April 8, 2020: Important update regarding the novel coronavirus (Covid-19) pandemic
Health Canada has issued a temporary Controlled 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.
For the purposes of this exemption, “adapt” means to change a patient’s prescription respecting the dose, regime, or dosage form of the prescribed drug, the de-prescribing of the prescribed drug, or the part-filling of the prescription, but does not include therapeutic substitution.1 Prior to adapting or renewing, pharmacists are expected to collaborate with the prescriber or primary care provider. If collaboration is not possible, in order to maintain continuity of care for the patient, pharmacists may proceed with the adaptation or renewal and notify the prescriber within a reasonable period of time. When adapting or renewing, the quantity prescribed/dispensed cannot exceed the amount originally authorized.
Pharmacy interns and registered pharmacy students are not named in this exemption therefore only a pharmacist may adapt, renew or transfer a prescription for a controlled substance.
Please refer to the College’s Guidance – Providing a Prescription for Controlled Substances during the Coronavirus Pandemic for further information.
Regulatory changes that would expand the scope of pharmacists to prescribe for minor ailments 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 prescribing a drug within a pharmacist’s authorized scope of practice 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, 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.
A pharmacist may initiate, adapt or renew a prescription only if:
- the pharmacist has sufficient knowledge and skills with respect to the relevant drug and condition to initiate, adapt or renew the drug safely and effectively
- the initiation, adaptation or renewal is in the best interest of the patient
A pharmacist is authorized to prescribe
- Varenicline tartrate and/or bupropion hydrochloride for the sole purpose of smoking cessation
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 record, etc.).
Pharmacists do not have the authority to renew or adapt 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 substitution1.
- 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 month supply.
Expectations for pharmacists initiating, adapting or renewing:
1. Assess patient
The pharmacist determines that the therapy is safe and effective by considering the risks and benefits and other relevant individual circumstances of the patient, including, but not limited to the following:
- The patient’s medical history, including co-morbid disease states and chronic conditions;
- Laboratory or other tests, as available;
- Symptoms reported by the patient;
- Any red flags associated with the condition;
- The patient’s allergies and other contraindications and precautions;
- Other medications the patient may be taking;
- The patient’s gender, age, weight and height (where applicable);
- Pregnancy and lactation status, if applicable;
- Any other inquiries reasonably necessary in the circumstances.
2. Obtain Informed Consent to Treatment
Prior to initiating a prescription, 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.
- 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. Prepare the prescription (if appropriate)
When initiating, adapting or renewing, 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, 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 have the option of taking it to the pharmacy of their choice for dispensing.
4. Document and Notify
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 provided to the patient or the patient’s authorized agent to take to a pharmacy of their choosing, if applicable;
- the rationale for initiating, adapting or renewing the prescription (i.e. patient assessment, monitoring plan, etc.);
- results of any laboratory or other tests considered;
- confirmation that informed consent was received;
- the date that the original prescriber (and primary care provider if different) were notified, if applicable, and;
- any other relevant details.
Pharmacists are expected to review and adhere to the College’s Record Retention, Disclosure and Disposal Guideline and Documentation Guidelines.
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.
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.
1The substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent.
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.|