Practice Review Program Insights: Drug Product Distribution Requirements

The Practice Review Program is picking up steam. College Compliance Officers are completing more and more practice reviews every week.

As a result, there will be a new series of ReadLinks articles that focus on topics related to either the Pharmacy Review or the Pharmacy Professionals Review.

This first installment of Practice Review Program Insights is on the topic of Drug Product Distribution Requirements.

Compliance Officers have been finding some non-prescription products placed in an incorrect area of a community pharmacy. The following table contains the correct drug schedules for non-prescription products that were found to be misplaced during the Pharmacy Reviews. Please review your pharmacy product storage and correct any misplaced products in order to meet compliance measures during a Pharmacy Review.

Drug	Drug Schedule
Antipyrine for otic or topical use	2
Dimenhydrinate and its salts (for oral use when sold in packages of greater than 30 dosage units or for parenteral use) Dimenhydrinate and its salts (for oral use when sold in packages of 30 dosage units or less or for rectal use)	2 3
Magnesium citrate (cathartics)	3
Sodium biphosphate (cathartic)/ Sodium phosphate (cathartics)	3
Famotidine and its salts (when sold in concentrations of 20 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 600 mg of famotidine)	3
Ranitidine and its salts (when sold in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 4 500 mg of ranitidine)	3
Pramoxine and its salts (for topical use on mucous membranes, except lozenges)	3
Hydrocortisone or hydrocortisone acetate (when sold in a concentration that provides 1% or less hydrocortisone in preparations for topical use on the skin, for adults and children 2 years of age and over, and in package sizes containing no more than 30 g)	3
Fluconazole (when sold in a concentration of 150 mg per oral dosage unit and indicated for the treatment of vaginal candidiasis, in package sizes containing no more than 150 mg of fluconazole	3

Schedule II drugs may be sold by a pharmacist on a non-prescription basis and which must be retained within the professional service area of the pharmacy where there is no public access and no opportunity for patient self-selection.

Exempted codeine products must be kept within the professional service area where they are inaccessible and not visible to the public.

If a patient purchases a Schedule II drug, a full, limited or student pharmacist must counsel the patient or the patient’s representative regarding the selection and use of the drug.

Schedule III drugs may be sold by a pharmacist to any person from the self-selection professional products area of a licensed pharmacy.

A full pharmacist must be available for consultation with a patient or patient’s representative who wishes to select a Schedule III drug.

In locations where a community pharmacy does not comprise 100 per cent of the total area of the premises, the pharmacy manager must ensure that:

the professional products area extends not more than 25 feet from the perimeter of the dispensary, and
the professional products area is visually distinctive from the remaining areas of the premises by signage, and
all non-prescription medications in this drug schedule must be either secured behind the “lock-and-leave” barrier or removed into the dispensary when the pharmacist is not on duty.

The Drug Product Distribution Requirements for Community Pharmacies document is a resource for pharmacy staff to help identify Schedule 2 and 3 products.

Note: As of February 25, 2015, the following products are still under Schedule 1 (i.e. requires a prescription) in British Columbia although they are listed as schedule 2 or 3 in other jurisdictions in Canada: