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Pharmacology > Cultural, Legal, and Ethical Considerations (Chapter 4) > Flashcards

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

1
Q

Bias

A

Any systematic error in a measurement process.

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2
Q

Black box warning

A

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.

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3
Q

Blind investigational drug study

A

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.

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4
Q

Controlled substances

A

Any drugs listed on one of the “schedules” of the Controlled Substance Act (also called scheduled drugs)

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5
Q

Culture

A

The customary beliefs, social forms, and material traits of a racial, religious, or social group.

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6
Q

Double-blind investigational drug study

A

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.

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7
Q

Drug polymorphism

A

Variation in response to a drug because of a patient’s age, gender, size, and/or body composition.

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8
Q

Ethics

A

The rules of conduct recognized in respect to a particular class or group of human actions

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9
Q

Ethnicity

A

Relating to or characteristic of a human group having racial, religious, language, and other traits in common

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10
Q

Ethnopharmacology

A

(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)

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11
Q

Expedited drug approval

A

Acceleration of the usual investigational new drug approval process by the FDA, usually for drugs used to treat life-threatening diseases.

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12
Q

Health Insurance Portability and Accountability Act (HIPAA)

A

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.

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13
Q

Informed consent

A

Written permission obtained from a patient consenting to a specific procedure.

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14
Q

Investigational new drug (IND)

A

A drug not yet approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy.

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15
Q

Investigational new drug application

A

An application that must be submitted to the FDA before a drug can be studied in humans.

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16
Q

Legend drugs

A

Another name for prescription drugs

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17
Q

Malpractice

A

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

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18
Q

Narcotic

A

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.

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19
Q

Negligence

A

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.

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20
Q

Orphan drugs

A

A special category of drugs that have been identified to help patients with rare diseases

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21
Q

Over-The-Counter drugs (OTC)

A

Drugs available to consumers without a prescription. Also called nonprescription drugs

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22
Q

Pharmacogenomics

A

(pharm-a-co-gen-omics)

The study of genetics in drug response

23
Q

Placebo

A

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.

24
Q

Race

A

Descendants of a common ancestor; a tribe, family, or people believed to belong to the same lineage.

25
Q

African: Common Health Beliefs and Alternative Healers

A
  • Practice folk medicine; employ “root doctors” as healers, spiritualists.
  • Use herbs, oils, and roots
26
Q

African: Verbal & Nonverbal Communication; Touch/Time

A
  • Asking personal questions of someone met for the first time seen as intrusive and not proper.
  • Direct eye contact seen as rude.
  • Present oriented
27
Q

African: Family

A
  • Have close extended family ties.

- Women play important key role in making health care decisions

28
Q

African: Biological Variations

A

Keloid formation, sickle cell anemia, lactose intolerance, skin color

29
Q

Asian: Common Health Beliefs and Alternative Healers

A
  • Believe in traditional medicine; hot and cold foods; herbs/teas/soups; use of acupuncturist, acupressurist, and herbalist.
  • Tai Chi; QiGong
30
Q

Asian: Verbal & Nonverbal Communication; Touch/Time

A
  • 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
31
Q

Asian: Family

A
  • Have close extended family ties

- Family needs are more important than individual needs

32
Q

Asian: Biologic Variations

A

-Many drug interactions, lactose intolerance, skin color, thalassemia

33
Q

Hispanic: Common Health Beliefs and Alternative Healers

A
  • 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
34
Q

Hispanic: Verbal & Nonverbal Communication; Touch/Time

A
  • Expressing negative feelings seen as impolite
  • Avoiding eye contact seen as respectful and attentive
  • Touching acceptable between two persons in conversation
35
Q

Hispanic: Family

A
  • Past cultural experiences in the family with illness and healing practices holds significant value
  • Strong adherence to cultural practices
36
Q

Hispanic: Biologic Variations

A

Lactose intolerance, skin color

37
Q

Native American: Common Health Beliefs and Alternative Healers

A
  • Believe in harmony with nature and ill spirits causing disease
  • Use medicine man
38
Q

Native American: Verbal & Nonverbal Communication; Touch/Time

A
  • Speak in low tone of voice
  • Light touch of a person’s hand is preferred versus a firm handshake as a greeting
  • Present oriented
39
Q

Native American: Family

A
  • Have close extended family ties

- Emphasis on family

40
Q

Native American: Biologic Variations

A

Lactose intolerance, skin color, cleft uvula problems

41
Q

African Americans’ response to antihypertensive drugs

A

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
42
Q

Asian response to antipsychotic and anti-anxiety drugs

A

Asians respond…

-Need lower dosages of certain drugs such as haloperidol

43
Q

Asian and Hispanic response to antipsychotic and anti-anxiety drugs

A

Asians and Hispanics respond…

-Respond better to lower dosages of antidepressants

44
Q

Chinese response to antipsychotic and anti-anxiety drugs

A

Chinese respond…

-Require lower dosages of antipsychotics

45
Q

Japanese response to antipsychotic and anti-anxiety drugs

A

Japanese respond…

-Require lower dosages of antimanic drugs

46
Q

Federal Food and Drugs Act (FFDA, 1906)

A
  • 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
47
Q

Sherley Amendment (1912) to FFDA

A

Prohibited fraudulent claims for drug products

48
Q

Harrison Narcotic Act (1914)

A

Established the legal term narcotic and regulated the manufacture and sale of habit-forming drugs

49
Q

Federal Food, Drug and Cosmetic Act (FFDCA, 1938; amendment to FFDA)

A
  • Required drug manufacturers to provide data proving drug safety with FDA review
  • Established the investigational new drug application process (prompted by sulfanilamide elixir tragedy)
50
Q

Durham-Humphrey Amendment (1951) to FFDCA

A
  • Established legend drugs or prescription drugs

- Drug labels must carry the legend, “Caution-Ferderal law prohibits dispensing without a prescription”

51
Q

Kefauver-Harris Amendments (1962) to FFDCA

A

-Required manufacturers to demonstrate both therapeutic efficacy and safety of new drugs (prompted by thalidomide tragedy)

52
Q

Controlled Substance Act (1970)

A
  • Established “schedules” for controlled substances

- Promoted drug addiction education, research, and treatment

53
Q

Orphan Drug Act (1983)

A

Enabled the FDA to promote research and marketing of orphan drugs used to treat rare diseases

54
Q

Accelerated Drug Review Regulations (1991)

A

Enabled faster approval by the FDA of drugs to treat life threatening

Pharmacology (4 decks)

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