Exempted Codeine Products are defined in section 36 of the Narcotic Control Regulations (Canada) as follows:
36 (1) A preparation containing not more than 8 mg or its equivalent of codeine phosphate per tablet or per unit in other solid form or not more than 20 mg or its equivalent of codeine phosphate per 30 mL in a liquid preparation if
a) the preparation contains
i) two additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-half the regular minimum single dose for each such ingredient, or
ii) three additional medicinal ingredients other than a narcotic in a quantity of not less than the regular minimum single dose for one such ingredient or one-third the regular minimum single dose for each such ingredient; and
b) there is legibly and conspicuously printed on the inner label and the outer label, as those terms are defined in section A.01.010 of the Food and Drug Regulations, a caution to the following effect:
“This preparation contains codeine and should not be administered to children except on the advice of a physician, dentist or nurse practitioner.”
The regulations go on to state that:
No pharmacist shall sell or provide a preparation referred to in subsection (1) if the pharmacist has reasonable grounds to believe that the preparation is to be used for purposes other than recognized medical or dental purposes.
ECPs are listed in Schedule 2 of the National Drug Schedules, which requires they be retained in an area of the pharmacy where there is no public access and no opportunity for patient self-selection and require professional intervention from the pharmacist at the point of sale and possible referral to a practitioner. When providing Schedule 2 medications, pharmacists are expected to meet the consultation requirements outlined in the College’s Standards of Pharmacy Operation – Community Pharmacy.
Sale of Exempted Codeine Products in Community Pharmacies Standards of Practice
The following Standards of Practice describe the minimum expectations for pharmacists who provide exempted codeine products (ECPs) to patients and are intended to promote consistency in the provision of the service to the people of the province.