Regulations dictating technology: Exploring the possibilities in drug supply chain
We all know how important technology is for the drug supply chain, especially when we are talking about increasing the velocity of authentication and speeding up the screening process of the drug consignments. Technology is fast and accurate, which makes it widely acceptable and adaptable. But, here's the glitch. A drug supply chain is often governed by FDA regulations, demanding certain processes to get the desired result. In certain cases, it also goes ahead and mandates a certain format of serialization so that all the stakeholders are on the same page when it comes to serialization and drug visibility.
Implementing the linear barcode is a case in point. Back in 2004, the FDA published their final barcode rule that required all stakeholders in the supply chain to have a linear barcode at the unit level to carry the National Drug Code. It took effect in 2006, allowing participants to put systems in place effective methods to adopt the mandate. Although it did not specify one particular barcode symbology, the instructions were pretty clear- the code had to be linear.
Now taking this as a cue, let's explore the pros and the cons of the process:
Pros
Whenever a situation is complicated, it is always better to have someone dictate to you what needs to be done. In a complicated environment like the pharma supply chain, this holds for the stakeholders. If we take the above-mentioned example, the members of the US pharma chain benefitted from the regulation of the linear bar code technology because all of them could be on the same page, preventing manufacturers from using a different type of technology that was not interoperable with the technology that other stakeholders used. The downstream players, as a result, we're able to invest in a single reader technology and establish a single operating process to read the NDC.
So, by enforcing this single technology standard, the FDA was able to ensure interoperability among the stakeholders.
Secondly, dictating the technology or the process can ensure that stakeholders do not spend unnecessary time looking for the right way to be compliant. This saves a lot of time and money on the part of the stakeholders if they already know what they should be looking for. Finding out the best vendor providing similar services would just be a matter of a click.
Thirdly, when any of the systems dictated by the FDA falter at any stage, the regulatory body will be the one solving it. No matter how much time it takes to rectify the situation, the onus is not on the stakeholders and they would not be penalized for deviating from the DSCSA compliance process.
Fourthly, without a mandate by the regulatory body in place, stakeholders will not take the technological changes seriously to the extent of not establishing the framework or the infrastructure that promises of the desired outcome.
Cons
The pharma supply chain is already a dynamic and complex ecology, demanding increasing care and attention from the stakeholders functioning within it. Now, if you add the DSCSA regulations and the dictates that follow, there is no room for being creative or imaginative in technological innovations. For instance, say a manufacturer foresees some issues with the linear barcode and realizes that it might not stand the test of time and the demand that might arise in the pharma supply chain shortly, he is not allowed to innovate because what he might have predicted, the others in the supply chain might not see. After all, being on the same page is important.
Our second analysis stems from the linear barcode example that we have stated above. Currently, the US FDA is considering to change the mandate regarding the linear barcode to allow other technologies to carry the NDC or the Standardized Numeric Identifier (SNI) that they had defined but not mandated in 2010. In other words, its time for GS1 to replace all formats to be able to include the GTIN and the SGTIN, which can extend up to 40 characters. To read such codes, a 2D code reader or an RFID scanner is important.
Now, here's the issue. Companies that had already implemented the linear code and the others who had deployed single scanners to be able to read them have already invested thousands of dollars to meet the compliance standard. Changing the format now means added investments that affect business profitability negatively. The former framework might have to be reworked upon attracting additional costs.
The last question that comes to one's mind is whether the framework that DSCSA provides is good enough to be future-ready. Now, we are fighting the counterfeit drug marketers to ensure that only legitimate drugs reach the end-user, there might be other demands or challenges that a supply chain may have to overcome in the future; And, which would need other traceability solutions stemmed in the working principles of high-tech information engineering like the BlockChain and the Big Data.
In other words, flexibility to adapt and interconnect might be stalled in the future, if we did not give a thought to other options.
We already have a solution
It is high time that DSCSA acknowledged the need for flexible and not rigid solutions to combat the challenges that rid the pharma supply chain. Clearly, the ever-changing guidelines would not do for a supply chain that takes as long as 12 years or more to produce a prescription drug.
TrackTraceRX, a reliable traceability solutions provider in the United States roots its innovations on flexibility. For instance,
The AR-enabled multiscanners: RFID is already a thing of the past and speed is what is most in demand in a drug supply chain. With AR-enabled multiscanners, both linear, 2D, 3D or GS1 codes are readable, which is not possible with single scanner RFID scans. Augmented Reality is an add on that is futuristic and fast, speeding up the requirements of the present-day supply chain and gearing up for the future that is deep-rooted in the principles of blockchain. So, all stakeholders need to do is capture the information and send the same to the centralized data inventory for later references. No need for manual investigation and data entry.
API-first technology: Each of the traceability software designed for the drug supply chain is based on API-first technology, which means implementing them in a regular framework is not an issue. The fluid workflow instructions are easy to follow without any external help and companies do not have to change their operational framework too, which demand additional investments. The API-first technology is extremely important for interoperability which is the demand of the time and will continue to be so in the future too.
Centralized master data: Time's up for inventory ledgers, which are localized and are prone to be non-interoperable; Because it depends on the stakeholders who build it for their convenience and security whether or not to provide the key for the same to the other participants when required. The centralized data, on the other hand, is the repository of all the data collected whenever drugs change hands. This data repository can be connected at any point, anytime, by anybody to verify a given product, especially during the VRS process.
[Read: Why you Need to Take Unit-level, Lot-level and Package-level Identifiers More Seriously!]
Conclusion
As much as the regulatory guidelines of DSCSA show stakeholders in the supply chain a definitive direction toward traceability, it is equally important to be creative to make track and trace technologies flexible to be able to adapt to more challenging supply chain environments in the future. It is, therefore, best to conclude that a supply chain should be combinedly governed by supply chain stakeholders and the FDA.