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The year 2023 marks a significant change for the pharmaceutical industry, as it implements the Drug Supply Chain Security Act (DSCSA) to bring transparency to the movement of drugs across the country's supply chains. This law requires all systems involved in the pharma supply chain to interoperate and function together seamlessly. The industry has different players, including manufacturers, distributors, dispensers, and 3PLs, each with their own interests, competitions, and marketplaces. However, implementing the law has brought solution providers to the scene, eager to solve the problem of interoperability. Regulators are also keen to obtain much-needed information to protect public health.
To protect the public and achieve interoperability, we can learn from the lessons of the Internet's success. The early versions of the internet were concerned about the right mechanisms to transport data - introducing packets as part of the ARPANET project. This was a significant change then when interconnectivity was viewed more like the telephone network, which used circuit switching – essentially dedicated connection. The Internet has changed much in the two decades since it came into existence. It was conceived in the era of time-sharing, but has survived into the era of personal computers, client-server and peer-to-peer computing, and the network computer. It was designed before LANs existed, but has accommodated that new network technology. One of the key tenets of the early days of the Internet was that multiple independent networks of arbitrary design could coexist, and interoperability mechanics could not dictate anything. The two winning tenets from those early internet days were: - 1) Be cognizant of the various network designs involved 2) Be focused on what is needed at a minimum to conduct a data connection. In the modern era, it's easy to connect to different networks, and it's essential to name entities in a way that encompasses all identification schemes used by different organizations, using global location numbers, accreditations, and licenses. Achieving interoperability successfully requires addressing both tenets 1 and 2, and the most common method is to simplify interoperability to its basic tenets. "The key takeaway is not to be sidetracked by the supply chain technology pressures and distractions but to focus on the greater good of protecting the public by loosely coupling the supply chain dependencies into a network of possibilities to get better overall" Achieving transparency across multiple supply chain ecosystems can be challenging, given that FDA approved medications may be manufactured in other countries, pass through different facilities and warehouses, making it impossible to collect the ownership history of a drug. Data privacy issues and market advantages also add to the challenge. However, transparency is critical for identifying risks and empowering decision-making. To achieve transparency, it is important to protect confidential commercial and trade secret information and standardize data sharing, allowing for commonality across the industry, thus improving. interoperability. The complexities of the supply chain result in inconsistent and non-standardized data, which can lead to supply and quality concerns for regulators, healthcare providers, and policymakers. Greater transparency of key indicators is crucial to pinpoint concerns and make investments to improve the resilience of the supply chain. However, improving standardized information requires tailored action based on national contexts. Since the medicine supply chain is global, international collaboration among governments, organizations, and industry is necessary to improve information flow and expand transparency. The needs of regulators are quite simple, needing only to know the manufacturer, distributor and dispenser that previously owned the product. Achieving this simple query alone provides critical information necessary to ensure the legitimacy of the drug and protection of the patient. If every dispenser ensures authorized sources, we strengthen the health of the entire drug supply chain of the country. Often, technologists are prone to diverting the conversation away from its intended purpose, being caught up in topics such as blockchains, credential technologies, trust relationships, and countless other technical jargon, leading to a more confusing discussion than when it began. The key takeaway is not to be sidetracked by the supply chain technology pressures and distractions but to focus on the greater good of protecting the public by loosely coupling the supply chain dependencies into a network of possibilities to get better overall. Engagement is the call of the hour, and we should keep it simple.