May 17, 2020

Leveraging technology and education in the high-stakes fight against fake medicines

pharmaceutical
Supply Chain
pharmaceutical
Supply Chain
Dr Iain Barton, Imperial Logis...
6 min
According to new data published by the World Health Organization (WHO), one in ten medical products circulating in low and middle-income countries is ei...

According to new data published by the World Health Organization (WHO), one in ten medical products circulating in low and middle-income countries is either substandard or falsified. It estimates that as many as 169 000 children may die each year from pneumonia due to substandard and falsified antibiotics.

Devastating statistics like these are unacceptable. Patients deserve the guarantee that the medicine they are receiving is safe and effective. Education, awareness, multi-stakeholder engagement and technology are our most powerful weapons in the fight against fake medicines.

We can be very proud of the enormous progress that has been made in the past decades by the worldwide cooperation in the fight against AIDS, for example; but there is still much work to be done, especially in Africa. We must, at all costs, prevent the scourge of counterfeit medicine from thwarting our efforts and setting us back several years by eroding confidence in healthcare and healthcare workers.

The WHO reports show that all disease areas are impacted by falsified medicines, with antimalarials and antibiotics being the most commonly reported. Most of the substandard and falsified medicines (42%) stem from sub-Saharan Africa, as the reports reveal. They note, however, that this is just the tip of the iceberg, since, given patchy reporting, it is highly likely that these figures represent just a small proportion of the problem.

Nearly any type of pharmaceutical product can be and has been falsified; from lifesaving medicines, including those used to treat malaria, tuberculosis, HIV/AIDS, cancer, heart disease, diabetes and other life-threatening conditions, to “lifestyle” medicines like those for erectile dysfunction and weight loss. Some estimates put the number of deaths by falsified medicines at 700 000 per year. The counterfeit drugs industry is estimated to be worth hundreds of billions of dollars annually.

Falsified medicines either fail to treat patients or poison them as a result of toxic ingredients. They can also prolong or worsen illnesses, leading to disability or loss of life. An additional danger lies in the fact that, by passing themselves off as genuine medicines, falsified medicines undermine public trust in health systems and healthcare professionals. A dire consequence of the flow of fake medicine is the crumbling of trust in healthcare and healthcare workers.

It is crucial that both civil society and businesses step up and educate local communities, and by doing so, empower them to counter the dangers of fake medicine themselves.

Initiatives like the powerful global action campaign “Fight the Fakes” are playing vital roles: in raising awareness of the public health threats that stem from fake medicines; and in educating and empowering communities. Fight the Fakes is a global movement of organisations and individuals who are striving to highlight the issue of fake medicines and fight this threat around the world. It was started in Geneva, Switzerland more than four years ago.

The campaign’s partners represent healthcare professionals, academia, NGOs, industry representatives and consumer protection organisations around the world. The International Federation of Pharmaceutical Wholesalers (IFPW) currently serves as the campaign’s Secretariat.

Fight the Fakes supports WHO leadership and works with key stakeholders to inform the public about the magnitude and dangers of falsified medicines and encourages anyone to report suspicious products.

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The campaign gives a voice to those who have been personally impacted and shares the stories of those working to put a stop to this threat to public health. It is building a global movement of organisations and individuals who are shining light on the devastating impact that fake medicines have on people around the globe and who are working together to reduce the negative consequences on individuals worldwide.

Fake medicines are everybody’s business, and a comprehensive strategy to combat the manufacturing and distribution of fake medicines requires active participation by all stakeholders. This is why Imperial Logistics has joined forces with Fight the Fakes, through our relationship with IFPW, the global trade association for pharmaceutical wholesalers and distributors. We believe that as a leading force in African healthcare supply chain management, as well as pharmaceutical wholesale and distribution, Imperial Logistics must be at the frontline in the fight against fake medicines.

In addition to getting behind this important initiative, it is important to leverage technology to combat the threat of fake and counterfeit medicines. In response to the global increase in fake medicines, the European Union and the United States have put strict regulations in place requiring pharmaceutical companies to ensure that their products are secure throughout the supply chain - from manufacturer to patient. Two technological innovations that have come to prominence to respond to counterfeits and falsified medications are serialisation and authentication.

Serialisation is the assignment of unique, traceable numbers to individual items. Think of a box of painkillers in blister packs. Each pack will have a serial number tag. This essentially provides traceability at all levels along the supply chain.

Product authentication allows someone to pick up a product at any point in the supply chain and to confirm that its constituents are all correct and authentic. This is possible thanks to Raman spectral techniques, which are commonly used in chemistry to provide a structural fingerprint by which molecules can be identified. It serves as a non-invasive, non-destructive and quick way to analyse medicine and determine whether it is real or counterfeit.

Both serialisation and authentication technology should be used by logistic companies to ensure that what we deliver is authentic medicine. With our distribution of pharmaceuticals around the African continent in particular, we appreciate the importance of setting a high quality standard, providing thought leadership and demonstrating capacity in every innovation that can help win the war against fake medicines.

As pharmaceutical companies work to comply with the new regulations to fight the danger posed by counterfeit drugs, we believe that logistics companies are in a position to support their clients by securing the storage and distribution of their products. Our serialisation and authentication capabilities and initiatives mean that we can also give patients the guarantee that the medicine they are receiving is safe and effective.

The latest development in our drive to track medicine on each step of its journey from manufacturer to recipient is a partnership between Imperial Logistics and German software giant SAP. This significant cooperation agreement was announced during the recent International Aids Conference in Amsterdam. Applying SAP’s technology will help to further improve the serialisation process, making it easier to prevent fake or sub-standard medicine from getting into the market. It will improve patient safety by increasing the opportunities to collect relevant medical data. The technology makes it easier for patients themselves to check whether their medicine is real or fake.

The threat of counterfeit medicine is massive and demands an urgent response. The time for action has really come and we must continue to leverage the power of partnerships, collaboration, education and technology to address this life-threatening global crisis.

Please attribute all responses to Dr Iain Barton, Imperial Logistics healthcare strategy executive

Edited on 8th August 2018 to reflect feedback received.

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Jun 10, 2021

The future of pharma: personalised healthcare

#pharma
#personalisedmedicine
#genomics
#diagnostics
6 min
Chris Easton, Global Commercial Lead at Takeda, tells us how the pharmaceutical sector can help deliver more personalised care

Ever since the very first healthcare systems were created, the earliest documented being in ancient Egypt, medical professionals have had a reactionary approach   to finding cures for ailments. That is to say that a solution is sought after someone has become sick, using whatever methods were thought to work at the time. Thousands of years later, with advances in genomics and molecular modelling, emphasis is starting to shift towards preventative, personalised healthcare rather than "sick care". 

This move is led by data analytics as well as genetic sequencing to inform decision-making, which can ultimately lead to more individualised care. "Identifying the right data will support personalised health outcomes", explains Chris Easton, who is Takeda’s Senior Director and Global Commercial Lead, specialising in personalised health and innovation and applying this to rare blood disorders. "It's about how we can empower patients, interpret data and then apply it."

"The historic pharma model, in a very simplified form, is: a patient has symptoms, gets diagnosed, and gets given drugs for symptoms", Easton says. "Now, with holistic patient care in mind, it's much more about the additional components to care that would make a difference. Yes, drug therapy is one of them, but likewise, it's okay to talk about mental health, as the impact of chronic diseases means often there is a mental health challenge. So what can we do to build a mental health and physical health support package, both of which have data associated with them, that we can use together?"

By way of example, Easton cites the approach taken by elite athletes and astronauts. "Their model is to keep as healthy as possible. If someone on a space mission gets a cold, they're off the mission - it's not affordable to send someone to space that might have a health issue. If you look at footballers and runners, their coaches maintain them at the highest level, and they're using technology and wearables to help monitor their health so that they can make adjustments to stay at peak level for as long as possible." 

The aim is to provide a complete, holistic package of care, which Easton acknowledges will pose some challenges to the pharmaceutical sector. "Our model is not necessarily that of a total care package. It's drug therapy or device and technology support therapy. So some things will need to evolve, and that's part of what my role is about." 

One way of effecting this change is by collaborating with other organisations, not necessarily limited to healthcare and life sciences. "I'm a big advocate of partnerships and joint ventures. For the pharma sector, these are traditionally through universities and research houses, but I think we need to be willing to look outside the box and look for scalable and transferable technology that is used in everyday life." 

"An example is the smartphone you probably have sitting on your desk or the smartwatch you're wearing.  These are gathering data all the time. There are probably hundreds of data points that we could use, just from our everyday technology", Easton adds. 

While apps like Apple Health, Google Health, and devices like Fitbit collect data, they could be linked to WhatsApp, WeChat or Telegraph to connect to members of a user's care team if a health issue arises. "It's using technology that is already embedded in our lives, that would enable us to share information and photographs. For example, if your knee is swelling and you want to ask a doctor for their opinion, you can send an image, then share the log from your treatment, and it becomes a way of integrating and sharing information." 

Shifting towards preventative medicine is one of Takeda's strategic goals for the next few years. An example of how this could work is how people affected by Von Willebrand disease could be supported. This lifelong bleeding disorder prevents blood from clotting and particularly affects girls and women, causing menstrual bleeding to be excessively long and heavy, which has a big impact on their quality of life. 

"It's a hereditary disorder, so many women in a family can be affected, but it's hard to diagnose", Easton explains. However, using existing technology that tracks the menstrual cycle via a smartphone perhaps an alert can be issued to let the user know when it's time to start taking replacement therapy for Von Willebrand. 

"This means that by the time a period begins, Von Willebrand levels are normalised, and menstrual flow goes down to normal levels. That's actually a massive outcome for someone who has been living with two-week-long periods that bleed through clothing every month. Suddenly for just four or five days, they can use regular tampons and pads. That's a huge improvement to life." 

The field of rare blood disorders typically hasn't seen the same amount of attention focused on it - at least in terms of tech innovation - as other chronic illnesses like diabetes. "Rare blood disorders are difficult to show returns on because you've got small patient numbers and often high costs. But if we think about the total patient journey, we could use technology to triage vast numbers of patients and data into more specific diagnosis boxes, so that what is then presented to physicians are smaller groups, of the more likely issues."

Data analysis could, for instance, show that the combination of headaches, nausea and lethargy equates to a specific type of bleeding disorder.  "You can start to put these things in categories", Easton says. "And then you're able to do differential diagnosis. But ultimately, what you're trying to do is get a faster, more accurate diagnosis, leading to a specific therapy." 

This would be more efficient than administering plasma-based treatments, for example. "A lot of bleeding disorders are caused by a deficiency of something", Easton explains. "There is a lot of combination therapy in blood disorders when you give people plasma-based products because plasma is like the golden chalice of medicine. It has a bit of everything you need. In some cases, when you don't know what the disorder is, this can help patients, but it's not the most precise way of doing it."

"That's one of the ways having very clear diagnostic support linked to advanced direct therapy can help, only treating what you need to. From a payer's perspective, it's very targeted, and there's no wasting money and resources on patients being hospitalised for things that are not necessary."

"If you go back 15-20 years, market access to the pharmaceutical industry was the emerging trend", Easton adds. "We saw all these diagrams of physician decision-making coming down and payer decision-making going up. Now we have another divergence of change, which is the application of technology to support personalised care.  This is one of the transformative pieces of pharma right now, and there are a lot of good companies, big and small, being very intelligent about how they're approaching it and investing in those spaces. There's definitely a community building." 

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