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Niagara Region Public Health is responsible for the distribution and handling of all publicly funded vaccines within our jurisdiction Proper storage ensures that administered vaccines are viable therefore reducing the likelihood of disease outbreaks. You can use your health unit as a resource for information about storage and handling of publicly funded vaccines.

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An application has to be completed, submitted to the MOHLTC annually and approved in order to prequalify for UIIP. Please use the left hand navigation menu to select Health Care Agencies and pharmacies Prequalification also includes an on-site inspection to ensure the premises’ are ready to store vaccine. This inspection is conducted by your health unit. Facilities and pharmacies must qualify before they can order/ store publicly funded MOHLTC flu vaccine. The application timelines vary.

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Staff responsible for vaccine management must know and be able to apply the Vaccine Storage and Handling Guidelines. Necessary items include a hard-sided cooler, digital transport thermometer, and cold packing materials such as ice and gel packs. The cooler, transport thermometer and packing materials will be provided to you by Niagara Region Public Health at your initial on-site inspection. It is important to be aware that you will be responsible for purchasing any replacement thermometers, coolers, etc. as needed. Fax a temperature log to Public Health (905-688-4667) for review once a minimum of seven days of twice daily temperature recordings (minimum, maximum, current) within the 2.0-8.0 °C range has been achieved.

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Having a vaccine appropriate monitored fridge is a key link in the cold chain.

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To ensure vaccines remain viable, they must be stored between 2.0°C and 8.0 °C . It is important that you report temperatures outside of this range to Public Health right away. If you report out-of-range temperatures promptly, the chance of administering non-viable vaccine is minimized. When people are immunized with vaccines which are not known to be viable, Niagara Region Public Health will recommend next steps which may include re-immunization. Please remember that vaccines are costly. By ensuring they are properly stored you can help reduce the financial impact to our healthcare system.

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The Vaccine Storage and Handling Guidelines include the information you need to know to properly store vaccines. It is available online or from Niagara Region Public Health. Pages 10-13 of the document outline how to set up and monitor your fridge and how to handle vaccines. The guidelines also recommend that one person (and a designated back-up person) be responsible for vaccine management.

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Prior to your inspection, you must obtain a fridge that is appropriate for storing publicly funded MOHLTC vaccine. This could be any fridge which can maintain temperatures between 2.0°C and 8.0°C. When choosing a vaccine fridge, consider whether storing additional medications such as insulin may increase the frequency of fridge door openings. Every time a fridge is opened, warm air rushes in and potentially raises the temperature of the fridge to greater than 8.0°C. If these instances are not observed and monitored, there is a greater risk of a cold chain incident. Vaccine fridges should have the required MOHLTC materials posted or nearby. The MOHLTC posters will be provided to you. Note the fridge is in a well-ventilated area away from direct sunlight and external walls. This reduces the likelihood that the fridge will be affected by extreme heat or cold. If your refrigerator outlet is easily accessible, it should be covered by a metal cage or marked with a DO NOT UNPLUG sticker. It is not recommended that you plug your fridge cord into a power bar as there is a risk it may be inadvertently turned off.

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This picture illustrates proper organization of a vaccine fridge. The fridge in this photo is a bar style fridge which is acceptable for use in Ontario. However, purpose-built vaccine refrigerators are preferred as they are more effective at keeping internal temperatures between 2.0°C and 8.0°C. Note that the ice packs are stored in the freezer so they are ready to use in the event that a cold chain incident occurs. Keep the freezer defrosted with less than 1 cm of ice build-up. Vaccines are stored in the middle of the fridge away from fridge walls, floors and cold air vents. Store the products on the shelves and not in the drawers or door. The vaccines should be kept in their original packaging and organized by product with space between to allow for air circulation. No specimens, food or drinks should be stored in the fridge. Products with the shortest expiry date should be stored in the front and used first.

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The thermometer probe should be in a vaccine box and positioned in the centre of the middle shelf. This will help ensure that the measured temperature is similar to that of a vial in its original packaging. You should have no more than a one month supply of vaccine on hand. Expired, damaged or wasted vaccine is to be returned to Niagara Region Public Health.

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It is recommended the thermometer be secured to the outside of the fridge, so temperatures can be read without opening the fridge door. Remember to remove vaccines from the fridge only for immediate use and to mark multi-dose vials with the date they are opened. Keeping your fridge between 2.0°C and 8.0°C requires: • Minimizing door openings/fridge access (warm air rushes in and increases the

temperature of the fridge) • Keeping water bottles in the door and on empty shelves helps to maintain ambient

temperatures • Making incremental adjustments to the fridge thermostat • In order to ensure your thermometer is working properly, it is recommended the

battery be changed at least every six months • Niagara Region Public Health can help with additional suggestions to keep

temperatures in range

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There are several varieties of min-max thermometers. Your thermometer must be able to record minimum, maximum and current temperatures within a tenth of a degree (0.1°C). You are required to document all of these temperatures twice daily. Typically, temperatures are recorded in the morning on arrival and in the evening on departure; every 12 hours is ideal. Remember to reset/clear the min and max each time temperatures are recorded.

If there is a temperature out of range, the length of exposure will be calculated based on the last in range recording. Out of range temperatures need to reported to Niagara Region Public Health right away in order to reduce the time that vaccines are exposed to temperatures outside 2.0°C and 8.0°C.

Your facility may be interested in purchasing a data logger as well. Data loggers continuously record fridge temperatures. Although they do not replace thermometers and the need for twice daily monitoring, they do more accurately record the actual length of time temperatures are out-of-range.

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This picture shows two days of temperatures recorded in the log book. For each entry, remember to include the date, time and initials. You are required to submit a current four week temperature log with each vaccine order. Print off your own temperature log from: http://www.health.gov.on.ca/en/pro/programs/publichealth/flu/docs/flu_temp_log_book_en.pdf Temperature log books can also be provided by Niagara Region Public Health.

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Vaccine Storage and Handling Guidelines should be adhered to at all times. Be aware that Niagara Region Public Health could come for unannounced site visits when you store publicly funded vaccines. If the guidelines are not being followed, it may result in your vaccine orders being put on hold until the issues are resolved.

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Main office (Thorold) Monday – Friday 8:30 a.m. to 4:30 p.m. Outer office deliveries occur every Monday and Wednesday with the exception of statutory holidays (Niagara Falls, Fort Erie, Welland) All orders must be picked up by 12 p.m. every Friday (orders cannot remain in the offices over the weekend).

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Do not use your fridge min-max thermometer; you will need to use a separate one for your cooler. The transport materials will be provided by Public Health at your initial inspection and include a thermometer appropriate for transport only.

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As soon as a cold chain incident is discovered, stop using the vaccines, and keep them between 2.0°C and 8.0°C until you receive vaccine stability and further instructions from Niagara Region Public Health

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In the event that your cold chain incident is due to a power outage or fridge failure, keep the vaccines between 2.0°C and 8.0°C by placing them in the hard-sided cooler with ice packets, fridge temperature gel blankets, and transport digital thermometer. Record temperatures (current, minimum, and maximum) on a temperature log.

This picture shows how to pack your vaccines. You must keep the thermometer display outside the cooler and the probe within the cooler. Return vaccines to the refrigerator when it has reached temperatures within the 2.0°C – 8.0°C range.

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Vaccines undergo rigorous clinical trials before they are approved for use in the population. In order to continuously ensure vaccine safety, adverse events following immunization, also known as AEFIs, must be reported to Public Health. The Health Protection and Promotion Act requires facilities/pharmacists to report AEFIs to their health unit within seven days. The World Health Organization defines an AEFI as: Any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease. For surveillance purposes, it is not necessary to report common or expected events as these are well-documented in pre-licensure trials. Reportable events are those that are severe or unusual such as a site reaction that crosses the joint or an event managed as anaphylaxis.

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The form for reporting AEFIs can be found on Public Health Ontario’s Resources page: http://www.publichealthontario.ca/en/eRepository/Report_Adverse_Event_Following_Immunization_Form_fillable_2013.pdf A public health nurse who investigates these events will contact you if necessary for further information. It is important to complete the report with all the necessary information as it will save you and the investigating nurse from seeking additional information or details.

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