Legal and ethical considerations Flashcards
agencies regulating and enforcing safety of medications
health canada
RCMP
individual provincial and territorial laws
CRNA and CNO created laws that allowed nurses to prescribe medications amd order diagnostic tests in AB who work in?
specialty areas
Canadian drug legislation began in?
1875
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?
The health products and food branch inspectorate (HPFB) of Health Canada
The two acts that from the underlying foundation for drug laws in Canada?
food and drugs act
controlled drug and substance act
Canadian federal authority that regulates these acts?
the therapeutic products directorate (TPD)
TPD- ensure drug effectiveness and protect patients
food and drugs act
controlled drug and substance act
designed to protect the consumer from potential health hazards and fraud or deception in the sale of foods, drugs, cosmetics, and medical devices
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…
the personal protection and electronic documents act (PIPEDA)
federal legislation is to ensure
safety and efficacy of new drugs and protect patient confidentiality
Food and Drugs Act
governs food, drugs, cosmetics, and medical devices in Canada
The legend, Canadian standard drug or CSD
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
Drug samples
are regulated
with exception of the distribution under prescribed conditions to physicians, dentists and pharmacists.
Pr symbol
prescription drug
Food and drug act also regulates
the information manufacturers may put on the drug label, including directions for use
Food and drug regulations
current, consolidated regulations of the food and drugs act
controlled drugs are dispensed only by
prescription
a controlled drug must be marked with the symbol
C, in a clear manner and in as conspicuous color and size in the upper left quarter of the label
controlled drugs and substances act (CDSA)
passed in 1997
provides the requirements for the control and sale of narcotics, controlled drugs, and substances of misuse
controlled substances
medical treatment legally obtained only with prescription from a licensed HCP
This symbol is printed on the label of controlled drugs
N
most dangerous drugs
Schedule 1
opiates- (opium, heroin, morphine, cocaine)
fentanyl
methampetamine
Schedule 2
synthetic cannabinoid receptor 1 agonists
all other cannabis drug are now regulated under
cannabis regulations and cannabis act
schedule 3
more dangerous drugs
amphetamines
lysergic acids diethyl amide (LSD)
schedule 4
dangerous but have therapuetic uses:
barbituates
anabolic steroids
prescription needed
schedule 5 and 6
contain precursors required to produce controlled substances
schedule 8 and 8
contain amounts of cannabis and cannabis resin required for charge and sentencing purposes
the RCMP is responsible for enforcing the
CDSA and related sections of crimminal code, and exempts police forces from sections of CDSA for the pupose of performing their duties
The benzodiazepines and other targeted substances
restrictions in regard to benzodiazepines, their salts and derivatives
the precursor control regulations
control for essential and precursor chemicals routinely used in clandestine labs for the production of methamphetamine, ecstacy, and other schedule 3 drugs
The cannabis act and cannabis regulations
address cannabis for medical purposes
prescription
access to cannabis
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
Natural health products regulations
cover natural health products such as vitamins/ minerals, herbal, traditional medicines…
probiotic, amino acid, essential fatty acids
The therapeutic products directorate
approves drugs for clinical safety and efficacy before they are brought to the market
priority review of drug submissions process
or fast track approval
eligible submission- target of 180 days compared to 300 days (for non-priority)
AIDS- public health crisis where TPD granted expedited drug approval
drug approval process
complex and prolonged
begins with preclinical testing phase (invitro studies and animal studies)
clinical (human) studies follow the preclinical phase
the drug is put to the market after phase 3 is completed if an investigational new drug application
submitted by the manufacturer is approved by TPD
notice of compliance
issued when health Canada decides that the drug and the manufacturing process are safe and effective, allowing manufacturers to sell the product by prescription
once a drug is approved for sale, it is assigned a computed generated
drug identification number (DIN)
In vitro
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
informed consent
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)
Phase I
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
Phase II
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
phase III
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
placebo-controlled study
incorporate a placebo
blinded investigational drug study
if subject does not know whether the drug is a placebo or the original drub
but the investigator know
double blind
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
Canadian Patent Act
20 years after discovery of molecules
and includes the 10 to 12 year period generally required to complete drug research
the drug manufacturer has 8 to 10 years after drug marketing recoup research costs
which are usually hundreds of millions
phase IV
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
3 designated classes of drug recall
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…
Special Access Program
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
barrier to access prescription drug and cause of non adherence
high cost
low income, no benefits, those in poor health
Prescription drugs are not covered under the
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.
most provincial plan provide for some cots of the drug for those who are
poor, OA, those with catastrophic drug cost and people with certain conditions (AIDS, HIV/ cancer)
the fedral governement provide coverage for
Indigenous Peoples
most drugs are paid for patients over 65 however they mut pay for
dispensing fees based on coverage plan
not all drugs are covered
decison of province/ territories to list a drug is based on
effectiveness, analyses, govt priorities, pt advocacy
some drugs may be restricted if
require special monitoring or high cost
drug advertising is regulated by
health Canada
direct to consumer ads
is restricted to simply give names of drugs
NO claims of effectiveness
nurse practice
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
provincial regulatory bodies
define specific nursing practices as guidlines concerning the admin of IV therapy
professional nursing groups such as CNA
help to identify the legal boundaries of nursing practice
case law/ common law
affects nursing practice
CNA
advances the practice and profession of nursing to improve health outcomes and stregthen Canada’s health care system
CNA
national voice for nurses and have developed standards for nursing practice, policy staements and similar resolutions
standards
describe scope, function, role of the nurse and establish clinical practice standards
accredited hospital must have
written policy and procedures
policy and procedure
one of the standard by which nurse will measured in a lawsuit
standards of care
determine if nurse is acting appropriately when performing duties
if standards of care not met, nurse is liable for negligence and malpractice
privary act
regulates how the federal govt collect, use, and disclose personal information
PIPEDA
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
In summary: federal, provincial/ territorial legislation, standards of care, nurse practice acts, institutional policies
provide legal framework for safe nursing practice- drug therapy and med admin
ensure safety and efficacy of drug therapy and nursing process
ethical considerations
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
ethical princeiples in nurisng
- provide safe, compassionate, competent care
- promote health and well being
- promote and respect informed decison making
- honour dignity
- maintain privacy and confidentiality
- promote justice
- being accountable
privacy guidelines
increased awareness concerning pt confidentiality and privacy
understanding federal, provincial legislations as it relates to drug therapy and nursing process
the food and drugs act
the controlled drugs and substances act
provide nurses with info on drugs that cause little to no dependence vs those associated with high level of abuse and dependency
always obtain
informed consent with complete understanding of your role and responsibilities as a pt advocate in obtaining such consent
In the IND research
adhere to study protocol
act as pt advocate and honour pt right to safe, quality, nursing care
placebo order
question prescriber about specific rationale
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?
Autonomy
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?
the pt has been informed of all the potential hazards and benefits of therapy
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?
phase IV
when discussing laws of legal marijuanna use in Canada, which facts does the nurse consider?
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
the nurse is reviewing the 4 clinical phases of investigational drug studies
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
Canadian Drug Legislation
The Health Products Food Branch Inspectorate(HPFB) of Health Canada:
Administers and enforces the
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)
Therapeutics Product Directorate (TPD)
Regulates the above Acts
The Health Products Food Branch Inspectorate(HPFB) of Health Canada
Therapeutics Product Directorate (TPD)
*Both are federally level entities
Food and Drug Act Regulations “Schedule”
schedule A to H
schedule A
Schedule A: List of diseases for which treatment may not be promoted
schedule B
Schedule B: compliance with official prescribing standards
schedule C
Schedule C: Radiopharmaceuticals List
schedule D
Schedule D: allergenic substances, immunizing agents (vaccines), insulin, anterior pituitary extracts, drugs obtained from rDNA technology, blood derivatives
schedule E
Schedule E: manufacturing, labelling, packaging, importing interprovincial and internationally
schedule F
Prescription Drug List (Schedule F): All drugs that require a prescription (Pr symbol on upper left label)
schedule G
Schedule G: controlled drugs – opioids and other narcotics, benzodiazepines (three parts) *See Controlled Drugs and Substances Act
schedule H
Schedule H: restricted drugs – psychotropic (amphetamines, LSD) *Same as above
Controlled Drugs and Substances Act
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
Schedule I
Schedule I- opium, heroin, morphine, cocaine, methamphetamine
Schedule II
Schedule II- cannabis-related drugs, including marihuana and its derivatives
Schedule III
Schedule III- amphetamines and lysergic acid diethylamide (LSD)
Schedule IV
Schedule IV- barbiturates and anabolic steroids (prescription required)
Schedule V and VI
Schedules V and VI- precursors required to produce controlled substances
Schedules VII and VIII
Schedules VII and VIII- amounts of cannabis and cannabis resin required for charge and sentencing purposes
Marihuana Use
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
October 17, 2018
Legal use of cannabis
The Cannabis Act and Cannabis Regulations
~Address cannabis for medical purposes
New Drug Development
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).
Four Clinical Phases of Investigational Drug Studies
Phase I to IV
First, informed consent must be obtained.
Phase I
Phase I: small number of healthy subjects (usually fewer than 100)
Phase II
Phase II: larger numbers of volunteers who have the disease or ailment (usually 100 to 300)
Phase III
Phase III: larger number of patients who are followed by medical research centres (1 000 to 3 000)
Phase IV
Phase IV: postmarketing studies voluntarily conducted by drug companies to obtain information of the therapeutic and adverse effects of the new drug
Special Access Programme
Limited to those?
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
Patient Access to and Costs of Prescription Drugs
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
Legal Nursing Considerations
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.
Areas of Potential Liability
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
Ethical Considerations
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
Legal and Ethical Nursing Considerations
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
Right of Nurse to Refuse Care
“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.
Use of Placebos
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.
Use of Placebos in Research
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.
