Protecting the Cold Chain Guideline

Purpose:

This guideline outlines the requirements for maintaining the quality and integrity of medications that are temperature-sensitive according to established standards, guidelines and regulations.

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Definitions:

Cold chain: A temperature-controlled supply chain for medications 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.

Cold storage equipment: The equipment (i.e., refrigerator or freezer) used to maintain medications within the required storage temperature range.

Temperature excursion: An event in which a product is exposed to a temperature outside of the required storage temperature range for any length of time. Also referred to as a “Cold Chain Incident”.

Guideline:

Publically funded vaccines must meet the standards specified in the Ontario Ministry of Health Vaccine Storage and Handing Guideline. Local public health units will work in collaboration with pharmacies to ensure compliance with these provincial requirements.

Guidelines for vaccine storage and handling may be consulted for best practices which can be applied to other medications that require cold chain and/or temperature-controlled storage.

Equipment and monitoring

A pharmacy must be designed and maintained to ensure the safe and appropriate storage of all medications. This requires suitable facilities, systems and equipment for temperature-appropriate storage, to safeguard the integrity of the pharmacy’s inventory, and in turn protect the health, safety and wellbeing of patients.

  • Cold storage equipment must be fit for purpose and well maintained.
  • Records for preventative maintenance, calibration, etc. should be kept.

Temperature monitoring and recording is critical to ensuring that products are stored within the recommended temperature range.

  • The Product Monograph and label for an approved Health Canada drug product specifies the recommended storage conditions for each dosage form.
  • Designated Managers and Hospital Pharmacy Administrators should determined what method of tracking is most appropriate, such as manual or electronic, based on their needs.
  • Temperatures must be monitored regularly. For manual recording, the minimum and maximum temperature should be recorded twice per day.
  • A temperature monitoring device that warns when temperatures are outside the recommended range is an essential component of effective temperature monitoring.
  • Clear procedures should outline the steps to take in a cold chain break, and may involve checking stability data for medications. The integrity of medications must be assessed and verified such that patients do not receive a potentially sub-potent product
  • For vaccines, follow the current Vaccine Storage and Handing Guidelines.

Expectations for Designated Managers and Hospital Pharmacy Administrators

The designated pharmacy manager and hospital pharmacy administrators are responsible for managing inventory and are accountable for ensuring the applicable standards, policies and guidelines are met.

  • Standard operating policies and procedures must be in place within the pharmacy to ensure that the cold chain is maintained throughout the time a product is received, stored, dispensed and delivered and/or administered to the patient.
  • All pharmacy and support staff involved in handling cold chain products must be trained on these policies and procedures.
  • Emergency preparedness processes should be in place to address any temperature excursions or breaks in cold chain (e.g. due to equipment failure, power outages, etc.).

Expectations for Pharmacy Professionals

  • Pharmacy teams are responsible for following policies and procedures to maintain the cold chain.
  • When dispensing a medication that is temperature-sensitive, patients should be informed and given instructions on appropriate storage requirements.
Legislative References:
Additional References:
Implementation

Published: July2021
Version #: 2.00
College Contact: Pharmacy Practice

Revision History
Version # Date Action
1 September 2012 Policy developed
2 July 2021 Reviewed policy and revised to a guideline. Guidelines provide detail around expectations while policies serve as a benchmark against which the conduct of the individual registrant is evaluated.