Chapter 4-Cultural, Legal, And Ethical Considerations

Question 0

Blackbox warning:

Answer 0

A type of warning that appears in a drugs prescribing information and is required by the US FDA (FTA) to alert prescribers of serious adverse effects that I’ve been occurred with the given drug. (P. 57)

Question 1

Bias:

Answer 1

Any systematic error and a measurement process. One common effort to avoid bias and research studies involve the use of blinded study designs. (P. 57)

Question 2

Blinded investigational drug study:

Answer 2

A research design in which subjects are purposely unaware of whether the substance administered as the drug understudy or a placebo. This method serves to minimize bias on the part of research subjects and reporting the body’s responses to investigational drugs. (P. 57)

Question 3

Controlled substances:

Answer 3

Any drugs listed on one of the “schedules”of the controlled substance act (also called scheduled drugs). (P. 55)

Question 4

Culture:

Answer 4

The customary beliefs, social forms, and material traits of a racial, religious, or social group. (Page 51)

Question 5

Double-blind investigational drug study:

Answer 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. Page 57

Question 6

Drug polymorphism:

Answer 6

Variation in response to a drug because of a patient’s age, gender, size, and or body composition. Page 52

Question 7

Ethnopharmacology:

Answer 7

The study of the effects of ethnicity bunch of responses, specifically drug absorption, metabolism, distribution, and excretion (i.e. Pharmacokinetics; see Chapter 2) as well as the study of genetic variations to drugs such as pharmacogenetics. Page 51

Question 8

Expedited drug approval:

Answer 8

Acceleration of the usual investigational new drug approval process by the FDA and pharmaceutical companies, usually for drugs used to treat life-threatening diseases. Page 55

Question 9

Health insurance portability and accountability act (HIPAA):

Answer 9

An act that protects health insurance coverage for workers and their families when they change jobs. It also protects patient information. The confidentiality of the patient is breached, severe finds may be imposed. Page 54

Question 10

Informed consent:

Answer 10

Written permission obtained from the 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. Page 56

Question 11

Investigational new drug (IND):

Answer 11

A drug not yet approved from marketing by the FDA but available for use in experiments to determine safety and efficacy. Page 56

Question 12

Investigational new drug application:

Answer 12

And application that must be submitted to the FDA before drug can be studied in humans. Page 56

Question 13

Legend drugs:

Answer 13

Another name for prescription drugs. Page 55

Question 14

Malpractice:

Answer 14

A special type of negligence or the failure of a professional and or individual with specialized education and training to act any reasonable and prudent way. Page 58

Question 15

Narcotic:

Answer 15

A legal term established under the Harrison narcotic act of 1914. It originally applied to drugs that produce 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 illegal settings
to refer to any illicit or “street “drug. Page 55

Question 16

Negligence:

Answer 16

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. Page 58

Question 17

Orphan drugs:

Answer 17

A special category of drugs that have been at identified to help treat patients with rare diseases. Page 55

Question 18

Over-the-counter drugs:

Answer 18

Drugs available to consumers without a prescription. Also called nonprescription drugs. Page 53

Question 19

Placebo:

Answer 19

And in active (inert) substance (e.g., saline, distilled water, starch, sugar) that is not a drug but is formulated to resemble a drug for research purposes. (P. 57)

Question 20

What is meant by some individual being known as slow acetylators?

Answer 20

This means that their bodies attach acetyl groups to drug molecules at a relatively slow rate, which results in elevated drug concentrations. This effect may warrant lower drug dosages.

–includes some individuals of European and African descent