Introduction to Pharmacy Law & Ethics

(Phar 4173)

Ch 2. Ethical Issues in Health Care

Instructor’s Name: Berhanemeskel W/Gerima

Email: aberhaneth@gmail.com
Cell Phone: +251912024213

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 Ch 2. Ethical issues in health care
Common ethical issues raised in healthcare are:
2.1. Law and Ethics

2.2. Rationing

2.3. Assisted Suicide

2.4. Human Drug Experimentation

2.5. Drug Formularies

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 2. Ethical issues in health care

Ethical Dilemmas
• Are situations in which a provider of medical care is forced to make a
decision that violates one of the four principles of medical ethics in
order to adhere to another of the principles

• Ethical dilemmas always involve disputes in which both sides have an

ethical underpinning to their position

• Surface when there are conflicting moral responsibilities

• When there is conflict between moral choices, in which to obey one would
result in transgressing another
– Legal vs Personal values
– Legal vs Ethical
– Professional vs Personal Religious 3
 2. Ethical issues in health care

What is an ‘Ethical Issue’?

• When you have to judge what is right or wrong
• Choosing between options
• Deciding whether to do something or do nothing
• Should I or shouldn’t I?
• Weighing up the potential impact of your decisions or actions
• A dilemma – making a difficult choice

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 2.1. Law and Ethics
• Many of the laws, regulations, and other rules that govern our daily life are an
outgrowth of our morality and ethics.

• Laws that prohibit homicide, robbery, and similar offenses are simply a
– codification of the values we share as members of society.

• Unfortunately, laws and regulations cannot be promulgated to cover every

– eventuality, nuance, condition, or situation.

• Laws are created in such a way as to provide legal guidelines

– for the “usual” or “most common” situation.

• What should be done, then, when the legal course of action is inconsistent with the
ethical course of action
• or example, when a person commits homicide in self-defense?

• Conflicts of this kind occur routinely in medicine. 5

 2.1. Law and Ethics
For example,
1. What should a pharmacist do when a patient’s prescription for heart medicine
has been depleted, no refills remain, and the prescriber is unavailable?
– Clearly, most pharmacists would do the ethical thing and
– Provide the patient with a few doses to hold the patient over until a new prescription can
be obtained,
– Even though this course of action is illegal.

To follow the example a bit further,

2. What if the medication is a controlled substance used for pain control in a
terminally ill patient?
– A pharmacist might be more reluctant to dispense a few doses,
– Even though the patient might be in just as much need,
– Due to potential legal ramifications from drug enforcement authorities.

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 2.2. Rationing
• As the cost of providing health care services continues to grow, some have
suggested and even attempted
– to implement a system that would ration the availability of health care. E.g. Oregon
Health Plan

• Health care policy makers have tried to avoid this approach because
– it contradicts a long-standing implicit belief that all that can be done for each patient
ought to be done.

• Where as Medical insurance providers, both publicly and privately funded

– have attempted to support this traditional ideal.

• But the lack of cost containment has resulted in rising insurance rates, thereby
– driving individuals out of the health insurance system and
– threatening the viability of governmental programs. 7
 2.3. Assisted Suicide
• Although medical euthanasia (“mercy killing”) has long been an ethical issue.
• It has only been in recent years that the question of assisted suicide has been
examined.
• The activities of Dr. Jack Kevorkian (frequently referred to as “Dr. Death” for his
activities assisting terminally and chronically ill patients to end their life)
– have spurred a great deal of public and professional discussion of this issue.

• Several states have considered the legality of assisted suicide.

– Some have rejected it,
– while others have accepted it within strict guidelines.

• In 1997, the U.S. Supreme Court ruled that assisted suicide is not a constitutionally
granted right,
– while upholding state laws in New York and Washington banning the practice.
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 2.3. Assisted Suicide

• However, the Court left to individual states

– the option of legalizing assisted suicide.

From an ethical perspective, the key issue remains

• whether assisted suicide violates the Hippocratic responsibilities of health care
practitioners to “do no harm.”
• Those who advocate its availability to patients suggest that
– allowing a patient to continue to experience unrelenting pain is to do harm.
– patients have the right to make an autonomous decision to end their life;

• Opponents worry that legal assisted suicide would be abused

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 2.4. Human Drug Experimentation

• A number of ethical codes have been established by the medical

community since 1945.
• Several of these codes deal with research on human subjects
– including the testing of drugs.

• Two important ethical aspects of human drug experimentation are

1. The role of the institutional review board (IRB) and

2. The use of placebos.

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 2.4. Human Drug Experimentation

Institutional Review Board (IRB)

• The IRB is the body responsible for overseeing all clinical research conducted
within a given institution.
– Traditionally, most clinical drug research was conducted in hospital settings.

• However, with the shift in the locus of health care delivery from the inpatient to
the ambulatory setting,
– IRBs are now found in managed care organizations and other ambulatory
facilities.

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 2.4. Human Drug Experimentation
The IRB has two primary responsibilities:
1. To ensure the integrity and scientific rigor of the proposed research
study.
– The IRB evaluates risks versus benefits to study participants.
– If the risks outweigh benefits, the IRB would likely reject the proposal.
– The board acts as somewhat of a “subject advocate” to ensure that the patient-subject’s
rights and welfare are protected.
2. To evaluate and approve informed consent forms used in conjunction
with the research.
– Such forms should be drafted in a manner consistent with the elements of informed consent
discussed previously.
• IRBs vary in their size and representation.
• Their membership may include
– physicians, nurses, other allied health professionals (including pharmacists), institutional
administrators, attorneys, clergy, medical ethicists, and community members.
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 Placebos
• Placebos have generally had two roles in medicine:
1. In clinical drug research, and
2. As a means of decreasing the dose of or weaning a patient off a
drug to which a patient has become dependent.
• The use of placebos has long been an integral component of clinical
drug research.
– Placebos have served as a point of comparison for determining therapeutic
efficacy.
• Whether the drug being tested is
– a new drug compound or
– an existing drug under study for a new indication

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 Placebos …

• Although the use of placebos in some instances

– has been shown to provide therapeutic usefulness (such as for pain control)
– placebos—by definition—are agents devoid of pharmacologic activity.
• Patient-subjects who receive placebos as a component of their
participation in a clinical drug study
– can generally not hope to derive any benefit (beneficence) from these
substances.
• This raises the question of whether the use of placebos in drug
research, despite the obvious scientific advantages, is ethical.
• This question is further complicated by
– the expectation that placebos will be employed in clinical research.

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 Placebos…..

• A Food and Drug Administration regulator has stated:

“It is desirable to include some placebo controlled studies unless it is
considered unethical to do so”.
• This suggests that the use of placebos is
– ethical in certain instances
– but unethical in others.
• In a meeting in the fall of 2000, representatives of the World Medical
Association approved a change in the 1964 Declaration of Helsinki
– stating “that the use of placebos in medical experiments is unethical when
treatments are available for the diseases that are under study”.
• Though this action does not have legal force in some countries like the United
States,
– it does carry considerable ethical weight worldwide.

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 Placebos…

• The use of placebos to address genuine or perceived dependence is even more

ethically problematic.
• The belief that the health care practitioner knows best and, therefore, is justified in
practicing medical paternalism has been a long-standing component of the “medical
authority” model of practice.
– Under this model, the patient’s perceptions and desires are subjugated to the judgment of the health
care professional.
– This type of thinking would be used, for example, as justification for a practitioner to shift a patient
judged to be drug dependent to a placebo without the patient’s knowledge.

• Today, such use of placebos with-out patient knowledge and consent might be judged
to be un-ethical—a direct violation of patient autonomy and informed consent.
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 2.5. Drug Formularies
• A drug formulary is a list of drugs that are approved for use either within an
institution (such as a hospital) or for reimbursement by a third-party payer.
• Its purpose is
– to eliminate therapeutic duplication and
– provide patients with the best drug at the lowest cost.
• In their early days, formularies were used by hospitals
– to control drug inventories and
– provide prescribers with a list of “drugs of choice” for various conditions.
• However, a drug’s absence from the formulary was not usually a great barrier to a
prescriber’s obtaining it for a patient.
• The prescriber could make
– a special request to a member of the hospital’s pharmacy and therapeutics committee and,
usually, the drug would be obtained.

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 2.5. Drug Formularies

• When managed care organizations and pharmacy benefit management

companies began to employ formularies, circumventing them became much
more difficult.
• This restrictive nature of formularies has led to a number of important ethical
questions.
For example:
– Does the use of generics or therapeutic substitution violate the autonomy of the patient or
prescriber?
– Is the use of such substitution a violation of informed consent?
– Does the use of formularies violate the ethical principles of beneficence (“do good”) and
non-maleficence (“avoid harm”)?
• However, one could argue that the use of formularies and the resultant
constraint on drug costs helps to ensure affordable access to quality health care
for more people (distributive justice).
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