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
Adolescents and Pharmacotherapy
Need understanding and respect, teens do not want to look “different” than their peers.
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
6 categories of Human-Integration Pyramid
TEST
Read in book**
- Age
- Gender
- Genetic predisposition
- Community-environment factors
- Culture and ethnicity
- Psychological-social-spiritual needs
Community Factors that Affect Pharmacotherapy
- Urbanization levels
- Age distributions
- Socioeconomic levels
- Occupational patterns
- Industrial growth
Drugs have 3 names:
- Chemical name
- Generic name:
- diazepam - Trade name:
- Valium
Trade name is capitalized
Pregnancy Category A drugs
- Studies performed w/ pregnant women
- No increased risk of fetal abnormalities shown
Pregnancy Category B Drugs
- Animal studies have shown no risk to fetus
- No studies done w/ pregnant women
Pregnancy Category C Drugs
- Animal studies have shown a risk to fetus
- No studies done w/ pregnant women
Pregnancy Category D Drugs
- Risk to fetus shown
- Benefits outweigh risk
