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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
Salicylic acid
willow bark is a source of salicin, which is metabolized to salicylic acid in the body
26
Salicin and salicylic are chemical precursors to ?
Apirin(N-acetyl salicylic acid) popular anti-inflammatory agent
27
willow bark and salicylates increase the risk of
bleeding/ulcers/ and tinnitus
28
hormones epinephrine also known as? it is a ____ and _____
adrenaline hormone and neurotransmitter
29
What was the first hormone isolated in 1897 by John Jacob Abel
epinephrine
30
epinephrine is produced in
neurons of CNS chromaffin cells of the adrenal medulla from amino acids, phenylalanine and tyrosine
31
what is necessary to produce TYROSINE in body
phenylalanine
32
Hormones Acetylcholine (Ach) neurotransmitter in acts on both ___ & ____ only neurotransmitter used in the ?
Autonomic nervous system peripheral and central nervous system motor division of the somatic nervous system
33
In cardiac tissue , acetylcholine neurotransmission has a ____ effect but behaves as an _____ neurotransmitter at neuromuscular junction in skeletal muscle
inhibitory; lowering heart rate excitatory ; neuromuscular junctions in skeletal muscle
34
Sulfa 1932 red dye tested = Prontosil Dye had no antibacterial properties but when chemical makeup changed....
Prontosil able to arrest infections in mice caused by streptococcal bacteria
35
active antibacterial portion of dye was named
sulfanilamide
36
what was the first effective treatment for pneumonia, meningitis, and other bacterial diseases
sulfanilamide
37
sulfa drugs pre dated the clinical used of penicillin ,carried by combat medics during WWII was sulfa powder because it reduced
mortality
38
sulfas used today to treat infections
urinary tract
39
Penicillin (1928)
mold known as penicillium notatum inhibited growth of staphylococcus aureus (bacteria)
40
Why was penicillin production needed in the US?
because of the ongoing war
41
what is the FDA?
food and drug administration agency involved in regulation of drug development
42
two reasons for FDA
evolved in response to a public need prior to 20th century, tampering and mislabeling of food and drugs was common
43
Pure Food and Drug Act 1906 prompted by: Law only required: 1) 2)
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
1932, Eli lily developed a sulfa drug called Strep- Elixir or Elixir Sulphonamide but,
could not disolve the drug molecule in anything other than diethylene glycol (antifreeze) toxic to the liver 107 people died
45
what was passed in 1938 in response to the strep elixir incident ?
Food and Drug Cosmetic Act
46
Food drug and cosmetic act of 1938
-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
Durham Humphrey Act of 1952
- 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
Kefauver Harris Amendments to the food and drug and cosmetic act (1962)
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
Orphan Drug Amendments of 1983
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
FDA expanded Access program , 1987, streamlined in 2017-2018
early access programs or compassionate use exemptions, begin during AIDS crisis
51
what is the intent of the FDA expanded access program
allow FDA to permit pharmaceutical companies to broaden access to investigational products while they're still undergoing clinical trials
52
Expedited drug approval act of 1992
allow accelerated FDA approval for drugs of significant medical need required detailed post marketing surveillance (phase IV clinical trials
53
FDA Modernization Act of 1997
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
Dietary Supplement Health and Education Act 1994
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
FDA oversees the safety, manufacturing and health calims made by dietary supplements but does NOT
evaluate efficacy of supplements FDA must demonstrate that a supplement is unsafe before taking actions against it
56
Federal Food, Drug, and Cosmetic Act of 2006
required the dietary supplement industry to report all serious dietary supplement related adverse drug events to the FDA
57
FDA Ammendments ACT (FDAA 2007)
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
Over the counter medications (OTC) medications FDA regulated drugs sold without a prescription
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
FDA also regulates the supplemental product manufactures (2007)
- to test products for purity - to assure that products do not contain containments - verify that contents within package matched labeling information
60
Controlled Substances are drugs that have some potential for abuse or dependence
FDA also regulates controlled substances
61
Controlled Substances ACT (CSA) 1970
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
before these laws, mixtures containing opium and cocaine were
sold over the counter
63
On march 22, 2016 the fda required
a boxed or black box warning which is the strongest warning
64
opioids are powerful pain relievers and include
morphine, hydrocodone, and codeine
65
a boxed warning was already issues in 2013 for labels of long acting opioid pain medications such as
Oxycontin
66
FDA is responsible for protecting the public health by
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
FDA is responsible for advancing the public health by
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
FDA has responsibility for regulating the
manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors
69
FDA plays a significant role in the nations counterterrorism capabiity 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
70
The clinical development phase of drug development is in US approx
~ 6 to 7 years 10 to 15 years
71
Phases of Drug development general phases of drug development
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
drug discovery phase
this phase produces new molecule first patents are filed at this stage and granted several years later
73
drug development phase
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
post approval regulation
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
What is the ANDA abbreviated new drug application
application for US generic drug approval for an existing licensed medication or approved drug
76
Why are ANDA abbreviated
bc generally not required to include preclinical (animal) and clinical (human) trial data to establish safety and effectiveness
77
short term toxicity testing
testing in animals general profile screen in mice determination of the lethal dose = LD50
78
determination of the lethal dose
LD50
79
Determination of effectiveness dose
ED50
80
Margin of safety
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
Long term toxicity known as chronic toxicity studies
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
studies on reproduction
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
studies on carcinogenicity
- 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
Investigational new drug application
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
contents of IND
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
Clinical studies phase 1
87
clinical studies phase 2
88
Clinical studies phase 3
89

Pharmacology/Ototoxicity (3 decks)

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