With a potential industry-wide savings of almost $21 billion and an impact on more than seven million patient lives, preventing harmful medication error is a significant improvement opportunity for health systems. Also known as adverse drugs events (ADEs), harmful medication errors comprise about 37 percent of all medical harm. Approximately 50 percent of ADEs are preventable, making their reduction a highly impactable area of patient safety. Current data and analytics workflow tools are making ADE surveillance, monitoring, and prevention increasingly more effective with four key capabilities: Perspective surveillance for ADEs and identification of previously undescribed ADEs. Identification of the root cause of many ADEs by drug class. Prescription at appropriate doses for patients with compromised kidney or liver functions. Identification of different types of harm to find causes.

1. Preventing Medication Errors:
A $21 Billion Opportunity

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Preventing Medication Errors
With countless hospitalized patients today receiving
medications, health systems face a significant risk for harmful
medication errors, or preventable adverse drug events (ADEs).
According to a 2008 estimate from the U.S. Department
of Health and Human Services, patient harm due
to ADEs comprise a sizeable yet impactable
portion of safety events:
• Permanent harm from a medical error affects
approximately one in seven hospitalized
Medicare patients.
• ADEs are associated with 37 percent of
medical harm events.
• 50 percent of the ADEs are preventable.

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Preventing Medication Errors
Error (medication of other) doesn’t correlate
one-to-one with harm.
Errors can be near misses, in which a mistake or
miscalculation doesn’t make it to the patient;
only a small portion filter through to cause harm.

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Preventing Medication Errors
The breadth and depth of ADE impact creates
an obvious cost and quality issue for healthcare
organizations but also a sizeable opportunity for
improvement–an almost $21 billion in potential
savings and an impact on more than seven
million patients.
Health systems haven’t historically addressed
ADEs effectively.
Today, however, with decision support software
enabling real-time surveillance of patient
populations, healthcare stands to make
significant improvements in ADE detection,
monitoring, and prevention.

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Patient Data Is Key to Preventing Medication Errors
Shared interest in drug safety between the
FDA and health systems sparked initial
research into ways to identify ADEs.
In the 1990s, a large health system used
its EMR data to identify specific types of
patient harm, similarly to how it used the
EMR in infectious disease surveillance.
The health system started using its EMR
data to develop triggers for specific types
of patient harm (e.g., sudden medication-
stop orders, antidote ordering, and certain
abnormal laboratory values).

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Patient Data Is Key to Preventing Medication Errors
The trigger system generated a daily list of
potential ADEs among the patient population,
and pharmacists classified risk according to
severity and risk type (e.g., dose dependent,
predictable, idiosyncratic, or allergic).
Using EMR data and triggers over 18
months, the health system verified 731
ADEs in 648 patients.
They compared the data– and analytics-
enabled approach to traditional detection
methods, which identified only nine
ADEs during the same period.

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Therapeutic Advances Raise ADEs Importance
Drug safety remains a hot topic in healthcare,
particularly as leading-edge therapies come
to market after clinical trials that include only
hundreds or thousands of patients from a
limited demographic.
For example, when the FDA approves a
new chemical entity for immunotherapy
for cancer treatment available, the drug
may have appeared relatively safe in
clinical trial participants.
Pre-marketing clinical trial enrollment
criteria, however, tends to exclude
patients with significant comorbidities.

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Therapeutic Advances Raise ADEs Importance
When the drug reaches the general public,
prescribing clinicians don’t have the data or
clinical trial experience to know how it affects
people with a variety of comorbidities.
These blind spots, along with exposing large
groups of patients to the agent (often larger
numbers than in the original clinical trials),
create a risk for ADEs that the premarketing,
phase three trials didn’t discover.

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Therapeutic Advances Raise ADEs Importance
If the general population outcomes are bad, the
FDA removes the drug from the market.
Pharmaceutical companies stand to lose up to
millions of dollars invested in getting the drug to
market, and patients lose the opportunity for a
potentially effective therapy.
This gap in the drug approval process—from
approval to the general public—opens
the opportunity for data- and analytics-
enabled post-marketing surveillance.

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Therapeutic Advances Raise ADEs Importance
A focused surveillance system for new
drugs and devices that provides rigorous,
prospective post-marketing surveillance
could enable early release of new
therapies.
The FDA could use this period to get real-
time, broader-population understanding
of the ADE risks and adjust guidelines
accordingly.
Extended surveillance could mean that
more drugs make it to the general public
with greater safety understanding.

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Post-Marketing Drug Surveillance Requires a
Clinical Workflow Tool
A clinical workflow (decision-support) tool that leverages
triggers (e.g., the Health Catalyst® Patient Safety
Monitor™ Suite: Surveillance Module) allows drug safety
teams to evaluate and take critical action against ADEs:
• Anticipate and detect an ADE
• Intervene and mitigate the risk
• Prevent the ADE

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Post-Marketing Drug Surveillance Requires a
Clinical Workflow Tool
For example, using decision-support triggers, the
workflow tool focuses clinician attention on a patient
receiving an anticoagulant who has a lab result for
unexplained bleeding—an activated partial
thromboplastin time (aPTT) of greater than 300
and a systolic blood pressure of <90 mmHg.
This indicates that the patient may be experiencing
a major drug-induced bleeding event.

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Post-Marketing Drug Surveillance Requires a
Clinical Workflow Tool
Figure 1 (next slide) shows the ADE clinical
surveillance workflow, including detection;
characterization and analysis; and measurement.
The workflow gives clinicians the data they need
to understand and make critical decisions about
ADE mitigation:
1. Which patients do I need to see?
2. What should I do?
3. Why should I do it?

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All Cause Harm Surveillance and Management
Epidemiologic-based workflow
Figure 1: ADE clinical surveillance workflow

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Four Meaningful Ways Post-Marketing Drug
Surveillance Improves Patient Safety
Post-marketing drug surveillance with an ADE clinical surveillance workflow
tool helps improve patient safety for hospitalized patients in four key ways:
Performs perspective surveillance for ADEs and identifies previously undescribed ADEs in the
patient population. If the drug proves harmful, or harmful to certain patients at certain doses, the
FDA removes it from the market.
Determines the root cause of many ADEs by drug class.
Enables drugs prescribed at appropriate doses for patients with compromised kidney or liver
functions (a high risk among patients today).
Identifies different types of harm to find causes.

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Safer Patients, Billions of Dollars Saved
As healthcare continues to develop and use
more, increasingly powerful drugs, risks for
ADEs will rise along with the potential for
effective treatments.
One way that health systems can help
manage patient harm due to medication is to
adopt a decision support tool that enables
real-time surveillance of patient populations
and advanced analytics to identify risk for
ADEs and suggest preventive action.

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For more information:
“This book is a fantastic piece of work”
– Robert Lindeman MD, FAAP, Chief Physician Quality Officer

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More about this topic
Link to original article for a more in-depth discussion.
Preventing Medication Errors:A $21 Billion Opportunity
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Other Clinical Quality Improvement Resources
Click to read additional information at www.healthcatalyst.com
Prior to Health Catalyst Stan has held several executive, clinical and research roles. Most
recently he was the Chief Strategy Officer for Pascal Metrics a federally-certified Patient
Safety Organization. Prior to that Stan was the founding CEO of TheraDoc, which he led for
10+years until its acquisition.
For 2+ decades Stan was a clinician, researcher and educator at the University of Utah School of
Medicine, College of Pharmacy and at IHC-LDS Hospital. Stan is clinically trained as a pharmacist
specializing in infectious diseases as well and has an advanced degree in medical informatics
specializing in clinical surveillance and expert system decision support technologies.
Stan Pestotnik, MS, RPh