Chapter 1 Flashcards by Chyanne Caniglia

what are the 3 human research core ethical principles

respect for persons
beneficence
justice

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what is respect for persons

treat as independent
aware of alternative options available
autonomy- respect patients right to make decision in their own interest
can refuse treatments

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what treatment can no person refuse

tuberculosis

-any communicable disease cannot refuse because contagious

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what is beneficence

duty to protect research subject from harm

analyzing and balancing

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what is justice

to be fair

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what are the resources that will tell you about a drug

United States Pharmacopeia national formality

the international pharmacopeia

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what are drug standards

any drug in the market should meet safety standards and effectiveness

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what are federal legislation

attempt to protect the public from drugs that are impure, toxic, ineffective or not tested before public sale.

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what are the Food and drug act of 1906

prohibited the sale of misbranded and adulterated drug but did not address drug effectiveness and safety

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what is the sherley amendment of 1912

prohibits false therapeutic claims on drug labels

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why was the sherley amendment established

because the soothing syrup was advised to treat teething and colic which contained morphine and led to many infant deaths

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what is the federal food, drug and cosmetic act of 1938

empowered FDA to ensure drug was safe prior to marketing

drug be labeled accurate

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what is the durham-humphrey amendment of 1951

distinguishes between drugs that could be sold with or without prescription by a licensed health care provider s

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what is the Kefauver-Harris amendment to the 1938 act of 1962

controls drug safety, required that adverse reactions and contradictions must be labels and included in literature

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why was the Kefauver-Harris amendment established

because of the thalidomide tragedy, European patients who took sedative-hyponotic thalidomide during the 1st trimester of pregnancy gave birth to infants with extreme limb deformities

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what is the Health insurance portability and accountability act of 1996 (HIPAA)

patients have more control over their health info

privacy of health info

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what is the patient protection and affordable care act of 2010

quality, affordable health care for all americans
improved quality
prevention of chronic diseases and improved public health
improved access to innovative medical therapies
community living services and supports

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what is teratogenic

abnormalities in fetal

what is Schedule 1 of controlled substances and what are some examples

no accepted use in the U.S, high potential for abuse

ex: heroin, LSD, Cannabis

what is Schedule 2 of controlled substances and what are some examples

high potential for abuse and may lead to psychological or physical dependence
ex: fentanyl, oxycontin, codeine, hydrocodone + acetaminophen, morphine

what is Schedule 3 of controlled substances and what are some examples

potential for abuse, low physical dependence, high psychological dependence
ex: codeine + acetaminophen

what is Schedule 4 of controlled substances and what are some examples

low potential for abuse

ex: alprazolam, diazepam, lorazepam, triazolam

what is Schedule 5 of controlled substances and what are some examples

low potential for abuse, concise of limited quantities of certain narcotics
ex: cough preparation with codeine

what are the 3 legal terms for offenses

misfeasance
nonfeasance
malfeasance

what is misfeasance

negligence, giving the wrong drug or dug dose resulting in client death

what is nonfeasance

omission, omitting a drug dose that results in client death

what is malfeasance

giving the correct drug by the wrong route resulting in client death

what is the chemical name of a drug

describe drug chemical structure

what is the generic name of a drug

official name, not owned by any drug company an dis universally accepted always in lowercase letters

what is the brand (trade) name of a drug

chose by drug company always with a capital letter

Nearly 80% of all prescription drugs in the U.S are ordered by

generic names

which drug brand is less expensive

generic brand

what is bioequivalence

a generic drug must be bioequivalent to the original product

what is the nurses role in over the counter drugs

help educate client in making educated choices

what are some interactions of ibuprofen people may not be aware of

increase fluid retention on a daily basis decease antihypertensive effect long term use increase risk of MI

what age should you never give aspirin

under 18

what can trigger an acute asthma attack for people with asthma

aspirin

if an acute asthma attack is triggered what does aspirin act as

a deregulator or leukotrienes

what is not recommended to children with viral infection associated with reyes syndrome which would result in liver/brain damage

aspirin

if you have impaired renal function you should avoid

aspirin, acetampinophen and ibuprofen long term use

what is idiosyocratic

unusual drug response

benadryl should never be give to a child under the age of

antihistamine act on ___ which helps sleep

CNS

what is SAFER

``` speak up ask questions find facts evaluate choices read labels ```