Designated Managers Practice Topic

It depends on the product’s classification at the federal level:

a) Natural Health Products (NHPs) containing pseudoephedrine and/or ephedrine (i.e., products assigned a NPN by Health Canada) are beyond the scope of the NAPRA National Drug Schedules (NDS) and therefore are not subject to the related NAPRA NDS conditions of sale. However, pseudoephedrine and ephedrine are still defined as ‘drugs’ by Ontario regulations, which limits their sale to accredited pharmacies in Ontario. In addition, Health Canada’s Ministerial Order sets out retail sale prohibitions for these NHPs across the country.

Designated Managers must ensure that these products are only available for sale while the pharmacy is in operation (i.e., when a pharmacist is physically present in the pharmacy, providing direct supervision to personnel).

Health Canada’s Order outlines the following conditions-of-sale restrictions:

Non-combination (“single entity”) NHPs containing only pseudoephedrine and/or ephedrine as medicinal ingredient(s) cannot be accessible to the public for self-selection (e.g., must be kept behind the counter).
Combination NHPs containing pseudoephedrine and/or ephedrine plus one or more other NHP ingredients (substances in Schedule 1 of the Natural Health Product Regulations) can be accessible to the public in the self-selection area of the pharmacy.
These restrictions also apply to remote dispensing locations (RDLs) and online sales. See related FAQ on “Who can sell products containing pseudoephedrine or ephedrine in the pharmacy.”

b) Health Canada’s Order does not apply to non-prescription drugs (NPDs) containing pseudoephedrine and/or ephedrine and other drugs (i.e., products assigned a DIN by Health Canada). Ontario regulations require pharmacies to follow the conditions of sale for a drug according to the NAPRA National Drug Schedules (NDS).

Therefore, if the NPD contains:

Schedule II or III drug(s): The ingredient with the most stringent NAPRA schedule determines its conditions for sale (e.g., if the NPD contains Schedule II and III drugs, then Schedule II applies).
Unscheduled (“Schedule U”) drug(s): They are not subject to the regulations and may be sold by any retail outlet.
In any case, the Designated Manager can choose to keep any NHP or NPD containing pseudoephedrine and/or ephedrine behind the counter if there are concerns about misuse or diversion.

It depends on the product’s classification at the federal level:

a) Natural Health Products (NHPs) containing pseudoephedrine and/or ephedrine (i.e., products assigned a NPN by Health Canada) are not included in the NAPRA National Drug Schedules (NDS) and therefore are not subject to the related NAPRA NDS conditions of sale. However, they are still defined as ‘drugs’ by Ontario regulations and Health Canada’s Ministerial Order sets out retail sale prohibitions for these products.

Designated Managers must ensure that these products are only available for sale while the pharmacy is in operation (i.e., when a pharmacist is physically present in the pharmacy, providing direct supervision to personnel).

Health Canada’s Order outlines the following conditions-of-sale restrictions:

• Non-combination (“single entity”) NHPs containing only pseudoephedrine and/or ephedrine as medicinal ingredient(s) can only be sold by a pharmacist or a person working under the supervision of a pharmacist.
• Combination NHPs containing pseudoephedrine and/or ephedrine plus one or more other NHP ingredients (substances in Schedule 1 of the Natural Health Product Regulations) can be sold only if a pharmacist is available to assist consumer prior to purchase if requested.

These restrictions also apply to remote dispensing locations (RDLs) and online sales. See related FAQ on “Can products containing pseudoephedrine or ephedrine only be sold in pharmacies?”

b) Health Canada’s Order does not apply to non-prescription drugs (NPDs) containing pseudoephedrine and/or ephedrine and other drugs (i.e., products assigned a DIN by Health Canada).

As Ontario regulations require pharmacies to follow the conditions of sale for a drug according to the NAPRA National Drug Schedules (NDS), if the NPD contains:

• Schedule II or III drugs
  • The ingredient with the most stringent NAPRA NDS conditions for sale determines whether pharmacist intervention is required; and
  • The Supplemental Standards of Practice for Schedule II and III Drugs apply.
• Unscheduled drug(s)
  • They are not subject to the regulations and may be sold by any retail outlet.

In any case, the Designated Manager can choose to implement procedures for a pharmacist to intervene in the sale of any NHP or NPD containing pseudoephedrine and/or ephedrine, if there are concerns about misuse or diversion.

The federal Precursor Control Regulations sets a maximum amount of pseudoephedrine and/or ephedrine that may be sold per package*, but not a limit on the total amount or quantity of pseudoephedrine and/or ephedrine that may be sold per transaction. Nevertheless, registrants have a professional and ethical obligation to prioritize the safety and best interests of the patient and the public.

If diverted to the illicit market, pseudoephedrine or ephedrine can be used to illegally produce D-methamphetamine (“meth”, “crystal meth”), which poses a significant risk to public health and safety. Given these risks, registrants must remain vigilant and exercise professional judgment when determining the quantity to sell, considering the patient and circumstances, to prevent potential substance misuse. For example, a registrant may restrict or limit the quantity sold to an individual if the request appears inappropriate based on their assessment.

*Based on maximum amount of pseudoephedrine and/or ephedrine base per package (e.g., maximum for pseudoephedrine base is 3 grams = 3.659 grams pseudoephedrine HCL). For conversion factors, refer to: https://www.deadiversion.usdoj.gov/quotas/conv_factor/index.html.

Providing a copy of the original with the transfer would be considered a best practice in the interest of patient safety. Unlike a refill, the logged prescription has never been dispensed and has not gone through the same complete checking process. This is the same reason registrants within their own practice site should be retrieving or viewing the original hardcopy before a logged prescription is dispensed.

The Code of Ethics also expects that when a patient moves from one healthcare provider to another, the relevant information is provided to the receiving healthcare provider, to ensure safe and effective transition of care

The College does not stipulate the number of hours a DM must work at their pharmacy nor set out time limits for absences. Rather, the responsibility is on the DM to determine the amount of time they need to be present to fulfill their obligations.

The DM is responsible for the overall day-to-day operation of the pharmacy whether they are physically present or not. In the event of an extended period of absence for any reason, it is up to the registrant to decide if they can continue to meet their obligations and duties as DM during this time or whether another pharmacist should take on this role in the interim. Whenever there is a change in the DM, the pharmacy owner must file notice of the change with the College.

Pharmacist owners/directors automatically assume responsibility in the absence of a DM. If there is no DM on a pharmacy’s record with the College, a representative from Pharmacy Applications & Renewals will follow up with the owner/director liaison. Compliance with the Drug and Pharmacies Regulation Act, which requires a DM to be on the public register, is a requirement for the annual renewal of the pharmacy’s certificate of accreditation.

Nothing prohibits a pharmacist from acting as the DM at more than one community pharmacy. It is the pharmacist’s responsibility to ensure they are capable of fulfilling their obligations at every pharmacy where they hold this designation.

The DM has authority and accountability over decisions affecting the operation of a pharmacy and is responsible for effectively overseeing the day-to-day management of the pharmacy.

Regulations place the responsibility of maintaining the standards of accreditation on the owner and DM. To ensure staff engagement and understanding in maintaining these standards, the DM must provide access and orientation to the pharmacy’s policies and procedures and have systems in place to assess ongoing compliance. For example, policies and procedures should address how pharmacy staff are required to collect, use, protect, store and dispose of personal health information, especially when using technology to deliver patient care.

DMs must meet and maintain the Standards of Operation for the pharmacy, which include implementation of the College’s Assurance and Improvement in Medication Safety (AIMS) program to support patient safety and continuous quality improvement. Internal policies and procedures must be regularly reviewed and updated in response to changes in the practice environment (i.e., public health emergencies, amendments to legislation, new equipment, etc.).

The Professional Supervision of Pharmacy Personnel Policy further describes the role of the DM in human resources management, such as ensuring:

• adequate supervision of both professional and lay staff to perform their assigned duties
• controlled acts are only performed by regulated staff or under delegation.
• workflow processes are sound, robust and consistently followed to optimize the delivery of professional services
• staffing supports registrants in meeting the standards of practice for patient care at all times

A comprehensive list of obligations can be found under the Role of Designated Manager section in the Application for a Certificate of Accreditation and/or Change of Designated Manager Form.