LawyersandSettlements.com (LAS): What does your role as vice president involve?
Hedy Cohen (HC): I give presentations to all healthcare stakeholders, I write articles for professional journals and the general press. I'm presently working on a consumer website that would provide an outlet for information and where consumers can share what they know. I also work for Pennsylvania Safety Authority, analyzing all reports that come in from the state of Pennsylvania.LAS: Where do the reports originate?
HC: Practitioners tell us about errors, near misses and hazardous conditions that are happening in the health care setting through the USP (U.S. Pharmacopoeia)-ISMP Medication Errors Reporting Program, which is confidential and voluntary. We analyze these issues then disseminate them through our four online Safety Alert newsletters. They go out to all American hospitals, the ambulatory care setting of community pharmacies and nursing homes, nurse advise-ERR and to the consumer.
Our turnaround is very fast, unlike journals that can take months, so the alerts are out in about 2 weeks or even faster. If we've seen a problem, take Heparin for example with its hypertension episodes, we knew about it before it was released to the public because people were telling us.
LAS: Where did the need for a safe medication practice body start?
HC: The ISMP was started in the 1970s by my husband, Michael Cohen, who is president. He was working at Temple University hospital and found that errors weren't just happening on one floor but within the whole building. He started wondering whether the same errors were happening in other hospitals and since he wrote a column for Hospital Pharmacy journal, he put the question out and behold, the same problems were occurring across the country. He then began to ask his correspondents to specify those problems and so from there, it just evolved.From our analysis, we learned about high alert drugs, how to concentrate on patient units, the free flow pumps, etc.
Since we're not a regulatory agency, we need other people. We work with the Food and Drug Administration (FDA) [as a MedWatch Partner], for example, but we can only give recommendations for enforcement.
LAS: Do you work with the public?
HC: People can report to us through the website (the new one is still under construction). We're not there to hear 'I don't think the doctor did this or that right', we're actually here to talk about adverse events so it's a little different from reporting on bad practices.
The information goes to the American Medical Association or the Nursing Boards. We're looking into information that will help us look at the system and make some adjustments, not looking into firing nurses because we know that the vast majority, up in the high 90s, are coming to work every day, trying to do the best that they can but sometimes they're working in systems that are just pretty broken.
LAS: What do you mean by adverse events?
HC: It is the unintentional outcome--the practitioner meant to give this but gave that--something you really didn't expect to happen.
You can have an adverse drug reaction you took that give you hives; if you never took that med before, it wasn't preventable-the practitioner didn't know. But, if you told your doctor when you take this medication it gives you hives, and he gave it to you anyway because he didn't have the information, that was preventable. So we're looking at anything that is preventable.
LAS: Within the last year, have you noticed any alarming trends?
HC: I don't think trends have changed; we're just seeing more transparency. Practices are getting safer but we're learning about some unsafe ones that are entrenched in our system. The public is now hearing about things, which is good because sometimes we need the public to force organizations to change.
LAS: How has the transparency come about?
HC: In the past, the paradigm of healthcare was that the doctor knew best; there was a hierarchy mentality but obviously things have changed. Maybe it's the baby boomers, and certainly with the Internet we are able to gather our own information, and that's a good thing.
Of course there are unintended consequences. There's been a boom in prescribing because of television. A patient might see a TV campaign and go to their doctor feeling they need that medication and sometimes, unfortunately, the doctor will prescribe it just to placate the patient.
Inversely, some people will find out about a medication, wonder if they need it, and go to the office to find out more about the medication, at a different level.
That the provider takes the opportunity to sit and discuss why they're going to prescribe a particular medication--then that's the best outcome.
When I was little, the doctor would scribble out the prescription on a pad and say, let me know if you're better in a few days; we didn't know what we were taking. Now, when I go to my physicians and they say I'd like to prescribe this for you, they're going to tell me why I should be taking it, give me the pros and cons and they let me make the last decision. So I choose my health care provider to meet my emotional needs.
Now another person might not want to be bothered with it.
LAS: How can patients protect themselves?
HC: We're so much more aware of everything we do these days. If we go to the movies we find out about the content, at a restaurant--is the dish broiled in butter, we ask all kinds of questions about our car, but when we walk into a physician's office or hospital, we all of a sudden become mute.
We should be asking the same kinds of questions: what am I taking, what is it for, what might be the downsides? This is pretty important.
LAS: Does labeling, for example Black Box labeling, help at all?
HC: Black box labeling is a wonderful warning to let consumers know this drug has a higher risk than most drugs. We often think that, in the case of over-the-counter drugs that it must be safe because they can be bought over the counter. But many people have had liver transplants from taking too much Tylenol or ulcers from Ibuprofen. We have to do a risk analysis, weighing the benefits against the risks. Especially in the case of long term medication like statins or antibiotics. And if you're unsure, consult your physician, your nurse practitioner and certainly the pharmacist. And that includes dentists, podiatrists and anyone else than can prescribe medication.
LAS: What other service does ISMP offer the consumer?
HC: For the moment we have a very small consumer focus (the new website should be up this year) where people can obtain a brochure, read anecdotal problems, and subscribe to our consumer newsletter that warns of safe medication practices in question.
We also share information from other sources--on the FDA site there is a place to report adverse drug reactions.
LAS: This is a huge field to tackle. What keeps you going?
HC: I love what I do, and we're a small grassroots organization with around 33 employees and though we don't always know where the money is coming from next year, after the 1999 Institute of Medicine report 'Do No Harm' on safety and the 2007 Medication Errors, people are becoming more aware and we're going to tilt and hopefully will bring more people on board. We want to give practitioners a fighting chance to do this the right way.
The Institute for Safe Medication Practices works in a strategic partnership with the American Hospital Association, is a member of the Joint Commission of Healthcare Organizations (JC) sentinel event and National Patient Safety Goals, and a member of the National Coordinating Council on Medication Error Reporting and Prevention.