January 11, 2019

Canadian Laws On Temperature Monitoring: Province Specific Standards

Written by Garret Weigel | Pharmacy Safety, Supply Chain

In our previous post, we outlined general recommendations and national standards for vaccine storage and monitoring in Canada. Despite what may be common practice in The States, pharmacists cannot immunize patients in every province and territory, which directly affects the need for temperature monitoring of vaccines in pharmacies. In addition to the general recommendations and national standards, laws and guidelines differ throughout Canada, depending on which the province or territory.

 

In short, pharmacists can immunize in Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, Saskatchewan, and Prince Edward Island provinces. Pharmacists cannot provide immunizations in Quebec province, or in the Northwest, Nunavut, and Yukon Territories.

 

Where Pharmacists Can Provide Immunizations

Generally speaking, regulations around the storage of pharmaceuticals are more focused around cold chain management throughout the distribution process, as opposed to on-site refrigeration. Additionally, there are a number of regulations and recommendations around the types of refrigerators that are used and how to “manage” their use, including review cadences and monitoring requirements.

 

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However, regulations and recommendations can vary significantly between jurisdictions. The following table outlines 3 primary areas of sophistication in pharmacy safety:

  • Monitoring indicates if regulations require or recommend a manual or a digital solution.

  • Cold Chain refers to whether or not jurisdictions require or recommend that the supply chain is monitored for excursions.

  • Reviews identifies the need for a trained staff member to review the temperature logs on a regular basis.

  • Notes includes additional information on each jurisdiction or clarifies the preceding columns.

 

Jurisdiction Monitoring Cold Chain Reviews Notes
Alberta Manual X Sites with $5,000+ of vaccines must have continuous temperature recording devices
British Columbia Digital X 3-year plan for continuous temperature recording plan
Manitoba Digital X X Allows manual or digital temperature checks
New Brunswick Digital X X References National Storage and Handling Guidelines for Vaccines
Newfoundland and Labrador Manual X Cold chain monitoring via time temperature indicators (TTI)
Nova Scotia Digital X Weekly reviews of the temperature logs
Ontario Manual X Digital temperature monitoring is not to be considered a substitute for manual recording of temperatures
Saskatchewan Digital X References United States CDC 2016 standards
Prince Edward Island Digital X X References National Storage and Handling Guidelines for Vaccines

 

Where Pharmacists Cannot Provide Immunizations

Interestingly enough, not every province or territory allows pharmacists to provide immunizations, which impacts the need for temperature monitoring of vaccines in pharmacies. Quebec and the Northwest Territories both make reference to the National Storage and Handling Guidelines for Vaccines, which recommends “detailed written protocols for routine vaccine storage and handling, for urgent vaccine storage and handling, and for cold chain breaks.” This will help to identify establish management workflows and identify temperature excursions but does not go far enough to prevent a refrigeration failure.

 

Nunavut recommends the use of a specific temperature logger by 3M. This is more robust than the recommendations outlined above, but depending on the model, does not have the ability to warn management of impending excursions, it simply records temperature and saves it for later review. Lastly, Yukon does not provide guidance on the type of temperature monitoring device to use. This is problematic, as not all temperature monitoring solutions are created equal.

 

Remote Temperature Monitoring

Temperature monitoring can vary widely depending on the province or territory the pharmacist is located in, so it's important to understand in detail what regulations are in place. SmartSense provides pharmacy monitoring solutions that help to maintain the integrity and quality of vaccines and medications and enables proactive management of temperature excursions.

 

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