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
The Consumer Perspective of the DSCSA
The short answer. None. Every general consumer i speak to has no idea what the DSCSA is about or that since a few years ago, every pharmaceutical product is serialized. Why is this? Before we can answer this question, let's discuss a little on the why.
Since the initial stages of the DSCSA, the focus has primarily, and understandably, been on operations that exist within the drug supply chain. Each year has brought new challenges and milestones that have demanded our attention as we work toward complete industry compliance by 2023. The far reaching goal of the DSCSA is to ensure the quality, safety, and integrity of pharmaceuticals as they make their way through the drug supply chain and into the hands of the consumers.
At the end of the day, it’s the consumer that’s the focus of the DSCSA, yet the industry has rarely considered how the DSCSA is perceived through the eyes of the consumer, and what these changes mean to them. There’s a strong argument that can be made that understanding the DSCSA from the consumer perspective might provide greater clarity and help the industry adapt to challenges in a way that’s beneficial for all.
The majority of pharmaceutical consumers have little, if any, familiarity with the Drug Supply Chain Security Act itself"
While the pharmaceutical industry is tied up in legalities and the complexities of compliance, the consumer perspective is a little different. In fact, it’s likely a true statement to say that the majority of pharmaceutical consumers have little, if any, familiarity with the Drug Supply Chain Security Act itself.
What they do know is how changes affect them, and this is where it becomes important to focus on their perspective. In the end, the changes brought about by the DSCSA are positive for consumers and ensure their safety. This doesn’t mean that consumers themselves won’t face some challenges along the way, especially as DSCSA milestones for pharmacies and distributors come into play,
Consumers, regardless of what it is that’s being consumed, have an expectation of excellence. Many of the regulations set forth in the DSCSA already existed as consumer expectations. When you or I take, or are administered a medication, we expect that its quality and integrity have been verified to the fullest extent. We expect the medication we take to be what it says it is and perform according to expectations. While the DSCSA helps to ensure this is the case, consumers might be a little perplexed, wondering why these guidelines haven’t been in effect for decades at this point.
Considering all this, it only makes sense that some consumers are going to approach the changes brought about by the DSCSA with a bit of skepticism, or even cynicism. It’s our responsibility as trading partners and peripheral operators in the drug supply chain, to do our part to ensure a positive consumer experience as we work our way through the next few years leading up to complete, industry wide compliance.
DSCSA Pain Points for Consumers
Honestly, with a few exceptions, consumers shouldn’t feel the changes brought on by the DSCSA. The milestones thus far have focused mainly on operational procedures that shouldn’t have much bearing on the end consumer experience. Except, that might not be their perception.
Consumers are struggling with rising health care costs, including the cost of prescription medications . They’re also facing the challenge of longer wait times to receive medical care. While neither of these are a result of the DSCSA, it’s reasonable to expect that some consumers might see it that way.
All that said, most drug supply chain trading partners don’t have direct contact with the end consumer on a daily basis. However, for pharmacies and dispensaries, the situation is a little different. These trading partners are the ones that engage with pharmaceutical customers on a one to one basis. It’s crucial that these drug supply chain trading partners be supported through the process so that they can provide the upper most level of care and service to their customers and minimize the potential for the rare negative impact of the DSCSA on their lives.
What Can We Do to Simplify the DSCSA for the Consumer?
First, education. The industry needs to do a better job in educating the consumer on the benefits of a serialization supply chain. The problem of why this is not happening is because the FDA is not mandating any consumer requirements. Once the dispensers dispenses, the trail dies. Wouldn't it be nice if the consumer simply scans the same 2D bar code using their mobile phone and a page appears with historical information of the product? The industry should go above and beyond the basic requirements of the DSCSA and implement these value added features for the consumer.
Communication should be next
The second most important thing we can offer is communication. If consumers come to us with questions, it’s imperative that we answer them within our capabilities. For most consumers, any concerns that they have center around the cost, availability, and accessibility of their medications. It’s simple enough for us to ease many of these concerns, at least from the standpoint of the DSCSA, by making communication a priority.
Secondly, it’s important that we continue to work towards solutions that streamline the operational processes. This affects the pharmaceutical customer on several levels. It can affect the speed with which the receive their medications, especially in the event of a suspicious product that has been quarantined. There’s currently a big push toward interoperable solutions, which are key for seamless reporting, investigations, and formulation of solutions.
Finally, those who have direct contact with consumers, such as pharmacies, physician offices, hospitals, and other medical care centers where medications are prescribed and/or dispersed, should be looking at serialization solutions that relieve the challenges and pain points in their own operations, so that those difficulties and frustrations aren’t passed on directly to the consumer.
We’re expecting to see some exciting gains in technologies for the DSCSA in the next couple years. As these technologies are developed and adopted by drug supply chain trading members, and interoperability becomes the standard across the industry, the DSCSA will become so integrated that consumers should have no reason to form any negative associations with the Drug Supply Chain Security Act, and its long term goals