DO PHARMACISTS HAVE THE RIGHT TO REFUSE TO DISPENSE A PRESCRIPTION BASED ON PERSONAL BELIEFS? 

By Stephanie E. Harvey,  Ei-Lun Lu,
Oscar Rivas and Julie Rodgers

    The authors wish to acknowledge the assistance of Cheryl A. Clarke, Bao Q. Bui, Siwhoung Khou, Mahshid Meimand, Lara H. Nakano, Elizabeth Perea, Cuong H. Phan, Linh Khanh Phan,  Megan E. Boule, Tam Hong Vu and their pharmacy law and ethics professor - David A. Gettman.

INTRODUCTION

The purpose of this article is to discuss legal and ethical issues regarding the pharmacist's right to refuse to dispense based on personal beliefs. Five ethical principles - nonmaleficence, beneficence, autonomy, loyalty, and justice are used to deliberate the issue. Legal facts are used to clarify the position that pharmacists may find themselves in should the decision to refuse to dispense be made. It is imperative that pharmacists assume responsibility for reducing the severity of the implications of this issue by taking a proactive approach in considering the impact of these and other moral dilemmas before they are presented in the workplace. The recommendation is made that each state, employer, pharmaceutical organization, and individual pharmacist develop, communicate, and implement a conscience clause that protects the pharmacist's rights without denying the patient access to treatment. A conscience clause is a declaration of conscientious objection to an issue. It explains the position a person, organization, or entity takes on a specific moral issue. The conscience clause can be used as an opening for discussion between all relevant parties. These measures are intended to limit problems that may arise by minimizing conflict in the workplace and preventing legal battles in the courtroom while providing outstanding patient care.

Recent legislation introduced in support of the patient's right-to-die assisted suicide, the use of abortifacients, and pain management increases the likelihood that a physician will prescribe a drug that presents a moral dilemma to a pharmacist. Numerous states have introduced legislation this past year regarding these issues, yet very few states have addressed the pharmacist's role in these cases. It is not clear whether a pharmacist is protected from repercussions as a result of either participating in one of these procedures by dispensing the drug or refusing to participate by not dispensing the drug. Accepted thinking condones the pharmacist's right to refuse to dispense based on professional judgement. It is specified in the pharmacy laws of many states that it is the pharmacist's duty to refuse to dispense if, in the pharmacist's professional judgement, the prescription does not seem to be valid, or if filling the prescription as written could cause inadvertent harm to the patient. What is not clear is whether a pharmacist has the right to refuse to dispense based on personal beliefs.

OBJECTIVES

This article will begin by presenting background information. Three short case scenarios are presented to familiarize the reader with a few of the moral dilemmas that may lead to a pharmacist's decision to refuse to dispense. Except in the short case scenarios used as examples, specific situations are purposely avoided to focus instead on the larger issue of the pharmacist's right to refuse to dispense without denying the patient access to the prescriptions. The methodology that was used to collect legal, ethical, and other data that will be presented, followed by results of the research. The discussion includes how ethical principles relate to the pharmacist's right to refuse to dispense and the patient's right of access to treatment. This article will attempt to answer these five questions: Does a pharmacist, when presented with a valid prescription for a drug that is to be used in a treatment that is in conflict with personal beliefs, have the right to refuse to dispense the drug? What duty does the pharmacist have to the patient in this situation? If the decision to refuse to dispense is made, what legal protection is afforded? What are the implications to the patient, the employer, co-workers, the profession of pharmacy, and society? What can be done to minimize the effects of this volatile issue? The article concludes with recommendations of what should be done.

THREE CASE SCENARIOS

    #1-Emergency Contraception

Mary Joe is an 18-year-old college student at UNM. She presents a prescription for four Ovral® tablets. The instructions are to take two immediately and two in twelve hours. Ovral® contains ethinyl estradiol and norgestrel and is used as a contraceptive when taken one tablet per day. When taken in the manner prescribed to Mary Joe it is intended as a morning-after-pill - emergency post-coital contraception, to inhibit or delay ovulation or to prohibit implantation of a fertilized egg within 72 hours of intercourse.1 The only pharmacist on duty, Phil, has strong pro-life beliefs. Firm in his beliefs, Phil refuses to dispense the prescription believing that the prescription is being used as an abortifacient. Mary Joe explains that she needs to have the prescription filled soon, because it is very close to 72 hours since intercourse. She begins crying and pleads with Phil to fill the prescriptions and explains that she can not have the prescription filled at another pharmacy because this is the only one that allows her to charge, and her financial aid has not come in yet. Phil advises Mary Joe that she should seek counseling and shares his religious belief with her. Mary Joe explains that she was walking home from her volunteer job at the children's hospital when she was attacked and raped. Mary Joe leaves the pharmacy very upset, without the prescription. Later she calls the pharmacy, explains the situation to the pharmacy manager, and demands that Phil be fired. Does Phil have a right to refuse to dispense the drug? What duty does Phil have to Mary Joe? What are the implications to the patient, the employer, co-workers, the profession, and society? What can be done to minimize the effects of this volatile issue?

     

    #2-Right to Die

You are the owner of a small, established pharmacy. Mr. Jones, who has been a patient of yours for a number of years, presents a prescription to your employee pharmacist, Suzi, for fifty MS Contin 100mg tablets. The instructions are ``Take as directed." Suzi approaches you after speaking for a short time with Mr. Jones, indicating that she believes that Mr. Jones may try to take all of the tablets at once to end his life. She indicates that she does not condone suicide, and will not fill the prescription. You know that Mr. Jones was diagnosed with liver cancer 6 months earlier and that the prognosis is poor. You ask him about his health and why the doctor prescribed the MS Contin. He tells you that the cancer has spread and he is in a great deal of pain. He reflects on his life, including the fact that when he was in the Korean conflict he was burned over one-third of his body, and never thought he would ever have to go through such pain again. He explains that the pain he is experiencing now is unbearable, and he knows that it is just a matter of time before he can be with his wife of 50 years again, finally. You are shocked because you know Mr. Jones is a strong, friendly man and had no idea he was so miserable with his condition. He whispers to you, ``I know I can count on you to help me."

Does Suzi have a right to refuse to dispense the drug? What duty does Suzi have to Mr. Jones? What are the implications to the patient, the employer, co-workers, the profession, and society? What can be done to minimize the effects of this volatile issue?

     

    #3-Assisted Suicide

Ms. Smith presents a prescription for a lethal dose of a drug. She explains that she intends to end her life and would like clarification on the directions and what she should expect to go through. The state you live in recently passed a death with dignity act, which enables a physician to prescribe life-ending drugs to mentally competent patients who are in the end stages of a terminal illness. You do not agree with the physician-assisted suicide act.

Do you have a right to refuse to dispense the drug? What duty do you have to Ms. Smith? What are the implications to the patient, the employer, co-workers, the profession, and society? What can be done to minimize the effects of this volatile issue?

METHODOLOGY

Research regarding court cases that resulted from a pharmacist's refusal to dispense was conducted using the lexis-nexis xchange. From the data that was generated, a manual review was done to ensure that only cases that are pertinent to the issue of the pharmacist's right to refuse to dispense were included.

Data was gathered from each state's pharmacy laws with the intent of determining whether the state has addressed the issue of the pharmacist's right to refuse to dispense and whether the state has or supports a conscience clause. A manual review of the pharmacy laws of the 50 states, Washington DC, and Puerto Rico was conducted using the most recent revisions of state laws and statutes at the UNM Law Library.

Articles from professional journals addressing ethical and legal issues and pharmacist's opinions on the topic were analyzed.

A website search of pharmacy-related organizations for information regarding laws and discussion regarding the pharmacist's right to refuse and whether the organization has adopted or supports a pharmacy specific conscience clause was conducted. Where the site has an imbedded search engine, the keywords: conscience clause, conscientious objection, right to refuse, pharmacist's right, refuse to dispense, unconscionable, ethical conduct, unethical conduct, discipline, and unprofessional conduct were used to search the site. If no search engine is imbedded, a manual search through the site was done.

Data from websites are used only if a reference to the original data is cited in the article or, in the case of journal articles if the article is published in hardcopy as well as online. In an attempt to keep the data as scientifically clean as possible, websites without pharmaceutical organizational or journal affiliation were discounted.

     

Court Cases

No court cases were found that ruled for or against a pharmacist's right to refuse to dispense based on personal beliefs. Most states require that the pharmacist exercise professional judgement with respect to the legitimacy of prescription orders dispensed. Specifically, in Indiana, the Supreme Court ruled that the pharmacist does have a duty to refuse to dispense based on professional judgment.2

There are numerous assisted-suicide cases that have been brought into the courts recently. Many consider the physician's right to refuse to participate, and specifically protect the physician that does participate. Some indicate that support personnel, including pharmacists, are also protected from legal repercussions, but none of them state whether law will protect a pharmacist who refuses to dispense a life-ending prescription. In the case Compassion in Dying vs. State of Washington, which is the first physician-assisted suicide case to be decided, the court found the Constitutional right in the due process clause. The ruling contends that physicians can prescribe life-ending medications for use by terminally ill competent adults who wish to hasten their own deaths. This decision states that physicians have the choice of whether to participate or not. The wording specifically protects the pharmacist and other support personnel, including friends and family, from repercussion as a result of participating, but does not state whether the pharmacist has a right to refuse to participate. Presumably, the pharmacist would have the option to refuse to participate, and would be covered under the same blanket of protection that nurses have been covered in the past.3

     

Pharmacy Laws

Previous to 1998, no state board of pharmacy had adopted a conscious clause in the pharmacy laws. On March 13, 1998, South Dakota became the first state to adopt a conscience clause, which specifically addresses pharmacist liability should the decision be made to refuse to dispense a prescription in one of three specific circumstances. Missouri has introduced House Bill 1183, which is pending approval. In both instances, the conscience clause was introduced with wording that specifically stated that a pharmacist could refuse to fill a prescription based on ethical, moral or religious beliefs. The South Dakota bill, House Bill 1244, was reworded with the original language referring to conscientious objection replaced with three specific situations of when a pharmacist can refuse to dispense. A pharmacist can refuse to dispense if there is reason to be that the medication will be used to: 1) Cause an abortion, 2) Destroy an unborn child as defined by law, 3) Cause the death of any person by any means of an assisted suicide, euthanasia, or mercy killing. The bill protects the pharmacist from claims for damages, and disciplinary, recriminatory, and discriminatory action as a result of refusing to dispense under these circumstances.4

     

Professional Journals

In a Drug Topics cover story, the majority of pharmacists surveyed - 76% - believe that they should be able to refuse to participate in physician-assisted suicide, but also felt that their job may be at stake if they did so. In another scenario presented, 82% believe that an owner-pharmacist has the right to deny an abortifacient drug based on the fact that the owner should have a right to decide what to stock and dispense to patients.5

In Oregon, where the Death with Dignity Act was passed in 1994, the role of the pharmacist is not entirely spelled out. Healthcare workers are provided protection from prosecution for participating; however, the wording excludes the pharmacist because it relates to healthcare workers that are involved in administering the lethal drug. The pharmacist does not administer, but dispenses. Would the pharmacist be covered? Confidentiality is the major issue preventing enactment of the Oregon act. Pharmacists feel that it is their right to know when a prescription for a life-ending drug is presented; however, the confidentiality of the patient will be compromised if the prescription is designated somehow to indicate the purpose. In a 1995 survey of Oregon pharmacists, 49% said that they would not participate professionally in physician-assisted suicide, and 36% said they would.6

In a 1997 Drug Topics Special Report, Carmen Catizone, Executive Director, National Association of Boards of Pharmacy, says that no state pharmacy act contains reference to a conscience clause of conscientious objector provisions, nor does the NABP Model Practice Act specifically address the issue. In Ohio, a proposed revision of the pharmacy act may not be approved because it does not contain a conscience clause.7

     

Websites

APhA has traditionally been the organization that pharmacy practice looks to for guidance. APhA adopted a conscience clause at the 1998 annual meeting to clarify the organization's policy regarding the pharmacist's rights regarding participation in activities that they find morally objectionable. The Policy Committee considered both the pharmacist's and the patient's needs when making their recommendations. The recommendation adopted states that a pharmacist should be allowed to refuse to participate, but must maintain a professional responsibility to the patient by making sure that the patient has access to the prescribed drug. The conscience clause states: APhA recognizes the individual pharmacist's right to exercise conscientious refusal and supports the establishment of systems to ensure patient access to legally prescribed therapy without compromising the pharmacist's right of conscientious refusal. APhA shall appoint a council to serve as a resource for the profession in addressing and understanding ethical issues.8

According to the National Conference of State Legislatures, 24 states introduced legislature concerning assisted suicide in 1998. Many of these pending laws do not specifically address the pharmacists' role.9

DISCUSSION

For the sake of brevity and clarity, three assumptions must be made. The first assumption made in this article is that pharmacy is a profession. Profession is defined in Webster's Dictionary as ``a vocation requiring knowledge of some department of learning or science."10 Fassett and Wicks write: ``Professionals are expected to exercise special skill and care to place the interests of their clients above their own immediate interests. Major professional associations have codes of ethics, and have promoted mandatory state licensure as a requirement for professional practice. Licensing and examining boards in turn often include explicit or implicit moral requirements in regulations."11 Pharmacy fits both descriptions. The American Pharmaceutical Association has developed and revised a code of ethics for pharmacists. Pharmacists provide a specialized function to society, learn their profession through schools of higher learning, and must be licensed to practice. The activities of each pharmacist are influenced by three forces: Satisfying societal needs, adhering to the code of ethics, and following the guidelines established by public policy as in pharmacy practice acts.

The second assumption is that pharmacy is a moral profession. The 1994 APhA Code of Ethics is based on moral obligations and virtues. It is expected that pharmacists apply moral and ethical principles conscientiously and consistently in making decisions. Veatch uses this argument in an American Journal of Hospital Pharmacy analysis and commentary. He writes, ``Health-care professionals are moral agents with the right and the responsibility to make moral assessments and to be accountable for their actions."12

The third assumption is that pharmacy fulfills more than a technical role. This assumes that the pharmacist uses more than just the technical knowledge learned in school and in on-the-job training. OBRA `90 has ensured this to be the case, by insisting that pharmacists provide pharmaceutical counseling to patients in a clear, concise, and complete manner.

     

Ethical Principles

When faced with ethical decisions, pharmacists must address the five normative principles of pharmacy practice:
1) Nonmaleficence - requires avoiding inflicting harm,
2) Beneficence - actively preventing harm or providing benefit,
3) Autonomy - self determination,
4) Loyalty - commitment, faithfulness, fidelity, and
5) Distributive justice - appropriate allocation of benefits and burdens.13

Each ethical value must be weighed with respect to the issue at hand and prioritized based on the particular situation. It is impossible to have one set of rules that can be administered in every situation. For a given situation, the principle that carries the most weight will be different than in another situation, which will lead the pharmacist to make a different decision about how to react. It is important that the pharmacist gather all of the information relevant to the case, apply ethical values, and determine which, if any conflict. With this information, the pharmacist must decide what options are available, what the repercussions of each of the options are, and determine a course of action.

Does a pharmacist, when presented with a valid prescription for a drug that is to be used in a treatment that is in conflict with personal beliefs, have the right to refuse to dispense the drug? What duty does the pharmacist have to the patient in this situation?

Pharmacies are privy to extremely sensitive information that, many times, is accessible only to other members of the healthcare team. Sharing this type of information puts the patient in a vulnerable position and it is the duty of the pharmacist and other healthcare team members, to only use this information for the benefit of the patient. The patient must trust in the pharmacist's belief of nonmaleficence so that they feel comfortable sharing such personal information. Patients trust in pharmacists to be the drug experts of the healthcare team, to provide information that they, as laypersons, do not know. They trust that the pharmacist will justly distribute this information to them as part of their healthcare, understanding that the pharmacist's vast knowledge is intended to be used to improve health. Patients trust that pharmacists will ensure that the pharmaceutical care that is provided to them will not harm them unnecessarily. A pharmacist has a duty to refuse to fill a prescription if, in the pharmacist's professional judgement, filling it as written will cause unnecessary harm to the patient. This includes if the physician made an error in the strength or dosage, if a drug interaction is possible, or if it seems, in the pharmacist's judgement, that the prescription was obtained illegally. However, more is expected of the pharmacist than just to monitor and correct technical errors of prescriptions. Patients expect pharmacists to use professional judgement to make sound, objective, and factual decisions that affect healthcare outcomes and to provide that care without personal judgement of the patient. The trust that patients put in pharmacists is similar to the trust they have in family and close friends. It is given with the expectation that the pharmacist knows that the patient is capable of understanding what healthcare options are available, what information is revealed to the pharmacist, and deciding with whom the information is entrusted. A patient need not divulge everything, but for competent health care, more information is better, and one way to get the necessary information is to develop a trusting relationship. For that trust, the patient expects a degree of loyalty from the pharmacist.

With the access that the pharmacist has to the information regarding the patient, and to preserve the trusting relationship between the patient and the pharmacist, comes the responsibility to fill valid prescriptions. Moral dilemma arises when a pharmacist is presented with a prescription that if filled, will cause harm to the patient. Depending on the situation this apparent moral dilemma may be resolved by the pharmacist gathering more information and developing a more clear understanding of the patient's situation. A genuine moral dilemma exists when the issue cannot be resolved with more information or discussion and the pharmacist feels morally unable to fill the prescription. If the pharmacist fills the prescription, the ethical principle of nonmaleficence is compromised; the pharmacist is knowingly contributing to harming the patient. If the prescription is not filled, it may appear to the pharmacist that the principle of beneficence is being fulfilled, but this may be at the expense of the patient's autonomy. By not filling the prescription using the reason that the pharmacist is preventing harm, the pharmacist assumes the paternalistic role of ``knowing what is best" for the patient. The pharmacist must recall that the trust developed between patient and pharmacist includes the understanding that the patient is capable of making informed decisions regarding health care. The trend in health care is toward empowerment of patients to control their own health care. Autonomy - self-determination - is expressed by freedom of choice based on informed decision-making. Adult human beings are entitled to make choices that affect their lives, even though others may not agree with those choices. Informed consent, the right a patient has to information, provides that the patient have access to the information necessary to make informed decisions. Pharmacists have the duty to help patients make informed decisions by supplying and interpreting information that the patient does not readily have available. The patient then has the obligation to weigh this information, including the risks and benefits, and make a decision. It is critical that the pharmacist determines that the patient has full understanding of the implications of the course of treatment, and once that has been accomplished, there is the expectation that the pharmacist will provide access to the prescribed drug. The pharmacist must have respect for the patient's autonomy. This is not to say that a pharmacist does not have the right to personal beliefs, but provisions must be made to accommodate both the patient's needs and the pharmacist beliefs, without destroying the patient-pharmacist relationship or infringing on the patient's right to treatment.

    If the decision to refuse to dispense is made, what legal protection is afforded?

Numerous states have specified that it is the pharmacist's duty to refuse to dispense based on professional judgement. This is supported by the Drug Enforcement Administration rule in the Code of Federal Regulations that states that a pharmacist has violated the law if a prescription is filled that is for a use that is not in the ordinary course of treatment.14 This does not address the issue of exercising moral or ethical judgement.

The issues of the right to refuse to participate and protection of participants and non-participants in abortion have been discussed and are included in abortion laws enacted in many states. These discussions and laws pertain to surgical abortion, and do not mention pharmacists because pharmacists were not traditionally involved in the surgical abortion issue. With increased prescribing of the morning after pill and more legislation to legalize abortifacients, pharmacists are now involved in the abortion issue. Under the surgical abortion laws, nurses and other support personnel are covered under the blanket of protection afforded physicians who participate and those that refuse to participate. Will pharmacists be included under the same blanket of protection? Those pharmacists that work in clinics and hospitals may, but those that are independent from the clinic or hospital may not.

South Dakota is the only state that has adopted a conscience clause in its pharmacy act. Presumably, only pharmacists in South Dakota who refuse to dispense based on personal beliefs will be protected by law. On the other hand, there are no states that have mandated that a pharmacist must dispense a prescription. Generally, as long as a pharmacist acts in good faith and people who need medications get them, they will not face disciplinary actions. This means that if a pharmacist does not morally agree with the course of treatment, there is a need to refer the patient to another pharmacist. There may be pharmacists that feel that the act of referring makes them a participant in a procedure that they are morally against. It would appear that this is where a patient or employer would have the most leverage legally. Pharmacists have a duty to provide access to drugs to people who need them. If there is a technical problem with a prescription, or if the pharmacist must make a professional judgement to refuse to dispense, it is the expectation that the physician be contacted. The same applies when a pharmacist is faced with making a moral decision. If nothing else, the physician should be contacted; preferably, the pharmacist will refer the patient to another pharmacist.

What are the implications to the patient, the employer, co-workers, the profession of pharmacy, and society?

The patient is entitled to continue the treatment that the physician has initiated.

When a pharmacist takes a job, that employee is obligated to comply with the employer's policies and procedures. It is important that the pharmacist in the job market understand the employer's position on issues that have the potential to conflict with personal values.

When such personal and volatile issues occur without notice in the workplace, people are caught off guard. The tendency is for co-workers to examine the moral beliefs of the pharmacist making the moral decision as well as their own. While this can be enlightening, the time and place is not particularly conducive to open discussion and finding a resolution to the issue.

The effect on the profession could potentially be negative, due to the perception of lack of support by professional organizations. Society has expectations of healthcare workers as professionals, including that there be guidelines by which members of the profession abide.

Options

  1. Nothing.
  2. Establish relationships between pharmacists and physicians.
  3. Encourage frank discussion between pharmacists - in the workplace, in pharmaceutical organizations, and in boards of pharmacy.
  4. Develop a conscience clause in the pharmacy act of each state, similar to the one South Dakota enacted and sanctioned by the Board of Pharmacy.
  5. Develop a conscience clause for each pharmaceutical organization, similar to the one approved by the American Pharmaceutical Association to clarify the position of pharmacy as a whole.
  6. Development of a conscience clause by each employer and each pharmacist to minimize conflict in the workplace.

CONCLUSIONS

It is imperative that pharmacists assume responsibility for reducing the severity of the implications of this issue by taking a proactive approach by considering the impact of these and other moral dilemmas before they are presented in the workplace. The recommendations are that pharmacists establish relationships with physicians, and encourage frank discussion between co-workers, employees, and employers. A further recommendation is that each state, employer, pharmaceutical organization, and individual pharmacist develop, communicate, and implement a conscience clause that protects the pharmacist' rights without denying the patient access to treatment.

The worst thing that can be done is nothing. This will give the perception of apathy by pharmacists and the profession of pharmacy and will neither ensure that patients have access to treatment nor that pharmacists' rights are protected.

REFERENCES

     1Glasier A. Emergency Postcoital Contraception [review article]. N Engl J Med .1997; 337:1058-64.

     2Hook=s Supers, Inc. v McLaughlin 642 N.E. 2d 514[Ind. 1994].

     3Compassion in Dying v. State of Washington 79 F.3d 790 [Wash. 1996].

     4http://www.ashp.org/public/proad/gad0498.html

     5Ethical Hot Spots [cover story]. Drug Topics1997;Jan 20:442-55.

     6Conlan MF. Pharmacists share divergent views on assisted suicide. Drug Topics 1997;Feb 3:86.

     7Ukens C. Duty vs. Conscience. Drug Topics 1997;Nov 3:54-5.

     8http://www.aphanet.org

     9http://www.ashp.og/public/pubs/ajhp/vol55/mum4/news.html

    10Webster=s Encyclopedic Unabridged Dictionary of the English Language, Deluxe Ed. New York: Random House, 1996, Profession; p. 1544.

    11Fassett WE, Wicks AC. Is Pharmacy a Profession? In: Weinstein BD, editor. Ethical Issues in pharmacy.

    12Veatch RM. Pharmacist=s refusal to dispense diethylstilbestrol for contraceptive use [analysis and commentary]. Am J Hosp Pharm. 1989;46:1413-6/

    13Campbell CS, Constantine GH. The Normative Principles of Pharmacy Ethics. In: Weinstein BD, editor.

    1421 Code of Federal Regulations Part I306.04.