Dialogue Volume 14 Issue 3 2018 - Page 17

OPIOIDS New rules for dispensed opioids Warning sticker, information handout must accompany the drug at the time of sale A s of October 23, 2018, practitioners and pharmacists who dispense prescription opioids to patients will need to apply a warning sticker to the prescription drug package and provide a patient information handout to accompany the drug at the time of sale. The sticker and handout are not required to accom- pany the opioid when the drug is to be administered under the supervision of a practitioner. Such situations would usually occur in a hospital ward for admitted patients, a nursing home, outpatient clinic, emergency department or outpatient surgery settings. Under the Food and Drug Regulations, the warning sticker and information handout must be provided with all prescription opioids that appear in Part A of the List of Opioids at the time of dispensing. Physicians 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. The sticker warns patients about the risks of de- pendence, addiction and overdose. The patient informa- tion handout contains broader information on the safe use of opioids as well as the risks associated with opioid use, including: serious warnings, signs of overdose, pos- sible side effects, and information on safe storage and disposal of opioids. The handout also provides a link to more detailed information on approved prescription opioids, which can be found in their official Canadian Product Monographs. These requirements are supplementary to existing prescription drug labelling requirements, which remain in effect. Digital representation of the warning sticker and pa- tient information handout are available on the Govern- ment of Canada’s website. MD ISSUE 3, 2018 DIALOGUE 17