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Pharm > Test 1 - Lecture 1 > Flashcards

Test 1 - Lecture 1 Flashcards

1
Q

Pharmacotherapeutics

A
  • The use of drugs to diagnose, prevent, or treat disease
  • the desired therapeutic effect of the drug
  • The medical use/purpose/indication of the drug.
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2
Q

Mystical Period

A

Primitive and prehistoric cultures
Treatments were magical, mystical, potions
Superstitious

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3
Q

Empirical period

A

~ 3000 BC
Animal extracts, plants: didn’t understand ‘how’ it worked just knew they worked.
Treatment based on observations w/o scientific basis.
Sumerians: 1st written prescriptions
Chinese: inventory of mixtures; natural healing; 1st Pharm Books
Egyptians: standardized drug prep, 1st to use polypharmacy, Mosaic Health Code (hygienic methods)

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4
Q

Medieval Period

A

1200-1400 AD
Galen: Father of Pharmacy; extensive records on treating gladiators; 1st to have stock of pharmaceuticals.
- Apothecary System
- Withering: Digitalis “Foxglove”- treat CHF
- Jenner: Father of Vaccinations (cow utters)

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5
Q

London Pharmacopoeia

A

1618
Became Mecca of medicine
Published PDR (book of drug inserts)

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6
Q

Contemporary System

A

Began Early 1800s
Period of Research
John Jacob Abel- Father of Pharm in US
Advances: relation tween pancreas and DM; development of antimicrobial drugs; develop new drugs, hormones and vac.

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7
Q

Pharmacology Today

A

Research done in rain forests
Genetic engineering, chem sythesis
Immunochemistry: Study antibody and antigens

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8
Q

Designer Drugs

A

Drugs made to match a persons DNA. Better efficacy, reduced side effects.

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9
Q

T or F

The advantage of genetically engineered drugs over those made from animals is less drug reactions?

A

TRUE

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10
Q

Generic Name

A
  • only one name
  • Always written lower case
  • *Orders written in Generic Name**
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11
Q

Trade Name

A

Multiple
always written upper case
Proprietary name

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12
Q

Drugs ending in -olol

A

Beta Blocker

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13
Q

Drugs ending in -pril

A

Ace Inhibitor

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14
Q

Drugs ending in sartan

A

ARBS

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15
Q

What are the 3 big differences between generic and trade?

A
  1. Bioavailability
  2. Cost
  3. Pharmacist needs approval from provider.
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16
Q

Bioavailability

A

Rate and extent to which the active ingredients are absorbed and made available at the site of action.
Main difference between generic and trade

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17
Q

Drug classifications - Chemical Composition

A

classify molecule by chemical base. Ex: Morphine (Opium) class is Opiate.

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18
Q

Drug classifications - Physiologic effect

A

Based on what is does. Ex: Morphine is a CNS depressent

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19
Q

Drug classifications- Therapeutic use or action

A

What its used for. Ex: Morphine- narcotic used for pain.

20
Q

Prototype

A

One representative drug from each class
usually first drug in its class
can be combination of traditional and new drugs
helps with learning pharmacology
Ex: metropolol: Prototype for beta blocker

21
Q

Phases of Clinical Development: Preclinical Testing

A

Lasts 6-7 years
Chemists have an idea and test on animals
Toxic?, Useful?, Effects, Any new use?
Only 1:1000 move on from this phase

22
Q

Phases of Clinical Development: IND (Investigational New Drug)

A

FDA Review

23
Q

Phases of Clinical Development: clinical Trials Phase I

A

1-2 yrs; small # (20-80)
Volunteers are healthy; paid to participate
Looking for: how does work in body, how does body metabolize, safety concerns?

24
Q

Phases of Clinical Development: clinical Trials Phase II

A

2 yrs; ~100-300 pts.
Pt have the disease
Determining dosage, any side effects?

25
Q

Phases of Clinical Development: clinical Trials Phase III

A

3-4 yrs; ~1000 - 3000 pt

Looking for any long term side effects. This is completely blind test; some pt receive placebo.

26
Q

Phases of Clinical Development: FDA reporting/NDA (New Drug Application)

A

This process can take 1-2 years to be reviewed. Once they receive acceptance the company can start marketing

27
Q

Phases of Clinical Development: clinical Trials Phase IV

A

On the market but can be pulled if too many reported issues (ex celebrex).
Dr. can write prescription but will be monitoring pt closely.

28
Q

Orphan Drugs

A

Abandoned; too expensive and company won’t recoup costs.

29
Q

orphan Drug Act

A

Tax incentive to get co to continue clinical development of an orphan drug

30
Q

Off label prescribing

A

relating to the prescription of a drug for a condition other than that for which it has been officially approved.

31
Q

Legend Drugs

A

Drugs that require a prescription.

32
Q

What is in the Black Box Warning (BBW)?

A
  • highlight most serious warning
  • usually found on drug label in black box
  • indicates adverse reactions
  • Patients that should NOT take drug
  • side effects
33
Q

Pure Food and Drug Act of 1906

A

Requires co to put a label on drug. Protect people in how food or drug is processed.

34
Q

Sherley Amendment to Pure Food and Drug Act

A

Setup to prohibit false thraputic claims.

35
Q

Federal food, drug, and cosmetic Act 1938

A

Prevent the sale of drugs not tested. Result of this act was the FDA.

36
Q

Durham Humphrey Amendment to Federal food, drug, and cosmetic Act

A

1951- Labeled for prescription only

37
Q

Kefauver-Harris Amendment to Federal food, drug, and cosmetic Act

A

1962- Co must prove effective before can market. Plus must have informed consent to test meds. Ex- sleep aid taken by pregnant women in Europe that caused malformed babies.

38
Q

GINA 2008

A

Prohibits discrimination in health coverage and employment based on genetic information.
Works with HIPPA.

39
Q

Controlled Substances Act (1970)

Schedule 1 includes?

A 
Abuse Potential - High
Dependance - severe
Drugs with no medical use
Street Drugs
Heroin, LSD, hashish
40
Q

Controlled Substances Act (1970)

Schedule II includes?

A

Abuse Potential - High
Dependance - severe
Narcotics - morphine, vicatin, amphetamines
No refills

41
Q

Controlled Substances Act (1970)

Schedule III includes?

A

Abuse Potential - moderate
Dependance - moderate
Written order accepted. May be refilled 5x w/i 6 mo, new script after 6mo
Codeine, hydrocodone, some CNS stimulants, anabolic steroids

42
Q

Controlled Substances Act (1970)

Schedule IV includes?

A

Abuse Potential - Low
Dependance - Limited
Same rules as schedule III
benzodiazepine, muscle relaxants, sedatives, some opioid narcotics

43
Q

Controlled Substances Act (1970)

Schedule V includes?

A

Abuse Potential - Limited
Dependance - Lowest
May be obtained w/o prescription
antidiarrheal, loperamide

44
Q

What is the worst FDA Pregnancy Category - A, D, or X

A

Category X: studies in animals or humans have demonstrated fetal abnormalities and/or there is + evidence of humanfetal risk based on adverse reaction data from investigational or marketing experience.
Pregnant women cant take at all. Ex. Acutane

45
Q

Complementary and alternative medicine (CAM)

A

Treatment practices that are not widely accepted or practiced by mainstream clinicians in a given culture.
Herbal/vitamin supplements
**Be sure to include these in med reconciliation

Pharm (11 decks)

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