Chapter 4 - Cultural, Legal, and Ethical Considerations (Flashcards)

Vocabulary-style flashcards covering cultural, legal, and ethical considerations in pharmacology and nursing, based on the provided notes.

Ethnopharmacology

The study of how cultural factors influence drug response.

Pharmacogenomics

The study of how genetic traits affect drug response.

Drug polymorphism

Variability in drug response due to age, gender, size, body composition, environment, culture, and genetics.

Adherence

The extent to which patients follow a prescribed regimen; varies by culture and may be influenced by beliefs, education, family, expectations, and finances.

Environmental factors

Diet, nutrition, poverty, and access to care that affect drug response and adherence.

Pharmacokinetics/dynamics

How the body processes a drug and how the drug affects the body; influenced by genetics such as CYP450 differences.

Cultural meaning of medications

In some cultures, medications may symbolize weakness or mistrust of healthcare.

Cultural assessment

Nursing assessment of cultural factors that must be completed before giving drugs, including language, Health beliefs and practices, remedies, prior use medications use of herbal/home remediesm folk medicine, and OTC drugs ususal response to illness and treatments family/community support roles, dietatry habits, and religious practices.

Languages and interpreter need

Languages spoken, read, understood, and the need for an interpreter.

Health beliefs and practices

Beliefs such as yin/yang or hot/cold and the use of folk remedies.

Past use of medications

Historical use of medications that may affect current drug response or adherence.

Herbal/home remedies

Use of herbal medicines, folk remedies, and OTC products.

Religious practices

Religious beliefs or practices that may lead to refusal or modification of medications.

Family/community support

Roles of family and community in health decisions and care.

Dietary habits

Regular dietary patterns that can interact with drug effects or adherence.

African American health beliefs

Folk medicine, extended family, women often key decision-makers, and certain predispositions (e.g., lactose intolerance).

Asian health beliefs

hot/cold balance, acupuncture, herbalists; avoid handshakes opposite sex; family > individual; thalassemia, drug interactions, lactose intolerance.

Hispanic health beliefs

bad deed or bad luck; curandero, spiritualists; avoid eye contact (respect); touching common; strong family role; lactose intolerance.

Native American health beliefs

harmony with nature; medicine man; low tone voice, light touch; extended family; lactose intolerance, cleft uvula

Slow acetylators

People (often of European/African descent) with slower drug metabolism leading to higher drug levels.

Rapid acetylators

People (often of Japanese descent) with faster metabolism leading to lower drug levels.

CYP450 variations

Genetic differences in CYP450 enzymes affecting metabolism and drug response.

Asians as poor metabolizers

A subgroup in which certain CYP450 enzymes metabolize drugs slowly, risking toxicity.

Whites as ultrarapid metabolizers

A group with very fast drug metabolism requiring higher doses for effect.

Drug response in African Americans

Better response to diuretics and calcium channel blockers; less response to some beta-blockers/ACE inhibitors.

Ethnicity and dosing (Asians/Hispanics)

Often effective with lower doses of antidepressants, antipsychotics, and antianxiety meds.

FDA

The U.S. Food and Drug Administration; regulates drug approval, safety, and efficacy.

DEA

The Drug Enforcement Administration; enforces controlled substance laws.

State laws

State-level regulations governing prescribing privileges and nurse practice.

1906 Pure Food and Drug Act (FFDA)

Act requiring labels to list dangerous or addicting substances.

Harrison Narcotic Act (1914)

Law regulating narcotics and their distribution.

FFDCA (1938)

Act requiring safety testing and the IND process for drugs.

Durham-Humphrey Amendment (1951)

Established prescription ('legend') drugs separate from OTC drugs.

Kefauver-Harris Amendment (1962)

Required proof of efficacy and safety for drugs (thalidomide tragedy context).

Controlled Substances Act (1970)

Created scheduling of drugs from C-I to C-V based on abuse potential.

Orphan Drug Act (1983)

Promoted development of drugs for rare diseases.

Accelerated Review (1991)

Fast-track approval for HIV/AIDS and other urgent indications.

HIPAA (1996)

Law protecting patient privacy and health information.

Medicare Part D (2003)

Program providing prescription drug coverage under Medicare.

C-I schedule

Drugs with no accepted medical use and high abuse potential (e.g., heroin, LSD).

C-II schedule

Drugs with accepted medical use but high abuse potential (e.g., morphine, oxycodone).

C-III schedule

Drugs with less abuse potential and accepted medical use (e.g., codeine combos).

C-IV schedule

Drugs with lower abuse potential (e.g., benzodiazepines, tramadol).

C-V schedule

Drugs with the lowest abuse potential (e.g., certain cough/diarrhea preparations with opioids).

FDA Preclinical

In vitro and animal studies conducted before human testing.

Phase I-III (clinical trials)

Phases evaluating safety, dosage, and efficacy in humans; large populations tested.

Phase IV

Postmarketing surveillance after a drug is approved.

Black box warnings

The strictest FDA warning for serious or life-threatening risks.

Recalls (Class I-III)

FDA recall classifications by severity of risk to health.

• Class I = severe risk/death.

• Class II = reversible effects.

• Class III = minor issues.

Legal Considerations in nursing

Governed by state/federal law, nurse practice acts, institutional policy

Nurse Practice Acts

State or national laws defining nursing scope of nursing,expanded roles, educational requirements, standards of care, and safe practice limits.

Liability in nursing

Legal responsibility for actions such as failure to assess, safety breaches, or fraud.

Nurses as patient advocates

Nurses must clarify unclear orders and document accurately to protect patients.

Ethical Considerations

ANA Code of Ethics, ICN Code of Ethics = frameworks

Ethical principles in nursing

Autonomy, beneficence, nonmaleficence, justice, veracity, and confidentiality.

Autonomy

Patients right to decide

Beneficence

Do good

Nonmaleficence

do no harm

Justice

Fairness

Veracity

truth-telling

confidentiality

Protect information. HIPPA reinformces

Placebos in research vs care

Placebos acceptable in research with informed consent; generally unethical in routine clinical care.

Cultural competence in nursing process

Assessment, planning, implementation, and evaluation tailored to cultural beliefs and practices.

Leininger & Giger-Davidhizar models

Cultural frameworks used to assess and apply culturally appropriate care.

Human Need Statements

Nursing diagnoses like altered sleep, deficient knowledge, or altered safety due to drug responses.

Adherence barriers

Factors like poverty, beliefs, and language that hinder medication adherence.