Medication Safety Programs Quiz

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Which program is a proactive surveillance system designed to detect early signs of medication risk and safety problems?

REMS

Sentinel Initiative (correct)

Postmarket labeling

MedWatch

What is the most serious classification of drug recalls?

Class II

Class I (correct)

Class III

Class IV

What is the responsibility of the manufacturer during a drug recall?

Notifying sellers of drug recalls (correct)

Conducting the recall without notifying anyone

Notifying consumers directly

Issuing refunds to affected patients

What defines a Class II drug recall?

May cause temporary or medically reversible adverse health consequences Signup and view all the answers

Which drug is exempt from the requirement of having child-resistant packaging?

Nitroglycerin Signup and view all the answers

What term is used to describe the use of a drug for an indication not approved by the FDA and not listed in the drug's labeling?

Off-Label Signup and view all the answers

Which term describes the failure to provide a patient package insert (PPI) when dispensing potentially dangerous drugs?

Misbranding Signup and view all the answers

When must pharmacists include a patient package insert (PPI) with each container dispensed?

For both initially dispensed and refilled containers Signup and view all the answers

MedGuides are mandated for drugs posing a 'serious and significant concern.' Which circumstances would require the FDA to determine that a MedGuide is necessary?

Serious risk or significant safety concern Signup and view all the answers

What type of claims are NOT allowed on dietary supplements according to DSHEA?

Disease claims Signup and view all the answers

What is the required statement that must appear on a dietary supplement label after a structure/function claim?

This statement has been evaluated by the FDA Signup and view all the answers

Which of the following is NOT considered a component that can be found in a dietary supplement as defined by DSHEA?

Antibiotic Signup and view all the answers

Why is it important to consult a doctor before using Aspirin products during the last 3 months of pregnancy?

To confirm the safety and necessity of using the product during pregnancy. Signup and view all the answers

Failure to provide MedGuide or PPI to patient is considered ________.

misbranding Signup and view all the answers

_ and _ are federally mandated (for certain drugs) and are considered labeling, therefore they require FDA approval before dissemination.

PPI's, MedGuides Signup and view all the answers

_______ is the written information provided by the pharmacy for all drugs.

Useful written consumer medication information (CMI) Signup and view all the answers

_______ does NOT replace the PPI or Medguide, it is NOT federally mandated, and does not require FDA approval before distribution.

Consumer medication information (CMI) Signup and view all the answers

Tampering _______ means that the packaging has an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.

evident Signup and view all the answers

Tamper- _______ regulations do not require tamper proof packaging - true for two-piece hard gelatin capsules.

evident Signup and view all the answers

The FDA requires that the pharmaceutical product bar code includes _____.

Drugs NDC Signup and view all the answers

______ refers to the date required on the manufacturer's containers.

Expiration Signup and view all the answers

The Consumer Product Safety Commission (CPSC) administers the _____.

Poison Prevention Packaging Act (PPPA) Signup and view all the answers

______ refers to the dating of drug products that are dispensed by pharmacists.

Beyond use date Signup and view all the answers

A package will fail the child resistant test if more than ______% of the children test panel can open the package in 10 min.

20 Signup and view all the answers

Manufacturers may market _____ size of an OTC product for the elderly/handicapped in noncompliant packaging.

one Signup and view all the answers

PPPA regulations state that pharmacists must normally dispense oral drugs in child resistant packaging EXCEPT when the physician or patient request _____.

noncompliant packaging Signup and view all the answers

Improper interference with the product for the purpose of making objectionable or unauthorized changes refers to _____.

tampering Signup and view all the answers

What does 'low sodium' mean? - contains 140 mg or less of Na per dosage unit _______ prohibited the FDA from regulating dietary supplements as drugs.

Dietary Supplement Health and Education Act of 1994 (DSHEA) Signup and view all the answers

Medication Safety Programs Quiz

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Questions and Answers

Which program is a proactive surveillance system designed to detect early signs of medication risk and safety problems?

What is the most serious classification of drug recalls?

What is the responsibility of the manufacturer during a drug recall?

What defines a Class II drug recall?

Which drug is exempt from the requirement of having child-resistant packaging?

What term is used to describe the use of a drug for an indication not approved by the FDA and not listed in the drug's labeling?

Which term describes the failure to provide a patient package insert (PPI) when dispensing potentially dangerous drugs?

When must pharmacists include a patient package insert (PPI) with each container dispensed?

MedGuides are mandated for drugs posing a 'serious and significant concern.' Which circumstances would require the FDA to determine that a MedGuide is necessary?

What type of claims are NOT allowed on dietary supplements according to DSHEA?

What is the required statement that must appear on a dietary supplement label after a structure/function claim?

Which of the following is NOT considered a component that can be found in a dietary supplement as defined by DSHEA?

Why is it important to consult a doctor before using Aspirin products during the last 3 months of pregnancy?

Failure to provide MedGuide or PPI to patient is considered ________.

_ and _ are federally mandated (for certain drugs) and are considered labeling, therefore they require FDA approval before dissemination.

_______ is the written information provided by the pharmacy for all drugs.

_______ does NOT replace the PPI or Medguide, it is NOT federally mandated, and does not require FDA approval before distribution.

Tampering _______ means that the packaging has an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.

Tamper- _______ regulations do not require tamper proof packaging - true for two-piece hard gelatin capsules.

The FDA requires that the pharmaceutical product bar code includes _____.

______ refers to the date required on the manufacturer's containers.

The Consumer Product Safety Commission (CPSC) administers the _____.

______ refers to the dating of drug products that are dispensed by pharmacists.

A package will fail the child resistant test if more than ______% of the children test panel can open the package in 10 min.

Manufacturers may market _____ size of an OTC product for the elderly/handicapped in noncompliant packaging.

PPPA regulations state that pharmacists must normally dispense oral drugs in child resistant packaging EXCEPT when the physician or patient request _____.

Improper interference with the product for the purpose of making objectionable or unauthorized changes refers to _____.

What does 'low sodium' mean? - contains 140 mg or less of Na per dosage unit _______ prohibited the FDA from regulating dietary supplements as drugs.

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Medication Safety Programs Quiz

Choose a study mode

Podcast

Questions and Answers

Which program is a proactive surveillance system designed to detect early signs of medication risk and safety problems?

What is the most serious classification of drug recalls?

What is the responsibility of the manufacturer during a drug recall?

What defines a Class II drug recall?

Which drug is exempt from the requirement of having child-resistant packaging?

What term is used to describe the use of a drug for an indication not approved by the FDA and not listed in the drug's labeling?

Which term describes the failure to provide a patient package insert (PPI) when dispensing potentially dangerous drugs?

When must pharmacists include a patient package insert (PPI) with each container dispensed?

MedGuides are mandated for drugs posing a 'serious and significant concern.' Which circumstances would require the FDA to determine that a MedGuide is necessary?

What type of claims are NOT allowed on dietary supplements according to DSHEA?

What is the required statement that must appear on a dietary supplement label after a structure/function claim?

Which of the following is NOT considered a component that can be found in a dietary supplement as defined by DSHEA?

Why is it important to consult a doctor before using Aspirin products during the last 3 months of pregnancy?

Failure to provide MedGuide or PPI to patient is considered ________.

_______ and _______ are federally mandated (for certain drugs) and are considered labeling, therefore they require FDA approval before dissemination.

_______ is the written information provided by the pharmacy for all drugs.

_______ does NOT replace the PPI or Medguide, it is NOT federally mandated, and does not require FDA approval before distribution.

Tampering _______ means that the packaging has an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.

Tamper- _______ regulations do not require tamper proof packaging - true for two-piece hard gelatin capsules.

The FDA requires that the pharmaceutical product bar code includes _____.

______ refers to the date required on the manufacturer's containers.

The Consumer Product Safety Commission (CPSC) administers the _____.

______ refers to the dating of drug products that are dispensed by pharmacists.

A package will fail the child resistant test if more than ______% of the children test panel can open the package in 10 min.

Manufacturers may market _____ size of an OTC product for the elderly/handicapped in noncompliant packaging.

PPPA regulations state that pharmacists must normally dispense oral drugs in child resistant packaging EXCEPT when the physician or patient request _____.

Improper interference with the product for the purpose of making objectionable or unauthorized changes refers to _____.

What does 'low sodium' mean? - contains 140 mg or less of Na per dosage unit _______ prohibited the FDA from regulating dietary supplements as drugs.

More Like This

Medication Safety Quiz: Test Your Knowledge on Medical Errors

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_ and _ are federally mandated (for certain drugs) and are considered labeling, therefore they require FDA approval before dissemination.