Questions & Answers
Storage & Handling - Vaccine Handling
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Questions

Vaccine Diluent and Storage practices

  1. What is the required refrigerator vs. freezer temperatures?
  2. What happens to vaccine contents when vaccines are not properly stored?
  3. Do vaccines need to be protected from light?
  4. How should vaccines be stored in the refrigerator/freezer?
  5. How should vaccines be labeled in the refrigerator and freezer?
  6. Can I remove the vaccine from its packaging to store more products in the refrigerator?
  7. Where is the appropriate place to store diluents?
  8. Can vaccines be stored in the same unit where employees' lunches are located?
  9. Is it safe to store vaccines and other biologics in the same refrigerator with lab specimens or blood products?

Emergency Procedure Recommendations

  1. What are the appropriate steps if a vaccine compromise is suspected?
  2. What steps should be taken if the vaccine storage unit malfunctions?
  3. What steps can be taken to prevent accidental loss of vaccine?
  4. How should vaccines be stored over a weekend or holiday if staff is not available?
  5. What is an Emergency Vaccine Retrieval and Storage Plan?
  6. Why is it important to identify an alternate storage location?

Vaccine Inventory Management

  1. What is the appropriate disposition for expired vaccine?
  2. When the expiration date of a vaccine indicates a month and year, does the vaccine expire on the first or last day of the month?

Vaccine Packing, Shipping and Transport

  1. What procedures should be developed for the storage and handling of vaccines?
  2. What type of storage containers should be used when administering immunizations offsite?
  3. How should storage containers be labeled when transporting vaccines offsite?
  4. Can vaccines be transported in a paper bag?
  5. What are the guidelines for storing vaccine during off-site clinics?

Vaccine Prep and disposal

  1. Can vaccines be pre-filled prior to an event?
  2. Can you pre-fill syringes prior to mass influenza vaccination clinic?
  3. How long can a multi-dose vial be used once it is opened and a dose is withdrawn?
  4. What information should be marked on the multi-dose vaccine bottle once it has been opened?
  5. How long can manufacturer-filled syringes be stored once the rubber tip is removed and the needle is added?
  6. Are vaccine diluents interchangeable?
Answers

Vaccine Diluent and Storage practices

  1. What is the required refrigerator vs. freezer temperatures?
    Store all vaccines according to the manufactures' package insert. Certain vaccines are sensitive to freezing temperatures and should be stored in temperatures of 35°F- 46°F (2°C-8°C). Other vaccines lose potency when exposed to increased temperatures because they contain live viruses and should be stored in the freezer at temperatures of 5°F (-15°C) or colder. An exception to the rule is for measles, mumps, and rubella vaccine (MMR) which is routinely stored in the refrigerator, but can also be stored in the freezer (MMR in the lyophilized state is not affected detrimentally by freezing temperatures).

  2. What happens to vaccine contents when vaccines are not properly stored?
    Excessive heat or cold exposure damages vaccine, resulting in loss of potency and once potency is lost it can never be restored. Each time vaccine is exposed to excessive heat or cold, the loss of potency increases and eventually, if the cold chain is not correctly maintained, all potency will be lost, and the vaccine becomes useless.

  3. Do vaccines need to be protected from light?
    Yes. HPV, MMR, MMRV, rotavirus, varicella, and zoster vaccines are sensitive to light, causing loss of potency, so must be protected from light at all times. Store these vaccines at the appropriate temperatures in their boxes with the tops on until they are needed.

  4. How should vaccines be stored in the refrigerator/freezer?
    Vaccines should be placed in the center of the refrigerator/freezer compartment, on the middle shelves, away from the walls, floor and doors of the unit in open containers so air can circulate around the vaccines. If the upper shelf of the refrigerator must be used for vaccine storage, it would be best to place MMR on this shelf because MMR is not sensitive to freezing temperatures.

  5. How should vaccines be labeled in the refrigerator and freezer?
    Staff can easily confuse the vaccines within the storage unit. Labeling the bin where the vaccine is stored can help staff quickly locate and choose the correct product – perhaps preventing a vaccine administration error. Depending on how the vaccines are organized within the storage unit (e.g., top two shelves for pediatric only vaccines, middle shelves for pediatric/ adolescent/adult vaccines and the bottom two shelves for adult only vaccines), labels can be attached to the slotted containers, the bins, or directly to the shelves where the vaccine is stored. Other helpful strategies to prevent administration errors include color coding the labels (e.g., one color for pediatric and one for adult vaccines), separating age-specific vaccines by shelf; and including additional information such as age indications, gender or other information unique to the vaccine on the label.

  6. Can I remove the vaccine from its packaging to store more products in the refrigerator?
    No. Storing loose vaccine vials outside of their boxes is not recommended. This practice makes inventory management more difficult, makes tracking expiration dates more difficult, predisposes to administration errors when vials are confused, and potentially exposes the vaccines to light.

  7. Where is the appropriate place to store diluents?
    Store all diluents according to the manufactures package insert. Diluents packaged separately from their corresponding vaccines can be stored at room temperature or in the refrigerator. Diluents packaged with their vaccines should be stored in the refrigerator next to their vaccines but unlike vaccines, diluents may also be stored on the refrigerator door. ACAM2000 diluent is shipped refrigerated with vaccine but should be stored on shelf at room temperature.

  8. Can vaccines be stored in the same unit where employees' lunches are located?
    No, biologics should never be stored with food or drinks.

  9. Is it safe to store vaccines and other biologics in the same refrigerator with lab specimens or blood products?
    CDC's vaccine storage and handling toolkit states, if possible, other medications and other biologic products should not be stored inside the vaccine storage unit. If there is no other choice, these products must be stored below the vaccines on a different shelf. This prevents contamination of the vaccines should the other products spill, and reduces the likelihood of medication errors.

Emergency Procedure Recommendations

  1. What are the appropriate steps if a vaccine compromise is suspected?
    Immediate action must be taken to correct improper vaccine storage conditions and this action should be documented. Label the vaccines "DO NOT USE" and immediately store them under appropriate conditions separate from other vaccine supplies. Notify the primary or back-up vaccine coordinator (if not available, immediate supervisor) immediately of any temperature excursion. Use the Potentially Compromised Vaccine Worksheet, found on the IHB website, to document the storage unit and ambient room temperatures, the length of time the vaccines may have been exposed to the inappropriate storage temperatures, the situation surrounding the potential loss, and an inventory of the vaccines affected. Note if water bottles were in the refrigerator and/or frozen coolant packs in the freezer at the time of the event. Contact USAMMA/DOC for guidance and their disposition for the affected vaccines. Do not discard vaccines unless directed to by USAMMA/DOC.

  2. What steps should be taken if the vaccine storage unit malfunctions?
    Move the vaccine to a properly functioning storage unit with internal temps within the recommended ranges, then attempt to troubleshoot the problem. Do not allow the vaccine to remain in a nonfunctioning unit for an extended period of time while you attempt to resolve the problem. If you are unsure how long the storage unit will not be functioning properly or you determine that the problem cannot be corrected in time to maintain the internal temperature within the recommended range, activate your clinics Emergency Vaccine Retrieval and Storage Plan.

  3. What steps can be taken to prevent accidental loss of vaccine?
    Post a "DO NOT UNPLUG" sticker near the electrical outlet and on the refrigerator or freezer alerting staff, janitors, and electricians not to unplug the unit. In addition, plug your vaccine storage unit directly into the outlets (never use extension cords or power strips), use a safety-lock plug or an outlet cover to reduce the chance of the unit becoming inadvertently unplugged and avoid using power outlets with built-in circuit switches (they have little red reset buttons) and outlets that can be activated by a wall switch. These can be tripped or switched off, resulting in loss of electricity to the storage unit. All storage devices and alarms should be plugged into back-up power plugs to reduce the chance of accidental loss of power to the units during an outage.

  4. How should vaccines be stored over a weekend or holiday if staff is not available?
    A continuous-monitoring temperature alarm/notification system should be considered, especially for practices with a large inventory, to help alert staff to after-hours emergencies. Alarms should be monitored electronically and physically on a 24 hours, seven days a week basis. Simple systems sound audible alarms when the temperatures inside the storage units exceed the recommended ranges, where as sophisticated systems sound an audible alarm and alert one or more designated person(s) at a specified phone or pager number. Storage areas with restricted access should have a device installed (light indicator/audible alarm) indicating when the storage unit temperature is out of range that can be checked without physically entering the restricted area.

  5. What is an Emergency Vaccine Retrieval and Storage Plan?
    The Emergency Vaccine Retrieval and Storage Plan provides up-to-date information regarding procedures to follow to protect and/or retrieve vaccines as quickly as possible when a potentially compromising situation occurs such as inclement weather conditions, natural disasters, or other emergencies that might disrupt power or flood any office where vaccine is stored. The immunization clinic vaccine coordinator should develop an Emergency Vaccine Retrieval and Storage Plan and keep it in a prominent and easily accessible location near the vaccine storage units.

  6. Why is it important to identify an alternate storage location?
    In case of an emergency situation, having an established working agreement with at least one alternate storage facility with a backup generator where vaccine can be appropriately stored and monitored for the interim, can save thousands of dollars worth of vaccines. Ensure that advanced arrangements are made with the facility(s) to store your vaccine when weather predictions call for inclement conditions (e.g., tornadoes, hurricanes, ice, severe snowstorms), when your vaccine storage equipment cannot be repaired, or when the power cannot be restored before the vaccine storage unit temperature rises above the recommended range.

Vaccine Inventory Management

  1. What is the appropriate disposition for expired vaccine?
    DoD activities are responsible for disposal of compromised or expired vaccine. Contact the pharmacy or logistics for specific policies regarding the disposition of unopened vials, expired vials, unused doses, doses drawn but not administered, and potentially compromised vaccine. DoD activities that provide anthrax and small pox vaccines will report vaccine inventories for destruction to their Service medical logistic agency by preparing a destruction document. The destruction document needs to be faxed to the USAMMA/DOC and must include the following information: date when the vaccine was destroyed; list of lot number(s) destroyed; number of unopened vials destroyed; method of destruction; for Navy ships, where was the vaccine acquired, i.e. FISC, another ship (include ship name), etc.; and signature block, e-mail, and phone number.

  2. When the expiration date of a vaccine indicates a month and year, does the vaccine expire on the first or last day of the month?
    When the expiration date is marked with only a month and year, the vaccine or diluent may be used up to and including the last day of the month indicated on the vial. Any unused vaccine or diluent should not be used after this month has passed. If the expiration date printed on all vaccines and diluent vials and boxes includes the month/day/year the vaccine or diluent may be used up to and including this date. Monitor and rotate your vaccine supply carefully so that vaccines do not expire.





Vaccine Packing, Shipping and Transport

  1. What procedures should be developed for the storage and handling of vaccines?
    You should develop storage and handling procedures that include contact information for the primary and back-up vaccine coordinators, logistics, pharmacy, and medical maintenance personnel; storage unit/alarm system repair companies; back-up storage areas and vaccine manufacturers. Additional SOPs should address daily/monthly operations and maintenance of equipment, transportation of vaccines, storage and handling of vaccines when off-site, and procedures for compromised vaccine. Refer to the Emergency Vaccine Retrieval and Storage Plan worksheet found on the IHB storage and handling webpage.

  2. What type of storage containers should be used when administering immunizations offsite?
    You must use validated storage containers and packing protocols which assures product safety and efficacy. You may use hard-sided insulated plastic and/or Styrofoam™ coolers with at least 2-inch thick walls, or other mobile temperature management units (i.e., AX27L formerly VaxiCool or PX1L formerly VaxiPac). Thin-walled Styrofoam™ coolers, such as those purchased at grocery stores to hold beverages, are not acceptable.

  3. How should storage containers be labeled when transporting vaccines offsite?
    Attach labels to the outside of the container to clearly identify the contents as being valuable and fragile vaccines. Record vaccine type(s), quantity, date, time, and originating facility on a label on the outside of the container. Document the vaccine storage unit temperature at the time the vaccine is removed for transport.

  4. Can vaccines be transported in a paper bag?
    No, you must use an approved insulated storage container, such as a hard-sided plastic cooler or Styrofoam™ cooler with at least 2-inch thick walls, with appropriate packing material and thermometer.

  5. What are the guidelines for storing vaccine during off-site clinics?
    Ideally, vaccines should be stored at the recommended temperatures inside a properly functioning storage unit (e.g., refrigerator, freezer) at the off-site clinic. If such a unit is not available, the vaccine must be maintained in a validated storage container as described above with a thermometer. During the off-site clinic, keep the storage container closed as much as possible and check and record the temperatures a minimum of every hour.

Vaccine Prep and disposal

  1. Can vaccines be pre-filled prior to an event?
    Vaccine doses should not be drawn into a syringe until immediately before administration. When the syringes are filled, the type of vaccine, lot number, and date of filling must be labeled on each syringe, and the doses should be administered as soon as possible after filling. ACIP discourages the routine practice of pre-filling syringes due to the potential for administration errors, because a majority of vaccines have a similar appearance. In addition, the FDA does not license administration syringes for vaccine storage due to the lack of data concerning the stability and sterility of vaccine stored in end user filled (i.e., not filled by the manufacturer) syringes. Unused syringes filled by the end user should be discarded at the end of the clinic day. This does not apply to manufacturer-supplied prefilled glass syringes.

  2. Can you pre-fill syringes prior to mass influenza vaccination clinic?
    In certain circumstances in which a single vaccine type is being used (e.g., in advance of a community influenza vaccination campaign), filling a small number of syringes (10 at a time) can be considered. When conducting an influenza clinic certain procedures should be followed: only one vaccine type may be administered at the clinic, vaccine should not be drawn up in advance of arriving at the clinic site, vaccine should be transported in the manufacturer supplied packaging, patient flow should be monitored to avoid drawing up unnecessary doses and any remaining vaccine drawn up in syringes and not administered, must be discarded at the end of the clinic day.  

  3. How long can a multi-dose vial be used once it is opened and a dose is withdrawn?
    Doses from a partially used multi-dose vial can be administered until the expiration date printed on the vial or vaccine packaging, provided that the vial has been stored correctly and that the vaccine is not visibly contaminated. The expiration date for reconstituted multi-dose vials varies from product to product and the new expiration date and time will differ from that printed on the vial. For example, after reconstitution, MMR vaccine must be administered within 8 hours and must be kept at refrigerator temperature during this time. Consult the package insert for the most up-to-date information about expiration dates and times following reconstitution. Unused reconstituted vaccines kept beyond these limits should not be administered.

  4. What information should be marked on the multi-dose vaccine bottle once it has been opened?
    Mark multi-dose vials with the date it was first opened and mark reconstituted vaccine with the date and time it was reconstituted. This is important for two reasons: some vaccines expire within a certain time after opening or after reconstitution. This may not be the same as the expiration date; and dating opened or reconstituted vials helps manage vaccine inventory by identifying which vials should be used first.

  5. How long can manufacturer-filled syringes be stored once the rubber tip is removed and the needle is added?
    When manufacturer-filled glass syringes are not supplied with needles, the needles should be attached just before administration. If a needle is attached to a sealed manufacturer prefilled syringe, the syringe should be used or discarded at the end of the clinic day because the sterile seal has been broken.

  6. Are vaccine diluents interchangeable?
    Diluents are not interchangeable, even diluents from the same manufacturer. Therefore, use only the specific diluent provided by the manufacturer for each type of vaccine to ensure adequate potency and safety of the resulting mixture.