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N1209 > Week 3 - The Law + Ethics > Flashcards

Week 3 - The Law + Ethics Flashcards

1
Q

Benzodiazepines + Other Targeted Subs Regulations

A
  • year 2000
    -specify requirements for:
    –> producing, assembling, importing, exporting, selling, providing, destroying benzo. + other targeted subs
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2
Q

benzodiazepines

A

-sedatives that are anxiety reducing, hypnotic and muscle relaxing

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3
Q

blinded investigational drug study

A

-research design
-subjects are purposely made unaware of if admin’d sub = drug or placebo
-minimizes bias

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4
Q

Canada Health Act

A

CAN’s federal legislation for publicly funded health care insurance

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5
Q

Controlled Drugs + Subs Act (CDSA)

A

Health Canada Act that states
–> possession, production, import/export of controlled subs = criminal offence

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6
Q

double-blind, investigated drug study

A

-research design
- the study investigators AND subjects are unaware if given drug or the placebo
-minimizes bias for both

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7
Q

Drug Identification Number (DIN)

A
  • computer generated by Health CAN
  • on label of OTC + prescription drugs
  • evaluated + approved for sale by Therapeutic Products Directorate (TPD)
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8
Q

Food + Drugs Act

A

-Protects consumers from contaminated, unsafe drugs + labelling practices
-Addresses approp. advertising + selling of drugs, foods, cosmetics + therapeutic devices

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9
Q

Investigational new drug (IND)

A

Drug not yet approved for marketing by TPD → ok for use in experiments to determine safety + efficacy

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10
Q

Investigational new drug application

A

App. submitted to TPD before drug is studied in humans

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11
Q

Malpractice

A
  • type of negligence
  • Failure of profesh./indiv. w/specialized ed. to act in a reasonable way
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12
Q

Negligence

A

Failure to act in a reasonable or prudent (careful) manner

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13
Q

New drug submission

A

App. submitted by drug manufacturer to TPD → following ✅ completion of required human research studies

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14
Q

Notice of compliance

A
  • Notification → issued when Health Canada decides a drug + manufacturing process = safe
  • Allows pharm. company to sell it by prescription (Canada)
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15
Q

Precursor control regulations

A

-Scheme to allow Canada to fulfill international + domestic needs about:
–> monitoring + controlling precursor chems. (chemicals used in illegal drugs e.g. methamphetamine)

  • These meds are listed in Schedules I, II, III of Controlled drugs and Substances Act
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16
Q

Priority review of drug submissions

A

Policy allowing earlier review of drug products
→ for serious, life-threat.,/severely debilitating diseases that don’t have an effective drug on the Canadian market

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17
Q

Special Access Programme

A

Allows HCP to apply for access to drugs currently unavailable for sale in Canada

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18
Q

prescription drug use

A
  • regulated by agencies e.g. Health CAN, RCMP, + prov./terri. laws
  • Dr. prescribes the meds
    –> NOW: dentists, podiatrists, pharmacists, physician’s assistants and NPs can too
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19
Q

Which province/territory allows RNs to prescribe meds? and which association made the framework to allow this?

A
  • Alberta
  • CNA
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20
Q

Health Canada’s Health Products + Food Branch (HPFB)

A

enforces:
- food + drugs act
- food + drug regulations
- controlled drugs + subs act

protects consumers from health hazards, fraud + deception

regulated by TPD federally

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21
Q

PIPEDA

A

Personal Info. Protection + Electronic Documents Act
-protects confidentiality

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22
Q

F&D Act: Schedule A

A

lists diseases, disorders, or abnormal physical states for which advertising/selling treatments to the general public is PROHIBITED

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23
Q

F&D Act: Schedule B

A

-lists official drug standards and reference texts that are recognized by Health Canada

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24
Q

pharmacopoeias

A

book describing how chemicals, drugs, other subs are used in meds

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25
F&D Schedule C
radiopharmaceuticals (radioactive drugs)
26
F&D Schedule D
biologic drugs and products derived from living organisms - vaccines - allergenic subs - insulin - Blood and blood derivatives
27
what replaced Schedule F?
Prescription drug list
28
prescription drug list
lists drugs requiring prescription due to their potential risks, therapeutic use, and side effects --> excluding narcotics + controlled subs
29
labelling requirements
- Canadian Standard Drug (CSD) legend must be on drug labels to indicate compliance w/prescribed standards
30
Pr
symbol for prescription drugs - on upper left of label
31
C
symbol for controlled drugs - on upper left of label
32
Drug samples
-distribution is regulated -restricted to physicians, dentists/pharmacists under specific conditions
33
Food + Drug Regulations
-detailed rules that support the Act -include Parts G and J
34
F&D Regulations Part G
-controlled drugs -outlines reqs for subs that have potential for abuse/addiction
35
F&D Regulations Part J
-restricted drugs -stubs that have potential risks to health (not necessarily more addictive than those in Part G) -often apply to prescription meds
36
Controlled Drugs + Subs Act (CDSA)
regulates control + sale of narcotics, controlled drugs, subs of misuse requiring a prescription
37
narcotics
-type of controlled drug -symbol = N
38
CDSA Schedule I
-MOST dangerous drugs -e.g. opiates, fentanyls, methamphetamine
39
CDSA Schedule II
- Synthetic cannabinoid receptor agonists
40
agonist
sub that attaches to a receptor to activate it and mimic body's natural chemicals
41
Schedule III
-Dangerous drugs w/potential misuse - e.g. amphetamines, LSD
42
Schedule IV
Therapeutic drugs that need prescription - e.g. anabolic steroids, barbiturates ([uncommonly used] CNS depressants → treat anxiety, insomnia, seizures)
43
Schedule V + VI:
- Precursors used to manufacturer controlled substances
44
Schedule VII + VIII:
Quantities of cannabis/cannabis resin for charges/sentencing - amount of weed that determine severity of legal consequences
45
RCMP
-enforces CDSA and its related Criminal Code sections
46
Therapeutic Products Directorate (TPD)
ensures patient safety + drug effectiveness through strict approval process
47
what historical event influenced influenced canada's drug approval stringentness?
thalidomide tragedy
48
natural health products regulations
- part of Bill C-51 -regulate vitamins, minerals, herbal remedies, probiotics, traditional meds, amino acids, omega 3s
49
TPD expedited approval
- shortens review time from 300 to 180 days for LIFE SAVING drugs
50
Drug developmental phases (2)
preclinical phase and clinical phase
51
preclinical phase
-lab testing --> in vitro + animal studies -small % of compounds progress to human trials
52
clinical (phase 1)
-initial testing on healthy volunteers -short duration -SMALL group (<100 HEALTHY volunteers) - assess safety (adverse effects), dosage range, pharmacokinetics
53
Clinical phase 2
-medium-scale trials (100-300 ppl w/TARGET CONDITION the drug is intended to treat) -assess drug effectiveness, refine therapeutic dosage, adverse effects
54
Clinical phase 3
-large-scale trials (1-3k ppl across multiple centers) -confirm safety, clinical efficacy, optimal dosage -identify RARE adverse effects -uses: Placebo-controlled/blinded study + double-blind studies
55
what happens after phase 3 and before phase 4?
new drug submission is made to the TPD + Biologics + genetic therapies directorate (BGTD) --> if approved, allows pharm company the right to market the drug
56
clinical phase 4
- post marketing surveillance to assess long-term safety + effectiveness - data collected for a min. 2 years post drug release
57
Health Canada Recalls
-Class 1: severe risk (death) -Class 2: less severe (temporary/reversible effects) -Class 3: minor risk
58
patent
legal right granted by a gov to an inventor -gives rights to make, use, sell or distribute it for a period of time
59
SAP
Special Access Programme
60
SAP function
-allows HCP to request compassionate access to drugs not approved for sale -helps patients with LIFE THREATENING/SERIOUS condtions
61
SAP eligibility (6)
-intractable depression -epilepsy -transplant rejection -hemophilia + other blood disorders -terminal cancer -AIDS
62
what can ads targeted directly at consumers display? (e.g. magazines, public trans)
ONLY drug names
63
what can profesh. ads display? (e.g. journal)
include claims + prescribing info
64
65
Who/what oversees ad regulations? (3)
-Food + Drugs Act -Advertising Standards Canada (ASC) -Pharmaceutical Advertising Advisory Board (PAAB)
66
NPA
nurse practice act
67
Main functions of an NPA (Nurse practice act) (4)
1. define nursing scope + practice 2. protect public health + safety 3. est. educational reqs 4. guide disciplinary actions (for addressing violations of nursing standards)
68
Case Law (common law)
previous court rulings that influence profesh nursing practice + define legal precedents
69
Areas of potential liability for nurses (3)
1. failure to ensure safety 2. med errors 3. failure to assess/evaluate
70
ICN code of ethics
globally accepted ethical guide for nurses based on social values + needs
71
key responsibilities in ICN (4)
-promoting health -preventing illness -restoring health -alleviating suffering
72
principle framework elements (4)
-nurses and people (respect + compassion) -nurses and practice (competence + accountability) -nurses and the profession (advancing the nursing profession) -nurses and co-workers (positive IPC)
73
Ethical responsibilities of nurses (4)
- patient centered care -right to refuse participation -nonjudgmental care -guiding resources (code of ethics, ICN etc.)

N1209 (5 decks)

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