The Cold Chain Sin of Assumption

Let’s pick up from where we left off with the sins of cold chain. It’s judgment day, and I, your very own modern-day Kenyan pharmaceutical Dante Alighieri, have consolidated the sins into 3: the sin of apathy, the sin of assumption, and the sin of Ignorance. In this article, I will start with the sin of assumption (and, of course, its offspring being the subject of the matter for today) that should cut deeper for the practitioners involved in handling medical cold chains. You are welcome to judge yourself more harshly if you are a medical professional. While practitioners can remedy Ignorance through research and training and apathy through motivation and maybe some environmental adjustments, assumptions speak to character and biases based on limited knowledge and often some level of impunity at the individual or organizational level. I will present the risks associated with some of the common assumptions and actionable options that could alleviate the situation.

Gut feeling over temperature monitoring—Let me be clear: temperature monitoring is the bare minimum risk mitigation strategy you can implement for a cold chain product at whatever stage of the distribution. Having reliable data ensures objective decision-making in the event of a system breakdown, which I can guarantee will occur at one time during storage or transportation. The type of temperature monitoring equipment and system is dependent primarily on the resources available, followed by a risk analysis which should consider the following:

• The need for reliable data that is not vulnerable to manipulation
• Stability of the product (s)
• The need for real-time data
• The opportunity for real-time intervention in the event of an excursion
• Available Human Resource capacity
• The scope of operations

Available options include:

• Digital thermometers are manually reset to indicate the minimum and maximum temperatures recorded during a specific period.
• Wireless systems are network-based and can transmit temperature readings from the probes to a cloud system accessible to users via mobile devices and computers.
• Data loggers are portable electronic devices capable of recording temperatures over a defined period. Their specifications vary with different manufacturers and are often dependent on available internal storage capacity and battery life.

They are stable; a little heat won’t hurt – Pharmaceutical product approval is based on the manufacturer’s ability to establish the product’s stability over normal and extreme conditions over a defined period to inform the shelf life. In the case of cold chain items, extreme conditions include elevated ambient room temperatures and even higher temperatures. While many cold chain products can withstand such conditions without adverse effects on their quality, some are invariably sensitive, and a slight deviation will render them ineffective and possibly harmful. Therefore, extrapolating the universal reliance on stability studies could lead to preventable damage to cold chain products. Additionally, while most vaccines routinely come labeled with the vaccine vial monitor that instantly informs you whether the quality has been compromised or not, many other cold chain products do not. Cumulative exposure to out-of-limit temperatures over time leads to quality deterioration. From a risk perspective, it is likely that this exposure would happen at the last mile stage to the patient. It’s, therefore, crucial for professionals at the distributor level to safeguard the integrity of the cold chain items to the greatest extent possible. So please shut out that little voice telling you otherwise and put that one single tiny ampoule of a cold chain item in a cold box like the little boss it is.

How hard can this be? More often than not, a professional is in charge of the process and decides to let personnel handle cold chain consignment without proper procedures and training, assuming they will figure it out. To be fair to the professionals, an organization may need more systems for defining procedures and training personnel. At the individual level, though, the professionals may deem training unnecessary or lack the knowledge and skills; in this case, they still have a professional responsibility to identify this as a risk and seek technical support. Have you ever heard of the phrase Ignorance is no defense? It’s talking about you if lack of knowledge was your crutch.

If your organization is struggling with the lack of a cold chain system, below is a starting point for you:

• Establish a list of the cold chain products in scope and the risk associated with each, then create a system to safeguard the item with the most stringent requirements.
• Define clear and concise procedures and instructions based on national and international standards and best industry practices, or talk to an expert like yours here, J. The takeaway here is to make the documents and infographics so clear that do not leave any aspect open to interpretation, e.g., how many ice packs to use in the cold box.
• Define the equipment and inputs, such as refrigerators, cold rooms, freezers, cold boxes, and, must I remind you, a temperature monitoring system. I may write something about cold storage equipment later.

The assumption is that the people supplying you with cold chain products must know what they are doing. Maybe I am being a little too harsh with this one. After all, there are all these big pharma distributors with well-renowned professionals that we look up to. But my point is that you need a system to verify that the quality standards you aspire to for your cold chain items are in place at your source distributor.

What do you have to lose by asking to verify the cold chain preparation process? If you need more confidence about what to look for, you could do some research or, you guessed it, call an expert!You may realize that you know much more than you are giving yourself credit for, and your questions and insights could have a huge positive impact on that supply chain process. A good start would be to incorporate a system for cold chain supplier evaluation, whether in-house or outsourced, into the procurement policy as a mandatory requirement.

That’s it for now; we shall crucify the ignorant and the apathetic in the coming posts!