Chapter 3 Definitions SLO 1.1 Flashcards
Bias
Any systematic error in a measurement process. One common effort to avoid bias in research studies involves the use of blinded study designs. (p. 41)
Benzodiazepines and Other Targeted Substances Regulations
Implemented in 2000, these regulations specify the requirements for producing, assembling, importing, exporting, selling, providing, transporting, delivering, or destroying benzodiazepines and other targeted substances. (p. 39)
Blinded investigational drug study
A research design in which subjects in the study are purposely made 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. (p. 41)
Canada Health Act
Canada’s federal legislation for publicly funded health care insurance. (p. 42)
Controlled Drugs and Substances Act (CDSA)
A Health Canada act that makes it a criminal offence to possess, traffic, produce, import, or export controlled substances. (p.39)
Controlled substances
Any drugs listed on one of the “schedules” of the Controlled Drugs and Substances Act (also called a scheduled drug if it is an item under the Food and Drug Regulations Part G). (p. 39)
Double-blind, investigated drug study
A research design in which both the study investigator(s) and the subjects are purposely made 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. (p. 41)
Drug Identification Number (DIN)
A computer-generated number assigned by Health Canada, placed on the label of prescription and over-the-counter drug products that have been evaluated by the Therapeutic Products Directorate (TPD) and approved for sale in Canada. (p. 40)
Ethics
A set of principles, rights and responsibilities, and duties governing the moral values, beliefs, actions, and behaviours of human conduct and the rules and principles that ought to govern them. (p. 44)
Food and Drugs Act
The main piece of drug legislation in Canada that protects consumers from contaminated, adulterated, and unsafe drugs and labelling practices; also addresses appropriate advertising and selling of drugs, foods, cosmetics, and therapeutic devices. (p. 38)
Food and Drug Regulations
An adjunct to the Food and Drugs Act, these regulations clarify terms used in the Act and state the processes that companies must carry out to comply with the Act in terms of importing, preparing, treating, processing, labelling, advertising, and selling foods, drugs, cosmetics, natural health products including herbal products, and medical devices. (p. 38)
Informed consent
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 the patient to make a sound or “informed” decision. (p. 40)
Investigational new drug (IND)
A drug not yet approved for marketing by the Therapeutic Products Directorate of Health Canada but available for use in experiments to determine its safety and efficacy. (p. 40)
Investigational new drug application
An application that must be submitted to the Therapeutic Products Directorate of Health Canada before a drug can be studied in humans. (p. 40)
Malpractice
A special type of negligence or the failure of a professional or individual with specialized education and training to act in a reasonable and prudent way. (p. 43)
Negligence
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. (p. 43)
New drug submission
The type of application that a drug manufacturer submits to the Therapeutic Products Directorate of Health Canada following successful completion of required human research studies. (p. 41)
Notice of Compliance
A notification issued when Health Canada decides that a drug and its manufacturing process are safe and effective, allowing the pharmaceutical company to sell the product by prescription to the Canadian population. (p. 40)
Placebo
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. (p. 41)
Precursor Control Regulations
A scheme intended to allow Canada to fulfill its international obligations and meet its domestic needs with respect to the monitoring and control of precursor chemicals such as methamphetamine, gamma-hydroxybutyric acid (GHB), and other drugs listed in Schedules I, II, and III of the Controlled Drugs and Substances Act, across Canadian borders and within Canada. (p. 39)
Priority Review of Drug Submissions
A Health Canada policy that allows for earlier review of drug products for serious, life-threatening, or severely debilitating diseases or conditions for which there is no effective drug on the Canadian market. (p. 40)
Special Access Programme
A program that allows health care providers to apply for access to drugs currently unavailable for sale in Canada. (p. 41)
