Course Content
What is Ethics?
Ethics has been described as using concrete judgments in situations in which action must be taken despite uncertainty.
The term ethical is often used synonymously with the term moral to describe an action or decisions as good or right.
Deciding on an ethical issue usually involves judgments between right and wrong human conduct.
Ethics is not the study of moral development, and it is not the law.
A professional will typically feel an intuitive sense of right and wrong when faced with an ethical dilemma. They have the feeling that the situation being confronted is a big deal and somehow anticipate that they should not address only personal preference in the matter at hand.
An ethical dilemma may be differentiated from other decisions by three characteristics:
There is no higher standard against which to measure the rightnessof the decision or action
Each party involved believes there is a right or wrong answer
The deliberation takes into account the welfare of all affected
Different Levels of Ethics
Micro level of health care related decision making involves decisions made at the individual professional-patient level of health care.
Meso level of decision making is described as occurring at the institutional/organizational level or at the community/regional levels.
Macro level of decision making often sets policy for the health system, as a standard established for an entire profession or through government as a law or regulation for the society as a whole.
Ethics versus Law
Laws are rules of conduct imposed by society on its members. Laws involve written rules set by the whole society (or its representatives) that address responsibilities of that society’s members.
Ethics are rules of conduct by which a particular group in society regulates its actions and sets standards for its members. Ethics focuses on explicit or implicit rules and standards set by a professional subgroup of society and addresses the responsibilities of only those who are members of that subgroup.
Professional ethical standards are often impossible to fully regulate by law.
It is understandable that pharmacists and other health care providers involved in medication therapy often turn to the law for clarification about duties to patients. However, law should be understood as one of many points of ethical inquiry, not the end of the ethics analysis.
While it is important to know the law, and to know the rules at one’s institution and of one’s profession, none of these sources of guidance answer the questions: “Is it right?” or “Is it good?” Right or wrong, just or unjust, and good or evil, are ethical judgments that are independent of regulatory rules and laws.
Ideally, laws should aim to respect the demands of ethical obligations.
Morality versus Ethics
Personal moral guides to decision making and behavior are usually learned from family and community as a function of particular cultures and internalized during childhood with little reflection.
Ethics, in contrast, is the systematic study of moral concepts and norms which entails evaluating the justifications for the moral beliefs, values, and action guiding principles we endorse in our personal morality.
Example:
Do you take care of the cat or do you ensure you will be invited back to the condo in Hawaii?
Code of Ethics for a Pharmacist
A pharmacist respects the covenantal relationship between the patient and pharmacist.
A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner.
A pharmacist respects the autonomy and dignity of each patient.
A pharmacist acts with honesty and integrity in professional relationships.
A pharmacist maintains professional competence.
A pharmacist respects the values and abilities of colleagues and other health professionals.
A pharmacist serves individual, community, and societal needs.
A pharmacist seeks justice in the distribution of health resources.
Adopted by the membership of the American Pharmacists Association October 27, 1994
Clash of Personal Values
Ethical conflicts that involve personal beliefs are often deeply difficult; however, ethical deliberation may reveal the means to resolving what was only an apparent dilemma.
A position statement by the American College of Clinical Pharmacy (ACCP) in 2005 has delineated situations in which pharmacists may decline to participate in care due to their personal moral, ethical or religious beliefs. Examples of such situations could include provision of medication or services to promote capital punishment, euthanasia, termination of pregnancy or contraception.
ACCP states that in exercising their prerogative, a pharmacist has a professional and ethical obligation to ensure patients who are seeking access to legally prescribed medications or services are referred to another pharmacist or health care provider in a timely, effective, professional and non-judgmental manner.
Danger: A person who has power over an essential resource is permitted to arbitrarily prevent that resource from being provided to a less powerful or powerless person using personally held beliefs as justification.
In other words, could you as a reasoning being accept as a principle for everyone that one person’s own moral judgments are subject to being overridden by another individual’s moral judgments just because the latter person has the power and will to do so?
Four Principle Approaches to Ethical Decision Making
The four principles include beneficence, nonmaleficence, autonomy, and justice. These concepts have been incorporated into a framework or guide for considering bioethical problems. This approach seeks to systematize thinking about the ethical issues involved in specific cases and to help ensure that important ethical features of cases are not overlooked.
Beneficence
Doing good for patients (beneficence) is often the reason a person initially decides to enter a health care profession, but in applying the principle of beneficence, we must know what “good” we aim for.
These are some common principles to examine in reference to the “good” of the patient:
There is a clinical “good” that is the role of the health care intervention
The “good” as perceived by the patient as it relates to inside particulars about a patient’s life
The “good” of the patient as a human person with the ability to reason and apply morals that will apply to any capacitated person irrespective of life situation
The ultimate “good”
Nonmaleficence
The principle of nonmaleficence is not the opposite of beneficence; instead, it requires that we avoid doing harm or increasing suffering, both actively and by omission.
The good in health care is often a mixed good, containing both good making and harmful elements. Making patients better could mean making them worse for a time (eg, chemotherapy or surgery) or it might mean a tradeoff of resources. In other words, affording costly medication may result in limiting finances in other areas of one’s life.
Autonomy
Autonomy is defined as the capacity to make an informed, uncoerced decision.
Health care professionals are not necessarily required to respect the content of a patient’s choice, but to respect the right of the patient to make free and informed choices.
Justice
The principle of justice in clinical ethics refers to distributive justice or fairness.
It considers justifications of alternative ways of portioning out resources, particularly scarce or life-extending resources. It makes no sense to distribute resources that are in limited supply, such as medications, organs, ventilators, etc. according to a principle of equality.
However, in deciding when it is ethically permissible to treat patients differently, justice in health care requires that we use only ethically relevant criteria, such as medical need.
Four Principle Approaches to Ethical Decision Making
In sum, the four principles reflect basic duties common to all health care professionals. In other words to do good for the patient (beneficence), to do no harm or increase suffering (nonmaleficence), to respect the right of the patient to choose (autonomy), and to respect medical needs of society as a whole and distribute resources fairly (justice).
Conflicts in what the different ethical principles permit or require are sometimes unavoidable. Different health care professionals may resolve the conflicts between principles differently. Several valid options for resolving a particular ethical problem may exist, as well as options that are unacceptable.
Steps in Analysis of Ethical Dilemmas
The following are steps used to analyze an ethical dilemma:
Identify the information at the root of the case
Consider the stakeholders
Establish the ethical issues in the case
Consider ethical guidance and legal constraints
Distinguish ethically acceptable resolutions
Identify practical issues
Identify Information at the Root of the Case
What are the medical facts about the patient (eg, diagnosis, prognosis, relevant medical history)?
Are there any other relevant facts (eg, patient social history, patient cultural factors such as religion, race, ethnicity, facts about the organization or provider)?
What essential facts are missing (eg, who is the health care surrogate?)?
Consider the Stakeholders
Identify all those who are involved in making the decision (family, provider, administrator) or impacted by the decision (eg, nursing staff).
What is their role in the case (eg, health care provider, patient, family, institution, uninvolved but impacted staff or other persons, society)?
Establish the Ethical Issues in the Case
Address the issue if it is an actual ethical issue. If it is not an ethical issue, refer the issue to an appropriate resource (eg, the problem is administrative and can be resolved via procedures or is it knowledge based and can be resolved by training/education).
What specific values or ethical precepts are at stake in the case? (ie, the goal of ethical thinking in this case or what is the “good” that is to be accomplished by the decision at hand).
Consider Ethical Guidance and Legal Constraints
Professional boards and societies have codes of ethics and various ethical guidance documents that are calibrated to the particular profession.
State bar associations publish health law and elder law cases and commentaries.
Statewide ethics networks and schools of medicine, nursing, and pharmacy often publish case studies, ethics handbooks, and other resources on ethics.
The US government has initiated several presidential commissions for the study of bioethical issues.
Common ethical issues are reported in professional journals and in published conference proceedings. Specific topics can be located through library indexes, PubMed and other subject matter indexes.
Distinguish Ethically Acceptable Resolutions
Often more than one ethically acceptable option exists, as well as solutions that are unacceptable ethically.
It is not obligatory that the optimal resolution be implemented, only that the solution is one that is both ethically acceptable and honors the ethical values at stake.
Identify Practical Issues
After determining ethically acceptable resolutions, some resolutions can be deemed unworkable in consideration of available resources.
Challenges in Patient Care
The pharmacist code of ethics explicitly addresses the roles and responsibilities of the pharmacist as a health care professional and as a fiduciary.
The pharmacist pledges to promote the dignity and autonomy of the patient and to encourage the patient to participate in decisions regarding his/her health. While the pharmacist’s primary obligation is to the individual patient, the code acknowledges the importance of respect for colleagues and other health care professionals, as well as societal needs and distributive justice regarding health care resources.
All of these align with the four principle approaches to ethical decision making and take into account beneficence, non-maleficence, autonomy, and justice.
Inter-professional challenges
The growing adoption of the inter-professional team practice model has been recognized as enhancing patient care. However, inter-professional relations can also precipitate ethical issues involving medical management concerns, disclosing errors, non-indicated antibiotics, addressing non-adherence, and informing patients about less expensive care options and medications. Stakeholder interests are a common source of ethical conflicts and may contribute to moral distress.
State Laws
State laws can vary and a pharmacist is required to understand his/her legal responsibilities in the state in which they practice. For example, some state laws can require dispensing of emergency contraception to assure that the patient has timely access to treatment regardless of the particular pharmacist’s personal moral values.
Case 1
No Money
SS is a 24-year-old pregnant woman who presents to your pharmacy on a Saturday evening a few minutes before the pharmacy closes.
SS would like to pick up her buprenorphine that was called into the pharmacy from the inpatient addiction treatment program she was discharged from this morning. She tells you she is 24 weeks pregnant and is really excited because she has done well in rehabilitation but she claims that if she does not get this medicine, she is afraid she will need to “go back to using heroin.”
SS has no insurance and cannot afford the buprenorphine.
Case 1
Ethical Analysis
Identify the Information at the Root of the Case
Medical facts:
The patient is pregnant and recently out of rehabilitation.
The patient is at risk for going into withdrawal if she does not get her medication.
The patient is at risk for relapse because without medication she may use heroin to help ease withdrawal symptoms.
No recommended alternatives exist except methadone for use in pregnancy and substance use disorder.
Other relevant facts:
The patient states she does not have money to pay for the medication.
The patient has no insurance.
Identify the Information at the Root of the Case (cont.)
Missing information:
Is S.S. eligible for insurance such as Medicaid?
Has the payment issue been addressed by the treatment center with the patient or the pharmacy?
Other relevant questions relating to payment such as
Are medication assistance programs available?
Is there a clinic that could be contacted that could provide the medication for free?
Are there any other available options to help the patient financially?
Consider the Stakeholders
Patient
Fetus
Pharmacist
Physician
Addiction Treatment Center
Grant/Public Assistance Programs
Establish the Ethical Issues in the Case
What is the role of the pharmacist?
Assess and communicate the risk of not having medication?
Coordinate with responsible payer (inpatient addiction center, halfway house, other/grant program, insurance company)?
Ensure the patient gets the medication? Without exception?
Beneficence obligates the pharmacist to aim for the good of the patient, which means addressing her immediate health needs appropriately. This means enabling the patient to obtain the necessary medications to avoid opioid withdrawal, relapse, preterm delivery, and/or negative fetal consequences.
Beneficence obligates the treatment center to have a discharge plan that maintains continuity of care when a patient is transferred to another facility or treatment environment.
Establish the Ethical Issues in the Case (cont.)
Non-maleficence obligates the pharmacist to avoid unnecessary, possibly catastrophic harm as a result of lack of medication and lack of essential continuity of care.
The pharmacist may think paying out of her own pocket for the medication is a solution, but this could potentially harm both the pharmacist and the patient:
The patient-pharmacist relationship would be changed from that of a fiduciary to that of creditor/debtor.
The patient may think of the pharmacist as a financial resource rather than a health care provider or think she can play on the pharmacist’s sympathy in the future.
If the patient tells other patients who then come in expecting similar help and the pharmacist does not provide the same assistance, it could be claimed that the pharmacist acts in a discriminatory fashion in deciding who she helps.
Establish the Ethical Issues in the Case (cont.)
Non-maleficence obligates the treatment center to ensure that the patient has the means to avoid relapsing and adequate support while transitioning to another level of care.
Autonomy obligates the pharmacist to involve the patient in considering what to do rather than solving the problem.
Justice obligates the pharmacist to ascertain whether the problem is a maldistribution problem or an unfair allocation of resources for patients trying to recover from addiction.
Ethical Guidance and Legal Constraints
The pharmacist could give the patient the medication and asks her to bring the money back on Monday.
The pharmacist tries to identify any resources available to the patient in this situation.
The pharmacist could call the addiction treatment center to inform them of the problem and to ask them to get involved in a solution.
The pharmacist could tell the patient they cannot do anything to help them at this time.
Tell S.S they are out of stock to justify transferring the prescription to another pharmacy. Passing the problem is not a solution and is ethically an unacceptable approach.
Distinguish Ethically Acceptable Resolutions
Contact the treatment center to determine if they have resources that are available to provide for this patient in this situation.
Help the patient identify and contact someone who would be able to help her in this situation.
Failing the two options above, contact the supervisor or owner of pharmacy to determine a procedure for providing essential medication and required documentation.
Identify Practical Issues
Not applicable to this situation.
Case 2
Intellectual Challenges
AS is a 22-year-old female who comes into the pharmacy requesting a prescription for birth control pills. AS works at the art shop next door but has no record of having filled any prescriptions in the pharmacy.
AS recently learned from a coworker who uses the pharmacy about the new law in the state permitting pharmacists to prescribe hormonal contraceptives. AS has mild cognitive disabilities due to Down syndrome that make it challenging for her to read and understand complicated material, but she can work in supportive environments. Because AS has Down syndrome her parents have always treated her as a little girl, and she does not think they will approve of her having a boyfriend.
AS and her boyfriend have decided she needs to get some method of birth control just in case.
More to the story…
When AS presents to the pharmacy and asks for hormonal contraceptives, the pharmacist sees that she is only mildly impaired, and she consults with AS about her desire for a hormonal contraceptive as she would any other patient.
Since AS is over 18 years old, the pharmacist proceeds with paperwork and asks AS to fill out the standard screening questionnaire used to rule out any contraindications for the medication. The pharmacist notices that it is taking AS a long time to read the questions and asks if she needs help. AS says that usually her mother takes care of her medical paperwork and that some of the questions were a little confusing.
The pharmacist is unsure if she has the capacity for informed consent.
Identify the Information at the Root of the Case
Medical facts:
The patient is currently on no form of contraceptive.
Most females with Down syndrome are fertile.
Other relevant facts:
Hormonal contraceptives do not protect against sexually transmitted infections.
Does the patient understand the screening questions and is she able to answer the questions sufficiently to rule out any contraindications to a hormonal contraceptive? Is any inability related to the physical environment or time pressure that should be addressed before making a determination that capacity is lacking?
Is AS. legally competent or does she have a guardian for medical care decisions?
Consider the Stakeholders
Patient
Boyfriend
Pharmacist
Family
Establish the Ethical Issues in the Case
Beneficence obligates the pharmacist to provide the patient with the information she needs and medication she seeks.
Beneficence obligates the pharmacist to preserve the patient’s confidentiality and maintain the patient’s trust.
Nonmaleficence obligates the pharmacist to avoid harm to the patient, which may include not dispensing a contraindicated medication, not dispensing a medication to someone who is incapable of following instructions, or failing to dispense because of implicit biases about people with intellectual disabilities.
Establish the Ethical Issues in the Case (cont.)
Autonomy obligates the pharmacist to support an emancipated patient’s ability to make decisions about her health care.
Autonomy obligates the pharmacist to ensure that the patient understands her options and their benefits and risks.
Justice obligates the pharmacist to treat like cases alike; that means that the patient’s needs and desires as a human being, not her disability, should be the leading consideration.
Ethical Guidance and Legal Constraints
An adult is considered to have the capacity to consent or refuse a health care intervention until the contrary is proven. Adults are presumed to be competent unless they have been evaluated and declared incapacitated by a medical professional or adjudicated as incompetent (legal minors) by a court.
If the patient is capacitated and not a medical minor (over 18 years old and does not have a legal guardian for medical decisions), the patient’s privacy is protected by HIPAA (Health Insurance Portability and Accountability Act).
Distinguish Ethically Acceptable Resolutions
If the patient provides an adequate medical history, the pharmacist should prescribe the medication as with any other patient that has no contraindications.
Based solely on objective criteria, refer the patient to her physician for the prescription if medical history or capacity is in doubt.
If she has a guardian for medical decisions, let the patient know that you are willing to assist in getting the guardian’s approval by consulting with the designated person or having a joint discussion to complete the questionnaire and provide necessary information to the responsible individual.
Identify Practical Issues
No practical issues exist beyond what has been identified above.
Any of these resolutions would be appropriate.
Confidentiality of Medical Information
Information that a patient discloses to a pharmacist is ethically and legally protected by confidentiality.
The general rules for confidentiality are spelled out in the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Although HIPAA is a law passed by Congress, its provisions about confidentiality in general track the ethical dimensions of this moral obligation.
Health Insurance Portability and Accountability Act
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. The US Department of Health and Human Services (HHS) issued the HIPAA Privacy Rule to implement the requirements of HIPAA.
The Privacy Rule standards address the use and disclosure of individuals’ protected health information (PHI) by entities subject to the Privacy Rule. These individuals and organizations are called “covered entities”. The goal of this rule is to ensure that PHI is secured while allowing the flow of health information necessary to provide optimal care to the patient and protect the wellbeing of the public as well as the patient.
HIPPA Covered Entities
The following are considered covered entities under HIPPA and are subject to follow the rules and regulations of the HIPPA Privacy Rule:
Healthcare providers
Health plans
Healthcare clearing houses
Business associates
HIPPA
Protected Health Information
Protected health information includes demographic information collected from an individual and:
Is created or received by a healthcare provider, health plan, employer, or healthcare clearinghouse AND
Relates to the past, present, or future physical or mental health or condition of an individual; the provision of healthcare provided to anindividual; or the past, present, or future payment for the provision of healthcare provided to an individual; AND
It identifies the individual OR
There is a reasonable basis to believe the information can be used to identify the individual
HIPPA
Permitted Disclosures
The Privacy Rule permits use and disclosure of protected health information, without an individual’s authorization or permission, for the following purposes:
When required by law
Public health activities
Victims of abuse or neglect or domestic violence
Health oversight activities
Judicial and administrative proceedings
Law enforcement
Functions (such as identification) concerning deceased persons
Cadaveric organ, eye, or tissue donation
Research, under certain conditions
To prevent or lessen a serious threat to health or safety
Essential government functions
Workers compensation
HIPPA Security Rule
To comply with the HIPAA Security Rule, all covered entities must do the following:
Ensure the confidentiality, integrity, and availability of all electronic protected health information
Detect and safeguard against anticipated threats to the security of the information
Protect against anticipated impermissible uses or disclosures
Certify compliance by their workforce
Confidentiality and Risk to Other Persons
Case A. A 32-year-old female is diagnosed with metastatic breast cancer. When you were sent in to discuss medication options with her she tells you she refuses hormonal therapy and chemotherapy. She instructs you not to inform her husband and says she does not intend to tell him herself. The next day, the husband calls to inquire about his wife’s health.
Case B. A 32-year-old gay man is diagnosed as HIV positive. You meet him as you go into the HIV clinic to talk to him about his new medications. He tells you that he cannot face the prospect that his partner will learn of the infection.
Case C. A woman arrives at the pharmacy with a new pain medicine prescription with serious contusions on her face and her nose appears to be broken. Her husband accompanies her. He explains that she tripped on the carpet and fell down a flight of stairs. She affirms his story. The pharmacist does not know the couple, but judges by their dress and manner that they appear to be respectable citizens.
Confidentiality and Risk to Other Persons
Case A
Metastatic Breast Cancer Diagnosis and Concerned Husband
The pharmacist should not divulge the wife’s diagnosis. The pharmacist, while disturbed by the situation, cannot justify disclosure because the legal obligation and ethical duty to respect the patient’s preferences outweigh possible harm to the husband from not knowing his wife’s diagnosis.
If you as the pharmacist feel strongly enough, encourage the patient to tell her husband of her diagnosis since it is likely to have a significant impact on him as well.
Confidentiality and Risk to Other Persons
Case B
Fearful of Partner’s Reaction to HIV Status
The pharmacist (or physician) has a duty to ensure that the partner is informed of his serious risk.
First, urge the patient to do so at his own will. If this fails, take the steps prescribed in public health law and practice regarding contact tracing and notification. This is sanctioned according to HIPPA regulations.
Confidentiality and Risk to Other Persons
Case C
Case of Suspected Spousal Abuse
The pharmacist must make the required report to authorities. The clinical standard for reporting child, spousal, or elder abuse is reasonable suspicion. State laws usually do not grant pharmacists the discretion not to report suspected abuse.
Abuse is defined by law as the infliction upon an adult by self or others of injury, unreasonable confinement, intimidation or cruel punishment with resulting physical harm, pain, or mental anguish.
A pharmacist should be familiar with the characteristic physical signs of abuse that can frequently be distinguished from other accidental trauma.
Confidentiality and Public Health and Safety
Information obtained from a patient may suggest that he or she might be a danger to others. Traditionally, certain communicable diseases have belonged in this category, and laws have been enacted that require healthcare workers to report cases of communicable disease to health authorities. Many jurisdictions require persons and sometimes their physicians to report health defects, such as seizures and cardiac diseases, that might render operators of vehicles dangerous to others.
Where reporting laws do not exist, and even where they do, ethical problems may arise.
Confidentiality and Public Health and Safety Communicable Diseases
The clinician or other responsible health care worker (this includes pharmacists) should notify the local health authority that a communicable disease exists within the particular jurisdiction.
Administrative regulations that describe which communicable diseases are to be reported and how they should be reported may vary greatly from one region to another because of different conditions and different disease frequencies. Each local health authority, in conformity with regulations of higher authority, will determine what diseases are to be reported routinely.
Confidentiality and Public Health and Safety
Most jurisdictions have statutes requiring the reporting of cases of certain types, such as sexually transmitted diseases, gunshot and knife wounds, and suspected child, partner, and elder abuse. The purpose of these statutes is to protect public health and safety, and their ethical justification arises from obligations of social justice.
The phrase “danger to self and/or others” is frequently found in law, regulation, and common discourse. This phrase is very general and may have a broad array of definitions depending on who is translating. For the purposes of clinical ethics, danger to self or others should be safest as interpreted in a narrow sense, that is, there should be some reliable evidence that a harmful act is imminent or highly likely to occur.
Case A. You are the pharmacist in the student health clinic at the local community college. A student has just been diagnosed with bacterial meningitis and culture results are still pending to determine if it is meningococcal meningitis. You walk in the room to counsel him on available options pending culture results. He refuses therapy and insists on returning to his college dormitory room because he has to study for finals.
Case B. A 26-year-old male presents to your pharmacy counter looking for pain medicine for an injury to his left shoulder. You inquire more to learn about the injury, and you find out he just bought a new shotgun and was injured while trying to learn to shoot it last night. In the course of your OTC consultation, he casually states that he would like to see all politician’s dead and was going to attend a political rally “to see what he could do.”
Case C. You are a pharmacist at a neurology clinic and you are seeing a very familiar patient with a history of idiopathic seizures who is diligent about taking anti-seizure medication. Her last major seizure was 4 months ago. To qualify for a driver’s license, state law requires a declaration that the patient has been free of seizures for 6 months. She pleads with you for this certification because she needs to drive in order to keep her job.
Confidentiality and Public Health and Safety
Case A
Bacterial Meningitis Dormitory Concern
Bacterial meningitis is an infectious disease and because the patient’s final diagnosis is not clear, it could be meningococcal meningitis, which is contagious, spreads rapidly in closed settings, and is a reportable disease.
The pharmacist should alert the physician the patient is leaving, and the responsible health care provider has the duty to communicate the information to college authorities.
Confidentiality and Public Health and Safety
Case B
Lethal Shooter Potential
No victim is identified, and the likelihood of violence is uncertain. The threat is vague and possibly empty. The pharmacist should probe for specific details: Where is the rally? What politician? What does he mean by “see what he can do?”
While pharmacists may not be experts on the psychological characteristics associated with threats of this sort, they can be sensitive to certain features and persuade patients to seek help.
In the current circumstances, the pharmacist should be inclined to report her suspicions after supporting the suspicion with reasonable inquiry.
Confidentiality and Public Health and Safety
Case C
Controlled Enough to Drive
The patient is asking the pharmacist to lie in order to provide a benefit for the patient, which may place others at risk.
The safety of the patient herself, of other innocent parties, the integrity of the medical profession, and the utility of the law oblige the pharmacist to deny her request.
Ethical Dilemmas
Drug Information
All pharmacists at one time or another are required to provide drug information. This can occur at the level of the patient-pharmacist, provider-pharmacist, or health systems level.
The following are some examples of ethical dilemmas that can occur specifically related to drug information. These dilemmas might arise in a wide variety of settings and circumstances where health care is practiced, or health care policy is set. It is important to identify the level of ethical decision making that each example seems to represent and consider what ethical issues might exist for each scenario.
The hospital pharmacist is asked to provide information that might be used to speed the ending of a terminal patient’s life.
The hospital only has enough of an oncology medication to treat one patient, but there are three patients who need treatment. The drug information pharmacist is asked to review literature to help decide which patient receives the medication.
The drug information pharmacist is confronted by an administrator, pressuring for a certain formulary recommendation that is more cost-containment than evidence-based.
The hospital pharmacist is asked to compound a medication for which there is little to no safety and efficacy data, based on the pharmacist’s review of existing literature.
The home health care pharmacist is asked to positively present questionably substantiated information on the efficacy of a given therapy, in order to support insurance reimbursement for a truly needy patient.
In previous slides we talked about the four principle approaches to ethical decision making. Recall that the four principles include beneficence, nonmaleficence, autonomy and justice.
In addition, several more principles are specifically related to ethical approaches concerning drug information dilemmas. These include the following:
Respecting the patient-professional relationship
Consent
Confidentiality
Privacy
Respect for persons
Veracity
Fidelity
Respecting the patient-professional relationship
The pharmacist’s primary duty is to the patient and tends to give the pharmacist, rather than the patient, control in the relationship. This may be judged by some as paternalistic. It is imperative that there is mutual respect on both sides of the patient – pharmacist relationship.
Consent
A moral rule related to the principle of autonomy which states that the client has a right to be informed and to freely choose a course of action.
Confidentiality
A moral rule related to the principle of autonomy, which addresses the individual client’s right to give or refuse consent relative to release of privileged information.
Privacy
Another rule within the principle of autonomy, more generally relating to the right of the individual to control his or her own affairs without interference from or knowledge of outside parties.
Respect for persons
This principle directly addresses a belief in the inherent value of human life, independent of characteristics or abilities of the specific human being.
Veracity
This term addresses the obligation to truth telling or honesty.
Fidelity
This term addresses the responsibility to be trustworthy and keep promises.
Ethical Dilemmas
Drug Information Cases
Case 1. JB is a new patient at the medical center. She calls the Drug Information Center where you work as a pharmacist. As the specialist in drug information she wants to know if she should be concerned about taking the trimethoprim-sulfamethoxazole just prescribed by her family practitioner.
Case 2. The members of your team include a physician and nurse as well as you the pharmacist. The team has just been brought together and charged to prepare an advertisement piece for a new diabetic drug. The promotional piece will be targeted toward consumers in the United States and also India, therefore, two different versions will be created. One version will meet the U.S. Food and Drug Administration guidance on drug promotion rules by including a description of safety issues. The other version will omit the safety information because it will be used in India where guideline adherence is not monitored as closely.
Drug Information Dilemma
Antibiotic Concerns – Case 1
Identify the Information at the Root of the Case
JB is approximately 7 weeks pregnant and has been diagnosed with acute bacterial rhinosinusitis.
She only recently began seeing her physician as her family just moved into town about 2 months ago.
Her physician is aware she is pregnant.
She states that she asked him about the safety of the drug, but he rather impatiently brushed off her questions by asking, “Don’t you trust me?”
Consider the Stakeholders
Pharmacist
Patient
Fetus
Physician
Family
Establish the Ethical Issues in the Case
The patient has a right to be informed and freely choose whether to take the prescribed antibiotic in relation to other available options.
The pharmacist has an obligation to support the professional relationship between the patient and her physician.
The pharmacist must respect her own professional relationship with the patient.
The pharmacist must provide adequate drug information that treats the infection while being safe for the fetus.
Both the patient and the family members have a right to the information that is due to them.
Ethical Guidance and Legal Constraints
The Code of Ethics for Pharmacists clearly indicates that the primary obligation of the pharmacist is to the patient and not the physician.
If there were no good alternative therapies for the patient, is it possible that the physician was concerned that probable nonadherence constituted a greater risk to her and/or her baby?
Distinguish Ethically Acceptable Resolutions
The pharmacist could discuss the risks versus benefits of using trimethoprim-sulfamethoxazole with the patient and urge her to return to her physician for a different alternative.
The pharmacist could call the physician and discuss the risks versus benefits of using trimethoprim-sulfamethoxazole in a pregnant patient and suggest alternatives.
Identify Practical Issues
No practical issues exist beyond what has been identified above.
Drug Information Dilemma
False Advertising – Case 2
Identify the Information at the Root of the Case
The professional members of the work group clarify their understanding of current U.S. FDA guidance on drug promotion and World Health Organization (WHO) criteria for ethical medicinal drug promotion that are available to the world community.
Two published reports analyzing compliance with WHO guidelines in India are reviewed and there has been an ongoing history of wide noncompliance with the WHO guidelines among companies marketing drugs in India.
Consider the Stakeholders
Pharmacist (and other health care professionals on the team)
Patients
Prescribers
Society
Establish the Ethical Issues in the Case
Difference in cultural and medical practices in India versus the United States.
In keeping with the WHO Guidelines, the group is compelled to advocate for complete and truthful information to be provided.
The group needs to give accurate information in order to do no harm to patients.
Providing a higher level of educational content only to countries subject to enforced regulations and guidelines does not coincide with justice to health care providers and patients in countries that have less stringent safety requirements.
A patient has a right to make an informed decision regarding the new medication which would require complete and accurate information.
Ethical Guidance and Legal Constraints
It is the company’s and the professionals’ obligations to the WHO guidelines, as well as other governmental and professional guidelines to provide accurate and complete drug information.
Distinguish Ethically Acceptable Resolutions
Provide the most relevant, informative, and complete materials for both India and the United States in accordance with WHO guidelines.
Identify Practical Issues
A more cost-effective approach would be to utilize the same campaign materials for both countries resulting in less time spent and less resources for developing two different advertisement campaigns.
Ethical Dilemmas
Drug Information
All pharmacists will be called on to provide drug information. On occasion they will encounter ethical dilemmas regarding what information, if any, should be provided.
It is important that the practitioner approach such moments prepared to quickly identify the pertinent facts, analyze relevant points of the situation, and rank or balance the pertinent ethical rules and principles that are involved.
Law and Ethics
Be Prepared
Both the organization and the individual practitioners have an obligation to plan in advance how they will handle situations where ethical conflict might arise, particularly relative to compliance with any policy affecting the employee’s patient care obligations.
Policies and procedures to inform and support the clinician in overall client interactions, and in ethical analysis and decision making, can better prepare the practitioner to address the real-life dilemmas he or she will encounter.
All health care professionals, including pharmacists, should demand the right to be a major role in organizational policy development that affects their practice, preferably with input from client/patient representatives in order to maintain a healthy and productive work environment and ensure the best outcomes for patients.
Conclusion
Health care professionals often intuit their preferred ethical solution in specific cases rather than following a stepwise process to arrive at a sound decision. Most professionals might find it difficult to trace how they arrived at a decision or provide justification or reasoning for the decision.
The literature includes many normative models for resolving ethical problems in the health professions, but all require critical thinking and should result in a choice that is ethically justifiable where justifiable means that the reasons can be publicized or made transparent to others and have considered all the relevant information, stakeholders, and ensure that all resources are being utilized justly.
Active Learning
The Ethics in Medicine website is an educational resource designed for clinicians in training and is hosted and maintained by the Department of Bioethics & Humanities at the University of Washington School of Medicine. The learner will find topics in bioethics related to end-of-life issues, genetics, confidentiality, informed consent, clinical ethics, and law and many more subjects. The topics, cases, and resources are intended to support other teaching and learning activities. The reader is encouraged to explore this site to enhance one’s knowledge on the topic of law and ethics. The website can be found at the following link:
https://depts.washington.edu/bhdept/ethics-medicine
References
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