Jay McHarg – CEO, AeroSafe Global
Imagine being asked to board a flight after learning that there were no air traffic controllers available to communicate with the pilot. The idea is ludicrous because it would never happen. Controllers are critical to air safety and are equipped accordingly. Working atop soaring structures with 360-degree views, communicating over advanced radio systems and interpreting radar signals, these resources can see something, say something, and most importantly, do something. Their presence keeps air travel safe; passengers feel confident when flying because of the personnel working in airfield control towers.
In contrast to the rigor and process surrounding air safety rules and regulations in the name of passenger safety, the medical system lacks such a comprehensive approach around patient safety. Since the 1999 Institute of Medicine’s landmark To Err is Human report revealed that nearly 100,000 patients die of medical errors annually in US hospitals, many quality improvement programs have been adopted. Provider education, embedded EHR alerts, better work-life balance strategies for burned out providers, and outcomes-based payment programs are all utilized to continuously reduce risk of patient harm.
Despite this focus on eliminating errors through technology, people and processes, the problem has not gotten better. A 2018 study by Johns Hopkins revealed that 250,000 people die every year in the US, the result of a medical mistake, making these errors a leading cause of death.
Why a Fortified Cold Chain Matters
When it comes to medication safety specifically, patients are generally confident that any treatment provided in a healthcare facility setting is safe. Until the COVID-19 vaccine was available, there was little understanding by the general public that vaccines and other therapies often require strict temperature control to be effective. Insulin, injectable fertility medications, immunotherapies, and inhalers are all commonly prescribed therapies that are temperature sensitive.
Should a temperature excursion happen during transit due to a delay or exposure to heat, the medicine may not work as intended. Given the vast distribution network moving medicines around the country, deviations will happen. In recent years COVID-19 has been a significant factor in supply chain delays – staff shortages and constrained ports. Then add in the recent regularity of severe weather events. If a temperature sensitive therapy sits in a truck for two extra days than projected, treatment efficacy may be diminished. Though patients have historically had little insight into the logistics surrounding their medication delivery, fears around spoilage are ever-present in-patient minds. One recent study found that over 40 percent of patients feared death or more severe illness because of improper handling along the supply chain.
The construct of a supply chain control tower is not new. Further, given the impact of COVID-19 on supply chains across nearly every industry, the need for the real-time visibility has never been more evident. According to research and consulting firm Gartner, supply chain visibility is the top funded investment initiative prioritized for nearly 50 percent of organizations.
Across many sectors control towers are mature offerings that provide visibility and oversight. Real-time data from carriers, IoT enabled devices, suppliers and more feed a pharmaceutical manufacturing or distribution control tower not unlike how real-time flight status updates, pilot calls and radar pings inform operators in an air traffic tower. In the pharmaceutical industry, these systems are fine-tuned to identify downstream issues such as delays leading to missed delivery deadlines and negatively impacting the patient. With capabilities that extend upstream, issues such as API shortages that surfaced in the early days of COVID-19 can be proactively identified in order to source a new supplier or change buying arrangements. Additionally, packaging inventory can be managed efficiently based on actual outbound activity. In this scenario, supplies can be automatically ordered and delivered on a just-in-time basis, creating operational efficiencies.
The Value in a 360-Degree View
Taking temperature-sensitive therapeutics as a biopharmaceutical use case, the need has been well established: In 2019 the IQVIA Institute found that this industry alone loses approximately $35 billion annually to temperature failures. Another study commissioned by Cargosense found that 25 percent of vaccines reach their destination degraded because of incorrect shipping; 30 percent of scrapped pharmaceuticals can be attributed to logistics issues; and 20 percent of temp-sensitive products are damaged during transport due to a broken cold chain.
When implemented as part of distribution operations, a “cold chain” control tower acts as an early warning system. The first requirement of maintaining temperature integrity is utilization of thermally robust product packaging. The is the best way to assure safety given the potential error points along the last mile. The next requirement is to embrace digital monitoring technology. IoT devices capable of monitoring, logging, and signaling status and condition of cold chain therapies during distribution are lighter, smarter and more affordable than ever.
IoT signals act as critical inputs along the distribution journey. These data points serve two purposes: in real-time they relay important status updates. Should monitored data feeds indicate any potential issue with the container or its payload – delays, temperature fluctuations, damage – real-time action can be taken. This is not unlike the role of an air traffic controller.
Secondly, IoT generated data can be aggregated and analyzed for longer term performance improvement. As patterns emerge over time that point to a particular shipping lane or distribution site as lower performing, operational changes can be implemented to remove the source of risk and reduce the incidence of alerts requiring intervention.
Ensuring Patient Safety and Optimal Outcomes
The ability to surface, normalize and analyze data is critical to the timely identification of outlier events requiring attention. The process of implementing actions in response to the exception is not as straightforward. Consider a delivery of artificial tissue that is to be used during a scheduled patient procedure. On top of having concern over product condition, the patient’s procedure may have to be re-scheduled. Cancelled procedures are problematic for patients seeking improvement in their well-being. They are also frustrating for providers if they create non-fillable schedule openings.
The goal of each operator intervention must be to help enable the best patient outcome despite the unexpected. Using the above scenario, one intervention could consist of placing a call to the clinic to relay the delay. This moves the onus of the situation largely to the end user to rectify. Looking at this differently, could an operator be trained and authorized to facilitate the procurement of a replacement product with overnight delivery – that phone call to the clinic has a much stronger service orientation to it. Simultaneously, the operator can retrieve the delayed package for return to the manufacturer for stability review based on the exception data.
Real World Effects of Excursions
Lack of access during the beginning months of COVID-19 led to an acceleration of telehealth and care-at-home models. Along with this evolution, home delivery of prescription medicines also became more routine and for some patients, the only way to access prescription medications. As a result of this evolution, a therapy that previously waited in a clinic refrigerator or freezer until the patient encounter now becomes the responsibility of the patient (or caregiver) to properly handle. Home-based care has helped mitigate safety issues such as hospital acquired infections or high patient loads, however, moving the responsibility of medication handling directly on to patients or caregivers carries risk. Luckily, much of this can be mitigated through people, processes and technology.
As another example, consider the potential impact of a control tower on the oncology patient at home, awaiting delivery of an injection needed to help stimulate the generation of white blood cells to protect against infection during times of immune suppression. If this treatment, which is not inexpensive, were to be delayed, the patient would need to make alternate arrangements to receive the injection. This is inconvenient and costly, not to mention the fact that the patient has been instructed to limit interaction with the outside world until the immune system has recovered.
An even worse scenario is if this package were left sitting outside on a patient’s front steps in the heat, diminishing efficacy. The patient, feeling overwhelmed, physically weak, anxious – takes it as directed by the treatment team – yet ultimately ends up admitted to the hospital with an infection because the therapy’s efficacy was compromised by the elements.
By prioritizing the retrieval of a potentially degraded therapy from last mile distribution, patients are spared the effects of receiving ineffective treatment whether that be medication to manage a chronic ailment, or a vaccine to prevent contracting disease. And in this time of widespread vaccine hesitancy, deploying control tower capabilities and signaling to eliminate degraded therapies from the medical ecosystem can be another tool to reduce concerns over product authenticity.
A Cold Chain Control Tower in Action
During the early months of 2021, mRNA-based COVID-19 vaccines garnered significant attention for their ultra-cold storage requirements. This was especially challenging during the planning for how to vaccinate nursing home residents as high priority recipients. These residents were essentially locked down and unable to travel to mass vaccination sites. Ultimately a great deal of innovation and collaboration helped move the vials along the last mile. However, other supplies were required to administer the vaccines: syringes, PPE, dry ice and alcohol wipes. With providers and pharmacies focused on keeping the rate of vaccination high, there was little time to re-source supplies as needs emerged – yet without these tools, vaccines could not be administered.
Thanks to the urgency of this situation, and the numerous stakeholders involved in generating and monitoring data signals, the supplier network elected to participate in a control tower to prevent bottlenecks. After needed vaccine supplies were procured to restock inventories and support patient encounters, each shipment was closely tracked to proactively address problematic carrier status changes as they were unfolding. At the first sign of a potential failure that could possibly cancel a clinic or lead to wasted doses, an operator intervened. This happened with nearly five percent of supply shipments due to weather delays, package mis-sorting and damage. After the alerting system identified the at-risk item, the operator would intervene to find an available replacement and have it shipped to the pharmacy in need. Over the course of this program that helped vaccinate residents across 30,000 long term care settings, more than 2,000 product replacements were sourced and delivered, enabling the ongoing delivery of these lifesaving vaccinations.
Driving Towards Autonomy
In the early phase of a supply chain control tower deployment, decision making is reactive based on the logic of real-time alerts. Over time as data accrues, patterns emerge and highlight discrete sources of risk that may have otherwise gone undetected. Consider shipping lane performance analysis. As data points to specific routes are high-risk based on intervention history, problematic lanes can be discontinued. Better, they can be replaced with lanes that are high-performing as evidenced by their on-time history. There may be opportunities to optimize packaging for both size and weight, for longer duration, and for lower cost carrier options.
Knowledge is Power
With a supply chain control tower focused on the logistics around temperature-sensitive therapies, a laser focus on addressing exceptional events is carried out through people and processes while the remainder of distribution activities seamlessly carry on. Over time problematic scenarios are reduced, driving better efficiency and informed decision making– all with the goal of better patient quality of life.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from Pharmaceutical Outsourcing – all delivered right to your inbox! Sign up now!