Ilya Preston, PAXAFE

Precision in the supply chain has never been more critical than when it involves transporting temperature-sensitive pharmaceutical products. Even small changes in temperature, short delays, or minor disruptions can compromise a product’s integrity, damage a company’s reputation, or endanger patient safety. Due to the sensitivity of the pharmaceutical cold chain and the value of its products, it is increasingly important to make thorough risk assessment an integral part of the shipping and distribution process.

Risk in the pharmaceutical cold chain can take several forms, but assessing risk combines two factors: the likelihood that a risk event could take place, and the severity of the consequences if the event does occur.

Vibrations and shock can cause physical harm or degradation of the product during transit. This can happen unexpectedly if a shipment is forced to change routes.

Supply chain bottlenecks, disruptions that prompt route changes, or other unforeseen events can cause delays. Natural disasters and manmade disruptions—ranging from hurricanes to political unrest—can cause ships, planes, and trucks to wait out delays or take an alternate route.

 Deviations from a specified temperature range can cause products to degrade, which is a particular problem for pharmaceuticals that must be kept refrigerated. The FDA estimates the pharma industry loses $35 billion a year because of cold chain failures.

 Most medicines that require refrigeration must be kept between 36°F and 46°F (2°C and 8°C). A deviation from that range of even a few degrees can spoil the product. This could be caused by mechanical failures, such as malfunctions in refrigerators, freezers, sensors, or human errors such as incorrect temperature settings, mishandling of goods, or communications failures.

The acceptable temperature range varies with the type of product. Products such as tablets, capsules, and powders are transported at room temperature, between 55°F and 75°F (15°C and 25°C), though some other products require a deep freeze. Several COVID-19 vaccine candidates were classified as “ultra-cold”

 and needed to be kept at -112°F (-80 °C) and cryogenic medicines (such as some vaccines and tissue samples) are kept between -238°F (-150°C) and absolute zero -460°F (-273°C).

. The value of some pharma products makes them attractive targets for theft in the supply chain.

 And the potential consequences of theft extend beyond financial losses and disruptions to operations. They can also profoundly impact patient well-being by causing delays in treatment, which can, in turn, lead to adverse health outcomes. Meanwhile, as the pharma supply chain becomes increasingly networked, it is also more vulnerable to cyberattacks,

 adding another reason for proactive risk assessment.

Once you’ve identified potential risks and the likelihood that they could occur, you can implement risk mitigation and control strategies, as part of an ongoing, cyclical process.

Identifying potential hazards and risks, such as temperature fluctuations or shock damage, could impact product quality and patient safety. In modern pharma supply chains, companies are turning to artificial intelligence in order to filter out noise from meaningful data in order to make intervention work easier and preventative.

When it comes to analyzing risk, being able to accurately assess them involves evaluating several factors: 

Product characteristics, including the inherent properties of the product, such as whether it is temperature-sensitive, fragile, or perishable.

The packaging and shipping systems being used, which are paramount in protecting products.

The transportation modes and routes for shipping products. and whether they could significantly impact the risk profile of shipments.

The environmental conditions encountered during transit and whether they could pose significant risks.

Regulatory requirements and how they apply to shipping and distribution.

Using fine-tuned cold chain large language models can enable drugmakers to better interrogate data from across their entire supply chain, and answer questions faster.

Devising effective strategies for mitigating and controlling risk involves making use of the data gathered from assessments, and often requires a tailored approach, based on the probability, severity, and potential impact of each risk. The strategies you choose can include:

Because staying within the required temperature range is essential, shippers need to ensure the reliability of their systems. This can include being able to make use of data from sensors and data loggers that monitor temperatures during transport, as well as other factors such as shock impact and location. Real-time monitors and data loggers can track fluctuations and humidity that can affect temperature-sensitive and perishable products. Data from other sensors can be analyzed and used to help optimize routes and avoid damage.

Organizations should be sure their packaging is sufficient to prevent product damage during transportation and handling.

 Implementing protections ranging from security cameras and container seals to cybersecurity measures and employee training can help deter theft and ensure product integrity.

Delays and disruptions can happen unexpectedly, but that doesn’t mean you have to be unprepared. Having contingency plans in place to address potential shipment delays can ensure quicker responses, which can reduce delays and lower risks.

While some companies do this in a reactive way, forward-thinking pharma organizations are finding ways to develop more proactive risk mitigation strategies. This involves transforming the volumes of data collected across the cold chain into actionable insights that allow companies to ensure the cold chain runs smoothly, and avoiding issues such as sub-optimal routes, problematic carriers, or inefficient or non-compliant packaging strategies before they become a problem.

Supply chain companies need to collaborate and communicate with all their stakeholders to gain a comprehensive understanding of risks and ensure the development of effective mitigation strategies. That includes internal stakeholders, such as those handling quality assurance, regulatory compliance, product development, supply chain management and procurement, as well as third-party suppliers.

Third parties with a stake in the process include any contracted manufacturers or packagers, and storage sites. They can be carriers, transport providers, and forwarders, as well as distributors. Last-mile partners such as clinics, hospitals, pharmacies, and patients are also stakeholders.

Today, these third parties are fragmented and drugmakers are forced to rely on third-party logistics providers to help piece together the story of what happened. Companies need to begin to figure out how to make their data work for them, using data to drive weekly or monthly risk review boards to ensure risks are communicated clearly and effectively.

Implementing the chosen risk mitigation strategies and monitoring their performance is another stage where being able to collect and analyze data can be effective in identifying areas for further improvement. Companies successful in this phase are able to gain insights into the data from across the supply chain not only to understand the baseline of where they are at, but to assess their performance against the plan in real time.

Pharmaceutical shipping and distribution requires that products arrive both on time and in good condition. The risks to that process are many, but a strategy of proactive risk assessment and mitigation can make organizations’ cold chains more resilient. By systematically identifying, assessing, and mitigating potential risks, companies can protect their products and help ensure timely deliveries that will build trust among patients and healthcare providers.

1. Cold Chain Management for Pharmaceuticals. Dickson Data. June 29, 2022. 

https://dicksondata.com/maintaining-cold-chain-essential-safe-product-healthy-bottom-lines

2. Motamedi, H.; Ari, M.M.; Dashtbin, S.; et al. An Update Review of Globally Reported SARS-CoV-2 Vaccines in Preclinical and Clinical Stages. 

3. Anderson, M. How Pharmaceutical Companies Work to Prevent Organized Crime in Their Supply Chains. 

https://www.healthcare-brew.com/stories/2023/06/08/how-pharmaceutical-companies-work-to-prevent-organized-crime-in-their-supply-chains

4. Cyber Threats in Pharma Supply Chain. World Bi Group. June 8, 2023. 

https://worldbigroup.com/Event-blogs/cyber-threats

Articles

When delays and disruptions threaten not only product integrity but patient
well-being, thorough risk assessment and mitigation are essential.