Cultural, Legal, and Ethical Considerations (Chapter 4) Flashcards
Bias
Any systematic error in a measurement process.
Black box warning
A types of warning that appears in a drug’s prescribing information and is required by the U.S. Food and Drug Administration (FDA) to alert prescribers of serious adverse events that have occurred with the given drug.
Blind investigational drug study
A research design in which the subjects are purposely unaware of whether the substance they are administered is the drug under study or a placebo. This method serves to minimize bias on the part of research subjects in reporting their body’s responses to investigational drugs.
Controlled substances
Any drugs listed on one of the “schedules” of the Controlled Substance Act (also called scheduled drugs)
Culture
The customary beliefs, social forms, and material traits of a racial, religious, or social group.
Double-blind investigational drug study
A research design in which both the investigator(s) and the subjects are purposely unaware of whether the substance is administered to a given subject is the drug under study or a placebo. This method minimizes bias on the part of both the investigator and the subject.
Drug polymorphism
Variation in response to a drug because of a patient’s age, gender, size, and/or body composition.
Ethics
The rules of conduct recognized in respect to a particular class or group of human actions
Ethnicity
Relating to or characteristic of a human group having racial, religious, language, and other traits in common
Ethnopharmacology
(Ethan-o-pharm-a-cology)
The study of the effect of ethnicity on drug responses, specially drug absorption, metabolism, distribution, and excretion as well as the study of genetic variations to drugs (i.e. pharmacogenetics)
Expedited drug approval
Acceleration of the usual investigational new drug approval process by the FDA, usually for drugs used to treat life-threatening diseases.
Health Insurance Portability and Accountability Act (HIPAA)
An act that protects health insurance coverage for workers and their families when they change jobs. It also protects patient information. If confidentiality of a patient is breached, severe fines may be imposed.
Informed consent
Written permission obtained from a patient consenting to a specific procedure.
Investigational new drug (IND)
A drug not yet approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy.
Investigational new drug application
An application that must be submitted to the FDA before a drug can be studied in humans.
Legend drugs
Another name for prescription drugs
Malpractice
A special type of negligence or the failure of a professional and/or individuals with specialized education and training to act in a reasonable and prudent way
Narcotic
A legal term established under the Harrison Narcotic Act of 1914. The term is currently used in clinical settings to refer to a medically administered controlled substance and in legal settings to refer to any illicit or “street” drug; also referred to as an opioid.
Negligence
The failure to act in a reasonable and prudent manner of failure of the nurse to give the care that a reasonably prudent (cautious) nurse would render or use under similar circumstances.
Orphan drugs
A special category of drugs that have been identified to help patients with rare diseases
Over-The-Counter drugs (OTC)
Drugs available to consumers without a prescription. Also called nonprescription drugs
Pharmacogenomics
(pharm-a-co-gen-omics)
The study of genetics in drug response
Placebo
An inactive (inert) substance (e.g., saline, distilled water, starch, sugar) that is not a drug but is formulated to resemble a drug for research purposes.
Race
Descendants of a common ancestor; a tribe, family, or people believed to belong to the same lineage.
African: Common Health Beliefs and Alternative Healers
- Practice folk medicine; employ “root doctors” as healers, spiritualists.
- Use herbs, oils, and roots
African: Verbal & Nonverbal Communication; Touch/Time
- Asking personal questions of someone met for the first time seen as intrusive and not proper.
- Direct eye contact seen as rude.
- Present oriented
African: Family
- Have close extended family ties.
- Women play important key role in making health care decisions
African: Biological Variations
Keloid formation, sickle cell anemia, lactose intolerance, skin color
Asian: Common Health Beliefs and Alternative Healers
- Believe in traditional medicine; hot and cold foods; herbs/teas/soups; use of acupuncturist, acupressurist, and herbalist.
- Tai Chi; QiGong
Asian: Verbal & Nonverbal Communication; Touch/Time
- High respect for others, especially individuals in positions of authority.
- Not usually comfortable with custom of shaking hands with those of opposite sex.
- Present oriented
Asian: Family
- Have close extended family ties
- Family needs are more important than individual needs
Asian: Biologic Variations
-Many drug interactions, lactose intolerance, skin color, thalassemia
Hispanic: Common Health Beliefs and Alternative Healers
- View health as a result of good luck and living right
- See illness as a result of doing a bad deed
- Heat, cold, and herbs used as remedies
- Use curandero, spiritualist
Hispanic: Verbal & Nonverbal Communication; Touch/Time
- Expressing negative feelings seen as impolite
- Avoiding eye contact seen as respectful and attentive
- Touching acceptable between two persons in conversation
Hispanic: Family
- Past cultural experiences in the family with illness and healing practices holds significant value
- Strong adherence to cultural practices
Hispanic: Biologic Variations
Lactose intolerance, skin color
Native American: Common Health Beliefs and Alternative Healers
- Believe in harmony with nature and ill spirits causing disease
- Use medicine man
Native American: Verbal & Nonverbal Communication; Touch/Time
- Speak in low tone of voice
- Light touch of a person’s hand is preferred versus a firm handshake as a greeting
- Present oriented
Native American: Family
- Have close extended family ties
- Emphasis on family
Native American: Biologic Variations
Lactose intolerance, skin color, cleft uvula problems
African Americans’ response to antihypertensive drugs
American Americans respond…
- Better to diuretics than to beta blockers and angiotensin-converting enzyme inhibitors.
- Less effectively to beta blockers.
- Best to calcium channel blockers, especially diltiazem
- Less effectively to single-drug therapy
Asian response to antipsychotic and anti-anxiety drugs
Asians respond…
-Need lower dosages of certain drugs such as haloperidol
Asian and Hispanic response to antipsychotic and anti-anxiety drugs
Asians and Hispanics respond…
-Respond better to lower dosages of antidepressants
Chinese response to antipsychotic and anti-anxiety drugs
Chinese respond…
-Require lower dosages of antipsychotics
Japanese response to antipsychotic and anti-anxiety drugs
Japanese respond…
-Require lower dosages of antimanic drugs
Federal Food and Drugs Act (FFDA, 1906)
- Required drug manufactures to list on the drug label the presence of dangerous and possibly addicting substances
- Recognized the U.S. Pharmacopeia and National Formulary as printed references standards for drugs
Sherley Amendment (1912) to FFDA
Prohibited fraudulent claims for drug products
Harrison Narcotic Act (1914)
Established the legal term narcotic and regulated the manufacture and sale of habit-forming drugs
Federal Food, Drug and Cosmetic Act (FFDCA, 1938; amendment to FFDA)
- Required drug manufacturers to provide data proving drug safety with FDA review
- Established the investigational new drug application process (prompted by sulfanilamide elixir tragedy)
Durham-Humphrey Amendment (1951) to FFDCA
- Established legend drugs or prescription drugs
- Drug labels must carry the legend, “Caution-Ferderal law prohibits dispensing without a prescription”
Kefauver-Harris Amendments (1962) to FFDCA
-Required manufacturers to demonstrate both therapeutic efficacy and safety of new drugs (prompted by thalidomide tragedy)
Controlled Substance Act (1970)
- Established “schedules” for controlled substances
- Promoted drug addiction education, research, and treatment
Orphan Drug Act (1983)
Enabled the FDA to promote research and marketing of orphan drugs used to treat rare diseases
Accelerated Drug Review Regulations (1991)
Enabled faster approval by the FDA of drugs to treat life threatening
