Drug Regulation and Control Flashcards

Questions and Answers

An injectable medication is recalled because it contains pieces of steel. Since this is likely to cause life-threatening adverse effects, it's an example of a:

Class II recall

Market withdrawal

Class III recall

Class I recall (correct)

Which responsibility may be performed by an IDS technician?

Revise brochures

Drug preparation (correct)

Review study protocols

Write study procedures

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

IRB (correct)

CDC

FDA

NDA

Which stage of the drug approval process gives the study compound to animals?

Preclinical Signup and view all the answers

What is an investigational drug?

A drug compound undergoing clinical testing in humans Signup and view all the answers

FDA may approve a Biologics License Application if the biologic proves to be:

Safe and effective Signup and view all the answers

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 3 Testing Signup and view all the answers

What type of drug is involved in a Class III recall?

Drugs unlikely to cause adverse events Signup and view all the answers

For an involuntary recall, who requires the recalled drug to be removed from pharmacy shelves?

Food and Drug Administration Signup and view all the answers

Which is an example of a medication that is part of a Class II recall?

A contaminated medication that could cause temporary, but reversible adverse effects Signup and view all the answers

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:

Market withdrawal Signup and view all the answers

To bring a generic medication to market, a manufacturer must submit a(n):

Abbreviated New Drug Application Signup and view all the answers

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

Authorized generic Signup and view all the answers

Mylan's clonazepam 1 mg is AB-rated to Klonopin 1 mg. This means:

Clonazepam is a therapeutic equivalent to Klonopin Signup and view all the answers

A brand-name patent gives a:

Drug company exclusive rights to the compound for a limited time Signup and view all the answers

Which resource contains TE codes to help guide generic substitution?

Orange Book Signup and view all the answers

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:

Therapeutic equivalent Signup and view all the answers

A system that allows pharmacists to automatically substitute with certain pharmacologic or therapeutic alternatives without calling the prescriber each time is known as a:

Collaborative Agreement Signup and view all the answers

A drug that contains the same active ingredient, but is a different strength is considered a:

Pharmacologic alternative Signup and view all the answers

Byetta and Victoza are both incretin mimetics used to treat diabetes. Byetta and Victoza are:

Therapeutic alternatives Signup and view all the answers

Paxil is an immediate-release paroxetine tablet. Paxil CR is a controlled-release paroxetine tablet. Both medications are used to treat the same condition. Paxil and Paxil CR are pharmacologic alternatives because they:

Contain the same active ingredient, but are different dosage forms Signup and view all the answers

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

Therapeutic alternative Signup and view all the answers

Which DAW code means that substitution is not allowed by the prescriber?

1 Signup and view all the answers

DAW 7 means:

Substitution is not allowed since the brand-name drug is mandated by law Signup and view all the answers

Which DAW code means the brand-name product is dispensed as generic?

5 Signup and view all the answers

Which DAW code is reserved and currently not in use?

9 Signup and view all the answers

DAW 0 means:

No product substitution is indicated, and substitution is allowed Signup and view all the answers

Which DAW code means substitution is not allowed because the generic drug is not in stock?

4 Signup and view all the answers

DAW 2 means:

Substitution is allowed by the prescriber, but the patient requested the brand-name product to be dispensed Signup and view all the answers

Study Notes

Drug Recall Classes

Class I Recall: Involves products likely to cause serious health consequences or death, such as contaminated injectable medications.
Class II Recall: Covers drugs that could cause temporary health issues but are not likely to lead to severe consequences.
Class III Recall: Pertains to medications unlikely to cause adverse effects, often including older or unapproved drugs.

Drug Approval Process

Preclinical Stage: The phase in which the drug is tested on animals before human trials.
Phase 3 Testing: Critical stage where the company submits a New Drug Application (NDA) after completion to sell the drug commercially.

Regulatory Bodies

Institutional Review Board (IRB): Protects the welfare of research volunteers by approving patient consent forms for drug trials.
Food and Drug Administration (FDA): Requires recalls and oversees the approval process for new drugs and biologics.

Investigational Drugs

An Investigational Drug is tested in humans during clinical trials to assess safety and efficacy.

Biologics Approval

Biologics License Applications must demonstrate that the biologic is both safe and effective for approval.

Generic Drug Applications

To market a generic medication, manufacturers submit an Abbreviated New Drug Application (ANDA).

Authorized Generics

Authorized Generic: A branded drug marketed under its chemical name, maintaining the same quality as the brand version.

Therapeutic Equivalence

Products are considered therapeutic equivalents if they contain the same active ingredients and provide equal therapeutic effects, allowing for substitution.

Collaborative Agreements

Systems enabling pharmacists to substitute medications with approved alternatives without needing prescriber approval for each change are termed Collaborative Agreements.

DAW Codes Explained

DAW 0: Allows product substitution; no restrictions.
DAW 1: Mandates no substitution as specified by the prescriber.
DAW 2: Permits prescriber-allowed substitution upon patient request.
DAW 4: Denotes that generic drugs are not available, preventing substitution.
DAW 5: Indicates that the brand-name product was dispensed as a generic.
DAW 7: Requires that the brand-name drug be dispensed legally, with no substitutions allowed.
DAW 9: A reserved code with no current usage.

Pharmacologic Alternatives vs. Equivalents

Pharmacologic Alternatives: Medications with the same active ingredients but different strengths or forms.
Therapeutic Alternatives: Drugs in the same class that provide similar therapeutic outcomes, despite different active ingredients.

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Description

Test your knowledge on drug regulation and control with these flashcards. Covering key concepts such as recall classifications and responsibilities within the field, this quiz is designed for students and professionals alike. Challenge yourself to understand the essential aspects of drug safety and compliance.