Legal/Ethical Considerations
summary – ch3
LEGAL CONSIDERATIONS:
• Prescription medications are vital for treating/preventing illnesses
• For safety reasons use is regulated by individual provincial/territorial laws
enforced by several agencies o Health Canada and Royal Canadian Mounted
Police
Authorized Prescribers:
• Doctors (traditionally of osteopathy and medicine)
• Dentists and podiatrists within scope of practices
• Physician’s assistants and nurse practitioners
Canadian Drug legislation began in 1875:
• Health products Food Branch Inspectorate of Health Canada o Federal
regulator responsible for administration/enforcement of Food and Drugs Act,
Food and Drug Regulations, Controlled Drugs and
substances Act o These two acts form the foundation
for drug laws in Canada
• Therapeutic Products Directorate o Canadian federal authority that regulates
the above mentioned acts
• Acts are designed to protect Canadian consumers from potential health
hazards and fraud or deception in the sale/use of foods, medications,
cosmetics, medical devices
The Personal Information Protection and Electronic Documents Act
(PIPEDA):
• Federal law governing the collection, use, and disclosure of personal
information
• Specific legislation may deal with this provincially/territorially
• For Ontario o Personal Health Information Protection Act (PHIPA) of 2004
Food and Drugs Act:
• Legislation that regulates foods, drugs, cosmetics, and medical devices in
Canada
The Controlled Drugs and Substances Act:
• Passes in 1997
• Sets out requirements for the control and sale of narcotics, controlled drugs,
and substances of misuse
777
, • Based on 8 schedules that list controlled drugs/substances based on their
potential harm or misuse
• Act is enforced by the RMCP and related sections of the criminal Code
Cannabis Act and Cannabis Regulations:
• Cannabis became legalized in October 2018
• Addresses the use of Cannabis for medical purposes
• Health Canada regulates the producers of cannabis for this purpose but not
involved in the decision-making process
Therapeutic Products Directorate:
• Health Canada is responsible for approving drugs for clinical safety/efficacy
before they are brought to the market
• Made certain lifesaving investigational drug therapies available sooner than
usual by offering an expedited drug approval process known as “fast track”
approval
Collective Goal of Drug-testing Phases:
• Provide information on the safety, toxicity, efficacy, potency, bioavailability
and purity of a new drug
• Informed consent is required prior to human testing – must be documented o
Explaining the purpose of the study, procedures used, possible benefits/risks
involved o Obtained from all patients (or legal guardians) before enrollment
into a drug trial
Phase I studies:
• Small number of healthy subjects – normally fewer than 100 o Rather than
those who have the disease or ailment the new drug is intended to tx o
Exception might be study involving a very toxic drug used to tx life-
threatening illness
Only study subject is those with the illness and whom other
viable treatment options are unavailable Purpose/Determine:
o Potential adverse effects o Optimal dosage range o Pharmacokinetics
of the drug
Absorption, distribution, metabolism, excretion o Is further testing
needed?
• Blood tests, urinalyses, assessment of VS, and specific monitoring tests are
also preformed Trials last a few days to a few weeks
PHASE II studies:
• Involves small number of volunteers (100 – 300) who have the disease or
ailment the drug is designed to treat
777
summary – ch3
LEGAL CONSIDERATIONS:
• Prescription medications are vital for treating/preventing illnesses
• For safety reasons use is regulated by individual provincial/territorial laws
enforced by several agencies o Health Canada and Royal Canadian Mounted
Police
Authorized Prescribers:
• Doctors (traditionally of osteopathy and medicine)
• Dentists and podiatrists within scope of practices
• Physician’s assistants and nurse practitioners
Canadian Drug legislation began in 1875:
• Health products Food Branch Inspectorate of Health Canada o Federal
regulator responsible for administration/enforcement of Food and Drugs Act,
Food and Drug Regulations, Controlled Drugs and
substances Act o These two acts form the foundation
for drug laws in Canada
• Therapeutic Products Directorate o Canadian federal authority that regulates
the above mentioned acts
• Acts are designed to protect Canadian consumers from potential health
hazards and fraud or deception in the sale/use of foods, medications,
cosmetics, medical devices
The Personal Information Protection and Electronic Documents Act
(PIPEDA):
• Federal law governing the collection, use, and disclosure of personal
information
• Specific legislation may deal with this provincially/territorially
• For Ontario o Personal Health Information Protection Act (PHIPA) of 2004
Food and Drugs Act:
• Legislation that regulates foods, drugs, cosmetics, and medical devices in
Canada
The Controlled Drugs and Substances Act:
• Passes in 1997
• Sets out requirements for the control and sale of narcotics, controlled drugs,
and substances of misuse
777
, • Based on 8 schedules that list controlled drugs/substances based on their
potential harm or misuse
• Act is enforced by the RMCP and related sections of the criminal Code
Cannabis Act and Cannabis Regulations:
• Cannabis became legalized in October 2018
• Addresses the use of Cannabis for medical purposes
• Health Canada regulates the producers of cannabis for this purpose but not
involved in the decision-making process
Therapeutic Products Directorate:
• Health Canada is responsible for approving drugs for clinical safety/efficacy
before they are brought to the market
• Made certain lifesaving investigational drug therapies available sooner than
usual by offering an expedited drug approval process known as “fast track”
approval
Collective Goal of Drug-testing Phases:
• Provide information on the safety, toxicity, efficacy, potency, bioavailability
and purity of a new drug
• Informed consent is required prior to human testing – must be documented o
Explaining the purpose of the study, procedures used, possible benefits/risks
involved o Obtained from all patients (or legal guardians) before enrollment
into a drug trial
Phase I studies:
• Small number of healthy subjects – normally fewer than 100 o Rather than
those who have the disease or ailment the new drug is intended to tx o
Exception might be study involving a very toxic drug used to tx life-
threatening illness
Only study subject is those with the illness and whom other
viable treatment options are unavailable Purpose/Determine:
o Potential adverse effects o Optimal dosage range o Pharmacokinetics
of the drug
Absorption, distribution, metabolism, excretion o Is further testing
needed?
• Blood tests, urinalyses, assessment of VS, and specific monitoring tests are
also preformed Trials last a few days to a few weeks
PHASE II studies:
• Involves small number of volunteers (100 – 300) who have the disease or
ailment the drug is designed to treat
777
