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AUDE 6120 > drug: history, fda > Flashcards

drug: history, fda Flashcards

1
Q

What is pharmacology?

A

-Pharmacology is defined as “the basic and clinical applied science that deals with the fate and actions of drugs in the body”
-The term pharmacology is a combination of the Greek words

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2
Q

Define Drugs

A

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

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3
Q

What is the doctrine of signatures?

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
-It’s believed that different elements of the earth were made to treat different treatments

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4
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
-FIRST SUCCESSFUL DRUG TO PREVENT MALARIA

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5
Q

What is synthesis of arsenicals? -1910

A

-Sahachiro Hata and Paul Ehrlich’s synthesized arsenicals by attaching an arsenic atom to a carbon atom
-It led to the use of arsphenamine (Salvarsan-first chemotherapeutic agent) to treat syphilis

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6
Q

What is digitalis?

A

-William Withering’s use of purple foxglove (digitalis purpurea) in 1783, lead to the isolation of digitalis
-He made a tea to treat the edema of cardiac “dropsy” (congestive heart failure)
-Digitalis is still the drug of choice for congestive heart failure
-Today the drug is still isolated from plants (digitalis lanata leaves rather than digitalis purpurea seeds) because it is too difficult and expensive to synthesize chemically

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7
Q

What is digital used for ?

A

-it’s used for heart disease and it’s still used today

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8
Q

Where did alkaloid morphine come from?

A

-The German chemist, Friedrich Serturner, isolated the alkaloid morphine from opium in 1805

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9
Q

What does caffeine stimulate in the body ?

A

-Caffeine works by stimulating the CNS, heart, and muscles
-It relieves mental and physical fatigue and increases mental alertness

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10
Q

What is opium used for ?

A

-Opium, a narcotic is used for pain control
-Opium had been used as a medical and recreational drug since prehistoric times
–The source of opium is the poppy plant (Papavir somniferum)
-Growth of poppy plants for medicinal use in the U. S. is highly regulated

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11
Q

What is atropa belladonna?

A

-(Devil’s cherries)
-The entire plant is extremely poisonous
-Belladona = an enchantress of exceeding loveliness

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12
Q

What are the 2 alkaloid substances isolated from plants?

A

-Atropine
-Scopolamine (extracted from Japanese Belladona)

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13
Q

What is atropine?

A

-Dilates the pupils (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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14
Q

What is Scopolamine (extracted from Japanese belladona)

A

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

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15
Q

What is salicylic acid ?

A

-Salicin and salicylic acid are chemical precursors to aspirin (N-acetyl salicylic acid), the popular analgesic/anti-inflammatory agent

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16
Q

Where did salicylic acid come from?

A

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

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17
Q

What did salicylic acid convert to?

A

-converted salicylic acid to the acetyl derivative
-Acetylsalicylic acid, also known as aspirin

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18
Q

Willow bark and salicylates increase the risk ?

A

-bleeding, ulcers and tinnitus

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19
Q

What is epinephrine known as ?

A

Adrenaline

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20
Q

What is epinephrine?

A

-It is a hormone and a neurotransmitter
-It was the first hormone isolated in 1897

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21
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
-Phenylalanine is necessary to produce tyrosine in the body

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22
Q

What is acetylcholine?

A

It is one of many neurotransmitters in the autonomic nervous system (ANS)

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23
Q

Where does acetylcholine act on ?

A

-It acts on both the peripheral and central nervous system
-It is the only neurotransmitter used in the motor division of the somatic nervous system

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24
Q

How does acetylcholine affect the cardiac tissue?

A

-In cardiac tissue, acetylcholine neurotransmission has an inhibitory effect, which lowers heart rate
-But acetylcholine also behaves as an excitatory neurotransmitter at neuromuscular junctions in skeletal muscle

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25
Q

What is a quick background of sulfa ?

A

-Gerhard Johannes Paul Domagk, a German biochemist, in 1932, 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)

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26
Q

What was the first treatment for pneumonia, meningitis, and other bacterial diseases?

A

-Sulfa

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27
Q

Why do we use sulfas today?

A

-To treat infections of urinary tract
-Sulfa drugs pre-dated the clinical use of penicillin
-One of the main components carried by combat medics during WWII was sulfa powder and sulfa tablets that greatly reduced mortality

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28
Q

How was penicillin discovered?

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
-He named the active ingredient penicillin

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29
Q

What is the FDA?

A

-The food and drug administration (FDA) is the regulatory agency that is involved in regulation of drug development

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30
Q

What is the pure food and drug act -1906?

A

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

31
Q

What law occurred because of the pure food and drug act ?

A

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

32
Q

What happened in 1932 with the sulfa drug?

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

33
Q

What was passed because of the 1932 incident?

A

-In 1938, Congress passed the Food and Drug Cosmetic Act in response to the Strep-Elixir incident
-but nothing happened to them

34
Q

What is the food, drug, and cosmetic act of 1938?

A

-It 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
-So labeling is now on products and it tells you the ingredients of the product

35
Q

What is the Durham- Humpgrey 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
-so you can go get meds without going to the doctor for obvious stuff

36
Q

What is the 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)

37
Q

What is the orphan drug amendment 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

38
Q

What is the FDA expanded access program, 1987?

A

-The intent of these programs is to allow FDA to permit pharmaceutical companies to broaden access to investigational products while they’re still undergoing clinical trials. For example,
-A drug is undergoing clinical trials for one type of cancer treatment
-A different type of cancer that will almost certainly kill the patient and all existing options have failed to treat that cancer
-The patient’s doctor believes that the drug being tested for the other type of cancer might be of some benefit to his patient
-Under this program, the patient could be given the medication for his cancer even though the drug trials are being conducted for a different type of cancer, which normally does not happen
-So the patient can get a med while its still on trial to treat one cancer while that med is supposed to treat something else (off label use)

39
Q

What is the 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)

40
Q

What is the FDA modernization of 1997?

A

Allowed drug manufacturers to discuss unapproved or “off label” indications for drug products with practitioners

41
Q

What did the FDA modernization act of 1997 provide?

A

-Provided for accelerated drug approvals for life-threatening medical disorders
-Made provisions for pediatric drug research
So there was now research for pediatric drug now
-Revised communications between FDA and researchers conducting clinical trials

42
Q

What is the 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
-The medication might be safe but it might not work for what you want it to
-FDA must demonstrate that a supplement is unsafe before taking action against it

43
Q

What is the 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

44
Q

What is the 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

45
Q

What did the FDA amendment act (FDAA-2007) focus on ?

A

-Focused on Risk Evaluation and Mitigation Strategies (REMS) for new and already approved drugs
- Objective: to ensure that benefit of a drug outweigh risk

46
Q

What does the FDA regulate when it comes to OTC?

A

1)FDA regulates 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
2)FDA also regulates the supplemental product manufacturers (2007)
-To test products for purity
-To assure that products do not contain contaminants
-To verify that contents within package matched labeling information

47
Q

Why are controlled substances regulated ?

A

-Controlled substances are drugs that have some potential for abuse or dependence
-FDA also regulates controlled substances

48
Q

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

49
Q

What did the FDA require on March 22, 2016?

A

-On March 22, 2016, the FDA required a boxed or black box (on the box) warning, which is the strongest warning, about
-“The serious risks of misuse, abuse, addiction, overdose, and death” for all short-acting opioid pain medications”

-A boxed warning was already issued in 2013 for labels of long-acting opioid pain medications, such as OxyContin
-Opioids are not meant for long-term use but that is how they were being prescribed generally until very recently, leading to adverse affects/addictions and the current opioid crisis

50
Q

What do opioids include?

A

Morphine, hydrocodone, and codeine

51
Q

Long term use of opioids may cause ?

A

hearing loss

52
Q

What is the FDA responsible for?

A

1)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 nation’s food supply, cosmetics, and products that emit radiation
2)FDA is responsible for advancing the public health by
-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
3)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
4)FDA plays a significant role in the Nation’s counterterrorism capability by
-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
-Today’s FDA is one of the strictest and most respected drug regulatory bodies in the world

53
Q

What is the clinical development phase of drug development?

A

-In the U. S., the time necessary to develop a new drug is approximately 10 to 15 years, with an average of ~12 years
-6 to 7 years
-Which makes the <1 year development of the mRNA COVID-19 vaccine truly remarkable
-The discovery and development of new drugs is a lengthy, high risk, and complex process

54
Q

What is the cost for developing a drug in the US?

A

The estimated cost of developing a drug in the U. S. from invention to pharmacy is ~ $1 to 2 billion depending on what the drug is for (this includes the cost of failed compounds)

55
Q

What are the 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
-Reporting any side effects

55
Q

How many drugs are approved and marketed?

A

1 out of 10 enter clinical testing is approved and marketed

56
Q

What is the drug discovery phase?

A

-This phase produces a new molecule
-Scientist think what molecules they can put together to produce a new drug
-Brainstorming phase
-First patents are filed at this stage and granted several years later

57
Q

What is the 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
-Investigating to see if this drug is safe

58
Q

What are post approval regulations?

A

-Once approved, a drug must be monitored for the remainder of its life span (Phase IV)
-it will be continue to be regulated for that drug life
- The first of the drug’s patents expires 20 years after its application
-after 20 years anyone can make it
-its open market
- Abbreviated New Drug Application (ANDA) can be filed before expiration of original patent
- Once the patent expires, generic versions can become available
-anyone can make it

59
Q

What is the Abbreviated new drug application?

A

-ANDA is an application for a U.S. generic drug approval for an existing licensed medication or approved drug

60
Q

Why are the ANDA applications abbreviated?

A

-These applications are “abbreviated” because they are generally not required to include preclinical (animal and in vitro) and clinical (human) trial data to establish safety and effectiveness
-Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator or original drug)
-One way to demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volunteers, which provides the rate of absorption or bioavailability
-Generic versions must deliver the same amount of active ingredients in a patient’s bloodstream in the same amount of time as the innovator drug
-So the generic version has to act the same way as the original drug (they have to be bioequivalent)

61
Q

What is short term toxicity testing?

A

-Testing in animals
-General profile screen in mice
-Determination of the lethal dose = LD50
-Dose of a drug that kills 50% of the total # of mice that received it
-If you have a study of 100 mice, you want 50 of the mice alive at the end of it or else it’s not a good dosage
-Determination of effectiveness dose = ED50
-Dosage of a drug that cause an effect in 50% of the total # of mice that received it

62
Q

What is margin of safety?

A

-The margin of safety is LD50 ÷ ED50
-If LD50 is 10 mg and ED50 is 2 mg then the margin of safety is only 5
10 divided by 2 = 5
-This means that the lethal dose is only 5x the effective dose, which may be predictive of a low margin of safety in humans
-Acceptable margin of drug safety in humans is greater than or equal to 2000

63
Q

What is 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

64
Q

What are questions that are asked that are applied to studies on reproduction?

A

-Does the the drug prevent ovulation ?
-Does the drug prevent fertilization?
-Does the drug cause the expulsion of embryo from the uterus ?
-Does the drug cause birth defects (teratogenicity)?

65
Q

What are questions that are asked that are applied for the studies of carcinogenicity ?

A

-Drugs are given to laboratory rats for over 6 months
-Do cancerous tumors appear ?
-What is the potential for causing bladder cancer in rats?
ANY SIGNS OF CANCERS ARE ENOUGH TO STOP TESTING OF A DRUG

66
Q

What is 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)

67
Q

What contents are involved in the 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

68
Q

In clinical studies, what is 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
they increase the dose to see how high it can get before it gets toxic
-Trial lasts for several months
-Non-blinded trials:
-People know what groups their in
-Participants and investigators are aware of what is being administered

69
Q

In clinical studies, what is 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
-Also studies adverse drug events
-The trial lasts for several months to two years
-Single-blind trial
-Drug of interest is evaluated against a placebo or existing therapy
-Why produce a new drug if something like it already exisit
-Participants are unaware of what they’re receiving

70
Q

In clinical studies, what is phase 3?

A

-Patient numbers in the study ranges from several hundred to several thousand and are more heterogeneous (more diverse)
-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
=NEITHER THE PARTICIPANT NOR THE INVESTIGATOR KNOWS WHICH GROUP THE SUBJECT IS IN
-It is the most effective design to distill true from placebo effects and from natural fluctuations in the course of the disease

71
Q

What problems might be seen in phase 3 of clinical studies?

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
-Drug toxicities which occur at less than 1 in 1000 exposures may not be revealed in Phase 3 clinical trials
-These toxicities may only be revealed after marketing when millions of people would take drug long term

72
Q

What is the New drug application (NDA)?

A

-Once everything is good, you can apply for this
-NDA is submitted after the successful conclusion of clinical trials

-If FDA approves, the drug manufacturer can sell the new product as an exclusive proprietary drug
-Patent on drugs lasts ~ 20 years after applying for the patent prior to Phase 1 of clinical testing

73
Q

In clinical studies, what is phase 4?

A

-It’s the post- marketing surveillance phase
-Occurs after FDA approval
-The drug is monitored for the remainder of its life span
-The drug is no used by a much greater number of people than in clinical studies
-There is a need to collect additional data to identify side effects
-A drug can be pulled off the market if new toxicities are uncovered
-Often, if problems result that are not life threatening, they can be addressed by relabeling of the drug with new warnings or precautions

AUDE 6120 (2 decks)

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