Chapter 4-Cultural, Legal, And Ethical Considerations Flashcards
Blackbox warning:
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)
Bias:
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)
Blinded investigational drug study:
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)
Controlled substances:
Any drugs listed on one of the “schedules”of the controlled substance act (also called scheduled drugs). (P. 55)
Culture:
The customary beliefs, social forms, and material traits of a racial, religious, or social group. (Page 51)
Double-blind investigational drug study:
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
Drug polymorphism:
Variation in response to a drug because of a patient’s age, gender, size, and or body composition. Page 52
Ethnopharmacology:
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
Expedited drug approval:
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
Health insurance portability and accountability act (HIPAA):
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
Informed consent:
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
Investigational new drug (IND):
A drug not yet approved from marketing by the FDA but available for use in experiments to determine safety and efficacy. Page 56
Investigational new drug application:
And application that must be submitted to the FDA before drug can be studied in humans. Page 56
Legend drugs:
Another name for prescription drugs. Page 55
Malpractice:
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