In order for pharmaceuticals to be securely distributed, careful planning, precautionary measures and reliable partners remain the key ingredients to success. Despite having these factors in play, products are handled by several parties during the distribution process, meaning mishandling is highly likely with costly ramifications.
Additionally, the inconsistencies in regulation throughout Europe add another layer of difficulty to an already complex cold chain. Managing and mitigating these difficulties remains a priority for supply chain logistics professionals, and a crucial task to achieve business success.
Sarah Fal speaks to an industry expert based in the U.K. to uncover exactly what these difficulties entail and how they can be overcome. Greater focus will be placed in the animal pharmaceutical industry as opposed to human health.
Sarah Fal: What is your main challenge in ensuring products arrive at their end destination within the right temperature range?
Industry Expert: The manner in which rounding of temperatures should occur has been ambiguous. If you have a significant figure like 8.1°C, and the measuring device only measures up to 8.154°C, it is unclear of whether to round up or down. In the temperature maintenance industry, most instruments measure half a degree but electronic instruments measure to 1001 of a degree. This is a significant issue, one that is rarely discussed by regulators.
SF: Is the ‘last mile’ still proving a major issue for industry?
IE: Yes, and in order to mitigate this issue, there are only two viable solutions. First, people within the industry need to be informed on the manner in which products need to be handled. What’s more, there should be an understanding of what is expected and all should adhere to these expectations due to the fragile nature of the products.
Second, those within the temperature monitoring field tend to lack certain information. This leads to the mishandling of temperature monitors. For instance, they may record temperature at the wrong time or do not switch off the monitors at appropriate times which can create deviations. The only solution to this issue would be to educate and train those within the field to fully understand the implications of certain actions.
SF: I have heard that temperature mapping is a topic that many would like to be more informed about, could you provide some clarity on this topic?
IE: I will explain this using an example. In a vehicle that is temperature-controlled, you would have to map out the facility to know exactly where the hot spots and cool spots are. With this information in mind, you would place your temperature controlling devices in these areas to create the right balance for your products.
The additional factors you would need to consider are: How long the storage space would maintain its temperature for, if there are emergency measures in place and if the right insulation has been used. In the pharmaceutical industry, it is a requirement to map out cold chain areas. For instance, fridges should be mapped, however, freezers are less likely to be mapped.
SF: Speaking of requirements, how does cold chain regulation work across Europe?
IE: Regulation across Europe tends to be inconsistent. Human health regulations tend to be more straightforward and stick to the Good Distribution Practices. However, when it comes to the veterinary industry, this is more complex. Regulation within this industry is managed by the U.K. Ministry of Agriculture as opposed to the Ministry of Health.
On the other hand, in Belgium, the rule of distribution is different – Human Health and Veterinary Health are placed within the same category. In Italy, there isn’t a distribution practice for animals written in the law at all. Ultimately, cold chain regulation cross Europe within the veterinary industry differs depending on the country, and there needs to be greater harmonization.