12 Clinical
Pharmacy Practice News • April 2022
Medication Safety
One Error, One Journal Article, One Movement Toward Medication Safety By Marie Rosenthal
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f you think it’s not possible to make a difference as one pharmacist, consider the story of Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.), FASHP, who was “just” a hospital pharmacist when he wrote about one medication error and turned that article into a movement dedicated to improving medication safety for all patients. Mr. Cohen is stepping back as the president of the Institute for Safe Medication Practices (ISMP), an organization that he founded almost 30 years ago. ISMP is now a leader in helping to prevent medication errors, not just in the United States but globally. Mr. Cohen and ISMP are called upon by hospitals, agencies like the FDA and even pharmaceutical and device companies to investigate medication errors or, more importantly, to provide solutions to prevent them.
ISMP’s Origin Story It all began in 1974, when he and his first collaborator, Neil M. Davis, PharmD, heard about a patient who had died from an overdose of insulin at a local hospital. Both men were pharmacists at Temple University Hospital, in Philadelphia, and were discussing the incident, when Dr. Davis suggested Mr. Cohen write it up as a cautionary tale for the journal Hospital Pharmacy, which Dr. Davis edited at the time (1975;10[3]).
The positive response led to a column about errors, which was based on real cases. “When we published information those first few months, we heard from pharmacists from all over the country, and out of complete altruism, they were willing to share information,” Mr. Cohen said, as long as he did not identify the individuals or the organization involved. “In fact, we’ve never done that in all the years we’ve been doing this work.” Withholding identities in the reports was important, because talking about medication errors in the 1970s was just not done, according to Mr. Cohen. Although the pharmacists and nurses appreciated the alerts, the C-suite would have preferred they remained silent. “People were kind of upset with us at first, so we didn’t know what was going to happen as we moved along,” Mr. Cohen admitted. “Pharmacists certainly got it. They saw these things happening in their own practice, and I think a lot of nurses did, too, but those in some leadership circles were upset that we were talking about very serious harms that could come to patients from medical errors,” and they thought that could scare patients away from care, he said. Dr. Cohen and his colleagues continued their efforts with a book, “Medication Errors: Causes and Preventions,” published in 1981 by G.F. Stickley Co. “It got a lot of publicity, and that brought us even more reports [of medication errors],
A Just Culture
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ne of the important tenets of the Institute for Safe Medication Practices (ISMP) is encouraging people to come forward and report errors. To do that, the focus needs to be on fixing and preventing the error from occurring again, rather than focusing on blame and punishment. The idea is to form a just culture, explained Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.), FASHP, the president emeritus of ISMP. “We subscribe to a just culture, and that isn’t necessary blame-free. There are some situations that cross over into reckless behavior.” Reckless behavior “truly should never happen, because we know better,” like taking shortcuts even though you are well aware that behavior can sometimes lead to patient harm, Mr. Cohen explained. But once a behavior is noticed, the organization can work to correct and change that behavior, he said. ISMP, however, analyzes the systems that healthcare workers use to see whether there is a better way to encourage safety. “Our work from the very start has been identifying the system-based causes of medication errors. We’ve never really focused blame on individuals when errors happen,” Mr. Cohen explained. “We are looking at the systems that literally set people up for making a medication error and identifying what they are.” In many cases, it is product related, he said (products with similar names and dosing, labeling issues, etc.). “So, those are the things that we focused on over the years and working with individuals, as well as organizations, hospitals, community, pharmacies, etc., and trying to work with drug companies and the Food and Drug Administration and regulators to make corrections that hopefully will not set people up for making errors. “That’s what it’s been about for us, and from the very beginning, we were not focusing on blame,” he said. —M.R.
Michael R. Cohen, RPh, MS, FASHP (second from right), was invited to the White House to discuss medication safety issues with former President Bill Clinton around the time the famous IOM report, “To Err is Human,” was released.
and then Dr. Davis and I started getting requests to go to state pharmacy meetings and give talks. We were thrilled to be able to do that, to share our information.”
The FDA Takes Notice People outside of pharmacy began to take notice, and by the late 1980s, the FDA asked to meet to discuss productrelated medication errors, and the agency formed the labeling and nomenclature committee. Mr. Cohen and Dr. Davis realized that this “could be a full-time operation,” said Mr. Cohen, who was then an assistant director of pharmacy at Temple. They sought help and received it initially from USP, and established a national reporting program. By the time ISMP was founded, Dr. Davis was retiring, and medication safety was becoming Mr. Cohen’s entire focus, but to call it a full-time job would be a gross understatement. For Mr. Cohen, it was a calling, a mission, a passion—one he is stepping away from, but not leaving completely, he told Pharmacy Practice News. “Why did I decide to retire? Well, I am not retired completely,” he admitted. “I couldn’t do it. This work is just amazing. It’s enjoyable to be in a position to help colleagues around the country, and to work with the kind of staff that we have at ISMP. “How can you just stop?” he asked, but admitted there were many activities he enjoyed outside of pharmacy that he wanted to start doing, including spending more time with his grandchildren. “I’m in my upper 70s, I hate to say that, and it’s time that I tried to enjoy life a little, too, so I’m trying to get a nice mix,” he said. “But so far, it hasn’t quite
worked out that way,” he joked, adding that he’s still working but finding time to grow orchids, play golf and travel as COVID-19 abates. Dr. Davis retired as ISMP was kicking off, and Mr. Cohen put together a board of trustees with the help of Allen Vaida, PharmD, FASHP, who retired in 2021 as the executive vice president of ISMP. At first, Mr. Cohen had no idea that those first couple of articles would be his life’s work, but by the time they were registered as a nonprofit in 1994, “I think we did have a premonition that this could turn into something big, and of course over time, with the help of organizations like ASHP that helped us get the word out, the Food and Drug Administration, USP and quite a few others, it really grew into something that has had a major impact on productand practice-related issues.”
Another Landmark: Medication Safety Self Assessments One program, the ISMP Medication Safety Self Assessments, is a shining example of how ISMP helps medical professionals. The self-assessments allow professionals in various healthcare settings to assess their practices and processes related to medication use. They are meant to be completed by an interdisciplinary team that includes front-line staff and management. The first assessment evaluated acute care and was done with support from the American Hospital Association. It had almost 200 characteristics of a safe drug distribution system in hospitals, and was released about the same time that the former Institute of Medicine (IOM; now the National Academy of Medicine) issued its famous report “To
