December 12, 2022: Important Update Regarding Initiating Paxlovid™ Treatment
Ontario Regulation 107/96 – Controlled Acts, under the Regulated Health Professions Act (RHPA), was amended to authorize a Part A pharmacist to prescribe Paxlovid™ (nirmatrelvir/ritonavir) antiviral treatment for COVID-19 in accordance with section 16 of the regulation (See Appendix 1) and the eligibility criteria set out by the Ministry of Health.
Pharmacists must possess the required clinical knowledge, skills and competency to prescribe and/or dispense Paxlovid™ for eligible individuals. A comprehensive patient assessment to identify and manage potential drug therapy problems (such as drug interactions, contraindications, the need for dosage adjustments, etc.) or to determine whether a referral to a primary care provider is necessary.
Additional resources to support pharmacists with clinical decision-making and links to the Ministry of Health Executive Officer notices can be found on the COVID-19: Information for Pharmacy Professionals page under Paxlovid™ – Prescribing & Dispensing.
No other registrant (i.e., Part B pharmacist, registered pharmacy student, intern, pharmacy technician, pharmacist (emergency assignment), or pharmacy technician (emergency assignment)) is authorized to prescribe Paxlovid™.
This guideline outlines legislative requirements for prescribing a drug within a pharmacist’s authorized scope of practice as defined in the Pharmacy Act. It is intended to be used alongside the Code of Ethics, Standards of Practice, Standards of Operation 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, material 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.
Minor Ailment: Health conditions that can be managed with minimal treatment and/or self-care strategies. Additional criteria include: usually a short-term condition; lab tests are not usually required; low risk of treatment masking underlying conditions; medications and medical histories can reliably differentiate more serious conditions; and, only minimal or short-term follow up is required.
A pharmacist has the authority to initiate, adapt or renew a prescription in accordance with the regulations if:
- The pharmacist possesses sufficient knowledge and skills respecting the drug and the patient’s condition to initiate, adapt or renew the drug safely and effectively
- The initiation, adaptation or renewal is in the best interest of the patient and appropriate, given the known risks and benefits of prescribing the drug
A pharmacist is authorized to prescribe the following:
- Varenicline tartrate and/or bupropion hydrochloride for the sole purpose of smoking cessation
- A drug in a category listed in Column 2 of Schedule 4 to O. Reg. 202/94 for the associated minor ailment in Column 1
- Prior to prescribing for minor ailments, Part A pharmacists must complete the mandatory OCP e-Learning module Orientation for Minor Ailments Prescribing
- Pharmacists are expected to critically evaluate information from relevant sources to inform their clinical decision-making
- The pharmacist must determine, through a therapeutic assessment, that the drug is the most appropriate treatment for the patient’s minor ailment
Adapting or Renewing therapy
The pharmacist must be in possession of the existing prescription to be renewed or adapted, or have access to the information contained in the original prescription (e.g., copy of the prescription, verbal confirmation from the original dispensing pharmacy, medical documentation or record, etc.).
Pharmacists do not have the authority to renew or adapt a prescription for a controlled substance (narcotic, controlled drug and/or targeted substance) or a drug designated as a monitored drug under the Narcotic Safety and Awareness Act.
- A pharmacist may adapt a prescription based upon the individual circumstances of the patient by altering the dose, dosage form, regimen or route of administration to address the patient’s unique needs and circumstances.
- Adapting a prescription does not include therapeutic substitution.
- A pharmacist may renew a prescription if the medication to be continued is for the purpose of continuity of care.
- The pharmacist can only renew a quantity of the drug that does not exceed the lesser of:
- The quantity that was originally prescribed, including any refills that were authorized by the prescriber; or
- A twelve (12) month supply.
Expectations for pharmacists initiating, adapting or renewing prescriptions:
1. Patient Assessment
The pharmacist determines that the therapy is safe and appropriate by evaluating the risks and benefits, considering the patient’s health status and unique circumstances. To inform their decision-making, the pharmacist should gather the available and relevant information necessary and as available for this assessment, including (but not limited to):
- Patient records (e.g., pharmacy profile, electronic health records, etc.)
- Past medical history (e.g., medical conditions, medications or natural health products, allergies, intolerances, etc.)
- Current medical history (e.g., indication/diagnosis, medications, signs and symptoms, etc.)
- Physical characteristics (e.g., age, weight, height, pregnancy, and lactation status, etc.)
- Results of physical assessment, laboratory, point-of-care, or other tests
- Lifestyle (e.g., nutrition, exercise, substance use, etc.) and socioeconomic factors
- Anything reasonable to identify possible drug therapy problems, contraindications, or precautions
2. Informed Consent to Treatment
Prior to initiating a prescription, a pharmacist must receive informed consent from the patient or their substitute decision maker. The information provided to patients to make more informed decisions about their healthcare should be consistent with the best available clinical evidence.
- Consent may be express or implied.
- Consent may be provided verbally or in writing.
- 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. Prescribing Drug Therapy (if appropriate)
When initiating therapy or adapting or renewing a patient’s prescription, the pharmacist must ensure the following information is recorded on the prescription:
- The name and address of the patient;
- The name, strength (where applicable), and quantity of the prescribed drug;
- The direction for the use of the drug, including its dose, frequency, route of administration, and any special instructions;
- The name, work address, telephone number, College registration number of the pharmacist issuing the prescription;
- The date the prescription was issued;
- The number of refills that the pharmacist has authorized, if applicable; and,
- When applicable, a reference to, or a copy of, the prescription being adapted or renewed (including the name and contact information of the prescriber).
At the time of initiating, adapting or renewing a prescription, the pharmacist must advise the patient or their authorized agent that they are entitled to the prescription and may take it to a pharmacy of their choice for dispensing.
Effective communication with patients and their healthcare team supports continuity of care and positive treatment outcomes. Pharmacists are expected to:
- Communicate the rationale for their decisions
- Educate the patient on their treatment plan including any monitoring and/or follow-up required
- Collaborate with colleagues and other health care professionals to facilitate quality patient care
A pharmacist must notify the primary care provider or prescriber within a reasonable time after initiating or renewing a prescription.
- Notification of the prescriber is also required if a pharmacist has adapted a prescription in a manner that is clinically significant in the individual circumstances of the patient, or necessary to support the patient’s care.
- If the patient’s primary health care provider is different from the original prescriber, they should also be notified in a reasonable time to ensure continuity of care.
Pharmacists are expected to review and adhere to the College’s Record Retention, Disclosure and Disposal Guideline and Documentation Guidelines.
When initiating, adapting or renewing, a pharmacist must document in the patient record:
- When adapting or renewing, reference to, or a copy of, the original prescription including the name and contact information of the prescriber;
- A copy of the prescription taken by the patient or their authorized agent to have dispensed at a pharmacy of their choosing, if applicable;
- The rationale for the decision to initiate, adapt or renew the prescription (i.e., patient assessment, clinical guidelines consulted, etc.);
- Results of any laboratory or other tests considered;
- Confirmation that informed consent was received;
- Follow-up and monitoring plan;
- Any other relevant details and/or recommendations; and,
- The date that the original prescriber (and primary care provider if different) were notified, if applicable.
Documentation sent to a prescriber should be concise and must include relevant details respecting the pharmacist’s initiation, renewal or, if appropriate, adaptation of the prescription to ensure that the patient record is complete in both locations.
- Code of Ethics
- Minor Ailments Resources
- Standards of Practice for Pharmacists
- Standards of Operation
- Clinical viewers: ConnectingOntario and ClinicalConnect
- Ministry of Health Executive Officer Notices
Published: January 1, 2023
Version #: 5.00
College Contact: Pharmacy Practice
|1.00||October 2012||Expanded Scope of Practice Orientation Manual.|
|2.00||February 2018||Guideline extracted from manual.|
|3.00||December 2020||Review, reformatting and inclusion of scope changes from O. Reg 202/94.|
|4.00||December 2022||Revised to include prescribing exemption for Paxlovid™ in O. Reg. 107/96.|
|5.00||January 2023||Revised to include prescribing for minor ailments.|
- Health Canada has issued aControlled Drugs and Substances Act (CDSA) subsection 56(1) class exemption to permit pharmacists to adapt and/or renew prescriptions for controlled substances for the purposes of facilitating continuation of treatment. The quantity prescribed/dispensed cannot exceed the amount originally authorized. Pharmacy interns and registered pharmacy students are not named in this exemption.Please refer to the College’s Guidance – Providing a Prescription for Controlled Substances during the Coronavirus Pandemic for further information. ↑
- The substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent. ↑