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24 Cards in this Set
- Front
- Back
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What's the oldest federal agency dedicated to consumer protection?
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The Food and Drug Administration (FDA)
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What's the enforcement branch of the FDA?
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The Office of Regulatory Affairs
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What's the mission of CDER?
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To assure that safe and effective drugs are available to the American people
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What's the mission of the CDER Office of Compliance?
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To promote and protect public health through strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs.
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Is CDER involved in the drug approval process?
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NO!
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Which act:
1.) Prohibited the importantion of adulterated drugs 2.) Established drug quality standards 3.) And was ineffective because of enforcement challenges? |
1848 Drug Importation Act
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Which act:
1.) Prohibited interstate commerce of misbranded and adulterated drugs? 2.) Identified official standards for drugs 3.) Has minimal labeling requirements 4.) No requirement for testing drug safety or efficacy |
1906 Pure Food and Drug Act
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Which act:
1.) Began the modern, scientifically based drug industry 2.) Required proof of safety prior to marketing 3.) Authorized inspections 4.) Outlawed false claims |
The Federal Food, Drug, and Cosmetic Act of 1938 (made no distinction between OTCs and Rx drugs)
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Which act:
1.) Defines a prescription drug 2.) Separated prescription drugs from Over-the-counter (OTC) products |
1951 Durham-Humphrey Amendment
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Which act:
1.) Required drugs to be both safe and effective 2.) Established Good Manufacturing Practices 3.) Applications required "substantial evidence" consisting of adequate and well controlled trials conducted by experts qualifed by scientific training and experience |
1962 Federal Food, Drug, and Cosmetic Act
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Roughly 2 percent of the 3.6 billion prescriptions filled in the US annually are ______
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are unapproved drugs
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The absence of proof of a problem is not proof ___
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of the absence of a problem
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What's E-ferol?
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E-ferol is Vitamin E. It killed 45 children because the manufacturer changed the route of administration of the drug (didn't change the active ingredient)
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True or False: all drugs in the PDR are safe and effective
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False
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What are the 3 Categories of Marketed Unapproved Drugs?
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1.) Drug Efficacy Study Implementation (DESI) Drugs
2.) Prescription "Wrap Up" 3.) Post '62 drugs |
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Are DESI drugs:
a.) grandfathered drugs? b.) generally recognized as safe and effective (GRAS/E)? |
a.) NO!
b.) NO! |
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Describe prescription wrap-up
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Drugs not covered by DESI review because there was no pre-62 application
These drugs are on the market based on a claim of being a pre-38 or pre-62 product or IRS to such a product |
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What are post '62 drugs?
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Drugs initally marketed after 1962
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All drugs must have FDA approval or comply with an OTC monograph unless (x 3)
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1.) DESI pending
2.) OTC monograph pending 3.) GRAS/E |
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How can a firm market a grandfathered drug?
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A firm must document that its product is identical in formulation, strength, dosage form, route of administration, indications, intended patient population, and other conditions of use to a drug marketed on the relevant date
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Name 2 internal federal reporting programs
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DOD and VA reporting program
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Name some examples of voluntary reporting programs
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1.) JCAHO Sentinel Events Reporting Program
2.) Medication Error Reporting Program (MERP) 3.) MEDMARX |
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The public has the right to every man's evidence except if:
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1.) Attorney-Client Privilege
2.) Peer Review Privilege 3.) Self-Critical Analysis Privilege |
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What's the purpose of the patient safety act?
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1.) To provide for the improvement of patient safety
2.) To reduce the incidence of events that adversely affect patient safety 3.) To encourage reporting of patient safety events |
