Ch. 4 Cultural, Legal, Ethical

Question 0

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.

Answer 0

Black box warning

Question 1

Any systematic error in a measurement process. One common effort to avoid bias in research studies involves the use of blinded study designs (see later).

Answer 1

Bias

Question 2

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

Answer 2

Blinded investigational drug study

Question 3

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

Answer 3

Controlled substances

Question 4

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

Answer 4

Culture

Question 5

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 or a placebo. This method minimizes bias on the part of both the investigator and the subject

Answer 5

Doubled- blind investigational drug study

Question 6

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

Answer 6

Drug polymorphism

Question 7

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

Answer 7

Ethics

Question 8

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

Answer 8

Ethnicity

Question 9

The study of the effect of ethnicity on drug responses, specifically drug absorption, metabolism, distribution, and excretion (i.e., pharmacokinetics; see Chapter 2) as well as the study of genetic variations to drugs (i.e., pharmacogenetics).

Answer 9

Ethnopharmacology

Question 10

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

Answer 10

Expedited drug approval

Question 11

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.

Answer 11

Health insurance portability and accountability act (HIPAA)

Question 12

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 or “informed” decision.

Answer 12

Informed consent

Question 13

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

Answer 13

Investigational new drug (IND)

Question 14

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

Answer 14

Investigational new drug application

Question 15

Another name for prescription drugs.

Answer 15

Legend drugs

Question 16

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

Answer 16

Malpractice

Question 17

A legal term established under the Harrison Narcotic Act of 1914. It originally applied to drugs that produced insensibility or stupor, especially the opioids (e.g., morphine, heroin). 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

Answer 17

Narcotic

Question 18

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.

Answer 18

Negligence

Question 19

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

Answer 19

Orphan drugs

Question 20

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

Answer 20

Over-the-counter drugs (OTC)

Question 21

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.

Answer 21

Placebo

Question 22

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

Answer 22

Race