Designated Manager – Medication Procurement and Inventory Management

Purpose

This policy articulates the College’s expectations of the Designated Manager (DM) with respect to the development of policies and standard operating procedures related to the procurement and management of drugs in community pharmacies.

Introduction

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 community 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.

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.

Definitions

Cold Chain: 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 required 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 narcoticscontrolled drugsbenzodiazepines and other targeted substances.

Narcotic: Any product or preparation which contains a drug named in the Schedule to the federal Narcotic Control Regulations (NCR). For the purpose of this policy, it does not include Exempted (“Low-Dose”) Codeine Preparations that may be sold without a prescription. (NCR)

Remote Dispensing Location: A place where drugs are dispensed or sold by retail to the public under the supervision of a pharmacist who is not physically present. Refer to the College’s guidance on the Operation of a remote Dispensing Location.

Policy

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.

Procurement

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

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 discovered, 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, as set out in the Time-Delayed Safes Policy
    • Although not mandatory, the DM is responsible for determining whether controlled drugs and targeted substances are secured within the time-delayed safe based on the unique circumstances of their pharmacy. Alternatively, storage in a safe without a time-delay mechanism is strongly encouraged.

Record-keeping

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.
Legislative References
Additional References
Implementation

Published: March 2024
Version #: 2.02
College Contact: Pharmacy Practice

Revision History
VERSION # DATE ACTION
1.00 2011 Newly developed policy
2.00 2014 Policy Reviewed
2.01 2023 Policy updated to include storage requirements for narcotics.
2.02 2024 Policy revised to reference Time-Delayed Safe Policy for narcotic storage requirements.