Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

STUDY CARDS > Legal and ethical considerations > Flashcards

Legal and ethical considerations Flashcards

1
Q

agencies regulating and enforcing safety of medications

A

health canada
RCMP
individual provincial and territorial laws

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

CRNA and CNO created laws that allowed nurses to prescribe medications amd order diagnostic tests in AB who work in?

A

specialty areas

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Canadian drug legislation began in?

A

1875

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

The federal regulator responsible for administration and enforcement of the food and drugs act and food and drugs regulations, and the controlled drug and substance act?

A

The health products and food branch inspectorate (HPFB) of Health Canada

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

The two acts that from the underlying foundation for drug laws in Canada?

A

food and drugs act
controlled drug and substance act

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Canadian federal authority that regulates these acts?

A

the therapeutic products directorate (TPD)

TPD- ensure drug effectiveness and protect patients

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

food and drugs act
controlled drug and substance act

A

designed to protect the consumer from potential health hazards and fraud or deception in the sale of foods, drugs, cosmetics, and medical devices

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

a federal law governing the collection, use, and disclosure of personal information

require all health care providers, insurance, employers … to maintain patient privacy

such as medications, account numbers, prescription…

A

the personal protection and electronic documents act (PIPEDA)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

federal legislation is to ensure

A

safety and efficacy of new drugs and protect patient confidentiality

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Food and Drugs Act

A

governs food, drugs, cosmetics, and medical devices in Canada

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

The legend, Canadian standard drug or CSD

A

must appear on the inner and outer labels of the drug packaging to show that a drug meets the standards for which it is prescribed

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Drug samples

A

are regulated

with exception of the distribution under prescribed conditions to physicians, dentists and pharmacists.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Pr symbol

A

prescription drug

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Food and drug act also regulates

A

the information manufacturers may put on the drug label, including directions for use

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Food and drug regulations

A

current, consolidated regulations of the food and drugs act

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

controlled drugs are dispensed only by

A

prescription

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

a controlled drug must be marked with the symbol

A

C, in a clear manner and in as conspicuous color and size in the upper left quarter of the label

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

controlled drugs and substances act (CDSA)

A

passed in 1997

provides the requirements for the control and sale of narcotics, controlled drugs, and substances of misuse

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

controlled substances

A

medical treatment legally obtained only with prescription from a licensed HCP

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

This symbol is printed on the label of controlled drugs

A

N

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

most dangerous drugs
Schedule 1

A

opiates- (opium, heroin, morphine, cocaine)
fentanyl
methampetamine

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

Schedule 2

A

synthetic cannabinoid receptor 1 agonists

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

all other cannabis drug are now regulated under

A

cannabis regulations and cannabis act

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

schedule 3

A

more dangerous drugs
amphetamines
lysergic acids diethyl amide (LSD)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

schedule 4

A

dangerous but have therapuetic uses:

barbituates
anabolic steroids

prescription needed

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

schedule 5 and 6

A

contain precursors required to produce controlled substances

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

schedule 8 and 8

A

contain amounts of cannabis and cannabis resin required for charge and sentencing purposes

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

the RCMP is responsible for enforcing the

A

CDSA and related sections of crimminal code, and exempts police forces from sections of CDSA for the pupose of performing their duties

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

The benzodiazepines and other targeted substances

A

restrictions in regard to benzodiazepines, their salts and derivatives

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

the precursor control regulations

A

control for essential and precursor chemicals routinely used in clandestine labs for the production of methamphetamine, ecstacy, and other schedule 3 drugs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

The cannabis act and cannabis regulations

A

address cannabis for medical purposes

prescription

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

access to cannabis

A

buying direct from a seller licensed by the govt, register eith health canada to produce prescribed amount of cannabis, assigning a designate to produce the product on their behalf

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

Natural health products regulations

A

cover natural health products such as vitamins/ minerals, herbal, traditional medicines…

probiotic, amino acid, essential fatty acids

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
34
Q

The therapeutic products directorate

A

approves drugs for clinical safety and efficacy before they are brought to the market

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
35
Q

priority review of drug submissions process

or fast track approval

A

eligible submission- target of 180 days compared to 300 days (for non-priority)

AIDS- public health crisis where TPD granted expedited drug approval

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
36
Q

drug approval process

A

complex and prolonged

begins with preclinical testing phase (invitro studies and animal studies)

clinical (human) studies follow the preclinical phase

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
37
Q

the drug is put to the market after phase 3 is completed if an investigational new drug application

A

submitted by the manufacturer is approved by TPD

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
38
Q

notice of compliance

A

issued when health Canada decides that the drug and the manufacturing process are safe and effective, allowing manufacturers to sell the product by prescription

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
39
Q

once a drug is approved for sale, it is assigned a computed generated

A

drug identification number (DIN)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
40
Q

In vitro

A

test the response of human/ mamalian cells and tissues to drugs

dead/ living subjects- surgical/ autopsy specimens

determine early if a substance is too toxic for humans

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
41
Q

informed consent

A

careful explanation to the human test patient or research subject of the purpose of the study, procedures, benefits, risks

followed by a written documentaion/ consent form

voluntary

obtained before they can be enrolled in investigational new drug (IND)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
42
Q

Phase I

A

involve small numbers of healthy subject (fewer than 100)

(EXCEPT a study involving a toxic drug intended to treat- subjects will have illness where other options are not available)

determine potential adverse effects, optimal dosage range, pharmacokinetics, determine if further testing is required

blood test, UA, VS, specific monitoring

few days to few weeks

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
43
Q

Phase II

A

involve larger number of volunteers (100-300)

have disease that drug is designed to diagnose or treat

closely monitored for effectiveness and adverse effects

therapuetic dosage range refined

if no adverse effect occur- can proceed to phase III

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
44
Q

phase III

A

establish drugs effectiveness, safety, and dosage range

1000 to 3000 participants

followed by medical research centres and other health facilities

may be treated at the centre or spread out

purpose of large sample size is to provide info about infrequent or rare adverse effects

to enhance objectivity- a placebo is incorporated (given to a portion of subjects) to separete real benefits from apparent benefits arising out from a researcher/ subject bias regaridng expected or desired results

after phase III- company can submit new drug submission

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
45
Q

placebo-controlled study

A

incorporate a placebo

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
46
Q

blinded investigational drug study

A

if subject does not know whether the drug is a placebo or the original drub

but the investigator know

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
47
Q

double blind

A

neither the staff nor the subject know

after the completion of study , the code on medication container is revelead in order to know who received the placebo

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
48
Q

Canadian Patent Act

A

20 years after discovery of molecules
and includes the 10 to 12 year period generally required to complete drug research

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
49
Q

the drug manufacturer has 8 to 10 years after drug marketing recoup research costs

A

which are usually hundreds of millions

50
Q

phase IV

A

post marketing study voluntarily conducted by pharmaceutical companies to obtain proof of therapeutic and adverse effect

studies may be mandated by health Canada

compare a new NSAID to ibuprofen

health Canada may request voluntary recall if there is a pattern of severe reactions

51
Q

3 designated classes of drug recall

A

class I- most serous

class II- less severe ; reversible health effects

class III- least severe

Health Canada does drug recall may be press release, website announcements…

52
Q

Special Access Program

A

allows HCPs compassionate access to drugs unavailable for sale in Canada

life threatening conditions-epilepsy, cancer, aids

require experimental drugfor compassionate reasons/ emergency basis

NOT coccaine, heroin, LSD

53
Q

barrier to access prescription drug and cause of non adherence

A

high cost

low income, no benefits, those in poor health

54
Q

Prescription drugs are not covered under the

A

Canada Health Act

patients pay for a drug unless the drug is covered by a private drug plan or a federal, provinvial or territorial drug plan.

55
Q

most provincial plan provide for some cots of the drug for those who are

A

poor, OA, those with catastrophic drug cost and people with certain conditions (AIDS, HIV/ cancer)

56
Q

the fedral governement provide coverage for

A

Indigenous Peoples

57
Q

most drugs are paid for patients over 65 however they mut pay for

A

dispensing fees based on coverage plan
not all drugs are covered

58
Q

decison of province/ territories to list a drug is based on

A

effectiveness, analyses, govt priorities, pt advocacy

59
Q

some drugs may be restricted if

A

require special monitoring or high cost

60
Q

drug advertising is regulated by

A

health Canada

61
Q

direct to consumer ads

A

is restricted to simply give names of drugs

NO claims of effectiveness

62
Q

nurse practice

A

the scope of nursing practice

expanded nursing roles

educational requirements for nurses

standards of care

minimally safe nursing practice

differences between nursing and medical practice

63
Q

provincial regulatory bodies

A

define specific nursing practices as guidlines concerning the admin of IV therapy

64
Q

professional nursing groups such as CNA

A

help to identify the legal boundaries of nursing practice

65
Q

case law/ common law

A

affects nursing practice

66
Q

CNA

A

advances the practice and profession of nursing to improve health outcomes and stregthen Canada’s health care system

67
Q

CNA

A

national voice for nurses and have developed standards for nursing practice, policy staements and similar resolutions

68
Q

standards

A

describe scope, function, role of the nurse and establish clinical practice standards

69
Q

accredited hospital must have

A

written policy and procedures

70
Q

policy and procedure

A

one of the standard by which nurse will measured in a lawsuit

71
Q

standards of care

A

determine if nurse is acting appropriately when performing duties

if standards of care not met, nurse is liable for negligence and malpractice

72
Q

privary act

A

regulates how the federal govt collect, use, and disclose personal information

73
Q

PIPEDA

A

defines rights and privilege of pts in order to protect privacy without diminishing access to quality care

respect individuals rights to privacy and confidentiality

prevents HCP from sharing info of pts

74
Q

In summary: federal, provincial/ territorial legislation, standards of care, nurse practice acts, institutional policies

A

provide legal framework for safe nursing practice- drug therapy and med admin

ensure safety and efficacy of drug therapy and nursing process

75
Q

ethical considerations

A

understand and recognize own values, be considerate, non judgemetal, and respectful of the values of others.

autonomy
beneficence- do good
nonmaleficence- do no harm, risk vs benefit
justice
fidelity- faithfulness/ loyal
veracity- facts, truth

76
Q

ethical princeiples in nurisng

A
  1. provide safe, compassionate, competent care
  2. promote health and well being
  3. promote and respect informed decison making
  4. honour dignity
  5. maintain privacy and confidentiality
  6. promote justice
  7. being accountable
77
Q

privacy guidelines

A

increased awareness concerning pt confidentiality and privacy

understanding federal, provincial legislations as it relates to drug therapy and nursing process

78
Q

the food and drugs act
the controlled drugs and substances act

A

provide nurses with info on drugs that cause little to no dependence vs those associated with high level of abuse and dependency

79
Q

always obtain

A

informed consent with complete understanding of your role and responsibilities as a pt advocate in obtaining such consent

80
Q

In the IND research

A

adhere to study protocol

act as pt advocate and honour pt right to safe, quality, nursing care

81
Q

placebo order

A

question prescriber about specific rationale

82
Q

Pt to undergo surgery and asks about a living will, He states “I do not want anybody making decisions for me. I dont want to prolong my life.” Pt is demonstrating?

A

Autonomy

83
Q

PT is counselled for a possible participation in a clinical trial for a new medication

The nurse is asked to obtain her consent

The nurse knows that this informed consent indicates?

A

the pt has been informed of all the potential hazards and benefits of therapy

84
Q

a new drug has been approved for use, and the manufacturer has made it available for sale

during the first 6 months health canada received reports of severe reactions that were not discovered before

this illustrates which phase of investigational drug studies?

A

phase IV

85
Q

when discussing laws of legal marijuanna use in Canada, which facts does the nurse consider?

A

marijuanna is considered a legal substance

medical marijunna is produced via Health Canada regulated procedures

licensed regulators are required to provdie reports upon request to provincial and territorial licensing bodies

medical marijuanna can legally be consumed in other forms

86
Q

the nurse is reviewing the 4 clinical phases of investigational drug studies

A

studies that involve small numbers of healthy subjects who do not have disease or ailment that the drug is intended to treat

studies that involve small # of volunteers who have the disease that the drug is designed to diagnose/ treat

studies that involve large # of patients who have disease that the drug is intended to treat, establish drug effectiveness, safety, and dosage range

studies are voluntarily conducted by pharmaceutical companies to obtain more info about the therapeutic and adverse effect of a drug

87
Q

Canadian Drug Legislation

The Health Products Food Branch Inspectorate(HPFB) of Health Canada:

Administers and enforces the

A

Administers and enforces the

Food and Drugs Act and Food and Drug Regulations
Controlled Drugs and Substances Act
Consumer protection from fraud, health hazards (food, drugs, cosmetics, medical devices)

88
Q

Therapeutics Product Directorate (TPD)

A

Regulates the above Acts

89
Q

The Health Products Food Branch Inspectorate(HPFB) of Health Canada

Therapeutics Product Directorate (TPD)

A

*Both are federally level entities

90
Q

Food and Drug Act Regulations “Schedule”

A

schedule A to H

91
Q

schedule A

A

Schedule A: List of diseases for which treatment may not be promoted

92
Q

schedule B

A

Schedule B: compliance with official prescribing standards

93
Q

schedule C

A

Schedule C: Radiopharmaceuticals List

94
Q

schedule D

A

Schedule D: allergenic substances, immunizing agents (vaccines), insulin, anterior pituitary extracts, drugs obtained from rDNA technology, blood derivatives

95
Q

schedule E

A

Schedule E: manufacturing, labelling, packaging, importing interprovincial and internationally

96
Q

schedule F

A

Prescription Drug List (Schedule F): All drugs that require a prescription (Pr symbol on upper left label)

97
Q

schedule G

A

Schedule G: controlled drugs – opioids and other narcotics, benzodiazepines (three parts) *See Controlled Drugs and Substances Act

98
Q

schedule H

A

Schedule H: restricted drugs – psychotropic (amphetamines, LSD) *Same as above

99
Q

Controlled Drugs and Substances Act

A

Passed in 1997, replacing the Narcotic Control Act (1952) and parts III and IV of the Food and Drugs Act
Prohibits activities such as possession, possession for the purpose of trafficking, trafficking, importing and exporting, and cultivation of narcotics or controlled and restricted drugs
The letter N and the symbol are printed on the label of every narcotic drug.
Enforced by the (RCMP)

Schedule I to VIII

100
Q

Schedule I

A

Schedule I- opium, heroin, morphine, cocaine, methamphetamine

101
Q

Schedule II

A

Schedule II- cannabis-related drugs, including marihuana and its derivatives

102
Q

Schedule III

A

Schedule III- amphetamines and lysergic acid diethylamide (LSD)

103
Q

Schedule IV

A

Schedule IV- barbiturates and anabolic steroids (prescription required)

104
Q

Schedule V and VI

A

Schedules V and VI- precursors required to produce controlled substances

105
Q

Schedules VII and VIII

A

Schedules VII and VIII- amounts of cannabis and cannabis resin required for charge and sentencing purposes

106
Q

Marihuana Use

A

The Marihuana Medical Access Program was replaced in 2014 with the Marihuana for Medical Purposes Regulations.

Health Canada regulates the producers of marihuana for this purpose but is not involved in the decision-making process.

Consumed in resins, oils, extractions, and edible forms, as well as in dried form for smoking

107
Q

October 17, 2018

A

Legal use of cannabis
The Cannabis Act and Cannabis Regulations
~Address cannabis for medical purposes

108
Q

New Drug Development

A

Ongoing process
Our system of drug research and development is one of the most stringent in the world
Developed out of concern for patient safety and drug efficacy
Canadian Natural Health Products Regulations (2003)
Health Canada drug approval process
Once approved, drug is assigned a Drug Identification Number (DIN).

109
Q

Four Clinical Phases of Investigational Drug Studies

A

Phase I to IV

First, informed consent must be obtained.

110
Q

Phase I

A

Phase I: small number of healthy subjects (usually fewer than 100)

111
Q

Phase II

A

Phase II: larger numbers of volunteers who have the disease or ailment (usually 100 to 300)

112
Q

Phase III

A

Phase III: larger number of patients who are followed by medical research centres (1 000 to 3 000)

113
Q

Phase IV

A

Phase IV: postmarketing studies voluntarily conducted by drug companies to obtain information of the therapeutic and adverse effects of the new drug

114
Q

Special Access Programme

Limited to those?

A

Allows health care providers compassionate access to drugs unavailable for sale in Canada

Limited to those with serious or life-threatening conditions
Intractable depression
Epilepsy
Transplant rejection

115
Q

Patient Access to and Costs of Prescription Drugs

A

High drug expense significant barrier for access to prescription drugs as they are not covered under the Canada Health Act.
People specifically affected include low income, those with no drug benefits, and those in poor health. (Most provincial plans will cover these groups)
Provincial plans will have variation in what drugs are covered/accessed
Federal government provides coverage for Indigenous peoples

116
Q

Legal Nursing Considerations

A

Nursing practice standards of care; Scope of practice is provincial/territorial
Case law or common law consisting of prior court rulings also affect professional nursing practice.
Canadian Nurses Association (CNA) is the national voice for nurses; Code of Ethics
Accreditation Canada requires accredited hospitals to fulfill certain standards in regard to nursing practice.

117
Q

Areas of Potential Liability

A

Liable for negligence and malpractice
Failure to assess or re-evaluate
Failure to ensure safety
Medication errors

*Context for consideration: You will need appropriate certifications to give certain types of medications: certification for administration of chemotherapeutic agents, Advanced Cardiac Life Support certification to administer certain cardiac meds given during cardiac arrest; NP’s can prescribe certain medications but not RNs

118
Q

Ethical Considerations

A

Ethical principles are useful strategies for health care providers and include standards or truths on which ethical actions are made.
Autonomy, beneficence, nonmaleficence, justice, fidelity, and veracity
CNA Code of Ethics for registered nurses (RNs)
International Council of Nurses (ICN) Code of Ethics for Nurses

119
Q

Legal and Ethical Nursing Considerations

A

Components of CNA Code of Ethics
Providing safe, compassionate, competent, ethical care
Promoting health and well-being
Promoting and respecting informed decision making
Honouring dignity
Maintaining privacy and confidentiality
Promoting justice
Being accountable

120
Q

Right of Nurse to Refuse Care

A

“Opportunity for the nurse to have a voice…”
Violates the nurse’s personal ethical principles
Nurse speaks to supervisor or manager to request unit transfer, but must not abandon the patient.
Nurse is responsible for providing nonjudgemental nursing care.
Nurse always acts in the best interest of the patient while remaining an objective patient advocate.

121
Q

Use of Placebos

A

Placebo is a drug dosage form without pharmacological activity.
Placebo is used frequently in experimental drug studies.
Except in new drug studies, placebo use is considered unethical, creating mistrust among the nurse, the prescriber, and the patient.
In Canada, there are no specific formal guidelines on the use of placebos.

122
Q

Use of Placebos in Research

A

An informed consent process must be followed.

Patients are informed of their right to
-leave the study without pressure or coercion.
-leave the study with no consequences to medical care.
-receive full and complete information about the study.
-be made aware of alternative options and receive information on all treatments, including placebo therapy.

STUDY CARDS (17 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions