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‘Clear-cut instructions needed to address cold chain breaches in the healthcare industry’

What do you consider to be the main issue plaguing the modern medical cold chain, with regard to avoiding temperature excursions that could potentially degrade the potency of medication and vaccines?

The main issue is the lack of international or uniform guidelines to instruct health providers/ consumers about “what to do in case of a cold chain breach”? We do know very well how those drugs should be kept, but we do not know how to manage if a cold chain breach (CCB) occurs. There is a clear lack of guidelines for these possible incidences. These incidences are not just limited to developing countries, but they could happen anywhere at any time; an example is a power outage due to maintenance/upgrade or even natural disasters that cannot be anticipated.

Does it vary from developed and developing countries as the level of investment among them must vastly differ? Do you see lack of innovation in equipment as a problem or is the problem mostly adoption and investment in more reliable equipment? Similarly, is there a gap in further training and awareness in the ‘last mile’?

Developed countries usually have a more reliable infrastructure and power supply, as compared to developing countries. But when you think of the level of investment in these countries, often developed countries rely on their reliable infrastructure and may not see the need to invest further on this. Evidence of this is our recent research that showed the lack of guidelines and concerns about awareness and planning in Australia, which is a developed country. Whereas developing countries are aware of their infrastructure limitations but may have difficulty in investing.

Certainly, there is an evident gap in training and awareness. I believe developing user-friendly guidelines that are evidence-based, accurate and easy to understand, would significantly help. For example, imagine if an expensive biological drug that is worth about USD 1,000 and is stored in a pharmacy or a hospital fridge is exposed to a higher temperature, due to a temporary power outage for certain number of hours. Although the temperature records are available, there is no reliable instruction to healthcare providers whether the drug is usable anymore or not? So individuals need to use their judgement whether to expose the drugs (that could be quite costly) or to continue supplying it to their patients (that could bear a risk). Developing guidelines can provide clear-cut instructions on how to deal with those situations. Data from a small local study indicate millions of dollars worth of medicines could be saved each year if additional data regarding the stability of medicines were available to the relevant parties

Could you briefly comment on the impact these power outages could have on the integrity of the vaccines and medicines?

To explain the impact of power outage and CCB, we can look at the global burden, as identified by the WHO. The WHO estimates that up to 50% of vaccines may be wasted globally every year because of temperature control, logistics and shipment-related issues. We found the gap in the knowledge, as we did not find any comprehensive international study that assessed the impact of CCB on non-vaccine medicines (those that need to be refrigerated). In our small local study we found that power outages could lead to significant financial loss, either to the healthcare providers that store the drugs or to the insurance companies, with regard to vaccination. The worst thing that could happen is that if healthcare providers or suppliers overlook a potential CCB and the medicine reaches the consumer, usually there is no way to assure the integrity of the medicines by the consumers or even by the healthcare providers. That may result in under-vaccination, without knowing about the potential CCB, and subsequently could predispose people to communicable diseases.

Are the government guidelines enough, in terms of securing a stringent cold chain? Where do you think are the most prominent gaps and what are your recommendations?

No. Government guidelines are often quite broad and do not provide practical solutions once CCB has occurred. For example, the WHO has developed a set of guidelines for governments in a bid to minimise exposure to high temperatures, if a power outage happens. But these guidelines don’t have any specific instructions on how healthcare facilities and pharmacies should implement backup systems. They also don’t provide a list of standardised equipment to prevent and deal with power outages. This would be helpful in both developed and developing country scenarios.

The most prominent gap is the lack of uniform evidence-based guidelines about transportation and storage or vaccines and medicines. Given that most pharmaceutical companies these days are international, similar or identical medicines are being marketed in different countries, so if manufacturers conduct comprehensive stability testing and transparently provide the information to the public, by collaboration between independent scientists and manufacturers, we can develop these guidelines.

Should energy insecure countries be more vigilant?

Yes, where power supply is not reliable, there is an increased incidence of power outage that can affect the integrity of medications. An interesting example is, when there was an Ebola outbreak in 2014 and or after the Nepal earthquake in 2015, there was not a reliable power source, due to being in remote locations and the natural disaster that affected the infrastructure, respectively. A vaccine storage device was developed and trialled that was called Arktek. It is a super-insulated device that maintains the integrity of vaccines by keeping them in ice, in its inner chamber. It can keep vaccines at a temperature between zero degrees C and eight degrees C for 30 to 60 days, depending on outside temperatures and humidity. Although this might have worked well in those outbreaks in remote areas, however, it may not be possible to use these devices in all settings.

You mentioned that actual cost of vaccine and pharmaceutical loss is poorly studied and requires further research. Could you comment on what are the key areas that you believe should be given more attention?

The key areas include vaccines that are extremely important to the public health and biological drugs that are quite costly for the consumers/health insurance/public healthcare systems.

Manufacturers can invest on developing heat-stable drugs so that drugs can be stored outside the cold chain for a longer time. This will significantly contribute to preventing wastage in medications and saving in logistics. But we should acknowledge that, this may not be so simple.

How can manufacturers help address the issue?

Manufacturers could conduct more vigorous stability testing, share their data transparently with independent scientists and invest in developing guidelines to deal with power outages for their own products. This is the least you can expect from manufacturers, especially for biological drugs, where usually each supply of the drug that lasts for a month is worth at least USD 1,000 or even more. So the investment is well justified.

 

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