LawyersandSettlements (LAS): Where did your motivation originate for the ISMP?
Michael Cohen (MC): I was a pharmacist at the Temple University hospital in Philadelphia and had the good fortune to work with the pharmacy director who was about to start a new program of placing pharmacists in the nurses units, and not in the main pharmacy. He asked me if I'd be interested in joining. I said no.
So he called my wife at home, and she talked me into it, and I'm glad she did because it turned out great.
On my first assignment I was placed in a 56-bed men's surgical ward so I got to know the nurses and doctors very well. They showed me different procedures, interacted with me, and asked me lots of questions about drug therapy and what to order.
After awhile they trusted me, knowing I wouldn't go to their supervisor if something went wrong. I started learning things that I had no idea were actually happening and I think they felt good about telling me because I would work to try to change things in the system whenever possible, to make it less likely for them to make that same mistake again, and I never focused blame on the individual; it was the system.
After awhile it became clear I could actually do something with this outside Temple University. I talked to my director, who happened to be a journal editor, and he suggested starting a column and inviting others to write about the issues. Letters started coming in from around the country, mostly from pharmacists. That was in '75. In '77 the Journal of Nursing asked me to do a similar column so I started hearing from nurses.
LAS: What kinds of errors were surfacing?
MC: We noticed there were things like look-alike products and satellite drug names. Besides writing about them, we also called the drug companies and told them that their product name contributed to an error.
LAS: How did trying to resolve those errors lead to the organization ISMP is today?
MC: Eventually it just turned into a formal reporting program. By '94, US Pharmacopoeia took over the program for us. We have a long term agreement with them and we still work closely today.
We learn from the reports and communicate about them so that others are aware. That information has become a monthly newsletter journal column and over the years we started our own publication [ISMP Medication Safety Alert!] which helps fund our operation. And we've gotten into hospital consulting and working to improve packaging and drug naming.
Today we're a public charity.
Also, we advocate with regulatory parties and device and pharmaceutical manufacturers when we feel something can be changed. This has resulted in literally hundreds and hundreds of practices and product related changes in name, labels and product withdrawal from the market.
LAS: Tell us about one change that had a great impact.
MC: One that comes to mind was a very dangerous situation. It involved intravenous infusion pumps, where often the IV solution contains some of the most harmful medications. I'm talking about all brands, not just one model. When you had to remove the patient's infusion from the pump itself, you relied on the nurse to manually close the flow control clamp when removing the sac. And, of course, occasionally the nurses would fail to clamp it; they just got caught up in removing a patient's gown, getting the bag or bottle through the sleeve and never really thought of closing the clamp, and as soon as they got the bag back up on the pole that IV sac was wide open and flowing right into the patient. We got a few reports from nurses, including from my own wife, who is a nurse, where she was taking someone back from the bathroom and they collapsed from an overinfusion of the drug.
So we started writing about it and the more I wrote, the more reports I got from people and so it became pretty clear we needed to work with the manufacturer to get them to build in some kind of fail-safe clamping mechanism that automatically closed and didn't depend on the nurse. All the manufacturers began working on that and now they've been redesigned; free flowing infusion pumps are no longer allowed.
LAS: Any obstacles to change?
MC: It's sometimes difficult to get a company or the Food and Drug Administration (FDA) engaged but they come around after awhile. We have to be patient with regulatory bodies but people yell, 'be patient when it's my life?!' But it's very hard to drive some companies; they have to go through the FDA, who take a long time to make a decision. We could certainly do better that we're doing now.
LAS: How else are you progressing?
MC: We're fostering now a proactive look at labeling, packing, device design, etc. We have our own operation where before a company sends a drug application to the FDA, they can avail themselves to experts who reveal what might be problematic down the line with the product and its name when it's launched.
That's what we do: we try to determine in advance what needs to be changed before a product harms a patient.
LAS: How have attitudes and regulations evolved in those 30 years?
MC: At first no attention was being paid to medication errors. I remember lecturing at the FDA in the '80s on drug name mix-ups. There was no consideration given to the product's role; it was always the fault of the doctor's handwriting or the pharmacist had misread but not the design or the name itself.
Now regulatory agencies have learned over the years that medication errors are a big issue for them and for everyone because they cause tragedies that are easily avoidable, with appropriate steps taken and changing the system. They've learned also not to rely on human beings alone to do the right thing, because they don't.
We're just now getting into a large mandatory reporting program here in Pennsylvania where all hospitals are required to report medication errors to the State and we are the organization to which they report them. We analyze them and make recommendations to the State's Patient Safety Authority who comes out with a bulletin every three months that carries the recommendations back to hospitals as well as to birthing centers and ambulatory surgeries.
Since the program began in 2004, some 200,000 reports have been made.
LAS: What has changed for practitioners?
MC: There's been a real change in the way people think and understand system-based causes. Whereas before, no thought was given to the instructions and communication--it was always blame the nurse, the doctor or the pharmacist, or a patient didn't use the drug right.
LAS: Tell us about the textbook 'Medication Errors', that you edit.
MC: The best patient safety experts and people on our board, including myself, have written chapters in this compilation book on preventing errors in pediatrics, in vaccines, labeling and packaging and prescribing issues. It's 653 pages, updated every 5 years, and a great reference for those who need to understand what's behind medication errors.
For example, the attorneys who might read your publication, I'll bet in many cases what they're being presented with by their clients we've already handled.
LAS: How can the ordinary consumer benefit from your work?
MC: We're working on a consumer website (it will be at www.consumermedsafety.org)
that will feature medication error reports, over 200 original articles written for the consumer, safety tools and self-assessments. They will also be able to communicate with us.
Michael Cohen was the 2205 recipient of the prestigious MacArthur Fellowship. He donated the award money to the creation of a drug safety fellowship at Temple University School of Pharmacy.