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Drug
any chemical that can affect living processes
Pharmacology
the study of drugs and their interactions with living systems
Clinical Pharmacology
the study of drugs in humans
Therapeutics
the use of drugs to diagnose, prevent or treat disease or to prevent pregnancy
The Ideal Drug Properties
Effectiveness
safety
selectivity
reversibility
predictability
low cost
ease of administration
freedom from drug interactions
chemical stability
simple generic name
Administration
medication errors
patient adherence
Pharmacokinetic Process
Absoportion
Distribution
Metabolism
Excretion
Pharmacokinetics
determine how much of an administred drug gets to its site of action
Pharmacodynamic Processes
Drug receptor interaction
patients functional state
placebo effects
Pharmacodynamic
determine nature and intensity of response
Sources of Individual Variation
Pathological
Physiological
Genetic
Physiological Variables
Age
Gender
Weight
Pathological Variables
diminished kidney liver function
major organs of drug eliminiation
The objective of drug therapy
maximize therapeutic benefit with minimum harm
Six Rights of drug administration
right drug
right patient
right route
right dose
right time
right documentation
2 areas to apply pharmacologic knowledge
paient education
patient care
The Nursing Process
Assessment
Diagnose
Planning
Implementation
Evaluation
Preadministration Assessment
Gather data to
:
Evaluate therapeutic and adverse effects
Identify high-risk patients
Assessment of the patients capacity for self care
Analysis and Diagnosis Phase
Judging appropriateness of the prescribed therapy
Identifying the potential health problems treatment may cause
Characterize the patients capacity for self care
Planning Phase
Defining goals
Establishing priorities
Establishing criteria for evaluating success
Evaluation Stage
Evaluate
:
Therapeutic respose
Adverse reactions and Interactions
Patient adherence
Patient satisfaction with treatment
Federal pure food and drug act of 1906
Free of adulterants
The food drug and cosmetic act of 1938
Drugsafety
Food Drug Administration
approves drugs for use to general population
Harris-kefauver amendments of 1962
drug have to be proved effective before marketing
Controlled substance of 1970
schedule drugs according to abuse potential
Schedule I
No medical use
High potential for abuse
Schedule II-V
Have medical uses
Have potential for abuse
Higher schedule # lower abuse potential
Accelerated approval change of 1992
for AIDS and cancer
ADV:
Meds are needed even if benefits are marginal
Unknown risk outweight the need for effective drug
DISADV:
Manufacturers do not complete follow up studies
No clear way to removefrom market if it does not pass more rigorous studies
Prescription Drug User Fee Act of 1992
pay the FDA fees for faster drug approval
Food and Drug Administration Modernization Act of 1997
Fast track system
clinical trial database
6 mos notice for dc medications
manufactures can give off label uses for drugs
Off Label Use
use of a drug that has not been evaluated by the FDA
Best pharmaceuticals for children act of 2002
Pediatric research equity act of 2003
conduct clinical trial for children
FDA Amendment Acts of 2007
rigorous oversight of drug safety
after
a drug has been approved
New Drug Development
Preclinical testing
Clinical testing
Preclinical Testing
in animals
1-5 yrs
evaluates:
toxicities
pharmacokinetic properties
potentially useful biologic effects
Clinical Testing
In humans
2-10 years
4 phases
Phase I clinical Trial
In healthy volunteers
Evaluate:
Drug metabolism
Pharmacokinetics
Bilogic effects
Phase II
In Patients
Evaluate:
Therapeutic effect
Dosage
Phase III
In patients
Evaluates:
Safety
Effectiveness
Phase IV
released for general use
postmarketing surveillance
Three Drug Names
Chemical
Generic
Trade
Chemical Name
description of drug using nomenclature of chemistry
Generic Name
name assigned by US
Only one generic name
Trade Name
name under which drug is marketed
also brand name
proprietary name
Over-The-Counter Drugs
Drugs that can be purchased without a R
x
Sources of Drug Information
People
Clinician
Pharmacist
Poison Control Center
Pharmaceutical Sales rep
Published Information
Text-like books
Newsletters
Reference Books
The Internet
Reference Books
Physician's Desk Reference
referenced work by pharmaceutical industry
Drug Facts and Comparisons
Monographs for all drugs marketed in US
Text-like Books
Goodman and Gillman
Science information hat underlies drug use
Phamacotherapy
Each chapter focuses on treatment of a specific disorder
Applied Therapeutics
Case study approach
Author
blkbunny20
ID
28961
Card Set
dmrn108
Description
Pharmacology
Updated
2010-08-04T21:59:56Z
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