CH 4: Cultural, Legal, and Ethical Considerations Flashcards
Any systemic erro in measurement process
Bias
A type of warning that appears in a drugs prescribing information and is required by the FDA to alert prescribers of serious adverse events that have occurred with the given drug
Black box warning
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
Blinded investigational drug study
Any drugs listed on one of the “schedules” of the Controlled Substance Acts (scheduled drugs)
Controlled substances
The customary beliefs, social forms, and material traits of a racial, religious, or social group
Culture
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
Double-blind investigational drug study
Variation in response to a drug because of patient’s age, gender, size, and/or body composition
Drug polymorphism
The rules of conduct recognized in respect to a particular class or group of human actions
Ethics
Relating to or characteristic of human group having racial, religion, language, and other traits in common
Ethnicity
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 (i.e., pharmacogenetics)
Ethnopharmacology
Acceleration of the usual investigational new drug approval process by the FDA, usually for drugs used to treat life-threatening diseases
Expedited drug approval
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 breathe, sever fines may be imposed
Health Insurance Portability and Accountability Act (HIPPA)
Written permission obtained form a patient consenting to a specific procedure
Informed consent
A drug not yet approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy
Investigational new drug (IND)
An application that must be submitted to the FDA before a drug an be studied in humans
Investigational new drug application
Another name for prescription drugs
Legend drugs
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
Malpractice
A legal term established under the Harrison Narcotic Act of 1914. The term is currently used in clinical setting 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
Narcotic
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 to use under similar circumstances
Negligence
A special category of drugs that have been identified to help treat patients with rare diseases
Orphan drugs
Drugs available to consumers without prescription
Over-the-counter drugs
An inactive (inert) substance (i.e., saline, distilled water, starch, sugar) that is not a drug but is formulated resemble a drug for research
Placebo
Descendants of a common ancestor; a tribe, family, or people believed to belong to the same linage
Race
