PPLE Final Exam Practice

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

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.

Any pharmacy or any pharmacist may allow a supervision ratio of up to____ registered pharmacy technicians to ______ pharmacist, as long as the pharmacist or registered pharmacy technicians are NOT engaged in sterile compounding.

6:1

Overuse of antibiotics and antibiotic resistance is an example of which of the following market failures?

A) Public goods

B) Externalities

C) Natural monopolies

D) Information Asymmetry

B) Externalities

(think actions have consequences)

Module 1 assigned reading

Which amendment established that "the powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people."

10th amendment

Administrative Agencies are created by the ____(1)____ branch and housed in the ____(2)____ branch.

1. legislative

2. executive

True or False: Statutory Law are statutes that are voted on by a state legislature.

False. Statutory Law can be voted on by state or federal legislature

True or False: Statutes are legislative laws while regulations are from administrative agencies (executive).

True

"_____________" is the body of law derived from judicial decisions.

A) Statutory law

B) Regulatory law

C) Administrative law

D) Common law

D) Common Law

Module 1 assigned reading

"_________" is the practice of courts adhering to precedent by following previous decisions when ruling on similar cases.

A) Precedentum juris

B) Stare decisis

C) Mens rea

D) Lex scripta

*Hint: meaning "to abide by decided cases."**

B) Stare decisis

Module 1 assigned reading

Which of the following is a daily publication that lists various federal actions, including proposed regulations, final regulations, and various government notices?

A) Congressional Record

B) Code of Federal Regulations (CFR)

C) Federal Register

D) Supreme Court Reporter

C) Federal Register

Module 1 assigned reading

Which of the following is an annual revised compilation of final regulations divided and indexed by subject matter?

A) Congressional Record

B) Federal Register

C) Code of Federal Regulations (CFR)

D) United States Statutes at Large

C) Code of Federal Regulations (CFR)

Module 1 assigned reading

The process on which the court has to interpret the meaning or intent of a statute is called?

A) Legal inquiry

B) Judicial review

C) Statutory interpretation

D) Legislative scrutiny

B) Judicial review

Pharmacist Becky forgot to include a Patient Package Insert when dispensing a prescription for Ortho Tri-Cyclen. This product is:

A. Adulterated

B. Misbranded

C. Both adulterated and misbranded

D. Neither adulterated nor misbranded

B. Misbranded

PPIs are required for oral contraceptives and estrogen-containing products with each prescription.

"Manufacturers must include a PPI for each package that it intends will be distributed to the patient, and in turn, pharmacists must include a PPI with each container dispensed regardless of whether it is initially dispensed or a refill. Failure to do so is misbranding." Textbook p205

Which of the following statements is true regarding the use of Medication Guides?

I. They are required when patient labeling could prevent serious adverse reactions

II. They are required if the drug has serious risks that patients should be made aware because it may affect their decision to use, or to continue the product.

III. They are required when patient adherence to directions is crucial to the drug's effectiveness.

A) I & II

B) I & III

C) II & III

D) I, II, & III

D) I, II, & III

The FDA is housed within which of the following organizations?

A. Center for Drug Evaluation and Research

B. Department of Health and Human Services

C. Drug Enforcement Agency

D. Center for Biologics Evaluation and Research

B. Department of Health and Human Services

Lecture 2.2 and Practice Exam on Canvas

True or False: Consumer Medication Information (CMI's) are reviewed and updated regularly by the FDA.

False.

CMI's are unreviewed and unregulated by the FDA

Module 2 Reading, p206

True or false: All controlled substance prescriptions must have the prescriber's name, address, and registration number.

True.

All controlled substance prescriptions must have:

- Date of issuance

- Patient full name and address

- Prescriber name, address, and registration number

- Drug name, strength, and dosage form

- Quantity prescribed

- Directions for use.

When partial filling a C2 prescription, the remainder of the prescription must be provided to the patient within ____ hours.

A) 24

B) 48

C) 72

D) 96

E) C2's are not allowed to be partially filled

C) 72 hours

If remainder of prescription is not provided to the patient within 72 hours, the remainder of the prescription is forfeited and a new prescription is required.

True or False: Prescriptions for compounded C2 medications are allowed as long the directions are for oral use.

False.

Faxes are allowed for compounded C2s administered parenterally, IV, IM, SC, or intraspinal infusion

A pharmacist can dispense an emergency C2 via oral authorization if:

A) The quantity prescribed and dispensed is limited only to the amount necessary to treat the patient for the emergency period.

B) The prescriber delivers a written prescription for within 72 hours after authorizing an emergency oral prescription.

C)The prescription is immediately reduced to writing by the pharmacist and

contains all required information except prescriber signature.

D) A & C

E) All of the above

D) A & C

For option B, the prescriber must deliver to the dispensing pharmacist a written prescription for the emergency quantity prescribed within 7 days after authorizing an emergency oral prescription. The prescription must have written on its

"Authorization for Emergency Dispensing" and the date of the oral order.

Which of the following regarding dispensing C3, C4, and C5s is false?

A) Valid as a written, faxed, electronic, or oral prescription

B) Can request refills from the prescriber

C) Legally allowed to be transferred for the purpose of refill dispensing from one pharmacy to another

D) Cannot fill or refill more than 12 months after the date of

issuance or more than 11 times, whichever comes first

D) Cannot fill or refill more than 12 months after the date of

issuance or more than 11 times, whichever comes first

**Cannot fill or refill more than 6 months after the date of

issuance or more than 5 times, whichever comes first**

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

A. A 1000-count bottle of Tramadol

B. A 500 mL bottle of Robitussin AC

C. A box of Duragesic patches

D. A 100-count bottle of Alprazolam

C. A box of Duragesic patches (Fentanyl CII)

remember your top 200

Inventories for schedule I and II substances must include an exact 365 count. Schedule III, IV, and V substances can be estimated; however, an exact count is required if the container holds more than 1,000 units.

All labels and other written, printed, or graphic matter upon any article or its containers, wrappers, or accompanying such article are known as?

A) Labeling

B) Packaging information

C) Product literature

D) Patient Package Insert

A) Labeling

Which of the following elements does the CSA NOT require to be on the pharmacy label of dispensed controlled substances in schedule II, III, and IV?

A. Prescription Number

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) Dispensing Pharmacist

D) Dispensing Pharmacist

The pharmacy label for controlled substance prescriptions dispensed must contain date of initial fill, refill date (if applicable), pharmacy name and address, prescription number, patient name, prescriber name, directions for use, and cautionary statement (for CII-IV medications) textbook p355

Congress enacts:

A) laws

B) regulations

C) laws and regulations

D) ordinances

A) laws

straight from the practice exam

Government regulation requires the provision of information and input by educated professionals into decisions about drug use in order to minimize the possibility of which market failure?

A) Public goods

B) Externalities

C) Natural monopolies

D) Information Asymmetry

D) Information Asymmetry

textbook p38

Electronic refill records must be maintained for at least _________.

A) 6 months

B) 1 year

C) 2 years

D) 3 years

C) 2 years

Which of the following is a two-factor authentication method prescribers must use access e-scribe?

A) a password or PIN number

B) a hard token separate from the computer such as a

personal digital assistant, cell phone, or flash drive

C) biometrics

D) All of the above

D) All of the above

* They must use 2/3**

Miranda has a new prescription for alprazolam at Publix that has never been filled. She would like to transfer this prescription to your Walgreens pharmacy. Which of the following is TRUE regarding the transfer of this prescription.

A) The receiving pharmacist must write "TRANSFER" on the incoming script in addition to all other necessary transfer information

B)Both the original and the transferred prescription must be kept for 2 years from the date of the last refill.

C)The transfer can only take place between two licensed pharmacists in direct communication

D) This prescription cannot be transferred

D) This prescription cannot be transferred

The prescription was never filled before so they cannot legally transfer it. For CIII-V you can transfer any remaining refills so long as the patient as filled it at least once before and the prescription had never been transferred prior.

465.026 Filling of certain prescriptions

(6) The transfer of a prescription for medicinal drugs listed in Schedules III, IV, and V appearing in chapter 893 for the purpose of refill dispensing is permissible, subject to the requirements of this section and federal law. Compliance with federal law shall be deemed compliance with the requirements of this section.

As of 2014, the Secure and Responsible Drug Disposal Act allows pharmacies to take CSs back for disposal as long as the pharmacy:

A) Is registered with the DEA as a collector site.

B) Provides educational materials to patients about proper disposal.

C) Receives approval from local law enforcement

D) Requires customers to present a valid prescription for disposal.

A) Is registered with the DEA as a collector site.

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

A) Statute of repose

B) Legal jurisdiction

C) Statute of limitations

D) Court precedence

C) Statute of limitations

Was covered on the practice exam

Which of the following is the specific type of justice referred to in the American Pharmacist's Association Code of as equitable distribution of health care resources?

A) Distributive justice

B) Procedural justice

C) Retributive justice

D) Restorative justice

A) Distributive justice

Was covered on the practice exam

You are filling a prescription for a patient on 04/28/24. The manufacture bottle has an expiration date of 09/2024. What should you label the beyond-use date for?

A) 04/28/25

B) 09/30/24

C) 09/01/24

D) 10/01/24

B) 09/30/24

USP guidelines stipulate that a pharmacist should label the beyond-use date for multiple-unitcontainers as either the expiration date on the manufacturer's container or one year from the date the drug was dispensed, whichever is earlier. Expiration is the last date of the month listed.

Long term care facilities have a partial fill time period of __________

A) 14 days

B) 30 days

C) 60 days

D) 90 days

C) 60 days

LTCF are NOT DEA registrants. The DEA prefers pharmacies that dispense to LTCF residents to dispense as minimal a quantity of controlled substances as possible

textbook p352

Who is the responsible for responsible for the proper control and accountability of the LTCF emergency kits?

A) The Drug Manufacturer

B) The LTCF

C) The Pharmacy

D) The DEA

C) The Pharmacy

"The DEA permits pharmacies to place sealed "emergency kits" in LTCFs (45 Fed. Reg. 24128, April 9, 1980), which are routinely stocked with commonly dispensed prescription drugs, including controlled substances. The kits are considered extensions of the pharmacy, and the pharmacy is responsible for the proper control and accountability of the kit"

textbook p354

_________ are defined as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases on man or other animals; or articles intended to affect the structure or any function of the body of man or animals"

A) Drugs

B) Nutraceutical

C) Dietary Supplements

D) Herbal Remedies

A) Drugs

module 2

__________ are defined as "items used in cleansing, beautifying, promoting attractiveness, or altering appearance"

A) Toiletries

B) Personal care products

C) Beauty aids

D) Cosmetics

D) Cosmetics

module 2

True or False: Under the law, soap is classified as a cosmetic product.

False.

The law specifies that soap is not a drug or cosmetic.

The textbook doesn't specify what it is lol just know what it isn't

module 2

Kim received Botox injections on her forehead to alter the appearance of her fine lines. Is this a :

A) Cosmetic

B) Drug

C) Device

D) Aesthetic treatment

B) Drug

Despite being used for beautifying purposes, the article still has chemical actions in the body and is considered a drug.

A drug company produced a drug product with the bottle containing 500 tablets, but each bottle in reality only contained 100 tablets. This product is:

A. Adulterated

B. Misbranded

C. Both adulterated and misbranded

D. Neither adulterated nor misbranded

B. Misbranded

True or False: The FDA does NOT have the authority to recall drugs however can seize any adulterated or misbranded food, drug, or cosmetic in interstate commerce.

True.

Lecture 2.3 slide 4. Know the FDA Enforcement of FDCA

There is a drug recall for Losartan 50mg tablets due to a newly incorporated excipient that when exposed to heat, is transformed into a carcinogen. This product is:

A. Adulterated

B. Misbranded

C. Both adulterated and misbranded

D. Neither adulterated nor misbranded

A. Adulterated

The excipient, not the actual drug, is contaminating the overall drug form.

Adulteration: something is wrong with the drug itself

-Prepared, packed, or held in conditions where it may have been contaminated

-Exposed to a container that may have contaminated it

-Manufactured under conditions that do not conform to current GMP

Kyle has a genetic mutation that make him unable to digest phenylalanine. He has to eat specific products that are formulated without the amino acid phenylalanine. This product is an example of?

A) Drug

B) Food

C) Medical Food

D) Nutraceutical

C) Medical Food

Medical Foods: for a special dietary need, but these foods DO NOT exist naturally in some form. NOT A DRUG!!

Example: foods formulated without the amino acid phenylalanine

True or False: Medical Foods require a prescription and must be formulated to be consumed or administered under the supervision of a physician.

False.

Per the FDA website: The Orphan Drug Act provides that medical foods must be formulated to be consumed or administered enterally under the supervision of a physician, but there is no requirement for a prescription.

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 prescriber signature

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

Module 3 review

A pharmacist who receives a prescription for a brand name drug shall substitute a less expensive, generically equivalent product UNLESS:

A) The prescriber writes the word "MEDICALLY NECESSARY".

B) The patient requested the brand name drug.

C) The prescriber indicates verbally for oral prescription.

D) All of the above

D) All of the above

True or False: A Pharmacist can issue a one time emergency refill of two vials of insulin to treat diabetes.

False.

A one time emergency refill of one vial of insulin to treat diabetes.

Infant formula, artificial sweeteners, and caloric supplements such as Ensure are examples of?

A) Drug

B) Special Dietary Food

C) Medical Food

D) Nutraceutical

B) Special Dietary Food

Special Dietary Food: for a special dietary need, but these foods exist naturally in some form

- Not a Drug

- Examples: infant formula, artificial sweeteners, caloric supplements (Ensure, Boost, Glucerna, etc.)

A Class ____ recalls occur when the product may cause temporary or medically

reversible adverse health consequences, but the probability of serious adverse consequences is remote.

A) I

B) II

C) III

D) IV

B) II

• Class I recalls are issued when there is a reasonable probability that the product will cause serious adverse health consequences or death.

• Class II recalls occur when the product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse consequences is remote.

• Class III recalls apply to products that are not likely to cause adverse health consequences.

___(1)____ is responsible for notifying ___(2)_____ of the recalls; __(2)______ is

responsible for contacting consumers, if necessary.

A) Manufacturer, FDA

B) FDA, Manufacturer

C) Seller, Manufacturer

D) Manufacturer, Seller

D) Manufacturers, Sellers

True or False: Product recalls require that written notes for Class I,II, and some III recalls be sent by first-class mail with envelope/letterhead marked in red labelled "URGENT: DRUG RECALL"

True

Which of the following is NOT part of the FDA's Role in a drug recall?

A) Oversee a company's strategy

B) Assess the adequacy of the recall

C) Classify the recall

D) Alerting the public

E) All of the above are roles of the FDA in a recall

E) All of the above are roles of the FDA in a recall

Which of the following is NOT a result of the Dietary Supplement Health and Education Act of 1994?

A) Places the burden of proof for safety and efficacy are on the manufacturer

B) Legally created the category of dietary supplements

C) Requires the FDA premarket approval of dietary supplements

D) Prohibits the FDA from regulating dietary supplements as food additives

C) Requires the FDA premarket approval of dietary supplements

The FDA cannot require premarket approval of dietary supplements as it does for drugs

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

(straight of the practice final)