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