chapter 3 part 4
Quiz yourself by thinking what should be in
each of the black spaces below before clicking
on it to display the answer.
Help!
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| generic drug dispensing saves | 30-80% of money compared to brand
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| multiple companies may competetively | price their generic drugs
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| generic drugs save customers | $10 billion+ each year
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| an ndc has a | labeler code, a product code, & a package code
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| the labeler code of the ndc identifies | the manufacturer
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| the product code of the ndc identifies | the drug
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| the package code of the ndc identifies | the size/type
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| ppi is | product package insert
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| the ppi has | a description, clinical pharmacology, indications, use, contraindications, warnings, precautions, adverse reactions, dependency, overdose, dose & administration, how supplied, & date of most recent labeling revision
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| all drugs have | toxicity risks
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| adr is | adrverse drug reaction
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| adr's may not always be | predictable or preventable
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| the fda has 2 central reporting systems to | defect & assess adverse reactions
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| the central reporting systems of the fda are | medwatch & vaccine adverse report system
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| vaers is | vaccine adverse event reporting system
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| adr happens when taking a drug gives | a negative consequence
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| medwatch is a clearinghouse for info on | drug safety alerts, biologics,diet supplements, & medical devices
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| the voluntary program medwatch lets any health care professional report | serious adverse events
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| medwatch's reports are based on | serious adverse events, product problems, & on medical errors which may involve drug recalls
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| medwatch may respond by improving | rx info, informing healthcare workers or customers, changing labels, & recalling products
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| black box warnings can be | communicated through medguides
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| the black box warnings by medguides gives patients | drug info, promotes drug use safety, & gives patients access to info on risks/benefits of the drug
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| the medguide is also | the patient medguide
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| medguide is written patient info mandated by the fda | for high risk drugs
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| the vaers is operated by | the fda as well as the cdc
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| the vaers collects adverse event info after vaccination has gotten | 123,000+ reports since 1990, & accepts reports online, by phone or by mail
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| the vaers is a | postmarketing surveillance system
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| the fda issues drug recalls when the | risks outweigh benefits
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| a manufacturer may withdraw a drug because of it's | future liability concerns
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| a drug recall is | a withdrawl of a drug by the fda or manufacturer because of the risks
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| drugs may be recalled based on | future risks
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| the fda has an on-line orange book provides info on | generic & therapeutic equivalent of different brands
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| the u.s. pharmacopeia describes | drug substances & dosage forms
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| the nat'l formulary describes | pharmaceutical ingredients
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