Maintaining product authenticity: The solution to a serial problem

pharmafile | December 6, 2021 | Feature | Sales and Marketing |   

Counterfeit medicines pose a serious risk to public safety, and, in some cases, can lead to serious adverse effects (SAE) and even death. Not only this, but they actively damage the pharmaceutical industry, throwing a spanner in the works by endangering revenues. The counterfeit industry is worth over $75 billion annually, highlighting the increasing need for pharma companies to implement the appropriate anti-counterfeiting technology and strategies (1). 

According to WHO, over 50% of medicines purchased on the internet are counterfeit, and it has been reported that up to 200,000 children die each year in developing countries due to fake drugs entering supply chains (2). Many more adults around the world are continually impacted by sub-standard and counterfeit medications every year. 

Speaking to Pharmafocus, Dr Pius Waldmeier, Head of Global Roche Anti-Counterfeit Commisssion (GRACC), commented: “Counterfeiting and falsification of pharmaceutical and diagnostic products is a criminal act that poses a significant global public health problem. These products are mostly offered for sale by unlicenced sources, whereby the negative implications for public health and safety of the patients are high. To combat this, Roche have established an internal Global Roche Anti-Counterfeiting Commission, which consists of members of all affected departments, and which is heavily involved in the coordination of many anti-counterfeiting activities. “Patient safety is our primary concern,” emphasises Dr Waldmeier.  

But how can the patient protect themselves? Dr Waldmeier says: “The best way to avoid counterfeit and falsified medicine is to purchase prescription medicines or diagnostic tools from a reputable pharmacy or from your physician.”

How effective are existing anti-counterfeiting methods? 

Serialisation is one of the strongest tools that companies have to combat counterfeiting, but what does this entail, and what other methods can pharmaceutical and healthcare companies adopt to mitigate this? 

Serialisation vouches for a product’s authenticity, and involves tracing each individual product via a unique serial number from the manufacturer right through to the end user – the patient. It allows pharma companies to trace back the original source of supply, through a unique serial number on the drug packaging. 

As the distribution of fake medicines becomes increasingly aided by worldwide internet adoption, companies are spending more money than ever on anti-counterfeiting technologies and methods. 

“In the case of counterfeit medicines, the consequences of counterfeit products can be serious for patients, especially since they are usually highly effective medicines from the high-price segment that are used, for example, in cancer therapy,” says Authena CEO, Matteo Panzavolta. “Furthermore, counterfeits also harm the pharmaceutical industry, which invests millions of euros in its research, which then has to be recouped through the sale of original products. Holograms and QR codes are the most used measures to fight counterfeiting of products nowadays. But, with the sophisticated technologies fraudsters are applying, they can easily be copied. 

“These measures are furthermore not protecting the product itself but the packaging. In some cases, the packaging of the drug is removed and the product is not protected anymore. Additionally, the packaging can be reused by fraudsters. Security seals attached to the product at the place of manufacture can be an effective remedy. The point is to be able to check the distribution channels from production to use in real time.”

As guaranteeing safe and effective medicinal products for patients is high priority, companies such as Roche have implemented different approaches to fight counterfeiting and falsification and implement technologies, such as special packaging and printing techniques of all its products, that make counterfeits both more difficult to make and easier to differentiate from genuine products. Dr Waldmeier said, “Serialised or digitalised products improve visibility and security in supply and distribution chains, and make it easier to track our medical products, and to prevent counterfeit and falsified products entering the supply chain. The company has also been working with other pharmaceutical manufacturers to promote a serialisation solution in Europe and many other countries, which enables pharmacists to compare a unique number on each pack of medicines against a central database to confirm its legitimacy. In countries where serialisation is strictly applied (often driven by government) and seriously used for verification, counterfeit products are scarce.”

What role has the internet played in expanding the counterfeit market? 

The deep recesses of the internet have undoubtedly opened pockets for the counterfeit market to flourish, enabling the relatively easy distribution of fake medicines. 

In their article Serialisation in the Pharmaceutical Industry – What You Need to Know, SL Control.com says that shutting down counterfeit manufacturing facilities and distribution sites does not solve the problem, due to the large proportion of fake medicines that are sold on the internet. “While authorities are getting better at policing the web, there is a long way to go.”

Panzavolta continued, “Counterfeiting has been around since ancient times, so the phenomenon is not really new. The internet however has massively increased the potential for counterfeiting in that counterfeiters today are global, fast, anonymously organised and networked, which also affects their procurement and sales channels. Websites offering counterfeit products are available in large quantities on the internet and serve a global sales market that moves ever faster and is not bound by any borders. The counterfeiting trade has indeed become a booming market: according to a recent report (Statista 2020), we’re looking at a global market for counterfeited drugs worth $200 billion a year. The most common counterfeited drugs are cancer treatments because of the high profit as well as antibiotics, erectile dysfunction, and pain drugs.

“Many states support this trend, at least implicitly, when they do not attach any legal significance to patent protection. Moreover, especially in the Asian region, the originals and the counterfeits are nowadays produced in the same factory, which makes subsequent verification more difficult. Only controls of the history, from production to the end customer, can remedy this situation. Interactive security systems with app control and enhanced security, such as those offered by Authena, are particularly suitable for this purpose. Counterfeiters are constantly developing more perfect methods, which call for new security concepts.”

“In the current digital world and due to the pandemic situation, more and more people have access to the internet and many nowadays buy almost everything online,” added Dr Waldmeier. “Therefore, there is also an increasing trend of purchasing medicines via online sources but unfortunately many people are not aware of the potential risks. Over the last months we have seen thousands of websites emerging trying to illegally sell falsified or substandard pharmaceutical products and the same is true via unsafe channels like social media e.g., Facebook, Instagram, Twitter, WhatsApp. 

“Sometimes products get offered without a prescription and/or at a significantly lower price, which makes it very attractive for customers. At the same time the current lack of legal regulations makes online sales of medicinal products an easy target for counterfeiters. If people buy medical products via illegitimate channels, there is no longer a control mechanism like a verification by a pharmacist or healthcare provider checking if the product is authentic or not. This makes it nearly impossible for consumers to distinguish between authentic products and their counterfeits and so potentially puts the safety of the patient at risk.”

How can pharma companies enhance their anti-counterfeiting technology?

As counterfeiting technologies advance, pharma companies need to ensure that they are keeping up to date, in order to compete. 

“Ensuring product safety means strict monitoring of all manufacturing, distribution and application processes,” said Panzavolta. “Digital systems that record the history of individual phases in minute detail and can provide rapid information about possible irregularities are ideal for this purpose. Authena’s solution is applied on the product itself and cannot be copied or removed from the product. This ensures an end-to-end traceability of the product. In pharma, we are enabling patients in different countries to verify the authenticity of their medicines by simply using their smartphones.

“There is no easy solution to the counterfeiting and falsification problem, and the consequences affect not only patients at the end of the supply chain, but also governments and healthcare companies. Counterfeits and falsified products normally enter the market at some point in the distribution channel or via purchase from unauthorised sources. The main aim should be patients’ health by ensuring the integrity of the whole supply chain.”

National authorities and agencies as well as international organisations have a very important responsibility for the prevention and control of counterfeiting and falsification. 

What are the disadvantages of serialisation? 

The main drawback of serialisation centres around the high cost of implementation as well as ongoing running costs, according to PharmOut’s 2020 article, Serialisation Requirements in the Pharmaceutical Industry. Aspects like data system integration and software can prove expensive, so companies need to ensure that they include this in their annual budget.

According to a 2014 article by Manufacturing Chemist, ‘The hidden challenges of pharmaceutical serialisation’, there are also issues associated with storing and maintaining the integrity of the vast amount of data that serialisation can create. Each item of data consists of two parts, a physical asset and a data asset, and the association between the two must remain linked from the moment a unique identity is assigned to a pack, to the moment it reaches the patient. The article states that, “This simple fact alone will require a modal shift in the manufacturing mindset, with each pack effectively a unique batch of one. Reconciliation, which has until now been a line side task completed once per batch, will in future need to extend right through the supply chain and be open to interrogation for the life of the product and beyond.”

Panzavolta highlights another lesser known weakness of serialisation, touched on earlier, which lies in the application on the outer packaging and the visibility of the code. He says, “Authena Shield overcomes this by applying the tag directly to the drugs primary packaging (eg, vial or syringe), and adding an additional level of security with blockchain.”

Whilst the counterfeiting market may be at its zenith, so is the technology that can combat it. As long as pharma companies recognise how they can use serialisation, and other digital systems, to leverage their products’ security, they will be equipped to deal with one of the most pervasive problems in the industry. Most importantly, they will be able to guarantee the safety of their patients, enhancing and cementing the trust that lies at the core of this relationship.  

References:

1.) Visit: https://nextbillion.net/building-a-business-around-combating-counterfeits/ 

2.) Visit: https://www.pharmout.net/serialisation-requirements-in-the-pharmaceutical-industry/ 

3.) Visit: www.roche.com/sustainability/anti-counterfeiting.htm 

4.) Visit:www.manufacturingchemist.com/news/article_page/The_hidden_challenges_of_pharmaceutical_serialisation/95367