Overcoming Obstacles in Cold Chain Distribution and Monitoring Systems

Cold Chains in the spotlight

A race for a COVID19 vaccine is being run to determine who will make a vaccine available soonest. This where the cold chain delivery and monitoring systems will be most carefully watched. As soon as an effective vaccine is announced, following testing, there will be a race to see who among logistics providers can distribute the vaccine quickly and safely.

Logistics related to transportation, infrastructure, and other factors are essentials for the meticulous planning and execution of the cold chain delivery system. All these are needed to guarantee that the products are carefully stored and maintained at the correct temperature. Temperature variations cannot be allowed during the transportation and distribution process as the medical purity of the vaccine is at risk.

There are other events that might compromise the integrity of biological products. Natural disasters such as earthquakes, flooding, hurricanes, and tsunamis can cause temperature variations in the cold chain which may destroy the safety of the medical products.

There will always risks associated with distribution once the products leave the manufacturing felicities, but, with an efficient cold chain and monitoring system that can make real-time decisions, we can reduce the probability of destruction of the biologicals.

The risks are high for brand integrity, customer confidence, patients’ lives, and market share if the Cold Chain system should fail.

Emerging technologies make new opportunities

Every day technology is changing. Technology is always making our lives a little easier. The same applies to the cold chain system. Each link in the chain needs to work together to keep medical products safe. Innovative technologies will include sensors, RFID, wireless and wired networks are all effective links in a Future Forward model that will ensure real-time recording of each product throughout its lifecycle. Information tracking of the status of products in the distribution system is imperative for providing data on which to make decisions for required responsive actions should issues arise in any link in the cold chain.

For Cold Chain management to be a success, you need a combination of enhanced Policy, Process, Performance, and Enablers. The first companies to innovate this technology were in the Food industry. They knew what it took to create a Cold Chain infrastructure that could prepare for the standards of Cold Chain distribution.

Frontliners for the cold chain

Heeding the pleas of millions of affected people, vaccinators and volunteers transport their precious cargo across affected areas. On their backs are coolers filled with polio vaccine. Every mode of transport, from boats, helicopters, by motorcycle and bicycle, on horseback, and even on foot, is utilized to get the vaccines to those in need.

Their common goal is to reach and immunize every child at risk. They are the front liners of the Cold Chain – doing their best to deliver lifesaving drugs and vaccines across global borders.

If vaccines were somehow compromised during transit before they reach the patient, all their efforts would be rendered useless. Unlike in food deliveries, damage to the products are not visible. Chemical changes in medical products can occur inside the vaccines. The changes can make the vaccine useless or, even worse, toxic to the patients.

Understanding the Cold Chain

What is a cold chain?

Cold Chain is a set of actions in the supply chain that starts with the production, and includes storage and distribution of products in which temperature control is essential to preserve medical product efficacy and value.

The term Cold Chain originated from ”the chain of custody” in the production, packaging, distribution, and control of temperature-sensitive products. The supply chain includes raw material acquisition, transformation and manufacturing process, packaging and product protection, storage, and distribution. These are all part of the cold chain.

The Cold Chain is technologies and processes for the storage and distribution of products that must be kept stable in the prescribed temperature and handling settings that are labeled on all product packaging and documentation.

There are many versions when it comes to “Cold Chain” compliance. Thus, it is a must that each specific product characteristic is clearly stated. Further caution is that most of the world uses Celsius in their temperature settings, except the United States, which uses the Fahrenheit scale. The implications of ignoring this are critical, as storing something at 30 degrees Fahrenheit would destroy the product.

The need for real-time monitoring of the cold chain

Complex cold chain operations require qualified experts who understand the systems, in order for the supply chain to be successful. They are the ones who have the expertise to react to any situations that might require their attention.

The difference between the monitoring and control of products in the Cold Chain is the need to record the “state” of the product as it transits through the process. Monitoring keeps up to date status records of each step in the storage and handling of the products during the supply delivery process. Monitors track the movement of the product to ensure handlers followed prescribed procedures. Control consists of active management of the technology, software and personnel that maintain the temperature and physical safety of the products.

Monitoring and control collaborate to augment the basic safety functions of supply chain management – item-level visibility – both in-transit and at rest. Modern technologies in tracking and assessment of the condition of the products monitor in real-time, throughout the different trans-shipment and interchange points.

These enhancements help inventory management and control, but there is still a need to include systems that transmit notices of deviations in temperature. These systems send alarms to managers so problem situations can be quickly addressed. This is where sensor technologies are applied.

Technology Alert system in Cold Chain

Technology has made it possible to give real-time reports on the conditions of the products in the cold chain. Here are some of the devices is used for the monitoring of pharmaceutical products.

Sensors

These devices monitor temperatures to ensure that they are maintained at the proper settings. The sensors are placed in key areas where the temperature and humidity fluctuations may occur. A good example of this is when a certain temperature is reached, the color of the label will change, thus indicating that the temperature may be outside of recommended parameters and warning that the product may have been compromised.

These devices can be attached during transit and in storage while awaiting transfer, thus ensuring the preservation of the efficacy of the products.

Transportation

The modes of transportation, storage, and logistics providers are getting more complex as the demand for these medical products increases. The requirement of specialized equipment and operations designed to optimize the temperature conditions is being aided by modern monitoring technology. Today, more reefers and medical refrigerators with back-up power are put into use in the cold chain delivery supply system.

Warehousing

Medical products require specialized warehouse management systems and technologies especially designed and developed to meet the challenges of temperature control.

Well-designed temperature control warehouses are not cheap. The storage of medical products must specify where and how they should be placed. They must be monitored continuously for the correct temperature to ensure the space they occupy is not prone to fluctuations, and there is adequate air circulation.

The higher the product value, the higher the stakes

Cold Chain’s role in the distribution of vaccines is more important than ever before due to the Covid-19 pandemic. Once a vaccine is produced and manufactured, producers will need more cold chain providers to distribute these to the whole world.  

This is due to the fact that many of these products are relatively unstable. These vaccines have biological and other components that become inactive or contaminated if not handled correctly. They have to be maintained at the correct temperature, which can be difficult to achieve, when transporting or administering them to humans in remote locations. The careful handling of these products is paramount, especially since some of these vaccines are in short supply.

Temperature parameters: Too much freezing can be as bad as too much heat

Maintaining the correct temperature cannot be over-emphasized, especially while vaccines are in transit. Any deviations, whether too hot, or too cold, can have disastrous effects on the products.

For example, if temperatures are too low: A shipment of vaccine was delivered for an immunization session at a school in the UK, and was placed in an insulated container with an ice pack. The pack came into contact with the vaccine, thereby freezing the contents and destroying them.

During a review board hearing it was revealed that records were not kept up to date from the origin point, to the arrival point in the UK, and there was no way to determine if the correct temperature was maintained during transit.

The manufacturer did not have the specifications of the cooling package prior to transit. In this case, the pharmaceutical wholesaler in charge of the distribution of the product was sanctioned by revoking its license to distribute, and a product recall was issued for failing to maintain adequate temperature-controlled conditions for Cold Chain product.

Products that are prone to freezing

• Vaccines, insulins, biotech products, blood products

• Products that are physically unstable – for example, some emulsion systems

Products at risk from elevated temperatures

• Vaccines, insulins, biotech products, blood products

• Products that are physically unstable

• Products that are chemically unstable at elevated temperatures – e.g., chloramphenicol eye drops

• Some semi-solid products – for example, fatty-based suppositories

The cold chain’s weakest link; underestimating the “Last Mile”

These medical products are essentially the lifeblood of the healthcare industry and have a very long manufacturing cycle. It takes years for vaccines to undergo processes from the initial discovery process to controlled clinical trials, to final Federal Drug Administration (FDA) approval. It takes considerable resources and billions of dollars before a new drug reaches the final stage.

In addition, it may only be possible to produce a limited number of batches per year, especially with some active ingredients that can only be sourced from a single place or entity. With that in mind, medical shipments should not be endangered during the last mile of delivery due to careless handling.

 The “last mile” is the final delivery point of consumption, such as a hospital, a health center, or home. Challenges still exist, as once products are in the possession of the user, the environment where they are stored may not be conducive to the prescribed settings.

Most pharmacies required to provide a product leaflet for every prescription, but they are seldom read by patients. When possible, doctors prefer to have a counseling session with the patient to ensure proper product use, storage and handling.

One such product known for its instability is insulin. The storage and handling of this product are important as potency can be destroyed by temperature fluctuations, shaking, or other poor handling. One of the most common problems can be traced to home delivery by expedited carriers and mail services. Some of the handlers do not know the safety protocols in delivering medicine. Once the damage is done, the medicine becomes ineffective and can be a real danger to the patients, especially children.

Complying with regulations

It is important that logistics providers are compliant with all government regulations pertaining to the cold chain process. In general, these are:

·         Documentation and Communication

Shipping tracking data must be sent to all parties, accessible through a shared network. Documentation ensures that the correct packaging, storage, and handling procedures are done correctly. This should be according to manufacturing specifications, and all written details must be written understood by the parties involved in the transit of the medical products.

·         Labeling

Protocols must be clearly written on the labels to show temperature, humidity, and other restrictions that apply. It is advisable to use color codes that should identify temperature-sensitive items. In case of a language barrier, using RFID sensors to monitor which of the products need special attention can reduce human error.

·         Training and Auditing

Now that the drug manufacturing is outsourced globally, there is a need to train healthcare givers in the proper storage and handling of sensitive products. Sales forces working with the pharmaceutical companies are the primary educators, visiting doctors, hospitals, and health care providers to teach them product prescription and control.

Wholesalers need to be familiar with the process of the cold chain delivery. They are the distributors of the products and must be vigilant for any excursions threatening the effectiveness of the products.

Even if stringent records are kept for certain drugs, in many cases the audits and controls are lax for Cold Chain products. Correcting these weak links are a potential area of opportunity for wholesalers and providers.

·         Remedy and Reward

It is imperative that all the players in the extended Cold Chain are qualified on procedures if a situation arises. For example, what indicators should be monitored and what must be done if a product is compromised? There should be responsive actions clearly outlined between all players in this critical supply chain. There should also be an incentive program for the providers, making them aware of the financial loss if poor housekeeping and material handling practices are not followed.

Government regulatory agencies: keepers of the cold chain compliance

Here are the different regulatory agencies, together with their areas of regulations and jurisdiction below:

• US Pharmacopoeia (USA): in charge of recommendations for the manufacturing, packaging, and distribution of pharmaceutical products. Once approved, these create a framework for FDA validation.

• Food and Drug Administration – FDA (USA): in charge of validating compliance and control across the Cold Chain.

• Medical & Healthcare Products Regulatory Agency – MHRA (Europe): Formerly Medicine Controls Agency. In charge of monitoring and enforcing cold chain regulations in Europe.

• The World Health Organization – WHO (Global): it is the foremost authority when it comes to defining packaging, storage, and handling requirements for Cold Chain products. In addition, within the pharmaceutical company, it must ensure that key personnel are kept up to date with changes to storage and handling requirements at the item level. This also applies to outside providers as well, especially in global distribution.

Conclusion

The effect of Globalization and the fast-paced evolution of new technology in medicines have exposed many variables in the continuing fight against old and new diseases, especially with the current pandemic. The pressure to quickly develop a vaccine against the Covid-19 threat has been unprecedented. It challenges now cold chain providers to be prepared to deliver this vaccine to a world desperate for it, as soon as it is ready. This effort will take the combined forces of both world governments and the private sector. It shows how easily a virus can spread all over the world and the need for a properly maintained cold chain delivery system for the vaccine.

Events such as the Covid-19 pandemic emphasize the need to take precautions, as well as to protect corporate brand reputations from the mishandling of the cold chain system. Investing in improved processes and technology will not only provide multiple benefits across the chain of custody but also better lives for everyone.

The key is to a better cold chain system is to share information about:

• Policy – key issues and philosophies

• Process – the interaction of the links in the chain

• Performance – service level agreements – metrics and controls

• Enablers – RFID, Tags, sensors, networks, packaging, and storage technologies

Knowing how global economic growth is tied to enhanced quality of life can improve the healthcare systems of nations. From birth to death, pharmaceuticals and their products are lifelines that bind us together. Let’s not underestimate how each link of the Cold Chain enhances them by keeping vigilant and upgrading them with better technology.