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Pharm & Ototoxicity > Lectures 3&4 > Flashcards

Lectures 3&4 Flashcards

1
Q

how do you define pharmacology

A

the basic and clinical applied science that deals with the fate and actions of drugs in the body

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2
Q

what are drugs

A

Any substance used in the diagnosis, prevention, or treatment of disease

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3
Q

drugs are made of

A

chemicals

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4
Q

what is pharmakon

A

poison or drugs

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5
Q

logos

A

study or discourse of

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6
Q

Humans have sough ___ and ___ roducts since the earliest of times to combat sickness and death

A

plant & animal

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7
Q

what has been common since religion and men have existed

A

Mixture of religion and use of plant substances

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8
Q

what is the doctrine of signatures (1500s)

A

Plant parts that resembled human body parts, animals, or other objects were thought to have useful relevance to those parts, animals, or objects
People thought that God had made herbs for the use of men and given them particular Signatures that could be read to cure disease, such as
Walnuts were good to cure ailments of the head because they had a perfect signature for the head!
The holes in the leaves of Saint Johns Wort resemble pores of the skin and, therefore, can treat disease and wounds of the skin

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9
Q

Oldest prescriptions were found on clay tablets written by _____ physicians around ____ BC

A

Sumerian
3000

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10
Q

one of the earliest urban societies to emerge in the world, in Southern Mesopotamia (modern day Iraq), more than 5000 years ago

A

Sumerians

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11
Q

What did hippocrates say

A

5th century BC) promoted the idea that disease results from natural causes rather than evil spirits
He believed that the body had abilities to recuperate from disease

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12
Q

In the early years, medicines were developed by isolation and use of nature substances from

A

botanical, mineral, and animal sources

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13
Q

In modern times, medicines are developed by

A

chemical synthesis of compounds that have biological activity

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14
Q

what is quinine

A

Bark of some trees contained quinine
Quinine is still used today as a drug of choice against malaria
The first specific drug used to treat an infectious disease

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15
Q

first successful drug used against malaria

A

quinine

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16
Q

when did synthesis of arsenicals come about

A

1910

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17
Q

Sahachiro Hata and Paul Ehrlich’s synthesized arsenicals by

A

attaching an arsenic atom to a carbon atom

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18
Q

(Salvarsan-first chemotherapeutic agent) to treat syphilis

A

arsphenamine

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19
Q

what is the primary use of digitalis

A

heart disease

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20
Q

William Withering’s use of purple foxglove (digitalis purpurea) in 1783, lead to

A

the isolation of digitalis

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21
Q

He made a tea to treat the edema of cardiac

A

“dropsy” (congestive heart failure)

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22
Q

Digitalis is still the drug of choice for

A

congestive heart failure

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23
Q

Today the drug is still isolated from plants (digitalis lanata leaves rather than digitalis purpurea seeds) because

A

it is too difficult and expensive to synthesize chemically

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24
Q

a narcotic is used for pain control

A

opium

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25
Q

had been used as a medical and recreational drug since prehistoric times

A

opium

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26
Q

most powerful pain killers

A

opium

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27
Q

The source of opium is th

A

poppy plant (Papavir somniferum)

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28
Q

Growth of poppy plants for medicinal use in the U. S. is highly regulated

A

true

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29
Q

The German chemist, Friedrich Serturner, isolated the alkaloid _______ from ______ in 1805

A

morphine
opium

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30
Q

By 1820, the isolation of morphine had lead the way to techniques for the isolation of

A

caffeine, atropine, & strychnine

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31
Q

the way we regulated morphine from poppy seeds was the same technique to regulate caffeine

A

true

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32
Q

atropine is used to

A

dilate your eyes

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33
Q

what is strychnine

A

poison

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34
Q

The history of coffee goes at least as far back as the _____ century

A

13th

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35
Q

The original native population of coffee is thought to have come from ______ specifically from ______

A

East Africa
Ethiopia

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36
Q

It was first cultivated by _____ from the 14th century and onward

A

Arabs

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37
Q

Caffeine is extracted from the coffee plant,

A

Coffea arabica

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38
Q

Caffeine works by stimulating the

A

CNS, heart, and muscles

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39
Q

It relieves mental and physical fatigue and increases mental alertness

A

caffeinr

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40
Q

an enchantress of exceeding loveliness

A

belladona

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41
Q

Devil’s cherries

A

Atropa belladonna

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42
Q

what are the two alkaloid substances isolated from a plant

A

atropine
scopolamine

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43
Q

can be used topically but not swallowed

A

atropa belladonna

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44
Q

what is atropine used for

A

(medicinal use)
Belladonna plasters often applied after a fall to the injured or sprained part
Ingestion in excess amounts is a poison

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45
Q

what is scopolamine used for

A

Used for motion sickness (Transderm Scōp - patch), sedative, truth serum, and mydriasis (prolonged or excessive pupil dilation)

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46
Q

what is salicylic acid

A

Willow bark is a source of salicin, which is metabolized to salicylic acid in the body

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47
Q

a precursor to aspirin (popular analgesic/anti-inflammatory agent)

A

salicin & salicylic acid

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48
Q

Acetylsalicylic acid,

A

aspirin

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49
Q

increase the risk of bleeding, ulcers, and tinnitus

A

Willow bark and salicylates

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50
Q

adrenaline

A

epinephrine

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51
Q

hormone & NT

A

Epinephrine, also known as adrenaline

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52
Q

first hormone isolated in 1897, by John Jacob Abel, a researcher at Johns Hopkins University and the father of modern pharmacology

A

Epinephrine, also known as adrenaline

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53
Q

where is epinephrine produced

A

Some neurons of the CNS
The chromaffin cells of the adrenal medulla from the amino acids, phenylalanine and tyrosine

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54
Q

who is the father of modern pharmacology

A

jacob abel

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55
Q

what is in the epipens?

A

epinephrine

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56
Q

what are phenylalanine and tyrosine?

A

essential amino acids - produced in the body

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57
Q

what is acetylcholine

A

one of many neurotransmitters in the autonomic nervous system (ANS)
acts on both the peripheral and central nervous system
only neurotransmitter used in the motor division of the somatic nervous system

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58
Q

It was isolated by Otto Loewi in 1914, and Henry Hallet Dale in 1936, who found that it was present in the autonomic and peripheral nervous systems

A

acetylcholine

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59
Q

acetylcholine is an amino acid

A

false
hormones

60
Q

In cardiac tissue, acetylcholine neurotransmission has an _____ effect, which lowers heart rate

A

inhibitory

61
Q

also behaves as an excitatory neurotransmitter at neuromuscular junctions in skeletal muscle

A

acetylcholine

62
Q

sulfa was founded by

A

Gerhard Johannes Paul Domagk,
germal biochemist in 1932

63
Q

how did sulfa come about

A

tested a red dye, Prontosil
The dye had no antibacterial properties, but when Domagk slightly changed its chemical makeup, Prontosil was able to arrest infections in mice caused by streptococcal bacteria
He discovered the active antibacterial portion of the dye and named it sulfanilamide (one of the first antibiotics)

64
Q

first effective treatments for pneumonia, meningitis, and other bacterial diseases

A

sullfa

65
Q

pre-dated the clinical use of penicillin

A

sulfa drugs

66
Q

One of the main components carried by combat medics during WWII was ______ and ______ that greatly reduced mortality

A

sulfa powder
sulfa tablets

67
Q

used today to treat infections of the urinary tract

A

sulfas

68
Q

who and when discovered penicillin

A

1928
Alexander Fleming

69
Q

what did alexander fleming discover in 1928

A

He accidentally discovered that a mold known as penicillium notatum inhibited growth of staphylococcus aureus (a bacteria) in a petri dish in his lab

named the active ingredient penicillin

70
Q

who in 1940, worked with penicillin and turned it into a usable product

A

Chain and Florey of Oxford University, U. K.,

71
Q

what is the FDA

A

regulatory agency that is involved in regulation of drug development
evolved in response to a public need

72
Q

The Pure Food and Drug Act -1906

A

Prompted by unsanitary and unsafe conditions in the meat packing industry, Congress created the FDA

73
Q

Prior to and at the start of the 20th century, tampering and mislabeling of food and drugs was common

A

true

74
Q

was used during WWII in 1941 and saved many live

A

penicillin

75
Q

The Pure Food and Drug Act -1906 required that

A

drugs meet standards of strength and purity
burden of proof was on the FDA to show that the drug was false/fraudulent before it could be taken off the market

76
Q

what are elixirs

A

syrups

77
Q

what drug was only able to be mixed with diethylene glycol, antifreeze?

A

a sulfa drug called Strep-Elixir or Elixir Sulphonamide

78
Q

In 1937, a 107 people, many of them children, had died from mass poisoning by this untested productdiethylene glycol, antifreeze

A

Strep-Elixir or Elixir Sulphonamide mixed with diethylene glycol, antifreeze

79
Q

what was passed by congress in response to Strep-Elixir incident

A

In 1938, Congress passed the Food and Drug Cosmetic Act

80
Q

what is the strep-elixir incident

A

Eli Lilly developed a sulfa drug called Strep-Elixir or Elixir Sulphonamide
But unknown to the public, while trying to make a mixture, they could not dissolve the drug molecule in anything other than diethylene glycol (a chemical analogue of antifreeze), which is toxic to the liver
In 1937, a 107 people, many of them children, had died from mass poisoning by this untested product

81
Q

Food, Drug and Cosmetic Act of 1938

A

Required proof of a drug’s safety and purity
Mandated that manufacturers obtain pre-market approval from the FDA contingent on demonstrated safety
Regulated labeling and packaging of drug products

82
Q

Durham-Humphrey Act of 1952

A

Granted the FDA authority to determine which drugs may be sold without a prescription
FDA examined a drug’s toxicity and the ability for someone to self-diagnose
OTC drugs are sold with lower dosage than their prescription counterparts and used primarily to treat symptoms, not cure diseases

83
Q

alleve is otc for what medication

A

naproxen - decrease in pain, inflammation and fever

84
Q

1962 Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act

A

Required proof of efficacy as well as safety for new drugs and drugs approved since 1938
Established guidelines for adverse event reporting, clinical testing, and advertising (drugs must be appropriately labeled)

85
Q

Orphan Drug Amendments of 1983

A

Provides manufacturers incentives, such as tax deductions for their clinical trials, to manufacture drugs that treat rare diseases (diseases that affect <200,000 people)
E.g., Lou Gehrig’s disease and Tourette’s syndrome

86
Q

what is efficacy

A

how well it works, does it work

87
Q

More commonly known as early access programs or compassionate use exemptions, began decades ago during the AIDS crisis

A

FDA Expanded Access program, 1987, streamlined in 2017-2018

88
Q

Expedited Drug Approval Act of 1992

A

allowed accelerated FDA approval for drugs of significant medical need
Required detailed post-marketing surveillance (Phase IV-Clinical Trials)

88
Q

when a drug is used for something else but was not approved for it

A

off label use

89
Q

FDA Modernization Act of 1997

A

Allowed drug manufacturers to discuss unapproved or “off label” indications for drug products with practitioners
Provided for accelerated drug approvals for life-threatening medical disorders
Made provisions for pediatric drug research
Revised communications between FDA and researchers conducing clinical trials

90
Q

Dietary Supplement Health and Education Act of 1994

A

Dietary supplements are defined as vitamins, minerals, herbs, botanicals, other plant-derived substances, amino acids, concentrates, metabolites and constituents and extracts of these substances
FDA oversees the safety, manufacturing and health claims made by dietary supplements
FDA does NOT evaluate efficacy of supplements
FDA must demonstrate that a supplement is unsafe before taking action against it

91
Q

Federal Food, Drug, and Cosmetic Act of 2006

A

Required the dietary supplement industry to report all serious dietary supplement-related adverse drug events to the FDA

92
Q

FDA Amendments ACT (FDAA – 2007)

A

In response to the safety issues of COX-2 inhibitors (anti-inflammatory drugs) that led to cardiac issues and strokes
Gave enhanced authority to FDA to manage safety of approved drugs
Focused on Risk Evaluation and Mitigation Strategies (REMS) for new and already approved drugs

93
Q

FDA regulates drugs sold without a prescription

A

FDA reviews OTC drugs for misbranding and adulteration
FDA sets guidelines to which OTC drugs are safe and effective
FDA has authority to prevent sales and to withdraw OTC drugs from the market

94
Q

Controlled substances are drugs that have some potential for

A

abuse or dependence

95
Q

FDA also regulates

A

controlled substances

96
Q

Controlled Substances Act (CSA) (1970)

A

The Drug Enforcement Administration (DEA) administers the CSA and regulates manufacture and distribution of substances with potential for abuse including
Opioids (narcotics), stimulants, and sedatives

97
Q

Before these laws, mixtures containing opium and cocaine were sold over-the-counter (OTC)

A

true

98
Q

strongest warning the FDA has

A

black bbox

99
Q

Opioids are powerful pain relievers and include

A

morpine, hydrocodone, and codeine

100
Q

FDA is responsible for protecting the public health by

A

Assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation

101
Q

Today’s FDA is one of the strictest and most respected drug regulatory bodies in the world

A

tru

102
Q

FDA is responsible for advancing the public health by

A

Helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health

103
Q

FDA has responsibility for regulating the f

A

Manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors

104
Q

FDA plays a significant role in the Nation’s counterterrorism capability by

A

By ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats

105
Q

In the U. S., the time necessary to develop a new drug is approximately ______ years, with an average of ____ years

A

10 to 15
~12

106
Q

The clinical development phase of drug development is ______ years

A

~ 6 to 7

107
Q

why was the covid vaccine remarkable

A

The clinical development phase of drug development is ~ 6 to 7 years
Which makes the <1 year development of the mRNA COVID-19 vaccine truly remarkable

108
Q

The estimated cost of developing a drug in the U. S. from invention to pharmacy is ~ $________depending on what the drug is for (this includes the cost of failed compounds)

A

$1 to 2 billion

109
Q

Only ______ drugs that enter clinical testing is approved & marketed
But then big commercial drug successes gross billions in annual drug revenues

A

1 of 10

110
Q

general phases of drug development

A

Synthesis or discovery of new chemicals from the test tube or plant(s)
Safety evaluation in animals and humans
Effectiveness evaluation in humans
Review of new drug application
Post-marketing surveillance to report all adverse effects

111
Q

Drug Discovery phase

A

This phase produces a new molecule
First patents are filed at this stage and granted several years later

112
Q

Drug Development phase

A

The process requires that biological characterization and toxicology animal studies be conducted prior to filing an Investigational New Drug (IND) application
An IND is required at the start of clinical (human) trials (Phase I to III)
At the conclusion of successful clinical trials, the drug company files a New Drug Application (NDA), which is reviewed by the FDA

113
Q

Post Approval Regulation

A

Once approved, a drug must be monitored for the remainder of its life span (Phase IV)

The first of the drug’s patents expires 20 years after its application

Abbreviated New Drug Application (ANDA) can be filed before expiration of original patent

114
Q

what is a patent

A

something is going to be of value and file this and only that specific company can produce that medicine

115
Q

LD50

A

Determination of the lethal dose
dose of the drug that kills 50% of the total numbers of mice that received it

116
Q

ED50

A

Determination of effectiveness dose

does of a drug that causes an effect in 50% of the total numbers of mice that received it

117
Q

What is the margin of safety

A

LD50 ÷ ED50

118
Q

If LD50 is 10 mg and ED50 is 2 mg then the margin of safety is

A

only 5
10 divided by 2 = 5

119
Q

acceptable margin of drug safety in humans is

A

> /= 2000

119
Q

waht does a margin of safety of 5 mean

A

that the lethal dose is only 5x the effective dose, which may be predictive of a low margin of safety in humans

120
Q

Short-term toxicity testing

A

Testing in animals
General profile screen in mice
Determination of the lethal dose = LD50
Determination of effectiveness dose = ED50

121
Q

Long-term toxicity

A

Also known as chronic toxicity studies
Daily dosing to rats and dogs from 3 months to 2 years
Observe for toxicities, evaluate blood chemistries
Sacrifice the animal, then evaluate histopathology
Many toxic effects appear only after repeated dosing over many months or years
That is the reason why post approval regulation is required

122
Q

Studies on reproduction

A

can females who are pregnant or trying to affect the fetus?
does the drug prevent ovulation
does the drug prevent fertilization
does the drug cause the expulsion of embryo from the uterus?

123
Q

Studies on carcinogenicity

A

does a drug cause cancers
Drugs are given to laboratory rats for over 6 months

124
Q

any signs of cancer are enough to stop testing of a drug

A

true

125
Q

Investigational New Drug Application (IND)

A

Submitted if the drug has an impressive margin of safety in mice
Submitted if a drug lacks long-term toxicities
Submitted if a drug does not cause cancer, reproductive effects, or birth defects
A 30-day approval by the FDA (usually takes longer)

126
Q

Contents of IND

A

Data acquired in animal studies
Protocols for human tests
Chemical structure of the drug
How the drug is synthesized
Formulation of dose form
Packaging information

127
Q

Clinical Studies – Phase 1

A

Begins immediately after IND approval
20 to 100 healthy volunteers (usually healthy males)
Primarily evaluates safety of the drug in humans
Determines pharmacokinetics (what the body does with the drug)
Establishes the dose at which toxicity appears
Trial lasts for several months
Non-blinded trials

128
Q

Clinical Studies – Phase 2

A

Given to patients having the condition for which drug is intended
Up to several hundred patients in the trial
Study of short-term effectiveness and safety
Establishes therapeutic efficacy, dose-response and dose range, kinetics, and metabolism

The trial lasts for several months to two years
Single-blind trial

129
Q

desctibe phase two

A

looking for PTs that have that condition that the medicine acts on

is it effective? does it treat the condition?
is it working?
how high can we go? how high can we raise it before we see toxicity occurring
how is it excreted how is it metabollized? (urine & blood tests to monitor)

longer trial times

130
Q

describe phase 2

A

no control, no experimental - just one group and the people know that they are getting the drug

want to see if it is dangerous or not
what level leads to issues but not death

131
Q

Non-blinded trials

A

participant and investigator are both aware of what is being administered

132
Q

Single-blind trial

A

drug of interest is evaluated against a placebo or existing therapy
participatn doesnt know if they are getting the drug or the placebo
control group - 2 groups of participants

133
Q

Clinical Studies – Phase 3

A

Patient numbers in the study ranges from several hundred to several thousand and are more heterogenous
Confirms drug safety, dosage, and effectiveness
Tries to detect adverse effects undetected in prior studies
Trial lasts one to four years
Randomized, double-blind studies
Participants randomly assigned to either the drug or placebo group

134
Q

heterogenous meaning in phase 3

A

mixture, more diverse
mixed gender, severity of disease can vary
more mixed group

135
Q

double-blind studies

A

Participants randomly assigned to either the drug or placebo group
highest level of research in heirarchy of research
neither investigator or participants know who gets what

136
Q

it is the most effective design to distill true effects from placebo effects and from natural fluctuations in course of the disease

A

Randomized, double-blind studies

137
Q

what is one problem in phase 3

A

One problem is the small number of patients taking the drug for maybe up to four years compared to potentially millions who will take the drug long term

138
Q

Drug toxicities which occur at less than 1 in 1000 exposures may not be revealed in Phase 3 clinical trials

A

true
These toxicities may only be revealed after marketing when millions of people would take drug long term

139
Q

New Drug Application (NDA) Process

A

submitted after the successful conclusion of clinical trials
after approx 8-9 yrs of animal and human testing

140
Q

Patent on drugs lasts _____ years after applying for the patent prior to Phase 1 of clinical testing

A

~ 20

141
Q

Post-marketing Surveillance – Phase 4 Studies

A

Occurs after FDA approval
The drug is monitored for the remainder of its life span
drug is now used by much greater number of people than in clinical studies

142
Q

A drug can be pulled off the market if new toxicities are uncovered. but what usually happens instead

A

if problems result that are not life threatening, they can be addressed by relabeling of the drug with new warnings or precautions

143
Q

why monitored so long?

A

things can happen on the market that didn’t happen during clinical trials because more people are taking it

144
Q

Clinical Phases of Drug Development (FDA Approval)

A

Phase 1
Involves 20 – 100 people in the clinical trial
Tested for safety in healthy volunteers
Phase 2
Up to several hundred people in the clinical trial with the disease
Tested for short-term safety and effectiveness
Phase 3
Several hundred to several thousand people involved in the trial
Tested for safety, dosage, effectiveness, adverse events
Phase 4
Post-marketing surveillance for adverse event monitoring for ever

145
Q

The entire process can take 8 to 15 years and cost ~$1 to 2 billion.

A

true

Pharm & Ototoxicity (10 decks)

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