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pht 100 7
chapter 3 part 4
| Question | Answer |
|---|---|
| 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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