Study Guides for Week 1 and 2 Flashcards

1
Q

Phase 1 clinical trial (copy from other deck)

A

first time used in humans
Goals:
- to find highest dose of new treatment that can be given safely without causing severe side effects
- help to decide on best way to give new treatment
- to determine what the drug does to the body and what the body does with the drug

*first few people get very low dose and are monitored closely – volunteers are usually young, healthy males

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2
Q

What is critical concentration?

A

The amount of drug that is needed to cause a therapeutic effect

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3
Q

What is pharmacogenomics?

A

The study of how a person’s unique genetic makeup (genome) influences his or her response to medications

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4
Q

What is the primary and secondary response of a medication?

A

the “primary response” refers to the intended therapeutic effect of a drug, meaning the desired beneficial action it is supposed to have, while the “secondary response” refers to any additional effects, whether beneficial or harmful, that occur alongside the primary effect, often called side effects.

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5
Q

Symptoms of hypokalemia

A
  • typically do not occur until levels below 3.0
  • decreased bowel sounds
  • fatigue
  • anorexia
  • nausea
  • vomiting
  • muscle weakness
  • leg cramps
  • decreased bowel motility
  • paresthesia
  • arrhythmias
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6
Q

Explain which medications are best distributed across the blood-brain barrier

A

High lipid soluble medications are more likely to get across the BBB and reach the CNS
- non-lipid soluble drugs can NOT cross BBB

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7
Q

What does blood urea nitrogen (BUN) measure? (cant find this in ppt just adding stuff from another resource)

A

It is a normal waste product resulting from the breakdown of proteins
Increased levels can indicate a kidney problem and be toxic in the body

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8
Q

What is loading dose?

A

Some medication take a long time to reach critical concentration, and if effect needed quickly, then loading dose given to reach critical concentration
- is a higher dose than usually used for treatment
- “jumpstart”

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9
Q

What is creatinine? (cant find this in ppt just adding stuff from another resource)

A

End product of muscle metabolism solely filtered from the blood via glomerulus

Normal levels: 0.6-1.2 mg/dl

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10
Q

What is dynamic equilibrium?

A

The actual concentration that makes it to the body

Depends on:
- absorption from site of entry
- distribution to the active site
- biotransformation (metabolism in the liver)
- excretion from the body

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11
Q

Schedule 2

A

has high potential for abuse that may lead to severe psychological or physical dependence
has a currently accepted medical use in treatment in US
– OR currently accepted medical use with severe restrictions
examples: morphine, cocaine, fentanyl, hydromorphone, oxycontin, PCP, methadone, Adderall

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12
Q

What are orphan drugs?

A

Orphan drugs are medications developed specific to treat a rare condition (small population of people; usually 1000 or less)

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13
Q

What is the definition of tonicity? How does it relate to body fluids?

A

Tonicity is the concentration (amount) of solutes in solution compared with blood steam

Isotonic, hypertonic, hypotonic solutions

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14
Q

How are medications excreted?

A

Kidneys are the major organ involved in drug excretion (drugs made water soluble for excretion)
- glomerular filtration
Other meds need active transport and will exchange an acid/HCO3 to do so - affects acid-base of urine

Also occurs via:
- skin
- lungs
- feces
- saliva
- bile

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15
Q

What are Parkinson-like side effects?

A

Dopamine levels are affected directly or indirectly
Symptoms:
- akinesia
- dyskinesia (spasms)
- muscle tremors)
- drooling
- change in gait
- rigidity
- restlessness

Ex: anti-psychotics, neuroleptics, lithium, HTN meds

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16
Q

Identify 3-5 roles that the kidneys play in the body

A

Kidneys are the major organ involved in drug excretion
kidneys regulate concentrations of most substances in the body by filtering plasma and then reabsorbing needed substances back into the vascular system

what we don’t need is excreted

removal of waste
regulation of blood pressure
regulation of electrolytes
acid-base balance
reabsorption of amino acids, glucose, and water
RBC, hormone, and enzyme production

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17
Q

Causes of hyperkalemia

A

Increased intake, certain medications, cell injuries, intravascular hemolysis, insulin deficiency, DKA, renal disease, metabolic acidosis

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18
Q

Schedule 4

A

low potential for abusive relative to drugs in schedule 3
has a currently accepted medical use in treatment in US
abuse may lead to limited physical or psychological dependence relative to schedule 3
Examples: benzodiazepines and tramadol

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19
Q

clinical trial phase 3

A
  • typically done on about 3000 participants
  • evaluates how this medication works in comparison to existing medications for the same condition
  • look at new indications (can it be used for other illnesses)
    – look at new formulations (different routes)
    – look at other patient populations (cancer, autoimmune, etc)
  • drug companies can apply for FDA approval upon the completion of the phase 3 trial
  • fast tracking like with COVID
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20
Q

What does isotonic, hypotonic and hypertonic mean? Give examples

A

Isotonic: same tonicity as the blood
- no fluid shifts and no change in cell size
- volume expander and to maintain access
- NSS, LR
Hypertonic: higher concentration than blood
- 5% dextrose in 0.9% NS, 5% dextrose in LR
Hypotonic: lower concentration than blood
- 0.45% NSS

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21
Q

Identify 3-5 adolescent concerns related to medications

A
  • must monitor for drug toxicity
  • need to have safe drug calculations
  • ordered in mg/kg
  • slower rate of absorption than adults
  • decreased protein binding to drugs (low albumin)
  • decreased renal blood flow before 9 months
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22
Q

Explain the factors which may interfere with metabolism

A

Liver and kidneys (renal or hepatic impairment)

  • first pass effect
  • hepatic enzyme system
    – inducers (increases metabolism)
    – inhibitors (decreases metabolism)
  • liver not working: proper metabolism will not occur
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23
Q

schedule 1 controlled substances

A
  • highest potential for abuse
  • has no currently accepted medical use in treatment in US
  • lack of accepted safety for use of drug under medical supervision
  • examples: heroin, LSD, ecstasy, marijuana (now state regulated but federally still not allowed)
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24
Q

What is the important of liver function tests?

A

Simple blood draws; done to monitor liver function to ensure the medication can be metabolized properly

AST: can be elevated in many body systems beside the liver
ALT: only elevated when liver is inflamed

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25
Q

What is the difference between an agonist and antagonist medication?

A

Agonists: occupy and activate receptors (full and partial)

Antagonists: occupy receptors, but do not stimulate them; keep the agonist from occupying the same spot and producing a response

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26
Q

What is the importance of high alert drugs?

A

These are medications that have the highest risk of causing patient harm

includes chemotherapy, insulin, opioids, potassium (IV), parenteral nutrition, anticoagulants, and look-alike/sound-alike drugs

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27
Q

What is a medication reconciliation?

A
  • Medication reconciliation is performed at admission, discharge, every home visit and at each clinic visit. It is done to prevent medication errors, drug interactions and multiple prescriptions of the same medication
  • Compare the orders to what the patient believes they are taking
  • include meds, OTC, herbals, supplements, vitamins
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28
Q

Differentiate between different controlled substance schedules

A

(copy from other deck)

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29
Q

Explain how the FDA communicate safety of medication in pregnant and breastfeeding women?

A

Categories A, B, C, D, and X (do not take X is pregnant)

New pregnancy-risk categories (PLLR)

Newest: written out information for pregnancy implications and breast-feeding considerations

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30
Q

Clinical trial phase 2

A

Studies those who have the disease:
- group of 25-100 participants with the same disease
- usually participants get the same dose (some studies randomly assign people to different treatment groups)
- groups may get different doses or get treatment in different ways - assessing best balance of safety and response

  • may be done at major medical centers, community hospitals, or physician’s office
  • continue to gather new information about side effects
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31
Q

What are the 4 main ways medications affect the body?

A

Replace or act as a substitute for missing chemicals (Ex. insulin)

Increase or stimulate certain cellular activities (Ex. beta agonists)

Depress or slow down certain activities (Ex. beta blockers)

Interfere with the functioning of foreign cells like microorganisms or neoplasms (Ex. antibiotics or chemo)

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32
Q

What are the types of skin rashes seen with medication administration?

A

Steven Johnson Syndrome

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33
Q

What happens when potassium levels are too low? Too high? Causes? Symptoms?

A

Normal levels: 3.5-5.5 meq/L
Hypokalemia: less than 3.5 meq/L
Hyperkalemia: more than 5.5 meq/L

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34
Q

What are the different phases of the clinical trials for development of a medication?

A

pre-clinical trial; phase 1; phase 2; phase 3; phase 4

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35
Q

schedule 2 controlled substances

A
  • has high potential for abuse that may lead to severe psychological or physical dependence
  • has a currently accepted medical use in treatment in US
    – OR currently accepted medical use with severe restrictions
  • examples: morphine, cocaine, fentanyl, hydromorphone, oxycontin, PCP, methadone, Adderall
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36
Q

Explain factors which affect absorption of medication through the GI tract?

A

Barriers:
- presence of food or drugs
- acidity of stomach: food in stomach increases the acidity and stomach empties slower so drug exposed to acid longer
- blood flow to the GI tract
- length of time in stomach

other factors:
- intestinal interference
- pain and stress response:
– decreased blood flow to GI tract (better blood flow allows better absorption)
– ANS response
- heavy high fat response

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37
Q

Identify 3-5 concerns related to adherence and the older adult

A
  • polypharmacy
  • difficult to keep a regular schedule
  • decreased vision, hearing, memory impairment, and decreased dexterity
  • economics
  • asymptomatic diseases
  • adverse reactions
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38
Q

What is the impact of pharmacokinetics on older adults?

A

They have more adverse events
- decreased number of receptors needed for drug distribution
- decreased absorption
- slower elimination due to decreased renal function

Beers criteria

39
Q

Differentiate between an inducer and an inhibitor

A

Inhibitors (slow):
- drug inhibits or slows the activity of the CYP enzyme often leading to high drug levels
- drug is slowly metabolized, hangs around
- may need to lower dose
- Ex: grapefruit juice

Inducers (fast):
- when a drug is able to increase the function of the CYP enzyme often causing sub-therapeutic effects
- drug is metabolism too fast
- may need to increase dose

40
Q

What is half-life? How many half-lives ensure the medication has been eliminated from the body?

A

Half life: time it takes for the concentration or amount of a drug to decrease by one-half of the peak level; when the drug is given on a regular schedule

Takes about 5 half lives for the medication to be considered eliminated

41
Q

What is therapeutic range?

A

Drug concentration from minimum effective concentration to the minimum toxic concentration

42
Q

What is the role of hematocrit in fluid balance?

A

It is the percent of blood that is made up of red blood cells

CBC: (female 36-48%; male 39-54%)
Hematocrit and BUN increases when dehydrated
- hematocrit increases from hemoconcentration

Decreased hematocrit: seen in fluid retention, anemia, and hemorrhage

43
Q

clinical trial phase 4

A
  • post-marketing; drug approved by FDA
  • studies may involve thousands of “real” people (those previously ineligible)
  • safety type of clinical trial

Looks at other aspects of treatment:
- quality of life
- cost effectiveness
- newer indications
- newer formulations

44
Q

Identify 3-5 ways a nurse can prevent medication errors.

A
  • avoid abbreviations
  • write out medication dosages
  • write out abbreviations
  • do not be afraid to admit to errors
  • be familiar with drugs you are administering
45
Q

What is the benefit of additive effect?

A

Additive effect: two meds given that do the same thing at a lower dose than one med at a higher dose

Benefit - decreases side effects

46
Q

What is an excipient? - I don’t recall learning this

A

an inactive substance that serves as the vehicle or medium for a drug or other active substance. – from internet

a substance in a drug that is not the active ingredient.

47
Q

schedule 5 controlled substances

A
  • low potential for abuse relative to drugs in schedule 4
  • has currently accepted medical use in treatment in the US
  • abuse may lead to limited physical or psychological dependence relative to schedule 4

Examples: Phenergan, codeine, cough syrup

48
Q

schedule 3 controlled substances

A
  • has potential for abuse but less so than 1 or 2
  • has a currently accepted medical use in treatment in US
  • abuse may lead to moderate or low physical dependence; high psychological dependence

examples: low doses of hydromorphone, tylenol with codeine, anabolic steroids

49
Q

What is the CYP450 system (as far as metabolism)?

A

Is part of the hepatic enzyme system (microsomal system)
- is phase 1 of the system
- has inducers and inhibitors

is essentially how good your metabolism is

50
Q

Causes of hypokalemia

A

Diuretics, vomiting, diarrhea, sweating, CHF, NGT suctioning, cirrhosis, GI suctioning, ileostomy, decreased PO intake, metabolic alkalosis, DKA, hypomagnesemia

51
Q

Define empiric therapy.

A

Medications given because of practical experience and known data

ex: antibiotics for a UTI because most are either E. coli or Staph saprophyticus

52
Q

What are the anticholinergic side effects?

A

Symptoms:
- dry mouth (xerostomia)
- dizzy
- taste changes
- paralytic ileus
- urinary hesitancy/retention
- blurred vision
- headache
- nasal congestion
- dry skin

Block parasympathetic nervous system by directly/indirectly; block cholinergic receptors

53
Q

Why is Stevens Johnson Syndrome so dangerous?

A

It is life-threatening
- begins with fever and flu-like symptoms
- in few days, skin blisters and peels
– seen on face and chest before spreading
- damages mucous membranes, urinary tract, eyes, and genitals

54
Q

Phase 1

A
  • first time used in humans

Goals:
- to find highest dose of new treatment that can be given safely without causing severe side effects
- help to decide on best way to give new treatment
- to determine what the drug does to the body and what the body does with the drug

*first few people get very low dose and are monitored closely – volunteers are usually young, healthy males

55
Q

Identify 3-5 pediatric considerations

A
  • infants and children are NOT small adults
  • must take into consideration growth and development
  • limited research in medication
  • dosing typically based on age, height, and weight
  • nurse must perform all calculations
  • children do not have the same amount of albumin receptors or muscle mass as adults
  • education is critical and must be accurate
  • make no assumptions
56
Q

Explain what it means when there is a drug interaction between calcium and a medication. What are the sources of calcium the patient must avoid?

A

That calcium interacts with the medication and can affect the way it acts?

foods with calcium to avoid - cheese, almonds, milk, yogurt, broccoli, leafy greens

57
Q

What is steady state? How does one determine it?

A

It is the amount of drug being absorbed EQUAL to the amount of drug being eliminated with continuous and/or repeated doses

the rule of thumb is the steady state will be achieved after 5 half lives

Steady state does not always mean a person is at or in the therapeutic range

58
Q

What are the lab tests which best reflect renal function?

A

Glomerular filtration rate?

59
Q

Schedule 3

A

a
has potential for abuse but less so than 1 or 2
has a currently accepted medical use in treatment in US
abuse may lead to moderate or low physical dependence; high psychological dependence
examples: low doses of hydromorphone, tylenol with codeine, anabolic steroids

60
Q

What is the role of the nurse in pharmacology care? What are some considerations the nurse should take before administering a medication?

A

The role of the nurse is to provide patient education, understand the effect of medication on the disease process, relate it to pathophysiology, provide nursing care interventions and monitor medication plan.

Some considerations include monitoring the medication plan to prevent medication errors, the 11 rights of medication, and be familiar with medication before administration

61
Q

schedule 4 controlled substances

A
  • low potential for abusive relative to drugs in schedule 3
  • has a currently accepted medical use in treatment in US
  • abuse may lead to limited physical or psychological dependence relative to schedule 3

Examples: benzodiazepines and tramadol

62
Q

List 4-5 homeostatic mechanisms that contribute to fluid balance

A
  • hydrostatic pressure
  • osmotic pressure
  • oncotic pressure
  • filtration
  • sodium-potassium pump
63
Q

hypotonic iv

A

Lower concentration than the blood
- water moves from lower concentration to higher solute concentration
- administer slowly to prevent cellular edema (causes cells to swell)
- used for dehydration

Ex: 0.45% NSS

64
Q

How does fluid volume deficit differ from dehydration?

A

Fluid volume deficit (hypovolemia):
- loss of extracellular fluid
- decrease in tissue perfusion
- can be loss of sodium and water:
– hemorrhage
– vomiting
– diarrhea
– CHF?

Dehydration:
- loss of water
- without equal loss of sodium
- decrease in size of body cells
- results in hypovolemia and hypernatremia

65
Q

What is drug tolerance?

A

Affects drug effect

Drug tolerance: built resistance
- opioids (multiple small doses)
- NTG

66
Q

Phase 4 clinical trial (copy from other deck)

A

post-marketing; drug approved by FDA
studies may involve thousands of “real” people (those previously ineligible)
safety type of clinical trial
Looks at other aspects of treatment:
- quality of life
- cost effectiveness
- newer indications
- newer formulations

67
Q

Compare and contrast hypovolemia and hypervolemia

A

Hypovolemia: fluid volume deficit
- decrease in tissue perfusion
- can be loss of sodium and water

Hypervolemia, also known as fluid overload, is a condition in which the body has too much fluid
- edema
- pulmonary edema
- edema from low albumin

68
Q

What is the difference between the generic and the trade name?

A

Generic name: official name of the medication; never changes
must meet same FDA standards
Helps indicate what class the drug falls into

Trade name: decided and patented by the manufacturer
can be several different names
Advil, Tylenol

69
Q

Phase 3 clinical trial (copy from other deck)

A

typically done on about 3000 participants
evaluates how this medication works in comparison to existing medications for the same condition
look at new indications (can it be used for other illnesses)
– look at new formulations (different routes)
– look at other patient populations (cancer, autoimmune, etc)
drug companies can apply for FDA approval upon the completion of the phase 3 trial
fast tracking like with COVID

70
Q

Schedule 1

A

highest potential for abuse
has no currently accepted medical use in treatment in US
lack of accepted safety for use of drug under medical supervision
examples: heroin, LSD, ecstasy, marijuana (now state regulated but federally still not allowed)

71
Q

What is a superinfection?

A

Online: a secondary infection that develops on top of an existing primary infection, often caused by a different microbe that is resistant to the treatment being used for the initial infection

72
Q

What are the parts of the CBC that the nurse must monitor when administering medications?

A

Peak and trough; maximum effective concentration, maximum tolerated concentration, therapeutic index

blood concentrations

idk

73
Q

What is first pass?

A
  • when a drug is administered orally, it is metabolized by the liver
  • a drug that is absorbed from the intestines it is carried by blood flow to the liver
  • during the drug’s first pass through liver, a large amount of drug is metabolized
  • once the drug has circulated through the rest of the body, about 30% circulated through the liver again

Intravenous and sublingual routes bypass the first pass effect

74
Q

What is the role of the DEA? FDA?

A

FDA: regulates food, drugs, medical devices, radiation emitting products, vaccines, blood and biologics, animal and veterinary, cosmetics, tobacco

DEA: drug enforcement agency; forces the United States’ controlled substance laws and regulations and aims to reduce the supply of and demand for such substances.

75
Q

hypertonic iv

A

Higher concentration than the blood
- water moves from area of lower to higher solute concentration
- monitor for fluid overload; but used to treat hypovolemia and replace fluid and electrolytes
- don’t want to dehydrate cells (water moves from cells into ECF)

Ex: 5% dextrose in 0.9% NS, 5% dextrose in LR

76
Q

What is off label drug use?

A

Medication is used for an indication other than what it was approved for; often supported in the literature but not FDA-approved use

77
Q

Why is patient education so important in the older adult population?

A
  • need to let them know why they are on meds, potential interactions, review generic and trade names, assessing adherence
  • keep senses are sharp as possible
  • speak in tones patient can hear
  • face patient when speaking
  • limit distractions
  • treat patient with respect
  • use large print and bright colors in teaching aids
78
Q

What is the impact that protein binding has in relation to medications?

A
  • drugs that are protein bound are inactive as the protein-drug complex is too big to enter the tissue
  • the free drug is small enough to pass through the capillary wall into the tissue fluid to exert its effect on the cell
  • the part of the drug which is bound is unavailable for use; the rest is free drug
  • highly protein-bound drug: 85-90% bound
    – part that is bound is inactive
  • not highly bound drug: 35-45% bound
79
Q

What does peak and trough mean?

A

Peak drug level:
- rate of absorption
- usually several hours after taking; depends on the med

Trough drug level:
- rate of elimination
- typically drawn right before the dose administered

80
Q

Phase 2 clinical trial (copy from other deck)

A

Studies those who have the disease:
- group of 25-100 participants with the same disease
- usually participants get the same does (some studies randomly assign people to different treatment groups)
- groups may get different doses or get treatment in different ways - assessing best balance of safety and response

may be done at major medical centers, community hospitals, or physician’s office
continue to gather new information about side effects

81
Q

Why is albumin important

A

oncotic pressure is a type of osmotic pressure exerted solely by albumin

albumin is the main colloidal protein in blood and maintains oncotic pressure
- attracts water and helps keep it inside the blood vessel
- is an indicator of nutrition
- when albumin is low: there is reduced oncotic pressure which raises hydrostatic pressure and pushes fluid in to the ISF and ICF

82
Q

How long can a medication remain under patent?

A

20 years

83
Q

Define pharmacodynamics vs pharmacokinetics

A

Pharmacodynamics: interaction between the living system (person) and the foreign chemicals; how a drug affects the body

Pharmacokinetics: the study of how the body processes a drug (4 stages: absorption, distribution, metabolism, excretion)

84
Q

What happens in the body when fluid volume is low?

A
  • thirst reflex
  • ADH (antidiuretic hormone)
  • RAAS (renin-angiotensin-aldosterone system): increased blood volume and increases BP
  • SNS: increases HR and leads to vasoconstriction
85
Q

Schedule 5

A

low potential for abuse relative to drugs in schedule 4
has currently accepted medical use in treatment in the US
abuse may lead to limited physical or psychological dependence relative to schedule 4
Examples: Phenergan, codeine, cough syrup

86
Q

What happens when BUN is too low? too high? (cant find this in ppt just adding stuff from another resource)

A

Increased levels can indicate a kidney problem and be toxic in the body
- you will see increased BUN and creatinine levels during kidney injury/failure

Low levels can be caused by things like liver disease, malnutrition or overhydration

Normal levels: 7-20 mg/dl

When dehydrated - hematocrit, BUN increase
When overhydrated - hematocrit, BUN decrease

87
Q

Describe therapeutic monitoring

A

Defined as the use of assay procedures (labs) to determine drug concentration in the blood
- assess toxic levels
- therapeutic index: margin of safety of drug
– low: narrow margin of safety
– high: less danger

Variation can occur based on pharmacokinetics, disease states, and possible drug interactions

Therapeutic range

88
Q

Why is potassium in the body important

A
  • major intracellular electrolyte
  • plays a role in:
    – nerve impulses in cardiac, smooth, and skeletal muscle
    – acid-base
    – ATP synthesis
    – osmotic balance
    – urine concentration
  • bulk is in the muscle (concentration changes has neuromuscular effects)
  • moves from ICF to ECF: can be affected by insulin, pH and epinephrine
89
Q

isotonic iv

A

Same tonicity as blood
- no fluid shifts and no change in cell size
- standard is 0.9% NSS
- volume expander and to maintain access

Ex: 0.9% NSS, LR

90
Q

What is the importance of look-alike/sound-alike drugs?

A

these, if mixed up, have the highest risk of causing patient harm

you need to use tall man lettering to distinguish between look-alike/sound-alike drugs

91
Q

What is stomatitis?

A

Inflammation of the mucous membranes
- common in chemo
- immune modulators

92
Q

Symptoms of hyperkalemia

A
  • typically do not occur until levels above 6.5, but may be seen sooner
  • fatigue
  • nausea
  • vomiting
  • colic
  • weakness
  • ventricular arrhythmias
  • cardiac arrest
  • metabolic acidosis
93
Q

How does the body gain and lose fluid

A
  • kidneys: daily urine volume of fluid in adults is typically 1.5 liters
    – output approx 0.5-1 mL of urine per kg of body weight per hour
  • skin: sensible perception
    – chief solutes of sweat are sodium, chloride, potassium
    – sweat loss varies from 0-1000 mL or more every hour
  • lungs
    – water vapor (insensible loss) is about 400mL per day
    – amount increases with increased RR and depth or dry climate
  • GI tract
    – fluid loss is about 100 mL per day even though 8L circulates through daily
    – bulk of fluid reabsorbed