What's keeping you up these days?
At this point in 2019, we’ve long since passed the official midway point to complete DSCSA implementation and compliance in 2023. As each phase of the drug supply chain act has moved along, we’ve had a front row seat in witnessing the benefits of the process, along with a few growing pains along the way. Each sector of the drug supply chain is affected by the DSCSA in different ways, and this includes how the act affects areas of their greatest concern, such as the impact on financials and operational procedures.
The scope of the DSCSA is immense, and health execs have long recognized that the potential for unintended consequences exists as every major deadline draws near. For health executives, mitigating the potential damages involves taking a closer look at which elements of the DSCSA can have the most significant impact from an individual company perspective.
“The final three years of implementation, spanning from 2020 to 2023, are going to bring a flurry of activity as stakeholders at every point along the drug supply chain work diligently to meet compliancy standards.”
The Unintended Consequences of the DSCSA From the Perspective of Health Execs
The November 2019 deadline is just the beginning of a period of rapid movement toward completion of the DSCSA. The final three years of implementation, spanning from 2020 to 2023, are going to bring a flurry of activity as stakeholders at every point along the drug supply chain work diligently to meet compliancy standards. One of the main pain points that will exist during this time is that many trading partners and stakeholders will remain at different points in their traceability and serialization processes.
This has the potential to create an undesirable amount of chaos for health execs in the DSCSA compliance process. To better understand, think only of the processes involved in moving pharmaceutical products among trading partners, placing each product into inventory, and then managing it along the next step in the journey. With the potential for trading partners to still be in completely different spots in regard to meeting end goal compliancy standards, something as simple as communication can create major pain points from an operational and financial perspective.
This brings us directly to one of the most significant unintended consequences of the DSCSA for health execs – inconsistencies in communication among stakeholders.
Currently, health execs are looking at how to handle serialized vs unserialized (grandfathered) product and how to effectively track and trace each individual unit while keeping their obligation to the end user – the consumer or patient – in mind during the process. Given that not all trading partners have the same capabilities for traceability and communication at this time, this leaves a wide gap in communication standards that demands immediate attention.
The immergence of interoperable solutions, including blockchain technology, is an area that is commanding the attention of health executives who are most impacted by the implementation of the DSCSA. With the current deadline approaching, the demand for an intense amount of communication is high. Health execs are hoping that the FDA recognizes the need for improved methods of communications among trading partners and continues to work towards alleviating the communication pain points that many stakeholders are currently inflicted with.
The Financial Impact of the DSCSA
Of course, finances are a main area of concern for health execs. Let’s face it, while the standards and regulations set forth in the DSCSA are important and necessary for the protection of consumers, the process has been extremely costly for many trading partners. With each new deadline, stakeholders are required to look at how the new standards are going to impact their operation – both directly and indirectly. It’s important that any changes in procedure, policy, or communication are handled in a way that maximizes efficiency while minimizing the potential cost to the operation. This is something that has hardly come easy for many stakeholders.
The financial impact of the changes brought about by the DSCSA have arguably been felt the most by smaller operations. Until 2023, when the DSCSA is fully implemented, trading partners can expect to experience learning curves and then to go back and revisit their current operations for efficiency and compliance. This is especially true considering that we’re really just beginning to realize the full potential of new technologies to streamline the process.
Today, interoperability is a main area of concern for health execs but in the future, that focus could easily shift to new solutions that offer not only interoperability but that also streamline processes and protect the financial health and revenue stream of pharmaceutical supply companies.
Staying Up To Date with the Latest DSCSA Compliancy Standards
This past year, we’ve begun to witness how the FDA intends to handle stakeholders who fail to meet the regulatory requirements of the DSCSA. We’ve seen warning letters issued on multiple charges for non-compliancy and have become more aware of the far-reaching consequences of not meeting each deadline before it passes. The serialization and traceability standards outlined in the DSCSA are complex enough for someone who is well versed in the act. For health execs who must keep every element of their operation’s success or failure in their line of sight, the complexity of the DSCSA becomes even more of an issue.
Health execs are beginning to demand an improvement in communication standards, along with more initiative by the FDA to communicate more effectively with them. At this point, the stakes of not meeting the requirements of the DSCSA are high and could impact an operation for years to come. Currently, there is a very finite number of individuals and stakeholders who are actively and directly involved in DSCSA compliance. Health execs have every right to request improved communications as we move toward the next deadline, and beyond.
COMMENTS