Serialization of Medicines: An Effective Tool in the Fight Against Frauds in the Pharmaceutical Market

The entire world recognizes the risks associated with using medicines of unknown origin. Numerous studies indicate a significant percentage of counterfeit medicines reaching patients. Patients often unknowingly acquire these products on auction platforms, various “markets,” from acquaintances, or even at pharmacies. While trading products outside of state control can only be limited through education and a firm stance by authorities, counterfeit medicines that reach pharmacies are more challenging to detect, posing a serious threat. 1. Why is medicine serialization important? Medicine serialization is the process of assigning each package of medicine an individual serial number, which is monitored at various stages of the supply chain. Thanks to unique serial numbers, it becomes easier to identify genuine products, helping to eliminate fake medicines and protect patients from harmful or ineffective substances. The serialization process allows tracking of each package of medicine from the moment of production to delivery to the patient. This enables a rapid response in case a defective batch needs to be withdrawn from the market. It’s worth noting that in many countries, such as EU member states (in line with the Falsified Medicines Directive) or the USA (DSCSA law), serialization is mandatory to enhance the safety of pharmaceutical products. Moreover, this system allows for more efficient management of drug inventories and control over their distribution, reducing the risk of errors, such as duplicate batches or improper handling of controlled medicines. There have been several prominent incidents in pharmaceutical history that exposed the problem of lacking adequate control mechanisms, such as serialization. In the 1930s in the USA, mass poisonings with “Elixir Sulfanilamide,” containing toxic diethylene glycol, led to the deaths of over 100 people, including children. The lack of regulation and control mechanisms like serialization contributed to this tragedy, which led to stricter laws being introduced (the Food, Drug, and Cosmetic Act, 1938). Thalidomide, used in the 1950s and 1960s as an anti-nausea medication for pregnant women, caused deformities in thousands of children. The lack of appropriate monitoring and serialization systems prevented a quick response and effective recall of the drug from circulation. In Nigeria, in the mid-1990s, fake antimalarial medicines flooded the market, leading to numerous deaths and health complications among people who unknowingly took ineffective or toxic substitutes. Unfortunately, this is not the only counterfeiting scandal remembered in Africa’s pharmaceutical history. In various African countries between 2000-2010, counterfeit antimalarial medicines, such as artemisinin, were widely distributed, leading to thousands of deaths due to ineffective treatment. None of the packages of the mentioned medicine had a serial number. While it may seem that the aforementioned pharmaceutical crimes took place long ago or do not concern the Western world, the case of contaminated heparin in 2007 feels much closer. Heparin is a commonly used blood thinner. Batches of this drug contaminated with chondroitin sulfate were previously produced in China and then imported into the USA, where they entered circulation, leading to hundreds of complications and 81 deaths. The lack of effective mechanisms for identifying individual product batches, such as serialization, made it difficult for authorities to swiftly withdraw the dangerous mediciness from the market. The problem was discovered only at the beginning of 2008 when a series of unexpected complications and deaths were reported in patients undergoing medical procedures in hospitals where heparin was administered. The heparin scandal clearly showed the importance of monitoring the medicine supply chain, especially in a global economy. Medicine serialization, which was later introduced as a standard in many countries, aimed to prevent similar scandals by allowing each package of medicine to be tracked from production to the patient, significantly enhancing safety. All these cases demonstrate how crucial it is to maintain thorough control over medicines and to be able to track them. The serialization of medicinal products is one of the tools that can help prevent such tragic incidents, ensuring patient safety and effective product recall from the market. 2. Verification through Unique Identifiers To combat counterfeit drugs, the obligation to verify the authenticity of medicines through serialization has been introduced. Medicineverification through unique identifiers is a key component of the system designed to prevent the falsification of pharmaceutical products. This process involves assigning each package of medicine a unique batch number (LOT), which is tracked at various stages of distribution. Each medicine box receives a unique identifier, which typically consists of: Global Trade Item Number (GTIN) – assigned to the pharmaceutical product, Serial Number (SN/NS) – unique for each package, Batch Number (LOT) – indicating the production batch, Expiry Date (EXP) – specifying the drug’s shelf life. All these details for a given batch of medicine are stored in the form of a 2D barcode (e.g., DataMatrix) or a QR code, which is placed on the medicine’s packaging. Verification of authenticity is done by scanning the code on the packaging, which is checked against a central database accessible to manufacturers, wholesalers, pharmacies, and relevant regulatory authorities. This system of medicine authenticity verification enables the checking of the origin of mediciness before they are dispensed to patients, as well as tracking each package of medicine throughout the entire supply chain. 3. Application of Advanced Information Technologies The online medicine verification system utilizes advanced information technologies, enabling effective verification and identification of medicines. The serialization process requires generating unique codes and printing them on the packaging. An important element is also print verification, which involves checking whether the medicine codes are readable and contain correct information. Image recognition techniques and large-scale data processing are used for this purpose. It is also worth mentioning that the use of advanced IT technologies, such as blockchain, cloud computing, IoT, AI, and Big Data, significantly increases the security and transparency of medicine verification. Blockchain is one of the newest medicine verification technologies, ensuring complete transparency and immutability of records. In blockchain, every transaction related to the medicine – from production, through distribution, to sale – is recorded as a block in the chain, which is publicly accessible and cryptographically secured. Cloud systems allow quick access to medicine-related data from anywhere in the world and integration of global systems (facilitating easy connection between different pharmaceutical supervision systems, enabling international cooperation). Big Data, or the analysis of large data sets, allows the identification of patterns, trends, and anomalies in the medicinesupply chain. By analyzing huge amounts of data on distribution, sales, and market monitoring, it is possible to detect irregularities early that suggest the presence of counterfeit medicines. IoT technology, in turn, enables communication between devices over the Internet. It can be used to monitor medicines at every stage of their journey. Drugs, especially those requiring special conditions (e.g., low temperature), are equipped with IoT sensors that monitor temperature, humidity, and other parameters during transport and storage. If storage conditions are exceeded, the IoT system automatically sends alerts to relevant personnel, allowing for immediate action and the withdrawal of drugs from circulation. AI and machine learning are increasingly used to analyze drug-related data and predict risks associated with counterfeiting. AI can predict potential counterfeiting threats by analyzing historical data and behaviors in the supply chain. AI systems can automatically analyze serialization data and report suspicious cases or deviations from the norm. The introduction of mobile applications allows patients and pharmacists to quickly verify the authenticity of drugs. Users can scan the 2D barcode on the medicine’s packaging using a smartphone and instantly check whether the drug is genuine, as well as obtain information about its origin, manufacturer, and expiration date. Examples: Mobile applications can alert patients if a counterfeit drug is detected, as well as allow for reporting suspicious products to regulatory authorities. RFID technology enables wireless identification of products using radio waves. Thanks to RFID chips, it is possible to monitor in real time where a particular drug is and whether it has reached the correct facility. 4. System Integration and Central Database Drug manufacturers must integrate new systems with existing ones or develop new solutions to enable the serialization process. System integration involves connecting various tools and technologies used by different entities in the drug supply chain, such as manufacturers, wholesalers, pharmacies, and regulatory bodies, into a single cohesive system. The goal of integration is to ensure smooth information exchange between these entities, enabling comprehensive monitoring and verification of medicines at every stage of their journey, from production to delivery to the patient. Each packaging line in the factory must be equipped with appropriate interfaces, printers, cameras, and computers to manage the drug serialization process. The central drug database is a centralized platform that collects and manages information about all medicines subject to serialization and monitoring. This database is a key element of the verification system, as it enables the storage of data on every package of medicine or medicinal product and its distribution history. An example of such a database in Europe is the European Medicines Verification System (EMVS), which allows drug verification in accordance with the requirements of the Falsified Medicines Directive (FMD). In the USA, this role is fulfilled by the Drug Supply Chain Security Act (DSCSA), which envisions the creation of a similar monitoring system. The central drug database forms the foundation of verification systems, providing full control over the authenticity and origin of drugs, preventing counterfeiting, and increasing patient safety. Furthermore, the costs associated with adding a drug to the central drug database are usually borne by the drug manufacturer. Through system integration and the collection and submission of codes from properly packaged products, effective verification of drug authenticity is possible at every stage of distribution. 5. Impact of Serialization on Pharmaceutical Infrastructure The implementation of the serialization process has had a significant impact on the pharmaceutical infrastructure and industry. This legal requirement has resulted in positive changes for the entire industry. First and foremost, every entity involved in the production and distribution of a drug must adapt production, distribution, monitoring, and data management processes. This affects all entities in the supply chain, from manufacturers to wholesalers to pharmacies. Every pharmacy has been equipped with terminals for verifying packages, allowing them to check the authenticity of drugs before dispensing them to patients. Moreover, the introduction of the serialization process required coordination among manufacturers, pharmacies, and other entities involved in the process. This certainly increased drug safety. However, ensuring compliance with global regulations has raised production costs. In many countries, serialization is required by law (e.g., in the European Union under the Falsified Medicines Directive – FMD, and in the USA under the DSCSA), meaning companies must adapt their infrastructure to meet these requirements. In Poland, the National Medicines Verification Organization (KOWAL) was tasked with overseeing and coordinating the implementation of the serialization process. Drug serialization forced pharmaceutical manufacturers to adapt to new regulations, which involved additional costs. Although this may seem challenging, the significant benefits of this process cannot be overlooked. One of the key advantages is the improvement of quality management, which these regulations enforce on manufacturers, ensuring a higher level of product control and increased patient safety. Serialization allows companies to better manage drug quality by monitoring the entire product lifecycle. This not only leads to improved quality and safety but also helps optimize costs and produce with greater respect for the natural environment. 6. Benefits of Serialization for Patients and the Pharmaceutical System The introduction of the serialization process for medicinal products has brought numerous benefits for patients and the entire pharmaceutical system. Most importantly, it has enabled the effective identification of genuine medicines and the detection of counterfeits, increased transparency (greater transparency in drug distribution has contributed to a better perception of the pharmaceutical system), as well as improved inventory management. Patients can have greater confidence that they are receiving safe and effective products rather than counterfeit drugs. Drug serialization also helps combat the gray market and the illegal trade of counterfeit medicines, contributing to the protection of public health. Additionally, improved control over drug distribution can help reduce treatment costs associated with the misuse of counterfeit or ineffective products. Serialization also helps protect patients from expired medications, as the system allows tracking of the expiration date of medicines at every stage of distribution. Patients only receive medications that fully comply with current quality standards and are not expired. 7. Medicine Serialization – Summary In summary, the introduction of the serialization process in pharmacy was an essential tool in the fight against counterfeit medicines, which simultaneously ensured safe and authentic products for patients. The use of advanced information technologies enabled effective drug verification and identification, as well as control over the distribution process. The benefits for patients, manufacturers, and the entire pharmaceutical system are evident, marking an important step towards ensuring the safety and authenticity of drugs on the market. In this fight against counterfeits, we are proud to be a provider of quality management solutions for the pharmaceutical industry. Acting as experts at TTMS in the field of drug serialization, we offer comprehensive services and consulting to help fully implement the serialization process. Our experienced team of specialists has the knowledge and skills to support you at every stage, from planning to implementation and maintenance. If you need support in implementing appropriate systems tailored to your needs, TTMS Quality is here to help. Our experts can provide not only technical solutions but also business consulting services. Contact us to learn more about our services and how we can assist you in implementing the serialization process. Together, we can ensure drug safety and authentic products for patients. We will support you in achieving success in the pharmaceutical industry.

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