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EMR Rollouts: Are They Ethical?

Here’s something you should really see for yourself. Over at Dr. Wes’s blog, the good doctor has written a long and thoughtful post on whether rolling out EMRs to patients actually constitutes medical experimentation without patient consent.

I thought readers who don’t have time to read all of Dr. Wes’s carefully-structured argument might be interested in hearing a bit of what he has to say, as I believe his conclusions are important. Here’s some of his assertions:

* EMR costs are ultimately passed along to patients, whether they like it or not. And with insurance premiums climbing as much as 20 percent in 2013, patients are already having serious trouble paying for care.

* With EMRs still not interoperable in most cases, the efficiencies we’d hoped for largely aren’t showing up yet. In fact, EMRs are adding to inefficiencies as doctors struggle to add needless data to electronic charts.

* With health data breeches continuing and errors growing, EMRs may be part of the problem and not the solution.

So, he suggests that we take a pause and ask ourselves some tough questions:

Does the ends of presumed cost savings to our national health care system justify the deployment of poorly integrated, difficult-to-use systems? Are patients being subjected to new risks heretofore never considered with the adoption of this technology? Could a tiny programming error occur that negatively impacts not just one patient, but millions? If so, what are the safeguards in place to prevent catastrophic error? Who will be responsible? Who is the oversight body that assures the guiding principles of the Belmont Report (respect for persons, beneficence and justice) with respect to EMR deployment are followed? The Secretary of the Department of Health and Human Services or a more nebulous body like Congress?

Dr. Wes, in summary, wonders whether it’s unethical to roll out EMRs en masse given the still-unanswered questions about their benefits, their safety and their efficiency. And I think he’s asked a question worth answering. How about you?

Study: Drug Problems Most Common EMR Safety Event

When the phrase “EMR problems” comes to mind, most of us get a mental image of hardware flaws, software bugs or integration problems. But according to a new study, the majority of EMR-related patient care problems stem from issues in how people interact with their system, specifically in documenting and administering medication.

In recent research, the Pennsylvania Patient Safety Authority queried the state’s patient safety reporting database to identify EMR-related events. After sifting out events that didn’t truly appear to be EMR-related, analysts were left with 3,099 patient safety issue reports. The events were then classified by the harm score assigned by the reporter.

As it turns out, the great majority of events (89%) resulted in no harm to the patient. Ten percent of events were reported as “unsafe conditions” but also resulted in no harm to the patient. Fifteen events actually resulted in temporary harm to the patient:

* Six cases of entering wrong medication data
* Three cases of administering the wrong medication
* Two cases of ignoring a documented allergy
* Two cases of failure to enter lab tests
* Two cases of failure to document

The only event that resulted in significant harm stemmed from failure to properly document an allergy, analysts said:

Patient with documented allergy to penicillin received ampicillin and went into shock, possible [sic] due to anaphylaxis. Allergy written on some order sheets and “soft” coded into Meditech but never linked to pharmacy drug dictionary.

All told, medication errors were the most commonly reported event (81 percent), largely wrong-drug, dose, time patient or route errors (50 percent) or omitted dose (10 percent).

It’s worthy of note that according to the researchers, the narrative reports of EMR-related reports dug up from the Pennsylvania database differed meaningfully from reports found in FDA database MAUDE and Australia’s Advanced Incident Management System, which have different reporting requirements.

It seems that there’s a lot more work to be done in exposing the types of patient safety errors that may be unique to EMRs, but this looks like a good start.

Are EMRs One of The Top Health Hazards for 2011?

One key benefit of implementing an EMR is improved patient safety, right? Better access to complete patient records, e-prescribing, easy-to-read physicians’ notes, drug interaction warnings and so on?

Not necessarily, says healthcare research organization the ECRI Institute. The group argues that HIT complications — which obviously dog EMR implementation and use — are one of the top health technology hazards for 2011.

According to the group’s research, dangerous HIT-related problems such as data loss, incompatibilities between multivendor software applications and systems, incorrectly entered or corrupted data, and errors in data analysis are quite capable of causing patient harm.

ECRI’s advice on reducing such risks includes the following, which should send a chill down the spine of any HIT manager: ”Remember that help desk calls regarding computer equipment and systems may now literally be a matter of life and death,” the group says in its “Top 10 Health Technology Hazards for 2011″ report.

As we all know, these problems are likely to get worse, not better, as EMR systems roll out, bringing with them a massively complex set of management and systems integration issues. Unfortunately, we don’t yet know just how bad things are likely to get.

Late last year, a patient safety organization called PDRSecure launched a Web site allowing visitors to report EMR safety-related events. (Those entering the reports have to supply their names, which is likely to slow things down more than a little.) So far, at least, PDRSecure hasn’t released data on incoming reports.

While your editor isn’t an academic, what little research I’ve seen on EMR safety seems to be inconclusive. Some general interest articles and bloggers argue that HIT errors are the big threat, and others suggest that mistakes made by still-training clinicians are far more dangerous, but I haven’t seen any hard evidence there either.

The bottom line, though, is that while we’re going through a comparatively giddy period of spending on EMRs, and awaiting the Meaningful Use dollars to come, it might be nice to keep the patient safety issue on the front burner. From where I sit, there’s been too little candid discussion of EMR risks.

So, where do you come down on this? How important is it to discuss EMR safety hazards? Have you seen incidents that concerned you? And here’s a scary thought: should the FDA regulate EMRs and demand routine critical incident reporting?

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EMR Rollouts: Are They Ethical?

Study: Drug Problems Most Common EMR Safety Event

Are EMRs One of The Top Health Hazards for 2011?

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