Final PTU Exam 1 Study Set

Mr. Wood is an inpatient at the hospital and is being treated with Fentora. What is a requirement for the TIRF program?

-The inpatient pharmacy must enroll in the program before dispensing Mr.Woods’s Fentora.

-The inpatient pharmacy must process Mr.Wood’s order through an electronic verification system

-Mr.Wood must sign a patient prescriber agreement before he can receive his first dose of fentora.

-Mr.Wood’s prescriber must enroll in the TIRF program before he can prescribe Fentora to Mr.wood.

The inpatient pharmacy must enroll in the program before dispensing Mr.wood’s Fentora.

Ms. Rodriguez is prescribed Lotronex. What is a feature of the LONTRONE REMS program?

-Ms.Rodriguez’s prescriber must enroll in an 8 hour training program.

-The pharmacy is allowed to accept an electronic Lotronex prescription for Ms. Rodriguez.

-The pharmacy must process Ms.Rodriguez’s Lotronex prescription through an electronic verification system.

-Ms.Rodriguez’s Lotronex prescription may not be refilled, and she must see her prescriber for a new prescription.

The pharmacy is allowed to accept an electronic Lotrnex prescription for Ms. Rodriguez.

Ms. Jade brings in a prescription for isotretinoin. What is the maximum number of refills allowed on the prescription?

-0

-1

-3

-5

0

Mrs. Trent brings a prescription into your community pharmacy for clozapine. what is a requirement of the Clozapine REMS program?

-Eligibility check

-Predispense Authorization code

-Risk management Authorization number

-Copy of the Patient-Prescriber Authorization form

Predispense authorization code

Which class of medications has a national registry to keep track of fetal malformations in pregnant patients?

-antiepileptics

-antifungals

-antihypertensives

-anti-inflammatories

-antiepileptics

The iPLEDGE program requires registration before prescribing or dispensing:

-clozapine

-isotretinoin

-pseudoephedrine

-thalidomide

-isotretinoin

Ms.Rodriguez is prescribed Lotronex. What is a feature of the LOTRONEX REMS program?

-Ms.Rodriguez’s prescriber must enroll in an 8-hour training program

-The pharmacy is allowed to accept an electronic Lotronex prescription for Ms.Rodriguez

-The pharmacy must process Ms.Rodriguez’s Lotronex prescription through an electronic verification system

-M.Rodriguez’s Lotronex prescription may not be refilled, and she must see her prescriber for new prescription.

The pharmacy is allowed to accept an electronic Lotronex prescription for Ms.Rodriguez

According to federal law, where should morphine be stored in the pharmacy?

-on a cart in the patient care area of the pharmacy or institution

-locked in the pharmacy manager’s office, away from other medications

-on pharmacy shelves in a separate area designated for C-II medications

-In a locked cabinet or dispersed throughout the pharmacy shelves with other prescription medications

in a locked cabinet or dispersed throughout pharmacy shelves with other prescription medications

Mr. Fox is prescribed Duragesic 25 mcg patches, According to federal law, how many refills is the Duragesic prescription allowed to have?

-0

-1

-5

-12

0

Some states allow mid-level prescribers to write controlled substance prescriptions. Which is considered a mid-level prescriber?

-Dentist

-Optometrist

-Podiatrist

-Veterinarian

Optometrist

Which schedule of controlled substances is Ambien classified under?

-II

-III

-IV

-V

IV

You file all the prescriptions brought to the pharmacy at the end of the day. If today’s date is 6/17/19, according to federal law, how many years should a pharmacy store prescription records for Schedule II medications?

-2

-5

-7

-indefinitely

2

According to federal law, which controlled substances must be kept in a secure, locked location on a patient care unit?

-Only Schedule II

-Only Schedule II, and III

-Only Schedule II, III, and IV

-Any controlled substance

Any controlled substance

Mr. Eddy brings in a prescription for oxycodone written by Dr. James Adkins. Which is a valid DEA number for Dr. Adkins?

-AA1779335

-AA8283953

-BA1376427

-BA8283905

BA8283905

Which medication is a Schedule V controlled substance?

-Lomotil

-Lopressor

-Lortab

-Lunesta

Lomotil

Which act, in combination with state laws and regulations, dictates the specifics for manufacturing, prescribing, and dispensing of schedule I through V medications?

-Controlled substance act

-Drug enforcement act

-Illegal and scheduled drug act

-Schedule I-V drug act

Controlled substance act

Which schedule of controlled substance is Valium classified under?

-II

-III

-IV

-V

IV

Mr. Burns takes clonazepam. According to federal law, what must be included on the prescription label?

-Date of filling

-Date of insurance

-Pharmacy’s DEA number

-Prescriber’s DEA number

Date of filling

According to federal law, which prescription is good for only 6 months after the date of issuance?

-Bactrim

-Percocet

-Valium

-Vyvanse

Valium

At the end of the day, you file all the prescriptions brought into the pharmacy. According to federal law, Mr. Jordan’s methadone prescription should be filed:

-Separate from all other pharmacy records

-Together will all prescription pharmacy records

-Together will all noncontrolled substance pharmacy records

-together with all schedule III and IV controlled substance pharmacy records

-Separate from all other pharmacy records

According to federal law, which item must be on a written phentermine prescription?

-Patient’s diagnosis

-Prescriber’s signature

-Patient’s drug allergies

-Pharmacy’s DEA number

Prescriber’s signature

The pharmacist needs to destroy defective oxycodone tablets. According to federal law, which DEA form is required when a controlled substance needs to be destroyed and disposed of at the pharmacy level?

-41

-106

-116

-222

41

According to federal law, which medication can be called into the pharmacy under most circumstances?

-Actiq

-Avinza

-Fiorinal

-Focalin

Fiorinal

According to federal law, how long des a pharmacy have to fill the remaining portion of a partial fll for an alprazolam prescription?

-1 day

-3 days

-7 days

-There is no time limit as long as Rx is not expired

There is no time limit as long as Rx is not expired

According to federal law, Ambien must be stored:

-in a locked cabinet in the OTC area of the pharmacy

-in a locked cabinet with other schedule II medications

-on pharmacy shelves with other prescription medications

-on pharmacy shelves in a separate area designated for controlled substance medications

on pharmacy shelves with other prescription medications

According to federal law, which medication can be called into the pharmacy under most circumstances?

-Actiq

-Avinza

-Fiorinal

-Focalin

Fiorinal

According to federal law, which prescription is good for only 6 months after the date of issuance?

-Bactrium

-Percocet

-Valium

-Vyvanse

Valium

Your pharmacy transfers a bottle of percocet to another pharmacy. According to federal law:

-A DEA form 222 is required when transferring the Percocet to the other Pharmacy

-Using an invoice system is optional when transferring the Percocet to the other pharmacy

-Your pharmacy is allowed to transfer a bottle of Percocet one time only without being considered a distributor.

-This practice is prohibited by federal law and is not allowed under any circumstance.

A DEA form 222 is required when transferring the Percocet to the other Pharmacy

According to federal law, how often is a pharmacy required to take a complete inventory of controlled substances?

-once a month

-twice a year

-once a year

-every 2 years

every 2 years

Which medication is a Schedule III controlled substance?

-Butalbital/aspirin/caffeine

-Hydromorphone

-Phenobarbital

-Pregabalin

Butalbital/aspirin/caffeine

Your pharmacy stocks 100-count bottles of diazepam. According to federal law, during inventory, the pharmacy must have an.

-exact count of diazepam

-virtual count of diazepam

-perpetual count of diazepam

-estimated count of diazepam

estimated count of diazepam

According to federal law, how long does a pharmacy have to fill the remaining portion of a Roxicodone prescription?

-1 day

-3 days

- 7 days

-There is no time limit as long as Rx is not expired

3 days

Mr.Jonas is prescribed Percocet 10/325 mg from a recent motorcycle accident. According to federal law, in most cases, the Percocet prescription:

-Can be called in by Mr.Jonas’ nurse to expedite the filling process

-Can be called in by Mr.Jonas’ prescriber to expedite the filling process

-Can be faxed to the pharmacy by Mr.Jonas tp expedite the filling process

-Must be hand-written or electronically prescribed by Mr.Jonas’ prescriber

Must be hand-written or electronically prescribed by Mr.Jonas’ prescriber

Highlight section

-benefits and risks of using the drug

-boxed warnings

-diseases/conditions the drug is approved to treat

What is the table of contents organized by?

Sections

Indications and usage

-tells which disease states/ conditions the medication has been approved by the FDA to treat

Off-label use

-drugs that have not yet been approved by the FDA for a particular condition

Dosage and administration

-recommended dosage for a medication

+disease states, or particular age groups

+special dosage requirements and administration requirements

Dosage forms and strengths

-tells what form the medication comes in and description of what it looks like

Contraindictions

-situations when a drug should NOT be used

-warnings about; allergic reactions, interacting drugs, and certain disease states

Warnings and precautions

-lists activities or situations that require caution while taking the medication (including boxed warnings)

-possible serious side effects

-notes about lab tests

Adverse reactions

-includes side effects reported from using the drug during its testing phases

-side effects reported AFTER the drug hit the market (postmarketing experience)

Drug interactions

-lists most significant drug to drug interactions with the medication

-(def: instances when 2 or more drugs react with each other)

Use in specific populations

-lists safety concerns when using the drug in certain patients

-pregnancy, elderly

Drug abuse and dependence section

-informs schedule and control of drug

-lists abuse and tolerance potential of the drug

-symptoms if the patient stops using the drug

Overdose section

-lists signs, symptoms and treatments for an overdose situation

Product description section

-gives chemical name, and structural formula of the drug

-listing of active and inactive ingredients

Clinical pharmacology section

-how the drug works

-how its absorbed, metabolized, and eliminated by the body

-explanations of the various studied performed

Nonclinical Toxicology section

-lists any cancer risks

Clinical studies section

-how well the drug works for its approved indications

How supplied/storage and handling section

-lists all of the medication’s dosage forms

-describes by color, shape and marking for easy identification

-provides any special storage and handling instructions for the drug

Which drug information source provides generic substitution equivalence ratings for Lasix?

-Red book

-Natural medicines

-United States Pharmacopeia-National formulary

-Approved Drug Products with Therapeutic Equivalence Evaluations

Approved Drug Products with Therapeutic Equivalence Evaluations

A dietary supplement is recalled because it was found to contain ingredients that weren’t listed on the label. It’s considered:

-Adulterated

-Adverted

-Misbranded

-Mislabeled

adulterated

One responsibility of the Food and Drug Administration is:

-Regulating infection control

-Approving over-the counter medications

-Creating standards for child-resistant packaging

-Enforcing the laws surrounding illegal drug substances

Approving over-the counter medications

Which governmental agency helps to enforce the laws and regulations surrounding controlled substances?

-BOP

-CDC

-DEA

-FDA

DEA

Which Law created two classes of medications, prescription and nonprescription?

-Pure Food and Drug Act of 1906

-Food, Drug, and Cosmetic Act of 1938

-Durham-Humphrey Amendment of 1951

-Omnibus Budget Reconciliation Act of 1990

Durham-Humphrey Amendment of 1951

Which medication must have an imprint code?

-Fluticasone 50 mcg nasal spray

-Fluconazole 150 mg tablet

-Fluticasone 0.05% cream

-Fluconazole 40 mg/mL powder

Fluconazole 150 mg tablet

According to the Poison Prevention Packaging Act of 1970, which medication can be dispensed in a non-child resistant package in an outpatient setting?

-Sublingual nitroglycerin tablets

-sublingual nitrofurantoin tablets

-extended-release nitroglycerin capsules

-extended release nitrofurantoin capsules

Sublingual nitroglycerin tablets

When must you provide a medication guide for medications that require one?

-For all inpatient prescriptions

-only when an inpatient is receiving a new order

-when an inpatient asks for a medication guide

-before the medication is ordered for an inpatient

when an inpatient asks for a medication guide

The drug price competition and patent term restoration act of 1984 is also known as the:

-Drug listing act

-Hatch-Waxman act

-Durham Humphrey amendment

-Omnibus Budget reconciliation act

Hatch-Waxman act

According to the HIPAA, a patient’s lab results are considered:

-BOP

-PPI

-PHI

-REMS

PHI

FDA-approved handouts that inform patients about risks of drugs that pose the most signification and serious health concerns are called:

-Medication guides

-Patient-packaging inserts

-Consumer medication leaflets

-Protected health information sheets

Medication guides

According to the Poison Prevention Act of 1970, which medication can be dispensed in a non-child-resistant package?

-Antibiotics

-Heart failure meds

-Inpatient meds

-Oral cortiscosteroids

Inpatient meds

Which medication must be accompanied by a patient package insert?

-Cartia XT

-Cenestin

-Cialis

-Crestor

Cenestian

For meds that require a medication Guide, you must give one:

-With all outpatient prescriptions

-Only when an outpatient is receiving a new prescription

-When the patient signs a medication guide authorization form

-Only when the prescriber writes “MedGuide required” on the face of the prescription

With all outpatient prescriptions

The food, drug, and cosmetic act of 1938:

-set requirements for dispensing controlled substances

-prohibits the sale of misbranded and adulterated products

-created 2 classes of medications, prescription and nonprescription

-requires manufacturers to prove a drug’s purity, strength, and safety before it can be sold

-requires manufacturers to prove a drug’s purity, strength, and safety before it can be sold

Which regulatory agency is responsible for creating standards for packaging to protect children from accidental poisonings with medication?

-food and drug administration

-consumer product safety commission

-centers for disease control and prevention

-occupational safety and health administration

consumer product safety commission

Which regulatory agency is responsible for creating standards for packaging to protect children from accidental poisonings with medicaitions?

-Food and Drug Administration

-Consumer Product Safety Commission

-Centers for Disease Control and Prevention

-Occupational Safety and Health Administration

Consumer Product Safety Commission

Which medication must be dispensed with a patient package insert?

-Aspirin

-Estrogen

-Ibuprofen

-Nitroglycerin

Estrogen

Exenatide and liraglutide are both incretin mimetics used to treat diabetes. Exenatide and liraglutide are:

-Pharmacologic alternatives

-Pharmacologic equivalents

-Therapeutic alternatives

-Therapeutic equivalents

Therapeutic alternatives

A drug that contains a different active ingredient, but is in the same drug class and works similarly to another medication is considered a:

-pharmacologic alternative

-pharmacologic equivalent

-therapeutic alternative

-therapeutic equivalent

Therapeutic alternative

A collaborative agreement is a system that allows pharmacists to automatically substitute:

-Brand-name and generic medications

-Misbranded and adulterated medications

-Pharmacologic and therapeutic equivalents

-Pharmacologic and therapeutic alternatives

Pharmacologic and therapeutic alternatives

Which type of drug is involved in a class III recall?

-Drugs that are older or unapproved

-Drugs unlikely to cause adverse events

-Drugs that can cause serious but adverse events or death

-Drugs that cause temporary, but reversible side effects

Drugs unlikely to cause adverse events

Who usually makes the decision to recall a drug product?

-DEA

-Drug company

-FDA

-Pharmacist

Drug company

Investigational drug returns may be performed by the:

-Drug manufacturer

-Drug sponsor

-IDS technician

-Nursing staff

IDS technician

A pharmacologic alternative is a drug that:

-is identical in active ingredient, strength, and dosage form

-contains the same active ingredient, but is a different strength

-is identical in active ingredient, but has different inactive ingredients

-contains a different active ingredient, but is the same drug class and works similarly

contains the same active ingredient, but is a different strength

Which DAW code means that no product selection is indicated and substitution is allowed?

-0

-2

-3

-7

0

Which is an example of a medication that is part of a class III recall?

-an unapproved medication

-a mislabeled medication that is unlikely to cause adverse effects

-a dietary supplement that contains undeclared amounts of active ingredients

-a contaminated medication that could cause temporary, but reversible adverse effects.

a contaminated medication that could cause temporary, but reversible adverse effects.

Which committee approves patient consent forms and protects the welfare of drug research volunteers?

-CDC

-FDA

-IRB

-NDA

IRB

What does DAW 3 mean?

-substitution is allowed by the prescriber but not by the patient

-substitution is allowed by the prescriber, but the generic is not in stock

-substitution is allowed by the prescriber. but the generic is not available in the marketplace

-substitution is allowed by the prescriber, but the pharmacist determines brand should be dispensed.

substitution is allowed by the prescriber, but the pharmacist determines brand should be dispensed.

Which involved introducing a drug for the first time in humans?

-phase 1 testing

-phase 2 testing

-phase 3 testing

-preclinical testing

phase 1 testing

A drug is usually permanently withdrawn from the market because it is considered:

-contaminated

-harmful

-misbranded

-mislabeled

Harmful

Which DAW code means that substitution is allowed by the prescriber, but the patient is requesting the brand name product to be dispensed?

-0

-1

-2

-8

2

What does DAW 1 mean?

-substitution is not allowed by the prescriber

-no product substitution is indicated, and substitution is allowed

-substitution is allowed by the prescriber, but the pharmacist recommends brand

-substitution is allowed by the prescriber, but the patient requested the brand-name product to be dispensed.

substitution is not allowed by the prescriber

A generic product has the same active ingredient, strength, and dosage form as the brand-name product. If this generic also absorbs and releases the same as the brand-name drug, it is considered a:

-pharmacologic alternative

-pharmacologic equivalent

-therapeutic alternative

-therapeutic equivalent

therapeutic equivalent

After which phase of the drug approval process, does the drug company file a new drug application (NDA) to then sell the drug on the market?

-Phase 1 testing

-Phase 2 testing

-Phase 3 testing

-Postmarket testing

Phase 3 testing

What is an investigational drug?

-a drug compound undergoing theoretical tests

-a drug compound undergoing tests to determine its use

-a drug compound undergoing clinical testing in humans

-a drug compound undergoing clinical testing in animals

a drug compound undergoing clinical testing in humans

FDA approved an ANDA. This means a manufacturer:

-Can bring a generic medication to market

-Can bring a brand name medication to market

-Has exclusive right to the drug compound indefinitely

-Has exclusive rights to the dug compound for at least 20 years

Can bring a generic medication to market

Which responsibility may be performed by an IDS technician?

-Drug preparation

-Review study protocols

-Revise brochures

-Write study procedures

Drug preparation

When you receive a new drug in the pharmacy, what’s the medication under?

-Pharmacologic brand name

-Pharmacologic generic name

-Protected brand name

-Protected generic name

Protected brand name

When a generic medication is identical in active ingredients, strength, dosage form, and route of administration as the brand-name product, it is considered a(n):

-abbreviated equivalent

-bioequivalent

-pharmaceutical equivalent

-therapeutic equivalent

pharmaceutical equivalent

What does DAW 5 mean?

-Substitution is allowed, but the generic is not in stock

-substitution requires an override from the insurance company

-substitution is allowed, but the brand-name is dispensed as generic

-substitution is allowed, but the generic is not available in the marketplace

substitution is allowed, but the brand-name is dispensed as generic

In 2004, the prescription medication Vioxx was removed from pharmacy shelves permanently due to the reports of increased heart problems. This is an example of a:

-Class 1 recall

-Class II recall

-Class II recall

-Market withdrawal

Market withdrawal

Quetiapine and aripiprazole are both atypical antipsychotics used to treat psychiatric disorders. Quetiapine and aripiprazole are therapeutic alternatives because they:

-Are AB-rated in the Orange book

-Are both immediate-release tablets

-Absorb and release the same in the body

-Contain different active ingredients, but in the same drug class

Contain different active ingredients, but in the same drug class

Which application is submitted for naturally sourced drug compound seeking FDA approval?

-BLA

-IBLA

-NDA

-PMA

BLA

A pharmacologic alternative is a drug that;

-is identical in active ingredient, strength, and dosage form

-contains the same active ingredient, but is a different strength

-is identical in active ingredient, but has different inactive ingredients

-contains a different active ingredient, but is the same drug class and works similarly

contains the same active ingredient, but is a different strength

A brand-name drug that is relabeled and marketed under a generic product name is a(n):

-authorized brand

-authorized generic

-bioequivalent brand

-bioequivalent generic

authorized generic

Topamax is an immediate-release topiramate tablet. Trokendi XR is an extended-release topiramate tablet. Both medications are used to treat the same condition. Topamax and Trokendi XR are:

-pharmacologic alternatives

-pharmacologic equivalents

-therapeutic alternatives

-therapeutic equivalents

pharmacologic alternatives

Which section of the package insert describes how a drug works?

-Clinical Pharmacology

-Dosage and administration

-Indications and usage

-Nonclinical Toxicology

Clinical Pharmacology