The changing face of pharmaceutical ethics
By Tony Gosgnach
Like many areas of the medical field in the last few decades, the pharmaceutical profession has undergone radical shifts in ethics as new technologies and discoveries in fields such as endocrinology, biotechnology, immunology and pharmacology have changed the paradigms under which it operates.
The changing milieu has raised the spectre of your friendly neighbourhood pharmacist dispensing medications that end life at either end of the continuum. How realistic is such a scenario? To begin with, it might be helpful to look at past, current and prospective pharmaceutical ethics in the province of Ontario. As the magazine Pharmacy Connection has pointed out, a consistent code of ethics for Ontario pharmacists was in place (having been revised only for editorial reasons) for 20 years until 1996. That code stressed the functional activities of the pharmacist and implied a product-focused role for him or her.
However, in 1996, the Ontario College of Pharmacists approved a revised code of ethics. The new code stressed a "patient-centred care" approach. Its principles were modelled after a code of ethics developed by the American Pharmaceutical Association and endorsed by member organizations.
The new code's preamble states that pharmacists have an obligation to act in the best interest of their patients, observe the law, uphold the dignity and honour of their profession, and practise "in accordance with ethical principles." These principles imply that the pharmacist:
• Establishes and maintains a unique relationship with each patient, a relationship based on an "ethical covenant"
• Actively promotes the well-being of every patient in a caring, compassionate manner
• Preserves the confidentiality of information he or she acquires in the course of practice, and does not divulge this information except when authorized by the patient or required by law
• Respects the autonomy, individuality and dignity of each patient
• Acts with honesty and integrity
• Continually improves his or her professional competence and strives to enhance service and care
• Collaborates with other health care professionals to achieve the best possible outcome for the patient
• Advocates for health promotion at the individual, community and societal levels
• Promotes the appropriate utilization of health care resources
• Practises only under conditions that do not compromise professional standards and enables other pharmacists to practise in accordance with high professional standards
The revised code contrasts with the old one in several areas. For example, the first section of the old code stated that a pharmacist "should hold the health and safety of patients to be of first consideration; he should render to each patient the full measure of his ability as an essential health practitioner."
Such clear language is curiously absent from the new code, which simply stresses the need for the pharmacist to have a "unique relationship" with the patient based on an "ethical covenant." This covenant implies that pharmacists have "moral obligations" in return for the trust given them by society. But the meaning behind, and implications of, the terms "unique relationship," "ethical covenant," and "moral obligations" are not spelled out.
Similarly, although Section Two of the old code stated that pharmacists should never knowingly condone the dispensation, promotion or distribution of drugs or medical devices that are not of good quality, do not meet standards of quality, or lack therapeutic value for the patient (emphasis added), such provisions are absent from the new code.
Perhaps the most disturbing aspect of the new code is a statement that makes it clear "no patient shall be deprived of pharmaceutical services because of the personal convictions or religious beliefs of a pharmacist. Where such circumstances occur, the pharmacist refers the patient to another pharmacist who can meet the patient's needs."
The latest code of ethics issued by the College of Pharmacists of British Columbia also includes a provision that a pharmacist must ensure "continuity of care in the event of job action, pharmacy closure or conflict with moral beliefs." This is while the pharmacist supports "the right of the patient to make personal choices about pharmacy care."
The changing face of pharmaceutical ethics doesn't seem to have bothered some in the pharmaceutical profession. Dr. Michael Rupp, a professor of pharmacy administration at Purdue University, gave a presentation on assisted suicide at a 1997 meeting of the U.S. National Association of Boards of Pharmacy. He noted that 72.6 per cent of U.S. pharmacists polled indicated they agreed patients were sometimes justified in wanting to end their own lives, and that 70.0 per cent believed prescription drugs were appropriate means for doctors to use when assisting a patient's suicide.
However, these findings ran alongside a Time magazine poll, taken around the same time, which found that 82 per cent of U.S. pharmacists believed they should have the right to refuse to dispense abortion-causing drugs such as RU-486.
Two years earlier, a U.S. legal expert told an annual meeting of the American Pharmaceutical Association that pharmacists would eventually be caught in the middle of the controversy over doctor-assisted suicide, and that they would need legal help if they were to avoid filling prescriptions meant to allow a customer to commit suicide.
"We propose that any legislation to legalize voluntary suicide include a conscience clause for pharmacists," said Bill Allen of the University of Florida's school of medicine. He added that personal arguments of conscience or religious belief would not be enough to protect pharmacists.
"The numbers of people who will seek assisted suicide are far smaller than abortion, but I wouldn't be surprised if the hard-core opponents of abortion try to polarize this issue as well," he said.
Jeanette Smith, one of the pharmacists at the meeting, said she was one person who would be able to keep her personal beliefs separate from her professional responsibilities. "I would fill the prescription even if I didn't agree with what the prescription was going to be used for. Everyone has their own life to live. People have strong feelings on certain issues and want to impose their beliefs on others."
Thomas W. Paton, chief and director of pharmacy at Toronto's Sunnybrook Health Science Centre and an associate professor at the University of Toronto, wrote in a 1995 article in Ontario Pharmacist magazine that developing a "covenantal relationship" with patients should be a pharmacist's primary goal, with all other issues becoming secondary.
"Each patient has a fundamental right to this care model and as such, we are obligated to provide it," he said.
More recently, the American Pharmaceutical Association, at its 1998 annual meeting in Miami Beach, decided to address the question of pharmacists who refuse to dispense birth control that causes early abortions. The move followed widespread media coverage of the refusal by California pharmacist John Boling to dispense the so-called morning-after pill.
APhA executive vice-president John Gans agreed that pharmacists have a moral choice, but on the other hand, "they're there to serve the patient. If a patient needs a certain type of care and has determined that he or she wants that care and it's legal to have that care, it's the pharmacist's responsibility ... to get (the patient) to another pharmacist who can provide that care."
Gans and APhA president Gary Kadlec said pharmacists should be upfront with employers about their moral views, and should together lay out a plan for dealing with potential ethical problems.
Karen Brauer, a pharmacist who was fired by the K-Mart department store chain for refusing to fill a prescription for an abortifacient medication, questioned whether such a policy is designed to "weed" pro-lifers out of the practice of pharmacy. "Increasingly, we are seeing that the so-called pro-choice view is not about choice at all," she said. "Doctors, nurses and other health care providers should take a lesson from the plight of pharmacists and guard their hard-earned autonomy assiduously."
In spite of Brauer's concerns, the APhA made the decision to pass a new conscience clause for pharmacists. The clause stated that the 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."
The APhA added that it would appoint a council to serve as a resource for the profession in addressing and understanding ethical issues.
Unfortunately, pro-conscience clause forces were unsuccessful in their attempts to pass provisions that included a right to refuse referrals, and to have the APhA push for enactment of conscience clauses at the legislative and board of pharmacy levels. However, they plan to pursue these matters further at next year's APhA convention in San Antonio, Tx.
"Pro-life pharmacists view it as a step in the right direction," Brauer said afterwards of the new conscience clause. "If the policy is generally accepted as a pharmacy standard, or is used as a model for legislation, pharmacists will no longer risk legal reprisals or loss of employment for refusing to participate in medical practices which they consider to be unethical."
That development followed other good news out of South Dakota, where a pharmacist's conscience clause - the first of its kind in the U.S. - last winter passed in the state house by a 57-10 vote, and in the state senate 30-3. The bill protects pharmacists from being sued or subjected to discrimination, recrimination or dismissal for refusing to dispense drugs if there is reason to believe the medication would be used to either cause an abortion, destroy an unborn child, or cause the death of a person by means of assisted suicide, euthanasia or mercy killing. It went into effect July 1.
"This bill is a giant step forward in progressive thinking by the people of the state of South Dakota and the South Dakota Pharmaceutical Association in protecting pharmacists who desire nothing more than the best care for all their patients - born, preborn or in the throes of despair," commented Pharmacists for Life executive director Bogomir Kuhar.
Efforts to pass conscience legislation were also underway in Wisconsin, Ohio, Kentucky and several other states. However, Michelle Grothe, public affairs director of Pro-Life Wisconsin, said there is a reluctance on the part of her state's pharmaceutical association to push for the measure. "They're nervous about being pulled into the abortion debate, and I've seen a real lack of sensitivity to the plight of pharmacists who are put in this moral quandry."
At the same time, 30 legislators were reported to have signed on as co-sponsors of the bill in the Wisconsin house.
The Associated Press, in its coverage of the passage of the North Dakota legislation, quoted Sisseton, S.D. pharmacist Jeff Gallagher, who last year refused to fill a prescription for the "morning-after pill." "I told (the patient) I couldn't dispense that medication. It was killing a potential baby. When I went into pharmacy, I went in to help people, not kill people."
But the conscience bill drew predictably hostile responses from South Dakota's pro-abortion elements. Pro-lifers have "been chipping away at Roe vs. Wade for years," said Thelma Underberg of South Dakota's National Abortion Rights Action League. "They're starting with what they can control."
On the other hand, the bill drew support from the state's academic community. "A pharmacist should not be forced to ignore his or her conscience," said Thomas Berg, a pharmacy professor at South Dakota State University. He added that pharmacists make judgements about prescriptions all the time, and although they rarely refuse to dispense a prescribed drug, they need legal protection if such a situation arises.
Terri McEntaffer, executive director of the South Dakota Pharmacists Association, agreed. She said the law provides pharmacists with the same protection given to doctors and nurses who choose not to participate in abortions or mercy killings.
More good news on the conscience front in the U.S. recently has come from:
• New Jersey, where that state's pharmacists' association has overwhelmingly passed a conscience clause
• Meetings of the Louisiana Society of Health-Systems Pharmacists and the American Society of Health-Systems Pharmacists, which both passed conscience clauses.
• The Maryland Board of Pharmacy, which revised its code of ethics to include a conscience clause with a proviso that the patient is to be provided with alternative means of obtaining sought medication
• The Delaware County (Pa.) Pharmacists Association whose board of directors by an overwhelming majority passed a solid conscience clause that was to be recommended for approval by the Pennsylvania Pharmacists Association
• Indiana, where the state house is likely to introduce a conscience clause when its next legislative session begins in January.
Pharmacists for Life International reports that conscience clauses have also been passed by pharmacy associations in Puerto Rico, and are being considered in about a dozen other states.
On the downside, the California Pharmaceutical Association moved away from a conscience clause passed two years ago by recently passing an amendment that "recognizes that a pharmacist has a professional responsibility to the care of the patient, and the duty of pharmacists who exercise their rights of conscience is to help patients obtain pharmaceutical care from another pharmacist in a timely and appropriate manner."
Pushes for conscience legislation have been continuing in Oregon, where a "death with dignity" law passed last fall is forcing more pharmacists to confront ethical dilemmas. At the request of the governor's office, Oregon's board of medical examiners developed a draft rule that protects a pharmacist's right to refuse to participate in an assisted suicide.
On the corporate side, the K-Mart department store in the U.S. indicated it doesn't care what kind of personal beliefs and convictions its employees have. "We tell pharmacists up front when we hire them that they are expected to fill any legally prescribed prescription by a physician for the health of a patient," said K-Mart spokesperson Daniel Jarvis.
After a recent incident in Utah where a pharmacist refused to dispense the "morning-after pill," K-Mart U.S. issued a statement declaring that, "K-Mart will distribute the morning-after pill when a doctor prescribes them. We will not tolerate a pharmacist who, on his own because of his own beliefs, will not distribute these medications."
Pharmacists have also been fired or essentially forced to resign by the U.S. Wal-Mart chain.
The ethical quandries pharmacists face are only bound to increase in coming years. Judie Brown, president of the American Life League, reported recently that a patent had been awarded by the European Patent Office to Michigan State University for euthanasia solutions that combine an anesthetic and an anti-malarial drug. While acknowledging that euthanasia is a felony in many countries, the university made it clear to the patent office that "if it should ever become legal to use the compositions in human beings, the patent claims should encompass the use of compositions of the present invention for this purpose."
Shortly afterwards, it was reported that the German chemical company Hoechst AG (parent company of the developers of abortion pill RU-486), and three of its divisions, had provided $350,000 in research grant funding to MSU for the development of a euthanasia composition.
Bioethicist and bio-medical researcher Lawrence F. Laberge says that research into still more embryonic-stage abortifacients is continuing and that the development of an abortifacient vaccine is almost complete.
"This technology is targeted for world distribution," he says. "The vaccines will mislead many to believe they are using a safe, effective method of birth control, when in reality, the vaccine will engineer a monthly abortion ... Advances in technology will reduce the fetal body count while vastly increasing the embryonic fatalities."
Laberge adds that a key paradigm shift has been the redefinition of the beginning of life as taking place at the uterine-implantation stage, rather than at conception. This has allowed for the justification of such activities as human embryo experimentation, the disposal of large numbers of embryos, and the expanded use of abortifacients that destroy early life.
The issue of conscientious objection first surfaced in the pharmaceutical world more than a decade ago, when two pharmacists in the state of Washington were fired for refusing to dispense birth-control pills because of their abortion-causing effects. Later years saw two pharmacists working for Safeway in Longview, Wash. dismissed for refusing to dispense abortifacient contraceptives, and the forced resignation of a pharmacist at the University of Florida, who in 1991 refused to dispense the "morning-after pill" to college girls.
On the Canadian side, as reported in the August issue of The Interim, efforts are continuing in Ontario to pass conscience legislation in the provincial legislature for healthcare workers in general. There are hopes that a private member's bill will be introduced this fall, backed by a Coalition for Conscience that has been formed.
Similar efforts are underway in Alberta. A preliminary draft of a conscience clause was presented June 1 under the oversight of the National Association of Pharmacy Regulatory Authorities, but PFLI says the Alberta Pharmaceutical Association has been "stonewalling" members who are pressing for the clause.
The latest developments cap a lengthy campaign by pro-conscience clause forces in Alberta, who first raised the issue at the 1994 convention of the Alberta Pharmaceutical Association. On that occasion, members passed a resolution that called for the Association to strike a committee to draft a conscience clause that would be added to the by-laws of the Alberta Pharmaceutical Profession Act.
That call was reinforced at the 1995 convention, with an added request that the University of Alberta's Bio-Ethics Centre be called on to provide input before the final adoption of a conscience clause. By 1996, the Association decided that, rather than make isolated amendments to the current code, the entire code be amended "to include principles based on moral obligations and virtues, and that intermediary amendments be delayed until a complete revision is available for the membership's consideration."
In 1997, a working group of the Association charged with developing a new code of ethics decided not to include a conscience clause in the form proposed by the membership, but rather to "provide guidelines within the interpretive section of the code of ethics which could assist pharmacists who are presented with a moral dilemma." The working group felt that would be "the best way to balance ... respect for the moral position of a pharmacist and the rights of a patient."
This year, a new code of ethics was adopted which did indeed include unclear provisions for the recognition and respect of the moral beliefs of pharmacists "within the interpretations of the code's principles." The Association added, however, that discussions would continue in the future on the concept of a conscience clause with pharmacists and other health professionals at both the provincial and federal levels.
Complicating efforts for conscience clauses is the fact that the Society of Obstetricians and Gynecologists of Canada recently issued a call for pharmacists to take a front-and-centre role in what it calls counselling for contraception. Pharmacists, the Society said, need to be proactive in "family planning" by being "askable" partners in a professional relationship.
Not surprisingly, the Society recommended that "emergency post-coital contraception" be made
available without prescription. "Pharmacists need to examine their own feelings and reactions
first, then respect the needs and wishes of their patients," said Thomas Brown, a pharmacist at
Winnipeg's Health Sciences Centre and an assistant professor at the University of Manitoba. "As
professionals, we need to be able to communicate to our patients that we're open, willing and
able to discuss contraception with them, just as we would any other medication."
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