Legal and Ethical Considerations Flashcards
What are the 2 federal level entities that regulate Canadian drug legislation
The Health Products Food Branch Inspectorate of Health Canada (HPFB)
Therapeutics Product Directorate (TPD)
What are Schedule A regulations
A list of diseases for which treatment may not be promoted
What are schedule B regulations
Compliance with official prescribing standards
What are schedule C regulations
Radiopharmaceutical list
What are schedule D regulations
Allergenic substances, vaccines, insulin, anterior pituitary extracts, drugs obtained from rDNA technology, blood derivatives
What are schedule E regulations
Manufacturing, labelling, packaging, importing, interprovincial and internationally
What are Schedule F regulations
All drugs that require a prescription
What are schedule G drugs?
Controlled drugs: Opioids, narcotics, benzodiazepines
What are schedule H drugs
Restricted drugs - psychotropic (amphetamines, LSD)`
What is the controlled drugs and substances act?
Prohibits activities such as possession, trafficking, importing, exporting, and selling of narcotics
When was the controlled drugs and substances act passed?
1997
What is in the schedule 1 description
opium, heroin, morphine, cocaine, methamphetamine
What is in the schedule 2 description
Cannabis and any derivatives
What is in the schedule 3 description
Amphetamines and LSD
What is in the schedule 4 description
Barbiturates and anabolic steroids
What is in the schedule 5 and 6 descriptions?
Precursors required to produce controlled substances
What is included in the schedules 7 and 8 descriptions?
Amounts of cannabis required to be charged and sentenced
When was cannabis use legalized?
October 17, 2018
What are the 4 phases of investigational drug studies?
1: tested on fewer than 100 healthy test subjects
2: tested on 100-300 subjects that have the disease or ailment
3: Tested on 1000-3000 subjects
4: Drug companies do marketing studies to obtain therapeutic and adverse effects
What is the special access program?
Allows health care providers compassionate access (for serious or life-threatening) to drugs unavailable for sale in Canada
Who provides coverage for indigenous peoples?
The federal government
What are the 3 areas of potential liability?
Failure to assess or re-evaluate
Failure to ensure safety
Medication errors
What is a placebo
Drug dosage form with no pharmacological activity used in drug studies
What is the ethical dilemma about placebo drugs
May cause mistrust with the patient and healthcare team but helpful in comparing actual therapeutic drug responses
What is included in informed consent for drug research
Patient can leave without pressure or coercion
Can leave with no consequences to medical care
Receive complete information about the study
Be made aware of alternative options/treatments
