By Christopher Guadagnino, Ph.D.

Published February 2000

• Impacts of error reduction initiatives
  

• Improving anesthesia safety
  

• React to this article in the Discussion Forum.

Michael Cohen is president of the Institute for Safe Medication Practices (ISMP), headquartered in Huntingdon Valley, Pa.

PND: How did the ISMP get started?

MC: Twenty-five years ago we started a column in a pharmacy journal where we asked for practitioners in pharmacy from around the country to tell us about actual errors or concerns that they felt might lead to someone making an error, for example, two drug packages that looked alike or drug names that were confused. I was a hospital pharmacist, and occasionally patients were harmed and there had been some deaths because of serious errors with medications in hospitals. Most of what we were hearing was not so much that the practitioner was incompetent or did something negligent, it was more the setup they were working in, like bad handwriting that led them to misread a drug order or abbreviations that were misunderstood. We saw the packaging and the labeling problems. We saw situations where patients weren’t identified properly. We also started to notice that it wasn’t just one thing, it was multiple factors that failed and led to error.

In 1992 I decided to try to make a full time operation out of medication error reporting and decided to form a non-profit. We reached an agreement with the United States Pharmacopeia for them to take over the reporting program. They help us by databasing the errors. The program is national in scope and we get well over a thousand individual reports every year. We also get reports from the Food and Drug Administration and state boards of Pharmacy, state boards of Nursing. The program is voluntary and practitioner-driven. The only reason for people reporting is altruism—they get nothing back for it other than knowing that someone else won’t fall into the same trap and that the patient won’t get hurt. In the 25 years of this program we have never had a single incident where we have even come close to identifying the reporter. Everything is 100 percent strictly confidential.

PND: What kind of reporting form do you use?

MC: We ask whether it was an error or near miss, a potential error. We ask for a description in the reporter’s words of what happened. We ask for a lot of information about the name of the company that manufactured the drug, the dose, the generic name and brand name. We ask them if they can provide us with a sample of the product labeling or packaging, or the physician order, without any identification, that was misread as another drug. The program can be accessed through our website at www.ismp.org or through the USP’s medication error reporting program website at www.usp.org. We now have 15 different journal or newsletter publications, including one that just started in Medical Tribune, a national news magazine.

PND: What are your primary sources of error reports?

MC: Of reports that come directly from practitioners, about 80 percent are pharmacists. The next group would be nurses and a very small percentage are physicians. We get community-based errors, some from drug stores. Most physicians are not going to report prescribing errors that they made. I think they should be able to, but right now the deck is stacked against them if they’re identified. The biggest barrier is if the information is subpoenaed by a plaintiff’s attorney and used against them in a lawsuit. Most of the errors that do occur take place at the drug administration phase or the drug dispensing phase. We don’t generally hear about prescribing errors. Many of them are very difficult to recognize.

PND: How is the data used, and by whom?

MC: There are thousands of reports now that are very useful. They’ve been used to affect drug standards, dosing information in textbooks on medication. Thousands of hospitals have changed practices and protocols and removed hazardous substances. Probably thousands of drug companies have changed labels or packages, and drugs have even been taken off the market as a result of very serious errors. It also affects design of medical devices. There is a program where hospitals can download their incident reports into a web-based program call MedMarx, which is housed at USP headquarters. The hospitals have a code number and no one knows where the individual information is coming from. This really increases the number of reports. Something we don’t want to do is attribute error to an individual because of the punitive aspects—they’re devastating to a hospital reporting program. If people know that they are going to receive some form of disciplinary action for involvement in a error, then I can guarantee you that the fact that an error took place is not going to be reported. It’s going to be diagnosed in a different way. It’s going to be defined in a different way. A good number of reports that we could learn from would never reach it to the reporting stage. Our purpose is looking at system-based causes and making recommendations to practitioners and hospitals. We rely on journal and newsletter columns, on our educational programs, on the FDA accepting this data and working with us and USP, and with the pharmaceutical industry, in making changes. We rely on the Joint Commission on Accreditation of Health Care Organizations, who receives this information, to provide some oversight when they do their surveys. We rely on the state boards and the state departments of health to receive this information.

PND: Are you satisfied with the way in which state and federal agencies use the data?

MC: We’ve been very frustrated by the fact that the oversight agencies, by and large, have done not such a great job with actually putting this information to use. There are isolated exceptions. We have seen an error with potassium chloride concentrate injections kill a patient in one hospital in south Florida and then, six months later, the same exact medication error killed another patient in Tampa, and then a year after that another patient in Stuart, Florida and another in Jacksonville. The problem was that people would draw it up right from the vial and not dilute it, or they would mix it up with another drug. We had that problem hundreds of times all over the United States. It only was recently that JCAHO actually sent out a sentinel event newsletter that mentioned potassium chloride as an overdose problem and suggested that it be removed from patient care areas wherever possible so that overdosing wouldn’t occur. Word then spread very quickly that when you get your JCAHO inspection they’re going to ask you about potassium chloride, so you better do something about it. I think over 90 percent of hospitals now have removed potassium chloride concentrate from almost all their patient care areas. That’s what I want to see happen throughout the country with other well-known, continuing problems.

PND: What are the obstacles to needed change?

MC: The culture that we’re working within is still to blame the individual who drew up that potassium. "They should have known better. If they would have done their job properly, this never would have happened." We’re not thinking, "What are all the failures in our health care system that repeat themselves that we need to learn from and put into action in a way that would benefit our patients?" We’re waiting for the errors to happen and then we react to them. We have to get the state agencies —that are set up right now to fine doctors, take away their licenses, fine hospitals, suspend a pharmacy’s license—to understand that they have probably one of the most important roles of all in reducing medical error. They need to understand that there are well-known problems that they have to provide oversight for. Just asking about them in some cases will work. Knowing what they are. Following the literature. Linking up with programs like ours.

PND: How is ISMP collaborating with the American Hospital Association?

MC: We helped them develop a communication that went to every one of their member hospital CEOs. It recommended changes that they could make in the system without consuming resources, things that they can do within the next month or so that would truly protect patients. We also made some long-term recommendations. We developed a hospital self-assessment tool for the CEO to utilize, where they would be able to assess the medication system at their institution for safety. The AHA and ISMP are both looking at ways to communicate error information so that the senior level managers are aware of patient safety issues and assure that they’re being addressed at their own institutions.