An Analysis of the Key Insights of the Drug Supply Chain

Pharma compliance is a joint effort that is pulled in by pharma supply chain stakeholders and regulatory bodies that ensure that drug production processes are carried out in a secured and safe manner. However, it is not as easy as it may sound because there are several complex factors that need to be considered to be able to enhance the compliance factor; Few of them being:

• The willingness of the stakeholders to adhere to the compliance policies
• The willingness and the realization of the stakeholders to invest in technologies to maintain the compliance standards.
• The type of technologies that have been deployed by the stakeholders
• The willingness to transparently communicate

The root of compliance lies in all the above-mentioned factors and their levels of acceptability in various stages of the supply chain. However, “willingness to invest” is not enough in an agile environment like that of the pharma supply chain. One has to be prepared for the changing requirements that the industry demands now and then; More so because the regulatory deadlines and compliance guidelines also change. In fact, the duo is interdependent on one another, which makes operations in a supply chain even more complex.

Here are a few lesser-known insights, rather challenges, in the drug supply chain that justify the complexity of the drug production process. We will also be discussing their simple, affordable solutions later.

Aligning stakeholders for a common compliance goal

The pharma industry was not as fast-paced as it is today, which means that the earlier traditional methods of compliance which were more departmentalized or localized will not work in today’s time. Traditionally, compliance has been managed by teams and departments, but that should not be the case now because compliance is more interconnected. There was a time when the rules and regulations were disconnected, making it easier for companies to turn a blind eye to compliance or work in a vacuum. But, that cannot be the case now because a single negligence, say at the manufacturing level can result in loss of millions of dollars at each of the phases of the supply chain.

Owing to the difference in perception of compliance by different stakeholders in the drug supply chain, the complexity only grows. However, the advent of technology can smoothen uneven surfaces, making interoperability the core of supply chain processes. With the present-day supply chain demanding alignment of thought-processes and functionalities, the goal is distinct and difficult.

High cost of compliance auditing

The DSCSA requires compliance auditing whenever the drug changes hands in the pharma supply chain, which requires manufacturing and transit details of the consignments and how the packages have been handled. Compliance audit and inspections are extremely costly because one may need to deploy additional manual resources to do the paperwork. Many companies try and avoid that, but end up paying more in fixing the mistakes and paying hefty penalties. It is, therefore important to have affordable audit-readiness in place that will assure of error-free auditing and also eliminate the necessity of deploying manpower for the purpose.

 Lack of technical integration and Big Data with old systems

Companies that have been using legacy software and systems to store data might want to drastically shift to Big Data. But do they have the bandwidth to accommodate an advanced technology as complex as the Blockchain? One, the system required for blockchain is not adaptable to legacy systems, which creates a chaotic supply chain operational environment for drug production. So, does that mean, Blockchain shouldn’t be considered at all? The ideal way to get out of this dilemma is to deploy systems that are easily interoperable and can communicate with any system at ease.

Why there’s a need to overcome the above challenges

Did you know that only 25% of the reporting systems used by stakeholders in the drug supply chain provide real-time compliance information? Also out of them, only 19% of those systems have the drill-down capacity. Now, when DSCSA compliance standards largely focus on data-sharing and transparent information exchange, this could be a major hurdle in maintaining compliance standards. In other words, without these fundamental capabilities, leaders and compliance specialists are fighting an uphill battle.

It is extremely important to attain data at a granular level in some of the important stages like the VRS where verification needs to be done from data repositories having details about the origin of the saleable return. Without drill-down capacity, systems would not be able to align with one another in terms of data-sharing, which in turn will increase the auditing costs because additional resources, such as manpower or third-party vendors, have to be deployed to retrieve unit-level information.

The need to eliminate the challenges become more urgent customer expectations are changing, disrupting the market in a major way. In this scenario, companies are struggling to drive innovation without compromising their regulatory integrity. While the two mandates are at odds, they are not impossible to achieve. Pharma companies are ready to invest in advanced technologies, such as the Blockchain and others, that are agile and adaptive to the ever-changing ecology of the pharma supply chain. However, they do not wish to tamper with their existing infrastructure because that requires fixing issues that need millions of dollars and long unproductive hours. So, that leaves them with a software that is responsive even in a vintage framework.

Solutions

There’s a reason why the insight discussed above look more like challenges; Because that’s what the stakeholders feel right now. Once they find a solution to implement them in their supply chain, these will easily change into drivers for the drug supply chain they are functioning in.

But, is it that simple to find solutions at hand that can enhance the functioning of a drug supply chain without disturbing it too much? We cannot ignore the fact that the supply chain is driven by regulatory guidelines of data-sharing; What if there were solutions that assured results under the compliance standards, while ensuring businesses run faster and smoother, positively affecting the ROI? What if these solutions offered more than we can expect- enhancing interoperability, in turn promoting transparent data sharing and drug visibility?

Consider these:

1. AR-enabled multiscanners: A brainchild of TrackTraceRX, this is not just any scanner. It used Artificial Intelligence to capture real-time information about the origins of drugs. It enhances the drill-down capacity of the supply chain, enabling easy verification of drugs whenever it changes hands or during the VRS process. It also reduces the cost of compliance auditing because the data it captures is stored in a centralized repository that when requested automatically furbishes the details during auditing processes, which is a significant step. After all, warehouse managers have to handle thousands of units for verification returns with a span of 24 hours. With direct-to-transfer data, the 23-pager auditing report is complete within no time.
2. Traceability Suite: Locate the drug you are looking for within seconds. From connecting with the look-up directory to retrieving data about a product, everything happens within minutes, helping warehouse managers take a quick decision as to whether a product should be destroyed or sent back to the mainstream supply chain in VRS stage.
3. Centralized data repository: The masterdata is the centralized repository of all information gathered from unit-level capturing of data with the help of multiscanners. These data can be retrieved by all the networked partners at any given point in the supply chain. In fact, TrackTraceRX is working toward strengthening it with the help of Blockchain technology that will soon becoming a norm in the operations of the drug supply chain.

As regulatory bodies continue to mull over the changes that need to be done in the future, stakeholders in the supply chain must adopt technologies that are flexible in the face of agility. Consider the working principle of TrackTraceRX’s solutions, which are built on the concept of API-first approach, which eliminates the most crucial challenge that supply chain stakeholders face- of implementing new technology in an old framework, disturbing the current workflow. Our solutions have been designed to integrate without dismantling the existing infrastructure, which makes the former flexible enough to any given framework even in the future.

Having said that, an integrated view of the enterprise that takes into consideration the criticality of advanced technology, alongside the need for efficient and modernized processes is critical. Now is the time for pharma companies to realign their processes to the demands of the future of traceability.