Exam One Flashcards

1
Q

What is the National Institutes of Health (NIH) Revitalization Act?

A

Ensures women and minorities are included in clinical research

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2
Q

What is Pre-Clinical Drug Testing and what does it study?

A
  • Performed on animals or human cells/tissues (outside of the body)
  • Studies toxic/pharmacological effects of drugs
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3
Q

What is informed consent and what does it include?

HINT: PECIVC

A
  • The right to be informed, participate voluntarily, and without coercion
  • Includes purpose of the study, what is expected of patient, and potential consequences of the study
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4
Q

Define autonomy

A

Right to make decisions for oneself

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5
Q

List the core ethical principals

A
  • Respect for persons
  • Beneficence
  • Justice
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6
Q

Define beneficence

A
  • Duty to protect research subjects from harm

- Ensuring benefits of the clinical study are greater than the risks

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7
Q

Define non-maleficence

HINT: Beneficence = Non-Maleficence

A

The act of “do no harm”

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8
Q

What is risk-benefit ratio and who determines it?

A
  • Risks of a clinical study must be balanced with the anticipated benefits
  • Determined by the Institutional Review Board (IRB)
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9
Q

Who/What is in-vitro testing performed on?

A

Human cells or tissues (outside of the body)

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10
Q

Who/What is in-vivo testing performed on?

A

Whole, living organisms (i.e. animals)

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11
Q

In-Vitro and In-Vivo testing are a part of what?

A

Pre-clinical drug testing

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12
Q

What is the Best Pharmaceuticals for Children Act?

A

Requires that drugs marketed for children be tested on children for safety and effectiveness

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13
Q

What is the Pediatric Research Equity Act?

A
  • Recognizes a child’s response to drugs are not solely affected by size and weight
  • Notes that “children are not just small adults”
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14
Q

What is the purpose of Phase 1 Drug Research? Who is it conducted on?

A
  • Tests for safety of the drug (i.e. safe dosage ranges and side affects)
  • Conducted on 20-100 healthy individuals with no underlying health conditions
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15
Q

What is the purpose of Phase 2 Drug Research? Who is it conducted on?

A
  • Tests for effectiveness of the drug

- Conducted on 100-300 people who currently have the condition the drug is meant to treat

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16
Q

What is the purpose of Phase 3 Drug Research? Who is it conducted on?

A
  • Tests for effectiveness compared to marketed drugs that treat the same condition
  • Conducted on large groups of >1000
  • Involves double-blind, randomized trials
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17
Q

What is the purpose of Phase 4 Drug Research? Who is it conducted on?

A
  • Tests the drug after approved for marketing for long term affects and safety
  • Can be prescribed and marketed to various populations
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18
Q

What is the importance of randomized controlled trials?

A
  • Most reliable way to evaluate drug therapy
  • Ensures differences in outcome result from drug treatment, NOT differences in subjects
  • Prevents bias and promotes fairness
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19
Q

What is a double blind study?

A

Neither the researcher or research subject know who is receiving experimental treatment

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20
Q

What is an experimental group?

A

A group that receives the drug/treatment being tested

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21
Q

What is a control group?

A

A group that receives no drug, a different drug, placebo, or the same drug at a different dose, frequency, or route

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22
Q

What is the American Nurses Association Code of Ethics?

A
  • States the nurses primary ethical duty is to care for the patient
  • Last revision addressed ethical considerations regarding social media, electronic health records, and expanding the nursing role in clinical research
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23
Q

What is the United States Pharmacopeia and National Formulary?

A
  • Authoritative source for drug standards in the US
  • Drugs included have met high standards of quality and safety
  • Initials “USP” will follow the official drug name to denote global recognition
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24
Q

Nurse accountability for controlled substances includes?

A
  • Verify orders before administering drug
  • Account for all controlled drugs
  • Maintain log of controlled substances
  • Document all discarded drugs, witnessed by another nurse
  • Timely documentation of drug administration
  • Document patient response
  • Keep all controlled drugs in locked storage container and double lock narcotics
  • Mandatory reporting of suspected or known drug diversion
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25
Q

What is a Schedule I controlled substance? Give examples.

A
  • Not safe or accepted for medical use
  • Highest abuse/addiction potential
  • Examples: heroin, LSD, peyote, crack cocaine, PCP
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26
Q

What is a Schedule II controlled substance? Give examples.

A
  • Safe and accepted for medical use
  • High abuse/addiction potential
  • Examples: cocaine, morphine, oxycodone, methadone, fentanyl
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27
Q

What is a Schedule III controlled substance? Give examples.

A
  • Less risk of abuse/addiction than Schedule II drugs

- Examples: acetaminophen with codeine, ketamine, anabolic steroids, testosterone

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28
Q

What is a Schedule IV controlled substance? Give examples.

A
  • Less risk of abuse/addiction than Schedule I, II, or III drugs
  • Examples: diazepam, lorazepam, tramadol, zolpidem
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29
Q

What is a Schedule V controlled substance? Give examples.

A
  • Lowest potential for abuse
  • Contain limited quantities of narcotics
  • Examples: cough preparations with <200mg of codeine per 100mL (Robitussin AC, phenergan with codeine, pregabalin)
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30
Q

What are chemical drug names?

A
  • Describes the chemical structures of drugs

- Not commonly used

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31
Q

What are generic drug names?

A
  • Official, nonproprietary, universal drug name
  • Not owned by any drug company
  • Only one name for each drug
  • No trademark, lowercase first letter
  • Same active ingredients as brand name drugs
  • May have different inert ingredients than brand name drug
  • Requires FDA approval
  • Example: acetaminophen, ibuprofen
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32
Q

What are trade/brand drug names?

A
  • Name owned by a drug company
  • Uppercase first letter, trademark follows name
  • Easier to spell and pronounce
  • Example: Tylenol, Advil
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33
Q

What are the responsibilities of the FDA?

A

Ensure drugs are labeled correctly, effective for marketed condition, and safe

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34
Q

What is ‘Respect for Persons’?

A

Patients should be allowed to make their own decisions

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35
Q

What is an example of fairness?

A

When performing a drug study, if one group is receiving substantial benefits, stop study and allow all people of study to use the drug

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36
Q

What are counterfeit drugs?

A
  • May contain wrong ingredients
  • May have insufficient amount of active ingredients
  • May have no active ingredients
  • May contain impurities and contaminants
  • May be distributed in fake packaging
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37
Q

What is the nurses role in regards to counterfeit drugs?

A

Educate the patient!

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38
Q

What is The Sherley Amendment?

A
  • Prohibits false therapeutic claims on drug labels
  • Mrs. Winslow’s Soothing Syrup, advertised to treat colic and teething, resulted in infant deaths because it contained morphine
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39
Q

What is The Federal Food, Drug, and Cosmetic Act?

A
  • Requires FDA to ensure a drug is safe before marketing
  • Requires FDA to ensure drugs are tested for harmful effects
  • Requires FDA to ensure drugs are labeled with correct information, including adverse effects
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40
Q

What is the Comprehensive Drug Abuse Prevention and Control Act?

A
  • Designed to lower problems of drug abuse by incorporating:
    1) promotion and research into prevention and treatment of abuse
    2) strengthening enforcement of authority
    3) establishing treatment and rehabilitation facilities
    4) creating schedules for drugs based on addictive tendencies
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41
Q

What is the Dietary Supplement and Education Act?

A
  • Classified dietary supplements as food
  • Enforced labeling requirements for FDA
  • Authorized FDA to promote safe manufacturing practices
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42
Q

What is the Health Insurance Portability and Accountability Act (HIPAA)?

A
  • Protects workers health insurance when they change or lose jobs
  • Sets privacy standards for individuals health information
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43
Q

What is the Food and Drug Administration Safety and Innovation Act?

A

-Enhances safety of the global drug supply chains

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44
Q

What is pharmacogenetics and what does it do?

A
  • How people respond to drug therapy related to their genetic makeup
  • Studies how patients genome affects drug response
  • Helps individualize optimal drug treatment regimes
  • Helps decrease drug reaction
  • Promotes drug regime adherence
  • Reduces costs of healthcare
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45
Q

Pharmacogenetics is the same as what?

A

Pharmagonetics

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46
Q

What type of patients may benefit from pharmacogenetics?

A
  • Those taking multiple prescription drugs
  • Those not responding to current therapy
  • Those having adverse drug reactions
  • Those taking black box warning drugs
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47
Q

Is pharmacogenetic testing available for every drug?

A

No

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48
Q

What legal and ethical considerations should be made regarding pharmacogenetics, specifically autonomy?

A
  • Patient may change their mind about genetic testing

- Patient may consent or refuse genetic testing

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49
Q

Define justice.

A

Equal and fair treatment for all

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50
Q

What are the four phases of pharmacokinetics?

A
  • Absorption
  • Distribution
  • Metabolism
  • Excretion
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51
Q

What is pharmacokinetics?

A

Body acting on the drug

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52
Q

What is pharmacodynamics?

A

Drug acting on the body

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53
Q

What are the three phases of pharmacodynamics?

A
  • Receptor binding
  • Post-receptor effects
  • Chemical reaction
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54
Q

What is drug absorption?

A

Drug movement from the GI tract into the bloodstream

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55
Q

What does drug absorption require?

A
  • Disintegration

- Dissolution

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56
Q

What is disintegration?

A

Breakdown of oral drugs into small particles

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57
Q

What is dissolution?

A
  • Process of combining small drug particles with liquid to form a solution
  • Not required if drug is already in liquid form
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58
Q

What are the different methods of absorption?

A
  • Passive transport
  • Active transport
  • Pinocytosis
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59
Q

What is the most common, cheapest, and easiest route to administer drugs?

A

Enteral (oral)

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60
Q

What drug resists disintegration in the gastric acid of the stomach? Where is this drug absorbed?

A
  • Enteric Coated (EC) drugs

- Small intestine

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61
Q

What factors affect drug absorption?

A
  • Blood flow, pain, stress, gastric pH
  • Food texture, fat content, temperature
  • Route of administration
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62
Q

What factors cause minimal drug absorption?

A

-Decreased blood flow (i.e. shock or extreme decrease in blood pressure)

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63
Q

Which route of drug administration has the fastest onset of action?

A

IV

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64
Q

Which route of drug administration is slowed, depending on blood flow to the area?

A

Subcutaneous (SubQ)

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65
Q

Which route of drug administration has a slow onset and is unpredictable?

A

Oral

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66
Q

Which drug route is slower than IV, but faster than Subcutaneous?

A

IM

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67
Q

Passive transport occurs through what?

A
  • Diffusion

- Facilitated Diffusion

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68
Q

What is diffusion?

A

Movement across a cell membrane from an area of higher concentration to an area of lower concentration

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69
Q

What is facilitated diffusion?

A

Movement across a cell membrane from an area of higher concentration to an area of lower concentration using a carrier protein

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70
Q

Which transport route does not require energy?

A

Passive transport

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71
Q

What is active transport?

A
  • The movement of a drug across a concentration gradient

- Requires a carrier protein or enzyme

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72
Q

Which transport route requires energy?

A

Active transport

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73
Q

What is pinocytosis?

A

A cell carries the drug across the membrane by engulfing the drug particles

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74
Q

What organ metabolizes most drugs?

A

Liver

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75
Q

What is first pass affect, or first pass metabolism?

A

When the liver metabolizes a drug to an inactive form and it is excreted, reducing the amount of active drug available to exert a pharmacological effect

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76
Q

What is bioavailability?

A

Percentage of the administered drug that reaches systemic circulation

77
Q

Drugs move from the GI tract to the liver via the what?

A

Portal vein

78
Q

What factors affect bioavailability?

A
  • Absorption
  • First pass affect
  • Drug form
  • Route of administration
  • Gastric mucosa and motility
  • Administration with food or other drugs
  • Changes in liver metabolism
79
Q

Decreased liver function increases what?

A

Bioavailability

80
Q

What is drug distribution?

A

Movement of drug from circulation to body fluids and tissues

81
Q

What factors influence drug distribution?

A
  • Protein binding
  • Free drugs
  • Blood brain barrier (BBB)
82
Q

As drugs are distributed in the plasma, many bind with what?

A

Plasma proteins

83
Q

What happens to a drug if it binds to a protein?

A
  • It is unable to affect the rest of the body/interact with tissue receptors
  • Becomes inactive
84
Q

What is a free drug?

A
  • Portion of a drug that is not bound to protein

- Able to exit blood vessels and reach a site of action resulting in a pharmacological effect

85
Q

What is the blood brain barrier? What is its purpose?

A
  • Blood vessels of the brain, made of special endothelial lining, compressed tightly together
  • Protects the brain from foreign substances
86
Q

What drugs are able to cross the blood brain barrier?

A
  • Highly-lipid soluble drugs

- Drugs with low molecular weight (benzodiazepines)

87
Q

Drug metabolism is also known as what?

A

Biotransformation

88
Q

What is drug metabolism? Where does it occur?

A
  • Process of the body chemically changing drug into a form that can be excreted
  • Occurs primarily in the liver
89
Q

If the liver function is decreased, what happens to the drug effects?

A

Increase

90
Q

What is prodrug? Why is it used?

HINT: Codeine and Morphine

A
  • Biologically inactive compound which is metabolized inside the body to produce an active drug
  • Improves drug delivery, decrease toxicity, targets specific cells/tissues
91
Q

What is a half-life?

A

Period of time required for concentration or amount of drug in body to be reduce by one-half

92
Q

What affects a drugs half-life?

A
  • Metabolism

- Elimination

93
Q

What does the half-life help determine?

A

Dosing intervals

94
Q

If liver and kidney function is decreased, the half-life will do what?

A

Increase

95
Q

Long half-life equals _____ frequent dosing.

A

Less

96
Q

Short half-life equals _____ frequent dosing.

A

More

97
Q

What is a steady state?

A

When the amount of drug administered equals the amount of drug eliminated

98
Q

Steady state requires how many half-lives?

A

Four (4)

99
Q

What is a loading dose? Give an example.

A
  • Large initial dose or series of doses to rapidly achieve therapeutic concentration and steady state
  • Example: Z-pac
100
Q

Name the different ways that drugs are excreted? What is the main route of drug excretion?

A
  • Kidney (Main route)
  • Liver
  • Lungs
  • Saliva, sweat, and breastmilk
101
Q

How are drugs excreted from the liver?

A

Through bile

102
Q

How are drugs excreted through the lungs?

A

Exhalation

103
Q

Liver dysfunction leads to what?

A

Decreased metabolism

104
Q

Kidney dysfunction leads to what?

A

Decreased excretion

105
Q

Urine pH will affect what phase of pharmacokinetics?

A

Excretion

106
Q

Acidic urine promotes the elimination of what drugs?

A

Alkalotic (Basic)

107
Q

Alkaline urine promotes the elimination of what drugs?

A

Acidic

108
Q

What drug is excreted rapidly in alkaline urine?

A

Salicylic acid (Aspirin)

109
Q

What tests determine renal function?

A
  • Creatinine

- BUN

110
Q

What is a primary effect?

A

Desirable response

111
Q

What is a secondary effect?

A

Desirable or undesirable response

112
Q

What is potency?

A

Amount of drug needed to initiate a physiological response

113
Q

What is high potency?

A

High therapeutic response at a low dosage

114
Q

What is low potency?

A

Low therapeutic response at a low dosage

115
Q

What is maximal efficacy?

A

No matter how much drug you take it will not work

116
Q

What is the difference between therapeutic dose and toxic dose known as?

A

Therapeutic index

117
Q

What medications have a narrow therapeutic index?

A
  • Warfarin
  • Digoxin
  • Phenytoin
118
Q

Define onset.

A

Time it takes drug to reach minimum effective concentration

119
Q

Define peak.

A

When drug reaches highest concentration in blood

120
Q

What is minimum effective concentration?

A

Minimum amount of drug necessary to produce an effect on body

121
Q

What is duration?

A

Length of time taken for a drug to exert a therapeutic effect

122
Q

What are peak and trough drug levels? What are they monitored for?

A
  • Rate of drug absorption and rate of drug excretion

- Monitor for drugs with small therapeutic index

123
Q

Which level is more commonly monitored, peak or trough? When do we draw this level?

A
  • Trough

- Right before the next drug dose is scheduled to be administered

124
Q

What is the peak time of an IV drug?

A

30-60 minutes

125
Q

What is the peak time of an oral drug?

A

2-3 hours

126
Q

What is the receptor theory?

A

-Drugs bind to receptors to activate or inactivate them

127
Q

Activating a receptor does what?

A

Produces a response

128
Q

Inactivating a receptor does what?

A

Blocks a response

129
Q

What is the role of agonists?

A

Activate receptors to produce a desire response

130
Q

What is the role of antagonists?

A

Prevent receptor activation and block the response

131
Q

Describe nonspecific drugs?

A

Affect different sites of the same receptor

132
Q

Describe nonselective drugs?

A

Affected different receptors

133
Q

What is an example of a nonspecific drug?

A

Bethanechol

134
Q

What is an example of a nonselective drug?

A

Epinephrine

135
Q

What is drug tolerance?

A

Decreased response to drug, requiring an increase in dosage to get desired affect

136
Q

What is tachyphylaxis?

A

When a drug suddenly stops working after one or several doses

137
Q

What is a side effect?

A
  • Predictable and often mild

- Secondary drug effect

138
Q

What is an adverse reaction?

A
  • Unexpected and undesirable reaction to drug
  • More severe than side effects
  • Can occur at normal dosage
139
Q

What is drug toxicity?

A
  • Drug level exceeds therapeutic range

- Over accumulation of drug

140
Q

Who is at risk for drug interactions? Who is at the highest risk?

A
  • Chronic health
  • Patients taking multiple medications
  • Patients taking different dietary supplements/herbs
  • Patients who see more than 1 HCP
  • Patient who use multiple pharmacies
  • Older adults (highest risk)
141
Q

What are drug interactions?

A

When one drug affects another

142
Q

What percentage of older adults take 5 or more different medications?

A

20%

143
Q

What factors affect changes in absorption?

A
  • Increase or decrease in gastric emptying time
  • Changes in gastric pH
  • Formation of drug complexes
144
Q

What happens if the production of hepatic enzymes are induced?

A

Drug is metabolized more quickly

145
Q

What happens if the production of hepatic enzymes are inhibited?

A

Drug is metabolized more slowly

146
Q

What are impotent inhibitors that increase toxicity?

A
  • Alcohol
  • Food
  • Diet
  • Grapefruit juice
147
Q

When two or more drugs are excreted through the same route, they do what?

A

Fight

148
Q

What is an additive interaction? Give an example.

A
  • Sum of effects of two drugs

- Hydralazine and nitro (cause vasodilation and low blood pressure)

149
Q

What is a synergistic interaction? Give an example.

A
  • Effect is much greater than effects of either drug alone

- Amoxicillin and Coagulonate (antibiotics)

150
Q

What is an antagonistic interaction?

A
  • One drug reduces or blocks effects of other drug

- Desirable nalaxone and protamine sulfate

151
Q

What occurs during a drug-nutrient interaction?

A

Food may increase, decrease or delay drug response

152
Q

What is an example of a drug-nutrient interaction?

A

MAOI’s taken with tyramine-rich foods such as cheese, wine, organ meats, beer, yogurt, sour cream, bananas can result in hypertensive crisis

153
Q

What occurs during a drug-laboratory interaction?

A

-Drugs may cause misinterpretation of drug results

154
Q

What is drug-induced photosensitivity?

A
  • Skin reaction caused by sunlight exposure

- Can be avoided

155
Q

What drug treats leukemia?

A

Mercaptopurine

156
Q

What drug treats colon cancer and small lung cancer?

A
  • Irinotecan

- Want to eliminate if you have genetic variation

157
Q

What drug treats HIV and affects 10% of the public with its life threatening effects?

A

Abacavir

158
Q

What drug is a vitamin K antagonist, anticoagulant, increases the risk of bleeding, and is not widely used?

A

Warfarin

159
Q

What drug class does codeine and tramadol fall under? Some people also lack the enzyme to convert this drug for pain control.

A
  • Opoids

- Mostly affects Asians, Middle Easterns, and Caucasians

160
Q

What drug is an anti-analytic, increases immune response and can cause the development of Steven Johnson syndrome?

A

Carbamazepine

161
Q

What should you do as part of the assessment for the nursing process of pharmacogenetics?

A
  • Assess family history back three generations

- Determine side effects/adverse effects to drug therapy

162
Q

What are the nursing interventions of pharmacogenetics?

A
  • Refer identified patients to genetic counseling as needed
  • Guide patients in the implications and uses of genetic results
  • Ensure patient knows to report genetic findings to all HCP’s
163
Q

What are botanicals?

A

Additive substances that come from plants

164
Q

What is an herb?

A

Any plant used for culinary or medicinal purposes

165
Q

What is phytomedicine?

A

A type of medicine that focuses on the therapeutic value of plants

166
Q

What did the Dietary Supplement Health and Education Act (DSHEA) do?

A

It is a US federal act that defined dietary supplements

167
Q

What is the Current Good Manufacturing Practices (CGMPs)?

A

US Food and Drug Administration standards requiring that package labels give the quality and strength of all contents and that products be free of contaminants or impurities

168
Q

What is Astralagus used for? What type of reaction can occur?

A
  • Used to boost the immune system and limit the effects of cold and flu symptoms
  • May interact with drugs that alter immune function such as cyclosporine
169
Q

What is Chamomile used for? What type of reaction can occur?

A
  • Used to treat sleeplessness, anxiety, and stomach ailments -Often used as a tea
  • Allergic reactions may occur in those allergic to ragweed.
170
Q

What is Cinnamon used for? What type of reaction can occur?

A
  • Used to treat bronchitis, GI problems, anorexia, and diabetes
  • May decrease blood clotting.
171
Q

What is Echinacea used for?

A
  • Used for colds, flu, and infections

- Stimulates the immune system.

172
Q

What is Garlic used for? What type of reaction can occur?

A
  • Used to lower cholesterol, decrease blood pressure, and reduce heart disease
  • Reduces blood clotting, risk for bleeding
173
Q

What is Ginkgo used for? What type of reaction can occur?

A

Used for asthma, bronchitis, fatigue, tinnitus, memory impairment, intermittent claudication, sexual dysfunction, and multiple sclerosis
-Increases bleeding risk

174
Q

What is Ginseng used for? What type of reaction can occur?

A
  • Used to boost the immune system, increase wellbeing, and stamina
  • Also used to treat erectile dysfunction, hepatitis C, menopausal symptoms, and to lower glucose and blood pressure
  • May cause hypoglycemia in diabetic patients
175
Q

What is Hawthorn used for? What type of reaction can occur?

A
  • Used for heart disease, digestive issues, and kidney disease
  • May interact with multiple drugs including those for erectile dysfunction, nitrates, and antihypertensives
176
Q

What is Licorice used for? What type of reaction can occur?

A
  • Used to treat stomach ulcers, bronchitis, sore throat, and viral hepatitis
  • May elevate BP, cause water retention, and lower potassium levels
177
Q

What is Kava Kava used for? What type of reaction can occur?

A
  • Used to aid relaxation and treat anxiety

- May cause liver damage, especially when taken with alcohol

178
Q

What is Milk Thistle used for? What type of reaction can occur?

A
  • Used to treat cirrhosis, chronic hepatitis, gall bladder disorders, elevated cholesterol, and type 2 diabetes
  • May cause allergic reaction in those allergic to ragweed
  • May also cause hypoglycemia
179
Q

What is Peppermint used for?

A

-Used to treat nausea, indigestion, IBS, cold symptoms, headaches, and muscle and nerve pain

180
Q

What is Saw Palmetto used for?

A

-Used to treat BPH, chronic pelvic pain, decreased libido, migraine, and hair loss

181
Q

What is St. John’s Wort used for? What type of reaction can occur?

A
  • Used to treat mental disorders, nerve pain, sleep disorders, malaria, and wounds
  • Has many drug interactions, like those that affect serotonin levels
182
Q

What is Turmeric used for? What type of reaction can occur?

A
  • Used for heartburn, stomach ulcers, gallstones, inflammation, and cancer
  • Need to avoid in those with gallbladder disease
183
Q

What is Valerian used for?

A

-Used for insomnia, anxiety, headaches, depression, irregular heart beat, and tremors

184
Q

When does the liver form enzymes?

A

When liver function is decreased

185
Q

List the different plasma proteins.

A
  • Albumin
  • Lipoproteins
  • Alpha-1-acid-glycoprotein (AGP)
186
Q

How does drug move throughout the body?

A
  • GI Tract
  • Portal Vein
  • Liver
  • Body
187
Q

What drug is given to treat salicylic acid toxicity in the body?

A

IV administration of sodium bicarbonate

188
Q

What three mechanisms affect drug-drug interaction?

A
  • Absorption
  • Metabolism
  • Excretion
189
Q

What education should you provide to patients taking herbal supplements?

A
  • Consult with HCP before taking
  • Report all herbal products to HCP
  • Inform HCP of any allergies associated with herbal products
  • Use caution if pregnant/breastfeeding
  • Do not take more than the recommended dose
  • Follow label instructions
  • Do not give to young children/infants
  • May contain multiple compounds not listed on the label