Patient safety depends on two things: the pharmaceutical industry’s ability to manufacture effective, high quality medicines; and the ability to distribute them through secure supply chains.
Historically, regulators have concentrated on ensuring medicines are safe and effective though detailed assessments and facility inspections. However, while this work continues, in recent years supply chain security has become more of a focus.
Pharmaceutical supply chains are complex, involving multiple stakeholders, which makes tracking drugs from manufacturer to patient a considerable challenge. To address this, regulators in most major markets have introduced legislation compelling manufacturers to mark products so they can be more easily followed.Compliance with these serialization requirements relies on the collation of accurate data that can be accessed by multiple stakeholders at all points in the supply chain. However, the benefits of such systems go far beyond the simple transmission of data to ensure compliance because they can facilitate better, more effective communication and information exchange between all parties. In the 2017 Global Drug Supply, Safety and Traceability survey by TraceLink, 78 per cent of contract manufacturing organisations (CMOs) said that they are already working on value-added serialization projects, compared to 19 per cent of pharma companies. In this article, Jean-Marie Aulnette, vice president of EMEA at TraceLink explores the potential value that can be achieved by implementing a track and trace program.
From a pharmaceutical industry standpoint, the most effective method of managing serialization data is to use a network-tenant solution that can be accessed by people involved in each stage of the supply chain.The ability to upload product serialization data and allow others to access it for verification purposes is core. However, it is equally important to allow users to interact and collaborate. Achieving such access can be a challenge given the disparate stakeholders involved.
One innovative way of achieving this is to develop data access apps – software applications – that are suited to the requirements of the stakeholder involved, whether they be at the manufacturing site or a wholesale warehouse.
The volume of data involved in a pharmaceutical supply chain is significant. Network-tenant systems are ideal for handling large amounts of information because storage capacity is distributed and easily extendable.One way of managing large amounts of information is to use master data functions, which are used to define the contextual attributes of a data object at a foundational level.
The functions include information such as product name, company location, partner shipping address, unit of measure, dosage form, contact email, government drug code. In addition, master data sets interact with transactional data, such as sale, shipment, or decommissioning of a product. This interaction facilitates tracking through the supply chain, streamlines the number of data elements and reduces the risk of data ending up in the wrong place or format.
Another benefit of using a platform is the breadth of data that can be stored. As previously stated, the effective management and storage of on-pack serialization data is key to supply chain management. However, such systems can also be used to transfer other information that is important to stakeholders.In addition to track & trace compliance information, an effective network can share detailed product information. This is potentially very useful for pharmaceutical products, which may be approved for different uses in different markets.
Patient centricity is an increasing focus for the pharmaceutical industry. Improved interaction can improve therapeutic outcomes by, for example, helping the patient to comply with their treatment regimen.
However, pharmaceutical companies and others in the supply chain also stand to gain from product usage information for forecasting and market analytics.The challenge is that, after commercialization pharmaceutical manufacturers have little access to patients. At present, drug companies buy information from brokerages that have collected consumer behaviour and market data from a range of sources. While this is useful, it is not real-time.Through a network, pharmaceutical companies have the ability to leverage real time usage data provided by stakeholders at the end of the supply chain, like pharmacists and wholesalers.
A network-tenant architecture also provides an effective and highly responsive means of recalling products.During a recall, ensuring patient safety is the primary concern. It is critical that potentially dangerous drugs are removed from the market as soon as possible, while ensuring safe products remain available to prevent shortages. It is also important that recalls are carried out effectively to minimize the impact on a drug manufacturer’s reputation, regulatory compliance or finances.
In practice, however, pharmaceutical recalls can take months using traditional distribution systems that do not allow companies to track their products to patients, trade partners and pharmacies.
A network has the potential to address hurdles that would otherwise delay a recall by providing a common, traceable channel through which information flows.For example, by leveraging serialized data flowing through a network, it is possible to identify the exact quantities and specific location of recalled products and provide members of the supply chain with handling and disposition instructions.In addition, it is possible to report on progress and determine the amount of pharmacy inventory already dispensed to patients and electronically send recall notifications.
Serialization is a major focus for the drug industry. Implementing an effective and compliant track and trace system is a complex process requiring interaction with multiple stakeholders throughout the supply chain. A network platform provides a way of collating data from each point in the supply chain, ultimately ensuring compliance with global track and trace regulations.
However, a network platform can provide even more benefits, by allowing parties involved in the distribution of pharmaceutical products to collaborate and interact in a way that generates invaluable market information.
Likewise, in the event of a recall such systems can accelerate operations be facilitating more rapid communication between disparate parties involved in the supply chain,
To read the full 2017 Global Drug Supply, Safety and Traceability Survey Report, visit https://www.tracelink.com/global-drug-supply-report/2017-report
The results of the report and their implications for the pharmaceutical industry will also be discussed at FutureLink Munich, which will take place June 5-7, 2018. The event will see leaders from across the pharmaceutical and healthcare industries gather to discuss regulatory compliance and shaping the future of digital drug supply with information sharing networks.
For more information and to reserve a seat, please visit FutureLink Munich.