This guideline outlines legislative requirements and expectations for pharmacy professionals administering substances by injection as authorized by the Pharmacy Act and in accordance with O. Reg. 202/94. It is meant to be used alongside the Standards of Practice, Standards of Operation, and Code of Ethics.
Informed Consent: Consent to treatment is informed if, before giving it, the person received the information about the nature, expected benefit, potential risks or side effects, other options and consequences of not having the treatment (or any information that a reasonable person in the same circumstances would require in order to make a decision about the treatment) and the person received responses to their request for additional information (Health Care Consent Act).
Pharmacist: For the purposes of this document where the term ‘pharmacist’ is used it is inclusive of pharmacy interns and students, and subject to any terms, conditions and limitations on their certificates of registration. Where this is not the case, it will be clearly identified.
A pharmacy professional is authorized under the Pharmacy Act to perform the controlled act of administering a substance by injection in accordance with the requirements established by O. Reg. 202/94 (“the regulations”).
The authorization to administer COVID-19 vaccine by injection is conferred by an exemption under O. Reg. 107/96.
Pharmacists are authorized to administer by injection:
- A substance included in Schedule 1 of O. Reg. 202/94
- The pharmacist must comply with any limitation specified within the Schedule (e.g., for patient education and demonstration purposes only; must not be administered intravenously, etc.)
- Administration through an established central or peripheral venous access device must only be done in collaboration with a registered nurse in the extended class (i.e., nurse practitioner (NP) or a physician (MD))
- Refer to Appendix A for additional information
- A vaccine included in Schedule 3 of O. Reg. 202/94, to a patient who is five (5) years of age or older
Pharmacists and pharmacy technicians are authorized to administer by injection:
- A publicly funded influenza vaccine in accordance with Ontario’s Universal Influenza Immunization Program (UIIP) to a patient who is two (2) years of age or older
- A publicly funded COVID-19 vaccine under the condition they are engaged to do so by an organization in an agreement with the Minister of Health governing the administration of the vaccine, to a patient of any age based on the eligibility criteria set out by the Ministry
To administer a substance by injection in any other circumstances, a pharmacy professional would require delegation of authority, such as a medical directive or direct order, from another regulated health professional.
Before administering a substance by injection, pharmacy professionals must:
1. Assess the environment
The Standards of Operation require the premises, facilities, and layout – along with its equipment, technology and staffing – to support practice, to mitigate risks associated with the delivery of services, and to safeguard the health, safety and wellbeing of patients.
- Administration of a substance must take place in an environment that is clean, safe, private, and comfortable for the patient, in a way that protects their confidentiality and dignity
- Safeguards and resources must be available to safely manage the outcome after administration
- If the substance being administered has an antidote, it must be available.
Community pharmacy owners and Designated Managers are expected to implement the Guiding Principles for Shared Accountability to support a suitable practice environment, which includes the physical working space as well as the practice culture, operating procedures, workflow, and available resources.
2. Assess their competency and certifications
The pharmacy professional must only administer a substance by injection when they can do so competently and safely by:
- Successfully completing an OCP-approved, CCCEP-accredited injection training course
- Registering their training with the College
- Obtaining and maintaining a valid certification in CPR and First Aid, at a minimum level equivalent to St. John Ambulance or Red Cross Standard First Aid & CPR/AED Level C [Pharmacists only]
- CPR and First Aid certification for pharmacy technicians is recommended but not mandatory at this time as they can only administer vaccines under supervision of another health care professional (HCP) who is required to have this certification.
- For administering via an established venous access device, successfully completing theoretical and practical training on administering intravenous therapy and venous access devices [Pharmacists only]
- A skills assessment component is required for the pharmacist to demonstrate their competency
- Training may be completed through a CCCEP-accredited provider and/or through an educational program approved by the organization where they will engage in this practice under the direction and supervision of a NP or MD
- Possessing sufficient knowledge, skill and judgment respecting the substance to be administered and the device(s) used to administer the substance
- Having sufficient understanding of the condition of the patient
- Having the resources necessary to meet their professional obligations and standards of practice
- Being of sound physical, emotional and mental capacity
- Addressing gaps or learning opportunities, identified through self- and/or peer-assessment, with continuing education and/or additional training
3. Assess the patient
The pharmacist must assess the patient to determine the appropriateness of the therapy and the route of administration. The decision to administer a substance is based on the patient’s individual needs, medical history, current health status, consideration of potential risks and benefits, and the pharmacist’s professional judgment.
For vaccine administration, a pharmacy professional must inform the patient of their eligibility for publicly-funded vaccination as per Ontario’s routine immunization schedule.
For more information, please refer to the Patient Assessment Practice Tool.
4. Confirm Infection Prevention and Control Procedures (IPAC) are in place
Pharmacies must have evidence-based Infection Prevention and Control (IPAC) measures in place to prevent or reduce the risk of transmission of microorganisms to patients, the public, and personnel.
- A ‘routine precaution’ approach should always be undertaken, with all patients. This includes proper hand washing and, when appropriate, use of personal protective equipment
- Refer to Routine Practices and Additional Precautions for Preventing the Transmission of Infection in Healthcare Settings from the Public Health Agency of Canada (PHAC)
- In the hospital setting, the organization’s IPAC Committee establishes IPAC policies and procedures
- In the community setting, the Designated Manager is responsible for establishing IPAC policies and procedures
- Refer to the PHAC Canadian Immunization Guide sections on Infection Prevention and Control and Immunization of Workers.
Pharmacies must have procedures in place for the safe handling, collection and disposal of medical sharps (i.e., needles):
- Do not recap, bend, or manipulate needles prior to disposal
- The device’s safety feature(s) should be activated if available. Safety-engineered needles licensed by Health Canada are required by O. Reg. 474/07 in certain workplaces
For additional information, refer to Appendix B and:
- The Ministry of Environment and Climate Change guidance on biomedical waste for more information on sharps management and disposal.
- The Ministry of Labour, Training, and Skills Development for Occupational Health and Safety IPAC- and sharps safety-related resources.
5. Obtain informed consent to treatment
Prior to administering a substance, the pharmacist must receive informed consent from the patient or their authorized agent.
- Consent is contingent on an individual’s capacity to understand why and for what the consent is being sought
- There is no minimum age of consent to treatment in Ontario
- Consent may be express or implied
- Express consent may be provided in writing or provided verbally and documented
- A pharmacy professional may determine that implied consent is provided, based on the patient’s action(s) or inaction in the circumstances at hand
- Confirmation that informed consent was received by the pharmacist must be documented on the patient record
Pharmacies participating in Ministry of Health programs to administer publicly funded vaccines (i.e., Ontario’s Universal Influenza Immunization Program (UIIP) and COVID-19 vaccines) must obtain consent as required by their Agreement with the Ministry and Executive Officer Notices.
6. Confirm proper storage and preparation
The pharmacy professional must determine that the substance is safe to administer by evaluating the stability and integrity of the drug.
- Follow Canadian Immunization Guide administration practices and manufacturer’s recommendations for reconstitution (if applicable), visual inspection, etc.
- Procedures must be in place to ensure that temperature-sensitive drug products are received and stored according to manufacturer’s recommendations
- Refer to the Guideline – Protecting the Cold Chain for further information, including links to the Ontario public health standards for storage of publicly funded vaccines
After administering a substance by injection, pharmacy professionals must:
7. Monitor the patient
The pharmacy professional must ensure that the patient is monitored for adverse reactions in an appropriate location, for a sufficient amount of time.
- For post-vaccine administration, refer to the Public Health Agency of Canada’s (PHAC) Canadian Immunization Guide for information on observation and management of early vaccine reactions including anaphylaxis
- Pharmacy professionals are required under the Health Protection and Promotion Act, R.S.O. 1990, c. H.7 s.7(1) to report certain Adverse Events Following Immunization (AEFI) to Public Health
- For administration of other substances, refer to the Product Monograph for warnings, precautions and adverse reactions
- Should a reaction occur, it should be immediately brought to the attention of the pharmacist or the supervising HCP to ensure timely assessment of the patient and to determine the appropriate course of action
- Determine if a monitoring plan and further follow-up is required
8. Document and notify
Documentation and notification requirements for the administration of influenza vaccine through the UIIP and the COVID-19 vaccine are established by the Ministry of Health.
The relevant details of the patient assessment and administration of a substance must be documented on the patient record. This includes confirmation that informed consent was received by the pharmacist or the supervising HCP, along with a brief overview of the information that was provided to the patient concerning the risks, benefits, and potential side effects.
Pharmacy professionals are expected to review and adhere to the College’s Record Retention, Disclosure and Disposal Guideline and Documentation Guidelines.
If applicable, patients should be reminded to update their immunization record.
Notification of the administration of a substance should be sent to both the prescriber of the substance (if any), as well as the patient’s primary care provider (if any, and if known):
- Where a substance is administered for education or demonstration purposes, notification may occur if the pharmacist determines the administration was clinically significant or important for continuity of care
- Where a substance is administered for treatment purposes, notification must occur within a reasonable time
Documentation sent to the other health care professionals must be concise and include pertinent details respecting administration to ensure the patient record is complete.
Patients who do not have a prescriber (i.e., have been administered a non-prescription substance) or a primary care provider should be advised that they, or another health professional providing care to them in the future, are entitled to access this information at any time. Patients may also wish to have a copy of the documentation from their record.
- Guidance — Administration of COVID-19 Vaccine by Pharmacy Professionals
- Policy — Medical Directives and the Delegation of Controlled Acts
- Administering Injections Practice Tool
- Infection Prevention and Control Practice Tool
- Vaccine Storage and Handling Protocol, 2018
- Pharmacy Connection article – Reporting Adverse Reactions to Vaccines and Medications
- Immunization Records: Canadian Immunization Guide
A Venous Access Device is a catheter inserted into a central or peripheral vein or artery that can be implanted or inserted under the skin, classified based on the insertion site and location of the device.
- Peripheral devices are inserted by percutaneous venipuncture with the terminal tip below the level of the axillary vein for upper extremity placement.
- Peripheral vascular access devices (PVADs) include short peripheral intravenous catheters (PIVs), midline and extended dwell catheters
- Central devices are inserted into a large vein in the central circulation system with the tip of the catheter terminating in the superior vena cava and advancing towards the heart.
- Central vascular access devices (CVADs) include central venous catheters (CVCs), peripherally inserted central catheters (PICCs), tunneled catheters, non-tunneled catheters and implanted vascular access devices (IVADs) or “ports”.
Administration through an established central or peripheral venous access device by a pharmacist must only be done in collaboration with a registered nurse in the extended class (i.e., nurse practitioner (NP) or a physician (MD)).
Ontario’s Provincial Infectious Diseases Advisory Committee on Infection Prevention and Control (PIDAC-IPC) advises Public Health Ontario and produces best practice documents for healthcare organizations, such as:
- Best Practices for Environmental Cleaning for Prevention and Control of Infections in All Health Care Settings
- Best Practices for Hand Hygiene in All Health Care Settings, 4th Edition
- Infection Prevention and Control for Clinical Office Practice
Ontario’s Public Health Units have the authority to conduct inspections/assessments/investigations related to infection prevention and control (IPAC) practices.
- In the event of a communicable and/or infectious disease transmission risk related to the conduct of a pharmacy professional, the regional board of health will involve the College on the matter, per the Infection Prevention and Control Complaint Protocol
Published: July 2023
Version #: 5.00
College Contact: Pharmacy Practice
|1||October 2012||Expanded Scope of Practice Orientation Manual.|
|2||February 2018||Guideline extracted from manual.|
|3||December 2020||Review, reformatting and inclusion of scope changes from O.Reg. 202/94.|
|4||November 2021||Inclusion of scope changes for technicians from O. Reg. 202/94|
|5||July 2023||Administering a Substance by Injection Guideline extracted from Administering a Substance by Injection or Inhalation Guideline.
Inclusion of scope changes to O. Reg. 202/94.