Revisions to the CDC’s Vaccine Storage and Handling Toolkit


March 2021 - Vol.18 No. 3 - Page #28

As a result of the COVID-19 pandemic, the lifesaving value of vaccines has never been more clear. With vaccination efforts underway, the process of receiving, handling, storing, and transporting vaccines must be perfect to avoid wastage while vaccinating as many patients as quickly as possible. Attention to detail and implementing vaccine storage and handling best practices during this time will only serve to better our vaccine efforts in the future.

The Centers for Disease Control and Prevention (CDC) provides comprehensive information about vaccine storage and handling in their Vaccine Storage and Handling Toolkit, which includes best practices and resources to assist in properly storing and handling vaccines. The COVID-19 vaccine storage and handling information addendum was included in February 2021. 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 points are highlighted herein.

 SECTION 1 
Vaccine Cold Chain

Vaccines require specific attention from manufacturing to administration in order to properly execute a temperature-controlled supply chain. As the vaccine is transported and the responsibility shifts from manufacturer to distributor to provider, it is critical that personnel at every step of the cold chain implement thorough storage and handling practices to avoid compromising vaccines.

The result of a cold chain failure can mean extra doses for patients, increased costs for providers, and damage to public confidence in vaccines. Above all, it can leave patients vulnerable. The need to revaccinate patients is both costly and creates an opportunity for patients to refuse revaccination, allowing them to remain unprotected from serious, vaccine-preventable diseases.

 SECTION 2 
Staff and Training

Training for vaccine-related practices must include the staff members responsible for receiving and handling vaccines as well as those administering the vaccines. Storage and handling training should be completed:

  • As part of new employee orientation
  • Annually for all staff involved in immunization and vaccine storage and handling activities
  • Whenever new vaccines are added to inventory
  • Whenever recommendations for storage and handling of vaccines are updated

In addition to training staff on routine vaccine storage and handling SOPs, staff should be informed of emergency SOPs addressing cases of equipment malfunctions, power failures, natural disasters, or other emergencies that might compromise vaccine storage conditions or necessitate emergency vaccine transport.

Designate a primary vaccine coordinator; this person will be responsible for ensuring all vaccines are stored and handled correctly and should be an expert on your facility’s storage and handling SOPs. Best practices include appointing an alternate vaccine coordinator to act in the absence of the primary coordinator.

 SECTION 3 
Vaccine Storage and Temperature Monitoring Equipment

Reliable temperature monitoring devices are critical for protecting vaccines. Have at least one backup temperature monitoring device in case a primary device breaks or malfunctions. Implement routine monitoring activities to more quickly identify temperature excursions and take immediate action to correct them.

There are many options for vaccine storage equipment. Pharmaceutical-grade units are specifically designed to store vaccines, and often possess CDC recommended features that assist in vaccine storage safety. Household-grade units can also be an acceptable option for vaccine refrigeration under the right conditions. However, freezers in household-grade units are not acceptable for vaccine storage. Dormitory-style or bar-style combined refrigerator/freezer units should not be used under any circumstances.

Recommended by the CDC, digital data loggers are temperature monitoring devices that provide the most accurate storage unit temperature information. Additional recommended features include:

  • Detachable probe that best reflects vaccine temperatures (eg, a probe buffered with glycol, glass beads, sand, or Teflon)
  • Alarm for out-of-range temperatures
  • Low-battery indicator
  • Current, minimum, and maximum temperature display
  • Recommended uncertainty of +/-0.5°C (+/-1°F)
  • Logging interval (or reading rate) that can be programmed by the user to measure and record temperatures at least every 30 minutes

 SECTION 4 
Vaccine Inventory Management

The vaccine coordinator or alternate coordinator should be immediately notified when vaccine shipments arrive. Shipments should then be examined for signs of damage as well as to guarantee receipt of the appropriate vaccine types and quantities. Vaccines and diluents should then be carefully unpacked, stored at the recommended temperatures, and documented.

Best practice is to use a stock record to account for and document every dose of vaccine and diluents. This record should be updated weekly. Additionally, at least once a month, and before placing any vaccine order, make sure the number of doses in the storage unit matches the number of doses documented in the stock record. Always check for and remove expired doses immediately.

 SECTION 5 
Vaccine Preparation

Vaccine preparation is the final step in the cold chain before administration, and properly handling vaccines is equally as important to ensure vaccine safety as proper storage. Best practice vaccine administration includes preparing vaccines in a designated area away from any space where potentially contaminated items are placed, only preparing vaccines when you are ready to administer them, and only administering vaccines you have prepared. Always check expiration dates and confirm you have selected the correct vaccine.

When the only option is to predraw vaccines, there are several steps you can take to increase safety: each person administering vaccines should draw up no more than 10 doses at one time, patient flow should be monitored to avoid drawing up unnecessary doses, and all predrawn syringes should be stored at the manufacturer-recommended temperatures until administration. At the end of the workday, any remaining vaccine in predrawn syringes must be discarded. Never transfer predrawn reconstituted vaccine back into a vial for storage.

 SECTION 6 
Vaccine Transport

Vaccines should not be routinely transported outside of emergencies, off-site clinics, or to ensure vaccines that are about to expire can be administered. When vaccine transport is necessary, appropriate packing materials include:

  • Portable vaccine refrigerator/freezer units (preferred option)
  • Qualified containers and packouts
  • Hard-sided insulated containers or Styrofoam (this system is only to be used in an emergency)
  • Coolant materials such as phase change materials (PCMs) or frozen water bottles that can be conditioned to 4°C to 5°C
  • Insulating materials such as bubble wrap and corrugated cardboard—enough to form two layers per container temperature monitoring devices for each container

Your facility should have a sufficient supply of materials needed for the vaccine transport of your largest annual inventory. Record the time vaccines are removed from the storage unit and placed in the transport container, the temperature during transport, and the time when transport has ended and vaccines are placed in a stable storage unit. Transport diluents with their corresponding vaccines to ensure there are always equal amounts of vaccines and diluents for reconstitution.

When transporting frozen vaccines, use a portable vaccine freezer unit or qualified container and packout that maintains temperatures between -50°C and -15°C (-58°F and +5°F). Temperature monitoring devices with a buffered probe are preferred for transporting frozen vaccines.

 SECTION 7 
Emergency Vaccine Storage and Handling

Unexpected emergencies such as equipment failures, power outages, severe weather conditions, or natural disasters can compromise vaccine storage conditions, and it is critical to prepare before these events occur. Keep information on after-hours building access and security procedures with SOPs as well as with building management and security staff, if appropriate. Make sure relevant staff have copies of this information available at home.

Establish a working agreement with at least one alternative storage facility even if you have a generator as backup equipment. Make sure you have 24-hour access to this facility.

During a power outage, only open the vaccine storage unit door when power has been restored, or it is determined that the vaccines need to be packed in separate storage containers and/or transported to an alternative storage facility.

Vaccines may remain inside a nonfunctioning unit as long as appropriate temperatures are maintained. Monitor your temperature monitoring devices to determine when additional action should be taken. Should temperatures fall outside of the recommended range, follow your procedures for temperature excursions.

COVID-19 Addendum

The CDC’s addendum focusing solely on COVID-19 vaccines will be updated with specific storage and handling information for each COVID-19 vaccine product as it becomes available.

When handling COVID-19 vaccines, it is recommended to use a type of temperature monitoring device called a digital data logger (DDLs), specifically a DDL with a buffered temperature probe, an air-probe, or a probe designed specifically for ultra-cold temperatures to get the most accurate measurement.

Best practices for storing COVID-19 vaccines correctly include:

  • Avoid placing or storing any items other than vaccines, refrigerated diluents, and water bottles inside storage units
  • Store vaccines and diluents in original packaging
  • Position vaccines and diluents two to three inches from the storage unit walls, ceiling, floor, and door. 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
  • Arrange vaccines and diluents in rows and allow space between them to promote air circulation
  • Should storage in household-grade refrigeration units be necessary, place water bottles on the top shelf, floor, and in the door racks of the units to help maintain stable temperatures. (Note: Water bottles are not recommended for use in ultra-cold freezers, all purpose-built, or pharmaceutical-grade units)

Due to the limited supply of the COVID-19 vaccine, if a temperature excursion occurs, certain steps must be followed so the manufacturer can determine whether a vaccine is likely to still be viable. To provide the manufacturer with sufficient information for determining vaccine viability, take the following steps after a temperature excursion:

  • Label the vaccine “Do Not Use” and store it at the recommended temperature range until you receive manufacturer guidance. If a frozen vaccine has been thawed, store it in the refrigerator between 2°C and 8°C until you receive manufacturer guidance, as refreezing the vaccine may damage it
  • Document the date and length of time of the excursion, the storage unit temperature (minimum/maximum, if available), and inventory affected
  • Record any other relevant information
  • Contact the manufacturer and/or immunization program for guidance on whether to use affected vaccines and whether patients need to be recalled for revaccination
  • Document the event and actions taken for record-keeping requirements

Maintaining the vaccine cold chain in transport situations, for emergency transport, transport for use at off-site clinics or satellite facilities, or for the relocation of stock, can vary in guidance. Some COVID-19 vaccine products may have specific transport guidance, however, general guidance can be found in TABLE 1.

Preparation for emergency situations is more vital than ever due to the limited supply of the COVID-19 vaccine. It is critical that COVID-19 vaccination providers have SOPs in place for emergency situations, and that staff be trained on executing these protocols.


Samantha Halvorsen is the associate editor at Pharmacy Purchasing & Products magazine. She can be reached via email at the address skhalvorsen@ridgewoodmedia.com.

Login

Like what you've read? Please log in or create a free account to enjoy more of what www.pppmag.com has to offer.

Current Issue

Enter our Sweepstakes now for your chance to win the following prizes:

Just answer the following quick question for your chance to win:

To continue, you must either login or register: