Unit 1 Flashcards

1
Q

pharmaceutics (definiton)

A

drug formulating

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2
Q

Pharmacotherapeautics (definition)

A

clinical; study of drugs in humans

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3
Q

Pharmacodynamics (definition)

A

mechanism of action of drugs (how and why they act on the body)

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4
Q

Pharmacokinetics (definition)

A

what the body does to the drug

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5
Q

Toxicology (definition)

A

study of toxic effects of the drug (the beneficial effects outweigh the bad effects)

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6
Q

Pharmacogenomics (definition)

A

genomic testing to predict how a patient will respond to a drug based on genetic makeup

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7
Q

therapeutic effect (definition)

A

the effect for which the drug is administered

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8
Q

side effect (definition)

A

any effect other than the one for which the drug is administered (often are predictable)

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9
Q

toxic/untoward, adverse effect (definition)

A

regarded as harmful or unpleasant; often worse than side effects

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10
Q

three cardinal rules for drug action

A
  1. all drugs are potential poison
  2. all drugs have more than one effect
  3. drugs do not cure disease, they relieve symptoms
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11
Q

What happened in 1848?

A

The drug importation act requires all drugs entering the US must be analyzed and inspected for “quality, purity and fitness for medical purposes”

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12
Q

What happened in 1901?

A

death of a group of children in St. Louis who were given diptheria antitoxin contaminated with tetanus

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13
Q

What happened in 1906?

A

Pure Food and Drug Act: required drugs to be labeled and manufactured according to standards set in USP and NF

Listed 11 narcotic and habit forming drugs and required they be labeled

Too many loopholes- drugs did not have to be safe or effective

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14
Q

What happened in 1937?

A
  • elixir of sulfanilamide
  • 107 deaths due to antifreeze being an elixir for sulfanilamide
  • The only law broken was the mislabeling (elixir implied alcohol)
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15
Q

What happened in 1938?(federal food, drug and cosmetic act)

A
  • federal food, drug and cosmetic act
  • Safety insured: tests required before petitioning FDA for approval to market the drug
  • Toxicity in animals
  • Human clinical trials
  • Quality and purity or origin assured
  • Must conform to standards in USP and NF
  • Labeling improved
  • Habit forming label warning
  • Directions for use
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16
Q

What happened in 1952? (durham-humphrey amendment)

A

Distinguishes between Rx vs OTC

Expanded dispensing laws for prescription drugs
Oral or telephone prescriptions

Refills
State-controls Physcians license to prescribe non-controlled legend drugs

17
Q

What happened in 1962? (Kefauver-harris drug amendments)

A
  • Drugs must be affective and safe
  • Senator-kefauver started investigating started investigating the drug industry in 1958
  • Thalidomide incident helped pass legislation
  • Safety also improved
  • Need more animal testing
  • Pregnant animals tested
  • drug usefulness must outweigh dangers
18
Q

What happened in 1970? (drug abuse prevention act)

A
  • AKA controlled substances act
  • Obtainable by prescription or federal permission not simple
  • Applies to all habit forming drugs, not just narcotics
19
Q

What are controlled substances and how do they differ from regular prescription drugs?

A
  • Controlled substances are based on medical usefulness and potential abuse
  • They are placed by the attorney general
20
Q

Schedule I drugs

A
  • All drugs begin here whether destined to become OTC, legend drugs, or controlled substances
  • Drugs remain here if there is no therapeautic use even with medical supervision
  • Use is forbidden except for research
21
Q

Schedule II-IV drugs

A
  • Ordered with prescription
  • Records kept for two years
  • DEA sets quotas for amount manufactured/ distributed
22
Q

Schedule V Drugs

A
  • No prescription necessary (still federally controlled)

- Pharmacy keeps record of purchaser for two years

23
Q

Form for writing prescriptions for scheduled drugs

A

Tamper- resistant security prescriptions forms required for schedule II-V

24
Q

How are drugs placed on the schedule?

A

A balance of both usefulness and potential for abuse

25
Q

Schedule II Drugs (prescription rules and dependence)

A
  • High potential for abuse
  • Possible severe physcological or physiological dependence
  • Prescription may not be refilled
  • Max of 30 day supply
  • After 30 days prescription must be rewritten on security paper
  • Prescriptions may be refilled by telephone, but a written prescription must follow by 72 hours after
26
Q

Schedule III drugs (prescription and dependence)

A
  • Moderate to low physical dependence; perhaps high psychological dependence
  • Prescription can be filled 5 times in 6 months, may be given to pharmacist if written immediately by pharmacist
27
Q

Schedule IV drugs (prescription and dependence)

A
  • Limited dependence

- Prescription can be filled 5 times in 6 months, may be given to pharmacist if written immediately by pharmacist

28
Q

DEA

A

Established in 1973

Controls distribution and sale of drugs

29
Q

FDA

A

Responsible for ensuring that drugs and medical devices are safe and effective

30
Q

Federal trade commission

A

Controls misleading advertising for over the counter drugs

31
Q

Efficacy

A

Largest effect a drug can produce

32
Q

Potency

A

Amount of drug needed to get that effect

33
Q

Significance of therapeutic index and how it is calculated

A
  • Can only be calculated in animals
  • Indicates relative margin of safety
  • High number desired
  • LD/ED= TI
34
Q

Additive

A

combined effect of two or more drugs administered at the same time is equal to the sum of their individual effects

35
Q

Antagonistic

A

combined effects of two or more drugs given together is less than the algebraic sum of the individual effects

36
Q

Synergistic

A

the combined effect of two or more drugs administered at the same time is greater than the sum of the individual effects

37
Q

Potentation

A

a drug that has no effect by itself increases the effectiveness of a different drug