pharm legal and ethical considerations

Question 1

what does the HPFB do

Answer 1

• administers and enforces:
  Food and drug act
  -controlled substance act
• consumer protection against fraud, health hazards, cosmetics, medical devices

Question 2

what does the TPD (therapeutic products directorate) do

Answer 2

regulates food and drug act and the controlled drug and substance act.

Question 3

what level are the HPFB and TPD

Answer 3

federal

Question 4

schedule A of FDA

Answer 4

list of diseases for which treatment may not be promoted

Question 5

schedule B of FDA

Answer 5

compliance with official prescribing standards

Question 6

schedule C of FDA

Answer 6

radiopharmaceuticals list (ex- diagnostic tests and CAT scan)

Question 7

schedule D of FDA

Answer 7

allergenic substances, immunizing agents (vaccines), insulin, ant pit extracts, drugs obtained from rDNA tech, blood derivatives

Question 8

schedule E of FDA

Answer 8

manufacturing, labeling, packaging, importing interprovincial and internationally

Question 9

schedule F of FDA

Answer 9

prescription drug list. all drugs that require a perscription

Question 10

schedule G of FDA

Answer 10

controlled drugs. opiates, narcotics, benzos

Question 11

schedule H of FDA

Answer 11

restricted drugs. ex- LSD

Question 12

when was the controlled drug and substance act passed

Answer 12

1997 replacing the narcotic control act of 1952

Question 13

what does the controlled drug and substances act do

Answer 13

prohibits the possession and transporting of narcotics and restricted drugs

Question 14

schedule 1 of controlled drugs and substances act

Answer 14

opium heroin, morphine, cocaine, methamphetamine

Question 15

schedule 2 of controlled drugs and substances act

Answer 15

cannabis related drugs, marihuana and its derivatives

Question 16

schedule 3 of the controlled drugs and substances act

Answer 16

amphetamines and lysergic acid diethylamide (LSD)

Question 17

schedule 4 of the controlled drugs and substances act

Answer 17

barbiturates and anabolic steroids (prescription required)

Question 18

schedule 5 and 6 of the controlled drugs and substances act

Answer 18

precursors required to produce controlled substances

Question 19

schedule 7 and 8 of the controlled drugs and substances act

Answer 19

amount of cannabis and cannabis resin required for charge and sentencing

Question 20

when was cannabis legalized

Answer 20

oct 17, 2018

Question 21

what does the cannabis act and cannabis regulations do

Answer 21

addresses cannabis for medical purposes

Question 22

how is cannabis consumed

Answer 22

resins, oils, extractions, edible, dried form for smoking

Question 23

first phase of investigational drug studies

Answer 23

small number of healthy subjects (less than 100)

Question 24

second phase of investigational drug studies

Answer 24

larg # of volunteers with disease (100-300)

Question 25

phase 3 of investigational drug studies

Answer 25

large # of patients who are followed by medical research centers (1000-3000)

Question 26

phase 4 of investigational drug studies

Answer 26

studies conducted by drug company to obtain therapeutic and adverse effects of new drug

Question 27

special access programe

Answer 27

allows health care providers access to drugs unavailable in canada. only for ppl with intractable depression, epilepsy, transplant rejection

Question 28

areas of potential liability

Answer 28

negilgence or malpractice, failure to assess, failure to ensure safety, med errors

Question 29

right of nurse to refuse care

Answer 29

• can ask to switch unit but cant abandon pt

Question 30

are placebos ethical

Answer 30

no, creates mistrust

Question 31

pts in drug research can…

Answer 31

• leave study without pressure
• leave with no medical consequences
• recieve full info about study
• be made aware of alternative treatments