Legal and Ethical Considerations

Question 1

What are the 2 federal level entities that regulate Canadian drug legislation

Answer 1

The Health Products Food Branch Inspectorate of Health Canada (HPFB)
Therapeutics Product Directorate (TPD)

Question 2

What are Schedule A regulations

Answer 2

A list of diseases for which treatment may not be promoted

Question 3

What are schedule B regulations

Answer 3

Compliance with official prescribing standards

Question 4

What are schedule C regulations

Answer 4

Radiopharmaceutical list

Question 5

What are schedule D regulations

Answer 5

Allergenic substances, vaccines, insulin, anterior pituitary extracts, drugs obtained from rDNA technology, blood derivatives

Question 6

What are schedule E regulations

Answer 6

Manufacturing, labelling, packaging, importing, interprovincial and internationally

Question 7

What are Schedule F regulations

Answer 7

All drugs that require a prescription

Question 8

What are schedule G drugs?

Answer 8

Controlled drugs: Opioids, narcotics, benzodiazepines

Question 9

What are schedule H drugs

Answer 9

Restricted drugs - psychotropic (amphetamines, LSD)`

Question 10

What is the controlled drugs and substances act?

Answer 10

Prohibits activities such as possession, trafficking, importing, exporting, and selling of narcotics

Question 11

When was the controlled drugs and substances act passed?

Answer 11

1997

Question 12

What is in the schedule 1 description

Answer 12

opium, heroin, morphine, cocaine, methamphetamine

Question 13

What is in the schedule 2 description

Answer 13

Cannabis and any derivatives

Question 14

What is in the schedule 3 description

Answer 14

Amphetamines and LSD

Question 15

What is in the schedule 4 description

Answer 15

Barbiturates and anabolic steroids

Question 16

What is in the schedule 5 and 6 descriptions?

Answer 16

Precursors required to produce controlled substances

Question 17

What is included in the schedules 7 and 8 descriptions?

Answer 17

Amounts of cannabis required to be charged and sentenced

Question 18

When was cannabis use legalized?

Answer 18

October 17, 2018

Question 19

What are the 4 phases of investigational drug studies?

Answer 19

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

Question 20

What is the special access program?

Answer 20

Allows health care providers compassionate access (for serious or life-threatening) to drugs unavailable for sale in Canada

Question 21

Who provides coverage for indigenous peoples?

Answer 21

The federal government

Question 22

What are the 3 areas of potential liability?

Answer 22

Failure to assess or re-evaluate
Failure to ensure safety
Medication errors

Question 23

What is a placebo

Answer 23

Drug dosage form with no pharmacological activity used in drug studies

Question 24

What is the ethical dilemma about placebo drugs

Answer 24

May cause mistrust with the patient and healthcare team but helpful in comparing actual therapeutic drug responses

Question 25

What is included in informed consent for drug research

Answer 25

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