Counterfeiting has always been one of the most serious and insidious threats faced by the pharmaceutical industry. Falsified or substandard drugs can cause significant damage in terms of consumer health, economic impact and public trust in healthcare systems, and this, therefore, represents a trend that must be opposed as strongly as possible.
Unfortunately, the events of 2020 have conspired to make this essential work more difficult than ever before. With the global COVID-19 pandemic still ongoing, a 'perfect storm' of circumstances has arisen for counterfeiters to distribute their illegal goods, aided by worldwide supply chain disruptions, regulatory confusion and an urgent public need for medical products.
With modern counterfeiting techniques growing more sophisticated, it has become essential for every organisation involved in the pharmaceutical supply chain – from international authorities to the manufacturers themselves – to arm themselves with the right methodology, analytical techniques and equipment to tackle this problem head on.
What is accelerating this problem?
As with so many of the most pressing issues facing industries across the world at present, COVID-19 can be blamed for taking the already serious threat posed by counterfeiting and magnifying it by several degrees.
The reasons behind this are clear: given the unprecedented public health crisis facing the entire global community, demand for medical solutions has spiked, both in terms of medicines like vaccines or health-related products such as masks and hand sanitiser. However, the pandemic has also created disruption, delays and confusion for supply chains and regular testing protocols, making it harder for legitimate products to be shipped out – and easier for illegitimate goods to slip through the net.
As such, illegal online pharmacies and other similar services are now finding it easier to sell and distribute their fraudulent wares. In March 2020, an Interpol initiative called Operation Pangea XIII saw authorities from 90 countries take collective action against the illicit online sale of medicines and medical products, resulting in the seizure of counterfeit pharmaceuticals worth more than $14 million.
The seized products included counterfeit facemasks, substandard hand sanitisers and unauthorised antiviral medication, with Interpol noting an 18% rise in the amount of fake antiviral medicines seized compared to the equivalent operation in 2018. Additionally, seizures of unauthorised supplies of the antimalarial drug chloroquine – often touted as a COVID-19 treatment – rose by more than 100%.
Since then, the global rollout of COVID-19 vaccines has created a new marketplace for these same fraudsters. Interpol issued a global alert in December to law enforcement in 194 countries warning them to prepare for organised crime networks targeting COVID-19 vaccines, while Chinese police have already seized over 3,000 fake COVID-19 vaccines in a series of raids, with vials of saline being falsely passed off as vaccine supplies.
Unfortunately, this is not the only operational challenge that pharmaceutical manufacturers are currently having to contend with. At the same time, UK and European companies are still having to adjust their processes to account for the end of the Brexit transition period, which means the UK is no longer under the jurisdiction of the EU’s Falsified Medicines Directive.
As of yet, a new national scheme for deterring falsified medicine has not been established by the UK government, potentially creating further ambiguity and uncertainty within medical supply chains already coping with once-in-a-generation pandemic pressures.
The long-term impact of counterfeit drugs
Although the last 12 months have thrown up exceptional challenges in terms of the proliferation of drug counterfeiting, it is important to remember that this is not a new problem. In fact, the pharmaceutical industry has been working to fight the sale of fake or falsified drugs for many years, and most are already well aware of just how damaging this trend can be.
Counterfeit medicine often contains no active ingredient or the wrong ingredients, failing to treat the diseases for which they are intended, or actively causing harm to the patient in question. They are easily available online to consumers who are increasingly willing to self-diagnose and self-prescribe medicines purchased from unregulated websites, and are often indistinguishable from the real thing, right down to their packaging.
Figures from the European Union Intellectual Property Office show that fake medicines cost the EU pharmaceutical sector around 10.2 billion euros each year, plus an additional 7.1 billion euros lost annually by related sectors. This is equivalent to 4.4% of the industry’s total yearly sales, and it is estimated that the problem could be resulting in 90,900 direct and indirect jobs being lost each year.
However, data from the World Health Organization shows that vulnerable populations in low and middle-income countries are at the greatest risk from this pernicious trend, with a 10.5% failure rate estimated in all medical products used in these regions due to them being substandard or falsified.
Using the right tools to tackle the problem
Clearly, the scale of the problem facing the industry at the moment is significant, but it is nevertheless one that can be mitigated with the use of the latest tools and technologies available for identifying and rooting out fake products that enter the supply chain.
With authorities like Interpol working hard to seize potentially suspicious shipments of medical products, it is necessary to be able to accurately analyse these questionable batches to find out whether any counterfeiting has taken place – and, if so, what should be done next. In this regard, elemental analysers can be one of the most powerful weapons in laboratories’ toolkits.
Using elemental analysis, labs are able to assess the microbial integrity of drug samples and identify potential signs of contamination to a high degree of precision and sensitivity. By combusting a sample at high temperatures, followed by a gas separation and detection process, the organic elemental constituents of a pharmaceutical ingredient can be accurately measured by highly efficient detectors, meaning any impurities and irregularities can be spotted easily.
These instruments release carbon content of the sample by oxidising it, either by breaking it down via UV/persulfate decomposition, or by placing it inside a high-temperature combustion furnace. The carbon is then converted into carbon dioxide gas, which can be identified using an IR detector. Generally, pharmaceutical manufacturers find that the UV/persulfate digestion method provides the most cheap and efficient performance, with the added bonus of providing lower detection limits, due to the fact that larger sample sizes can be analysed.
Although counterfeiting methods are becoming more advanced, so too are the elemental analysis tools used to tackle them. The most sophisticated modern elemental analysers allow for the analysis of carbon, hydrogen, nitrogen, sulphur and oxygen quantities within a sample with minimal need for oversight or downtime, delivering greater efficiency than ever.
Not only can these tools be used to check the purity of ingredients, they can also be used to check whether the equipment used in the production process has been properly cleaned. Additionally, stable isotope analysis can also help determine similarities and unique chemical fingerprints in different batches of seized drugs, allowing criminal forensic teams to trace trafficking routes back to their original source.
As such, instruments such as these can play a pivotal role in helping the pharmaceutical industry to overcome the unique challenges they are facing at the moment, ensuring that counterfeiters are stopped from causing any further harm to vulnerable populations at this critical juncture. Although the disruptions caused by COVID-19 are likely to take some time to put right, making use of the right methods and tools will give the pharmaceutical industry the best chance of bringing supply chains back under normal levels of control.
By Mike Seed, IRMS sales and product manager for Elementar UK