Anytime the government moves faster than you, there’s a problem. In this case, pharmaceutical companies that hesitate to digitize may be surprised to learn that multiple regulatory agencies have digitized ahead of them. For example, the U.S. Food and Drug Administration (FDA) has not only gone digital with its internal document control, it has continually embraced new ways to use technology to ensure the safety of the products it regulates. A perfect example of this is the U.S. Drug Supply Chain Security Act (DSCSA), which aims to increase traceability throughout the supply chain.
DSCSA outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs. The legislation went into effect in 2013, but pilot projects to explore useful technologies only started this past February. The FDA has made it clear that they are open to pretty much anything and everything that supports enhanced product tracing and verification. Keeping that in mind, there are steps pharmaceutical manufacturers can take now to begin preparing for the interconnected, digital supply chain.
Where we are
The first step is admitting you have a problem. And most pharmaceutical manufacturers have the same problem — paper. Paper-based processes are imprecise, slow and cumbersome. A hybrid system that includes some digital elements, such as Excel, isn’t any better. These methods still require manual data input, limit accessibility and hinder communication. This creates a scenario in which problems are likely to slip through the cracks and, when they are detected, the ensuing recall process is as slow as any other paper-based process.
When it comes to manufacturing, many pharmaceutical companies are still printing out standard operating procedures (SOPs), signing off on training using physical documents, and populating their batch records by hand. Manually inputting data introduces human error which slows down the manufacturing and recall processes, ultimately costing time and resources. Manual data entry is also imprecise, which leads to pharmaceutical companies pulling more lots from shelves than were likely affected. While it’s better to pull more product than not enough, this still represents unnecessary waste that could be avoided with a better system.
Digitizing with manufacturing software, such as an MOM, MRP, MES, etc., can help with some of these problems, but still leaves much to be desired. A perfect example of this is batch records. Pharmaceutical companies that implement electronic batch records (EBRs) are looking to automate their processes and reduce the problems caused by human error. Unfortunately, with rare exception, EBRs usually over promise and under deliver, so even companies that have digitized end up with batch records that are difficult to review and disconnected from the operator, leaving out critical elements in understanding what happened in the manufacturing process.
Why are we still here?
Pharmaceutical companies, along with other highly regulated companies, suffer from being overly cautious. This isn’t always a bad thing — the drug approval process exists for a reason. However, when it comes to technology, pharmaceutical companies would do well to move a little faster. Compliance is a concern and it should be a factor when considering digitization. Keeping that in mind, there are still many solutions that would expedite pharmaceutical manufacturing processes while maintaining compliance. With proper research, companies can make this move without worry.
Another point to consider is a problem that plagues every industry — an aversion to change. “This is the way we’ve always done it” and “If it ain’t broke, don’t fix it” are not valid reasons to maintain the status quo. Furthermore, digitizing is no longer a matter of outpacing competitors, it’s a question of just keeping up. Pharmaceutical manufacturers, according to McKinsey, “face a stark choice: Either evolve with the new era and build an organization that has digital at its core or risk losing ground.”1
Even pharmaceutical manufacturers that have digitized are held back by the siloed nature of their systems. When systems aren’t integrated and can’t communicate with each other, employees are forced to manually transfer data from one system to another, reintroducing the human error that digitizing was expected to fix. Isolated systems also have the same problems in supply chain visibility that slow down the recall process and result in wasted time and product.
Where we can be
The FDA expects this interconnected, digital supply chain to be up and running in 2023. That might be several years in the future, but pharmaceutical companies need to act now to prepare. Pharma companies are already preparing by following the guidance that is gradually being released by the FDA as we inch toward 2023. Even as they move to meet these requirements, some of them are still relying on paper. The supply chain that the FDA wants isn’t possible in the present, but there are technological advances currently available of which some pharmaceutical manufacturers aren’t taking advantage.
As mentioned, a problem with existing manufacturing software systems is the lack of interconnectivity between systems. During a recall, the typical EBR would provide a batch record — and that’s it. Let’s say a pharma manufacturer determined that there is a problem with one of its ingredients. To find out which batches were affected, they would have to start sifting through documents. Whether those are physically printed or static electronic documents, the result is the same. However, there are some manufacturing software systems that provide more connectivity. A connected solution expedites a recall by telling you exactly which batches were affected, which supplier was responsible for that ingredient, and what the root of the problem was so you can avoid it in the future. It can further connect to your customer relationship management system so you can identify and notify those customers who have been affected.
Avoiding that problem and future recalls requires a system that can connect to quality functions, such as corrective and preventive action (CAPA). A truly connected platform lets quality personnel see the problem, update the associated procedures, and automatically send out training tasks to manufacturing personnel. This avoids having the same problem cause recalls multiple times, and using a digital system ensures that everyone who needs to know about the update is trained. Implementing the system across multiple sites brings the biggest benefit to make sure the entire company is on the same page.
Fully taking advantage of these solutions requires a move to the cloud, which most pharmaceutical companies have been slow to adopt. One of the biggest concerns that companies have is that their data will be less secure in the cloud. In reality, it is more secure. Software as a service (SaaS) companies have more IT resources dedicated to protecting the data and more frequent updates mean that any possible security problems are fixed sooner than they would be with an on-premise solution. Data needed for a recall are better protected by a constantly vigilant vendor team as opposed to an in-house one that can only tackle security on an ad hoc basis.2
What the future holds
DSCSA is about more than just recalls, although anything that increases the security of the supply chain should lead to fewer, less costly recalls. The FDA’s vision for the future will provide complete visibility and assumes that a level of interoperability will be possible that currently isn’t. The goal of these initiatives is to protect patients from suspect and illegitimate drugs that enter the supply chain. Since the Act was enacted in 2013, the FDA’s been busy with developing regulations, holding public meetings and getting feedback from the industry. Most recently, distributors are working to comply with the requirement to verify saleable returned drug products.
In the next few years, the focus will shift to the aforementioned interoperable system. The FDA is currently working on guidance for the interoperable data exchange and regulations for an enhanced drug distribution security system. Pharmaceutical manufacturers have a little breathing room in this area since they aren’t expected to start implementation until late 2021 and the deadline isn’t until 2024. At that point, this technology will have done more than just securing the supply chain. Additional benefits mentioned by former FDA Commissioner Scott Gottlieb include:
- The use of predictive analytics to reduce health care fraud, waste and abuse
- Avoidance of costly or dangerous supply disruptions
- Support innovative manufacturing and distribution technologies in an era of precision medicine3
Those are important benefits, but there’s still a large gap between where we are and where the FDA wants the industry to be. Fortunately, the FDA is listening to industry feedback and is willing to adjust its timelines accordingly. The aforementioned distributor requirement was meant to go into effect on Nov. 27, 2019, but due to industry concerns the agency stated it will not take action against noncompliant distributors until Nov. 27, 2020. The process of ensuring that the pharmaceuticals that reach the public are safe shouldn’t interfere with getting those drugs to the public.
How do we get there?
We already have some of the technology — or are beginning to explore the technology — necessary to make this a reality, including automation and sensors. Robotics and radio-frequency identification (RFID) are already being used to improve productivity and lower operating costs. The benefits of RFID are usually tied to retail, but pharma can benefit as well. RFID can be used to prevent counterfeiting, manage expiration dates and track raw materials. Since some drugs are temperature sensitive, RFID can also be used to constantly ensure the temperate falls within acceptable parameters.
One of the biggest players in the new supply chain is blockchain technology. Blockchain is an unalterable online ledger that can be used to grant authorized access to a single source of truth in tracking a product. In theory, pharmaceutical manufacturers could “identify counterfeit materials, malfunctions, or environmental breakdowns, and can validate that materials or components have not been tampered with or subject to adverse environmental conditions.”4 Pharmaceutical companies are working to make this a reality, but it’s already been accomplished in the food industry where one company gives customers such detailed information that they know the name of the chicken that laid the eggs they’re buying. The same can eventually be a reality for the pharmaceutical industry.
Besides complete visibility into the actual supply chain, a virtual supply chain can also be helpful. These virtual supply chains, known as digital twins, offer simulations of a pharmaceutical manufacturer’s supply chain. Digital twins are formed and run on the use of Internet of Things (IoT), sensors, artificial intelligence (AI), machine learning, augmented reality and cognitive data analytics. Most experts expect digital twins to provide insights into market demand, supply chain capacity and how to maximize efficiency, among other things. For fulfilling the FDA’s plan, digital twins can also be used to detect and avoid potential problems, such as security risks.5
From start to finish
Recalls are the bane of pharma. They’re expensive, injure the company’s reputation and take time — a lot of it. The key to beating recalls is digitizing, specifically with a system that connects the entire supply chain. Highly regulated industries have traditionally lagged behind others when it comes to adapting technology and processes, but now’s the time to catch up. The interoperable supply chain system doesn’t yet exist, but there are software solutions that provide similar visibility into the manufacturing process and expedite recalls. Complying with DSCSA means taking small digital steps now so that when 2023 hits and that interoperable system is up and running, pharma can keep up.
1. Fox, Brian, Paley, Amit, Prevost, Michelle and Subramanian, Nisha, “Closing the digital gap in pharma.” November 2016.
2. Jardine, James, “10 Ways Cloud Technology Is Reversing a Pharma Trend.” July 2, 2019.
3. Gottlieb, Scott, “Remarks on Enhancing Drug Distribution Security.” February 28, 2019.
4. Close, Karalee, Serazin, Emily, et al., “A Prescription for Blockchain in Health Care.” April 20, 2019.
5. Dayal, Sudeep and Sherman, Richard, “Digital Twins: Through the Supply-Chain Looking Glass.” July 18, 2019.