by, Mark Ross, Global Brand Manager for TITAN Containers ArcticStore
In an era where medical advancements are revolutionising healthcare, ensuring the potency and efficacy of pharmaceuticals is essential.
However, amidst the complex logistics of transporting pharmaceuticals, one critical factor often overlooked is temperature control. As temperatures fluctuate, so does the efficacy and safety of medicinal products. One study found that the pharmaceutical industry loses $35 billion each year to ineffectual temperature-controlled logistics.
So, how can effective cold storage management prevent further losses and reduce the harm caused by ineffectual medicines?
Impact of temperature fluctuations
Many medications, particularly antibiotics and vaccines, are sensitive to temperature fluctuations. Some products may also be impacted by exposure to adverse humidity levels.
When exposed to temperatures outside the recommended range, these medications can become compromised or lose their potency.
Temperature fluctuations not only compromise the efficacy of the medications but also pose significant health risks if people do not get access to vaccines. This was particularly evident during the Covid-19 pandemic. Vaccines developed to protect against the Covid-19 virus had strict temperature requirements, raising concerns about whether this could be adequately maintained, especially in developing countries.
Other medications such as monoclonal antibodies, often used for the treatment of cancer, are stored at temperatures between −20°C to −80°C. When stored in warm temperatures outside the manufacturer’s recommendations, efficacy dramatically decreases.
One report estimates that around half of vaccines distributed around the world go to waste because of poor temperature management. A report by the United Nations Environment Programme estimated that at this spoilage rate, a billion vaccines could be wasted. It highlights that even if valued at a non-profit cost of around $10 a vaccine, this is a massive loss.
Ineffective temperature control can lead to increased pharmaceutical waste, contributing to environmental pollution and requiring complex disposal procedures. The NHS estimates that over 156,000 tonnes of medical waste is produced annually, which requires high-temperature incineration (HTI) or alternative treatment. By implementing a comprehensive waste strategy, it is estimated that this could save over £11 million in costs and dramatically reduce CO2 emissions.
Effective temperature control in the pharmaceutical supply chain is essential to minimise drug wastage, reduce environmental pollution and avoid the complex procedures associated with dealing with pharmaceutical waste.
Identify weaknesses in the cold storage chain
It’s essential to evaluate the accuracy and reliability of temperature monitoring devices and data logging systems to mitigate the risks associated with temperature fluctuations in the cold storage chain.
These systems must be capable of providing real-time data and generating automatic alerts when deviations occur. Ensuring their accuracy involves regular calibration and maintenance.
Failures in cold storage may be visible through conditions such as condensation or mould growth. These are likely to occur when there is poor ventilation, fluctuations in temperature or poorly stored materials. Effective tracking systems are crucial in ensuring that these problems are dealt with before risking a loss of product.
Redundant temperature control systems are also beneficial for ensuring that there is adequate power and cooling capabilities in the event of a failure. Backup generators or alternative cooling units will maintain temperatures and ensure that nothing goes to waste.
Prioritise compliance with regulatory standards
Regulatory bodies impose strict guidelines on temperature control during the storage and transportation of pharmaceuticals. Adhering to these standards not only upholds quality assurance but also mitigates the risk of non-compliance penalties and reputational damage.
Regulatory standards vary globally, and multinational pharmaceutical companies must navigate different compliance landscapes. Adopting the most stringent standards can help ensure universal compliance and quality.
In the UK, best practice suggests that temperature monitoring should take place in all refrigerated transport but especially within shipments of high-risk products. Temperatures are required to be strictly controlled and monitored to provide temperature data for the entire journey.
Using electronic tracking systems built into cold-storage units allows for easy monitoring and ensures that all records are kept in one place. This data is also required to be retained for five years.
The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK carries out inspections to check that distribution sites comply with Good Distribution Practice (GDP). During these inspections, GDP inspectors will analyse several areas including the equipment used to distribute medicine – this can include temperature monitoring and transportation arrangements.
Maintain risk mitigation strategies
There are several risks to consider in the logistics industry from cybersecurity threats to transportation and equipment breakdowns.
As supply chains become more complex, pharmaceutical and logistics industries are more at risk of being exploited by criminals. In 2021, hackers targeted COVID-19 vaccine developers. The logistics industry is at a large risk of being hacked. One UK-based logistics company entered administration following a ransomware attack, which had caused major disruption.
This highlights the real-world threats that can occur as a result of cyber-attacks. Protecting against such threats requires robust cybersecurity measures, including data encryption and regular security audits.
Transportation delays, which have recently been experienced in the Red Sea, have posed some significant challenges for global trade. As a result of unrest in the area, shipping companies have been forced to divert from usual trade routes and opt for more time-consuming routes.
Regular drills and scenario planning can help ensure that teams are prepared to respond effectively to real-life incidents, minimising the impact on temperature-sensitive products.
Ensure visibility within the partner network
Integrated tracking systems provide transparency throughout the supply chain, empowering stakeholders to identify and address potential temperature deviations promptly. With many stakeholders involved in the logistics industry, each handoff in the supply chain introduces a potential risk for temperature deviations, mishandling, or delays.
Reliable tracking systems can mitigate these risks by providing real-time data and alerts. In the event of a temperature deviation, stakeholders can take immediate action to prevent damage to the product. As technology rapidly develops, maintaining digital records of temperature data becomes more efficient, ensuring transparency and accountability. Advanced sensors can continuously monitor environmental conditions and log this data to one platform that is easily accessible to multiple stakeholders.
