Ongoing Challenges for Pharmacists
Abstract and Introduction
The pharmacist on duty at a community pharmacy in Oregon receives a phone call from a local physician who says he intends to write a prescription for a lethal dose of secobarbital to end a patient's life. The physician says that in his oncology practice, patients occasionally request physician-assisted suicide, which is permissible in Oregon. Now he has a patient who is suffering from cancer and has less than six months to live. The physician asks if the pharmacist is willing to dispense the medication.
Situations such as this already occur in Oregon and two other states, raising a number of important considerations for pharmacists, including patient counseling issues, legal requirements, moral and ethical concerns, and possible consequences for refusing to dispense the medication. So far in the ongoing controversy over physician-assisted suicide, the major focus has been physicians and patients. However, in most cases a pharmacist plays a large role in physician-assisted suicide—not only as a member of the interdisciplinary patient care team but also as the dispenser of lethal doses of medication.
Eligibility and Counseling
The legal foundation of physician- assisted suicide is Death with Dignity Act (DWDA) legislation, which has been enacted by Oregon and Washington; in 2008, a supreme court judge in Montana ruled in favor of legalized physician-assisted suicide. Oregon enacted its DWDA in 1994, and the law became effective in 1997. Oregon's DWDA permits a terminally ill patient to request a prescription for a self-administered lethal dose of medication to end his or her life. The patient must be at least 18 years of age, a legal resident of Oregon, capable of making and communicating health care decisions, and diagnosed with a terminal illness that will lead to death within six months.[1,2] The patient must make two oral requests to a physician for a lethal medication dose, at least 15 days apart, and provide a written request to an attending physician, the person with the primary responsibility for the patient's care and treatment of the terminal illness; the request must be signed before two witnesses.
The attending physician must refer the patient to a consulting physician to confirm the diagnosis and prognosis and determine whether the person is capable of making health care decisions. If either physician suspects the patient may be suffering from a psychiatric or psychological disorder that could impair judgment, the individual must be referred for a mental health evaluation. The psychiatrist or psychologist should evaluate the patient for mental disorders, including depression and delirium, and decision-making abilities.[1,2]
After those steps are completed, the prescribing physician must notify the patient of alternatives to suicide, including comfort care, hospice care, and pain management. The physician must also recommend that the patient notify his or her next of kin. Also, the patient may rescind the expressed desire for a lethal medication dose at any time, and the physician must explicitly offer an opportunity to rescind upon the second oral request.
A physician is permitted to dispense the medication directly to patients provided he or she is registered as a dispensing practitioner with the Oregon Medical Board and maintains a current Drug Enforcement Administration certificate.[1,2] Physicians issuing prescriptions to be dispensed at a pharmacy must notify the pharmacist in advance. The physician must either deliver the written prescription personally or mail it to the pharmacist. Once the prescription is filled, it may be obtained by the physician, the patient, or an agent of the patient (e.g., family member).[1,2] Oral medication counseling must be offered to the patient or patient's agent and provided in person, whenever practical, and in a private area; the pharmacist can offer to provide counseling over the telephone.
Drug Information Issues
Currently in Oregon, secobarbital is the medication most commonly prescribed for physician-assisted suicide, followed by pentobarbital. The lethal dose prescribed is typically 9 g of secobarbital in capsules or 10 g of pentobarbital liquid, to be consumed at one time.[4–6] The contents of the secobarbital capsules or the pentobarbital liquid should be mixed with a sweet substance such as juice to mask the bitter taste. Until the time of use, the medication must be stored out of reach of children and kept away from others to prevent unintentional overdose or abuse.
The pharmacist or physician should instruct patients to take the lethal dose on an empty stomach to increase the rate of absorption. The typical dose of pentobarbital as an oral hypnotic for adults is 100–200 mg at bedtime, and that of secobarbital is 100 mg orally at bedtime. Patients receiving the lethal dose of secobarbital or pentobarbital should be instructed to take an antiemetic (e.g., metoclopramide) about one hour before ingesting the barbiturate to prevent nausea and vomiting. Cases of vomiting after taking an antiemetic have been reported; in the event of vomiting after medication ingestion, patients should be instructed to have a family member contact the attending physician to determine the course of action. Also, patients should be instructed that if they decide not to end their life after ingesting the medication, they must contact emergency medical services to begin lifesaving measures.
Patients need to be informed of appropriate disposal methods in case the medication is not taken; the Food and Drug Administration provides guidance on that issue. Secobarbital and pentobarbital are not among the medications recommended for disposal by flushing, and they should be placed in the household trash after mixing with an unpalatable substance such as coffee grounds. Unused medications also can be brought to a drug "take-back" program involving law enforcement personnel. Patients are not permitted to return controlled-substance medications to a pharmacy.
Proper reporting by pharmacists to the Oregon Department of Human Services is mandated by the DWDA so the agency can collect information and publish an annual statistical report. Pharmacists are required to complete and submit, within 10 calendar days of dispensing a lethal medication dose, a pharmacy dispensing record form with the following information: the patient's name and date of birth; the prescribing physician's name and phone number; the pharmacist's name, address, and phone number; the medication and quantity dispensed; and the dates the prescription was written and dispensed.
Since the Oregon DWDA took effect in 1997, 460 patients have died by self-administration of a lethal dose of a prescription medication. In 2009, 95 prescriptions were written for lethal medications, resulting in 59 deaths (in the remaining cases, the medication was not ingested). About 80% of the patients had malignant cancer, and the most commonly ingested lethal medication was secobarbital (85% of cases). About 78% of the patients were 55–84 years of age. The time from ingestion to death ranged from two minutes to 4.5 days.[3,11]
The state of Washington passed a DWDA that mirrors Oregon's statute and became effective in March 2009. Participating pharmacists in Washington must submit the pharmacy dispensing record within 30 days of dispensing to the registrar of the state's Center for Health Statistics. The Washington State Department of Health issued its first report in March 2010. According to the report, a lethal dose of medication, usually secobarbital (89% of cases), was dispensed to 63 patients by 29 different pharmacists. Of those 63 patients, 36 individuals died as a result of ingesting the medication, 7 died without ingestion, and data are missing for 4 individuals; data collection for the remaining 16 individuals is pending. The most common reported illnesses were cancer (79%), respiratory disease or other illnesses (12%), and amyotrophic lateral sclerosis (9%). The required dispensing record form was submitted to the Department of Health for all 63 patients. The reported times from medication ingestion to death ranged from nine minutes to 28 hours.
Pharmacists and physicians cannot be held liable for participating in physician-assisted suicide in Oregon and Washington if they adhere to the legal requirements.[1,12] In December 2008, the Montana supreme court ruled that physician-assisted suicide is legal after a patient with terminal cancer sued the state in the case of Baxter v. Montana,[14,15] but legal requirements such as reporting regulations have not been established. A bill to ban the practice in Montana was introduced in the state legislative session on January 6, 2011, and a hearing scheduled for late January. Montana still has not established rules and regulations.
Physician- assisted suicide remains a very controversial topic throughout the country. Terminally ill patients, physicians, and pharmacists often have different beliefs about the practice. The Code of Ethics for Pharmacists, developed by the American Pharmacists Association (APhA) in 1994 and endorsed by ASHP, does not discuss physician-assisted suicide. The code describes the roles and responsibilities of the pharmacist with statements such as, "A pharmacist is dedicated to protecting the dignity of the patient," and "A pharmacist promises to help individuals achieve optimum benefit from their medications, to be committed to their welfare, and to maintain their trust." In the context of physician-assisted suicide, the code may be interpreted differently, depending on the individual pharmacist's perspective.
APhA does not endorse a specific moral position on the issue of physician-assisted suicide, according to APhA-adopted policies, but supports the use of pharmacists' professional judgment under such circumstances. ASHP issued a policy of neutrality on physician-assisted suicide in 1999; that document does not provide clear guidance for pharmacists regarding physician-assisted suicide and the pharmacist's role in dispensing lethal medications.[18,19] Pharmacists' right to "conscientious objection," or the refusal to participate in activities they consider to be against their moral, ethical, or religious beliefs, comes to mind when faced with the personal decision of whether to dispense a medication dose that is intended for use in ending a patient's life. The "pharmacist conscience clause" supported by APhA recognizes the pharmacist's right to conscientious objection but expresses the importance of ensuring that patients have access to therapy. The conscience clause seems to be in keeping with state laws on physician-assisted suicide, which clearly state that pharmacists are not required to participate in the DWDA by dispensing medication or to refer patients to participating pharmacists.[1,12] When Oregon's DWDA first became effective in 1997, physicians were not required to inform pharmacists of the purpose of a lethal medication dose; in 1999 the statute was amended to require that the pharmacist be notified of the intended use in advance.
Pharmacy owners in states with DWDA statutes must determine whether their establishment will participate in physician-assisted suicide so they may inform their employees and create written policies and procedures so that the staff is equipped to respond to physician requests. Staff meetings and continuing education may be beneficial to initiate discussion and provide an open forum for questions and concerns. A pharmacy might choose to issue a press release about its decision not to participate. The Washington State Hospital Association (WSHA) has developed draft guidance for issuing such press releases, as well as web page statements and model policy statements. A key point emphasized in the guidance is that nonparticipating facilities cannot prohibit their pharmacists from providing information on the DWDA and physician-assisted suicide to a patient upon the patient's request. Pharmacists may provide information but should refer a patient to the attending physician to discuss the request in detail, the WSHA guidance says. Also, pharmacists choosing not to dispense a lethal medication dose in a participating facility are permitted but not required to suggest a pharmacist willing to fill the prescription. Compassion & Choices, a nonprofit organization that advocates for more DWDA legislation and provides support and education, can be contacted to obtain contact information on participating pharmacists; a pharmacist may wish to have this information available for patients and physicians even if he or she has chosen not to participate in physician-assisted suicide or works at a nonparticipating facility.
Studies examining pharmacists' attitudes toward physician-assisted suicide demonstrate that a large number find it acceptable under certain conditions.[24-27] However, only about one third would be willing to personally dispense lethal medication doses, survey findings suggest. The studies also indicated that younger pharmacists and those who describe themselves as more religious are more likely to oppose physician-assisted suicide. Pharmacists' attitudes on the practice may be influenced by personal experiences.[27-30]
Guidance and Resources
Efforts to legalize physician-assisted suicide in other states seem to be growing. Pharmacists should stay abreast of any pertinent state legislation. DWDA bills died during the 2010 legislative sessions in Hawaii and New Hampshire. In Massachusetts, a DWDA bill was discussed at the statehouse in February 2010, with testimony presented in favor of and against the legislation, but no immediate action was taken. In Connecticut, a supreme court judge rejected the request of two physicians to prescribe lethal doses of medication in the case of Blick v. Connecticut in June 2010.
Pharmacists participating in physician-assisted suicide may enhance their knowledge of pain management and palliative and end-of-life care through Purdue Pharma's Medical Education Resource Catalog, which contains free web-based courses and resources. Additionally, the American Academy of Pain Management Learning Center maintains a comprehensive resource library, including clinical tools and continuing-education courses on pain management and palliative care.
The Death with Dignity National Center (DDNC) is one of the leading organization advocates of physician-assisted suicide. DDNC's mission is "to provide information, education, research, and support for the preservation and implementation of the Oregon Death with Dignity law" and to advocate for a DWDA in all 50 states. Leaders of DDNC wrote the Oregon DWDA, and DDNC was instrumental in the passage of Washington's DWDA. The organization began an advocacy campaign in Washington in April 2005 after identifying it as the state most likely to implement a DWDA.
The Oregon Death with Dignity Act: A Guidebook for Health Care Professionals is a comprehensive resource that outlines the legal requirements of physician-assisted suicide in a clear and concise format. Pharmacy schools should incorporate the topic into the curriculum, so that students are prepared once they enter the profession. More research is needed, including surveys of pharmacists (e.g., those in Washington State) to determine their attitudes on the practice, surveys to determine how pharmacy students' views on physician-assisted suicide might differ from those of medical students, and other studies to assess pharmacists' attitudes on the practice and its impact on the profession.
The Oregon Death with Dignity Act: Oregon revised statutes. www.oregon.gov/DHS/ph/pas/docs/statute.pdf (accessed 2010 Dec 27).
Task Force to Improve the Care of Terminally-Ill Oregonians. The Oregon Death with Dignity Act: a guidebook for health care professionals. www.ohsu.edu/xd/education/continuing-education/center-forethics/ethics-outreach/upload/Oregon-Death-with-Dignity-Act-Guidebook.pdf (accessed 2010 Dec 27).
Oregon Department of Human Services. 2009 summary of Oregon's Death with Dignity Act. www.oregon.gov/DHS/ph/pas/docs/year12.pdf (accessed 2010 Dec 27).
Oregon Department of Human Services. Fifth annual report on Oregon's Death with Dignity Act. www.oregon.gov/DHS/ph/pas/docs/year5.pdf (accessed 2010 Dec 27).
Okie S. Physician-assisted suicide— Oregon and beyond. N Engl J Med. 2005; 352:1627-30.
Wineberg H. Oregon's Death with Dignity Act: fourteen months and counting. Arch Intern Med. 2000; 160:21–3.
McEvoy GK, Snow EK. Barbiturates. www.ahfsdruginformation.com/support/not_in_print/a382386.aspx (accessed 2011 Jan 14).
U.S. Food and Drug Administration. Disposal by flushing of certain unused medicines: what you should know. www. fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/
Drug Enforcement Administration. Office of Diversion Control questions & answers. www.deadiversion.usdoj.gov/faq/general.htm (accessed 2010 Dec 27).
Oregon Department of Human Services. Pharmacy dispensing record. https://egov.oregon.gov/DHS/ph/pas/docs/pharform.pdf (accessed 2010 Dec 27).
Oregon Department of Human Services. Table 1. Characteristics and end-of-life care of 460 DWDA patients who died after ingesting a lethal dose of medication, by year, Oregon, 1998–2009. www.oregon.gov/DHS/ph/pas/docs/yr12-tbl-1.pdf (accessed 2010 Dec 27).
The Washington Death with Dignity Act, chap. 70.245 RCW. https://apps.leg.wa.gov/RCW/default.aspx?cite=70.245 (accessed 2010 Dec 27).
Washington State Department of Health. Washington State Department of Health 2009 Death with Dignity Act report executive summary. www.doh.wa.gov/dwda/forms/DWDA_2009.pdf (accessed 2010 Dec 27).
Robert Baxter v. State of Montana andSteve Bullock. In the Supreme Court of the State of Montana (No. DA 09-0051), brief amicus curiae of International Task Force on Euthanasia & Assisted Suicide (LexisNexis Academic; accessed 2010 Jun 3).
The Associated Press. Montana judge endorses right to assisted suicide. www.nytimes.com/2008/12/07/health/07montana.html?_r=1&pagewanted=print (accessed 2010 Dec 27).
American Pharmacists Association. Code of ethics for pharmacists. www.pharmacist.com/AM/Template.cfm?Section=Code_of_Ethics_for_Pharmacists&TEMPLATE=/CM/HTMLDisplay.cfm&CONTENTID=2654 (accessed 2010 Dec 27).
American Pharmaceutical Association. Report of the 2004 APhA house of delegates. J Am Pharm Assoc. 2004; 44:551–6.
American Society of Health-System Pharmacists. ASHP statement on pharmacist decision making on assisted suicide. Am J Health-Syst Pharm. 1999; 56:1661–4.
Baluch WM. Perplexed about ASHP council's perspective on assisted-suicide policy. Am J Health-Syst Pharm. 2000; 57:998–9. Comment.
Wernow JR, Grant DG. Dispensing with conscience: a legal and ethical assessment. Ann Pharmacother. 2008; 42:1669–78.
Oregon Department of Human Services. FAQs about the Death with Dignity Act. www.oregon.gov/DHS/ph/pas/faqs.shtml (accessed 2010 Dec 27).
Washington State Hospital Association. Death with Dignity Act. www.wsha.org/page.cfm?ID=0302 (accessed 2010 Dec 27).
Compassion & Choices. About Compassion & Choices. www.compassionandchoices.org/learn (accessed 2010 Dec 27).
Rupp MT. Physician-assisted suicide and the issues it raises for pharmacists. Am J Health-Syst Pharm. 1995; 52:1455–60.
Veatch RM. The pharmacist and assisted suicide. Am J Health-Syst Pharm. 1999; 56:260–6.
Rupp MT, Isenhower HL. Pharmacists' attitudes toward physician-assisted suicide. Am J Hosp Pharm. 1994; 51:69–74.
Vivian JC, Slaughter RL, Calissi P. Michigan pharmacists' attitudes about medically-assisted suicide. J Mich Pharm. 1993; 31:490–3.
Death with Dignity National Center. The dignity report: DDNC spring 2010 newsletter. www.deathwithdignity.org/2010/03/24/spring-2010-newsletter/ (accessed 2010 Dec 27).
Purdue Pharma. Medical education resource catalog. www.purduepharmamededresources.com (accessed 2010 Dec 27).
American Academy of Pain Management. American Academy of Pain Management Learning Center. https://aapm.cecity.com/ce-bin/owa/pkg_explorer_search.prof_sel ect?ip_company_code=AAPM&cookie=34933145&ip_subj ect=125451&v_url=pkg_curriculum%2emycurriculum_w%3fv_company_code%3dAAPM%26cookie%3d34933145 (accessed 2010 Dec 27).
Death with Dignity National Center. Death with dignity must be made available in all 50 states. www.deathwithdignity.org/2009/02/26/press-releasere-final-exit/ (accessed 2010 Dec 27).