Administering a Substance by Injection or Inhalation

For COVID-19 vaccine, please refer to the College’s guidance document titled Administration of COVID-19 Vaccine by Pharmacy Professionals which serves as a supplement to the Executive Officer Notices and guidance from the Ministry of Health.

Purpose:

This guideline outlines legislative requirements and expectations for pharmacy professionals administering substances by injection and inhalation 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 Operations, and Code of Ethics.

Definitions:

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.

Guideline:

A pharmacy professional is authorized to perform the controlled act of administering a substance, by injection or inhalation, in accordance with the requirements established by O. Reg 202/94 (“the regulations”). To administer a substance not listed in the regulations, or if any conditions of the regulations cannot be met, a registrant would require delegation of authority, such as a medical directive or direct order, from another regulated health professional.

Pharmacists are authorized to administer for the purposes of education and/or demonstration:

Pharmacists are authorized to administer for the purpose of treatment:

Pharmacy technicians are authorized to administer for the purpose of treatment:

Prior to administering a substance by injection, pharmacy professionals must:

Pharmacists must:

Note: For pharmacy technicians, valid certification in CPR and First Aid is recommended but not mandatory at this time as they will only administer vaccines under supervision of another health care professional (HCP) who is required to have this certification.

Expectations for pharmacy professionals administering any substance regardless of the route of administration or purpose:

1. Assess patient

Prior to administering a substance, a pharmacist must assess the patient to determine appropriateness of therapy. This decision is made based on the individual patient’s need, history, current health status, an assessment of potential risks and benefits, and professional judgment exercised accordingly.

Prior to administering influenza vaccine, a pharmacy technician must confirm that a pharmacist or another HCP with similar scope has performed the patient assessment.

2. Obtain Informed Consent to Treatment

Prior to administering a substance, a pharmacist must receive informed consent from the patient or their substitute decision maker.

  • Consent may be express or implied
  • Consent may be provided verbally or in writing
    • Pharmacies participating in Ontario’s Universal Influenza Immunization Program (UIIP) must obtain consent as per the UIIP agreement
  • There is no minimum age of consent in Ontario
  • Consent is contingent on an individual’s capacity to understand why and for what the consent is being sought

Prior to administering influenza vaccine, a pharmacy technician must confirm that a pharmacist or another HCP has received informed consent.

3. Store Drugs Appropriately

Pharmacies must be designed, constructed and maintained to provide appropriate storage conditions to safeguard the integrity of all drugs. This includes the proper conditions of sanitation, temperature, light, humidity, ventilation, segregation and security.

Procedures must be in place to ensure that temperature-sensitive products are properly received and stored appropriately according to manufacturer’s recommendations prior to dispensing. The pharmacist must determine whether the substance will be safe to administer considering the storage integrity of the drug, including an unbroken cold chain. Please refer to the Guideline — Protecting the Cold Chain for further information, including the Ontario public health standards for storage of publicly funded influenza vaccines required for the UIIP.

4. Ensure Safe and Appropriate Environment

Substances must be administered in an environment that is clean, safe, private, and comfortable for the patient, with appropriate resources available to safely manage the outcome.

5. Monitor the Patient

Following administration, pharmacy professionals must ensure that the patient is being monitored for adverse reactions in an appropriate location. For post-vaccine administration, refer to the Public Health Agency of Canada’s (PHAC) Canadian Immunization Guide for important information on observation and management of early vaccine reactions including anaphylaxis. 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 determine the appropriate course of action.

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 more information, please refer to the Pharmacy Connection article – Reporting Adverse Reactions to Vaccines and Medications article.

6. Follow Infection Prevention and Control Procedures

Pharmacies must have evidence-based Infection Prevention and Control (IPAC) measures in place to prevent or reduce the risk of transmission of microorganisms.

The pharmacy 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.

7. Document and Notify

Documentation and notification requirements for the administration of influenza vaccine through the UIIP are established by the Ministry of Health.

Document

A record of the relevant details of the administration of a substance must be made 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 should refer to the Immunization Records: Canadian Immunization Guide for information on recording administration of vaccines. Patients should be reminded to update their paper or online immunization record.

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

Notify

The prescriber (if any), as well as the patient’s primary care provider (if any), must be notified within a reasonable time after administering a vaccine for the purpose of treatment to the patient.

Where a substance is administered for education or demonstration purposes, the pharmacist may wish to notify the prescriber if they feel the administration is clinically significant or important for continuity of care.

Documentation sent to a primary care provider must be concise and include pertinent details respecting administration to ensure the patient record is complete in both locations.

Legislative References:
Additional References:
Implementation

Published: December 2020
Version #: 4.00
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
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