With only eight months to go before the final phase of the Drug Supply Chain and Security Act (DSCSA) is enforceable by the FDA, pharmaceutical manufacturers and their distribution partners are focused on implementing new tools, processes, and procedures. The DSCSA was signed into law in 2013 to create national standards around how pharmaceuticals are tracked and traced. The new regulations require an electronic tracing of pharmaceutical products at the package level to identify and remove counterfeit or otherwise adulterated drugs from the supply chain more effectively.
Counterfeited prescription drugs are a significant patient safety issue, though one that has not received much public attention. Over a five-year period, from 2016-2021, the FDA registered 130 enforcement actions stemming from pharmaceutical counterfeiting operations. Non-temperature-sensitive pharmaceuticals are common product targets by counterfeiting rings worldwide – pills and tablets, such as painkillers, ADHD medications, sleeping aids, and even antibiotics. With that said, just because a therapy requires additional storage and handling requirements around temperature control does not mean it is out of reach for those seeking to do harm.
Instances of fake versions of Botox, Avastin, and even some vaccines have all been reported over the last ten years. However, the reality is that when it comes to the potential of temperature-sensitive therapies to be a danger to patients, it is likely due to adulteration stemming from improper handling and storage.
The advent of COVID vaccines opened many peoples’ eyes to the importance of the cold chain in protecting mRNA-based therapeutics. Drugs commonly used to treat diabetes, cancer, and auto-immune disorders have also routinely required specialized thermal packaging components to maintain effectiveness. Should these medicines be exposed to elements, hot or cold, for too long, they may not work as intended by the time they reach the patient.
For pharmaceutical manufacturers and distributors feeling angst about DSCSA compliance, there are existing frameworks, deployable today, that can ease the burden. Consider supply chain Control Tower services as one example. These technology-enabled systems are fed by data inputs to surface bottlenecks and delays across distribution networks. Serialized packages enable visibility along with a check-and-balance for packaging that lacks expected identifications. For specialized therapies that have temperature requirements, pairing serialized packaging with monitors, such as IoT-enabled temperature gauges, reduces the risk of a therapy impacted by exposure to heat or cold.
A tremendous benefit of a Control Tower is its ability to facilitate action. An operator can ping connected packages for real-time condition feedback. Data signals can inform calculations around whether the therapy will be safe to take once it is estimated to reach its destination. If calculations point to the strong likelihood of an excursion that has or will negatively impact the therapeutic efficacy of the medication, alerts are triggered to recall and replace the product.
While Control Tower services are helpful for monitoring supply chains in real-time to take immediate action based on thresholds and alerts, there are additional benefits that emerge and accrue over time. As these systems generate data based on real-world experiences of packages along with interventions taken, when looked at retrospectively, the data can be modeled to inform future decision-making. This is true ongoing process optimization that can point to opportunities to make packaging changes, route modifications, carrier service level agreements, and more.
For drug supply chain partners concerned with the onus to meet the final deadline later this year, service-based options can help streamline compliance efforts. For example, trading partners who invested in serialized packaging components early on now have mature track-and-trace efforts as a result. Many of these capabilities have progressed in recent years with the advent of smarter packaging components – embedded monitors, smarter and tamperproof boxes, and connected labels. When placed in a Control Tower framework, these tools enable newfound visibility and intervention capabilities to ensure therapies are kept safe as they make their way to patients across an extensive network of pharmacies, physician practices, hospitals, and increasingly, private homes.
As with many federally instituted regulation changes, the DSCSA reflects a shift from a general carrot-based approach – the issuance of guidelines, lack of standards from state to state, and assumptions that all parties will do the right thing in the face of problems – to the stick. Entities that are found to be out of compliance with DSCSA tenets after November 2023 can face fines and penalties that have the potential to range from license revocation to jail time.
Though the final phase of DSCSA legislation has been a long time coming, change can be hard. While associated supply chain fortification improvements will lead to enhanced patient safety in the short term, it’s important to think about the long-term impact, as well. Specifically, how this all lays a foundation for the timely, effective distribution of high-value, high-impact drug breakthroughs that are on the horizon. An investment into protecting the drug supply chain today creates more opportunities for tomorrow.