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Tim's Cards > Pharmacology I > Flashcards

Pharmacology I Flashcards

1
Q

T/F
Chinese developed drugs in 2700 BC in Doctrine of Signatures. The oldest prescription is on a Sumerian Tablet around 3000 BC.

A

True

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2
Q

T/F

Hippocrates big insight was that disease is from natural causes.

A

True

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3
Q

What was the 1st specific drug used to treat a specific disease?

A

Quinine from Peruvian Tree bark used to treat Malaria

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4
Q

What is the single most important drug discovery in medicine?

A

Acetylsalicylic Acid - aspirin - 1890’s

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5
Q

What treatment/drug for Congestive Heart Failure is still isolated from the Foxglove plant?

A

Digitalis

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6
Q

How are arsenicals made?

A

Arsenic to Carbon atom attachment

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7
Q

What 2 Alkaloid substances were isolated from Atropa belladonna?

A

Atropine (pupil dilator)

Scopolamine (motion sickness)

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8
Q

T/F

Penicillin was used in WWI

A

False

not until WWII

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9
Q

How long does it take to develop and bring a new drug to market?

How much does it cost?

A

15 years

360 million

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10
Q

____ out of 10 compounds that are developed reach market.

Of those, ___ out of 10 have ROI.

A

2

3

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11
Q

How long does a Patent for a new drug last?

A

17 years

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12
Q

Define Margin of Safety:

A

LD50 divided by ED50

lethal dose/effective dose

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13
Q

What is an acceptable Margin of Safety?

A

2000 or more

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14
Q

Animal Testing and Margin of Safety (LD50/ED50) are part of ______ Testing

A

Short-term Toxicity

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15
Q

What is another name for Long-term toxicity studies?

A

Chronic Toxicity Studies

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16
Q

T/F
Chronic Toxicity Studies involve daily dosing of dogs/rats from 3 months to 2 years, than animals are killed and histopathology is studied

A

True

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17
Q

What are 2 Specialized animal studies done for Safety?

A

Reproduction (teratogen)

Carcinogenicity

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18
Q

What can be submitted if drug has adequate margin of safety in rats, there are no long-term toxicities, no carcinogenic effects, non-teatogenic?

What is the Approval Time?

A

IND - Investigational New Drug Application

30 days

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19
Q

In what phase are drugs evaluated in humans for the 1st time?

When does it begin?

A

Clinical Studies - Phase 1

Immediately after IND approval

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20
Q

Who is studied in Phase 1?

A

20-80 healthy male humans

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21
Q

What is determined in Clinical Studies - Phase 1?

3 things

A

Safety Profile

Pharmokinetics

Toxicity dose

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22
Q

At what clinical phase of the study are new drugs given to patients that have the condition for which the drug is intended?

A

Phase 2

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23
Q

How many subjects are in Phase 2 studies?

What is determined?

A

100-300 subjects

Short-term effectiveness

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24
Q

T/F

Phase 1 establishes therapeutic efficacy, dose response/range, metabolism, and adverse drug events.

A

False

*Phase 2

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25
Q

What Phase studied Long Term Efficacy?

A

Phase 3

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26
Q

How many subjects are in a Phase 3 study?

A

1000 - 3000

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27
Q

T/F
Phase 3 clinical studies are to confirm drug safety/efficacy and to try to detect adverse effects that are undetected in prior studies.

A

True

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28
Q

Phase 3 studies are always _____

A

Double Blind

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29
Q

Name 2 potential limitations in Phase 3 testing.

A

More Short term than Long term participants

Toxicities occurring less than 1 in 1000 will not be revealed

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30
Q

If Phase 3 testing is successful, what can be submitted (this is after 8 years of animal/human testing)?

A

NDA - New Drug Application process

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31
Q

T/F

If an NDA (New Drug Application) is accepted by the FDA, it can be sold exclusively and have a 17 year patent.

A

True

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32
Q

When are Phase 4 Studies done?

A

Post-marketing Surveillance

After FDA approval

***Drug pulled off market if new toxicities are uncovered

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33
Q

T/F

Often the result of Phase 4 study/surveillance is relabeling with new warnings and precautions

A

True

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34
Q

4 Phases Drug Testing Summary:
Phase 1:

Phase 2:

Phase 3:

Phase 4:

A

20-80, test for safety in “normals”

hundreds, Safety and Effectiveness

thousands, safety, dose, effectiveness, adverse events

Post-marketing surveillance

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35
Q

Define Chemical, Generic, and Trade name of drugs:

A

Chemical: structure (combo letters/numbers)

Generic: lower case, official name

Trade: marketed commercially

*all drugs have on generic name and many trade names

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36
Q

The active ingredient in Generic Drugs must enter the blood at the _____ rate as the Trade brands

A

Same

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37
Q

Name 8 pieces of legislation that regulate drug marketing and safety:

What do each do?

A

1906 Pure Food and Drug Act
(created FDA, standards purity/quality, correct/truthful labels)

Federal Food and Drug Cosmetic act of 1938
(Requires proof of safety/purity)

FDA Modernization Act of 1997

Durham-Humphery Act of 1952
(FDA authorized to determine what drugs can be sold w/o prescription)

Kefauver-Harris Amendment of 1962
(requires proof efficacy/safety of new drugs)

Controlled Substances Act of 1970
(abuse - DEA)

Dietary Supplement Health and Education Act of 1994
(FDA must demonstrate supplement unsafe before taking action against)

Federal Food, Drug, and Cosmetic Act of 2006
(supplement industry must report side effects)

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38
Q

T/F
The FDA controls OTC drugs, reviews for misbranding and adulteration, sets guidelines for safety/efficacy, and can prevent the sale and withdraw a drug from market

A

True

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39
Q

The Orphan Drug Amendments of _____ provides incentives to treat orphan diseases.

The Expedited Drug Approval Act of _____ allows accelerated FDA approval for drugs of significant need with detailed post-marketing _______.

The Harrison _______ act of 1914 first established regulations governing opiates and cocaine and preceded the Controlled Substances Act of 1970

A

1983

1992

Surveillance

Narcotic

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40
Q

A drug is a ______ substance

The are used for what 4 things?

A

Chemical

Diagnosis, Prevention, Treatment, Prego prevention

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41
Q

What is the study of how drugs enter the body, circulates, changes, and leaves?

A

Pharmacokinetics

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42
Q

What are the 4 steps the body takes a drug through?

A

Absorption

Distribution

Metabolism

Excretion

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43
Q

For the following describe how it influences passing a lipid bilayer:
Solubility:

Charge:

Size:

Shape:

A

Solubility: more soluble, passes easier

Charge: cannot pass if charged

Size: Small crosses easily

Shape: must fit through membrane

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44
Q

What is the study of biochemical and physiologic actions, and the mechanism of drug action at cell/sub-cell level?

A

Pharmacodynamics

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45
Q

T/F

Lipid solubility, degree of ionization (charge), size, and shape are all characteristics of drug molecules

A

True

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46
Q

The lower the pKa, the _____ the acid

A

Stronger

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47
Q

Weak Acid in Acidic =

Weak Acid in Basic =

Weak Base in Acidic =

Weak Base in Basic =

A

Lipid Soluble

Water Soluble

Water Soluble

Lipid Soluble

***Like with like = Lipid `

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48
Q

_____ is administered into the GI tract and ______ bypasses via injections, inhalation, topical administration

A

Enteral

Parenteral

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49
Q

T/F

Enteral drug administration is the cheapest and is poorly/irregularly absorbed

A

True

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50
Q

Inhalation, IV, IM, Topical, Subgingival, SubQ, Sublingual, and transdermal are all…

A

Parenteral

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51
Q

IV is the most _____ and ______.

IM has the most ______ effect.

Transdermal is more _______ than others.

A

Rapid, Predictable

Sustained

Concentrated

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52
Q

What route goes into the spinal or subarachnoid space?

A

Intrathecal

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53
Q

Tablets and Capsules are _____ and _____-

A

Slow

Unpredictable

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54
Q

Solution, syrup, suspension, emulsion, tincture, elixir all have a ______ control rate

A

Continuous

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55
Q

T/F

Ointments and Creams have problematic dosage controls

A

True

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56
Q

What has slow, continuous delivery and must be changed?

A

Transdermal patches

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57
Q

T/F

Inhalants have slow onset

A

False

*rapid

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58
Q

What are 3 mechanisms by which drugs penetrate biological membranes?

A

Diffusion - passive

Filtration - through pores

Specialized Transport - Facilitated/Active

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59
Q

T/F

Topical drugs cause systemic effects

A

False

*can be local or systemic, depending on dosage

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60
Q

Local anesthetics are usually delivered by what route?

A

Subcutaneous

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61
Q

What are 3 fast and 3 slow onset drug delivery methods?

A

Fast: IV, Sublingual, Inhalation

Slow: IM, Patch, Subcutaneous

62
Q

Drug dissolved in aqueous solution:

Drug dissolved in saturated aqueous solution of sugar:

Drug dissolved in sweetened water/alcohol solution:

Drug dissolved in pure alcohol:

Drug dissolved in oil phase:

Drug not dissolved but…

A

Solution

Syrup

Elixir

Tincture

Emulsion

Suspension

63
Q

T/F

IV faster than IM faster than Oral

A

True

64
Q

What does the following pathway describe?

Oral - Stomach - Intestines - Portal veins - Liver

A

First Pass Effect

65
Q

What is the fraction of administered drug that becomes available in the plasma?

A

Bioavailability

***Frequently influenced by the “vehicle” of the drug

66
Q

What is the only type of drug administration that gives 100% bioavailability?

A

IV

67
Q

T/F

The FDA mandates that generics have 90% bioavailability

A

True

68
Q

What 2 forms do drugs take in the body?

*What can pass across membranes?

A

Bound to Plasma Proteins = Inactive

*Free = Active (passes membranes)

69
Q

What are 2 potential barriers to drug distribution in the body?

A

BBB - blood brain barrier (only small, lipid soluble drugs pass through)

Placenta - most drugs pass, lipid soluble cross easiest

70
Q

What must happen for a drug to terminate its activity?

A

Redistribution

***off site of action

71
Q

What is the term for drug metabolism so it can be excreted by the kidneys?

A

Biotransformation

72
Q

Biotransformation converts _____ soluble drugs to ______ soluble metabolites.

A

Lipid

Water

73
Q

Where does biotransformation take place?

A

Liver

74
Q

What are the 2 Phases of Biotransformation?

A

Phase 1 - Liver modification (redox/hydrolysis)

Phase 2 - Conjugation. Pharmacologically inactive

75
Q

What does LMOES stand for?

A

Liver Microsomal Oxidation Enzyme System

76
Q

LMOES usually occurs in what phase of biotransformation?

A

Phase 1

77
Q

An electron transport system requiring NADPH and Oxygen, present in the Liver (primarily), GI tract, and kidney.

A

LMOES - Liver Microsomal Oxidation Enzyme System

78
Q

What 3 factors control the rate of drug metabolism in LMOES?

A

Cytochrome P-450

NADPH-cytochrome C reductase

Competing substrates

79
Q

What are the 2 general (descriptive) ways to eliminate drugs from the body?

A

Zero Order - constant (alcohol)

First Order - constant fraction (exponential)

80
Q

6 routes of Drug excretion:

A

Kidney (urine)

Bile (feces)

Sweat

Saliva

Lungs

Breast Milk

81
Q

What is the time needed for the plasma concentration of a drug to fall to one half its blood level?

A

Biological Half Life

82
Q

If a constant fraction of drug is eliminated over time, this is _____

A

First Order

83
Q

If the rate of Intake = rate of Elimination of a drug, it has reached…

A

Plasma steady state concentration

84
Q

T/F
At a regular dosing frequency, a drug reaches a steady state or equilibrium because the process of elimination is concentration dependent.

A

True

85
Q

T/F

Drugs only interact with receptors covalently

A

False

Covalent, ionic, hydrogen, hydrophobic, Van der Waals

86
Q

What are the 2 most common ways drugs bind to receptors?

A

H-bonding

Ionic bonding

87
Q

T/F
The affinity of a drug for a particular receptor and the type of binding is intimately related to the drug’s chemical structure.

A

True

88
Q

How long does it take for a drug to be cleared from the body?

A

4 to 5 half lives

89
Q

A drug that causes a conformational change in protein is the ______ model

A

Induced Fit

90
Q

T/F
Drug receptors are proteins that recognize selected molecules at the external surface and transmit information to inside the cell.

A

True

91
Q

T/F

Membrane spanning protein receptors communicate with both sides of the cell, which allows drug to act without entering

A

True

92
Q

A hormone, neurotransmitter, GF, or drug that binds a receptor protein/glycoprotein is called a…

A

Ligand

93
Q

A conformational change that causes a signal in response to a ligand is known as…

A

Cell Signaling

94
Q

Name 4 Cell Signaling substances in the body:

A

Hormones

Neurotransmitters

Growth Factors

Drugs

95
Q

What are 4 examples of cellular responses that occur following cell signaling?

A

Ion channel opening/closing

2nd Messenger formation

Gene expression alters

Cell growth/differentiation

96
Q

T/F

Drug interaction with receptors that control ion channels are found in excitable tissues

A

True

97
Q

A drug that binds a receptor that controls ion channels will increase permeability to _____ and _____, that will determine _____ of the nerve.

A

Potassium, Sodium

Depolarization/hyperpolarization

98
Q

Ligand gated ion channels, G proteins, Intracellular receptors, and Tyrosine Kinase receptors are all involved in Signal Transduction

A

True

99
Q

Parasympathetic - Acytylcholine - muscarinic cholinergic receptors

Sympathetic - Norepinepherine - Adrenergic receptors

A

True

*these generate second messengers

100
Q

T/F

Ligand binding causes events that generate 2nd messengers that pass message from inside the cell to effector organ

A

True

101
Q

What in the internal membrane regulates the generation of 2nd Messengers?

A

Intracellular G-Protein Complex

102
Q

What 3 responses can an Activated G-Protein Complex Induce?

A

Adenylyl Cyclase - generate cAMP

Phospholipase C - phosphorylates proteins

Membrane channel - changes ionic conductance

103
Q

The amount of drug necessary to produce an effect is what?

A

Drug Potency

104
Q

The maximum intensity of a drug’s effect is the…

A

Drug Efficacy

*maximum response produced by the drug

105
Q

Demerol and Morphine have similar ______, but differ greatly in ______.

A

Efficacy

Potency

106
Q

A drug that is able to bind to a receptor to produce an effect is an….

A

Agonist

107
Q

A drug that binds to the same receptor as an agonist but is unable to Activate the receptor (produces to effect) is what?

A

Antagonist

108
Q

If an agonist and antagonist are administered together, what binds the receptor first?

A

Antagonist

109
Q

T/F

An Antagonist can be either competitive or non-competitive

A

True

110
Q

A Competitive Antagonist is ______ and physically blocks the receptor

A

Reversible

111
Q

T/F

Administering additional agonist will displace the antagonist from the receptor

A

True

112
Q

A Non-Competitive Antagonist will bind ______ and binds either the same or different sites. (both inhibit agonist)

A

Irreversibly

*cannot be displaced - think botox

113
Q

A Physiological Antagonist will oppose an agonist by ______.

A Pharmacologic Antagonist will oppose an agonist by ______.

A

Activating pathways

Binding first and preventing pathway

114
Q

The range of doses that elicit a therapeutic response without unacceptable side effects is known as the ______.

A

Therapeutic Window

115
Q

If the Therapeutic Window is small, the blood plasma level of a drug must be closely monitored

A

True

116
Q

T/F

Receptor molecules include proteins and glycoproteins

A

True

117
Q

T/F

Binding of ligand to receptor occurs through induced fit

A

True

118
Q

T/F
Receptors recognize ligands at external cell surface and transmit info into the cell.

Cell signaling involves Conformational Change in receptor molecule due to ligand binding

Cell signaling substances can be hormones, neurotransmitters, growth factors, and drugs

A

All True

119
Q

TD50 (toxic) / ED50 (therapeutically effective), defines what?

A

Quantitative measure of Therapeutic Window

120
Q

Cell and Tissue damage due to overdose that leaves permanent micro/macro and Intolerable effects is _____

A

Toxicity

121
Q

Undesired effects that are tolerable, reversible, and dose related are…..

A

Side effects

122
Q

Multiple medications given to a pt (5 or more), is known as….

Taking multiple supplements is known as….

A

Polypharmacy

Polyherbacy

123
Q

What report, in terms of percentage of population affected, is categorized by body/organ system for each drug?

A

Monograph

*required by FDA

124
Q

T/F

Hypersensitivity rxns manifest as skin rash, asthmatic rxns, rhinitis, and anaphylaxis

A

True

125
Q

T/F

A person must have a previous exposure to a drug to have an allergic rxn

A

True

126
Q

What are the 3 types of allergic rxns associated with drugs and what are the antibodies associated with them?

A

Type 1 - IgE

Type 2 - IgG, IgM

Type 3 - IgG

127
Q

Type 1 IgE hypersensitivity rxns are the most severe and include what 4 symptoms?

A

Anaphylaxis

Asthma

Rhinitis

Dermatitis

128
Q

Type 2 hypersensitivity (IgG, IgM) is manifested by what?

A

Hemolysis of RBC’s

129
Q

Type 3 hypersensitivity (IgG) rxs include these 3…

A

Arthralgia

Fever

Lymphadenopathy

130
Q

Causing defects in developing embryo

A

Teratogen

131
Q

FDA pregnancy risk categories and what they mean:

A

A = failed to demonstrate risk to fetus

B = animal studies no risk demonstrated

C = animal studies reveal risk to fetus, no human data

D = positive data human fetal risk, but useful benefits

X = animal and human fetal risk demonstrated (contraindicated)

132
Q

What sedative used to relieve morning sickness caused limb defects in the 1960’s?

A

Thalidomide

133
Q

What is the modern use of Thalidomide?

4 things

A

Oral ulcers from AIDS

Multiple myeloma/other blood dyscrasias

Leprosy sores

Reverses wasting in AIDS

134
Q

What field studies the genetic variability of drug effects?

A

Pharmacogenetics

*often by misspelled genes

135
Q

Pharmacogenetic variability can alter pharmacokinetics seen by______, and pharmacodynamics seen by ______.

A

drug plasma levels

therapeutic effects of drugs

136
Q

How do “misspelled genes” affect the following drug interactions:
Albuterol:

Prozac:

Isoniazid:

A

Albuterol ineffective in dilating smooth muscle in bronchioles

Prozac metabolized so slowly becomes toxic

Isoniazid (TB drug) metabolized too rapidly to be effective

137
Q

What 4 Factors greatly influence the effectiveness and safety of drugs?

A

Biological variation

Hypersusceptibility

Drug idiosyncrasy

Age

138
Q

Pediatric pts will have lower dose because of _______ kinetics

Geriatric pts will have lower dose because of _______ clearance

A

Increased

Decreased

139
Q

In Liver Disease, ____ is reduced, so _____ must be reduced.

A

Metabolism

Dose

140
Q

T/F

In Renal Disease, drug excretion is inhibited

A

True

141
Q

A rapid development of Tolerance (e.g. - local anesthesia wears off quickly) is knows as…

A

Tachyphylaxis

142
Q

What 3 effects can drug interactions have?

A

Enhancement

New

Inhibition

143
Q

What are the 4 basic mechanisms of Drug Interactions?

A

Synergistic (similar effects)

Metabolic (induction, inhibition)

Absorption (altered pH, binding in stomach)

Displacement of plasma proteins (more active free drug in circulation)

144
Q

Name the components of the Heading, Body, and Closing of a prescription.

A

Heading: name, address, tele# of presciber and pt, DATE

Body: Name, dosage size/concentration, amount dispensed, directions to pt

Closing: Presciber signature, DEA number, Refill instructions

145
Q

In prescription writing, define Rx:

Mitte:

Sig:

A

Rx: Recipe

Mitte: Quantity

Sig: How should be taken

146
Q

What are the 4 factors that determine dosage?

A

Age

Body Weight

Total body surface area

Usage

147
Q

1 Tube

1 (one) 15 gm tube

A

Incorrect

Correct

148
Q

Any Scheduled Drug, a prescription for a controlled substance, requires what?

A

DEA#

149
Q

Define Schedule 1:

Schedule 2:

Schedule 3:

Schedule 4:

Schedule 5:

A

CI: high potential for abuse

CII: high abuse, severe dependence

CIII: lesser abuse, moderate dependence

CIV: low abuse, moderate dependence

CV: low abuse, moderate dependence

150
Q

What is the best Drug Library available for a dentist?

A

Lexi-Comp

Tim's Cards (140 decks)

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