Cold Chain Logistics’ Importance in the Healthcare Industry

Many classes of pharmaceuticals and medical items, as well as biologics and samples from clinical trials, are particularly sensitive to heat, humidity, and other factors. What can we do to stop the $35 billion in annual losses caused by mishandling?

Because of aging demographics in wealthy countries and rising wealth levels in emerging countries, the global pharmaceutical market is expected to increase to over $1 trillion by 2022. Biologics, such as those used in gene therapy, is likely to account for a growing percentage of this industry. Given these growing MHRA approved warehousing UK tendencies, losses are likely to increase unless preventative logistic methods to preserve commodities during shipment and storage are developed. Improving current supply chains to ensure a focus on exact temperature monitoring, cold chain monitoring, and data logging can help you maintain product integrity, save money, and deliver better therapies for patients.

The cost of cold-chain logistics for biopharmaceutical commodities alone was above $13 billion in 2017. Twenty percent to forty percent of the products covered in that estimate are damaged before they reach the end-user. The entire amount of pharmaceutical losses worldwide is enormous, given the steady expansion in global spending in the business.

The standard online pharmacy procedure

When a patient obtains medications from an online pharmacy, the following normally occurs:

1. They visit the doctor for a checkup and are given a prescription.
2. They use an internet pharmacy to fill the prescription.
3. They get the drug in the mail from a licensed pharmacy, and pharmacists are on hand to answer any questions they may have regarding the purchase.

The portion that end-customers don’t see is the entire supply chain process that occurs between filling and receiving the prescription: in order to deliver a pleasant customer experience, the online inventory must be managed (including being safeguarded and verified for safety requirements). As a result, anyone who runs an online pharmacy must be skilled at collaborating with suppliers and transporters. In addition, they should invest in data monitoring and reporting for their pharmaceutical supply.

The increased complexity of the healthcare industry is a problem

Pharmaceutical items are more sensitive to or vulnerable to a wider range of conditions than practically any other industry’s products. Many types of pharmaceuticals and medical items, including biologics, clinical trial samples, and many classes of medications and medical products, are particularly sensitive to heat, humidity, and even light. Many compounds, on the other hand, are sensitive to vibrations and shocks.

While these things can save lives, they are more difficult to research, create, transport, and store due to the need for each product to be as close to perfect as possible. No one wants potentially lethal side effects from their drug.

Different raw materials and final commodities may need to be stored at different temperatures to retain their effectiveness. Any change in temperature or improper handling of the goods could permanently ruin it. This could lead to ineffective immunizations, the need to discard medications and other temperature-sensitive products, and the loss of critical data from clinical trials. In addition to the financial loss, you may face reputational harm and regulatory action.

Is shipping-related damage really such a big deal? It is, without a doubt. Even if the number is insignificant, any item that does not arrive in one piece is an inefficiency. However, the number is not insignificant. It’s obvious that you’ll need a system that can adapt to changing healthcare challenges.

The actual quantity of damaged pharmaceutical goods is difficult to determine, according to an article published in the journal Pharmacy and Therapeutics. That’s because the true figure would include things that make it to the end user but aren’t as successful as they could be. The numbers are bound to change depending on who and how the estimate is made. However, some sources claim that the figure is at least 20%, if not greater.

From a financial and environmental basis, losing more than a fifth of any supply should not be tolerated. At that point, it’d definitely be better to just have 20% less business overall, because you’d save money on production, shipping, and storage.

Damage can be caused by a multitude of factors. Among them are the following:

• During the selection, packing, shipping, and receiving processes, packaging was dropped.
• Temperatures that are outside of the safe range. This doesn’t just apply to keeping medications cool. Some items must be kept at room temperature. Some items must be refrigerated. Others must be halted. And many people cannot be permitted to go into a coma.
• Light exposure, which can cause some items to decline.
• For humidity-sensitive items, incorrect humidity settings in the freight compartment.
• Shocks and vibrations that cause packages to tilt or tumble over during transit

Implement or improve cold chain logistics as a solution.

Implementing cold chain logistics may help ensure temperature monitoring and management at every step of the process, whether your medical products require constant room temperature or need to be cooled, frozen, or deep frozen. The management of a supply chain for commodities that must be kept at exact temperatures and/or humidity levels is referred to as cold chain logistics. This type of supply chain is significant in the healthcare area as well, with refrigerated vehicles and storage facilities for perishable commodities, as it has long been in the food industry.

Regulations governing the cold chain differ by area. In the European Union, for instance, all medication packaging must include a unique serial number and identify. Given the complex regulatory landscape – which includes guidelines from the EU Guide to Good Manufacturing Practice, the CDC Guidelines for Maintaining and Managing the Vaccine Cold Chain, and the US Code of Federal Regulations – it’s critical to double-check with your regulatory body to ensure your cold chain procedures are compliant.

The following are some of the different issues that the manufacturer, retailers, and sometimes even the end-customer must consider:

• Methods for storing and managing refrigerated and frozen vaccinations.
• Equipment like as storage units and thermometers are taken into account.
• Methods for preserving the cold chain.
• Storage and handling procedures that are followed on a regular basis.
• Inventory control and emergency preparations for safeguarding vaccine stocks (Source: VBI Vaccines).

The many guidelines established by these various authorities exist to ensure that pharmaceutical products are both safe and effective. Not adequately monitoring freight can put any pharmacy in serious danger. The World Health Organization and the European Commission have set tight guidelines for the shipping and storage of pharmaceuticals.

The significance of data logging

As the healthcare business develops, technological advancements will be needed to ensure that manufacturing and distribution can keep up with the cutting-edge nature of these products. Temperature monitoring and data logging in cold chain solutions offer enormous potential for protecting product integrity, minimizing waste, saving money, and improving health and safety.

Monitoring as part of the shipping process is the best approach to ensure that pharmacy freight arrives safely. Here’s why data tracking is critical for online pharmacy operations.

The following are crucial elements:

• Temperature, vibration, humidity, and other informatics are captured by data logging devices.
• Temperature monitoring and other readings are provided by devices positioned in manufacturing plants, storage rooms, transit vehicles, or with the product.
• Real-time data updates are provided by advanced devices with GPS and RFID capabilities.
• Light sensors are embedded in packages to ensure that the product has not been tampered with.
• All of the data from the data recorders is recorded and analyzed by software.
• Temperature-monitoring packaging that can actively regulate the temperature of the products as needed.

What role does data recording play in any of these issues? It’s straightforward. You can keep track of how often appropriate conditions are fulfilled and when they are not by monitoring the conditions under which pharmaceutical goods are transported. You can utilize that information to prevent future disasters and improve shipping conditions once you have it.

Many things become too harmful to use when they are ruined, in addition to really spoilt goods. As a result, even a suspicion that a product is unusable leads to its destruction, merely owing to the hazards posed by a lack of knowledge about whether or not it is safe to use.

Let’s pretend you have a better way of determining whether a certain element of your shipment is still viable. Simply raising the monitoring precision from one to two measuring points enhances the likelihood of determining only a fraction of the shipment is unsuitable. What if, on average, only half of the contents of your spoiled shipments are genuinely spoiled? The estimated 20% loss is immediately halved.

In a million-dollar-a-year shipping firm, that may mean saving up to $100,000 through a modest investment. The more exactly you can demonstrate that a product is useable, the less likely you are to lose it due to mishandling. Even a modest, obvious indicator of monitoring in place encourages careful package handling.

The following is how it works:

• One or more sensors that record data input are installed. Each sensor is tailored to capture specific types of data. They could, for example, record sound, temperature, light, humidity, and so on. These are normally battery-powered, but you can also use external power connectors to power them.
• The sensor device, sometimes known as a data logger, will include a microprocessor and memory to retain the data, which can then be sent to a computer or, more likely currently, to cloud software for immediate monitoring and use. With real-time monitoring, cloud computing has dramatically improved the online pharmacy procedure.
• Supply chain managers monitor reporting status and analyze acquired data in order to develop supply chain plans while taking each sensitivity into account.

Is monitoring, however, truly necessary?

Yes, as I’ve already established, monitoring your supply chain has immediate and tangible consequences. For starters, keep in mind that at least 20% of pharmaceutical freight is destroyed during shipping, according to estimates. Your organization will suffer genuine financial damages as a result of this.

This 20 percent damage could imply the following:

• Hundreds of millions of dollars in supplies has been lost.
• The company’s reputation is being harmed as a result of products coming to customers in poor shape.
• Consumers’ trust is eroding.
• Environmental damage caused by discarded items and trash.
• Legal ramifications.
Assurance of quality builds trust

As a result, reputation and end-customer trust are important considerations. A strong brand presence and a positive public impression are critical components of running a successful online pharmacy. Because the pharmaceutical company is in the business of assisting people in becoming healthier, it is critical that the medications arrive in perfect condition. The only way to ensure that you can guarantee the quality of your products is to be aware of every element of the supply chain.

When you use a suitable data logger to monitor what your products go through during shipping and storage, you can not only be confident in the validity of your goods, but you can also show the data to any authorities asking questions about your operations, and even to end-users if the logger is exceptionally efficient (Logmore and Finnish pharmacies are currently running a pilot project in which data loggers are attached to the product until it reaches the end-use). The credibility that your firm achieves through transparent processes is what ensures you new partners and customers – and a good reputation all around.

There are various types of data loggers available, however it’s better not to utilize standalone loggers that require data to be manually transferred to a computer for pharmaceutical shipment. That is inefficient and time-consuming. Instead, the ideal option is to use a wireless logger connected to a cloud service. It can give quick data uploads so that everyone who requires access to the data can see it right away.

To sum it up

Any cold chain-dependent operations, or any temperature-sensitive logistics in general, require effective data logging. While the cost may appear to be an additional expense at first, merely knowing which products can be used and which cannot can result in a significant increase in your bottom line simply because you can reduce the number of things you have to consider ruined due to uncertainty. On the other hand, having all of that information about how well your operations are performing allows you to enhance them even more while also increasing your transparency in the eyes of authorities, partners, and consumers.