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PHT 100 -1

chapter 2 part 1

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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