When was the last time you questioned the quality of the drug you were about to take? We give it no thought, really. We blithely accept the convenience and effectiveness of the medicines we buy off the shelf, or those that are prescribed by our doctor, administered at a clinic or hospital, purchased over the counter, or received through mail order pharmacy, and assume that they are pure, safe, and viable. Our assumptions, in all likelihood, are probably correct. We are truly fortunate – not just because the drugs we take are safe, but by the fact that we have access to them at all.

According to Share the World’s Resources, the politically unaffiliated, non-profit, London-based think tank, more than 90% of the global burden of disease falls on countries in the southern hemisphere – populations that have access to just 10% of all medical resources. Every year, nine million children under the age of five die, half of them in sub-Saharan Africa where Malaria kills a child every 30 seconds. Sub-Saharan Africa alone accounts for 95% of the world’s one million malaria deaths, two-thirds of the estimated 33.4 million people infected with HIV worldwide, and one-third of the roughly 9.4 million tuberculosis cases each year. Neglected diseases claim hundreds of thousands of additional lives in this impoverished area of the world.

The International Energy Agency states that access to energy is an indispensable element of sustainable human development. Without access to modern, commercial energy, poor countries can be trapped in a vicious cycle of poverty, social instability and underdevelopment. And while electricity supplies over the last quarter century have been extended to 1.3 billion people living in developing countries, it has not kept pace with population growth in most areas. Roughly 1.6 billion people, or one-quarter of the global population, still have no access to electricity. More than 99% of the global populations without electricity live in developing regions of the world, and four out of five live in rural areas of South Asia and sub-Saharan Africa. The proportion of the world’s population with access to electricity is expected to continue to rise over the next 20 years. However, under the status quo and absent radically new innovations in global energy policy, by 2030 it is estimated that 1.4 billion people still will not have access to electricity.

Without modern energy services like electricity, millions of men, women and children continue to face debilitating illness or premature death. In addition, basic social services like vaccination, health care and education are more costly in both real and human terms, and economic development is more difficult to sustain. On its most basic level, electricity creates conditions for improved living standards in areas of public health, education, family life and social structure.

The lack of electricity makes it challenging to deliver basic healthcare to such remote populations. And one of the basic tenets of healthcare is immunization against such debilitating diseases as polio, diphtheria, tetanus, yellow fever, hepatitis B, rubella and measles. Refrigeration is not only a basic and vital element for the preservation and safe consumption of foods; it can play a critical role in the life of preventive vaccines for these diseases.

“All vaccines are sensitive to heat and some to freezing,” explained Dr. �mit Kartoglu, technical officer and scientist at the World Health Organization in a 2009 Case Studies for Global Health article. “The vaccines leave the production facility in temperature-controlled trucks, are flown as cargo to the country’s capital city for storage, then transported deeper into the country, stored again, and finally delivered to where the they will be administered. Storage facilities often have sporadic electricity or no electricity at all.”

He continued, “Transport might be between islands or on dirt roads or across rivers and swamps. Healthcare workers carry the vaccines using trucks, motorbikes, boats, canoes and bicycles and, in many cases, on foot. With all these steps, the journey might take a year, with the most challenging leg at the very end where the vaccinator struggles to reach populations dispersed by difficult geography, famine or war. The vaccine is at constant risk of damage.”

In the past there was no way for healthcare providers in these remote locations to determine if the vials of vaccines were spoiled as a result of the cumulative effects of heat exposure along their year-long journey. Do providers risk administering costly but now ineffective vaccines on patients and leave them vulnerable to disease afterwards? Or do they dispose of expensive and perfectly viable vaccines as a safeguard measure any time the vaccine’s efficacy is in doubt? Neither alternative is acceptable at the bottom of the healthcare pyramid, where diseases can advance quickly and resources to prevent or treat illnesses are severely limited.

In the past, it was virtually impossible to visually determine when a vaccine was damaged by exposure to heat. Somevaccines are extremely sensitive to heat and can be rendered useless by just a few degrees difference in temperature or severely degraded by exposure to temperature changes over prolonged periods of time. Now, a deceptively simple sticker, small enough to be incorporated into the vial label or applied to the vaccine vial or ampoule, can warn healthcare providers if a vaccine has been exposed to heat and to whatextent such heat exposure has affected the viability of the vial’s contents. Itdoes this elegantly by virtue of asimple and irreversible color change. It is called a Vaccine Vial Monitor, or VVM, for short.

Here’s how it works: its basic design consists of a small square of heat-sensitive material located in the center of an outer circle. The square is of the same hue as the outer circle but when it is applied to the vaccine, it appears at about 10% of the color saturation. Gradually, the color within the square darkens, permanently and irreversibly with exposure to heat. If the square becomes the same color as the outer circle, then the vaccine bearing the label must be discarded because it is no longer effective. If the inner square is darker than the outer circle, the vaccine is long past the discard point and is not used. If the gradual darkening of the square over time remains lighter than the circle – and the vial is not past its expiry date – then the vaccine is still usable. The color change is a continuous process and is directly related to the degradation of the vaccine as a result of the combined effects of time and temperature.

The concept for the VVM was first proposed in 1979 by the World Health Organization and took a constant and prolonged push by many organizations to master the reliability of the technology. It took more than two decades to put into common practice in developing countries where adding even a penny’s worth of additional cost was a burden many hesitated to bear.

It is estimated that by 2019 VVM will allow healthcare workers to recognize and replace more than 230 million doses of unusable vaccines. VVM reduces wastage, saving around $5 million worth of vaccines annually. VVM also facilitates immunization outreach and increases immunization access and coverage. Over the next decade healthcare workers will be able to administer in excess of 1.5 billion more doses, including delivering the birth dose of hepatitis B vaccine to millions of newborns in remote areas. VVM also helps identify breaks in the cold chain and adds significantly to the management of vaccine inventories by making decisions with the help of VVM readings.

“A new and previously unrecognized advantage of using VVMs is beginning to emerge,” said Dr. Kartoglu, who is one of the early pioneers in the development and implementation of VVM and a tireless champion for its global use. “Today, VVM is seen as a catalyst for much-needed changes in strategies of vaccine distribution via the cold chain. VVM allows immunization programs to exploit the stability of each vaccine to the fullest, minimize distribution costs, improve inventory management and increase flexibility in the field, thus helping to make operations more effective.”

And although VVM was developed as a heat-exposure indicator, it also contributes significantly as a tool to reduce accidental freezing, as it is now possible to detect and avoid excessive heat exposure when methods are employed to store and transport vaccines without ice and equipment that is a known source of freeze damage. Healthcare workers can now feel confident that a shipment of vaccines will not necessarily go bad in the event of an electrical power failure. The VVM allows health workers to visually ascertain the heat stability of the drug and accept that freezing is a greater risk than mild heat exposure. All this benefit from a color impregnated sticker. Imagine that.

So, when was the last time you checked the quality of the medicine you were about to take? All we really haveto rely on is expiration date. VVM technology is not applied to any of the medications you and I take. My question is, why not?

Kevin O’Donnell is director and chief technical advisor to industry at Tegrant Corp., ThermoSafe Brands. He can be reached at kevin.o’[email protected]. His blog, Where Cooler Heads Prevail, can be found at http://www.coolerheadsblog.com/blog/