Managing Vaccine How to keep vaccines viable and patients protected Only viable vaccine will protect your patients. You can’t tell by looking at vaccine whether it has lost potency through mishandling or improper storage. Everyone who works with vaccines must to be familiar with best practices for minimizing the risk of vaccine becoming nonviable. Overview of this section "It is better to NOT vaccinate than to administer a mishandled Best Practices Checklist: Managing Vaccine Managing Your Vaccine vaccine!" Donna Weaver, CDC Ordering Vaccine and Managing Inventory Receiving Vaccine Storing and Handling Vaccine Who to Call Disposing of Vaccine Planning for Vaccine Storage Emergencies Packing and Transporting Vaccine Minnesota Vaccines for Children 651-201-5522 Key Resources for Managing Vaccine Minnesota Immunization Program 800-657-3970 651-201-5503 July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 1 Best Practices Checklist: Managing Vaccine The information in this checklist will be covered in more detail throughout this section. Ordering vaccine and managing inventory Disposing of vaccine We keep an up-to-date list of the vaccines our clinic uses and where/how to order them. We dispose of spoiled or expired vaccine and diluents properly. We check our vaccine inventory at least monthly and with each vaccine order. Planning for vaccine storage emergencies We rotate vaccines at least monthly by placing lots with the earliest expiration dates in front so they will be used first. Receiving vaccine We make sure all staff know what to do with vaccine when it arrives. We train our staff on the appropriate arrival condition of each vaccine. We keep a log of all vaccines received. Storing and handling vaccine We train our staff to be familiar with proper vaccine storage and handling (e.g., protecting MMR from light, refrigerated vs. frozen vaccines). We have a plan for storing and transporting vaccine in an emergency and staff are trained accordingly. We have identified an alternate site to store vaccine in case of a lengthy power outage. Packing and transporting vaccine We keep a list of clinics and contact names in case we need to transfer or transport vaccine. We use coolers and thermometers that meet all the specifications for transferring or transporting vaccine. Our staff is familiar with how to pack vaccine according to established standards. We keep a list of packing suppliers. We use refrigerator(s) and freezer(s) that meet all the specifications for proper vaccine storage. We store vaccine in the recommended compartments - frozen vaccine in the freezer and refrigerated vaccine in the refrigerator. We use our refrigerators and freezer only for vaccine storage (i.e., no food or beverages). We only use calibrated thermometers. We check and record temperatures on a log twice a day and post it on the refrigerator/freezer door. We train our staff to take immediate action when temperatures are out of range. We perform routine maintenance on our vaccine storage units. We safeguard the power supply of our vaccine storage units by posting Do Not Unplug and Warning stickers. 2 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Managing Your Vaccine “Vaccine quality is the shared responsibility of all handlers of vaccines from the time a vaccine is manufactured until administration.” Vaccines are expensive — one of the most valuable assets a clinic has — so it is important to keep them safe. Taking care that all staff adhere to vaccine management policies will best protect this costly asset. ACIP General Recommendations on Immunizations, 2011 The cost of vaccine adds up quickly — even for a small immunization clinic. Take a moment to think about what your clinic's refrigerator and freezer are worth and make a commitment to adopt solid storage and handling policies. What’s your refrigerator and freezer worth? Over $38,000.00!* Refrigerator-only unit $5567.20 $910.80 DTaP 20 doses PedvaxHib Freezer-only unit 20 doses 20 doses Rotateq PedvaxHib $5437.50 $2415.50 20 doses Rotateq 20 doses MMR $3536.00 20 doses 10 doses MMR MMR Frzn Pack Frzn Pack $4029.00 old Cold C ack P Pack 30 doses 20 doses PCV PCV $2605.40 $2068.20 20 doses Gardasil 20 doses 30 doses Pediarix 40º 0º Pediarix $1497.20 20 doses 20 doses Varicella 20 doses 20 doses 20 doses Menveo Adacel Adacel 10 doses Varicella Varicella Frzn Pack Frzn Pack $807.50 $247.10 $209.60 $547.80 $213.70 $758.60 10 doses 10 doses 20 doses 10 doses 20 doses 5 doses IPOL Infanrix Havrix Engerix-B PPSV Zoster $525.00 10 doses Cold Cold Pack Pack HepB Adult H2O $394.00 $5246.40 $1025.00 40 doses 100 multi-dose vials 20 doses Afluria Flumist Fluzone Peds H2O H2O H2O Frozen Pack Frozen Pack Frzn Pack Frozen Pack Frzn Pack Frzn Pack H2O Value of vaccine in freezer = $7252.00 Value of vaccine in refrigerator not including flu = $24,151.10 Value of vaccine in refrigerator including flu = $30,816.50 *Based on 2010 vaccine prices and inventory of a small clinic. Brand name identification is for sample purposes and is not an endorsement of one product brand over another. July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 3 Ordering Vaccine and Managing Inventory General instructions for ordering vaccine yy Write a procedure for the primary and backup vaccine coordinators to follow for ordering vaccine from both the MnVFC program and from manufacturers/ distributors. yy Keep an up-to-date list of the vaccines your clinic uses and where to order them. Managing vaccine inventory yy Review your vaccine inventory each month and with each vaccine order to avoid over-ordering. Make sure you: ○○ Check vaccine expiration dates. ○○ Rotate your supply by placing vaccines with the earliest expiration dates in front of others and always using them first. Mark the packages "use first" to alert staff. If the expiration date is listed by month and year, the vaccine expires the last day of the month (for example, "06/2011" means the vaccine will expire on June 30, 2011). yy Keep a log of all vaccines in inventory; see Monthly Vaccine Inventory Log on page 39. At the very least, make sure you record the: ○○ Vaccine name ○○ Manufacturer ○○ Lot number ○○ Number of doses ○○ Expiration date ○○ Date of receipt ○○ National Drug Code (NDC) number yy Use the log as a tool to provide information on how much of each vaccine your clinic uses. You may need to refer to it if you have a storage and handling mishap or if you need to find a recalled vaccine. Implementing a new combination vaccine yy Work with the physician(s) on staff to use up current stock of vaccine while transitioning to the new combination vaccine (i.e., completing a series with the current brand and starting the new vaccine only in children beginning a series). yy If you have excess vaccine you won't use after transitioning to the new combination vaccine try to transfer it to another clinic where it can be used before it expires. TAKE ACTION If you have excess vaccine or vaccine that will expire within three months: 1. Don't wait until the last minute. Determine which vaccines can be used before they expire. 2. Transfer vaccines you won't use to another clinic where they can be used before they expire. 3. If it is MnVFC vaccine, call the MnVFC program at 651-201-5522 for guidance. For private purchase vaccine, check your purchase agreement for guidance. 4 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 General instructions for receiving vaccine yy Write a procedure for receiving vaccine. yy Make sure all staff know what to do with vaccine when it arrives. yy Be familiar with the appropriate arrival condition of each vaccine; see Guide to Receiving, Storing, and Handling Vaccines on page 19. yy Open containers immediately upon receipt, inspect vaccine for damage, and check the warm- or cold-mark temperature indicators (if included in the package). If you have questions about the condition or viability of the vaccine at the time of delivery, see the TAKE ACTION box on page 6. yy Check quantities ordered, lot numbers, and expiration dates against the invoice or packing slip. For MnVFC vaccine, report any discrepancies or concerns within two hours of receiving the vaccine. For private purchase vaccine, check your purchase agreement for guidance. yy Keep invoices and/or packing slips and record the date the vaccine was received on them. Receiving MMRV, varicella, and zoster vaccine yy Regardless of whether these vaccines are ordered privately or come from the MnVFC program, they are shipped directly to the clinic from the manufacturer/ distributor. yy MMRV, varicella, and zoster vaccines should arrive frozen. yy Based on manufacturer recommendations, redistribution of MMRV, varicella, and zoster vaccines to other clinic sites is not allowed. Redistribution of these vaccines is not allowed by the MnVFC program. yy If you receive MnVFC MMRV, varicella, or zoster vaccine from somewhere other than the manufacturer (i.e., your parent clinic or central pharmacy) please call the MnVFC program for guidance. July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE Receiving Vaccine Did you know that MIIC can help you manage vaccine inventory? Here's how: yy When you receive vaccine, record it in MIIC. yy Each time a vaccine is given MIIC tracks the amount of vaccine left in inventory. yy MIIC automatically inserts the lot number, expiration date, and manufacturer when you enter each vaccination. yy Using MIIC takes a little time up front but will save many steps in the long run. www.health.state.mn.us/immunize 5 Receiving Vaccine TAKE ACTION If you have questions about the condition or viability of the vaccine at the time of delivery, for example: yy Refrigerated vaccines arrive warm or frozen. yy MMRV, varicella, or zoster vaccine arrives thawed. yy The color of the cold- or warm-mark temperature indicator (if included in the package) has changed or the thermometer indicates an out-of-range temperature. yy Vaccine vials or syringes are damaged. 1. Mark the vaccine “DO NOT USE” so staff won't inadvertently administer it. 2. Store the vaccine at the correct temperature – apart from other vaccines – until you can determine if it is viable. Do not throw it away! 3. Call the MnVFC program within two hours of receipt if the vaccine in question is from MnVFC. For private purchase vaccine, check your purchase agreement for guidance. ○○ Be ready to provide temperature details, lot numbers, and expiration dates. ○○ If you are instructed to contact the manufacturer, make sure to ask to speak to the medical consultant or quality assurance staff. 3. Document your actions; see Vaccine Troubleshooting Log on page 51. 6 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 M DH does not endorse or recommend a particular brand of refrigerator/freezer or thermometer, but we do recommend certain features. Have the right refrigerators/freezers Use the Volume Based Refrigerator and Freezer Recommendations table on page 9 to help you choose the right refrigerator and/or freezer for your facility based on the volume of vaccine you need to store. Essential refrigerator/freezer features yy Ability to maintain uniform temperatures, preferably with a preset temperature of 40°F (4°C) in a refrigerator and 0°F (-18°C) or colder in a freezer yy Enough usable space to hold the year’s largest inventory, such as the back-toschool rush or flu season, and still have room for air circulation yy Automatic defrost cycle yy Separate exterior doors and separate controls in each compartment if using a combination refrigerator/freezer Storing and Handling Vaccine Don't use a combination refrigerator/freezer with one exterior door because they are unable to maintain the temperatures needed for storing vaccines. Desirable refrigerator/freezer features yy Negative-pressure doors that close automatically yy Built-in thermometers that come with a certificate stating they have been calibrated according to standards set by the National Institute of Standards and Technology yy Security locks yy Wire racks (as opposed to glass) yy Visible temperature displays Unacceptable refrigerator/freezer features yy Visible cooling plates or open coils on the back wall of the unit yy Combination refrigerator/freezer with one exterior door, including lab- or pharmacy-grade units, because they are unable to maintain the temperatures needed for storing vaccines yy A manual defrost freezer combined with a cyclic defrost refrigerator compartment July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 7 Refrigerator / Freezer Advantages and Disadvantages Storage unit type Advantages Disadvantages yy Able to maintain stable temperatures Lab- or pharmacygrade purpose-built: yy Temperatures can be pre-set yy Refrigerator-only yy Good temperature recovery after the unit has been opened to get vaccines yy Freezer-only yy All internal space in the unit can be used to store vaccines yy Under-counter y y Most provide an internal thermometer refrigerator-only with an external display yy Under-counter yy Offers the option of alarm and safety freezer-only features to alert you to and/or minimize temperature fluctuations Cost: $900 to yy Includes key locks so only authorized $10,000 staff can lock and unlock the doors yy Variety of sizes are available yy May be the most expensive option yy Sold by specialty distributors so may be less convenient to buy yy Having the built-in thermometer calibrated maybe an additional cost yy Should be plugged into a back-up emergency power supply (additional cost) yy Able to maintain stable temperatures yy Some units allow enough usable space for the year’s largest inventory, (e.g., back-to-school rush or flu season) and still have room for air circulation yy Available through major appliance retailers yy Variety of sizes are available yy More usable space than a householdstyle combination yy No cold air vent from freezer which provides more stable temperatures (refrigerator-only units) yy Temperature control dial has arbitrary scale; difficult to accurately set desired temperature yy Changes in the room temperature affect the temperature inside the unit yy Defrost function can cause temperature fluctuations (freezer-only units) yy Slow temperature recovery yy Must also purchase a calibrated thermometer yy Able to maintain stable temperatures yy Separate exterior doors and separate controls in each compartment yy Variety of sizes are available yy Available through major appliance retailers yy Usable space is limited in refrigerator compartment where only the middle shelves can be used yy Temperature control dial has arbitrary scale which makes it difficult to set temperature for each compartment; setting freezer at 0°F/-18°C or colder can make the temperature in the refrigerator too cold for refrigerated vaccines yy Changes in the room temperature affect the temperature inside the unit yy Defrost function can cause temperature fluctuations yy Slow temperature recovery yy Must also purchase a calibrated thermometer yy Smaller units (18 cubic feet or less) aren't able to maintain stable temperatures and may contain hot or cold spots that put vaccines at risk Household: yy Refrigerator-only yy Freezer-only Cost: $400 to $4,000 Household-style combination (dual zone unit): yy Refrigeratorfreezer with separate exterior doors and separate controls in each compartment Cost: $400 to $4,000 8 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Storing and Handling Vaccine Volume-Based Refrigerator and Freezer Recommendations Volume High Approximate doses/year Recommended refrigerators/freezers 10,000 or more • Large capacity purpose-built (lab or pharmacy grade) refrigerator-only or freezer-only unit designed for optimum cooling capacity and stable temperature control Medium 2,000-10,000 Low 2,000 or less July 2011, Minnesota Department of Health In order of preference, with the first being the best: yy Purpose-built (lab or pharmacy grade) refrigerator-only or freezer-only unit designed for optimum cooling capacity and stable temperature control yy Household refrigerator-only or freezer-only unit (can be an under-counter model) In order of preference, with the first being the best: yy Smaller under-counter version of a purpose-built (lab or pharmacy grade) refrigerator-only or freezer-only unit yy Household refrigerator-only or freezer-only unit yy Household-style combination refrigerator/freezer with separate exterior doors and separate controls in each compartment Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 9 Storing and Handling Vaccine Safeguard the power supply In-use outlet covers yy Place Do Not Unplug stickers on the: ○○ Refrigerator/freezer Stickers are available ○○ Power cord at no cost from MDH. ○○ Wall outlet ○○ and Warning stickers on the circuit breaker/fuse box yy Plug refrigerators/freezers into backed-up (emergency power supply) power outlets, where available. yy Don't plug refrigerators/freezers into ground fault circuit interrupter (GFI or GFCI) outlets or extension cords. Safety-lock plugs yy Use "in-use outlet covers" or "safety-lock plugs" to avoid accidentally unplugging the unit. Some outlet covers also come with a locking mechanism. yy Plan in advance for needed maintenance/electrical work. Make sure you have a policy/plan in place for scheduled maintenance/electrical work that may interrupt the power. Communication with building maintenance staff is essential. How to check the refrigerator or freezer door seal Place a piece of paper between the door and the unit and shut the door. If the paper stays in place, the seal is good. If the paper slides, the seal is bad. 10 www.health.state.mn.us/immunize Perform routine maintenance Keeping your refrigerators and freezers running properly requires some routine maintenance. Add these tasks to your storage and handling policy. yy For household-style refrigerators and freezers, each month: ○○ Clean the inside when you do inventory. ○○ Vacuum behind refrigerators/freezers and their coils. ○○ Check and clean the door seals to make sure they are sealing completely. yy For purpose-built (lab or pharmacy grade) refrigerator-only or freezer-only: ○○ Follow the manufacturer’s maintenance schedule. Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Storing and Handling Vaccine Have the right thermometers Essential thermometer features yy A certificate stating the thermometer has been calibrated according to national standards (Without this certificate, thermometers are not acceptable because their accuracy cannot be guaranteed.) yy A battery backup, if the thermometer uses an electrical power source Desirable thermometer features yy A probe inserted into a biosafe liquid (This more accurately reflects the actual temperature of the packaged vaccine inside the unit.) yy An internal probe and an external read (This allows you to read the temperature without opening the refrigerator/freezer.) yy An alarm for out-of-range temperatures yy Easy-to-read digital readout (So you don't have to interpret a scale.) yy Provides a paper or electronic history of past temperatures yy Minimum/maximum display of the highest and lowest temperatures Unacceptable thermometer features yy Doesn't use a probe inserted into a biosafe liquid (So it only reads the air temperature inside the unit - not the temperature of the vaccine.) yy Doesn't have external-read capability (You need to open the door to read the temperature.) yy Can't be calibrated Other considerations when purchasing a thermometer yy If your clinic maintains vaccine valued at $15,000 or more per year, consider purchasing a temperature alarm system that will notify staff after hours if temperatures are out of range; see Electronic temperature monitoring systems below. Acceptable thermometers Chart recorder Minimum / maximum digital with biosafe liquid probe Data logger Data logger with biosafe liquid probe Unacceptable thermometers yy Make sure you have a backup thermometer to use for transport and in case your current thermometer stops functioning. yy If your thermometer uses batteries, replace them every six months. Electronic temperature monitoring systems If your clinic maintains vaccine valued at $15,000 or more per year, consider purchasing an electronic temperature monitoring system that will notify staff after hours if temperatures are out of range. yy Make sure you have a written policy for handling out-of-range temperatures that includes emergency 24-hour contacts and their backups. yy Set time and temperature alarm parameters to allow for changes in temperatures due to frequent opening of the unit during the day and for nonuse during the night (e.g., set the alarm to go off if the refrigerator temperature is above 47°F or below 33.5°F for 30 minutes). yy Temperatures should still be checked and recorded manually twice a day. July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE Dial Non-digital fluid-filled biosafe liquid probe Minimum / maximum digital with standard probe www.health.state.mn.us/immunize 11 Storing and Handling Vaccine Did you know the accuracy of a calibrated thermometer is only guaranteed for a specific period of time? yy Look for the recalibration due date on the thermometer and on the certificate that comes with it. yy Write the recalibration due date on the front of the thermometer as a reminder. yy Replace or recalibrate thermometers that have reached their recalibration due date. yy All thermometers, even fluid-filled, need to be recalibrated. Monitor temperatures twice a day yy Check and record temperatures of refrigerator(s) and freezer(s) twice a day – even if you have an electronic temperature monitoring system. yy If you use a minimum/maximum-type thermometer, make sure you reset the memory each time you check and record the temperatures (twice a day) and after an out-of-range temperature reading. yy Record temperature readings on a temperature log posted in a visible location on or near the refrigerator and freezer; see Vaccine Storage Temperature Logs on pages 47-50. yy Record temperature readings consistently in one scale, either Fahrenheit or Celsius. yy Keep temperature logs for three years. You may need to refer to them for temperature trends or if you have a storage and handling mishap. yy Take immediate action on all out-of-range temperatures! See the TAKE ACTION box on page 14. Store vaccine and diluents correctly yy Place a thermometer in the center of the refrigerator and freezer near the vaccines. yy Use open trays, wire baskets, or other uncovered containers to help organize vaccines. Containers should have openings on all sides to allow air circulation around the vaccine. yy Clearly label each container with the vaccine type. Avoid storing "look-alike" and "sound-alike" vaccines next to each other (e.g., Tdap and DTaP, HepA and HepB and Hib). Check out CDC's Vaccine Storage and Handling Toolkit: www2a.cdc.gov/vaccines/ ed/shtoolkit/default.htm yy Keep vaccines in their original packaging to protect them from light. yy Store diluents packaged together with their corresponding vaccines (e.g., Pentacel, Menveo). yy Store diluents packaged separately from their corresponding vaccines in the refrigerator or at room temperature and clearly label them (e.g., MMR diluent, ActHIB diluent, Hiberix diluent). yy Open only one multi-dose vial of a specific vaccine at a time. yy Post a list on every refrigerator and freezer showing which vaccines are stored there. yy For storage of vaccines during off-site vaccination clinics, see Acceptable Coolers for Vaccine Transfer or Transport on page 35. yy For specific storage requirements for each vaccine, see Guide to Receiving, Storing, and Handling Vaccines on page 19. 12 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Storing and Handling Vaccine Additional guidelines for storing vaccine in a household-style refrigerator or freezer For an illustration of how to properly store vaccine in this type of unit, see the Vaccine Storage Guide on page 15. yy It is difficult to set the temperature for the freezer compartment of a householdstyle combination refrigerator/freezer at 0°F/-18°C or colder without making the temperature in the refrigerator too cold for refrigerated vaccines. If you use the freezer compartment of a household-style combination refrigerator/freezer to store frozen vaccine, consider purchasing a separate household freezer. Don’ts yy Never store food or beverages with vaccine. yy Never store vaccines in the door or drawers of the refrigerator/ freezer. yy Store vaccines only on the middle shelves and two to three inches from the walls of the refrigerator/freezer. yy Remove vegetable bins and crisper drawers or use the bins and drawers to store water bottles or jugs or other medical supplies (e.g., diabetic and lab supplies or allergy serum). This will help avoid storing vaccine in the wrong place. yy Keep vaccine away from the cold air vent in the refrigerator compartment. yy Keep water bottles, jugs, or cold packs in the refrigerator and frozen packs or other ice-filled containers in the freezer to help maintain temperatures. Water bottles can be stored in the door and water jugs in the bottom of the unit. Don't store gallon water jugs in the door because the door may not close properly. It's important to label any substance stored in the refrigerator, so make sure to label water bottles and water jugs. yy Consider locking the refrigerator or freezer at the end of the day to prevent accidently leaving the door ajar overnight. yy Make sure there is enough usable space to hold the year’s largest inventory, such as the back-to-school rush or flu season, and still have room for air circulation. If your refrigerator or freezer is packed full, consider purchasing a larger unit. July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 13 Storing and Handling Vaccine TAKE ACTION On out-of-range temperatures: Refrigerator: ○○ Below 35°F (2°C) ○○ Above 46°F (8°C) (Aim for 40°F / 4°C) Freezer: ○○ Above 5°F (Aim for 0°F / -18°C) 1. Determine the problem; it might be easily corrected (e.g., door not closed tightly, unit malfunction, power outage). 2. Adjust the thermostat, if necessary. 3. Keep refrigerator/freezer door closed. 4. Monitor the temperature every 30 minutes until it stabilizes in the correct range. If the temperature doesn’t stabilize in the correct range within 30 minutes go to step 5. 5. Immediately contact your primary and backup vaccine coordinator and: ○○ Emergency staff and others, as necessary ○○ Alternate vaccine storage facility(s) if you are moving the vaccine to them 6. If the temperature remains out of range after checking every 30 minutes for two hours: ○○ Stop using the vaccine, but do not throw it away! ○○ Mark the vaccine “DO NOT USE” so staff won’t inadvertently administer it. ○○ Move the vaccine to a refrigerator/freezer that’s maintaining the correct temperature – apart from other vaccines – until you can determine if it is viable. 7. Call for guidance right away. If the vaccine in question is from MnVFC, call the MnVFC program. For private purchase vaccine, check your purchase agreement for guidance. ○○ Be ready to provide the temperature details, lot numbers, and expiration dates. ○○ If you are instructed to contact the manufacturer, make sure to ask to speak to the medical consultant or quality assurance staff. 8. Document your actions; see Vaccine Troubleshooting Log on page 51. 14 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Available on the web at www.health.state.mn.us/divs/idepc/immunize/hcp/vaxhandling.html July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 15 H2O Flu Tdap Hib 40º Hep B H2O H2O HPV Flu MCV Hep A Flu Rota PCV For all units: 0º Frozen Pack Varicella Zoster MMR Fill space with frozen packs. Frozen Pack Frozen Pack Varicella Varicella MMRV DTaP MMR DTaP No food in freezer! Place thermometer probe in the center of the unit. Post a temperature log on the door. Post Do Not Unplug stickers on electrical outlets. Plug in only one unit per outlet. Keep vaccine 2-3 inches away from walls and other boxes. Frzn Pack Frzn Pack Frzn Pack Frzn Pack Frzn Pack Fr zn Pack Too warm Varicella H2O Flu Hep A Hib Hep B Tdap Zoster HPV DTaP No vaccine on top shelf! MMRV Frozen Pack CCold Pack CColold Pack Cold Pack Page 1 of 2 (5/12) IC# 141-0110 Adapted with permission from the California Department of Public Health Cold Pack No vaccine in doors! Fill space with cold packs and water bottles. Cold Pack Cold Pack Cold Pack Frzn Packk No food or beverage in refrigerator or freezer! zn Pack Frzn Pack Fr No vaccine in doors! Fill space with frozen packs. No vaccine in drawers or on floor H2O H2O of refrigerator! Fill space with cold packs or water jugs. 40º PCV 0º Frozen Pack Dashed lines show usable space. X’s and lines show areas to avoid. H2O MPV/MCV IPV DTaP Rota DTaP No vaccine near cold air vent! MMR Frozen Pack Combination refrigerator/freezer unit 58ºF ( 50°C) to 5ºF ( 15°C) No vaccine in doors! Fill space with frozen packs. Frzn Pack Frzn Pack Too cold Aim for 0ºF ( 18ºC) Don’t freeze liquid vaccines! Freeze MMR, MMRV, varicella, and zoster. Proper FREEZER Temperatures Freezer-only unit Too warm Group vaccines by type. Clearly label the designated space for each vaccine. No vaccine in drawers or on floor of refrigerator! Fill space with cold packs or water jugs. H2O PPSV MPV IPV DTaP DTaP DTaP No food or beverages in refrigerator! Minnesota Dept. of Health, Immunization Program Cold Cold Pack k Pac olldd Cold Coacckk Pack Pa No vaccine in doors! Fill space with cold packs and water bottles. 35°F (2°C) to 46°F (8°C) Refrigerator-only unit Proper Set-Up Too cold Aim for 40ºF (4ºC) influenza, IPV, Japanese encephalitis, meningococcal, pneumococcal, rabies, rotavirus, typhoid, and yellow fever. Proper REFRIGERATOR Temperatures 1A.Refrigerate Proper Freezer Temperatures anthrax, DTaP, DT, Td, Tdap, hepatitis A and B, Hib, HPV, Vaccine Storage Guide Available on the web at www.health.state.mn.us/divs/idepc/immunize/hcp/vaxhandling.html 16 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Adapted with permission from the California Department of Public Health Immunization Program 0/æ"OXæ 3Tæ0AULæ-.æ æ www.health.state.mn.us/immunize s If you have stock of both private and MnVFC vaccine, mark them clearly. s Call the MnVFC program if you have MnVFC vaccine that will expire within æMONTHSæTHATæYOUæCANNOTæUSEæ s Identify vaccine that will expire and determine if it should be transferred. sæ2OTATEæYOURæVACCINEæSUPPLYæBYæPLACINGæ vaccines with the earliest expiration dates in front of other vaccines and always use them first. sæ#HECKæVACCINEæEXPIRATIONæDATES monthly basis and with each vaccine order to avoid over-ordering. the refrigerator or freezer near the vaccines. certificate stating they have been calibrated according to national standards. Thermometers without this certificate are not acceptable. sæ-AKEæSUREæYOUæHAVEæENOUGHæSPACEæTOæ store vaccine for the back-to-school rush and flu season. sæ+EEPæWATERæBOTTLESæJUGSæORæCOLDæPACKSæ in the refrigerator and frozen packs or other ice-filled containers in the freezer. Mark water bottles “DO NOT $2).+v sæ3TOREæVACCINESæONæTHEæMIDDLEæSHELVESæ ANDææTOææINCHESæFROMæTHEæWALLSæOFæTHEæ combination refrigerator/freezer, not in the door or bins. sæKeep vaccines in their original packaging. sæClearly label each container with the vaccine type. Avoid storing look-alike, sound-alike vaccines next to each other (e.g., Tdap and DTaP, HepA and (EP" sæ5SEæOPENæTRAYSæWIREæBASKETSæORæOTHERæ uncovered containers to help organize vaccines. sæTake immediate action on all out-of-range temperatures! sæ-AKEæSUREæTHEæDOORæISæSHUT sæ"EæSUREæTOæKEEPæTEMPERATUREæLOGSæFORææ years. sæ2ECORDæTEMPERATUREæREADINGSæONæAæ temperature log and post it in a visible location on or near the refrigerator or freezer. sæ#HECKæANDæRECORDæREFRIGERATORæANDæ freezer temperatures twice a day, first thing in the morning and last thing at the close of business. Page 2 of 2 (5/12) IC# 141-0110 sæDocument your actions. sæ#ALLæFORæGUIDANCEæRIGHTæAWAYæ For MnVFC vaccine call æORæ For private purchase vaccine, check your purchase agreement for guidance. sæMove the vaccine to a refrigerator/freezer that’s maintaining the correct temperature. sæ-ARKæTHEæVACCINEæh$/æ./4æ53%v sæStop using the vaccine. If the temperature doesn’t stabilize in the correct range within 2 hours: sæContact the vaccine coordinator. sææMonitor the temperature. sææAdjust the thermostat, if necessary. sææDetermine the cause. Designate one fully trained staff member to be the primary vaccine coordinator and at least one person to be backup. Ensure ongoing training for all immunization staff. Manage vaccine inventory Store vaccine correctly Monitor temperatures Take action on out-of-range temperatures s 2EVIEWæYOURæVACCINEæINVENTORYæONæAæ sæ0LACEæAæTHERMOMETERæINæTHEæCENTERæOFæ sæ5SEæTHERMOMETERSæTHATæCOMEæWITHæAæ Proper Management Vaccine Storage Guide Items to Post on or Near Refrigerators and Freezers The illustration below shows essential tools that should be posted on refrigerators/freezers used to store vaccine. All are available from MDH. Tip: Use these helpful magnets Who to Call About Vaccine Storage Mishaps Keep Vaccines Safe Keep Vaccines Safe! Make sure your vaccines are stored at the right temperature Refrigerator 35˚ — 46˚F 2˚ — 8˚C Aim for 40˚F (5˚C) Freezer 5˚F or colder -15˚C or colder Aim for 0˚F (-18˚C) If your refrigerator or freezer temperatures fall outside this range, follow these three easy steps: 1. Stop using the vaccine. 2. Call MDH for guidance. Adjust thermostat. 1-800-657-3970 Be ready to give: current temperature and temperature log details. 3. Document your actions. MDH Immunization Program: 1-800-657-3970 IC#399-1744 10/09 Vaccine Storage Temperature Log for recording temperature readings Keep Vaccines Safe! Make sure your vaccines are stored at the right temperature July 2011, Minnesota Department of Health Refrigerator 35˚ — 46˚F 2˚ — 8˚C Aim for 40˚F (5˚C) Freezer 5˚F or colder -15˚C or colder Aim for 0˚F (-18˚C) If your refrigerator or freezer temperatures fall outside this range, follow these three easy steps: 1. Stop using the vaccine. Adjust thermostat. 2. Call MDH for guidance. 1-800-657-3970 Be ready to give: current temperature and temperature log details. 3.Vaccine Document your actions. Troubleshooting Log Date & Time Storage Unit Problem Action Taken MDH Immunization Program: 1-800-657-3970 Outcome Location Temp Is Vaccine Supervisor Viable? Notified No IC#399-1744 Immunization Program P.O. Box 64975 St. Paul, MN 55164-0975 1-800-657-3970 or 651-201-5522 www.health.state.mn.us/immunize Yes No Yes Initials Do Not Unplug stickers should be attached to: ○○ Power cord ○○ Storage unit ○○ Outlets Warning stickers should be attached to: ○○ Circuit breaker/ fuse box 10/09 Vaccine Troubleshooting Log to document actions taken if you have a storage and handling mishap See any patterns of problems with temperatures? Take action to keep vaccines safe! (3/11) Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 17 18 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 19 • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen DTaP–HepB–IPV DTaP–IPV–Hib Pentacel Pediarix DT generic, Td generic, Decavac Immunization Program P.O. Box 64975 St. Paul, MN 55164-0975 651-201-5503, 1-800-657-3970 www.health.state.mn.us/immunize • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Tetanus, diphtheria (DT, Td, ) Daptacel, Infanrix Preparing/reconstituting Shelf life after opening/reconstituting Handling • Administer immediately after drawing up in syringe or after placing needle on pre-filled syringe. • Multi-dose vials: refrigerate unused portions. May be used until expired, unless contaminated. Page 1 of 7 (10/13) • Refrigerate immediately at • Reconstitute just before using. • Administer immediately after • Gently shake vial of liquid 35º to 46ºF (2º to 8ºC). withdrawal from the vial. DTaP-IPV and withdraw entire • Discard if not used within 30 • Don’t expose to temperatures contents. 32°F or below. minutes of reconstitution. • Inject DTaP-IPV into the vial • Protect both diluent and of ActHIB powder and shake powder from exposure to light well. (i.e., store in original box). • Withdraw entire contents, about 0.5 mL. • Refrigerate immediately at • Shake vial well before use. • Administer immediately after drawing up in syringe or after 35º to 46ºF (2º to 8ºC). • Look for floating particles; placing needle on pre-filled • Don’t expose to temperatures don't use if they don't dissolve. syringe. 32°F or below. • Use until expiration date noted on vial, unless contaminated. • Refrigerate immediately at • Shake vial well before use. 35º to 46ºF (2º to 8ºC). • Look for floating particles; • Don’t expose to temperatures don't use if they don't dissolve 32°F or below. • Refrigerate immediately at • Shake vial well before use. • Administer immediately after 35º to 46ºF (2º to 8ºC). drawing up in syringe or after • Look for floating particles; • Don't expose to temperatures don't use if they don't dissolve. placing needle on pre-filled 32°F or below. syringe. Storage requirements Arrival condition • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Storing Receiving Diphtheria, tetanus, pertussis (DTaP) Vaccine Open multi-dose vials can be used until the expiration date on the vial, unless contaminated. Keep vaccines in their original boxes to protect them from exposure to light (which can affect potency) and to help keep them organized. Visually inspect vaccines for floating particles and/or discoloration before administration. This guide is not a substitute for the package insert included with each vaccine. Guide to Receiving, Storing, and Handling Vaccines 20 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Hepatitis B (HepB) • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Hib–HepB MDH, Immunization Program Comvax Twinrix HepA–HepB Engerix-B, Recombivax HB Havrix, Vaqta • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Hepatitis A (Hep A) ActHIB Hiberix PedvaxHIB Haemophilus influenzae type b (Hib) Adacel, Boostrix • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Tetanus, diphtheria, pertussis (Tdap) Kinrix Preparing/reconstituting Shelf life after opening/reconstituting Handling Page 2 of 7 (10/13) • Use until expiration date • Refrigerate immediately at • Shake vial well before use. • Look for floating particles; noted on vial, unless 35º to 46ºF (2º to 8ºC). • Don't expose to temperatures don't use if they don't dissolve. contaminated. 32°or below. • Refrigerate immediately at • Shake vial well before use. • Administer immediately after drawing up in syringe or after 35º to 46ºF (2º to 8ºC). • Look for floating particles; placing needle on pre-filled • Don't expose to temperatures don't use if they don't dissolve. 32°or below. syringe. • Use until expiration date noted on vial, unless contaminated. • Refrigerate immediately at • Shake vial well before use. • Administer immediately after drawing up in syringe or after 35º to 46ºF (2º to 8ºC). • Look for floating particles; placing needle on pre-filled • Don't expose to temperatures don't use if they don't dissolve. syringe. 32°or below. • Refrigerate immediately at • Shake vial well before use. • Administer immediately after drawing up in syringe or after 35º to 46ºF (2º to 8ºC). • Look for floating particles; placing needle on pre-filled • Don't expose to temperatures don't use if they don't dissolve. syringe. 32°or below. • Refrigerate immediately at • Use only diluent supplied with • Administer immediately after drawing up in syringe. 35º to 46ºF (2º to 8ºC). ActHIB or Hiberix. • Don't expose to temperatures • Reconstitute ActHIB or • Use ActHIB and Hiberix 32°or below. within 24 hours of Hiberix just before using. • Protect from exposure to light • Inject the entire volume of the reconstitution when stored in (i.e., store in original box). refrigerator. diluent into the vial of vaccine. • Diluent: may be refrigerated or • Shake well. stored at room temperature 68º • Withdraw entire volume of to 77ºF (20º to 25ºC). reconstituted ActHIB or 0.5 mL Hiberix. • Refrigerate immediately at • Shake vial well before use. • Administer immediately after drawing up in syringe or after 35º to 46ºF (2º to 8ºC). • Look for floating particles; placing needle on pre-filled • Don't expose to temperatures don't use if they don't dissolve. syringe. 32°or below. • Refrigerate immediately at • Shake vial well before use. • Administer immediately after drawing up in syringe or after 35º to 46ºF (2º to 8ºC). • Look for floating particles; placing needle on pre-filled • Don't expose to temperatures don't use if they don't dissolve. 32°or below. syringe. • Use until expiration date noted on vial, unless contaminated. Storage requirements Arrival condition • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Storing Receiving DTaP–IPV Vaccine July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 21 • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Japanese Encephalitis (JE) MDH, Immunization Program Ixiaro Flumist • May arrive frozen or partially frozen • Packed with refrigerator packs Influenza, live attenuated (LAIV) Afluria, Agriflu, Fluarix, Flublok, Flucelvax, Flulaval, Fluvirin, Fluzone Influenza, inactivated (IIV) Ipol • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Polio, inactivated vaccine (IPV) Cervarix, Gardasil Preparing/reconstituting Shelf life after opening/reconstituting Handling • Administer immediately after reconstitution. • Use within 8 hours after reconstitution. • Refrigerate immediately at • Shake vial well before use. 35º to 46ºF (2º to 8ºC). • Look for floating particles; • Don’t expose to temperatures don’t use if they don’t dissolve 32°F or below. • Protect from exposure to light (i.e., store in original box). Page 3 of 7 (10/13) • Administer immediately after removing from the refrigerator. • For use during current flu season; check expiration dates. • Note: shelf life is 18 weeks (4½ months). • Refrigerate immediately at • Remove the rubber tip 35º to 46ºF (2º to 8ºC). protector from the sprayer. • Don't store in the freezer. • Deliver ½ dose into one • Don’t expose to temperatures nostril. 32°F or below. • Remove the dose-divider clip and deliver the remaining ½ dose into the other nostril. • Administer immediately after • Refrigerate immediately at • Shake vial well before use. withdrawing from the vial or • Look for floating particles; 35º to 46ºF (2º to 8ºC). after placing needle on pre• Don’t expose to temperatures don't use if they don't dissolve. filled syringe. 32°F or below. • Multi-dose vials: refrigerate • Protect Fluarix,Flulaval, unused portions. May be Flucelvax, and Flublok from used until expired, unless exposure to light (i.e., store in contaminated. original box). • For use during current flu season; check expiration dates. • Refrigerate immediately at • Shake vial well before use. • Administer immediately after drawing up in syringe or after 35º to 46ºF (2º to 8ºC). • Look for floating particles; placing needle on pre-filled • Don’t expose to temperatures don't use if they don't dissolve. 32°F or below. syringe. • Multi-dose vials: refrigerate unused portions. May be used until expired, unless contaminated. • Refrigerate immediately at • Shake vial well before use. • Administer immediately after 35º to 46ºF (2º to 8ºC). drawing up in syringe. • Look for floating particles; • Don’t expose to temperatures don't use if they don't dissolve. • Discard if not used by end of 32°F or below. workday. • Protect from exposure to light (i.e., store in original box). Storage requirements Arrival condition • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Storing Receiving Human papillomavirus (HPV) Vaccine 22 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 • Administer immediately after withdrawal from the vial. • Mark the date and time the vial was removed from the freezer. • Use within 30 minutes of reconstitution when protected from light. • Don't freeze reconstituted vaccine. MDH, Immunization Program Menactra • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Page 4 of 7 (10/13) • Refrigerate immediately at • Shake vial well before use. • Administer immediately after 35º to 46ºF (2º to 8ºC). withdrawal from the vial. • Look for floating particles; • Don't expose to temperatures don't use if they don't dissolve. 32°or below. • Reconstitute just before using. • Use only the diluent supplied with the vaccine. • Inject 0.7 mL of diluent into the vial of vaccine and shake well. • Withdraw entire contents, about 0.5 mL. Meningococcal conjugate (MCV) • Diluent: may be refrigerated or stored at room temperature, 68º - 77ºF (20º - 25ºC). Don't expose to temperatures 32°or below • Keep frozen below 5ºF (-15ºC). • Once vaccine has been removed from the freezer it can be stored in the refrigerator and administered up to 72 hours, but can’t be re-frozen. • Protect from exposure to light (i.e., store in original box). Shelf life after opening/reconstituting • Reconstitute just before using. • Administer immediately after • Use only the diluent supplied withdrawal from the vial. with the vaccine. • Use within 8 hours of • Inject the entire volume of the reconstitution when stored diluent into the vial of vaccine in refrigerator and protected and shake well. from light. Discard unused • Withdraw entire contents, portions after 8 hours. • Don't freeze reconstituted about 0.5 mL. vaccine. • Multi-dose vials: refrigerate unused portions. May be used until expired, unless contaminated. Preparing/reconstituting Handling • Refrigerate immediately at • Reconstitute just before using. • Administer immediately after reconstitution. 35º to 46ºF (2º to 8ºC). • Use only the diluent supplied • Discard if not used within 30 • Don’t expose to temperatures with the vaccine. minutes of reconstitution. 32°or below. • Inject 0.6 mL of diluent into • Don’t freeze reconstituted • Diluent: may be refrigerated the vial of vaccine and gently vaccine. or stored at room temperature, shake well. 68º to 77ºF (20º to 25ºC).Don’t • Withdraw entire contents, expose to temperatures 32°or about 0.5 mL. below. • Should arrive frozen • Diluent: may be refrigerated or stored at room temperature, 68º to 77ºF (20º to 25ºC). Don't expose to temperatures 32°or below. • Refrigerate immediately at 35º to 46ºF (2º to 8ºC) OR freeze below 5ºF (-15ºC). • MDH recommends storing MMR in the freezer, not the refrigerator. • Protect from exposure to light (i.e., store in original box). Storage requirements Arrival condition • Packed with refrigerator packs Storing Receiving Meningococcal C/Y –Hib • Packed with refrigerator Menhibrix packs in winter OR frozen packs in summer • Never frozen ProQuad Measles, mumps, rubella, varicella (MMRV) M-M-R II Measles, mumps, rubella (MMR) Vaccine July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 23 Storage requirements Arrival condition Preparing/reconstituting Shelf life after opening/reconstituting Handling • Refrigerate immediately at • Shake vial well before use. • Administer immediately after 35º to 46ºF (2º to 8ºC). • Look for floating particles; withdrawal from the vial. • Don’t expose to temperatures don't use if they don't dissolve. • Multi-dose vials: refrigerate 32°F or below. unused portions. May be used until expired, unless contaminated. • Refrigerate immediately at • Reconstitute just before using. • Administer immediately after 35º to 46ºF (2º to 8ºC). withdrawal from the vial. • Use only the diluent supplied • Don't expose to temperatures with the vaccine. • Use within 30 minutes of 32°or below. • Shake vial gently to suspend reconstitution. mixture. • Refrigerate immediately at • Reconstitute just before using. • Administer immediately after 35º to 46ºF (2º to 8ºC). • Use only the diluent supplied withdrawal from the vial. • Don’t expose to temperatures with the vaccine. • Use within 24 hours of 32°F or below. • Mix oral diluent into powder, reconstitution when stored in • Protect from exposure to light shake, and return mixed the refrigerator. (i.e., store in original box). liquid to oral applicator to administer. • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Pneumococcal polysaccharide (PPSV) MDH, Immunization Program Rotarix Rotavirus (RV1) Imovax, RabAvert Rabies Pneumovax Prevnar 13 Page 5 of 7 (10/13) • Refrigerate immediately at • Shake vial well before use. • Administer immediately after 35º to 46ºF (2º to 8ºC). withdrawing from the vial or • Look for floating particles; • Don’t expose to temperatures don't use if they don't dissolve. after placing needle on pre32°F or below. filled syringe. • Administer immediately after reconstitution. • Discard if not used within 30 minutes of reconstitution. • Don't freeze reconstituted vaccine. • Multi-dose vials: Mark with date of use and refrigerate unused portions. Use within 35 days of reconstitution. Pneumococcal conjugate (PCV) Menomune • Refrigerate immediately at • Reconstitute just before using. 35º to 46ºF (2º to 8ºC). • Use only the diluent supplied • Don't expose to temperatures with the vaccine. 32°or below. • Inject 0.7 mL of diluent into • Diluent: may be refrigerated the vial of vaccine and gently or stored at room temperature, shake well. 68º to 77ºF (20º to 25ºC).Don't • Withdraw entire contents, expose to temperatures 32°or about 0.5 mL. below. • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Meningococcal polysaccharide (MPSV) Menveo • Packed with refrigerator packs • Never frozen • Refrigerate immediately at • Reconstitute just before using. • Administer immediately after • Gently shake vial of liquid 35º to 46ºF (2º to 8ºC). reconstitution. MenC,Y,W-135 and withdraw • Use within 8 hours of • Protect both diluent and entire contents. powder from exposure to light reconstitution. • Inject MenC,Y,W-135 into (i.e., store in original box). the vial of MenA powder and • Don’t expose to temperatures shake well. 32°F or below. • Withdraw entire contents, about 0.5 mL. Storing Receiving Meningococcal conjugate (MCV) Vaccine 24 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen MDH, Immunization Program YF-Vax Yellow fever • Diluent: may be refrigerated or stored at room temperature, 68º to 77ºF (20º to 25ºC).Don’t expose to temperatures 32°or below. • Refrigerate immediately at 35º to 46ºF (2º to 8ºC). • Diluent: may be refrigerated or stored at room temperature, 68º - 77ºF (20º - 25ºC). Don't expose to temperatures 32°or below Page 6 of 7 (10/13) • Reconstitute just before using. • Administer immediately after • Use only the diluent supplied reconstitution. with the vaccine. • Use within 1 hour of • Inject the entire volume of the reconstitution. diluent into the vial of vaccine and allow to sit for 2 minutes; then carefully swirl mixture. • Do not shake vigorously. • Withdraw entire contents, about 0.5 mL. • Administer immediately after withdrawal from the vial. • Mark the date and time the vial was removed from the freezer. • Use within 30 minutes of reconstitution when protected from light. • Don't freeze reconstituted vaccine. • Keep frozen below 5ºF (-15ºC). • Once vaccine has been removed from the freezer it can be stored in the refrigerator and administered up to 72 hours, but can’t be re-frozen. • Protect from exposure to light (i.e., store in original box). • Should arrive frozen • Reconstitute just before using. • Use only the diluent supplied with the vaccine. • Inject 0.7 mL of diluent into the vial of vaccine and shake well. • Withdraw entire contents, about 0.5 mL. • Oral capsule • Refrigerate immediately at • Oral capsule 35º to 46ºF (2º to 8ºC). • Don’t expose to temperatures 32°or below. • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Varicella (VAR) Varivax Shelf life after opening/reconstituting • Administer immediately after withdrawal from the vial. Typhoid, oral Vivotif Preparing/reconstituting • Refrigerate immediately at • Shake vial well before use. • Look for floating particles; 35º to 46ºF (2º to 8ºC). • Don’t expose to temperatures don’t use if they don’t 32°or below. dissolve. • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Typhim Vi Rotateq Typhoid, inactivated Storage requirements Handling • Refrigerate immediately at • Remove dosing tube from • Administer immediately 35º to 46ºF (2º to 8ºC). pouch, turn the cap clockwise after removing from the • Don’t expose to temperatures to puncture the tube, and refrigerator. 32°F or below. unscrew the cap counter• Protect from exposure to light clockwise so that the liquid (i.e., store in original box). can be squeezed from the tube for oral administration. Arrival condition • Packed with refrigerator packs in winter OR frozen packs in summer • Never frozen Storing Receiving Rotavirus (RV5) Vaccine July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 25 Storage requirements Arrival condition • Diluent: may be refrigerated or stored at room temperature, 68º - 77ºF (20º - 25ºC). Don’t expose to temperatures 32°F or below. • Keep frozen below 5ºF (-15ºC). • Once vaccine has been removed from the freezer it can be stored in the refrigerator and administered up to 72 hours, but can’t be re-frozen. • Protect from exposure to light (i.e., store in original box). Storing Receiving • Should arrive frozen MDH, Immunization Program Zostavax Zoster (ZOS) Vaccine • Reconstitute just before using. • Use only the diluent supplied with the vaccine. • Inject 0.7 mL of diluent into the vial of vaccine and shake well. • Withdraw entire contents, about 0.65 mL. Preparing/reconstituting Page 7 of 7 (10/13) • Administer immediately after withdrawal from the vial. • Mark the date and time the vial was removed from the freezer. • Use within 30 minutes of reconstitution when protected from light. • Don't freeze reconstituted vaccine. Shelf life after opening/reconstituting Handling 26 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 V accine may need to be disposed of because it spoils (e.g., storage and handling mishap), expires, or is replaced by a newer product. Proper disposal of vaccines is everyone’s responsibility to protect our environment. Before disposing of vaccine, contact the MnVFC program (for MnVFC vaccine) or the manufacturer/distributor (for privately purchased vaccine) to see if it can or should be returned. For MnVFC vaccine: yy Call MnVFC for guidance and approval. yy Once you have MnVFC approval, return all spoiled and expired MnVFC vaccine to McKesson following the instructions on the Returning Nonviable MnVFC Vaccine form. Never return empty vials or syringes, open multi-dose vials, or syringes with needles. yy See the MnVFC Policy and Procedure Manual for more information. Disposing of Vaccine Be familiar with your facility's disposal procedures! For privately purchased vaccine: yy Check your purchase agreement for guidance. If there is none, call the manufacturer for guidance and ask to speak to the medical consultant or quality assurance staff. See Resources on page 217 for telephone numbers. Disposing of vaccine in Minnesota Sometimes vaccine cannot be returned to the distributor or manufacturer (for example, partially used multi-dose vials or private-purchase vaccines). Instead, providers are responsible for disposal. To dispose of vaccines appropriately, you need to know if they are hazardous waste, infectious waste, both hazardous and infectious waste, or neither. For more information, see Where to Dispose of Vaccine, Vials, and Syringes on page 29. Hazardous waste According to Minnesota Hazardous Waste Rules (Minn. R. 7045.0127, subp. 2.), vaccines containing any amount of the preservative thimerosal (which contains ethylmercury) are considered hazardous waste. Most multi-dose vials contain thimerosal and some pre-filled syringes contain trace amounts of thimerosal. So these vaccines/presentations must be disposed of in a hazardous waste container - not an infectious waste (sharps) container. However, empty thimerosalcontaining vaccine vials and syringes (see definition below) are considered nonhazardous and noninfectious waste. For an up-to-date listing of vaccines that contain thimerosal, see: Wondering if a vaccine contains thimerosal? Check the package insert. Details on the use of preservatives is provided under the "Description" heading. yy www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ UCM096228 yy www.vaccinesafety.edu/thi-table.htm July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 27 Disposing of Vaccine What does "empty" mean and why does it matter? According to Minnesota Hazardous Waste Rules, a vial or syringe containing any amount of thimerosal is only considered empty when 3% by weight or less of the original vaccine liquid remains. Practically speaking, this means: yy A vial or syringe is considered empty when there isn't any remaining liquid that can be removed from it. yy A vial or syringe that still has any liquid with any amount of thimerosal in it must be disposed of as hazardous waste. What is a trace amount of thimerosal? • Vaccines labeled as "preservative-free" may contain trace amounts of thimerosal that was used during manufacturing but later removed, leaving only a trace amount (about 1/100th of the amount found in vaccines that use thimerosal as a preservative). Vaccines with even trace amounts of thimerosal need to be disposed of as hazardous waste according to state rules. • Vaccines labeled as "thimerosal-free" do not contain thimerosal and are not considered hazardous waste. For information on hazardous waste disposal in your area, call your city or county environmental health office. Disposing of hazardous waste If you already work with a hazardous waste disposal company, you might want to use them to dispose of vaccine that is considered hazardous. However, it is generally less expensive to go through a Very Small Quantity Generators (VSQG) site. If you have never generated or shipped hazardous waste before, the VSQG site or hazardous waste disposal company will help with that. For a fact sheet about VSQGs for disposal of hazardous waste, go to www.pca. state.mn.us/index.php/waste/waste-permits-and-rules/waste-permits-and-forms/ hazardous-waste-publications.html and look for the article titled VSQG Collection Program Requirements for Generators and List of Licensed Programs. Infectious waste Infectious waste has the potential to transmit disease to humans. It is also called biohazardous, red bag, or regulated medical waste. Infectious waste disposal is not the same as hazardous waste disposal. yy All live virus vaccines (LAIV, MMR, MMRV, rotavirus, oral typhoid, varicella, yellow fever, and zoster) must be managed as infectious waste according to Minnesota Infectious Waste Rules. yy In addition, empty syringes with a used needle attached are infectious waste because they may contain infectious bodily fluids. Nonhazardous and noninfectious (normal trash) Nonhazardous and noninfectious waste is waste that can be disposed of in the normal trash. It is also called solid waste or industrial solid waste. 28 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Disposing of Vaccine Where to Dispose of Vaccine, Vials, and Syringes Vaccine waste items Hazardous Infectious Nonhazardous & noninfectious Thimerosal-free inactivated vaccines yy Unused, spoiled, or expired X yy Empty used vial X yy Empty used syringe with needle attached X yy Empty used syringe without needle attached X Live virus vaccines (thimerosal-free) yy Unused, spoiled, or expired X yy Empty used vial X yy Empty used syringe with needle attached X yy Empty used syringe without needle attached X yy Empty used oral applicator (rotavirus) or nasal sprayer (LAIV) X Thimerosal-containing multi-dose vials or preservative-free single dose inactivated vaccines (which contain trace amount of thimerosal) yy Unused, spoiled, or expired X yy Empty* used vial X yy Empty* used syringe with needle attached X yy Empty* used syringe without needle attached Where to dispose *A practical definition of "empty" is a vial or syringe with no remaining liquid you can remove from it. (See page 27 for a formal definition as it applies to Minnesota Hazardous Waste Rules.) X Hazardous waste container Sharps container Normal trash Sharps Container Make sure to follow hazardous waste management requirements. July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 29 Planning for Vaccine Storage Emergencies R efer to the Worksheet for Developing an Emergency Plan for Managing Vaccine on page 43 to develop your own site-specific plan for storing and transporting vaccines in the event of a refrigerator or freezer malfunction, power failure, natural disaster, or other emergency that might compromise appropriate vaccine storage conditions. yy Be sure your plan includes procedures for situations when you will have some lead time (e.g., when you know your office is moving) as well as those when you have no lead time (e.g., a sudden power outage). yy Your plan should also identify an alternate site (e.g., a hospital or long-term care facility) that has a backup generator to store your vaccine in case of a lengthy power outage. yy If there is no hospital or long-term care facility with a backup generator in your area, contact a pharmacy or grocery store to pre-arrange vaccine storage in the event of a lengthy power outage. yy Larger clinics should consider purchasing their own backup generator. yy Go over the plan with staff each year and update it as needed. TAKE ACTION If your refrigerator/freezer is not working: 1. Call for service immediately. 2. Refer to your emergency plan for managing vaccine for guidance on storing and transporting vaccines in a power outage or other emergency. 3. Stop using the vaccine if temperatures are out of range. ○○ Mark the vaccine “DO NOT USE” so staff won’t inadvertently administer it. ○○ Move the vaccine to a refrigerator/freezer that’s maintaining the correct temperature – apart from other vaccines – until you can determine if it is viable. ○○ Do not throw it away! 4. Call for guidance right away. If the vaccine in question is from MnVFC, call the MnVFC program. For private purchase vaccine, check your purchase agreement for guidance. ○○ Be ready to provide the temperature details, lot numbers, and expiration dates. ○○ If you are instructed to contact the manufacturer, make sure to ask to speak to the medical consultant or quality assurance staff. 5. Document your actions; see Vaccine Troubleshooting Log on page 51. 30 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 General instructions for packing vaccine 1. Use hard-sided or Styrofoam coolers with at least two-inch thick walls; see Acceptable Coolers for Vaccine Transfer or Transport on page 35. ○○ Don’t use thin-walled Styrofoam coolers, soft-sided coolers, or lunch bags found at grocery stores or gas stations. 2. Depending on the type of vaccine, place cold/frozen packs on the bottom of the cooler and at the sides to surround the vaccine. ○○ Don’t transport refrigerated vaccines in the same cooler with frozen vaccines. ○○ Don’t place vaccines directly on or next to cold/frozen packs; see Packing frozen vaccines on page 32. 3. Place a minimum of two inches of insulating barrier over the cold/frozen packs. This will help keep the vaccine from touching the packs and prevent accidental freezing and shifting during transport. Some examples of insulating barrier include: ○○ Bubble wrap ○○ Brown packing paper ○○ Newspaper Packing and Transporting Vaccine Packing Supplies Calibrated thermometer Cooler Cold or frozen packs Plastic bags Packing tape Insulating barrier: ○○Bubble wrap ○○ Brown packing paper ○○ Newspaper 4. Place vaccines (in their original packaging) in a plastic bag on top of the insulating barrier. 5. When transport will take more than one hour, place a calibrated thermometer on top of the vaccine, preferably one with an internal probe and external read. 6. Add another two-inch layer of insulating barrier. 7. Add another layer of cold/frozen packs. 8. Secure lid; tape if necessary. Packing refrigerated vaccines 2 inches 2 inches Cold or Frozen Packs Cold or Frozen Packs Refrigerated vaccines include DTaP, DT, Td, Tdap, hepatitis A and B, Hib, HPV, influenza (TIV, LAIV), IPV, meningococcal, pneumococcal, rotavirus, and combinations of these vaccines. MMR can also be packed as a refrigerated vaccine. yy Keep cold at 35° to 46°F (2° to 8°C), but do not freeze. yy Use cold or frozen packs depending on the outdoor temperature: 2 inches Frozen Cold Packs OR ○○ Frozen packs for Insulating barrier temperatures of 75°F or Thermometer more Vaccine ○○ Cold packs for Insulating barrier temperatures of 74°F or Frozen Cold Packs OR less Walls must be at least 2 inches thick Inside view of cooler for refrigerated vaccines July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 31 Packing and Transporting Vaccine Transfer or transport of frozen vaccines (MMRV and varicella) is not permitted by the MnVFC program; call them for guidance. Packing frozen vaccines Frozen vaccines include MMRV, varicella, and zoster. Even if you pack and transport them with frozen packs, the viability of these vaccines may not be preserved At best, their shelf life will be reduced. These vaccines are extremely fragile and should only be packed and transported when: yy You need to give one or two prescheduled doses at an off-site location. yy There is an emergency such as a weather-related disaster. yy There may be a long-term power outage (four hours or more). Keeping vaccine frozen between -58°F and +5°F (-50°C and -15°C): yy Use frozen packs to pack and transport frozen vaccine because it can maintain the temperature between -58°F and +5°F. yy Do not freeze diluent; the vials may break. yy Do not use dry ice. yy Pack frozen vaccines immediately before transporting them. www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE 2 inches Frozen Pack 2 inches 32 Frozen Pack Using frozen packs: yy Use a minimum of 6 frozen packs to surround the vaccine on all sides. yy Place vaccines (in their original 2 inches packaging) in a plastic bag Frozen Pack Frozen Pack Frozen Pack Frozen Pack directly on frozen packs; you Thermometer don't need an insulating barrier. Vaccine yy Place a calibrated thermometer between the vaccine and frozen Frozen Pack Frozen Pack Frozen Pack Frozen Pack packs, preferably between the Walls must be at least 2 inches thick. vaccine boxes. Inside view of cooler using frozen packs yy Tape the cooler shut until you are ready to unpack the vaccine. yy Check the temperature of the cooler immediately upon arrival and: ○○ If the temperature is between -58°F and +5°F (-50°C and -15°C), the vaccine is still considered frozen and can be placed in the freezer. ○○ If the temperature is 5°F to 32°F (-15°C to 0°C), the vaccine is still considered frozen and can be placed in the freezer. However, because the temperature exceeded 5°F (-15°C) the expiration date may need to be adjusted. Contact the manufacturer (ask for the medical consultant or quality assurance staff) for guidance on adjusting the vaccine expiration date. Be ready to provide temperature details, transport time, lot numbers, and current expiration dates. ○○ If the temperature is 33°F to 46°F (1°C to 8°C), the vaccine is no longer frozen and should be placed in the refrigerator and used within 72 hours. ○○ If the temperature is 47°F (9°C) or above, place it in the refrigerator marked “DO NOT USE,” and call the MDH Immunization Program for guidance right away (651-201-5522, 1-800-657-3970). Follow the steps in the TAKE ACTION box on page 30. ○○ Document your actions; see Vaccine Troubleshooting Log on page 51. Minnesota Department of Health, July 2011 Packing and Transporting Vaccine Transferring and transporting vaccine Whether you are transferring vaccine to another provider or transporting vaccine to an off-site clinic, follow these tips: yy Pack the vaccine correctly in an appropriate cooler; see Acceptable Coolers for Vaccine Transfer or Transport on page 35. yy Pack refrigerated vaccines first and frozen vaccines immediately before transporting them. yy Keep the cooler in a temperature-controlled environment (e.g., don’t put it in the trunk of a car or the back of a pick-up truck, and don’t leave it in a car on a hot summer day or a cold winter day). yy Attach labels to the outside of the cooler to clearly identify the contents as valuable and fragile. yy Clearly mark vaccine packages with the date and time they were removed from the refrigerator/freezer. yy Put a list of vaccine types, quantities, lot numbers, expiration dates, and the originating facility in the cooler. yy Open and close the cooler as little as possible. Transferring vaccine to another clinic or provider: yy Hand deliver the cooler with vaccine to the vaccine coordinator at the accepting facility. yy Ensure the vaccine is immediately stored correctly, i.e., placed in the refrigerator or freezer. Transporting vaccine to an off-site clinic: yy Transport only the quantity of vaccine needed. yy Don’t use home refrigerators/freezers for overnight storage of any vaccine; see Acceptable Coolers for Vaccine Transfer or Transport on page 35. yy Never pre-draw vaccine for transport. yy Check and record vaccine temperatures hourly if transport time is longer than one hour, preferably using a thermometer with an internal probe and external read. July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 33 34 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Acceptable Coolers for Vaccine Transfer or Transport It is essential to maintain proper storage temperatures while transferring vaccine to another provider/clinic or transporting vaccine to an off-site clinic. The table below may help you choose the type of cooler that fits your needs. Make sure to follow the best practices for packing and transporting vaccine to keep your vaccine safe. A thermometer with an internal probe and external read is preferred over one that is placed inside the cooler and can only be read by opening the cooler. The Minnesota Department of Health does not endorse or recommend any specific brand of cooler. Cooler type Description When and how to use Compressor Small portable For use off-site over cooler that is cooled several days cooler by a compressor. An option for staff Can be plugged into a vehicle’s power source or into an electrical outlet traveling to several sites and staying overnight Examples: FridgeFreeze WAECO Personal cooler Hard-sided cooler with a hard cover Example: Igloo Playmate Cooler Industrial Styrofoam cooler Must meet industry standard for transport of vaccine Monitoring temperatures off-site It can be challenging to achieve and maintain the correct temperature when this type of cooler is plugged into a vehicle’s power outlet. Check and record temperatures several times: o Hourly during transport in a vehicle o On arrival at your home or hotel o One hour later o When you retire for the night o First thing in the morning o Hourly during clinics To maintain the temperature, open the cooler as little as possible. For transferring Check and record temperatures hourly when using vaccine to another clinic or provider (e.g., 1 hour or less) For same-day clinic; use within 6-8 hours after packing the vaccine Must be properly packed and used for no more than 6-8 hours the cooler for more than one hour. To maintain the temperature, open the cooler as little as possible. Styrofoam coolers For transferring that vaccine is vaccine to another delivered in from the clinic or provider manufacturer or (e.g., 1 hour or less) distributor For same-day clinic; Styrofoam coolers use within 6-8 hours with walls at least 2 after packing the inches thick vaccine Check and record temperatures hourly when using the cooler for more than 1 hour. To maintain the temperature, open the cooler as little as possible. Do Not Use! Thermoelectric cooler that can be plugged into a vehicle’s power source or into an electrical outlet Thin-walled Styrofoam coolers purchased at grocery stores or gas stations to hold beverages Soft-sided coolers or lunch bags These types of coolers are not adequate at any time for transporting or storing vaccines. They can’t maintain the correct temperatures. Immunization Program P.O. Box 64975 St. Paul, MN 55164-0975 651-201-5503, 1-800-657-3970 www.health.state.mn.us/immunize (03/11) Page 1 of 1 Available on the web at www.health.state.mn.us/divs/idepc/immunize/ipi/coolerrecs.pdf July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 35 36 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Key Resources for Managing Vaccine For Managing Vaccine yy Monthly Vaccine Inventory Log (MDH) Log for managing your vaccine inventory. www.health.state.mn.us/divs/idepc/immunize/hcp/vaxinv.pdf yy Guide to Managing Out-of-Range Temperatures (MDH) An algorithm to help determine next steps when discovering out-of-range temperatures, page 41 For copies of the MDH materials listed here use the Immunization Materials for Professional Use order form at www. health.state.mn.us/ divs/idepc/immunize/ ordermat.html or you can download many of them from the web. yy Worksheet for Developing an Emergency Plan for Managing Vaccine (MDH) A worksheet to help you plan for managing your vaccine in case of an emergency. www.health.state.mn.us/divs/idepc/immunize/hcp/worksheet.pdf yy Do Not Unplug and Warning stickers (MDH) Stickers (pictured below) to affix to refrigerator/freezers and circuit breakers to prevent accidental unplugging. (Actual size: 4¼ X 4¼) (Actual size: 3½ X 8½) yy Vaccine Storage Temperature Log (MDH) Log to post on the refrigerator and freezer to record temperatures (Celsius or Fahrenheit). www.health.state.mn.us/divs/idepc/immunize/hcp/vaccine.html#storage yy Vaccine Troubleshooting Log (MDH) Log to record actions you take if a temperature is our of range or a vaccine storage and handling mishap occurs. www.health.state.mn.us/divs/idepc/immunize/hcp/vaxlog.pdf July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 37 38 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Available on the web at: www.health.state.mn.us/divs/idepc/immunize/hcp/vaxinv.pdf July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 39 MDH, Immunization Program Vaccine manufacturer CSL Biotherapies GlaxoSmithKline ID Biomedical Massachusetts Biologic Labs MedImmune, Inc. Merck & Co., Inc Novartis Pfizer sanofi pasteur Inc Wyeth Vaccines Code CSL SKB IDB MBL MED MSD NOV PFR PMC WAL Vaccine manufacturer1 Lot number Packaging type Single-dose vial Multidose vial Manufacturer-filled syringe Tubes (Rotateq) Nasal sprayer (LAIV) 2 Packaging type2 Code SD MD MF T NS Vaccine expires in 3 months Expiration date Vaccine expires in 3 months3 MnVFC vaccine Private purchase vaccine Staff initials (3/11) Page 1 of 2 If you have excess vaccine or vaccine that will expire within 3 months 1. Determine which vaccines can be used before they expire. 2. Transfer vaccines you won’t use to another clinic where they can be used before they expire. 3. If it’s MnVFC vaccine or vaccine that will expire within 3 months, call the MnVFC program at 651-201-5522 for guidance. For private purchase vaccine, check your purchase agreement for guidance. 3 National Number of Drug Code doses (NDC) Check vaccine expiration dates. Rotate your vaccine supply, placing vaccines with the earliest expiration dates in front of other vaccines and always using them first. Mark these packages “use first” to alert staff. If the expiration date is listed by month and year, the vaccine expires the last day of the month (e.g., “06/2012” means the vaccine will expire on June 30, 2012). Vaccine or diluent name 1 y y y Use this log to record your vaccine inventory each month and with each vaccine order to avoid over-ordering. Make sure you: Month and Year ________________________________________ Monthly Vaccine Inventory Log Available on the web at: www.health.state.mn.us/divs/idepc/immunize/hcp/vaxinv.pdf July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 40 Vaccine manufacturer1 Packaging type2 Immunization Program P.O. Box 64975 St. Paul, MN 55164-0974 651-201-5503, 1-800-657-3970 www.health.state.mn.us/immunize Vaccine or diluent name Lot number National Number of Drug Code doses (NDC) Expiration date Vaccine expires in 3 months3 MnVFC vaccine Private purchase vaccine (3/11) Page 1 of 2 Staff initials Guide to Managing Out-of-Range Temperatures Out-of-range temperature discovered! • Determine cause and follow algorithm below. • Immediately adjust thermostat, if necessary. • Keep refrigerator/freezer door closed as much as possible. • Monitor temperature every 30 minutes. If temperature has not started to correct within 30 minutes: TAKE ACTION 99 Contact immediately: • Primary and backup vaccine coordinator • Emergency staff and others as necessary • Alternate vaccine storage facility(s) if you need to move the vaccine If temperature remains out of range after checking every 30 minutes for 2 hours: 99 Stop using the vaccine: yy Mark the vaccine “DO NOT USE” so staff won’t inadvertently administer it. yy Move the vaccine to a refrigerator/freezer that’s maintaining the correct temperature – apart from other vaccines – until you can determine if it is viable. Do not throw it away! 99 Call for guidance right away: If the vaccine in question is from MnVFC, call the MnVFC program (651-201-5522). For private purchase vaccine, check your purchase agreement. yy Be ready to provide temperature details, lot numbers, and expiration dates. yy If you are instructed to contact the manufacturer, make sure to ask to speak to the medical consultant or quality assurance staff. 99 Document your actions; see Vaccine Troubleshooting Log on page 51. Yes Temperature back in range within 60 minutes? Does your facility have a backup generator? Power failure? (storm, flood, tornado, other) No Determine cause • Start backup generator. • Monitor temperature every 30 minutes. Yes! Monitor temperature and be ready to follow TAKE ACTION steps above, if necessary. Prepare to move vaccine according to your emergency plan for managing vaccine. Call for service immediately. Mechanical malfunction? If it will be more than 2 hours before the unit will be functioning, follow the TAKE ACTION steps above, and be ready to move vaccine, if necessary, according to your emergency plan for managing vaccine. Immunization Program P.O. Box 64975 St. Paul, MN 55164-0974 651-201-5503, 1-800-657-3970 www.health.state.mn.us/immunize July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE (03/11) www.health.state.mn.us/immunize 41 42 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Worksheet for Developing an Emergency Plan for Managing Vaccine In advance of an emergency, complete this worksheet and store it in an easily accessible area near vaccine storage unit(s). Emergency Plan for Managing Vaccine Checklist of essential items: Designated primary and backup vaccine coordinators with emergency contact information Emergency staff contact list in order of priority Vaccine storage unit specifications (type, brand, model number, serial number) Alternate vaccine storage facility(s) Written protocols and identified vehicles and drivers for transporting vaccine to and from the alternate vaccine storage facility(s) Written instructions for how to enter your facility and access vaccine storage units if the building is closed or it’s after hours. Include the building security afterhours access procedure, a floor diagram, and the locations of: • Doors • Flashlights • Spare batteries • Light switches • Keys • Locks • Alarms (including instructions for use) • Circuit breakers • Packing materials Written protocol for vaccine packing Appropriate packing materials to safely transport and/or temporarily store vaccine Written protocol for appropriately storing vaccine at the alternate storage facility(s) Up-to-date list of manufacturer quality control office phone numbers MnVFC Program: 651-201-5522 Page 1 of 4 Available on the web at: www.health.state.mn.us/divs/idepc/immunize/hcp/worksheet.pdf July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 43 Worksheet for Developing an Emergency Plan for Managing Vaccine Page 2 of 4 Vaccine Coordinators Phone Numbers (home, cell) Name Email (work, home) Primary Backup Emergency Staff Contact List Name (list in order of priority) Emergency Role (driver, vaccine packer, etc.) Phone Numbers (home, cell) 1. 2. 3. 4. 5. 6. Vaccine Storage Unit Specifications Type of Unit (refrigerator or freezer) Brand Model Number MnVFC Program: 651-201-5522 Serial Number www.health.state.mn.us/vfc Available on the web at: www.health.state.mn.us/divs/idepc/immunize/hcp/worksheet.pdf 44 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Worksheet for Developing an Emergency Plan for Managing Vaccine Page 3 of 4 Emergency Resources Contact List Emergency Resources Company Name Contact Person Phone Numbers Electric power company Generator repair company Generator fuel source Refrigeration repair company Local Health Department State Health Department Immunization Program 800-657-3970 651-201-5501 State Health Department MnVFC Program 651-201-5522 Alternate Vaccine Storage Facility(s) Facility Name Contact Person Phone Numbers Storage Capacity Transportation to Alternate Vaccine Storage Facility(s) Company Name Contact Person Phone Numbers Refrigerated vehicle company Refrigerated vehicle company (alternate) Private vehicle Private vehicle (alternate) MnVFC Program: 651-201-5522 www.health.state.mn.us/vfc Available on the web at: www.health.state.mn.us/divs/idepc/immunize/hcp/worksheet.pdf July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 45 Worksheet for Developing an Emergency Plan for Managing Vaccine Page 4 of 4 Packing Materials Company Name Contact Person Phone Numbers Insulated containers or coolers Insulated containers or coolers (alternate) Fillers (e.g., bubble wrap, brown packing paper, newspaper) Fillers (alternate) Cold / frozen packs Cold / frozen packs (alternate) Dry ice vendor (if inventory includes MMRV, varicella, or zoster vaccine) Dry ice vendor (alternate) Certified, calibrated thermometers Certified, calibrated thermometers (alternate) Based on CDC’s Emergency Vaccine Retrieval and Storage Plan Worksheet from the Storage and Handling Toolkit. www2a.cdc.gov/vaccines/ed/shtoolkit/resources/Emerg_Vac_Rtrvl_Strg_Plan_Worksheet.htm MnVFC Program: 651-201-5522 www.health.state.mn.us/vfc Available on the web at: www.health.state.mn.us/divs/idepc/immunize/hcp/worksheet.pdf 46 www.health.state.mn.us/immunize Got Your Shots? Providers Guide - MANAGING VACCINE Minnesota Department of Health, July 2011 Available on the web at: www.health.state.mn.us/divs/idepc/immunize/hcp/provguide/mangvax.html#logs Location of Unit:______________________________ Month/Year: _____ 3 pm pm am am 4 pm pm pm am 6 pm am 7 pm am 8 pm am 9 pm am 10 pm am 11 pm am 12 pm Adjust j thermostat h o and call c MDH M for f guidance gu n . Take T e immediate m e t action a o iff temperature mpe t is in i shaded h e area a a am 5 -50° or am 1 pm am 2 pm Immunization Program 800-657-3970, 651-201-5503 www.health.state.mn.us/immunize OTHER -17° -16° -15° -14° -13° -12° OTHER min/max DAY TIME Freezer - Aim for -18°C 5 pm am 6 pm am 7 pm am 8 pm am 9 pm am 10 pm am 11 pm am 12 pm Adjust thermostat h o and call MDH M for guidance u n . Take T e immediate m e t action a o iff temperature m e t is in i shaded h e area a a am Adjust u thermostat h o and call c MDH M for f guidance u n am am 4 Take T e immediate m d t action c o iff temperature mpe u is in n shaded h e area a a pm 3 1° am 2 OTHER 2° 3° 4° 5° 6° 7° 8° 9° 10° 11° OTHER DAY 1 TIME am pm min/max Refrigerator - Aim for 4°C am am 13 13 pm pm am am 14 14 pm pm 15 pm pm am am 16 16 pm pm Page 1 of 2 IC# 141-2232 (9/11) am am 15 Days 1-16 • Twice a day place an “X” in the box that corresponds with the current temperature and time. If the temperature is not on the grid, write the actual temperature in the “OTHER” box; do not use an X. • Fill in the minimum and maximum temperatures at the same time (if you have that information). • Take immediate action on any temperature you find in the shaded area! • If the temperature in your refrigerator/freezer is not on the grid or is in a shaded area, mark the vaccine in question and do not use it until you’ve called the Minnesota Immunization Program, 800-657-3970 or 651-201-5522. • If the vaccine has gotten too warm or too cold, you will not be able to distinguish viable from nonviable vaccine by looking at it. • Keep these monthly temperature logs for 3 years. Vaccine Storage Temperature Log (Celsius) Too warm Too cold Store at 2°– 8°C. Aim for 4°C! Too warm Got Your Shots? Providers Guide - MANAGING VACCINE Store at -15°C or July 2011, Minnesota Department of Health www.health.state.mn.us/immunize 47 Available on the web at: www.health.state.mn.us/divs/idepc/immunize/hcp/provguide/mangvax.html#logs Got Your Shots? Providers Guide - MANAGING VACCINE Location of Unit:______________________________ Month/Year: _____ pm am am 19 pm pm am am 20 20 pm am 21 pm am 22 pm am 23 pm am 24 pm am 25 pm am 26 pm am 27 pm am -50° or am 17 pm am 18 pm Immunization Program 800-657-3970, 651-201-5503 www.health.state.mn.us/immunize OTHER -17° -16° -15° -14° -13° -12° OTHER min/max DAY TIME Freezer - Aim for -18°C OTHER 1° 2° 3° 4° 5° 6° 7° 8° 9° am 21 pm am 22 pm am 23 pm am 24 pm am 25 pm am 26 pm am 27 pm am Adjust d thermostat t m t and call c MDH M for fo guidance c . Take immediate a action a o iff temperature m e u is i in n shaded a d area r pm Adjust d thermostat t m t and call MDH M for f guidance u c Take immediate a action a o iff temperature mpe u is i in n shaded a d area re Adjust d thermostat t m t and call c MDH M for f guidance c . am 19 Take a immediate a action a o iff temperature m e u is i in n shaded a d area r pm 18 11° am 17 10° OTHER DAY TIME min/max Refrigerator - Aim for 4°C 28 28 pm pm am am 29 29 pm pm am am pm pm am am 31 31 pm pm Page 2 of 2 IC# 141-2232 (9/11) 30 30 Days 17-31 • Twice a day place an “X” in the box that corresponds with the current temperature and time. If the temperature is not on the grid, write the actual temperature in the “OTHER” box; do not use an X. • Fill in the minimum and maximum temperatures at the same time (if you have that information). • Take immediate action on any temperature you find in the shaded area! • If the temperature in your refrigerator/freezer is not on the grid or is in a shaded area, mark the vaccine in question and do not use it until you’ve called the Minnesota Immunization Program, 800-657-3970 or 651-201-5522. • If the vaccine has gotten too warm or too cold, you will not be able to distinguish viable from nonviable vaccine by looking at it. • Keep these monthly temperature logs for 3 years. Vaccine Storage Temperature Log (Celsius) Too warm Too cold Store at 2°– 8°C. Aim for 4°C! Too warm www.health.state.mn.us/immunize Store at -15°C or 48 Minnesota Department of Health, July 2011 Available on the web at: www.health.state.mn.us/divs/idepc/immunize/hcp/provguide/mangvax.html#logs am 1 pm am 2 pm am 2 pm am 3 pm am 4 pm pm pm am pm pm a tio am 7 am pm am 9 iff t m e 8 pm t am pm i i 10 am pm am 12 h ded a 11 pm a am 5 pm am 6 pm am 7 pm am 8 pm am 9 pm am 10 pm am Adjust Adj just st thermostat th hermo ostat and call MDH MDH for g guidance guidan uidance nce 11 pm am 12 pm Take T ake e immediate im mmediat e te action actio on iff temperature tem mpe erature is in shaded sh hade ed area area a Adjust Adj just thermostat th hermo ostat and call MDH MDH for guidance g guidan u nce T ke im edi t am 6 -58° or Immunization Program 800-657-3970, 651-201-5503 www.health.state.mn.us/immunize OTHER 3° 4° 5° 6° Adjust j thermostat h o t and call MDH M for guidance n pm am 5 Take T e immediate m e t action a o iff temperature m e t is in shaded h e area a a 1 pm 4 7° am am 3 8° OTHER min/max DAY TIME Freezer - Aim for 0°F OTHER 33° 34° 35° 36° 37° 38° 39° 40° 41° 42° 43° 44° 45° 46° 47° 48° 49° OTHER min/max DAY TIME Refrigerator - Aim for 40°F • • • • • • am am 13 13 pm pm am am 14 14 pm pm am am pm pm am am 16 16 pm pm Page 1 of 2 IC# 141-2233 (9/11) 15 15 Days 1-16 Location of Unit:______________________________ Month/Year: _____ Twice a day place an “X” in the box that corresponds with the current temperature and time. If the temperature is not on the grid, write the actual temperature in the “OTHER” box; do not use an X. Fill in the minimum and maximum temperatures at the same time (if you have that information). Take immediate action on any temperature you find in the shaded area! If the temperature in your refrigerator/freezer is not on the grid or is in a shaded area, mark the vaccine in question and do not use it until you’ve called the Minnesota Immunization Program, 800-657-3970 or 651-201-5522. If the vaccine has gotten too warm or too cold, you will not be able to distinguish viable from nonviable vaccine by looking at it. Keep these monthly temperature logs for 3 years. Vaccine Storage Temperature Log (Fahrenheit) Too warm Store at 35°– 46°F. Aim for 40°F! Too cold Too warm Got Your Shots? Providers Guide - MANAGING VACCINE Store at 5°F or July 2011, Minnesota Department of Health www.health.state.mn.us/immunize 49 Available on the web at: www.health.state.mn.us/divs/idepc/immunize/hcp/provguide/mangvax.html#logs Got Your Shots? Providers Guide - MANAGING VACCINE am 17 pm am 18 pm am 18 pm am 19 pm am 20 am pm am pm am 23 pm am 24 pm am 25 pm am 26 pm am 27 pm am pm am 21 pm am 22 pm am 23 pm am 24 pm am 25 pm am 26 Adjust Adj Ad djust st thermostat therm mostatt and call MDH MDH for for g guidance guidanc idance ce pm am 27 pm am Take Tak ke immediate im mme edia ate action actio on iff temperature tem mpe eratu ure is is in n shaded sha aded d area are ea Adjust dj thermostat t m t and call MDH M for f guidance g c Take k immediate m e a action a o iff temperature mpe u is i in n shaded a d area e pm 22 -58° or Immunization Program 800-657-3970, 651-201-5503 www.health.state.mn.us/immunize OTHER 3° 4° 5° 6° Adjust d thermostat t m t and call MDH M for f guidance u c pm am 21 Take immediate a action a o iff temperature m e u is i in n shaded a d area r 17 pm 20 7° am am 19 8° OTHER min/max DAY TIME Freezer - Aim for 0°F OTHER 33° 34° 35° 36° 37° 38° 39° 40° 41° 42° 43° 44° 45° 46° 47° 48° 49° OTHER min/max DAY TIME Refrigerator - Aim for 40°F 28 28 pm pm am am 29 29 pm pm am am pm pm am am 31 31 pm pm Page 2 of 2 IC# 141-2233 (9/11) 30 30 Days 17-31 Location of Unit:______________________________ Month/Year: _____ • Twice a day place an “X” in the box that corresponds with the current temperature and time. If the temperature is not on the grid, write the actual temperature in the “OTHER” box; do not use an X. • Fill in the minimum and maximum temperatures at the same time (if you have that information). • Take immediate action on any temperature you find in the shaded area! • If the temperature in your refrigerator/freezer is not on the grid or is in a shaded area, mark the vaccine in question and do not use it until you’ve called the Minnesota Immunization Program, 800-657-3970 or 651-201-5522. • If the vaccine has gotten too warm or too cold, you will not be able to distinguish viable from nonviable vaccine by looking at it. • Keep these monthly temperature logs for 3 years. Vaccine Storage Temperature Log (Fahrenheit) Too warm Store at 35°– 46°F. Aim for 40°F! Too cold Too warm www.health.state.mn.us/immunize Store at 5°F or 50 Minnesota Department of Health, July 2011 Available on the web at: www.health.state.mn.us/divs/idepc/immunize/hcp/vaxlog.pdf July 2011, Minnesota Department of Health Got Your Shots? Providers Guide - MANAGING VACCINE www.health.state.mn.us/immunize 51 Date & Time Problem Immunization Program P.O. Box 64975 St. Paul, MN 55164-0975 1-800-657-3970 or 651-201-5522 www.health.state.mn.us/immunize Location Temp Storage Unit Outcome No Yes Vaccine Affected No Yes Supervisor Notified (7/12) See any patterns of problems with temperatures? Take action to keep vaccines safe! Action Taken Vaccine Storage Unit Troubleshooting Log Initials
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