Lecture 1 Flashcards
Preclinical Investigation
- Involves lab research
- Tests done on cells and animals
- Determines drug-dose range
- Examines adverse effects
- Results are inconclusive
Clinical Investigation
- Longest part of approval process
- Termed “clinical-trials phase”
- Evaluates human benefits
Review of New Drug Application (NDA)
-Average review time 17-24 months
- Drug approved: process continues
- Drug rejected: Process suspended
Post-marketing Surveillance
- New drug placed on market
- Surveyed for harmful effects in larger population
- FDA holds annual public meetings
Controlled substances
Have a high potential for addiction or dependence
- Physical dependence
- Psychological dependence
Non-Regulated Potentially Abusive Drugs
- Tobacco
- Alcohol
- Caffeine
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
Schedule 1 Drugs
- Highest abuse potential
- Limited or no therapeutic use
Ex.
Heroin & LSD
Schedule 2 Drugs
- High abuse potential
- High physical and psychological dependence
Ex.
Morphine
methadone
Schedule 2 Drug
-Restrictions
- No refills permitted
- Client must see health-care provider first before prescription is given
Schedule 5 Drugs
- Therapeutic use w/out prescription
- Lowest abuse potential
Ex.
OTC cough medicines w/ codeine
6-best-selling herbal supplements
- Garlic
- Echinacea
- St. John’s-wort
- Saw Palmetto
- Ginkgo
- Ginseng
Dietary Supplement Health and Education Act of 1994
DSHEA
- Regulatory act for dietary supplements
- Less rigid than FDA
- Exempts dietary supplements from FDA standards
Nurse’s role w/ Complimentary Alternative Medicine CAM
TEST
- Maintain non-judgmental attitude *
- Keep pt and those around them safe*
School-Age children and Pharmacotherapy
-Longer, more detailed explanations, but still basic information
