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Pharmacology/Ototoxicity > Lectures 3 & 4: Drugs: History, FDA, & Society > Flashcards

Lectures 3 & 4: Drugs: History, FDA, & Society Flashcards

1
Q

Pharmacology defined

A

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

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2
Q

pharmacology is a combination of the greek words

Pharmakon =

Logos =

A
  • poison or drugs
  • study or discourse of
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3
Q

drugs

A

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

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4
Q

Since religion and men have existed

A

mixture of religion and use of plant substances has been common

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5
Q

In order to combat sickness and death, humans have sought plant and animal products since the earliest of time

  • many of these products discovered ______ and initially cuased
A
  • by trial and errors
  • more harm than good
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6
Q

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

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7
Q

Ppl 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
  • holes in leaves of Saint Johns Wort
A

walnuts were good to cure aliments of the head bc they had a perfect signature for the head

resembled pores of the skin and can treat disease and wounds of the skin

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8
Q

oldest prescriptions were on

A

clay tablets written by Sumerian physicians around 3000 BC

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9
Q

In southern Mesopotamia (modern day Iraq) more than 5000 years ago

A

summerians were one of the earliest urban societies to emerge in the world

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10
Q

Hippocrates (5th century BC) promoted the idea that

A

disease results from natural causes rather than evil spirits

believed body had abilities to recuperate from disease

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11
Q

how were EARLY medicines developed

A

by isolation and use of nature substances from botanical, mineral, and animal sources

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12
Q

How are medicines developed in MODERN time

A

chemical synthesis of compounds that have biological activity

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13
Q

Quinine
- contained
- drug against
- to treat

A
  • contained in some bark of trees
  • used as drug of choice against malaria
  • first specific drug used to treat an infectious disease
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14
Q

Synthesis of arsenicals (1910)

Sahachiro Hata and Paul Ehrlichs synthesized arsenicals by

led to use of arsphenamine (Salvarsan first chemotherapeutic agent) to TREAT?

A

attaching an arsenic atom to a carbon atom

  • syphilis
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15
Q

Digitalis

william Witherings use of purple foxglove (digitalis Purpurea) lead to isolation of digitalis

made tea to treat edema of?/still used as choice

drug is still isolated from plants (leaves rather than seeds) because

A

cardiac “dropsy” (congestive heart failure)

it is too difficult and expensive to synthesize chemically

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16
Q

German Chemist, Friedrich Serturner, isolated the alkaloid morphine from opium in 1805

narcotic used for?

used for ?

Source of opium?

Growth of poppy plants for medicinal use is

A
  • pain control
  • medical and recreational drug
  • poppy plant (Papavir Somniferum)
  • highly regulated bc its addictive
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17
Q

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

A

caffeine, atropine, and strychnine

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18
Q

Caffeine

history goes back as far as 13th century

original native population of coffee is thought to have come from ?

first cultivated by ?

A
  • east africa, Ethiopia

-Arabs

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19
Q

caffeine is extracted from coffee plant

A

coffee arabica

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20
Q

how does caffeine work?

what does it relieve

A

by stimulating the CNS, heart, muscles

mental and physical fatigue and increases mental alertness

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21
Q

Atropa belladonna (devils cherries)

the entire plant is?

Belladona? =

A

extremely poisonous

an enchantress of exceeding loveliness

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22
Q

two alkaloid substances isolated from plant?

A

Atropine

Scopolamine

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23
Q

Atropine

Belladonna plasters often applied after

ingestion in excess amount

A

dilates pupils

  • fall to the injured or sprained part

is poison

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24
Q

Scopolamine (extracted from Japanese Belladona)

used for ?

A

motion sickness, sedative, truth serum, and mydriasis (prolonged or excessive pupil dilation)

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25
Q

Salicylic acid

A

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

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26
Q

Salicin and salicylic are chemical precursors to ?

A

Apirin(N-acetyl salicylic acid) popular anti-inflammatory agent

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27
Q

willow bark and salicylates increase the risk of

A

bleeding/ulcers/ and tinnitus

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28
Q

hormones

epinephrine also known as?
it is a ____ and _____

A

adrenaline
hormone and neurotransmitter

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29
Q

What was the first hormone isolated in 1897 by John Jacob Abel

A

epinephrine

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30
Q

epinephrine is produced in

A

neurons of CNS

chromaffin cells of the adrenal medulla from amino acids, phenylalanine and tyrosine

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31
Q

what is necessary to produce TYROSINE in body

A

phenylalanine

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32
Q

Hormones

Acetylcholine (Ach)

neurotransmitter in

acts on both ___ & ____

only neurotransmitter used in the ?

A

Autonomic nervous system

peripheral and central nervous system

motor division of the somatic nervous system

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33
Q

In cardiac tissue , acetylcholine neurotransmission has a ____ effect

but behaves as an _____ neurotransmitter at neuromuscular junction in skeletal muscle

A

inhibitory; lowering heart rate

excitatory ; neuromuscular junctions in skeletal muscle

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34
Q

Sulfa

1932 red dye tested = Prontosil

Dye had no antibacterial properties but when chemical makeup changed….

A

Prontosil able to arrest infections in mice caused by streptococcal bacteria

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35
Q

active antibacterial portion of dye was named

A

sulfanilamide

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36
Q

what was the first effective treatment for pneumonia, meningitis, and other bacterial diseases

A

sulfanilamide

37
Q

sulfa drugs pre dated the clinical used of penicillin ,carried by combat medics during WWII was sulfa powder because it reduced

A

mortality

38
Q

sulfas used today to treat infections

A

urinary tract

39
Q

Penicillin (1928)

A

mold known as penicillium notatum inhibited growth of staphylococcus aureus (bacteria)

40
Q

Why was penicillin production needed in the US?

A

because of the ongoing war

41
Q

what is the FDA?

A

food and drug administration agency involved in regulation of drug development

42
Q

two reasons for FDA

A

evolved in response to a public need

prior to 20th century, tampering and mislabeling of food and drugs was common

43
Q

Pure Food and Drug Act 1906

prompted by:

Law only required:
1)
2)

A

unsanitary and unsafe conditions in the meat packing industry, congress created FDA

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

44
Q

1932, Eli lily developed a

sulfa drug called Strep- Elixir or Elixir Sulphonamide but,

A

could not disolve the drug molecule in anything other than diethylene glycol (antifreeze) toxic to the liver

107 people died

45
Q

what was passed in 1938 in response to the strep elixir incident ?

A

Food and Drug Cosmetic Act

46
Q

Food drug and cosmetic act of 1938

A

-required proof of a drugs safety and purity

  • mandated that manufactures obtain pre-market approval from the FDA contingent on demonstrated safety
  • regulated labeling and packaging of drug products
47
Q

Durham Humphrey Act of 1952

A
  • granted the FDA authority to determine which drugs may be sold without a prescription
  • FDA examined a drugs toxicity and the ability for someone to self diagnose

-OTC drugs are self with lower dosage than their prescription counter parts and used primarily to treat symptoms and not cure diseases

48
Q

Kefauver Harris Amendments to the food and drug and cosmetic act (1962)

A

required proof of efficacy(how well it works) 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)

49
Q

Orphan Drug Amendments of 1983

A

provides manufactures incentives such as tax deductions for their clinical trials, to manufacture drugs that treat rare diseases (diseases that affect <200,000 people)

ex: Lou Gehrigs disease and Tourette’s syndrome

50
Q

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

A

early access programs or compassionate use exemptions, begin during AIDS crisis

51
Q

what is the intent of the FDA expanded access program

A

allow FDA to permit pharmaceutical companies to broaden access to investigational products while they’re still undergoing clinical trials

52
Q

Expedited drug approval act of 1992

A

allow accelerated FDA approval for drugs of significant medical need

required detailed post marketing surveillance (phase IV clinical trials

53
Q

FDA Modernization Act of 1997

A

allowed drug manufactures to discuss unapproved off label indication drug products with practitioners

provided accelerated drug approvals for life threatening medical disorders

made provisions for pediatric drug research

revised cimmunication between FDA and researchers conducting clinical trials

54
Q

Dietary Supplement Health and Education Act 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

55
Q

FDA oversees the safety, manufacturing and health calims made by dietary supplements but does NOT

A

evaluate efficacy of supplements

FDA must demonstrate that a supplement is unsafe before taking actions against it

56
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

57
Q

FDA Ammendments ACT (FDAA 2007)

A

response to the safety issues of COX-2 inhibitors 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

objective: to ensure that benefits of a drug outweigh risks

58
Q

Over the counter medications (OTC)

medications

FDA regulated 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

59
Q

FDA also regulates the supplemental product manufactures (2007)

A
  • to test products for purity
  • to assure that products do not contain containments
  • verify that contents within package matched labeling information
60
Q

Controlled Substances are drugs that have some potential for abuse or dependence

A

FDA also regulates controlled substances

61
Q

Controlled Substances ACT (CSA) 1970

A

the drug enforcement administration (DEA) administers the CSA and regulates manufacture and distrubtion of susbtances with potential for abuse including

Opioids, stimulants, and sedatives

62
Q

before these laws, mixtures containing opium and cocaine were

A

sold over the counter

63
Q

On march 22, 2016 the fda required

A

a boxed or black box warning which is the strongest warning

64
Q

opioids are powerful pain relievers and include

A

morphine, hydrocodone, and codeine

65
Q

a boxed warning was already issues in 2013 for labels of long acting opioid pain medications such as

A

Oxycontin

66
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 nations food supply, cosmetics, and products that emit radiation

67
Q

FDA is responsible for advancing the public health by

A

helping to speed innovations that makes 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

68
Q

FDA has responsibility for regulating the

A

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

69
Q

FDA plays a significant role in the nations counterterrorism capabiity by

A

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

70
Q

The clinical development phase of drug development is

in US approx

A

~ 6 to 7 years

10 to 15 years

71
Q

Phases of Drug development

general phases of drug development

A

synthesis or discovery of new chemicals from the test tube or plants

safety evaluation in animals and humans

effectiveness evaluation in humans

review of new drug application

post marketing surveillance to report all adverse effects

72
Q

drug discovery phase

A

this phase produces new molecule

first patents are filed at this stage and granted several years later

73
Q

drug development phase

A

process requires that biological characterization and toxicology animal studies be conducted prior to filling an investigational new drug application

An IND is required at the start of clincal (human) trials (phase I to III)

at conclusion of succesful clinical trials the drug company files a new drug application (NDA) which is reviewed by the FDA

74
Q

post approval regulation

A

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

first of the drugs patents expires 20 years after its application

Abbreviated new drug application (ANDA) can be filed before expiration of original patient

75
Q

What is the ANDA
abbreviated new drug application

A

application for US generic drug approval for an existing licensed medication or approved drug

76
Q

Why are ANDA abbreviated

A

bc generally not required to include preclinical (animal) and clinical (human) trial data to establish safety and effectiveness

77
Q

short term toxicity testing

A

testing in animals
general profile screen in mice
determination of the lethal dose = LD50

78
Q

determination of the lethal dose

A

LD50

79
Q

Determination of effectiveness dose

A

ED50

80
Q

Margin of safety

A

LD50 / ED50

if LD50 os 10mg and ED50 is 2 mg then the margin of safety is only 5

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

81
Q

Long term toxicity

known as chronic toxicity studies

A

daily dosing to rats and dofs from 3 months to 2 years

observe for toxicities, evaluate blood chemistries

sacrifice the animal, then evaluate histopathology

82
Q

studies on reproduction

A

does drug prevent ovulation
does drug prevent fertilization
does drug cause the expulsion of embryo from the uterus

does drug cause birth defects (teratogenicity)

83
Q

studies on carcinogenicity

A
  • do cancerous tumors appear?
  • what is the potential for causing bladder cancer in rats?
  • any signs of cancer are enough to stop testing of a drug
84
Q

Investigational new drug application

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

85
Q

contents of IND

A

data required in animal studies
protocols for human tests
chemical structure of the drug
how the drug is syntehsized
formulation of dose form
packaging information

86
Q

Clinical studies phase 1

A
87
Q

clinical studies phase 2

A
88
Q

Clinical studies phase 3

A
89
Q
A

Pharmacology/Ototoxicity (3 decks)

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