More than 214 people have been diagnosed with aspergillus meningitis after having received an injection of the drug Methylprednisolone. Tests showed the drug was contaminated with a fungus. As of this writing, there have been 15 deaths in 15 states. The current CDC numbers are here.
Meanwhile, and perhaps previously unrelated, there's been another contamination event going on related to healthcare information technology. In the media, and specifically an article in The New York Times and an opinion piece in The Wall Street Journal, the topic of healthcare delivery in general, and the value of a policy that provides funding for healthcare IT has heated up with the political season.
Two thoughtful and accomplished professors, Ross Koppel and Stephen Soumerai, wrote the opinion piece. In it, they stated that the benefits of healthcare information technology are wildly overblown and represent a fanciful initiative that should be shut down.
A number of knowledgeable healthcare IT experts have identified a series of flaws in their reasoning. They include the failure to consider the time frame of expected benefits relative to the tests the authors were applying.
Physicians Peter Basch and Michael Zaroukian wrote a comprehensive 6-part blog that challenges the position of Koppel and Soumerai. The blog’s overview is here, with links to each installment.
In essence, these experts were asserting that the professors were contaminating the public discourse, framing a debate of the facts where no debate truly exists. So let's look into this meningitis outbreak and its healthcare IT implications.
The scientific promise of medicine is that we can identify, predict and mitigate disease, either with the impact of primary prevention, limiting the condition from happening in first place, or to cure or mitigate the impact of disease. The intent, of course, is to maintain as much function as possible, prolong healthy life, and reduce or avoid pain in the process.
Applying that to the drug contamination issue, the challenge was to identify the aspergillus meningitis, identify the cause—the contaminated Methylprednisolone—and eliminate subsequent cases by removing the medication from the drug supply. The process included identifying those patients who had already received the drug, but had not yet expressed signs of the disease, for prophylactic treatment where appropriate.
This raises many IT questions I would like you to consider. Do providers who have implemented an electronic health record (EHR) to meet MU Stage One criteria have a better chance to support handling the identification and management of this outbreak? Did those providers using EHRs have a higher rate of identifying patients with the contaminated drug-induced meningitis than providers who did not have electronic health records meeting Stage One criteria?
Did providers with EHRs whose patients received the drug receive quicker notification and follow up for assessment? And, being more forward-looking, should we use cases like this outbreak to inform the use cases that will be specified as test cases in MU Stages Two and Three?
The data underlying the answers to these questions should be collected very soon by state health departments, the CDC, and other agencies involved in the investigations currently underway. This could be done by simply documenting where EHRs were being used, and the data they contained relative to the investigation.
What would that look like? For each patient, was their care managed using an EHR? Was that record certified for Stage One, and had the provider using that system attested to MU or was it in the process of doing so?
Further, what elements of the case report for each patient were electronically available on the systems? For example, was CPOE used to order the medication for the injection, perhaps as part of an order set? Was cerebrospinal fluid drawn on the patient to establish the diagnosis, and was that result electronically captured and integrated with the patient's record? How about the culture results for those tests? Were the procedure codes, CPT, J Codes, etc., captured in the practice management portion of the EHR to reliably identify patients at risk?
Then we come to the analysis. Was there a material difference between using EHRs versus other methods in the time to diagnosis and treat these patients? And finally, were the mortality rates different between those patients whose care was managed using an EHR and those who were not?
How we manage and treat this instance of drug contamination and its impact can shed light on how we deal with the arguably contaminated claim that electronic health records are immaterial to improving health and reducing the cost of care delivery. The data to have an informed policy going into the election are directly in front of us. We have only to collect it, record it, and interpret it wisely.
You know my position; what do you think?
Joseph I. Bormel, MD, MPH
CMO and Vice President
QuadraMed Corporation
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Comments
Searching EHRs for information relate to Public Health Outbreak
Dr. Bormel – Thank you for an excellent and thought provoking post. Showtime indeed! It will be interesting to see how and if the questions you pose are definitively answered.
Time will tell how this particular public health case story will play out… However, I’m also struck by the need for organizations to think beyond a specific clinical department as they “push and pull” on their EHRs to reveal potential patients at risk for negative medication safety outcomes.
I believe their queries in to their EHR need to be multi-dimensional and across many departments in looking for telltale signals identifying potential patients at risk.
As I am a pharmacist, I can easily appreciate the power of any informational system to quickly and reliably determine if the contaminated drug by line item is on my shelf and/or if it was utilized in one’s organization.
However, other than lot number tracking on vaccines and blood product type medications, most organizations do not track every lot number of every medication dose administered (a topic for another time!). So, tracking of the contaminated product “XYZ” may be “all or none” task.
I can imagine the sigh of relief from Risk Management officers who
quickly called the Director of Pharmacy to ask “do we/did we have
“XYZ”? Is it now out of the organization’s supply?” I can see
how that the response of “whew, we don’t have it” could lead to thinking “done and off the hook”. But while the initial question posed only explores the issue of identifying patients directly affected by an organization’s initial treatment, what about patients who received the problematic medication elsewhere
and now show up with symptoms and need for treatment and care (downstream event from the initial injection event).
Can the second organization with an EHR identify these patients at risk? Are we querying the EHRs for information on the utilization of anti-fungal treatment drugs and/or querying for lab results and looking closely in the absence of having information about utilization of drug XYZ?
As you point out, there is a plethora of potential data points (symptom codes, lab results, formulary drug listings, billing codes etc.) to evaluate both concurrently and retrospectively. I think we need to ask lots and lots of questions, even when one of the first questions “do we have the offending drug” seems to get us out of the immediate need to track and search for patients. And as you point out, EHRs can be tools to help readily search and find such answers.
Policy Expectations of EHRs
LTL, Thanks for your kind words and pharmacy perspective.
I waited a few weeks before replying, in part to privately check in with my friends at the CDC. The scale of this active outbreak is huge. It will take some time, probably months, before it's appropriate to ask the question, "Where Certified EHRs helpful in managing the Outbreak?"
Like many questions, it's easy to state; it's neither faster nor cheap to answer, especially if the question is not built into our investigatory processes. One thing is clear. We wont get Healthcare to CMMI Level 5 without EHRs.
Policy Expectations of EHRs
LTL, Thanks for your kind words and pharmacy perspective.
I waited a few weeks before replying, in part to privately check in with my friends at the CDC. The scale of this active outbreak is huge. It will take some time, probably months, before it's appropriate to ask the question, "Where Certified EHRs helpful in managing the Outbreak?"
Like many questions, it's easy to state; it's neither faster nor cheap to answer, especially if the question is not built into our investigatory processes. One thing is clear. We wont get Healthcare to CMMI Level 5 without EHRs.
Meaningful Use
Dr. Joe,
It is an insult to healthcare providers that we are still being coerced to justify the adoption of electronic medical records. Further, it is outrageous and irresponsible for any major media outlet to publish unfounded opinions that are critical of programs designed to assist us in doing so. A degree of responsibility goes with the right to free speech.
You have done a masterful job of explaining how we can all gather and present the facts about EMR/EHR systems and their use to consumers and government representatvies alike. I commend you for your efforts.
I think that evidence of using a certified EHR in the example you provided is much more important at this point than whether or not a hospital has attested to MU Stage One. Is there a specific reason you included this in your post? I must be missing something as to its importance at this particular juncture.
Also, do you think the public and healthcare providers would be better served if all of the resources various agencies are using to investigate the meningitis outbreak were consolidated under a single body to lead the way? It seems to me that in doing so there would be common goals set and far less duplication of effort. In this case, CDC would seem to be the logical agency to take charge.
In conclusion, I could not agree more with the comment posted by HITmaven. The myopic views taken by acedemics are too often misleading and without merit. Healthcare providers are working to both control the cost of health care and to provide more focus on prevention to help ensure the public's well being. That can hardly be said for the world of higher education with its out of control cost increases that can easily leave students in debt for decades.
Thank you for taking a stand in this post. Only the truth will keep people such as Koppel and Soumerai at bay. Keep up the good work!
Rosemary Carlisle
Never let a crisis go to waste!
Thanks for the kind words. Regarding your questions:
We shouldn't let a crisis go to waste. This outbreak is an opportunity to see how well EHRs are performing. More broadly, are care delivery organizations who have clinically transformed, establishing workflows, policies and culture to exploit EHRs better able to respond to this crisis? If so, let's call it out and use it as validation and inspiration. If not, let's figure that out, too.
Thanks again for your thoughtful comments.
HIT contamination events
Dr. Joe,
As a former EDI standards advocate and a former hospital operations professional, I fully concur with your assessment that one of the strong suits of EHRs is their ability to enable a maximum response to patient-threatening emergencies like the aspergillus meningitis situation. Myopia is perhaps inbred in the academic situation where researchers who obtain less-than-perfect results from their test, tend to ascribe fault to the test materials (i.e., the EHRs themselves) rather than to the test methods. Similarly, the “silly season” pre-election political posturing your blog alludes to faults the entire industry for not having completed the full path of EHR interoperability evolution, which only began in 2005 after the catastrophic drowning of paper records in Hurricane Katrina.
Remember how stakeholders cobbled together KatrinaHealth.org? Here’s an excerpt from a post-Katrina article in CIO.com to help refresh memories:
CIO.com
By Susannah Patton
Tue, November 15, 2005
“Many Hurricane Katrina evacuees lost their paper medical records in the storm. Consequently, they have no documentation of their medication histories and neither do their doctors and pharmacies. To help the hurricane’s victims get appropriate medical treatment, the federal government, with help from other public and private groups, has established a website where health-care workers can retrieve prescription histories and related information on evacuees.
“The site, www.katrinahealth.org, was assembled by networking existing databases from retail pharmacies and government health programs such as Medicaid. David Brailer, National Coordinator for Health Information Technology who is in charge of federal efforts to promote the adoption of electronic medical records systems, says the experience shows how quickly health-care information can be gathered electronically on a national level.”
How different today when we read about St. John's Regional Medical Center, Joplin, Missouri, that was wiped out by a tornado in May, 2011:
St. Louis Post-Dispatch
By Blythe Bernhard
June 02, 2011
“The information wasn't lost, because the hospital had joined its parent company Mercy's electronic medical record system just three weeks earlier to back up the paper records. Those servers were not damaged by the tornado.
"’Our electronic health record contains all of the records of our patients before the storm. We don't have to worry about losing a paper chart or having it damaged by water or rain,’ said Dr. Bob Dodson, in a statement about the opening of a temporary Mercy hospital in Joplin.”
From my hospital operations days, I know only too painfully how loss or non-availability of paper records can adversely impact patients and their care – and how impossibly arduous and time-consuming it is to manually extract information on which patients got which drugs. And from my EDI days, I know the speed and analytics potential of electronic data.
Those organizations that can use their EHR investments of time and resources to quickly deliver a superior response to the outbreak should do so, and they should be recognized and commended for delivering a higher value to their community and patients than those whose practices responded slowly or not at all from being mired in paper or who have failed to harness the existing power of their EHRs. Those federal and state investigations have a duty to call out the benefits of the HHS EHR Incentives Programs where MU EHR-enabled responses are found to be superior.
So a pox on all those nay-sayers who have conveniently forgotten the tragic lessons of Katrina and the billions of dollars invested in “never again” infrastructure like levees and EHRs. Holding back on the development of those life-saving infrastructures will doom a lot more people than it will ever save.
Do EHRs impact outcomes during an outbreak?
HITmaven,
Thanks for your comment. I found your comment interesting:
"Those federal and state investigations have a duty to call out the benefits of the HHS EHR Incentives Programs where MU EHR-enabled responses are found to be superior."
You went further in your thinking than I had. I was only arguing that we need to collect the information about the context of the care delivery (presence or absence of a certified EHR), so that we can see if there is an impact on outcomes.
Thanks for sharing your observation and the historical context. Very valuable.