Module 1 Slide Notes Flashcards

Describe the origin of these words and define. Understand the difference between class and category. Learn the basic classification systems used for this course.

1
Q

Fields of pharmacology

A

Molecular, toxicology, clinical.

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2
Q

Molecular pharmacologists

A

Design drugs on a molecular level

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3
Q

Toxicology

A

Study of toxic or poisonous drug effects

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4
Q

Clinical pharmacology

A

The testing and therapeutic use of drugs.

Sub specialties include: neuropharmocology, cardiovascular pharmacology, etc.

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5
Q

Drugs

A

Any biologically active substance

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6
Q

Medicine

A

A drug administered deliberately for prevention, diagnosis, or treatment of a condition or malady.

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7
Q

ATC

A

Anatomical Therapeutic Chemical classification system

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8
Q

ATC system defined

A

Used for classification of drugs. Published in 1976 by WHOCC. It divides drugs into groups according to the organ/system that they act upon.

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9
Q

USP

A

Unites States Pharmacopeia. Classification model which organizes drugs into a hierarchy of 41 therapeutic categories. This is then broken into 146 classes.

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10
Q

Which classification system does this class use?

A

Simplified USP model with “basic” categories.

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11
Q

Three general uses of drugs

A

Treat, diagnose, and prevent disease.

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12
Q

Use of antibiotics

A

Bacterial infections

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13
Q

Use of analgesics

A

Control of pain

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14
Q

Use of hormones (as a medicine)

A

Hormone replacement therapy (HRT)

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15
Q

Examples of preventative uses of drugs

A

Vaccinations, immunizations

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16
Q

Natural source drugs

A

Those derived from plant/animal sources

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17
Q

Digitalis (lanoxin)

A

Derived from the foxglove plant. Used in cases of heart failure to increase contractions of the heart.

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18
Q

Scopolamine and atropine

A

Derived from the belladonna plant. Used by Italian women to dilate the eyes.

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19
Q

Scopolamine

A

used for motion sickness prevention

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20
Q

Alexander Flemming

A

Developed penicillin

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21
Q

Ephedrine

A

Natural source. Comes from ephedra species of plant, used as a bronchodilator and decongestant.

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22
Q

Galantamine (Reminyl)

A

Natural source. New drug derived from daffodil bulbs. Used to treat Alzheimer’s disease.

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23
Q

Botox

A

Natural source. Botox is a diluted form of botulinum toxin. Derived from bacteria that causes botulism. Used in cosmetics for the treatment and prevention of wrinkles. Recently used as an injection to treat migraines.

24
Q

Common animal source drugs

A

Thyroid hormone, Premarin (estrogen) which is from PREgnant MAres urINe, and insulin

25
Q

Three names given to drugs

A

Chemical, generic, trade or brand

26
Q

Common mineral source ingredients

A

Potassium, lithium, iron, calcium

27
Q

Reasons for FDA drug recall

A

Contamination, shorter shelf-life than advertised, below tolerance standards, or new or worse side effects

28
Q

Other duties of the FDA

A

Sanitation requirements for interstate travel

29
Q

OTC

A

Over-the-counter

30
Q

Schedule I drugs

A

No medical advantages, usually highly addictive. Examples: LSD, heroin, GHB, ecstasy, dimethyltryptamine (DMT), psilocybin.

31
Q

Schedule II

A

Accepted for some medical uses. May cause dependence and addiction. Examples: Adderall, cocaine, hydromorphone, Ritalin (methylphenidate), morphine, oxycodone.

32
Q

Schedule III

A

Accepted for medical uses. May lead to moderate dependence. Less likely to be abused. Example: barbiturates such as aprobarbital (Alurate) and butabital, as well as muscle-building steroids.

33
Q

QD

A

Once a day

34
Q

BiD

A

Twice a day

35
Q

TID

A

Three times a day

36
Q

DS

A

Double strength

37
Q

Process of drug testing

A
  1. Proof of concept sent to animal testing
  2. Drug is tested on animals
  3. Drug is sent to FDA for IND (investigational new drug application)
  4. Three phases of clinical trials, each with larger sample sizes
  5. After 6-8 years, successful drugs are filed with NDA (new drug application)
38
Q

Wiley Act

A

Pure Food and Drug Act of 1906, stipulated that food and drug manufacturers use pure ingredients and accurate labeling.
***The first federal drug legislation.

39
Q

FDCA

A

Food, Drug, and Cosmetic Act of 1938. Replaced the “Wiley Act”. Added requirements to test for the safety of drugs. Still used as the basic law today.
***Created the FDA (Food and Drug Administration)

40
Q

Thalidomide

A

An antinausea drug marketed during the late 1950s. Responsible for thousands of birth defects (mostly in Europe). Also responsible for strengthened laws in 1962.
Dr. Frances Kelsey kept it out of the U.S. market

41
Q

FDA

A

Food and Drug Administration. Regulates & supervise food safety, tobacco products, dietary supplements, prescription, & OTC medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
Has the authority to pull a drug from the market

42
Q

Prescription Drug Amendment

A

Established in 1951. Defined prescription drugs as those that required supervision of an MD and OTC drugs as those that didn’t. Main criteria were drug safety & addiction potential.

43
Q

CSA

A

Controlled Substances Act, established in 1970

44
Q

DEA

A

Drug Enforcement Administration. Established 1973, defined schedule drugs (I-V).

45
Q

Schedule III Drugs

A

Tylenol #3, Vicodin

Can be phone in

46
Q

Schedule IV Drugs

A

lithium, Valium

47
Q

Schedule V

A

Cough syrups w/low does of codeine

48
Q

Orphan Drug Act

A

Established in 1983. Developed to facilitate the development of drugs for rare, “unprofitable” disorders. Offers tax credits, exclusive marketing rights, and simplified FDA approval.

49
Q

Dietary Supplements and Health Education Act

A

Established in 1994. Loose, hard-to-enforce “guidelines” which don’t effectively regulate or educate. Manufacturers remain liable for damages but they can make whatever claims about their drug that they wish and can be sold anywhere.

50
Q

FDA Modernization Act

A

Established in 1997. Provides for an “expedited review” if the sponsor of the drug will pay an additional fee. The review will be completed in half the time. Focused on drugs used in life threatening situations (like in the movie Philadelphia)

51
Q

Harrison Narcotic Act

A

Established in 1914, regulates cocaine and heroin.

52
Q

Naming Drugs

A

Drugs are named according to the disease process they treat, the part of the body treat, may reflect the generic name, source of the drug, action or desired effect, a combination of several drug names, dosing schedule, indicated duration, indicated potency, active ingredient, or a company name.

53
Q

Genetic Engineering

A

Recombinant gene splicing, isolating a gene to code for a certain drug or hormone and placing into bacterium. Example: E. coli bacteria producing insulin or human growth hormone.

54
Q

Genentech

A

Company responsible for producing the first recombinant DNA drug (human insulin). South San Francisco, CA in 1982

55
Q

proof of concept

A

when a drug company thinks they have a new compound that could become a successful drug they draw this up and submit the drug to animal testing