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Healthcare and pharmaceutical policy in Canada

Pharmacy Ethics
&
Regulations

Misbah Biabani, Ph.D


Director, TIPS Review Centers
A professional Exams Preparation Centre
5460 Yong St. Suites # 209 and 210, Toronto, ON, M2N 6K7
WWW.PHARMACYPREP.COM
416-223-PREP/ 647-221-0457/416-696-2455
Toronto Institute of Pharmaceutical Sciences Inc (TIPS).
2000- 2009 TIPS Inc. All Rights Reserved.

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DISCLAIMER

Your use and review of this information constitutes acceptance of the following terms
and conditions.
The information contained in the notes are intended as educational aid only. It is not
intended as medical advice for individual conditions or treatment. It is not a substitute for a
medical exam, nor does it replace the need for services provided by medical professionals. Talk
to your doctor or pharmacist before taking any prescription or over the counter drugs (including
any herbal medicines or supplements) or following any treatment or regimen. Only your doctor
or pharmacist can provide you with advice on what is safe and effective for you. Pharmacy
Prep makes no representation or warranty as to the accuracy, reliability, timeliness, usefulness
or completeness of any of the information contained in the products. Additionally, Pharmacy
Prep does not assume any responsibility or risk for your use of these pharmacy preparation
manuals.
In our teaching strategies, we utilize lecture-discussions, small group discussions,
demonstrations, audiovisuals, case studies, written projects, role play, gaming techniques, study
guides, selected reading assignments, computer assisted instructions (CAI), and interactive
video discs (IVD).
Our preparation classes and books are not intended as substitutes for the advise of the
PEBC. Every effort has been made to ensure that the information provided herein is not
directly or indirectly obtained from PEBCs previous exams or copyright materials.
2000-2009 TIPS. All rights reserved.

Foreword by:
Misbah Biabani, Ph.D
Coordinator, Pharmacy Prep
Toronto Institute of Pharmaceutical Sciences (TIPS) Inc
5460 Yonge St. Suites 209 and 303
Toronto ON M2N 6K7, Canada

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Healthcare and pharmaceutical policy in Canada

Healthcare and
Pharmaceutical policy in
Canada
This chapter summarizes the federal, provincial, and territorial agencies that are responsible for
delivering healthcare and pharmaceutical care to the Canadian public.
Canadas federal, provincial and territorial governments ensure to provide safe and
effective healthcare and pharmaceuticals. However the Canadian healthcare system is
mostly decentralized, that means, it owned and operated by provincial governments. Most
of essential services are provided at no cost rather free to all citizens, immigrants on
equality basis. However other services like dental, optometric care, hearing care long-term
residential care, are not universally covered. The provincial governments determine what
are the essential services that covered or not covered.
The role of Canadas federal, provincial and territorial in providing healthcare services has
been determined by the Constitution Act 1867.
Provincial acts, enforced by provincial pharmacy regulatory authorities, regulate the
profession and the practice of pharmacy and may specify conditions of sale. Within these
acts, drugs are classified into categories (called drug schedules) with conditions imposed
on their sale.
The federal legislation is designed to ensure that all residents of Canada have access to
needed medical care. This means that medically necessary hospital services, physician
services, and certain surgical dental procedures are available to everyone on an equal basis.
Hospital services include, in patient care at the standard ward level, all necessary drugs,
biological, supplies and diagnostic tests, as well as a broad range of outpatient services.
Physician services include: all medically required services provided by medical
Practitioners in hospitals, clinics, or physician offices where services are offered.
Under the Canadian healthcare system of government, the health-care system is the
Responsibility of the provincial government, which determines the nature of the Programs
and extent to which it wishes to establish publicly funded programs.
1959 Federal Hospital Insurance and Diagnostic Services Act.
1962 Introduction of Canadas (and North Americas) first Medicare program.
1965 Royal Commission on Health Services under Emmett Hall
recommends a universal, comprehensive national health insurance
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program.
1966 Bill 227 creates a national Medicare program. Federal government
agrees to pay 50% of provincial health costs.
1977 Federal transfers for health and post-secondary education now placed
under Established Programs Financing. Federal government replaces
50:50 cost sharing with five-year block funding that gives provinces
more control over health expenditures. The Federal government steps
away from a percentage of tax points (12.5 points of personal income
and 1% of corporate income) in lieu of 100% cash transfers. The
value of these contributions starts to increasingly (lag?) the growth in
health care expenditures.
1984 Canada Health Act unanimously passed in Parliament, with
adherence to the 5 principles, enforced by threat of withholding
funds. Extra billing is banned as a restriction on access.
1995 Canada Health and Social Transfer (CHST) is announced in 1995
Budget as the Canada Social Transfer, and came into effect in April
1, 1996. It replaced the federal transfers for (a) social assistance
and social services under the Canada Assistance Plan (CAP),
legislated into existence in 1966 and (b) for health and postsecondary education under Established Programs Financing (EPF).
Total transfers, which had been dwindling since 1985, plummeted
after 1995.
1997 National Forum on Health calls for medicare to be extended to cover
home care and pharmacare, and for an (end?) to fee-for-service.
1999-2000 Partial (or full, depending upon whose version one accepts)
restoration of federal transfers to provinces.

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The Canadian health care system


The Canadian health care system is universal health care, this mean that all citizens and
immigrants will have access to health care regardless of their ability to pay. All Canadian are
insured on equality basis and offered health in all ten provinces and three territories.
The Canada Health Act (CHA)
The Purpose and Scope of the CHA
To protect, promote, and restore the physical and mental well being of residents of Canada
(citizens, and permanent residents) and to facilitate reasonable access to health services
without financial or other barriers. However, the Canada Health Act omits significant areas of
health care.
Principles of the CHA
Federal funding of health care is contingent on provincial adherence to the following five
principles, which are at the core of the CHA.
Public administration
Comprehensives
Universality
Portability
Accessibility
Public administration: Health-care insurance is to be administered on a non-profit basis by a
public authority responsible to the province and subject to audit.
Comprehensiveness: The insurance must cover all insured services supplied by hospitals,
medical practitioners and dentists (certain dental surgical procedures). Each province
determines which services are insured.
Universality: All insured parties are entitled to equal access to insured services.
Portability: A series of obligations on provinces which essentially guarantee any Canadian
resident (after a maximum wait of three months upon first becoming a resident) access
anywhere in Canada on the same basis as local residents.
Accessibility: Charges or other obstacles must not impede access to insured services.
The CHA covers
Medically necessary hospital services.
Medically required physicians services.
Medically or dentally required surgical dental services requiring a hospital for proper
performance.
The coverage reflects the two-stage evolution of public health care insurance in Canada.
The 1959 Hospital Insurance and Diagnostic Services Act and the 1966 Medicare Act,
respectively, brought hospital and medical insurance to the federal level.

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CHA does not cover


The following services are not covered under the CHA:
Services delivered by health-care professionals other than doctors, particularly outside
of hospitals (some provinces do cover some of these services, but are not obligated to
do so under the CHA).
Services in sectors outside the hospital. These include long-term care facilities and
home care. Pharmaceuticals, rehabilitation services and dental care are also not
covered when provided outside of hospitals.
Levels of health care delivery systems
It can be categorized as primary, secondary and tertiary health care delivery systems
Primary care: This is first contact a person makes a contact with the system when a person feels
necessity of health care. This usually occurs through the family physician, pharmacist, or nurse
at medical centres
Secondary care: This is specialized service from a specialist. This requires referral from
primary health care levels.
Tertiary care: This is specialized in diagnosing and highly technical care and treating
complicated or unusual health problems. This generally takes place in hospital setting where
generally diagnostic and complicated therapies can takes place.
Health promotion and disease prevention
Health promotion was defined by the world health organization (WHO) in 1986 as the process
of enabling people to increase control over, and improve their health.
Disease prevention is focuses on efforts to avoid disease and injury. Some examples of the
disease prevention include smoking cessation programs, breast screening, and pap smear
screening.
EPF: Established Programs Finance Act: (1977)
Insured services: Hospitals, Diagnostics and Physicians. EPF for more flexibility to provinces
implemented extra billing.
Healthcare and pharmaceutical policy
The Health Protection Branch (HPB) of Health Canada is responsible for drug quality, safety
and efficacy. It regulates drugs imported into and manufactured for sale in Canada.
Federal Public Drug Benefit Programs
The federal government oversees drug benefit programs for the following client groups:

First nations (aboriginal), or natives and Inuit and matis;


Veterans

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Healthcare and pharmaceutical policy in Canada

Canadian Forces members;


Members of the Royal Canadian Mounted Police (RCMP);
Certain designated classes of migrants (refugee); and inmates of federal penitentiaries
and some former inmates on parole.

Non-Insured Health Benefits (NIHB) Program


Health Canada's Non-Insured Health Benefits (NIHB) Program provides coverage for a
limited range of these goods and services when they are not insured provinces and territories or
other private insurance plans.
Veteran Affairs Canada (VAC)
provide pensions for disability or death, economic support in the form of allowances, health
care benefits and services to:members of the Canadian Forces and Merchant Navy veterans
who served in the First World War, the Second World War or the Korean War
certain civilians who are entitled to benefits because of their wartime service
former members of the Canadian Forces (including those who served in Special Duty Areas)
and the Royal Canadian Mounted Police survivors and dependents of military and civilian
personnel.
Health Canada's Therapeutics Access Strategy (TAS)
Provides canadians with improved access to safe, high quality, therapeutically effective and
appropriately used therapeutic products in a timely and cost-effective manner.
Health Canada's Health Products and Food Branch
The Health Canada's Health Products and Food Branch (HPFB) evaluates and monitors the
safety, efficacy and quality of thousands of human and veterinary drugs, medical devices,
natural health products and other therapeutic products available to Canadians, as well as the
safety and quality of food in Canada. The Branch also contributes to the health and well-being
of Canadians in a variety of other ways, which include developing nutrition policies and
standards.
Pharmaceutical market authorization decision
Drug Submissions
If, at the completion of a new drug review, HPFB concludes that the benefits outweigh the risks
and that the risks can be mitigated and/or managed, the product is issued a letter known as a
Notice of Compliance (NOC) and a Drug Identification Number (DIN), as required in the Food
and Drugs Act and Regulations. This allows the manufacturer to sell the product in Canada.

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Natural Health Product Applications


Natural health products are issued a product licence if the application is determined to meet
regulatory requirements. Each natural health product approved to be marketed is assigned a
Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM).
Special Access Programme (SAP)
HPFB's Special Access Programme (SAP) allows health care professionals to gain limited
access to drugs, natural health products and medical devices that have not been authorized for
sale in Canada.
Special access can be requested for emergency use or if conventional therapies have failed, are
unsuitable or are unavailable to treat a patient. The SAP can also respond to specific health
crises, such as an outbreak of a communicable disease.
The SAP is not intended to be a mechanism to promote or encourage the early use of
therapeutic products where the degree of risk and efficacy may not be known or to circumvent
the regular therapeutic product review process, but rather to provide compassionate access to
therapeutic products on a case-by-case basis.
SAP: Flucytosine (antifungal drugs) can be accessed by SAP.
Penicillin Benzathine available through SAP.

Common Drug Review (CDR)


The Common Drug Review (CDR) began in the fall of 2003. CDR involves a single process to
assess new drugs for potential coverage by participating federal, provincial and territorial drug
benefit plans. The Canadian Agency for Drugs and Technologies in Health CADTH develops
evidence-based clinical and pharmacoeconomic reviews to assess a drug's cost-effectiveness.
These reviews are used by the Canadian Expert Drug Advisory Committee (CEDAC), an
independent advisory body of professionals in drug therapy and evaluation, as the basis for its
recommendations on what drugs to include in the formularies of the participating drug plans.
Federal, provincial and territorial governments (with the exception of Quebec) examine the
CDR recommendations but retain the final say over which drugs to include in their respective
formularies.

Adverse Reaction Reporting (ADR reporting)


An Adverse Reaction Report contains information about the affected patient, the suspected
association between the therapeutic product and the adverse reaction, and the treatment and
final outcomes of the product use. The identities of both the patient and the person reporting are
kept confidential by HPFB.
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Report:
New side effect, not known before
Rare but serious side effect
Report to:
Health Canada
Manufacturer

Office of Controlled Substances


The Office of Controlled Substances (OCS) works to ensure that drugs and controlled
substances are not diverted for illegal use. This involves developing legislation, regulations,
policies and operations that support the control of illicit drugs and other substances.
Activities in this area include:
licencing manufacturers and distributors of drugs and controlled substances and issuing
import/export permits when necessary, to manage and track the movement of drugs and
controlled substances across the Canadian border;
authorizing the disposal of illegal drugs that have been discovered or seized;
licencing individuals and companies to undertake activities under the Industrial Hemp
Regulations;
managing an exemption process that allows individuals with legitimate scientific or
medical reasons to possess a controlled substance; and
working with other groups such as the law enforcement community to address compliance
issues.
Who regulates Canadian prescription medication?
When a product is offered for sale in Canada to treat or prevent diseases or symptoms, it is
regulated as a drug under the Food and Drugs Act. Health Canada's Therapeutic Products
Directorate (TPD) is responsible for evaluating and monitoring the safety, effectiveness and
quality of pharmaceutical drugs and other therapeutic products available to Canadians.
Health Canada's Therapeutic Products Directorate is the Canadian federal authority that
regulates pharmaceutical drugs and medical devices for human use. Prior to being given market
authorization, a manufacturer must present substantive scientific evidence of a product's safety,
efficacy and quality as required by the Canadian Food and Drugs Act and Regulations.
Canadian prescriptions
Canadian prescriptions are medications which have been approved by Health Canada (Canada's
equivalent regulatory body to the FDA) for use by the more than 32 million Canadian citizens.
All Canadian prescription medications have a DIN or Drug Identification Number which
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uniquely identifies a medication's strength and manufacturer. Prescription packaging and labels
are in both French and English, the two official languages of Canada.
Prescription drug prices in Canada
Prescription drug prices in Canada are set by the PMPRB (Patented Medicine Prices Review
Board) which was founded in 1987. Its mandate is to ensure that prices charged by
manufacturers of patented medicines in Canada are not excessive, report annually to the
Canadian Parliament on price trends of all medicines in Canada and to report on research &
development expenditures versus sales by patentees.
The PMPRB does the following:

Existing patented drugs prices cannot increase more than the Consumer Price Index
(CPI)
Protects consumers by ensuring that prices charged by manufacturers are not excessive
Only regulates patented-medications (A patent expires 20 years after filing in Canada)
Most new patented drug prices are limited so that the cost of therapy is in the range of
the cost of therapy for existing drugs
Breakthrough drug prices are limited to the median of the prices for the same drugs
charged in other industrialized countries (France, Germany, Italy, Sweden, Switzerland,
U.K. and the U.S.)
In addition, the Canadian prices of patented medicines can never be the highest in the
world

For these reasons patented Canadian prescriptions are less expensive in Canada than the United
States. The PMPRB does not regulate the prices of generic drugs. That is why generic
medications are less expensive in the United States than Canada.
OTC prices is set by pharmacist/pharmacy manager
Off-label use
Off label use involves using medications for indications not specifically approved by the FDA
or health Canada.
It is accepted principle that once the FDA approves a drug for marketing, a physicians
discretionary use of product is not restricted to the uses indicated on the FDA

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NAPRA

NAPRA
The Harmonized National
Drug Model
NAPRA= National Association of Pharmacy Regulatory Authorities
The National Association of Pharmacy Regulatory Authorities (NAPRA) is an association
comprised of mainly the provincial regulatory authorities (the registrars of each province that
has a college of pharmacy that licenses and regulates its member pharmacists).
Drug Scheduling in Canada:
Controlled by the National Association of Pharmacy Regulatory Authorities
National Drug Scheduling Advisory Committee (NDSAC) advisory committee that
makes recommendations to the provincial regulatory authorities established 1995.
Implementation is still not all over Canada, some have adopted the harmonized model, and
some have moves on adapting the said format.
Outline of the Schedules:
Schedule I drugs require a prescription for sale and are provided to the public by the
pharmacist following the diagnosis and professional intervention of a practitioner. The sale is
controlled in a regulated environment as defined by provincial pharmacy legislation.
Schedule II drugs while less strictly regulated, do require professional intervention from the
pharmacist at the point of sale and possibly referral to a practitioner. While a prescription is
not required, the drugs are available only from the pharmacist and must be retained within an
area of the pharmacy where there is no public access and NO opportunity for patient selfselection.
Schedule III drugs may present risks to certain populations in self-selection. Although
available without a prescription, these drugs are to be sold from self-selection area of the
pharmacy, which is operated under the direct control. Such an environment is accessible to the
patient and clearly identified as the professional services area of the pharmacy. The
pharmacist is available, accessible and approachable to assist the patient in making an
appropriate self-medication selection.

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NAPRA

Unscheduled drugs can be sold without professional supervision. Adequate information is


available for the patient to make a safe and effective choice and labelling is deemed sufficient
to ensure the appropriate use of the drug. These drugs are not included in Schedules I, II, III
may be sold from any retail outlet.
Outline of the Scheduling Process
Factors for Schedule I
1. Indications for use of the drug are identifiable only by the practitioner.
Diagnosis of the indication requires intervention by the practitioner before the drug is
used
2. Use of the drug requires adjunctive therapy or evaluation.
Adjunctive therapy could include other drugs, non-pharmacological measures or
specialized drug delivery devices.
Evaluation could include indicated laboratory or clinical assessments.
3. Use of the drug may produce dependency.
The drug may cause addiction or become habit forming.
Control of access and duration of therapy or clinical assessments
4. Serious adverse reactions to the drug are known to occur or have a recognized
potential to occur at normal therapeutic dosage levels
Adverse reactions to the drug are known to occur or have a recognized potential to
occur at normal therapeutic dosage levels
Adverse experiences require special monitoring or intervention by a health care
professional.
5. There exists a narrow margin of safety between the therapeutic and toxic dosages of the
drug, either in the general population, or in identified subpopulations, or in patients with
multiple medical problems.
Safe use requires the involvement and intervention of a health care professional
6.

Serious interactions of the drug are known to occur.


Such interactions (drug-drug, drug-food, drug-disease) require special monitoring or
intervention by a health care professional
7. Use of the drug has contributed to, or is likely to contribute to, the development of
resistant strains of micro organisms.
Appropriate use, and/or the decision to continue treatment, requires evaluation by the
practitioner
8. The mechanism of action of the drug is known but the consequences of widespread use
are not adequately established.
Unexpected effects of the drug must be evaluated and reported by a health care
professional.
9. The therapeutic effects of a newly released drug are based on new or unknown
mechanisms of action, but the consequences of a widespread use are not adequately
established.
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NAPRA

Close monitoring of the patient is required by a health care professional for


unanticipated effects.

Factors for Schedule II


1. The initial need for a drug is normally identified by the practitioner, in addition chronic,
recurrent, or subsequent therapy must be monitored by the pharmacist.
A prescription should not be required to obtain a drug if the patient can understand
directions for continued use through the intervention of the pharmacist. Therefore, the
patient should have access to the drug subsequent treatment and use following the first
diagnosis and prescription by the practitioner. This collaborative approach enhances
patient care.
2. The drug must be readily available under exceptional circumstances when a prescription
is not practical.
Such a drug might be required for a serious medical situation and the patient should
have access to it to prevent a possible health emergency. An example of such an
exceptional circumstance is available of Injectable epinephrine for anaphylactic
reactions.
3. The drug is intended for administration in a health care setting or under direction of a
health care professional, or is in an Injectable dosage form and is not otherwise included
in Schedule I
Examples include preoperative or diagnostic agents and products used for immunization
or desensitization.
4. Evidence of abuse of the drug has been reported, due to its inherent pharmacological
action, which has the potential for abuse.
Monitoring by a health care professional is necessary.
5. The selection of the drug may require intervention by the pharmacist to confirm that an
appropriate self-assessment has been made by the patient.
Dosage form. For example, may be an important consideration.
6. Use of the drug may delay recognition or mask the symptoms of serious disease
Intervention by the pharmacist is necessary to ensure appropriate referral to the
practitioner.
7. The drug may cause important adverse reactions, including allergies, or interacts with
other drugs, foods, or disease states that cannot be adequately addressed through
product labelling.
Intervention by the pharmacist is necessary to assess patient risk to prevent such
problems for an individual patient through interpretation and clarification of labelling.
8. Use of the drug requires reinforcement or an expansion of the directions for use,
through pharmacist- patient dialogue.
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NAPRA

Such reinforcement and expansion may include the explanation of the use of a drug
delivery system.
9. The drug is a new ingredient for self-medication and monitoring by the pharmacist is
necessary to facilitate observation and reporting of any unexpected event.
10. The maximum labelled dosage directions exceed the generally accepted or usual limit
for Schedule III status

Factors for Schedule III


1. The initial need for a drug is normally identified by the patient, physician, or
pharmacist, but chronic, recurrent, or subsequent therapy can be monitored by the
pharmacist.
2. The maximum recommended duration of use of the drug is limited and specified on the
product label.
The pharmacist is available to explain that the consequences of not following the period
of use may be serious and that persistence of symptoms may suggest an underlying
ailment.
3. The maximum recommendation duration of use of the drug is not specified on the label,
but continued use may delay recognition or mask the symptoms of serious disease.
The pharmacist is available to help in interpretation of symptoms, to assist in selection
of alternative therapy, or to provide appropriate referral.
4. The drug is used to treat a persistent, chronic or recurring condition and the availability
of the pharmacist to provide advice can promote appropriate use.
The pharmacist should be available to direct the patient to a practitioner for assessment
if the treatment period has been inappropriate or the therapy has been ineffective.
5. The drug is used for self-treatment of self-limiting ailments; however, where product
selection has been identified as likely to cause patient confusion and the availability of
the pharmacist to provide advice can promote appropriate use.
Many product selections may be confusing for the patient. Different forms of available
therapy or dosage forms further complicate these choices.
6. The drug has adverse effects, which includes allergies, or interacts with other drugs,
foods, or disease states that can be identified in product labelling, but appropriate
product selection and explanation of risk may require the advice of the pharmacist
If a person who is taking a traditional MAO inhibitor are aware that certain drugs
should be avoided but might require assistance in selecting a safe product to use.
7. The drug is a new ingredient for self-selected self-medication and the availability of the
pharmacist to provide advice can promote appropriate use.
The pharmacist is available to answer questions about this new ingredient.
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NAPRA

8. The drug has inherent pharmacological action, which has the potential for non-medical
use, which may result in adverse patient outcomes.
9. The maximum-labelled dosage direction exceeds the generally accepted or usual limits
for scheduled status.
Scheduling a drug under the harmonized system:
1. Review
NDSAC will review and make a recommended on the placement of a drug when:
There is a federal government proposal to deregulate a prescription status drug, and the
manufacturer submits a request to NDSAC for a particular non prescription schedule
recommendation
A new drug is approved for sale in Canada on a non prescription basis, and the drug
manufacturer submits a request to NDSAC for a particular non prescription schedule
recommendation; or
A request is made by a manufacturer, the public or other stakeholder to reassess or review
the recommended schedule status of drugs included in the three-schedule/four-category
model, as determined by the Committee or previously by the Canadian Drug Advisory
Committee
NDSAC has developed a series of factors for each schedule in the three-schedule/ four
category national model against which it will assess the drug. The factors are different for
each schedule and pertain to the different for each schedule and pertain to the differing
degrees of counseling/supervision that would be necessary to encourage the appropriate use
of the drug.
The review process embodies a cascading principle where the drug is first assessed using
the factors for schedule I (prescription).
Should sufficient factors pertain, the drug remains in this schedule. If not, the drug is
assessed against the factors for schedule II (non-prescription-behind the counter) and if
appropriate, subsequently assessed against the factors for schedule III (non-prescription-self
selection in a pharmacy). Should the drug not meet the factors for any schedule, it becomes
unscheduled (sold in any retail outlet).
2. Recommendation:
Once NDSAC identifies which set of factors the ingredient best applies to, it is able to
make a recommendation on scheduling placement to NAPRA and the provincial pharmacy
regulatory authorities. To date, most provinces have indicated their support for NDSAC and
implemented the recommendations.
3. Making a submission
Submission to NDSAC must be based on a special drug ingredient rather than a drug
product.
When a manufacturer submits a New Drug Submission (NDS) for non-prescription status
or applies to have a drug removed from schedule F, it should also make a submission to
NDSAC to have the scheduling status of the ingredient reviewed. This helps to ensure that
the drug is scheduled by the time it is ready to go to market
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NAPRA

Manufacturers wanting to make a submission should advise NAPRA as early as possible so


that a specific processing time table can be planned and Committee time appropriated. Ten
copies of the submission and supporting documentation must be submitted to NAPRA at
least 30 days before the committee hearing is scheduled, to give members time to review
the material and, if needed, to ask the manufacturer for clarification and additional
information.
NDSAC meets to review ingredients at least four times a year.
When a manufacturer submits a New Drug Submission (NDS) for non-prescription status
or applies to have a drug removed from schedule F, it should also make submission to
NDSAC to have the scheduling status of the ingredient reviewed. This helps to ensure that
the drug is scheduled by the time it is ready to go to market.
Manufacturers wanting to make a submission should advise NAPRA as early as possible so
that a specific processing time table can be planned and committee hearing is scheduled to
give members time to review the material and, if needed, to ask the manufacturer for
clarification or additional information.

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CDSA

Controlled Drugs and


Substances Act
The Controlled Drugs and Substances Act (CDSA), 1997, is an act sets standards for the
control of narcotics, controlled drugs and targeted substances. It is a federal act and the
strictest of all the acts that govern the pharmacy industry.
It repeals the Narcotic Control Act and Parts III and IV of the Food and Drug Act and
establishes eight Schedules of controlled substances and two Classes of precursors. It provides
that "The Governor in Council may, by order, amend any of Schedules I to VIII by adding to
them or deleting from them any item or portion of an item, where the Governor in Council
deems the amendment to be necessary in the public interest."
The Act serves as the implementing legislation for the Single Convention on Narcotic Drugs,
the Convention on Psychotropic Substances, and the United Nations Convention Against Illicit
Traffic in Narcotic Drugs and Psychotropic Substances.
CDSA regulates:
Narcotics, controlled drugs, targeted substances, pharmacies, wholesalers, practitioners, and
record keeping.
Lists the responsibilities of pharmacist:
Ordering
Dispensing
Record keeping for sale
Purchase of narcotics
Narcotic Control Act
Regulates narcotics drugs
Sales
Purchasing
Prescription requirement

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CDSA

Drugs regulated by the CDSA are grouped into 8 schedules.


Schedule I: Narcotics, opium poppy, coca, phenylpiperidine (pthedine)
Schedule II: Cannabis and cannabis preparations
Schedule III: Amphetamines, methylphenidate, LSD plus other listed psychoactive substances
Schedule IV: Barbiturates, specific anorexiants, benzodiazepines, and anabolic steroids
Schedule V: Phenylpropanolamine and others
Schedule VI: Ephedrine, ergotamine, pseudoephedrine and others
Schedule VII: Cannabis that serves enforcement purposes regarding possession and trafficking
Schedule VIII: Cannabis that serves enforcement purposes regarding possession and trafficking

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FDA

The Food and Drug Act (FDA)

This federal legislation controls the manufacture of all drugs in Canada. Also, the act controls
manufacturing conditions, packaging, advertising standards and the sale of foods, drugs,
cosmetics and therapeutic devices. As with all the laws in Canada, the law exists to protect the
consumer or the public.
Symbols
The symbols Pr, N, C/T and C are used only for drugs listed in Schedule F, N, or G
respectively.
N in a circle for narcotics,
C in a diamond for controlled drugs
Pr in a rectangle for Schedule F drugs.
C/T for benzodiazepines
Schedules of the FDA include
Schedule A
A list of disorders, diseases or abnormal physical states. No manufacturer can advertise a drug,
cosmetic, food or medical service to be sold as a preventive, treatment or cure for the
conditions listed.
Schedule B
A list of official books accepted as a set of standards for drug purity e.g., the British
Pharmacopoeia.
Schedule C
A list of radiopharmaceuticals and substances used in the preparation of radiopharmaceuticals.
Schedule D
A list of biological products such as hormones, allergenic extracts, immunizing
agents, sensitivity discs.
Schedule E
No drugs appear in Schedule E.

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FDA

Schedule F
Schedule F, FDA, remains in effect. The same drugs are listed in Schedule I,
NAPRA Harmonized Schedules.
Schedule F consists of two parts, Part I and Part II.
The drugs listed in Part II, Schedule F, may be sold for veterinary use, provided the product is
in a form not suitable for human use and labeled as such.
Schedule F Section 15
Only one drug is listed, thalidomide.
The FDA labeling requirements,
Those drugs that are in Schedule I NAPRA and are not FDA, require a prescription in each
province across Canada but the Pr symbol is not used, i.e., the symbol Pr does not appear
in the label of these products. Some examples of these are: quinine,
(Therapeutic) device is described as: any article, instrument, apparatus or contrivance,
including any component, part of an accessory manufactured, sold or represented for use:
In the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal
physical state or the symptoms treated in a man or animal;
Restoring, correcting or modifying a body function or the body structure of a man or
animal;
The diagnosis of pregnancy;
The care of humans or animals during the pregnancy and after birth of the offspring,
including care of the offspring and includes a contraceptive device, but does not include
a drug.
Drug: includes any substance or mixture of substances manufactured, sold or represented for
use in:
The diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal
physical state or the symptoms thereof;
Restoring, correcting or modifying organic functions in a man or animal;
Disinfection in premises in which food is manufactured, prepared or kept.
Food: is any article manufactured, sold or represented for use as a food, or drink for man,
chewing gum, and any ingredient that may be mixed with food for any purpose whatsoever.
Cosmetic: includes any substance or mixture of substances manufactured, sold or represented
for use in cleansing, improving or altering the complexion, skin, hair, or teeth and includes
deodorants and perfumes. The act distinguishes between a drug, cosmetic and a food.
Some definitions under The Food and Drugs Act include:
expiration date is the earlier of the date until which a drug maintains its
labeled potency, purity and physical characteristics, and the date after
which the manufacturer recommends that the drug not be used.
internal use is ingestion by mouth or application for systemic effect to any
part of the body in which the drug comes into contact with mucous
membranes.
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FDA

official drug is one for which a standard is provided in the regulations.


parenteral is the administration of a drug by means of a hypodermic
syringe needle or other instrument through or into the skin or mucous
membrane.
Retention of Prescription Records
The length of time prescription files must be retained is two years. This now means that for all
provincial and federal legislations, records must be kept for two years.
Safety Containers
Drugs are to be dispensed in safety vials. It is prudent that for a patient who asks for snap cap
vials, a special release form be signed and a record kept in file. An example of a form is
shown.
Prescription Transfers
A pharmacist may transfer a drug referred to in Schedule F to another pharmacy. For transfer,
the pharmacy transferring the prescription must document:
The date
The store name
The store address
The receiving pharmacists name
The transferred prescription is marked transferred copy and contains:
The name and address of the patient
The physicians name and address
The directions for use
The identity of the manufacturer of the drug dispensed
The prescription number
The date the prescription was issued by the prescriber
The original dispensing date
The date of the last refill
The number of authorized repeats remaining
Store name, address, telephone number
The transferring pharmacists name
Prescriptions for controlled drugs and narcotics cannot be transferred.
Repeat Prescriptions of Schedule F Drugs
A drug referred to in Schedule F may not be repeated unless authorization has been
obtained from the practitioner. The drug may not be refilled more than the number of times
indicated in the prescription.
When a prescription is repeated, the following information is placed in a patient record or at the
back of the original prescription:
The date
The quantity
The signature of the pharmacist who dispensed it
The initials, name, address and telephone number if authorized by a different physician
than the original prescriber.
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Narcotic Regulations

Narcotic Regulations
These drugs must have a N symbol in the upper left portion of the label. The list of narcotic
drugs also appears under Schedule N, The Food and Drugs Act (FDA).
Narcotics

Straight
Narcotics
1 or 1+1

Narcotic preparations
Or Verbal narcotics
1+2

OTC or exempted
Narcotics

Straight Narcotics
Requirements for prescribing, dispensing and record-keeping

Narcotic
drugs
Prescription
Refills or repeat
Part Fill
Transfers
Record Keeping
Sales Report
Loss & Thief
Reports

Written
Verbal
Written
Verbal
Written
Verbal

Narcotic Drugs
Preparations

Permitted

Permitted

Not Permitted

Permitted

Not Permitted

Not Permitted

Not Permitted

Not Permitted

Not Permitted

Permitted

Not Permitted

Not Permitted

Permitted

2 years
Required

Yes
Tylenol # 4
1 or 1+1

Permitted

2 years
Not Required

Yes
Tylenol # 2 and 3
1+2

Written Rx may be prescribed to be dispensed in divided portions (Part-fills), for part fills;
copies of Rx should be made in reference to the original Rx. Indicate on the original Rx:
the new Rx #, the date of the part-fill, the quantity dispensed and the pharmacist initials.
Except for dextropropoxyphene, propoxyphene.
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Narcotic Regulations

Within 10 days to the Office of Controlled Substances.

Straight
narcotics

Narcotic
prep

1 narcotic (e.g. cocaine, codeine, hydromorphine, morphine)


1 narcotic + 1 active non narcotic ingredient (e.g. Tylenol No. 4)
All narcotics for parenteral use (e.g. Fentanyl, pethidine), all
product containing diamorphine, hydrocodone, oxycodone,
methadone or pentazocine, dextropropoxyphene (e.g. Dravon-N,
642)
1 narcotic + 2 or more active non narcotic ( e.g. Fiorinal with
codeine, Robitussin AC, Tylenol No. 2, No. 3)

Narcotic Regulations
Reportable (Straight) Narcotics, Schedule I
A narcotic drug (a reportable narcotic, also called a straight narcotic), is one that contains at
least one drug listed in Schedule I, CDSA; one narcotic and only one other medical ingredient
not in Schedule I in a recognized therapeutic dose; a narcotic intended for parental use; any
compound containing heroin, methadone, hydrocodone, oxycodone and pentazocine.
Propoxyohene (Darvon N) is a narcotic that requires a written or faxed prescription but does
not required an entry into sales record.
Examples of reportable narcotics
Product containing one narcotic
Codeine phosphate, Morphine hydrochloride, Statex (morphine),
Contin, Alti-Morphine Sulphate SR, M-Eslon, hydromorphone,
Hydromorph Contin, Dilaudid, and KadianSR.

Demerol (meperidine), MS

One narcotic and one other medicinal ingredient (1+1)


Tylenol #4, Lomotil, Emtec-30 (acetaminophen + codeine 60 mg + Caffeine 15mg)
One intended for injection
Demerol in ampoules
Codeine phosphate in ampoules
Any product containing hydrocodone Hycodan, Hycomine, Tussionex, Novahistex
Any product containing oxydone Percocet, Endocet, Endodan, Oxycocet, Oxycodan,
OxyContin.
Any product containing pentazocine: Talwin
There are no examples of a commercially prepared drug product containing two narcotics.
Purchases: these drugs may be purchased by written or by electronic means.
A written order requires a signature of a pharmacist with signing authority.
For an electronic order, distributors require the identification number of the pharmacist
with signing authority be submitted.
A written order must be submitted to the distributor, signed by the pharmacist with
signing authority, within 5 working days.
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Narcotic Regulations

Purchase Record: a record of purchases is entered into the purchase records of the Narcotic
and Controlled Drug Register or other record system.
Prescription Requirement: maybe written, or faxed. The physicians signature should be
verified an all faxes should be verified.
Sales Record: an entry is required in the sales register of the Narcotic and Controlled Drug
Register or computer system (automatically reported).
Narcotic and Controlled Drug File: prescriptions for all categories of narcotics and
controlled drugs must be maintained on a separate file, exclusively for narcotics and controlled
drugs.
Repeats: not permitted a new prescription maybe authorized in writing or by fax.
Part-Fills: a physician prescribes narcotics to be dispensed in divided portions (part-fills)
subject to professional discretion. The total quantity must be indicated as well as the part-fill
quantity. The time interval does not have to be included.
Transfers: transfers of part-fills are not permitted.
Outdated Narcotics and Controlled Drugs
Unopened bottles
Unopened bottles of narcotics and controlled drugs may be returned to a distributor or
manufacturer depending on their return policy for credit after obtaining written or faxed
permission to do so.
For part bottles
For part bottles, permission to destroy must be obtained from Office of control substance.
A request including a list of expired drugs and quantities can be faxed and destroyed after
authorization has been given.
The destruction of these drugs must be witnessed by another health professional such as
another pharmacist, pharmacy intern or a field representative from college of pharmacies.
The inventory of destroyed or stapled? to the pharmacys Narcotic and Controlled Drug
Register.

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Narcotic Regulations

Narcotic Preparations Regulations


Verbal Prescription Narcotics, Schedule I CDSA
Examples: (1+2)
Tylenol #2 and #3
Atasol15 and 30mg
Robitussin AC
Dimetapp C
Co-Actifed Syrup
A verbal prescription narcotic (a verbal narcotic preparation) is defined as a medication that
contains, in addition to a narcotic, two or more medicinal ingredients other than a narcotic, in a
recognized therapeutic dose and which is not intended for parental use (i.e. for injection) and
does not contain: heroin, methadone, hydrocodone, oxycodone and pentazocine.
Purchase Record: a record of purchases is entered into the purchase records of the Narcotic
and controlled Drug Register or other record system.
Prescription requirements may be written, verbal or faxed. The physicians signature should be
verified. All faxes should be verified.
Sales Record: no entry is required.
Repeats: not permitted: a new prescription maybe authorized verbally, in writing or by fax.
Part-fills: a physician prescribes narcotics to be dispensed in divided portions (part-fills_
subject to professional discretion. The total quantity must be indicated, as well as the part-fill
quantity. The time interval does not have to be included.
Transfers: transfers of part-fills are not permitted.
OTC Narcotics, or Exempted Narcotics
OTC narcotics are a special category of narcotics that are listed in Schedule II under the
NAPRA Harmonized Schedules.
Examples of OTC narcotics:
Tylenol#1, 222s, AC&C 8mg, Acetaminophen compound with codeine 8 mg Robaxacet with
Codeine 8mg, and Mersyndol.
Codeine phosphate is the only narcotic used in exempted narcotic preparations and these
products contain not more than 8mg per solid oral dose or 20 mg per 30 mL oral liquid of
codeine phosphate. In addition, there must be two other medicinal ingredients in a recognized
therapeutic dose.
A caution label must be applied to the product. This preparation contains codeine and should
not be administered to children except on the advice of a physician.
Exempted narcotic preparations are sold only in pharmacies and may be sold without a
prescription. The preparations must be stored in the dispensary in a non-patient access area
(not involved in the sale and the sale of the product may be documented.
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Narcotic Regulations

Purchases: these drugs may be purchased by written, verbal or by electronic means. A


written order required a signature of a pharmacist with signing authority.
For verbal or an electronic order, distributors require the identification number of the
pharmacist with signing authority be submitted. For an electronic or verbal order, a written
order must be submitted to the distributor, signed by the pharmacist with signing authority,
within 5 working days.
Purchase Record: a record of purchases is entered into the purchase records of the Narcotic
and Controlled drug Register or the record system.
Sales Record: No prescription is required. No sales report require but sales may be
documented.
Narcotic Tips

Straight narcotic 1 or 1+1


Codeine 1 mg
Tylenol # 4
Narcotic prep = Verbal narcotics
OTC narcotics or exempted narcotic
8mg codeine + 2 non narcotics
19.8 mg/30 ml codeine + 2 non narcotics
Tylenol # 1
222
Robaxacet 8

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Benzodiazepines Regulations

Benzodiazepine and Other


Targeted Substances
Regulations
The Controlled Drugs and Substances Act has a regulation regarding Benzodiazepines and
Other Targeted Substances that came into effect in September 2000. This changes the status of
these drugs from Schedule I (NAPRA Schedule Model) to Class I Targeted Substances.
Benzodiazepine and other targeted substances category by themselves, subject to differing sales
and ordering requirements. The symbol for targeted substances is T/C in a rectangle.
Requirements for prescribing, dispensing and record-keeping

Benzodiazepines & Targeted


Substances
Prescription
Refills
Part Fill
Transfers
Record Keeping
Sales Report
Loss & Thief
Reports.

Written
Verbal
Written
Verbal
Written
Verbal

Permitted
Permitted
Permitted
Permitted
Permitted
Permitted
Permitted once only
2 years
Not required

Yes

Written Rx may be prescribed to be dispensed in divided portions (Part-fills), for part fills;
copies of Rx should be made in reference to the original Rx. Indicate on the original Rx: the
new Rx #, the date of the part-fill, the quantity dispensed and the pharmacist initials.
Within 10 days to the Office of Controlled Substances.
Transfer of Rx permitted except for Rx that has been already transferred.

Benzodiazepines, ethchlorvynol, and meprobamate.

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Benzodiazepines Regulations

Commonly used benzodiazepines are:


Alprazolam, Diazepam, Oxazepam, Lorazepam, Temazepam, Triazolam,
Nitrazepam.
Other targeted substances include: ethchlorovinyl, mizindol, pipradol and meprobamate.
Purchasing: These drugs may be purchased by written, verbal or electronic means. The written
order must be signed by a pharmacist with signing authority.
For purchases ordered by verbal or electronic means, the distributor requires the identification
number of a pharmacist with signing authority. For verbal and electronic orders, a written
order must be submitted to the distributor, signed by a pharmacist with signing authority within
5 working days.
Purchase Record: a record of all purchases is required, whether in the Narcotic and Controlled
Drug Register or other purchase record system.
Prescription Requirement: may be written, verbal or faxed.
Sales Record: The hard copy may be filed as a regular and not a narcotic prescription record.
There is no other record of sale required for these drugs.
Repeats: The prescription may permit refills. However, refills are valid only for one year from
the date the prescription was issued.
Transfers: A prescription with valid repeats may be transferred, but only once.
Returns: Returns of full, unopened containers are permitted to licensed dealers only upon
prior receipt of written authorization. Destruction of expired or unserviceable drugs is
permitted, however prior notification of Health Canada is NOT required as long as procedures
as stated in the regulations are followed.
Destruction of returned benzodiazepines:
List unusable benzodiazepines mailed or faxed to drug control unit.
You need not to wait for acknowledgment from the office of control substances
You may destroy the products once confirmation received for narcotics only.
The destruction must be witnessed by another health professional such as:
Pharmacist
Pharmacy intern
Field representative from college
The inventory of destroyed material is to be signed by both parties; it should then be placed
in the narcotic prescription file the date destroyed, or staples to the pharmacy narcotic and
control drug register for receipt (green pages).
Request for benzodiazepines and targeted substances, is not required but the quantities must
be recorded and the destruction witnessed as done with narcotics and controlled drugs.

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Controlled Drug Regulations

Controlled Drugs
These drugs must have a C symbol on the upper left portion of its label. The list of controlled
drugs appear in schedules listed under the CDSA, the FDA.
Requirements for prescribing, dispensing and record-keeping

Controlled Drugs
Part I
Part II
Written
Verbal
Written
Verbal
Written
Verbal

Prescription
Refills
Part Fill
Transfers
Record Keeping
Sales Report
Loss & Thief
Reports

Part III

Permitted

Permitted

Permitted

Permitted

Permitted

Permitted

Permitted

Permitted

Permitted

Not Permitted

Permitted

Permitted

Permitted

Permitted

Permitted

Permitted

Permitted

Permitted

Not Permitted

Not Permitted

Not Permitted

2 years

2 years

2 years

Not Required

Not required

Yes

Yes

Required

Yes

Written Rx may be prescribed to be dispensed in divided portions (Part-fills), for part fills;
copies of Rx should be made in reference to the original Rx. Indicate on the original Rx: the
new Rx #, the date of the part-fill, the quantity dispensed and the pharmacist initials.
Within 10 days to the Office of Controlled Substances.
Sales report required except for controlled drug preparations.
Part I

Part 2

Part 3

Amphetamines (Dexedrine), Methylphenidate (Ritalin), Concerta, Aderral,


Pentobarbital (Nembutal). 1 controlled drug + 1 or more active non controlled
drug.
Barbiturates, Butorphanol (Stadadol NS), Diethylpropion (Tenuate),
Nalbuphine (Nubain), and Phenteramine (Lonamin). (Bellegral).
1 controlled drug + 1 or more active noncontrolled drug (Fiorinal, Neo-Pause,
Tecnal)
Anabolic steroids (Methyltestosterone, nandrolone, and decanoate)

Reportable (Straight) Controlled Drugs, CDSA -Schedule III


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Controlled Drug Regulations

A reportable or straight controlled drug is one that contains a drug in Schedule III, Part I,
CDSA and Schedule G, FDA.
Examples include:
Part I: Dexedrine (dextroamphetamine), Methylphenidate (Ritalin)
Part II; Barbiturates: Seconal (secobarbital), Tuinal which contains amobarbital and
secobarbital.
Purchasing: these drugs may be purchased by written or electronic means. A pharmacist must
sign the written order with signing authority.
For purchases by electronic means, the distributor requires the identification of a pharmacist
with signing authority. For electronic orders, a written order must be submitted to the
distributor, signed by a pharmacist with signing authority within 5 working days.
Purchase Record: A record of all purchases is required in the Narcotic and Controlled Drug
Register or other purchase record system.
Prescription Requirement: maybe written, verbal or faxed.
The Physicians signature should be verified
Sales Record: A record of sale is required in the sales report section of the Narcotic and
Controlled Drug Register or in a computer from which a printout maybe readily obtained. All
commercial pharmacy computer systems automatically record sales of Schedule III, Part I
drugs when dispensed.
Narcotic and Controlled Drug File: The prescription must be maintained in a separate file,
exclusively for narcotic and controlled drugs.
Repeats: Repeats are legal when the repeats are authorized on a written prescription, and the
prescriber has his writing on the original prescription, indicating both the number of repeats
and the time interval or dates between each refill. Refills are not permitted if the original
prescription is verbal.
Transfers: transfers of authorized repeats are not permitted.
Controlled Drug Products, Schedule III
A controlled drug product is one that contains only one controlled drug listed in Schedule III,
Part I, and one more medicinal ingredient in a recognized therapeutic dose. There is currently
only one example of a controlled drug product: Cafergot PB suppositories.
Purchases: These drugs may be purchased by written, verbal or electronic means. The written
orders require the signature of a pharmacist with signing authority.
For purchases by verbal or electronic means, the distributor requires the identification number
of a pharmacist with signing authority.
For purchases by verbal or electronic means, the distributor requires the identification number
of a pharmacist with signing authority. For verbal or electronic orders, a written order must be
submitted to the distributor, signed by the pharmacist with signing authority, within 5 working
days.

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Controlled Drug Regulations

Purchase Record: a record of purchases is entered into the purchase records of the Narcotic
and Controlled Drug Register or other record system.
Prescription Requirement: may be written, verbal or faxed.
The physicians signature should be verified and all faxes
Sales Record: None required for a controlled drug prescription. The filed prescription is the
record of sale.

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Pharmacy ethics

Ethical Principles
This chapter summarizes the ethical principles in patient consultation such as beneficence,
Non-maleficence, autonomy, justice, veracity and fidelity. What situations these ethical
principles are followed and violated are presented as scenario.
Beneficence
Beneficence = to do good or doing good
The health professional should act in the best interest of patient.
Decisions made with perception are based on what patient needed.
In other words:
Acting in the patients best interest = The best interest of patient
Past models doctor made decision
Current thinking is to involve patient letting the patient determine what is in their best
interest.
Pharmacists demonstrate beneficence whenever they provide critically needed prescription
drugs to their patients in emergency situations without regard to possible legal
consequences.
Nonmaleficence
Nonmaleficence = do no harm or preventing harm.
Pharmacists who refuse to fill a prescription order because of their concern for patient
safety or well being observed the principle of non-maleficence.
Autonomy
Letting the patient have the final decision, even if it is not in their best interest i.e.
refusing treatment, surgery, etc.
In other words:
Patients right to self-determination: To choose what will be done to them.
Veracity

Act with honesty without deception

Honesty = The patient has the right to the truth of medical condition, course of the disease
and treatments.
Code of ethics states that:
A pharmacist, has the duty to tell the truth and to act with conviction of conscience
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Pharmacy ethics

Rapport is built on trust, which is based on honesty.


Fidelity
The right of patients to have practitioners provide services that are in the patients best
interest.
Infidelity from a prescriber could be:
Recommending vitamins that patients dont need
Failing to confront a doctor with an inappropriate prescription out of fear that the doctor
will direct his/her patients elsewhere
In other words: Fidelity is the right of a patient to have health professionals provide
services that promote patient interests rather than their own.
Justice

Equitable distribution of benefits and burdens. The distribution of service based on a firstcome first-serve basis.

First come first serve.


Paternalism
When one fails to respect anothers autonomy, and act with disregard to the individual
rights.
Substitute their own beliefs, opinions and judgment to that of another. Claim they acted in
the persons best interest.

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Fed. Legislation and Ethics

Social and behavioral


aspects of pharmacy
profession
Professionalism
Professionalism is described as the competence and skill expected and required of a
professional. Professions have a formal knowledge base that is continually upgraded and
practitioners usually require a long period of preparation and hands on training before
they become independent practitioners.
To become professional a candidate must meet certain educational standards, usually
these set by regulatory bodies.
Professions are committed to the public through their code of ethics. Healthcare
professions are constantly changed with latest developmental technologies, identification
of new diseases & treatments consequently there is emphasis on adopt to change and
meet the rising expectations.
Personal attributes of professionals
Practice ethics and high moral standards
Reflection and self awareness
Responsibility/accountability of actions
Cooperative attributes of professionals
Respect for patients
Working as team
Taking social responsibility.
A report on professionalism in medicine, the CMA (2001) states that, professionalism is:
A strong commitment to the well being of others
High moral standards
Mastery of body of knowledge and skills
A high degree of autonomy

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Fed. Legislation and Ethics

Professional boundaries
Professional boundaries are the defining lines that separate the professional relationship
from any other behavior. The professional relationship is a purposeful relationship in
which the clients healthcare needs are priority.
There are warning signs, that can prompt professional. It is health professional
responsibility identifies and deal with boundary of violations if they arise.
Some warning signs that professional boundaries are being crossed are:
Noticing sexual content in interactions with the client
Favouring one clients care at the expense of anothers.
Giving/receiving gifts or continued or continued contact after discharge.
Acting and or feeling possessive about the client.
Giving special attention /treatment to this client which differs from that given to other
clients.
Denying the fact that you have crossed the boundaries from professional relationship to
non professional relationship,
Reporting requirements
Reporting wrong behavior of healthcare professional protect public and reputation of
healthcare system. Each regulatory bodies have set different requirement for reporting by
the members of the profession.
Here are some situations you may be expected to report
Sexual abuse of patients
Misconduct, incapacity, incompetence
Unsafe practice
Scope of practice of some healthcare professions
Pharmacist
Physicians
Veterinarians
Dentists
Nurses
Dieticians
Pharmaceutical Care Delivery System
The major pharmaceutical care activities takes place in the following systems
A. Community pharmacy
B. Hospital pharmacy
C. Long term care facilities
D. Specialty hospital units
Community Pharmacies:
Community pharmacies are considered one of the important components of the
pharmaceutical care delivery system. However, health related services are primarily
limited to dispensing medications and patient counselling.
They can be subdivided into three categories:
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Fed. Legislation and Ethics

1. Chain-retail pharmacy services,


2. Individually owned pharmacy
3. Internet pharmacies (mail order pharmacies)
Retail pharmacy and individually owned pharmacies work in a similar fashion.
However, mail order pharmacy service is a little bit different in aspect of retail
pharmacy. The latter lacks face-to-face patient counselling and OTC services.
Informed consent
Requires honesty and autonomy to exist
Patients have the right to full information of all relevant facts and must give explicit
consent before treatment
Informed consent exists when:
All relevant information has been provided
The patient understands the information
Consent is freely given and there is no coercion
The patient is capable of understanding the information
Note: Often, practitioners rely only on the disclosure part of the list!
Confidentiality
From the patients perspective this is self-disclosure and they should be the ones
making this decision.
Patients are expected to divulge information to practitioners, the only choice is which
one
Trust in confidentiality becomes very important.
In other words:
The principle of confidentiality serves to assure the patient that information about
their health, medical condition, treatment will not be given to individuals without
their permission.
Confidentiality of Patient Information
The pharmacist preserves the confidentiality of information about individual patient
acquired in the course of his or her professional practice, and does not divulge this
information except where authorized by the patient or required by law.
Spouses
If someone is asking a copy of his or her spouses prescription information, get
permission from the patient whose information is being released.
Children
Children aged 13 and above are entitled to decide who will have access to their
information. This may not be true if the parents insurance is paying for the
prescription, but let the parent get that information from the insurer and not from you.
Estates
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Fed. Legislation and Ethics

The executor of the estate is entitled to request the prescription information of


someone who is deceased and he is also entitled to give permission for its release to
another party.
Third Parties
Third parties payers right to information regarding its subscribers are governed by the
agreement they have with their subscribers and the pharmacy.
Investigations
Police are entitled to information only if they have a search warrant.
Mailing of Prescription to Patients while in the U.S.
Narcotic and controlled drugs cannot be mailed to the U.S.
U.S. customs requires some documentation for all medications sent to Canadian
Citizens at U.S. address.
If a patient carries these types of medications into U.S., they are advised to obtain a
letter from their physician attesting to their treatment.
Can a Canadian pharmacy accept prescription from a U.S prescriber?
Can we transfer prescription to another province of Canada?
First prescription can be filled. For refill, prescription is from the same province.

Copyright 2000-2009 TIPS Inc. Unauthorized reproduction of this manual is prohibited. This
manual is being used during review sessions conducted by PharmacyPrep

36