Cultural, Legal, and Ethical
Considerations
Jan Bazner-Chandler
RN, MSN, CNS, CPNP
Federal Food and Drugs ACT
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FFDA
Required drug manufactures to list on the
drug product label the presences of
dangerous and possible addicting
substances.
U.S. Pharmacopeia
Drug Enforcement Administration
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DEA is charged with the enforcement of
Controlled Substance Act.
DEA
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Individuals and companies legally allowed to
handle controlled substances must register
with DEA, keep accurate records of all
transactions, and provide secure storage of
drugs.
Physicians assigned number by DEA and
must put number on all prescriptions of
controlled substance.
DEA and the consumer
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DEA will monitor the number of controlled
substance prescriptions a consumer is using
and from what physicians the prescriptions
are being dispensed.
Schedule I Drugs
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Drugs with high abuse risk. These drugs
have NO safe, accepted medical use in the
US. Some examples are heroin, marijuana,
LSD, PCP and crack cocaine.
Schedule II Drugs
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Drug with high abuse risk, but also have safe
acceptable uses in the United States. These
drugs can cause severe psychological or
physical dependence.
Schedule II Drugs
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Schedule II drugs include: certain narcotic,
stimulant and depressant drugs.
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Morphine sulfate
Cocaine
oxycodone (Percodan)
dextroamphetamine (Dexedrine) for Attention
deficit disorder
Schedule II Drugs
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Must be kept locked and signed out only by
registered personal.
On the wards need key or code to gain
access to medications – narcotics for pain
relief.
Schedule II - prescription
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At this time NP and PA do not have
prescription writing ability.
In the hospitalized client narcotics often need
to be re-ordered every 36 hours.
In the community – number of pills dispensed
is regulated.
Schedule III, IV or V
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Drugs with an abuse risk lower than
Schedule II. These drugs also have safe and
accepted medical use in the US. Drugs may
contain safer and small amounts of certain
narcotic and non-narcotic drugs, anti-anxiety,
tranquilizers, sedatives, stimulants, and nonnarcotic analgesics.
Schedule III Drugs
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Schedule III: Less potential of abuse –
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acetaminophen with codeine or Tylenol #3
hydrocondone with codeine or Vicodin
diazepam or Valium
Schedule IV and V Drugs
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Schedule IV: Appetite suppressant drugs
Schedule V: OTC pain medications
Student Nurse and Controlled Drugs
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In the clinical you will always administer
medication with the clinical instructor.
Narcotics cannot be accessed by student –
must be done with instructor or registered
nursing personal.
Specific hospital procedures and protocols
need to be followed.
New Drug Development
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Pharmaceutical industry is a multibillion dollar
industry.
Drug Development
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FDA approves studies – reviews lengthy
testing protocol.
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Animals
Randomized controlled studies on humans
Data collection
FDA approves drug for distribution
Food and Drug Administration
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FDA
Purpose: to protect the patient and ensure
drug effectiveness.
Responsible for approving drugs for clinical
safety and efficacy before they are brought to
market.
Marketing of Drugs
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A billion dollar industry
New drugs are protected by patent for 14
years during which time only the
pharmaceutical that has developed it can
market it
After the fourteen years drugs with similar
chemical composition can be developed and
sold as generic drugs – cost less
Cost
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Have you even wondered why a drug that
costs pennies as an OTC can be so
expensive when administered in the hospital
setting?
The Tylenol given for fever may cost as much
as $5.00 a pill
This pays for the processing of the physician
order, pharmacy and the nurse that
administers the drug
The Million Dollar Pill
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Research! Research! Research!
Legal Issues and Nursing
Implications
Standards and scope and role of
processional nursing.
Legal Framework
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Federal and State Legislation
Standards of Care
Nurse Practice Act
Medication Administration
Ethical Practices
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American Nurses Association Code of Ethics
for Nurses
Serves as integral part of the foundation of
professional nursing.
Ensures that the nurse is acting on behalf of
the patient and with the patient’s best interest
at heart.
Cultural Considerations
“one size fits all”
Cultural Implications
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Culture
Culture competence
Ethnicity
Ethnopharmcology
Race
Culture
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An integrated system of beliefs, values, and
customs that are associated with a particular
group of people and are generally handed
down from generation to generation.
Cultural Competence
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The ability to work with patients with proper
consideration for cultural context, which
includes patients belief systems and values
regarding health, wellness and illness.
It involves learning about different patients
and their specific responses to treatment,
including drug therapies.
Ethnicity
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Ethnic affiliation based on shared culture or
genetic heritage or both.
Ethnopharmacology
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Study of the effects of ethnicity on drug
responses, specifically drug absorption,
metabolism, distribution, and excretion.
Race
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Class of individuals with common lineage.
Race is often used to refer to geographical
origins of ancestry.
Ethnicity and Genetics
Drug polymorphism
Drug Polymorphism
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How the same drug may result in very
different responses in different individuals.
What can influence response?
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Age
Gender
Size
Body composition
What are cultural influences?
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Level of patient compliance with the therapy
regimen.
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Cultural beliefs
Experiences with medications
Personal expectations
Family expectations
Family influence
Level of education
Alternative Therapies
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Herbal
Homeopathic
Environmental Considerations
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Diet
Malnutrition
Cultural Assessment
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Health beliefs and practices
Past uses of medicine
Use of folk remedies
Use of home remedies
Use of over-the counter drugs – OTC
Usual response to illness
Responsiveness to medical treatment
Religious practices and beliefs
Dietary habits