PH505 Ethics & Law Part I

The two most common allegations that make up 75% of all lawsuits against pharmacists are:

Tort and contract are examples of :

Which of the following is an example of a regulatory organization?

Drug products with the following risk have a REMS program:

State or cities cannot make laws _____ stringent than federal law.

In the two-letter coding system, a first letter A implies:

An Orphan Drug (ODE) is granted market exclusivity for how long?

A drug is considered misbranded if the label is missing :

The Prescription Drug User Fee Act:

Which clinical phase has to do with post marketing surveillance of new drugs?

Immanuel Kant's philosophy is based on:

Patient's insurance will only cover a 90 day supply of their cholesterol medication.

Failure Modes and Effects Analysis (FMEA) :

Which clinical phase has several thousand patients and establishes final formulation?

Orphan Drugs are used to treat "rare diseases" occurring in less than 200,000 persons in the U.S.

Responsible for reimbursement policies and procedures for pharmacies participating in Medicare and Medicaid:

Which of the following lists marketed drug products that provide therapeutic equivalence information?

Examples of how FDA enforces regulations are:

A patient's primary care office wants to reach to more patients with hypertension is an example of:

Market exclusivity granted by the FDA is a benefit of NDA licensing

The U.S. Constitution ______ the legislature to make laws.

Compounds characterized as biologics are reviewed by:

Laws made to protect the public as a whole from harmful acts of others are:

Ethical duty to avoid harming others.

Ordered by Federal court and prevents a company from selling, distributing, moving, or tampering with a product.

Laws passed by city governments are called:

Federal Trade Commission (FTC) is in charge of :

Implied consent is a form of informed consent.

Common law is also known as _______.

Less serious offense, imprisonment for up to one year:

Root Cause Analysis (RCA) is considered to be:

Which of the following determines Medicaid policies and pharmacy reimbursement rates?

Becaus of patient's autonomy, health care professionals may lie sometimes to patients.

A patient refusing to take their blood pressure medication because the feel "okay" is an example of:

A local pharmacy orders extra flu vaccines due to an outbreak in the community.

Believed in a person as a total person: mind, body, and spirit.

Punishment of death or imprisonment in a state or federal prison for more than one year:

Enforces unfair business practices and antirust violations

Which clinical phase has subjects with the disease or condition being studied ?

Considered how people acquire their perspectives on ethical thinking, moral reasoning, and ethics decision making.

Laws that are passed by legislative bodies, either Congress or a state legislative are known as:

The first step in a risk management process is :

A drug is considered adulterated if the strength, quality , or purity do not meet standards.

Believe in the different levels of principled, conventional, and premoral.

Which of the following is a source for laws?

Checks and balances is the separation of power into three branches:

Based on OBRA 90, the offer to counsel must be given to:

Distributive justice refers to the appropriate and fair distribution of the benefits and burdens offered by society.

Enterprise risk management is using knowledge and experience to manage risks within a business setting.

What are biologics?

Another name for pharmacist's malpractice is:

FDA Form 483s is given to the manufacturer with any violations in which of the following?

Constitutional laws consists of both U.S. Constitution and constitutions of individual states.

John Rawls's philosophy is based on:

A civil injury or wrongful act that is committed against another person resulting in harm is called:

Not likely to cause adverse health consequences.

Which of the following administers state pharmacy law?

Occurs when either party fails to comply with terms of the agreement:

Used when a patent has expired for a product that has been on the US market a company wishes to market a copy:

If a company refuses to recall a product, the FDA will seek an ______ against the company.

Rules or laws passed by agencies are called:

Which of the following regulates licensing of pharmacists and pharmacy technicians?

Physicians may request that all prescribed medications for a patient not be dispensed with a child-resistant closure.

John Stewart Mill's philosophy is based on:

Autonomy as fidelity is _______.

You should prioritize the risks based on frequency, severity, and time to probable impact and warning time.

Believed in I-Thou, I-You, I-It, and I-I relationships.

The right of an autonomous person to privacy or control health-related information is autonomy as _______.

The first letter of the two-letter coding system determines:

A statute that authorizes administrative agencies to make laws:

May cause temporary or medically reversible adverse effects on health.

The four elements of informed consent include competence, voluntary, disclosure, and authorization.

Which clinical phase has less than 100 healthy subjects?

The two primary principles that underly the U.S. legal system are:

Law's primary purpose is to function as a tool with which we organize ourselves as an advanced, democratic society.

Made by judges when applying previous court decisions to current cases:

Believed in how people can achieve the highest level of good or 'virtue', in practical wisdom, and eudaimonia.

A physician must make self-initiated specific request for information on a drug is to prescribe an off label use

Federal Agency that enforces the Controlled Substances Act:

Which of the following type of recall has serious adverse effects on health or even death?

Pregnancy categories include:

A healthcare professional should act with kindness and charity.

A patient refusing to get a flu shot because his family told him it will make him really sick is an example of:

Federal agency that approves new drugs and issues recalls is:

The right of a patient to choose what happens to their body is autonomy as ________.

St. Thomas Aquinas philosophy is based on :