PTU Study Guide Questions with 100%
Correct Answers Graded A+
According to HIPAA, which is considered protected health information?
- Co-pay amount
- Prescriber's phone number
- Patient's prescription record
- Product's NDC number
Patient's prescription record
Which law requires the pharmacist to consult about new prescriptions with patients?
- DSHEA
- Hatch-Waxman Act
- HIPPA
- OBRA '90
OBRA '90
Which act requires putting a child-resistant cap on Mr. Dunn's Neurontin prescription bottle?
- Pure Food and Drug Act of 1906
- Food, Drug, and Cosmetic Act of 1938
- Poison Prevention Packaging Act of 1970
- Drug Listing Act of 1972
Poison Prevention Packaging Act of 1970
DSHEA requires that a:
- Medication is safe and effective before coming to market
- Pharmacist counsel patients on prescription medications
- Dietary supplement must make true claims
- Solid dosage form of a medication has an imprint code
Dietary supplement must make true claims
According to the Poison Prevention Act of 1970, which medication class can be dispensed in a non-
child-resistant package in an outpatient setting?
- Antidepressant
- Antihypertensives
- Opioids
- Oral contraceptives
Oral contraceptives
Which section of the NDC identifies the name, strength, and dosage form of the medication?
- First
- Second
- Third
- Fourth
Second
,Patient package inserts contain information about the:
- Role of Food and Drug Administration
- Benefits and risks of using a medication
- Dispensing requirements for controlled substances
- Packaging requirements to protect children from harmful meds
Benefits and risks of using a medication
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 regulatory agency is responsible for creating standards for packaging to protect children from
accidental poisonings with medications?
- Food and Drug Administration
- Consumer Product Safety Commission
- Centers for Disease Control and Prevention
- Occupational Safety and Health Administration
Consumer Product Safety Commission
What did the Drug Listing Act of 1972 require?
- Consultation on all new medications
- Each new medication to have an NDC number
- All dietary supplements to go through clinical trials
- Prescription drugs to be store separately from over-the-counter drugs
Each new medication to have an NDC number
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
For meds that require a Medication Guide, you must give one:
- With all outpatient prescriptions
- Only when an outpatient is receiving a new prescriptions
- 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
,Which governmental agency helps to enforce the laws and regulations surrounding controlled
substances?
- BOP
- CDC
- DEA
- FDA
DEA
Which medication must be accompanied by a patient package insert?
- Cartia XT
- Cenestin
- Cialis
- Crestor
Cenestin
Which medication must have an imprint code?
- Preparation H suppositories
- Prempro 0.625/2.5mg tablets
- Pred-Forte 1% ophthalmic suspension
- Protonix 40mg granules for suspension
Prempro 0.625/2.5mg tablets
When Mr. Reynold's picks up his prescriptions, he tears off the tags and medication information sheet
for you to dispose of. Since the paperwork has Mr. Reynold's name, phone number, and medication
name on it, how would you dispose of it?
- Place it on the shelf to handle later
- Place is in the paper product recycling bin
- Put it in the trash bin labeled for shredding
- Tear the paperwork in half and place in the trash bin
Put it in the trash bin labeled for shredding
Which is a principle of HIPPA?
- To counsel patients on new and refill prescription medications
- To dispense prescription medications with child-resistant packaging
- To dispense certain prescription medications with a MedGuide
- To use and disclose the minimum necessary amount of protected information
To use and disclose the minimum necessary amount of protected information
The Food, Drug, and Cosmetic Act of 1938:
- Set requirements for dispensing controlled substances
- Prohibits the sale of misbranded and adulterated products
- Created two 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 section of the NDC identifies the manufacturer?
- First
- Second
- Third
- Fourth
First
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
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
FDA-approved handouts that inform patients about risks of drugs that pose the most significant and
serious health concerns are called:
- Medication guides
- Patient package inserts
- Consumer medication leaflets
- Protected health information sheets
Medication guides
Drug Price Competition and Patent Term Restoration Act of 1984 is also known at the:
- Drug Listing Act
- Hatch-Waxman Act
- Durham-Humphrey Amendment
- Omnibus Budget Reconciliation Act
Hatch-Waxman Act
The NDC number for Benicar 40mg is 65597-0104-30. The "30" identifies:
- Dosage form
- Manufacturer
- Medication name
- Package size
Package size
Correct Answers Graded A+
According to HIPAA, which is considered protected health information?
- Co-pay amount
- Prescriber's phone number
- Patient's prescription record
- Product's NDC number
Patient's prescription record
Which law requires the pharmacist to consult about new prescriptions with patients?
- DSHEA
- Hatch-Waxman Act
- HIPPA
- OBRA '90
OBRA '90
Which act requires putting a child-resistant cap on Mr. Dunn's Neurontin prescription bottle?
- Pure Food and Drug Act of 1906
- Food, Drug, and Cosmetic Act of 1938
- Poison Prevention Packaging Act of 1970
- Drug Listing Act of 1972
Poison Prevention Packaging Act of 1970
DSHEA requires that a:
- Medication is safe and effective before coming to market
- Pharmacist counsel patients on prescription medications
- Dietary supplement must make true claims
- Solid dosage form of a medication has an imprint code
Dietary supplement must make true claims
According to the Poison Prevention Act of 1970, which medication class can be dispensed in a non-
child-resistant package in an outpatient setting?
- Antidepressant
- Antihypertensives
- Opioids
- Oral contraceptives
Oral contraceptives
Which section of the NDC identifies the name, strength, and dosage form of the medication?
- First
- Second
- Third
- Fourth
Second
,Patient package inserts contain information about the:
- Role of Food and Drug Administration
- Benefits and risks of using a medication
- Dispensing requirements for controlled substances
- Packaging requirements to protect children from harmful meds
Benefits and risks of using a medication
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 regulatory agency is responsible for creating standards for packaging to protect children from
accidental poisonings with medications?
- Food and Drug Administration
- Consumer Product Safety Commission
- Centers for Disease Control and Prevention
- Occupational Safety and Health Administration
Consumer Product Safety Commission
What did the Drug Listing Act of 1972 require?
- Consultation on all new medications
- Each new medication to have an NDC number
- All dietary supplements to go through clinical trials
- Prescription drugs to be store separately from over-the-counter drugs
Each new medication to have an NDC number
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
For meds that require a Medication Guide, you must give one:
- With all outpatient prescriptions
- Only when an outpatient is receiving a new prescriptions
- 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
,Which governmental agency helps to enforce the laws and regulations surrounding controlled
substances?
- BOP
- CDC
- DEA
- FDA
DEA
Which medication must be accompanied by a patient package insert?
- Cartia XT
- Cenestin
- Cialis
- Crestor
Cenestin
Which medication must have an imprint code?
- Preparation H suppositories
- Prempro 0.625/2.5mg tablets
- Pred-Forte 1% ophthalmic suspension
- Protonix 40mg granules for suspension
Prempro 0.625/2.5mg tablets
When Mr. Reynold's picks up his prescriptions, he tears off the tags and medication information sheet
for you to dispose of. Since the paperwork has Mr. Reynold's name, phone number, and medication
name on it, how would you dispose of it?
- Place it on the shelf to handle later
- Place is in the paper product recycling bin
- Put it in the trash bin labeled for shredding
- Tear the paperwork in half and place in the trash bin
Put it in the trash bin labeled for shredding
Which is a principle of HIPPA?
- To counsel patients on new and refill prescription medications
- To dispense prescription medications with child-resistant packaging
- To dispense certain prescription medications with a MedGuide
- To use and disclose the minimum necessary amount of protected information
To use and disclose the minimum necessary amount of protected information
The Food, Drug, and Cosmetic Act of 1938:
- Set requirements for dispensing controlled substances
- Prohibits the sale of misbranded and adulterated products
- Created two 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 section of the NDC identifies the manufacturer?
- First
- Second
- Third
- Fourth
First
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
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
FDA-approved handouts that inform patients about risks of drugs that pose the most significant and
serious health concerns are called:
- Medication guides
- Patient package inserts
- Consumer medication leaflets
- Protected health information sheets
Medication guides
Drug Price Competition and Patent Term Restoration Act of 1984 is also known at the:
- Drug Listing Act
- Hatch-Waxman Act
- Durham-Humphrey Amendment
- Omnibus Budget Reconciliation Act
Hatch-Waxman Act
The NDC number for Benicar 40mg is 65597-0104-30. The "30" identifies:
- Dosage form
- Manufacturer
- Medication name
- Package size
Package size
