CHAPTER 4: CULTURAL, LEGAL, AND ETHICAL CONSIDERATIONS Flashcards

1
Q

bias

A

any systematic error in a measurement process. one common effort to avoid bias in research studies involves the use of blinded study designs

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2
Q

black box warning

A

a type of warning that appears in a drug’s prescribing information and is required by the US 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

blinded investigational drug study

A

a research design in which the subjects are purposely unaware of whether he 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 Substances Act

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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-blinded investigational drug study

A

a research design in which both the investigator(s) and the subjects are purposely unaware of whether the substance administered to a given subject is the drug under study to 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 of human actions or a particular group

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9
Q

ethnicity

A

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

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10
Q

ethnopharmacology

A

the study of the effect of ethnicity on drug responses, specifically drug absorption, metabolism, distribution and excretion (i.e. pharmacokinetics) 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 and pharmaceutical companies, usually for drugs used to treat life-threatening diseases

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12
Q

health insurance portability and accountability act (HIPPA)

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 (e.g. receiving an investigational drug), after the patient has been given information regarding the procedure deemed necessary for him or her to make a sound “informed” decision

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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

17
Q

malpractice

A

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
Q

narcotic

A

a legal term established under the Harrsion Narcotic Act of 1914. It originally applied to drugs that produced insensibility or stupor, esp the opioids (e.g. morphine,
heroin). The term is currently used in clinical settings to refer to any medically administered controlled substance an in legal settings to refer to any illicit or “street” drug

19
Q

negligence

A

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
Q

orphan drugs

A

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

21
Q

over-the-counter drugs

A

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

22
Q

placebo

A

an inactive (inert) substances (eg saline, distilled water, starch, sugar) that is not a drug but is formulated to resemble a drug for research purposes

23
Q

race

A

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