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pht 100 7

chapter 3 part 4

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



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