Chapter 1 Flashcards
what are the 3 human research core ethical principles
respect for persons
beneficence
justice
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
what treatment can no person refuse
tuberculosis
-any communicable disease cannot refuse because contagious
what is beneficence
duty to protect research subject from harm
analyzing and balancing
what is justice
to be fair
what are the resources that will tell you about a drug
United States Pharmacopeia national formality
the international pharmacopeia
what are drug standards
any drug in the market should meet safety standards and effectiveness
what are federal legislation
attempt to protect the public from drugs that are impure, toxic, ineffective or not tested before public sale.
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
what is the sherley amendment of 1912
prohibits false therapeutic claims on drug labels
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
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
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
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
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
what is the Health insurance portability and accountability act of 1996 (HIPAA)
patients have more control over their health info
privacy of health info
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
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
2
antihistamine act on ___ which helps sleep
CNS
what is SAFER
speak up ask questions find facts evaluate choices read labels
