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Toxicology-JS > Drug Safety > Flashcards

Drug Safety Flashcards

1
Q

What happened in the 1906 pure food and drug act

A

first attempt to protect consumers in manufacture of drugs/food

minimal standards

label if dangerous

2 references

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2
Q

What were the 2 references for the 1906 pure food and drug act

A

USP- United States Pharmacopeia

NF- National Formulary

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3
Q

what happened in the 1938 Federal food, drug, and cosmetic act

A

passed after sulfa drug incident

safety for new drugs, factory inspections, new standards for food

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4
Q

what happened in the 1951 FD &C Durham-Humphrey Amendment

A

Defined drugs that could only be purchased if the patients had a prescription from a licensed practitioner

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5
Q

what happened in the 1958 FD &C Food additives amendment

A

approval of new food additives

“No additive shall be deemed safe if it is found to induce cancer when ingested by man or animal”

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6
Q

What were the amendments to the FD & C food additives

A

GRAS (generally recognized as safe)

if FDA or USDA had previously approved them

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7
Q

what happened in the 1960 FD &C Color additives amendment

A

all colors must be approved

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8
Q

what happened in the 1962 FD &C Kefauver-Harris amendment

A

standard labeling for adverse reactions/ contraindications

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9
Q

what happened in the 1970 FD &C comprehensive drug abuse prevent and control act

A

controlled substances act

regulate dispensing of drugs

assigned 5 schedules

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10
Q

what happened in the 1994 Dietary supplements health and education act

A

FDA responsible for taking actin against any unsafe supplement after it reaches market

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11
Q

Schedule 1

A

high abuse potential

no medical use

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12
Q

Schedule 2

A

high abuse potential

accepted medical use

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13
Q

Schedule 3

A

moderate abuse potential

accepted medical use

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14
Q

Schedule 4

A

low abuse potential

accepted medical use

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15
Q

Schedule 5

A

limited abuse potential

accepted medical use

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16
Q

examples of schedule 1 drugs

A 
heroin 
LSD
marijuana
ecstasy
methaquaione
peyote
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17
Q

examples of schedule 2 drugs

A 
Vicodin
cocaine
dilaudid
Demerol
ocycontin
Dexedrine
Adderall
ritalin
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18
Q

examples of schedule 3 drugs

A

tylonol with codeine
ketamine
anabolic steroids
testosterone

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19
Q

examples of schedule 4 drugs

A 
Xanax
soma
Darvocet
valium
Ativan
ambien
tramadol
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20
Q

examples of schedule 5 drugs

A 
robitussin AC (codeine)
lomotil
motofen
lyrica
parepectalin
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21
Q

Reinvestigation of 1996 Food quality protection act

A

pesticide tolerance levels

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22
Q

FDA

A

Food and drug administration

Food labeling
food ingredients and packaging
pharmaceuticals
supplements
medical devices
vaccines
animal food
tabacco
cosmetics
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23
Q

DEA

A

Drug Enforcement Administration

Controlled substances only

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24
Q

USDA

A

US Department of Agriculture

Food distribution
school lunch programs

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25
Q

EPA

A

Environmental protection agency

Agricultural and industrial chemicals
water

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26
Q

CPSC

A

Consumer products safety commission

Recalls

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27
Q

OSHA

A

Occupational safety and health administration

workplace chemical exposure

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28
Q

What are the 2 requirements FDA must meet prior to use in humans

A

1-efficacy

2-safety

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29
Q

LD50

A

lethal dose that will kill 50% of animals tested

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30
Q

TI

A

therapeutic index

LD50/ED50

used to establish dosage levels in animal trials

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31
Q

NOAEL

A

no observed adverse effect level

highest dose without any adverse effect

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32
Q

LOAEL

A

lowest observed effect level

lowest level which there was still a statistically significant observed adverse effect

33
Q

Adverse effects are dependent on what

A

Dose

34
Q

What are common adverse effects to oral drugs

A

GI issues N/V/D

35
Q

What are teratogens

A

causes birth defects from maternal drug administration

36
Q

what are carcinogens

A

promote growth of cancerous cells

37
Q

what is a drug allergy

A

Drugs acts as an antigen and
body produces antibodies against the drug

histamine released from mast cells

38
Q

What is a hypersensitivity

A

milder response, usually

rash, hives, itching, runny nose

39
Q

What is anaphylaxis

A

severe, possibly fatal reaction

Urticaria, vascular collapse, low BP, shock, cyanosis, laryngeal edema, bronchoconstriction, dyspnea

40
Q

What is an idiosyncasy

A

unique, unusual, or unexpected response because of genetic variations in enzymes altering drug metabolism

41
Q

what is a paradoxical effect

A

opposite effect from what is expected

42
Q

what is tolerance

A

decreased response that develops after repeated doses are given

43
Q

what is dependence

A

acquired need for a drug, may produce psychological or physical symptoms of withdrawal when discontinued

44
Q

Most susceptible to direct toxic action

A

liver-metabolically active
kidneys-filter waste
lungs-position and function

45
Q

Why is an organ targeted for direct toxic action

A

Blood flow
particular enzymes
organ specialization
detoxification system

46
Q

How much CO does the liver receive

A

2%

47
Q

What is steatosis

A

fatty liver

increase in triglycerides

48
Q

What is cytotoxic damage

A

cell death

49
Q

What is cholestatic damage

A

damage to biliary system

50
Q

What is cirrhosis

A

scaring of liver due to chronic damage/repair

51
Q

What is proliferations of perioxisomes

A

modulation of gene expression

52
Q

How do they detect liver damage

A

AST and ALT are both increased
bilirubin is increased
albumin is DECreased

53
Q

AST

A

aspartate transaminase

54
Q

ALT

A

alanine transaminase

55
Q

How much CO does the kidney receive

A

25%

56
Q

How do they detect kidney damage via bloodwork

A

BUN increased

creatine increased

57
Q

BUN

A

blood urea nitrogen

58
Q

how do they detect kidney damage via urinalysis

A 
urine volume
pH
specific gravity
Y-glutamyltransferase
N-acetylglucosaminidase
59
Q

How much CO do lungs receive

A

100%

60
Q

Is there a biochemical test for lung damage

A

NO

61
Q

How do they test for lung damage

A

Forced expiratory vol
forced vital capacity
biopsy

62
Q

Pharmacokinetic based effects

A

increased concentration of the compound or active metabolite

63
Q

pharmacodynamic based

A

altered responsiveness of the target site

64
Q

What causes respiratory failure

A

insecticides and nerve gases

65
Q

what causes CNS disturbances

A

organophsophates

insecticides

66
Q

What alters BP

A

RX meds

67
Q

What alters blood glucose

A 
RX meds
industrial solvent (hydrazine)
68
Q

what causes anesthesia

A

toxic solvents

carbon tetrachloride
vinyl chloride

69
Q

what causes electrolyte imbalances

A

furosemide
caffeine
ethanol
mercury

70
Q

When is a fetus most susceptible to gross anatomical abnormalities from teratogens

A

organogenesis

days 18-55

71
Q

Common immunotoxicity: drugs

A

penicillin

72
Q

Common immunotoxicity: industrial chemicals

A

toluene

73
Q

Common immunotoxicity: natural chemicals

A

pentadecylcatechol

74
Q

Common immunotoxicity: food additives

A

tartrazine

FD&C yellow 5

75
Q

Common immunotoxicity: food constituents

A

egg white (albumin)

76
Q

Mutagenesis

A

drug interacts directly with DNA → DNA damage

77
Q

clastogenesis

A

chromosomal damage

78
Q

aneugenesis

A

acquisition or loss of complete chromosomes

Toxicology-JS (10 decks)

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