Maintaining vaccines in a temperature-controlled supply chain, or cold chain, from clinical development to commercial distribution is one of the biggest barriers to vaccine efficacy. In remote areas this critical issue is heightened by the lack of sufficient ICT infrastructure and reliable sources of power necessary for fridges to adequately store vaccines.
Beyond Wireless Founder and CEO, Ian Lester, explains how his Johannesburg-based company has locally developed a high-impact, user-friendly eHealth solution to address the global challenge of monitoring the vaccine cold chain, helping to prevent millions of deaths in developing countries.
According to the International Vaccine Access Center (IVAC), rolling out childhood immunisations against Hib, pneumococcal and rotavirus diseases in the world’s 73 poorest countries over the next decade will result in an estimated $63 billion in treatment and productivity savings and avert 3.7 million deaths. The challenge, however, is that these countries are often ill equipped to transport, store and distribute vaccines.
Governments around the world are focusing on legislation that aligns their pharmaceutical industries with international best practice, which includes requiring constant temperature monitoring of vaccines at every leg of the cold chain, which must be stored between 2 and 8˚C. Temperature excursions outside of this band can reduce and even destroy the effectiveness of vaccines.
However, even though global best practice suggests automatic temperature monitoring of vaccine and other temperature-sensitive drugs as the best option for maintaining the cold chain, many countries in the developing world still lag behind in this regard. In February 2015 a new legislation was promulgated in South Africa that required anybody who stores, distributes or sells vaccines to have a World Health Organisation Performance Quality and Safety (WHO-PQS) certified monitoring device on their refrigerators to maintain and manage the quality of those products, yet the majority of people and organisations along the cold chain are still not compliant. This could be due to ambiguity and lack of clear guidelines, but in reality most people just do the bare minimum of what’s required due to a catch-me-if-you-can approach to compliance.
A local solution for a global problem
In the early 2000s while working as a Manager at MTN I witnessed the potential that cell phone networks could have in addressing some of these big social issues affecting South Africa, and other such developing regions. As a result I left MTN and founded Beyond Wireless in 2003, an Internet of Things (IoT) company, with the vision of building the capability to remotely monitor assets of any description, from air quality monitoring in the mining industry to foot traffic monitoring in the retail space.
One of our earliest customers required a solution to monitor the temperature of South Africa’s precious blood reserves, which led to us developing the ColdCloud™ solution. In 2006 the first 10 units were deployed with the South African National Blood Service (SANBS) and since then the technology has evolved quite significantly.
ColdCloud™ comprises a web portal and a GSM enabled battery powered remote temperature monitoring device called an ice3 that has a run-time of 7 to 10 years without the need to recharge or replace the battery pack. Being completely off the grid makes the ice3 immune to damage from spikes, surges, brownouts and blackouts, which is a major advantage in the developing world where mains power can be both unreliable and dirty. Being web based (i.e. no software required) makes the system easy to deploy and completely scalable.
The ColdCloud™ is the only solution available in South Africa, and one of only four in the world, that is WHO-PQS approved as well as ISO 9001:2008 certified – the ice3 sits in the fridge and monitors power supply, door position and temperature, and escalates alarms via email, SMS and via a smart-phone app when anything goes wrong. For example, if your power goes off in the middle of the night or if a door is accidentally left open.
ColdCloud™ is also accessible from any standard browser or smart device with an internet connection, so if, for example, you’re involved with a health NGO that has vaccine fridges in far-flung locations around the world, you can pull out your phone or tablet wherever you are, log in, and check on the status of every fridge being monitored, as well as pulling up historical data, which allows you to see trends and make informed decisions.
There are a number of circumstances that transcend any technological or traditional understanding of what issues you might encounter in the cold chain, for example vaccine fridges being used to store food. ColdCloud™ can address such situations by giving you visibility of the problems, and allowing you to address them and prevent them from happening again.
ColdCloud™ also enforces accountability, because in many instances before introducing such monitoring technology people were required to essentially write down the temperature twice a day and weren’t held accountable if they failed to do so. With real-time visibility, alarms will notify you when your cold chain is broken and spur you to take action to fix it.
Beyond Wireless has partnered with global NGOs and health organisations, including the WHO, UNICEF and the International Committee of the Red Cross, to monitor pharmaceutical and vaccine cold chains in third world countries. ColdCloud™ is currently in use in 54 countries across five continents, and in South Africa, other than SANBS, ColdCloud™ is used by Dischem Pharmacy, United Pharmaceutical Distributors (part of the Clicks Group), Netcare pharmacy, and a number of other pharmaceutical companies.
Using data to improve the cold chain
In 2011 we developed a smart-fridge radio-frequency identification (RFID) real-time inventory management solution. It’s an integrated system that uses RFID tag readers to simultaneously monitor temperature and interrogate stock levels in the fridge to help you manage stock. As it stands today, the technology is in our opinion still ahead of its time as it requires the entire industry to agree and collaborate on making this a reality. I believe the market will be ready for it in three to five years from now when real-time temperature monitoring and stock management becomes a de facto part of refrigeration technology.
In 2017 we will be embarking on a two-year study in collaboration with a major pharmaceuticals manufacturer to collect data to determine the true state of the cold chain, because currently no one really knows that answer. Our technology will aid in answering that question; but it’s a complex issue because it’s difficult to track a supply chain as long and as complex as this where there are multiple parties from manufactures to distributors to retailers to government agencies. Hopefully we’ll one day get to the point where the cold chain is viewed as a single continuum from manufacturer to patient that is completely transparent to all parties so that there can be collective ownership of the cold chain as opposed to each party looking at their part of the cold chain as an island.