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PHT 100 -1
chapter 2 part 1
| Question | Answer |
|---|---|
| Many organizations exercise control | Courts, Federal and state legislatures Federal and state regulatory agencies, US Pharmacopeia Professional organizations, municipal governing councils, pharm] institutions, Individual institutions (hospitals, pharmacies, etc.) |
| pharm] standards are established by | professional organizations |
| drug control laws are | more strict in the u.s. than other countries |
| u.s. pharm]s need to consider | drug interactions & overdoses |
| by many u.s. citizens, drugs from canada & mexico are | being illegaly imported into the states |
| contemporary pharm] is subject to control at | fed., state, & local levels |
| the state & fed. regulatory agencies that exercise drug control are | the fda, the drug enforcement administration (who watches controlled substances), the occupational safety & health administration, the fed. trade commision, the state health & welfare, the state board of pharm], etc. |
| the professional organizations, that exercise drug control are | the american pharmacists association, american association of boards of pharm], joint commision, american society of health system pharmacists, & academy of managed care pharm] |
| a law is passed by | the legislative branch of gov't |
| the legislature represents | consumers in passing laws for protection |
| regulations are rules that | carry out lwas of the gov't |
| the fda published regulations on | drug approval, generics substitutions, counceltations, & adverse reaction reporting systems |
| the DEA (drug enforcement agency) has rules regulating | how controlled drugs are distributed, stored, documented, & filled |
| pharm] members must follow medicare part d & medicaid regulations when | dispensing & billing rx's |
| the pharm] stateboards has regulations within | the state's pharm] practice |
| the more strict law/regulation applies when | fed. & state laws & regulations conflict |
| a standard is a criteria set to measure | product quality or professional performance against a norm |
| with input from scientists, the u.s. pharmacopeia sets a standard criteria for drug quality to | be met by pharmaceutical companies before a drug is submitted to the FDA |
| joint commission gives higher standards of care in | healthcare facilities through inspection in accreditation process |
| joint commission was once known as | joint commission on accreditation of healthcare organizations |
| joint commission accreditation is equal to | getting good housekeeping seal of approval |
| accreditation is | legally voluntary |
| many insurance carriers require | accreditation for reimbursement |
| ethics are standards of | personal conduct within professions |
| ethics are also standards of | behavior for pharm] staff |
| standards of ethics are | compared when there is a legal challenge |
| in the 1800's, drugs were | unregulated |
| in the 1800's, drugs weren't proven | safe when marketed |
| in the 1800's, opium abuse was popular when brought by | chinese laborers of the transcontinental railroad |
| in the 1800's, opium was available | without a prescription |
| boisterous charlatans of the 1800's aould take their traveling medicine shows to | towns in the west to proclaim the latest "miracle cure" |
| in the 1800's, there was no labeling regulations for | drugs and no research done to support claims |
| most of the potions of the 1800's contained a high content of | alcohol & were not so innocuous & caused injury or death |
| at the turn of the 19th century, statutory laws were established to | protect consumers from dangers of unregulated drugs (especially those from other countries) |
| statutory laws are passed by | legislative bodies (fed., state, & local) |
| in 1906, the u.s. congress passed a law regulating the | development & dispensing of drugs |
| the pure food & drug act of 1906, made it illegal for | interstate transportation or sales of adulterated/misbranded food/drugs |
| the pure food & drug act of 1906, meant that labeled drug info | cannot be false |
| new legislation was later required for | the pure food & drug act of 1906 |
| in 1937, there were 107 deaths from | sulfa drugs that had diethylene glycol which is used today in antifreeze |
| one of the most important pieces of legislation of pharm] is | the 1938 food drug & cosmetic act (FDC) |
| the fdc brought forth the fda & required pharmaceutical manufacturers to | file an (NDA) new drug application |
| in 1938, drugs on the market needed to | be proven safe |
| in 1938, each new drug needed | fda approval |
| in 1938, manufacturers had to submit | toxicology results on animals followed by human clinical trials to determine degree toxicity & effect |
| in 1938, the nda must detail | chemical compositions of the drugs |
| the fdc act of 1938, extended & clarified | the definitions of misbranded names |
| the fdc act of 1938, defined the relevant official compendia as | the u.s. pharmacopeia & national formulary |
| the pure food & drug act of 1906 was passed to | fight abuses in drug formulations labeling & marketing |
| the pure food & drug act of 1906 proved | to be unenforceable |
| the pure food & drug act of 1906 forbade drug labels | from having false info |
| the food, drug, & cosmetic act of 1938, was a response to | manufactured drugs that were powerful & potential dangers |
| the food, drug, & cosmetic act of 1938, required new drug makers to file | nda's (new drug applications) to prove that drugs were safe & conducted studies & submitted results |
Created by:
frescah
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