The Root Cause of Cold Chain Gaps and Their Solutions

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Cold Chain

Despite the advent of new and improved vaccines, there are challenges in the cold chain that hamper the distribution of these life-saving products. Addressing the root cause of gaps in the cold chain is crucial. Cold chain systems are struggling to ensure the viability, availability, safety, and potency of vaccines, especially with the advent of mRNA based vaccines, such as the Pfizer and Moderna COVID-19 vaccines. These must be kept at ultra-low temperatures, down to -90°C.

covid-19 vaccine distribution challenges to avoid cold chain gaps
COVID-19 vaccines from Pfizer and Moderna are mRNA based and require ultra-low cold chain during transport and storage.

The Clinton Health Access Initiative, Inc. (CHAI) has worked with ten countries — Ethiopia, Nigeria, Kenya, Malawi, Tanzania, Uganda, Cameroon, Mozambique, Lesotho, and India— helping them improve their immunization programs.

Since 2010, CHAI has been identifying the root causes and solutions of the common issues challenging cold chain management. Here are some of their biggest challenges and the solutions that the organization and countries have come up with in their long years of collaboration.

Cold Chain Challenges and Their Solutions

Insufficient Cold Chain Capacity

The introduction of new vaccines is the major driver for the expansion of capacity. This is followed by other factors like routine immunization needs, campaigns, and population growth. All these contribute to a steady rise in demand for increased and more efficient cold chain capacity.

increase and forecast for US cold chain
the US cold chain market is increasing, as it is in many other countries. However, not all can keep pace with the requirements, especially for the COVID-19 vaccine

However, in some countries, when the demand for larger capacity is not matched with improved infrastructure, it will drag down the efficiency of the production, manufacturing, and distribution of vaccines.

The most noticeable effect of this phenomenon is the delay in vaccine delivery. This affects patients the foremost. Their health and fate depend on the drug. Another problem resulting from less capacity is the mishandling of too many vaccines. When there’s a bigger demand for vaccines but fewer people and machinery to handle them, temperature excursions are more likely to happen. Excursions or temperature deviating from the acceptable range weaken the potency of vaccines rendering them ineffective.

Lastly, when this lack of capacity is not managed well over long periods of time, vaccine prices tend to soar. That’s because managing insufficient capacity amplifies delivery challenges. When higher levels of the supply chain increase delivery frequency, space is created, but delivery costs increase.

Why Is There a Lack of Capacity?

A lack of cold chain capacity is often a result of poor visibility, forecasting, and implementation. Poorly visible settings lack investments in real-time data technologies capable of reading, interpreting, and predicting the current status of their industry

Apart from technologies, most inventories are not equipped with a system for routine data collection. It helps accountability systems to generate accurate inventory updates.

Another leading cause of insufficient capacity is the neglect of an efficient forecasting system. Anticipating future needs is vital as lead times, or the time it takes to procure and reinstall equipment, usually spans a year or two. So, knowing the data beforehand enables the management to have a solid and detailed plan of the capacity. That includes the cost and number of vaccines, people, equipment, etc.

The last contributor to insufficient capacity is the non-existence of efficient implementation systems. It’s one thing to measure real-time data and predict outcomes, and it’s another thing to implement the information in the business process. This lack of implementation is a product of many factors. Chief among them is inadequate financing. When the budget is constricted, purchasing equipment and stocks will often lead to insufficient capacity not catering enough for the market.

Solutions

CHAI was able to see through the problem with three solutions and recommendations. None of these would be easy, but if the management tackles them slowly one by one, the result will deliberately improve.

One of these solutions is identifying the gap within the system. This is after recognizing there’s a problem. This next part is identifying the problem that needs to be solved. To achieve this step, it’s best to know the data on the available equipment, its status, type, and age. The next is to have information on the site: target population, power availability, weather conditions, and a lot more.

This has to be done regularly. Regular visibility is a product of structural reporting, accountability, responsible data reporting, and the updated collection and analysis of the past, present, and future capacity needs.

After carefully identifying the gaps, it’s time to devise a resource mobilization plan to implement actions. Financing is critical. There are lots of organizations tasked to help other countries struggling in this aspect. Examples are Gavi’s Health Systems Immunization Strengthening (HSIS) and the Cold Chain Equipment Optimization Platform (CCEOP) grants.

But to meet the demands of the immunization drive, the government must fund it internally. That means the costs must be included within the nation’s budget. Of course, this entails implementation planning where it secures the availability of resources at the time they are needed.

The last stage is the monitoring of implementation. Implementing gap solutions is not enough. There should be a constant lookout for the actions taken. This step is a central element of national and sub-national logistics. When there’s a regular assessment of equipment procurement and installation,  more room is given to corrective action to keep operations within the timelines.

Unsafe Technology and Outdated Equipment

old refrigerators and cold chain equipment

Most of the time, the reason that a cold chain is prone to failure is due to the use of outdated and near-breakdown equipment. They pose a higher risk to the products and the cold chain as a whole as tend to underperform in temperature maintenance.

Temperature failure due to outdated devices can be costly. In Ethiopia, for instance, poor temperature control can lead to vaccine wastage that costs eight million dollars a year.

CHAI’s experience with this problem led them to hypothesize the characteristics of cold chain problems with underdeveloped equipment. In their constant partnership with ten countries, they found that between 15 and 50 percent of the equipment used is older than the recommended 10-year lifespan. 

Another thing they noticed is that immunization programs of countries use domestic fridges. The reason it being cheaper than what’s recommended. They are also widely available, hence, easily purchased anywhere. But despite these pros, domestic fridges cannot maintain optimal temperatures for vaccines and other cool cargo. Still, some countries depend on this cold chain equipment (CCE) for their needs.

An absorption-type fridge is also one unrecommended yet widely used product. They account for 60 to 80% of some countries’ CCE. Like domestic fridges, absorption-type ones provide an unstable cold temperature. Moreover, limited production, procuring, and funding of fuel can disrupt their optimal operations.

Why is There Less Safe and Updated Equipment?

According to CHAI, there are three reasons why some companies are still operating on a set of outdated technologies. First, it has something to do with how they perceive new and old. Most of the time, it’s the lack of awareness of the existence of newer designs and their benefits that some programs remain stuck. They are also not aware of the risk associated with old equipment. Hence, they tend to play by the sides and not invest in better and more efficient devices.

The second and third reason is the cost of switching to newer models and their expenses. Expenses will always play a vital role in the challenges of the cold chain. Some people have concerns about the performance and reliability of new equipment. Because they are new in the market, they are somehow less efficient and needed to be tested more. Without some type of evidence disseminated to the market, immunization programs are more hesitant to shift away from a model that does not work well.

Newer models are expensive but they are more efficient. This means that the price per energy use is getting lesser than using their older counterparts. And because better manufacturers are emerging, newer technologies are getting more advanced, in short, more cost-competitive.

The problem here is the additional prices tend to discourage buyers from purchasing new equipment without even looking at several benefits of industry-standard technologies.

Solutions

In-country piloting can help spread awareness on the benefits of updated products. It helps countries gather their evidence regarding the performance, cost-effectiveness, and usability of equipment.

If the government sees the benefits first-hand on a smaller scale, they can level it up to a wider scale, hence, improving the overall cold chain efficiency of the country. Piloting can help minimize the risk of using newer models on a wide-scale, while also leveraging the advantages that it has to offer that might be missed when not considered.

The ability to use the tools for their own sake can be a good solution. Using the technology first hand might provide necessary information on the best guide equipment selection. This ensures that the government gets the best value over the lifetime of the equipment (including costs of maintenance, repair, and energy). For example, in Uganda, they benefited more from solar direct drive refrigerators in electricity-poor settings than absorption equipment. They had saved 3.45 million dollars in energy costs for five years.

To further improve the products, buyers must be in constant communication with the suppliers. Buyers can provide helpful insights on how to improve the products. Through time, countries can benefit more from the increased efficiency. Rather than relying on the developing capability of the manufacturers, country-buyers are like product-testers and their experience could lead to major improvements.

Inadequate Temperature Control and Maintenance

Maintaining the required temperature range remains to be a struggle in the cold chain. According to CHAI, 17 to 33% of the cold chain equipment in four countries they surveyed are found to be inactive at the time of the assessment.

Their monitoring studies found that some of the working equipment is not functioning properly enough to maintain a stable cold life for the vaccines. Between 10 and 46% of cold chain equipment is estimated to be unstable and is exposing vaccines to freezing risk.

Repairing equipment is half the problem. It takes two months to two years to fix equipment back at its optimal level. But the biggest problem is that temperature maintenance is getting less accurate. This means temperature excursions are getting harder to be detected mainly due to fewer TMC devices or inefficient equipment.

For instance, CHAI studied several countries and found that 9 to 20% of the equipment in the facilities maintain super-low temperatures, lower than zero for 24 hours. And between 12 and 13% of these equipment studied were found to have temperatures above the recommended 8°C for longer than five days.

Why Is There No Efficient and Temperature Control and Maintenance Systems?

While it’s easier to detect equipment breakdowns, temperature excursions are a lot harder to measure without accurate monitoring devices. And this is where some programs fall short. They don’t have a monitoring system in place. And if they have, most of it is not specific to determine cumulative temperature exposures. An example is the use of stem thermometers. They are inept measuring devices that cannot detect freeze or hot exposures.

Another problem is that most CTMDs expire after three years. Beyond that, they won’t work well. The bad thing is that some managers don’t notice it and continue using these devices in hope of serving them well, which unfortunately won’t happen.

And even if there are available and functioning CTMDs, some gaps are attributed to the action it takes to correct an alert sent by the devices. While awareness of the functionality of different technologies is vital, post-action is as much important. Meaning the alarms the devices give off should be tied to skilled personnel.

That is where the problem kicks in as some technician cohorts are underskilled and understaffed. There are also small resources for the replacement and hiring of understaffed and underskilled workers.

The implementation of automated monitoring, cloud-based IoT technologies and sensors can elevate some of the above issues. Solutions such as these are provided by AKCP and Pharma-Mon.

Solutions

One big step for some underperforming countries is the introduction of better technologies and devices. For instance, the use of controlled temperature monitoring devices can give that extra kick to propel the program to greater heights. These types of technologies can provide visibility about the fridge performance, including the temperature range of the cool cargo. This can help give information on the skilled staff to take corrective and substantive actions. To maintain this improvement for a long time, the purchase of CTMDs should be part of the budget planning process.

Personnel that is tasked to handle the vaccines should be more competent enough to deal with temperature excursions. That means they should know how to handle the equipment, and to interpret the data it gathers so this can be followed with the appropriate actions. This will minimize further unhealthy exposures and reduce wastages.

Lastly, programs must ensure the availability of spare parts. Technicians work best when they have all the parts at their disposal. That can reduce the time and effort it takes to fix the items therefore helping close the cold chain gaps easily in terms of temperature excursions.

Conclusion

Most cold chain gaps are seemingly insurmountable. They have been plaguing a good supply chain for decades. And they account for a huge amount of product loss and financial repercussions. Although they might not be eradicated, they can still be improved. This has been proven by many other successful countries in their immunization programs. Some of the solutions presented here are not exhaustive. They are mere suggestions and their application will still depend on the unique situation of a country.


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