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March 26, 2021

Protecting the COVID-19 Vaccine Supply Nationwide

Written by SmartSense | Pharmacy Safety, Supply Chain, vaccines, pharmacies, Coronavirus

As the U.S. enters the second year of the COVID-19 pandemic, the great news is that vaccination programs are now in Phase 2 in most states across the country. Pharmacies, supersites, clinics, hospitals, and community centers are all working overtime to inoculate the population at large and return our lives back to a sense of normalcy. From a business perspective, here at SmartSense, we approached the pandemic as a means to provide greater service to the customers and communities we serve.

SmartSense is playing an important role in this nationwide vaccination initiative by supporting the distribution and storage of vaccines. Of all best practices for handling COVID-19 products approved for administration by the CDC, perhaps none is more crucial than temperature monitoring. That’s because vaccines must be kept at temperature along the cold supply chain from the time they are manufactured until just before they are administered, thereby protecting their potency and effectiveness.

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A SmartSense team member preparing to install at the CIC Supersite hosted at Gillette Stadium in Boston, MA.

Each of the vaccines currently in distribution requires a different and specific range of safe holding temperatures from refrigerated to ultra-low frozen as prescribed by each manufacturer. Any product that falls outside of these safe ranges is considered a "temperature excursion" that requires immediate action to ensure the vaccines remain viable. Otherwise, any adversely affected inventory must be discarded, which can cause expensive and timely delays in controlling the pandemic and restoring public health.

 In a previous post, we discussed why the CDC strongly recommends automatic Digital Data Loggers (DDLs) to continuously monitor and record temperatures for all medications at risk of excursions. Now, because of the specific volatility of the COVID-19 vaccines and the state of emergency, the CDC is mandating the use of DDLs by any pharmacy or site distributing vaccines.

The SmartSense Pharmacy Monitoring solution meets and exceeds all CDC requirements for monitoring the temperatures of all three vaccine candidates, from the ultra-low ranges for Pfizer to the more standard ranges for Moderna & Johnson & Johnson.

For this very reason, our current customers and operators of new sites approached us to provide continuous monitoring for conventional fridges and freezers, as well as newly acquired ultra-low freezers. In a matter of months, we added protection at nearly 30,000 sites.

 

SmartSense DDLs Are on the Front Lines

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A SmartSense Display indicates the holding temperature inside of a critical vaccine freezer.

SmartSense is currently monitoring approximately 90% of the pharmacy locations participating in the Federal Retail Pharmacy Program for COVID-19 Vaccination. This collaboration between the government and a network of pharmacies across the country is expanding access to vaccines for the American public. As availability increases, the program will include more than 40,000 pharmacies.

The government understands pharmacists are trusted healthcare providers who are trained to administer vaccines and have direct access to medical knowledge about their customers. By ensuring the efficacy of their vaccine inventories, SmartSense is a partner in this program and helps pharmacies maintain their good reputations for safety and reliability.

In addition to our service to pharmacies, SmartSense is also monitoring the COVID-19 vaccine inventories at two supersites operated by CIC Health, one located in Gillette Stadium and the other at Fenway Park in the backyard of our corporate headquarters in Boston.

 

SmartSense DDLs Meet & Exceed CDC Regulations

SmartSense is fully prepared to support our pharmacy customers and supersites according to CDC regulations. As part of the COVID-19 Vaccination Provider Agreement, providers are required to:

  • Store and handle COVID-19 vaccines under proper cold chain conditions, including ultra-cold freezer temperatures between -76° F and -112°
  • Continuously monitor storage unit temperatures at all times, using a digital data logger (DDL) with a buffered temperature probe and valid NIST Certificate of Calibration Testing
  • Record details on how long a freezer unit has been operating outside the recommended temperature range
  • Preserve all records related to COVID-19 vaccine management for a minimum of three years

The CDC approves ONLY temperature monitoring devices with all of these features, considering them the "most accurate." SmartSense DDLs meet these requirements, and more. That's why we're taking the lead on the COVID-19 vaccination front lines.

For more information about our solutions, please download our Pharmacy Compliance Monitoring brochure.

 

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