The challenge of cold chain breaches in a medical setting

In an article published in the Journal of Clinical Pharmacy and Therapeutics, researchers from the University of Canberra highlight the need for further research into the preservation of medicines and the maintenance of the cold chain. Essential medical supplies could be compromised and discarded in the event of a power outage.

Many medicines, including vaccines, must be kept at temperatures between 2 and 8°C from the time of manufacture until they are administered. These temperature regulations ensure that medicines and vaccines can be used safely. Power outages can cause this ‘cold chain’ to fail, leading to the degradation of pharmaceutical materials. As it is difficult to confirm the stability of medicines after a break in the cold chain, they are often discarded.

The researchers conducted a survey of community pharmacies regarding the issue of cold chain breach. They found that 50% of pharmacies had experienced a power outage in the last 12 months, but backup procedures varied widely. When questioned about the disposal of medicines after a cold chain breach, many respondents also listed pharmaceuticals which could in fact be safely stored at higher temperatures, if only for a limited time. This surely contributes to the high cost of replacing impaired medicines; the average was estimated to be AUD 13,168 per pharmacy. If 10% of Australian pharmacies encounter one significant power outage per year, the annual cost for the recovery of medicines could be as high as AUD 7.6 million (€4.8).

The study calls for clearer protocols to follow in the event of a power failure, and contingency plans to preserve pharmaceutical materials as well as possible. Such procedures may include the provision of back-up power to refrigerators, transport of medicine to alternative sites, or the use of insulated coolers and ice/gel packs. The researchers also note that vaccines are often stored in purpose-built refrigerators which are not manufactured to any exact standard. Specific guidelines for the production and performance of refrigeration equipment in the healthcare industry are recommended.

Though there is little concrete data available, the researchers suggest that medicine loss due to cold chain breaches could represent a considerable financial burden for healthcare providers around the world. They argue that ‘millions of dollars’ worth of medicines could be saved each year if additional data regarding the stability of medicines were available to the relevant parties’. Further research and clearer guidelines for health professionals could prevent or mitigate medicine loss in the future.

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