Pharmacy plays a vital role in maintaining the vaccine cold chain. The processes of receiving, handling, storing, and transporting vaccines require a detailed focus to ensure product safety and efficiency. Employing the following tips will bolster the effectiveness of your vaccine protocols.
The Centers for Disease Control and Prevention (CDC) provides comprehensive information about vaccine storage and handling in its Vaccine Storage and Handling Toolkit, which includes the COVID-19 vaccine storage and handling information addendum that is continually updated as new information becomes available. The information provided herein is from the CDC as of August 31st, 2021. Implementing best practices and recommendations from this addendum will help protect patients, safeguard the vaccine supply, and avoid the unnecessary costs of revaccinating patients and replacing vaccines.
Storage Unit Organization
The placement of the refrigeration storage unit and the organization of its contents both factor into creating a suitable environment for vaccines. To promote good air circulation around the outside of the storage unit, place the unit in a well-ventilated room, leaving space between the unit, ceiling, and walls. Ensure that nothing is blocking the cover of the motor compartment, the unit is firm and level, and the door opens and closes smoothly and fits squarely against the body of the unit.
Best practices include storing each type of vaccine or diluent in its original packaging and in separate containers. Position vaccines and diluents 2-3 inches from the unit walls, ceiling, floor, and door, as this space promotes important air circulation. If using a household-grade unit, avoid storing vaccines and diluents in any part of the unit that may not provide stable temperatures or sufficient airflow, such as directly under cooling vents, in drawers, or on refrigerator door shelves. The instability of temperatures and airflow in these areas may expose vaccines to inappropriate storage temperatures.
Select a Temperature Monitoring Device
The CDC recommends a specific type of temperature monitoring device called a digital data logger. Most digital data loggers use a buffered temperature probe, rather than a standard thermometer, to provide the most accurate storage unit temperature information. A digital data logger provides detailed information on all temperatures recorded at preset intervals. When selecting a temperature monitoring device, key features to consider include:
Equipment Upkeep and Maintenance
Considering the crucial role vaccine storage units and temperature monitoring devices play in pharmacy, it is of utmost importance that they are properly maintained. Conduct the following routine maintenance for all vaccine storage units and related equipment to ensure equipment is functioning at maximum efficiency:
Over time, temperature monitoring devices can experience a drift, affecting their accuracy. Regular calibration testing ensures the accuracy of the temperature monitoring device’s readings against nationally accepted standards and should be done every 2 to 3 years, or according to the manufacturer’s suggested timeline.
Stabilize Refrigerator Temperatures
A newly installed or repaired refrigerator may take 2 to 7 days to achieve a stabilized temperature. Before using a unit for vaccine storage, check and record the minimum and maximum temperatures each workday for 2 to 7 days. If temperatures cannot be recorded digitally, check and record temperatures a minimum of twice each workday. Once the unit has produced recorded temperatures within the recommended range for 2 consecutive days, the unit is stable and ready for use.
Vaccine Inventory Accounting
Managing vaccine inventory properly and efficiently is essential for appropriate vaccine ordering and stock rotation. Use a stock record to account for and document every dose of vaccine when tracking inventory. For best practice, update this record weekly and include the following information:
If the numbers in the storage unit do not match the doses documented in the stock record, enter the correct number based on your count on a separate line below the old balance on the stock record. Make a note next to the new entry indicating confirmation of the new balance and use the corrected balance for calculating stock quantities in the future. Diluents should be documented on a separate stock record and should equal the quantities of the corresponding vaccines.
When transporting vaccines is necessary, either to an off-site clinic or in the event of an emergency, always transport diluents with their corresponding vaccines to ensure equal amounts of both products for reconstitution. Recommendations for transport include placing an insulating barrier like bubble wrap between the diluents and conditioned water bottles or phase change materials. It is also important to take the diluent’s temperature during transport into consideration. For example, if diluents stored at room temperature (20°C to 25°C [68°F to 77°F]) are going to be transported with refrigerated vaccines, refrigerate them in advance for as long as possible so they do not raise the container temperature when placed with refrigerated vaccines. It is important to never freeze diluents, not even during transport. Follow the manufacturer’s guidance for specific temperature requirements.
Storage Unit Temperature Adjustment
Storage unit temperatures may require adjustment over time. In some situations, thermostats may need to be reset in summer and winter, depending on room temperature. All storage unit temperature adjustments should be made by the primary or alternate vaccine coordinator and should be based on information from the temperature monitoring device and temperature monitoring log. Remember that temperatures within any storage unit will vary slightly, even with normal use. Therefore, before making any adjustment:
If it is determined that an adjustment is needed, begin with the following steps:
Establish Emergency SOPs
Emergencies, like equipment failures, power outages, severe weather conditions, or natural disasters, often happen without warning, prompting the need for emergency standard operating procedures (SOPs). Train all staff members on emergency SOPs, which must include after-hours roles and responsibilities. Storage and handling SOPs should include instructions for accessing vaccine storage units when the building is closed, with a building map/diagram and locations of: