Chapter 4

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1

Bias

any systematic error in a measurement process

2

Black box warning

a type 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

3

Blinded 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 of a placebo.

4

Controlled substances

any drugs listed on one of the schedules of the controlled substance Act

5

Culture

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

6

Double-blind investigational drug study

a research design in which both the investigators and the subjects are purposely unaware of whether the substance administered to a given subject is the drug under study or a placebo

7

Drug polymorphisms

variation in response to a drug because of a patient's age, gender, size and/or body composition

8

Ethics

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

9

Ethnicity

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

10

Ethnopharmacology

the study of the effect of ethnicity on drug responses, specifically drug absorption, metabolism, distribution and excretion as well as the study of genetic variations to drugs

11

Expedited drug approval

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

12

Health insurance portability and accountability act (HIPAA)

an act that protects health insurance coverage for workers and their families when they change jobs; also protects patient information; if confidentiality is breached, severe fines may be imposed.

13

Informed consent

written permission obtained from a patient consenting to a specific procedure

14

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

15

Investigational new drug application

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

16

Legend drugs

another name for prescription drugs

17

Malpractice

a special type of negligence or the failure of a professional and/or individual with specialized education and training to act in a reasonable and prudent way

18

Narcotic

a legal term established under the Harrison Narcotic Act of 1914. The term is currently used in clinical settings to refer to any medically administered controlled substance and in legal settings to refer to any illicit or street drug; also referred to as opioid

19

Negligence

the failure to act in a reasonable and prudent manner or failure of the nurse to give the care that a reasonably prudent (cautious) nurse would render or use under similar circumstances

20

Orphan drugs

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

21

Over-the-counter drugs

drugs available to consumers without a prescription; also called nonprescription drugs

22

Pharmacogenomics

the study of genetics in drug response

23

Placebo

an inactive substance that is not a drug but is formulated to resemble a drug for research purposes; ex. Saline, distilled water, starch, sugar

24

Race

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

25

Common health beliefs and alternative healers for African:

practice folk medicine, employ root doctors as healers and spiritualists; use herbs, oils and roots

26

Common health beliefs and alternative healers for Asian:

believe in traditional medicine; hot and cold foods; hebers/teas/souples; use of acupuncturists, acupressurist, and herbalist; tai chi, qigong

27

Common health beliefs and alternative healers for Hispanic:

view health as a result of good luck and living right, see illness as a result of doing a bad deed; health, cold and herbs used as remedies; use curandero, spiritualist

28

Common health beliefs and alternative healers for Native American:

view health as a result of good luck and living right, see illness as a result of doing a bad deed; health, cold and herbs used as remedies; use curandero, spiritualist

29

Verbal and nonverbal communication; touch/time for African:

asking personal questions of someone met for the first time seen as intrusive and not proper; direct eye contact seen as rude; present oriented

30

Verbal and nonverbal communication; touch/time for Asian:

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

Verbal and nonverbal communication; touch/time for Hispanic:

expressing negative feelings seen as impolite; avoiding eye contact seen as respectful and attentive; touching acceptable between two persons in conversation

32

Verbal and nonverbal communication; touch/time for Native American:

speak in low tone of voice; light touch of a person's hand is preferred versus a firm handshake as a greeting; present oriented

33

Family for African:

have close extended family ties; women play important key role in making health care decisions

34

Family for Asian:

have close extended family ties; family needs more important than individual needs

35

Family for Hispanic:

have close extended family ties; all family members involved in health care decisions; past cultural experiences in the family with illness and health practices holds significant value; strong adherence to cultural practices

36

Family for Native americans:

have close extended family ties; emphasis on family

37

Biological variations for African:

keloid function, sickle cell anemia, lactose intolerance, skin color

38

Biological variations for Asians:

many drug interactions, lactose intolerance, skin color, thalassemia

39

Biological variations for Hispanic:

lactose intolerance; skin color

40

Biological variations for Native Americans:

lactose intolerance, skin color, cleft uvula problems.

41

Federal Food and Drugs Act

required drug manufacturers to list on the drug product label the presence of dangerous and possibly addicting substances; recognized the U.S. pharmacopeia and national formulary as printed reference standards for drugs

42

Sherley Amendment (1912) to FFDA

prohibited fraudulent claims for drug products

43

Harrison Narcotic Act (1914)

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

44

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)

45

Durham - Humphrey amendment 1941 to FFDA

established legend drugs or prescription drugs; drug labels must carry the legend; caution; federal law prohibits dispensing without a prescription

46

Kefauver-harris amendements 1962 to FFDCA

required manufacturers to demonstrate both therapeutic efficacy and safety of new drugs

47

Controlled substance act 1970

established schedules for controlled substances promoted drug addiction education, research and treatment

48

Orphan Drug Act 1983

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

49

Accelerated Drug review regulations 1991

enabled faster approval by the FDA of drugs to treat life threatening illnesses

50

Health Insurance portability and Accountability Act

More commonly known by its acronym, HIPAA; officially required all health-related organizations as well as schools to maintain privacy of protected health information

51

Medicare Prescription drug improvement and modernization act 2003

more commonly known as Medicare part d; provides seniors and disabled persons with an insurance benefit program for prescription drugs; the cost of medications is shared by the patient and the federal government.

52

Schedule C-I : abuse potential – high; medical use: none; dependency potential: severe physical and psychological

abuse potential: high; medical use: none; dependency potential: severe physical and psychological

53

Schedule C-II:

abuse potential: high; medical use: accepted; dependency potential: severe physical and psychological

54

Schedule C-III:

abuse potential: Less than C-II; medical use: accepted; dependency potential: moderate to low physical or high psychological

55

Schedule C-IV:

abuse potential:Less than C-III; medical use: accepted; dependency potential: Limited physical of psychological

56

Schedule C-V:

abuse potential: Less than C-IV; medical use: accepted; dependency potential: Limited physical of psychological

57

Schedule C-I: Dispensing restrictions:

only with approved protocol

58

Schedule C-I: Examples of meds:

heroin, marijuana, methaqualone, lysergic acid diethylamide (LSD), mescaline, peyote, psilocybin

59

Schedule C-II: Dispensing restrictions:

Written prescription only; no prescription refills; container must have warning label

60

Schedule C-II: Examples of meds:

Codeine, cocaine, hydrocodone, hydromorphone, meperidine, morphine, methadone, oxycodone, amphetamine, methylphenidate

61

Schedule C-III: Dispensing restrictions:

Written or oral prescription that expires in 6 months; no more than 5 refills in a 6 month period; container must have warning label

62

Schedule C-III: Examples of meds:

codeine with selected other medications; pentobarbital rectal suppositories and dihydrocodeine combination products

63

Schedule C-IV: Dispensing restrictions:

Written prescription only; no prescription refills; container must have warning label

64

Schedule C-IV: Examples of meds:

phenobarbital, chloral hydrate, meprobamate, benzodiazepines, tramadol and others

65

Schedule C-V: Dispensing restrictions:

Written prescription or over the counter

66

Schedule C-V: Examples of meds:

Medications generally for relief of coughs or diarrhea containing limited quantities of certain opioid controlled substances

67

Nurse practice acts

NPA are state laws that are instrumental in defining the scope of nursing practice and protect public health, safety and welfare.

68

Autonomy:

self-determination and the ability to act on one's own; related nursing actions include promoting a patient's decision marking, supporting informed consent, and assisting in decisions or making a decision when a patient is posing harm to himself or herself

69

Beneficence:

the ethical principle of doing or actively promoting good; related nursing actions include determining how the patient is best served

70

Confidentiality:

the duty to respect privileged information about a patient; related nursing actions include not talking about a patient in public or outside the context of the health care setting

71

Justice:

the ethical principle of being fair or equal in one's actions; related nursing actions include ensuring fairness in distributing resources for the care of patients and determining when to treat

72

Nonmaleficence:

the duty to do no harm to a patient; related nursing actions include avoiding doing any deliberate harm while rendering nursing care

73

Veracity:

the duty to tell the truth; related nursing actions include telling the truth with regard to placebos, investigational new drugs, and informed consent

74

Areas of potential liability for nurses:

failure to assess/evaluate, failure to ensure safety, medication errors