreases the chance of the fertilized egg attaching to the uterine wall. It can also inhibit ovulation all together.3 Plan B is an emergency contraceptive product manufactured by DuraMed for this purpose. It comes in a package of two tablets, each containing 0.75 mg of a single active steroid ingredient, levonorgestrel. The patient is instructed to take one table as soon as possible after having unprotected sex or in cases of sexual assault. The patient then takes another tablet 12 hours after the first dose. If it is taken within 72 hours after unprotected sex, it will decrease the chance of pregnancy by up to 89%. The manufacturer recommends that Plan B is not for routine use.4 The FDA has also approved Preven which is similar to Plan B, but contains ethinyl estradiol and levonorgestrel. It is used for the same purpose. Preven is provided in a kit containing four tablets and a urine pregnancy test to determine if the patient is already pregnant. Preven has voluntarily been removed from the U.S. market due to the superior sales of Regular oral contraceptives can also be used as emergency contraceptives. The FDA recognizes this use of Ovral, where the patient can take two tablets per dose. Also, Nordette, Levlen, Levora, Lo/Ovral, Triphasil, Tri-Levlin, or Trivora are approved by the FDA as emergency contraceptives at doses of 4 tablets per dose, as well as Levlite, in which the patient is instructed to take 5 tablets. With all of these medications, a second dose must be taken 12 hours after the first, as is done with the Plan B and Preven. 3 As indicated above, there are several medications available to induce abortion and prevent pregnancy. Along with the controversy surrounding abortion, there is the ethical issue of whether a pharmacist should have the right to refuse to dispense these medications based on the principle of conscientious objection, due to moral or religious beliefs. This issue has been further accelerated due to the fact that the FDA has approved Plan B for over the counter sale to patients 18 years old and above as of August 24, 2006.5 This has made emergency contraception more readily available to patients, and has increased the pressure on pharmacist whom feel the use of this medications is immoral. The debate continues as to whether these pharmacists should be allowed to abstain from dispensing these medications. Another area of medicine in which pharmacists may object to filling prescriptions is in physician-assisted suicide. According to the American Medical Association (AMA), “Physician- assisted suicide occurs when a physician facilitates a patient's death by providing the necessary means and/or information to enable the patient to perform the life-ending act (e.g., the physician provides sleeping pills and information about the lethal dose, while aware that the patient may commit suicide).”6 This happens when a patient is terminally ill or in severe pain that will not improve, and the patient has come to the conclusion that death is the only way to end the suffering. Physician-assisted suicide is somewhat distinguishable from euthanasia, in that the patient is administering the end of life dose to themselves. This is a very prominent issue in the state of Oregon, where physician-assisted suicide is legal. Oregon passed the Death with Dignity Act in 1997, allowing terminally ill patients to end their lives. There are several restrictions and regulations involved, but in essence, a physician prescribes a lethal dose of a medication, and the patient self administers the drug to cause death. Other medical practices that facilitate death, which are distinguishable from physician-assisted suicide include: terminal sedation, , and administration of pain medications at
doses that will lead to respiratory depression and death.7 Pharmacists often will be involved in all of these circumstances by performing order review in hospitals and dispensing these medications in community pharmacies. The issue of whether a pharmacist should be able to refuse to dispense or endorse the medications used in these practices is an ethical issue that In addition to controversial use of pain medications in facilitating death, some pharmacists may also refuse to dispense medications in pain management because of moral objections. Pain management is very important to relieving the suffering in patients. Proper management of pain greatly improves quality of life. There are many ethical issues related to pain management. A pharmacist may decide not to fill a prescription because he or she feels the medication is more potent than what is required for the ailment. For example, a pharmacist may feel that strong opioids are not needed for a broken foot. There are also different perceptions of pain based on cultural beliefs. Studies show that belonging to a particular ethnic group makes an individual respond to pain differently.8 Pharmacists with different cultural backgrounds may bring their own experiences of pain with them as they practice. Should these pharmacists be able to refuse to dispense pain medications, based on their experiences and ideals of morality? A pharmacist may also feel that in dispensing an addictive narcotic, they are introducing the patient to substance abuse, detrimental to the patient’s mental and physical health. In this situation the pharmacist may feel they are violating the principle of nonmaleficence previously discussed. We have now covered several instances where pharmacists may refuse to dispense medications based on personal moral ideals. It is now important to see how laws and regulations affect this issue, as well as the opinions of professional and religious organizations. Several states across the country have enacted policies with regard to the pharmacist’s rights to refuse. This issue has been greatly debated and brought up in legislature in nearly all states. It is generally recognized that pharmacists have the duty not to fill improper prescriptions. This indicates that pharmacists are permitted to refuse to dispense medications. The grounds on which they can abstain from dispensing are the issue. For this reason many states have issued “refusal clauses” or "conscience clauses." These clauses allow pharmacists to make a personal choice to refuse to dispense prescriptions based on their own principles or values. Some states have clauses specific to certain medications. For example, Arkansas, Georgia, Mississippi, and
South Dakota have passed laws which allow pharmacists to refuse to fill emergency contraceptives. Mississippi law goes on to specify that pharmacists, and other healthcare providers, can deny any health service if it interferes with religious or ethical background.9 Other state laws are broad in nature and do not specifically mention pharmacists. Many states have bills in the 2007 legislature regarding the rights of pharmacists to refuse. California has some interesting accompaniments to their "conscience clauses." California allows pharmacists the right to refuse to dispense medications based on ethical, moral, or religious grounds. The law goes on to state that pharmacists can only refuse, “when their employer approves the refusal and the woman can still access her prescription in a timely manner.”9 A new bill signed into law on September 26, 2006 requires, “The State Board of Pharmacy to create and provide a sign informing a patient of his or her right to timely access to a prescribed drug or device that a licensed pharmacist has refused to dispense based on ethical, moral, or religious grounds. The bill would require pharmacists authorized to make such a refusal, or their employers, to visibly place the sign at or near the entrance of the business.”9 This will give patients an idea of what pharmacies will be able to provide them with services they need. This may also cause less confusion and disruption when patients are denied the ability to fill certain prescriptions. It will be interesting to see if similar stipulations are added to clauses in other states as awareness of these actions spreads. While these previously mentioned states allow pharmacists the right of conscientious objection regarding dispensing medications, some states forbid this. In November 2007, the state of New Jersey added a law stating, “A pharmacist shall not refuse to dispense or refill a prescription or medication order solely on the grounds that to dispense or refill the prescription or medication order would contravene the pharmacist's philosophical, moral or religious beliefs.”10 Illinois previously had an emergency rule prohibiting pharmacists’ right to refuse. The rule stated that pharmacists must dispense FDA approved contraceptives. 9,11 Recently that rule has been adapted to allow pharmacists to have the prescription remotely reviewed and verified by an off-site pharmacist. The medication can then be dispensed by the pharmacy owner or other employee. Morally objecting pharmacists are still disappointed in that they are indirectly providing the medication to the patient. Pennsylvania, North Carolina, and Massachusetts also have regulations that imply pharmacists must dispense or transfer all medications if appropriately prescribed.11 Several states, including these mentioned, have bills currently in the legislature both for and against the pharmacist right of conscientious objection. It will be interesting to see which of these will be incorporated into state law. In addition to state laws for and against the right to refuse, many professional organizations have weighed in with opinions on this issue. Some of the major pharmacists’ organizations have expressed support for the pharmacist’s right. The American Society of Health-System Pharmacists (ASHP) is a national organization with over 30,000 members. They include pharmacists practicing in a variety of settings including hospitals, long term care facilities, and health maintenance organizations. They represent a diverse group of pharmacists who are affected by the right to refuse based on moral principles in different ways. The organization states, “ASHP recognizes a pharmacist’s right to decline to participate in therapies that he or she finds morally, religiously, or ethically troubling and supports the establishment of systems that protect the patient’s right to obtain legally prescribed and medically indicated treatments while reasonably accommodating in a nonpunitive manner the pharmacist’s right of conscience.”12 The group feels that it is important to respect the pharmacist’s right to not partake in acts deemed personally immoral, but also sees the need for patients to obtain the medications prescribed to them. They also want their members (pharmacists) to understand the issue of conscientious objection, so they have published the following guideline, stating pharmacists 1. His or her own views regarding controversial drugs and topics. Knowing the situations that are likely to present an ethical or moral problem ahead of time can help avoid potential problems in practice . Make employers and coworkers aware of any objections that are held, and try to determine how situations will be handled 2. The policies and procedures of his or her employer. As long as it does not violate state or federal law, employers have the right to set any policy that they choose regarding this issue. Ensuring employment with an entity that shares the practitioner’s viewpoint on this issue can help avoid conflict in future 3. The laws and board of pharmacy rules in his or her state. Legislation regarding this dynamic issue is quickly changing. Regardless of the pharmacist’s or employer’s viewpoints, state law will take precedent. Violating board of pharmacy rules, whether actual legislation or not, can result in injunctions against a practitioner’s license, and violation of state law can result in fines and even jail time. 4. How to voice his or her opinion. If a practitioner has especially strong views on this issue, it is his or her duty to make those views known to the legislative bodies that are addressing the issue. Probably the single most effective means of doing so is joining local, state, and national professional organizations that have strong lobbying groups. Direct communication with legislators is also important, as are education and encouragement of other professionals through continuing education and in-service training.12 The American Pharmacist Association (APhA) has also published its stance on the issue. The APhA has over 60,000 members which are not restricted to pharmacists. The group also includes pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in advancing the profession.13 An article in the APhA publication, Pharmacy Today, quotes APhA personnel as stating, “APhA supports the premise that pharmacists - like doctors and nurses - should not be required to participate in activities they find personally objectionable. But recognizing the pharmacist’s role in the healthcare system, APhA also supports the establishment of systems that ensure patient access to that legally prescribed therapy.”14 This is similar to the stance of the ASHP. Pharmacists should have the right, but also respect the patient’s autonomy and allow them access to medications, by referring them to a pharmacy or pharmacist who can dispense the drug. It is clear that pharmacy-focused professional organizations are for the rights of conscientious objection by pharmacists, but what about professional organizations for physicians? The American Academy of Family Physicians (AAFP) is composed of 94,000 family physicians, medical residents, and medical students. This group has offered its support for pharmacist’s right to refuse, stating that the right should be, “reasonably accommodated.” The group stresses the importance of governmental policy to be sure patients receive medications in a In addition to professional organizations, religious groups have chimed in on this topic. Religious beliefs are a major influence on what people feel is moral and immoral. Many religions are pro life and therefore are against abortion, contraception, and physician-assisted suicide. Most religions feel that their God has brought people life, and no one else shall take life, except God. The opinion is that physicians and pharmacists would be “playing God,” if they were to prescribe and dispense medications that prevent life and cause the end of life. Many religious groups support pharmacists’ conscientious objection and the right to uphold their We have discussed how state legislature, professional organizations, and religious groups have shared their view on this issue. Now we will look at the arguments for and against the pharmacist right of conscientious objection. One of the major arguments for the right to refuse is that nearly every other profession allows for denial of services deemed immoral. Why shouldn’t pharmacists be allowed the same right? Physicians are not forced to perform abortions, or to prescribe oral contraceptives. They do not have to prescribe medications for physician-assisted suicide or pain medications stronger than they feel appropriate. Patients who want these services or medications know they will have to seek alternate physicians who do participate in these acts. The argument is that it should be no different for pharmacists. Pharmacists are recognized as professionals of the healthcare community. They should be afforded their own autonomy and There is also the debate that in a democratic society, citizens have a right to conscientious objection. “It is supported by an honorable tradition regarding compulsory military service and civil rights.” 16 Pharmacist should be allowed this right in their practice environment. Members of a democracy should not be forced to perform acts against their will. Dispensing medications is no different. Along with this argument, comes the issue of freedom of religion. The First Amendment in the United States Constitution implies that there shall be no prohibiting of the exercise of one’s religion. Arguments for the right to refuse dispute that one should not have to go against his/her religious beliefs in order to keep his/her job as a pharmacist. The fact that pharmacists are not just servants to whatever a physician prescribes is another argument for the right to refuse.16 Pharmacists must practice with autonomy and use discretion in evaluating and dispensing prescriptions. If conscientious objection of pharmacists was to be completely outlawed, this may begin a slippery slope toward limiting pharmacists’ clinical judgments. Pharmacists have a duty to be critical in evaluating prescriptions to be sure medications are used safely and effectively. The argument is that this should not be hindered in There are also many arguments expressed against a pharmacist’s right to refuse. One of the main cases is that in choosing a career as a pharmacist, one assumes you will be dispensing all medications needed to serve your patients. People should not choose to become pharmacists if they have objections to moral issues they will be faced with in the practice of pharmacy and medicine. This can be related to the respect for the patient’s autonomy. The APhA Code of Ethics states, “A pharmacist respects the autonomy and dignity of each patient.”17 It can be argued that pharmacists are going against this code in refusing to fill their patient’s prescription. Advocates for this argument feel that pharmacists are judging their patients. Why should a pharmacist make a decision on whether a patient wants to end his/her suffering in physician- assisted suicide? A pharmacist should not reject the wishes of a patient to prevent pregnancy. There is also the argument that pharmacists are causing patient harm by not dispensing medications. An article published in Science by Dr. Marcia Greenberger and Rachel Vogelstein presents this issue. They indicate that, “Pharmacist refusals can have devastating consequences for women's health.”18 The article mentions that pregnancy in some women can cause great health risks and put women’s lives in danger. Also discussed is the fact that oral contraceptives are used for reasons other than to prevent pregnancy, such as amenorrhea, dysmenorrhea, and In a similar respect, pharmacists who have moral objections to dispensing certain pain medications may also be affecting patients’ health. Studies indicate that adequate pain control can improve clinical outcomes. Patients will also be less stressed and have less suffering if pain is properly managed. People against the conscientious objection of pharmacist also feel that a pharmacist should not be the one to decide how much pain and suffering a patient is going The issue of pharmacist abuse of conscientious objection has also been raised.19 If pharmacists can refuse to fill medications based on moral grounds, what are the limits? A pharmacist who feels an HIV patient transmitted the disease through promiscuous sexual activity may not want dispense his/her medications. Pharmacists may also refuse to fill an erectile dysfunction medication for an unmarried man if they are against extramarital sex.19 These are concerns of those against the right to refuse based on moral ideals. This document has addressed some of the most common reasons and situations where pharmacists may use conscientious objection in refusing to dispense medications. We have also covered how state legislature and other organizations have influenced this issue, as well as reasons for and against the matter. Now I will discuss my own opinion regarding this There are logical and proper arguments for and against the right to refuse. There is no cut and dry answer or solution to the problem. That is why this topic offers the opportunity for discussion of the ethical issues involved. It is my recommendation, that in choosing the profession of pharmacy, you must consider this issue. In any profession, you must consider your future work environment and evaluate the moral issues that will be present in that environment. Along with ASHP’s guidelines, I feel it is very important to understand the laws and regulations of the state in which you practice. You must also be aware of the policies of your employer. In the case of a pharmacist not agreeing with the policies of the employer or the laws of the state, then it is the pharmacist’s duty to seek other employment. With regards to conscientious objection of the pharmacist, I feel that no pharmacist should have to perform any act against his/her moral and religious values. This must be balanced, however, with respect to caring for your patients. The key to a solution in this matter is balance. I feel that there should be “conscientious clauses,” allowing the right to refuse. Pharmacists are professionals and deserve that right as nearly all other professionals do. Pharmacists must also realize that patients’ needs must be met. It is the pharmacists’ duty to make sure patients are treated appropriately, regardless of personal beliefs. Pharmacists must respect the covenantal relationships made with patients. Their autonomy must be respected. Therefore, it is important that if a pharmacist refuses to dispense a medication, based on moral grounds, they make every attempt to provide an avenue for the patient to receive the medication. This must be done in a timely fashion, so that the patient’s health is not adversely affected by the pharmacist’s decision. An objecting pharmacist may still feel he/she is going against his/her morals by indirectly providing the medication to the patient. In this case, the pharmacist should choose to practice in an environment where this situation will not present itself. For example, practicing in religious healthcare settings, such as Catholic hospitals or Jewish pharmacies would I also am in agreement with the California law enacted that was mentioned previously. This law requires signage posted at the pharmacy to indicate the pharmacist’s right to refuse, as well as the patient’s right to still have access to their medication by other means. This will make patients aware of the conscientious objection clause and should decrease confrontations. For this issue to be resolved, everyone must be informed. The pharmacists and patients must realize and respect each other’s rights and wishes. The arguments for and against the right of pharmacists to refuse to dispense based on moral grounds will continue to be debated. Regardless of the pharmacists’ beliefs and the patients’ desires, no one should be judged. Respect, acceptance, and tolerance are the keys to resolving this issue. 1. Autonomy in Moral and Political Philosophy. Stanford Encyclopedia of Philosophy. www.plato.stanford.edu/entries/autonomy-moral/ (accessed 2007 Nov 24). 2. Micromedex® Healthcare Series [intranet database]. Version 5.1. Greenwood Village, 3. Dickerson L, Bucci K, Contraception. In: Dipiro, et al. Pharmacotherapy. Sixth ed. New York, NY: The McGraw-Hill Companies, Inc., 2005: 1459. 4. Package Insert. Plan B (levonorgestrel). Pomona, NY: Duramed Pharmaceuticals Inc., 5. FDA Approves Over-The-Counter Access for Plan B for Women 18 and Older Prescription Remains Required for Those 17 and Under. U.S. Food and Drug Administration. www.fda.gov/bbs/topics/NEWS/2006/NEW01436.html (accessed 2007 Nov 24). 6. E-2.211 Physician-Assisted Suicide. American Medical Association. www.ama- assn.org/ama/pub/category/8459.html (accessed 2007 Dec 3). 7. Braddock C. Ethics in Medicine: Physician Assisted Suicide. University of Washington School of Medicine. http://depts.washington.edu/bioethx/topics/pas.html (accessed 2007 Dec 3). 8. Lasch K. Culture and Pain. Pain: Clinical Updates. International Association for the 9. Pharmacist Conscientious Clauses: Laws and Legislations. National Conference of State Legislatures. www.ncsl.org/programs/health/conscienceclauses.htm (accessed 2007 Dec 3). 10. State of New Jersey: 212th Legislature. www.njleg.state.nj.us/2006/Bills/S1500/ 11. Hopkins D, Boss M. Pharmacists’ Right to Refuse to Dispense Prescriptions Based on Moral Grounds: A Summary of State Laws and Regulations. Hospital Pharmacy 2006;41:1176-78. 12. Evans E. Conscientious Objection: A Pharmacist’s Right or Professional Negligence? 13. About APhA. American Pharmacists Association. www.pharmacist.com/AM/Template.cfm?Section=About_APha2&Template=/TaggedPage/TaggedPageDisplay.cfm&TPLID=83&ContentID=8229 (accessed 2007 Dec 3). 14. Lamb E. Dispensing With Dilemma. Pharmacy Today 2005;11. Epub Aug 2005. www.pharmacist.com/AM/Template.cfm?Section=Search1&section=PT_Archive_PDfs_&template=/CM/ContentDisplay.cfm&ContentFileID=2275 (accessed 2007 Dec 5). 15. Pharmacists’ Right of Conscientious Objection. American Academy of Family Physicians. www.aafp.org/online/en/home/policy/policies/p/ pharmacistsright.html (accessed 2007 Dec 5). 16. Hepler C. Balancing Pharmacists' Conscientious Objections With Their Duty to Serve. Medscape. www.medscape.com/viewarticle/509672 (accessed 2007 Dec 5). 17. Code of Ethics for Pharmacists. American Pharmacists Association. www.pharmacist.com/AM/Template.cfm?Section=Code_of_Ethics_for_Pharmacists&Template=/CM/HTMLDisplay.cfm&ContentID=5420 (accessed 2007 Dec 5). 18. Greenberger M, Vogelstein R. Pharmacist Refusals: A Threat to Women's Health. 19. Cantor J, Baum K. The Limits of Conscientious Objection — May Pharmacists Refuse to Fill Prescriptions for Emergency Contraception? The New England Journal of Medicine 2004;351:2008-12.

Source: http://rxethics.org/rhys.pdf

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