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36 Cards in this Set
- Front
- Back
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The Pure Food and Drugs Act of 1906 had 3 standards
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strength, quality and purity
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Food, Drug and Cosmetic Act made sure drugs were...
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safe and effective
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Who is responsible for classifying drugs from Rx to OTC?
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FDA
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What percentage of OTC meds are bought by older americans? (> 65 years)
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40%
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The growth of OTC drugs sales has increased mainly because of what?
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heightened awareness of consumers
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Formulation and Production of non-prescription drugs is overseen by whom?
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The Center for Drug Evaluation and Research
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What is the New Drug Application's role in the drug approval process?
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It sees if drugs are safe and effective in humans
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Explain the Grandfather clause theory
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Products market prior to 1938 are exempt from the NDA requirement
(ex. aspirin) |
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Components of monographs include:
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active and inactive ingredients
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are dietary supplements regulated as drugs?
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no
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Most OTC drugs require an expiration date on the label, what is the exception?
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OTC drugs without a dosage limit and are stable for 3+ years
(skin protectants, lotions, astringents) |
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OTC drugs have to have tamper-evident packaging?
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Yes so patient will be able to tell, there must also be a statement identifying tmaper -evident feature
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When did the Nonprescription drug advisory committee become established?
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1991
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What are the benefits of switching from Rx to OTC?
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1. save consumers money
2. prevent sicks days at work 3. decrease cost of treating disease |
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What are the two main behind the counter medications?
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1. Plan B
2. pseudoephedrine |
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Plan B is BTC med because why?
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ensure that it is dispensed to 17+ year olds
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Who is responsible for OTC advertising claims?
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Federal Trade Commission
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What are drug-cosmetic products?
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toothpaste, deodorant, anti-dandruff shampoo
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What is the main AE reporting system used by pharmacists?
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FDA Medwatch program which a voluntary AE reporting system
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When can the FDA seize a product and order that it be held?
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when a drug was misbranded or adulterated
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Which class of product recall could cause serious health problems or death?
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Class I
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Which class of product recall might cause temporary health problem or slight threat of a serious nature?
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Class II
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Who is responsible for carrying out provisions of DSHEA
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CFSAN
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Are manufacturer's of Dietary supplements required to prove safety or efficacy?
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No
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After October 15th, 1994, a manufacturer must notify the FDA of the intent to market the dietary supplement product how many days in advance and what else?
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75 days in advance and have evidence for safety in humans when taken as directed
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In 2007, the FDA issued a rule for good manufacturing practices for dietary supplements...what were they requiring of manufacturers?
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1. must be manufactured in a quality manner w/o alterations of impurities
2. must be labeled correctly |
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Labels of dietary supplement must include what?
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1. name
2. the word supplement 3. quantity 4. name of manufacturer 5. directions for use |
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Dietary supplements cannot claim to diagnose, cure, mitigate, treat, or prevent a disease? True or False
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True
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Claims of supplements must be supported by evidence and can be disease specific? T or F?
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F, cannot be disease specific
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If herbal supplement is going to make a claim, manufacturers must notify the FDA of exact wording within how many days after the product is marketed?
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30
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The dietary supplement and nonprescription drug consumer protection act required what of manufacturer's?
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To report public AE's
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Are Consumer Labs that test products relating to health affiliated with manufacturers?
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No, which is good b/c patients can trust it
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The Office of Dietary supplements was created as a part of what?
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DSHEA
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What are some issues with studies on herbals?
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small sample size, brief duration of study, improperly controlled pt populations, inappropriate dosage regimens, so it makes it difficult to determine actual safety and efficacy
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When a manufacturer substitutes a different dietary supplement for an ingredient in short supply, this is considered unintentional or intentional adulteration?
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intentional
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Unsafe products that can cause organ failure or death
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aristolochic acid
belladonna broom comfrey lobelia pennyroyal |
