foundations of pharm: quality and safety Flashcards

1
Q

describe pharmacology

A

study of drugs that alter functions of living organisms

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2
Q

describe drug therapy

A
  • use of drugs to prevent, diagnose, or treat signs, symptoms, and disease processes
  • AKA pharmacotherapy
  • when prevention or cure is not a reasonable goal, relief of symptoms can greatly improve a pts quality of life
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3
Q

describe medications

A
  • drugs given for therapeutic purposes
  • given for either local or systemic effect
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4
Q

describe effects of medications

A
  • effects of medications refers to where they work or produce effects
  • two categories are local and systemic
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5
Q

describe local effects

A
  • act mainly at the site of application
  • examples include sunscreen lotions, hydrocortisone creams, and local anesthetics
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6
Q

describe systemic effects

A
  • drugs are taken into the body, and circulated by the bloodstream to sites of action in various body tissues, and are eventually eliminated from the body
  • most drugs are given for their systemic effects
  • an example would be intravenous antibiotic therapy
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7
Q

True or False?
pharmacology is the use of drugs to prevent, diagnose, or treat signs, symptoms, and diseases

A

False

Rationale:

-Pharmacology is the study of drugs that alter functions of living organisms

-Pharmacotherapy (clinical pharmacology) is the use of drugs to prevent, diagnose, or treat signs and symptoms and diseases

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8
Q

name some different drug sources

A
  • plants
  • animals
  • minerals
  • synthetic compounds
  • semisynthetic
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9
Q

Altropa belladonna, papavarum somniferum, tobacco, and rautwolfia serpentina are all examples of…

A

plants that can be used for drug sources

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10
Q

describe synthetic compounds

A
  • manufactured in laboratories
  • more standardized in chemical compounds, more consistent in effect, and less likely to produce allergies
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11
Q

describe semisynthetic drugs

A
  • naturally occurring substances that have been chemically modified
  • ex: many antibiotics
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12
Q

drugs are classified according to effects on…

A

-specific body systems

-therapeutic uses

-chemical characteristics

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13
Q

True or False?

Drugs often overlap classifications

A

True

  • example: Morphine*
  • specific body systems: central nervous system depressant
  • therapeutic uses: potent analgesic
  • chemical characteristics: narcotic
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14
Q

describe a prototype

A
  • individual drugs that represent groups of drug
  • often the first drug of a particular group to be developed
  • usually the standards against which newer, similar drugs are compared
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15
Q

name some examples of prototypes

A
  • Morphine - represents opioid analgesics
  • Penicillin - represents beta-lactam antibacterial drugs
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16
Q

individual drugs may have several different names, but the two that are most commonly used are…

A

the generic (official) name and the brand (trade) name

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17
Q

describe a generic drug name

A
  • chemical or official name
  • independent of the manufacturer
  • nonproprietary - not protected by trademark or patent or copyright
  • often indicates a drug group (e.g. drugs with generic names ending in “cillin” are penicillins)
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18
Q

name an example of a generic drug name

A

acetaminophen / amoxicillin

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19
Q

describe a brand (trade) name

A
  • designed and patented by the manufacturer
  • proprietary - manufactured and sold only by the owner of the patent, formula, brand name, or trademark associated with the product
  • examples include Tylenol and Amoxil
20
Q

for NCLEX prep you will need to study which drug names?

A

generic names

21
Q

True or False?

Over the Counter medications are not regulated by law

A

False

Rationale: Over the counter medications are regulated by various drug laws

22
Q

describe prescription drugs

A
  • written by a licensed health care provider, such as physician, dentist, or nurse practitioner
  • requires a written order
23
Q

describe over the counter (OTC)

A
  • drugs available without a prescription
  • regulated by various laws
  • ease of access of these drugs has the potential to be dangerous
24
Q

describe orphan drugs

A
  • drugs that are not financially viable and not adopted by a drug company
  • experimental drugs, usually funded by the government, rare
25
Q

Which law (and its amendments) requires that official drugs meet standards of purity and strength?

a. Durham-Humphrey Amendment

b. Comprehensive Drug Abuse Prevention and Control Act

c. Food, Drug, and Cosmetic Act of 1938

d. Controlled Substances Act

A

c. Food, Drug, and Cosmetic Act of 1938

Rationale: The Food, Drug, and Cosmetic Act of 1938 requires that official drugs meet standards of purity and strength as determined by chemical analysis or bioassay

  • the Durham-Humphrey Amendment designates which medications mist be prescribed by a health care professional
  • the Comprehensive Drug Abuse Prevention and Control Act regulates manufacturing and distribution of controlled substances
  • the Controlled Substances Act categorizes controlled substances according to therapeutic usefulness and potential for abuse
26
Q

Describe the Controlled Substances Act (1970)

A
  • Title II of the Comprehensive Drug Abuse Prevention and Controlled Substances Act
  • regulates manufacturing and distribution of narcotic, depressants, stimulants, hallucinogens, and anabolic steroids
  • developed categories for ranking the abuse potential of various drugs
27
Q

describe the Drug Enforcement Administration (DEA)

A
  • enforces Controlled Substance Act
  • registers individuals and companies legally empowered to handle controlled substances
  • regulates documentation and handling of controlled substances
28
Q

name the 5 categories of controlled substances

A
  • schedule I
  • schedule II
  • schedule III
  • schedule IV
  • schedule V
29
Q

define schedule I drugs and give examples

A
  • high potential for abuse
  • not currently accepted for medical use in U.S.
  • lack of accepted safety for use of the drug under medical supervision
  • Examples:* heroin, LSD, methamphetamine (MDMA or ecstasy), peyote, marijuana
30
Q

define schedule II drugs and give examples

A
  • high potential for abuse
  • currently accepted medical use in the U.S.
  • abuse may lead to severe psychological or physical dependence
  • Examples:* hydromorphone, methadone, oxycodone, fentanyl, morphine, opium, codeine, cocaine, amphetamine, methamphetamine
31
Q

define schedule III drugs and give examples

A
  • potential for abuse less than schedule I and II drugs
  • currently accepted medical use in the U.S.
  • abuse may lead to moderate or low physical dependence or high psychological dependence
  • Examples:* Vicodin, tylenol with codeine, ketamine, anabolic steroids (depo-testosterone), mixtures containing small amounts of controlled substances
32
Q

define schedule IV drugs and give examples

A
  • lower potential for abuse less than schedule III drugs
  • currently accepted medical use in the U.S.
  • abuse may lead to limited physical or psychological dependence relative to schedule III substances
  • Examples:* lorazepam, alprazolam, clonazepam, sedative hypnotics, and some prescription appetite suppressants
33
Q

define schedule V drugs and give examples

A
  • low potential for abuse relative to schedule IV substances
  • currently accepted medical use in the U.S.
  • abuse may lead to limited physical or psychological dependence relative to schedule IV substances
  • Examples:* Robitussin AC, antidiarrheal drugs, cough suppressants containing small amounts of codeine
34
Q

what organizations regulates the development and sale of drugs

A

FDA

35
Q

which laws further regulate and approve prescription and OTC drugs

A

local

36
Q

which law set standards for toxicity and monitoring labeling

A

federal food, drug, and cosmetic act of 1938

37
Q

describe FDA pregnancy safety categories

A

used to have categories. in 2015, due to confusion the FDA no longer uses these categories, but nurses will still see them r/t the complex transition of the new system which includes risk levels

38
Q

describe category A of the FDA pregnancy categories

A

controlled studies of pregnant women show no risk in first trimester

39
Q

describe category B of the FDA pregnancy categories

A

animal studies show no risk, or animals show risk unconfirmed in humans

40
Q

describe category C of FDA pregnancy categories

A

animal studies show risk, caution is advised, benefits may outweigh risks

41
Q

describe category D of the FDA pregnancy categories

A

evidence of risk to human fetus, benefits may outweigh risks in serious conditions

42
Q

describe category X of the FDA pregnancy categories

A

risk outweighs benefit

43
Q

medication administration nursing guidelines are dictated by…

A

QSEN

44
Q

dictates procedure and protocol for safe medication administration

A

The institutes for safe medication practices (ISMP)

45
Q

what are some sources of drug information

A
  • pharmacology and textbooks
  • drug reference books
  • journal articles
  • internet sites