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.
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: February 2018, April 2020
College Contact: Pharmacy Practice
For the purposes of this document, where the term ‘pharmacist’ is used, it is inclusive of pharmacy students and interns according to any terms, conditions and limitations on their certificates of registration. Where this is not the case, it will be clearly identified.
This guideline outlines the requirements for initiating, renewing or adapting a prescription within the authorized scope of practice of a pharmacist.
- Pharmacy professionals have an obligation to protect and promote the health and well-being of patients and all pharmacy services are provided to support this obligation and the best interest of the patient;
- 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;
- When initiating, adapting or renewing prescriptions, a pharmacist assumes full responsibility and liability for that prescription, documents actions as required, and undertakes notifications as appropriate; and
- Pharmacy services are provided within the context of the Code of Ethics, Standards of Practice, legislation and College Policies and Guidelines.
A pharmacist may initiate, adapt or renew a prescription only if:
- the pharmacist has the required knowledge and skills with respect to the relevant drug and condition to initiate, adapt or renew the drug safely and effectively, and
- the treatment, adaptation or renewal is in the best interest of the patient.
The following requirements must be met for a pharmacist to initiate, adapt or renew a prescription:
- Initiating therapy
A pharmacist may initiate a prescription for the purpose of smoking cessation, for a drug specified in the regulations. These medications are varenicline tartrate and bupropion hydrochloride.
- Adapting or Renewing a prescription
The pharmacist must be in possession of the existing order or 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 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 original prescriber; or
- A six month’s supply.
When initiating, adapting or renewing, the pharmacist must ensure the following:
1. Patient Assessment
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:
a) The patient’s medical history, including co-morbid disease states and chronic conditions;
b) Laboratory or other tests, as available;
c) Symptoms reported by the patient;
d) The patient’s allergies and other contraindications and precautions;
e) Other medications the patient may be taking;
f) The patient’s gender, age, weight and height (where applicable);
g) Pregnancy and lactation status, if applicable;
h) Any other inquiries reasonably necessary in the circumstances.
2. Obtain Informed Consent
Informed consent to treatment requires that the patient or patient’s authorized agent has received enough information regarding the risks and benefits of therapy to make a decision about receiving the treatment. The patient or patient’s authorized agent must 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 his or her consent freely without any kind of coercion or deception.
Depending on whether initiating, adapting or renewing a prescription, the required level of informed consent to be obtained by the pharmacist may differ.
- Initiating: The pharmacist must always obtain informed consent.
- Adapting or renewing: The pharmacist may rely on the informed consent that the patient, or his or her authorized agent, has already given to the prescriber for the patient’s treatment (i.e. implied consent). If in the pharmacist’s professional judgement, a proposed adaptation will have clinically significant outcomes, the pharmacist must seek additional consent from the patient or his or her authorized agent. A good indication of whether to seek consent is whether the pharmacist considers the change significant enough to notify the prescriber of the adaptation.
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 in the case of initiating or adapting in a clinically significant manner, consent 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. The Prescription
When initiating, adapting or renewing, the pharmacist must ensure the following information is recorded on the prescription:
a) The name and address of the person for whom the drug is prescribed;
b) The name, strength (where applicable), and quantity of the prescribed drug;
c) The direction for the use of the drug, including its dose, frequency, route of administration, and any special instructions;
d) The name, address, telephone number, College registration number, and signature of the pharmacist;
e) The date the prescription was issued;
f) The number of refills that the pharmacist has authorized, if applicable; and
g) In the case of adapting or renewing, a reference to the original prescription, including the name and contact details of the original prescriber.
At the time of initiating, adapting or renewing, the pharmacist must advise the patient or his or her authorized agent that he or she has the option of having the prescription dispensed at another pharmacy if they wish.
4. Documentation and Notification
When initiating, adapting or renewing, a pharmacist must document in the patient record:
a) a copy of the prescription, containing all necessary prescription information, provided to the patient or the patient’s authorized agent (recorded at the time of initiating, adapting or renewing),
b) reference to, or a copy of, the original prescription if adapting or renewing,
c) his or her rationale for initiating, adapting or renewing the prescription (i.e. patient assessment, monitoring plan, etc.)
d) results of any laboratory or other tests considered,
e) details regarding patient consent,
f) the date that the original prescriber (and primary prescriber if different) were notified, as applicable and
g) 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 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 notification is necessary to support the patient’s care. If the patient’s primary health care provider is different from the original prescriber, he or she should also be notified in a reasonable time to ensure continuity of care.
Any documentation sent to a prescriber should be concise and must include relevant details respecting the pharmacist’s initiation, adaptation or renewal 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.