The New Era of Healthcare Visibility Compliance

At a recent conference held by Tracelink (Nexus Conference, New Brunswick, NJ, Septmber 2011), Bob Celeste from the GS1 organization shared his views on how the new era of visibility in the healthcare landscape is evolving. Visibility is a term which comprises the entire space including subsets defined as Track & Trace/Traceability. This term can also comprise the status of items that have expired, or have been disposed of, which is an important element for counterfeit. (Some counterfeiters sell expired product on the open market by accessing product that has been disposed of). Visibility is a term that may also comprise other attributes of the product. For example, the status of the product’s temperature stability is critical for biological products, (a topic that we cover next when we discuss cold chain distribution). It may also include information about whether the item is damaged, fit for use, has been delivered on time to the right location, and can provide information on the status of the item (whether it is in transit, in inventory, etc.). Visibility is, in a sense, the “holy grail” of supply chain systems, where users can see what is happening to a product in real time and understand its status in the supply chain.

The terms “Traceability” and “Track and Trace” are interchangeable. GS1 typically refers to an item’s traceability, while the FDA uses the Track and Trace terminology in the context of anti-counterfeiting requirements. Traceability/Track & Trace refers to the systems capability of tracking forward to not only where the item is currently, but also to trace back to where it came from and where it has been in its journey to the current state. This capability is more complex than simply identifying where an item is today – it requires a master data system that is essentially a log of an item’s original birth to cradle to grave in the life cycle.

Finally, “Pedigree” is a subset of the Track and Trace capability. It is a specific requirements defined by a US state, by the Federal government, or other countries, and refers to the specific information that provides data on the distribution history of an item. The information may also include details on the “Chain of Custody” (e.g. who touched the product in its journey or had it in their possession), or the chain of ownership (e.g. owned it but didn’t touch it during distribution). The definition around the level of information required by different governments globally varies significantly, as well as the form in which they require it. Projections are that by 2016, all pharmaceuticals will be identified in the GTIN (identification network) and have a unique serial number, and willl have dispositions associated with each item required and tracked through the entire end to end supply chain. This will be a major change in the way that business is done today.

Much of this activity is being driven by the California legislation around pedigree, which states that by 2015, manufacturers must have 50% of their medicines serialized, with the remaining in 2016. By 2017, wholesalers and pharmacies will also be required to have full serialization of products in their pipeline.

The sheer underlying complexity required to comply with these requirements is overwhelming. It is one thing for a set of politicians to enact legislation, and quite another to deal with the technical details, IT infrastructure, and logistical details that go into compliance with the legislation. There are multiple issues to confront in this environment, and large global companies have a lot of complexity in the requirements to distribute globally. First, there are many parties that will be impacted in the supply chain. This includes pharmaceutical manufacturers, contract manufacturers, biologics manufacturers, re-packagers, hospitals, 3PLs’, return processers, etc. In short, anyone who touches the product will have some form of requirement on them, and will rely on biopharmaceutical manufacturers to provide information to fulfill their legal compliance requirements.