Intro Flashcards
What is a drug
any chemical that can affect living processes
What are pharmocotherapeutics
the use of drugs to diagnose, prevent, or treat disease
the desired therapeutic effect of the drug
Preclinical testing
only done in animals
focused on toxicity and pharmokinetics
Phase1 testing
done on healthy volunteers
looking how drug is mestabolized and moves trhough the body
phase 2 teasting
done on patients
focus is terapeutic utility and dose range
phase 3 testing
done on patients, focus on safety and effectiveness
phase 4 testing
postmoarketing surevillance, countinues public monitoring
Why were women originallly banned from phase 1/2 until 1980
concerns about effecting fertility
when are children included
only if they have disease
Pure food and drug act
1906
first law to regulate drugs, quality, purity and strength
shirley amendment
prohibited manufacturers from labeling medicine with false claims
Druham-humphrey amendment
any drug that is habit forming had to be prescribed
controls what is a med that needs to be prescribes
Kefauver-harris amendment
drugs need to be proven to be effective before they can be marketed
Controlled substance act
set rules about distribution of drugs that can cause dependence, like narcotics
The schedule classifications
Schedule 1
no recognized medical use, high abuse potential
Heroin, LSD, meth
schedule 2
written prescriptions required, cannot be done over the phone
codeine, morphine, amphetemines
schedule 3
prescriptions required ro be rewritten after 6 months or 5 refills
lower amounts of codeine, butabarbital
schedule 4
prescriptions required to be rewritten after 6 months after 6 months or 5 refills
Pentaazocine
Schedule V
dispensed as any nonnarcotic prescription
Category A
no risk to fetus in first trimester of ppregnancy
Category B
animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in women
category C
animal reproducction studies have shown addverse effect in fetus and there are no studies in humans, BUt potential benefit may outweighg risks
category D
there is positive edidence of human fetal risk based on human studies, but potential benefits may warrant use of drug in pregnant women
category X
proven risk, benefits to no outweigh cost, would not give to pregnant women
complementary and alternative medicine
treatment practices not widely accepted or practiced by mainstream clinicians
like herbal supplements
Dietary supplement health and education act of 1994
manufacturers do not need to give proof of safety/ effectiveness
presumes safe until proven harmful
orphan drugs
medications for rare medical conditions
off label prescribing
meds being used fo rthings other than their specific purpose
legend drugs
prescription drugs
blackbox warning
highlights most serious warning about medications
adverse reaction + who should not take the drug
how are drugs classified
based on chemical composition
physiological effect
therapeutic use
Generic name
small caps, non-proprietary
ex. acetaminophen
chemical name
chemical makeup of drug, most complicated
trade name
brand name, proprietary
ex. tylenol
Differene in med based on brand
bioavailability might differ based on trade name
prototype
representitive drug of each class, usually the first
most common elderly drugs
statins, beta-blockers, insulin
most common adult drugs
cholesterol, antideppressants, pain meds
most common adolescnet drugs
oral contraceptives, stimulants, bronchodilators
most common pediatrics
stimulants, bronchodilators, antibiotics
7 +4 rights of drug administration
drug, patient, dose, route, time, documentation, implementation
assessmnet, evaluation, of patient to refuse, of patient to education
assessment in drug administration
identify drug is being used, identify pt risk factors like age
baseline data: therapeutic/adverse effects, allergies
patient knowledge and ability for selfcare
Labs, vital signs, height/weight, specific body assessment
NANDA label
providng a standard wording in identifying helath problems
planning in drug administration
Identify desired goals/outcomes, specific interventions, evaluation criteria to be met
Implementation in drug administration
pt teaching, drug administration based on past intervention
evaluation in drug administration
health status pre/post med administration
PRN decisions
up to RNs discretion
polypharmacy
people who take lots of meds, some of which treat side effects of other meds
ways to manage toxicity
know early signs + management procedures
AGS beers criteria
Meds not safest for older adults
1. avoided by most older people unless paliative/hospice
2. avoided by older people with specific health conditions
3. possibility of negative drug-drug interaction
4. used with caution do to negative side effects
5. dosed differently or avoided with renal pts