S & A PHARM 411 Ethics

A 47 year-old female patient has progressive dementia and no longer has decision-making capacity. She is on a temporary ventilator support for a treatable pneumonia. Life expectancy is still years. She is not in obvious pain, occasionally gets very agitated, but generally seems happy. Her only relative, a 21 year old daughter has said, "Mom would not want to live like this." The daughter has asked that the vent be removed and that "nature be allowed to take its course." Identify whether the facts below are clinical or contextual: 1. The patient has progressive dementia and a treatable pneumonia 2. The daughter has the authority to discontinue the ventilator because she is the closest relative 3. The daughter values her mother's quality of life 4. The patient is expected to live for years after treatment

1. Clinical 2. Contextual 3. Contextual 4. Clinical

Identify differences between the 1852 and 1994 pharmacist codes of ethics

1852 Pharmacist Code of Ethics o Main focus on how business is seen o Relationships between pharmacist & physician o Very little reference to patient 1994 Pharmacist Code of Ethics o Puts patient first o Honesty & integrity in professional relationships o Individual, community, & societal needs o Less emphasis on business

Describe the prevalence and sources of sexual harassment for pharmacists

23% of female pharmacists and 11% of male pharmacists have experienced sexual harassment in the workplace Sources = colleagues and patients

Define implicit bias

Associations made outside conscious awareness that lead to a negative evaluation of a person on the basis of a characteristic or their identity

Explain the roles of autonomy, beneficence (for the subject and society), nonmaleficence, and justice in conducting human research

Autonomy · "Respect for persons" o Protecting people with diminished autonomy o Informed consent should be sought and obtained under conditions that are not coercive or unduly influential Beneficence · Subject o Minimizes the risks o Considers who is taking the risks o Assessment of whether potential for significant risk exists without any potential of individual benefit acceptable · Society o Maximizes benefit o Balances risk to individuals with benefit to society Nonmaleficence · Minimizes harm, particularly of individuals o Considers whether a significant risk exists and if there is any potential of individual benefit that is acceptable Justice · Selection of subjects appropriate to the research o Risks of participating in research and beneficial results of research should be distributed fairly across both groups to which the research subjects belong and the larger society o Consider who is targeted and who benefits from the research o Example: Global health research with HIV and Ebola virus

Define autonomy and paternalism

Autonomy: self-governance that is free from controlling interference and limitations that prevent meaningful choice Paternalism: intentional overriding of someone's preferences or actions by another person - person who overrides justifies this action by appeal to goal of benefitting or preventing harm

Discuss the roles of beneficence, nonmaleficence, and fidelity in substandard care intervention

Beneficence · Intervening when care is substandard and patient is harmed - acting to prevent harm in one or more patients Nonmaleficence · Poor care being providing violates this principle (preventing harm) Fidelity · Considering intervention can create a fidelity-fidelity conflict · Priority to current and future patients

Define beneficence and nonmaleficence

Beneficence- Refers to the moral obligation to act for the benefit of others, including actions taken to prevent harm Nonmaleficence - Refers to the moral obligation to avoiding causing harm; NOT taking an actions

Identify sources of moral disagreement in patient care scenarios

Can arise from: Factual disagreements Insufficient information The relevant principles and their relative weights Who should be protected by moral principles

Explain why codes of ethics, consequentialist theory, and Kantian theory are challenging to apply to specific ethical situations

Codes of Ethics · Limited in their applicability to real-world situations · They are not a direct reflection of moral philosophy · Does not address all situations · Too abstract to use in specific situations · Revised for changing practice standards and expectations Consequentialist Theory (Normative) · The rightness/wrongness of an act is judged only on whether its consequences produce more benefits or disadvantages; utilitarianism (benefits maximized in society) o Outcomes could be achieved through immoral actions o Too demanding, makes persons responsible for consequences they fail to prevent and what they directly cause o Permits the interests of the majority to override the rights of minorities, can result in unjust distribution Deontological Theory (Nonconsequentialist/Kantian) · Actions must be in accordance with moral rules and with the intention of being moral (moral motive) o Inadequate to handle the problem of conflicting obligations - obligated to do the impossible when rule is categorical o Better suited for relationships among strangers than relationships among friends/intimates o No moral worth for actions based on sympathy, emotion

Compare different methods of "fair" pricing

Definition 1: a company sets any price it wants (based on supply and demand) and as long as the consumer gets what was paid for, the price is fair o Usually met in the pharmaceutical industry Definition 2: considering the principles of complete life, limited resources, values, and comprehensiveness o Unit of analysis shouldn't be one year or another limited time frame, but the impact over one's entire lifetime o The just price of a drug should reserve enough resources for people to pursue valuable life activities o There should exist a close relationship between the actual benefits of an intervention and its price o Life activities other than health matter; in considering the benefits of treatment, we should also consider how it affects education, employment, and other valuable life activities Definition 3: a company sets a single price for a good or service o Negotiated based on market power, provides an economic advantage in the competitive marketplace o If a certain margin is met by a seller, lower prices negotiated by some are offset by higher prices of others o Negotiator for PBM has commitment to the PBM to lower its cost for the clients, which may be at the expense of others in society

Define distributive justice, procedural justice, and corrective justice

Distributive Justice: concerned with the fair distribution of the benefits/burdens in society Procedural Justice: concerned with fair methods of making decisions and settling disputes Corrective Justice: concerned with correcting wrongs/harms through compensation and retribution

Apply distributive and procedural justice to an ethical situation

EXAMPLE: Pharmacy buyers at hospital told managing pharmacist that sodium bicarbonate emergency syringes are not available. Supply will be intermittent over the next few months o Stage 1: implement strategies to preserve the standard of care and best practices to greatest extent possible within available drug supply o Stage 2: Apply primary allocation principles to optimize therapeutic benefit § Urgent/emergent medical need prioritized § Prioritizes patients who will both benefit and avoid harm from receiving the drug o Stage 3: Apply secondary allocation principles to ensure fair access to needed care § First-come, first-served § Another procedure approved by the affected stakeholders that does not discriminate between patients outside of their clinical situation o After reaching consensus from stakeholder group, implement the shortage plan § Communicate plan directly to pharmacy department, affected areas, and administration

Define an ethical dilemma

Ethical Dilemma: moral obligations demand/appear to demand that a person adopt each (2+) alternative but incompatible actions, such that a person cannot perform all the required actions o Unclear if act is morally acceptable or morally wrong o Belief that you are obligated to perform 2+ mutually exclusive actions

Define an ethical situation and list signaling words

Ethical Situation: situation where rights and welfare of people are impacted o Verbs: want, desire, prefer, should, feel obligated/obliged, ought o Nouns: benefits, harm, duty, responsibility, obligation, rights o Adjectives: good, bad, right, wrong, fitting, responsible

Describe the pharmacist's role regarding patient confidentiality

Expected to serve their patients in a private and confidential manner, which preserves HIPAA and maintains patients' trust in the healthcare system

Describe and apply the general guideline, and exceptions, for upholding the principle of veracity in patient care

General guideline: · Tell patients what they need to know so that they can make an informed decision - tell them what a reasonable person would want to know in the context of their own values and life circumstances · There is almost never a good reason to lie to a patient · Withholding information because you're concerned a patient will make a "bad" decision is rarely justifiable Exceptions: · Lying/withholding information to prevent imminent and serious harm (e.g., homicide or suicide) · Withholding irrelevant information · Withholding information that violates the trust of another patient · The patient requests the information to be withheld

Describe methods used to influence health care professionals

Gifts of all sizes - create a sense of reciprocity (a feeling that you owe that person something)

Explain the implications of implicit bias on patient interactions with health care providers and patient outcomes

Higher levels of bias are associated with poorer health outcomes for patients

Describe why moral reasoning skills are important.

Higher levels of moral development - behave in more professional manner concerning clinical decision-making Greater inclination to provide patient-center care Community pharmacists at higher moral reasoning levels perform better at measures of clinical performance

Describe the primary concern for each of the three levels (realms) of ethics, the relationships among the three levels, and use these levels to analyze patient cases from a justice perspective

Individual - Balance of benefits/harms within and between individuals § Individual benefits/values/needs (physical, mental, emotional, spiritual) § Weighing and balancing the competing values, benefits, needs, and loyalties between individuals § Considering probability of long- and short-term tradeoffs, and extent of harms and benefits · Organizational/Institutional - Net organizational benefit § Enables organization to maximize its purpose now and into the future · Societal - Common good of society § Common good: that which constitutes the safety, the integrity of its basic institutions and practices, the perseveration of its core value § Balance the many conflicting common needs/goods (e.g., education, housing, defense, health care, art, infrastructure, etc.) Inter-related Levels of Ethics: · Individual choices impact organizations and society · Organizational choices impact individuals (both within and outside the organization) and society (the society within which the organization exists and outside society) · Societal choices impact organizations and individuals (both within and outside the society)

Identify the principle of autonomy in patient care scenarios, recognizing when it is being supported or overridden/restricted

Justifying Paternalism - hard paternalism justified if all criteria are met: o Patient is at risk of significant, preventable harm o Paternalistic action will probably prevent harm o Prevention of harm to patient outweighs risks to patient of action taken o No morally better alternative to the limitation of autonomy that occurs o The least autonomy-restrictive alternative that will secure the benefit is adopted

Provide an example of pharmacist behavior that matches each CMD level

Level 1: "What's in my best interest" regardless of the effects on others; focus is on the self; may provide a low level of care if cost outweighs the benefit-not getting anything extra for spending more time with a patient Level 2: Patient-care consistent with federal and state laws; likely relinquish care when faced with moderate situational pressure (increased workload or reward system) Level 3: High level of patient care provided despite moderate situational pressure; if faced with significant negative pressures, would likely leave pharmacy

Describe the three levels of Kohlberg's Theory of Cognitive Moral Development (CMD) and identify the level in which most adults reside

Level 1: Pre-conventional Morality - usually occurs in children (under age 9); no personal code of morality; moral code shaped by adult standards; focus is on consequences of following or breaking the rules; 2 stages (1: obedience & punishment orientation and 2: individualism and exchange) Level 2: Conventional Morality - adolescents and adults MOST ADULTS RESIDE IN THIS CATEGORY; begin to internalize moral standards of valued adult role models; reasoning based on norms of social groups; 2 stages (3: good interpersonal relationships and 4: maintaining social order) Level 3: Post-Conventional Morality - only 10-15% adults do this level of abstract thinking; individual judgement based on self-chosen principles; moral reasoning based on individual rights and justice; 2 stages (5: social contract and individual rights and 6: universal principles)

Describe how nonmaleficence and beneficence apply to the pyramid of moral obligations

Moral Ideals - Non-obligatory Beneficent Actions (aspirational) · Severe sacrifice, altruism Special Relationship Obligations - Professional Obligations (Family, Friends...) General Moral Obligations - Obligatory Beneficent Actions (strangers) · Nonmaleficence

Define privacy protective behaviors, identify the consequences of these behaviors, and recognize them in patient care scenarios.

Privacy Protective Behaviors - actions taken by individuals to prevent their information from being shared with others, often this information is sensitive · These types of behaviors can lead to poor health outcomes for both individuals and populations due to insufficient or incorrect information · Examples of behaviors: o Asking provider not to document information o Withholding information about "taboo" behaviors o Paying out of pocket despite insurance o Using the internet to find information to avoid interaction with provider

Define the two major types of sexual harassment and identify these in a scenario

Quid Pro Quo · Sexual bribery or coercion when a superior bases an employment decision on the rejection of or submission to sexual demands Hostile Work Environment · Sexual harassment that creates an environment that violates a person's civil rights by subjecting him or her to unwelcome sexual conduct (usually on a regular basis) that interferes with the person's work o Sexual jokes o Compliments based on physical attributes or clothing o Unwelcome touching

Apply the rules of obligatory beneficence and their exceptions to a given scenario

Rules of Obligatory Beneficence · Protect/defend the rights of others · Prevent harm from occurring to others · Remove conditions that will cause harm to others · Help persons with disabilities · Rescue persons in danger Exceptions to Violations of Beneficence · Requires severe sacrifice · Requires extreme altruism · Action is unnecessary Action is unlikely to cause the good intended

Explain the difference between hard and soft paternalism

Soft paternalism: inventions intended to prevent or mitigate harm or benefit a person when the person has not made an autonomous decision Hard paternalism: interventions intended to prevent or mitigate harm to benefit a person despite the person's risky choices and actions are informed, voluntary, and autonomous

Describe sources of medical information for patients, how the principle of veracity may be violated by these sources, and the pharmacist's role

Sources of Medical Information · Direct-to-consumer advertising · Mass Media · Medical practitioner · Friends/family · Pharmaceutical industry How Veracity May Be Violated · Information can be inaccurate/use confusing terms · Can provide information in a misleading way (e.g., reporting absolute vs. relative risk) · Reporters may not understand what they are reporting to the public Role of the Pharmacist · To help the patient receive/understand the relevant information

List the characteristics of a profession and describe how pharmacy meets these characteristics

Specialized knowledge/training - Go to professional level school; residency programs/fellowships Commitment to providing important services or information to patients, clients, students, or consumers - Patient-centered care; more than just filling prescriptions (MTM) Maintaining self-regulation - Pharmacy has regulatory boards (state and federal) Control entry into occupational roles through formal certification - Obtaining licensure; NAPLEX & law exam to practice pharmacy Specify and enforce obligations of members - Pharmacy Code of Ethics

Define veracity and fidelity and apply these principles to patient cases

Veracity: principle concerned with truthfulness - the delivery of accurate, timely, objective, and comprehensive information. · It's not just what you say, but how you say something · Essential for provider-patient trust; don't deceive listeners · Form of respect Fidelity: an obligation to fulfill one's commitments - to follow the law; to follow the rules/principles of one's employer; to follow the rules/ethical rule of one's employer

Which ONE of the following statements about the WI conscience clause is FALSE? a. The conscience clause permits pharmacies to refuse patients access to contraceptives. b. The conscience clause applies to contraceptives only. c. A conscience clause provides legal permission for conscientious objection.

a. The conscience clause permits pharmacies to refuse patients access to contraceptives - the WI conscience clause permits pharmacists to refuse to fill a valid prescription for a contraceptive, but the pharmacy is still responsible for ensuring timely access for the patient

Dr. Gucci's research interest is prevention of sexually transmitted disease among adolescents using educational interventions. Which of the following statements primarily reflects the principle of justice in his research? a. The benefits of preventing sexually transmitted disease outweigh the minimal risks to the adolescents from participating in the study. b. Dr. Gucci selects adolescents across many sociodemographic categories so the results will be beneficial to society and the burden of the study risks is not borne by one group. c. Because many of the subjects are minors, special protections should be in place.

b. Dr. Gucci selects adolescents across many sociodemographic categories so the results will be beneficial to society and the burden of the study risks is not borne by one group - the selection of the subject sample that distributes the burdens and benefits equitably is supported by the principle of justice

Which of the following choices is TRUE regarding beneficence, nonmaleficence, and the pyramid of moral obligations? a. Nonmaleficence is a moral ideal b. Nonmaleficence is a general moral obligation c. Obligatory beneficence is a moral ideal

b. Nonmaleficence is a general moral obligation - we strive to avoid causing harm to all persons, all the time

Which of the following statements describes a limitation of applying consequentialism to real-world ethical problems? a. Consequentialism obligates persons to simultaneously honor conflicting obligations b. Consequentialism does not cover every ethical situation c. Consequentialism holds persons accountable for consequences they could not have predicted d. Consequentialism is periodically revised to reflect changing practice standards and expectations

c. Consequentialism holds persons accountable for consequences they could not have predicted - consequentialism is a demanding moral theory in which the consequences that actually occur determine if the action was moral; this is challenging to apply to patient care situations because we cannot predict what will happen to individuals

Dr. Todd Packer, a pharmacist at a community pharmacy, has just received a 90-day refill prescription for valproic acid for a young woman who takes the medication to prevent migraines. The young woman tells Dr. Packer that she had a positive pregnancy test a couple months ago, but hasn't her first appointment with her physician yet - is there anything she should worry about with this medication? Dr. Packer knows that valproic acid is contraindicated in pregnancy due to a high incidence of birth defects. He is also concerned that if he tells the young woman this woman that she will consider an abortion, an action against his morals. What would Dr. Packer do if he followed the incompatibility thesis? a. Tell the patient she cannot get her prescription b. Ask another pharmacist to counsel the patient c. Counsel the patient on the medication and adverse side effects as part of his professional obligation

c. Counsel the patient on the medication and adverse side effects as part of his professional obligation - under the incompatibility thesis, Dr. Packer must fulfill his professional duties regardless of his moral beliefs.

Which of the following is a disadvantage of the egalitarian approach to rationing? a. Patients with chronic illnesses are systematically disadvantaged b. Prioritizes patients based on their ability to pay c. Ignores patient need and the prospect of benefit d. Emphasizes equal moral status among individuals

c. Ignores patient need and the prospect of benefit - the egalitarian approach, in considering all individuals equal, does NOT factor in the clinically relevant differences among individuals and allow prioritization

Which of the following statements is false regarding privacy protective behaviors? a. Privacy protective behaviors lead to worse health outcomes, such as untreated conditions and incorrect diagnoses b. Privacy protective behaviors result from a lack of trust between a patient and provider or the health care system c. Privacy protective behaviors only impact the individual patient

c. Privacy protective behaviors only impact the individual patient - the information being withheld as a result of privacy protective behaviors can lead to inaccurate health records and public health reporting; when these behaviors are prevalent, the inaccurate data can affect an entire population and decisions about their care.

Which of the following choices is TRUE regarding beneficence, nonmaleficence, and the pyramid of moral obligations? a. The law requires persons to act in accordance with moral ideals b. The law provides guidance in all ethical situations c. The law may conflict with your ethical responsibility d. The law does not permit any unethical actions

c. The law may conflict with your ethical responsibility - although uncommon, the requirements of the law may conflict with your moral responsibility which can lead to an ethical dilemma

Describe the steps of informed consent and how autonomy is reflected in this process

o Competence: ability to perform a task o Disclosure: provision of information by heath care worker o Understanding: acquired pertinent information and have relevant beliefs about the nature and consequences of their action o Voluntariness: person wills this action without being under the control of another person or condition o Consent: person's verbalized agreement to course of action

Demonstrate how pharmacists and other health care professionals incorporate autonomy in the shared decision-making model

o Optimal health care decision reached involving, at minimum, the clinician and the patient o Distinct from formal process of consent, but incorporates similar elements o Encourages autonomous decisions from patients

Explain what "prima facie" means with respect to nonmaleficence

· "Accepted as correct until proven otherwise" · Harmful actions require justification that: o The principle of nonmaleficence is NOT, in fact, being violated o Other principles outweigh the harm being caused

Identify the three requirements of a covenantal relationship and describe how these requirements are met in the patient-pharmacist relationship

· A gift/labor or service between the covenant partners o Patients give "gift" of health information and we give them the "gift" of our medical expertise · A promise based on this exchange o Our promise = help patients achieve optimal health benefits from medications; be committed to their welfare; maintain their trust · The shape of the subsequent life for each partner o Patients help us grow as professionals and as persons

Discuss the relationship of ethical principles to sexual harassment

· Autonomy: quid-pro-quo violates because of the role of coercion · Nonmaleficence: all sexual harassment violates due to emotional and physical harm that can be caused o Feelings of anger, fear, shame, self-blame o Physical health symptoms o Mental health effects: PTSD, anxiety, depression o Alcohol abuse o Educational and professional harm

Discuss the relationship of ethical principles to patient confidentiality

· Autonomy: respects patients' decisions about what is done with their information · Fidelity: health care provider's commitment to patients, commitment to employer, and commitment to society/law

Differentiate privacy from confidentiality.

· Breach of confidentiality o When we fail to protect information trusted to us or deliberately disclose this information without consent o Example: two pharmacists discussing a patient care issue in an elevator and someone who knows the patient overhears · Breach of privacy o Accessing information which you have no authority to access, whether or not protections are in place o Example: a hacker accesses a clinic's health and billing records

Differentiate clinical and situational/contextual facts

· Clinical: indications, known risks/benefits of treatment, likelihood of response, etc. · Situational/Contextual: values, perspectives, authority, and relationships of those involved, communication, cultural/religious factors, setting and time constraints

Describe three arguments that support a right to health care

· Collective Social Protection o Definition: similarities between health needs and other needs that government has traditionally protected; consistency suggests that critical health care assistance in response to threats to health should likewise be a collective responsibility o Criticism: different perspectives on the role of government in society, so these government protections are neither obligatory nor essential. There are also relevant dissimilarities between the good of health care for individuals and other public programs · Reciprocity o Definition: society has a right to expect a decent return on investment made in health care profession education, funding for biomedical research, and funding for various parts of the medical system that pertain to health care paid for with tax dollars · Fair Opportunity o Definition: Justice requires that we use societal health care resources to give persons a fair chance to use their capabilities, especially the worst off due to disease and injury - equity

Compare and contrast conscience absolutism with the incompatibility thesis

· Conscience Absolutism o Health care professionals have no obligation to perform ANY action that is contrary to their conscience · Incompatibility Thesis o Any refusal to provide legal and professionally permitted services within the scope of a clinician's competence is incompatible with professional obligations to patients

Differentiate conscientious objection from conscience clause

· Conscientious Objection = refusal to participate o Judgement formed on the basis of sincerely held moral values that participation in some particular action would be violating one's own moral standards · Conscience Clause = legal permission to invoke conscientious objection o Still facilitates access o Example, duty to dispense contraceptives

Describe how moral status affects ethical decision-making

· Determines who is owed moral obligations and to what degree · Can help determine the prioritization of ethical principles in decision making o Full moral status = consider rights and welfare equally with other stakeholders o Partial moral status = rights and welfare of those with full moral status can be prioritized o No moral status = rights and welfare not considered in the deliberation

Explain the ethical implications of direct and indirect controls in pharmacy benefit management

· Direct control in pharmacy benefit management: access is limited by policies and procedures - limiting access to drugs via step procedures, PA's, excluding non-formulary drugs o Justice - sometimes, health care resources are limited, and PBM is to allocate them fairly. Welfare of the worst off should be protected à policies shouldn't impose a disproportionate burden on the most vulnerable à limited access to drugs o Autonomy - no, choices among prescription drugs or benefit policies proposed by patients/physicians aren't necessarily respected o Beneficence - yes, for society as a whole · Indirect control in pharmacy benefit management: incentivize or motivate providers and patients to choose lower cost drugs à physician capitation for rx drugs per patient, patient copayments, caps on pharmacy benefits o Justice o Autonomy o Fidelity

Explain the three objectives of universal health coverage

· Equity in access to health care services (everyone who needs services should get them, not only those who can pay for them) o Promotive, preventative, curative, rehabilitative, and palliative health services · The quality of health services should be good enough to improve the health of those receiving services · People should be protected against financial risk, ensuring that the cost of using services does not put people at risk of financial harm

Discuss the relationship of ethical principles to conscientious objection

· Fidelity o Commitment to patient, to law, to religion, employer/organization · Veracity o Avoid providing information that is misleading, manipulative, or biased o Be truthful to employers, colleagues, and patients · Autonomy o Impact of biased information on informed consent o Denying access to valid therapy violates patient's autonomy Being forced to perform an "immoral" act violates the pharmacist's autonomy

Explain how general moral obligations, special relationship obligations, and moral ideals are different

· General Moral Obligations o What strangers are expected to do to/with/for other strangers · Special Relationship Obligations o Professional obligations for family/partner/friend/patient · Moral Ideals o Saints and martyrs

Describe the role of the UW-Madison Institutional Review Board in ensuring human research is conducted in an ethical manner

· Health Sciences IRB o Reviews clinical trials/research protocols involving biomedical interventions on a weekly basis o Reviews medical records research, research database, and tissue banking projects, survey and interview research, and exemption applications every other week · Education and Social and Behavioral Sciences IRB o Reviews social, behavioral, and non-medical health research o Concentrates on K-12 education research o Usually meets once a month, but can meet under expediated circumstances · Primary role of IRB o To protect the rights and welfare of human subjects; evaluates risks/benefits of proposed research; makes sure patients make adequately informed decisions; population recruited is appropriate for study aims

Describe four theories of how moral status is granted and recognize application of these theories in a case.

· Human Properties Theory o All humans have full moral status and only humans have that status · Cognitive Theory o Individuals have moral status because they are able to reflect on their lives through their cognitive capacities and are self-determined in their belief in ways incompetent humans and nonhumans are not · Moral Agency Theory o Moral status derivates from the capacity to act as a moral agent, the ability to judge right from wrong · Sentience Theory o Having the capacity to feel sentience (ability to feel pain and pleasure and to suffer) is a sufficient condition of moral status

Describe ways that pharmacist can violate nonmaleficence in their practice

· Inadvertently o Dispensing wrong medication/dose o Making assumptions about patients · Intentionally o Administering vaccines (needle poke) o Asking sensitive questions (HIV-status - stigma associated with disease)

Create a plan for approaching a provider with suspected substance abuse, including resources available to impaired pharmacists

· Include documentation of concerning behavior · Discuss and obtain support from supervisor in advance · Plan out a meeting with the provider · Have information ready about various assistance programs

Describe the approach for determining when to intervene and apply the approach to a patient care scenario

· Include seriousness: harm/damage/trouble at stake · Include specificity: more specific vs. general · Include concreteness of issue: more concrete issue vs. abstract issue *As each of these factors become stronger, the needed for more immediate intervention becomes necessary on your part*

Identify the required elements of informed consent

· Includes a statement that the study involves research · Explanation of the purpose of the research · Expected duration of the subject's participation · Description of procedures to be followed · Identification of procedures that are experimental · Description of reasonably foreseeable risks · Description of benefits to subject to others · Disclosure of appropriate alternative procedures or treatment if appropriate · Extent to which confidentiality of subject records will be maintained · For more than minimal risk, whether any compensation or medical treatments will be provided, what they are, or where to obtain further information · Whom to contact for answers about research and subjects' rights · Whom to contact in the event of an injury · Statement that participation is voluntary · Statement that refusal to participate will not result in penalty or loss of benefits Statement that subject may withdraw at any time

Identify stakeholders at each level (realm) of ethics (individual, organizational, societal)

· Individual: individual persons · Organizational/Institutional: Families, unions, businesses, hospitals, religious community · Societal: city, state, national, global community, etc.

Discuss the relationship between ethics and law

· Law provides boundaries of acceptable actions in society, but does not provide guidance on the most ethical choice of several actions · Usually legal to do the right thing, BUT sometimes ethics and law conflict

Describe ethical exceptions to maintaining patient confidentiality.

· Legal requirement based on greater good of society (can vary by state) o Reportable infectious diseases o Safety concerns of health care institutions o Prescription Drug Monitoring Program o Suspected abuse (child or elder) · Serious, credible threat of harm to the patient or specific individuals or groups

Identify signs and symptoms of substance abuse in pharmacists

· Manifested in physical or professional observations · Often several signs and symptoms occur together and represent a significant change from individual's previous pattern of behavior · Sometimes no signs or symptoms at all

Explain why a failure to do a good act is not always a violation of beneficence

· May fall under the act of a moral ideal, which is non-obligatory · Example: it would be really heroic for me to go into a burning building to save some kids, but since I would essentially be sacrificing my life to save them and I'm not a firefighter, it would NOT fall under the act of an obligatory beneficent action or a professional obligation · Violations = obligatory action (general or professional) is not done

Recognize how the US health care system supports a minimum level of health care for some populations

· Medicare Part A, for all enrollees · Medicaid, for those who qualify

Explain how personal accountability could (in theory) be incorporated into health care policy

· Moral hazard: when a person bears less risk of the consequences, they may pursue more risky behaviors o Are they owed the same minimum health care o Do they forfeit all or some of their right to health care o Do they contribute more to health care resources? · Society must identify the risky health behaviors and use solid evidence to demonstrate the behaviors cause disease or illness · Individual's decision to engage in the risky behavior is autonomous - they know the risks of the behaviors before taking it

Describe how individuals may be differentiated when allocating scarce resources and identify the strategies most relevant for medical rationing

· Most Medically Relevant o Prospect of success: scare medical resources should be distributed only to patients who have a reasonable change of benefitting o Medical utility: rule of giving priority to the sickest patients or those with the most urgent medical needs · Least Medically Relevant o Constituency: social factors of the clientele, geographic boundary o Social utility: rule of giving priority to individuals with the most value to society

Describe characteristics of procedural justice

· Oversight by a legitimate institution (e.g., hospital) · Transparent decision making (e.g., explained to everyone involved) · Reasoning according to information and principles that all can accept as relevant (e.g., use best evidence to create allocation plan and a published framework) · Procedures for appealing and revising individual decisions (e.g., make revisions if situation changes, stakeholder group will review and make changes) · Meaningful public engagement (e.g., patient representative in stakeholder group)

Apply the principles of beneficence and nonmaleficence to an ethical situation

· Patient with asthma and diabetes needs steroids o Benefits: Steroids will help improve asthma o Harms: Worsen diabetes control, complications in the long-term · Surgeon recommends total hip replacement o Benefits: improve pain/ability to walk o Harms: Risks of hospitalization (infections, delirium), risks of anesthesia, lost wages, pain, limited mobility for a while after surgery

List vulnerable populations and explain why they are provided additional protection in human research.

· Pregnant women, children, and prisoners · People unable to provide fully informed consent o Cognitive capacity o Status relationship with PI o Economically or educationally disadvantaged o Impaired freedom · Cultural and translational issues · Approaches for enrollment o Research Power of Attorney o Healthcare Power of Attorney

Recognize the pharmacist's primary interest, and list common secondary interests.

· Primary o Can vary by the practice setting or discipline (patient care, research, education, etc.) à but usually patient's welfare o Attending to your own well-being in order to provide high quality care in the future is aligned with your primary interest · Secondary o Personal financial gain, reputation, avoidance of conflict, family, friends, etc.

Explain the balancing process

· Process of prioritizing one principle over another · Concerned with the relative weights and strengths of different principles - it is a personal judgement

Explain the conscience clause for pharmacy practice, including implications for the pharmacy, the pharmacist, and the patient

· Provides legal protection for individual pharmacists who refuse to dispense contraceptives · Pharmacy still facilitates access and meet's the patient's need · Patient experiences disadvantages and advantages o Still able to obtain contraception o BUT possibly longer wait times, feel stigmatized for decision?

Describe common biases in health care

· Race · Age · Disability · Sexual orientation · Gender · Social Worth · Cultural background · Religion · Obesity

Describe at least two strategies individuals can use to reduce implicit bias

· Recognize we all have bias · Practice Constructive Uncertainty = you don't know what you don't know · Explore your awkwardness and discomfort · Amplify marginalized voices and perspectives · Perspective-taking

Describe how the US private insurance model results in inequity

· Reliance on employers for financing health insurance o People with medium- to large-sized employers are better covered and subsidized by tax breaks · When employed people who are not covered become ill, taxpayers usually pick up the cost (not employers) · Low-income families spend more of their income on insurance compared to high-income families · Many individuals who do not qualify for group coverage pay significantly more for the same coverage than those who qualify in a group

Explain how the ethical principle of justice is violated by discriminatory practices

· Requires fair and equitable treatment of others · Many common foundations of bias are not under the control of the individual à have no relevance to clinical decision making · To base medical decision making upon biases (explicit or implicit) violates the principle of justice

Describe ways that pharmacists can support beneficence in their practice

· Respecting the relationship between the patient and pharmacist o Pharmacist promises to help individuals achieve optimal health benefit from the medications, to be committed to their welfare, and maintain their trust · Pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner · Pharmacist maintains professional competence

List and briefly describe each step of the 5-Step Model

· Response to sense/feeling that something is wrong o Acknowledge that an ethical situation is occurring o Intuition, heightened emotional sensitivity, avoidance, nagging, silence o Signal to analyze the situation feeling · Gather information/make an assessment o Clinical: indications, known risks/benefits of treatment, likelihood of response, etc. o Situational/Contextual: values, perspectives, authority, and relationships of those involved, communication, cultural/religious factors, setting and time constraints · Identify the ethical problem/consider a moral diagnosis o Identify the values, rights, duties, or principles that are in conflict o All Badgers Must Jump Very Fast § Autonomy § Beneficence § Nonmaleficence § Justice § Veracity § Fidelity · Seek a resolution o Propose multiple courses of action and examine the ethical justification of each o Consider the likely consequences and the intention of each action o Which actions can you be proud of and justify to others · Work with others to determine a course of action o A better decision can be reached if the people who are legitimately involved have the opportunity to discuss their perceptions, values and concerns, resulting in a more comprehensive decision that is ethically justifiable o Decision implies the prioritization of your values

Differentiate the right to health and the right to health care

· Right to health o Health is a status, not an object, action, or rule o Cannot "owe" health to a person o There is no right to a specific health status · Right to health care o Society can impact public heath through a clean environment, workplace safety, education, etc. o There can be a right to facilities, goods, services, and conditions necessary for the realization of the highest attainable standard of health

Define conflict of interest.

· Set of conditions in which professional judgement concerning a primary interest tends to be unduly influenced by a secondary interest · Risk of personal, secondary interests causing temptation or biases leading to a breach of role responsibilities

Explain why the Golden Rule is not appropriate for ethical analysis

· Treat others how you want to be treated · Every healthcare decision has its own benefits and harms from the clinician and patient perspective - the patient might disagree with the way in which you are medically treating them o End-of-life stuff: patient might want palliative care and to be comforted, whereas provider might want them to enroll in a study for a new cancer drug o Provider reflecting bias/prejudice

Describe the strategies for distributing scarce resources (rationing) and the limitations of each

· Utilitarian: to each person according to rules and actions that maximize social utility (welfare) o Limitation: may result in unequal distribution of resources across individuals, despite the overall societal benefit · Libertarian: to each person a maximum of liberty and property resulting from the exercise of liberty rights and participation in free-market exchanges à on a level playing field, each is entitled to what their skills attain for them o Limitation: prioritizes individual rights over welfare of society, assumption of level playing field for all · Egalitarian: to each person an equal measure of liberty and equal access to the goods in life that every rational person values o Limitation: ignores factors that are intuitively important in health care, such as patient need and likelihood of benefit · Prioritarian: to help those who are the worst off o Limitation: greatest need can be defined in different ways, which can discriminate against certain patient groups