Deploying AI in the War on Counterfeit Drugs

Introduction To provide patients with timely access to novel and effective therapeutics, pharmaceutical organisations must maintain robust, trustworthy supply chains. But this is no mean feat.

Creating and managing a reliable supply chain is essential for many reasons, including success in the market, to protect consumer safety, and to comply with mandatory regulations. However, supply chains are growing increasingly global and complex, opening them up to dangerous quality control and safety issues like theft, fraud, and counterfeiting. These issues have only been compounded during the COVID-19 pandemic due to associated supply chain restrictions, product shortages, price increases, and a disrupted pace of production and distribution.

Advanced technologies, such as blockchain and artificial intelligence (AI), can help to overcome the challenges of supply chain fraud and theft, and ensure that global supply chains remain safe, agile, visible, and reliable. The resiliency offered by such technologies is essential to maintain consumer access to potentially life-saving new therapies and better protect an organisation from disruptive events like COVID-19. The Dangers of Counterfeiting and Theft Combating the presence of substandard drugs in supply chains is a priority for the pharmaceutical industry and a topic of significant concern for associated health officials and regulatory bodies.

Substances can leave supply chains via theft or enter them in substandard or fraudulent forms as a result of counterfeiting. Counterfeit products have a range of potential health impacts and can lead to preventable deaths. Approximately one million people die annually as a result of toxic or ineffective counterfeit products2 . In contrast, others are denied effective treatment as they unknowingly administer a substandard and less effective medicine that will fail to treat or prevent disease. In the case of Malaria, for example, up to 450,000 people die annually due to reliance upon counterfeit pills3 .

Additionally, in times of disruption, such as during the ongoing COVID-19 pandemic, it’s not unusual for patients, governments, and even health organisations to stockpile medicinal supplies, sometimes in substantial quantities. However, this causes the prices of raw ingredients to skyrocket. As an example, this year, the raw ingredients of the anti-malarial drug hydroxychloroquine recently rose from $100 to $1150 per kilogram in Pakistan1, resulting in some companies trying to source alternatives.

Counterfeit medicines are a significant concern on a global scale. Falsification of medicine disproportionately affects poorer and more vulnerable nations, which have reduced access to high-quality medicines. In 2017, the World Health Organization estimated that one in 10 medical products circulating in low- and middle-income countries is either falsified or substandard4 . Further, up to 30% of medicines sold in Asia, Africa, and Latin America and 64% of the anti-malarials sold in Nigeria are thought to be counterfeit5 .

Complex distribution networks create more opportunities for counterfeits to enter legitimate supply chains, too, making them increasingly difficult to detect. Supply chains are growing in scale and intricacy, with numerous different interacting steps and components. Many third parties are involved in processing vast volumes of transactions, with each link in the chain offering another chance for fraud or theft – whether opportunistic or planned. This situation has worsened amid COVID-19related disruptions, as volatility has brought vulnerability; emphasis has shifted to progressing essential medicines to market, resulting in an easing of some enforcement guidelines. Consequently, the industry has experienced more supply chain restrictions and shortages than expected. Some oversight and approval procedures have also weakened, workforces are reduced and low on morale, and supply shortages are piling on the pressure. The result is an upsurge in attempted fraud, bribery, and corruption across the globe6 . Tracking and Tracing Global Supply Chains Efforts to battle counterfeiting and theft in pharmaceutical supply chains are ongoing. For example, under the US Drug Supply Chain Security Act (DSCSA), manufacturers have employed serialisation to achieve individual unit and lot-level traceability since 2018. By 2023, DSCSA mandates complete product traceability from manufacturer to dispenser – from plant to patient.

In working to meet these goals and regulations, the industry is making significant progress. Globally, over 40 countries are now implementing a ‘track and trace’ regime. Track and trace solutions record all information generated at each step throughout the distribution chain and store this in a traceable, transparent, and secure central database. Packaging and distribution chains have complete traceability due to the application of batch coding, serialisation, and aggregation to product packs as they prepare to leave a facility. As supply chains become less linear and more collaborative and network-like, track and trace assures complete knowledge of product provenance, location, interactions, and other essential characteristics.

Implementation of track and trace is also a significant stride towards achieving something essential for robust, efficient supply chains: interoperability. However, it is hugely challenging to make track and trace systems globally interoperable and to unify global supply chain regulation as more countries and companies get involved. For example, many drug companies feed into a single distributor, which in turn distributes to many outlets. To minimise the number of systems they must implement, pharma companies may tend toward complying with the most comprehensive or strictest policies. A globally interoperable system would minimise such considerations, allowing different distributors and regulatory regions to work collaboratively with full transparency and integrity.

The Benefits of Advanced Technology Advanced digital solutions offer a way forward

for effective supply chain management. Blockchain is the leading example of such technology currently implemented by the industry and is being implemented in the aforementioned track and trace systems to help companies meet DSCSA and other regulations.

With blockchain, as a substance or product travels through the supply chain, data are generated at each step and an unchangeable code is added to the entry. If one step is broken, then the system can flag for investigation, assuring that accuracy, traceability, and authenticity are upheld for every product and process step, and weak points in the chain can be addressed. Notably, blockchain maintains a trackable chain of custody in a permanent ledger that is visible to and governed by all stakeholders within a network.

Such a system also enables ‘proofs of data’ to stand in for actual data, allowing competitors to collaborate on a shared platform to assure drug safety without compromising sensitive or proprietary information. With the kind of ‘granular visibility’ enabled by blockchain – in other words, visibility and control over a supply chain at a point-by-point level – organisations can gain a full understanding of the state of their supply chain operations and efficiently identify areas of current or potential risk. Enter AI The data gathered by blockchain technology can, in turn, be used to feed analytics and solutions powered by AI. AI offers real-time data availability and accessibility across the supply chain. It enables companies to manage silos of data more effectively, collate data from a wide range of sources, and implement ‘big data’ and machine learning applications to unlock the full power of their data. Big data and machine learning allow multiple, large datasets to be aggregated and analysed intelligently to reveal subtle patterns and rich insights. Identifying such patterns and areas of concern ahead of time can help inventory management, excessive inventory financing, holding, waste, recalls, and crucially, protect against fraud in vulnerable parts of the supply chain.

Overall, the modelling and analytics capabilities brought by AI enable more informed decision-making – a critical factor in managing risk and product quality, as well as harmonising and optimising supply chain management. From Hesitancy to Data Integrity: The Hurdles to AI Rollout Despite their promise, several challenges face the widespread adoption of AI solutions. For one, the pharmaceutical industry is riskaverse, with many companies adopting a ‘wait-and-see’ approach to implementing innovation, and technology is also outpacing regulators’ ability to manage it, complicating the current and future compliance landscape. Important considerations also concern the integrity of the data itself: the pharmaceutical industry generates data in vast volumes and at differing qualities. But how can organisations manage such large amounts of data and be confident that each data point is reliable? And how do we determine which data are useful to collect, and which are not? While data are undeniably valuable, not every data point must or should be kept – and those who fall into this trap run the risk of becoming ‘digital hoarders’, making their systems more challenging to manage and optimise as a result.

Ensuring data quality and integrity are prominent (if not the most important) challenges in the implementation of AI. Regardless of the power of an AI tool, rubbish in equals rubbish out – high-quality data inputs are fundamental for achieving robust models and unlocking the full predictive potential of AI. Models must then also be checked against high-quality data to verify predictivity, so a pool of robust verification data must be accessible and available for the context within which the AI tool is operating.

Conversely, machine learning applications – by which a system is fed data to learn and generate novel output — require more data to self-improve. Still, organisations have been hesitant to share relevant datasets (and some organisations may lack the data needed to generate appropriate models without collaboration). Datasets that could be immensely valuable, if used in concert with others, are often closely guarded as part of efforts to protect organisational secrecy and data security, making data collaboration a significant hurdle to overcome. However, blockchain is enabling companies to share material while maintaining their proprietary information, opening up new avenues for cooperation. By moving towards a more open, decentralised model for data collaboration, organisations can build and share the kind of verified, high-quality datasets needed to deploy valuable AI solutions effectively. The Future Power of AI Despite these challenges, AI has the power to increase the agility and visibility of pharmaceutical supply chains. This is essential for protecting patients worldwide and making the industry more resilient so it can better respond to events such as the COVID-19 pandemic. For instance, AI can be used to predict where disease outbreaks will occur using contact tracing data. Such knowledge would be vital to monitoring the spread of the disease to ensure the timely delivery of a presumptive vaccine or PPE to at-risk locations.

The predictive power of AI holds exceptional promise in the realm of supply chain management. For instance, AI tools can predict where a supply chain is likely to be disrupted by traffic, extreme weather, or geopolitical events such as protests or pandemics, and pre-emptively reroute medicine deliveries to avoid disruption. Such tools could also be leveraged in exploratory or diagnostic ways to protect supply chains, e.g., identifying weak points during distribution or likely sources of counterfeits. Additionally, by modelling whether orders could be consolidated in the production and distribution chain, AI-based tools for logistics and fulfilment can seek areas where increased efficiency can protect profit margins and improve performance. Conclusion From manufacture through to packaging and distribution, pharmaceutical supply chains can stretch across numerous countries and continents. Optimising these long, complex supply chains and associated distribution networks is vital in ensuring that legitimate, high-quality medicines reach patients faster.

Advanced tools based on AI and blockchain are aiding global efforts to manage complex supply chains and protect them from safety issues like counterfeiting and theft. Although many challenges must be overcome to enable the widespread implementation of AI-based solutions, these tools promise significant benefits for a wide range of supply chain processes, including forecasting, inventory management, procurement automation, and production optimisation.

Advanced technologies enable a fuller understanding of the dynamics and processes at play across a complicated supply chain, enabling better assessment and monitoring

of risk, protection of profits and performance, and optimised operations. They also open up new opportunities for predictive modelling of potential disruption and triangulation of counterfeit products, helping pharmaceutical organisations prevent supply chain fraud and protect both the integrity of their products and the safety of the patient. REFERENCES 1. Piranty, S. (2020) Coronavirus fuels a surge in fake medicines, BBC World

Service. https://www.bbc.co.uk/news/ health-52201077 2. Shujath, J. (2018) How tackling counterfeit drugs will drive improvements in the pharma supply chain, Pharmaceutical

Commerce. https:// pharmaceuticalcommerce.com/brandmarketing-communications/howtackling-counterfeit-drugs-will-driveimprovements-in-the-pharma-supplychain/ 3. Karunamoorthi, K. (2014) The counterfeit anti-malarial is a crime against humanity: a systematic review of the scientific evidence. Malar J. 2014; 13: 209. 4. World Health Organization (2017) 1 in 10 medical products in developing countries is substandard or falsified. https://www. who.int/news-room/detail/28-11-2017-1in-10-medical-products-in-developingcountries-is-substandard-or-falsified 5. Blackstone, E., Fuhr Jr., J. P. and Pociask, S. (2014) The Health and Economic Effects of Counterfeit Drugs. Am Health Drug Benefits. 2014 Jun; 7(4): 216–224. 6. Geschonneck, A. (2020) The supply chain fraud pandemic. KPMG, 7 May 2020. https://home.kpmg/xx/en/blogs/ home/posts/2020/05/supply-chainfraud-pandemic.htmltion to COVID-19.

Jaleel Shujath

Jaleel Shujath is the VP of Marketing at Absorption Systems. A 30-year veteran of the industry, Jaleel has worked in all areas of the life sciences value chain, focusing on leveraging new technologies to enhance processes and regulatory compliance. Jaleel has a Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals from RAPS, and is a member of the Editorial Board of the American Pharmaceutical Review. Absorption Systems is a fullservice non-clinical contract research organisation (CRO) developing innovative services and solutions for the pharmaceutical, biotech, medical device, and regenerative medicine industry. The company's mission is to continually develop innovative research tools that can be used to predict human outcomes more accurately or to explain unanticipated outcomes when they occur.