To Err is Human, But Patient Safety Matters

Hard to believe it has been over 20 years since the Institute of Medicine’s landmark To Err is Human report revealed that nearly 100,000 patients die of medical errors annually in US hospitals. Since then, better provider education, embedded EHR alerting technology, and outcomes-based payment programs have been deployed as strategies to reduce patient harm.

Despite significant focus on eliminating errors through technology, people and processes, the problem has in fact gotten worse, not better. A 2018 study by Johns Hopkins revealed that more than 250,000 people in the US die every year because of medical mistakes, making these errors a leading cause of death.

The hospital has traditionally been the care setting where most errors occur given the acuity of cases and complexity of care delivered. But as the US healthcare system continues to transform amid the COVID pandemic and some root causes of medical errors have been mitigated, new sources have and will continue to emerge.

Case in point: temperature-controlled therapies.

With the marked uptick of care-at-home models, prescription treatments are increasingly being delivered via a direct-to-patient model, meaning a therapeutic that may have previously waited in a clinic refrigerator or freezer until the scheduled encounter now becomes the responsibility of the patient. While home-based care may mitigate some safety issues such as exposure to infectious agents or heavy provider workloads, placing the responsibility of medication handling directly on patients or caregivers is not without risk.

Insulin, injectable fertility medications, immunotherapies, and inhalers are just a few kinds of therapies that are temperature sensitive. These require proper thermal packaging on the journey to patient homes until they can be stored in a refrigerator. Should a temperature excursion happen during transit due to a delay or exposure to heat, the medicine may not work as intended. Though such deviations may only happen a small percentage of the time, patients often aren’t aware, and don’t know if treatment efficacy has been diminished. This can have a significant negative impact patient safety. In fact, a recent study found that over 40% of patients feared death or more illness as a result of improper handling along the supply chain.

For manufacturers, distributors and payers interested in the reaping the benefits of direct- to-patient delivery, including lower cost, greater centricity opportunity and new brand awareness channels, following are approaches to mitigate the risk of error stemming from mishandled cold chain therapies:

1. Digital packaging. Imagine smart packaging that can alert a patient visually if the therapy was exposed to efficacy limiting conditions? This is readily available today with early adopters eyeing IoT innovation to control risk associated with last mile delivery. At a minimum embedded devices record all temperature activity to ensure thermal integrity. Greater technological sophistication can limit who actually opens the package in order to assuage concerns about authenticity.
2. Robust engineering, simple instructions. As consumers are exposed to non-stop messaging in smaller and smaller bytes, it is important to overcome noise with directions that are simple yet clear. From clear steps on how to open the package, interact with any components, and store therapies, making it error-proof for patients irrespective of reading level is vital. An example is a one-way opening mechanism that requires little strength and does not interfere with the therapy inside.
3. Real-time support. For many patients, prescription medicine is the difference between lying in bed and having a productive day. Despite thermal integrity, digital protection, and user-friendly language and graphics, sometimes there are questions. Having access to a responsive professional that can answer delivery-related questions in real-time is absolutely critical to boosting patient confidence in and acceptance of new care models.

To Err Is Human asserts that the problem is not bad people in healthcare, rather good people are working in bad systems that can and need to be made safer. To learn more about how AeroSafe Global is moving temperature sensitive medicines to patients with 100% certainty, visit us at Asembia’s 2022 Specialty Pharmacy Summit.