(also includes Performing a Procedure on Tissue Below the Dermis)
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.
This guideline is under review in 2020. This webpage will be updated once the guideline has completed the review process and any relevant changes are made.
Revised: October 2017
- Documentation Guidelines
- Infection Control for Regulated Professionals: Pharmacists’ Edition
- Patient Safety and Infection Prevention and Control (Pharmacy Connection Winter 2020)
- Policy – Medical Directives and the Delegation of Controlled Acts
- Policy – Protecting the Cold Chain Policy
College Contact: Pharmacy Practice
For the purposes of this document where the term ‘pharmacist’ is used it is inclusive of pharmacy students and interns. Where this is not the case, it will be clearly identified.
This guideline outlines requirements for administering a substance for any purpose within a pharmacist’s authorized scope of practice.
Substances that may be administered by a pharmacist are found in regulations, and other than in the context of a medical directive, a pharmacist may not administer any other substance by injection or inhalation. A pharmacist may only administer an injection for any purpose to a child 5 years of age or older.
- Pharmacy professionals have an obligation to protect and promote the health and well-being of patients;
- Pharmacy professionals are accountable for practicing within their scope of practice, the terms, conditions and limitations on their certificate of registration, if any, and in accordance with their knowledge, skill, and judgment;
- A pharmacist may administer substances only for the benefit of the patient and based on the individual nature of the patient’s need/history and professional judgment exercised accordingly; and
- Pharmacy services are provided within the context of the Code of Ethics, Standards of Practice, legislation and College Policies and Guidelines.
A pharmacist is required to have completed specified training and to be certified in CPR and First Aid prior to administering a substance by injection. A list of approved courses can be found on the College website along with instructions on how to register injection training. Once these requirements are met, the pharmacist will complete a declaration on the College’s website to register his or her training.
Where a patient meets publicly funded eligibility criteria the pharmacist must inform a patient of his or her eligibility for free administration of a publicly funded vaccine from his or her primary care provider prior to administering a vaccine at a cost to the patient, where appropriate.
Pharmacists are authorized to administer a substance in the following circumstances:
- To a patient who has been prescribed a self-administered injection or inhalation of a substance specified in the regulation, when the patient or his or her authorized agent, chooses to have the injection/inhalation both dispensed and administered by the pharmacist for the purpose of education and demonstration.
- To a patient who has been prescribed a Schedule I vaccine specified in the regulations.
- To a patient who requires a Schedule II vaccine specified in the regulations.
- In the case of the influenza vaccine, only a Part A pharmacist, pharmacy student or intern located in a pharmacy is permitted to administer the publicly funded vaccine in accordance with the Universal Influenza Immunization Program (UIIP) as described on the Ministry of Health and Long-Term Care website.
- Substances not listed in the schedules to the regulations may only be administered in the context of a medical directive.
- A pharmacist may only administer an injection for any purpose to a child 5 years of age or older.
A pharmacist administering any substance for treatment or education and demonstration, regardless of the route of administration, must ensure the following:
1. Assess and screen your patients1
Prior to administering a substance the pharmacist should assess relevant patient factors to determine the pharmaceutical and therapeutic appropriateness of the drug therapy for the specific patient.
2. Informed Consent to Treatment
Prior to administering any substance a pharmacist must receive express consent from the patient or a substitute decision maker. Express consent is consent that is directly given, either orally or in writing from an informed patient or their substitute decision maker.
A person is said to have given informed consent to treatment when they have received enough information to make a decision about the treatment and have had an opportunity to ask questions and receive further information as necessary. In order for a patient’s consent to be regarded as informed the patient must have provided their consent freely without any kind of coercion or deception.
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. Consent does not necessarily need to be in writing, but should be noted on a patient record along with a brief overview of the information that was provided to the patient concerning the risks, benefits, and potential side effects of the proposed treatment.
3. Appropriate Storage of Drugs
The pharmacist is required to store and maintain all drugs appropriately. A number of injectable and inhaled medications require refrigeration, so it is important to ensure that the refrigerator is of sufficient size to store drugs and that it is maintained at the proper temperature, as suggested by the drug manufacturer.
The College’s Cold Chain Policy is a policy requirement of the College for the protection of all temperature-sensitive pharmaceutical and biologic products that are at risk of damage if handled improperly and is aligned to the requirements of the UIIP.
4. Safe and Appropriate Environment
When the pharmacist administers a substance he or she must do so in an environment that is clean, safe, private, and comfortable for the patient.
Each pharmacy is required to have a dispensary which has the capacity for cleaning the equipment and surfaces involved in the preparation, dispensing, distribution, and storage of drugs, and a sink with a supply of hot and cold running water. It is expected that suitable attire and protective coverings will be utilized as necessary.
Point-of-use disposal receptacles and puncture resistant containers to reduce risk of leakage are appropriate for the disposal of sharps. It is recommended not to recap, bend, or manipulate needles when disposing of used sharps.
5. Infection Prevention and Control Procedures
The College’s Infection Control for Regulated Professionals: Pharmacists’ Edition, describes the appropriate precautions that should be taken in community settings to mitigate the risk of infection. Infection control practices must meet professional requirements including the application of evidence-based measures and professional judgment. Pharmacists must follow all government recommendations on health alerts, surveillance, screening and reporting of respiratory and influenza-like illness.
The Infection Control Guideline takes a ‘routine precaution’ approach that should be undertaken at all times, with all patients. These include hand washing and use of personal protective equipment. It is recommended that pharmacists take steps to prevent spreading infectious diseases, including that immunizations are up-to-date and that the member has an annual influenza vaccination.
6. Administering a substance
Administering a substance by injection or inhalation best takes place in the context of a collaborative relationship between the pharmacist, the patient, and the patient’s primary healthcare provider to maintain a complete patient record.
The pharmacist is responsible for the provision of optimal patient care, adhering to the standards of practice related to the administration of injections, and monitoring drug therapy.
A pharmacist may administer substances only for the benefit of the patient and based on the individual nature of the patient’s need/history and professional judgment exercised accordingly.
The pharmacist must determine whether the substance will be safe to administer considering the storage requirements of the drug, including protecting the cold chain, and the relevant circumstances of the patient, including but not limited to:
a. The potential risks and benefits;
b. The safeguards and emergency response resources available in the circumstances to safely manage the outcome of administering the substance; and
c. Other relevant factors specific to the situation.
Following the administration, the pharmacist must ensure that the patient is monitored for adverse reactions and allergies in an appropriate location for the recommended period of time.2
7. Documentation and Notification
When administering a substance the pharmacist must make a record of the relevant details on the patient 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 patient’s primary care provider (if any) within a reasonable time after administering a substance for treatment purposes to the patient.
Where a substance is administered for education or demonstration purposes, the pharmacist may wish to notify the primary prescriber if he or she feels the administration is clinically significant.
Any documentation sent to a primary care provider must be concise and include details respecting administration to ensure the patient record is complete in both locations.
Performing a Procedure on Tissue Below the Dermis
All of the requirements when administering a substance by injection or inhalation also apply when performing a procedure on tissue below the dermis, as appropriate.
Pharmacists, pharmacy students and interns and pharmacy technicians under the direction of a Part A pharmacist who is physically present on the premises are authorized to perform a procedure on tissue below the dermis.
Training, educating and counselling patients or informal care givers on chronic disease management and the appropriate use of monitoring devices is a core competency of pharmacy practice. With the consent of the patient or his or her authorized agent, the pharmacy professional may pierce a patient’s dermis to demonstrate the proper use of lancet-type devices for the patient’s self care and education or for the patient’s self monitoring of his or her chronic disease.
The pharmacy professional will only consider performing the procedure if he/she has an understanding of the value and limitations of self care devices and monitoring tools and is able to educate the patient on how to self monitor and when to contact a health professional.
A pharmacy professional must still provide the patient with sufficient information for the patient to provide informed consent, but the pharmacy professional can assume that consent is implied3, 4 when a patient extends his or her finger to allow the pharmacist to use a lancing device to obtain a blood sample in the context of demonstrating the use of the device.
A pharmacy professional is required to use professional judgement regarding the clinical significance of performing a procedure and may choose not to notify the primary prescriber about performing the procedure. Where the pharmacy professional feels that notification is required for continuity of patient care, he or she may provide information to the prescriber.
- Canadian Committee on Antibiotic Resistance (2012). Infection Prevention and Control Best Practices for Long Term Care, Home and Community Care including Health Care Offices and Ambulatory Clinics. Canadian Committee on Antibiotic Resistance — Public Health Agency of Canada. Retrieved at: https://www.publichealthontario.ca/en/eRepository/BP_IPAC_Ontario_HCSettings_2012.pdf
- Canadian Immunization Guide. Retrieved at: https://www.canada.ca/en/public-health/services/canadian-immunization-guide.html
- Implied consent is consent that occurs when surrounding circumstances are such that a reasonable person believes that consent had been given, although no direct, express, or explicit words of agreement had been uttered.
- College of Physicians and Surgeons of Ontario. Consent to Medical Treatment. January/February 2006; Endnote 11. [CPSO has revised this policy and the original is no longer available.]