healthy4u: postmarketing surveillance

A report "Quality and Safety Implications of Emergency Department Information Systems" appeared in the Oct. 2013 issue of "Annals of Emergency Medicine."  It is available fulltext at <a href="http://www.annemergmed.com/article/S0196-0644%2813%2900506-4/fulltext">http://www.annemergmed.com/article/S0196-0644%2813%2900506-4/fulltext</a>, or in PDF via the tab, free as of this writing. First, a preamble:  I once tried to alert a hospital where I'd trained decades before, Abington Memorial Hospital (<a href="http://www.amh.org/">http://www.amh.org/</a>), of impediments to safe care I'd noted in their EHR's, predominantly their ED EHR.  They did not listen.  In fact, their response to my concerns was characterized by an apparent incompetence regarding conduct of safety investigations.  For instance, to my written concern in an April 2010 letter to the CEO and CMO about the ED EHR that: <blockquote class="tr_bq"> ... I've also had to stop administration [to my mother] of an antibiotic (Levaquin) in the recent past in the ED that she has had an adverse reaction to (torn rotator cuff), despite my having told ED intake she was allergic to it. She relates that administration of Levaquin was then almost repeated on the floor until she herself refused it during that past admission.</blockquote> This was the sworn testimony in May 2013 about the "investigation" that resulted, from the hospital's VP of Risk Management, <a href="http://www.corporationwiki.com/Pennsylvania/Abington/regina-sturgis/81813980.aspx">Regina Sturgis</a>: <blockquote class="tr_bq">A:      Deborah [hospital General Counsel] asked me to investigate the Levaquin issue which I did. Q:      Did you do that on your own or did you delegate some of the -- A:      No.  I did it on my own. Q:      Do you know whether any of the IT folks were ever brought in to look at the -- the EMR issues referenced in this letter? A:     No, I do not.  I know that I was asked to look at the Levaquin because of my clinical background. Q:      Okay.  Did you come up with any conclusions? A:      Yes. Q:      What was your conclusion? A:      That she had been ordered Levaquin in the ETC [Emergency Trauma Center a.k.a. ED], that it had been discontinued about a very short period of time later, under a half an hour, and that she never received it. </blockquote> So, the investigation of a complaint that family and then the patient themselves had to stop the administration of a drug whose staff and EHR had been informed of an allergy consisted of confirming that the medication was never given.  No problem, the ED EHR is safe. (I am not joking; that is the testimony given.  Imagine such an investigation and conclusion about, say, reported aircraft flaws, or, in the industry in which I was once a safety officer, public transit vehicle defects and dangers.) However, when competent people investigate similar issues, the findings are concerning.  From Modern Healthcare (<a href="http://www.modernhealthcare.com/">http://www.modernhealthcare.com/</a>), a publication for healthcare executives, on the new Annals of Emergency Medicine article: <blockquote class="tr_bq"><a href="http://www.modernhealthcare.com/article/20130624/NEWS/306249952/">ED EHR systems pose serious concerns, report says</a> By <a href="mailto:jconn@modernhealthcare.com" target="_blank">Joseph Conn</a> Modern Healthcare <div>June 24, 2013</div></blockquote><blockquote>Electronic health-record systems used in <a href="http://www.modernhealthcare.com/section/articles?tagID=5739" target="_blank">emergency</a> departments are beset with poor data displays, loaded with so many alerts warning of potential <a href="http://www.modernhealthcare.com/section/articles?tagID=51" target="_blank">patient-safety issues</a> that they can lead to user alert fatigue, and may be generating incorrect physician orders, according to a report by two emergency physicians' study groups. Meanwhile, providers wanting to address these <a href="http://www.modernhealthcare.com/section/articles?tagID=975" target="_blank">EHR</a> issues are hampered by a lack of research and solid evidence of the extent of the problem with these systems, and by contract provisions with EHR vendors that stymie the free flow of information about system-linked safety concerns, the report authors say. </blockquote> So, ED's across the country are rolling out technology, often taking advantage of ARRA's HITECH incentives ... but there is a lack of research and solid evidence into the risks.  Allow me to opine - that's simply crazy. <blockquote class="tr_bq">The groups found that “poor data display is a serious problem with many of today's EDISs,” while “the sheer volume” of alerts that range from the “completely irrelevant to life threatening” [or lack of appropriate alerts to relevant, simple issues such as data input errors - ed.] can “dull the senses, leading to a failure to react to a truly important warning.” They also found that “an alarming number of clinicians are anecdotally reporting a substantial increase in the incidence of wrong order/wrong patient errors while using the computerized physician order entry component of information systems.”</blockquote> The word "anecdote", as I have written, is being misused.  The reports are not "anecdotes."  They are risk management-relevant incident reports.  (See "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things" at <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html</a>.) <blockquote class="tr_bq">Two study groups from the American College of Emergency Physicians have recommended a program of systemic vigilance over electronic health-record systems used in emergency departments to improve patient safety and enhance quality of care. ACEP workgroups on informatics and on quality improvement and patient safety published their findings in an article, “<a href="http://www.annemergmed.com/article/S0196-0644%2813%2900506-4/abstract" target="_blank">Quality and Safety Implications of Emergency Department Information Systems</a>,” in the current issue of the Annals of Emergency Medicine. </blockquote> Post marketing surveillance, a standard for decades in other healthcare sectors, has been absent from health IT due to a long-obsolete special regulatory accommodation afforded that industry.  This accommodation was initiated when systems were simple and merely advisory - not the comprehensive enterprise clinical resource and clinician command-and-control systems they are today.  Now, clinician investigators of the technology such as the authors of this study are realizing that continuing this accommodation is a mistake. <blockquote class="tr_bq">It follows in the wake of, and references, an Institute of Medicine report from 2011, “Health IT and Patient Safety: Building Safer Systems for Better Care.” That report concluded that “current market forces are not adequately addressing the potential risks associated with the use of health IT.” It also comes eight months after the New England Journal of Medicine published “<a href="http://www.nejm.org/doi/full/10.1056/NEJMsb1205420" target="_blank">Electronic Health Records and National Patient-Safety Goals</a>,” which warned that recent evidence “has highlighted substantial and often unexpected risks resulting from the use of EHRs and other forms of health information technology.”</blockquote> I note that if you frequent this blog, you likely read material similar to the bolded red statements above here first, as authored by me, dating to the founding of this blog in 2004. <blockquote class="tr_bq">... “The rush to capitalize on the huge federal investment of $30 billion for the adoption of electronic medical records led to some unfortunate and unintended consequences, particularly in the unique emergency department environment,” said Dr. Heather L. Farley, the lead author of the report, in a news release. “The irreversible drive toward EDIS implementation should be accompanied by a constant focus on improvement and hazard prevention." Farley is assistant chairwoman of the Department of Emergency Medicine at Christiana Care Health System in Newark, Del.</blockquote> Ironically, I note in Dr. Farley's statement some of my own advice, given to ED staff when I was Chief Medical Informatics Officer at Christiana Care 1996-8.   I had in that time period advised <a href="http://www.christianacare.org/bodymod.cfm?id=169&action=detail&ref=1909">Charles Reese IV, MD</a>, Chair of Emergency Medicine, to not implement EHRs or, at best, implement document imaging systems (since ED charts are not that long or complex), not full field-based EHRs, due to the "unfortunate and unintended consequences" of bad health IT in such an environment I recognized even then.  It was only a few years ago that my advice was finally overturned. <blockquote class="tr_bq">The authors also report “(t)here are few consistent data on how commonly these errors occur, and few studies are actually focused on collecting evidence of these errors.” Meanwhile, “there is currently no mechanism in place to systematically allow, let alone encourage, users to provide feedback about ongoing safety issues or concerns” with EHRs in general, and EDISs specifically.</blockquote> On its face, that is not a safety-conscious environment and the rollout and use of such systems seems a fundamental violation of patient's rights, made worse by the fact that there is no informed consent process whatsoever to ED EHR use. <blockquote class="tr_bq">The workgroups came up with seven recommendations: appointing an emergency department “clinician champion,” creating within healthcare delivery organizations an EDIS performance improvement group and an ongoing review process, paying timely attention to EDIS-related patient-safety issues raised by the review process, disseminating to the public lessons learned from performance improvement efforts, distributing vendors' product updates in a timely manner to all EDIS users and removing the “hold harmless” and “learned intermediary clauses” from vendor contracts. </blockquote> Many of these issues have been discussed on this blog. <blockquote class="tr_bq">“The learned intermediary doctrine implies that the end users (clinicians) are the medical experts and should be able to detect and overcome any fallibility or contributing factor of the product,” the authors said.</blockquote> I have also pointed out the absurdity of such a "doctors are clairvoyant" attitude, e.g., at my 2011 post on basic common sense on IT adverse consequences at <a href="http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html">http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html</a>. <blockquote class="tr_bq">They conclude that the “lack of accountability for vendors through hold harmless clauses and the shifting of liability to the clinicians through the learned intermediary doctrine are significant and additional impairments to safety improvement. Electronic health records and EDISs are sufficiently complex that the physician and other users cannot be expected to anticipate unpredictable errors.” </blockquote> That aligns with the work of Dr. Jon Patrick in Sydney, whose treatise "A study of an Enterprise Health information System" on the Cerner FirstNet ED EHR is available here: <a href="http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146">http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146</a> <blockquote class="tr_bq">Earlier this month, the Electronic Health Record Association, an EHR developers trade group affiliated with the Chicago-based Healthcare Information and Management Systems Society, announced the launch of a voluntary “<a href="http://www.modernhealthcare.com/article/20130611/NEWS/306119952/ehr-trade-group-issues-code-of-conduct-to-improve-patient-safety" target="_blank">code of conduct</a>” in which adherents would agree to drop “gag clauses” in the contracts with their provider customers. </blockquote> Great.  Per the wonderful 2007 article "The Denialists' Deck of Cards: An Illustrated Taxonomy of Rhetoric Used to Frustrate Consumer Protection Efforts" by Chris Jay Hoofnagle, available at <a href="http://papers.ssrn.com/sol3/papers.cfm?abstract_id=962462">http://papers.ssrn.com/sol3/papers.cfm?abstract_id=962462</a>, as of this writing free: <blockquote class="tr_bq"> ... At this point [of losing the argument], the denialist must propose "self regulation" to deal with the problem that doesn't exist. The cool thing about self regulation is that it cannot be enforced, and once the non-existent problem blows over, the denialist can simply scrap it! [20] [20] In the runup to passage of bank privacy legislation, data brokers created a group called the "Individual Reference Services Group" that promptly disappeared after the legislation passed.</blockquote> ("Denialism" is the use of rhetorical techniques and predictable tactics to erect barriers to debate and consideration of any type of reform, regardless of the facts.) IMO 'self regulation' of healthcare is, on its face, a deception.  There are simply too many conflicts of interest. On use of "integrated" big systems: <blockquote class="tr_bq">“These systems do have glitches [indeed - see <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> - ed], but it can be plain and simple bad design that can lead to clinical errors,” Cozzens said.  But ED physicians, he said, are “having the enterprise systems forced upon them. To think you can take one system and adapt it to those different environments is totally wrong. That's why you see low physician satisfaction and the productivity is going down, all for the sacrifice of having an integrated system.”</blockquote> In fact, so-called "best of breed" systems can be bad health IT as well.  See the aforementioned evaluation by Dr. Patrick in Australia. <blockquote class="tr_bq">Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, hard to customize, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  </blockquote> Through my own work, I've seen bad health IT result in patient harm and death.  It's just unfortunate that I got started in this line of work by being, in effect, shot out of a cannon.  That is, my own mother was a victim. -- SS Addendum 10/8/13: From the article: <blockquote class="tr_bq">End-User Recommendation 4: EDIS-related patient safety concerns identified by the review process should be addressed in a timely manner by ED providers, the EDIS vendors, and hospital administration. Each of these processes should be performed in full transparency, specifically with openness, communication, and accountability. </blockquote> I'm not sure the aforementioned levaquin near-accident "investigation" meets these standards. -- SS

Quality and Safety Implications of Emergency Department Information Systems: ED EHR Systems Pose Serious Concerns, Report Says

A report " Quality and Safety Implications of Emergency Department Information Systems " appeared in the Oct. 2013 issue of "...

Đọc thêm »