PHM 338 Quiz 1

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full agonist

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Tags and Description

Biology

50 Terms

1

full agonist

Ability of a drug to produce 100% of the maximum response regardless of the potency

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2

agonism

production of a molecular/cellular response to an interaction between a molecule and a receptor that activates the receptor; can be a drug or endogenous ligand

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3

body systems

groups of organs that perform specific functions in the human body; can see measurable actions; ex. beta-blockers --> reduces pulse rate

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4

component tissues

beta-blockers --> negative chronotrope

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5

cellular level

beta-blockers --> prevents elevation of cAMP

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6

molecular level

beta-blockers --> competitive antagonism of norepinephrine to cardiac beta1 receptors

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7

levels of drug activity

-body systems

-component tissues

-cellular level

-molecular level

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8

replace

iron in anemia is an example of how drugs ________

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9

interrupt

ipratropium slowing down mucus production is an example of how drugs __________

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10

potentiate

to make more active; to strengthen; cathartics before sigmoidoscopy is an example of how drugs ___________

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11

existing

drugs modify ______________ functions

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12

multiple

drugs exert _______________ effects

ex. Minoxidil lowers blood pressure AND prevents hair loss

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13

interact

drugs typically ____________ with something to exert an effect

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14

pharmaceutics

The science of preparing and dispensing drugs, including dosage form design

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15

dosage form

form in which drugs are manufactured; includes elixirs, tablets, capsules, suppositories, parenteral drugs, and transdermal systems

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16

pharmacokinetics

The study of the absorption, metabolism, distribution, and elimination of drugs; "what the body does to the drug"

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17

pharmacodynamics

the study of the action or effects of drugs on living systems; "what the drug does to the body"

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18

schedule I drugs

  • High Potential for abuse

  • no medical use

  • research protocol only

  • may lead to severe dependence

  • ex. heroin, marijuana, LSD, mescaline, peyote, ecstasy

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19

schedule II drugs

  • high abuse potential

  • accepted medical use (ONLY DIFFERENCE FROM SCHEDULE I)

  • may lead to severe dependence

  • must be written on an official prescription form

  • no refills

  • ex. oxycodone, morphine, meperidine, cocaine, pentobarbital, amphetamine

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20

schedule III drugs

  • less abuse potential than I & II

  • accepted medical use

  • low/moderate physical dependence, high psychological dependence

  • written/oral prescription

  • 6 months of refills

  • acetaminophen w/ codeine, buprenorphine (Suboxone), anabolic steroids, ketamine

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21

schedule IV drugs

  • less abuse potential than III

  • accepted medical use

  • limited dependence

  • written/oral prescription

  • 6 months of refills

  • phenobarbital, diazepam (Valium), carisoprodol (Soma)

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22

schedule V drugs

  • less abuse potential than IV

  • accepted medical use

  • limited dependence

  • may or may not require prescription

  • codeine in limited quantities (cough syrup)

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23

pharmaceutical equivalence & bioequivalence

generic drug approval criteria

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24

pharmaceutical equivalence

medications that have the same active ingredients, dosage form, strength, route; may differ in shape, scoring, excipients (inactive ingredients)

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25

bioequivalence

The rate and extent of absorption of drug are not significantly different from pioneer drug

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26

80-125%

The bioequivalence of a generic drug must be at least _____________%

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27

Pure Food and Drug Act of 1906

  • protects public from adulterated/mislabeled drugs and food

  • Requires drug companies to list if 1 of 11 dangerous/addicting drugs present

  • Prohibits false/misleading claims about curative properties of drug on package

  • Only drugs sold via interstate/international commerce were covered

  • Designated The United States Pharmacopeia and National Formulary as official standards for strength and purity

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28

Food, Drug, and Cosmetic Act of 1938

  • Drug manufacturers must:

    • Test for harmful effects

    • Drug labels must be accurate and complete

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29

Durham-Humphrey Amendment of 1952

Specified how prescription drugs can be ordered and dispensed

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30

Kefauver-Harris Amendment of 1962

  • Required proof of both safety and efficacy prior to approval

  • Permitted generic versions of drugs initially marked from 1938-1962

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31

Drug Price Competition and Patent Term Restoration Act of 1984

  • Generics submit Abbreviated New Drug application

  • Provides 5 years of market exclusivity for pioneer drugs

    • For development of new indications, dosage forms, dosage regimens

  • Generics could be approved for drugs introduced after 1962

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32

Controlled Substances Act of 1970

  • Classifies controlled substances according to their abuse potentials

  • Prescriptions are electronically transmitted to the DPS

    • Identify shady prescribers, potential abusers, diversion (pharmacies that order much more than what is distributed)

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33

NDA

  • Phase I

    • Initial pharmacologic evaluation

    • Small number of normal volunteers

  • Phase II

    • Limited controlled evaluation

    • Increasing doses, pts with disease

    • Effectiveness and side effects

  • Phase III

    • Extended clinical evaluation

    • Determines clinical effectiveness, drug safety, establishment of safe/effective dose

  • Preclinical (6.5 years), Phase I (1.5 years), Phase II (2 years), Phase III (3.5 years), FDA review (1.5 years)

    • 5 enter trials → 1 approved

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34

Phase I

  • Initial pharmacologic evaluation

  • Small number of normal volunteers

  • 1.5 years

    • 5 enter trials

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35

Phase II

  • Limited controlled evaluation

  • Increasing doses, pts with disease

  • Effectiveness and side effects

  • 2 years

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36

Phase III

  • Extended clinical evaluation

  • Determines clinical effectiveness, drug safety, establishment of safe/effective dose

  • 3.5 years

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37

Phase IV

  • FDA Review

  • 1.5 years

  • only 1 drug approved

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38

ANDA

  • 2 requirements:

  • Pharmaceutical equivalence

    • Same active ingredients, dosage form, strength, route

    • May differ in shape, scoring, expedients

  • Bioequivalence

    • Rate & extent of absorption are not significantly different from pioneer drug

    • AUC (total drug exposure in body), Cmax (concentration max), T max (time to reach Cmax)

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39

plants, animals, microbes, minerals, synthetics, semi-synthetics, biosynthetics

sources of drugs

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40

plants

  • drug source

  • aspirin - willow tree

  • laudanum - opium poppy

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41

animals

  • drug source

  • Insulin - cows/pigs

  • Conjugated estrogens - horses

  • Pepsin - cow stomach

  • Fish oil - anchovies, sardines

  • Antitoxin sera - diphtheria, tetanus

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42

microbes

  • drug source

  • Penicillin - penicillium molds

  • Dextran - lactobacillus family

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43

minerals

drug source

  • Ferrous sulfate - pts with iron deficiency anemia

  • Magnesium sulfate - constipation

  • Selenium - dandruff

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44

synthetics

drug source

  • Aspirin

  • Antihistamines

  • Anesthetics

  • Fentanyl

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45

semi-synthetics

drug source

  • Ampicillin - from penicillin

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46

biosynthetics

drug source

  • Hepatitis B vaccine (yeast), recombinant insulin (bacteria)

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47

primary reference

  • Clinical research studies

  • Provides most recent information

  • Requires longer time commitment and skilled expertise in literature evaluation to assess application to patient care

  • Ex. New England Journal of Medicine, Clinical Nursing Research

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48

secondary reference

  • Databases used to search for primary literature

    • Ex. Medline database

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49

tertiary reference

  • Summarizes, evaluates, or interprets primary sources

  • Ex. textbooks, journal review articles, clinical guidelines, databases (Daily Med, Orange Book), Compendia (Davis’s Nursing Drug Guide)

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50

plants

most common drug source

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