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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
Phase 1 study
a pilot study of a potential drug using a small number of selected, usually healthy human volunteers
26
a pilot study of a potential drug using a small number of selected, usually healthy human volunteers
Phase 1 study
27
Phase II study
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
28
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
Phase II study
29
Phase III study
Use of a proposed drug on a wide scale in clinical settings with patients who have the disease the drug is thought to treat
30
Use of a proposed drug on a wide scale in clinical settings with patients who have the disease the drug is thought to treat
Phase III study
31
Phase IV Study
Continuous evaluation of a drug after it has been released for marketing
32
Continuous evaluation of a drug after it has been released for marketing
Phase IV study
33
Preclinical trials
The initial trial of a chemical thought to have therapeutic potential, uses lab animals not humans
34
The initial trial of a chemical thought to have therapeutic potential uses lab animals, not humans
Preclinical trials
35
Teratogenic
having adverse effects on the fetus
36
having adverse effects on the fetus
Teratogenic
37
Clinical pharmacology addresses what 2 concerns?
The drugs affect on the body & the body response to the drug
38
Nursing responsibilities to administer drug therapy include?
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
What are the natural sources a drug can come from?
Plants, animals or inorganic compounds
40
To become a drug a chemical must demonstrate?
therapeutic value without severe toxicity or damaging properties
41
PLANT Ricinus Communis Produces what product?
Seed oil castor oil
42
PLANT digitalis purpurea (foxtail) Produces what?
Leaves Dried leaves Digitalis leaf
43
PLANT Papaver somniferum (poppy)
Unripe capsules Juice opium (paregoric) Morphine (MS contin) Codeine Papaverine
44
What is an example of a synthetic version of a drug listed in the book
dronabinol (marinol), which contains delta-9-tetrahydrocannabinol found in weed, helps prevent nausea and vomiting in cancer patients without adverse effects
45
The body converts natural licorice into
false aldosterone - fluid retention&hypokalemia or low potassium levels
46
Animal products are used to replace chemicals if
the body fails to produce them due to disease or genetic problems
47
Until recently, insulin was from
Pancreas of cows and pigs
48
Genetic engineering allows scientists to produce insulin by altering
Escherichia coli bacteria, making it a better product without the impurities from animals
49
The ELEMENT Aluminum has what therapeutic use?
-Antacid to decrease gastric acidity -Management of hyperphosphatemia -Prevention of the formation of urinary phosphate stones
50
The ELEMENT Fluorine (Fluoride) has what therapeutic use?
-Prevention of cavities -Prevention of osteoporosis
51
The ELEMENT GOLD has what therapeutic use?
-Prevention of rheumatoid arthritis
52
The ELEMENT IRON has what therapeutic use?
-Treatment of iron deficiency anemia
53
The FDA is an agency of
U.S Dept of health and human services regulates development and sales of drugs
54
Before receiving final FDA approval, a drug must pass through what trials?
Preclinical trials, phases I, II, III studies
55
What happens in preclinical trials>
Drugs are tested on animals - needs to be tested on living organisms
56
What are the 2 main purposes of preclinical trials>
1. to determine if they have presumed effects on living tissue, 2. eval any adverse effects
57
What are the 4 reasons a drug might not pass clinical trials>
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
What are phase I studies>
-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
At the end of phase I studies chemicals are dropped due to what reasons?
-Cause unacceptable adverse effects -highly teratogenic -too toxic -Lack evidence of therapeutic effects in humans
60
What hypertensive drug was found effective but had adverse effects?
Minoxidil, unusual hair growth on palms and other body areas. Now used in rogaine
61
What are phase II studies?
Allows clinical investigators to try the drug out on patients who have the disease
62
What are phase III studies?
involves the use of a drug in a vast clinical market
63
What are the reasons drugs can be dropped from phase II studies?
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
What are the reasons drugs would be dropped from phase III studies?
- Produce unacceptable side effects - Produce unexpected responses
65
What happens when drugs pass phase III studies?
They are approved for marketing by FDA and proceed to phase IV for continued evaluation
66
What is the 1906 pure food and drug act
preventing the marketing of unadulterated drugs; requires labeling to prevent false claims
67
What is the 1938, Federal food, drug and cosmetic act?
Mandated test for drug toxicity and provided means for recall of drugs, est procedures for introducing new drugs, gave FDA power of enforcement
68
What is the 1951 Durham-Humphrey Amendment?
Tightened control "may not be distributed w/o prescription."
69
What is the 1962 Kefauver-Harris act?
Tightened control over the quality of drugs, FDA power over drug investigations
70
What is the 1970 controlled substances act?>
Defined drug abuse and classified drugs as their potential for abuse, provided strict controls over distribution, storage and use of these drugs
71
What is the 1983 Orphan drug act?
Provided incentives for the development of orphan drugs for treatment of rare diseases
72
A drug with a HIGH risk for pregnancy indicates?
Research has shown fetal toxicity
73
A drug with HIGH risk for lactation indicates?
Drug is known to enter breast milk and could cause problems for the infant
74
a drug with LOW risk would indicate>
Research has not shown any problems this far
75
What is a category A drug mean for pregnancy>
Adequate studies have shown no risk for pregnant woman in first trimesters, no evidence of risk in later trimesters
76
What does a category B drug mean for pregnancy?
Aminal studies have not shown risk to a fetus. There are no adequate studies in pregnant women
77
What does a category C drug mean for pregnancy?
Animal studies have shown an adverse effect in fetus, but there are no adequate studies in humans **Benefits may be acceptable
78
What does a category D drug mean for pregnancy?
There is evidence of human fetal risk. Potential benefits may outweigh the risk
79
What does a category X drug mean for pregnancy?
Studies in animals or humans show fetal abnormalities or adverse effects, reports indicate evidence of fetal risk. The risk outweighs the benefit
80
What does Schedule I (C-I) controlled substance mean?
High abuse potential and no accepted medical use (heroin, LSD)
81
What does Schedule II (C-II) controlled substance mean?
High abuse potential with severe dependence liability (narcotics, amphetamines, barbituates)
82
What does Schedule III (C-III) controlled substance mean?
Less abuse potential than schedule II and moderate dependence liability (non-barbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics)
83
What does Schedule IV (C-IV) controlled substance mean?
Less abuse potential than schedule III and limited dependence liability (some sedatives, antianxiety agents, nonnarcotics analgestics)
84
What does Schedule V (C-V) controlled substance mean?
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
What is the time limted patent on a generic drug
- 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
Bioequivalent medicines?
work on the body the same way & substances should have same amount of an active ingredient
87
What does "Dispense as written" DAW mean?
That the brand name product be used
88
What are the problems with OTC drugs that nurses should look for>
- 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
The drug label identifies?
brand and generic names dosage expiration dates special warnings Some also include, routes & dose for administration
90
What are the labels blacked out?
WARNINGS NDC number - used to identify a specific drug BRAND NAME GENERIC NAME DRUG DOSE - dose avail in this product
91
What are the labels greyed out?
LOT NUMBER - specific batch drug was produced, important for recall EXPIRATION DATE QUANTITY DRUG MANUFACTURER
92
What are the labels in red?
PRESCRIPTION STATUS STORAGE INFO ADMINISTRATION - some labeled indicate route and dosage
93
What is the Physicans desk reference>
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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