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Safety in use of veterinary vaccines – transport and storage recommendations

Notice type: Advisory

Date: 06/02/2017

  

Product name or type:
Veterinary vaccines

Target Audience:
Vets, Licensed Merchants, Pharmacists and Farmers 

Problem Or Issue:
Vaccines are sensitive to heat but some are also sensitive to cold or freezing temperatures. They must be maintained under the storage conditions identified on the product packaging e.g. store between 2 – 8°C. Unless stored appropriately through the distribution chain to the point of use (i.e. the animal’s side) the potency and effectiveness of the vaccine may deteriorate. 

Background Information Or Related Documents:
Storage is a critical parameter in maintaining the quality, safety and efficacy of all medicines. The shelf life/expiry date is determined based on stability testing of the product conducted at the conditions specified on the packaging / labelling for product storage. The underlying principle in ensuring optimum vaccine performance in the field or clinic is that the vaccine is delivered to the animal under the same storage conditions as those in place following its production and release from the manufacturing plant. The product quality, safety or efficacy can be adversely affected by temperature excursions outside of the specified storage conditions. For vaccines in particular, there may be a risk of deterioration in the potency of the vaccine antigens if the product is subjected to temperatures outside of the specified range, even temporarily. For example, if vaccines recommended to be stored at 2 – 8°C are subject to freezing or exposure to heat even for a brief period during transport or storage on farm prior to use, this could lead to a loss of effectiveness.

Actions To Be Taken:
Health care professionals who store vaccines for dispensing or use should:
• Verify that the storage conditions specified on the packaging / labelling of the products are maintained while the products are under their control. If refrigerated storage is recommended, the products should not be in contact with moisture, water or ice, or in hot/cold spots in the fridge (e.g. adjacent to the chiller or ice box unit or in door shelves). 
• Ensure that they have a back-up contingency plan in place in the event of fridge failure.
• Ideally ensure that fridge temperatures for vaccine storage are monitored and recorded using an independent calibrated probe/logger. 

Health care professionals who supply vaccine to farmers should:
• Ensure that the storage conditions of the products are maintained during transportation to the end user (e.g. by the use of validated cold chain delivery systems – the concept of validation here relates to having data to know that the required temperature conditions can be met by the cold storage unit for the period that the packs of vaccines are within it). 
• If frozen ice-packs are used within a box (such as a styrofoam box) to keep the temperature inside between 2 – 8°C, be sure not to let the ice-packs make direct contact with the packs of vaccines, as this can led to freezing of the vaccine and a loss in its potency.   
• If refrigerated storage is recommended, inform your customers that the product(s) require immediate refrigeration. 
• Do not accept returned products back into saleable stock.

Farmers should:
• Purchase vaccines only from a reliable health-care professional
• Be suspicious of vaccines offers made over the phone, internet or social media, in case they have not been stored correctly or have are due to pass the expiry date imminently
• Purchase only sufficient vaccine for their immediate needs (in order to safeguard the product from straying outside the specified storage temperature range or beyond as the expiry date)
• Ensure that any vaccines requiring refrigerated storage are stored on their farms in fridges, but away from any cold or hot spots within the fridge and not in the door shelves. 
• For vaccines that are given by injection, ensure that they have sufficient sterile needles and syringes to administer the vaccine safely (a new needle for each animal). 
• Report any suspected product lack of efficacy or adverse effects to the person from whom they purchased the vaccine, or to the HPRA directly via the online reporting form available at:


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