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Article

Emergency Preparedness Vaccine Cold Chain Breakdown Guidelines

For Public Health Services Use

The success of any immunization program is dependent, among other factors, on the effective

vaccine “cold chain” maintenance.

The term “cold chain” refers to all the material, equipment, and procedures used to maintain

vaccines within the required range of +2˚ to + 8˚ C at all times during handling, storage and

transport. Break in the cold chain can result in decreased vaccine effectiveness, undue vaccine

failures, and an increased rate of local reaction after vaccine administration.

Severe weather conditions and other events may disrupt power or otherwise compromise the

“cold chain”. The purpose of this guideline is to provide Public Health staff with information for

vaccine management during such emergencies.

Pre Emergency Preparedness:

1.      Identify all alternative storage facilities (hospitals, packing plants, other offices, etc) with

back up power (generator), where the vaccine can properly be stored and monitored for

the duration of the storm. Have agreement with facility/ies for transportation of vaccines

in emergencies.

 

2.      Ensure availability of appropriate packing containers, cold packs, etc.

 

3.      Identify who to call for the following: Equipment problems, back up storage, back up

transportation and security.

 

4.      Develop a communication strategy for vaccine providers to facilitate appropriate action

and minimize vaccine wastage.

 

5.      Prepare a list of emergency phone numbers that may be needed during the emergency

such as:

 

    Power company

    Temperature alarm monitoring company

    Back up storage facility

    Transport company

    Weather service

    Staff on call

    Manufacturers:

                      -Merck
                      
-Sanofi
                      
-Shire
                      
-GlaxoSmith Kline
                      
-Wyeth

6.      Ensure all appropriate staff are knowledgeable about cold chain maintenance, vaccine

packing and transport.

 

In Advance of the Event:

When vaccine providers/local Public Health office have reasonable cause to believe that weather

conditions have potential to disrupt power and/or  flood any office that vaccine is stored,

following actions should be taken:

1.      Inform all vaccine providers of actions to be taken prior to impending storm such as but

not limited to(see also Post Event Preparedness below):

 

      Document name, expiry date and number of each vaccine in the refrigerator.

      Record refrigerator temperature, time and date.

      Pack the refrigerator vaccine with adequate cold packs and water bottles while

      power is still on.

      Provide instruction about vaccine packing and transport to local storage area (if

      appropriate).

      Reinforce not to open the vaccine refrigerator door during power outage until it is

      absolutely necessary.

      Document the time and temperature when power returns and again one hour after

      power comes on.

      Inform Public Health Services before using any vaccine exposed to cold chain

      failure or before returning such vaccines to Public Health Services.

2.      Plan for availability of adequate staff to pack and move the vaccine.

3.      Plan for transport of vaccine to the secure storage facility/ies.

4.      Inform facility/ies about impending transport of vaccine to their storage area.

5.      Pack and transport all vaccines to the back up storage areas. If there are high volumes of

vaccines on hand, prioritize transportation to:

      Vaccines that are more sensitive to heat such as varicella and MMR vaccines,

      More expensive vaccines such as pneumococcal conjugate, HPV,

      Vaccines that may be hard to replace. (ie: rabies, Hepatitis B)

6.      Monitor time on route to storage area.

7.      Update emergency phone numbers as required and post near vaccine refrigerator.

Post Event:

 

In the case of a cold chain failure, the following steps must be taken:

1.      Do not discard vaccine/s.

2.      Store exposed vaccines in a separate container/bag marked “Power Failure” or other

related events, with a record of complete list of products, expiry dates, quantities of each

vaccine, the maximum -minimum temperature exposed to, and the duration of exposure.

If specific time/temperature details are not available, assume the refrigerator

malfunctioned immediately after the power outage and assume that the refrigerator took 2

hours to warm to temperature outside the range +2E to + 8E C.

3.       Return the container/bag to the refrigerator or cold box with a high-low thermometer,

until it is determined which product is useable and which must be replaced.

4.       Use the 2010 Vaccine Stability Chart to determine whether or not the vaccines can be

used or need to be discarded.

5.       Consult with the HPP, CDPC Responsibility Centre if assistance is required with # 4.

6.       Once determination is made that these vaccines could be used, mark the products as

       being exposed to cold chain break.

7.       Use the vaccines exposed to cold chain break down before using any additional vaccine

supplied to you.

8.       Do not use the exposed vaccines if another cold chain break down occurs.

9.       Document name, number, expiry date of vaccines returned and send to main Public Health office in the District Health Authority.

10.    10. Inform other Public Health vaccine providers of the steps above (1-7).

11.    11. Document all vaccine loses due to cold chain break down, keeping track of name, expiry date, quantity and cost for each vaccine.

12.    12. Submit this information to the Provincial Biological Depot.

 

Assessing Vaccine Stability:

 

All vaccines must be routinely stored at the temperatures recommended by the manufacturers

and the Canadian Immunization Guide.

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