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 community pharmacy. It is the responsibility of the DM to actively and effectively participate in the day-to-day management of the pharmacy.
Cold Chain: A cold chain is a temperature-controlled supply chain for drugs that require a specific temperature range during distribution and storage from the time of manufacture to administering to an individual. The cold chain includes all of the materials, equipment and procedures used to maintain the requirement temperature range.
Controlled substance: A drug named in the federal Controlled Drug and Substances Act (CDSA), Schedules I, II, III, IV, V. These drugs are also listed in the schedules to the regulations as narcotics, controlled drugs, benzodiazepines and other targeted substances.
Remote Dispensing Location
A remote dispensing location is a place where drugs are dispensed or sold by retail to the public under the supervision of a pharmacist who is not physically present. See the College’s guidance on the Operation of a remote Dispensing Location.
A time-delayed safe is a safe that:
- is constructed of solid metal;
- contains an integrated electronic locking mechanism with a time-delay release; and,
- is secured in place or is of a size and weight that it cannot be easily removed.
The DM is accountable for the overall operation of the pharmacy including supervision of staff, facilities, equipment, and supplies. The DM is also responsible for the supervision of all aspects of the operation of remote dispensing locations, if any.
The DM is responsible for meeting the Standards of Operation ensuring 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.
- 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 must ensure that inventory is appropriately managed, and while they may not be directly in charge of medication distribution and supply, the DM is accountable for ensuring that all related standards are met.
- The DM ensures that there are policies and standard operating procedures in place to maintain safe and effective medication procurement and inventory management.
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.
An effective procurement process ensures the availability of drugs that are appropriate to the patient’s circumstances, at recognizable standards of quality. The DM ensures that all drugs purchased for use or sale are of an acceptable standard and quality and are approved for sale in Canada.
The DM ensures that the policies and procedures for procurement comply 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.
- 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, in accordance with the College’s Guideline – Protecting the Cold Chain
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 using the most appropriate methods.
The DM ensures that policies and procedures are in place to guarantee the proper storage of all inventories that are not offered for sale immediately.
- The DM ensures 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 there is a method for identifying drugs 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 with a dispensary.
Controlled Substances (Narcotics, Controlled Drugs, and Targeted Substances)
The DM ensures that policies and procedures are in place and takes reasonable steps to ensure the security of controlled substances in the pharmacy’s inventory.
- The DM ensures and oversees 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. Whenever losses of controlled substances are reported, the DM ensures that such losses are reported to Health Canada
- The DM ensures that all narcotics are securely locked in a time-delayed safe, which is located inside the dispensary. The time-delay must be set to a minimum of five minutes.
- Although not mandatory, the DM is responsible for determining whether controlled drugs and targeted substances are stored within the time-delayed safe based on the unique circumstances of their pharmacy.
- Controlled drugs and targeted substances must be stored in the dispensary area where only authorized pharmacy personnel have access. Storage in a safe (with or without a time-delay mechanism) is strongly encouraged.
The DM ensures that procedures are in place to maintain the records required by federal and provincial legislation governing the procurement, movement, and sale of drugs in a manner that is secure, auditable, traceable, and allows for their easy retrieval.
Remote Dispensing – Additional Requirements
Where the certificate of accreditation of the pharmacy permits the operation of (a) remote dispensing location(s), the DM shall supervise inventory management by establishing, implementing, and monitoring the use of, policies and procedures for the safe and appropriate storage of drugs as required by the Standards of Operation and regulations. This includes:
- Regularly inspecting the location to ensure proper storage conditions and the integrity of drugs are being maintained
- Ensuring that any automated pharmacy systems in use are loaded by the DM or their delegate, in a manner that is accurate and traceable.
The DM ensures that systems are in place to track the movement of drugs 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, in accordance with the College’s Guideline – Protecting the Cold Chain.
- Ontario Drug and Pharmacies Regulation Act, 1990 and Regulations
- Ontario Drug Interchangeability and Dispensing Fee Act, 1990 and Regulations
- Federal Controlled Drugs and Substances Act, 1996 (CDSA)
- Narcotic Control Regulations (NCR, s42, 43, 63)
- Benzodiazepine and Other Targeted Substances Regulations (BOTSR, s72)
- Federal Food and Drug Regulations, (C.R.C., c.870) Part G (FDR, G03.012, G03.013, G05.004)
- Model Standards of Practice for Canadian Pharmacists
- GUIDELINE – Protecting the Cold Chain
- GUIDANCE – Operation of a Remote Dispensing Location
- FACT SHEET – Controlled Substances: Purchase & Sales Record Requirements (Federal)
Published: March 2023
Version #: 2.01
College Contact: Pharmacy Practice
|1.00||2011||Newly developed policy|
|2.01||2023||Policy updated to include storage requirements for narcotics.|