Expanded Scope Orientation Manual

Table of Contents
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
How to use this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Expectation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
PART 1: EXPANDED SCOPE ACTIVITIES . . . . . . . . . . . . . . . . . . . . .6

Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Initiating Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
The Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Renewing or Adapting a Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Executing a Prescription Renewal or Adaptation . . . . . . . . . . . . . . . . . . 8
The Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Performing a Procedure on Tissue below the Dermis . . . . . . . . . . . . . . . . . . . . . . . . . 11
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Performing the Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Administering Substances by Injection or Inhalation . . . . . . . . . . . . . . . . . . . . . . . . . 12
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
General Guidance for the Administration of Injections and Inhalations . . . . 12
- Administration of Injections for the Purpose of Demonstration . . . . . . 13
- Administration of Inhalations for the Purpose of Demonstration . . . . . 13
- Administration of the Influenza Vaccine . . . . . . . . . . . . . . . . . . . . 14
Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Infection Prevention and Control . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Documentation and Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Documentation: Sample template . . . . . . . . . . . . . . . . . . . . . . . . . 17
Documentation: Template notes . . . . . . . . . . . . . . . . . . . . . . . . . . 18
continued
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Table of Contents
PART 2: THE HEALTH CARE DELIVERY FRAMEWORK . . . . . . . . . . . . 19
Interprofessional and Collaborative Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Patient Privacy and Access to Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

The Health Information Custodian (HIC) . . . . . . . . . . . . . . . . . . . . . . 20
Circle of Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Relying on Assumed Implied Consent in the Context of
Releasing Personal Health Information . . . . . . . . . . . . . . . . . . . . . . 21
Resources for HICs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Consent to Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Principles of Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
PART 3: APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Appendix 1: Practice Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
1. Initiating a Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2. Renewing a Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3. Adapting a Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4. Performing a procedure on the tissue below the dermis for
education and chronic disease monitoring . . . . . . . . . . . . . . . . . . . 32
5. Administering a substance by injection or inhalation for
the purpose of patient education and demonstration . . . . . . . . . . . . . 33
Appendix 2: Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Appendix 3: Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Part A Pharmacist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Registered Pharmacy Student . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Intern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Pharmacy Technician . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Expanded Scope: By Membership Class . . . . . . . . . . . . . . . . . . . . . . 45
Appendix 4: Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Chronic and Long-Term Condition . . . . . . . . . . . . . . . . . . . . . . . . . 46
Health Information Custodian . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Medication Therapy Management (MTM) . . . . . . . . . . . . . . . . . . . . . 46
Patient Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Self-administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
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EXPANDED SCOPE OF PRACTICE - ORIENTATION MANUAL
Introduction
In 2009, the Ontario government passed Bill 179, the Regulated Health Professions Statute
Law Amendment Act, 2009. The purpose of the legislation is to ensure that Ontarians have
access to the right number and mix of qualified health care providers, now and in the future,
by expanding the scope of practice for a number of health professionals. The authorized acts
enabled for the practice of pharmacy in the updated Pharmacy Act are:
1. D
ispensing, selling or compounding a drug or supervising the part of
The expanded scope of pharmacy a pharmacy where drugs are kept.
2. Administering,
by injection or inhalation, a substance specified in the
practice supports the delivery of
regulations.
safe and effective patient care by 3. Prescribing
a drug specified in the regulations.
4. Prescribing
a drug, other than a drug mentioned in paragraph 3, in
permitting members to optimize accordance with the regulations.
patient outcomes. 5. Performing
a procedure on tissue below the dermis.
The expanded scope of pharmacy practice supports the delivery of safe and effective patient
care by permitting members to optimize patient outcomes. While prescribing is not a legally
defined term, in the context of the regulation, prescribing refers to initiating therapy,
and adapting or renewing prescriptions. Once the member has assessed the patient and
established the need for an action related to the expanded scope, communicating with the
patient is the key to engaging support and consent for the members actions. The member
concludes the activity by documenting his or her actions in the patient record, including the
rationale, and notifying the prescriber, as necessary.
Part 1 of this manual provides members with an overview that will support the exercise of
their expanded scope of pharmacy practice:
1. Initiating a Prescription;
2. Adapting or Renewing a Prescription;
3. Performing a Procedure on Tissue below the Dermis; and
4. Administering Injections or Inhalations.
This section also includes information related to documentation, including a template that
can be used for this purpose.
Part 2 of the manual presents a summary of the fundamentals that support the delivery
of patient care in Ontario, including an outline of interprofessional and collaborative care,
patient privacy, and access to personal health information, informed consent to treatment
and documentation and notification. These sections also contain references to allow the
practitioner to access more detailed information.
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Appendices:
Appendix 1 is comprised of practice examples that illustrate the application of the expanded
scope in the context of specific scenarios, and how a member might document the rationale
for clinical decision-making and create notes for monitoring and follow-up. Appendix 2 of
this manual contains the wording of the regulation and Appendix 3 summarizes the roles and
responsibilities of the different classes of members. Finally, Appendix 4 provides definitions
of some key terms.
As members move forward to maximize their full educational and professional competencies,
they will be challenged to change the way that they provide care and services to patients.
Fortunately, in Ontario the integration of regulated pharmacy technicians has preceded the
expanded scope of pharmacy practice, permitting workplaces to have the pharmacist focus
on the therapeutic aspects of care while the pharmacy technician takes on a greater role in
the technical aspects of dispensing.
How to use this Manual

The manual is organized by first outlining the minimum expectations of the College for
a member to initiate therapy, renew or adapt a prescription, perform a procedure on
tissue below the dermis, administer an injection or inhalation therapy or administer an
influenza vaccine as part of the Universal Influenza Immunization Program. In providing
care, members are also required to meet the standards of professional
practice and uphold the Code of Ethics of the profession. Additionally
The expectation of the College they have a fiduciary duty to act in the patients best interests and
practice within legal requirements, including all relevant federal and
is that prior to exercising the
provincial legislation.
expanded scope, members will
The summaries in Part 2 provide information related to collaborative
review and understand both the care, patient privacy, access to information, and consent to treatment.
regulation and the information This information is meant to supplement the practice of the expanded
scope and provides an overview of Ontarios health care delivery
contained in this manual. On framework.
renewal in March 2013, the
Members are encouraged to review the Colleges Documentation
College will ask all members to Guidelines for more information on documenting patient care and
declare that they have done so. the Record Retention, Disclosure, and Disposal Guideline for an
overview of the legal requirements associated with creating and
keeping patient records.
Expectation
The expectation of the College is that prior to exercising the expanded scope, members
will review and understand both the regulation and the information contained in this
manual. On member renewal in March 2013, the College will ask all members to declare
that they have done so.
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Part 1: Expanded Scope Activities
This information has been prepared to assist members in the implementation of their
expanded scope of practice.
Principles
The following principles underlie practice.
1. Members have an obligation to protect and promote the health and well-being of patients;
2. Members are accountable for practicing within their scope of practice, the terms,
conditions and limitations on their certificate of registration, if any, and in accordance with
their knowledge, skill, and judgment;
3. The services included within the expanded scope of pharmacy practice are part of ongoing
medical care and take place in the context of a collaborative relationship between the
pharmacist, the patient, and the patients primary health care provider;
4. Members initiate, adapt and renew prescriptions, administer substances by injection or
inhalation only for the benefit of the patient and based on the individual nature of the
patients need/history and professional judgment exercised accordingly;
5. When initiating, adapting and/or renewing prescriptions, the member assumes full
responsibility and liability for that prescription, documents actions as required, and
undertakes notifications as appropriate; and
6. Pharmacy services are provided within the context of the legislative requirements,
Standards of Practice, and Code of Ethics.
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Expanded Scope Activities
Initiating Therapy
Introduction
Prescriptions may be initiated for the purpose of smoking cessation in the following
circumstances:
1. The treatment is in the best interest of the patient;
2. The drug is specified in the regulations;
3. The member has the knowledge, skill, and judgment, with regard to the drug and the
condition for which the member is prescribing it, to prescribe a drug safely and effectively;
and
4. The member determines that the drug is safe and effective, considering
As specified in the regulation the known risks and benefits to the patient and other relevant factors
specific to the situation including:
pharmacists can initiate, for the
a. The patients symptoms;
purpose of smoking cessation, b. Co-existent disease states and chronic conditions;
c. T he patients allergies and other contraindications and precautions;
a prescription for either; d. O ther medications the patient may be taking;
Varenicline or Bupropion e. T he patients gender, age, and weight;
f. Pregnancy and lactation status, if applicable; and
g. A ny other inquiries reasonably necessary in the circumstances.
5. The member discusses the therapy, including risks and benefits, with the patient or his or
her authorized agent and consent is given for the treatment.
6. The patient or his or her authorized agent understands that the prescription can be taken
to another pharmacy for dispensing.
7. The member documents his or her rationale for initiating smoking cessation therapy in the
patient record.
8. The member notifies the patients primary health care provider within a reasonable time
when initiating smoking cessation therapy.
The Prescription
A member who prescribes a drug is required to prepare a prescription which includes the
following:
1. The name and address of the person for whom the drug is prescribed;
2. The name, strength (where applicable) and quantity of the prescribed drug;
3. The direction for the use of the drug, including its dose, frequency, route of
administration, and any special instructions;
4. The name, address, telephone number, College registration number and signature of the
member issuing the prescription;
5. The date the prescription was issued by the member; and
6. The number of refills that the member has authorized, if applicable.
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Renewing or Adapting a Prescription
Introduction
In 2011, changes to the regulations under the Drug and Pharmacies Regulation Act (DPRA)
provided pharmacists with the authority to refill prescriptions in specific circumstances.
Those provisions are revoked and replaced by the members independent authority to renew
prescriptions, as per this regulation.
Medication therapy management optimizes therapeutic outcomes for

In light of this new regulation, individual patients utilizing a members unique knowledge and experience.
Prescribing includes the ability of the member to renew or adapt a
pharmacists authority to refill
prescription based on the patients individual circumstances.
prescriptions under the Drug
and Pharmacies Regulations
Narcotics, controlled drugs and targeted substances
Act (DPRA) is revoked. Members do not have the authority to renew or adapt a narcotic, controlled
drug, or targeted substance, nor a drug designated as a monitored drug
under the Narcotic Safety and Awareness Act.
Considerations
A member will consider renewing or adapting a prescription only in the following

circumstances:
1. The member has determined the drug will be safe and effective, considering the relevant
circumstances of the patient, including, but not limited to the following:
a. The patients medical history, including co-morbid disease states and chronic
conditions;
b. Laboratory or other tests as available;
c. Symptoms reported by the patient;
d. The patients allergies and other contraindications and precautions;
e. Other medications the patient may be taking;
f. The patients gender, age, weight and height (where applicable);
g. Pregnancy and lactation status, if applicable;
h. Any other inquiries reasonably necessary in the circumstances including those with
respect to the use of cigarettes and alcohol.
2. The drug is prescribed in a circumstance which is within the members area of practice,
knowledge, and skills.
Executing a Prescription Renewal or Adaptation
1. A prescription may be renewed or adapted for the purpose of medication therapy

management where the member has:
a. Considered the potential risks and benefits to the patient of adapting or renewing the
prescription;
b. Determined that a prescription renewal or adaptation is in the best interest of the
patient; and
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c. The member is in possession of the existing order or prescription to be renewed or

adapted, or has access to the information contained in the original prescription (copy,
verbal confirmation from the pharmacy, or medical record).
Renewal
2. The member will renew the prescription based upon the circumstances of the particular
patient:
a. The medication to be continued is for a previously diagnosed chronic and long-term
condition; and
b. The patient has tolerated the medication without serious side effects.
3. The member shall not prescribe a quantity of the drug that exceeds the lesser of:
a. The quantity that was originally prescribed, including any refills that were authorized
by the original prescriber; or
b. A six months supply.
Adaptation
4. The member will adapt the prescription based upon the circumstances of the particular
patient by altering the dose, dosage form, regimen, or route of administration to
address the patients unique needs and circumstances. This does not include therapeutic
substitution.
Consent
5. When the member renews a prescription, he or she may rely on the consent that the
patient, or his or her authorized agent, has already given to the prescriber for their
treatment. However, if in the members professional judgment a proposed adaptation is
clinically significant, it is appropriate to seek an additional consent from the patient or
his or her agent. A good indication of whether to seek consent is whether the member
considers the change significant enough to inform the prescriber of the adaptation.
Choice
6. The patient or his or her authorized agent has the option of having the prescription
dispensed immediately or may choose to take it to another pharmacy.
Documentation
7. Prescription information is:

a. Recorded by the member at the time of prescribing, and
b. Documented in the patient record.
8. The prescription, or a copy thereof, should be kept together or linked to the original
prescription. The members documentation of his or her rationale for prescribing should
be linked to the renewed or adapted prescription and be easily retrievable.
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Notification
The purpose of notification is to ensure continuity of care:

9. In the case of a prescription renewal, the member notifies the original prescriber and, if
known to the member and different from the original prescriber, the patients primary
health care provider.
10. Where an adaptation is clinically significant, the member notifies the original prescriber
and, if known to the member and different from the original prescriber, the patients
primary health care provider.
Notification of a prescription renewal or adaptation should take place within a reasonable
period of time. The member does not have to ensure receipt of the notification.
The Prescription
A member who renews or adapts a previously issued prescription must ensure the following
information is recorded on the prescription:
1. The name and address of the person for whom the drug is prescribed;
2. The name, strength (where applicable) and quantity or amount of the prescribed drug;
3. The direction for the use of the drug, including its dose, frequency, route of
administration, and any special instructions respecting the use of the drug;
4. The name, address, telephone number and College registration number of the member;
5. The signature of the member;
6. The date the prescription was issued;
7. The number of refills that the member has authorized, if applicable; and
8. A reference to the original prescription that the member renewed or adapted, including
the name and contact details of the original prescriber.
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Performing a Procedure on Tissue below the Dermis
Introduction
Training, educating and counselling patients or informal care givers on chronic disease
management and the appropriate use of monitoring devices is a core competency of
pharmacy.
Considerations
The member will only consider performing the procedure if he or she has the knowledge,
skill, and judgment to do so safely and effectively with regard to the proper techniques
for performing the procedure. The member must have an understanding of the value and
limitations of self care devices and monitoring tools and be able to educate the patient on
how to self monitor and when to contact a health professional. A pharmacy technician is
authorized to perform this procedure under the direction of a Part A pharmacist who is
physically present on the premises.
Performing the Procedure
With the consent of the patient or his or her authorized agent, the member may pierce a
patients dermis to demonstrate the proper use of lancet-type devices for the patients self
care and education or for the patients self monitoring of his or her chronic disease.
The member will:
1. Make a determination that the procedure is appropriate for the patient having
considered the potential risks and benefits to the patient of performing the
A pharmacy technician procedure, and other relevant factors specific to the situation including the
safeguards and resources available in the circumstances to safely manage the
is authorized to perform
outcome of performing the procedure;
this procedure under 2. Explain the purpose of the demonstration to the patient or his or her
authorized agent;
the direction of a 3. Maintain an appropriate environment in which the procedure is to be
Part A pharmacist who administered. Such area shall be clean, safe, appropriately private, and
comfortable for the patient;
is physically present on 4. Adhere to the Standards of Practice;
the premises 5. Follow good infection control procedures to help prevent the spread of
infection; and
6. Document and maintain relevant records as appropriate.
Documentation
A member who performs a procedure on tissue below the dermis will make a record that
includes:
1. The name and address of the patient and the member performing the procedure;
2. The date the act was performed and results, if any; and
3. Confirmation of consent by the patient or his or her authorized agent.
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Administering Substances by Injection or Inhalation
Introduction
Training and educating patients or care givers to appropriately use medication is a

core competency of pharmacy. Once a patient receives a prescription for a self-
administered injection or inhalation of a substance specified in the regulation, the
patient or his or her authorized agent has the choice of having the injection/inhalation
both dispensed and administered by the member for the purpose of
Both students and interns, education and demonstration without having to wait for access to another
health professional.
under the direction of
a Part A pharmacist, A member is required to have completed training and to have valid certification in
CPR and First Aid prior to exercising his or her authority to administer injections.
are authorized to The member must also register the completion of injection training with the
administer injections College. A list of approved courses can be found on the College website along
with instructions on how to register.
or inhalations for the
purpose of education or In the case of the influenza vaccine, only a Part A pharmacist located in a
pharmacy approved to participate in the Universal Influenza Immunization
demonstration Program (UIIP) is permitted to administer an influenza injection.
Considerations
The member will assess the risk of administering the prescribed substance to the patient and
ensure that emergency protocols are in place, and that they are sufficient to address the
risks of administering the specific substance. The utilization of a drug administration check
list is recommended.
General Guidance for the Administration of Injections

and Inhalations
The member may administer injections and inhalations for the purpose of patient education
and demonstration, or for the purpose of administering the influenza vaccine in a UIIP-
approved pharmacy, in the following circumstances:
1. The member has been certified in first aid and cardio-pulmonary resuscitation as required
by the Standards of Practice;
2. The drug is specified in the regulations and is prescribed for self-administration;
3. The member has the knowledge, skill and judgment with regard to the drug and its
administration;
4. The member has explained the purpose of administering the substance to the patient or
his or her authorized agent;
5. The member has determined the drug will be safe to administer considering the
storage requirements of the drug, including protecting the cold chain, and the relevant
circumstances of the patient, including but not limited to:
a. The potential risks and benefits;
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b. The safeguards and resources available in the circumstances to safely manage the
outcome of administering the substance; and
c. Any factors specific to the situation.
6. The patient or his or her agent has consented to the administration of the substance;
7. The member confirms: the right patient; the right drug; the right dose; the right route; the
right reason, the right time, and the right documentation;
8. Other than when administering an influenza vaccine in a UIIP-approved pharmacy, the
member administers the substance only for the purpose of demonstrating how to do so to
the patient or their care giver;
9. The member administers the substance in an environment that is clean, safe, private, and
comfortable for the patient;
10. The member insures that there is an inventory of appropriate drugs and is prepared to
treat a possible emergency;
11. The member has appropriate infection control procedures in place, including when a drug
is administered in the patients home;
12. The member provides post-therapy observation for the suggested duration following
administration of the substance and ensures that the appropriate support is available to
the patient; and
13. The member communicates any clinically significant information to the original
prescriber or primary health care provider.
Administration of Injections for the Purpose of Demonstration
The member is required to have completed the required training and indicated
Substances for completion on the College register. It is important that before a member
administers an injection he or she assesses the patient to determine if there are
administration by injection
any changes in their health status that contraindicate the administration of the
are listed in Table 1 of the prescribed substance. A member will not administer an injection to a child under
5 years old.
regulation
The member will:
1. Develop and maintain a policy and procedure manual for provision of this service which
addresses appropriate aseptic techniques, documenting informed consent, handling
emergencies and disposing of sharps. Review annually and revise as needed; and
2. E
nsure the patient has the appropriate supplies for self administration and aseptic technique.
Administration of Inhalations for the Purpose of Demonstration
The member will:

Substances for inhalation 1. Develop and maintain a policy and procedure manual for provision of this
service including documenting informed consent and handling emergencies.
are listed in Table 2 of the
Review annually and revise as needed;
regulation 2. Demonstrate correct technique based on the type of inhaler required by the
patient;
3. Have the patient/care giver demonstrate his or her inhaler technique. Review the
technique until the patient/care giver is able to repeat the demonstration;
4. Provide patient information highlighting the steps needed for correct self-administration.
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Administration of the Influenza Vaccine
A Pharmacist may only administer the influenza vaccine within the context of the
Universal Influenza Immunization Program (UIIP). The UIIP is Ontarios program to
provide individual protection against influenza, reduce the number and
severity of influenza cases, and decrease the economic impact of influenza.
Information requests regarding Only those pharmacies that have been prequalified and inspected by the
local public health unit will receive publically-funded influenza vaccine.
the UIIP should be directed to
The Colleges Cold Chain Policy is a policy requirement of the College for
the Ministry of Health and Long the protection of all temperature-sensitive pharmaceutical and biologic
products that are at risk of damage if handled improperly and is aligned to
Term Care (MOHLTC) at the requirements of the UIIP.
UIIP.MOH@ontario.ca
Only Part A pharmacists are permitted to administer the influenza vaccine.
The pharmacist will administer the vaccine by injection to a patient who is five
years of age or older, if the pharmacist:
a. Administers the vaccine in accordance with the UIIP;
b. Receives an informed consent from the patient or his or her authorized agent; and
c. Adheres to all other requirements for administering substances by injection.
Documentation
The member must maintain a patient record that includes:

1. The informed consent of the patient or his or her authorized agent;
2. The name and address of the patient and the member;
3. The name of the substance and total dose administered;
4. The lot number and expiry date of the substance, where necessary;
5. The date of the administration;
6. The circumstances relating to the administration of the substance or influenza vaccine to
the patient and any adverse reaction experienced by the patient; and
7. Details of communication to the original prescriber or primary health care provider,
if any.
Environment
When the member administers a substance (or performs a procedure below the dermis)
he or she must do so in an environment that is clean, safe, private, and comfortable
for the patient. Every pharmacy in Ontario is required to have a dispensary which
has the capacity for cleaning the equipment involved in the preparation, dispensing,
distribution, and storage of drugs and a sink with a supply of hot and cold running water.
It is expected that suitable attire and protective coverings will be utilized as necessary.
A number of injectable and inhaled medications require refrigeration, so it is important
to ensure that the refrigerator is of sufficient size to store drugs and that is maintained
at the proper temperature, as suggested by the manufacturer and in alignment with the
Colleges Cold Chain Policy.
page 14
Point-of-use disposal receptacles and puncture resistant containers with clear labels, a
handle, and tight fitting lid to reduce risk of leakage are appropriate for the disposal of
sharps. It is recommended not to recap, bend, or manipulate needles when disposing of
used sharps.1
Infection Prevention and Control
The College has developed a resource for members, Infection Control for Regulated
Professionals: Pharmacists Edition, which describes the appropriate precautions that
should be taken in community settings. Infection control practices must meet professional
requirements including the application of evidence-based measures and professional
judgment. Where members are employees, the guideline specifies the requirement to
abide by the employers infection control program. Members must follow all government
recommendations on health alerts, surveillance, screening and reporting of respiratory and
influenza - like illness.
The Infection Control Guideline takes a routine precaution approach: routine precautions,
including hand washing, use of personal protective equipment, etc. should be undertaken at
all times, with all patients. It is recommended that members take steps to prevent spreading
infectious diseases, including that immunizations are up-to-date and that the member has an
annual influenza vaccination.
1. Canadian Committee on Antibiotic Resistance (2007) Infection Prevention and Control Best Practices for Long Term Care, Home
and Community Care including Health Care Offices and Ambulatory Clinics.
page 15
Documentation and Notification

The College has published a Documentation Guideline which establishes the expectations of
the College for the documentation of patient care.
Documentation
Depending on the practice setting as well as the circumstances which warrant an adaptation or
prescription renewal, members must use professional judgment in choosing a documentation
style and determining how much information to convey to an original prescriber. If possible,
members should collaborate with the prescribers with whom they frequently interact in order
to determine the best way to implement the expanded scopes of practice in a manner that will
ensure continuity of patient care.
The member is expected to be consistent when documenting his or her rationale for
prescribing, taking into account the assessment of the patient, including their best interests,
and the circumstances under which the drug is prescribed. Members may wish to note a
follow up or monitoring plan as well.
Notification
The notification provisions of the regulation specify that a member will notify a prescriber
within a reasonable time after initiating or renewing a prescription, and if he or she has
adapted a prescription in a manner that is clinically significant.
In scenarios which involve a simple adaptation such as a solid to a liquid formulation, the
member may consider that this adaptation is not clinically significant in the circumstances of
the patient and may choose not to notify the prescriber about the adaptation.
However, in situations where, in the view of the member, adapting the
The documentation/ prescription will likely have clinically significant outcomes, the member must
notify the prescriber.
notification template found
in this manual can be used In the event that the member decides to share additional information with the
prescriber, it is recommended to be as brief and concise as possible. When
as is, or adapted to suit the notifying the prescriber the member may wish to provide additional information
members needs (i.e. rationale and/or monitoring/follow-up plan) so that the patient record
is complete in both locations. Depending on the situation, the member may
choose to notify the prescriber utilizing the template in this manual.
page 16
page 17
Documentation: Template notes

The preceding template may serve as a sample and guide to the requirements needed for
documentation and/or notification purposes. It is a NOT a stand alone document and each
practice setting may interpret and develop their own method and criteria for documentation and
notification purposes for expanded scope of practice. The following information may appear in
the patient record and/or in the documentation notes to be linked with the patient record or
notification to the original prescriber:
Patient Information This section contains the patients full name and current address. Depending
on the computer software available at the pharmacy, this section may contain additional
information including phone number, email address, emergency contact, allergies etc.
Pharmacist Information This section will contain the name and the registration number of the
pharmacist issuing the prescription. This information along with other pertinent information such
as the address and telephone or fax number of the pharmacy, will need to be communicated and/
or forwarded to an original prescriber, should the pharmacist decide to notify them.
Prescription Information The purpose of this section is to provide an effective method that
displays and links the original prescription to an adapted/renewed prescription where relevant.
Depending on the documentation practices, patient record or electronic software available
at the pharmacy, the intent of this section is to allow for information to be easily retrievable
and accessed. Where applicable, reference to the prescription that the pharmacist adapted or
renewed, including the name and contact details of the original prescriber must be included. It
should be noted that prescription details (such as name, strength, quantity, duration) are needed
for both original and adapted prescriptions. It is up to the pharmacist to decide whether or not
they would like to attach a copy of the original prescription, for quick reference purposes as long
as the method allows for prescription information to be easily retrievable.
Rationale for Prescribing The intent of this section is to allow the pharmacist to document
their thought process when he or she chooses to prescribe. The pharmacist is expected to have
considered the best interests of the patient, conducted an assessment, considered any available
laboratory test information, potential drug therapy problems, and/or other considerations
that warrant a prescription to be adapted or renewed. The key is to be concise and brief in the
documentation, especially if the pharmacist chooses to share their rationale to the original
prescriber.
Monitoring/Follow-up Plan This section needs to be sufficiently detailed in order to monitor

the patients progress. The pharmacist may choose to share their monitor/follow-up plan with
another regulated health professional and/or original prescriber if they believe that it would
ensure continuity of care to their patient.
Notification Information when an adaptation is clinically significant and in the case of a

prescription renewal, it is a requirement to notify the original prescriber within an appropriate
timeframe. The name of the original prescriber, date, and method of notification and/or other
pertinent caregivers must be included within the documentation and/or patient record.
page 18
Part 2: The Health Care Delivery Framework
Interprofessional and Collaborative Care

The delivery of a new scope of practice is not a stand-alone or isolated opportunity.
While members of the pharmacy profession have always worked closely with other health
professionals in the delivery of patient care, the expanded scope of practice is based upon
both more coordination and more independence in practice.
Interprofessional care takes place within the context of a collaborative team-based approach
to providing care by multiple health professionals through the provision of comprehensive
services. The collaborative relationship is founded upon the expectations of each participant,
including patients, to support mutual therapy goals through sharing relevant health
information. Interprofessional care can provide numerous benefits including improved patient
care and safety, access, enhanced provider satisfaction and better organizational efficiency.
Interprofessional care can also contribute to system innovation and sustainability.2
Research has confirmed that incorporating pharmacists into the circle of care can help
optimize prescribing and use of medications, thus helping to reduce drug-related problems
and subsequent medication-related hospitalizations.3 Interprofessional care
The delivery of a new scope is particularly important for the effective treatment of patients with chronic
disease. The intervention of members in chronic disease management in
of practice is not a stand-
collaboration with other health professionals has also been found to improve
alone or isolated opportunity management of asthma, medication compliance in the elderly, and to reduce
the number of hospitalizations of those suffering from heart failure.4
Collaborative care may be instituted in the community or institution within the context of
established inter-professional relationships or through the shared management of a patient
with a chronic medical condition. Regardless of the determining factor, communication is
the key to efficient and effective collaborative care. Appropriate communication strategies
can improve patient safety and health outcomes as well as help to avoid the duplication
of services. Many members already have experience in the delivery of collaborative care
through the provision of methadone maintenance treatment and dispensing, and through
the provision of services funded through Ontario Public Drug Programs which support
collaboration between pharmacists and prescribers.5
2. HealthForceOntario Interprofessional Care: A Blueprint for Action for Ontario; p.15. July 2007.
3. The Translator Pharmacists help optimize prescribing in primacy care settings. Canadian Pharmacists Association, 2009
4. Ibid.
5. Ministry of Health and Long-Term Ontario Public Drug Programs
page 19
The Health Care Delivery Framework
Patient Privacy and Access to Information

As regulated health professionals, members of the College are required to meet the record
keeping standards in place for all health professionals. These rules require the pharmacy to
maintain patient records for 10 years from the last date that patient care was provided or
until 10 years after the day on which the patient reaches or would have reached the age
of 18 years, whichever is longer, and to ensure the confidentiality of patient information.
These obligations are not new with the expanded scope of practice; however, given that
members will be providing new services, it is important that they review the requirements
related to privacy and access, in order to ensure that they are fully informed of the rules.
The Colleges Record Retention, Disclosure, and Disposal Guideline provides guidance to
members in this area.
The following is a general overview of privacy and access rules and contains links to primary
sources for those who wish to know more.
The Health Information Custodian (HIC)
No person may examine a patient health record or access information from a record except
as required and permitted by law.6 A HIC is a person or organization that has custody or
control of personal health information, including doctors, hospitals, long-term care facilities,
health care clinics, laboratories, the Ministry of Health and Long-Term Care, and other
health-related organizations.7, 8 Pharmacies are HICs as defined by the Act.9 The owner of
the pharmacy is ultimately accountable for the personal health information collected and
retained within the pharmacy, including with respect to a remote dispensing location if any;
however, the Designated Manager must ensure that:
The pharmacy practice meets the requirements of legislation and regulation and that
patient health information is collected and stored appropriately;
The appropriate policies and procedures required to use, protect, store and dispose of
personal health information are in place;
Staff receive training on their duties with respect to personal health information;
The appropriate record retention schedules are in place; and
Back up and recovery systems are maintained according to legislated standards.
The Ministry of Health and Long-Term Care has several resources in place for those who
wish to know more about the role of the health information custodian.10
6. Information and Privacy Commission or Ontario A Guide to the Personal Health Information Act December 2004
7. Government of Ontario Personal Health Information Protection Act, 2004
8. Ontario Ministry of Health and Long-Term Care Health Information Protection Act, 2004
9. Ibid.
10. O ntario Ministry of Health and Long-Term Care Personal Health Information Protection Act, 2004: An Overview for Health
Information Custodians.
page 20
Circle of Care
The circle of care is a term commonly used to describe the health information custodians
ability to assume an individuals implied consent to collect, use or disclose personal health
information for the purpose of providing health care.11 Clinical information can only be
shared with other health providers currently involved in the patients care. When, in the
course of providing care, the member establishes a relationship with the patient or his or her
agent and other providers included in the circle of care the member may then assume they
have implied consent to collect, use, and/or disclose personal health information with the
other providers. The member is permitted to confer about test results and discuss symptoms
and treatment options with other members of the health care team without needing to seek
additional consent from the patient or substitute decision maker.
Relying on Assumed Implied Consent in the Context of

Releasing Personal Health Information
There are six criteria that must be met before a health information custodian can assume
implied consent to share personal health information:
1. The HIC must fall within a category of health information custodians that are entitled to
rely on assumed implied consent, for example, health care practitioners, long-term care
homes and community care access centres are all entitled to rely on assumed implied
consent.
2. The personal health information to be collected, used, or disclosed by the health
information custodian must have been received from the individual, his or her substitute
decision-maker, or another health information custodian.
3. The HIC must have received the personal health information that is being collected, used
or disclosed for the purpose of providing or assisting in the provision of health care to the
individual.
4. The purpose of the collection, use, or disclosure of personal health information by the HIC
must be for the provision of health care or assisting in the provision of health care to the
individual.
5. The disclosure of personal health information by the HIC must be to another health
information custodian.
6. The individual has not expressly withheld or withdrawn consent to the personal health
information being collected, used, or disclosed. In the event that an individual has blocked
access to their personal health information, it is up to the receiving HIC to seek consent to
access the information directly from the individual.12
More information on sharing information within the circle of care can be accessed at
http://www.ipc.on.ca/images/Resources/circle-care.pdf 13
11. Information and Privacy Commissioner Circle of Care: Sharing Personal Health Information for Health-Care Purposes.
12. Cavoukian, A (2005). Lock-box Fact Sheet. Fact Sheet #8, July 2005.
13. O
ffice of the Information and Privacy Commissioner Circle of Care: Sharing Personal Health Information for Health-Care
Purposes. September 2009.
page 21
Resources for HICs
The legislation regarding the collection, use, disclosure, retention, and disposal of personal
health information is complex. HICs are encouraged to review materials offered by the
Information and Privacy Commissioner, including A Guide to the Personal Health Information
Protection Act and the resources provided by the Ministry of Health and Long-Term Care.14, 15
The member may wish to create his or her own template to authorize the disclosure of a
patients personal health information to another person or utilize the sample form provided
by the Ministry of Health and Long-Term Care for use by a health information custodian.16
Individuals who wish to access their own personal health information may use the sample
form supplied by the Information and Privacy Commissioner.17
14. Information and Privacy Commissioner A Guide to the Personal Health Information Protection Act December 2004.
15. Ontario Ministry of Long-Term Care Health Information Protection Act, 2004
16. M
inistry of Health and Long-Term Care Consent to Disclose Personal Health Information Pursuant to the Personal Health
Information Protection Act, 2004 (PHIPA)
17. Information and Privacy Commissioner Request to Access Personal Health Information
page 22
Consent to Treatment
There are many terms relevant to pharmacy practice that are used when discussing the
concept of consent to treatment, including, for example, informed consent, implied consent
and included consent. A person is said to have given informed consent to treatment when
they have received enough information from a health practitioner to make a decision about
the treatment and have had an opportunity to ask questions and receive further information
as necessary. The health practitioner who proposes a treatment is, in fact, obligated to seek
the patients informed consent.
Principles of Informed Consent
1. The best interests of the patient are central to all member/patient interactions.
2. Respect for the autonomy and personal dignity of the patient is central to the provision
of ethically sound patient care. The individual has a fundamental right to decide which
medical interventions will be accepted and which will not.
3. In order to exercise his or her autonomy, the patient must be capable of
The health practitioner who making informed decisions about their health care.
4. The goals of the Health Care Consent Act, 1996 (HCCA) include promoting
proposes a treatment is, in
individual autonomy and decision-making capacity, and facilitating
fact, obligated to seek the communication between health care practitioners and their patients.
5. Members have the obligation to secure consent and patients have the legal
patients informed consent right to either consent to or refuse treatment. 18
Included consent
Unless it is unreasonable to do so, in most cases a member may rely on the notion of an
included consent to treatment when adapting or renewing a prescription.19 According to
the Health Care Consent Act, a health practitioner is entitled to presume that a consent to
treatment that has previously been given includes consent to variations or adjustments in
the treatment, as well as consent to the continuation of the same treatment in a different
setting. Where the member renews a prescription, the member is entitled to presume that
consent has already been given for the treatment, however patients should be informed of
therapy being provided. Where the member adapts a prescription, the member must rely
on his or her professional judgment to determine whether an adaptation of the patients
treatment is significantly different from the original treatment in its nature, expected
benefits, material risks, and material side effects. If there is a significant difference, the
member must seek a new consent from the patient or his or her agent.
Implied consent
Generally, consent to treatment is given directly by the patient or his or her agent, implied
consent on the other hand, occurs when surrounding circumstances are such that a
reasonable person believes that consent had been given, although no explicit words of
agreement have been uttered.20 Members may rely on implied consent for the purpose of
18. I College of Physicians and Surgeons of Ontario. Consent to Medical Treatment. January/February 2006. . .
19. Health Care Consent Act, 1996, 1996, S.O. 1996, Chapter 2, Schedule A; s.12
20. College of Physicians and Surgeons of Ontario Consent to Medical Treatment. January/February 2006; Endnote 11
page 23
health planning and management, risk assessment, education and reimbursement, and/
or verification of claims and when filling a prescription or fulfilling a prescription transfer.
For example, when a patient presents a prescription, requests a prescription transfer, or
asks for a prescription refill, the patient is providing implied consent for the members
subsequent technical and cognitive activities.
The expanded scope of pharmacy practice creates an obligation on members to receive a

patients consent in specific circumstances, including when initiating treatment, administering
a substance or when performing a procedure on tissue below the dermis. The member will
also need to determine whether consent is required in other circumstances, including when
proposing an adaptation to a current prescription if it is considered to be clinically significant.
There is no minimum age of consent in Ontario; consent is contingent on an individuals

capacity to understand why and for what the consent is being sought. Consent does not
necessarily need to be in writing, but should be noted on a patient record along with a brief
overview of the information that was provided to the patient concerning the risks, benefits,
and potential side effects of the proposed treatment. The practice examples included in
Appendix 1 will help to illustrate circumstances where consent is required and how it could
be documented.
Substitute decision making
The Health Care Consent Act, 1996 outlines the rules related to substitute decision-making
and sets out the following hierarchy of individuals/agencies who may give or refuse consent
on an incapable persons behalf:
1. Guardian
2. Attorney for personal care
3. Representative appointed by Consent and Capacity Board
4. Spouse or partner
5. Child or parent or individual/agency entitled to give or refuse consent instead of a parent
(this does not include a parent who has only a right of access)
6. Parent with right of access only
7. Brother or sister
8. Any other relative (related by blood, marriage or adoption)
9. Public Guardian and Trustee
The highest-ranking person on this list, if available, capable, and willing, is the substitute
decision maker for the incapable person.21 In the context of this manual, the substitute
decision maker is also referred to as the agent of the patient.
21. College of Physicians and Surgeons of Ontario Consent to Medical Treatment.
page 24
Part 3: Appendices
Appendix 1: Practice Examples
1. Initiating a Prescription
Example 1.0 Initiating a Prescription

Mr. GF is at the dispensary for cough drops for a cold and during the conversation with the pharmacist reveals that
he feels like his cough is so bad due to smoking. The pharmacist determines that he would like to quit smoking and
feels ready to do so, and is not currently using any smoking cessation therapy. The pharmacist offers support and to
prescribe therapy for smoking cessation. The pharmacist and Mr. GF discuss the various treatment options and decide
upon bupropion as the treatment of choice. Mr. GF states that he does not currently have a primary care physician and
regularly uses a walk-in clinic in the area.
The pharmacist prescribes bupropion
XXXXXXXX N/A
10/11/2012
N/A
Bupropion 150mg X 3d then
increase to 150mg bid (patient to set a
quit date during 2nd week of therapy)
Qty: 12 weeks Jane Doe, RPh
4 XXX-XXX-XXXX
- the patient is ready to initiate cessation therapy

- patient does not have any contraindication to therapy (i.e. history of seizure,
history of eating disorder etc.)
- counselled patient on directions for use and to contact pharmacist if

experiencing any side effects
- set-up dates for follow-up calls with patient at 1 week, 1 month
- informed patient to notify physicians of this therapy
N/A (no primary care provider)
page 25
Practice Examples
2. Renewing a Prescription
Example 2.0 Renewing a Prescription

Mrs. DL enters the pharmacy on a Friday night asking for the pharmacists help with a situation involving her atorvastatin
medication. On return from vacation Mrs. DL discovered that their regular physician is away for holidays for the next 3
weeks. She only has 1 week of medication left and will be leaving for a business trip on Sunday to Asia for the next 3
weeks. Mrs. DL requests that the pharmacist dispense her atorvastatin medication. On checking her health records the
pharmacist notes that she has been on atorvastatin 40 mg i tab daily for the past 2 years. Her last prescription was filled
at this pharmacy and the quantity indicated was for 90 days with 3 refills. Further questioning revealed that her last
check up was several months ago, and all lab results appeared normal.
The pharmacist renews the patients prescription X 90 days
XXXXXXXX 10/11/2012
10/22/2011
renewal of atorvastatin i tab daily
X 90 days
Atorvastatin 40mg i tab daily X 90 days
Refills X 3
Dr. X
4 XXX-XXX-XXXX
- patient leaving for trip for next 3 weeks needs extension

- stable dose and cholesterol levels X 2 years
- advised patient to set up appointment with physician
Dr. X
10/11/2012
XXX-XXX-XXXX
page 26
Practice Examples
3. Adapting a Prescription
Example 3.0 Incomplete Information

Ms. HF enters the pharmacy with a prescription for venlafaxine XR daily. No strength was indicated on the prescription.
The pharmacist checks the patient records and notes that she has been on venlafaxine 150 mg XR for the past 18
months. Upon questioning her, the pharmacist finds out that her physician has indicated for her to continue the
venlafaxine and there are no changes to her therapy.
The pharmacist adapts the prescription by adding the missing strength
page 27
Practice Examples
Example 3.1 Changing Formulation

The pharmacist receives a new prescription for amoxicillin 500 mg capsule tid x 5 days for Ms. MS, a 10 year old, 37.5
kg female patient. Upon discussion with the MSs mother, the pharmacist learns that the girl has acute otitis media, has
trouble swallowing pills and usually favours liquid formulations.
The pharmacist adapts the prescription to a liquid suspension
page 28
Practice Examples
Example 3.2 Changing Dosage and Regimen

It is a Saturday and the pharmacist receives a prescription from Mr. SC for Symbicort 200 g 1 inhalation bid which has
been the patients dose for the past 2 years. Mr. SC explains that his regular physician was away on vacation for the past
3 weeks, and that he went to a walk-in clinic 4 days ago for the Symbicort prescription. Mr. SC also indicated that for
the past 2 days, he has noticed an increased need for his salbutamol. The family physician will be returning on Monday
and he has already made an appointment to see her that day.
The pharmacist increases the Symbicort dose
10/11/2012
10/11/2012
increased dose of Symbicort to 200ug
2 inh bid X 2 days until sees physician
Symbicort 200 ug i inhalation bid X 1 for maintenance/reliever therapy
inhaler
Dr. X
4 XXX-XXX-XXXX
- chronic asthma, stable dose X 2 years

- symptoms of worsening asthma
- increased need for salbutamol for the past 2 days (< 8 puffs/day)
- patient will be seeing family physician in 2 days for regular visit

- counselled patient to visit walk-in clinic/ER if worsening signs of asthma
- will follow-up with patient on Monday
Dr. X and Dr. Y

10/11/2012
XXX-XXX-XXXX
page 29
Practice Examples
Example 3.3 Changing Dosage

Mrs. MM is a 70 y.o. woman who is a new patient in a long-term care home where the pharmacist regularly participates
as a member of the health care team. Her current medications include glyburide 2.5mg bid, metformin 500mg tid,
bisoprolol 5 mg daily, ramipril 5 mg daily, and rosuvastatin 10 mg daily. Her main medical conditions include
DM type 2 and hypertension. Her hypertension is currently well controlled. Mrs. MM started therapy with glyburide 3
weeks ago since her HbA1c had increased to 8.0% while on metformin monotherapy. Mrs. MM has had 2 episodes of
hypoglycemia during the past 2 weeks and has a fasting blood glucose (FBG) 4.0 mmol/L.
The pharmacist decreases the glyburide dose
XXXXXXXX 10/11/2012
09/19/2012
decreased glyburide dose to
2.5mg daily
Glyburide 2.5 mg bid standing order
Dr. X
4 XXX-XXX-XXXX
- patient experiencing signs and symptoms of hypoglycemia X2,

fasting blood glucose of 4.0
- in elderly patients the initial dose of a sulfonylurea should generally be
50% of usual initial dose
- counselled patient: on new dosage of glyburide and to contact pharmacist

or nurse if continued s/s of hypoglycemia
- monitor fasting and post-prandial blood glucose levels over the next 2 weeks
- follow-up HbA1c required in 3-4 months
Dr. X
10/11/2012
Note in Patient Chart
page 30
Practice Examples
Example 3.4 Changing Dosage and Regimen

Mrs. AF is a 85 y.o. woman who is in your office today for a medication review. Her current medications include
warfarin 3 mg daily, bisoprolol 5 mg daily, ramipril 5 mg daily, rosuvastatin 10 mg daily, omega 369 300 mg cap
daily, acetaminophen XS prn, and Sulfatrim DS 1 tab bid. Her main medical conditions include atrial fibrillation and
hypertension (both controlled with medications). Her warfarin dose has been stable for the most part x 2 years. She
has INR monitored q4 weeks in a lab. Mrs. AF has recently been dealing with recurrent UTIs and has been on and off
sulfatrim for over a month. She is on her last course now with 2 days left. She just had her INR measured and current
reading (yesterday) is 4.0. (Based on indication of atrial fibrillation, INR goal range = 2.0-3.0). The last prescription for
warfarin was filled at this pharmacy and was for a 6 month supply.
The pharmacist decreases the warfarin dose
XXXXXXXX 10/11/2012
09/01/2012
decrease in warfarin dose to 2.5mg
daily X 5 days
Warfarin 3 mg daily X 6 months
Dr. X
4 XXX-XXX-XXXX
- current INR of 4.0 (INR goal range = 2.0-3.0)

- Sulfatrim interacts with warfarin, finished in 2 days but takes 3-5 days
for INR to adjust
- counselled patient: on new dosage for warfarin and to contact pharmacist or

physician if patient continues to experience s/s of increased bleeding (i.e. bruising
or has nose bleeds, blood in stool etc.)
- repeat INR required in 5 days, then weekly until INR stabilized in goal range
Dr. X
10/11/2012
XXX-XXX-XXXX
page 31
Practice Examples
4. Performing a Procedure on the Tissue Below the Dermis for

Education and Chronic Disease Monitoring
Example 4.0
Mrs. MM is a 50 y.o. woman who is picking up a refill of her metformin and glyburide and asks if the pharmacist can
assist her in monitoring her diabetes as she isnt sure when and how often she should be testing. Her current medications
include glyburide 2.5 mg bid, metformin 500 mg tid, bisoprolol 5 mg daily, ramipril 5 mg daily, rosuvastatin 10 mg
daily, and acetaminophen XS prn. Her main medical conditions include DM type 2 and hypertension. The patient
was diagnosed with DM type 2 6 months ago. Her physician recently added glyburide (about 2 months ago) because
the blood work he did still showed her blood glucose levels were high but she doesnt remember further details. Her
hypertension is currently well controlled. She currently tests her blood glucose once a month and doesnt record her
readings. She tells the pharmacist she thinks her reading was around 9.0 or something like that but cant remember
if it was before or after eating. After further discussion about why the patient doesnt test more often the pharmacist
learns that she finds testing painful and is afraid to do it more often. The patient brought in their glucometer to show the
pharmacist which one she is using.
he pharmacist demonstrates how to correctly use the glucometer and lancet

T
and documents the following in the patients profile:
page 32
Practice Examples
5. A
dministering a Substance by Injection or Inhalation for the Purpose
of Patient Education and Demonstration
Example 5.0
Mrs. FS presents a prescription for Lantus 10 units qhs. The pharmacist learns that Mrs. FS has DM type 2, and that this
will be her first time using insulin. She has an appointment with a diabetes clinic in 2 weeks, but is very nervous about
injecting her insulin prior to this appointment. The pharmacist explains that he can administer the insulin for her at the
pharmacy to show her how to properly perform the injection. The pharmacist ensures there are no contraindications to
therapy with Lantus, and he brings Mrs. FS to a private counselling area to administer the injection.
he pharmacist performs the insulin injection for the purpose of patient education and
T
demonstration and documents the following:
page 33
Regulation
Appendix 2: Regulation
ONTARIO REGULATION 302/12
made under the
PHARMACY ACT, 1991
Made: August 30, 2012

Approved: September 26, 2012
Filed: October 1, 2012
Published on e-Laws: October 1, 2012
Printed in The Ontario Gazette: October 20, 2012
Amending O. Reg. 202/94
(GENERAL)
Note: Ontario Regulation 202/94 has previously been amended. For the legislative history of
the Regulation, see the Table of Consolidated Regulations Detailed Legislative History at
www.e-Laws.gov.on.ca.
1. Ontario Regulation 202/94 is amended by adding the following Part:
PART VII.3
CONTROLLED ACTS
Interpretation
31. In this Part,

adapt means to change a patients prescription respecting,
(a) the dose of the prescribed drug,
(b) the dosage form of the prescribed drug,
(c) the directions for use of the prescribed drug, or
(d) the route of administration for taking the prescribed drug, but does not include
therapeutic substitution;
Part A pharmacist means a member who holds a certificate of registration as a pharmacist

and who is listed in Part A of the register;
prescriber means a person who is authorized under the laws of a province or territory of
Canada to give a prescription within the scope of his or her practice of a health profession;
prescription means a direction from a prescriber directing the dispensing of a drug or

mixture of drugs for a specific patient;
renew means to provide a patient with a prescription that repeats a prescription previously
provided to that patient;
page 34
Regulation
therapeutic substitution means the substitution of a drug that contains chemically different
active ingredients that are considered to be therapeutically equivalent.
32. (1) Where the provisions of this Part are inconsistent with a law of Canada respecting
prescriptions, including those related to a targeted substance, the law of Canada shall prevail
and the provisions of this Part to the extent they are inconsistent with that law shall not
apply.
(2) Where the provisions of this Part are inconsistent with the provisions of the Narcotics
Safety and Awareness Act, 2010, the provisions of that Act shall prevail and the provisions of
this Part, to the extent they are inconsistent with that Act, shall not apply.
Controlled Acts
33. A member shall not perform a controlled act under paragraph 2, 3, 4 or 5 of

subsection 4 (1) of the Act except in accordance with this Part.
34. (1) For the purposes of paragraph 2 of subsection 4 (1) of the Act, a member referred
to in subsection (2) who meets all the requirements in subsection (3) is authorized to
perform the following acts:
1. Administering a substance specified in Table 1 to this Regulation by injection to a patient.
2. Administering a substance specified in Table 2 to this Regulation by inhalation to a patient.
(2) A Part A pharmacist, an intern or a registered pharmacy student is authorized to perform

an act provided for in subsection (1), subject to the terms, conditions and limitations imposed
on his or her certificate of registration.
(3) A member may only perform an act provided for in subsection (1) if he or she complies
with the following:
1. The member may only perform the act for the purpose of patient education and
demonstration, and before performing the act,
i. must explain that purpose to the patient or his or her authorized agent, and
ii. must receive an informed consent from the patient or his or her authorized agent.
2. The member shall ensure that he or she only performs the act in an environment that is
clean, safe, private and comfortable for the patient.
3. The member shall ensure that appropriate infection control procedures are in place.
4. The member must possess sufficient knowledge, skill and judgment respecting the
substance to be administered, and sufficient understanding of the condition of the patient,
to be able to administer the substance safely.
5. The member must consider whether administering a substance by injection or inhalation
to the patient is appropriate, given the known risks and benefits to the patient and the
safeguards and resources available to safely manage the outcome after administration and
any other relevant circumstances.
6. The member must maintain a patient record that includes,
i. the name and address of the patient,
ii. the name and address of the member,
iii. the date the act was performed,
page 35
Regulation
iv. the name, strength (where applicable) and quantity of the substance that the member
administered to the patient,
v. the circumstances relating to the administration of the substance to the patient and any
adverse reaction experienced by the patient, and
vi.confirmation that an informed consent was given by the patient or his or her
authorized agent.
(4) For the purposes of paragraph 2 of subsection 4 (1) of the Act, a Part A pharmacist is
authorized to administer influenza vaccine by injection to a patient who is five years of age or
older, if the Part A pharmacist,
(a) administers the vaccine in accordance with Ontarios Universal Influenza Immunization
Program as described on the Ministrys website;
(b) receives an informed consent from the patient or his or her authorized agent; and
(c) meets all the requirements in paragraphs 2 to 6 of subsection (3).
to in subsection (3) who complies with the other requirements of this section is authorized
to prescribe the following specified drugs:
1. Varenicline Tartrate.
2. Bupropion Hydrochloride.
(2) A drug mentioned in subsection (1) may only be prescribed by a member for the sole
purpose of smoking cessation.

the act provided for in subsection (1), subject to the terms, conditions and limitations
imposed on his or her certificate of registration.
(4) A member may only prescribe a drug under this section if he or she,
(a) possesses sufficient knowledge, skill and judgment respecting the drug and the
patients condition to prescribe the drug for the patient;
(b) has considered whether prescribing the drug for the patient is appropriate, given the
known risks and benefits of prescribing the drug for the patient and other relevant
factors respecting the patient;
(c) gives the prescription to the patient or his or her authorized agent;
(d) advises the patient or his or her authorized agent, at the time of giving the
prescription, that he or she may elect to take it to a pharmacy of his or her choosing
for dispensing;
(e) notifies the patients primary care provider (if any) within a reasonable time, that
the member prescribed a drug for the patient and provides details respecting the
prescription; and
(f) complies with the additional requirements under sections 37 and 38.
to in subsection (3) who complies with the other provisions of this section is authorized to
perform the following acts:
1. Adapting a patients prescription.
2. Renewing a patients prescription for the purpose of continuity of care.
page 36
Regulation
(2) Subsection (1) does not authorize a member referred to in subsection (3) to adapt or
renew a prescription for a controlled substance as defined in the Controlled Drugs and
Substances Act (Canada) or a drug designated as a monitored drug by the regulations under
the Narcotics Safety and Awareness Act, 2010.

an act provided for in subsection (1), subject to the terms, conditions and limitations imposed
on his or her certificate of registration.
(4) A member may only perform an act provided for in subsection (1) if he or she complies
with the following:
1. The member must either possess the patients prescription to be adapted or renewed or,
i. receive a copy of the prescription directly from the pharmacy where the prescription was
dispensed to the patient,
ii. be satisfied based on verbal confirmation from a pharmacist at the pharmacy where
the prescription was dispensed to the patient as to the existence and details of the
prescription, or
iii. have access to the medical record that contains information about the prescription.
2. If the member is renewing a prescription, he or she must not prescribe a quantity of the
drug that exceeds the lesser of,
i. the quantity that was originally prescribed, including any refills that were authorized by
the prescriber, and
ii. a six months supply.
3. The member must, within a reasonable time, notify the prescriber identified on the
prescription adapted or renewed by the member, as well as the patients primary care
provider if the member knows that the patient has such a care provider other than the
prescriber, providing details about the patients prescription, when the member,
i. renews a patients prescription, or
ii. adapts a patients prescription, if, in the members opinion,
A. adapting the prescription is clinically significant in relation to the patient, or
B. the notification is necessary to support the patients care.
4. At the time that the member adapts or renews the patients prescription, the member
must advise the patient or his or her authorized agent,
i. that he or she is entitled to the prescription, and
ii. that he or she may take the prescription to a pharmacy of his or her choosing for
dispensing.
5. The member must comply with the additional requirements under sections 37 and 38.
37. A member who performs an act provided for in section 35 or 36 must ensure that the
following information is recorded on the prescription:
1. The name and address of the patient for whom the drug is prescribed.
2. The name, strength (where applicable) and quantity of the prescribed drug.
3. Directions for the use of the drug, including its dose, frequency, route of administration
and any special instructions.
4. The name, address, telephone number and College registration number of the member
issuing the prescription.
5. The date the prescription was issued by the member.
page 37
Regulation
6. If applicable, reference to the prescription that the member adapted or renewed, including
the name and contact details of the original prescriber.
7. The number of refills that the member authorized, if applicable.
8. Any other information required by law.
38. A member who performs an act under section 35 or 36 must maintain a patient record
that includes details of the members rationale for his or her decision to act under section 35
or 36 and the following information, if applicable:
1. Reference to, or a copy of, the patients prescription that the member renewed or adapted,
including the name and contact information of the prescriber.
2. A copy of the prescription that the member gave to the patient or his or her authorized
agent under clause 35 (4) (c) or that the member gave to the patient or his or her
authorized agent to take to a pharmacy of their choosing under paragraph 4 of subsection
36 (4).
3. A record of the results of laboratory or other tests that the member considered in making
the decision to act under section 35 or 36.
4. The date on which the member notified the following persons, as applicable, and the
method by which the notification occurred:
i. The patients primary care provider notified under clause 35 (4) (e) or paragraph 3 of
subsection 36 (4).
ii. The patients prescriber notified under paragraph 3 of subsection 36 (4).
to in subsection (2) who meets all the requirements in subsection (4) is authorized to
perform the act of piercing a patients dermis with a lancet-type device to obtain blood.
(2) A member who is a Part A pharmacist, an intern, a registered pharmacy student or a

pharmacy technician is authorized to perform the act provided for in subsection (1), subject
to the terms, conditions and limitations imposed on his or her certificate of registration.
(3) A pharmacy technician shall not perform the act provided for in subsection (1) unless,
(a) a Part A pharmacist is physically present on the premises at the time when the
pharmacy technician performs the act; and
(b) the pharmacy technician is under the direction of a Part A pharmacist at the time
when the pharmacy technician performs the act.
(4) A member may only perform the act provided for in subsection (1) if he or she complies
with the following:
1. The member may only perform the act for the purpose of demonstrating the appropriate
use of lancet-type devices for the patients self care and education or for the patients self
monitoring of his or her chronic disease, and before performing the act,
i. shall explain that purpose to the patient or his or her authorized agent, and
ii. shall receive an informed consent from the patient or his or her authorized agent.
2. The member shall ensure that he or she only performs the act in an environment that is
clean, safe, private and comfortable for the patient.
3. The member shall ensure that appropriate infection control procedures are in place.
4. The member must possess the knowledge, skill and judgment respecting the performance
of the act and understand the condition of the patient, to perform it safely and effectively.
page 38
Regulation
5. The member must consider whether performing the act on the patient is appropriate,
given the known risks and benefits to the patient and the safeguards and resources
available to safely manage the outcome and any other relevant circumstances.
6. The member must maintain a patient record that includes,
i. the name and address of the patient and the member,
ii. the date the act was performed, and
iii. confirmation that an informed consent was given by the patient or his or her authorized
agent.
2. The Regulation is amended by adding the following Tables:
page 39
Regulation
page 40
Regulation
page 41
Regulation
page 42
Regulation
page 43
Roles and Responsibilities
Appendix 3: Roles and Responsibilities

The Pharmacy Act defines the scope of pharmacy practice for the profession as a whole;
however, an individual members scope of practice is enabled according to the terms,
conditions, and limitations on his or her certificate of registration.
Part A Pharmacist
A Part A pharmacist is permitted to independently practice the full expanded scope without
additional training, with the exception of the administration of injections. The pharmacist
is required to complete an injection training program approved by the College, including
valid certification in CPR and First Aid (equivalent of the Red Cross Standard First Aid with
CPR C plus AED Course level). The administration of the influenza vaccine is limited to
pharmacies approved by public health in the context of the Universal Influenza Immunization
Program (UIIP).
Only pharmacists who have completed and registered approved injection training will be
permitted to supervise students and interns in the administration of injections for the
purpose of patient education and demonstration.
Registered Pharmacy Student
A registered pharmacy student is engaged in attaining education and training in an approved

program.
Role and Responsibilities
In order for a registered pharmacy student to engage in the practice of pharmacy

they must:
Remain active in the program
Be under direct supervision* of a pharmacist (or other regulated health professional if
approved by the education program)
Only perform the controlled acts under the direct supervision of a pharmacist.
A registered student cannot supervise a pharmacy or delegate or accept delegation of a
controlled act.
Intern
An intern is a graduate of an approved program.
An intern:
Shall only engage in practice when under direct supervision* of a pharmacist in an
accredited pharmacy or under supervision of a pharmacist in all other cases;
Shall not supervise a pharmacy;
Shall not delegate a controlled act.
page 44
Roles and Responsibilities
Pharmacy Technician
A pharmacy technician has successfully completed education and training either through a
bridging process or an accredited program.
As regulated health professionals, pharmacy technicians work collaboratively with

pharmacists, and under their direction or supervision. The pharmacy technician undertakes
specific technical duties to enhance the service provided to patients including alerting the
pharmacist to discrepancies in the accuracy of prescriptions and performing a final technical
check for product release. They cannot supervise a pharmacy or delegate a controlled act.
Under this new regulation, a pharmacy technician can perform a procedure on tissue below
the dermis under the supervision of a Part A pharmacist who is physically present on the
premises at the time the technician performs the act.
Expanded Scope: By Membership Class
Members will have different roles and responsibilities in implementing the expanded scope
of practice according to their status. For example, only a Part A pharmacist is permitted
to administer an influenza vaccine in a pharmacy approved to administer the vaccine in
accordance with Ontarios Universal Influenza Immunization Program.
The table below provides additional clarity on the ability of a member to perform the
controlled acts associated with the new scope of practice.
page 45
Definitions
Appendix 4: Definitions
Chronic and Long-Term Condition: A chronic and long-term condition requires ongoing
management through medication and/or therapy. While there is no definitive list of long
term conditions, conditions such as diabetes, asthma, coronary heart disease, chronic
obstructive pulmonary disease, and mental health issues are all regarded as long term
conditions.
Health Information Custodian: A health information custodian (HIC) is a person

or organization that has custody or control of personal health information. A health
information custodian includes doctors, other health care practitioners, hospitals, and long-
term care facilities. It also includes health care clinics, laboratories, pharmacies, the Ministry
of Health and Long-Term Care, and other health-related organizations.
Medication Therapy Management (MTM): The term used to describe a group of services
that, when taken together, optimizes therapeutic outcomes for individual patients utilizing a
members unique knowledge and experience. MTM services may include, but are not limited
to, the following:
1. Performing or obtaining a patient assessment including a comprehensive medical history
and medication review;
2. Identifying, resolving, or managing actual and potential drug therapy problems in
collaboration with the patient and other health care professionals;
3. Formulating a medication treatment plan;
4. Selecting, initiating, and adapting prescriptions; and, administering injections and
inhalations;
5. Monitoring and evaluating the patients response to therapy, including safety and
effectiveness;
6. Providing follow-up, including referring to another health professional as required;
7. Documenting the care delivered and communicating with the patients primary health
care providers;
8. Providing education and training to the patient to enhance patient understanding and
appropriate use of medication;
9. Providing information, support services and resources designed to enhance patient
adherence with therapeutic regimens; and
10. Coordinating and integrating MTM services within the broader health care management
services being provided to the patient.
Patient Record: A patient record is a complete reference of all documentation related to

the care of a patient including the patient profile. The record includes the patient profile,
scanned copy of the original prescription, prescription information, dispensing record of all
prescriptions (new and refill) with pharmacist/technician signature and any documentation
or information about the patient, including notes related to the members critical thinking,
judgment, recommendations and interventions, as well as discussions between members,
other health care providers, and patients, consent forms, and any other records or
documents essential for continuity of care.
page 46
Definitions
Record Keeping: All records and documents produced by members in the context of
patient care and through the operation of an accredited pharmacy must be kept according
to the Standards of Practice and as required by legislation and regulation, both provincial
and federal The Documentation and Record Retention, Disclosure, and Disposal Guidelines
provide direction for members in this area.
Self-administration: The process of a person administering a substance to his or her self.

In the context of this manual, self-administration includes circumstances where a parent or
caregiver administers a substance to another person.
page 47

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Table of Contents

PART 1: EXPANDED SCOPE ACTIVITIES . . . . . . . . . . . . . . . . . . . . .6

Patient Privacy and Access to Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Appendix 3: Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

How to use this Manual

Part 1: Expanded Scope Activities

Expanded Scope Activities

Expanded Scope Activities

Renewing or Adapting a Prescription

Medication therapy management optimizes therapeutic outcomes for

A member will consider renewing or adapting a prescription only in the following

Executing a Prescription Renewal or Adaptation

1. A prescription may be renewed or adapted for the purpose of medication therapy

Expanded Scope Activities

c. The member is in possession of the existing order or prescription to be renewed or

7. Prescription information is:

Expanded Scope Activities

The purpose of notification is to ensure continuity of care:

Expanded Scope Activities

Performing a Procedure on Tissue below the Dermis

Performing the Procedure

Expanded Scope Activities

Administering Substances by Injection or Inhalation

Training and educating patients or care givers to appropriately use medication is a

General Guidance for the Administration of Injections

Expanded Scope Activities

Administration of Injections for the Purpose of Demonstration

Administration of Inhalations for the Purpose of Demonstration

The member will:

Expanded Scope Activities

Administration of the Influenza Vaccine

The member must maintain a patient record that includes:

Expanded Scope Activities

Infection Prevention and Control

Expanded Scope Activities

Documentation and Notification

Expanded Scope Activities

Expanded Scope Activities

Documentation: Template notes

Monitoring/Follow-up Plan This section needs to be sufficiently detailed in order to monitor

Notification Information when an adaptation is clinically significant and in the case of a

Part 2: The Health Care Delivery Framework

Interprofessional and Collaborative Care

The Health Care Delivery Framework

Patient Privacy and Access to Information

The Health Information Custodian (HIC)

The Health Care Delivery Framework

Relying on Assumed Implied Consent in the Context of

The Health Care Delivery Framework

Resources for HICs

The Health Care Delivery Framework

Principles of Informed Consent

The Health Care Delivery Framework

The expanded scope of pharmacy practice creates an obligation on members to receive a

There is no minimum age of consent in Ontario; consent is contingent on an individuals

Substitute decision making

21. College of Physicians and Surgeons of Ontario Consent to Medical Treatment.

Example 1.0 Initiating a Prescription

The pharmacist prescribes bupropion

- the patient is ready to initiate cessation therapy

- counselled patient on directions for use and to contact pharmacist if

N/A (no primary care provider)

Example 2.0 Renewing a Prescription

The pharmacist renews the patients prescription X 90 days

1. A prescription may be renewed or adapted for the purpose of medication therapy

c. The member is in possession of the existing order or prescription to be renewed or

4. Performing a Procedure on the Tissue Below the Dermis for

he pharmacist demonstrates how to correctly use the glucometer and lancet

(3) A Part A pharmacist, an intern or a registered pharmacy student is authorized to perform