CHAPTER 4: CULTURAL, LEGAL, AND ETHICAL CONSIDERATIONS

Question 1

bias

Answer 1

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

Question 2

black box warning

Answer 2

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

Question 3

blinded investigational drug study

Answer 3

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

Question 4

controlled substances

Answer 4

any drugs listed on one of the “schedules” of the Controlled Substances Act

Question 5

culture

Answer 5

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

Question 6

double-blinded investigational drug study

Answer 6

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

Question 7

drug polymorphism

Answer 7

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

Question 8

ethics

Answer 8

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

Question 9

ethnicity

Answer 9

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

Question 10

ethnopharmacology

Answer 10

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)

Question 11

expedited drug approval

Answer 11

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

Question 12

health insurance portability and accountability act (HIPPA)

Answer 12

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

Question 13

informed consent

Answer 13

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

Question 14

investigational new drug (IND)

Answer 14

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

Question 15

investigational new drug application

Answer 15

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

Question 16

legend drugs

Answer 16

another name for prescription drugs

Question 17

malpractice

Answer 17

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

Question 18

narcotic

Answer 18

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

Question 19

negligence

Answer 19

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

Question 20

orphan drugs

Answer 20

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

Question 21

over-the-counter drugs

Answer 21

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

Question 22

placebo

Answer 22

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

Question 23

race

Answer 23

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