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NAPSR Pharmaceutical Sales Training > Chapter 4 - Introduction to Clinical Pharmacology > Flashcards

Chapter 4 - Introduction to Clinical Pharmacology Flashcards

1
Q

The study of the structures of the body.

A

Anatomy

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2
Q

The study of how body structures function.

A

Physiology

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3
Q

Study of the effects and movement of drugs in the human body.

A

Clinical Pharmacology

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4
Q

Study of the biochemical and physiological effects of drugs and their mechanisms of action, i.e., the study of what a drug does to the body.

A

Pharmacodynamics

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5
Q

Study of how a drug is processed by the body, with emphasis on the time required for absorption, duration of action, distribution, and method of excretion, i.e., the study of how the body affects drugs.

A

Pharmacokinetics

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6
Q

Any substance (other than a food or device intended for use in the diagnosis, cure, relief, treatment, or prevention of disease) intended to affect the structure or function of the body.

A

Definition of a Drug

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7
Q

By law, drugs are divided into what two categories?

A

Prescription and non-prescription.

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8
Q

Alternative medicines, such as nutraceuticals and medicinal herbs, are not covered under the FDA laws. True or false?

A

True.

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9
Q

What are the three types of names most drugs are given?

A

Chemical name (the atomic or molecular structure of the drug), generic name (less complex and cumbersome than chemical name), and trade name (chosen by pharmaceutical company).

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10
Q

Generic versions of a drug can be sold under their generic name or under their own trade name. True or false?

A

True.

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11
Q

What name are patented drugs usually sold under?

A

Their trade name.

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12
Q

How are drugs typically classified?

A

First by therapeutic group and then by class.

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13
Q

Do all cells have a nucleus?

A

No.

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14
Q

Specialized cells and tissues grouped together to perform a specific body function for a common purpose.

A

Organs

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15
Q

What are the three types of muscle tissues?

A

Skeletal, smooth, and cardiac.

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16
Q

Involuntary movements are mostly associated with which type(s) of tissue?

A

Cardiac and smooth muscle.

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17
Q

What is the name for the liquid portion of blood that carries proteins and other substances?

A

Plasma.

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18
Q

Do vitamins have to be administered from outside the body?

A

Yes.

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19
Q

Is water a nutrient?

A

No.

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20
Q

Which process is most associated with pharmacokinetics?

A

ADME (absorption, distribution, metabolism, excretion)

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21
Q

Do all drugs have side effects?

A

Yes.

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22
Q

What is toxicity?

A

The adverse affects a drug has on the body.

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23
Q

When is a drug with serious adverse side effects considered to be a viable therapy?

A

When other treatments cause yet-even more serious problems and are less effective for the intended use.

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24
Q

What is the therapeutic window?

A

The dosage range of a drug that is safe and produces a beneficial result.

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25
Q

Do peoples’ bodies respond to drugs differently?

A

Yes.

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26
Q

What factors affect drug responses?

A

Age, weight, genetic make-up, and comorbid disorders.

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27
Q

Can people have withdrawal symptoms after taking a placebo?

A

Yes.

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28
Q

What percentage of study participants taking a placebo improve in a clinical study?

A

50%.

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29
Q

How long does it take a drug to be approved by the FDA? (Through the whole process of pre-clinical and clinical testing to being available to patients.)

A

10 years.

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30
Q

Only about 5 of 4,000 drugs studied in the laboratory are studied in people, and only 1 of 5 drugs studied in people is approved. True or false?

A

True.

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31
Q

Can the FDA withdraw their approval?

A

Yes. If new evidence arises.

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32
Q

Define ‘margin of safety’.

A

The difference between the usual effective dose and the dose that induces severe or life-threatening side effects.

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33
Q

Why is intravenous injection the most common form of distribution?

A

The drug is immediately delivered to the bloodstream and tends to take effect more quickly than when given by any other route.

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34
Q

What is ‘subcutaneous injection’?

A

A needle is inserted into fatty tissue just beneath the skin.

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35
Q

What are the 7 rights of drug administration?

A

Right patient, drug, dose, route, time, technique, and documentation.

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36
Q

What is the most common medication error?

A

Dosage.

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37
Q

How quickly and how much of a drug reaches its intended target site of action.

A

Bioavailability

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38
Q

When are drugs considered bioequivalent?

A

When they contain the same active ingredients, and also produce virtually the same blood levels over time.

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39
Q

What is ‘therapeutic equivalence’?

A

Producing the same medicinal effect.

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40
Q

How long does it typically take blood to circulate?

A

1 minute.

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41
Q

What type of drugs typically cross cell membranes more quickly?

A

Fat-soluble.

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42
Q

Is the protein part of a drug usually inactive or active?

A

Inactive.

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43
Q

Pro-drugs are administered in an active form, which is metabolized into an inactive form. True or false?

A

False.

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44
Q

Which organ is involved in the metabolism of most drugs?

A

The liver.

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45
Q

Which organ(s) are involved in the excretion of drugs?

A

The kidneys.

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46
Q

How efficient is the kidney of an 85-year old when compared to that of a 35-year old?

A

Only half.

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47
Q

The science of formulating drugs into different kinds of preparations such as tablets, ointments, injectable solutions, and eye drops.

A

Pharmaceutics

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48
Q

What is the name of the coating that prevents drugs from dissolving in the stomach?

A

Enteric.

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49
Q

Describe a ‘caplet’.

A

It’s shaped like a capsule, but has the form of a tablet. The shape and film coating makes it easier to swallow.

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50
Q

A molecule with a specific three-dimensional structure to which only very specific substances can fit and attach.

A

Cell Receptor

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51
Q

Can agonist and antagonist drugs be used together?

A

Yes. They are used together on patients with asthma.

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52
Q

What are drugs that target enzymes called?

A

Inhibitors or activators (inducers).

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53
Q

Can drugs change the basic nature of biologic functions or create new functions?

A

No. They can only affect the rate at which existing biologic functions proceed.

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54
Q

What must drugs that activate receptors (agonists) have?

A

Affinity (attraction) and intrinsic activity (ability to produce an effect).

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55
Q

In what terms can a drug’s effects be evaluated?

A

It’s strength (potency) or effectiveness (efficacy).

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56
Q

What are the types of different drug to drug interactions?

A

Duplication, opposition (antagonism), and alteration.

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57
Q

Where are drug interactions listed?

A

In the prescribing information, in the patient information insert, or on the container.

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58
Q

Can dietary supplements interact with prescription or over-the-counter drugs.

A

Yes.

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59
Q

What is difference between drug tolerance and resistance?

A

Tolerance refers to a person’s diminished response to a drug, where resistance refers to the ability of a microorganisms or cancel cells ability to withstand a drugs effects.

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60
Q

What percentage of hospital admissions in the U.S. are attributed to adverse drug reactions?

A

3% to 7%.

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61
Q

What are the types of adverse drug reactions?

A

Augmented reaction (Type A), idiosyncratic reaction (Type B), continuing or chronic (Type C), delayed (Type D), and end-of-use (Type E).

62
Q

Is there a universal scale for describing or measuring the severity of an adverse drug reaction?

A

No. Assessment is largely subjective.

63
Q

What two things do physicians consider when assessing the benefits and risks of prescribing a drug?

A

The severity of the disorder being treated and the effect it is having on the patient’s quality of life.

64
Q

What is compliance in regards to drugs?

A

The degree to which a person takes prescribed drugs as directed.

65
Q

What is the name of the organization that assigns a drug’s generic name?

A

The United States Adopted Name (USAN) Council

66
Q

Which organization must approve all trade names for drugs?

A

The FDA.

67
Q

How long do drug patents usually grant a company exclusive marketing rights?

A

20 years.

68
Q

Which types of drugs are exempt from any generic drug requirements?

A

Pre-1938 drugs.

69
Q

In what way do most generic drugs differ from the original drug?

A

Inactive ingredients.

70
Q

How much how can different versions of a drug vary legally?

A

Up to 20%.

71
Q

What is API?

A

Active Pharmaceutical Ingredient.

72
Q

What two categories do APIs fall into?

A

Biologic (large molecule) or chemical (small molecule).

73
Q

What are excipients?

A

The inactive ingredients blended with the API to create the drug product.

74
Q

The process by which a given drug works in the body to achieve its desired therapeutic effect.

A

Mechanism of Action

75
Q

When a given dose of a drug is being taken at regular intervals, absorption and elimination become fairly constant. This is called what?

A

Steady State

76
Q

Process of adjusting drug doses to achieve the maximum therapeutic effects while minimizing adverse or side effects.

A

Titration

77
Q

Basic clinical pharmacology involves what three main concepts?

A

Pharmacodynamics, Pharmacokinetics, Drug Distribution & Elimination

78
Q

Every drug has at least three names. What are they?

A

Chemical Name, Generic Name, Trade Name

79
Q

Patented drugs are sold under a trade name. True or False?

A

True.

80
Q

Broadly, drugs are classified by therapeutic group. True or False?

A

True.

81
Q

A major goal of pharmacology is to limit the number and severity of adverse drug reactions. True or False?

A

True.

82
Q

How does the FFDCA define a “drug?”

A

Any substances intended for use in diagnosis, cure, mitigation, treatment, or prevention of a disease.

83
Q

The branch of medicine concerned with the prevention of disease and treatment of suffering.

A

Therapeutics

84
Q

The application of drugs for the purpose of disease prevention and treatment of suffering.

A

Pharmacotherapeutics

85
Q

Substances applied for therapeutic purposes fall into one of the following three general categories:

A

Drugs/Medications, Biologics, CAM therapies (Complementary Alternative Medicine)

86
Q

Are refills for Schedule II drugs permitted?

A

No.

87
Q

A substance that has the potential to cause a defect to an unborn child during pregnancy.

A

A Teratogen; Class A, B, C, D or X

88
Q

Pharmacokinetics uses a process called _______ testing to assess the actions of the body on a drug.

A

ADME

89
Q

What does ADME stand for?

A

Absorption, Distribution, Metabolism, Excretion

90
Q

Oral administration is a relatively quick acting option. True or False.

A

False. It’s slow. Drug must be digested first before it enters the bloodstream.

91
Q

Some people seem more susceptible to the placebo effect than others. True or False and Why?

A

True. People who have a higher opinion of drugs, doctors, nurses etc. are more likely to respond favorably to placebos.

92
Q

Any drug can have a placebo effect unrelated to its specific mechanism of action. True or False?

A

True.

93
Q

The main goals of drug development are __________ and __________.

A

Effectiveness and Safety

94
Q

The wider the margin of safety, the more useful the drug. True or False?

A

True.

95
Q

The ________________ form the operational basis for the safe delivery of medication and are recognized by such organizations as the Institute for Sale Medication Practices. They offer a simple, practical guideline for physicians and Pharma Reps to use during drug preparation, delivery and administration.

A

Five/Seven Rights of Drug Administration

96
Q

What are the three systems of measurement used in pharmacology?

A

Metric, Household, Apothecary

97
Q

Name the route of administration: Taken in by the lungs in aerosol form, then absorbed into the bloodstream from inside the lungs. Commonly used in general anesthesia or anti-asthmatic drugs.

A

Inhalation Route

98
Q

Name the route of administration: Given by direct injection into the muscle tissue – buttocks, upper arm or thigh. How quickly the drug is absorbed into the bloodstream depends on the blood supply to the muscle.

A

Intramuscular Injection

99
Q

Name the route of administration: Inserted between two vertebrae in the lower spine and into the space around the spinal cord, then into the spinal canal. This route is used when a drug is needed to produce rapid or local effects on the brain, spinal cord, or layers of tissue covering them.

A

Intrathecal Injection

100
Q

Name the route of administration: Injected directly into veins via single dose or continuous infusion.

A

Intravenous/IV

101
Q

Which route of administration is used when administering an irritating solution that would cause pain and tissue damage if injected subcutaneously or intramuscularly?

A

Intravenous/IV

102
Q

When a drug is injected intravenously, it is immediately delivered to the bloodstream and tends to take effect more quickly than when given by any other route. True or False?

A

True.

103
Q

Name the route of administration: A needle is inserted into fatty tissue just beneath the skin. The drug moves into capillaries and is carried away by the bloodstream or reaches the bloodstream through the lymphatic vessels.

A

Subcutaneous Injection

104
Q

Which route of administration is used for protein drugs and why?

A

Subcutaneous Injection; . Because such drugs would be digested if taken orally.

105
Q

Name the route of administration: Usually refers to tablets, capsules, and liquids taken by mouth. Absorption may begin in the mouth and stomach, but most of the drug is usually absorbed by the small intestine.

A

Oral Administration or p.o.

106
Q

Which route of administration is most convenient, safest, and least expensive and therefore most often used?

A

Oral Route

107
Q

Name the route of administration: Drug is mixed with a waxy substance that dissolves or liquefies after it is inserted as a suppository. Given to people who cannot take a drug orally (can’t swallow, nausea, eating restrictions due to surgery).

A

Rectal Route

108
Q

Name the route of administration: Cream, gel, tablet, solution or suppository inserted into the vagina.

A

Vaginal Route

109
Q

Name the route of administration: Drugs taken under the tongue and absorbed directly and immediately into the bloodstream through he mucous membranes of the mouth.

A

Sublingual Route

110
Q

Name the route of administration: Used to treat eye disorders. Almost always used for their local effects.

A

Ocular Route

111
Q

Name the route of administration: Breathed in and absorbed through the thin mucous membrane that lines the nasal passages; must be transformed into tiny droplets in air (atomized).

A

Nasal Route

112
Q

Name the route of administration: Administered through the skin for local effects on that area.

A

Topical or Cutaneous

113
Q

Name the route of administration: Drugs taken through the skin into the systemic circulation, such as through a patch.

A

Transdermal Route

114
Q

The most common medication error is ___________.

A

Dosage

115
Q

How quickly and how much of a drug reaches its intended target site of action. (i.e. the process whereby a drug moves from muscle, digestive tract, or other site of entry towards the circulatory system.)

A

Bioavailability

116
Q

Drug products are considered ________________ when they not only contain the same active ingredient, but also produce virtually the same blood levels over time.

A

Bioequivalent

117
Q

Bioequivalence insures Therapeutic Equivalence. True or False?

A

True.

118
Q

Pro-drugs are administered in an active form, which is metabolized into an inactive form. True or False?

A

False. Pro-drugs are administered in an INACTIVE form, then metabolized into an ACTIVE form; thus the resulting metabolites produce the desired therapeutic effects.

119
Q

Most drugs must pass through the _______, which is the site of most drug metabolism.

A

Liver.

120
Q

The group of _________ enzymes is the liver’s primary mechanism for chemically altering drugs. The levels of these enzymes control the rate at which the drugs are metabolized.

A

P450

121
Q

The main route of drug excretion is the ___________.

A

Kidney.

122
Q

The kidney’s ability to excrete drugs depends on (4 factors)?

A

Urine flow, urine acidity, blood flow through the kidneys, kidney condition

123
Q

The kidney of an 85 year old, excretes drugs about ______% as efficiently as that of a 35 year old person.

A

About 50%

124
Q

The normal age-related decrease in kidney function can help doctors determine an appropriate dosage based solely on a person’s age. True or False?

A

True.

125
Q

Failure to administer a drug in the correct form.

A

Medication Error

126
Q

How do elixirs differ from tinctures?

A

Elixirs are sweetened.

127
Q

Drugs that target receptors are classified as either ________ or ________.

A

Agonists or Antagonists

128
Q

Drugs that active or stimulate the receptors, triggering a response that increases or decreases the cell’s activity.

A

Agonist Drugs

129
Q

Drugs that block the access or attachment of the body’s natural agonists, usually neurotransmitters, to their receptors and thereby prevent or reduce cell responses to agonists.

A

Antagonist

130
Q

Drugs that target enzymes are classified as _________.

A

Inhibitors or inducers

131
Q

Drugs affect only the rate at which existing biological functions proceed; they do not change the basic nature of these functions or create new functions. True or False?

A

True.

132
Q

Are interactions between drugs and receptors or drugs and enzymes reversible?

A

Yes.

133
Q

Drugs effects can be evaluated in terms of _______ and _______.

A

Strength (potency); Effectiveness

134
Q

Smoking decreases the effectiveness of some drugs. True or False? And why?

A

True. Chemicals in cigarette smoke can increase the activity of some liver enzymes.

134
Q

Between ___ and ___% of hospital admissions in the United States are estimated to be for treatment of adverse drug reactions.

A

3% and 7%

135
Q

Each time a person is hospitalized, the risk of having at least one adverse drug reaction is ___ to ___%

A

10% to 20%

136
Q

In older people, which organ is most commonly affected by an adverse drug reaction?

A

The brain

137
Q

What is the difference between Tolerance and Resistance?

A

Tolerance is a diminished response to a drug, while Resistance refers to the “cancel cells” abilities to withstand a drug.

138
Q

Describe the universal scale for quantifying the severity of an adverse drug reaction.

A

There is no such scale.

139
Q

Who assigns the generic name of a drug?

A

United States Adopted Name Council (USAN)

140
Q

In the U.S, a company that develops a new drug can be granted a patent for what 4 aspects of a drug?

A

The drug itself, the way it’s made, the way it’s used, the method of delivering and releasing the drug into the bloodstream.

141
Q

Patents grant a company exclusive rights to a drug for ____ years.

A

20; But it can take 10 to receive a patent.

142
Q

Drugs created before the year _______ are exempt from generic drug requirements.

A

1938

143
Q

Legally, bioequivalence of different versions of a drug can vary by up to _______%

A

20%

144
Q

“Large molecule” products derived from living materials. Called “large molecule” because the proteins or peptides that they consist of are larger than those in chemical chains. They are the source of vaccines.

A

Biologics

145
Q

“Small molecule” products developed and manufactured by a chemical process.

A

Chemical Products

146
Q

The ingredient in drugs that is intended to produce the desired change in the body is known as the…

A

Active Pharmaceutical Ingredient (API)

147
Q

APIs fall in two categories. What are they?

A

Chemical and Biological

148
Q

The way in which an API works in the body is referred to as its ________________.

A

Mechanism of Action

149
Q

The API is blended with products known as _____________ to create the drug product, known as the _____________.

A

Excipients (i.e. fillers, dyes and flavors); formulation

150
Q

Excipients serve what functions?

A

Making the manufacturing process easier, enhancing delivery of the active ingredient, and making the product more attractive or recognizable.

151
Q

The amount of drug reaching the systemic circulation is reduced by what is known as the ____________.

A

First-Pass Effect

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