Drug Supply Chain Security Act (DSCSA) outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs, being a “track-and-trace” part of the Drug Quality and Security Act (DQSA). As stated by the FDA, proper implementation of DSCSA regulations will improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Many companies within the industry are impacted by the regulation, including manufacturers, repackagers, wholesale distributors, and dispensers.
Robotic Process Automation (RPA) is quickly gaining ground in business, as it now allows tasks, which used to be handled by employees for many hours, to be reduced to automated processes that take much less time.
Automation is carried out through dedicated software bots that have been programmed to perform specific tasks according to rules and commands previously written in a computer program. This allows them to support employees that have to deal with repetitive, serial actions.
Without the need for any software integration and complicated programming, robots help fill out records and documents, and can be used to send automatic notifications, make schedule entries, transfer data between systems, create documents, as well as for reporting, controlling, or ensuring data compliance.
Especially this implementation flexibility makes RPA a good software to be used in achieving DSCSA compliance - it’s guaranteeing interoperable characteristics of the system, required by the regulator.
FDA defines “interoperability” as the ability to exchange the product tracing information:
In order for any system, process, or practice to be interoperable, the subsequent purchaser must be able to successfully capture and maintain the product tracing information, regardless of whether the information is provided in a paper or electronic format.
In more general terms, interoperability is the “ability of computer systems or software to exchange and make use of information.”
Because RPA software does not require programming skills to start using robots and allows to automate tasks across any combination of applications and databases, it’s a great solution for companies that are working with a mix of legacy systems and newer solutions, have to deal with multiple manual tasks to comply with DSCSA requirements, and do not want to spend additional time and resources on complicated integrations with multiple systems.
In this article, we focused on a small part of the automation strategy, which is the use of RPA software for streamlining manual and error-prone processes, which can be identified and linked with DSCSA compliance requirements.
It’s worth noting that it would be impossible to find today a pharmaceutical company that did not implement any sort of electronic document workflow. But with all the changes that are happening within the industry, it is essential to ensure that such document circulation systems still properly serve their purposes, which are most of all:
Many companies have implemented an electronic document workflow without proper thought. That is why we can find even today companies that struggle with outlandish and intricate processes executed in an even more outlandish way.
To learn more about what a company should consider to assure that automation is being implemented and used in the most effective way, we invite you to read our in-depth guide on How to streamline and automate processes and workflows in your company.
After analyzing Drug Supply Chain Security Act we can identify main areas, on which companies have to focus to assure compliance regulations:
In each of those areas, we can help you to identify repetitive processes that can be streamlined with Robotic Process Automation. A good example will be combining RPA software (for example UiPath) with optical character recognition (OCR), which allows converting print or handwritten text into machine-encoded text, allowing the company to easily digitize and effectively used data that are received in paper format.
Robots are also capable to work with any technology that your company is using, not only old legacy systems but with enterprise applications including SAP, Salesforce, Oracle, Microsoft, Google, ServiceNow, and hundreds of others.
If you are unsure if robotic process automation is right for your company, get in touch with one of our experts. Book a free, 30 minutes consultation and we will break down how well RPA solutions fit into your business specifics.
As for now, FDA seems to have no intention to postpone the deadline for pharmaceutical companies - they need to be ready to comply with interoperability requirements by November 27, 2023.
As procedural works within FDA proceed, the agency publishes guidances that should help the industry to prepare accordingly. On June 3, 2021, it released one new draft guidance, two final guidances, and a revised draft guidance document regarding the Drug Supply Chain Security Act.
A thorough analysis of the documents allows identifying some automation opportunities in them, that the pharmaceutical industry can benefit from.
This Draft Guidance provides recommendations for the industry on the “enhanced system” attributes necessary for secure tracing of products at the package level, which includes interoperable, electronic, package-level tracing systems and processes, recognizing a need to use proper inference and aggregation tools. Especially aggregation (collection of information strung together to complete a report or analysis) is easily automatable with RPA tools.
Incorporation of Product Identifier in Product Tracing Information:
As stated by FDA, this requirement refers to both, Selling and Purchasing Trading Partners:
Handling Aggregation Errors and Other Discrepancies
Gathering Product Tracing Information:
Enhanced Product Verification:
Illegitimate Product Alerts:
With this update, FDA earlier draft guidance, addressing how trading partners should identify a suspect product, notify the agency, and terminate the notifications in consultation. As the requirement is to notify the FDA and all trading partners who could receive the illegitimate product no later than 24 hours after discovering the issue, opportunities for automation arise in multiple areas.
FDA determined three high-risk factors that, if any is present, require the company to notify FDA and the immediate trading partners within 24 hours - RPA can be used not only to identify such cases but also to automate the notification process, by gathering the required information from various sources and compiling them.
Another use case could be creating and storing required reports, which prove that appropriate actions have been taken by the company. Such reports should be easily accessible for future controls, and as multiple examples within the industry show, companies have problems complying with this requirement.
We have analyzed cases investigated by FDA, related to DSCSA compliance and warning laters which have been issued, to see what are the most common problems, and how automation could help companies in solving these issues. As observed problems are similar, we focused on the first (and most widely discussed) warning letter, to show automation opportunities with life cases.
The first warning letter citing failure to comply with requirements of the Drug Supply Chain Security Act (DSCSA) was issued to McKesson Corporation in San Francisco on February 7, 2019. This warning letter was widely commented on within the industry, and companies analyzed what specific activity or process the FDA found objectionable, to learn what precautions they should take.
According to the FDA warning letter, McKesson Corporation failed to:
This case describes a situation when several bottles of oxycodone hydrochloride received by pharmacies were either empty or were substituted with other pharmaceutical drugs. Upon investigation, McKesson determined it was likely that the oxycodone was replaced with other products while they were in McKesson’s control.
According to FDA, McKesson failed to:
From a business perspective, each of those tasks could be automated in a way assuring effective compliance, by creating proper alerts, sending automated notifications, or compiling data for records to prove that appropriate actions have been taken.
Example 2. Missing both lot number and expiry date
Identification of Suspect Product and Notification guidance describes the lack of lot number and expiry date on a drug as an example case suggesting “the likelihood that they are suspect products”.
When such an event was reported to McKesson, it should have triggered some action or further investigation. Initial company response could be automated, to avoid delays in reaction frequently occurring when manual actions are required.
McKesson did not demonstrate that it quarantined all products and conducted an investigation to determine whether the products were confirmed as illegitimate, according to the warning letter, in particularly:
Automatic notifications also, in this case, could be a solution, as well as proper reports created with data aggregated from various company systems, to assure that all records from the investigation and quarantine process will be in place for future controls.
With many of the DSCSA elements in place, there is still a lot to be done to assure full compliance with interoperability requirements by November 27, 2023. The remaining steps of implementation from the FDA standpoint include:
We should expect multiple changes, especially with further clarifications of the FDA's understanding of certain technologies that can be used to comply with DSCSA requirements.
For pharmaceutical companies, deepening the digitization and automation of processes in can be a future competitive advantage. On the other hand, the efficiency and effectiveness of digital transformation implementation largely depend on the plan and strategy.
If you are wondering how to start or improve the implementation of automation and digitization of processes and document flow in your company, get in touch with one of our consultants. You can book free 30 minutes consultation with us and we will help you identify your needs and pick the right technology to match your challenges.