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Is the Executive Branch/HHS Trying to Put Lipstick on a Pig Regarding Health IT?

In another example of executive branch spin on healthcare - this time, the <a href="http://healthit.hhs.gov/portal/server.pt?open=512&objID=1200&mode=2">Office of the National Coordinator of Health IT</a> (ONC) within <a href="http://www.usa.gov/Agencies/Federal/Executive/HHS.shtml">HHS</a> - data that gave an off-narrative message about healthcare IT was initially withheld according to Modern Healthcare's Joseph Conn. The data withholding is reminiscent of the data manipulation practiced in the pharmaceutical industry. Legislative branch, take note: <div style="border: medium none; text-align: left; background-color: transparent; color: rgb(0, 0, 0); overflow: hidden; text-decoration: none;"> <blockquote> <a href="http://www.modernhealthcare.com/article/20110124/blogs02/301249999">Not-so-rosy rumors</a>By Joseph ConnModern Healthcare.com Last week, Dr. David Blumenthal <a href="http://www.modernhealthcare.com/article/20110117/blogs02/301179963">announced the results</a> of two surveys funded by the Office of the National Coordinator for Health Information Technology on hospital and physician participation in the federal electronic health-record incentive programs. But Dr. B left out a few numbers in going over the results of the survey of office-based physicians conducted by the National Center for Health Statistics. On request, the ONC and NCHS released those missing numbers. Docs were asked: "Are there plans to apply for Medicare or Medicaid incentive payments for <a href="http://www.modernhealthcare.com/meaningfuluse">meaningful use</a> of health IT?" Blumenthal reported on their answers in part, noting that 41.1% indicated "yes" and 14% said "no." However, a 44.9% plurality, which he did not mention, chose "uncertain whether we will apply." [<a href="http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html">Nothing to see here</a> ... move along - ed.] Those who answered "yes" were asked a follow-up question: "What year do you expect to apply for the meaningful-use payments?" Of the 41.1% of docs who indicated they were sure they would apply (a figure Blumenthal released), nearly one in five (19.7%, a number he didn’t mention) were unsure as to when. [Must be the Luddite faction - ed.] Additionally, the NCHS asked physicians, "Which incentive payment do you plan to apply for?" Their responses to this question also weren’t mentioned by Blumenthal last week. Not surprisingly, given current eligibility thresholds, 65.1% selected Medicare and just 6.8% chose Medicaid, but again there was considerable uncertainty, with 28.2% choosing "unknown" or leaving the choice blank. [This finding suggests rank confusion to me more than anything else. In case nobody noticed, physicians are rather busy these days taking care of patients, and don't have time to find out what's in lengthy government documents - ed.] </blockquote> Read the whole article. It seems the executive is simply determined to push this technology onto a significantly skeptical physician community - skeptical of the incentives, of MU, of government intentions, and/or of the technology itself. Of course, perhaps they feel that such data on a beneficent technology that will absolutely, positively benefit medicine and patients needs to be withheld - for the greater good, of course, which some people have to suffer to achieve (see the post "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">MAUDE and HIT Risks: Mother Mary, What in God's Name is Going on Here?</a>"). ONC on healthcare IT in recent months: <blockquote><a href="http://healthcarereform.nejm.org/?p=3732&query=home">http://healthcarereform.nejm.org/?p=3732&query=home </a> ... The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice. (Also see <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html</a>). and <a href="http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented">http://www.massdevice.com/news/blumenthal-evidence-adverse-events-with-emrs-anecdotal-and-fragmented</a> ... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said. (Also see <a href="http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html">http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html</a>). </blockquote> A good number of physicians still appear to possess critical thinking skills. Perhaps the new Congress (i.e., legislative branch) can benefit from physician-style skepticism about health IT as well. -- SS </div>

Is the Executive Branch/HHS Trying to Put Lipstick on a Pig Regarding Health IT?

In another example of executive branch spin on healthcare - this time, the Office of the National Coordinator of Health IT (ONC) within HHS...

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The Impact of eHealth on the Quality and Safety of Health Care: You Heard Much of This First On Healthcare Renewal ...

A PLoS article was recently published on health IT's impacts on healthcare quality and safety. In the article, a form of meta-research was performed; systematic review articles were collected and then reviewed systematically. <blockquote>Black AD, Car J, Pagliari C, Anandan C, Cresswell K, et al. (2011) The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview. PLoS Med 8(1): e1000387. doi:10.1371/journal.pmed.1000387.</blockquote> A text version can be seen at <a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387">this link</a> and a PDF downloaded at <a href="http://www.plosmedicine.org/article/fetchObjectAttachment.action;jsessionid=472E204B9D8D4CB5CF520DEB894BFA55.ambra02?uri=info%3Adoi%2F10.1371%2Fjournal.pmed.1000387&representation=PDF">this link</a>. I will reproduce only the abstract here, and then make a few comments (over and above the hundreds of posts on these issues I've authored at this blog since 2004): <blockquote>The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview.Ashly D. Black<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff1">1</a>, Josip Car<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff1">1</a>, Claudia Pagliari<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff2">2</a>, Chantelle Anandan<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff2">2</a>, Kathrin Cresswell<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff2">2</a>, Tomislav Bokun<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff1">1</a>, Brian McKinstry<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff2">2</a>, Rob Procter<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff3">3</a>, Azeem Majeed<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff4">4</a>, Aziz Sheikh<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#aff2">2</a><a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#cor1" class="fnoteref">*</a><a name="aff1" id="aff1"></a>1 eHealth Unit, Department of Primary Care and Public Health, Imperial College London, London, United Kingdom, <a name="aff2" id="aff2"></a>2 eHealth Research Group, Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, United Kingdom, <a name="aff3" id="aff3"></a>3 National Centre for e-Social Science, University of Manchester, Manchester, United Kingdom, <a name="aff4" id="aff4"></a>4 Department of Primary Care and Public Health, Imperial College London, London, United Kingdom<h2>Abstract<a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387#top"></a></h2> <h3>Background</h3> There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. [I believe it would be more accurate to write "always at considerable cost, with generous profits being made by the IT merchants, implementers and consultants"- ed.] In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care. <h3>Methods and Findings</h3> We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice guidelines in effective development and deployment strategies are lacking. <h3>Conclusions</h3> There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. [You've heard that here before - ed.] In addition, there is a lack of robust research on the risks [I believe it would be more accurate to say there's been a suppression of research and/or of publicity on the risks - ed.] of implementing these technologies and their cost-effectiveness has yet to be demonstrated [in other words, healthcare IT is an experimental technology. You've heard that here before, too - ed.], despite being frequently promoted by policymakers and “techno-enthusiasts” as if this was a given. [In other words, there's an irrational - or contrived - exuberance. You've heard that here before, too - ed.] In the light of the paucity of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, it is vital that future eHealth technologies are evaluated against a comprehensive set of measures, ideally throughout all stages of the technology's life cycle. [You've heard that here before, too - ed.] Such evaluation should be characterised by careful attention to socio-technical factors to maximise the likelihood of successful implementation and adoption. [You've heard that here before, too, as well as at my site "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties</a>", as a matter of fact previously entitled "Sociotechnologic Issues in Medical Informatics...", started in 1999 - ed.]</blockquote> I can add these additional comments: <ul><li>The findings of this study were of no surprise to me or likely to readers of this blog. I've been writing on these issues since the 1990's, and on this blog since 2004.</li></ul><ul><li>In the main article itself it is stated "... there remains a disparity between the evidence-based principles that underpin health care generally and the political, pragmatic, and commercial drivers of decision making in the commissioning of eHealth tools and services." In other words, the rigor of medical science itself is lacking in healthcare IT. I've written that repeatedly here and elsewhere. I ask again: how can IT "transform" ot "revolutionize" healthcare when the culture of IT itself is in need of reform?</li></ul><ul><li>Also stated in the article's body was this: "Risks largely went ignored apart from anecdotal evidence of time-costs associated with recording of data due to both end-user skill and the inflexibility of structured data, increased costs of EHRs, and a decrease in patient-centeredness within the consultation." See my prior post "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">MAUDE and HIT Risks: Mother Mary, What in God's Name is Going on Here?</a>" for what I find as deeply concerning ("hair-raising") revelations regarding risk that you should think about next time you find yourself in a computerized hospital or doctor's office.</li></ul><ul><li>Also in the article body: "Our major finding from reviewing the literature is that empirical evidence for the beneficial impact of most eHealth technologies is often absent or, at best, only modest. While absence of evidence does not equate with evidence of ineffectiveness, reports of negative consequences indicate that evaluation of risks – anticipated or otherwise – is essential. Clinical informatics should be no less concerned with safety and efficacy than the pharmaceutical industry. [Having worked in both sectors, hospital and pharma , you've read that here before - ed.] Given this, there is a pressing need for further evaluations before substantial sums of money are committed [as you've read here in numerous posts, that's BEFORE, NOT DURING OR AFTER - ed.] to large-scale national deployments under the auspices of improving health care quality and/or safety." Are governments listening, I ask? </li></ul><ul><li>Study methodology and source material limitations were noted. However, also noted was this: "Our greatest cause for concern was the weakness of the evidence base itself. A strong evidence base is characterised by quantity, quality, and consistency. Unfortunately, we found that the eHealth evidence base falls short in all of these respects. In addition, relative to the number of eHealth implementations that have taken place, the number of evaluations is comparatively small." In my view, national re-engineering programs involving a large portion of the economy and a critical societal function should not be undertaken when the evidence base is weak and the number of evaluations is small. Further, national leaders should not be making statements of certainty such as made by the HHS ONC office as I wrote about at "<a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">Science or Politics? The New England Journal and The 'Meaningful Use' Regulation for Electronic Health Records</a>" and at "<a href="http://hcrenewal.blogspot.com/2010/05/david-blumenthal-on-health-it-safety.html">Blumenthal on health IT safety: nothing to see here, move along</a>."</li></ul><ul><li>This article might be compared to the Dec. 2009 Milbank Quarterly article "Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London. I wrote about that article at <a href="http://hcrenewal.blogspot.com/2009/12/healthcare-it-as-cybernetic-miracle.html">this link</a>. It was also a meta-analysis; its major conclusion was that "the tensions and paradoxes revealed in this study extend and challenge previous reviews and suggest that the evidence base for some EPR programs is more limited than is often assumed."</li></ul> Read the entire PLoS article at the links above. -- SS

The Impact of eHealth on the Quality and Safety of Health Care: You Heard Much of This First On Healthcare Renewal ...

A PLoS article was recently published on health IT's impacts on healthcare quality and safety. In the article, a form of meta-research ...

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Dr. Extormity's Testimony at Healthcare IT Hearing

At "<a href="http://hcrenewal.blogspot.com/2011/01/dr-monteith-hit-testimony-to-hhs.html">Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith</a>" I reproduced a physician's testimony on "Meaningful Use" of Health IT. I thought his testimony illustrated the issues quite well. However, Dr. Monteith's been outdone, this time by Dr. Extormity. Click to play: <div style="text-align: center;"><a href="http://www.youtube.com/watch?v=mYZwbtNekS8&feature=player_embedded"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5564684296131576562" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgxJvdDACxop8Np7td9Y-Btuj-LVcTu1DFXN8N8OomDi77jtHUotPuYaqk7MWSbMsOOWnRg8xdoa_yoQdrQ_x2JrMWGEaqg2yDbOFIKwJ76zBln3Om_gHEuF7diYgzfkPBE7z7BvQhEfQnI/s320/drextormity.jpg" style="cursor: pointer; display: block; height: 196px; margin: 0px auto 10px; text-align: center; width: 320px;" /></a>Dr. Extormity's Testimony at Healthcare IT Hearing - click to play. </div> Also see my May 2008 post "<a href="http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html">SEEDIE, the Society for Exorbitantly Expensive and Difficult to Implement EHR’s</a>" for more on Dr. Extormity's fine work. Note: this was a "medical humor break" of the kind Residents need to stay sane on the battlefield. (Hat tip to <a href="http://ducknetweb.blogspot.com/2011/01/extormity-ehr-testimony-at-health-it.html">ducknetweb.blogspot.com</a>). -- SS

Dr. Extormity's Testimony at Healthcare IT Hearing

At " Interesting HIT Testimony to HHS Standards Committee, Jan. 11, 2011, by Dr. Monteith " I reproduced a physician's testimo...

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MAUDE and HIT Risks: What in God's Name is Going on Here?

As I wrote at my last post "<a href="http://hcrenewal.blogspot.com/2011/01/healthcare-it-delirium.html" style="font-family: arial;">Healthcare IT Delirium</a>": <blockquote style="font-family: arial;">The field of health IT has become delirious. On top of an irrational exuberance (see <a href="http://hcrenewal.blogspot.com/search?q=irrational+exuberance">this blog query</a>) largely unsupported by the literature (e.g. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a>), the technology is <a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment">experimental</a>, its rollout is a grand national experiment in social re-engineering of medicine, there is no patient <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">informed consent</a>, nobody is in control, and <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">nobody is taking responsibility for regulating the domain</a> despite known risks. The results will very likely reflect the Wild West free-for-all that is now extant.</blockquote> It's worse. Some time ago I posted on a number of cases of health IT malfunction from the FDA's <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">MAUDE</a> (Manufacturer and User Facility Device Experience) database of medical device risks. See posts on MAUDE <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=MAUDE">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death">here</a>. Center for Public Integrity Investigative reporter Fred Schulte had also written on the MAUDE reports and other "glitches" at a Nov. 2009 report "<a href="http://www.publicintegrity.org/2009/11/24/7011/switch-electronic-records-getting-mixed-reviews-hospitals-and-clinics" target="_blank">Switch to electronic records getting mixed reviews at hospitals and clinics</a>." <blockquote style="font-family: arial;">MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. </blockquote> Either I missed a Titanic boatload of cases, or MAUDE has been appended since my posts, because MAUDE links such as <a href="http://google2.fda.gov/search?q=maude+cerner+millenium&x=8&y=7&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*&ie=UTF-8&access=p&sort=date%3AD%3AL%3Ad1&entqr=3&oe=UTF-8&ud=1&filter=0">this</a> , <a href="http://google2.fda.gov/search?q=Cerner+millenium&x=6&y=7&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*&ie=UTF-8&access=p&sort=date%3AD%3AL%3Ad1&entqr=3&oe=UTF-8&ud=1&filter=0&start=50">this</a> and <a href="http://google2.fda.gov/search?q=cerner+powerchart&x=19&y=18&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*&ie=UTF-8&access=p&sort=date%3AD%3AL%3Ad1&entqr=3&oe=UTF-8&ud=1&filter=0&start=30">this</a> are now returning a Mother Lode of cases, at least from one vendor where these events are reported (other vendors' products suffer similar problems). Examples just from light browsing cause the hair to stand up on my head (there are many, many more at the MAUDE links above):<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581240"></a> <blockquote face="arial"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1584195" style="font-family: arial;">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1584195</a> CERNER MILLENIUM CPOE, POWER CHART Event Type Injury Patient Outcome Life Threatening; Event Description The cpoe system serves and documents all transactions of communication pertaining to the patient's care. Orders are entered and delivered to an anticipated recipient and the action ordered is executed. The device-recipient interface has been unreliable with specific etiologies for failure not yet resolved or understood. Examples include orders to transfer patient from icu to a non-icu bed. Patient is moved to another bed but recipient care team does not receive communication and was not aware patient was under their charge. Patient had seizures on floor for hours throughout the night. Other patients had orders for lab tests, chemical tests on body fluids, cytological analysis of body fluids, cultures on body fluids, pathology on or specimen, and others that are not executed by the recipient, leaving the patient undiagnosed after having taken risks for a procedure. Such interface failures have been known by the vendor for years as reported by its own support team. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581240">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581240</a> CERNER MILLENIUM CPOE, POWERCHART Back to Search Results Event Type Injury Patient Outcome Life Threatening; Hospitalization Disability Event Description The displays, formats, layouts, and interfaces of the cpoe tools at this institution contain elevated degrees of user unfriendliness. This toxic effect on the user is manifested by, to mention a few, more than 20 electronic silos in which orders are stored and extensive wordiness using descriptors that are highly irrelevant to the task of the care of pts with critical illness. This manifests itself in several ways, one of which is the ordering of duplicate medications and treatments, some of which get to the pt. These should be reported to pharmacopoeia data bases but often are not. This pt was being infused both total parenteral nutrition and a concentrated dextrose solution, the combined rate of which and cumulative dose caused pulmonary edema. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577753">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577753</a> CERNER MILLENIUM CPOE Back to Search Results Event Type Injury Patient Outcome Life Threatening; Hospitalization Disability Event Description Stress test orders are ambiguous. An example of the order states "stress test adenosine/dobutamine w/imaging nm -stress test adenosine nm-". Order displays on 4 lines on the screen. The type of test that the doctor intended to be performed is unclear, resulting the risk of incorrect pharmacological modalities being used. This caused life threatening acute asthma attack in patient with background asthma who incorrectly received an infusion of adenosine. All patients ordered pharmacological stress tests become subject to said risk. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1578421"> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1578421</a> CERNER MILLENIUM CPOE Back to Search Results Event Type Injury Patient Outcome Life Threatening; Other Event Description When a pt having been in the hospital preoperatively, begins its post-operative course in the recovery room or intensive care unit, post op orders are electronically entered by deleting the unneeded orders that have been active, leaving the orders that are still needed, and adding new ones. There can be upwards of 300 lines of "active" orders on a complicated pt. Precise and safe post-operative ordering requires a time consuming line by line review of each order, counter-intuitively canceling those that are not needed. This does not always occur for any number of reasons, not the least of which is that the task is time consuming and user-unfriendly. The incidence of commingling the pre and post op orders in a hospital with cpoe instruments of care is unk, but not uncommon. At least one pt was placed at risk when the clean post operative abdomen was irrigated based on the pre-op order. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1574909"> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1574909</a> CERNER MILLENIUM CPOE Back to Search Results Event Type Injury Patient Outcome Life Threatening; Event Description This cpoe product allows doses to be ordered that are not a multiple-s- of the pill size. A representative example is 20mg atenolol po daily. Pill size is 25mg. This feature facilitates dosing errors and enables dangerously absurd dosing without warning. When the reports such dose having been given, the clinician is left to wonder, what dose was given, actually. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570802">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570802</a> CERNER MILLENIUM CPOE, POWER CHART Back to Search Results Event Date 07/11/2006 Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention Event Description Hospital wide breakdown of system of electric charts and electric order gadgets resulted in confusion, neglect, failed communications and delayed treatments in the days immediately following the surgery, leaving patient with permanent musculoskeletal disability and mental anguish. Breakdowns of this magnitude endanger hundreds of patients simultaneously. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1665473">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1665473</a> CERNER MILLENIUM CPOE, POWER CHART Back to Search Results Event Date 10/09/2006 Event Type Malfunction Patient Outcome Other; Event Description It has been discovered that the medication review screen consisting of a list of the medications on the left most column and a grid indicating the number of doses administered in each time period. The defect manifests itself in the representation of exactly what medication was administered. For pts who are taking two or more forms of the same pharmacological agent, eg nitroglycerin in the paste form, sub lingual form, and pill form, the name of the medication is represented as "nitroglycerin" on the list. The number of times it was administered is confusingly listed as a number in parentheses without clarity on which form of the medication was administered, creating confusion in the clinician and risk to the pt. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1726923">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1726923</a> CERNER MILLENIUM CPOE, POWER CHART Event Date 04/03/2010 Event Type Injury Patient Outcome Life Threatening; Other Event Description The computerized physician order entry instruments were deployed. Pleural fluid specimen were obtained. Chemical and cytological analysis was ordered on the specimen using the cpoe instruments. The specimen was not analyzed as ordered. Cytology results did not become available. Similar dysfunction appeared in more than 6 patients. The hospital has resorted to paper forms to clarify the dysfunction of this cpoe instrument. The patients may have cancer causing the fluid build up. This will not be known until time passes. There may be resultant delay in diagnosis of chest organ cancer. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1766892">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1766892</a> CERNER MILLENIUM CPOE Event Date 07/08/2010 Event Type Injury Patient Outcome Life Threatening; Event Description The active and active prn medication list had 7 potassium doses and routes, 2 tylenol doses and routes, 3 magnesium doses, 3 narcotic medications and doses, and 6 sodium chloride and sodium phosphate orders. The defects in the device and human factors at the interface enabled duplicate, triplicate, and more medications, enabling the nurse to potentially decide the treatment for this pt. The exact incidence of medication duplication from (b)(4) systems is unk, but common. </blockquote> Some examples of mere "malfunctions", again just from random browsing of the MAUDE data: <blockquote> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=358222">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=358222</a> Model Number RELEASE 500 Event Date 10/03/2001 Event Type Malfunction Patient Outcome Other; Event Description Please see initial report. Event Description A user entered an order during the order entry process, with a frequency of every 8 hours and then used the ad hoc scheduling feature to modify the defaulted administration times for that frequency. After this was done, the user changed the frequency of the order to a 12-hour frequency without modifying the ad hoc administrations times. The software did not clear the previously entered ad hoc administration times to adjust to the default times for the new frequency. This resulted in a patient receiving a medications 3 times a day as opposed to 2 times a day. The drug was carbamazepene. This incorrect order frequency was repeated for 3 days, ultimately resulting in the patient receiving of total of 3 extra doses over a 3-day period (1 extra dose per day). On the fourth day, the nurse caring for the patient noticed the inconsistency in the order and conducted a further investigation with the pharmacist. The patient was discharged on time; no extended stay was necessary as a result of the overmedication. The patient's carbamazepene levels were checked during a follow-up visit that occurred 5 days after discharge, and were noted as normal at that time.<a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1365512">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1365512</a> Model Number 2007.01 - 2007.17 Event Date 12/30/2008 Event Type Malfunction Patient Outcome Other; Event Description The issue involves cerner millennium powerchart message center inox. When the results folder is filtered by event set and the event set display and event set name are different, result filtering may not function correctly. If the result filter is in message center and is an inclusive filter, results may be filtered out incorrectly. The impact associated with this issue is that patient care may be delayed or missed as follow-up may not occur. Cerner has not received communication on any adverse patient events as a result of this issue. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1247673">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1247673</a> Model Number 2007 Event Date 10/30/2008 Event Type Malfunction Manufacturer Narrative Cerner distributed a priority review flash notification on nov 13, 2008 to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. A software modification is being developed to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the software correction is available. Event Description This issue involves the overview with reminder functionality on powerchart and affects sites that use cerner millennium powerchart (powerchart. Exe). If a currently open pt chart is replaced with another pt chart, and reminders are subsequently viewed in the detail pane of this visit, the incorrect patient's reminder may de displayed. Pt care could be adversely affected, as clinical decisions could be based on the wrong pt info. Cerner has not received communication of any adverse pt events as a result of this issue. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1097561"> http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1097561</a> Model Number 2007.13 Event Date 06/30/2008 Event Type Malfunction Event Description The issue involves the task list functionality in carenet, and affects users that utilize the task list to view and document pt activities. When encounter security is turned on and the user documents an activity in task list, utilizing the previous or next arrows to select another pt chart, the single pt task list displays tasks for incorrect pt. Clinicians may view and document a pt's activity in another pt's record. Pt care may be affected as clinical decisions could be based on incomplete, invalid, or inappropriate info. Cerner has not received communication of an adverse pt event as a result of this issue. Cerner has distributed a priority review flash notification july 30, 2008, to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. A software modification is being developed to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the modification is available. Additional model #: 2007. 16. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1051313">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1051313</a> Model Number 2001 THROUGH 2007 Event Date 04/23/2008 Event Type Malfunction Manufacturer Narrative Cerner has distributed a priority review flash notification may 23, 2008 to all potentially impacted clients sites. The notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. User documentation is being updated to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the documentation is available. Event Description The issue involves the order entry formats in powerorders and affects sites that use powerorders and medication profile. When creating the volume dose detail in the order entry formats (oef), the strength order formats require the volume dose to have an "=" sign as a prefix label. Failure to adhere to this build can result in an inpatient prescription order converted to produce an outpatient prescription that may be misleading. This only occurs when the inpatient order used is verified with a pharmacy product and the formulation used does not exactly match the dose. A formulation factor of more or less than one is used to achieve the volume and the order is then converted to a prescription. For example, 500 mg = 1 tab or 250 mg times 2 tabs = 500 mg. Patient care could be adversely affected, as a patient could receive either more or less of a medication therapy than intended. Cerner has received communication of order discrepancies discovered during a chart review as a result of this issue. </blockquote>Again, there are many, many more examples like these in MAUDE, and I haven't even looked for data from other mfg's yet. My relative was nearly killed last year by this technology due to issues like these, the risks of which I've been writing about for more than ten years now. Alert to Sarah Palin: "Death panels?" Who needs death panels when technology like this is mediating our care and is planned for "urgent" national rollout with "meaningful use" rules and Medicare-penalty extortion - er, gentle coercion - directed towards healthcare organizations and clinicians? I repeat, from the title of this post: What in God's Name is Going on Here? and: U.S. government, regulatory agencies and consumer watchdogs: where are you? -- SS Jan. 21, 2011 addendum: One wonders if the EHRevent site I wrote about at "<a href="http://hcrenewal.blogspot.com/2010/11/ehreventorg-web-site-to-collect-ehr_15.html">EHRevent.org: Web Site to Collect EHR Safety Reports</a>" and at "<a href="http://hcrenewal.blogspot.com/2010/11/emrevent-survey-amateurism-bias-or.html">EHRevent: survey amateurism, bias, or something else?</a>" will be as frank as MAUDE.

MAUDE and HIT Risks: What in God's Name is Going on Here?

As I wrote at my last post " Healthcare IT Delirium ": The field of health IT has become delirious. On top of an irrational exuber...

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Healthcare IT Delirium

The delirium surrounding healthcare IT seems to be worsening. In an Aug. 2010 post "<a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html">EPIC's outrageous recommendations on healthcare IT project staffing</a>" I wrote that health IT company <a href="http://www.blogger.com/www.epic.com/">Epic</a>, one of the largest, seemed to not care about healthcare or IT education or experience in its recommendations to hospitals on staffing of safety critical projects (i.e., the implementation of safety critical clinical cybernetic devices): <blockquote style="font-family:arial;">Epic emphasizes that many hospitals can staff their projects internally, choosing people who know the organization. However, they emphasize choosing the best and brightest, not those with time to spare. Epic advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say. The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores. </blockquote>Based on a presentation by the company at my university, they apparently they mean it: <blockquote style="font-family:arial;">Career Presentation: Epic Systems Corporation - TONIGHTThe Drexel Women in Computing Society (WiCS) will organize a career presentation by Epic Systems Corporation tonight, January 19, 2011, from 6 to 7 p.m. at University Crossings, room 149 (32nd and Market Streets).Epic Systems Corporation, located in Madison, Wisc., creates software for the healthcare industry and is hiring for many positions. They are recognized nationally as a leader in moving healthcare organizations from paper medical records to completely electronic ones. Epic hires from all majors, all degrees and all experience levels, and requires no software experience. [Or, as is obvious from this solicitation, healthcare experience - ed.] The presentation will include an overview of Epic's industry work, corporate philosophy and role-specific expectations.This presentation is open to all graduate and undergraduate students at Drexel University. Pizza will be provided and resumes will be accepted after the presentation.</blockquote> Other health IT merchants will probably soon follow suit. As I also wrote at the aforementioned post: <blockquote style="font-family:arial;">Medical environments and clinical affairs are not playgrounds for novices, no matter how "smart" their grades and test scores show them to be, and these practices as described, in my view, represent faulty and dangerous advice.The advice also is at odds with the taxonomy of skills published by the Office of the National Coordinator I outlined at the post "<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">ONC Defines a Taxonomy of Robust Healthcare IT Leadership</a>."</blockquote> This talent management ideology is also alien to medicine (at least since the Flexner Report of 1910), and at odds with critical thinking and common sense. Then there's this, an attempt by Medical Informatics researchers of the American Medical Informatics Association (AMIA) to ex post facto put a scientific veneer on the troublesome and extremely costly "Meaningful Use of health IT" criteria mandated by the US Government. Those criteria were largely arrived at through "off-the-top-of-their heads" committee meetings (see "<a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2010/12/meaningful-use-and-devil-in-details.html">Meaningful Use and the Devil in the Details: A Reader's View</a>" on this blog and "<a style="font-family: arial;" href="http://histalk2.com/2011/01/18/the-mu-hearings-drlyle-goes-to-washington-11811/" rel="bookmark" title="Article about: The MU Hearings: DrLyle Goes to Washington 1/18/11">The MU Hearings: DrLyle Goes to Washington 1/18/11"</a> at the HIStalk site): <blockquote style="font-family: arial;">On behalf of the CISWG Leadership Team [AMIA Clinical Information Systems work group - ed.] In light of the HITECH Act and subsequent Meaningful Use objectives, it is imperative for the informatics community to consider the current science behind clinical information systems and to identify areas requiring further research. In keeping with this, the CISWG leadership is interested in developing a white paper, “The Science Behind the Meaningful Use Criteria”. The purpose of this paper will be to synthesize the existing literature regarding each of the meaningful use criteria and develop recommendations for future research. We are requesting your assistance in this work. We ask you, as experts in the field, to help identify current literature and subject matter experts for EACH of the meaningful use criteria. In addition, please state if you (1) believe there is evidence for the objective, and (2) if the evidence is supporting of the objective. Please do not delete other’s input but rather add your comments directly to the document (even if in conflict with others). The document should result in a great asynchronous discussion. Please provide your input by the 7th of February. We appreciate any input you are able to provide. Thank you for your assistance and we look forward to sharing the results of this work in the future</blockquote> My contribution will probably be that it's probably better to examine the science in a domain before putting it into national policy, not after ... I'd also observed at "<a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2010/07/meaningful-use-final-rule-have.html">Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?</a>" and at the followup post "<a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">Cart before the horse, again: IOM to study HIT patient safety for ONC</a>" that a focus on "meaningful use" before a focus on health IT "meaningful usability" and health IT safety was putting the cart before the horse. Recklessly so, in fact. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiyR04XtQiwxZH-TTsZEalW0xlRbKsjUUOL6btjzNUcrdKzoibZQDecVGvhWr9gY0uuvx66BxBBAOlKKZwzP6O4ZGEWL7mNdGLaLq0YTLuFf3Aizl0KsGKGMBU-SaOaUcEARLjquiAJXqLP/s1600/horse-cart.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5564282328497907874" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiyR04XtQiwxZH-TTsZEalW0xlRbKsjUUOL6btjzNUcrdKzoibZQDecVGvhWr9gY0uuvx66BxBBAOlKKZwzP6O4ZGEWL7mNdGLaLq0YTLuFf3Aizl0KsGKGMBU-SaOaUcEARLjquiAJXqLP/s320/horse-cart.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 252px; height: 156px;" /></a>How not to do health IT: by putting the cart before the horse on usability and safety </div> Finally, in light of the recent experiences of a medical informatics-skilled hospitalist as I posted at "<a style="font-family: arial;" href="http://hcrenewal.blogspot.com/2011/01/md-on-ehrs-i-might-have-inadvertently.html">An MD hospitalist on EHR's: I might have inadvertently skipped something during the mayhem</a>" ... <blockquote style="font-family: arial;"> [The NY Times article on information overload in the military causing deaths] was eerily similar to / descriptive of my experience last night in the hospital: processing multiple information sources related to multiple different problems for a new admission (patient, family, ED staff, disjointed EMR - some documents in the Documents tab of the [major EHR vendor name redacted - ed.] system but most others in the hospital system Portal requiring a separate lookup, some radiology studies available through the EMR on any workstation but others requiring accessing the PACS system directly on scarcer dedicated workstations - plus paper record components, including EKGs, progress notes) ... all while various drone-equivalents are channeling information regarding multiple other admissions in the wings and/or patients decompensating on the floors or in the ICU. Oh yeah, and then there's the "12 hour shift" thing. Oops, gotta run... Just slept all day after my night shift and have to head back to hospital for the next one. Still haven't submitted any charge tickets, btw, even for last week's shifts (I'm carrying around paper face sheets with scribbled notes on the back; I'm supposed to fax them to the billing office once I figure out what CPT / visit intensity code I want to use.) Gosh, I hope I remembered to touch on 10 bullet points related to ten organ systems for my ROS for each of my admissions; might have inadvertently skipped something during the mayhem... PS. I'd love to be wearing one of those brain wave contraptions mentioned in the article to see what my theta wave activity was.</blockquote> ... and the injury of my relative in 2010 due to interference of healthcare IT in clinician-clinician communications (including, but not limited to, me communicating with those caring for my relative, and them communicating among themselves and <a href="http://www.tinyurl.com/hostileuserexper">with the technology itself</a>), all I can say is: The field of health IT has become delirious. On top of an irrational exuberance (see <a href="http://hcrenewal.blogspot.com/search?q=irrational+exuberance">this blog query</a>) largely unsupported by the literature (e.g. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a>), the technology is <a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment">experimental</a>, its rollout is a grand national experiment in social re-engineering of medicine, there is no patient <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">informed consent</a>, nobody is in control, and <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">nobody is taking responsibility for regulating the domain</a> despite known risks. The results will very likely reflect the Wild West free-for-all that is now extant. This is crazy stuff. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhA-qrjYybZPlz2HBlFu5FpGVOgsaHi26r5Og_73CNBiQT7S8iMkSjk2pzI2RhPrlrHus59lt09nEB3X2xy2a3eirUS3mewe3eC-r0OzTIkGC3Vp6XSIZDWto7HgalSUwNf19n-xF6Rhn5Z/s1600/trainwreck.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5564284191038181458" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhA-qrjYybZPlz2HBlFu5FpGVOgsaHi26r5Og_73CNBiQT7S8iMkSjk2pzI2RhPrlrHus59lt09nEB3X2xy2a3eirUS3mewe3eC-r0OzTIkGC3Vp6XSIZDWto7HgalSUwNf19n-xF6Rhn5Z/s320/trainwreck.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 205px; height: 247px;" /></a>Running off the rails. We seem to be going out of our way looking for this with HIT, sending it out full speed ahead on far too short a track ... </div> There's very little else I can do about it at this point, having tried writing, speaking, and political venues. This will affect your healthcare, not just mine (at least I know what to look out for). I suggest litigators stay closely attuned to hospital morbidity and mortality incidence (and incidents). -- SS

Healthcare IT Delirium

The delirium surrounding healthcare IT seems to be worsening. In an Aug. 2010 post " EPIC's outrageous recommendations on healthcar...

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An MD hospitalist on EHR's: I might have inadvertently skipped something during the mayhem

At "<a href="http://hcrenewal.blogspot.com/2011/01/clinicians-going-for-swim-but-drowning.html">Clinicians Going for a Swim and Drowning in Information</a>" I commented on a NY Times article about how information and cognitive overload can lead to deadly consequences in warfare. My implication was that medical care (e.g., the ED) bears some similarities. I received this reply from a clinician hospitalist I know, who also is well versed in Medical Informatics: <blockquote> Wow, great piece, but a little too close to home for me right now. Eerily similar to / descriptive of my experience last night in the hospital: processing multiple information sources related to multiple different problems for a new admission (patient, family, ED staff, disjointed EMR - some documents in the Documents tab of the [major EHR vendor name redacted - ed.] system but most others in the hospital system Portal requiring a separate lookup, some radiology studies available through the EMR on any workstation but others requiring accessing the PACS system directly on scarcer dedicated workstations - plus paper record components, including EKGs, progress notes) ... all while various drone-equivalents are channeling information regarding multiple other admissions in the wings and/or patients decompensating on the floors or in the ICU. Oh yeah, and then there's the "12 hour shift" thing. Oops, gotta run... Just slept all day after my night shift and have to head back to hospital for the next one. Still haven't submitted any charge tickets, btw, even for last week's shifts (I'm carrying around paper face sheets with scribbled notes on the back; I'm supposed to fax them to the billing office once I figure out what CPT / visit intensity code I want to use.) Gosh, I hope I remembered to touch on 10 bullet points related to ten organ systems for my ROS for each of my admissions; might have inadvertently skipped something during the mayhem... PS. I'd love to be wearing one of those brain wave contraptions mentioned in the article to see what my theta wave activity was.</blockquote> This is not atypical of IT's effects on healthcare today. -- SS

An MD hospitalist on EHR's: I might have inadvertently skipped something during the mayhem

At " Clinicians Going for a Swim and Drowning in Information " I commented on a NY Times article about how information and cogniti...

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Why is Johnson and Johnson "Spinning Out of Control?"

Last week, a New York Times article by Natasha Singer and Reed Abelson <a href="http://www.nytimes.com/2011/01/16/business/16johnson-and-johnson.html">cataloged</a> some of the problems afflicting the giant health care corporation Johnson and Johnson.  <blockquote>Little red flags jut out from the shelves at a CVS drugstore in suburban Boston, alerting shoppers to shortages of nearly a dozen Johnson & Johnson products. Among them are Motrin, Rolaids, children’s Tylenol liquid and adult Tylenol, Mylanta, Pepcid AC and even some Neutrogena skin care products. 'Looking for Tylenol pain relief products?' asks one of the signs. The notices at CVS serve as a stark reproof to Johnson & Johnson, whose brands have for more than a century been synonymous with quality. Some of its products are in short supply at drugstores and supermarkets because the McNeil Consumer Healthcare unit of J.& J. last year recalled about 288 million items, including about 136 million bottles of liquid Tylenol, Motrin, Zyrtec and Benadryl for infants and children. Johnson & Johnson has had to recall such a variety of products because of quality-control problems across product lines, in multiple factories and in several units last year. Some of its consumer products, for instance, may have contained bits of metal. Others came in bottles with a moldy smell. And some products have gone missing from stores with hardly an explanation. All of this has put the company and its manufacturing under the intense scrutiny of lawmakers and officials at the Food and Drug Administration. 'It looks like a plane spinning out of control,' says David Vinjamuri, a former J.& J. marketing employee who now trains brand managers at his company, ThirdWay Brand Trainers. </blockquote> The article noted how the current widespread manufacturing problems at J+J seem to contradict the company's famous credo. <blockquote>dating from 1943, saying that the company owed its first responsibility to the mothers and fathers, doctors, nurses and patients who use its products. </blockquote> The article noted that the company's problems <blockquote>have not been limited to its over-the-counter products, which could suggest that the company may suffer from even broader problems. Last year, its DePuy medical device unit recalled two kinds of hip implants, affecting tens of thousands of patients worldwide. Its vision care unit recalled millions of soft contact lenses sold abroad. </blockquote> In fact, the company also has had major ethics problems. We noted <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>, for example, that last October J&J and Ortho-McNeil Janssen, a Johnson and Johnson subsidiary,were found by a jury to have defrauded the Lousiana Medicaid system by minimizing safety problems with the atypical anti-psychotic drug Respirdal, with a penalty of over $250 million. Moreover, the NY Times summary is already out of date. The Los Angeles Times just <a href="http://www.latimes.com/health/os-tylenol-recalled-again-20110118,0,6893986.story">reported</a> yesterday even more recalls. Why does the company seem to be in a tail-spin? Ms Singer and Mr Abelson listed several possible causes: <blockquote>The reasons for McNeil’s woes remain unclear. Some critics, including former employees, say Johnson & Johnson has lost sight of its credo, while others suggest that the company decentralized its oversight of manufacturing and quality control in error. Others say it was simply a matter of cost-cutting. The December lawsuit, for example, cited two unnamed former employees who contended that the company failed to address the manufacturing problems at McNeil because it was trying to save money. Other former employees who are not involved in the lawsuit say that J.& J. seemed to hesitate in recent years to invest in new manufacturing equipment. 'It takes a lot of money to buy equipment and maintain quality,' says Patrick Bols, who left Johnson & Johnson’s pharmaceutical division in the late 1990s and owns stock in the company. </blockquote> Why, however, would the company lose sight of its sacred credo? Why would it excessively cut costs in a way that would diminish its ability to carry out its most basic function, to produce pure and unadulterated drugs? I submit that one clue can be found in a recent news article in Nature Biotechnology about the march of drug and biotechnology companies forced into <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a>. [Ratner M. Crossing the line. Nature Biotech 2010; 12: 1232-1235. Link <a href="http://www.nature.com/nbt/journal/v28/n12/abs/nbt.1726.html">here</a>.] <blockquote>People are rewarded for improving a firm's financial performance - right up the chain to the CEO, [former US Department of Justice and current Vogel, Slade & Goldstein attorney Ms Shelley] Slade says. 'Their concerns are pleasing Wall Street and shareholders, and bonuses are driven by financial performance. There's a real conflict between what the compliance folks want them to do and what's in their immediate financial self-interest. Sometimes the compliance people don't get the full story from the people in operations.</blockquote> So what we have here is another argument for the importance of perverse incentives as drivers of health care dysfunction. It is likely that all the management of nearly all health care organizations are driven, not by mythic credos or high-minded mission statements, but by the impetus for short-term revenues driven by desire to earn big bonuses and keep their total compensation in six- through eight-figures. These sorts of incentives will predictably lead to excess cost-cutting, unethical behavior, and outright crime. So, to repeat like a broken record (if anyone remembers what that means, a broken vinyl audio recording skipping due to surface scratches) - if we really want health care reform, if we really want to lower costs, improve access, and improve quality, we need to abolish the perverse incentives that drive managers of health care organizations.  Somehow we need to make the leadership of health care organizations accountable for fulfilling their credos, mission statements, and really their basic responsibilities.  The patients' interests need to come first.  Drug companies must make pure, unadulterated drugs, and promote them honestly and ethically, and their leaders must first be accountable for doing so.

Why is Johnson and Johnson "Spinning Out of Control?"

Last week, a New York Times article by Natasha Singer and Reed Abelson cataloged some of the problems afflicting the giant health care corp...

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