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pht 100-4
chapter 2 part 4
Question | Answer |
---|---|
the fda has limited oversight in diet supplement market because | they don't regulate them |
the dietary supplement health & education act of 1994 defined & gave | guidelines on diet supplements |
the fda may only look at false advertisements & monitor safety thus | removing dangerous supplements after having proven that it is dangerous |
the health insurance portability & accountability act of 1996, has | a wide range of provisions |
the health insurance portability & accountability act of 1996 is | the HIPAA |
pharmacists must tell patients how their info is kept safe & provide | proof of that, plus they should have employees renew their training yearly |
the food/drug administration modernization act (1996-2003), was passed to update rx labeling which | authorized the NDA fees that the FDA uses to increase new drug reviews |
the medicare rx drug improvement & modernization act of 2003 was | better known as medicare part d |
the medicare part d gives medicare eligible patients | rx drug coverage |
medicare part d of 2003 is a voluntary programwhere patients pay | an extra premium & usually has deductibles |
the combat methamphetamine epidemic act of 2005, put restrictions on the availibility of | pseudo[ephedrine] & phenylpropanolamine |
nat'l oversight agencies are | the FDA, the drug enforcement, the occupational safety & health administration, the nat'l association of boards of pharm], & the state boards of pharm] |
the fda is a fed. gov't agency responsible for monitoring | safe & efficient food/drugs prepared for market |
the fda is under the | health & human services dept. |
the fda's center for drug evaluation & research (cder) impacts pharm]s with | new drug development/review, generic review, otc review, & post drug approval activities |
the fda's primary resposibility is to enforce laws & they have no legal authority over | pharm] practice in each state |
the fda's activities are to get applications for investigation & approval as filed by | manufacturers, to give packaging & advertising guidelines, to oversee dangerous product recalls, & to produce an annual orange book reference |
the fda regulates otc labels to be | understandable in layman's terms |
the DEA is the branch of u.s. justice department that's responsible for | regulating sale/use of potentially addictive drugs |
most of the dea's efforts are spent on | illegal drug trafficking & they supervise legal controlled drugs |
the dea inspects medical facilities/pharm]s that | may be suspected of suspicious acts |
the dea also maintains an audit trail of narcotics from | manufacturer>warehouse>pharm]>patient |
a dea registration is needed for organizations that want controlled substances for | manufacturing, distributing, dispensing, researching, instructing activities, detox programming, im/exporting, & compounding |
the csa defines who can | buy controlled substances |
rx's for C scheduled must be | handwritten for reasons relating to physicians practice |
phoned/faxed controlled rx's are | for emergencies only |
the occupational safety & health administration ensures | the safety & health of u.s. workers |
the osha role in health care environments to protect workers against | inadvertent needle stabs, oversee policies protecting against unnecessary drug exposure & ensure safe syringe disposals |
the nat'l association boards of pharm] represents pharm] practice in | each state & develops pharmacists licensure exams |
the administrative process of relicensure of pharmacists in another state | is known as reciprocation |
the nabp has no regulatory authority, coodinates reciprocation of | pharmacists practicing in other states, guides state boards of pharm] & developes model state pharm] practices act for nat'l continuity |
the state board of pharm] has leaders from | the pharm] community & consumer members |
the state board of pharm] reviews applications & | administers examinations developed by the nabp |
the state board of pharm] maintains a database of | active pharmacists & inspects all new pharm]s |