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Pharm > Chapter 1 > Flashcards

Chapter 1 Flashcards

1
Q

Adverse effects

A

Sometimes called side effects, that are not desired therapeutic effects, may be unpleasant or even dangerous

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2
Q

Sometimes called side effects, that are not desired therapeutic effects, may be unpleasant or even dangerous

A

Adverse effects

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3
Q

Brand name

A

Name given to a drug by the pharmaceutical company that developed it, also called trade name or proprietary name

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4
Q

Name given to a drug by the pharmaceutical company that developed it, also called trade name or proprietary name

A

Brand name

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5
Q

Chemical name

A

Name that reflects the chemical structure of the drug

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6
Q

Name that reflects the chemical structure of the drug.

A

Chemical name

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7
Q

Drugs

A

Chemicals that are introduced to the body to bring about a change

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8
Q

Chemicals that are introduced to the body to bring about a change

A

Drugs

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9
Q

Food and Drug administration FDA

A

A federal agency responsible for the regulation and enforcement of drug evaluation and distribution policies

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10
Q

A federal agency responsible for the regulation and enforcement of drug evaluation and distribution policies

A

Food and Drug administration

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11
Q

Generic drugs

A

Drugs sold by their generic name; not brand name or trade name

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12
Q

Drugs sold by their generic name; not brand name or trade name

A

Generic drugs

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13
Q

Generic name

A

The original designation that a drug is given when the drug company that developed it applies for the approval process

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14
Q

The original designation that a drug is given when the drug company that developed it applies for the approval process

A

Generic name

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15
Q

Genetic engineering

A

Process of altering DNA, usually of bacteria, to produce a chemical to be used in a drug

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16
Q

Process of altering DNA, usually of bacteria, to produce a chemical to be used in a drug

A

Genetic engineering

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17
Q

Orphan drugs

A

Drugs that have been discovered but would not be profitable for a drug company to develop, usually drugs that would only treat a small number of people. These orphans can be adopted by drug companies to develop

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18
Q

Drugs that have been discovered but would not be profitable for a drug company to develop, usually drugs that would only treat a small number of people. These orphans can be adopted by drug companies to develop

A

Orphan drugs

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19
Q

Over the counter drugs

A

Drugs that are available without a prescription for self treatment, deemed safe when used as directed. often formally only available by prescription

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20
Q

Drugs that are available without a prescription for self-treatment, are deemed safe when used as directed. Often formally only available by prescription

A

Over the counter drugs

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21
Q

Pharmacology

A

The study of the biological effects of chemicals

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22
Q

The study of the biological effects of chemicals

A

Pharmacology

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23
Q

Pharmacotherapeutics

A

Clinical pharmacology - branch of pharmacology that deals with drugs; chemicals that are used in medicine for the treatment, prevention, and diagnosis of disease in humans

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24
Q

Clinical pharmacology - branch of pharmacology that deals with drugs; chemicals that are used in medicine for treatment, prevention and diagnosis of disease in humans

A

Pharmacotherapeutics

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25
Q

Phase 1 study

A

a pilot study of a potential drug using a small number of selected, usually healthy human volunteers

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26
Q

a pilot study of a potential drug using a small number of selected, usually healthy human volunteers

A

Phase 1 study

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27
Q

Phase II study

A

a clinical study of a proposed drug by selected physicians using actual patients who have the disorder the drug is designed to treat, patients must provide informed consent

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28
Q

a clinical study of a proposed drug by selected physicians using actual patients who have the disorder the drug is designed to treat, patients must provide informed consent

A

Phase II study

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29
Q

Phase III study

A

Use of a proposed drug on a wide scale in clinical settings with patients who have the disease the drug is thought to treat

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30
Q

Use of a proposed drug on a wide scale in clinical settings with patients who have the disease the drug is thought to treat

A

Phase III study

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31
Q

Phase IV Study

A

Continuous evaluation of a drug after it has been released for marketing

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32
Q

Continuous evaluation of a drug after it has been released for marketing

A

Phase IV study

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33
Q

Preclinical trials

A

The initial trial of a chemical thought to have therapeutic potential, uses lab animals not humans

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34
Q

The initial trial of a chemical thought to have therapeutic potential uses lab animals, not humans

A

Preclinical trials

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35
Q

Teratogenic

A

having adverse effects on the fetus

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36
Q

having adverse effects on the fetus

A

Teratogenic

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37
Q

Clinical pharmacology addresses what 2 concerns?

A

The drugs affect on the body & the body response to the drug

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38
Q

Nursing responsibilities to administer drug therapy include?

A
  1. administer drugs
  2. Assessing drug effects
  3. Intervening to make drug regimen more tolerable
  4. Providing drug teaching
  5. Monitoring patient care plan to prevent med errors
39
Q

What are the natural sources a drug can come from?

A

Plants, animals or inorganic compounds

40
Q

To become a drug a chemical must demonstrate?

A

therapeutic value without severe toxicity or damaging properties

41
Q

PLANT
Ricinus Communis
Produces what product?

A

Seed
oil
castor oil

42
Q

PLANT
digitalis purpurea
(foxtail)
Produces what?

A

Leaves
Dried leaves
Digitalis leaf

43
Q

PLANT
Papaver somniferum
(poppy)

A

Unripe capsules
Juice
opium (paregoric)
Morphine (MS contin)
Codeine
Papaverine

44
Q

What is an example of a synthetic version of a drug listed in the book

A

dronabinol (marinol), which contains delta-9-tetrahydrocannabinol found in weed, helps prevent nausea and vomiting in cancer patients without adverse effects

45
Q

The body converts natural licorice into

A

false aldosterone - fluid retention&hypokalemia or low potassium levels

46
Q

Animal products are used to replace chemicals if

A

the body fails to produce them due to disease or genetic problems

47
Q

Until recently, insulin was from

A

Pancreas of cows and pigs

48
Q

Genetic engineering allows scientists to produce insulin by altering

A

Escherichia coli bacteria, making it a better product without the impurities from animals

49
Q

The ELEMENT
Aluminum
has what therapeutic use?

A

-Antacid to decrease gastric acidity
-Management of hyperphosphatemia
-Prevention of the formation of urinary phosphate stones

50
Q

The ELEMENT
Fluorine (Fluoride)
has what therapeutic use?

A

-Prevention of cavities
-Prevention of osteoporosis

51
Q

The ELEMENT
GOLD
has what therapeutic use?

A

-Prevention of rheumatoid arthritis

52
Q

The ELEMENT
IRON
has what therapeutic use?

A

-Treatment of iron deficiency anemia

53
Q

The FDA is an agency of

A

U.S Dept of health and human services regulates development and sales of drugs

54
Q

Before receiving final FDA approval, a drug must pass through what trials?

A

Preclinical trials, phases I, II, III studies

55
Q

What happens in preclinical trials>

A

Drugs are tested on animals - needs to be tested on living organisms

56
Q

What are the 2 main purposes of preclinical trials>

A
  1. to determine if they have presumed effects on living tissue, 2. eval any adverse effects
57
Q

What are the 4 reasons a drug might not pass clinical trials>

A
  1. Chemical lacks therapeutic activity
  2. Chemical is too toxic
  3. Chemical is highly teratogenic (harm fetus)
  4. Safety margins are too small = would not be useful in clinical settings
58
Q

What are phase I studies>

A

-Uses human volunteers to test drugs
-Tightly controlled & performed by specially trained clinical investigators
-Test subjects are healthy young men and women/ must sign consent

59
Q

At the end of phase I studies chemicals are dropped due to what reasons?

A

-Cause unacceptable adverse effects
-highly teratogenic
-too toxic
-Lack evidence of therapeutic effects in humans

60
Q

What hypertensive drug was found effective but had adverse effects?

A

Minoxidil, unusual hair growth on palms and other body areas.

Now used in rogaine

61
Q

What are phase II studies?

A

Allows clinical investigators to try the drug out on patients who have the disease

62
Q

What are phase III studies?

A

involves the use of a drug in a vast clinical market

63
Q

What are the reasons drugs can be dropped from phase II studies?

A
  1. Less effective than expected
  2. too toxic
  3. Produce unacceptable side effects
  4. Have low benefit-to-risk ratio
  5. Not as effective as available drugs
64
Q

What are the reasons drugs would be dropped from phase III studies?

A
  • Produce unacceptable side effects
  • Produce unexpected responses
65
Q

What happens when drugs pass phase III studies?

A

They are approved for marketing by FDA and proceed to phase IV for continued evaluation

66
Q

What is the 1906 pure food and drug act

A

preventing the marketing of unadulterated drugs; requires labeling to prevent false claims

67
Q

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

A

Mandated test for drug toxicity and provided means for recall of drugs, est procedures for introducing new drugs, gave FDA power of enforcement

68
Q

What is the 1951 Durham-Humphrey Amendment?

A

Tightened control
“may not be distributed w/o prescription.”

69
Q

What is the 1962 Kefauver-Harris act?

A

Tightened control over the quality of drugs,
FDA power over drug investigations

70
Q

What is the 1970 controlled substances act?>

A

Defined drug abuse and classified drugs as their potential for abuse, provided strict controls over distribution, storage and use of these drugs

71
Q

What is the 1983 Orphan drug act?

A

Provided incentives for the development of orphan drugs for treatment of rare diseases

72
Q

A drug with a HIGH risk for pregnancy indicates?

A

Research has shown fetal toxicity

73
Q

A drug with HIGH risk for lactation indicates?

A

Drug is known to enter breast milk and could cause problems for the infant

74
Q

a drug with LOW risk would indicate>

A

Research has not shown any problems this far

75
Q

What is a category A drug mean for pregnancy>

A

Adequate studies have shown no risk for pregnant woman in first trimesters, no evidence of risk in later trimesters

76
Q

What does a category B drug mean for pregnancy?

A

Aminal studies have not shown risk to a fetus. There are no adequate studies in pregnant women

77
Q

What does a category C drug mean for pregnancy?

A

Animal studies have shown an adverse effect in fetus, but there are no adequate studies in humans

**Benefits may be acceptable

78
Q

What does a category D drug mean for pregnancy?

A

There is evidence of human fetal risk. Potential benefits may outweigh the risk

79
Q

What does a category X drug mean for pregnancy?

A

Studies in animals or humans show fetal abnormalities or adverse effects, reports indicate evidence of fetal risk. The risk outweighs the benefit

80
Q

What does Schedule I (C-I) controlled substance mean?

A

High abuse potential and no accepted medical use (heroin, LSD)

81
Q

What does Schedule II (C-II) controlled substance mean?

A

High abuse potential with severe dependence liability (narcotics, amphetamines, barbituates)

82
Q

What does Schedule III (C-III) controlled substance mean?

A

Less abuse potential than schedule II and moderate dependence liability (non-barbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics)

83
Q

What does Schedule IV (C-IV) controlled substance mean?

A

Less abuse potential than schedule III and limited dependence liability (some sedatives, antianxiety agents, nonnarcotics analgestics)

84
Q

What does Schedule V (C-V) controlled substance mean?

A

Limited absue potential. Primarily small amounts of narcotics (codine) used in antitussives. Under federal law limited quantities of schedule V may be purchased without a prescription directly from a pharmacist. Must be 18 and show iD, transaction must be recorded by pharmacist.

85
Q

What is the time limted patent on a generic drug

A
  • given after approval for marketing from FDA
    -Once time runs out, drug can be produced by other companies
    -Patent length depends on chemicals involved
86
Q

Bioequivalent medicines?

A

work on the body the same way & substances should have same amount of an active ingredient

87
Q

What does “Dispense as written” DAW mean?

A

That the brand name product be used

88
Q

What are the problems with OTC drugs that nurses should look for>

A
  • drugs could mask signs and symptoms of underlying disease
    -Taking OTC with prescriptions could cause drug interactions and interfere with drug therapy
    -not taking as directed could result in OD
89
Q

The drug label identifies?

A

brand and generic names
dosage
expiration dates
special warnings

Some also include, routes & dose for administration

90
Q

What are the labels blacked out?

A

WARNINGS
NDC number - used to identify a specific drug
BRAND NAME
GENERIC NAME
DRUG DOSE - dose avail in this product

91
Q

What are the labels greyed out?

A

LOT NUMBER - specific batch drug was produced, important for recall
EXPIRATION DATE
QUANTITY
DRUG MANUFACTURER

92
Q

What are the labels in red?

A

PRESCRIPTION STATUS
STORAGE INFO
ADMINISTRATION - some labeled indicate route and dosage

93
Q

What is the Physicans desk reference>

A

a compilation of all package insert info for drugs in US, along with some drug advertising

*this info comes directly from manufacturer and its not referred in anyway. This may not be the best info to use

Pharm (16 decks)

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