Frequently asked questions: Subsection 56(1) class exemption for patients, practitioners and pharmacists prescribing and providing controlled substances in Canada during the coronavirus pandemic
The World Health Organization’s declaration on March 11, 2020, that the novel coronavirus (COVID-19) is now a pandemic and has marked a significant shift in the response from communities across Canada and at all levels of government.
In response to this evolving health risk, Health Canada has issued a short-term subsection 56(1) exemption from the Controlled Drugs and Substances Act in the public interest. This exemption authorizes pharmacists to prescribe, sell, or provide controlled substances in limited circumstances, or transfer prescriptions for controlled substances.
Specifically, and subject to the laws and regulations of the province or territory in which the pharmacist is entitled to practice, this exemption will:
- Permit pharmacists to extend and renew prescriptions;
- Permit pharmacists to transfer prescriptions to other pharmacists;
- Permit practitioners to verbally prescribe prescriptions with controlled substances; and
- Allow an individual to deliver controlled substances to patients (at their homes or an alternate location).
Health Canada will continue to work closely with stakeholders to ensure that any concerns are adequately addressed, and will continue to support the implementation of the exemption.
The following aims to further clarify the scope of the exemption on providing controlled substances during the Coronavirus pandemic.
The use of couriers to ship controlled substances is a well-established practice. For clarity on other options to transport prescriptions with controlled substances, please refer to the document “Transportation of Controlled Substances in Canada” found on Health Canada’s website. The intention of this exemption is to enable an individual (e.g., pharmacy technicians, pharmacy employee, courier or individual requested by the patient, etc.) to be able to assist in delivering controlled substances to those patients in self-isolation or in other similar situations.
Frequently asked questions
Can a prescription be initiated via a verbal order under this exemption?
Yes. A practitioner can provide a new prescription for controlled substances to a pharmacist verbally under this exemption. Once the prescription has been “ordered” all other authorities under the exemption apply (i.e. transfer, renew, extend).
Does the exemption require that a patient be an existing/previous client of a pharmacy?
No, this can apply to any new customer or client as well, though the patient must be a under the professional treatment of a pharmacist at the time they are conducting the activity. Provincial/territorial guidelines for pharmacists will often define or help determine when a client would be under the professional care or treatment of a pharmacist.
Must a pharmacist be authorized to initiate a new prescription (i.e., start a therapeutic treatment regime) to benefit from this exemption?
The intent of the exemption is for pharmacists to be able to renew, extend, and transfer prescriptions. Under this exemption, a pharmacist must be authorized and entitled under the laws of a province or territory to practice pharmacy. In addition, their scope of practice must include prescribing of drugs in a manner consistent with any applicable provincial or territorial pharmacy legislation and any applicable policies of a provincial or territorial licensing authority. What this means is that in order to benefit from the exemption the pharmacist must be entitled to conduct the activity that they are conducting (i.e. extend, renew, transfer) by their provincial or territorial legislation, regulation and scope of practice.
What is meant by the phrase “...must be for the purpose of facilitating continuation of treatment that the patient was already receiving”? Does this phrase mean that the exemption applies only to prescriptions that had been dispensed before the date of this exemption?
This means that pharmacists can extend, renew or transfer prescriptions that have been initiated by a practitioner before or after the date of this exemption subject to the terms and conditions of the exemption. Pharmacists cannot initiate new treatments or drugs.
The exemption requires a note from the pharmacist if a prescription is being delivered, which sets out the name of the drug in the package. Can this note be inside the package/bag to respect a patient’s privacy?
Yes, it is not necessary to include details of what is being delivered on the exterior of the packaging. The packaging should include contact information to reach the pharmacist in case there are any questions or issues that arise during the delivery.
If a prescription is transferred to another pharmacy, can it be delivered or must it be picked up?
Once the prescription is transferred, the medication can be picked up or delivered.
Can prescriptions be transferred to another province?
Prescriptions transferred under this exemption cannot be transferred to another province.
Can I refill a prescription when a patient presents at my pharmacy with a vial/bottle of a narcotic drug that was dispensed by another pharmacy? How could this exemption apply in this case?
Pursuant to this exemption, pharmacists can only dispense medications when they are in possession of a prescription or written order. If a prescription at another pharmacy exists, it could be transferred, or the pharmacist could contact the prescribing physician to obtain a verbal prescription, if appropriate. It is also important that pharmacists continue to rely on any policies and/or guidelines established by the provincial or territorial government and by any relevant provincial or territorial licensing authorities.
Can I refill a prescription if a client of my pharmacy asks that I do so and the drug is a narcotic drug and there is no prescription on file for this patient? How could this exemption apply in this case?
As above, there must be an existing prescription or written order in order for the pharmacist to dispense, extend or renew a prescription. The patient would have to have the medication prescribed to them by a practitioner, including via verbal prescription pursuant to this exemption.
Is Health Canada going to monitor/inspect against compliance with this exemption?
At this time, Health Canada’s inspection programs are conducting only critical inspections during the pandemic. When the regular pharmacy inspection program resumes, Health Canada inspectors may verify records that must be maintained as part of their usual practice to verify compliance in relation to pharmacy practice generally.
Why does the exemption state that Health Canada can suspend or revoke this exemption?
Exemptions are granted on an exceptional basis and the ability to suspend or revoke is often included in exemptions. However, the exemption would not be suspended or revoked unless warranted and reasonable in the circumstances. Given the purpose of this exemption and its national application, if any issues of noncompliance arose, Health Canada would make best efforts to work with the relevant party to bring about compliance before considering suspension.
Respecting revocation: This exemption automatically expires no later than September 30, 2020. However, if the exemption is no longer necessary prior to that date, consideration could be given to revoking the exemption.
It should also be noted that Health Canada would consider issuing a new exemption if the exemption expires, but is still necessary.
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