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Dispensing opioids and labels

I am an RN, working in an outpatient chronic pain clinic.  I was told there will be new requirements when providing opioids to clients.  What are these requirements? 

On Oct. 20, 2018 there will be new requirements under the Food and Drug Regulations to ensure patients are provided with clear, consistent information about the safe use of opioids, and the risks associated with their use. The new laws will require nurses dispensing a Class A opioid to:

It is important to note that dispensing is not the same as administering a medication. The College of Nurses of Ontario defines “dispensing” as selecting, preparing and transferring stock medication for one or more prescribed medication doses to a client or the client’s representative for administration at a later time. 

A nurse will not need to provide a warning sticker or an information handout to a client if the nurse is administering the prescription opioid directly to the client. 

For more information about these new requirements, you can review Health Canada’s Q&As

For more information about nurses’ accountabilities related to all medication practices, including dispensing, you can read the Medication practice standard or view the Medication Decision Tool.

What is considered a Class A opioid? 

Under the Food and Drug Regulations, a warning sticker and patient information handout must be provided with all prescription opioids that appear in Part A of the List of Opioids at the time of dispensing.

You can refer to Health Canada’s List of Class A Opioids for an up-to-date list of all opioids subject to these prescription labelling requirements. 

What are my accountabilities when dispensing Class A opioids? 

In order to comply with the new rules, nurses who dispense prescription opioids must apply a warning sticker to the prescription bottle, container or package; and provide a patient information handout to accompany the drug. 

The warning sticker and patient information handout are available on the Government of Canada’s Information for Patients Concerning Opioids webpage. Health Canada will not distribute copies of the warning sticker or the patient information handout. 

Nurses who dispense Class A opioids are responsible for ensuring their practice is consistent with Health Canada’s requirements. Nurses are encouraged to collaborate with their employer to understand the issue and obtain or produce copies of the sticker and handout. 

For more information on accountabilities related to medication practices, please see the Medication practice standard.

Page last reviewed August 02, 2018