Investigational Drugs: Strategies for Sponsors, FDA, and Clinical Sites to Prevent Product-Related Errors (Part II)

Limited regulatory guidance exists for investigational drug labeling, packaging, and nomenclature, exposing sites that participate in clinical trials to many troubling product-related safety risks....

Investigational Drugs: Product-Related Issues Pose Significant Challenges (Part I)

An investigational drug is a chemical or biological substance that has been tested in the laboratory and approved by the US Food and Drug Administration (FDA) for testing in people during clinical ...

Severe Under Dosing of Insulin With U-500 Pen

An emergency department (ED) pharmacist was talking to a patient about his U-500 insulin dose. The patient, who had been using a U-500 insulin pen, told the pharmacist that his dose was 75 units b...

Severe Hyperglycemia in Patients Incorrectly Using Insulin Pens at Home

The Institute for Safe Medication Practices (ISMP) National Medication Errors Reporting Program (MERP) has received several reports of patients who failed to remove the inner cover of a standard in...

Using Information From External Errors to Signal a “Clear and Present Danger”

Chances are you’ve scanned the headlines and read many of the stories about medication errors published in the ISMP Medication Safety Alert!, particularly the tragic errors. Just a few examples of ...

Reporting and Second-Order Problem Solving Can Turn Short-Term Fixes into Long-Term Remedies

Problem: Healthcare practitioners are repeatedly challenged by unexpected problems they encounter due to both large and small work system failures that hinder patient care. A medication needed for ...

Selected Medication Safety Risks to Manage in 2016 That Might Otherwise Fall Off the Radar Screen—Part II

Some medication safety risks are painfully apparent in an organization, while many others lie dormant in the system until an error or adverse event draws attention to them. We thought it would be u...

Selected Medication Safety Risks to Manage in 2016 That Might Otherwise Fall Off the Radar Screen—Part I

It would be an incredibly arduous and a near impossible task to list all the risks associated with medication use that could lead to harmful medication errors. This is often at the heart of wonderi...

Raising the Index of Suspicion: Red Flags that Represent Credible Threats to Patient Safety

Disruptive behaviors, intimidation in the workplace, and a culture of disrespect among healthcare professionals have repeatedly surfaced as a significant barrier to patient safety. The hierarchical...

Just Culture and Its Critical Link to Patient Safety (Part II)

In our May 17, 2012 newsletter, we published Part I of a feature on Just Culture in which we shared key questions to help organizations assess their progress toward creating a Just Culture. We chos...

Just Culture and Its Critical Link to Patient Safety (Part I)

Do you believe your organization operates within a Just Culture? We have asked this question many times while working collaboratively with healthcare organizations and professionals in pursuit of o...

Building Patient Safety Skills: Common Pitfalls When Conducting a Root Cause Analysis

Most hospitals are acquainted with the root cause analysis (RCA) process and have conducted numerous RCAs in the past 15 years since The Joint Commission first required its use to investigate senti...