When Safe Drugs Become Risky: The Clinical Danger Zone

Each year in the U.S., approximately four billion prescriptions are filled. That's a big number. But perhaps an even "bigger" number is the four to eight million of those dispensed that will potentially involve life-threatening errors. Going to the pharmacy for a necessary medicine is not supposed to be a high-stakes game. But, even physicians and the nation’s most trusted profession -- pharmacists -- aren’t infallible. Generally, it’s not their fault. What goes wrong?

Prescription errors take place within EHR-based prescribing environments: sometimes referred to as “the typos that can kill.” They range from selecting the wrong prescription, to the wrong dose or the wrong patient recipient. Yet despite the innocent reasons, these errors can result in tragedy, and often result in unspeakable harm. But they are only part of a larger problem.

Each person is unique, and each person may have a different reaction to the same drug. Adverse drug effects (ADEs) present with the changing clinical statuses of patients. ADEs -- more than sixty percent of medication-related problems--can take place any time during the course of treatment and are usually under diagnosed or diagnosed too late. Hints, clues and aggravating factors are, in many occasions missed by providers, exposing patients to potential harm.

When a patient’s clinical status changes -- and this is the key point -- a previously safe medication may become dangerous. This exposes patients to unexpected events that can be anything from a nuisance to life-threatening. Patients and providers are left completely exposed to these unwanted outlier risks.  And it's a simple reality that clinical status is far from the fixed reality that exists at the time of prescribing a drug.

There is a potential safety net.

Drawing upon technology used in financial services that monitors credit card purchases, MedAware, is using an artificial intelligence (AI)-based technology that draws upon the outlier detection system that keeps your wallet safe. Rather than working with pre-assigned rules, MedAware AI learns the prescribing patterns of the physician, institution and patient. It generates models of normal prescribing patterns to find the outlier prescriptions that could be dangerous errors or could lead to ADEs.  It's a needle in the haystack system that keeps people safe much like credit card companies send you alerts for unusual purchase patterns.

Urgency and collaboration save lives.  Rather than find out about an error in the ER, when it might be too late, MedAware provides a system that taps into the physician’s workflow via the EMR. After all, with time sensitive medication-related errors, there is the danger of falling into the “medical danger zone,” -- the gap between an error realized and an action taken by the physician is time sensitive. The MedAware system enables the doctor to engage and correct.

MedAware’s technology acts as a protective layer above EMRs and clinical decision support tools. When a prescription outlier is detected, physicians receive notification within the electronic prescribing environment. The “typos” are either caught at the point of care -- when the patient is still with the prescriber and updated on the spot. Or the error is addressed following a change in the patient’s clinical record (i.e. new lab result or vital sign), after the prescription was entered. These alerts are displayed as a physician’s task, within the physician’s workflow and the EMR user interface. This enables the prescriber to protect the patient from an evolving ADE even after they’ve left for home.

In recent results reported in a live clinical implementation at Sheba Medical Center in Israel, a 1,900 bed and one of the country’s largest medical centers, MedAware notifications were 80% on time and on target. While understanding the importance of avoiding the medical danger zone is a given, physicians, seeing the immediate benefits to their patients, are paying attention to MedAware notifications.

When it comes to ADE risk, there is little alert fatigue. Every doctor and every patient appreciates having a little added intel -- even if it is artificial intelligence -- looking over their shoulder and out for their mutual best interest. When MedAware sends an alert, physicians were shown to revisit and change their prescriptions in a majority of cases -- here’s a case where med/tech is improving care, protecting patients and eliminating unnecessary risk.

Score one for technology.

A version of this article first appeared on Forbes.

I am the Founder of NOSTALAB -- a leading digital health think tank providing business and marketing insights to help the life science industry navigate the complex aspects of innovation in the context of exponential change. I help define, dissect and deliberate global trends in digital health as an active participant working with clinicians, innovators and patients.

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