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chapter 1 information, etc. Flashcards

1
Q

What are the 4 different sources of information for drugs?

A
  1. Explain Discuss
  2. Reference Texts
  3. Association Journals
  4. Internet
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2
Q

When a drug is being investigated & identified by chemical structure it is known as __?

A

chemical name

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3
Q

Proprietary name is also known as the __?

A

trade name

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4
Q

Another name for trade name is the __?

A

brand name

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5
Q

What are the 4 requirements of Drug substitution?

A
  1. The FDA requires that the active ingredient of the generic enters the bloodstream at the same rate as the trade name
  2. Chemically equivalent
  3. Biologically equivalent
  4. Therapeutically equivalent
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6
Q

This act was created in 1914 and provides federal control over narcotics and required registration of those giving an rx.

A

Harrison Narcotic Act

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7
Q

This act was created in 1906 & was the 1st fed law to regulate interstate commerce of drugs

A

Food & Drug Act

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8
Q

FDA functions are __?

A
  1. Part of the health and human services,
  2. Grants approval so drugs can be marketed
  3. Determines drugs to be safe & effective
  4. Decides which drugs or OTC or Rx
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9
Q

FTC functions are __?

A
  1. Regulates trade practices of drug companies

2. Prohibits false advertising of fodds, OTC drugs & cosmetics

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10
Q

DEA functions are __?

A
  1. Part of the Dept of Justice
  2. Administers the controlled substances act of 1970
  3. Regulates the manufacture/districution of substances with abuse potential
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11
Q

Omnibus Budget Reconciliation Act

A

This act was created in 1990 and states that phamacists MUST provide patient counseling

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12
Q

Phase I in the clinical evaluation of a new drug consists of __?

A
  1. Small doses
  2. Given to a limited number of people
  3. Determines:
    a. Biological effects
    b. Metabolism
    c. Safe dose range
    d. Toxic effects of the drug
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13
Q

Phase II in the clinical evaluation of a new drug consists of __?

A
  1. Given to a large number of people

2. Determines: Effectiveness

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14
Q

Phase III in the clinical evaluation of a new drug consists of __?

A
  1. Given to a larger number of people who have the condition for which the drug is indicated
  2. Determines:
    a. Safety
    b. Efficacy
    c. Dosage
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15
Q

Phase IV in the clinical evaluation of a new drug consists of __?

A

Phase IV in the clinical evaluation of a new drug consists of __?

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16
Q

What does Phase I treatment determine about a new drug?

A
  1. Biological effects
  2. Metabolism
  3. Safe dose range
  4. Toxic effects of the drug
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17
Q

What does Phase II treatment determine about a new drug?

A

Effectiveness

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18
Q

What does Phase III treatment determine about a new drug?

A
  1. Safety
  2. Efficacy
  3. Dosage
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19
Q

What does Phase IV treatment determine about a new drug?

A
  1. Drug toxicity
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20
Q

This act was created in 1952 and Amends Food, Drug, Cosmetic Act of 1938. It requires Rx for certain drugs to be sold

A

The Durham-Humphrey Law of 1952

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21
Q

This Amendment required that manufacturers must demonstrate drug effectives, follow rules in testing, & to submit reports of adverse effects

A

The Drug Amendments of 1962

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22
Q

This amendment accounts for drugs with abuse potential

A

Drug Abuse Control Amendments of 1965

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23
Q

This amendment sets current requirements for writing prescriptions for drugs

A

The Controlled Substance Act of 1970-

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24
Q

What are some of the specific details involving the controlled substance act of 1970?

A
  1. Any Rx for controlled substance requires DEA #
  2. Schedule II through IV requires Rx
  3. Sch. II Rx-written in pen or typed-The RDH may write but the DDS must sign
  4. Sch. II Rx-cannot be phoned in; exception-emergency
  5. Sch. II- no refills; obtain new Rx
  6. State requirements-duplicate; triplicate-DDS gets 1, pt gets 2nd, RPH sends 1 to state board.
  7. Sch. III & IV-can phone in; refilled no more than 5 times in 6 months-if so, noted on Rx
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25
Schedule I narcotics: Abuse potential, Examples and Handling
Abuse Potential: Highest Examples: Heroin, LSD, Pot Handling: No accepted medical use; experimental only
26
Schedule II narcotics: Abuse potential, Examples and Handling.
Abuse Potential: High Examples: Oxycodone, Morphine, amphetamine Handling: Written RX with provider's signature, no refills
27
Schedule III narcotics: Abuse potential, Examples and Handling.
Abuse Potential: Moderate Examples: Codeine, Hydrocodone Handling: Rx can be phoned in, no more than 5 refills in less than 6 months
28
Schedule IV narcotics: Abuse potential, Examples and Handling:
Abuse Potential: Less Examples: Diazepam Handling: Rx can be phoned in, no more than 5 refills in less than 6 months
29
Schedule V narcotics: Abuse potential, Examples and Handling
Abuse Potential: Lease Examples: Some codeine cough syrups Handling: Can be OTC in some states
30
Purpose of Prescription writing is __?
1. Saves time-don't need to clarify 2. Decrease in mistakes 3. Originally in Latin 4. Recent years-simplified
31
Which measurement system: 1. Has calculations are based on 10 2. Language of scientific measurement a. Kilogram-weight b. Liter- volume 3. Solid drugs dispensed by weight 4. Liquid drugs dispensed by volume
Metric
32
1 kilogram =
1000g
33
1 gram =
1,000,000 micrograms
34
The process of manipulating DNA and RNA and recombining genes into hybrid molecules that can be inserted into living organisms and repeatedly reproduced. (ex: E. Coli)
Biotechnology
35
name given to a drug designed by manufacturers.
Brand/ Trade Name
36
Drugs that are categorized my federal law according to therapeutic usefulness and potential for abuse.
Controlled substance
37
Drugs are classified according to there effect on particular body systems, therapeutic use, and their chemical characteristics.
Drug classifications
38
related to the chemical or official name of the drug; independent of the manufacturer and often indicates the drug group
Generic name
39
drugs available with out a prescription
Over-the-counter (OTC) drugs
40
involves the cost of drug therapy including cost of purchasing, dispensing, storage, administration, lab and other tests used to monitor patient responses and loses due to expiration
Pharmacoeconomics
41
an inactive substance similar in appearance to the actual drug
Placebo
42
access to threapeutic drugs order for medication is written by a licensed health care provider.
Prescription Drugs
43
an example of a group of drugs often the first one of the group to be developed
Prototype
44
drugs that are absorbed by the body circulates through the bloodstream to their sites of action in various body tissues, and eventually are eliminated from the body
Systemic effects
45
is the study of drugs
pharmacology
46
alter functions of living organisms
Chemicals
47
Drug therapy use,drugs to ,prevent diagnoses treat signs and symptoms and disease
pharmocotherapy
48
helps with qulity of life
medications
49
out side body topical,
local effects
50
inside body, curculates threw the blood stream most drugs r give thew systemic effects
systemic effects
51
historicaly meds are from
plants, animals,minerals
52
medication now
synthetic compounds manufacterd in labs
53
importent source of drugs, manipulating DNA,&RNA then recombinding genes into hybrid molecules(colones) that can be inserted into living organisms hybrid molecules colones for example escherichia coli bacteria
Biotechnology
54
individual drugs that represent groups of drugs
prototypes
55
opioid Analgeics
morphine (prototype)
56
antibotics
penicillen(prtotype)
57
related to chemical of offical name and is indeprndent of manufactors always lowercase, less expensive but equal to brand
generic drugs
58
Brand or ,trade name
capitalized
59
involve cost of drugs and all who help docter, nureses techs goals are to identify drug therapy provid benifet and is cost effective
pharmaconomics
60
regulates manfactures distribution advertising & labeling of drugs
food drug and cosmetic Act 1938
61
must be prescribed Lincience Physical
Durham-Humphrey Amendment
62
Enforces the law
Food Drug Adminisrations (FDA)
63
Regulates vaccines & other biological pruducts
Public Health
64
can supress misleading advertiment of non-prescriptios drugs
Federal Trade commission
65
Specific body systems Therapeutic uses Chemical characteristics
Classifications
66
Title II: Controlled Substances Act
Regulates manufacturing and distribution of Narcotics, depressants stimulants, hallucinogens Anabolic steroids
67
Approves many new drugs annually Both prescription and OTC May change status from prescription to OTC Potential advantages and disadvantages
Food and Drug Administration (FDA) (cont.)

pharmacology (5 decks)

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