Professional Documents
Culture Documents
Pharmacy Ethics
&
Regulations
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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.
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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1
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.
Canada’s 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 Canada’s 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 Canada’s (and North America’s) 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.
1999-2000 – Partial (or full, depending upon whose version one accepts)
restoration of federal transfers to provinces.
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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.
The federal government oversees drug benefit programs for the following client groups:
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.
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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.
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Report:
New side effect, not known before
Rare but serious side effect
Report to:
Health Canada
Manufacturer
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.
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 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.
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.
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 physician’s
discretionary use of product is not restricted to the uses indicated on the FDA
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2
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 self-
selection.
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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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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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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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
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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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.
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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3
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.
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4
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
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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Schedule F
Schedule F, FDA, remains in effect. The same drugs are listed in Schedule I,
Schedule F Section 15
Only one drug is listed, thalidomide.
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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5
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
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
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.
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Purchase Record: a record of purchases is entered into the purchase records of the Narcotic
and Controlled Drug Register or other record system.
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.
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.
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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 physician’s 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.
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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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6
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.
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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Purchase Record: a record of all purchases is required, whether in the Narcotic and Controlled
Drug Register or other purchase record system.
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.
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7
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.
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 Amphetamines (Dexedrine), Methylphenidate (Ritalin), Concerta, Aderral,
Pentobarbital (Nembutal). 1 controlled drug + 1 or more active non controlled
drug.
Part 2 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)
Part 3 Anabolic steroids (Methyltestosterone, nandrolone, and decanoate)
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.
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.
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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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 physician’s 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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Pharmacyprep.com Pharmacy ethics
8
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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Fidelity
The right of patients to have practitioners provide services that are in the patient’s best
interest.
Infidelity from a prescriber could be:
Recommending vitamins that patients don’t 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 first-
come first-serve basis.
First come first serve.
Paternalism
When one fails to respect another’s 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 person’s best interest.
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9
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.
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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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 another’s.
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
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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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.
Spouses
If someone is asking a copy of his or her spouse’s 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 parent’s 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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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.
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