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
Q

Schedule I narcotics: Abuse potential, Examples and Handling

A

Abuse Potential: Highest
Examples: Heroin, LSD, Pot
Handling: No accepted medical use; experimental only

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26
Q

Schedule II narcotics: Abuse potential, Examples and Handling.

A

Abuse Potential: High
Examples: Oxycodone, Morphine, amphetamine
Handling: Written RX with provider’s signature, no refills

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27
Q

Schedule III narcotics: Abuse potential, Examples and Handling.

A

Abuse Potential: Moderate
Examples: Codeine, Hydrocodone
Handling: Rx can be phoned in, no more than 5 refills in less than 6 months

28
Q

Schedule IV narcotics: Abuse potential, Examples and Handling:

A

Abuse Potential: Less
Examples: Diazepam
Handling: Rx can be phoned in, no more than 5 refills in less than 6 months

29
Q

Schedule V narcotics: Abuse potential, Examples and Handling

A

Abuse Potential: Lease
Examples: Some codeine cough syrups
Handling: Can be OTC in some states

30
Q

Purpose of Prescription writing is __?

A
  1. Saves time-don’t need to clarify
  2. Decrease in mistakes
  3. Originally in Latin
  4. Recent years-simplified
31
Q

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
A

Metric

32
Q

1 kilogram =

A

1000g

33
Q

1 gram =

A

1,000,000 micrograms

34
Q

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)

A

Biotechnology

35
Q

name given to a drug designed by manufacturers.

A

Brand/ Trade Name

36
Q

Drugs that are categorized my federal law according to therapeutic usefulness and potential for abuse.

A

Controlled substance

37
Q

Drugs are classified according to there effect on particular body systems, therapeutic use, and their chemical characteristics.

A

Drug classifications

38
Q

related to the chemical or official name of the drug; independent of the manufacturer and often indicates the drug group

A

Generic name

39
Q

drugs available with out a prescription

A

Over-the-counter (OTC) drugs

40
Q

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

A

Pharmacoeconomics

41
Q

an inactive substance similar in appearance to the actual drug

A

Placebo

42
Q

access to threapeutic drugs order for medication is written by a licensed health care provider.

A

Prescription Drugs

43
Q

an example of a group of drugs often the first one of the group to be developed

A

Prototype

44
Q

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

A

Systemic effects

45
Q

is the study of drugs

A

pharmacology

46
Q

alter functions of living organisms

A

Chemicals

47
Q

Drug therapy use,drugs to ,prevent diagnoses treat signs and symptoms and disease

A

pharmocotherapy

48
Q

helps with qulity of life

A

medications

49
Q

out side body topical,

A

local effects

50
Q

inside body, curculates threw the blood stream most drugs r give thew systemic effects

A

systemic effects

51
Q

historicaly meds are from

A

plants, animals,minerals

52
Q

medication now

A

synthetic compounds manufacterd in labs

53
Q

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

A

Biotechnology

54
Q

individual drugs that represent groups of drugs

A

prototypes

55
Q

opioid Analgeics

A

morphine (prototype)

56
Q

antibotics

A

penicillen(prtotype)

57
Q

related to chemical of offical name and is indeprndent of manufactors always lowercase, less expensive but equal to brand

A

generic drugs

58
Q

Brand or ,trade name

A

capitalized

59
Q

involve cost of drugs and all who help docter, nureses techs goals are to identify drug therapy provid benifet and is cost effective

A

pharmaconomics

60
Q

regulates manfactures distribution advertising & labeling of drugs

A

food drug and cosmetic Act 1938

61
Q

must be prescribed Lincience Physical

A

Durham-Humphrey Amendment

62
Q

Enforces the law

A

Food Drug Adminisrations (FDA)

63
Q

Regulates vaccines & other biological pruducts

A

Public Health

64
Q

can supress misleading advertiment of non-prescriptios drugs

A

Federal Trade commission

65
Q

Specific body systems
Therapeutic uses
Chemical characteristics

A

Classifications

66
Q

Title II: Controlled Substances Act

A

Regulates manufacturing and distribution of
Narcotics, depressants
stimulants, hallucinogens
Anabolic steroids

67
Q

Approves many new drugs annually
Both prescription and OTC
May change status from prescription to OTC
Potential advantages and disadvantages

A

Food and Drug Administration (FDA) (cont.)