Best practices for pharmacies in storage, monitoring and maintenance of their Covid vaccine shipments
Pharmacies across the US are stepping up their role in the country’s Covid-19 vaccination rollout. More states are turning to pharmacies to offer shots at their retail locations, as overwhelmed health districts and hospitals struggle to keep pace with public health officials’ vaccination goals. And because the federal government now plans to quickly release second doses that were being held back, pharmacies will need to ensure that they have the right equipment and management plans in place to receive vaccine shipments.
They’ll also need the tools to maintain and monitor the correct storage temperatures, which vary by vaccine manufacturer. The Pfizer-BioNTech vaccine arguably has the most challenging requirements. It was originally restricted to ultracold shipping and storing at -80°C to -60°C (-112°F to -76°F) prior to thawing and administration. The required specialized freezers can be in short supply and costly—outside the budget of many independent, small and rural pharmacies. In late February, the FDA did ease temperature requirements for the vaccine, allowing for storage and shipping at -25°C to -15°C (-13°F to 5°F) for up to two weeks.
Frozen, Moderna’s vaccine must stay between -25°C to -15°C as well. The Centers for Disease Control and Prevention (CDC) notes that this range is narrower than what’s required for most routine vaccines. Thawed and ready for use, the Moderna vaccine can stay refrigerated between 2°C and 8°C (36°F and -46°F) for 30 days.
The CDC recommends that Johnson & Johnson’s vaccine is stored between 2°C and 8°C (36°F and -46°F). It does not need to be frozen.
Most pharmacies already have the freezers and refrigerators they need to safely store the vaccines. But to make sure that not a dose is spoiled or wasted, they also need digital monitoring equipment for their storage units.
When vaccine storage units fail, chaos follows
Like any appliance, vaccine storage units can have mechanical problems. That’s what led to an “all-hands-on-deck” situation one Monday morning in early January at a small hospital in Mendocino County, CA. A freezer holding hundreds of doses of the Moderna vaccine had failed over the weekend, and so had the alarm that was supposed to alert staffers.
With only two hours of vaccine viability remaining, hospital executives and staffers scrambled to get the doses into arms—and succeeded. Their efforts made state news. But they also spawned conspiracy rumors in the community that the hospital had somehow staged the freezer failure to get around rules about who should get the shots first, creating a community trust problem for the hospital.
Community health center employees in Waterbury, CT, faced a similar scramble on Christmas Day after a post-storm power outage that left them with 12 hours to distribute 200 doses. They only knew about the problem because concerned employees had gone to the center on their day off to check on their vaccine storage freezer.
It’s critical to avoid wasting vaccine, but having to improvise, shot clinics can create logistical and reputational issues that make an existing crisis more difficult to manage. With effective monitoring equipment, alert protocols and best practices, pharmacies can protect their vaccine stock and avoid racing to use vaccine before it goes bad.
Monitoring recommendations for vaccine storage units
The CDC and other health authorities recommend that every site receiving Covid-19 vaccines should set up temperature monitoring devices that include digital data logging. Digital data loggers (DDLs) can be low-cost, quick to deploy, secure ways to maintain and monitor vaccine storage temperature.
For example, a wireless remote temperature sensor placed inside a vaccine storage unit can measure the temperature at pre-set intervals and wirelessly send that data to a secure gateway for transmission to an account in the cloud. Pharmacy employees with access to the cloud account can see the temperature readings in real time, review historical temperature readings and get immediate alerts via text, phone or email if the storage unit temperature goes out of range. They can see all of that information without opening the unit to check the temperature manually or even being onsite.
Because the stakes are so high for protecting Covid-19 vaccine doses, the CDC has other specific recommendations for DDLs to monitor vaccine storage, in addition to the out-of-range alarm. The CDC also recommends that each DDL unit has a low battery alert feature, to avoid monitor failure. The DDL should be accurate to within +/- 0.5°C (33°F, 31°F), come with proof of calibration testing and take readings at least every 30 minutes.
Minimum and maximum historical temperatures should be tracked along with real-time readings. These range readings are important because they can show pharmacy managers if the temperature inside the units is fluctuating widely or rising. Either of those situations can indicate a problem with the unit that needs attention to protect the vaccine. The CDC advises pharmacies and other providers to keep their vaccine storage unit temperature data for at least three years and maybe longer if required by state law. A DDL that has an associated cloud storage account will handle this data storage task automatically.
Following best practices for vaccine freezers and refrigerators
Automated temperature monitoring and logging is one aspect of a successful vaccine storage program, but there are other best practices that pharmacies should follow as well. One is to protect vaccine storage units from possible failure by maintaining them per the manufacturer’s guidance and having them serviced when there appear to be problems with temperature consistency. Another is to reduce the risk of accidental disconnection from the power supply, by clearly labeling each storage unit’s power cord, outlet and circuit breaker and by ensuring that cords are kept away from areas where they might be unplugged by someone tripping on them, moving equipment or cleaning.
Because the temperature inside a storage unit can vary based on how close vaccine vials are to fans and to each other, the CDC recommends making sure vaccines are arranged to allow airflow for more even and consistent cooling. This may require adding another storage unit to prevent overcrowding that could compromise vaccine quality. Because it can take a few days for a freezer or refrigerator to reach a consistent temperature, it’s important to plan as far ahead as possible for the amount of storage space required.
Pharmacies of all sizes can play an important role in helping bring the coronavirus pandemic under control. By preparing now with the right storage units, remote temperature sensors to record and store readings, regular maintenance and other best practices, pharmacies can work as efficiently and safely as possible when they receive their vaccine shipments.
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