April 20, 2020: Important update regarding the novel coronavirus (COVID-19) pandemic
In addition to adhering to Routine Practices and Additional Precautions for infection prevention and control, pharmacists should refer to the Public Health Ontario IPAC Recommendations for Use of Personal Protective Equipment for Care of Individuals with Suspect or Confirmed COVID-19 when providing care to a patient who either meets the case definition through active screening by the pharmacist or self-identifies as meeting the case definition.
Regulatory changes that would expand the scope of pharmacists to administer certain substances by injection and/or inhalation for purposes that are in addition to patient education and demonstration have not yet been approved by the government. Details about future expanded scope regulatory approvals will be shared with registrants via e-Connect and on this website.
This guideline outlines legislative requirements for administering vaccines and substances for the purpose of education and/or demonstration as defined in the Pharmacy Act. It is meant to be used alongside the Standards of Practice, Standards of Operations, Code of Ethics and O. Reg. 202/94.
Informed Consent: a 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 pharmacist is authorized to perform the controlled act of administering a substance, by injection or inhalation, in accordance with the requirements established by the O. Reg 202/94. To administer any other substance, or if any requirements of the regulations cannot be met, a pharmacist 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:
- A substance included in the lists in Schedule 1 by injection (O. Reg 202/94)
- A substance included in Schedule 2 by inhalation (O. Reg 202/94)
Pharmacists are authorized to administer for the purpose of treatment:
- A vaccine included in Schedule 3 (O. Reg 202/94) to a patient who is five (5) years of age or older
- 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
Prior to administering a substance by injection pharmacists must:
- Successfully complete an OCP-approved injection training course
- Obtain and maintain a valid certification in CPR and First Aid (the equivalent of St. John Ambulance or Red Cross Standard First Aid & CPR/AED Level C)
- Register their training with the College
- Inform the patient of their eligibility for free vaccination (when applicable) in Ontario’s routine immunization schedule
Expectations for pharmacists administering any substance regardless of the route of administration or purpose:
1. Assess patient
Prior to administering a substance, the pharmacist must assess the patient profile 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.
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
- Confirmation that informed consent was received must be noted in the patient record
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 prior to dispensing. Many injectable products require refrigeration between 2 and 8⁰C. 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 Policy — 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
The pharmacist must administer a substance in an environment that is clean, safe, private, and comfortable for the patient, with appropriate resources available to safely manage the outcome.
Following administration, the pharmacist must ensure that the patient is monitored for adverse reactions in an appropriate location. For vaccine administration, pharmacists should 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.
5. Follow Infection Prevention and Control Procedures
Prior to administering a substance, the pharmacist must have evidence-based Infection Prevention and Control (IPAC) measures in place to prevent or reduce the risk of transmission of microorganisms.
- In the community setting, a ‘routine precaution’ approach should be undertaken at all times, 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
- In the hospital setting, pharmacists should adhere to the organization’s IPAC policies and procedures
- As recommended in the Canadian Immunization Guide, pharmacy professionals should have their immunizations up-to-date and receive an annual influenza vaccination
- For administering injections, pharmacists should refer to the PHAC Canadian Immunization Guide
- Additional resources are available from the Provincial Infectious Diseases Advisory Committee (PIDAC) and in the Article — Patient Safety and Infection Prevention and Control
The pharmacy must have procedures in place for the safe handling, collection and disposal of medical sharps (i.e. syringes with needles, lancets, pen needles, etc.). 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. Refer to the Ministry of Environment and Climate Change guidance on biomedical waste for more information on sharps management and disposal.
Refer to the Ministry of Labour Training and Skills Development Occupational Health and Safety IPAC-related resources.
6. Document and Notify
Documentation and notification requirements for the administration of influenza vaccine through the UIIP are established by the Ministry of Health.
When administering a substance the pharmacist must make a record of the relevant details on the patient record. This includes confirmation that informed consent was received, along with a brief overview of the information that was provided to the patient concerning the risks, benefits, and potential side effects.
Pharmacists 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.
A pharmacist will notify the prescriber (if any), as well as the patient’s primary care provider (if any), within a reasonable time after administering a substance 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.
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.
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.
- Policy — Medical Directives and the Delegation of Controlled Acts
- Administering Injections Practice Tool
- Standards of Operation for Pharmacies
- Vaccine Storage and Handling Protocol, 2018
Published: December 2020
Version #: 3.00
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.|