Proper vaccine management is critical in the effort to prevent and eradicate many common vaccine-preventable diseases. However, storage and handling errors can result in the need for revaccination along with significant financial loss as a consequence of wasted vaccines. In addition, failure to store vaccines appropriately can reduce vaccine potency, causing inadequate immune responses in patients and poor protection against disease.
The Centers for Disease Control and Prevention (CDC) provides comprehensive information about vaccine storage and handling in their revised Vaccine Storage and Handling Toolkit, which was extensively updated in 2019 to provide new and more concise information, recommendations, and resources to assist in properly storing and handling vaccines. Implementing best practices and recommendations will help protect patients, safeguard the vaccine supply, and avoid unnecessary costs of revaccinating patients and replacing expensive vaccines.
While the toolkit is available in its entirety at: www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html, key sections are highlighted herein.
Vaccine Cold Chain
Proper storage and handling require an effective vaccine cold chain. The cold chain begins with the cold storage unit at the manufacturing plant, extends to the transport and delivery of the vaccine and correct storage at the provider’s facility, and ends with patient administration. If any point in the cold chain is not properly maintained, vaccine potency may be lost, resulting in a useless vaccine supply. Potency is reduced every time a vaccine is exposed to an improper condition, including overexposure to heat, cold, or light. For example, a single exposure to a freezing temperature can destroy potency.
Ensuring vaccine quality and maintaining the cold chain are shared responsibilities among manufacturers, public health staff, and health care providers. An effective cold chain relies on three main elements:
Vaccine storage and handling practices are only as effective as the staff that implements them. Crucial to ensuring vaccine potency and patient safety is ensuring that staff members are well-trained in both vaccine storage and handling principles as well as the institution’s SOPs.
The CDC recommends that facilities develop and maintain clearly written, detailed, and up-to-date vaccine storage and handling SOPs. All staff members who receive deliveries and those who handle or administer vaccines should be familiar with the SOPs. Storage and handling training should be completed:
A primary vaccine coordinator should be designated. Coordinator responsibilities should include:
Use pharmaceutical grade units; do not store vaccines in dormitory-style combined refrigerators/freezers under any circumstances. Refrigerators should maintain temperatures between 2°C to 8°C (36°F to 46°F). The CDC recommends a specific type of temperature monitoring device: a digital data logger (DDL), which provides the most accurate storage unit temperature information. Temperature data from a DDL can be downloaded to a computer or retrieved from a website. Retain the data for 3 years so it can be analyzed for long-term trends and/or recurring problems.
A temperature monitoring best practice is to check the temperature each time vaccines are accessed in the unit. Review storage unit temperature readings and continuous DDL software or website information at least weekly for changes in temperature trends that may require action.SECTION 4
Proper vaccine inventory management is critical for appropriate vaccine ordering and stock rotation, and ensures your facility has sufficient vaccines to meet patient needs. Vaccines are costly, so making sure they are unpacked, stored, prepared, administered, and transported correctly is essential.
Vaccines and diluents should be carefully unpacked, stored at the correct temperature, and documented immediately upon receipt. Examine shipments for signs of damage and to ensure the vaccine types and quantities are correct. Order and stock only as many vaccines as necessary to meet patient needs. Storing a larger volume than necessary can increase the risk of wasted vaccines.
Vaccine stock must be rotated and checked for expired doses regularly. Expired vaccines and diluents should be removed immediately to avoid inadvertent administration. Organize stock for each vaccine type so that the doses with the earliest expiration dates are placed in front of those with later dates.SECTION 5
Vaccine preparation is the last step in the cold chain prior to administration. Handling vaccines with care is just as critical as storing them properly. Best practice is to prepare vaccines in a designated area away from space where potentially contaminated items are located. Only prepare vaccines when you are ready to administer them. Be sure to check the expiration dates and confirm you have selected the correct vaccine. In addition, vaccines should only be administered by the staff member that prepared the vaccine—this is a quality control and patient safety issue and a best practice standard of medication administration.SECTION 6
Vaccines from an organization’s supply should not be routinely transported. In situations where transport of vaccine from your supply is required, be sure to take appropriate precautions to protect the supply. Vaccines should only be transported using proper packing materials that provide maximum protection.
Transport diluents with their corresponding vaccines to ensure there are equal amounts of vaccines and diluents for reconstitution. The facility should have a sufficient supply of materials needed for vaccine transport of your largest annual inventory. Appropriate transport materials include the following:
Soft-sided containers specifically engineered for vaccine transport may be used. Do not use commercially available soft-sided food or beverage coolers because most are poorly insulated and likely to be affected by room or outdoor temperatures. The same shipping materials the vaccines were initially shipped in are not suitable as they are not meant for reuse. Using these materials could put the cold chain, and ultimately, the viability of the vaccines, at risk.SECTION 7
Emergencies such as equipment failure, power outages, severe weather conditions, and natural disasters may occur without warning and can compromise vaccine storage conditions. In addition to vaccine transport planning, it is critical to make additional plans for emergencies.
Even if your facility has a generator as backup equipment, organizations should establish a working agreement with at least one alternative storage facility. Be sure you have 24-hour access to this facility. Your organization may also choose to have a backup storage unit to avoid the need to pack and move vaccines to an alternative storage facility, should the primary storage unit fail.
Because situations may arise outside of normal business hours, maintain a good working relationship with your facility’s building manager and security staff. Your facility’s storage and handling SOPs should include instructions for accessing the vaccine storage units when the building is closed, and should also include a building map and locations of spare batteries, flashlights, keys, locks, circuit breakers, and emergency transport equipment and materials.
Jennifer Karpinski is a senior editor at Pharmacy Purchasing & Products magazine.
Additional CDC Vaccine Storage and Handling Information
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