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Flashcards in Lecture 1 Deck (27):
1

Preclinical Investigation

-Involves lab research
-Tests done on cells and animals
-Determines drug-dose range
-Examines adverse effects
-Results are inconclusive

2

Clinical Investigation

-Longest part of approval process
-Termed "clinical-trials phase"
-Evaluates human benefits

3

Review of New Drug Application (NDA)

-Average review time 17-24 months

-Drug approved: process continues
-Drug rejected: Process suspended

4

Post-marketing Surveillance

-New drug placed on market
-Surveyed for harmful effects in larger population
-FDA holds annual public meetings

5

Controlled substances

Have a high potential for addiction or dependence
-Physical dependence
-Psychological dependence

6

Non-Regulated Potentially Abusive Drugs

-Tobacco
-Alcohol
-Caffeine

7

Controlled Substance Act of 1970
-Comprehensive drug abuse prevention and control Act

-Restricts use of drugs w/ potential for abuse
-Restricted drugs placed into 5 schedules

8

Schedule 1 Drugs

-Highest abuse potential
-Limited or no therapeutic use

Ex.
Heroin & LSD

9

Schedule 2 Drugs

-High abuse potential
-High physical and psychological dependence

Ex.
Morphine
methadone

10

Schedule 2 Drug
-Restrictions

-No refills permitted
-Client must see health-care provider first before prescription is given

11

Schedule 5 Drugs

-Therapeutic use w/out prescription
-Lowest abuse potential

Ex.
OTC cough medicines w/ codeine

12

6-best-selling herbal supplements

1. Garlic
2. Echinacea
3. St. John's-wort
4. Saw Palmetto
5. Ginkgo
6. Ginseng

13

Dietary Supplement Health and Education Act of 1994
DSHEA

-Regulatory act for dietary supplements
-Less rigid than FDA
-Exempts dietary supplements from FDA standards

14

Nurse's role w/ Complimentary Alternative Medicine CAM
**TEST**

-Maintain non-judgmental attitude *
-Keep pt and those around them safe*

15

School-Age children and Pharmacotherapy

-Longer, more detailed explanations, but still basic information

16

Adolescents and Pharmacotherapy

Need understanding and respect, teens do not want to look "different" than their peers.

17

Absorption of Drugs Slower in Older Adults...

-Diminished gastric Motility
-Decreased blood flow to digestive organs
-Increased gastric pH

-Increased body fat
-Reduced plasma level
-Less body water

18

6 categories of Human-Integration Pyramid
***TEST***
Read in book**

1. Age
2. Gender
3. Genetic predisposition
4. Community-environment factors
5. Culture and ethnicity
6. Psychological-social-spiritual needs

19

Community Factors that Affect Pharmacotherapy

-Urbanization levels
-Age distributions
-Socioeconomic levels
-Occupational patterns
-Industrial growth

20

Drugs have 3 names:

1. Chemical name
2.Generic name:
-diazepam
3. Trade name:
-Valium

Trade name is capitalized

21

Pregnancy Category A drugs

-Studies performed w/ pregnant women
-No increased risk of fetal abnormalities shown

22

Pregnancy Category B Drugs

-Animal studies have shown no risk to fetus
-No studies done w/ pregnant women

23

Pregnancy Category C Drugs

-Animal studies have shown a risk to fetus
-No studies done w/ pregnant women

24

Pregnancy Category D Drugs

-Risk to fetus shown
-Benefits outweigh risk

25

Pregnancy Category X Drugs
-Contraindicated

-Studies done w/ animals or pregnant women
-Fetal abnormalities shown

26

Illnesses Requiring Drug Therapy for:
-Middle-Aged Adults

1. Cardiovascular disease
2. Hypertension
3. Diabetes
4. Cancer

27

Established risk factors influence pharmacotherapeutic outcomes:
Including:

-Age
-Genetics
-Biologic characteristics
-Personal habits
-Lifestyle
-Environment