PPLE final

When you use old cases verdicts to determine a decision on a new case, this would be an example of?

A) Standing

B) Stare decisis

C) VoireDire

D) Summary Judgement

B) Stare decisis

Mary is a pharmacist employed by XYZ pharmacy. She misfiles a prescription and John is injured as a result. In order to bring a suit against Mary or the pharmacy, john must have what?

A) Standing

B) Stare decisis

C) VoireDire

D) Summary Judgement

A) Standing

Before the trial, the jury was questioned by attorneys to see who would be eligible to serve on the jury, this is an example of?

A) Standing

B) Stare decisis

C) VoireDire

D) Summary Judgement

C) Voire Dire

—Preliminary examination of a witness or juror by a judge or counsel

There is a lawsuit from Mary against John, but John believes the case has no merit BEFORE the trial begins, what is this an example of?

A) Motion for directed verdict

B) Summary Judgement

B) Summary Judgement

There is a lawsuit from Mary against John, the evidence was presented at trial, but John still believes the case has no merit, and moves for the case to be dismissed BEFORE being presented to the jury, what is this an example of?

A) Motion for directed verdict

B) Summary Judgement

A) Motion for directed verdict

There are Federal and State Courts, both of which have trial courts. In a lawsuit based on the negligent filling of a prescription, which of the following best describes the choice of court in which the plaintiff may file a suit alleging malpractice?

A) The Plaintiff has the absolute right to choose either the State or Federal Courts, without qualification. The same facts will allow the plaintiff to enter either State or Federal Court

B) If the lawsuit is against only one defendant, it must be filed in State Court

C) If the lawsuit is for more than $10,000, it MUST be filed in Federal Court; if it is for $10,000 or less, it MUST be filed in State Court

D) There are several qualifications to enter Federal Court, including parties from different states and federal constitutional question or federal law. If these requirements are not met, the plaintiff must file in State Court

D) There are several qualifications to enter Federal Court, including parties from different states and federal constitutional question or federal law. If these requirements are not met, the plaintiff must file in State Court

The case of Lee v. DrugMe Corporation involves a patient suing a pharmacy, and was filed in state court. This case is:

A) Administrative action

B) Civil action

C) Either a criminal or civil action

D) Criminal action

B) Civil action

--Private party vs private party, to compensate injured party

John lost the case against Mary, and as a result, his license has been revoked. This is an example of what?

A) Administrative action

B) Civil action

C) Either a criminal or civil action

D) Criminal action

A) Administrative action

--Agency vs private party (warnings, fines, licensure revocation, suspension, etc)

A case where a defendant who intentionally killed another person and is charged with homicide and also sued for wrongful death, this is an example of what?

A) Administrative action

B) Civil action

C) Both a criminal and civil action

D) Criminal action

C) Both a criminal and civil action

A defendant murdered another individual and is charged for homicide, this is an example of?

A) Administrative action

B) Civil action

C) Both a criminal and civil action

D) Criminal action

D) Criminal action

--Government vs private party to deter, punish or rehabilitate

T/F: After the statute of limitations has expired, a case can be brought to court.

False, it can no longer be brought at that point

What is an out of court testimony by a witness under oath?

A) Complaint

B) Summons

C) Answer

D) Deposition

D) Deposition

What contains all material facts of case and remedy requested?

A) Complaint

B) Summons

C) Answer

D) Deposition

A) Complaint

What is admitting to or denying allegation?

A) Complaint

B) Summons

C) Answer

D) Deposition

C) Answer

What is issued by a court notifying defendant of suit and commanding defendant to file an answer?

A) Complaint

B) Summons

C) Answer

D) Deposition

B) Summons

Who enact laws or statutes?

A) Congress

B) Administrative

C) Local governments

A) Congress

Who enacts ordinances?

A) Congress

B) Administrative

C) Local governments

C) Local governments

Who enacts regulations?

A) Congress

B) Administrative

C) Local governments

B) Administrative

Assume that the Supreme Court of Florida issued an opinion that pharmacists have a legal duty to warn the prescriber and the patient if a prescription is written for a dangerously high dosage. The opinion:

A) would be binding on lower courts in every state

B) is merely advisory opinion and carries no precedential authority

C) would be binding on all lower courts in florida

D) would be considered by lower courts in florida but is not binding

C) would be binding on all lower courts in florida

--judicial opinion is binding

In part, antibiotics are regulated as prescription-only products because their indiscriminate use could lead to increased resistance in the population. This reason to regulate antibiotics can best be described under the market failure of:

A) Natural monopolies

B) Externalities

C) Information asymmetry

D) Public goods

B) Externalities

Having an exclusivity for a long time WITHOUT a generic being offered is a failure of:

A) Natural monopolies

B) Externalities

C) Information asymmetry

D) Public goods

A) Natural monopolies

Orphan drugs is an example of:

A) Natural monopolies

B) Externalities

C) Information asymmetry

D) Public goods

D) Public goods

A patient prescribed a new drug, but not knowing if it would work, is a failure of:

A) Natural monopolies

B) Externalities

C) Information asymmetry

D) Public goods

C) Information asymmetry

--no free samples, have to buy! Requirement for pharmacists to offer counseling points to patient because of this!

T/F: Administrative agencies are CREATED by the legislative and is HOUSED in the executive branch of government

True

T/F: Law is NOT a subset of ethics

False, it IS a subset of ethics

In the context of health care ethics, including pharmacist ethics, which of the following is the specific type of justice intended in the American Pharmacist's Association Code of Ethics?

A) Poetic Justice

B) Distributive Justice

C) Criminal Justice

B) Distributive Justice

T/F: Ethics is NOT a subset of law

True

T/F: The relationship between law and ethics is largely distinct (completely distinct) with little to no overlap.

True

What is the Kefauver Harris Act of 1962?

A) Required all drugs approved from 1962 on to be proven safe and effective

B) Required drugs to be proven as safe and effective for all drugs introduced from 1938 forward

C) Extended the Food, Drug, and Cosmetic Act of 1938 requirement that drugs must be

D) Transferred authority for regulation of prescription drug ads from the Food and Drug Administration to the Federal Trade Commission

B) Required drugs to be proven as safe and effective for all drugs introduced from 1938 forward

T/F: The Durham Humphrey Amendment of 1951 established two classes of drugs (prescription and over the counter), electronic prescriptions, and prescription refills

False, it is oral prescriptions, everything else is right though.

The 1906 Pure Food and Drug Act (Wiley act) established?

A) Labeling; USP and NF

B) Non-labeling

C) The will to live

A) Labeling; USP and NF

--had issue with misbranding and adulteration

Which of the following is the correct definition of a narrow therapeutic index drug?

A) A drug in which there is less than a two-fold difference between the median lethal does and the median effective dose

B) A drug in which there is less than a two-fold difference between the minimum toxic concentrations and the minimum effective concentrations in the blood

C) A drug in which the potency difference between the brand name and generic drugs is between 95% and 105%

D) A and B

D) A and B

A manufacturer markets a drug in two different strengths. The lower strength is OTC and the higher strength requires a prescription. The best reason for this difference is likely because:

A) The lower strength is less toxic

B) The 2 different strengths have different indications

C) The higher strength is more effective

D) The manufacturer chose to sell the different strengths in this manner for marketing purposes

B) The 2 different strengths have different indications

The label of a drug product not listed in the USP states that the drug is 0.25 mg. In actuality, the product strength is 0.50 mg. This product is:

A) Adulterated

B) Misbranded

C) Both

D) Neither

C) Both

T/F: Misbranded is OUTSIDE the bottle

True

T/F: Adulteration is INSIDE the bottle

True

Which statement about black box warnings is correct?

A) They have proven very effective at alerting healthcare professionals of a drug's serious adverse effects

B) The FDA requires that pharmacists must counsel patients of the warnings

C) Only the labeling of drugs that may cause death or serious injury must contain the warning

D) All prescription drugs approved after the passage of the FDAAA must contain a black box warning

C) Only the labeling of drugs that may cause death or serious injury must contain the warning

What is the ratio for non-sterile compounding?

A) 3:1

B) 5:1

C) 6:1

D) 8:1

C) 6:1

What is the ratio for sterile compounding?

A) 3:1

B) 5:1

C) 6:1

D) 8:1

A) 3:1

What is the ratio for non-dispensing?

A) 3:1

B) 5:1

C) 6:1

D) 8:1

D) 8:1

A non-resident pharmacy must, for at least 6 days per week and a minimum 40 hours per week, do which of the following?

A) Make patient records available for inspection

B) Keep the pharmacy department open for patients needing prescription drugs

C) Provide online internet access to a pharmacist, with the pharmacy's url on the label of the drug

D) Provide toll-free telephone access to a pharmacist, with the toll-free number on the label

D) Provide toll-free telephone access to a pharmacist, with the toll-free number on the label

An entity in Florida with which of the following permits is exempt from certain establishment, security, and storage requirements otherwise required in Florida Law?

A) Prescription drug wholesale distributor-broker permit

B) Restricted prescription drug distributor permit

C) Prescription manufacturer (virtual) permit

D) Prescription drug wholesale distributor-broker permit

C) Prescription manufacturer (virtual) permit

Which of the following permits is required in Florida for an retail pharmacy whose wholesale distribution activity is less than or equal to 30% of the total annual purchase of prescription drugs?

A) Retail pharmacy drug wholesale distributor permit

B) Prescription manufacturer (virtual) permit

C) Prescription drug wholesale distributor permit

D) Restricted prescription drug distributor permit

A) Retail pharmacy drug wholesale distributor permit

Which of the following permits is required in Florida for an retail pharmacy whose wholesale distribution activity is more than 30% of the total annual purchase of prescription drugs?

A) Retail pharmacy drug wholesale distributor permit

B) Prescription manufacturer (virtual) permit

C) Prescription drug wholesale distributor permit

D) Restricted prescription drug distributor permit

C) Prescription drug wholesale distributor permit

Which of the following permits is required in Florida for an retail pharmacy whose wholesale distribution activity does not have physical possession and exceeds 30%?

A) Retail pharmacy drug wholesale distributor-broker permit

B) Prescription manufacturer (virtual) permit

C) Prescription drug wholesale distributor-broker permit

D) Restricted prescription drug distributor permit

C) Prescription drug wholesale distributor-broker permit

Which permit is for the return or destruction of drugs or drugs and containers used only for blood collection, blood therapy, and blood derivatives?

A) Retail pharmacy drug wholesale distributor permit

B) Veterinary Prescription drug distributor permit

C) Prescription drug wholesale distributor-broker permit

D) Restricted prescription drug distributor permit

D) Restricted prescription drug distributor permit

Which statement below correctly describes the written single page DEA form 222?

(SELECT ALL THAT APPLY)

A) Controlled substances may be ordered from schedules 1 and 2

B) The form contains 20 lines, and the purchaser must record on the form the number of the last line completed

C) Only an authorized person may sign this form

D) None of the above

A, B, C

Which of the following does the CSA require to be on the pharmacy label of dispensed controlled substances in schedule II, III, and IV?

A) Patient name

B) Pharmacy address

C) The statement "Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed"

D) All of these are correct

D) All of these are correct

--Cautionary statement is ONLY for II, III, and IV schedule of drugs

Which of the following does the CSA require to be on the pharmacy label of dispensed controlled substances in schedule II, III, IV and V?

A) Patient name

B) Pharmacy name and address

C) Name of prescriber

D) Serial number of the prescription

E) Directions for use and cautionary statements, if any

F) All of the above

G) None of the above

F) All of the above

--textbook reading, page 221 under labeling of schedule 2, 3, 4, and 5 presctiptions

Jake, a pharmacist, dispensed a prescription drug to a patient without placing a pharmacy-generated label on the container. The FDA brought action against the pharmacist for violating the FDCA. The pharmacist contends that the FDCA is not applicable. Which of the following would be the best answer?

A) The FDA most likely would have authority over the pharmacist based upon the interstate commerce clause of the U.S. Constitution.

B) The FDA most likely would have authority over the pharmacist on the basis of the due process clause to the U.S. Constitution.

C) The FDA most likely would have authority over the pharmacist on the basis that the U.S. Constitution specifically permits Congress to regulate drug products to the consumer.

D) The FDA most likely would not have authority over the pharmacist in this situation, as this is a state law issue.

A) The FDA most likely would have authority over the pharmacist based upon the interstate commerce clause of the U.S. Constitution.

If a pharmacist violates a regulation on a state level, it would be from which amendments to the US constitution?

A) 9th

B) 10th

C) 14th

D) 12th

B) 10th

Which of the following can legally make structure/function claims without being considered a drug?

A) An oral contraceptive, since it makes no claims to treat a disease or condition.

B) Dietary supplements containing drugs

C) Nutraceuticals

D) A dietary supplement

D) A dietary supplement

The principle of beneficence supports:

A) patient self-determination

B) promoting patient best interests

C) preventing harm

D) fair allocation of benefits and burdens

B) promoting patient best interests

The principle of non-maleficience supports:

A) patient self-determination

B) promoting patient best interests

C) preventing harm

D) fair allocation of benefits and burdens

C) preventing harm

The principle of Autonomy supports:

A) patient self-determination

B) promoting patient best interests

C) preventing harm

D) fair allocation of benefits and burdens

A) patient self-determination

The principle of Justice supports:

A) patient self-determination

B) promoting patient best interests

C) preventing harm

D) fair allocation of benefits and burdens

D) fair allocation of benefits and burdens