Vaccines are the most effective way to prevent the spread of infectious diseases. However, without the right storage and handling conditions, vaccine efficacy can only extend so far. The CDC estimates that over 300 million pounds worth of vaccines are destroyed globally due to improper storage and handling.
Maintaining Vaccine Cold Chain Requirements
To ensure Center of Disease Control (CDC) guideline compliance, every practice is mandated to have a Primary and Back-Up Vaccine Coordinator who evaluate general vaccine management practices and cold chain procedures in place. A cold chain is the range of temperatures that must be maintained from production to vaccine use. There are two cold chain temperature ranges that depend on if a vaccine should be stored frozen or at room temperature. Exposure to any conditions outside the cold chain can destroy vaccine potency, which cannot be restored.
To ensure your practice’s vaccine storage conditions are adequate, the CDC recommends using pharmaceutical-grade storage units designed to house biologics. If that’s not feasible for your practice, stand-alone household-grade units can be utilized. All units should have enough space to store the largest inventory expected at the busiest point in the year without crowding, it’s recommended to fill the unit at 50% capacity. Every lot is delivered equipped with storage instructions that dictate whether the vaccines should be stored in a refrigerator or freezer. Storage units should maintain cold chain temperatures, refrigerators should remain between 2°C and 8°C (36°F and 46°F), and freezers should remain between -50°C and -15°C (-58°F and +5°F). Additionally, your team should inspect vaccine storage conditions daily. To best monitor temperature conditions, your practice should obtain temperature monitoring devices (TMDs) with a digital data logger (DDL) to record data every 30 minutes.
Facilitating Quality Control
Upon the arrival of a vaccine lot, the Vaccine Coordinator should inspect vaccine conditions. With an eye for detail, they should consider handling requirements, signs of damage, and expiration dates. Another quality control tactic to consider adopting is maintaining an updated vaccine stock record of all new and inventoried vaccines. A vaccine stock record can be used to ensure your practice has enough inventory to meet the needs of your patients and monitor vaccine status. The record should consist of the vaccine name, expiration date, quantity of doses received, manufacturer and lot number, and more.
To prevent misuse, vaccines should be stored in their original packaging and closed-lid, separate containers. Additional best practices include keeping space between the vaccine vials and the refrigerator walls for air circulation, organizing inventory with the oldest vaccines in front so they’re used first, and installing “Do not unplug” and “Do not turn off” signs next to storage fridges and freezers.
Building an Emergency Storage Plan
A vaccine's efficacy and success depend on the quality of your practice’s management and storage conditions. To properly handle your vaccine inventory, your practice should consider developing a Standard Operating Procedure (SOP) for emergency vaccine management in addition to general vaccine management. In case of natural disasters, power failures, or equipment malfunctions, having measures in place to ensure cold chain maintenance will provide structure in a time of chaos. This plan could also include owning backup equipment or purchasing a power generator to prevent storage breakdowns.
To maximize your practice’s vaccine offerings, it’s important to remain compliant with the CDC and manufacturer storage and handling guidelines. To do so, provide your team with the necessary reminders and resources to adhere to CDC guidelines. Have any questions about vaccine storage or expanding your current vaccine offerings? Please reach out to our team, and we’d be happy to help.