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Basic Pharmacology > Drug Safety > Flashcards

Drug Safety Flashcards

1
Q

Unintended, harmful reactions to medicines are among the leading causes of death in many countries

A

Adverse Drug Reaction

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2
Q

True or False

The majority of adverse drug reactions (ADR) are PREVENTABLE

A

True

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3
Q

it is the science of collecting, monitoring, researching, assessing, and evaluating the information on the adverse effect of medication.

A

Pharmacovigilance

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4
Q

It identifies new information about hazards associated with medicines

A

Pharmacovigilance

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5
Q

An organization that is responsible for evaluating the safety of a drug by looking at the side effects, how it’s manufactured, results of animal testing and clinical trials, and more.

A

Food and Drug Administration

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6
Q

What republic act represent BFAD

A

Republic Act 3720

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7
Q

It refers to the degree to which a drug is able to induce maximal effects

A

efficacy

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8
Q

It is the maximal effect of a drug

A

Efficacy

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9
Q

It is also known as potency

A

Effective dose concentration

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10
Q

It is the measure of how much drug is required to elicit effect or a given response

A

Potency

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11
Q

True or False

The higher the dose required for a given response, the more potent the drug is.

A

False

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12
Q

Which is more potent for post-operative pain. Morphine or codeine?

A

Morphine

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13
Q

This represents a decrease response to a drug

A

Tolerance

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14
Q

If the patient has developed a high tolerance to the drug, what action should be done?

A

Increase the dose of a drug to achieve the same effect

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15
Q

It is the state resulting from chronic use of drugs that have produced tolerance

A

Dependence

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16
Q

Abrupt discontinuation of drugs can lead to

A

Negative physical symptoms of withdrawal

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17
Q

a group of symptoms that occurs upon the abrupt discontinuation or a decrease in dosage of the intake of medications

A

withdrawal

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18
Q

these are the high points of fluctuations

A

Peaks

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19
Q

What are the adverse effects of discontinuation of SSRI or SSNRI

A

Irritability, Agitation, Dizziness, Sensory Disturbance, Anxiety, Confusion, Headache, Lethargy, Emotional, Insomnia, Hypoemia, Tennitus, and seizures

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20
Q

It is the range of drug dosage which can treat the disease effectively while staying within the safety range

A

Therapeutic Window

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21
Q

these are low points of fluctuation

A

Troughs

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22
Q

The symptoms of withdrawal are often the?

A

opposite of the effects achieved by the drug

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23
Q

What are the types of dependence

A

Physical and Psychological

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24
Q

This is a result when a patient consumes 1 or more of a certain drug for a certain period of time.

A

Withdrawal

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25
Q

Occurs when a person developed a tolerance to a drug in a certain classification that may result in tolerance to another drug in that same classification

A

Cross Tolerance

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26
Q

The withdrawal symptoms from one drug in a classification can be relieved by another of the same class

A

cross dependence

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27
Q

What drugs are given to alcoholics to prevent withdrawal symptoms

A

Barbiturates and tranquilizers

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28
Q

this is given to heroin users to counteract withdrawal symptoms

A

Methadone

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29
Q

It is the index of safety between the minimum therapeutic concentration and the minimum toxic concentration of a drug.

A

Therapeutic Window

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30
Q

It is used to determine the range of plasma levels that is acceptable when designing a dosing regimen.

A

Therapeutic Window

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31
Q

In the therapeutic window, the minimum effective concentration will usually determine the?

A

Trough Levels

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32
Q

In the therapeutic window, the minimum toxic concentration determines the?

A

Peak Plasma Concentration

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33
Q

the toxic concentration theophylline drug is

A

15mg/L to 20mg/L

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34
Q

The Therapeutic concentration of theophylline drug is

A

7mg/L to 10mg/L

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35
Q

The therapeutic window for the drug theophylline is fixed in the range

A

8mg/L to 18mg/L

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36
Q

It is the dosages of medication between the amount that gives an effect and the amount that gives adverse effects than desired effects

A

Therapeutic Window

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37
Q

It is the ratio of the dose that produces toxicity to the dose that produces a clinically desired or effective response in a population of individuals

A

Therapeutic Index

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38
Q

It is a measure of drug’s safety

A

Therapeutic Index

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39
Q

True or False

A drug with a low therapeutic index requires a large increase in dose to achieve toxicity.

A

False

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40
Q

Drugs with this type of therapeutic index indicate that there is a wide margin between doses that are effective and doses that are toxic

A

Large therapeutic index

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41
Q

Fetus exposed to thalidomide are born with a condition called

A

Phocomelia

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42
Q

It is a congenital malformation wherein the hands and feet of the fetus are attached to the abbreviated arms and legs

A

Phocomelia

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43
Q

This induces or increases the production of P450 enzymes

A

Vices: Smoking and Drinking

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44
Q

It is the regulatory body that proposes and administers drug regulations

A

Food and Drug Administration (FDA)

45
Q

FDA requires the following before human testing is permitted

A
  1. Evidence of relative safety derived from acute and subacute toxicity testing in animals
  2. probable therapeutic action from the pharmacologic profile in animals.
46
Q

These are not required before human studies are started

A

Chronic Toxicity Test Results

47
Q

This animal is used for neurological research

A

Cats

48
Q

This animal is used for cardiology, endocrinology, and bone and joint studies

A

Dogs (Beagle)

49
Q

This is widely used to develop new medicines and to test the safety of the products

A

Animal Testing or Animal Experiments

50
Q

This requires less extensive drug testing

A

Occasional, non-systemic drug

51
Q

These drugs require less evidence of safety than do drugs used in less threatening disease

A

Anti-cancer drugs and AIDS Drugs

52
Q

These are the set of principles that scientists are encouraged to follow to reduce the impact of research on animals

A

Reduce, refinement, and replacement

53
Q

How can we reduce the number of animals being used in the laboratory?

A
  1. Improving the experimental techniques
  2. Improving techniques of data analysis
  3. Sharing information with other researchers
54
Q

How can we refine the experiment or the way the animals are cared for?

A
  1. Using less invasive techniques
  2. Better medical care
  3. Better living conditions
55
Q

what alternative techniques used to replace animal experiments

A
  1. Experimenting on cell cultures instead of whole animals
  2. Using computer models
  3. studying human volunteers
  4. Using epidemiological studies
56
Q

This involves single administration of the agent up to the lethal level in at least two species

A

Acute Toxicity

57
Q

This type of testing is required or done for agents that are intended for chronic use

A

Sub-acute and chronic toxicity

58
Q

This is a description of all the pharmacologic effects of a drug

A

Pharmacologic Profile

59
Q

Effects that pharmacologic profile measures are

A 
Blood pressure
gastrointestinal activity
respiration
renal function
endocrine function
central nervous system
60
Q

The induction of generally nonheritable development defects in the fetus by exposure to a drug

A

Teratogenesis

61
Q

It is the development stage where the organ of the fetus taken place

A

Organogenesis

62
Q

These drugs are known to have teratogenic effects

A 
Thalidomide
Ethanol
Glucocorticoids
Valproic Acid
Isotretinoin
Warfarin
Lithium
Androgens
63
Q

It is a pregnancy category that demonstrates an adequate and well-controlled studies that have failed to demonstrate a risk to the fetus in the first trimester of pregnancy

A

Category A

64
Q

Medications that belong to Category A of FDA pregnancy category are

A

Vitamins and Levothyroxine

65
Q

In animal reproduction studies have failed to demonstrate a risk to the fetus but there are no test done on pregnant women

A

Category B

66
Q

Examples of medications under Category B

A

Acetaminophen and Amoxicillin

67
Q

Drugs in this category can be given to the pregnant women if the benefit to the mother outweighs the risks to the fetus

A

Category C

68
Q

Examples of medication under category c are

A

Diltiazem and Spironolactone

69
Q

There are evidence of human fetal risks based on adverse reaction data but the benefits to the mother may be acceptable despite the risks to the fetus

A

Category D

70
Q

Drugs in this category may be used in pregnancy if the benefits to the mother outweighs the risks tot he fetus

A

Category D

71
Q

Examples of medications under category D are

A

Phenytoin and Valproic Acid

72
Q

A category that demonstrates teratogenic effects both in human and animal experiments

A

Category X

73
Q

Examples of medications under category X are

A

Thalidomide and Warfarin

74
Q

It is the induction of changes in the genetic material of animals of any age and therefore induction of heritable abnormalities

A

Mutagenesis

75
Q

it is the standard in vitro test for mutagenicity

A

Ames Test

76
Q

it uses bacteria that naturally depend on specific nutrients in the culture medium.

A

Ames Test

77
Q

Loses of natural dependent bacteria during Ames test is an indication of

A

Mutation

78
Q

It is an in vivo mutagenicity test carried out in mice.

A

Dominant Lethal Test

79
Q

It is a sign of mutation when a male mice exposed to dominant lethal test produces

A

Abnormalities in subsequent mating (Loss of embryos, deformed fetuses)

80
Q

Examples of agents that have a carcinogenic effects are

A

Coal tar, aflatoxin, dimethylnitrosamine and other nitrosamines, urethane, vinyl chlorine, and the polycyclic aromatic hydrocarbons in tabacco smoke (Benzo[a]pyrene)

81
Q

It is the induction of malignant characteristics in cells

A

Carcinogenesis

82
Q

because carcinogenicity is expensive and difficult to study, this test is used to screen chemicals

A

Ames Test

83
Q

True or False

There is low degree of correlation between mutagenicity in the Ames Test and carcinogenicity in some animal tests

A

False. High degree

84
Q

Examples of carcinogens that have mutagenic effects

A

Aflatoxin, cancer chemotherapeutic drugs, and other agents that bind to the dna

85
Q

This requires prior approval from the Investigational New Drug Exemption application which the manufacturer will submit to the FDA

A

Clinical Trials

86
Q

It is a legal-defined process of a person being told about key facts involved in a clinical trial before deciding whether or not to participate.

A

Informed consent

87
Q

An informed consent includes

A

purpose, duration, required procedures, risks, potential benefits, and key contacts of the experiment

88
Q

True or False

The patient can withdraw at any time without penalty

A

True

89
Q

It consists of careful evaluation of the dose-response relationship in small number human volunteers

A

Phase 1 Trial

90
Q

This phase finds the maximum tolerated dose and it is designed to prevent toxicity

A

Phase 1 Trial

91
Q

Approximately how many human healthy volunteers are involved in Phase 1 trial

A

20-30

92
Q

It involves evaluation of a drug in a moderate number of patients

A

Phase 2 trial

93
Q

This phase goal is to determine whether the agent has the desired therapeutic effect at doses that are tolerated by sick patients

A

Phase 2 trial

94
Q

Approximately how many human healthy volunteers are involved in Phase 2 trial

A

200 to 300 patients

95
Q

To explore the spectrum of beneficial actions of a new drug and compare it to older therapies and discover toxicities

A

Phase 3 trial

96
Q

This represents the post-marketing surveillance phase of evaluation

A

Phase 4 trial

97
Q

This phase goal is to detect and report immediately toxicities that occur very infrequently.

A

Phase 4 trial

98
Q

In this phase the acute effects of the drug is studied over a broad range of dosage, starting with one the produces new detectable defect progressing to one that produces either major therapeutic response or a very minor toxic effect

A

Phase 1 Trial

99
Q

Agents that are exempted during phase 1 trial

A

Cancer Chemotherapeutic Agents

100
Q

This phase ha the highest rate of failures

A

Phase 2 trial

101
Q

The one administering the drug knows whether it is a placebo or an actual drug but the on receiving it does not.

A

Single-Blind

102
Q

Both the one administering and the one receiving do not know whether the drug being administered is a placebo or an actual drug

A

Double-blinded

103
Q

Dogs specifically beagles, are used to test for?

A

endocrinology, cardiology, and bone and joint studies

104
Q

what animals are usually used in laboratory experiments

A

Rats, rodents, guinea pigs, rabbits, etc.

105
Q

Which of the following only needs less extensive drug testing

- Occasional, non-systemic drugs
- Chronic systemic administration
A

Occasional, non-systemic drugs

106
Q

it is a study that is required for all drugs

A

Acute toxicity

107
Q

How long are a test for subacute to be carried out

A

2-4 weeks

108
Q

How long are a test for chronic agents to be carried out

A

6-24 months

Basic Pharmacology (10 decks)

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