Logistics & Supply Chain Management
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 96 INTERNATIONAL PHARMACEUTICAL INDUSTRY
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 Spring 2021 Volume 13 Issue 1
