When ordering vaccines, a vaccine inventory and pre-order evaluation is required to ensure adequate vaccines and diluents are available. Determining factors for ordering include anticipated demand, storage capacity and available vaccine supplies. Many country and local vaccination information systems (IIS) have vaccine inventory calculation functions and VFC providers may need to use IIS to track the inventory. Detailed information on inventory accounting, sample stock records and daily spreadsheets are available.
Preparing the Cold Vaccine for Transport
A facility must have the necessary supply of supplies to transport the largest annual vaccine inventory. Soft-sided containers specifically designed for vaccine transport may be part of an acceptable, qualified container and packaging system. Commercially available soft-edged food or beverage coolers should not be used, as many are poorly insulated and are likely to be affected by room or outdoor temperatures. It should be ensured that there is a TMD for each container used during transport, as well as suitable coolants and transport materials according to the specific transport systems used. The same shipping containers in which vaccines were originally shipped may only be used for emergency transport as a last resort.
Cold Vaccine Transport
To maintain the vaccine supply, the vaccine must be delivered directly to the facility where it will be used. However, sometimes the vaccine needs to be moved to an offsite facility or satellite facility for an event such as an on-site vaccination clinic. Transport may also be required in emergencies, such as prolonged power outages, floods, or other natural disasters that could jeopardize the supply of vaccines. In these cases, certain measures should be taken to protect the vaccine supply. Vaccine transport to offsite or satellite facilities is different from both transport and emergency transport. Shipping often requires a professional carrier and a long distance and time frame for vaccines to be transported between locations. Transplantation involves movement of the vaccine within a short period of time and distance between providers. Depending on the situation, the shipping recommendations may vary. An organization’s SOPs should clearly define handling procedures for all possible scenarios and be used by trained personnel for any vaccine transplant.
Transport of cold vaccines to off-site or central facilities
There are best transport practices and they are as follows:
• Total time for transplant only or transplant plus clinic day should be a maximum of 8 hours.
• Diluents should be carried with the respective vaccines to ensure that there is always an equal amount of vaccine and diluent for reconstitution.
• Only the required amount of vaccine should be carried during the day.
• If a non-commercial vehicle has to be used, shipping containers must be placed in the passenger compartment instead of the luggage.
Transport of vaccines in emergency situations
In addition to the information summarized above, in case of an emergency, the following should be considered:
• Before packaging any vaccines, an alternative vaccine storage facility should be contacted to confirm that vaccines can be accepted for storage.
• The protective measures available at the time of the incident should be noted, eg water bottles, battery operated TMD, transport to alternative facility, etc.
• The vaccine storage unit door should only be opened when ready to pack the vaccine into transport containers or when power is restored.
If an emergency can be anticipated, for example, vaccination activities should be suspended before the onset of emergencies to ensure sufficient time for weather, packing and shipping.
Storage of Cold Vaccines at Destination
Vaccines should be stored in a suitable storage unit with a TMD as soon as they arrive off-site. There are recommended guidelines for monitoring and recording storage unit temperatures, as follows:
• If the device displays minimum / maximum temperatures, this information should be checked and recorded.
• If the device does not display the minimum / maximum temperatures, the current temperature should be checked and recorded at least twice.
If vaccines cannot be stored in on-site storage, vaccines should be placed in a TMD as close as possible (preferably with a probe in thermal buffer) and their temperature should be checked and recorded hourly. In addition, its container should be kept closed as much as possible and, using guidance, it should be kept in a portable vaccine storage unit.
Planning and Receiving Cold Vaccine Deliveries
When vaccinations arrive, the vaccine coordinator or substitute should be notified immediately. Vaccine delivery should only be scheduled on dates and when staff will be available. A vaccine dispenser should never be left unattended and the package opened immediately.
Unpacking Cold Vaccines
Vaccines and diluents should be removed from their packaging and stored immediately at recommended temperatures. Also, vaccines should not be stored in an unopened shipping box. However, the points to be considered are as follows:
• The shipping container and contents should be inspected for signs of damage.
• Its contents must be compared with the packing list, for frozen vaccines, the packing list may indicate the maximum time for transport according to the vaccine’s shipment date.
• Make sure that lyophilized vaccines come with the correct type and amount of diluent.
• The expiration dates of the vaccine and diluent should be checked to ensure that there are no expired or near expiry products.
• If applicable, the cold chain monitor (CCM) should be checked for any temperature deviation during shipping. Also, an important point is that CCMs are for one-time use and should be discarded after being checked.
However, if there are any inconsistencies between ingredients and packing lists, or any other ingredient concerns (including temperature change), the vaccine manufacturer should be reported immediately. When a temperature change is suspected, vaccines should be labeled DO NOT USE and stored separately from other vaccines in the appropriate vaccine storage unit until vaccine viability is determined. The country or local vaccination program should be contacted regarding any VFC or other vaccines purchased with public funds.
Cold Vaccine Stock Rotation and Removal
The vaccine stock should be rotated and checked regularly for expired doses. Expired vaccines and diluents should be removed immediately to prevent accidental administration.
Understanding Cold Vaccine Expiration Dates
Determining the expiration date of a vaccine or diluent is an important step in proper storage and use of the vaccine. Administration of expired vaccine remains one of the most important vaccine storage and processing errors, so it is essential that staff understand how to read expiration dates to prevent patients from receiving invalid vaccine doses. When the expiration date includes only one month and year, the product can be used until the last day of that month. If a day is included in the month and year, the product can only be used until the end of that day. Contaminated or compromised products should not be used regardless of the expiration date.
In some cases, vaccines must be used before the expiration date on the label, such as when the manufacturer indicates a non-use date (BUD). The BUD is calculated based on the first puncture date of the vial and the storage information in the package insert. If the vaccine does not have a BUD, the vaccine must be used until the expiry date specified by the manufacturer. The BUD replaces the expiration date and must be specified on the label together with the initials of the person performing the calculation. Examples are as follows:
• Reconstituted vaccines have a limited lifetime after the vaccine has been mixed with a diluent. For example, if the package insert states that the reconstituted vaccine should be used within 30 minutes, it should be discarded if it has not been used until then. This time frame can only be valid as long as the reconstituted vaccine is still in the vial, not after it has been drawn into a syringe and therefore its package insert should be carefully checked.
• Multi-dose vials (MDVs) may have a certain time frame for use after being entered with a needle. For example, it may be stated in the package insert that the vaccine should be discarded 28 days after it is entered. If the vial was entered on June 1, 2020, the BUD is June 29, 2020.
• Expiry dates shortened by the manufacturer may apply when the vaccine has been exposed to improper storage conditions. The manufacturer can determine that the vaccine can still be used but will expire earlier than the date on the label.
In addition to the BUD, some multi-dose vials have a certain number of doses that can be withdrawn, and the vial should be discarded after the maximum number of doses has been removed, even if there is vaccine residue in the vial.
Cold Vaccine and Equipment Destruction
Sometimes unused vaccine and diluent doses, unopened bottles, expired bottles, and potentially compromised vaccines may be returned for credit even if they need to be discarded. For vaccine specific information, refer to the country or local vaccination program and the vaccine manufacturer. Open and broken vials and syringes, syringes filled by the activated manufacturer, and vaccines pre-drawn by the providers are not returnable and must be discarded according to country requirements. Immediately after use, all used syringe and needle devices should be placed in sealed, puncture-resistant, sealed on the sides and bottom, labeled or color-coded biohazard containers. This app helps prevent accidental needle sticks and reuse. Used needles must not be resealed, cut or removed from syringes before disposal.
Empty, expired or compromised vaccine bottles are generally not considered hazardous or pharmaceutical waste and should not be disposed of in a biomedical waste container. However, country requirements for disposal must be checked and complied with. Medical waste disposal requirements are determined by the country’s environmental institutions. The country or local vaccination program or country environmental agency should be contacted for guidance.