December 27, 2018

Canadian Laws On Temperature Monitoring: National Standards

Written by Garret Weigel | Pharmacy Safety

The Public Health Agency of Canada (PHAC) and Health Canada have developed guidelines and regulations around the storage of pharmaceuticals on a national level. Additionally, the province and territory level regulations are primarily focused on cold chain management throughout the distribution process as it relates to vaccinations. The mandates don’t stop there: there are also many regulations and recommendations around the types of refrigerators that are used and how to “manage” their use for storing drug products.


General Recommendations

There appears to be few specifics on temperature monitoring outside of the Vaccine Storage Guidelines. These then get a bit more specific on Temperature Monitoring and acceptable temperature monitoring devices but significantly less so than the Centers for Disease Control and Prevention (CDC) in the United States.


Let’s take a look at some of the Canadian laws on temperature monitoring for medications and vaccines.


Recommendations for Ongoing Use

In order to effectively manage medication efficacy, continuous temperature monitoring that provides minimum and maximum temperatures over a time-series is critical to understand whether or not product quality is compromised. A display that presents current temperature should also be present so that immediate action can be taken should a pharmacist notice that temperature is outside of the acceptable range.


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Ambient temperature is a good indicator of temperature excursions, but it does not provide accurate insight into actual product temperature. For this reason, Health Canada has identified the improvements that glycol vials can have over thermometers that simply measure air temperature. By using an enclosed probe located within the unit, the temperature of vaccines can be measured precisely without the need to physically probe the product.


Both systems should be battery powered, wireless, and capable of providing real-time alerts to notify management of temperature excursions. Temperature data should also be stored and available on-demand to assist with compliance and provide visibility not possible with pen and paper solutions.


Acceptable Practices for Ongoing Use

Despite the strong recommendations outlined above, The PHAC and Health Canada have made a separate set of suggestions that are considered “acceptable,” rather than “recommended.” At the minimum, healthcare organizations should use a digital thermometer that has a digital reading, identifying minimum and maximum temperatures over a time-series. The temperature sensors should send alerts when a specific threshold is met to notify key stakeholders when an excursion is detected. This strategy is effective, but the guidelines also make note that air temperature is a less accurate measure than glycol can offer.


Practices to Avoid

Thankfully, there are just a few monitoring practices to avoid, making adherence simple. Fluid-filled, bio-safe liquid thermometers do not provide an accurate reading into product temperature. Bi-metal stem and household mercury thermometers are simply not accurate or sophisticated enough to provide the level of insight required to understand product quality.


Any temperature monitoring product similar to the ones outlined above can be misleading and as such should not be implemented to prevent medications from losing their efficacy.


National Standards for Vaccine Storage and Monitoring

In addition to general recommendations for ongoing use of temperature monitoring, regulatory agencies in Canada have strongly recommended that all staff members be trained in proper vaccination storage. Proactive monitoring of equipment is key to maintaining medication efficacy, but the importance of people in any system should not be taken for granted. Robust training programs can significantly reduce the chance of medication losing its effectiveness and patient safety being compromised. On top of training, each site should have a designated Vaccine Coordinator to manage storage, handling, and proper corrective actions if an excursion is detected.


Sensors that have calibration accuracy to ±5°C should be utilized to improve understanding of temperature performance. Vaccinates can lose their efficacy from a 5-10°C change in temperature for a short period of time, highlighting the importance of a continuous monitoring solution that can notify key stakeholders of an excursion as soon as it is detected to give ample time to remedy the situation.


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Topics: Pharmacy Safety

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