Administration of COVID-19 Vaccine by Pharmacy Professionals

GUIDANCE

Published: January 27, 2021

Updated: March 16, 2021; March 23, 2021; December 24, 2021

Ontario Regulation 107/96 under the Regulated Health Professions Act (RHPA) was amended on January 13, 2021 to allow a Part A pharmacist, intern, registered pharmacy student or pharmacy technician to administer the COVID-19 vaccine under the condition they are engaged to do so by an organization or other entity that is in an agreement with the Minister of Health (MOH) governing the administration of the vaccine, including a community pharmacy with a COVID-19 Vaccine Agreement.

On December 22, 2021, a subsequent amendment allows “any person” to administer the vaccine under the above condition, provided that they are supervised by a Part A pharmacist, physician, or nurse (RN, RN(EC)) who:

i. is present at the premises where the vaccine is administered, and
ii. is accessible to the person administering the vaccine to discuss questions relating to, or give directions with respect to, the administration of the vaccine.

The regulation is in effect until it is revoked on June 30, 2022.

Purpose

This guidance outlines expectations and resources for pharmacy professionals administering COVID-19 vaccines and serves as a supplement to the Executive Officer Notice: Administration of Publicly Funded COVID-19 Vaccines in Ontario Pharmacies from the Ministry of Health and Public Health Units. This information should be applied within the framework established by the Standards of Practice, Code of Ethics, and existing policies and guidelines to support safe, outcome-focused, collaborative patient care.

In addition, organizations or entities that enter into an agreement with the Minister may have additional expectations for pharmacy professionals administering the COVID-19 vaccine in that particular setting.

Background

The amendment to O. Reg. 107/96 exempts a Part A pharmacist, intern, registered pharmacy student or pharmacy technician from Section 27(1) of the Regulated Health Professions Act (RHPA), which otherwise restricts a person from performing the controlled act of administering a substance by injection unless:

  • They have the authority to administer that substance by injection in their scope of practice as conferred by a health discipline Act, or;
  • They do so under delegation of authority from another health professional who has the scope of practice to administer that substance by injection (see section on Delegation of Authority)

Normally, outside of this amendment, a pharmacy professional’s scope of practice as conferred by the Pharmacy Act and O. Reg. 202/94 does not include the authority to administer COVID-19 vaccine by injection:

  • For pharmacists, registered pharmacy students and interns, COVID-19 vaccine is not one of the vaccines listed in Schedule 3 of the regulation
  • Pharmacy technicians are not authorized to administer any substance by injection (Section 34(2) of the regulation)

Therefore, this exemption in the RHPA enables pharmacy professionals to administer the COVID-19 vaccine (although outside of scope and without requiring delegation of authority) ONLY if and when they have been engaged to do so by an organization or other entity that has an agreement with the Minister of Health (MOH). Hospitals, Public Health Units, selected primary care settings and pharmacies in certain regions are examples of organizations or other entities who have agreements with the MOH at this time. Mass immunization clinics are also being planned in different regions.

Guidance

Pharmacy professionals performing any patient care activities must adhere to the Standards of Practice and Code of Ethics at all times.

  • In emergency situations, including pandemics and other public health emergencies where the health of the patient or the public is at risk, registrants have a duty to provide patient care within their professional competence and expertise.
  • Registrants ensure that they only practice when they are competent, with respect to both relevant knowledge and skill and physical, emotional and mental capacity, to do so.

Key Requirements

Part A pharmacists, interns or registered pharmacy students administering the COVID-19 vaccine are expected to adhere to the following expectations outlined in the OCP Guideline – Administering a Substance by Injection or Inhalation:

  • Have sufficient knowledge, skill and judgment to safely and effectively administer the vaccine:
  • Assess the patient
  • Ensure informed consent to treatment from the patient or their agent has been obtained
  • Follow recommended infection prevention and control procedures
  • Have appropriate resources available to safely manage any adverse reactions and ensure the patient is monitored accordingly
  • Document the administration of COVID-19 vaccine as required by the Ministry of Health and/or Public Health Unit

Pharmacy technicians administering the COVID-19 vaccine are expected to adhere to the following expectations outlined in the Guideline – Administering a Substance by Injection or Inhalation:

  • Have sufficient knowledge, skill and judgment to safely and effectively administer the vaccine:
    • Successfully complete an OCP-approved injection training course
    • Register their training with the College
    • Valid certification in CPR and First Aid is recommended but not mandated at this time as pharmacy technicians will only administer the vaccine under supervision and in a setting where other health care professionals are required to have this certification
  • Ensure the patient has been assessed by a pharmacist or other regulated health professional who has the scope to perform clinical patient assessments and that vaccine administration is appropriate
  • Follow recommended infection prevention and control procedures
  • Ensure that there are appropriate resources available to safely manage any adverse reactions and that the patient is monitored accordingly
  • Document the administration of COVID-19 vaccine as required by the Ministry of Health and/or Public Health
Additional Considerations

Pharmacy professionals who are exempted from Section 27(1) of the RHPA are still subject to the terms, conditions and limitations on their certificate of registration under O. Reg. 202/94 of the Pharmacy Act.

Supervision requirements

  • Part A pharmacists do not require supervision to administer the COVID-19 vaccine unless stipulated by the organization or other entity that is in an agreement with the Minister of Health
  • Interns and registered pharmacy students cannot practice independently and may only administer the COVID-19 vaccine while under the supervision of a pharmacist or another regulated health professional with similar scope
  • Pharmacy technicians cannot provide clinical assessment or patient education that requires therapeutic knowledge of a drug and therefore may only administer the COVID-19 vaccine while under the supervision of a pharmacist or regulated health professional who has the scope to perform these activities
    • Interns, registered pharmacy students and Part B pharmacists cannot be responsible for supervising a pharmacy technician
  • Unregulated personnel must be supervised by a Part A pharmacist to administer the COVID-19 vaccine who is present and accessible as per the amendment to the regulation dated December 22, 2021 and in effect until it is revoked on June 30, 2022.
    •  Pharmacists must uphold the Standards of Practice and ensure that personnel working under their direct supervision, for whom they are responsible, have the appropriate training and competently perform administration of the vaccine.
    • Pharmacists must have completed an OCP-approved injection training course, ensured their First Aid and CPR certification is up to date, and registered their training with the College before supervising the administration of COVID-19 vaccine by another person.

Delegation of Authority

In situations where the condition set out in O. Reg. 107/96 has not been met (i.e., if the registrant has not been engaged to administer the vaccine by an organization or entity that has an agreement with the Minister of Health) delegation of authority from another regulated health professional is still required (e.g., a medical directive).

  • Only physicians and nurse practitioners can delegate the authority to administer the COVID-19 vaccine as this is within their scope of practice

Pharmacy professionals cannot delegate the authority to administer the COVID-19 vaccine to another person, regardless of terms, conditions and limitations (TCL) of their certificate of registration, as it is not within their independent scope of practice as currently defined in the Pharmacy Act.

Pharmacy professionals may accept delegation of authority to administer the COVID-19 vaccine subject to a TCL applied to their certificate of registration under O. Reg. 202/94:

  • Part A pharmacists, interns and pharmacy technicians can accept delegation of authority
  • Registered pharmacy students cannot accept delegation of authority
  • Part B pharmacists cannot accept delegation of authority due to the TCL that they cannot provide patient care
  • Pharmacy professionals accepting delegation must adhere to the Policy – Medical Directives and the Delegation of Controlled Acts
Legislative References
Additional References
External References