The Pharmaceutical Cold Chain – Medicine for the masses
When it comes to temperature-controlled vaccines and drugs, getting the right medication to the relevant person isn’t straight forward. In 2014 it was estimated around 15% of temperature-sensitive pharmaceuticals were wasted. In 2019 an IQVIA Institute study found that the pharmaceutical industry loses around $35 billion annually for temperature-related issues. While this monetary loss may be significant, you can also not put a price on the danger posed by degraded pharmaceuticals and in-effective vaccination programs.
A study performed by cargosense came up with the folllwing numbers :-
- 25% of vaccines reaching their destination have degraded efficacy due to failures to maintain the cold-chain
- 30% of scrapped temperature sensitive pharmaceuticals can be put down to cold chain logistics issues
- 20% of all temperature sensitive pharmaceuticals are damaged or exposed to significant temperature excursions during transport
Whether you look at these numbers from a financial or a humanitarian point of view, they are unacceptable. The pharma industry and other stakeholders in the cold chain logistics and distribution need to invest heavily into systems that can prevent temperature excursions taking place. The fact that we have these statistics at all shows that some level of monitoring is in place, temperature data loggers and vaccine vial indicators for example. But they are retrospective, giving data that concludes the product is compromised. Surely a proactive system that leverages on modern technology and communications capabilities would be better.
Rather than the medical and pharma industry being able to identify when a temperature excursion has occurred, and removing those products from circulation, it would be far better to have live data and be able to take action before or as the excursion takes place. This can save millions of dollars in lost product but also save lives, ensuring the vaccines provide the protection they should and drugs are effective at treating the disease they were engineered for.
Cold Chain Challenges
The main challenge facing the maintenance of the cold chain is when shipping to less developed parts of the world, which tend to have less than reliable infrastructure, adherence to protocol and demanding climates.
The transportation route may take the product through the hot jungle, or cold mountain passes potentially exposing the pharmaceutical product to freezing or high temperatures. It is essential that prior planning about the best route to take be conducted, and measures are taken to protect and maintain the stability of the cold chain environment throughout. Some innovative ideas have sprung up, not least contracting the distribution to Coca Cola. The soft drinks company has the capacity to deliver cold beverages to innermost Africa, so why not vaccines?
Local bureaucracy is another factor. Unplanned delays and hold ups at airfields and ports due to customs clearance procedures can result in temperature excursions. A pallet left out on the airside tarmac can very quickly warm up. the Cargosense study states: “A pallet of unprotected product on an airport tarmac with an ambient temperature of ~70°F (21°C) can quickly reach temperatures above ~130°F (55°C). At that temperature, you can fry an egg in 20 minutes.” These instances happen more often than you may think. UPS, one of the worlds leading logistics companies estimates 9% of all electronic customs entries contain errors that result in delays.
End to End Visibility
The ability to track, monitor and log data on shipments or batches of pharmaceutical products is a growing need. Although there are new pharmaceuticals and vaccines that are less temperature sensitive, there is still a need for ambient temperature monitoring as there will always be limits to what temperatures pharmaceutical products can withstand.
There has been a growth in gene based, personalized medications which also travel through the cold-chain logistics channels. These require speedy shipping and strict temperature control compliance.
Growing concern and tighter controls concerning the traceability of pharmaceutical products are also expected to have an impact on the cold chain monitoring industry.
In order to comply with government regulations, reduce wastage and improve the quality of the end product, it is necessary for the cold chain logistics and pharmaceutical industry to invest in realtime monitoring technologies.
Alexander · May 21, 2021 at 12:27 pm
Couldn’t there be a way to design the vaccine to negate the reliance on such temperature sensitivity? That’d reduce the need of monitoring and refrigeration costs greatly. Just a different approach to diving the same problem…