Pharmacy Bioethics Exam

Ethics is the study of right action based upon reason and critical thinking; ethics provides direction based on elements rooted in our human nature or what appears to be required for the common good. Ethics is rooted in morality. A moral person is an ethical person. (do the right thing) In terms of classifying Ethics among the various University “disciplines,” it is part of Philosophy, which is one of the humanities.

The systematic study of the moral decisions, vision, conduct and policies pertaining to health and the biomedical sciences, especially genetics, neurology, and reproductive physiology.
[The systematic study of the moral dimensions of the life sciences and health care in an interdisciplinary setting.]
[The systematic study of human conduct in the area of life sciences and health care based on moral values and principles.]

standards and practices that have merit and importance

application of the ethical values to establish guidelines on how to make decisions when faced with complex issues

an equilibrium (look at both sides and try to come out in the middle)

Clinical Equipoise - when two hcps disagree on something
confidentiality and privacy
full disclosure informed consent informed refusal

conflicts of interest
accepting gifts from clients

sensitivity towards addicted pts and LGBT pts
Medication errors

Quarantine requirements (by who, how long, how complete) different from individual freedom

mandatory vaccination
Religious exemption

Disposal of prescriptions

Providing drugs for euthanasia/assisted suicide

Universal healthcare
right or a privilege

Is drug addiction a disease or crime?

Drug prices (price gouging)
Are drug prices too high or justified due to RnD costs

abortion (ban completely?)
pregnancy termination pills- who has the right, is it legal

Volunteers
Payment?
informed consent in clinical trials
Institutional review boards (IRBs)
ensure safety
how do you choose who gets the drug vs. placebo
Clear results one way or the other
ethical concern to prematurely halt study or
does consent override ethics

prove a patient is incompetent and can't make decisions
Excessive antipsychotic meds in LTCs

Suicide prevention
Assisted suicide/Death with dignity
2 physicians can sign on to approve assisted suicide for a terminally ill patient with less than 6 months to live
8 states have legislation
Advanced directive in patient’s will
What happens to the patient in certain cases (unable to eat, breath, etc.)
POLST - Practitioner Order for Life Sustaining Treatment
specify type of treatment patient would like to receive during serious illness

can we used gene testing to test drug efficacy, predisposition to diseases
determine pt has lift threatening disease, won't survive very long → right to terminate preg?
confidentiality (if there’s a crime, need evidence)

pharmacy routinely serve in hospitals (transplant team)
distributive justice- is there a fair distribution of a limited resource
10 livers vs 100 people → who gets the livers?

proper disposal of sharps
give directions for destruction

APhA and NABP handouts

fear of getting caught doing something wrong
religious convictions- based on morals and ethics
pride and reputation - want to be known as ethical person, honest and moral
Concern of the welfare of others; altruism or concern for society
Cost effective to be ethical, ppl will trust you more

Straight Talk” – “Tell it like it is…”
You tell the truth; you’re honest and direct. Give full disclosure and don’t try to hide things
may require courage because you are telling people things they do not want to hear
remember to be sensitive and not to belittle people or be demeaning

Demonstrate respect for patients, colleagues and business associates –
project caring and concerned attitude toward pts, colleagues
address by pt name, eye contact

Transparency - no hidden agendas –
don't manipulate your patients, tough but fair

Correcting wrongs -- The value and the risk of an apology –
Dispense a medication → wrong capsules → person takes 5 and ODs and goes to hospital → daughter accuses you, what do you do?
Confirm you gave wrong dose and don’t cover it up
“thanks, we’ll look into it, sorry bout your mom tho”
dont admit mistake, but be sympathetic
Be very meticulous about wording when responding to accusations or else can result in lawsuit

Respect for all persons –
treat everyone with dignity
never lose temper even when provoked
no sarcasm, no profanity
don’t discriminate for any reason

Respect for Patient Confidentiality –

Honesty, integrity, and candor – Involves candor, but with sensitivity. It’s often necessary to tell patients (or others) things they don’t want to hear (unwelcome questions or news). Need to communicate with great sensitivity, respect and confidence. When expressing criticism (as of company policies) do so respectfully and constructively not appearing to be a chronic complaint or mal-content. And go through appropriate channels.
instead of saying you have a 50% chance to live, get their hopes up by delivering the message in a different way! Say it’s their best shot at survival bc it’s the best medication out there at the moment

Responsibility for patient care –
theyre always the center of the universe

Awareness of limitations and need for professional growth
Understand that after you graduate pharmacy school you still need to learn (still need CE credits)
always room for growth

Professional deportment (including portrayal on social media) –
be careful what you post!!!!!!
believes freedom of speech, technically true but employer has freedom to fire you, not hire you bc youre crazy
employers do a social media search- post within reason and can have implications

Avoid conflicts of interest –
disclose conflicts
don't get caught in a cover-up cus most times the cover-up is worse than the crime
don't take bribes that promote products

Respect for Laws –
follow the law duh
don’t run from the law, only Taylor and Ed can

Respect for the personal ethical/moral/religious beliefs of patients and colleagues –
don't try to impose your views on others

Responsibility for professional peers and for the behavior of co-workers (except cory) –
Report crackheads like Ravi
Nonmaleficence
Duty to do no harm to the patient

Integrity in research - vaccine-autism study

is an expression of ethical principles and commitments –
Virtually all pharmacists take this oath, often as a part of their graduation ceremonies.
● Service (altruism) – concern for others

● Welfare of Humanity (beneficence) – do what's good for the pt

● Optimal Patient Outcomes (beneficence; non-maleficence) – do the best, do no harm

● Lifetime obligation to improve professional knowledge and competence (CPE)

● Moral, Ethical and Legal Conduct (inter-related concepts) – hold yourself and your colleagues to the highest ethics of your profession

● Embrace changes that improve patient care – don’t be resistant to change just cus you never done it before

Abusive or threatening behavior of any kind – e.g., assault & battery; profanity….
If you are being assaulted by a patient, you need to be cool, collected, and professional even if it is under pressure (unless it’s Ravi; then you throw hands)

● Unlawful harassment or discrimination based on characteristics that are protected by federal or state laws –
don't discriminate for any reason, esp not age, gender, race, religion, sex orientation, econ status, edu status, marital status

● Inappropriate or unauthorized accessing of patient records or inappropriate entries in patient records –

Be cautious about HIPAA and HITECH laws.

Reasonable Safeguards:
avoid conversations that people can overhear when counseling patients,
lower your voice
verify the ID of the patient/caregiver when in the pharmacy

4

Overbilling Medicaid
Illegal payoffs or bribery by the Pharmaceutical Industry to win business in foreign countries
Failure to properly provide patient counseling on new prescriptions or new doses of existing prescriptions
Criminal indictments and convictions of pharmacists in compounding pharmacies resulting from grossly incompetent quality control in sterile injectable products resulting in numerous deaths and morbidity.
Also civil penalties

ENRON and the Sarbanes-Oxley Legislation – 2001-2002. – Enron, a major energy company based in Texas, suffered a major financial collapse, resulting in the loss of millions of dollars that had been invested in ENRON stock for retirement investments, and the loss of thousands of jobs. The financial collapse resulted from false and misleading accounting practices involving several senior company officials and their supposedly independent accounting/auditing firm (Arthur Anderson).
TLDR; lied about their financial position

Sarbanes-Oxley Act (“The Public Company Accounting & Responsibility Act”) – Congressional legislation enacted in response to major corporate and accounting firm (external audit)) scandals (especially , but not solely Enron) that cost investors billions of dollars when share prices collapsed, shaking public confidence. The Sarbanes-Oxley Act set new and enhanced standards for all U.S. publicly-held company Boards, management, and public accounting firms. It provides for greater accountability, especially for any type of fraud; assurance of auditor independence; and enhanced full disclosure. Although Sarbanes-Oxley only applies to “for-profit” corporations, the practices reflected in the legislation have been effectively adopted by many “not-for-profit” organizations, and especially health symptoms.

Requires truthful accounting and independent audits

Types of numerous disciplinary actions taken against pharmacists, pharmacies, pharmacy technicians or interns -reported periodically by Boards of Pharmacy (through NABP):
• Revocation of license
• Suspension of license –
• Reprimand or Censure –
• Voluntary surrender of license –
• Fines –
• Other – [denial of initial license, denial of license renewal, directed plan of correction, modification or restriction on license, etc.] “Once you get your license, be careful not to lose it.”

• Breach of confidentiality.
• Conduct evidencing ethical or moral unfitness
• Failing drug screenings
• Expired drugs in inventory.
• Failure to comply with patient consultation regulations
• Inadequate supervision or delegation
• Inadequate security for controlled substances
• Sexual misconduct
• Failure to cooperate in Board investigation. –
• Violation of Federal or State statutes or regulations –
• Diversion of Controlled Substances –
• Error in prescribing, dispensing or administering medications –
• Failure to comply with C.P.E. requirements –
• Fraud –
• Criminal conviction –
• Practicing without a valid license –
• Allowing or aiding unlicensed practice – (including unlicensed pharmacy techs)
• Unauthorized dispensing –
• Alcohol or other substance abuse –

● The reality of the current job market for pharmacists, particularly new graduates– It is now widely acknowledged within the profession that there is no longer a shortage of pharmacists in the U.S., and that a surplus has developed in most areas of the United States. The shortage of pharmacists essentially ended by 2007. The job market is now competitive in most states, and this situation is not expected to change dramatically for the foreseeable future. All sectors of the profession have been impacted. Hospital positions increasingly expect a minimum of 1 year residency and increasingly 2 years.

The changes in the job market have resulted from various factors, but mostly as a result of an unprecedented increase in the number of new pharmacy studies in the last two decades. An article entitled “A Looming Joblessness Crisis for New Pharmacy Graduates and the Implications it Holds for the Academy,” by Daniel Brown in the American Journal of Pharmaceutical Education 2013; 77 (5), states: “Regardless of the job market, those new graduates who are “fittest” will be able to find employment.”
“move to Ding-Dong, Alaska for good money!”

• A potentially positive outcome from a surplus of pharmacists –
Forces consideration of other options that may have not been previously considered

• Potential to reduce or compromise standards in pharmacy education –
When supply of students is low, lowering of admission standards

•Effects on Pharmacists’ salaries –
leveled off salaries cus too many pharmacists so now jobs dont pay as much

● Be aware, be informed, be realistic 😭, be prepared, and adjust your approach and expectations accordingly –
know what ppl are getting paid 🙁

● Avoid waiting too long to focus on making arrangements for employment success –-

● Be sure you have met the “minimum job requirements” –

● Maintain flexibility and do not narrow your options excessively – multiple options (but cancel retail)

● “Network” as much as possible, and don’t try to “go it alone.” –

● Be well prepared for an interview –
Look up your interviewer stalk stalk them be their biggest fan follow them everywhere
● Project a professional appearance –eye contact, boomer talk

● Be succinct in answering written questions – avoid vague responses – and be sure you are asking the question that was asked –

● Be conscious of your non-verbal communication. – dont let them see you wringing your hands, dont look like a f—n liar

● Do not disparage past colleagues – dont moan

● Follow-up – ALWAYS DO IT

The ethical basis for licensure is: to protect the public health by ensuring and establishing minimal levels of competence for those practitioners holding a current and valid license.]

On-line application is now the only option – http://www.state.nj.gov/lps/ca/pharm; www.nabp.net
have a look in advance to know what it requires so you can apply once you qualify

● Be of good moral character ---- basically this means to be an “ethical person.” If you have “character,” this means that you are ethical and trustworthy a moral person

Transfer NAPLEX score to two other states for free
Decide within 90 days
MJPE does not have score transfer bc each state has their own law exam

Diminished paternalism –

Unavoidable Ambiguity –

Ethical perspective- and Ethical Decision Making (E.D.M.) –

Resolution of Moral Dilemmas –

The Pharmacist-patient relationship –

Informed consent / Informed Refusal – full disclosure necessary

Truth telling and confidentiality –

Allocation of scarce resources – distributive justice

lists Ethics among the “required elements of the Doctor of Pharmacy curriculum.” ACPE defines “ethics” as the “exploration of approaches for resolving ethical dilemmas in patient care, with an emphasis on moral responsibility and the ability to critically evaluate viable options against the needs of patients and other key stakeholders. In all healthcare activities, demonstrate knowledge and sensitivity towards the unique characteristics of each patient. Comply with all Federal, State and local law and regulations related to pharmacy practice. Demonstrate caring and professional behavior in all practice activities.”

Demonstrate caring, ethical and professional behavior when interacting with patients, colleagues and caregivers.
Demonstrate sensitivity and responsiveness to all aspects of diversity including:
same sex marriage

Practice ethically, including
How you respond to a medication error
Confidentiality (HIPAA + HITECH):

also called moral dilemma, is defined as a situation where there are two equally justifiable solutions.

Respect for patients, healthcare colleagues (including pharmacists) and employees.
Honesty (truth telling, veracity) and integrity .
Professional dress!
Appropriate work ethic.
Respect for patient confidentiality and privacy
Personal responsibility and accountability.
Honoring promises and keeping commitments (trustworthiness)
Punctuality

Recognizing the limitations – Some skeptics say professional ethics is “caught and not taught!”
Can be taught in classes, cases can be reviewed
applied philosophy- behavior can be modified

Nope, basic principles are in the oath of Hippocrates

a research endeavor that seeks to answer the question on bioethics that draws upon philosophical and empiric analysis

● Ethics as the basis for Law – “To say that men and women should not inject their ‘personal morality’ into public policy debates is a practical absurdity. Our law is by definition a codification of morality, much of it grounded in the Judeo-Christian tradition.” -- Senator Barack Obama (2006).

Before laws, society was governed by religious rules

Laws tell us what we have the right to do; ethics tells us what is the right thing to do.
generally they are the same

● Practical value of an ethical focus in the legal practice of pharmacy – mandate ethical behavior
violate ethics → loss of personal reputation , not so much a monetary loss
Reduces probability that you inadvertently break laws
generally the ethical thing is also legal

A claim of “acting in good faith” in a law case may carry some weight, but it is by no means a “full-proof” defense if a law has been violated. So despite the value of showing that you have acted ethically, you still need to be attentive to the details of the law, because “ignorance of the law is no excuse.” (ex: fines for lack of CS documentation)

Primarily because the major (only) thrust of managed care is (at least appears to be) cost containment.
Is everything that causes cost containment ethical?
Big corporations have high salaried CEOs who focus on the bottom line (cost containment) → ethics sometimes thrown out the window
Ongoing consolidation (CVS buying everybody), mergers

Ability to recognize those situations that arise in pharmacy practice that benefit from the application of Ethical Decision-Making (EDM)

Ability to comfortably and authoritatively (convincingly) discuss ethical issues that arise in pharmacy with colleagues and patients. –
Enhance your reputation and respect from employees, colleagues, and patients
if your decisions and reasons are ethic, practical, and properly communicated, uhhh… something (I forget what he said)
if ever attacked on your ethical decision making, you can fight back

Ability to apply your Critical Thinking Skills to the process of Ethical Decision-Making (EDM) – Here is a 4-step method; more elaborate models exist. These “steps” become automatic and instinctive with experience.

Identify the issues – formulate concise and succinct statement of issues, prioritize stakeholders, recognize conflicts that may exist between stakeholders (patient vs insurance; employer vs you; you vs profession)

Select the appropriate ethical principles (values, virtues) on which to base your analysis of the ethical problem – Determine which ones apply to your specific case; every case does not involve each principle. Prioritize principles

Arrive at a decision – Only after considering the possible options and how each stakeholder will be affected

Be able to defend and justify your position, especially upon challenge – assume when you make an ethical decision someone will challenge, possibly in court; not only the ethical thing to do but legal and as fair as possible to ALL stakeholders (distributive justice- whatever decision you make, you might not benefit one of the patients aka just be fair, wont satisfy them all)

defense should be logical, convincing, eloquent

The patient – priority, the first concern in EDM analysis, but not the only concern.
The Prescriber – physician or nurse practitioner: basically anyone that prescribes
Other Health Care Colleagues – pharmacy colleagues, employees you work with, physicians, RNs, etc.
Your Employer – Many times seen as an adversary but they are not. Loyalty is healthy and wise (debatably) for advancement, but blind loyalty should not be the standard
The Public Health (The Global Welfare; Societal Welfare; The Health Care System) – The stakeholder people forgot about during COVID → people were selfish af and didn’t want to wear masks or get vaccinated.
Your Profession – how do your actions affect the perception of the public on practice of pharmacy? you’re the only visible figure a lot of ppl see. it is the sole understanding of pharmacy that ppl see.
Yourself /your family - you could lose job, go to jail, lose license, etc

still have a lot to prove to people outside our profession of our full capabilities

▪ Compassion – awareness and concern for the feelings of others; you’re a sensitive listener. The lowest level/value

▪ Sympathy – related to compassion, but goes beyond compassion because sympathy involves experiencing feelings of regret at the pain, misfortune, and diseases of others (patients). (if you can’t be sympathetic, at least be compassionate)

▪ Empathy – highest level; goes beyond sympathy actively feeling what others are feeling; may have experiences of what others have gone through. basically can put yourself in someone else’s shoes

▪ Respect for the dignity of others – means not “putting others down;” avoids embarrassing or belittling any stakeholders; allowing others to maintain their dignity. e.g., not letting patients wait at the pharmacy counter for extended periods without any recognition or eye contact. @cory (lol no because I do) why does cory do none of these.

▪ Veracity – (an ethical mandate) – The moral principle that obliges one to tell the truth and to not lie or deceive others. Philosophical ethics has generally treated veracity as an obligation flowing from more fundamental ethical principles such as duty, practical value (“utility”), respect for persons or some combination of beneficence, fidelity, and autonomy. The virtues of candor and truthfulness are among the most widely praised character traits of healthcare professionals in contemporary bioethics. Veracity (truthfulness ) supports diverse ethical values: respecting others, avoiding coercion and manipulation, supporting the value of communication, eliminating the costs and complications of deception, and maintaining trust.
full disclosure
Truth = fidelity (?)

▪ Justice (often called Distributive Justice) – Distributive justice means treating patients equally, with fairness in the distribution of limited health care resources. An action-guiding moral principle that obliges us to treat those who are equal in the same manner. When individuals are unequal, the obligation is to treat them in a fair manner. This means that those who have the greater need may justly receive more of a particular resource than those with lesser need. Realizing that resources are always limited, to meet the goal of equality of healthcare, society is morally obligated to provide a decent minimum of healthcare to all claimants. Procedural justice requires that the process for making decisions involving patients be fair and just, including decisions involving health insurance company decisions.

▪ Autonomy (dignity) → the patient’s self determination. right to accept or reject treatment (must be informed either way)

Sensitivity to the needs of the patient – includes the following
Timely service – no waiting; encourage people to order thing ahead of time

Treating patients (and other stakeholders) courteously at all times. - based upon respect and maintaining dignity

Professional Competence. [essential – but…”I don’t care how much you know until I know how much you care.”

Responsiveness - to patient complaints and questions; be patient, don’t show you’re irritated, don’t cut the patient off even if it’s a stupid question. (Just curse them out in your mind) it’s your job to educate these dumbasses

Since the 1970s, the profession of pharmacy has shifted from a product focus to a patient focus. At the same time, public attitudes have shifted to a greater awareness of their “rights.” Patients demand “autonomy” in decisions affecting them, and have higher expectations

• “Patient Protection and Affordable Care Act – March 23, 2010 – (upheld twice by US Supreme Court)
felt it was adding cost to society
gave a safety net

• Strengthening Medicare Part D and Phasing-out the “Doughnut Hole” over time – Helping patients with the donut hole created an ethical dilemma because you would have to manipulate their plan

• An emphasis on MTM–[which has led APhA and ASHP to emphasize the need for “Provider Status” for pharmacists. Problem not exclusively for pharmacists, but important; if going to get paid need provider status

Integrated Health Care. (“Medical Homes”) – ACOs represent a team-oriented, comprehensive approach to the delivery of health care and the management of patients. It involves the formation of alliances of physicians (both primary and specialty care), hospitals, and other providers, including pharmacists to care for a defined population of insured patients. The goal is to better coordinate care, to provide quality care, to improve outcomes, and to generate savings. If savings are generated, the providers will share in the savings. Pharmacists can potentially play a role by improving pharmacotherapy and patient compliance.

Moving into the health care business; emphasizing direct patient care and the value of the pharmacist’s services - [This trend was evident in the decision of CVS/Caremark change their corporate name to “CVS Health” and to phase out the sale of tobacco products in their pharmacies. As noted in a Feb 5, 2014 report in The New York Times, “The company’s move was yet another sign of its metamorphosis into becoming more of a health care provider than a largely retail business, with its stores offering more mini-clinics and health advice to aid customers visiting its pharmacies.” The CEO of CVS stated: “We have about 26,000 pharmacists and nurse practitioners helping patients manage chronic problems like high cholesterol, high blood pressure and heart disease, all of which are linked to smoking.”] In 2018, CVS acquired (merged with) the comprehensive health insurance company, Aetna. In completing this historic merger, CVS emphasized its intention to have its pharmacies evolve into centers for the comprehensive delivery of healthcare.

encouraged limits to opioid prescriptions

passed compounding rules; tried to regulate drug imports (APIs from other countries)
US based APIs: more control over purity of ingredients

More transparency on rebates, violate patient autonomy by requiring use of mail order services

continual increase in price of drugs, higher than any other healthcare cost
Drug shortages [no adderall :(]
Import of APIs
generics- not happening bc they want to keep price of brand high
making of sterile preparations- dont cost alot so no one is making them
Bribing: excessive gifts to doctors to prescribe certain manufacturer’s brands
companies withholding adverse effect info from public

● Unfulfilled healthcare needs and pharmacists’ potential – The pharmacists are by far the best qualified professional to manage prescription therapy but we are limited due to the lack of reimbursement and the lack of prescriptive authority (#stopnurseprescribing)


● The impact of the pharmaceutical industry – “a lack of congruence of interests”
The Pharmaceutical Industry does not explicitly endorse the need for a specialist in MTM to ensure the proper use of modern pharmaceutical products, choosing, in general, to remain silent on this issue (worried about losing money). Another example of the lack of “a congruence of interests” has been the industry’s lack of support for a “pharmacist-only” (3rd class) of drugs in the U.S.

▪ Educating patients –
During COVID, the performance of pharmacists was impressive and rapid with regard to vaccines and tests → patients reacted well
Demonstrated to other stakeholders that patients were ready to accept direct care from pharmacists
“COVID was fantastic for pharmacists!” Angelo Coryfaldi

▪ Ensuring selectivity – increasing number of pharmacy schools but that is finally starting to slow

● The traditional boundaries – Thought leaders within the profession have opined that the traditional roles of dispensing and drug product distribution have been too limiting. Unfortunately, some of these limitations have been self-imposed over the years, especially in years prior to the “clinical era” which developed in the 1970s. In decades prior to the 1970s, the profession was too “passive.” This has changed in recent decades, and the profession has begun to press for more autonomy and more of a direct patient care role. The current “push” to obtaining provider status and greater prescribing authority are examples.

● Increasingly limiting legal boundaries – Until 1850, there were no restrictions on what drugs U.S. pharmacists could dispense without a formal prescription. In 1850, only “poisons” became restricted. Gradually, most of the discretion and professional autonomy that pharmacists had as to what could be dispensed has been restricted. Pharmacists are now trying to reverse some of this (e.g., efforts to gain prescriptive authority at least on a par with Nurse Practitioners and Physician Assistants).

Modern versions of State Pharmacy Practice Acts (e.g., NJ – July 1, 2004)

▪ Expanded view of Pharmacy –

▪ Collaborative Medication Therapy Management (MTM) – Rules and regulations based on the 2003/2004 update of the New Jersey Pharmacy Practice Act, were ultimately approved and implemented in February, 2013.

voluntary, registered with board, protocols set, come up with a contract signed by doctor, pharmacist, patient that is to be reviewed and renewed
rules on what pharmacists can and can't to
cover clinical lab test
recognize pharmacy techs and interns and externs

▪ Clinical Lab tests –

▪ Pharmacy Technicians –
Interns + Externs
Increased regulatory recognition of P.T.s in NJ and elsewhere is an indication of the change in the role of the pharmacist, beyond dispensing and distributive roles, and more direct patient care roles. NJBOP regulations allow the pharmacist to delegate to P.T.s (also interns/externs) only the following duties: recording of the prescription; selection of the drugs, container and diluent; typing of labels; compounding of preparations. The pharmacist shall ensure that each task has been performed correctly in the dispensing process. Pharmacists shall provide immediate personal supervision of P.T.s who are performing sterile and non-sterile compounding. The ratio of dispensing pharmacists to P.T.s shall not exceed 1:2. If the P.T.s have passed the national P.T. certification exam, the ratio may exceed 1:2, but there must then be a policy and procedures manual regarding P.T.s, and their names must be included on pharmacy permit renewal applications.

The law is a model for other states. It allows pharmacists/pharmacies to contract with ACOs, health systems, and third-party payers; provide services; and bill for services. This opens the door for pharmacists to provide clinical services and bill like any other provider. On the other hand, it does not address reimbursement directly, nor does it require commercial insurers, government programs, or other third-party payers to begin paying pharmacists for services they were not paid for in 2013.

California, Oregon, Colorado, Maryland, Hawaii, New Mexico

● How to use the medication –
● What to avoid while taking the medication –
● How to monitor the pharmacotherapy –
● How to recognize serious and common ADEs –
● Whom to call if concerns/problems arise –
● Follow-up needed –

Pharmacists: knowledgeable, good communicator, dedicated, patient,
Physicians: knowledgeable, good communicator, empathy & compassion, thorough
Nurses: knowledgeable, empathy and compassion, friendly,, accurate
Patients: knowledgeable, empathy and compassion, friendly, accurate, attentive

The NJBOP may refuse to issue a license (or to renew a license) to any applicant who has violated any law or regulation related to the practice of pharmacy. The Board may also refuse a license (or renewal) – or may suspend or revoke an existing license – because of any of the following reasons that may constitute: “Grossly unprofessional conduct:”NJSA 45:14-65 (refer to p.136 of his textbook)

Establishing an effective Health Care Provider – Patient Relationships: – Requires meaningful, practical and ethical patient counseling, IF THEY WANT IT, particularly in the community pharmacy (or any out-patient/ambulatory) setting
includes increased visibility and accessibility of the pharmacist to patient (not very common in the Hospital setting)
includes the follow-up monitoring of patients who have received prescription medications.

its our ethical responsibility to decrease waste and limit costs

CMS requires pharmacists who are involved in Medicare and Medicaid programs to complete some form of training on an annual basis . This may be handled through the Medicare plan sponsors (Prescription Drug Programs) or by State Medicaid review boards. Our responsibility is to prevent fraud, waste, and abuse ⇒ ILLEGAL & UNETHICAL

Inappropriate billing (billing and not filling it)
Intentional “shorting”
e.g Rx is 60; filling 50 tablets
Inappropriate pricing
Dispensing one generic and billing for a more expensive generic - NDC doesnt match
Intentional forging or altering of prescriptions (criminal)
Dispensing expired medications ⇒ once expiration date is expired CAN’T dispense it

one of the most problematic areas
45% of all pregnancy are unplanned
there has been a push to make birth control OTC
would make a lot of sense, because then more people would be able to get it
this is an ethical issue → if it became OTC, it would become an easier decision
Religiously: regarding emergency contraceptives, there are different personal\/religious beliefs
in those circumstances, you CANNOT impose your belief on others
we know how to deal with this issue legally - wont violate ethics, the law, and the #1 stakeholder (the patient

What about morning after pills?
different states deal with it differently

Drugs for fertility clinics? Should they be dispensed by specialty clinics, or can it be dispensed by any pharmacy?
During pregnancy and lactation, RPh have a responsibility to educate effects of drug on pregnancy and lactation

Federal rules of pregnancy warnings:
this is the legal requirement (imposed on manufacturer)
we have an ethical requirement as well - RPhs have to explain it to the patient

Physician Assisted Suicide – [“Aid in Dying for the Terminally Ill” ]
NJ is the 8th state to pass this Act
Not considered “suicide” if it is in the ambit of the law
Need to verify the patient is terminally ill:
< 6 months to live ⇒ certified by 2 physicians
Disabilities are NOT terminal illnesses

Fear that patient may want to d/c life saving drug
Patient has requirements to d/c life saving drug:
Must submit a request in writing AND VERBALLY TWICE in 15 days
To ensure pt doesn’t change their mind
2nd physician needs to verify dx of the first

Patient needs to verify that they have been told of other pain and palliative care options
**2 witnesses must verify that the patient is acting voluntarily -- CANNOT be a relative

If all done properly, the physicians and pharmacists are protected from arrest and loss of licensing
Presents an ethical issue for the pharmacist dispensing the EOL medication
What if you do not believe that it is proper to dispense medication to end someone’s life? Do you have an obligation before dispensing to inform the family, if they do not know? Or is that confidential information between the patient and the pharmacist?

TLDR: follow legal rules first, then personal ethical considerations
There is no family notification requirement in NJ, if you notify a family member you could be ethicially violating your trust from the patient

Generally applies to hospitals (not really community)
In general, It’s NOT ethical to withhold or withdraw this tx BUT there are exceptions:
Comatose patients on IV TPN ⇒ is it worth keeping them alive if there is no hope for recovery?
Or terminal illness
Can be dealt with if pt has a living will, pulse, advance directive
If patient authorized, then can withhold

Not only an ethical issue, but also a political concern
ethics of the patient who cannot afford a life-saving drug
you have to ask, “is the high cost of the drug that extends someone’s life for a few days or weeks justifiable?” esp in specialty drugs that are expensive (50% of drug spending)
Someone must decide if it is worth stressing out the system to use a drug that only extends life by a few weeks but costs a lot of money per dose and prevents treatment of other individuals with curable conditions or conditions where their lives can be extended for years
Becomes issue of distributive justice

Ethical approaches to the treatment of chemically impaired patients, especially in regard to dependence on prescription opioids (e.g., narcotic analgesics); also dealing with patients with psychological diseases and the use of pharmacotherapy in treating depression and mental illness.
Ethically and legally restricted: haloperidol, chlorpromazine, risperidone, alprazolam, diazepam, clonazpam

Informed Consent – full disclosure to volunteers along with a “Statement of informed Consent,” fully explaining the risks, benefits and procedures to be carried out; signed by each participant, and witnessed.
Phase I and II - written consent
Phase III - oral consent
Ethical Principles involved:
Veracity (truth)
Patient autonomy

Fabrication of results is UNETHICAL
Thimerosal drug - someone lied in journal article about drug causing autism where they only used limited data → misled everyone for years about the drug

Misleading interpretation of research data. E.g., “data mining”
Use statistical methods to force a conclusion that you want

Full disclosure of results.
important to disclose NEGATIVE results of trials
Phase IV - have an ethical obligation to report all adverse drug reactions

Often, RPh is part of organ transplant team
ethical issue: prioritize a scarce resource (distributive justice)
Patient factors to look at:
Age
Disease/health
reason or disease (self imposed or something you “caught”)
Chance of success (that organ will not be rejected)
Ability to pay

RPh obligation to assign effective immunosuppressive drugs that will prevent rejection of organ and the RPh has to maintain contact with patient to ensure adherence to the regimen

strict requirements for humane treatment in animals!!
was not always the case but it is now

Complex and/or controversial decisions or problems involving conflicting interests among multiple stakeholders.

• The reasons for increasing exposure to Ethical Dilemmas:
RPh legal and ethical obligation to counsel patients, informed consent and refusal
increased involvement in direct patient care (i.e immunizers)
Involvement in collaborative practice - working with doctors and patients to expand responsibility (MTM)
Increase in cost and complexity of the RxTx being dispensed

BOTTOM LINE: We need ethical decision making (EDM) to reduce variability and ensure some consistency the way each RPh deals with these issues
Will never be 100% but MUST TRY to minimize variability

Less reliance on the experience, background and personal philosophies of the pharmacist. Instead, use a more systematic approach based on ethical principles and theories, allowing pharmacists to utilize alternative theoretical approaches to resolving ethical problems

The Social Contract Theory
The Ethics of Care Theory
The Traditional and Fundamental Ethical Principles Theory
Relying on the Character or Virtuosity of the Pharmacist
Linking and Balancing patients’ rights with their corresponding duties
Professional Codes of Ethics

Because pharmacists are licensed health care professionals, society in general, as well as patients, have a fundamental right (or contract) to automatically assume and expect a competent and supportive professional relationship with the pharmacist. It is not based on a legal or written contract, but on the norms of acceptable professional and ethical conduct.
True of all HCPs -- adds that RPh will not intentionally undercut other HCPs and will not undercount meds, diluting expensive IVs (common problem in hospitals when Rph prepares solutions and only puts ½ pain med and sells unused portion)
Social contract indicates that if you are asked to counsel, must warn about ALL HARMFUL effects of the drugs as well as its benefits (does not mean super RARE but rather the common ADRs)

This is an ethical theory that applies uniquely to health care professionals. It assumes that healthcare professionals have an inherent, natural instinct and emotional inclination to provide quality patient care. (assumes commitment to beneficence, nonmaleficence, and all other ethical values)

Approach in which an RPh applies this theory takes 2 forms: (depending on RPh’s philosophical inclinations)
• Consequentialism: “The end justifies the means.” [aka Relativism]
Political standpoint: LIBERAL
Focus on the outcome/consequences of your decision
Everything depends on the benefit or the harm of the pt and other stakeholders
Ex. It’s okay to use placebo for pt in psychological disorder if it actually relieves their depression and anxiety ⇒ lying to the patient BUT it works, so that’s why you’re doing it
Answer to ethical question is that it always depends upon the outcome
Extreme consequentialism = relativism

• Non-Consequentialism: “The end never justifies the means.” [aka Absolutism]
Political Standpoint: Conservative side
even if it works, that does not matter
the approach emphasizes FULL DISCLOSURE + FULL PATIENT AUTONOMY
Ex. patient unknowingly on placebo → treatment would NEVER be ethical under the principle of giving a placebo for a psych issue (possibly even in clinical trials)
Extreme = absolutism
NEVER AN EXCEPTION AND NO FLEXIBILITY
everything is based on the actions of the RPH - not the outcome

RPh need to use BOTH consequentialism AND non-consequentialism -- (middle/centered approach)
Most pharmacists tend to be, and need to be, neither ethical absolutists nor ethical relativists.
Rather, they need to be ethical realists.
There is a relative quality to most ethical judgments, so some degree of flexibility is needed, but not to be carried to excess.

dherence to the basic ethical values or principles becomes the basis for EDM.

• Beneficence: do good for the patient as the first consideration of the multiple stakeholders
Realize that the patients are the most vulnerable because they are the most sick
Patients lack knowledge about the drugs
thus this principle mandates that the RPh advocates for the patient but must still consider the impact on all the other stakeholders
• Non-Maleficence: do no harm to the patient
protect the patient from ineffective medications and ADRs must be counseled and considered in risk-benefit analysis
“Duty to Warn”
have to give them information without scaring them
The harm of “Do No Harm”
must counsel on the harm of NOT taking the medication and on vaccine hesitancy
in the end, must recognize patient autonomy and their right to informed decision making
Legal reasons for not filling a prescription – “Refusal to Fill” –

Outside the scope of practice –
If it’s outside the scope of practice, you should question it / follow up if it is appropriate
**FOR EXAMS: If you see “must” or “never” usually NOT the right answer**

Questionable validity –
refusing to fill opioid prescriptions after consulting PMP - should not refuse for patients who really do need it

To protect the health and welfare of the patient –
Wrong dose
Wrong drug
Severe allergic reaction or toxicity
Patient might be getting addicted
drug is not for legit medical purpose
**do not use these are singular excuse to not fill a script - follow up with the prescriber
Ex. people dont believe that suboxone should be used for opioid addiction, but you do not have a good reason to not fill it

[Some States add a 4th reason.] –

Note: The religious beliefs of the pharmacist is not universally regarded as a legal reason to refuse to fill a prescription. NJSA 45:14-67.1 (pg 121)

• Justice/Distributive Justice:
Esp relevant in RxTx
Lets us know that we have an ethical obligation to help our patients when they insurance problems with the drugs that are being dispensed
Not a LEGAL responsibility but ETHICAL - must find a way to help them, make phone calls
When applied, must be FAIR
Financial distributive justice includes:
Insurance coverage
Patient’s ability to pay
• Autonomy:
Opposite Paternalism
Must respect patient’s right of informed refusal
Make sure that patient is compliant and has mental capacity and state of mind to make reasonable decisions about their health

● Some additional and specific values that may be useful to modern pharmacists (modern extensions of the
“basic values:”
Fidelity (commitment, trustworthiness) – keeping your promises ⇒ don’t make promises you can’t keep
Fairness – closely related to distributive justice
you need to be tough but fair
Patient-centeredness – emphasized in various codes of ethics ⇒ applies to ALL HCP
Evidence based – related to good science and professionalism
highlights value of controlled clinical trials to show safety and efficacy
makes you question ethics of dietary supplements, homeopathic medications, and off-label uses ⇒ not unethical but should think harder about them when recommending

“Character” or “Integrity” –
The assumption with this theoretical approach is that the pharmacist is a moral and trustworthy person.
[a person of character] – NOT 100% true (medication fraud) *sadge*
works best when there is a trusting relationship between patient and RPh
• “What a moral person will ordinarily do” –
In general, would come out in a legal case

[Every right comes with a corresponding duty; and vice versa.]

• The NABP “Pharmacy Patient’s Bill of Rights” – 1992 –
94 Code of Ethics
Theoretical approach that linked rights with responsibilities
emphasized patient autonomy and balance paternalism with patient responsibility

• The American Hospital Association’s “A Patient’s Bill of Rights” – 1992 –
Deals with the concepts of Living Wills, Advance Directives, Durable Power of Attorney, and Medical Power of Attorney - requires witnesses AND notarization; GENERALLY PREPARED BY A LAWYER and part of a will

Advance Directives: put together by a lawyer -- prepared by patient when competent/coherent
indicates who should act as surrogate decision maker if they are incompetent to make decistions and/or what medical interventions should be allowed

Living Wills: Put together by a lawyer -- often synonymous with an advance directive
tells medical professionals what life sustaining treatments they should get if they are terminal (respirator, IV nutrition, IV hydration, etc)

Healthcare Proxies: [Sometimes referred to as “Durable Power of Attorney”]
Created by lawyer - become effective when patient lacks decision making
Says that if patient is unable to make medial or financial decisions, they appoint person X to make medical decisions and be able to have access to medical records
can be the same or different person for medical vs financial proxies
if you dont have these and someone becomes incompetent, it is hard to get them! (takes a long time)
better to do this in advance
if you are appointed, you need this proxy because hospitals will not release any medical records unless you have the Power of Attorney
make many copies because places will require original copies
Rules vary state to state - Cifaldi recommends to have one

These are documents that only become effective once the patient lacks decision-making capacity or is unable to communicate due to illness. Rules governing these documents vary somewhat from state to state, and deal with issues like withdrawal of nutrition/hydration/antibiotics, DNR orders (not even CPR)and morphine infusions that hasten death.

Theoretical approach to solving ethical problems is often used
Criticism: some claim it is too “cook-book in nature.] ⇒ TOO “cookie-cutter”
Some people say to make code for all HCPs, but that is a bad idea
Blueprint/map that reflects wide range of practitioners options
Professional consensus

This 4th Century B.C. document initiated a strong ethical component to Western health care that also led to a tradition of significant self-discipline for health care professionals.
This self-regulation has significantly eroded in and been reversed in recent decades, with a great increase in the statutes and regulations that apply to health care professionals, perhaps mainly due to incidents of unethical behavior by health care professionals.

Lacked patient autonomy, distributive justice
self regulation is eroded
replaced by statutes and regulations that pertain to healthcare

8 ideas in this oath:
Beneficence and non maleficence
Confidentiality
Need to avoid your position to take advantage of the patient
Selectivity and allowing people into the profession
Specifically mentioned that drugs should not be used as poison or to assist in suicide
Respecting professional boundaries
Stressed objective training
Stressed non-discrimination

Codes reflect the changing paradigms (patterns, philosophies) of contemporary professional practice.
In contemporary pharmacy, for example, the current Code takes into account the transformation from a product orientation to a patient-focused orientation evident in the past half-century.
Reflect societal changes that occur over time, such as the growing willingness of patients to accept pharmacist counseling and the provision of information about their medications.
However, codes are also based on the unchanging principles of moral philosophy.

Avoid self-serving Codes
results in loss of credibility for the profession - lots of old pharmacist codes were self-serving

Should be broad statements of principles
Not too detailed or TOO specific ⇒ avoid “cookbook” pharmacy

Illustrate the broad principles with case studies

The 1852 Code of Ethics – “The primary goal in the case of medication errors is to protect the reputation of the physicians and the pharmacists.”
Limitations: not looking out for the patient→ no one would allow it today
self-serving; too detailed and cook book; too product focused and not patient centered
very self-limiting - you had to tell the patient if they had a question, to speak to the doctor
encouraged you to not speak to the RPh

The 1952 Code of Ethics – Lasted until 1968 (16 years). Replaced in 1969, in recognition of the fact that the profession was in the very initial stages of the transformation to a clinical profession.
1952: “The pharmacist does not discuss the therapeutic effect or composition of a prescription with a patient. When such questions are asked, he suggests that the qualified practitioner is the proper person with whom such matters are discussed.”
too self limiting
too subservient to physicians
our responsibility: compound the drug and dispense it, keep pharmacy neat and clean
pharmacist should have trusting relationship with patient
good news: not cook book

The 1994 Code of Ethics - It has been in effect for 25 years which indicates that it was forward-focused and in tune with the modern directions of the profession. It is a good example of what a modern Code should be, because it is based on a broad statement of principles; is not too specific; is not “cook-book” in nature. It is occasionally cited in court decisions.

A pharmacist respects the covenantal relationship between the patient and pharmacist. - fidelity
Interpretation: Considering the patient-pharmacist relationship as a covenant means that a pharmacist has moral obligations in response to the gift of trust received from society. In return for this gift, a pharmacist promises to help individuals achieve optimum benefit from their medications, to be committed to their welfare, and to maintain their trust -

A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner. - compassion, sympathy, empathy
Interpretation: A pharmacist places concern for the well-being of the patient at the center of professional practice. In doing so, a pharmacist considers needs stated by the patient as well as those defined by health science. A pharmacist is dedicated to protecting the dignity of the patient. With a caring attitude and a compassionate spirit, a pharmacist focuses on se8rving the patient in a private and confidential manner.

A pharmacist respects the autonomy and dignity of each patient. ⇒ adds the concept of non discrimination
Interpretation: A pharmacist promotes the right of self-determination and recognizes individual self- worth by encouraging patients to participate in decisions about their health. A pharmacist communicates with patients in terms that are understandable. In all cases, a pharmacist respects personal and cultural differences among patients.

A pharmacist acts with honesty and integrity in professional relationships. - veracity
Interpretation: A pharmacist has a duty to tell the truth and to act with conviction of conscience. A pharmacist avoids discriminatory practices, behavior or work conditions that impair professional judgment, and actions that compromise dedication to the best interests of patients.

A pharmacist maintains professional competence. ⇒ talked about obligation to stay current
Interpretation: A pharmacist has a duty to maintain knowledge and abilities as new medications, devices,and technologies become available and as health in-formation advances.

A pharmacist respects the values and abilities of colleagues and other health professionals. ⇒ your concern for the other stakeholders in the ethical analysis
Interpretation: When appropriate, a pharmacist asks for the consultation of colleagues or other health professionals or refers the patient. A pharmacist acknowledges that colleagues and other health professionals may differ in the beliefs and values they apply to the care of the patient.

A pharmacist serves individual, community, and societal needs.
Interpretation: The primary obligation of a pharmacist is to individual patients. However, the obliga tions of a pharmacist may at times extend beyond the individual to the community and society. In these situations, the pharmacist recognizes the responsibilities that accompany these obligations and acts accordingly.

A pharmacist seeks justice in the distribution of health resources. - distributive justice
Interpretation: When health resources are allocated, a pharmacist is fair and equitable, balancing the needs of patients and society.

[A little more detailed and specific than either the APhA or the AMA Codes.]
More self serving
Primary emphasis is on the patient, but for some reason, it differs from pharmacy because it encourages unionization does mention involvement in professional associations
importance of delegation of appropriate tasks to nurses (self serving and not of help to the pharmacists’ code of ethics)

Responsive care: need to respond and be respectful to your patients wants and needs
Evidenced-based care: rely on only the facts
Encouraging dialog: encourage the patient to talk with you, smile without a mask on, don’t be sarcastic and nasty
Empathetic care: modern ethical value - more recent than beneficence and non-maleficence
when people are ill, they are usually not happy

● Ethical basis: Autonomy:
The patient has the right to take or not take their medicine or to take or not receive their treatment; also they don’t have to adhere to their medication schedule but as a pharmacist, you have an obligation to counsel on proper adherence and its benefits

● Practical considerations –
Info given via a big piece of paper that usually gets thrown out
Can’t force people to accept counseling, but still have a responsibility to let patient know important things
Verbal communication is best

5 Levels -
label and package insert,
med guide
communication plan
ETASU
Limited distribution systems

rph-patient model is relatively new vs physician-pt
less well established

Definitely making progress:
From recent legal decisions → courts are now recognizing the pharmacist’s duty to warn and holding them responsible in negligence lawsuits
but can be sued if you do something wrong; more liability

Comfort-level among pharmacists varies:
some are comfortable and some are uncomfy
newer are more uncomfy

Inconsistency causes patient confusion:
All pharmacists do not act the same
Some counsel, some don’t → leads to different views by patients

Pharmacists must go beyond meeting the minimum legal requirements in our relationship with patients. This means that ethical obligations need to be emphasized and taken more seriously. If patients are to become more accepting, and expecting of pharmacist’ patient-centered roles, pharmacists need to be more directly involved in interpersonal relationships with patients.

Legal representation claims of responsibility solely for “safe, accurate and legal distribution of drugs:”
rphs used to always be exonerated if they put the label on right, correct drug in bottle, nothing else
not anymore :)
Courts are holding pharmacists responsible for not giving approp warnings, not counseling, improper dispensing
Used to be that “The doctor should have noticed ____” = doctor always responsible

Detracts from efforts to promote the pharmacist’s direct patient care roles:
Pharmacist is now legally responsible in patient centered care


Ability of pharmacists to win lawsuits on the basis of “No duty to warn:”
“it’s the doc’s job” → defense lawyers always say this

Being patient-centered even in casual encounters with patients:
Always be aware of legal and ethical ramifications of the counseling you give
includes when you give OTC advice

Inconsistency and relatively recent history: OBRA90 was a turning point- first time fed govt said pharmacist has duty to do prospective DUR, counseling, keep records → all states adopted it

Access to full patient profile: not a boundary anymore cus have full patient profile, most patients go to 1 pharmacy

Mercantile setting?: Pharmacies are no longer traditional; no more soda fountain

● Beneficence [ and patient advocacy] – rph is patient’s advocate

● Non-maleficence: three examples of the application of this bioethical principle –

REMS (Risk Evaluation & Mitigation Strategies):

Increasing (although still inconsistent) expectations that the pharmacist has a “duty to warn:”

Inconsistency of tobacco and alcohol sales and efforts by pharmacy chains to portray pharmacies as (primary) health care facilities:

● Autonomy –

Informed acceptance/Informed refusal:
Full disclosure always required

Assessing patient comprehension:
Medical literacy for patients widely varies; different competencies
How to convey information in an understandable way depending on patient education, literacy,
ask for feedback to see if patient is understanding what you just said (teach back method)
dont make them nervous

Patients who do not accept the “offer to counsel” or who fail to adhere to prescribed medication regimens
Patient have the right to not follow your instructions but you should document their refusal
Still need to counsel on importance of proper adherence and document so that you are covered
Ethical duty to make the effort to counsel
Explain what their failure to follow therapy is gonna do to them. make them understand & explain risks

● Fidelity (Fiduciary responsibility) –
duty to do what’s best for the patient
Give them the truth


● Confidentiality and Privacy – privacy is fundamental ethical principle (HIPAA adds to that in HITECH and is the legal justification)
Exceptions:
if forced by court order signed by a judge (NOT LAWYER) → gotta turn over information
when you can turn over info:
signed HIPAA release
life threatening situation/pending emergency
Prevent immediate and foreseeable harm

Requests from law offices or other emergency-type requests:
EX. police come in saying someone had passed out and is in a coma and they need to know what they took
If it is not an emergency and they request then do not provide
Consult PIC, lawyer, or supervisor in order to cover yourself

Court Order requests for access to prescription files –
tell the police to get a court order or warrant to turn over information
Court subpoena
Requires HIPAA release
NJBOP or US Attorney General Subpoenas don’t require release
FDA
Warrant specifies what they can look at. They cannot look at anything outside the warrant unless given permission

● Veracity – The duty to tell the truth is an obviously important ethical principle. However, it is not an absolute ethical requirement, because there may be a limited number of exceptions, although very few (ie double blind trials). There are some cases where consequentialism (“end justifies the means”) may apply: e.g., the use of placebos in clinical trials. But when a pharmacist receives a request from a patient’s spouse or parent, your obligation to confidentiality is greater than your obligation to veracity. Don’t let an excessive emphasis on veracity be an excuse to violate confidentiality and HIPAA.

The definition of clinical research –any research involving human participants including psychological studies.

Performed according to a strict protocol that is detailed and that is designed to yield scientifically valid data.

The protocol must define all procedures and specify the design techniques: randomization; blinding; placebo control; best currently available treatment control; cross-over design; type of statistical analysis; etc.

Ethical requirements:
benefits of study, even if potential, must outweigh the risks to the participants
no beneficial to participants alone but extend to group or class of people that have the disease
overall the benefits should not be trivial (e.g. drug increases pt. life for 5 days is not enough)
ideally patients should benefit from phase 2 and 3

consent must be completely voluntary
For initial enrollment and throughout the study
Patients need to understand that at anytime they are free to drop out w/o prejudice
If paying patients, there has to be a provision in the consent form explaining what happens monetarily depending on when a patient exits a study

Preclinical studies must justify the appropriateness of the clinical trial

Avoidance of harm or suffering to patients is a high priority in trials

Must discontinue the trial when there is a high rate of foreseeable injury to participants
hard to d/c when millions have been spent

Test groups are randomized between investigation drug, best current option, and placebo
When doing a double blind, one group is not favored over the other
Ethical question: How do you choose who gets a placebo?
If it becomes apparent that one group is significantly disadvantaged, the trial might have to be discontinued

IRB sometimes referred to as Ethics committee → Ensure the ethical treatment of volunteers to represent best interests
IRB has ethical and legal responsibility
Any group conducting clinical trials must have functional IRB

Decisions based on
Protocol
Preclinical data
Approved IND
Written statement of informed consent

Composition: Who’s on the IRB
Physicians
Pharmacists (That’s me!)
Nurses
Scientists
Statisticians
Lawyers
Administrators
Community Reps
Experts in ethics (Ethicians)

Responsibilities:
make sure study protocol is appropriate (ethical and legal), design and scientific integrity is safe, assure volunteers are given adequate informed consent

Written in clear language:

Thorough and detailed: but not too overwhelming to confuse the participant

Signed and witnessed: by every participant

Voluntary participation: Let them know they have the ability to leave and what happens monetarily when they leave

No excessive pressure to attract volunteers.
No exorbitant stipends.
don't make it so that people don’t have a choice but to participate
Ex. giving someone in a low income country a high level of compensation
Avoid the use of prisoners , mental patients, homeless people as volunteers.
Try for racial and gender equality

Require that the identity of any and all volunteers be held as strictly confidential.
Data presented in reports or publications must not be linked to the names of specific patients or volunteers.
All names must be de-identified by use of codes.
As part of the Informed Consent, patients must also be made aware of their HIPAA rights.

Formal training for all personnel working in the study
FDA has a right to inspect the trial sites
IRB board has a right to inspect and observe ongoing trials

FDA requires full disclosure of both positive and negative results
Has to be done in a way that is protective of the patients
Disclosure must be in a reasonable period of time

ADRs need to be reported with their degree of severity
Report to FDA anyone who has withdrawn from study due to ADRs or has suffered permanent injury or death

Approved drug vs investigational drug

People can withdraw at their own discretion.
report even if they withdrew not from ADRs, cannot exclude (basically report all withdrawals)

Ethical Issues –
Children cannot provide consent
Pediatrics were the last group given permission to get COVID shots so that safety could be established before they received the vaccines

Scarcity of pediatric trials (therapeutic orphans)

Calculation of pediatric doses
Based on extrapolation of adult doses → many times an educated guess

Many times a drug is not approved for use in children due to liability issues

Hard to get parents to agree to clinical trials
Ex. Refusing to give their younger children the COVID vaccines while taking it themselves

Child consent is sometimes required
Age is dependent on the trial

Incentives in the FDA modernization act to include pediatric trials in drug research
6 month patent extension

(different from the right to try law)
life threatening disease w/ clinical trial but cant get into trial
treatment for pts with serious disease/ conditions who lack therapeutic alternative and cant get into clinical trial
federal regulation provide exception to FDA act that say manufacturer cant distribute biological without efficacy AND safety yet

qualifications
didn't get into trial
immediately life threatening disease
reasonable likelihood that death will occur within a matter of month or premature death likely without treatment
serious disease: morbidity that has substantial impact on day to day function

expanded access qualifications
go to licensed physician and request access to investigational drug
Physician assesses that there is no other beneficial treatment
physician decides that probable risk of the drug is not greater than the probable risk of the disease
all parties must sign and submit to FDA

FDA determines if it is at least safe/effective and providing this drug will not interfere with ongoing clinical trials
drug manufacturer submits protocol how they can use drug, physician complies with informed consent for the expanded use (w/in rules of IRB) and agrees to report ADRs (even though they cant affect the clinical trial going on)
manufacturer must submit this use to FDA even though it doesn't affect their clinical trial
FDA allows manufacturer to charge the patient
not used a lot bc its a lot of work for the manufacturer :(

Signed into law in 2018
Mirrors expanded access
Circumvents steps like getting permission from the FDA
Request the drug directly from manufacturer w/o FDA oversight
Still has to meet the same requirements as expanded access

1 caveat
Investigational New drug has to have complete phase 1 trials
FDA does not approve the drug for any use
Has not been withdrawn by manufacturer or banned by FDA

Results cannot adversely affect a clinical trial result
There’s no liability to the manufacturer or the physician unless a high standard of recklessness or willful misconduct is shown.

In order for the prescribing and dispensing of off-label drugs to be ethical, it must be based on peer-reviewed publication; and there should be a conviction, based on collective experience, that the off-label use will be safe and effective.

Ethically appropriate (required): Covers veracity, maleficence, autonomy, beneficence

Good Business: builds trust with your patients, and they will have fidelity (be loyal)

Using a “single pharmacy”: promotes use, allows you to be more effective pharmacists bc you know what they are taking providing better drug regimens

Patient adherence: Effective communication is the best way to ensure they take their drugs as prescribed

Prevents Medication errors: talking to them about interactions and adverse events. helps you in a law suite to say that you counseled the patient

Pharmacist job satisfaction: happier to go to work if the patients are nice to you :) a happy pharmacist makes less mistakes

Trend is improving

Evolving and changing standards and expectations – pharmacists must recognize patient’s rights (pt. autonomy)
pharmacists ensure patients understand the pluses and minuses of treatment

● More is not always better – dont overwhelm pt with info, their head will explode and shut down, limit info to what is important (don't say every side effect), use your judgment (side effects> 1% are good to say)
limit adverse drug reaction to at least one in patient counseling (but should probably do more)
● Timing Matters – try to access the individuals right when they’re picking up medications
If agitated or uninterested or want an alternative → acknowledge it’s a bad time, offer to counsel over the phone at a later time or whatever works best for them

Full and judicious disclosure: is the basic principle, especially on each new prescription. But if patients resists such counseling, or actually declines counseling, the pharmacist cannot force them. But if there are serious ADRs or DDIs possible (greater than 1% probability ), or if there are “special use” issues, the pharmacist must (ethically) alert the patient to the pharmacist’s concerns, while not being rude or excessively aggressive. The pharmacist also needs to walk the “fine line” of providing realistic warnings without scaring the patient from taking a drug whose benefits outweigh the risks

General trend observations – The trend is gradual and mixed, but discernible. (product → patient)
Court decisions have expanded the liability of pharmacists and pharmacies in negligence actions (failure to warn, discuss BBWs, discuss DDIs, etc.)

Initially medicare, then adopted by all states
Required a DUR, patient profile records, and counseling

generally pharmacists are on committee
insurance companies have them
PBMs also have them
required for medicare part D providers

Cannot have conflicts of interest, and if they do they need to disclose them in advance (this normally requires recusal)
Recusal: the withdrawal from a case on the grounds that they are unqualified to perform duties because of a possible conflict of interest or lack of impartiality

ethical principles involved in P&T committee:
veracity
nonmaleficence
beneficence
distributive justice
prescriber autonomy

Stakeholders:
Patients
Prescriber
Pharmacy
Hospital
PBM
Manufacturer
Healthcare system as a whole
Society as a whole

cost effectiveness
Most insurance plans will only pay for generic
PBM limits patient autonomy by forcing patients to use generics

● Up to 1985 – Technical accuracy in dispensing was essentially the only standard pharmacists were held to in court cases.
correct tablet, correct instructions, keep temp stable (product oriented)
could kill people w/o being held responsible
● Since 1985 - Special Situations or circumstances that result in an “Expanded Duty” that pharmacists have to patients –holding pharmacists liable

● Exceptions that can result in “Expanded Responsibilities” beyond the “No Generalized Responsibility to warn ” rule –

1) Obvious Error – courts are gonna hold you responsible if you see the error and still ignore it.
dose enough to kill a horse :) → maybe don’t dispense

2) Knowledge of allergies – If the pharmacist has knowledge of an allergy, the pharmacist will be held responsible. Includes if the pharmacist knows a patient abuses (dr. greer would be proud of my terminology. im proud of you too) alcohol or other substances.

3) Knowledge of “Conflicting Drug Use” -- clinically significant DDI,


4) Provision of Patient Education (Counseling) – ???

5) Representations to the Public (Advertising) –
Drug adverts everywhere!
If you advertise your pharmacy and say your computer catches every DDI and then someone dies bc of a DDI, you’re gonna be held liable
Don’t advertise something if you can’t 100% back it up/meet the standard

6) Withdrawn Drugs – if withdrawn drug is dispensed, you’re gonna be responsible even if doc wrote script for it

7) Contraindications – Be aware of BBWs and make sure your patients do not have a contraindication

8) Mandated Medication Guides – if you dont dispense guide, you’re gonna be responsible cus by law you gotta dispense the med guide

These are some of the general types
of considerations judges will use that may result in an acceptance or a rejection of the patient’s claim that the pharmacist owed them an “expanded duty.

1) Pragmatism - (33%) “Do the benefits from the expanded duties justify the cost of providing these duties?”
i.e. do you get paid enough to have this counseling liability imposed on you
probably down to 20%

2) Command and Control (aka Excessive Interference) – (43%) “Is an expanded role for the pharmacist likely to interfere with the well-established (and revered) doctor-patient relationship”
by the pharmacist providing counseling, are they interfering with the doc?
NO they are augmenting what the doc said → % lowered

3) Moral Hazard - (7%)
“Pharmacists are not mere bystanders in the drug therapy decision-making process, but an active participant when they fill prescriptions.”

now much higher than 7%

4) Professional Responsibility - (17%)
“Pharmacists have knowledge and skills which can improve the outcomes of drug therapy.”
You have something to offer the patients
unfair to say pharmacists would be blameless

From a legal (not ethical) point of view, Pharmacists’ professional responsibilities depend on the perspective of the judge in a courtroom. In the abstract, without the consideration of moral hazard or professional responsibility perspectives, judges have trended toward seeing the pharmacist’s role as being that of product distribution. But those judges who consider the value pharmacists can add to drug therapy, and the hazards of not requiring pharmaci- sts to add value, tend to see the role of the pharmacist more in line with the concepts embodied in the clinical pharmacy and pharmacy care models that have evolved and enveloped our profession in the last four decades. Despite the inherent unpredictability and variability of court cases, overall decisions in recent decades reveal a gradual, broader trend or tendency to place more responsibility for patients’ prescription drug use on pharmacists.

Bottom Line: The trend-line is gradually moving in the direction of court decisions indicating that the pharmacist’s role goes beyond just accurately dispensing the medication that was prescribed.

[Note: Medication Guides are the most common element of FDA’s Risk Evaluation and Mitigation Strategies program – “REMS”]
most of the stuff is overkill
printouts are helpful but how many people actually read them? not me
the med guides have so much info and its lowkey still in medical writing (even tho law says they have to be in plain language for normal people to read)
concerned that no one really paying attention
in the end you dont know what they do when they get home
nonmaleficence: do no harm

● Reinforcement - use to add to what physician said (augment, NOT replace)
what did the MD tell you? ivermectin cures covid yeehaw

● Augmentation – Reinforce/Supplement what the physician said. Ask the patient what the MD told them

● Clarification – Answer any questions the patient has
“the doctor explained this to me; you just explained this to me. I don’t fully understand. Could you explain it again?”
Sure, dumbass. Listen this time

● Validation – Use teach-back method. Ask them questions to determine if they understood what you told them. let them repeat it back. dont be didactic, be friendly

● Judicious use of terminology – don't use big medical words that they don't understand, simple and clear terms, unless the patient is sophisticated

Manufacturers
Direct to consumer
Directed to HCPs, but mainly directed at patients
Need to be truthful (veracity) → full disclosure
Respects autonomy and distributive justice

What’s the problem?
“patients are dictating what they wanna be prescribed even tho that’s the doc’s job.” - Scotty (abbreviated)
patient feels like they're the doctor bc they saw a commercial
patient harasses MD :)
distributive justice
PRO: can promote medications that can be used

used to be considered unprofessional, but now insurances pay for ads

● Access to patients’ medical information – hamstrung if patient is going to more than 1 pharmacy cus then you don’t know everything they’re taking. best if patient going to 1 pharmacy
● Physical barriers – Not a rational problem anymore as pharmacists are interacting with patients
● Lack of privacy – when HIPAA first came out, it was hard to respect patient privacy cus everything was wide open, but now pharmacies are generally HIPAA compliant → no longer an issue
● Language barriers – predominant language may not be english; have a tech that can speak the language chinglish, spanglish, and denglish to the rescue
● Insufficient motivation or inadequate skills on the part of the pharmacist – should be well trained, but generally should not be a barrier

already and ethical requirement; now catching up legally

● Court Rulings since 1970 (see previous discussion) – regardless of the variability in individual court decisions, pharmacists have a responsibility to counsel and warn based on non-maleficence, beneficence, voracity, fidelity, empathy…

● The “Professional Practice Standard” –

● The “Objective Disclosure Standard” – Gives the pharmacist flexibility on how far to go in disclosing adverse drug reactions, based on patient variables, as in the case example we had in which too much information concerning a tricyclic antidepressant was given to the patient who ultimately used the drug to commit suicide.

● The “Reasonable Pharmacist Standard” (or “What would a reasonable pharmacist do in similar situations?”) –

● “OBRA-90” Requirements in New Jersey –

requires fairness in the allocation of health care resources. It is a fundamental ethical value. All health care resources are limited.
In pharmacy, involves pharmacy products and services

Pharmaceutical products + Pharmaceutical services Distributive justice does not require that everyone gets equal access to healthcare resources. One consideration: “Who has the greater need?”
Does not require that everyone gets equal access → who has the greatest need when there is a limit
Emphasis on fairness
Looking at the equity of the situation (Ex. COVID vaccines)

● Changing perceptions – up to the 1980s highly regarded industry → over time, outrageous cost of medications and defects associated with them brought shame to the industry

Much of the public blames pharmacies for the cost of medications, when in reality this is not the case
PBMs and Manufacturers are responsible for it

New England Compounding Pharmacy problem → shed poor light on compounding area
(503A vs 503B-outsourcing facility, must follow GMPs)

Perception that branded prescription drugs are too expensive; and huge price increases of older drugs, including generics.

Perception of excess profitability of the “Big Pharma” companies.
people believe they overcharge

Excessively aggressive and unethical marketing tactics.
Manufacturers used to give gifts to doctors to prescribe their drugs

Excessive lobbying. [e.g., government’s inability to negotiate prices for Medicare Part D drugs.]
pharm industry has one of the best lobbies in congress next to the NRA. AMA is also aggressive lobby

Lack of full disclosure of unfavorable clinical trial data. [Highly publicized withdrawals]
Vioxx litigation → pulling ppl out bc of AEs

Shortages of critical drugs.

Tactics to delay the entry of generics.
go for lesser prices, paying off generic manufacturer NOT to manufacture them

Impressive breakthroughs.
Save countless lives; lightening speed covid vaccines;

Desirable industry to keep or attract to a state.

Pays lots of taxes \$\$
they pay their fair share
unlike trump and every billionaire they pay their fair share of taxes

Generally safe and adequate supply of drugs historically, although the persistent shortages in recent years have been troubling .

AEs are generally disclosed in package insert

2017: change from “Generic Pharmaceutical Association” to “Association for Accessible Medications”
Perception that “Medicines should be affordable”

● Public attitude toward prescription prices: they've been good in explaining to pts that its not their fault
still on top as most trusted professions
we are changing the perception why drug prices are high :)

Veracity
Patient/Prescriber autonomy
Beneficence/Nonmaleficence
Distributive Justice
Empathy

not just changing a generic or therapeutic biosimilar
reduces cost
Perceived as having greater risk potential than generic substitution
may be true if not done by competent and ethical pharmacists.
Therapeutic interchange can benefit the health care system (as well as PBMs and employers of pharmacists, and hopefully the patient), by reducing costs.
However, some physicians feel it is a threat and challenge to their autonomy-in prescribing medications.

Lot of issues: drug security

Based upon veracity and non-maleficence
Drugs from foreign country
How are they tested?
Internet sites for drugs; consumer access on off-shore websites

US Drug supply chain is (usually) secure
Control of manufactured domestically

Questionable wholesaler issues

Diverted Drugs; stolen drugs; brought back from patients
don't know what patients do with drugs (how do we know the drugs aren’t degraded?)
Adultered drugs

Track and trace” → last part going into effect Nov
3 major distributors
Cardinal Health
McKesson
AmerisourceBergen

Prescription Drug Reimportation (or importation) – Technically illegal, but not rigorously enforced. Pharmacists have the ethical obligation to point out the risks of counterfeits and inferior quality products. The benefit is lower costs. (You can tell pt that its risky but they won’t listen to you if it’s much cheaper for them)

see: www.nabp.net
need to go to VIPPS certified pharmacy if you wanna buy online. rest assured that VIPPS stores are safe cus its not easy to get VIPPS certified by NABP.
considered “rogue” site if not VIPPS certified. dont buy from these stores
You can rely on the integrity of sites with this NABP designation. The majority of websites do not have this designation, probably because they do not meet the required standards.

The Internet Pharmacy Consumer Protection Act] – Named for an 18 yr teenager who died in 2008 from a Vicodin® overdose. He had purchased the Vicodin® from the internet without ever seeing a physician. The Act makes it illegal to provide Rx only drugs solely based on filling out a questionnaire online. It empowers States to close down rogue sites. Sites must also disclose the names of the pharmacist and physicians who are associated with the site. It requires that the physician authorizing the sale of the Rx-only drug conduct a face-to-face examination of the patient. It makes the advertising and the illegal sale of Controlled Substance Drugs a criminal offense. [Does NOT REQUIRE VIPPS if registered/licensed with DEA.]

Onco drugs, sterile parenteral drugs, antibiotics, ADDERALL, Injectables, Generics, Single source drugs, grandfather drugs

▪ Contributing Factors –
Manufacturing problems –
Natural disasters
Breakdowns in the GMP practices of the manufacturer → FDA closes them down
Delays on obtaining raw materials such as APIs from foreign countries
Shortages of APIs
Product recalls –
Defect in manufacturing → duh shortage
Inventory issues (e.g., stockpiling) – Katherine Mazujian was using too much toilet paper people start stockpiling → due to panic/ media/ false sources
Unanticipated demand – e.g. hydroxychloroquine due to unintended use
unintended company mergers - when big companies merge, there may be lower production in less-utilized drugs

Ethical Principles
Beneficence
Nonmaleficence
Distributive Justice

Executive Order 13558 (2011)
Required manufacturers to notify the FDA of any potential limiting factors that would shorten supply of any drugs

FDA Administrative Safety and Innovation Act (2012)
FDA gets additional authority to anticipate drug shortages and ways to ameliorate the issue (ie extend exp date)

What to do in a shortage?
what’s the fine line between hoarding and ordering more drugs? none Cifaldi dont know
HOARD THE DRUG? (ethical dilemma)
look for alternatives
Who gets the drug?
Established patients (can give them adv notice) or new patients?
Convert between dosage forms to conserve the affected drug
Prioritize patients with the greatest need. Consider: Age (young vs old)

unethical, encourages pts on demand ABC when they don't need, ABZ resistance, might not be medically indicated putting pts at risk

QALYs
How much is the drug worth in terms of life extension?
Ex. \$2 million drug extends life by x years.
Expensive even for insurance company, might go bankrupt → can’t save other ppl

Beneficence
Autonomy
Distributive Justice
Empathy

Obligation to at least try to help patients find a solution when they can’t afford medications
not required to do everything or give it for free
just do your best okay :)

“Chandler health clinic”
manufacturer provides FQHCs with drugs at reduced rate or for free
find where FQHCs are and refer pts to them
help pts apply for medicaid or PAP
administered by office of pharmacy affairs (OPA) at HRSA

A program in which manufacturers provide medical assistance in the form of prescription products to low income patients. The patients must go through an application process and be enrolled in the PAP.

Ethical concerns – a lot of people fear that drug companies use PAPs as an excuse to justify their high prices
Excuse they use: “the reason for high prices is cus we have to give away some drugs to indigent populations”

the primary targets are patients who are not covered by Medicare or Medicaid.

Some FQHCs have a relationship with certain drug companies, and they receive medications from the company to dispense to their patients at low or no cost. This saves patients from going through the PAP application process, which can be daunting for some.

More common for brand name drugs than for generics.

Surveys reveal that 26% of all families have not filled a prescription because of cost. (Of course, not all of these would be cases that would involve eligibility for PAPs.)

The enactment of Medicare Part D has also helped to lessen the demand for PAP programs, especially the gradual phasing out of the “Doughnut Hole” as part of the Affordable Care Act.

Contact the Call Center at the Company and speak to the Medication Information Division – or ask for the PAP Center.
Also, check if the company has a PAP website.
Refer to “Partnership for Prescription Assistance” – www.pparx.com
The patient must fill out the application, and a physician’s signature is required.
The prescriber MUST approve
Income verification is also required – The patient must prove low income by “poverty level guidelines.”
Once approved (one-week turn-around time), the drug is then shipped to the physician – or the physician could arrange for the patient to pick up the drug at a pharmacy. The drugs are usually provided free or at a nominal cost. Applications are accepted, rejected, or returned for more information.

▪ www.NeedyMeds.org helps patients to seek for applicable programs.
▪ Partnership for Prescription Assistance: www.pparx.org or 1-888-477-2669 - helps match patients to more than 475 public and private programs. [ sponsored by PhRMA] –
▪ www.RxAssist.org allows patients to search database of PAPs by medication.

Educational level; language limitations; paperwork challenges. [Pharmacists have an ethical obligation to try to assist patients in overcoming such barriers.]

● Key features of the Federal Right-To-Try Law –
Drug had to be in a clinical trial

● States that have enacted Right-To Try Laws –
PA, CT, CA, FL, etc.
not in NJ or NY yet so use federal law

● Advantages and disadvantages of Right-To-Try laws –
ADV
Can save or extend lives of terminal patients who cannot wait for FDA approval of a drug
Much more favorable and easy to use than compassionate use exception (takes too long)

DISADV
Increased risk to patient by removing the FDA
Manufacturer may feel the law interferes with their clinical trials
40+ state programs have been ineffective and have weakened the FDA’s authority

means a decision by a qualified terminally ill patient to request and obtain a prescription for medication that the patient may choose to self-administer to end the patient's life in a humane and dignified manner

means a capable adult who is a resident of New Jersey and has satisfied the requirements to obtain a prescription for medication

means that the patient is in the terminal stage of an irreversibly fatal illness, disease, or condition with a prognosis, based upon reasonable medical certainty, of a life expectancy of six months or less.

means a psychiatrist, psychologist, or clinical social worker

means that the medical opinion of the attending physician has been confirmed by a consulting physician who has examined the patient and the patient's relevant medical records.

means to perform the duties of a health care provider in accordance with the provisions of this act, but does not include:
i. Making an initial determination that a patient is terminally ill and informing the patient of the medical prognosis
ii. Providing information about the provisions of this act to a patient upon the patient's request
iii. Providing a patient, upon the patient's request, with a referral to another health care provider.

means a qualified terminally ill patient's act of physically administering, to the patient's own self, medication that has been prescribed

means that the patient is in the terminal stage of an irreversibly fatal illness, disease, or condition with a prognosis, based upon reasonable medical certainty, of a life expectancy of six months or less.

A terminally ill patient may make a written request for medication that the patient may choose to self-administer if they are:
i. An adult resident of New Jersey
ii. Capable and has been determined by the patient's attending physician and a consulting physician to be terminally ill
iii. Have voluntarily expressed a wish to receive a prescription for medication to terminate their life

A valid written request for medication shall be in substantially the form set forth in this act, signed and dated by the patient and witnessed by at least two individuals who, in the patient's presence, attest that, to the best of their knowledge and belief, the patient is capable and is acting voluntarily to sign the request

At least one of the witnesses shall be a person who is NOT:
1. A relative of the patient by blood, marriage, or adoption
2. At the time the request is signed, entitled to any portion of the patient's estate upon the patient's death under any will or by operation of law and
3. An owner, operator, or employee of a healthcare facility, other than a long term care facility, where the patient is receiving medical treatment or is a resident
ii. The patient's attending physician at the time the request is signed shall not serve as a witness.

a. The attending physician shall ensure that all appropriate steps are carried out before writing a prescription for medication including such actions as are necessary to:

i. Inform the patient of:
1. The patient's medical diagnosis and prognosis
2. The potential risks associated with taking the medication to be prescribed
3. The probable result of taking the medication to be prescribed
4. The feasible alternatives to taking the medication, including, but not limited to,
a. Concurrent or additional treatment opportunities
b. Palliative care
c. Comfort care
d. Hospice care
e. Pain control

ii. Advise the patient about the importance of having another person present if and when the patient chooses to self-administer medication prescribed and of not taking the medication in a public place
iii. Inform the patient of the patient's opportunity to rescind the request at any time and in any manner.

b. The attending physician will:
i. Dispense medication directly, including ancillary medication intended to facilitate the desired effect to minimize the patient's discomfort, if the attending physician is authorized under law to dispense and has a current federal DEA certificate of registration; or
ii. Contact a pharmacist to inform the latter of the prescription, and transmit the written prescription personally, by mail, or by permissible electronic communication (escript) to the pharmacist, who shall dispense the medication directly to either the patient, the attending physician, or an expressly identified agent of the patient.
iii. Medication dispensed pursuant to this subsection shall not be dispensed to the patient by mail or other form of courier (concern of diversion → unintentional death)

a. The consulting physician must verify that the patient is a qualified terminally ill patient.
b. In the medical opinion of the attending physician or the consulting physician, a patient requesting medication that they may choose to self-administer may not be capable, the physician shall refer the patient to a mental health care professional to determine whether the patient is capable

a. Notifying the next of kin
i. A qualified terminally ill patient shall not receive a prescription for medication unless the attending physician has recommended that the patient notify the patient's next of kin of the patient's request for medication
ii. Exception: a patient who declines or is unable to notify the patient's next of kin shall not have the request for medication denied for that reason
b. In order to receive a prescription for the medication, the patient shall make two oral requests and one written request for the medication to their attending physician
c. A qualified terminally ill patient may rescind the request at any time and in any manner without regard to the patient's mental state.
d. At the time the patient makes an initial oral request for medication, the attending physician shall recommend to the patient that the patient participate in a consultation concerning concurrent or additional treatment opportunities, palliative care, comfort care, hospice care, and pain control options, and provide the patient with a referral to a health care professional qualified to discuss these options with the patient.
e. Documentation of NJ Residency - NJ does not become destination for assisted suicide!
i. A request for medication shall not be granted unless the qualified terminally ill patient has documented that individual's New Jersey residency by furnishing to the attending physician a copy of one of the following:
1. A driver's license or non-driver identification card issued by the New Jersey Motor Vehicle Commission
2. Proof that the person is registered to vote in New Jersey
3. A New Jersey resident gross income tax return filed for the most recent tax year
4. Any other government record that the attending physician reasonably believes to demonstrate the individual's current residency in this State.
f. Disposal of medication if patients choose not to self-administer
i. Any medication dispensed that a qualified terminally ill patient chooses not to self-administer shall be disposed of by lawful means, including, but not limited to: disposing of the medication consistent with State and federal guidelines concerning disposal of prescription medications or surrendering the medication to a prescription medication drop-off receptacle
ii. The patient shall designate a person who shall be responsible for the lawful disposal of the medication.

a. The Commissioner of Health shall require that a health care professional report the following information to the Department of Health on a form and in a manner prescribed by regulation of the commissioner:
i. No later than 30 days after the dispensing of medication, the physician or pharmacist who dispensed the medication shall file a copy of the dispensing record with the department, and shall otherwise facilitate the collection of such information as the director may require
ii. In the event that anyone required to report information to the department provides an inadequate or incomplete report, the department shall contact the person to request a complete report
iii. To the maximum extent practicable and consistent with the purposes of this section, the department shall seek to coordinate the process for reporting information pursuant to this subsection with the process for reporting prescription monitoring information by a pharmacy permit holder.
b. Any information collected that contains material or data that could be used to identify an individual patient or health care professional shall not be included under materials available to public inspection
c. The department shall prepare and make available to the public on its Internet website an annual statistical report of information collected

Any action taken in accordance with the provisions of New Jersey's Aid in Dying for the Terminally III Act shall not constitute suicide or assisted suicide.

a. A person shall not be subject to civil or criminal liability or professional disciplinary action, or subject to censure, discipline, suspension, or loss of any licensure, certification, privileges, or membership, for any action taken in compliance with the act, including being present when a qualified terminally ill patient self-administers medication prescribed or for the refusal to take any action in furtherance of, or to otherwise participate in, a request for medication
i. The provisions of this section shall not apply to acts or omissions constituting gross negligence, recklessness, or willful misconduct.
b. Any action taken in accordance with the provisions shall not constitute patient abuse or neglect, suicide, assisted suicide, mercy killing, euthanasia, or homicide under any law of this State.
c. Any action taken by a healthcare professional to participate shall be voluntary on the part of that individual.
i. If a healthcare professional is unable or unwilling to carry out a patient's request and the patient transfers the patient's care to a new health care professional or health care facility, the prior health care professional shall transfer, upon request, a copy of the patient's relevant records to the new health care professional or health care facility
Can refuse to fill based off religious moral ethical reasons. The prescription can be sent elsewhere