Protecting the Cold Chain

POLICY

Approved: September 2012

Legislative references:

  • Food and Drugs Act
  • Food and Drug Regulations
  • Drug and Pharmacies Regulation Act
  • Health Protection and Promotion Act

Additional references:

  • Ontario Public Health Standards
  • Vaccine Storage and Handling Protocol, 2010
  • Vaccine Storage and Handling Guidelines

College Contact: Pharmacy Practice


Introduction

The cold chain begins with the manufacturer and ends with the patient. Products that have not been handled according to the conditions set by the manufacturer are considered to be unsafe for use as quality and effectiveness may be compromised.

Safe temperature and humidity ranges for products vary according to the conditions required to ensure their continued quality. All temperature-sensitive pharmaceutical and biologic products are at risk of damage if handled improperly. The conditions for the transportation and storage of drug products by wholesalers are set by Health Canada through the Food and Drugs Act and Regulations and storage requirements for publicly funded vaccines are set by the Minister of Health and Long- Term Care according to the requirements set out in the Vaccine Storage and Handling Protocol under the Ontario Public Health Standards, published under the Health Protection and Promotion Act.1,2The Drug and Pharmacies Regulation Act establishes accreditation requirements for pharmacies in Ontario.3

Note: In addition to these requirements, members storing and handling publicly funded vaccines must meet the Ontario standards specified in the Vaccine Storage and Handling Guidelines. Local public health units will work in collaboration with members to ensure adherence with these provincial policies.


Principles:

  1. Members have an obligation to protect patient safety by ensuring that drugs and biological products requiring temperature protection are received, stored and dispensed according to the manufacturer’s specifications;
  2. The requirements to protect temperature-sensitive drugs include taking steps to assist patients and their caregivers to protect drugs and biological products once they have been dispensed.

Definition

“Cold Chain” A cold chain is a temperature, humidity, and light-controlled supply chain for products that require a specific temperature range during distribution and storage. Specifically, this refers to a supply chain that includes the handling, transportation, and storage of temperature-controlled drug substance or finished drug product.4


Policy

Standard operating policies and procedures must be in place within the pharmacy to ensure that temperature-sensitive products are properly received, stored, and dispensed. These should be reviewed at least yearly and key staff members trained and monitored to ensure cold chain practices are followed.

The Role of the Designated Manager

The Designated Manager (DM) is responsible for ensuring that all drugs and biological products purchased by a pharmacy for use or sale are of an acceptable standard and quality.5 The DM is also accountable for ensuring that there are appropriate policies and procedures in place to manage the cold chain once the pharmacy takes custody of the product. Where there is a remote dispensing system operated by the pharmacy, 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. The DM must also ensure that all pharmacy staff members are trained on the protocols necessary to receive, store, and dispense products at the appropriate temperature when these activities are within their duties.

Accreditation and the Cold Chain

The accreditation provisions of the Drug and Pharmacies Regulation Act provide the College with the authority to inspect pharmacies and all pharmacies are inspected before opening and then generally once every three years to ensure they continue to meet accreditation standards. Inspections focus on the operational requirements of the pharmacy, to ensure that the operation is safe and the public is protected, and to assist members to comply with legislated requirements. Inspectors are also a resource for the pharmacy and can provide information and advice regarding the pharmacy’s operations.An inspector will confirm that the refrigerator in the pharmacy meets the temperature requirements and that nothing other than drugs or medications requiring refrigeration are stored in the refrigerator. The inspector will also confirm that the contents are stored appropriately. Where the pharmacy operates a remote dispensing location, the inspector will confirm that the location has an alarm system that provides immediate notification to the DM of any alteration in the temperature of the location outside of the approved standards.

Recommended Equipment

  • Commercial grade equipment is recommended; however, if a domestic refrigerator is used, a frost-free unit provides more uniform temperatures;
  • A separate freezer, or a unit with a separate external freezer door;
  • A digital automatic temperature recording and monitoring device that indicates minimum,
  • maximum and current temperatures;
  • A data logger (a battery-powered, stand-alone temperature monitor);
  • A backup electricity supply;
  • A 24/7 temperature alarm system; and
  • Insulated containers to store and transport products along with gel/ice packs and packaging as
  • required.

Recommended Cold Chain Practices

Temperature monitoring is critical to ensuring that products are stored within the recommended temperature range. Temperature variations outside of labeled storage conditions for brief periods may be acceptable; however, where a variation has occurred, it must be documented and checked against stability data for that particular substance in order to demonstrate that product quality has not been affected.

General Practices:

  • The refrigerator must be well maintained and free from excessive frost build up. Frequent opening of the door can lead to temperature instability, so the door should be opened only when absolutely necessary.
  • Very sensitive products should be kept in a separate refrigerator and consideration should be given to storing vaccines separately.
  • No vaccines or medications should be stored on the door.

Receiving:

  • Protect deliveries from poor weather during unloading and examine containers to ensure there is no damage.
  • Follow internal standards of practice (SOPs) for good cold chain receiving: Ensure that temperature-controlled drug products received by or distributed from the
    • pharmacy are suitably packaged in containers that maintain an appropriate
    • environment during extreme weather conditions;
    • Examine delivery documents to ensure product was not subjected to distribution delay;
    • Identify products that should not be stored at room temperature on receipt; and
    • Document information about ordered products that were unusable because they were exposed to temperatures outside the recommended range.6
  • Transfer the contents of a shipment promptly to the appropriate, environmentally controlled storage area.

Storage:

  • Follow internal SOPs for good cold chain storage:
    • Identify products to be stored in a frozen state or those within a specific temperature range;
    • Check freezer sections for drugs that should not be frozen;
    • Check refrigerator and other locations for inappropriately stored drugs;
    • Store drugs in a manner that does not block airflow within refrigerator;
    • Ensure that drug storage refrigerators are dedicated to drugs; and
    • Establish schedule to check expiration date and rotation of temperature controlled products.7

Dispensing:

  • Educate patients regarding the cold chain and appropriate storage and use of medications:
    • Identify temperature-controlled drugs and methods for proper handling and storage in the home and workplace and while traveling;
    • Provide written instructions if necessary;
    • Instruct patients to avoid unintended exposure of drugs to abnormal temperatures; and
    • Instruct patients to avoid exposure and storage in high humidity environments (e.g. bathroom).
  • Ensure that the pharmaceutical packaging for home delivery meets the specifications required for the product.8

Vaccines

It is critical to maintain cold chain protection for vaccines; if vaccines are stored or administered at temperatures that are too high or too low, the patient may be inadequately protected or harmed.9Protection from light and humidity is also a necessary condition for some vaccines. Any loss of vaccine potency is permanent and irreversible. For frozen vaccines the optimum temperature is -15°C or lower and there may be additional restrictions on their use. For example, the Zostavax® vaccine must be maintained at a temperature of -15°C or colder and, once it is reconstituted, must be used within 30 minutes.10

Cool vs. Cold: What’s the Difference?10,11

  • Frozen – Maintained in a place where the temperature is between -10°C and -25°C
  • Cold - Any temperature not exceeding +8°C (in Ontario a pharmacy is required to have a refrigerator with a temperature between +2°C to + 8°C)
  • Cool - Any temperature between +8°C and +15°C
  • Controlled Room Temperature - Thermostatically controlled temperature of +20°C to +25°C
  • Room temperature – Temperature prevailing in a working area; not thermostatically controlled
  • Warm - Any temperature between +30°C and +40°C
  • Excessive heat - Any temperature above +40°C

References

  1. Health Canada / Health Products and Food Branch Inspectorate. Guidelines for Temperature Control of Drug Products during Storage and Transportation.
  2. Ontario Ministry of Health and Long-Term Care. Vaccine Storage and Handling Guidelines.
  3. Drug and Pharmacies Regulation Act, Ontario Regulation 264/16. Part IV: Standards of Accreditation.
  4. Ziance, R., Chandler, C. and Bishara, R. Integration of temperature-controlled requirements into pharmacy practice. Pharmacy Today.
  5. Ontario College of Pharmacists. Medication Procurement and Inventory Management[SS1]
  6. Ziance, R., Chandler, C. and Bishara, R. Integration of temperature-controlled requirements into pharmacy practice. Pharmacy Today.
  7. Ibid, p. 38
  8. Ibid, p. 39
  9. O’Donnell, Kevin and Patrick McGrath. The Changing Landscape for Vaccine Administration. July 13, 2011.
  10. Merck-Frosst Canada Inc. (2011) Product Monograph: Zostavax®
  11. Reed, Carla. Cold Chains are Hot! Mastering the Challenges of Temperature-Sensitive Distribution in Supply Chains; p.3. February 2005. ©ChainLink Research 2002-2005.
  12. U.S. Pharmacopeia. Preservation, Packaging, Storage and Labeling.