Originally published by our sister publication Pharmacy Practice News
Reducing the risk for adverse events in hospitalized patients is as challenging as it was more than three decades ago when the Harvard Medical Practice Study first spotlighted the extent of patient harm in this care setting, according to a new report in The New England Journal of Medicine (2023;388[2]:142-153). The retrospective cohort study was based on a random sample of 2,809 admissions to 11 Massachusetts hospitals. It identified at least one adverse event in nearly one-fourth (23.6%) of the admissions. Approximately one-third (32.3%) of these events had a severity level of “serious,” and 22.7% were judged to be preventable. Of concern, the highest proportion of the 978 reported events involved adverse drug events (ADEs).
Pharmacy Practice News spoke with Rita K. Jew, PharmD, MBA, BCPPS, the president of the Institute for Safe Medication Practices (ISMP), about the medication safety implications of the new study.
The inpatient healthcare study found that ADEs accounted for nearly 40% of adverse events and were the most likely—along with patient care adverse events—to be preventable. Obviously, not all the ADEs were due to medication errors, but what was your reaction to this finding?
My first reaction was to look at the previous report [N Engl J Med 1991;324(6):370-376]. The numbers are pretty similar. So, one might think we have made minimal progress toward improving safety. But are we really doing such a bad job? Drugs have many more side effects, and care is becoming more and more complex. Some chemotherapeutic agents now come in oral form, and people are taking them at home. The risk profiles of these agents are much higher. In addition, while a lot of the older problems, including handwriting illegibility, have been fixed by technology, new ones arise from its use. That’s also why the numbers appear not to have changed as much.
What can be done to change this?
There are two things that I’ve been talking to a lot of people about. One is that we traditionally focus on solving very specific issues. For example, at ISMP we focus on high-risk medications while the rest of the medical world may focus on tackling [issues such as] central line-associated bloodstream infections. We sometimes fix one problem and cause another one somewhere else [see story on page 8]. We need to take a systems approach when addressing patient safety. That means looking at the tools we offer to people, the environment and the tasks at hand. Then we design processes that produce better outcomes and don’t cause other problems.
That sounds like a big job.
Most people haven’t taken the time to understand human factors: how people interact with the environment and the technologies we’re introducing to them. One problem we have always faced in rolling out technology is that folks focused on the software build. Redesigning the workflow came second.
How do you address that?
We need to first consider the new workflow. When you do that, the issues you uncover can be mitigated by a different way you build software. The technology that supports these efforts can help prevent errors from happening. Creating a workflow after the fact, on the other hand, can result in a cumbersome and nonintuitive system that causes people to find workarounds. That is human nature. If you try to make nurses do impossible tasks when delivering care to their patients, they are going to find workarounds that they think are practical and efficient. At times they unknowingly bypass the safety features of the new technology. I also recommend performing a failure mode and effects analysis every time new technology is implemented. Proactively thinking through the entire workflow and discovering what could go wrong can generate strategies that mitigate those safety gaps.
The new hospital safety study makes the point that adverse events are substantially undercounted because many U.S. hospitals rely solely on voluntary incident reporting. ISMP has long promoted the adoption of a “just culture” to increase voluntary reporting. How can that help to improve medication safety?
Just culture embraces not blaming individuals when a human error occurs. But it also takes into consideration that if you’re blatantly engaging in reckless behavior, you should be held accountable. An algorithm developed by The Just Culture Company goes into what constitutes an unintended human error versus risky or reckless behavior (bit.ly/45ktuhr). And the actions for each one of them are different.
Medication Errors: The Year in Review
Can a just culture get more people to report errors?
I’ve seen it work beautifully when people feel totally comfortable in reporting errors, knowing they and their friends are not going to get into trouble. That is how we uncover safety gaps and put safeguards into place to prevent future errors from happening.
Since the 2000 “To Err Is Human” report (National Academies Press; 2000. doi:10.17226/9728), an increasing portion of patient care is now carried in outpatient settings, including at home. How has this shift affected medication safety efforts?
It’s uncovered one of the biggest vulnerabilities. Traditionally we have focused on safety in acute care. But when care is moving more and more to the ambulatory setting, we need to put an even greater emphasis on accurate and meaningful medication reconciliation during transitions of care. In general, we have to spend a lot more time on medication safety in the outpatient setting. That is something that ISMP is concentrating on. This year we launched our first Targeted Medication Safety Best Practices for Community Pharmacy [bit.ly/44PN4Sc].
You mentioned earlier that medications have become more complex and riskier since the publication of the Harvard study in 1991. That is certainly true of specialty drugs.
Yes. These high-cost, high-touch medications have a lot of safety implications. So, at ISMP we’ve created a medication safety membership specifically for specialty pharmacy, just to focus on the vulnerabilities in these areas and build best practices to mitigate risk.
Is there reason for optimism?
I would say I am cautiously optimistic because we have healthcare providers who truly care about the safety of the patient. Post-pandemic, there’s a lot of renewed energy when it comes to safety. One of your previous questions concerned where hospitals are in adopting the idea of a just culture. I think a huge part of that [depends on] executive leadership embracing patient safety. When you have leadership investing time and money to prioritize patient safety, we’ll be heading in the right direction.
Dr. Jew reported that she performs limited consulting work for TB Alliance, assisting in developing extemporaneous formulations of tuberculosis medications for pediatric patients in underdeveloped countries.