Test 1 - Lecture 1

Question 1

Pharmacotherapeutics

Answer 1

• 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.

Question 2

Mystical Period

Answer 2

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

Question 3

Empirical period

Answer 3

~ 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)

Question 4

Medieval Period

Answer 4

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)

Question 5

London Pharmacopoeia

Answer 5

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

Question 6

Contemporary System

Answer 6

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.

Question 7

Pharmacology Today

Answer 7

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

Question 8

Designer Drugs

Answer 8

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

Question 9

T or F

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

Answer 9

TRUE

Question 10

Generic Name

Answer 10

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

Question 11

Trade Name

Answer 11

Multiple
always written upper case
Proprietary name

Question 12

Drugs ending in -olol

Answer 12

Beta Blocker

Question 13

Drugs ending in -pril

Answer 13

Ace Inhibitor

Question 14

Drugs ending in sartan

Answer 14

ARBS

Question 15

What are the 3 big differences between generic and trade?

Answer 15

1. Bioavailability
2. Cost
3. Pharmacist needs approval from provider.

Question 16

Bioavailability

Answer 16

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

Question 17

Drug classifications - Chemical Composition

Answer 17

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

Question 18

Drug classifications - Physiologic effect

Answer 18

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

Question 19

Drug classifications- Therapeutic use or action

Answer 19

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

Question 20

Prototype

Answer 20

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

Question 21

Phases of Clinical Development: Preclinical Testing

Answer 21

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

Question 22

Phases of Clinical Development: IND (Investigational New Drug)

Answer 22

FDA Review

Question 23

Phases of Clinical Development: clinical Trials Phase I

Answer 23

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?

Question 24

Phases of Clinical Development: clinical Trials Phase II

Answer 24

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

Question 25

Phases of Clinical Development: clinical Trials Phase III

Answer 25

3-4 yrs; ~1000 - 3000 pt | Looking for any long term side effects. This is completely blind test; some pt receive placebo.

Question 26

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

Answer 26

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

Question 27

Phases of Clinical Development: clinical Trials Phase IV

Answer 27

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

Question 28

Orphan Drugs

Answer 28

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

Question 29

orphan Drug Act

Answer 29

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

Question 30

Off label prescribing

Answer 30

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

Question 31

Legend Drugs

Answer 31

Drugs that require a prescription.

Question 32

What is in the Black Box Warning (BBW)?

Answer 32

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

Question 33

Pure Food and Drug Act of 1906

Answer 33

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

Question 34

Sherley Amendment to Pure Food and Drug Act

Answer 34

Setup to prohibit false thraputic claims.

Question 35

Federal food, drug, and cosmetic Act 1938

Answer 35

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

Question 36

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

Answer 36

1951- Labeled for prescription only

Question 37

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

Answer 37

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.

Question 38

GINA 2008

Answer 38

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

Question 39

Controlled Substances Act (1970) | Schedule 1 includes?

Answer 39

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

Question 40

Controlled Substances Act (1970) | Schedule II includes?

Answer 40

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

Question 41

Controlled Substances Act (1970) | Schedule III includes?

Answer 41

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

Question 42

Controlled Substances Act (1970) | Schedule IV includes?

Answer 42

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

Question 43

Controlled Substances Act (1970) | Schedule V includes?

Answer 43

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

Question 44

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

Answer 44

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

Question 45

Complementary and alternative medicine (CAM)

Answer 45

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