As part of its efforts to inform the public about best practice with antibiotics and the risks involved with their use, the World Health Organisation (WHO) designated one week in November as World Antibiotic Awareness Week.
The WHO launched World Antibiotic Awareness Week in 2015. This year’s event runs from 12 to 18 November and is centred around increasing global knowledge of anti-microbial resistance (AMR) and focusing on strategies to avoid the further spread of deadly, multi-drug resistant infections.
Packaging provider Origin believes that innovating pharmaceutical packaging can help to reduce AMR. Head of new product development and innovation Jon Lant discusses the multifaceted threat of AMR to patients, healthcare systems and the supply chain, how pharmaceutical packaging can help to overcome the challenges faced in tackling AMR.
Allie Nawrat: What are the main risks AMR poses to the pharmaceutical supply chain?
Jon Lant: The risks that AMR poses to the pharma supply chain are quite far-reaching. AMR results in prolonged diagnosis, more complications, higher mortality rates and the accelerated effect of it reduces the number of effective treatments. Ultimately it is compromising the effect of medication generally because of the risk of infection.
It also plays a role in increasing financial pressure on global healthcare systems. It is claiming around 50,000 lives each year across Europe and the US; 700,000 lives globally.
These figures are set to rise dramatically over the next 30 years. There are figures that claim that the mortality from AMR by 2050 [will be] a staggering 10 million per annum, which represents a greater death toll than cancer and diabetes combined.
Antibiotic supply chains are very complex; they often go through multiple distributors before they reach the patient. There is low visibility, low accountability and little alignment to ensure supply matches demand. This means we get populations with shortages, and we get others with a lot of unused medicines.
Shortages mean that doctors have to resort to less optimal treatments, which makes the patient harder to cure. In turn this creates opportunities for bacteria to adapt to the drugs.
AN: Why has AMR proven such a difficult issue to address in the pharma sector?
JL: As bacteria have developed resistance to our drugs, initially the pharma industry could react quickly and provide alternatives. But now we are at the point where the first and second choice antibiotics are no longer effective. In British hospitals, there was resistance to penicillin a mere 60 years after its development.
Another problem is that new drug development is seriously lacking in resources and investment. In the profit driven world of pharmaceuticals, which is unfortunately very much what is it, antibiotics are not huge revenue generators, which is a serious hurdle.
In terms of packaging, for example, we, at Origin, are tasked with new packaging concepts and the first thing we are always hit with are: this is our budget. With drugs for cancer, they will spend as much as they want to develop secure packaging solutions. I think antibiotics are the poor neighbour of some of the other drugs on the market.
AN: How can pharmaceutical packaging be improved to prevent the misuse of antibiotics by patients?
JL: There is a growing body of evidence that there is a mismatch between the dosage amounts and the course length being mandated by prescribers.
In 2017, the British Medical Journal (BMJ) declared there is absolutely no evidence for the arbitrary length of time that people are told to take antibiotics, which can range from two to ten days, or even longer. The paper goes on to say that it is likely to be better for people to stop as soon as they do feel better than to reduce the global growth of antibiotic resistant bacteria.
The findings were found in a similar publication, the Lancet, by Professor Harold Lambert; he was an Emeritus professor at St Georges Hospital, who predicted that antibiotic resistance is more likely to be encouraged by longer than shorter courses.
This is leading to a considerable quantity of wasted and redundant antibiotics, or even antibiotics that are doing harm in terms of lowering people’s resistance.
There [also] needs to be clarification of the dosage on antibiotics and when to stop taking them. There is a very clear role needed in the labelling of drugs and in the prescribing of them, in terms of what the patient should do when they do begin to feel better.
It is normal for patients to read the instruction leaflet on antibiotic packaging and it will tell them quite clearly to continue with the course and finish it, even if you start to feel better.
So if research and investigation by leading hospitals is proving that is not necessarily true, I think it is urgent that that message is altered.
I think there needs to be a review of the packaging to ensure pharmacists, who are dispensing the medicine, give the dose patients actually need, rather than off-the-shelf, one-size-fits-all approach.[Currently,] antibiotics come in fixed dosage, so a patient gets seven or 21 tablets in a pre-finished pack. Even if they only need eighteen tablets, they will get 21.
AN: Can pharmaceutical packaging help to reduce other causes of rising AMR, such as pollution or falsified medicine? If so, how?
JL: According to the UN, the release of antibiotics into the environment is accelerating bacterial evolution and the emergence of more resistant strains as a result. As pharmaceutical waste includes degraded, contaminated products, pharma packaging can play an important role in mitigating that too.
In the pharmaceutical industry, innovation has always been synonymous with new drug discovery and approval. Although there is no arguing about the importance of new antibiotic development in the fight against AMR, the next generation of packaging and delivery deserves that same investment attention.
A sufficient dose of the right antibiotic medicine early will kill susceptible strains and help suppress newly mutated pathogens from spreading. However, if the medicine being relied upon is of poor quality or falsified, the whole treatment process is undermined.
The sale of counterfeit medicines is the largest fraud market, it is worth than $200bn per annum.
Packaging solutions are making better supply chain visibility and making falsification harder. Digital mass serialisation is becoming a popular solution to combat counterfeiting. It is an advance on a printed serialisation code, which can be easily copied and cloned.
Digital cloning is also becoming easier and there is a need for a new generation of random pseudo coding and using technology and discrete databases for verification purposes.
AN: How do Origin’s products attempt to address problems related to AMR?
JL: Origin has developed products called SmartEye and PharmiTrack, which are aimed directly at dealing with this particular challenge.
PharmiTrack works through the control of physical products in the supply chain can be applied to any size of batch, even a single unit of measure. The beauty of what we have created is, while it is a digital code, as soon as the code is read, the code changes.
This means that only our secure server system knows what the next valid code is and therefore would-be counterfeiters that are reading digital code, which is very easy to do and very easy to copy and paste, it is rendering the code that they cloned as single-use only and if that code is entered again in a search engine then it will read as invalid.
That is a patented process that we have been working on. It was developed in other industries, but we see a clear use for it in tackling falsified medicines.
AN: What other pharmaceutical packaging innovations can you foresee emerging that could further improve the mitigation of AMR?
JL: I think the other great role of digital is monitoring and tracking the actual dosage pattern of the patient.
We are looking at blister strips now, which have an integral printed circuit over them, that can actually monitor when a dose is extracted from the pack.
We can add some personal data to this. We can monitor who is opening the pack, we can monitor how they are taking it and how often they are taking it. We can even alert the patient if they have missed a dose.
We can even, on the PharmiTrack product, make it a two-way communication panel. So if a patient misses a dose, or feel bad side effects, or if they actually feel better, they can feed that information straight back to their health professional, and they can give them advice.
Digital technology exists and is not expensive. The two-way communication channel is really important, particularly so in clinical trials and drug development, to give feedback since some of the consequences are quite serious and it’s common for participants to not get in touch about what they should do.
However, I think we can take the technology beyond clinical trials and beyond just antibiotics.