Chapter 1 Flashcards

(63 cards)

1
Q

Pharmaco

A

Drug, medicine

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2
Q

Logy

A

Study of

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3
Q

Pharmacology

A

The study of drugs and their interactions with living cells and systems

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4
Q

What are the types of names for a drug?

A

Chemical name
Code name
Trade name
Generic name

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5
Q

Which name is always capitalized?

A

Trade name

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6
Q

Which name is not capitalized?

A

Generic name

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7
Q

What are requirements for drug substitution?

A

Chemically equivalent
Biologically equivalent
Therapeutically equivalent

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8
Q

Chemically equivalent

A

Two formulations of a drug meet the chemical and physical standards established by regulatory agencies

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9
Q

Biologically equivalent

A

Two formulations of a drug produce similar concentrations of the drug in blood and tissues

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10
Q

Therapeutically equivalent

A

Two formulations of a drug have an equal therapeutic effect

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11
Q

What are the Federal Regulations and Regulatory Agencies

A
Harrison Narcotic Act
U.S. Food and Drug Administration (FDA)
Federal Trade Commission (FTC)
Drug Enforcement Administration (DEA)
Omnibus Budget Reconciliation Act (OBRA)
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12
Q

Harrison Narcotic Act

A

Established regulations governing the use of opium, opiates, and cocaine; Marijuana added later.

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13
Q

Food and Drug Administration (FDA)

A

Approval for drugs marketed in U.S.
Quality control in drug manufacturing plants
Determines which drugs can be sold prescribiton/OTC
Regulates advertising and labeling

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14
Q

What is the FDA part of

A

U.S. Department of Health and Human Services (DHHS)

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15
Q

Federal Trade Commission (FTC)

A

Regulates the trade practices of drug companies

Prohibits the false advertising of foods, OTC drugs, and cosmetics

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16
Q

Drug Enforcement Administration (DEA)

A

Administers the Controlled Substances Act

Regulates the manufacturing and distribution of substances that have a potention for abuse

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17
Q

Omnibus Budget Reconciliation Act

A

Pharmacists must provide patient counseling and a prospective drug utilization

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18
Q

What is the DEA part of?

A

Department of Justice

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19
Q

Phase 1 of clinical studies

A

Small groups of people with increasing doses administered to healthy human volunteers
Determines biologic effects (metabolism, safe dose, toxic effects)

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20
Q

Phase 2 of clinical studies

A

Larger groups of humans

Adverse reactions are reported to FDA

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21
Q

Phase 3 of clinical studies

A

Drug given to larger amount of people who have the condition for which the drug is indicated
Safety and efficacy must be demonstrated
Dosage is determined

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22
Q

Phase 4 of clinical studies

A

Postmarketing surveiliance

Toxicity that occurs in patients taking the drug after it is released is recorded

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23
Q

This is required for prescribing drugs

A

DEA number

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24
Q

Schedule II-IV drugs

A

Must require a prescription

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25
These type of schedule drugs must be typed or written in pen or indelible ink
Schedule II
26
Prescriptions cannot be telephoned to pharmacist
Schedule II
27
Prescriptions require a new written prescription for refill
Scheule II
28
Schedule III-IV drugs may not be..
Refilled more than five times in 6-month period
29
What is the most abusive class of scheduled drugs
I
30
What is the least abusive class of scheduled drugs
V
31
Schedule I
Heroin, LSD, hallucinogens
32
Schedule II
Oxycodone, morphine, amphetamine, secobarbital
33
Schedule III
Codeine (Tylenol 3) and hydrocodone (Vicodin) mixtures
34
Schedule IV
Dextropropoxyphene forms (Darvon), diazepam (Valium)
35
Schedule V
Some codeine-containing cough syrups
36
Purpose of Black Box warning
To draw attention to safety concerns associated with the drug
37
Labeled uses
Indicates that the FDA has approved the drug for specific use
38
Off-label use
Is use outside the stated FDA indications
39
Orphan Drugs
Drugs developed to treat rare medical conditions
40
What is involved in the prescription format
``` Heading Body RX Closing Subsitution ```
41
Heading of a prescription
Prescribers name, address, telephone # Patients name, address, age, telephone # Date of prescription
42
Body of a prescription
RX sympol Drug name and dose size or concentration Directions to patient - Sig:
43
RX of a prescription
Drug name # mg table Disp: # ___ Sig:
44
Closing of a prescription
Prescribers signature DEA number, if required Refill instructions
45
Substitution of a prescription
Permitted | Not permitted
46
bid
Twice a day
47
- | c
With
48
cap
capsule
49
d
day
50
disp
dispense
51
gm
gram
52
h
hour
53
hs
at bedtime
54
- | p
after
55
pc
after meals
56
PO
by mouth
57
prn
as required, if needed
58
q
every
59
qid
4 times a day
60
- | s
without
61
sig
write (label)
62
tab
Tablet
63
tid
3 times daily