Immunization Healthcare Branch. Storage & Handling Questions and Answers. Prepared by. Immunization Healthcare Branch (IHB), Defense Health Agency

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1 Immunization Healthcare Branch Storage & Handling Questions and Answers Prepared by Immunization Healthcare Branch (IHB), Defense Health Agency Last Updated: 06 Feb GET-VACC

2 Storage & Handling Questions and Answers Vaccine Storage A. General information B. Vaccine Storage Equipment C. Temperature Monitoring Vaccine Handling A. Vaccine Diluent and Storage practices B. Emergency Procedure Recommendations C. Vaccine Inventory Management D. Vaccine Packing, Shipping and Transport E. Vaccine Prep and disposal Adapted from the Immunization Action Coalition (with permission) and the Centers for Disease Control and Prevention (CDC). - Page 2 of Feb 15

3 Vaccine Storage A. General information 3. What is Cold Chain Management? Cold Chain Management is the process of preparing temperature-sensitive medical products (TSMP) for shipment utilizing standardized systems and procedures, ensuring that required temps are maintained throughout the supply chain, and the validation that those conditions are met during all phases of distribution until delivery. What is proper vaccine storage and handling? Vaccines are stored, shipped, and handled according to pharmaceutical manufacturers' instruction as outlined in the product's package insert or other guidance. Failure to adhere to recommended specifications for proper storage and handling temperatures may reduce vaccine potency, resulting in an inadequate immune response and inadequate protection against the vaccine preventable disease. Who is USAMMA/DOC? United States Army Medical Material Agency/Distribution Operation Center (USAMMA/DOC) is the DoD agency responsible for the management, coordination, and execution of distribution services. Specifically, the packing and storage of Temperature Sensitive Medical Products (TSMPs) requiring refrigeration or other special handling requirements while maintaining close in-transit visibility in support of our internal and external customers. The DOC operates under the clinical and technical direction of USAMMA's Pharmacy Consultant who is also the Deputy Director for Distribution Operations of the Immunization Healthcare Branch. 4. How can USAMMA/DOC be reached? 5. For vaccines and temperature sensitive product questions contact USAMMA /DOC during the hours of EST at phone: , 3017, 4198/ DSN: , 3017, 4198/Fax: ; after hours call: , , or for urgent issues only. NIPR For more information go to the following website: /cold_chain_management.cfm Who is DLA Troop Support? Defense Logistics Agency-Troop Support (DLA-TS) provides United States armed services members with food, clothing, textiles, medicines, medical equipment, and construction supplies and equipment. The pharmaceutical division offers most vaccines for purchase by eligible DoD customers. More information can be found at the following website: Page 3 of Feb 15

4 6. 7. What vaccine storage and handling training should immunization departments implement? All staff members who administer vaccines should be trained during orientation and annually about the importance of vaccine cold chain management and storage/handling practices. In addition, they should be familiar with the correct storage temperatures for the various vaccines and procedures for what to do if the temperature is out-of-range, i.e., power outage, equipment failure, etc. Where can additional storage and handling information guidelines be found? The IHB website has a webpage dedicated to vaccine storage and handling, which includes tools and products to help you build quality storage and handling practices. The CDC also has a vaccine storage and handling webpage, that includes numerous resources including forms, checklists, posters, and guidelines on proper vaccine storage and handling. B. Vaccine Storage Equipment 3. Is there a DoD policy requiring certain vaccine storage equipment to be purchased? No, clinics should follow guidance for appropriate storage equipment as outlined by the Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices (ACIP), National Center for Immunization and Respiratory Diseases (NCIRD), or service policies. What are the general requirements for the type of refrigerator, freezer, or combined refrigerator/freezer unit used to store vaccines? CDC strongly recommends the use of stand-alone refrigerators and stand-alone freezer units, meaning a self-contained unit that only refrigerates or freezes and is suitable for vaccine storage. These units can vary in size, from compact, under-the-counter style to a large, stand-alone, pharmaceutical grade storage unit. The characteristics of a recommended storage unit include: enough room to store the year's largest inventory without crowding and sufficient room to store water bottles in the refrigerator and frozen coolant packs in the freezer to stabilize the temperature and minimize temperature fluctuations that can impact vaccine potency. In addition, frost-free or automatic defrost cycle units are preferred. Can I use a combination household style refrigerator/freezer to store vaccines? CDC recommends the use of stand-alone units as a best practice. An alternative to stand-alone units is to use only the refrigerator compartment of a combination household refrigerator/freezer unit to store refrigerated vaccines and to be very careful not to use the top shelf if the vent from the freezer opens there. A separate stand-alone freezer should then be used to store frozen vaccines; this is because the freezer compartment of a combined house-hold unit should not be used for vaccine storage if the refrigerator unit is being used for that purpose. The usual house-hold single-condenser combination refrigerator/freezer units are less capable of simultaneously maintaining proper storage temperatures in the refrigerator and freezer compartments. These refrigerators are cooled - Page 4 of Feb 15

5 4. 5. by venting cold freezer air into the refrigerated section thus there is a real risk of freezing vaccine near the cooling vents. Can a dormitory style refrigerator be used to permanently store vaccines? CDC does not recommend the use of dormitory-style or bar-style combined refrigerator/freezers for ANY vaccine storage. How can you stabilize temperatures in the refrigerator? You can help stabilize and maintain the temperature in the refrigerator by adding buffers such as at least two or three large containers of water placed against the inside walls and in the door racks. The addition of water bottles (not gel packs) reduces the risk of freezing due to the tremendous latent heat released from water prior to freezing. Not only will water bottles help maintain an even temperature they also help keep the temperatures stable in the event of a power failure How can you stabilize temperatures in the freezer? You can help stabilize and maintain the temperature in the freezer by adding buffers such as frozen packs along the walls, back, and bottom of the freezer compartment and inside the racks of the freezer door. What are the requirements for the vaccine storage room? Good air circulation around the vaccine storage unit is essential for proper heat exchange and cooling functions. The unit should be placed in a well-ventilated room and should have space around the sides and top. If the room temperature is too hot it is recommended that a small AC portal unit or extra ventilation vents are added to ensure room temperature remains stable and does not cause the refrigerator/freezer temperatures to shift outside of normal range. - Page 5 of Feb 15

6 8. What regular maintenance should be conducted on vaccine storage equipment? Users should conduct regular maintenance tasks that can be divided into daily, weekly, monthly and periodic actions such as: on a daily basis check the temps and ensure the storage unit doors are closed; on a weekly basis defrost the freezer; on a monthly basis clean the coils and motor, clean the storage unit compartments, and check the door seals; and periodically check/clean the drain pan. Facilities should maintain a logbook which contains records indicating the serial numbers of each piece of equipment, the date each piece of equipment was installed, the dates of any routine maintenance tasks (such as cleaning), the dates of any repairs or servicing, and the name of the person performing each of these tasks. This logbook is also an ideal place to keep the instructions that came with the equipment. C. Temperature Monitoring What type of thermometer is best for measuring temperatures in a vaccine storage unit? CDC recommends the use of a digital thermometer with a biosafe glycol-encased probe or a similar temperature buffered probe that will more closely approximate the measure of liquid temperature. A temperature buffer enables a thermometer probe to more closely match the temperature changes experienced by stored vaccine. Examples of temperature buffers are a probe inserted into a glycol-filled vial or one inserted into glass beads. To ensure validity of temperature measurements, only calibrated thermometers with a certificate of Traceability and Calibration should be used. Where within the vaccine storage unit should the thermometer be placed? In the refrigerator, it is important that the glycol-encased or similar temperature buffered probes be placed in close proximity to the vaccines being stored. Proper placement is very important since it helps the staff to most accurately identify the actual vaccine vial temperatures and to take appropriate corrective actions quickly if necessary. How often should temperatures be recorded for refrigerator and freezer compartments where vaccines are stored? And how should you document temperatures? Temperatures inside refrigerator and freezer compartments should be measured and recorded on a temperature log a minimum of at least twice a day (the room temperature should also be recorded on the log); once at the start of the day and a second time before the area is closed whether or not you have an alarm system installed. Army immunization areas must record the temperature a minimum of 4 times per day. Immediate action must be taken if the temperature is outside the recommended range for either compartment. Should I have a digital data logger along with a thermometer in the vaccine storage unit? Yes. CDC's interim guidance suggests the use of digital data loggers with detachable probes that allow the reading of temperatures without opening the door and record & store temperature information at frequent programmable intervals for 24 hour temperature monitoring rather than non-continuous temperature monitoring. - Page 6 of Feb 15

7 Vaccine Handling How often should I set the digital date logger to measure temperature? CDC's interim recommendation is to set the digital data logger to measure every 15 minutes. If you wish to set the data logger to measure temperature more frequently or if the manufacturer recommends a more frequent setting, that is acceptable. CDC is currently working with the National Institute of Standards and Technology (NIST) to evaluate the most efficient and effective settings for digital data logger temperature measurements. Do twice daily physical temperature checks need to occur if a data logger and/or alarm system is in place? Yes. CDC still recommends documenting twice daily temperature checks even with a continuous data logger and/or alarm system because twice daily checks will give you a better indication of any problem with your storage units function. Relying solely on alarms can lead to complacency and inappropriate temps may not be discovered in a timely manner (e.g., alarm battery failure). DoD has had many vaccine losses due to failure of alarm or call systems that were not being physically checked, these losses could have been avoided if someone was physically checking the temperatures. Who should adjust the temperature of a vaccine storage unit? Only the primary or backup vaccine coordinator should adjust the temperature of a vaccine storage unit. Limiting access to the thermostat reduces the risk that the temperatures will be adjusted inappropriately. A warning sign should be posted on the storage unit that says, "Do not adjust refrigerator or freezer temperature controls. Notify (insert name) if adjustments are necessary". How long should temperature logs be maintained? Temperature logs should be kept for 3 years or per service/local policy. Archived temperature logs can show how well the vaccine storage unit is working overtime and can be used to determine when a unit may need adjustment, maintenance, or replacement, such as when temperatures are consistently at the limit or sometimes beyond the limit of the recommended temperature range. A. Vaccine Diluent and Storage practices 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). 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 - Page 7 of Feb 15

8 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. 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. 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. 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. 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. 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. Can vaccines be stored in the same unit where employees' lunches are located? No, biologics should never be stored with food or drinks. Is it safe to store vaccines and other biologics in the same refrigerator with lab specimens or blood products? - Page 8 of Feb 15

9 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. B. Emergency Procedure Recommendations 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. 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. 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. 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 - Page 9 of Feb 15

10 5. 6. 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. 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. 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. C. Vaccine Inventory Management 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, , and phone number. 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. - Page 10 of Feb 15

11 D. Vaccine Packing, Shipping and Transport 3. 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. 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. 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? - Page 11 of Feb 15

12 5. 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. 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. E. Vaccine Prep and disposal 3. 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. 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. 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. - Page 12 of Feb 15

13 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. 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. 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. - Page 13 of Feb 15