Professional Documents
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com
Pharmacy Ethics
&
Regulations
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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
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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Report:
New side effect, not known before
Rare but serious side effect
Report to:
Health Canada
Manufacturer
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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
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NAPRA
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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
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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
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CDSA
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CDSA
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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
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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
Straight
narcotics
Narcotic
prep
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
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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
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Narcotic Regulations
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Benzodiazepines Regulations
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.
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Benzodiazepines Regulations
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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
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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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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
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
Equitable distribution of benefits and burdens. The distribution of service based on a firstcome first-serve basis.
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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 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:
Copyright 2000-2009 TIPS Inc. Unauthorized reproduction of this manual is prohibited. This
manual is being used during review sessions conducted by PharmacyPrep
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PharmacyPrep.Com
Copyright 2000-2009 TIPS Inc. Unauthorized reproduction of this manual is prohibited. This
manual is being used during review sessions conducted by PharmacyPrep
36