PHM 338 Quiz 1

full agonist

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

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

body systems

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

component tissues

beta-blockers --\> negative chronotrope

cellular level

beta-blockers --\> prevents elevation of cAMP

molecular level

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

levels of drug activity

\-body systems

\-component tissues

\-cellular level

\-molecular level

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replace

iron in anemia is an example of how drugs \________

interrupt

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

potentiate

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

existing

drugs modify \______________ functions

multiple

drugs exert _______________ effects

ex. Minoxidil lowers blood pressure AND prevents hair loss

interact

drugs typically \____________ with something to exert an effect

pharmaceutics

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

dosage form

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

pharmacokinetics

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

pharmacodynamics

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

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

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

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

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)

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)

pharmaceutical equivalence & bioequivalence

generic drug approval criteria

pharmaceutical equivalence

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

bioequivalence

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

80-125%

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

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

Food, Drug, and Cosmetic Act of 1938

* Drug manufacturers must:
* Test for harmful effects
* Drug labels must be accurate and complete

Durham-Humphrey Amendment of 1952

Specified how prescription drugs can be ordered and dispensed

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

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

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)

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

Phase I

* Initial pharmacologic evaluation
* Small number of normal volunteers
* 1.5 years
* 5 enter trials

Phase II

* Limited controlled evaluation
* Increasing doses, pts with disease
* Effectiveness and side effects
* 2 years

Phase III

* Extended clinical evaluation
* Determines clinical effectiveness, drug safety, establishment of safe/effective dose
* 3.5 years

Phase IV

* FDA Review
* 1.5 years
* only 1 drug approved

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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)

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

sources of drugs

plants

* drug source


* aspirin - willow tree
* laudanum - opium poppy

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animals

* drug source
* Insulin - cows/pigs
* Conjugated estrogens - horses
* Pepsin - cow stomach
* Fish oil - anchovies, sardines
* Antitoxin sera - diphtheria, tetanus

microbes

* drug source
* Penicillin - penicillium molds
* Dextran - lactobacillus family

minerals

drug source

* Ferrous sulfate - pts with iron deficiency anemia
* Magnesium sulfate - constipation
* Selenium - dandruff

synthetics

drug source

* Aspirin
* Antihistamines
* Anesthetics
* Fentanyl

semi-synthetics

drug source

* Ampicillin - from penicillin

biosynthetics

drug source

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

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

secondary reference

* Databases used to search for primary literature
* Ex. Medline database

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)

plants

most common drug source