Angela Kerr, SpotSee

Angela Kerr, VP, Customer and Channel Support, SpotSee

The recent approvals of respiratory syncytial virus (RSV) vaccines by GSK and Pfizer highlight a significant milestone for the medical community as it looks to protect countless lives who suffer from this ailment. Yet, as the US reflects on the journey of the COVID-19 vaccine distribution, the path to delivering these life-saving solutions will be defined by how well supply chain challenges can be managed and combatted. Successful vaccine distribution relies heavily on a seamless supply chain. Past rollouts of new therapies have exposed the fragility of this network with temperature excursions, logistical bottlenecks, and unforeseen disruptions creating obstacles in delivering vaccines to the masses. Thus, a robust supply chain strategy is just as important as the effectiveness of the vaccine; it is imperative to learn from the successes and failures of the pandemic to ensure these vaccines arrive safely to those who need them most.

When it comes to achieving successful vaccine distribution, the first step in doing so would be to bolster the cold chain’s resilience. The complexities of this issue were amplified during the COVID pandemic, as some vaccines required ultra-low temperature storage, introducing extreme transport conditions that further stressed the cold chain infrastructure. These vulnerabilities were brought to light during the early stages of COVID vaccine distribution when vaccines faced potency challenges due to temperature fluctuations. In fact, 20% of temperature-sensitive pharmaceuticals facing disposal due to cold chain logistics shortcomings.

In the evolving landscape of RSV vaccines, manufacturers should consider prioritizing cold-storage infrastructure, quality controls, and temperature monitoring solutions. Data loggers can serve as an asset in this regard. Used for its temperature capabilities, this monitoring tool offers real-time insights to manufacturers during the storage and transportation process, resulting in control over vaccine conditions. Additionally, the full implementation of the Drug Supply Chain Security Act (DSCSA)—whose implementation will not enforced by FDA until November 2024—will require supply chain companies to adopt some of these temperature monitoring practices in order to adhere to these new regulatory standards.

Temperature excursions during transportation represent a critical concern that manufacturers must address as multiple versions of RSV vaccines emerge. As such, maintaining optimal temperatures for vaccines from production to administration can mitigate losses in vaccine distribution. Real-time monitoring is key for vaccine rollouts. Incorporating advanced monitoring technologies that can alert both delivery drivers and healthcare professionals to temperature deviations during transit should be implemented during vaccine deliveries to avoid efficacy degradation.

The economic toll of failed temperature-controlled logistics in the biopharma industry is a reportedly staggering $35 billion, underscoring the collective responsibility that manufacturers and stakeholders bear. Public and private partners need to work together and should even consider embracing alternative solutions and adopting successful practices. 

Collaboration is paramount, especially as different versions of RSV vaccines vie for market presence. By fostering transparent communication, sharing best practices, and adhering to stringent guidelines, the entire industry can unite to ensure the successful and efficient distribution of these critical vaccines.

As technology continues to rapidly advance, medical breakthroughs are bringing more and more vaccines to market. It is essential that supply chain efficacy keeps pace with growing medical developments in preventative care. The challenges faced in the past during the critical stage of distribution should not be used as an excuse, but rather an opportunity to help ensure every vaccine dose reaches its destination with optimum potency.

1. 38% of Logistics Operators Still Finding Time on the Tarmac a Key Challenge. Pharma Logistics. November 8, 2018. 

https://www.pharmalogisticsiq.com/logistics/articles/38-of-logistics-operators-still-finding-time-on-the-tarmac-a-key-challenge

Angela Kerr is Vice President of Customer and Channel Support at SpotSee.

Articles

How they embrace collaboration will be key to the battle against RSV.

Fortifying Vaccine Supply Chains

In the wake of the COVID-19 pandemic, the supply chain industry experienced a renewed sense of why maintaining a safe, unbroken, and properly functioning delivery system is important, especially for pharmaceutical products. Within this, the cold chain has two main responsibilities: keeping temperature-sensitive products within their required temperature range and facilitating the product transfer from touchpoint to touchpoint.

The cold chain must maintain integrity, visibility, and accountability every step of the way to satisfy increasing demands from a variety of stakeholders. Medicines, test kits, and vaccines have always used the cold chain, but the temperatures and conditions seen at the forefront of the COVID vaccination efforts exemplified why maintaining a steady cold chain is so crucial. Even now, with infection rates surging around the world, many are seeking the vaccine, as well as the booster shot to add an extra layer of protection, with the understanding that it will be as effective as possible.

Because of this increased need, those who rely on the cold chain to keep products within a certain threshold are now dealing with the daily struggle of new guidelines and regulations, as well as the growing room for error that comes with the handling and distribution of large quantities of temperature-sensitive products. The expedited transfer of vaccines and medical products in general can affect the cold chain negatively, especially when products do not arrive at their destination in the expected condition.

With all of the opportunities for deviation throughout the supply chain process, temperature-monitoring devices are essential in ensuring the most effective delivery from beginning to end. Potential errors, including broken storage containers and freezers, spilled product, and even product spoilage when exposed to improper temperatures or impacts, make the shipping and delivery process high stakes for both shippers and consumers, but these issues can be monitored and prevented with the right technology.

Within the pharma industry, products are categorized based on a wide range of variables such as type, use, and even temperature threshold. Some products, like a few of the COVID vaccines, require ultra-cold temperatures to maintain efficacy, ranging from -130 to -76°F. Some products, such as insulin, might not require a below-zero environment, and can have a larger temperature threshold, but still require some form of refrigeration to maintain the typical range of 36 to 46°F. Even still, other products can be maintained at a controlled room temperature (CRT), usually between 60 to 77°F.

Regardless of its temperature threshold, a pharma product should always be kept within the outlined range—from the beginning of the supply chain all the way through the last mile—to ensure efficacy. Unfortunately, this doesn’t always happen. Freezers break, unexpected delays occur, warehouses are warmer than expected, and prescriptions are left sitting on doorsteps for hours before the recipient retrieves the package. There are numerous things that could happen at any point within the cold chain to push a product out of its desired temperature range. Thankfully, there are several devices that companies can incorporate to monitor and track the temperatures of their products throughout the entire length of the supply chain.

Before implementing a temperature-monitoring device, it’s important to first identify the point within the supply chain where it’s needed, how detailed the monitoring should be, and what the desired temperature range is. These key points will then inform the type of device that would be best suited for the given product. There are several options to pick from when optimizing the cold chain, including temperature indicators, recorders, and labels. For example, a manufacturer looking for a device with a visual indication might be best suited to implement a single-use, color-changing indicator. Another manufacturer looking to track and have recorded proof of temperature excursions might be better off using a temperature recorder that either provides downloadable information via USB or utilizes a wireless network to transfer the measurements as soon as the product in question is exposed to an out-of-tolerance temperature.

Indicators are both easy to use and easy to implement. Typically, single-use can be applied to individual products or entire packages within a shipment. Several indicators leverage color-changing technology, allowing them to deliver clear evidence of unacceptable temperature exposure and even the length of time of the temperature excursion. Available in multiple ranges, these time-temperature devices change color to indicate temperature changes and the length of time that those changes were maintained. This data allows handlers the ability to make quick decisions, such as if a product needs to be thrown out or used first in inventory rotations. Its irreversible nature also makes it impossible for mishandling to go unnoticed. For example, if a shipment was left out in the sun too long, then put back into a freezer, the affixed indicator would still show that a deviation had occurred.

These devices can also be field-armable, meaning they can be activated right before use. If a supply chain anticipated deviations at one specific checkpoint, an indicator could be applied and activated before transporting the shipment through that specific stage of the supply chain, to make sure deviations are avoided, if possible, but caught if they occur.

Similarly, recorders can be helpful for products with stringent handling and temperature requirements. Like indicators, recorders provide handlers with the knowledge necessary to decide if a shipment or product is safe to use. It also provides incontrovertible proof of the temperatures reached during transit, whether within the set threshold or not. Lastly, it allows manufacturers, shippers, and other parties within the supply chain to correlate deviations with specific locations. For example, continuous use of a recorder might reveal temperature deviations at one specific warehouse for every shipment. That key information then enables companies to make decisions best suited for their business and optimization needs. Unlike color-changing indicators, recorders are more in-depth, recording the entire length of the supply chain, and then providing downloadable data via USB when the transfer is completed.

Regardless of the device used, having something to monitor and track the temperature of products through the supply can greatly reduce the chance of temperature excursions. When handlers understand that a monitoring program is in place, they are more likely to take greater responsibility with the shipment.

As these devices continue to evolve alongside new rules and regulations, partners in the cold chain remain dedicated to solving some its biggest challenges. The Drug Supply Chain Security Act (DSCSA) requires that the industry develops methods of tracking certain prescription products with the goal of protecting consumers from counterfeit, stolen, contaminated, or otherwise harmful products. The interoperable databases that will link the supply chain is a logical place for product conditions, such as temperature throughout the supply chain, to reside.

For manufacturers and distributors looking to improve their supply chain, temperature-monitoring devices are a valuable and viable option. Choosing the right device starts with understanding the capabilities needed for a specific treatment. Following the identification process, handlers can then decide what device works best given their schedule, quantity of shipments, key locations, and other relevant variables. Despite ongoing challenges, it is possible to create a more efficient and transparent transportation process, with a comprehensive view of supply chain performance, as well as insight into individual checkpoints.

Angela Kerr is Vice President, Product Portfolio, SpotSee.

Selecting the appropriate type of temperature-monitoring device starts with
understanding the capabilities needed for a specific product

Choosing the Right Monitoring Device

When it comes to the operation and optimization of supply chains, cold chain products have proven to be a temperamental obstacle. Medical and pharmaceutical companies have relied on temperature-controlled supply chains for several decades to preserve and maintain the usability of their temperature-sensitive products. Without total transparency or the ability to monitor temperature at every link in the chain between production and consumption, these complex cold chains are subject to detrimental disruption and irreversible product damage.

While the need for a reliable cold chain is far from new, this demanding logistic segment must now grapple with additional challenges brought about by the global pandemic. Increasing demand at reduced capacity is amplifying the potential for disruption along the chain, while new products and regulations relating to COVID-19 are introducing unprecedented obstacles. Despite these issues, the fight to defeat COVID-19 has made secure transportation of temperature-sensitive pharmaceuticals, test kits, and related medical supplies more critical than ever before. Fortunately, temperature-monitoring devices offer an integral solution for current challenges in securing pharmaceutical cold chains.

Temperature control is a top issue in cold chain logistics because even the slightest variations can significantly affect the quality and safety of products. Medical supplies, pharmaceutical products, and vaccines need cold temperatures for storage throughout their lifecycle. Blood, transplant organs, medications, tissue samples, and several other medical products have extremely strict temperature-control regulations that must be prioritized to ensure their usability. Because the chemical makeup of different pharmaceutical products varies significantly, so do their relative storage requirements. When a medication is exposed to climates outside a specific temperature range, whether it be too high or too low, its chemical stability will likely be impacted. These drugs will degrade and form impurities that could pose potential health threats if administered to patients.

Changes to a drug’s physical properties such as variations in color or texture and presence of strong odor are obvious indicators of improper storage. In some cases, however, impurities are not visible to the human eye. If consumed or used, these products could range from being simply ineffective to incredibly dangerous to the consumer’s health. In addition to the physical harm it can cause patients, a breach in the cold chain can also cause economic harm to suppliers. The cost of disposing and replacing these pharmaceuticals can amount to tens of billions of dollars annually.

All these issues remain growing threats to cold chain logistics, as the number of cold chain products continues to grow exponentially, and the industry increasingly focuses on product quality and sensitivity.

Now that we are in the middle of a pandemic, the dangers of temperature deviations for pharmaceutical products also apply to COVID-19 test kits, related medical supplies, and vaccines. A COVID-19 test involves swabbing a patient’s nose and mouth, and transporting the swab in a kit to a predetermined testing lab. According to the Centers for Disease Control and Prevention’s (CDC) guidelines, these specimens must be refrigerated within a temperature range of 2–8 °C, then processed within 72 hours after collection. Some major commercial labs prefer specimens to be frozen at -20 °C during transportation. Refrigerated samples older than 72 hours and samples exposed to temperatures outside the required range may lead to faulty results and rejections. Temperature deviations can cause the virus to die in transit, potentially leading to false negative results if not detected and rejected. Patients may then unknowingly continue to spread the virus. Rejected samples require re-tests that take valuable time and may lead to the need for additional testing as a patient with false results infects more people, using valuable lab capacity and costing more money.

Vaccines are one of the most common cold chain products in the medical field. A vaccine’s potency is reduced every time it is exposed to an improper condition, including overexposure to heat, cold, or light at any point between manufacturing and administration. Once lost, potency cannot be restored. Regulations for different vaccines vary in much the same way as medications, but every vaccine is considered a cold chain product. In a world eclipsed by COVID-19, several biopharmaceutical companies across the globe are working tirelessly to pursue a vaccine to stop its spread, each of which are using different methods and technologies for a unique product. As such, there is no current universal temperature requirement for maintaining the vaccines’ stability.

An unbroken and properly functioning cold chain delivery system keeps temperature-sensitive pharmaceutical and medical products within the required ranges from their manufacturing stage to their point of use.

Medicines, vaccines, test kits, and other pharmaceutical products are made and packaged by the manufacturer before being transported in refrigerated vehicles or insulated containers to their destination, where they are then sold or administered. Depending on demand, capacity, and location, products may also be stored in refrigerated warehouses before or between shipments.

With numerous touchpoints and transportation methods to consider for each medicine, the stakes remain high for logistics providers tasked with safely transporting these products across the world.

The COVID-19 pandemic has disrupted the cold chain process for pharmaceuticals and medical products as related shutdowns have limited cold chain capacity while the demand for product delivery only continues to soar.

Additional pressure has been placed on carriers to meet delivery demands of COVID-19 test kits, vaccine trials, protective medical equipment, and prescriptions for at-risk individuals sheltering at home. Prioritizing these products means that other temperature-sensitive medications are subject to unexpected delays and subsequent temperature deviations. New laws and regulations from US and foreign jurisdictions have also impacted the development and transportation of COVID-19-related products.

Test kits and vaccine trials have their own unique set of standards regarding temperature during transportation, and many organizations that rely on these cold chains must now consider foreign regulations, geography, and accessibility in their effort to maintain control over the climate their products experience.

Despite all the complexities, cold chains demand integrity and accountability. Digital technologies like temperature loggers can play a major role in ensuring these demands and securing cold chains in the age of COVID-19 and beyond.

Temperature monitors are portable instruments designed to sense and record temperatures of the indoor and/or outdoor environments of cargo on the cold chain. Consisting of two main parts, the recording system picks up the temperature measured at preset intervals by the sensor and saves the measurements. This provides manufacturers, transporters, and recipients a comprehensive record, complete with time stamps, of the various conditions the products have been exposed to. Not only do these devices certify the safety and usability of the product, but they provide real-time visibility throughout the chain. Logistics operators are then able to pinpoint inconsistencies, proactively respond to disruptions, and reduce the likelihood of product damage.

Temperature loggers are available in several different models to address the various needs of users. For most in-transit purposes, temperature recorders have both a sensor and data recorder integrated into a compact and lightweight device. At the end of its journey, data is retrieved from these recorders and downloaded using a USB.

More advanced models allow the use of a wireless network to transmit the measurements. With this method, manufacturers, handlers, shippers, and recipients are alerted when a product is exposed to temperature conditions beyond a specific threshold.

Single-use temperature indicators are another option in the cold chain cycle. These strips are available at several temperature thresholds to alert users of exposure to unacceptable 

temperature conditions and the time duration during which the products remained outside their ideal range. These types of monitors can be used to ensure COVID-19 test kits remain frozen during shipment as well as storage to avoid false negatives and meet Centers for Disease Control and Prevention (CDC) shipping guidelines.

Altogether, there is a wide range of devices currently available to meet the evolving protection standards for cold chains and solve some of its greatest challenges. Without sensors, there is little-to-no comprehension of climate conditions once pharmaceuticals and medical products leave their labs or manufacturing facilities. Products can unknowingly be damaged by temperature variations and can put patients at risk. Implementing temperature-monitoring devices within the shipping and handling stages of the pharmaceutical and medical cold chain render them more transparent, reliable, and secure.

These cost-effective monitors are a necessary investment for managing the transportation and distribution of medicines, test kits, and vaccine trials during the pandemic, and will likely play a vital role in the discovery and subsequent administration of a COVID-19 vaccine for the global community.

Angela Kerr is vice president of product portfolio and program management at SpotSee 

The role of these tools amid evolving regulatory, geography, and accessibility considerations