- Model Standards of Practice for Canadian Pharmacists
- Drug and Pharmacies Regulation Act and Regulations
College Contact: Pharmacy Practice
To clarify the obligations of the designated manager (DM) with respect to the development of policies and standard operating procedures related to the procurement and management of drugs and medications in the pharmacy.
As defined in the Drug and Pharmacies Regulation Act, 1990 (DPRA) the DM is the pharmacist designated by the owner of the pharmacy, in information provided to the College, as the pharmacist responsible for managing the pharmacy.
The DM is a pharmacist in Part A of the register who is responsible for the human resources management in a pharmacy, including the supervision of both professional and lay staff. Part B pharmacists are permitted to supervise registrants in hospitals or health care facilities as managers; however, they remain ‘non-practicing’ pharmacists.
The DM’s responsibilities are equal to that of the person, or the directors of a corporation, who have been issued a certificate of accreditation to ensure that the pharmacy conforms to the requirements set out in legislation and regulations.
Where a panel of the Accreditation Committee believes a DM has contravened the provisions of the DPRA, the Committee may refer allegations of proprietary misconduct against the DM for breaches of the DPRA to the Discipline Committee which can make a finding of proprietary misconduct against the DM.
The DM has the same professional practice obligations as all registered pharmacists, and in addition to these, the DM has authority and accountability over decisions affecting the operation of a pharmacy. It is the responsibility of the DM to actively and effectively participate in the day-to-day management of the pharmacy.
- Patient safety is a priority in procurement and inventory management;
- An effective procurement process ensures the availability of drugs and medications that are appropriate to the patient’s circumstances, at recognizable standards of quality;
- Good inventory control supports procurement and utilizes appropriate systems to track shipments and inventory, and to forecast needs to ensure that patients continue to have reasonable access to pharmaceutical products for their health and well-being; and
- All registrants in the pharmacy who have a role in medication procurement and inventory management must receive training with respect to their legal obligations and expected standards of practice.
Automated Pharmacy System
An automated pharmacy system is a mechanical system that performs operations or activities with respect to the storage and packaging of drugs or medications, and with respect to their dispensing or distribution directly to patients.
A cold chain is a temperature-controlled supply chain. A cold chain is mandatory where products require a given temperature range during distribution and storage. Products that have not been maintained at the appropriate temperature are considered to be unsafe for distribution and sale.
Remote Dispensing Location
A remote dispensing location means a premises where drugs are dispensed or sold by retail to the public and that is operated by, but is not at the same location as, a pharmacy whose certificate of accreditation permits its operation.
The DM is accountable for the overall operation of the pharmacy including supervision of staff, facilities, equipment, and supplies. It is the responsibility of the DM to ensure that the layout of the pharmacy conforms to legal requirements and that the placement of non-prescription products conforms to the provisions outlined in the legislation and regulations. The DM must ensure that inventory is appropriately managed, and while he or she may not be directly in charge of medication distribution and supply, he or she is accountable for ensuring that all related standards are met. The DM is responsible to ensure that only registrants with the Ontario College of Pharmacists perform the controlled acts permitted according to the terms, limits, and conditions of their certificates of registration. A pharmacist must be present at all times that the pharmacy is open.
The DM ensures that there are policies and standard operating procedures in place to maintain safe and effective drug and medication procurement and inventory management. It is the responsibility of the DM to ensure that staff members whose duties include procurement and inventory management are appropriately trained, and that record keeping and documentation systems are in place as required in legislation and regulation.
The DM is responsible for the supervision of all aspects of the operation of remote dispensing locations, if any. Where a pharmacy whose certificate of accreditation permits it to operate a remote dispensing location that is an automated pharmacy system, only the DM, or their delegate, is permitted to load drugs into the system.
The DM ensures that all drugs and medications purchased for use or sale are of an acceptable standard and quality. The DM ensures that the policies and procedures that support procurement are in compliance with federal and provincial legislation. The DM ensures there are appropriate policies and procedures in place to manage the cold chain in product delivery, once the pharmacy takes custody of the product, to ensure product quality and efficacy and thus patient safety.
Inventory management is to be executed in a manner which protects patient safety through the identification and disposal of outdated, deteriorated, recalled, obsolete, or hazardous drugs and medications using the most appropriate methods. The DM ensures that policies and procedures are in place to guarantee the proper storage of all medications, natural health products, and drug products that are not offered for sale immediately and that such products are stored in an area that is clean and organized with appropriate temperature, light, humidity, ventilation, regulation, security, and safety. The DM ensures that systems are in place to track the movement of drugs and other medications between and among the pharmacy and its remote dispensing locations. Where a cold chain is required, the DM ensures that products are received and stored within their appropriate temperature ranges and that the cold chain is not broken.
The DM ensures that systems are in place to allow for tracking of the movement of drugs and medications within the pharmacy and between the pharmacy and remote dispensing locations. The DM ensures there is a method for identifying products that are outdated, deteriorated, recalled, obsolete, or hazardous, and that such products are disposed of in a safe, legal, and environmentally sound manner. The DM ensures that drugs are located in the area of the pharmacy appropriate to their drug classification and that storage areas are only accessed by designated personnel who are appropriately trained, including in a remote dispensing location that operates a dispensary.
Narcotic and Controlled Drugs
The DM ensures that policies and procedures are in place to secure and protect the controlled and targeted substances in the pharmacy’s inventory. The DM directs that a physical count and reconciliation of all narcotics, controlled drugs and targeted substances is conducted regularly, at least once every six months, and that the results of the inventory count are retained in the pharmacy’s records for a two-year period in a readily retrievable format. The DM investigates where shortages or losses occur. Where losses of narcotics, controlled drugs, or targeted substances are reported, the DM ensures, as required by law, that such losses are reported to the appropriate authority.
The DM ensures that policies and procedures are in place to create a record of every sale of a drug referred to in the Schedules of the Controlled Drugs and Substances Act and/or the Schedule to the Narcotic Control Regulations.
Where the certificate of accreditation of the pharmacy permits remote dispensing, the DM shall establish and implement and be responsible for monitoring the use of policies and procedures to address the safe operation of the remote dispensing location(s) and automated pharmacy system(s) as required in regulation.