Vaine Storage and Handling Guidelines
Table of Contents 2 Introdution 3 Definitions 3 The Importane of the Cold Chain 3 Proteting Ontario s Vaine Supply 4 Maintaining Vaine Poteny and Minimizing Wastage 4 Staff Designated to Monitor the Vaine Storage and Handling Praties in the Offie/Faility 4 Contingeny Planning for Refrigerator Malfuntions or Eletriity Disruptions 5 Vaine Storage and Handling Praties 5 Maintaining the Required Refrigerator Temperature 6 Cheking, Reording and Monitoring the Required Refrigerator Temperature 7 How to Use a Digital Maximum-Minimum Thermometer 8 Data Loggers 9 Paking a Cooler for Vaine Transportation or Storage 9 How to Transport Vaines Outside the Offie Setting 10 Proteting Vaines During Immunization Sessions/Clinis 11 Eletriity Disruptions (loalized or general) 12 How to Proeed When the Eletriity Supply to the Refrigerator is Restored 12 What to Do When the Temperature is Below + 2 C or Above + 8 C 13 Inadvertent Administration of Exposed/Expired Vaine 14 Ordering Vaines 14 Reeiving Vaine Deliveries 14 Returning Vaines 15 List of Publi Health Units in Ontario
Introdution Immunization programs are among the most ost-effetive ways to prevent disease. The suess of these programs depends heavily upon the maintenane of vaine poteny and stability. By understanding and implementing proper vaine storage and handling praties, staff in physiians offies and other health are failities an play a ritial role in improving the health of Ontarians by ensuring that the administered vaines retain their poteny and that vaine wastage is redued. This doument is intended to assist physiians offies and other health are failities to properly store and handle provinially funded vaines. 2 Vaine Storage and Handling Guidelines
Def initions Cold Chain The old hain inludes all of the materials, equipment and proedures used to maintain vaines in the required temperature range of + 2 C to + 8 C from the time of manufature until the vaines are administered to individuals. Exposed vaine Vaine that is stored or handled at temperatures below + 2 C or above + 8 C for any period of time, or that is not stored aording to the manufaturer s reommendations is onsidered to be exposed. Spoiled vaine Spoiled vaine is vaine that annot be used beause of exposure to temperatures below + 2 C or above + 8 C for a speifi period of time. This will depend on the speifi vaine. The loal publi health unit assesses all provinially funded vaines that have been exposed to determine whether they an be used. Wasted vaine Any vaine that annot be used is onsidered to be wasted. This inludes vaines that are spoiled and those that have expired. The Importane of the Cold Chain Vaines are sensitive biologial substanes that an lose their poteny and effetiveness if they are exposed to heat and/or diret sunlight or fluoresent light. For example, ertain vaines lose poteny when exposed to room temperature for as little as 30 minutes, or when exposed to light. Freezing damages most vaines. Exposed vaines an result in a redued immune response and/or inreased loal reations. The loss of vaine poteny annot be reversed. Proteting Ontario s Vaine Supply The Mandatory Health Programs and Servies Guidelines, issued under the Health Protetion and Promotion At, require loal publi health units to inspet premises where provinially funded vaine is stored, at least one annually. Reent inspetions of refrigerators in physiians offies and other health are failities have shown that improper storage and handling of vaines is still a signifiant problem in Ontario. Vaines may be wasted if they have been exposed to temperatures below + 2 C or above + 8 C, and are spoiled, or if they have expired before they an be used. Vaine wastage results in inreased osts (to replae the wasted vaines). Also, with the globalization of the vaine manufaturing industry, and intermittent global vaine shortages, it is not always possible for Ontario to quikly obtain additional quantities of vaines to replae vaine that is wasted. Patients/lients who are immunized with exposed vaines often need to be realled by the health are pratitioner and reimmmunized to ensure that they are proteted against the speifi vaine preventable disease(s). Vaine Storage and Handling Guidelines 3
Staff Designated to Monitor the Vaine Storage and Handling Praties in the Offie/Faility Maintaining Vaine Poteny and Minimizing Wastage There are several key steps to ensuring that potent vaines are administered to vaine reipients: Monitor and doument refrigerator temperatures twie daily (inluding the time the temperature was taken). Call your loal publi health unit immediately to report vaines that have been exposed to temperatures below + 2 C or above + 8 C. Never administer or disard exposed vaine until your loal publi health unit has assessed the situation. Spoiled or expired vaine should always be returned to your soure of supply (i.e., loal publi health unit or Ontario Government Pharmaeutial and Medial Supply Servie (OGPMSS)). Persons storing and handling provinially funded vaines require knowledge of: The importane of the old hain. Vaine storage and handling praties. The appropriate ation to be taken in the event of a vaine exposure. One person in eah offie/faility should be designated to monitor vaine storage and handling praties to ensure that vaines are kept at the required temperatures. However, all staff members should also be trained in reading the vaine refrigerator thermometers, and doumenting and monitoring the vaine storage temperatures to provide bakup in the event of staff vaations or other absenes. Your loal publi health unit an assist you with this training. Contingeny Planning for Refrigerator Malfuntions or Eletriity Disruptions Eah physiian s offie/faility should have a ontingeny plan for vaine storage in the event of a refrigerator malfuntion or eletriity disruption. Arrangements should be made in advane with a faility that has a bakup generator/power soure. You may wish to disuss this with your loal publi health unit. See page 15 for more information. 4 Vaine Storage and Handling Guidelines
Vaine Storage and Handling Praties To retain their poteny and to be effetive, most vaines must be kept refrigerated between + 2 C and + 8 C at all times. For detailed vaine storage and handling information, please refer to the speifi produt monograph. Always store vaines on the middle shelves of the refrigerator. Never store vaines in refrigerator door shelves as they may be exposed to warmer temperatures. Leave spae between the vaine pakages in the refrigerator to allow air to irulate. Plae vaines of the same type together. Chek vaine expiry dates regularly. Always move vaines with shorter expiry dates to the front of the refrigerator so that they an be used first. Always hek expiry dates before you use vaines. Remove expired vaines and return them to your vaine supply soure. ALL VACCINES: Take vaines out of the refrigerator only when ready to administer. MULTI-DOSE FORMAT: Return unused vaine to the refrigerator immediately after the required dose has been drawn up. Mark the date on all multi-dose vials when the first dose is withdrawn. One opened, multi-dose vials must be used within 30 days (unless otherwise indiated on the produt monograph). Asepti tehnique for the withdrawal of vaines must be followed at all times. Protet all vaines from sunlight and fluoresent light. Never leave vaines out on the ounter or the floor. Maintaining the Required Refrigerator Temperature Ensure that your refrigerator apaity is large enough to store your vaine supply. There must also be enough room to allow air to irulate around the vaine pakages. Do not store anything else (e.g., lunhes, drinks, or laboratory speimens) in the refrigerator with vaines. Minimize the number of times the refrigerator door is opened. Always ensure that the refrigerator door is losed tightly. Installing an inexpensive velro lath from a hardware store an help ensure that the door is not aidentally left ajar during the day, or by leaning staff after hours. Ensure that the eletrial outlet and refrigerator plug are seured to prevent the refrigerator from aidentally being unplugged or turned off. Plae a highly visible stiker by the eletrial outlet to make sure that the refrigerator is not unplugged (e.g., to plug in a vauum) OR over outlet with a age to prevent aidental disonnetion. (See stiker provided.) Keep iepaks in the freezer ompartment to use for transporting vaines. In the ase of a refrigerator malfuntion or eletriity disruption, iepaks an be put inside the refrigerator to keep the temperature from inreasing. Defrost the refrigerator when there is more than 1 m (1/4 inh) of ie in the freezer ompartment. While defrosting the refrigerator, transfer vaines to an insulated vaine ontainer (for no longer than three hours) with iepaks and a maximum-minimum thermometer OR transfer vaines to another monitored refrigerator, and hek the temperature regularly. Storing filled water bottles on the lower shelf and the door of the vaine refrigerator may help maintain an even, stable temperature inside the refrigerator. Vaine Storage and Handling Guidelines 5
Cheking, Reording and Monitoring the Required Refrigerator Temperature Maintaining aurate and up-to-date doumentation of refrigerator temperatures is neessary to maintain vaine poteny. This information will also assist the publi health unit in the assessment of old hain exposures (determining the temperature variation and duration of exposure) should these our. Your loal publi health unit staff will be able to determine whether any vaine whih has been exposed an still be used. Chek and reord the refrigerator temperature twie daily (preferably at the beginning and end of the day) to make sure that vaines you will be using have been stored at the right temperature, and have not been exposed to temperatures below + 2 C or above + 8 C. Note: A refrigerator that feels old may range in temperature from -5 C to + 15 C, a definite risk to vaine poteny. Aurate thermometer readings are neessary to determine whether the vaines are being kept at the required temperature to maintain their poteny. 6 Vaine Storage and Handling Guidelines
How to Use a Digital Maximum-Minimum Thermometer There are several types of digital maximumminimum thermometers available on the market. Always use a digital maximum-minimum thermometer that is alibrated to within ±1 C auray. Your loal publi health unit an assist you in seleting an appropriate thermometer. Eah digital thermometer has slightly different operating instrutions. Instrutions for the use of one thermometer (Thermor brand) are inluded here. Attah the thermometer to the outside wall of the refrigerator using double-sided tape. Seure the able to the entre of the middle shelf inside the refrigerator. The sensor of the digital thermometer should be plaed inside the pakaging of one of the vaine pakages that is stored on the middle shelf of the refrigerator. The pakaging redues the likelihood of the sensor measuring brief temperature flutuations when the refrigerator door is opened. Do not plae the sensor into fluid. If the digital thermometer has an IN-OUT swith, make sure it is always in the OUT position. The OUT position atually reads the temperature inside the refrigerator, whih is deteted by the sensor at the end of the able. The IN position reads the temperature outside the refrigerator, whih is deteted by the built-in sensor. You do not have to open the refrigerator door to take the temperature readings. Chek and reord the temperatures as follows: 1. Chek and reord the urrent refrigerator temperature. 2. Chek and reord the maximum refrigerator temperature. 3. Chek and reord the refrigerator minimum temperature. 4. Always remember to reset the thermometer. To reset the thermometer, press the CLEAR button twie: one after the maximum temperature reading and one after the minimum temperature reading. Change the battery every six months (i.e., seasonal, with the time hange) as a low funtioning battery may give false temperature readings. Chek your thermometer and always have spare batteries on hand. Vaine Storage and Handling Guidelines 7
Digital Maximum-Minimum Thermometer ontinued What the Thermometer Reading Tells You The maximum (highest) temperature reahed sine the thermometer was last reset an be seen by pressing the memory maximumminimum button. You will see the word MAX appear on the right portion of the display. The minimum (lowest) temperature reahed sine the thermometer was last reset an be seen by pressing the memory maximumminimum button a seond time. You will see the word MIN appear on the right portion of the display. Remember to reset your thermometer after reording the readings. Data Loggers Data loggers are ontinuous temperature reording devies, whih offer a historial aount of refrigerator temperatures. These devies store information whih an be downloaded onto a omputer. If your offie/faility uses data loggers, please ensure that temperatures are monitored twie daily. Print the temperature readings out on a weekly basis and retain them for one year, or until the next inspetion by your loal publi health unit. Built in sensor Current time Indiates temperature inside the fridge Current temperature Please ontat your loal publi health unit immediately if any of the reorded temperatures are outside of the + 2 C to + 8 C range. In-out swith Minute button Min-max button Clear button Cable sensor Time set swith Hour button 8 Vaine Storage and Handling Guidelines
Paking a Cooler for Vaine Transportation or Storage Pre-hill the insulated ontainer (espeially in the summer) by plaing iepaks or oolant paks inside the ooler for at least an hour. Iepaks ome out of the freezer at a temperature of approximately -20 C. Keeping the iepaks at room temperature for a period of time allows the ie at the ore of the iepak to rise to 0 C. This proess is alled onditioning. An iepak is adequately onditioned as soon as beads of water over its surfae. Note: Vaines are vulnerable to freezing when transported in an insulated ontainer if iepaks have not been orretly onditioned. Vaines should be paked with a temperaturemonitoring devie (preferably a digital maximum-minimum thermometer) with the sensor plaed in the entre of the vaine pakage. The vaine pakages should be loosely wrapped in effetive insulation material (e.g., bubble wrap, shredded paper). This allows for ool air irulation around the vaines and minimizes the risk of hot or old spots. How to Transport Vaines Outside the Offie Setting Vaines must be transported in insulated and monitored ontainers (oolers) so that they stay between + 2 C and + 8 C. An insulated vaine ooler with iepaks and a thermometer is required to pik up the vaines from the loal publi health unit and transport them to the offie/faility. A vaine ooler is also required to transport the vaines from the offie/faility to another loation. Vaines must be proteted from heat, old, sunlight and fluoresent light at all times. An insulated ontainer/ooler (whih maintains the internal temperature within the + 2 C to + 8 C range with oolant paks) is used for: Transporting vaine Temporary storage of vaine during equipment maintenane periods (e.g., when leaning or defrosting refrigerator) Emergeny storage of vaine (e.g., refrigerator malfuntion or an eletriity disruption) Vaines must never be transported in the trunk of a ar due to the risk of exposure to temperature extremes. Vaine Storage and Handling Guidelines 9
Proteting Vaines During Immunization Sessions/Clinis Only pak the amount of vaine you expet to use during the immunization session/lini. Maintaining the vaines at the required temperature (between + 2 C and + 8 C) during an immunization session/lini is important to ensure that the administered vaine retains its poteny. Minimize the number of times that the ooler is opened during the immunization session/lini. Temperature readings in the insulated ontainer/ooler should be reorded: 1. Before leaving the offie/faility with the ooler. 2. Upon arrival at the lini loation, but prior to the immunization session/lini. 3. Every three hours during the session/lini (if the session/lini is longer than three hours). 4. Upon ompletion of the session/lini (before transport bak to the offie/faility). 5. After return to the offie/faility, but before the vaines are put bak in the refrigerator. This will ensure that the vaines are maintained at the required temperatures throughout the proess, and that the vaines that are returned to the refrigerator have not been exposed to temperatures below + 2 C or above + 8 C. 10 Vaine Storage and Handling Guidelines
During an eletriity disruption, take ation to protet your vaines. Eletriity Disruptions (loalized or general) In this setion, a non-funtioning refrigerator refers to a refrigerator that is not funtioning due to a disruption of the eletriity supply. Reord the time and internal temperature (maximum-minimum and urrent) of the non-funtioning refrigerator (as soon as possible after the start of the eletriity disruption) in the vaine temperature log book and reset the thermometer. 1. Eletriity disruption of four hours or less: The refrigerator door should be kept losed. You do not have to open the refrigerator door to take the temperature readings. 2. Eletriity disruption ontinues for more than four hours: Remove the vaines from the non-funtioning refrigerator, plae them in an insulated ontainer with iepaks (see page 9, Paking a Cooler for Transport or Storage ). If vaines an be transported to a funtioning and monitored refrigerator: If possible, transfer the vaines to a funtioning monitored refrigerator (i.e., in a faility that has power or a bakup generator). The refrigerator should be monitored with a maximum-minimum thermometer. If the vaines need to be transported, please follow the instrutions on page 9 Paking a Cooler for Transport or Storage. Note: If the only alternative is to transfer the vaines to your home (whih has power or a bakup generator), transfer the vaines to a separate refrigerator in your home, and monitor the refrigerator with a maximumminimum thermometer. Do not store the vaines in the kithen refrigerator, as the temperature flutuates when the door is opened and losed. Store the vaines with the probe/sensor plaed inside the pakaging of one of the vaine pakages that is stored in the middle shelf of the refrigerator. Minimize the number of times the fridge door is opened. Continue to monitor and reord the temperatures twie daily. If vaines annot be transported to a funtioning and monitored refrigerator: Keep the vaines in the non-funtioning refrigerator and plae iepaks (if required and/or available) into the refrigerator to help maintain the orret temperature. Keep the refrigerator doors losed (opening the doors will let ool air out of the refrigerator and let warm air in). It is not neessary to open the refrigerator door to take the temperature readings. Keep the ambient temperature in the offie low (i.e., lose window blinds) in the summer. In the winter, protet the ambient temperature from extreme old or freezing. Continue to monitor and reord (maximum, minimum and urrent) vaine temperatures twie daily. Transfer the vaines to a funtioning, monitored refrigerator as soon as possible. Call your loal publi health unit for further advie. Vaine Storage and Handling Guidelines 11
How to Proeed When the Eletriity Supply to the Refrigerator is Restored Reord the time and refrigerator temperature when the eletriity supply is restored, and again when the thermometer reading is within the + 2 C to + 8 C range. Continue to read and reord the temperature twie daily (a.m. and p.m.). Call your loal publi health unit immediately to report any exposures to temperatures BELOW + 2 C or ABOVE + 8 C. All vaines need to be assessed to determine if the vaine poteny has been affeted by storage temperatures below + 2 C or above + 8 C during the eletriity disruption. DO NOT USE OR DISCARD THE VACCINE UNTIL YOUR LOCAL PUBLIC HEALTH UNIT HAS ASSESSED THE SITUATION. For reurring eletriity disruptions: Plae the vaines in a labeled ontainer or bag marked DO NOT USE. Put the labeled ontainer bak in the refrigerator. Reord the time, maximum, minimum, and urrent temperature (if possible) at the time of eah eletriity disruption in the log book. Reord eah time the eletriity supply is restored and measure and doument the maximum, minimum and urrent temperatures. What to Do When the Temperature is Below + 2 C or Above + 8 C A maximum, minimum or urrent temperature reading below + 2 C or above + 8 C means that your vaines may have lost their poteny. In this ase you should: Segregate the exposed vaines in the refrigerator by plaing these vaines in a labeled ontainer (or bag), marked with the date and time and DO NOT USE. Do not use any of the exposed vaines until your loal publi health unit has assessed whether any of the vaines an still be used. Call your loal publi health unit immediately to report the vaine exposure. Chek that your thermometer is working orretly (e.g., hek the probe plaement, hek the battery). If in doubt, replae the battery. After heking the thermometer and the refrigerator (to make sure it is plugged in), reord the date, time and temperature in your temperature log book. Always remember to reset your maximum-minimum thermometer after eah reorded temperature. If the urrent temperature is too low or too high, move these vaines to a properly funtioning, monitored refrigerator, OR plae the vaines in a monitored insulated ontainer with iepaks and a maximum-minimum thermometer inside the vaine pakage. This will limit the number of temperature exursions outside of the + 2 C to + 8 C range, and help to avoid vaine wastage. 12 Vaine Storage and Handling Guidelines
Insulated ontainers will only keep vaines at the appropriate temperatures for a short period of time. Vaines will need to be moved to a funtioning, monitored refrigerator if the refrigerator does not stabilize at the required + 2 C to + 8 C range within a ouple of hours. Never use or disard the vaine until your loal publi health unit has assessed the situation. Inadvertent Administration of Exposed/Expired Vaine If exposed/expired vaine has been inadvertently administered, please ontat your loal publi health unit immediately. The loal publi health unit staff will assist you to determine whether reimmunization is reommended. Vaine Temperature Log Chart Temperature ( O C) 12 11 10 9 8 7 6 5 4 3 2 1 0-1 -2-3 -4 1 2 3 4 5 6 7 8 Days of the Month Morning Reading Afternoon Reading Out of Range (Contat your publi health unit ASAP) Any readings above or below the aeptable range must be reported to your loal publi health unit immediately. Vaine Storage and Handling Guidelines 13
Ordering Vaines To order the hepatitis A and hepatitis B vaines for high-risk persons, or to order post-exposure rabies vaine and immune globulin, all your loal publi health unit (both within and outside Toronto). Routine Vaine Orders In Toronto, order all other routine vaines from the OGPMSS at 416-327-0837 or fax your order to 416-327-0818. Outside Toronto, order all other routine vaines from your loal publi health unit (see list on page 15). Maintain no more than a one-month supply of vaine at a time. One vaines leave the vaine supply soure, they annot be returned for re-stoking. Ordering exess vaine an inrease the risk of wastage. To know how muh vaine you will need, look at the average amount of eah vaine you use eah month. Chek vaine expiry dates regularly. Reeiving Vaine Deliveries When you reeive your order, hek to ensure that you reeived your full order, and to ensure that the order mathes the paking slip. Plae vaines in the refrigerator right away. If you did not reeive everything you ordered, or your order does not math the paking slip, notify your vaine supply soure immediately. Returning Vaines Call your loal publi health unit for advie if you suspet that vaine has been exposed to temperatures below + 2 C or above + 8 C. Never disard vaine with your offie waste. Always return expired or spoiled vaine to your vaine supply soure (i.e., loal publi health unit or the OGPMSS) for disposal. The Ministry of Health and Long-Term Care may be reimbursed by manufaturers for returned vaines. Offies/Failities in Toronto: Please ensure that you have some vaine return forms and vaine return labels in your offie/faility. These may be obtained from the OGPMSS. Proedure for Returning Wasted Vaines 1. Obtain a return authorization number for wasted vaines from the OGPMSS (see telephone number below). 2. Complete the returned vaines wasted form (pink form). 3. Affix a returned vaines wasted label (pink label) to the outside of the pakage. You may also obtain this label from the OGPMSS driver. Please note that the OGPMSS driver will not aept returned vaines that are not pakaged/labeled properly or do not have the proper doumentation (i.e., ompleted vaine return form). Offies/Failities Outside Toronto Return all wasted vaines to your loal publi health unit. For more information or assistane, please all the OGPMSS at 416-327-0837, or your loal publi health unit. 14 Vaine Storage and Handling Guidelines
List of Publi Health Units in Ontario Distrit of Algoma...705-759-5287 Peel Regional...905-791-7800 Brant County...519-753-4937 Perth Distrit...519-271-7600 Chatham-Kent...519-352-7270 Peterborough County-City...705-743-1000 Durham Region...905-668-7711 Porupine...705-267-1181 Eastern Ontario...613-933-1375 Renfrew County & Distrit...613-732-3629 Elgin-St. Thomas...519-631-9900 Simoe Muskoka Distrit...705-721-7330 22M De/05 Queen s Printer for Ontario Grey-Brue...519-376-9420 Haldimand-Norfolk...519-426-6170 Haliburton, Kawartha, Pine Ridge Distrit...905-885-9100 Halton Regional...905-825-6060 Hamilton...905-546-2424 Hastings and Prine Edward Counties...613-966-5500 Huron County...519-482-3416 Kingston, Frontena, Lennox & Addington...613-549-1232 Sudbury & Distrit...705-522-9200 Thunder Bay Distrit...807-625-5900 Timiskaming...705-647-4305 Toronto Publi Health Unit (Immunization Line)...416-392-1250 Waterloo Regional...519-883-2000 Wellington-Dufferin-Guelph...519-843-2460 Windsor-Essex County...519-258-2146 York Regional...905-895-4511 County of Lambton...519-383-8331 Leeds, Grenville and Lanark...613-345-5685 Middlesex-London...519-663-5317 Niagara Regional Area...905-688-3762 North Bay-Parry Sound Distrit..705-474-1400 Northwestern...807-468-3147 Ottawa...613-580-6744 Oxford County...519-539-9800 Vaine Storage and Handling Guidelines 15