How EMR and EHR systems can kill patients

Back in the times when EHRs were just EMRs, they had a very simple and humble mission.

The software was supposed to help providers of health care services better manage their business. EMRs were supposed to help physicians adhere to CMS documentation rules, automate patient flow management and get rid of all the mountains of paper floating around a typical medical office or hospital. It was assumed that EMR software will increase reimbursement rates, streamline workflow and even make the doctor more efficient. After all, every other industry that switched to computerized business management realized bottom line improvements.

Along the way, bolder statements started appearing, mainly from EMR vendors trying to sell their wares. EMRs could also reduce medical errors. The most common argument was for the benefits of replacing the notoriously illegible physician hand writing. Prescription errors would be reduced if only pharmacists and nurses could get a nice legible script. Then came the frequently misplaced paper charts.

If the chart resides in the computer, it cannot be misplaced, it is always available to all and it is complete. All the information you need right at your fingertips, regardless of your physical location. It could save lives or at the very least, it could save time. The EMR was nothing more than an electronic chart. One vendor went so far as to create a computerized image of a yellow manila folder with tabbed pockets for various items in the electronic chart.

Nobody thought the electronic chart needed to be regulated by the FDA any more than the paper chart was. After all, the EMR was not providing medical care; it was just a more effective place to record administered care. Or was it? There is a funny thing about computers. They have a mind of their own, a mind created by programmers, a mind which makes them interactive.

A paper chart is passive. If you want to see all lab results in a paper chart, you have to decide where to look and actively flip the pages. If you missed one page, it’s your omission, not the chart’s mistake. If you want to see all lab results in an EMR, you click a button and the software does all the paging returning a convenient list for you to look at. If the software missed a page, it’s the software’s fault, not yours. The software is controlling what you see and how you see it. This small fact renders the electronic chart a full partner in delivering health care; it is now a medical instrument.

And then the EMR grew up and became an EHR. The EHR performs tasks for you, like calculating dosage for medications or just simple BMI. The more advanced EHRs presume to give you advice on what to order for a certain condition, or what not to order based on what it knows about your patient.

There are EHRs now, and there will be more in the future, which communicate with other software and automatically, bring in medical data and place it in the chart. This sophisticated software makes decisions regarding patient identities and about schedules for preventive care and disease management. Computers are not infallible. Their mistakes are called “bugs” or “software glitches” and just like the nurse or the medical records clerk sometimes placed the wrong piece of paper in the chart, EHRs can, and do, corrupt medical records. Incorrect, incomplete and indecipherable medical records can lead to injury and even death. But does it really happen?

Do EHRs actually kill people?

The Huffington Post has been investigating this exact question. Between January 2008 and February 2010, the Huffington Post identified 237 reports in the voluntary incident reporting FDA database related to HIT, including 6 deaths and 43 injuries. However, a closer looks reveals that only a small fraction of these reports are actually related to EHRs per se.

Most reports involve PACS, medication dispensing systems, blood banks and other FDA regulated equipment. Out of the 6 reported deaths (2 of which occurred in 2006), one was related to a PACS system latency, another to human error in labeling an x-ray cassette and another to a hospital pharmacy system. 2 deaths were attributed to system wide failures of CPOE and one to lack of intuitiveness in display of notes. As to injuries, out of the 43 reported, I could only count 17 directly related to EHR software and most have to do with CPOE.

Is this the tip of the iceberg, as some contend? Are there many more unreported deaths caused by EHR software? There may be, but frankly, the evidence of massive numbers of adverse events is not there. It does, however, stand to reason that voluntary reporting would be incomplete and the fact that only a couple of EHR vendors are represented in the FDA database is suspicious to say the least. On the Health Care Renewal blog they are engaging in what I think they know are rather creative mathematics, to project hundreds of thousands of injuries per year if, and when, EHR adoption really takes off.

If EHRs become pervasive in everyday medicine as Office of the National Coordinator for Health Information Technology (ONC) is proposing, every patient will eventually be touched by an EHR. It is very likely, that some errors will be prevented by the sheer existence of an EHR, but new and unfamiliar errors will also be introduced as side effects. Of course, the potential benefits must be shown to significantly outweigh the hazards, and we already have accepted mechanisms for such assessments.

While ONC is exploring collaboration with the FDA, and the FDA seems willing to engage, the customary counterargument is that FDA processes will stifle innovation and make EHRs unaffordable. There is validity to such arguments, but as long as money seems to be no object for HITECH, maybe we can spend some of it on devising reasonable and affordable methods of testing patient safety, both pre and post market. Innovation will take care of itself and the alternative is unconscionable.

Margalit Gur-Arie is a partner at EHR pathway, LLC and Gross Technologies, Inc. She blogs at On Healthcare Technology.

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  • MillCreek

    As a healthcare risk manager, I have also been the recipient of the marketing pitches on how ‘EHR saves lives, reduces errors and your malpractice insurance should be cheaper as a result’. The funny thing about that is there is yet no data on this that convinces the medmal insurance company actuaries that premiums should go down solely due to use of an EHR. I wonder if such data will ever be derived.

  • jsmith

    Twenty one years in family medicine tell me that the bigger potential problem is indirect:
    Today’s EHRs could dissuade even more med students from entering primary care, so as to avoid the soul-crushing computer work. So numerous effective primary care interventions simply don’t done, resulting in a higher population death rate.
    The soul-crushing computer work distracts the docs that do exist from actually paying attention to the pt in front of them, resulting in mis-diagnosis.
    Docs are so tired from the extra hour or two per day doing the soul-crushing computer work that they make mistakes, hurting pts.
    Doctors attempting to avoid the extra hour or two per day rush through their pts so as to get to their real work, that is, the soul-crushing computer work, and so they miss things.
    I’ve said it before and I’ll say it again. Doctoring and clerical work simply do not mix.

  • Mark

    There is no way younger docs will want to work anywhere without an EMR system. The idea of using paper charts seems totally archaic to me. There are always going to be errors no matter how you handle the data, but the upsides of EMRs are huge.

    • jsmith

      It depends on how the system is set up. I can dictate and the transcriptionist enters it into our EHR. If you type, you are slowing yourself down and shortchanging your patients. Hear me now and believe me later, young doc.

  • http://onhealthtech.blogspot.com/ Margalit Gur-Arie

    I agree with Mark. Younger docs are used to EMR, and it’s all about what one is used to. And yes, EMRs have huge upsides, but in order to realize those upsides, there must be some sort of quality supervision, whether it is FDA or a different agency.
    I don’t see how EMRs where deployed in a hospital setting without any sort of approval to start with. Every other technology and software package, such as blood banks or PACS, requires FDA approval. I can see no reason for EMRs to be exempt from safety regulations.

    • jsmith

      Huge upsides? Come on. Show us the data.
      There are lots of people who want very much for EHRs to fulfill their dreams, so they believe it will happen. When evidence fails to back them up, they say “it will get better in the future.” When it doesn’t they say “well, it’s here anyway, so you might as well get used to it.”

      • http://onhealthtech.blogspot.com/ Margalit Gur-Arie

        There is no data. The little data that is available points to risks to patient care, just like the new Leapfrog report on CPOE published today.

        The only way to infer upsides is to look outside of the field of health care and see that computers were able to bring efficiencies to almost everything we do today. There is no reason for this observation to not be applicable to health care, if (big if) properly done.
        I don’t think paper is a viable option any longer. The transition to electronic records is going to occur one way or the other. I just want it to occur in a safe and responsible way.

  • http://diagnosticinformationsystem.com Bob Coli, MD

    Margalit,

    I have found no evidence that any existing EMR, EHR, PHR or HIE platform software is currently able to return a truly “convenient” list of clinical laboratory test results to the physician requesting it.

    The reason is that the hundreds of commercial and home-grown EHR, PHR and HIE platforms are still using infinitely variable reporting formats to display oceans of fragmented, incomplete and hard-to-read test results data to their physician and patient users. The result is industry-wide duplicate and non-contributory testing, errors of omission and commission and reduced patient safety.

    The logical solution is an intuitive, content exchange standard format that can display clinically integrated, complete and easy-to-read test results information on up to 80 percent fewer screens and printed pages.

    Designed specifically to enable all cumulative test results to be viewed and shared more efficiently, this standard reporting format is analogous to the Continuity of Care Document (CCD) specification, which is an XML-based markup standard intended to specify the encoding, structure and semantics for efficiently viewing and exchanging a patient medical record summary document.

  • Marc Gorayeb, MD

    Have you seen what electronic medical records have done to patient medication allergy lists? Seemed like a good idea at the time….

  • http://onhealthtech.blogspot.com/ Margalit Gur-Arie

    Bob,
    Most EHRs out there are indeed local in nature. All the lists, convenient or otherwise, are very much limited to what was ordered by the clinic/hospital itself. Receiving results from other health care settings and integrating them into the local medical record is not happening on a wide scale.
    The new Government regulations are converging on LOINC for that purpose, but I think we are several years away from widespread utilization.
    And hopefully, Marc, it won’t look like the allergy lists, which BTW, should also be codified and standardized, but this seems a bit more difficult than labs.
    All in all, the promise is there, we just need to be very careful with the execution, I think.

    • Marc Gorayeb, MD

      Execution??
      I don’t think you really understand what computerizing allergy/sensitivity lists has done to patient care. For example,
      A patient informed me they are allergic to acetaminophen because they were told so by a nurse. The nurse read it from a computerized database that interpreted a reaction to percocet as a reaction to oxycodone and to acetaminophen.
      A patient informed me they are allergic to cephalosporins. They were told so by a pharmacist. the pharmacist got that information from an electronic database that dissuaded him from filling a prescription for a cephalosporin because the patient had a history of a reaction to amoxicillin. It took a long conversation with the patient and a phone call to the pharmacist before I could proceed with my plan of treatment.
      I routinely see patients who are currently taking the very medications they have been electronically deemed to be allergic to.
      And just try to make any corrections to a patient’s electronic allergy list. Lots of garbage makes its way in from many sources; very little of it can be removed without a time-consuming and frustrating effort.

      I personally haven’t seen any evidence that it has prevented medication reactions. The medication allergy list used to be coordinated between the primary physician and the patient, the patient keeping and updating the list on a card and the physicians and hospital updating their list as needed. The patient was always the central authority and keeper of the list. As long as the patient or their loved one is attentive, that system has worked well.

      • http://onhealthtech.blogspot.com/ Margalit Gur-Arie

        Marc,
        I’m not sure what software you are using, and I know most of them leave a lot to be desired, but inactivating an allergy should be trivial to do in any decent EMR.
        The issue with multiple sources of data and the misinformation is in my opinion due to the fact that allergies are not as well codified as meds and most software allows free text for allergies anyway. The other problem occurs when someone enters an allergy by class instead of a specific compound.
        Just to be clear, I am very aware of the incalculable damage these “small things” are causing, and this is why I believe the FDA must get involved and regulate all these “small things” which of course are not small things at all.

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