Download Pharmacology and the Nursing Process, 4th ed. Lilley/Harrington

Cultural, Legal, and Ethical
Considerations
Mosby items and derived items © 2011, 2007, 2004 by Mosby, Inc., an affiliate of Elsevier Inc.
Winter 2013
1
Schedule
Abuse
Liability
Approved
Medical Use
Availability
Schedule I
High
No
investigational
use only
Schedule II
Schedule III
High
Moderately
High
Examples
LSD, mescaline, peyote
Heroin, marijuana
Yes
written
prescription
with no refills
amphetamine, methamphetamine,
cocaine
codeine, levorphanol, meperidine
methadone, morphine, opium
amobarbital, pentobarbital,
secobarbital
phencyclidine
Yes
written or
telephone
prescription
with refills
Tylenol with codeine, paregoric
chlorphentermine
anabolic steroids
chloral hydrate
chlordiazepoxide, diazepam,
flunitrazepam
meprobamate
methohexital, phenobarbital
Robitussin A-C (contains less than
100 mg codeine per 100 ml)
Schedule IV
Moderate
Yes
written or
telephone
prescription
with refills
Schedule V
Low
Yes
prescription
not necessary
5/23/2017
Winter 2013
Winter 2013
2
2
 Investigational

Informed consent
 U.S.




new drug (IND) application
FDA drug approval process
Preclinical testing
Clinical studies
Investigational drug studies
Expedited drug approval
Winter 2013
3
 Preclinical
investigational drug studies
 Informed consent
 Clinical phases of investigational drug studies




Phase I
Phase II
Phase III
Phase IV
Winter 2013
4
 CLINICAL
TRIALS FOR NEW DRUGS

ANIMAL STUDIES

PHASE I – DRUGS ARE GIVEN TO A SMALL GROUP OF
HEALTHY VOLUNTEERS



SAFE DOSAGES
ROUTES OF ADMINISTRATION
ABSORPTION, METABOLISM, EXCRETION, TOXICITY

ADVERSE EFFECTS
5/23/2017
Winter 2013
5
5
 PHASE

DOSES ARE GIVEN TO A SMALL GROUP OF PATIENTS
WITH THE DISEASE OR SYMPTOM
 PHASE


III
LARGE GROUP OF PEOPLE – PLACEBO,
DOUBLE BLIND STUDY
 PHASE

II
IV
FDA EVALUATES THE DATA FOR POSSIBLE APPROVAL
FOLLOW-UP STUDIES POST MARKETING
SURVEILLANCE
5/23/2017
Winter 2013
6
6
 Assess
the influence of a patient’s cultural,
beliefs, values, and customs
 Drug polymorphism
 Compliance level with therapy
 Environmental considerations
 Genetic factors
 Varying responses to specific drugs
Winter 2013
7
 Changing
national demographics
 Influence of ethnicity and genetics
 Rapid and slow acetylators
 Examples of various ethnic groups found in
the U.S.





Asian
African American
Hispanic
Native American
Caucasion
Winter 2013
8
 Health
beliefs and practices
 Past uses of medicine
 Folk remedies
 Home remedies
 Over-the-counter drugs and treatment
 Herbal remedies
Winter 2013
9
 Usual
response to illness
 Responsiveness to medical treatment
 Religious practices and beliefs
 Dietary habits
Winter 2013
10