PPLE Final

Mary is a pharmacist employed by XYZ Pharmacy. She misfills a prescription, and John is injured as a result. In order to bring a suit against Mary or the pharmacy, John must have ____________.

A. stare decisis

B. standing

C. voire dire

D. summary judgment

B. standing

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. an administrative action

B. a civil action

C. either a criminal or civil action

D. a criminal action

B. a civil action

Congress enacts:

A. laws

B. regulations

C. laws and regulations

D. ordinances

A. laws

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 an 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

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

Administrative agencies are:

A. created by the judicial branch of government

B. housed under the legislative branch of government

C. created by the executive branch of government

D. housed under the executive branch of government

D. housed under the executive branch of government

What is a statute of limitations?

A. It limits the types of evidence that can be introduced at trial.

B. It specifies a limit on the amount of monetary damages that can be paid for pain and suffering.

C. It limits the period of time in which a case can be filed.

D. It limits the number of potential jurors that an attorney can dismiss without cause during the process of jury selection.

C. It limits the period of time in which a case can be filed.

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. Distributive justice

B. Poetic justice

C. Criminal justice

D. Retributive justice

A. Distributive justice

When analyzing the relationship between law and ethics, which of the following is TRUE:

A. They are largely distinct, with little overlap

B. Ethics is a subset of law

C. Law is a subset of ethics

D. They are completely distinct with no overlap

C. Law is a subset of ethics

The Kefauver-Harris Act of 1962:

A. required all drugs approved from 1962 on to be proven safe and effective.

B. Extended the Food, Drug, and Cosmetic Act of 1938 requirement that drugs must be proven safe for FDA approval retroactively to apply to drugs introduced from 1906-1938.

C. Required drugs to be proven as safe and effective for all drugs introduced from 1938 forward.

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

C. Required drugs to be proven as safe and effective for all drugs introduced from 1938 forward.

The Durham-Humphrey Amendment of 1951 established:

I. Two classes of drugs, prescription and over the counter

II. oral prescriptions

III. prescription refills

A. I only

B. II and III

C. I and III

D. I, II, and III

D. I, II, and III

USP guidelines stipulate that a pharmacist should label the beyond-use date for multiple-unitcontainers as:

A. The expiration date on the manufacturer's container

B. One year from the date the drug was dispensed

C. Either the expiration date on the manufacturer's container or one year from the date the drug was dispensed

D. Either the expiration date on the manufacturer's container or one year from the date the drug was dispensed, whichever is earlier

D. Either the expiration date on the manufacturer's container or one year from the date the drug was dispensed, whichever is earlier

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. Both A and B above.

D. a drug in which the potency difference between the brand name and generic drugs is between 95% and 105%.

C. Both A and B above.

A manufacturer of breakfast cereal advertised that its particular brand of cereal would effectively treat hypercholesterolemia. Under which of the following categories would this product be regulated by the FDA?

A. As a food

B. As a drug

C. As a nutraceutical

D. As a food and a drug

D. As a food and a drug

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 two 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 two 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 adulterated and misbranded

D. Neither adulterated nor misbranded

C. Both adulterated and misbranded

In Florida law, a pharmacist who receives a prescription for a brand name drug shall substitute a less expensive, generically equivalent drug product:

A. Unless requested otherwise by the purchaser

B. Unless the prescriber indicates that the brand name product is medically necessary

C. Unless the generically equivalent drug product is more expensive than the brand name drug

D. Unless requested otherwise by the purchaser or the prescriber indicates that the brand name product is medically necessary

D. Unless requested otherwise by the purchaser or the prescriber indicates that the brand name product is medically necessary

In the event a pharmacist receives a request for a prescription refill and the pharmacist is unable to readily obtain refill authorization from the prescriber:

A. The pharmacist may dispense a one-time emergency refill of up to a 72-hour supply of the prescribed medication.

B. The pharmacist may not refill the prescription without authorization from the prescriber's on call covering authorized prescriber.

C. The pharmacist may dispense a one-time emergency refill of no more than a one week supply of the prescribed medication.

D. The pharmacist may not refill the prescription.

A. The pharmacist may dispense a one-time emergency refill of up to a 72-hour supply of the prescribed medication.

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.

Electronic prescribing for medicinal drugs shall NOT:

A. show information regarding a payor's formulary.

B. interfere with a patient's freedom to choose a pharmacy.

C. be used for controlled substance prescriptions, since counterfeit-proof prescription pads are required.

D. require the signature of the prescribing practitioner, since the e-prescription is encrypted.

B. interfere with a patient's freedom to choose a pharmacy.

In Florida, who may accept an oral prescription?

A. Only a licensed pharmacist.

B. Only a licensed pharmacist or a registered pharmacy intern under the supervision of the pharmacist in charge (PIC).

C. Only a licensed pharmacist, registered pharmacy intern, or registered pharmacy technician.

D. Only a licensed pharmacist or registered pharmacy intern under the supervision of a pharmacist.

D. Only a licensed pharmacist or registered pharmacy intern under the supervision of a pharmacist.

In Florida, any pharmacy or any pharmacist engaged in sterile compounding shall not exceed a ratio of __:__ registered pharmacy technicians to licensed pharmacist(s).

A. 6:1

B. 3:1

C. 1:1

D. 4:1

B. 3:1

An applicant for a pharmacy permit must submit the fingerprints of all owners of over 5% of the company or for company with over $100,000,000 of taxable assets in Florida, the prescription department manager or consultant pharmacist. These fingerprints will be submitted by the Florida Department of Health to:

A. The FBI

B. The DEA

C. The Florida Department of Law Enforcement (FDLE)

D. The FBI and the Florida Department of Law Enforcement

D. The FBI and the Florida Department of Law Enforcement

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

Which of the following best describes the difference between a Class I institutional pharmacy and a Class II institutional pharmacy?

A. In Class I institutional pharmacies, all medicinal drugs are dispensed in individual containers to individual patients on the premises, whereas Class II institutional pharmacies may dispense medicinal drugs to outpatients upon discharge from that institution.

B. In Class I institutional pharmacies, no medicinal drugs may be dispensed, whereas in Class II institutional pharmacies, drugs may be dispensed, but only for patients of that institution on the premises, except in emergencies declared by the Governor.

C. In Class I institutional pharmacies are those in short term, primary care treatment centers in which the pharmacist in charge may dispense medicinal drugs only to outpatients of that primary care treatment center, whereas Class II institutional pharmacies may only dispense medicinal drugs for patients on the premises.

D. In Class I institutional pharmacies, most drugs are administered from individual prescription containers to the individual patient, whereas in a Class II institutional pharmacy the pharmacist is allowed to dispense prescription drugs to patients only upon discharge for outpatient use.

B. In Class I institutional pharmacies, no medicinal drugs may be dispensed, whereas in Class II institutional pharmacies, drugs may be dispensed, but only for patients of that institution on the premises, except in emergencies declared by the Governor.

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. Retail pharmacy drug wholesale distributor permit

C. Prescription manufacturer (virtual) permit

Which of the following permits is required for any person or entity in Florida who engages in the receipt or distribution of a prescription drug in this state for the purpose of processing its return or its destruction (other than the person initiating the return, the wholesale supplier, or the manufacturer)?

A. Prescription manufacturer (virtual) permit

B. Retail pharmacy drug wholesale distributor permit

C. Restricted prescription drug distributor permit

D. Prescription drug wholesale distributor-broker permit

C. Restricted prescription drug distributor permit

Which of the following permits is required in Florida for an entity whose wholesale distribution activity does not exceed 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-broker 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 entity or person who engages in the wholesale distribution of prescription drugs and does not take physical possession of any prescription drugs?

A. Retail pharmacy drug wholesale distributor permit

B. Restricted prescription drug distributor permit

C. Prescription drug wholesale distributor-broker permit

D. Prescription manufacturer (virtual) permit

C. Prescription drug wholesale distributor-broker permit

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

A. Controlled substances may be ordered from schedules II-IV.

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

C. Only a pharmacist may complete and sign the form.

D. All of these are correct.

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

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.

Bling Pharmacy called Zing Phamacy requesting a transfer of a C-III Rx to Bling for a patient. The prescription had 2 refills remaining. Which of the following would be correct (assume that Bling and Zing do not share common electronic files).

A. The pharmacist at Zing could instruct the technician to orally transfer the required prescription information to Bling.

B. If the patient wants the last refill at Zing, Bling could subsequently transfer the prescription back to Zing.

C. Bling must record on the prescription it transcribes from Zing the word "transfer" together with several other points of information including Zing's prescription number.

D. Zing should inform Bling that the prescription legally can't be transferred.

C. Bling must record on the prescription it transcribes from Zing the word "transfer" together with several other points of information including Zing's prescription number.

John Johnson is a physician's assistant authorized by the state he is licensed in to prescribe certain controlled substances. What is an acceptable DEA number for John?

A. JJ4354433

B. AJ5354434

C. MJ6354435

D. BJ3354433

C. MJ6354435

During a controlled substances inventory, which medications require an exact count?

A. A 100-count bottle of hydrocodone with acetaminophen.

B. A 1000-count bottle of lorazepam.

C. A 500 mL bottle of a schedule V cough syrup.

D. A box of 20 diazepam suppositories.

A. A 100-count bottle of hydrocodone with acetaminophen.

Which copy of the triplicate carbon copy DEA 222 form does the supplier forward to the DEA?

A. Copy 1

B. Copy 2

C. Copy 3

D. Copy 4

B. Copy 2

Prescription Drug Monitoring Programs:

A. require records of all controlled substances that have been prescribed, administered, or dispensed to be reported to the DEA.

B. have been implemented in most states.

C. are sponsored by states, which are prohibited by HIPAA from reporting their data across state lines.

D. typically require prescribers and dispensers of controlled substances to report to the state each controlled substance dispensed.

D. typically require prescribers and dispensers of controlled substances to report to the state each controlled substance dispensed. (?)

A pharmacy received a hand-written CII prescription for a one month supply of a pain medication without the prescriber's signature. Is this a valid prescription that the pharmacist can dispense?

A. Yes, but only after the pharmacist contacts the prescriber and documents that the prescriber verified the prescription.

B. Yes, but only after the pharmacist verifies that the prescriber wrote the prescription, and then prints the prescriber's name on the prescription.

C. Yes, but only if the pharmacist compares the prescription to other handwritten prescriptions from this prescriber and verifies that the handwriting is the same.

D. No, the prescription is not valid and cannot be dispensed.

D. No, the prescription is not valid and cannot be dispensed.

Based on federal regulations a prescriber would like a patient to be able to obtain a three-month supply of a CII without having to return to the office for new written prescriptions during that time fram. What is/are the legal option(s) for the patient and the prescriber, assuming legitimacy is not an issue?

A. A prescriber can issue one CII prescription for a three-month supply.

B. The prescriber can issue three prescriptions, each for a 30-day supply. Each prescription except the first would specify the earliest date upon which the prescription can be filled.

C. The prescriber can issue an electronic prescription for the CII medication any required time interval without the patient having to come to the office.

D. All of these are correct.

D. All of these are correct.

Which statement regarding a pharmacy reporting lost or stolen controlled substances is accurate?

A. The pharmacy must report the theft to the DEA, but not the loss.

B. The pharmacy must report all stolen and lost medications to the DEA.

C. The pharmacy must report any losses to the DEA, but may report the theft to either the police of the DEA.

D. The pharmacy must report thefts to the DEA and any losses that were significant.

D. The pharmacy must report thefts to the DEA and any losses that were significant.