Vaccines only work when they are viable, intact, and undamaged. For this reason, the appropriate handling and storage of vaccines are vital parts of an immunization program.
Comprehensive Storage and Handling page to be used as a reference for setting up and maintaining vaccine storage and handling procedures in your office.
Epidemiology and Prevention of Vaccine-Preventable Diseases, The Pink Book, 13th Edition (2015) Chapter 5: Storage & Handling
The Immunization Action Coalition also offers several Storage and Handling tools that are useful for office-based immunization programs. This website includes information regarding vaccine handling tips, common storage and handling errors, and FDA Package Inserts.
Participation in the Vaccines for Children (VFC) program requires practices to adhere to strict storage and handling guidelines. Check out California’s VFC Resource: Storage and Handling
The California Vaccines for Children Program maintains their website with a variety of useful resources including video demonstrations, vaccine inventory management recommendations, and vaccine administration information. View the California VFC program's website
Ideally, vaccine deliveries should only be made when the vaccine coordinator or back-up person is present. Packages should be opened immediately and inspected for any damage. The coordinator should check the quantities, lot numbers, and expiration dates against the packing slip in addition to the condition of vaccines. Packages will often have temperature indicators that should be checked to ensure the vaccine has not been exposed to improper temperatures. If there are no temperature indicators, verify that the container includes appropriate insulation and refrigerant (e.g. dry ice, gel packs, or ice packs). When the shipment arrives, verify that the inactivated vaccines are cold but not frozen; inactivated vaccines are damaged by freezing. Live virus varicella-containing vaccine must arrive frozen. MMR may be frozen, but this is not required. If the product seems to have been exposed to extremes of temperature (by appearance or by package indicator), separate the vaccine in a marked container (label: “DO NOT USE”), store in the refrigerator at the proper temperature, and immediately contact the source of shipment for further instructions.
The refrigerator/freezer designated for vaccine storage must be used exclusively for the storage of pharmaceuticals and biological products. The unit should be large enough to hold the largest month’s vaccine inventory, typically the fall influenza vaccine order. Dorm style or bar-style refrigerators are never acceptable for vaccine storage, due to their inability to reach or maintain proper temperatures. While a dedicated vaccine refrigerator will have built-in temperature monitoring, domestic refrigerators can also be adapted for use. Any domestic refrigerator can be used, provided it has separate doors for the refrigeration and freezer compartments. When using domestic refrigerators, place large plastic water jugs on the bottom level of the refrigerator and ice packs in the freezer to help maintain temperature stability especially in the case of a power outage. The middle of the refrigerator should be used for vaccine storage. This keeps vaccine away from the sides or too close to the freezer compartment. The oldest vaccines should be stored toward the front of the shelf. When new product arrives, it should be placed behind the older product. This allows the older vaccines to be used before their expiration date.
Regardless of refrigeration/freezer type, daily temperature records must be kept and maintained for at least three years. If you are using a domestic refrigerator, use only traceable calibrated thermometers certified by National Institute of Standards and Technology (NIST) or the American Society for Testing and Materials (ASTM) in each compartment.
In the event of a refrigeration failure, all vaccines should be placed immediately in a preplanned location that has adequate refrigeration. Any vaccine exposed to temperatures out of range due to power failure or mismanagement of any type should be separated from undamaged vaccines and refrigerator and freezer temperatures noted. The manufacturer and/or the state health department should be contacted with this information for instructions on handling the damaged vaccine. If it is deemed appropriate to use the vaccines in question, a revised expiration date may be assigned to these vaccines.
Always safeguard the electrical supply to the refrigeration unit. The unit should be plugged into a protected outlet that will not be accidentally or intentionally disconnected. Label the refrigeration unit, the electrical cord, the outlet, and plugs with a “DO NOT UNPLUG” notation to further safeguard the electrical supply. If possible, connect the refrigeration unit to a circuit with emergency backup power. There are alarm systems that can be purchased to provide timely warning of electrical failure when the practice is unstaffed.
In the event of an emergency, from a natural disaster or other unforeseen event, it is important to have a backup plan in place, in order to protect our vaccine supply. In their storage and handling toolkit the CDC provides emergency procedures for protecting vaccine inventories to help your office make preparations to keep your vaccines safe.
Although these regulations are extensive, they are essential to providing safe and effective vaccine to patients. Identifying an office vaccine coordinator and back-up can help create a smooth transition for an office just starting an immunization program.