Administering a Substance by Injection

Purpose:

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.

Definitions:

Pharmacy professional: Pharmacy professional refers to a pharmacist and/or a pharmacy technician. For the purposes of this guideline, where the term ‘pharmacist’ is used, it means a pharmacist in Part A of the register and 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.

Guideline:

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”). To administer a substance by injection that is not authorized by the regulations, or if the requirements established in the regulations cannot be met, a pharmacy professional requires delegation of authority, such as a medical directive or direct order, from another regulated health professional.

* Denotes a requirement in the regulations (O. Reg. 202/94, s34)

Pharmacists are authorized to administer by injection:

  • Substances 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).
    • 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).
  • Vaccines included in Schedule 3 of O. Reg. 202/94 to a patient 5 years of age or older unless specified otherwise:
  • COVID-19 vaccines to a patient 6 months of age or older, 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.

Pharmacy technicians are authorized to administer by injection:

  • Specific vaccines included in Schedule 3 of O. Reg. 202/94, namely:
  • COVID-19 vaccines, to a patient 6 months of age or older, 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.

Note: The authority for pharmacy professionals to administer coronavirus (COVID-19) vaccines is conferred by an exemption under O. Reg. 107/96, in effect until March 31, 2024. On April 1, 2024, the regulation adding COVID-19 vaccines to Schedule 3 of O. Reg. 202/94 comes into force and this authority will move under the Pharmacy Act.

Before administering a substance by injection, pharmacy professionals must:

1. Assess the environment

The Standards of Operation require the pharmacy premises, facilities, and layout – along with its equipment, technology, and staffing – to support practice, mitigate risks associated with the delivery of services, and 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 resources available.

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, where it will appear on the public register.
  • 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 a pharmacist (or 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, and pursuing continuing education and/or additional training.

3. Assess the patient

The pharmacist must assess the patient to determine the therapeutic appropriateness of the substance(s) or vaccine(s) to be administered.

  • The decision to administer a substance by injection is based on its approved indication(s), the patient’s age, individual needs, medical history, current health status, consideration of potential risks and benefits, and the pharmacist’s professional judgment.
  • For more information, please refer to the Patient Assessment Practice Tool.

For vaccines, the pharmacy professional must inform the patient of their eligibility to receive a publicly funded vaccine from their primary care provider or local public health unit as per Ontario’s routine immunization schedule, if applicable.

4. Confirm Infection Prevention and Control (IPAC) Procedures 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.

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:

5. Obtain informed consent to treatment

Prior to administering a substance, the pharmacist must receive informed consent from the patient or their authorized agent*.

Under the Health Care Consent Act, consent to treatment is informed if, before giving it, the person received:

  • Information about the nature, expected benefit, potential risks or side effects of the proposed treatment.
  • Information about other options and consequences of not having the treatment.
  • Any information that a reasonable person in the same circumstances would require to make a decision about the treatment.
  • Responses to their request for additional information.

The information provided to patients to make informed decisions about their healthcare should be consistent with the best available clinical evidence.

  • 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 by the patient in writing or provided verbally and documented by the pharmacist.
    • The pharmacist may determine that implied consent is provided, based on the patient’s action(s) or inaction in the circumstances at hand

Pharmacies participating in Ministry of Health programs to administer publicly funded vaccines (i.e., Influenza 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.
  • Please 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 PHAC Canadian Immunization Guide for information on observation and management of early vaccine reactions including anaphylaxis.
  • For administration of other substances, refer to the Product Monograph for warnings, precautions and potential 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. Communicate & Educate

Effective communication with patients and their healthcare team supports continuity of care and positive treatment outcomes. Pharmacists are expected to:

  • Collaborate with colleagues and other health care professionals to facilitate quality patient care.
  • Educate the patient on their treatment plan including any monitoring and/or follow-up required.
  • If applicable, patients should be reminded to update their paper or online immunization record and advised of the timing of their next injection.

9. Document & Notify

Pharmacy professionals are expected to review and adhere to the College’s Record Retention, Disclosure and Disposal Guideline and Documentation Guideline.

Documentation and notification requirements for pharmacies participating in Ministry of Health programs to administer publicly funded vaccines (i.e., Influenza and COVID-19 vaccines) are established by their Agreement with the Ministry and Executive Officer Notices.

Document

The relevant details of the administration of a substance must be documented on the patient record*:

  • Name and address of the patient
  • Name and address of the pharmacy professional
  • Date the substance was administered
  • Name, strength (where applicable) and quantity of the substance administered
  • The circumstances relating to the administration of the substance to the patient and any adverse reaction experienced by the patient, and
  • Confirmation that an informed consent was given by the patient or their authorized agent
    • A brief overview of the information provided to the patient concerning the risks, benefits, and potential side effects should be included.

Documentation sent to the other HCPs 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 for this purpose.

Notify

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*.

* Denotes a requirement in the regulations (O. Reg. 202/94, s34)

Legislative References:
Additional References:
External References:

APPENDIX A: Administration Through an Established Central or Peripheral Venous Access Device[1],[2]

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)).

APPENDIX B: Additional IPAC Information

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:

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
Implementation

Published: December 2023
Version #: 6.00
College Contact: Pharmacy Practice

Revision History

 

VERSION # DATE ACTION
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.
6 December 2023 Changes to Schedule 3; minor content revisions.

 

  1. Registered Nurses’ Association of Ontario (RNAO). Vascular access. 2nd ed. Toronto (ON): RNAO; 2021 https://rnao.ca/media/3639/download
  2. Doyle, G. R., McCutcheon, J. A. Clinical procedures for safer patient care. BCcampus; 2015 https://opentextbc.ca/clinicalskills/
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