If we are going to say we are 'patient first' as an industry, we must take a look at the pharmaceutical cold chain from a patient’s perspective.
The fact is that one in six adults over 45 and one in four over 75 have vision issues. Many struggle to read important safety instructions, such as storage temperature, on drug vials and boxes due to small print. Unless these patients have reading glasses or a zoom-capable camera, this vital task can become unnecessarily challenging.
Even comprehending instructions such as “do not freeze” or “keep below 86°F” can be hard to discern and confusing. For example, it can often be unclear how to determine if the medication has been exposed to freezing or excessive heat, highlighting a significant gap in temperature monitoring for medicines. Another concerning issue is the misconception of a ‘stability budget,’ where some believe medicines remain effective despite temperature deviations. However, critical details about this tolerance typically aren't disclosed, posing a risk for those who make the assumption that the excursion is ok.
Furthermore, if you call an insulin manufacturer’s helpline and ask if using insulin above 86°F — even briefly for 15 minutes — is safe, they’ll almost certainly give a clear answer to avoid using it and dispose of the compromised medication. The reason for this answer is patient safety and liability. Pharma manufacturers know that diabetics unknowingly using compromised medicine, there can be severe, even fatal, consequences. If that is the answer of the manufacturer, then it is concerning that we turn a blind eye patient level excursions in the rest of the supply chain, relying on the myth of the concealed stability budget instead.
During a recent discussion with pharma manufacturers, a prominent concern highlighted the crucial gap in temperature monitoring as medicines reach patients, emphasizing the growing importance of strict temperature control, especially with the rise of tailored and temperature sensitive medicines.
However, the substantial investments made in temperature control, logistics infrastructure and regulations fall short of effectiveness if patients or administrators aren’t aware of temperature requirements and excursions. It’s essential to examine where the industry stands in regulating medicines and the improvement areas from the dispenser to the patient level, ensuring a safer and more reliable pharmaceutical supply chain for patients.
Regulators are getting closer to the patient, but aren’t there yet
Regulations are essential to keeping medicines safe and effective. The Drug Supply Chain Security Act (DSCSA), the EU Medical Directive, and 40 other global regulations help ensure medicines stay safe throughout their journey. They bring pharma companies, wholesalers and dispensers closer, using simple methods like the incorporation of 2D barcodes that help provide important, standardized, information about the medicine and where it has been.
The FDA recently made its rules clearer regarding medicines that should not be used due to various reasons. The new guidelines have gone beyond counterfeit and adultered pharmaceuticals to now include pharmaceuticals that have been exposed to 'temperature excursions' at a saleable unit level which can harm patients and impact efficacy. What this means is if a medicine needs to be stored at a specific temperature and it’s not, those handling the medicine must make sure it’s still safe to use, particularly at the saleable unit level. This is a significant step toward keeping patients safe from temperature-related issues, but drives significant changes in the methods of how pharmaceuticals in the cold chain are monitored today.
The DSCSA and similar rules mainly focus on tracking and tracing the pharmaceutical journey from manufacturer to dispenser, which includes a standardized method to communicate excursions. However, stopping at the dispenser level overlooks the crucial aspect of ensuring safe delivery from the dispenser to the patient. Currently, patients and those managing the pharma supply chain are often unaware of whether the medicine was exposed to unfavorable temperatures, exposing a big gap in protecting patients from harm, and the reason for saleable unit level monitoring.
Closing the temperature monitoring gap
Despite improvements in monitoring cold chain conditions, challenges persist in ensuring smooth sharing of information from manufacturer to patient. Many monitoring systems require specific apps, platforms, readers, subscriptions and passwords, each with its own way of organizing data, making it difficult to integrate seamlessly across the supply chain. Not to mention the difficulty that older populations have with adopting these new technologies.
Today’s monitoring efforts predominantly focus on pallets or shipments due to the high costs associated with equipping individual products with specialized devices. Common methods involve using cellular or Bluetooth temperature trackers, but their effectiveness is hindered by inconsistent network coverage across different regions as well as interoperable reading (i.e. everyone needs to download an app). Moreover, heavy reliance on ‘validated packaging’ becomes inadequate once the bulk packaging is opened, leaving gaps in monitoring from the dispenser to the patient. In short, a validated package does not indicate if an excursion occurred.
Identifying a temperature excursion at the point of consumption is essential for regulatory compliance, emphasizing the importance of a holistic strategy that integrates validated packaging and dependable temperature monitoring methods. Affordable temperature indicators, accurate within ±1 degree Celsius, play a critical role in this approach. Displayed as, or complimentary to 2D or QR codes, these indicators can significantly improve usability and seamless integration throughout the pharma supply chain, ultimately placing patient safety and product quality at the forefront and closing the temperature monitoring gap from pallet to patient.
The key to patient monitoring is in our pockets
Pharma manufacturers agree that the ultimate goal in temperature monitoring is to directly receive compliance information from patients or administrators, serving as the Holy Grail of quality assurance and patient safety. This confirmation is pivotal as it signifies that the pharmaceuticals were preserved and utilized as intended after enduring the challenges of extensive transportation involving planes, trains, automobiles and refrigeration. However, the obstacle lies in establishing a simple, user friendly, communication channel to obtain this critical compliance information.
Currently, communication operates primarily in a one-way direction, with manufacturers providing instructions on the packaging and hoping that all stakeholders in the supply chain – especially the patients – read, comprehend and adhere to these instructions. The development of products and services that enable confirmation of adherence to these instructions is becoming increasingly vital, as it ensures a safer and more accountable pharmaceutical supply chain, ultimately enhancing patient well-being.
In recent years, advancing technologies have remarkably expanded our potential, promising a wealth of possibilities. With over 90% of the global population now having a mobile phone, patients can now wield the power of their mobile phones to detect potential harmful temperature incidents in specific pharmaceuticals, and seamlessly share that information back through the supply chain. This convenient access to vital information and the seamless sharing of insights across the supply chain represent a significant milestone. With this valuable data at their fingertips, pharma companies can enrich their understanding of temperature control at a patient level, enabling them to design supply chains and define partners that are dedicated to enhancing patient well-being globally.
Until now, the last mile of pharmaceutical temperature monitoring has been the longest and hardest to achieve. Now, with the simple use of our mobile phones and temperature indicating technologies, we can close the gap, ensuring pharmaceutical efficacy and patient safety.
