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Toxicology > Exam 1 > Flashcards

Exam 1 Flashcards

1
Q

What was the 1st attempt to protect consumers in the manufacture of food and drugs?

A

Food and drug act 1906

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2
Q

What did the food and drug act require?

A

All drugs meet minimal standards of strength, purity and quality
MUST label container if drug contains dangerous ingredients

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3
Q

What are the 2 references the food and drug act established?

A

USP- United States pharmacopeia

NF- national formulary

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4
Q

What are the 3 published drug references?

A

USP/NF
PDR
AHFS- American hospital formulary service

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5
Q

What are the 4 internet drug and supplement references?

A

Medscape
Natural medicine databases
Medline plus
WebMD

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6
Q

What are the 4 definitions of a drug according to the food, drug and cosmetic act?

A

1 a substance recognized in an official pharmacopeia of formulary
2 a substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of a disease
3 a substance other than food intended to affect the structure or function of the body
4 a substance intended for use as a component of a medicine

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7
Q

Which amendment established that drugs need a prescription from a licensed practitioner?

A

FD & C Durham Humphrey- 1951

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8
Q

What established that new food additives be approved and determined for safety before being marketed?

A

FD&C food additives amendment- 1958

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9
Q

What are the 2 food additives amendment exceptions?

A

GRAS- generally recognized as safe

Substances which FDA or USDA approved as safe prior to amendment

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10
Q

What was used as a sleep aid and for morning sickness that caused birth defects in 1960?

A

Thalidomide

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11
Q

What is the official name for the controlled substances act?

A

Comprehensive drug abuse prevent and control act- 1970

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12
Q

What was created to regulate the dispensing of drugs with potential for abuse and created the 5 schedules to classify drugs?

A

Comprehensive drug abuse prevent and control act AKA

Controlled substances act

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13
Q

What schedule has high potential for abuse and no medical use?

A

Schedule 1- heroine, LSD, marijuana, ecstasy, methaqualone and peyote

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14
Q

Which schedule has high abuse potential but has a medical use?

A

Schedule 2- Vicodin, cocaine, dilaudid, Demerol, OxyContin, Dexedrine, adderall, Ritalin

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15
Q

Which schedule has moderate abuse potential and accepted medical use?

A

Schedule 3- Tylenol with codeine, ketamine, anabolic steroids, testosterone

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16
Q

Which schedule has low abuse potential and accepted medical use?

A

Schedule 4- xanax, soma, darvocet, Valium, Ativan, ambien, tramadol

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17
Q

Which schedule has limited abuse potential and accepted medical use?

A

Schedule 5- robitussin AC, lomotil, motofen, lyrica

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18
Q

What established that the FDA is responsible for taking action against any unsafe dietary supplement after it reaches market?

A

Dietary supplements health and education act- 1994

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19
Q

Which act reinvestigated pesticide tolerance levels and developed stricter standards especially for children?

A

Food quality protection act- 1996

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20
Q

Who regulates agricultural and industrial chemicals and water?

A

EPA

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21
Q

Who recalls unsafe consumer products?

A

CPSC- consumer products safety commission

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22
Q

Who regulates workplace chemical exposure?

A

OSHA- occupational safety and health admin.

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23
Q

What are the 2 requirements for FDA to approve a drug for use in humans?

A

Efficacy

Safety

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24
Q

What is the pharmaceutical development and approval process?

A

1 discovery and development- 1-2 years
2 pre-clinical research and development- institutional review boards, testing etc. 3-6 years
3 clinical trials- 3 phases; 6-7 years
4 FDA review NDA (new drug application) 1-2 years
5 manufacturing

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25
Q

What is the therapeutic index

A

TI= LD50/ED50

Used to establish dosage levels in animal trials

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26
Q

What is the highest dose without any adverse effect?

A

NOAEL- no observed adverse effect level

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27
Q

What is the lowest dose found by experiment or observation at which there was a statistically significant observed adverse effect?

A

LOAEL- lowest observed adverse effect level

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28
Q

What is unique about supplements?

A

There is no FDA approval required to market it is only the FDA’s job to prove it is unsafe

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29
Q

Adverse side effects are typically

A

Dose dependent

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30
Q

What are the 6 pregnancy FDA categories?

A

A- no study has been able to measure risk
B- no studies done in humans, but animals show no risk
C- no studies on humans or animals or if there were on animals, there is some teratogenic potential
D- drug has revealed adverse effect to effect, benefit to risk ratio must be assessed
X- studies have shown teratogenic effect in animals and women; contraindicated in pregnancy
NR- not yet rated by FDA

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31
Q

What are the common drugs that have shown teratogenic effect on fetus?

A 
Androgens
Carbamazepine (anti-seizure) 
Diethylstillbesterol (estrogen)
Estrogen
Lithium
Phenytoin (Dilantin)- anti-seizure 
Retinoic acid
Thalidomide (immune modulator; leprosy and MM)
Warfarin
Depakote (anti-seizure)
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32
Q

What are the 4 unexpected adverse drug effects?

A

Idiosyncrasy
Tolerance
Paradoxical
Dependence

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33
Q

What is the term to describe an unusual, unique or unexpected response to a drug that can cause genetic variations in enzymes or alter metabolism?

A

Idiosyncrasy

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34
Q

What is the term to describe an adverse effect with the opposite effect of what was intended?

A

Paradoxical

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35
Q

What is a decreased response that develops from a drug after repeated doses given?

A

Tolerance

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36
Q

What are the 5 types of toxic responses?

A 
1 direct toxic action- tissue lesions
2 pharmacological, physiological and biochemical effects
3 teratogenesis
4 immunotoxicity
5 mutagenesis
6 carcinogenesis
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37
Q

What direct toxicity- tissue lesion what happens and what is targeted?

A

Cell death- reversible or irreversible
Target organ toxicity- any organ but some are more susceptible
most susceptible: Liver, Lung, Kidneys

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38
Q

What % of adverse drug effects the liver?

A

9%

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39
Q

What percent of CO does the liver receive?

A

25%

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40
Q

What are the types of liver toxicity?

A 
Steatosis
Cytotoxic damage
Cholestatic damage
Cirrhosis 
Vascular lesions
Tumors
Proliferation of peroxisomes
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41
Q

What does liver damage look like on blood work?

A

Increased: AST, ALT
Decreased: bilirubin

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42
Q

What % CO for kidneys?

A

25%

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43
Q

What does blood work show with kidney damage?

A

Increased: BUN, creatinine

Urine volume, pH and specific damage abnormal with damage
Y-glutamyltransferase/ N-acetylglucosaminidase present in urine with damage

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44
Q

What are the types of lung damage?

A 
Irritation
Allergic response
Cell damage
Fibrosis 
Pulmonary cancer
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45
Q

No biochemical tests with lungs but what do we look at?

A

Decreased FEV- forced expiratory volume/ forced VC

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46
Q

A pharmokinetic based toxic effect is an increase in?

A

Concentration of the compound or active metabolite

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47
Q

A pharmodynamic based toxic effect is?

A

An altered responsiveness to target site

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48
Q

When is a fetus most susceptible to gross anatomical abnormalities?

A

Organogenesis 18-55 days

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49
Q

When drug interacts directly with DNA and causes damage?

A

Mutagenesis

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50
Q

What is clastogenesis?

A

Chromosomal damage

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51
Q

What is an acquisition or loss of complete chromosomes?

A

Aneugenesis

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52
Q

What is unrestrained cell replication and what are the steps?

A

Carcinogenesis

Initiation- DNA mutation
Promotion- altered gene expression and regulation
Progression- another mutation leading to proliferation

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53
Q

Chemical carcinogens may cause?

A

Unusual tumors or increased incidence of typical tumors

54
Q

What are the 3 phases of drug activity?

A

Pharmaceutic
Pharmokinetic
Pharmodynamic

55
Q

What phase involves disintegration and dissolution of the dosage form?

A

Pharmaceutic phase

56
Q

What is the pharmaceutic phase affected by?

A

Form of drug and route of administration

57
Q

Which phase is described as what happens to the drug as it moves through the body?

A

Pharmokinetic- ADME

Absorption
Distribution
Metabolism
Excretion

58
Q

What are the 4 ways drugs can be absorbed?

A

Passive diffusion
Active transport
Pinocytosis
Filtration

59
Q

Ionized molecules do not readily cross membranes so what needs to be done?

A

Needs to be un-ionized for absorption to occur

Acid drugs in acidic fluid
Basic drugs in alkaline fluid

60
Q

What can we do in cases of toxicity to increase excretion?

A

Change pH of urine

61
Q

Most drugs are water soluble what is an example of lipid soluble?

A

Anesthesia, marijuana

62
Q

GI tract and lung absorption occurs mostly as?

A

Passive diffusion

Both have large surface area

63
Q

What limits absorption of foreign compounds through skin?

A

Keratin rich epidermis

64
Q

Passive diffusion may occur with skin absorption but only certain compounds, what are they?

A

Lipophilic- often use carriers

65
Q

The % of a dose that reaches the bloodstream is called?

A

Bioavailability

66
Q

How much of oral meds typically reach blood?

A

20-40%

67
Q

How much drug reaches an organ or area depends on?

A

Plasma protein binding
Blood flow
Specific tissue barriers
Selective distribution

68
Q

With plasma binding only ______ drug molecules can exert a pharmacological effect

A

Unbound, free;

some drugs are in competition and if one displaces another concentration of free drug increases and can lead to overdose

69
Q

What are the 2 tissue barriers?

A

BBB

Placental barriers

70
Q

What is the affinity or attraction of a drug to specific organ or cells?

A

Selective distribution

Ex. Amphetamines have selective distribution to CSF

71
Q

What is the time required for blood/plasma concentration of drug to fall to 50% of original level?

A

Half life t1/2

72
Q

What are the metabolism AKAs?

A

Biotransformation and detoxification

73
Q

Whenever a drug or other foreign substance enters the body, it tries to eliminate it. This chemical alteration is known as?

A

Metabolism, biotransformation, detoxification

74
Q

Why do we metabolize?

A

Make more polar/ water soluble for excretion
Decrease half-life
Prevent accumulation
Change bio activity

75
Q

What is cytochrome P450 referred to as?

A

Drug microsomal metabolizing system

76
Q

When a drug is taken repeatedly, the DMMS increases and leads to faster rate of drug metabolism and drug action is decreased. What is this phenomenon called?

A

Enzyme induction

77
Q

What happens when the DMMS enzymes are inhibited thus increasing the duration and intensity of a drug?

A

Enzyme inhibition

78
Q

What is first pass metabolism?

A

After oral administration all drugs are absorbed into the portal circulation; some metabolized significantly as they pass the 1st time

79
Q

First pass metabolism can significantly reduce what?

A

Bioavailability and amount of drug that reaches general circulation

80
Q

What are the major excretion sites?

A

Urine, bile, lungs, GI, breast milk

81
Q

What are the minor excretion sites?

A

Sweat, tears, saliva, semen

82
Q

What are the 3 methods of urinary excretion?

A

Filtration from blood through pores in glomerulus
Diffusion from blood to tubules
Active transport into tubular fluid

83
Q

What are the 2 methods of biliary excretion?

A

Active transport into bile- can be saturated; liver toxicity
Gut bacteria metabolize compounds- increase liver toxicity

84
Q

What is the cycle of enterohepatic circulation?

A

Blood -> liver -> bile -> intestines ->

85
Q

Where does passive diffusion of volatile metabolites from blood occur?

A

Lungs

86
Q

Where does passive diffusion of weak bases into intestinal lumen occur?

A

GI tract

87
Q

Where does passive diffusion of fat-soluble compounds occur?

A

Breastmilk

88
Q

What is the action of the drugs on living tissue?

A

Pharmacodynamic phase- affected by form and route of administration

89
Q

Drug concentration -> Pharmacological effect -> clinical response -> toxicity or effectiveness

A

Pharmacodynamics

90
Q

Dose administered -> absorption or distribution -> concentration in systemic circulation or elimination-> concentration at site of action

A

Pharmacokinetics

91
Q

Number of patients who leave doc with at least 1 prescription

A

2/3

92
Q

Percent of population that have 4 or more prescriptions

A

40%

93
Q

When does the rate of adverse drug reactions increase dramatically?

A

After 4 or more prescribed

94
Q

What drug reacts with NSAIDS, sulfa drugs, macrolides, quinolones, phenytoin, statins and thyroid meds?

A

Warfarin

95
Q

What drug reacts with potassium and spironolactone?

A

ACE inhibitors

96
Q

What drug recommends you check with doctor if taking tranquilizers, sedatives, HBP meds or antidepressants?

A

Antihistamines

97
Q

What percent of adults use dietary supplements?

A

50% or more

98
Q

What supplement is an inducer of CP450 and can reduce concentration of drugs in blood?

A

St. John’s wort

99
Q

What can interfere with bleeding effects of Coumadin, heparin, aspirin and NSAIDs?

A

Ginseng

100
Q

What can decrease effectiveness of anticonvulsant therapy (tegretol, depakote)

A

Ginkgo biloba

101
Q

What may reduce effects of BP drugs and diuretics and increase risk of lanoxin toxicity?

A

Licorice

102
Q

MAO inhibitors shouldn’t be consumed with excessive amounts of?

A

Chocolate

103
Q

Calcium fortified orange juice interacts with

A

Fluoroquinolones (cipro)

104
Q

Cranberry juice interacts with

A

Warfarin

105
Q

Grapes with

A

Cyclosporine (immunosuppressant)

106
Q

Pomegranate with

A

Carbamazepine (anticonvulsant)

107
Q

Grapefruit, apple or orange juice with

A

Fexofenadine (Allegra)

108
Q

What food increases effect of diabetes meds?

A

Carrot

109
Q

Broccoli, cauliflower, watercress, spinach, tomato and avocado effect?

A

Warfarin

110
Q

Patients taking MAOIs need to avoid

A

High tyramine foods

111
Q

High tyramine foods also need to be avoided with

A

St. John’s wort

112
Q

What foods induce CYP?

A 
Alcohol
Caffeine
Garlic
Grape seed
Licorice
St. John's wort
Tobacco
113
Q

What foods inhibit CYP?

A 
Black cohosh
Echinacea
Feverfew
Ginkgo
Ginseng
Goldenseal
Grapefruit
Milk thistle
Peppermint
114
Q

What depletes C, B12, D, Calcium, iron, zinc and folic acid?

A

Antacids

115
Q

What depletes Vit K?

A

Antibiotics

116
Q

What depletes B12, folic acid, thiamin, magnesium and COQ10?

A

Antidiabetics

117
Q

What depletes zinc, COQ10, melatonin, copper, B6?

A

Antihypertensives

118
Q

What depletes folate, iron, C, K and melatonin?

A

NSAIDs

119
Q

What depletes sodium and melatonin?

A

SSRIs

120
Q

What depletes COQ10?

A

Statins

121
Q

What is an example of an absorbent?

A

Activated charcoal

122
Q

What is the term for pumping the stomach?

A

Gastric lavage

123
Q

What are the contraindications for inducing vomiting?

A

Ingestion of corrosive substances, volatile petroleum products, convulsants
If patient is semi-conscious, inebriated, in shock, convulsing or has no gag reflex
Patients less than 1 year
Patients with cardiac or vascular disease

124
Q

History of poisoning/toxicity

A

1906- pure food and drug act, paved way for modern FDA
1910- radium, advertised as health cure
1918- Charles Norris appointed chief medical examiner
1920- prohibition
1924- lead added to gas, caused dementia, DC in 1996
1953- first poison control center in Chicago

125
Q

What is the lethal amount of methanol?

A

2-8 oz

126
Q

What does methanol poisoning lead to?

A

Liver ->formaldehyde ->formic acid -> leads to metabolic acidosis and tissue injury

127
Q

Sx of methanol poisoning

A 
Difficult breathing
Blurred vision, blindness
Agitation
Coma
Severe abdominal pain
128
Q

What was sold as rejuvenating tonics and dial painters ingested large amounts leading to death?

A

Radium

129
Q

Sx of radium poisoning

A

Anemia
Jaw necrosis
Osteogenic carcinoma
Malignancies

Deposits in bone similar to calcium

130
Q

Handling of this substance lead to severe mental deterioration and some deaths, developed by GM as anti-Knock formula

A

Leaded gas

131
Q

Stings by bees, wasps, scorpion or fire ant may require

A

Epinephrine or corticosteroids

Cleanse, remove stinger, apply ice

132
Q

With a snake bite what must you not do?

A

Apply tourniquet or ice

Toxicology (2 decks)

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