Supply of veterinary medicines that are heat sensitive

Care in the supply of veterinary medicines

Certain veterinary medicines e.g. vaccines must be stored and maintained under cold chain conditions right through from manufacture to use on the farm or in a practice. This can pose a challenge, particularly during hot weather. Unless the recommended temperatures are followed, vaccines and other heat-sensitive veterinary medicines can rapidly degrade and become ineffective.


Importance of storage, including storage during transit

Storage is a critical parameter in maintaining the quality, safety and efficacy of all medicines, including veterinary medicines. The shelf life/expiry date of each medicine is determined based on stability testing of the product conducted at the specified storage conditions. Stability can be affected by adverse storage conditions which may impair the product quality, safety or efficacy. Veterinary medicines that are heat-sensitive are recognisable by their packaging labelling statements “Store between 2 - 8˚C”. 

For vaccines in particular, there may be a risk of deterioration due to physical or chemical changes if the product is subjected to temperatures outside of 2 - 8˚C. This narrow temperature range requires extra care when handling, storing and using such products. Freezing or heating even a brief period may lead to a loss of efficacy.


Tips for Best Cold Chain Practice


On Receipt of heat-sensitive veterinary medicines

  • Verify 2 - 8˚C storage conditions have been maintained during transport from supplier
  • Give priority to placing product into the fridge unit

 

On Operating the Fridge Unit

  • Identify hot/cold spots and ensure products not stored in those locations (e.g. adjacent to the chiller or ice box unit or in door shelves)
  • Products should not be in contact with moisture, water or ice
  • A back-up/contingency plan should be in place in the event of fridge failure
  • Monitor and record temperatures using an independent calibrated probe/logger
  • Investigate excursions outside of the specified temperature range and determine the impact on the products stored

Supplying Heat-sensitive veterinary medicines

  • 2 - 8˚C should be maintained during transportation to the end user (e.g. by use of validated cold chain delivery systems, cold boxes etc)
  • Inform your customers that the product(s) require immediate refrigeration
  • Do not accept returned products back into saleable stock