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NAPSR Pharmaceutical Sales Training Manual | 18th Edition > Chapter 4 | Introduction to Clinical Pharmacology > Flashcards

Chapter 4 | Introduction to Clinical Pharmacology Flashcards

1
Q

Anatomy

A

The study of the basic structures of the body

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2
Q

Physiology

A

The study of how those body structures function

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3
Q

Clinical pharmacology

A

The study of the effects and movement of drugs in the human body

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4
Q

More than 3 billion prescriptions are dispensed each year in the U.S.

A

True

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5
Q

About one half of all Americans take 1 prescription drug regularly and one out of six persons takes at least 3 prescription drugs

A

True

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6
Q

The Babylonians recorded the earliest surviving prescriptions on clay tablets in 3000 b.c.; Chinese recorded the Pen Tsao (Great Herbal), a 40 volume compendium of plant remedies dating to 2700 b.c.; the Egyptians followed in 1500 b.c. by archiving their remedies on a document known as the Eber’s Papyrus

A

True

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7
Q

The first recorded reference to the word pharmacology was found in a text entitled “Pharmacology sen Manudictio and Material Medicum” by Samuel Dale, in 1693; before this date, the study of herbal remedies was called “Materia Medica”

A

True

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8
Q

Friedrich Serturner

A

first isolated morphine from opium in 1805

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9
Q

Pharmacology as a distinct discipline was officially recognized when the first department of pharmacology was established in Estonia in 1847

A

True

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10
Q

John Jacob Abel

A

the father of American pharmacology, founded the first pharmacology department in the US at the University of Michigan in 1890

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11
Q

Pharmacodynamics

A

The study of the biochemical and physiological effects of drugs and their mechanisms of action. Drug dynamics described their therapeutic effects of drugs, their side effects, their sites of actions.

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12
Q

A drug’s effects on the body may be influenced by many factors, such as:

A

a person’s age and genetic makeup and disorders the person has other than the one being treated

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13
Q

Pharmacokinetics

A

Pharmacokinetics: 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.

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14
Q

Drug distribution and elimination

A

Drug delivery systems, route of administration, modes of excretion.

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15
Q

Every drug has at least three names

A

-chemical name
-generic (nonproprietary or official) name
-trade (proprietary or brand) name

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16
Q

Chemical name

A

describes the atomic or molecular structure of the drug.

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17
Q

Generic name

A

usually have the same ending

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18
Q

Trade name

A

is chosen by the pharmaceutical company that manufactures or distributes the drug

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19
Q

Drugs are classified by:

A

therapeutic group; by what disorder or symptom they are used to treat.
(drugs to treat high blood pressure are called antihypertensives; drugs used to treat nausea are called antiemetic drugs (emesis is the technical term for vomiting)

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20
Q

Primary role of a pharma sale rep is to educate and detail physicians so that prescribed medications are delivered in a safe manner and their responsibilities include knowledge and understanding of the following:

A
  • Why your drug should be ordered
  • Name (generic and trade) and drug classification
  • Intended or proposed use of your drugs
  • Effects on the body of your pharmacology product
  • Contraindications
  • Special considerations (how age, weight, body fat distribution, and individual pathophysiological state affect pharmacotherapeutic response
  • Potential side effects
  • Why the medication has been prescribed for a particular patient
    How the medication is to be administered, including dosage ranges
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21
Q

Anaphylaxis

A

a severe type of allergic reaction that involves the massive, systemic release of histamine and other chemical mediators of inflammation that can lead to life threatening shock

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22
Q

Allergic and anaphylactic reactions are particularly serious side effects that must be carefully monitored and prevented.

A

True

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23
Q

Pharmacokinetic and pharmacodynamic concerns including:

A

adverse drug reactions, contraindications, drug-food interactions, and drug-drug interaction issues

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24
Q

A drug is any substance that produces a physical or psychological change in the body. This definition includes products that are considered medicines (aspirin/antibiotics), products contained in foods (caffeine), and products delivered through other means (nicotine/fluoride)

A

True

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25
Q

Under the FFDCA (Federal Food, Drug and Cosmetic Act), a drug is defined as any substance “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or a substance other than food “intended to affect the structure or function of the body.”

A

True

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26
Q

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

A

True

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27
Q

Pharmacotherapy or pharmacotherapeutics is:

A

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

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28
Q

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

A

-Drugs or medications
-Biologics
-Complementary and alternative medicine therapies

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29
Q

Drugs or medications

A

A drug is a chemical agent capable of producing biologic responses within the body; desirable (therapeutic) or undesirable (adverse). After a drug is administered, it is called a medication.

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30
Q

Biologics

A

Agents naturally produced in animal cells, by microorganisms, or by the body itself (hormones, monoclonal antibodies, natural blood products and components, interferons, and vaccines)

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31
Q

Complementary and alternative medicine (CAM) therapies:

A

These involve natural plant extracts, herbs, vitamins, minerals, dietary supplements; herbal and alternative therapies.

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32
Q

Definition of the cell

A

The basic structural and functional units of the body and all living organisms

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33
Q

Parts of the cell

A

-cell membrane
-cell membrane receptors
-nucleus
-cytoplasm/protoplasm
-extracellular fluid
-tissues
-organs
-muscle tissues
-plasma

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34
Q

The Body’s Major Systems:

A

Cardiovascular
Respiratory
Gastrointestinal
Nervous
Musculoskeletal
Reproductive
Immune

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35
Q

Classes of Nutrients:

A

proteins
fats
carbohydrates
vitamins
minerals

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36
Q

Cell membrane

A

All cells are wrapped in semi-permeable membrane that protects them from outside elements and distinguishes them from their surroundings

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37
Q

The nucleus

A

The brain of the cell that regulates all activities

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38
Q

Muscle tissues:

A

Skeletal
Smooth
Cardiac

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39
Q

Plasma

A

the liquid portion of the blood that carries proteins and other substances

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40
Q

Proteins

A

made up of chains of amino acids

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41
Q

Fats

A

Stored in special body tissues as a great source of reserve energy

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42
Q

Carbohydrates

A

The body’s immediate source of energy. It is broken down into glucose and used for immediate metabolic reactions

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43
Q

Vitamins

A

Substances necessary for growth, development, and normal regulation of metabolic processes. Must be taken in from outside of the body

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44
Q

Minerals

A

Substances necessary for bodily processes such as the balance of body fluids, the formation and maintenance of bones and teeth, and the proper functioning of muscles.

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45
Q

The main minerals:

A

Calcium
Potassium
Iron
Sodium
Phosphorous
Iodine

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46
Q

Water

A

Not a nutrient, but necessary for all body functions (fluids, mostly water, make up at least 60% of the body’s weight)

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47
Q

Cardiovascular System

A

heart
blood vessels
blood

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48
Q

Respiratory System

A

nasal passages
trachea
diaphragm
lungs

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49
Q

Gastrointestinal System

A

mouth
esophagus
stomach
liver
pancreas
gallbladder
small & large intestines

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50
Q

Nervous System

A

central nervous system: brain/spinal cord
peripheral nervous system: electrical signals

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51
Q

Musculoskeletal System

A

muscles
bones
other minor systems

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52
Q

Reproductive System

A

penis
testes
seminal fluid
ovaries
oviducts
uterus
vagina
mammary glands

53
Q

Immune System

A

lymph nodes
vessels
cells

54
Q

Drugs that have a significant potential for abuse are placed into five categories called schedules:

A

Schedule I drugs have the highest potential for abuse; Schedule V drugs have the lowest potential for abuse.

55
Q

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

A

Classification of teratogenic risk places drugs into categories A, B, C, D, and X. Category A is the safest group of drugs; Category X poses the most danger to the fetus.

56
Q

Pharmacokinetics and Pharmacodynamics:

A

A drug’s formulation is designed to optimize the ability of the body to properly use and then rid itself of the drug.
Pharmacokinetics uses a process called ADME testing to assess the actions of the body on the drug; it measures the rate at which the body absorbs the drug, distributes it to the organs necessary to produce the desired effect, metabolizes it into waste material, and then excretes it from the body.

57
Q

Therapeutic Window:

A

The dosage range of a drug that is safe and produces a beneficial result
Absorption
Distribution
Metabolism
Excretion

58
Q

Drug design and development

A

-Selectivity: ability to target the intended site
-Affinity: remain attached to the site
-Potency: optimize its strength
-Efficacy: effectiveness
-Safety

59
Q

What the body does to the drug

A

drug kinetics

60
Q

What the drug does to the body

A

drug dynamics

61
Q

The Rights of Drug Administration

A
  1. Right Patient
    1. Right Medication
    2. Right Dose
    3. Right Route of Administration
    4. Right Time of Delivery
      Right to Refuse Medication
      Right to Receive Drug Education
      Right Preparation
      Right Documentation
62
Q

Drug Orders and Time Schedules

A

-STAT: statim; immediately (within 5 mins)
-ASAP: within 30 mins
-Preoperative Order: single order for a drug that is to be given once; PRN pro re nata
Orders not written as STAT/ASAP/NOW/PRN are routine orders within 2 hours
-Standing Order: written in advance of a situation that is to be carried out under specific circumstances.

63
Q

Teratogen

A

A teratogen is a substance that has the potential to cause a defect in an unborn child during pregnancy. Classification of teratogenic risk places drugs into categories A, B, C, D, and X. Category A is the safest group of drugs; Category X poses the most danger to the fetus.

64
Q

Dosages are labeled and dispensed according to:

A

their weight or volume

65
Q

The three systems of measurements used in pharmacology:

A

metric, apothecary, and household.

66
Q

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

A

margin of safety

67
Q

Drugs from laboratory to medicine cabinet

A

the whole process takes about 10 years

on average, 5 of 4,000 drugs studied in the lab are studied in people; only 1 of 5 drugs studied in people are approved

68
Q

MAR

A

medication information system

69
Q

Routes of Drug Administration: Inhalation

A

Drugs taken through the lungs by inhaling in aerosol form.

70
Q

Injection Routes

A

Administration by injection (parenteral administration); a drug product can be prepared or manufactured in ways to prolong drug absorption from the injection site for hours, days, or longer; do not need to be administered as often as drug products with more rapid absorption

71
Q

Intramuscular Injection

A

Drugs given by direct injection into muscle tissues such as the butt, upper arm, or thighs; longer needle because muscle lies below skin and fatty tissue.

72
Q

Intrathecal Injection

A

Needle inserted between two vertebrae in the lower spine into the space around the spinal cord

73
Q

Intravenous or IV

A

Drugs injected directly into the veins; infusion by gravity or infusion pump; the effect lasts for a shorter time.

74
Q

Subcutaneous Injection

A

Needle inserted into fatty tissue just beneath the skin; injected then moves into small blood vessels (capillaries) and is carried away by the bloodstream or reaches the bloodstream through lymphatic vessels. Most protein drugs are used by this method because if taken orally they would be digested in digestive tract.

75
Q

Oral Administration

A

Tablets, capsules, and liquids taken by mouth; most convenient and usually safest and least expensive.

76
Q

Rectal Route

A

Suppository; drugs mixed with waxy substance that dissolves or liquefies after inserted into rectum; prescribed for people who cannot take drug orally because they have nausea, cannot swallow, or have restrictions on eating

77
Q

Vaginal Route

A

Solution, tablet, cream, gel, or suppository that slowly absorbs through vaginal wall.

78
Q

Sublingual Route

A

Drugs taken under the tongue; absorbed directly and almost immediately into the blood stream through mucous membranes.

79
Q

Ocular Route

A

Drugs taken to treat eye disorders

80
Q

Nasal Route

A

Drug breathed in and absorbed through thin mucous membrane that lines the nasal passages; it must be transformed into tiny droplets in air (atomized)

81
Q

Topical or Cutaneous

A

Drugs administered through the skin

82
Q

Transdermal Route

A

Drugs taken through the skin into the systematic circulation; such as a patch; drug can be delivered slowly and continuously for many hours, days, or even longer. As a result, levels of the drug in the bloodstream can be kept relatively constant.
Examples: nitroglycerin for angina, scopolamine for motion sickness, nicotine for smoking cessation, clonidine for high blood pressure, fentanyl for pain relief.

83
Q

Medication Errors

A

First Stage: involves prescribing or ordering medication

Second Stage: when medication is dispensed to patients

Third Stage: when medication is administered and monitored for side effects

*The most common error is dosage; errors also involve antibiotics and analgesics.

84
Q

Drug Absorption

A

The movement of a drug into the bloodstream.

85
Q

Drug absorption affects:

A
  • Absorption affects bioavailability (how quickly and how much of a drug reaches its intended target site of action; or whereby the drug moves from the muscle, digestive tract, or other site of entry into the body toward the circulatory system)
86
Q

Once absorbed, most drugs do not spread evenly through the body

A

True

87
Q

Drug (active ingredient) and additives (inactive ingredient); i.e. tablets are a mixture of drugs, dilutents, stabilizers, disintegrants, and lubricants. The mixture is granulated and compressed into a tablet. The type and amount of additives and the degree of compression affect how quickly the tablet disintegrates and drug is absorbed.

A

True

88
Q

Drug products are considered bioequivalent when…

A

they not only contain the same active ingredients, but also produce virtually the same blood levels over time.

89
Q

Bioequivalence ensures therapeutic equivalence.

A

True

90
Q

enteric

A

protective coatings for oral drugs that do not harm stomach lining and intended to dissolve in small intestine

91
Q

Drug Distribution

A

The movement of a drug to and from the blood and various tissues of the body (fat, muscle, brain tissue). After the drug is absorbed into the bloodstream, it rapidly circulates through the body; the average circulation time of blood is only one minute

92
Q

Drug Metabolism:

A

The chemical alteration of a drug by the body. The substances that result from metabolism (metabolites) may be inactive, or they may be similar to or different from the original drug in therapeutic activity or toxicity. Some drugs, called pro-drugs, are administered in an inactive form, which is metabolized into an active form; the resulting metabolites produce the desired therapeutic effects.
Most drugs pass through the liver; the group of P450 enzymes is the liver’s primary mechanism for chemically altering drugs.

93
Q

Drug Elimination and Excretion:

A

The last stage of pharmocokinetics. The main route of drug excretion is via the kidneys.

Lungs
Breast Milk
Sweat, tears, urine, feces
Bile
Saliva
Exhaled Air

94
Q

The kidneys’ ability to excrete drugs also depends on:

A

urine flow, blood flow through the kidneys, and the condition of the kidneys.
The kidney of an 85 year old person excretes drugs only about half as efficiently as that of a 35 year old person.

95
Q

Many of the concepts applicable in the study of pharmacology apply equally to unforeseen or inadvertent reactions including adverse drug reactions, adverse effects, drug allergies, drug interactions, and idiosyncratic reactions.

A

True

96
Q

Drug Forms

A

Formulations determine whether a drug acts locally or is absorbed into the systemic circulation. Drug dosage forms are classified according to their physical state (liquid or solid) and chemical composition.

97
Q

Drug Forms

A
  • Preparations for Oral Use
    • Powders
    • Pills
    • Granules
    • Tablets
    • Capsules
    • Sustained Release
    • Enteric Coating
    • Caplets
    • Gel Caps
    • Liquid Drugs
    • Syrups
    • Solutions
    • Elixirs
    • Fluid Extracts
    • Mixtures and Suspensions
    • Tinctures
    • Spirits or Essences
    • Magmas
    • Troches or Lozenges
    • Aerosols
    • Injectable Drugs
    • Topical Drugs
    • Liniments
    • Semisolid Drugs
    • Gels or Jellies
    • Emulsion
    • Creams
    • Lotion
    • Ointments
    • Plasters
    • Transdermal Patches
    • Gaseous Drugs (Inhalation Drugs)
    • Ophthalmic Drugs
    • Otic Drugs
    • Nasal Drgus
    • Vaginal Drugs
    • Rectal Drugs
98
Q

Dispensing Drugs

A

OTC over the counter and Rx prescription

99
Q

Site Selectivity

A

How do drugs know where to exert their effects? The answer involves how they interact with cells or substances such as enzymes.

100
Q

Cell Receptors

A
  • A receptor is a molecule with a specific three dimensional structure to which only very specific substances can fit and attach…like a key fits its lock.
    • Drugs that target receptors are classified as agonists or antagonists.
    • Agonist drugs activate or stimulate their receptors, triggering a response that increases or decreases the cell’s activity.
    • Antagonist drugs 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.
101
Q

Enzymes

A

Instead of receptors, some drugs target enzymes, which regulate the rate of chemical reactions. Drugs that target enzymes are classified as inhibitors or activators (inducers).

101
Q

Affinity and Intrinsic Activity

A

A drug’s action is affected by the degree (affinity) between it and its receptor on the cell’s surface and, once it is bound to its receptor, by its ability to produce an effect (intrinsic activity)
Drug receptor complex must be capable of producing an effect in the target area.

102
Q

Potency and Efficacy

A

Strength and effectiveness

103
Q

Drug Response

A
  • Genetic Makeup
  • Drug-Drug Interactions
    ○ Duplication
    ○ Opposition (Antagonism)
    ○ Alteration
  • Dietary Supplement-Drug Interactions
  • Drug-Food Interactions
  • Drug-Disease Interactions
  • Tolerance and Resistance
104
Q

Adverse Drug Reactions

A

-Type A (augmented) reaction
-Type B (idiosyncratic) reaction
-Type C (continuing or chronic) reaction
Persist for a long time - corticosteroids can cause adrenal suppression
-Type D (delayed) reaction
Take some time to develop - some neuroleptics can cause tardive dyskinesia
-Type E (end of use) reaction

105
Q

Risk Factors

A

-Use of several drugs
-Age (especially in infants / elderly)
-Pregnancy & breast feeding

106
Q

Young children are at high risk of overdose toxicity

A

True

107
Q

Children are less likely than adults to take or be given drugs as directed

A

True

108
Q

Ways to encourage compliance with drug treatment

A

-good communication
-encouraging patient participation
-liking their providers
-using only one pharmacist
-support groups
-memory aids and specially designed medication containers

109
Q

Results of not complying with drug treatment

A

it is estimated to result in 125,000 deaths due to cardiovascular disease each year; up to 23% of nursing home admissions, 10% of hospital admissions, etc.

110
Q

Names of drugs

A

First, the chemical name

Next, a shorthand version of the chemical name or code name

When a drug is approved by the FDA, it is given a generic (official) name and a trade name (proprietary/brand)

111
Q

Generic and trade names must be unique to prevent one drug from being mistaken for another when drugs are prescribed; to prevent this possible confusion, the FDA must agree to every proposed trade name.

A

True

112
Q

Generic drug development

A

-generic version is equivalent (within a few percentage points) to original
-appropriate inactive ingredients are used
-the generic version differs from its trade name counterpart in size, color, and shape (a legal requirement)

113
Q

Legally, bioequivalence of different versions of a drug can vary by up to 20%; however, actual differences are typically only about 3.5% on average and rarely exceed 10% in any single study

A

True

114
Q

API

A

active pharmaceutical ingredient

115
Q

APIs fall into two basic categories

A

chemical and biological

116
Q

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

A

mechanism of action

117
Q

Most drugs are either agonists or antagonists

A

agonists: drugs that attract or bind to cell receptors in order to mimic of enhance endogenous chemical messengers

antagonists: drugs that interfere with destructive or undesirable cell functions

118
Q

Insulin

A

agonist: administered to diabetics who no longer produce it in sufficient quantities

119
Q

Steroids

A

antagonists: they block cell activities that lead to inflammation

120
Q

The APT is usually blended with products known as excipients (fillers, dyes, flavors) to create the drug product, which is also known as

A

the formulation

121
Q

Excipients are sometimes referred to as

A

inactive ingredients; they also serve such functions as making a drug more stable, easier to administer, or longer-acting through sustained release of the API

122
Q

Formulated products are sometimes offered in various strengths and administered using different delivery methods to aid absorption or enhance convenience

A

True

123
Q

Strength refers to

A

the amount of active pharmaceutical ingredient in the drug

124
Q

Common delivery methods are

A

-parenteral (intravenous, intra-muscular, subcutaneous)
-rectal (suppository)
-oral (tablet, capsule, liquid)
-transdermal (via skin)

125
Q

Excipients are the inert ingredients in a drug formulation and serve the following functions:

A

-making the manufacturing process easier
-enhancing delivery of the active ingredient
-making the product more attractive or recognizable

126
Q

Excipient Classes

A

Binders
Fillers
Glidants
Colors
Flavors
Suspending/Dispersing agents
Disintegrants
Lubricants
Compression aids
Sweeteners
Printing inks
Film former/coatings

127
Q
A

NAPSR Pharmaceutical Sales Training Manual | 18th Edition (23 decks)

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