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JAMIA: Reduction in medication errors in hospitals due to adoption of computerized provider order entry systems

A new article appeared online 20 February 2013 in the Journal of the American Medical Informatics Association entitled "Reduction in medication errors in hospitals due to adoption of computerized provider order entry systems" (<a href="http://jamia.bmj.com/content/early/2013/01/27/amiajnl-2012-001241.full" target="_blank">link to fulltext</a>) by David C Radley, Melanie R Wasserman, Lauren EW Olsho, Sarah J Shoemaker, Mark D Spranca and Bethany Bradshaw. The authors performed a meta-analysis of the literature on Computerized Practitioner Order Entry (CPOE) systems in inpatient settings and concluded: <blockquote class="tr_bq">"Processing a prescription drug order through a CPOE system decreases the likelihood of error on that order by 48% (or in  a range of 41% to 55% with ninety five percent confidence).  Given this effect size, and the degree of CPOE adoption and use in hospitals in 2008, we estimate a 12.5% reduction in medication errors, or ∼17.4 million medication errors averted in the USA in one year." </blockquote> It is important to know the potential benefits of CPOE, as the government has been pushing this technology since the foundation of the <a href="http://www.healthit.gov/newsroom/about-onc" target="_blank">Office of the National Coordinator</a> (for health IT) within HHS since 2004.  Indeed, reimbursement penalties on Medicare will start in 2015 for non-adopters of government <a href="http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html" target="_blank">certified</a> health IT. It is especially important to get to the truth about CPOE specifically, and health IT in general, in terms of risks, benefits, return on investment, improvements, and alternatives. Not long before this new JAMIA article appeared, an active study of EHR problems with voluntary reporting by members of the <a href="https://www.ecri.org/Pages/default.aspx" target="_blank">ECRI Institute's</a> Patient Safety Organization (PSO) <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html" target="_blank">produced some concerning data</a>.  Namely, that over a 9-week period starting April 16, 2012, and ending June 19, 2012, 171 health information technology-related problems were reported from just 36 healthcare facilities, primarily hospitals. Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths. Obviously, extrapolating those number to:  1)  a much higher number of hospitals, of which the U.S. alone has <a href="http://www.aha.org/research/rc/stat-studies/fast-facts.shtml" target="_blank">approximately 5,700</a> plus other facilities such as long-term care, and private physician offices; 2)  over a full year, not just 9 weeks;  3) accounting for the perhaps 5% voluntary reporting level (per Koppel) of issues such as medication errors; 4) plus accounting for (per FDA) the issue of lack of recognition of IT as contributing to medical incidents (this list is not all-inclusive) - the results are of concern. Thus, work such as in this new JAMIA article on CPOE is important.  The article can be downloaded in its entirety as of this writing from the link above.  The article describes a methodology that is quite complex, and obviously a great deal of time and effort was put into it.  It appears to be a valiant effort to get us one step closer to the truth.  This should be applauded. I was impressed on first reading of this literature meta-analysis and its statistical calculations. (Actually I needed to read it several times to fully grasp the methodologies involved.) The question arose in my mind, however: can this article's conclusions be true, and the ECRI PSO Deep Dive study be true, at the same time? Prior to going into an analysis and perhaps detailed critique of the methodology, and knowing the difficulties and contradictions the literature on this topic presents, I decided first to look at the source articles selected from the literature for inclusion in the JAMIA meta-analysis. In doing so, issues became apparent that shed light on the difficulties of meta-analyses on topics such as this. The only methodological issue I will mention at this time is that the study used a <a href="http://hcrenewal.blogspot.com/2008/06/criticism-of-surrogate-endpoints-in.html" target="_blank">surrogate endpoint</a> - medication "error" rates before, and after, implementation of CPOE, rather than patient outcomes.  (The reason I put "error" in quotes is that, as the authors describe regarding study limitations, the exact definition varies from site to site and study to study.  They also acknowledge the limitations of using such an endpoint.)  Surrogate endpoints, however, may or may not reflect the actual information being sought regarding outcomes. As Roy Poses noted in a June 2008 post "<a href="http://hcrenewal.blogspot.com/2008/06/criticism-of-surrogate-endpoints-in.html" target="_blank">Criticism of Surrogate Endpoints in Whose Interests?</a>": <blockquote class="tr_bq">... The problem with surrogate endpoints is that they are surrogates for the real thing. In many cases, a treatment may appear beneficial when measured by its affect on such endpoints, but not turn out to be beneficial when measured by its affect on real clinical outcomes, e.g., alleviation of symptoms, improvement of function, and prolongation of survival. There are many reasons why this may be the case. </blockquote>This weakens the present study as a basis for social re-engineering.  The authors responsibly acknowledge that via the statement in the conclusion that: <blockquote class="tr_bq">Future research in this area will be critically important to inform policy and funding decisions regarding the development and implementation of CPOE in care delivery. </blockquote> When I reviewed the studies that were used for the meta-analysis, however, my enthusiasm for the results was diminished. The authors write: <blockquote class="tr_bq">Using the search terms of Ammenwerth et al, we updated the search using PubMed in February 2009, identifying 390 studies. Each was reviewed by two study authors (MRW and DCR). After applying the a priori inclusion/exclusion criteria, 10 studies were retained. [Listed in footnotes 10–19 - ed.]</blockquote><div id=":1cb"> Here are the 10 studies retained, as per footnotes #10 - 19.  Short excerpts (I am trying to keep this post relatively short) and my very brief comments about each of them are as follows.  Hyperlinks to the summaries and in some cases to fulltext are present in the online study itself at the full text link at top of this post. First, I note no randomized, controlled clinical trials, the gold standard of medical research.  That lack is not the fault of the authors; it is a general feature in the domain of healthcare information technology. That said:  Included study #1 (footnote 10): </div><div id=":1cb">Bates DW, Teich JM, et al, The impact of computerized physician order entry on medication error prevention. Brigham and Women's Hospital, J Am Med Inform Assoc 1999;6:313–21.</div><div id=":1cb"> <blockquote class="tr_bq">... During the study, the non-missed-dose medication error rate fell 81 percent, from 142 per 1,000 patient-days in the baseline period to 26.6 per 1,000 patient-days in the final period (P < 0.0001). Non-intercepted serious medication errors (those with the potential to cause injury) fell 86 percent from baseline to period 3, the final period (P = 0.0003). Large differences were seen for all main types of medication errors: dose errors, frequency errors, route errors, substitution errors, and allergies. For example, in the baseline period there were ten allergy errors, but only two in the following three periods combined (P < 0.0001).  The study periods were as follows: baseline, 51 days, Oct-Nov 1992; period 1, 68 days, Oct-Dec 1993; period 2, 49 days, Nov-Dec 1995; and period 3, 52 days, Mar-Apr 1997. </blockquote> I note that this was a highly advanced setting with long-standing Medical Informatics expertise, performed by Medical Informatics experts of the highest caliber.  This was an ideal environment for the implementation of good health IT.  The results may thus not be generalizable to facilities without that level of experience.  </div><div id=":1cb"></div><div id=":1cb">Also, the study was a considerable number of years ago, some of it two decades ago.  While one might assume the technology has improved, the increased commercial sector involvement since the 1990's, and especially after the HITECH incentives of 2009, may be creating an increased occurrence of bad health IT, and/or implementation in facilities with far less (if any) informatics expertise. Thus, in my view the study's applicability to current times and to all medical organizations is not extremely strong.  Included study #2 (footnote 11): Medication Administration Variances Before and After Implementation of Computerized Physician Order Entry in a Neonatal Intensive Care Unit, Pediatrics 2008;121:123–8 <blockquote class="tr_bq">... Data on 526 medication administrations, including 254 during the pre-computerized physician order entry period and 272 after implementation of computerized physician order entry, were collected. Medication variances were detected for 19.8% of administrations during the pre-computerized physician order entry period, compared with 11.6% with computerized physician order entry (rate ratio: 0.53). Overall, administration mistakes, prescribing problems, and pharmacy problems accounted for 74% of medication variances; there were no statistically significant differences in rates for any of these specific reasons before versus after introduction of computerized physician order entry.</blockquote> Here, 'n' is very small, and there is a finding that the CPOE had no effect on administration mistakes, prescribing problems, and pharmacy problems.  Thus, a ringing endorsement for national CPOE implementation this study is (unfortunately) not.  Included study #3 (footnote 12): The effect of computer-assisted prescription writing on emergency department prescription errors, Acad Emerg Med 2002;9:1168–75.<cite></cite> Without even a summary, my concern here is that ePrescribing and CPOE are different entities.   Inclusion of ePrescibing in a study of CPOE is not entirely without some risk of conflation of results of one with the other.  Included study #4 (footnote 13): Impact of computerized physician order entry on clinical practice in a newborn intensive care unit, J Perinatol. 2004 Feb;24(2):88-93. This article studies gentamicin dosing and turn around times and found that: <blockquote class="tr_bq">"...the accuracy of gentamicin dose at the time of admission for 105 (pre-CPOE) and 92 (post-CPOE) VLBW infants was determined. In the pre-CPOE period, 5% overdosages, 8% underdosages, and 87% correct dosages were identified. In the post-CPOE, no medication errors occurred. Accuracy of gentamicin dosages during hospitalization at the time of suspected late-onset sepsis for 31 pre- and 28 post-CPOE VLBW infants was studied. Gentamicin dose was calculated incorrectly in two of 31 (6%) pre-CPOE infants. No such errors were noted in the post-CPOE period. </blockquote> My comments are that a NICU is a specialized environment with a high ratio of clinicians/staff to patients.  Findings in such an environment again may not be generalizable.  Also, one should ask if complex CPOE systems are really needed for dosing calculations and turn around time improvements.  Simpler and cheaper human/technological solutions might have achieved similar or better results.  Thus, again, while not demeaning the results achieved by this study's interventions in 2004, I have my concerns that this study is not strong evidence of generalizability of even the CPOE surrogate measurement, namely decrease of med "errors."  Included study #5 (footnote 14): A computer-assisted management program for antibiotics and other antiinfective agents. N Engl J Med 1998;338:232–8. <blockquote class="tr_bq">We have developed a computerized decision-support program linked to computer-based patient records that can assist physicians in the use of antiinfective agents and improve the quality of care. This program presents epidemiologic information, along with detailed recommendations and warnings. The program recommends antiinfective regimens and courses of therapy for particular patients and provides immediate feedback. We prospectively studied the use of the computerized antiinfectives-management program for one year in a 12-bed intensive care unit. RESULTS: During the intervention period, all 545 patients admitted were cared for with the aid of the antiinfectives-management program. Measures of processes and outcomes were compared with those for the 1136 patients admitted to the same unit during the two years before the intervention period. The use of the program led to significant reductions in orders for drugs to which the patients had reported allergies (35, vs. 146 during the preintervention period; P less than 0.01), excess drug dosages (87 vs. 405, P less than 0.01), and antibiotic-susceptibility mismatches (12 vs. 206, P less than 0.01). There were also marked reductions in the mean number of days of excessive drug dosage (2.7 vs. 5.9, P less than 0.002) and in adverse events caused by antiinfective agents (4 vs. 28, P less than 0.02).  [Several other benefits omitted for brevity - they can be seen at the JAMIA footnote hyperlink -  ed.]</blockquote></div> My thoughts here are that, while the results were commendable, once again this study took place 15 years ago, and was in a high-staff-to-patient specialized ICU environment.  I also wonder if complex, expensive CPOE is needed to accomplish these tasks as opposed to, say, an online DSS and appropriate workflows and process.  Included study #6 (footnote 15): Impact of computerized prescriber order entry on medication errors at an acute tertiary care hospital. Hosp Pharm 2003;38:227–31. <blockquote class="tr_bq">The authors analyzed medication errors documented in a hospital's database of clinical interventions as a continuous quality improvement activity. They compared the number of errors reported prior to and after computerized prescriber order entry (CPOE) was implemented in the hospital. Results indicated that in the first 12 months of CPOE, overall medication errors were reduced by more than 40%, incomplete orders declined by more than 70%, and incorrect orders decreased by at least 45%. Illegible orders were virtually eliminated but the level of medication errors categorized by drug therapy problems remained significantly unchanged. The study underscores the positive impact of CPOE on medication safety and reemphasizes the need for proactive clinical interventions by pharmacists.</blockquote> This study appears reasonable for inclusion in a meta-analysis, although ideally there might have been accounting for possible influence of non-intervention (computer)-related pre-post interval changes.  The transition to CPOE, training, increased awareness, etc. can influence results, especially short term.  Included study #7 (footnote 16): Error reduction in pediatric chemotherapy: computerized order entry and failure modes and effects analysis. Arch Pediatr Adolesc Med 2006;160:495–8. <blockquote class="tr_bq">Before-and-after study from 2001 to 2004. After CPOE deployment, daily chemotherapy orders were less likely to have improper dosing (relative risk [RR], 0.26; 95% confidence interval [CI], 0.11-0.61), incorrect dosing calculations (RR, 0.09; 95% CI, 0.03-0.34), missing cumulative dose calculations (RR, 0.32; 95% CI, 0.14-0.77), and incomplete nursing checklists (RR, 0.51; 95% CI, 0.33-0.80). There was no difference in the likelihood of improper dosing on treatment plans and a higher likelihood of not matching medication orders to treatment plans (RR, 5.4; 95% CI, 3.1-9.5).</blockquote> Again, the results appear commendable.  However:  there was no difference in the likelihood of improper dosing on treatment plans, and worse, there was found a higher likelihood of not matching medication orders to treatment plans. In fact, this article was accompanied by a letter in response entitled "Primum non nocere", David Dickens, MD; Dianne Sinsabaugh, RPh; Brenda Winger, PharmD, Arch Pediatr Adolesc Med. 2006;160(11):1185-1186 (after some digging, text found at <a href="http://archpedi.jamanetwork.com/article.aspx?articleid=486317" target="_blank">http://archpedi.jamanetwork.com/article.aspx?articleid=486317</a>): <blockquote class="tr_bq">Kim et al. demonstrated that in the practice of pediatric oncology, computerized physician order entry (CPOE) reduced improper dosing, missing cumulative doses, and incomplete nursing checklists.  In contrast to these benefits, however, CPOE also resulted in a 5-fold increase in “not matching medication orders to treatment plans.” Although little detail was provided on the nature of these medication order/treatment plan “mismatches,” it implies that chemotherapy ordered through CPOE deviated more often from intended protocol therapy as compared with paper-ordered chemotherapy. While CPOE ostensibly led to more precise chemotherapy dosing, it increased the risk of that chemotherapy being the wrong chemotherapy.</blockquote> The author did respond: "Mismatches between treatment plan and orders at point of therapy increased, but were intercepted and clarified at POC. [By people - ed.].  No incorrect meds were given. On its face, this is not an entirely dispositive proof of CPOE beneficence and raises significant concern that, sooner or later, a person might miss the discrepanc(ies) resulting in unintended adverse consequences.  Included study #8 (footnote 17): Effects of an integrated clinical information system on medication safety in a multi-hospital setting. Am J Health Syst Pharm 2007;64:1969–77. <blockquote class="tr_bq">This study took place at Lifespan health care system that includes Rhode Island Hospital (RIH), a private, 719-bed, not-for-profit, acute care hospital and academic medical center that has a pediatric division, the Hasbro Children’s Hospital; and The Miriam Hospital (TMH), a 247-bed, not-for-profit, acute care general hospital. Methods. The integrated systems selected for implementation included computerized physician order entry, pharmacy and laboratory information systems, clinical decision-support systems (CDSSs), electronic drug dispensing systems (EDDSs), and a bar-code point-of-care medication administration system. The indicators for CPOE with inherent CDSSs demonstrated a significant effect of this functionality on reducing prescribing error rates for three of the four indicators measured: drug allergy detection, excessive dose, and incomplete or unclear order. The fourth indicator measured, therapeutic duplication, did not show a significant effect on prescribing error rates. For the rules engine software CDSS, the colchicine indicator did not show a statistically significant effect on prescribing error rate, but a significant decrease in prescribing errors related to metformin use in renal insufficiency was observed after implementation of the rules engine software and integration with CPOE. </blockquote> Again, these are commendable results, but on its face the technologies involved went far beyond just CPOE, and the results were not uniform.  The actual reduction figures for seven categories were mostly in 50% range, one at 86% (allergy), but the duplicates issue at 8%, not felt statistically significant. Of more concern, there was this in the news in 2011.  A software bug at this organization led to thousands and perhaps tens of thousands of prescription errors that could have (and without definite proof, despite organization denials I would be concerned did) led to injury and death.  I wrote about the malfunction at <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html</a>.  The bug was not discovered for about a year. Other organizations, especially those new to CPOE and/or health IT, face similar risks. Again, this is not a caveat-free endorsement of national CPOE rollout in 2013. Included study #9 (footnote 18): Effect of computer order entry on prevention of serious medication errors in hospitalized children. Pediatrics 2008;121:e421–7. 627 pediatric admissions, with 12 672 medication orders written over 3234 patient-days.  The rate of non-intercepted serious medication errors in this pediatric population was reduced by 7% after the introduction of a commercial computerized physician order entry system, much less than previously reported for adults, and there was no change in the rate of injuries as a result of error. Several human-machine interface problems, particularly surrounding selection and dosing of pediatric medications, were identified. The issues of concern here are bolded and underlined above and need not be restated. Lastly: Included study #10 (footnote 19): Evaluation of reported medication errors before and after implementation of computerized practitioner order entry. J Health Inf Manag 2006;20:46–53. <blockquote class="tr_bq">While a major objective of CPOE is to reduce medication errors, its introduction is a major system change that may result in unintended outcomes. Monitoring voluntarily-reported medication errors in a university setting was used to identify the impact of initial CPOE implementation on medical-surgical and intensive care units. A retrospective trend analysis was used to compare errors one year before and six months after implementation. Total error reports increased post-CPOE but the level of patient harm related to those errors decreased. Numerous modifications were made to the system and the implementation process. The study supports the notion that CPOE configuration and implementation influences the risk of medication errors. Implementation teams should incorporate monitoring medication errors into project plans and expect to make ongoing changes to continually support the design of a safer care delivery environment.</blockquote> This study appeared more a study reporting unintended outcomes than benefits. The total medication error reports increased post-CPOE but the level of patient harm related to those errors decreased.   (That decrease might have been due to human factors, or to serendipity, both of which cannot be expected to protect forever.) The reasons for the changes were described this way: <blockquote class="tr_bq">... Contributing causes. To assist in the development of safety interventions, contributing causes were identified for reported errors. The most common contributing cause was noncompliance to policy and procedure, identified in 40 percent of errors. For example, a previous order may not have been discontinued when a new dose change was entered, resulting in two active orders for the same medication with different dosages  The next most common contributing cause was computer entry errors, seen in 25 percent of mistakes. One example was if a medication order was placed on the wrong patient.  ["Use error" due to confusing user interfaces as recently defined by NIST - as opposed to "user error" - was likely to have contributed to at least some of these errors - ed.]  The next most common error was initial load errors (19 percent). During entry of all current medications on the day of activation, multiple category B errors were made. An example was a written order for sliding scale calcium gluconate “PRN,” which was entered into the CPOE system as “scheduled.” There were also computer design issues that contributed to 10 percent of errors. An example was when the pharmacist received two printouts for methylprednisolone 500 mg IV. He assumed it was a duplicate order, but when he reviewed the CPOE system, he saw that one order was for today and the other was for tomorrow. The dates for these orders were not visible on the order printout from the CPOE system. [This again seems to be 'use error' - ed.]</blockquote><div><div> <div><div> These issues can and will occur anywhere.  Once again, this is not entirely an article, either by itself or in a meta-analysis, that I find ideal in attempted proof of CPOE effectiveness and beneficence. In fact, after I reviewed this source, I noted that this study was eliminated from the inclusion set: <blockquote class="tr_bq">... Based on later expert reviewer feedback, we eliminated one additional study that solely used a voluntary reporting method for error detection, leaving nine studies for our final pooled analysis. </blockquote></div></div><div><div> It would probably not be hard to convince critical thinkers of the possibility this study was removed for reasons other than stated. In summary, while one should not and cannot expect perfection in the studies available in a meta-analysis, due to the difficulties in this domain the literature resources utilized were not ideal, and the surrogate endpoint also raises concern.  (I have not reviewed the entire corpus of potential literature myself.)  The authors conducted a difficult and rigorous study, but one cannot turn data "lead" (as in Pb) to gold (as in Au), no matter how hard one works or however good one's intentions are. The authors did note the limitations of the study, although their conclusion will likely be taken by the industry as a "full steam ahead" signal.   (I do note with some irony the proximity of this article's release to the soon-to-start massive <a href="http://www.himssconference.org/" target="_blank">HIMSS 2013 Annual Conference & Exhibition trade show</a>, March 3-7, 2013 in New Orleans, LA.)  While likely a coincidence, my concern is that CPOE vendors will be talking nonstop about these results. Thus, I agree with the author's conclusion (especially in view of the recent voluntary reporting-based ECRI PSO study) that "future research in this area will be critically important to inform policy and funding decisions regarding the development and implementation of CPOE in care delivery." From a clinical perspective, "primum non nocere" and the avoidance of gambling billions of dollars applies, at least until a better understanding of the technology's risk/benefit ratio and how to improve it occurs. A fraction of those billions would pay for more robust, current studies on the scale needed to get closer to the truth, such as formal post-market, mandatory surveillance that measures not surrogate but primary variables - such as outcomes both positive and negative.  As noted by the authors, voluntary reporting has the least sensitivity towards uncovering error:  <blockquote class="tr_bq">... Reviewed studies used various medication error detection methods. Research suggests that the highest error rates are found through direct observation, followed by chart review, then automated surveillance, and voluntary reporting.  [Citations were made to papers by Flynn and Jha regarding these points - ed.] </blockquote> Formal studies are essential from the basis of medical (e.g., safety and public health), business (e.g., ROI and liability), and social policy perspectives (e.g., are we spending the billions of dollars this technology costs wisely). -- SS Addendum:    I have often been the <a href="http://hcrenewal.blogspot.com/2013/02/modern-healthcare-health-it-iconoclasts.html" target="_blank">fire-breathing and </a><a href="http://hcrenewal.blogspot.com/2013/02/modern-healthcare-health-it-iconoclasts.html" target="_blank">über-skeptic iconoclast</a> on matters such as this.  However, I will allow a true international expert to take on that role this time, Dr. Richard Cook, who had a guest post here yesterday (<a href="http://hcrenewal.blogspot.com/2013/03/dr-richard-cook-on-health-it-sectors.html" target="_blank">link</a>).  Dr. Cook's opinion on this JAMIA study (again, reproduced here with permission) was this: <blockquote class="tr_bq"><div>A meta-analysis of the literature on the nature of the universe in the mid 1500's would have concluded that the sun revolves around the earth. The data isn't fake, just worthless.  </div></blockquote> -- SS </div></div></div></div>

JAMIA: Reduction in medication errors in hospitals due to adoption of computerized provider order entry systems

A new article appeared online 20 February 2013 in the Journal of the American Medical Informatics Associati...

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Dr. Richard Cook on the Health IT Sector's Ills

This explanation of the health IT sector's ills comes from <a href="http://www.ctlab.org/Cook.cfm" target="_blank">Dr. Richard Cook</a>, a physician, educator, researcher, and patient safety expert formerly at the University of Chicago and now Professor of Healthcare System Safety at the <a href="http://www.kth.se/en" target="_blank">Royal Institute of Technology, Stockholm, Sweden</a>. Dr. Cook was also a member of the U.S. Institute of Medicine panel that studied health IT safety, leading to the 2012 IOM report ("<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf" target="_blank">Health IT and Patient Safety: Building Safer Systems for Better Care</a>"). He was also co-author of an article I consider a must-read for anyone in the health IT sector, <a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf" target="_blank" title="">Hiding in plain sight: What Koppel et al. Tell Us About Healthcare IT</a>, Journal of Biomedical Informatics. 38 (4): 262-3. Reproduced with his permission: <blockquote class="tr_bq"><div>My views are already <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=uz6ChcdyrkeOYFL4EuIDrhmmC6lS6s8IkJmPCr9naZhUHotWy3h9rPnb30JIu5ahw5YrZSAtNdg.&URL=http%3a%2f%2fbooks.nap.edu%2fopenbook.php%3frecord_id%3d13269%26page%3d193" target="_blank">on record</a>. [This links to his IOM report dissent where he made the case that health IT is a Class 3 medical device and should be regulated - ed.]</div><div> </div>Politically important activities (cynically, things that cost >10B$) are never neutral. HIT techno-fantasies are common and easily commandeered. Claims about the present and future efficacy of HIT have been altered in bewildering patterns to fit the circumstances of the moment.  This is not uncommon for expensive technologies with a few dominant producers and strong government ties (cf. Mackenzie's Inventing Accuracy, MIT Press, 1993).  <div> </div>The recent history of HIT is dominated by the social construction of several myths.  Although there are technical threads in the history, they are exceptionally frail. There have been myths of safety, of productivity, of economic efficiency, of clarity, of precision, of reliability.   <div> </div><div>The truth is that the Obama administration depended, in part, on savings to be obtained from HIT for claims it made prior to the election of 2008 about the savings to be derived from the plan to "reform" healthcare. These interests aligned with those of the industry and a faction from academic medicine and the result was the usual sausage.</div><div> </div><div>A central problem with techno-fantasies is that they are impossible to disprove. They are claims about the future. HIT's cornucopia has been promised repeatedly since the 1960's. Nothing like the promises has materialized.  Indeed, the IOM committee that was commissioned to evaluate the best evidence on this subject found no persuasive evidence that HIT improved patient safety. I know because I was there.</div><div> </div><div>But this is not the point and never has been. Privileged entities marshall arguments in favor of their purposes. The devil can cite scripture to his purpose. The result is what matters to them and the goal here was to get the government to fund private HIT installation in private healthcare facilities by offering first a carrot and then a stick. They steamrollered the opposition -- which was much more nuanced and thoughtful than the attacks on you [Scot Silverstein] make it appear -- and made it happen.</div><div> </div><div>To be clear, there was no conspiracy here. This is not deal done in back rooms by a few executives and cigar smoking pols. Instead it is the entirely predictable result of a confluence of interest among powerful stakeholders to advance their agendas. There is nothing shocking about an inferior, ill-conceived product getting government support, viz. Solyndra. Ultimately, the technical issues serve to the socio-political ones. </div><div> </div><div>It's no better over here.  [That is, in Sweden - ed.] We face the same problems in Sweden that you do in the U.S. We have the advantage of paying about 1/3 of what you do for healthcare and getting, objectively, better medical care and a better life than you do in the U.S.  But we have the same fractionated approach that you do and the same age bulge looming in the next 2 decades and there are plenty of problems with safety and humaneness, just like in your country. </div></blockquote><div> </div><div>I present this without any changes that might have occurred when unpleasant truths or opinions undergo peer review in a specialized, non-transparent and highly profitable sector.</div><div> </div><div>-- SS</div>

Dr. Richard Cook on the Health IT Sector's Ills

This explanation of the health IT sector's ills comes from Dr. Richard Cook , a physician, educator, researcher, and patient safety expe...

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Arguments with Pavlov's Dogs: Health IT Regulation Will "Harm Innovation"? How, exactly?

Health IT hyper-enthusiasts, when faced with the prospect of government regulations, react like <a href="http://en.wikipedia.org/wiki/Classical_conditioning" target="_blank">Pavlov's dogs</a> with the response "regulation of health IT will harm innovation." Here's a soliloquy of critical questions that need be asked: ----------------------- Now, Mr. (or Dr.)  Hyper-Enthusiast, you state HIT regulation will harm innovation. What aspects of regulation, specifically, will harm innovation? Good manufacturing processes (GMPs)? Building a safety case for review and inspection? Pre-market safety/fitness/quality/reliability testing? Post-marketing surveillance? What? Innovations happen before regulatory evaluation, do they not? What, exactly, are your objections to safety and quality testing of innovations? Don't innovations need to be tested for safety and quality? If innovations are not safe, should they not be used on live patients? How can the industry with its conflicts of interest effectively regulate HIT? Even if it could, again, how would additional regulatory oversight harm innovation? -----------------------  And perhaps this needs to be asked as well: <ul><li>Don't you really mean regulation would harm the bottom line? </li></ul> -- SS

Arguments with Pavlov's Dogs: Health IT Regulation Will "Harm Innovation"? How, exactly?

Health IT hyper-enthusiasts, when faced with the prospect of government regulations, react like Pavlov's dogs with the response " ...

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Hospital Retaliation Against Outspoken Physician Reaches New Levels - La Cosa Nostra Levels, That Is

Physicians, take note: <blockquote class="tr_bq">The Advisory Board Company Feb. 14, 2013   <a href="http://www.advisory.com/Daily-Briefing/2013/02/15/Jury-Hospital-CEO-framed-physician-by-planting-gun" target="_blank">Hospital Framed Physician; Planted a Gun </a> A jury has ordered a California hospital chain to pay physician Michael Fitzgibbons $5.7 million after its former CEO allegedly framed him by planting a gun in his car. In 2006, Fitzgibbons—an infectious disease specialist and former chief of staff at Western Medical Center—was arrested in the hospital parking lot after police found a pair of black gloves and a handgun in his car. Police questioned Fitzgibbons and searched his car after an anonymous 9-1-1 call claimed that the doctor had brandished the gun in traffic. DNA evidence from the gloves and gun exonerated Fitzgibbons, and he was never charged. However, the arrest followed a series of disagreements between Fitzgibbons and the leadership of Integrated Healthcare Holdings Incorporated (IHHI), which owned the Santa Ana hospital. Fitzgibbons and his attorney—Ted Mathews—alleged that IHHI's then-CEO, Bruce Mogel, had framed Fitzgibbons in an effort to silence him. Specifically, Mathews said that the frame was part of Mogel's attempt to "humble" Fitzgibbons after the doctor won a legal victory over IHHI in June 2006. During the trial, former IHHI President Larry Anderson testified that Mogel had instructed him to create a $10,000 contract for a "scary guy" named Mikey Delgado immediately after Fitzgibbon's legal victory. The contract was for unnecessary work on the health system's website. In his testimony, Anderson said he realized after Fitzgibbons was arrested that the contract was actually for the frame. Mathews told the jury that the $10,000 was used to "[get] Dr. Fitz set up." IHHI's board learned of the $10,000 contract during Anderson's deposition in 2008. Instead of firing Mogel, the board awarded him an eight-month consultancy worth $43,750 per month, Mathews says. This showed that IHHI board "knew what Mogel did to Dr. Fitzgibbons," Mathews told the jury, adding, "They ratified it, and they gave him a golden handshake goodbye.</blockquote> The article notes Board acquiescence. Two questions come to mind: 1.  Have the involved people been permanently removed from positions of authority in healthcaree? 2.  Have the persons involved been charges criminally? <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEilmYlDXF0wtZWXy1i_Qce5WGtXzfJhnM2jwPUoB_AD06s_waEqlZyWng7l078AfCON-jrqQwmzZ-npxbJ3w66ZsTv53A1dbmrREys3idjEO9K6iBwgPffmubMHGPIwfO81GDQVOGmlFo3d/s1600/goldfinger-54.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEilmYlDXF0wtZWXy1i_Qce5WGtXzfJhnM2jwPUoB_AD06s_waEqlZyWng7l078AfCON-jrqQwmzZ-npxbJ3w66ZsTv53A1dbmrREys3idjEO9K6iBwgPffmubMHGPIwfO81GDQVOGmlFo3d/s320/goldfinger-54.png" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><a href="http://www.youtube.com/watch?v=QtkFmufS6k8" target="_blank">Shocking.  Positively shocking.</a></td></tr></tbody></table> -- SS

Hospital Retaliation Against Outspoken Physician Reaches New Levels - La Cosa Nostra Levels, That Is

Physicians, take note: The Advisory Board Company Feb. 14, 2013 Hospital Framed Physician; Planted a Gun A jury has ordered a California h...

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Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI "Deep Dive" Study of Health IT "Events"

FDA's <a href="http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/default.htm" target="_blank">Center for Devices and Radiological Health</a> director Jeffrey Shuren MD JD voiced the opinion a few years ago that what FDA knows about health IT risks is the "tip of the iceberg" due to systematic impediments to knowledge gathering and diffusion.   See links to source <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html" target="_blank">here</a> and to the FDA Internal Memo on HIT risk - labeled "internal document not intended for public use" and unearthed by investigative reporter <a href="http://www.publicintegrity.org/authors/fred-schulte" target="_blank">Fred Schulte</a> several years ago - <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf" target="_blank">here</a> (PDF). At my Feb. 9, 2013 post "<a href="http://hcrenewal.blogspot.com/2013/02/ecri-institute-pso-uncovers-health.html" target="_blank">A New ECRI Institute Study On Health Information Technology-Related Events</a>" I opined that a new ECRI study was beginning to peer beneath the waterline of Jeff Shuren's iceberg tip, at what may reside underneath that waterline.  Iceberg tips, needless to say, are usually tiny compared to the iceberg's overall size. Reporter Kevin O'Reilly at AMNews (<a href="http://amednews.com/" target="_blank">amednews.com)</a> has now written about that ECRI report. The results of the report are concerning: <blockquote class="tr_bq"> <a href="http://www.ama-assn.org/amednews/2013/02/25/prsa0225.htm" target="_blank">Ways EHRs can lead to unintended safety problems</a> Wrong records and failures in data transfer impede physicians and harm patients, according to an analysis of health technology incidents. By Kevin B. O'Reilly, amednews staff, posted Feb. 25, 2013. In spring 2012, a surgeon tried to electronically access a patient’s radiology study in the operating room but the computer would show only a blue screen. The patient’s time under anesthesia was extended while OR staff struggled to get the display to function properly. That is just one example of 171 health information technology-related problems reported during a nine-week period to the ECRI Institute PSO, a patient safety organization in Plymouth Meeting, Pa., that works with health systems and hospital associations in Kentucky, Michigan, Ohio, Tennessee and elsewhere to analyze and prevent adverse events. Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths, said the institute’s 48-page report, first made privately available to the PSO’s members and partners in December 2012. The report, shared with American Medical News in February, highlights how the health IT systems meant to make care safer and more efficient can sometimes expose patients to harm.</blockquote>  Mar. 1, 2013 addendum.  From ECRI, the denominator is this: <blockquote class="tr_bq"><div class="MsoNormal">Participating facilities submitted health IT related events during the nine-week period starting April 16, 2012, and ending June 19, 2012. ECRI Institute PSO pulled additional health IT events that were submitted by facilities during the same nine-week period as part of their routine process of submitting event reports to ECRI Institute PSO’s reporting program. The PSO Deep Dive analysis consisted of 171 health IT-related events submitted by 36 healthcare facilities, primarily hospitals.   [I note that's 36 of 5,724 hospital in the U.S. per data from the American Hospital Association (<a href="http://www.aha.org/research/rc/stat-studies/fast-facts.shtml" target="_blank">link</a>), or appx. 0.6 %.  A very crude correction factor in extrapolation would be about x 159 on the hospital count issue alone, not including the effects of the voluntary nature of the study, of non-hospital EHR users, etc.  Extrapolating from 9 week to a year, the figure becomes about x 1000.  Accounting for the voluntary nature of the reporting (5% of cases per Koppel), the corrective figure approaches x20,000.  Extrapolation of course would be less crude if # total beds, degree of participant EHR implementation/use, and numerous other factors were known, but the present reported numbers are a cause for concern - ed.] </div></blockquote> Sept. 2013 addendum:  Health Leaders Media has more on the ECRI Deep Dive study at <a href="http://www.healthleadersmedia.com/print/TEC-290834/HIT-Errors-Tip-of-the-Iceberg-Says-ECRI">http://www.healthleadersmedia.com/print/TEC-290834/HIT-Errors-Tip-of-the-Iceberg-Says-ECRI</a>: <blockquote class="tr_bq">HIT Errors 'Tip of the Iceberg,' Says ECRI Cheryl Clark, for HealthLeaders Media , April 5, 2013 Healthcare systems' transitions from paper records to electronic ones are causing harm and in so many serious ways, providers are only now beginning to understand the scope. Computer programs truncated dosage fields, leading to morphine-caused respiratory arrest; lab test and transplant surgery records didn't talk to each other, leading to organ rejection and patient death; and an electronic systems' misinterpretation of the time "midnight" meant an infant received antibiotics one dangerous day too late. These are among the 171 health information technology malfunctions and disconnects that caused or could have caused patient harm in a report to the <a href="https://www.ecri.org/Pages/default.aspx" target="_blank">ECRI</a> Institute's Patient Safety Organization. ... The 36 hospitals that participated in the ECRI IT project are among the hospitals around the country for which ECRI serves as a Patient Safety Organization, or PSO. The 171 events documented, break down like this: <ul><li>53% involved a medication management system. <ul><li>25% involved a computerized order entry system</li><li>15% involved an electronic medication administration record</li><li>11% involved pharmacy systems</li><li>2% involved automated dispensing systems</li></ul></li><li>17% were caused by clinical documentation systems</li><li>13% were caused by Lab information systems</li><li>9% were caused by computers not functioning</li><li>8%. Were caused by radiology or diagnostic imaging systems, including PACS</li><li>1% were caused by clinical decision support systems</li></ul> Karen Zimmer, MD, medical director of the institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring.  The volume of errors in the voluntary reports was she says, "an awareness raiser." "If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported."</blockquote> As at the opening of this post, "tip of the iceberg" is a phrase also used by FDA CDRH director Jeffrey Shuren MD JD regarding safety issues with EHRs and other health IT. Along those lines, at my April 2010 post "<a href="http://hcrenewal.blogspot.com/2010/04/if-benefits-of-hit-can-be-guesstimated.html" target="_blank">If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers</a>" I proposed a "thought experiment" to theoretically extrapolate limited data on health IT risk to a national audience, taking into account factors that limited transparency and thus reduced known injury and fatality counts. The results were undesirable, to say the least - but it was a thought experiment only. Using the current data, coming from a limited, voluntary set of information over 9 weeks, I opine that the results of an extrapolation to a national (or worldwide) level, in an environment of rapidly increasing adopters (many of whom are new to the technology), on an annual basis, not a mere 9 weeks - would not look pretty. <blockquote class="tr_bq">The institute’s report did not rate whether electronic systems were any less safe than the paper records they replaced. The report is intended to alert hospitals and health systems to the unintended consequences of electronic health records. </blockquote> Ethically, this is really not relevant towards national rollout, especially with penalties beginning to accrue to non-adopters of HHS "Certified" technology in a few years. As I've written on this blog, medical ethics generally do not condone experimentation without informed consent, especially when the experimental devices are of unknown risk. Not knowing the risks of IT, it really doesn't matter, ethically, what the safety of paper is.  "Hope" is not a valid reason for medical experimentation.  (See below for what a PubMed search reveals about risks of paper records.) The unspoken truth prevalent in healthcare today seems to be this:  the sacrifice of individual patients to a technology of unknown risk is OK, as long as - we hope -  it advances the greater good.    Perhaps that should be explicitly admitted by the HIT industry's <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html" target="_blank">hyper-enthusiast proponents</a> who ignore the downsides, so the spin can be dropped and there can be clarity? <blockquote class="tr_bq">The leading cause of problems was general malfunctions [also known by the benign-sounding euphemism "<a href="http://hcrenewal.blogspot.com/search/label/glitch" target="_blank">glitches</a>" - ed.]  responsible for 29% of incidents. For example, following a consultation about a patient’s wounds, a nurse at one hospital tried to enter instructions in the electronic record, but the system would not allow the nurse to type more than five characters in the comment field. Other times, medication label scanning functions failed, or an error message was incorrectly displayed every time a particular drug was ordered. One system failed to issue an alert when a pregnancy test was ordered for a male patient. [These 'general malfunctions' are thus not just computer bugs undetected due to inadequate pre-rollout testing, but also examples of design flaws due to designer-programmer-seller-buyer-implementer lack of due diligence, i.e.,  negligence - ed.] A quarter of incidents were related to data output problems, such as retrieving the wrong patient record because the system does not ask the user to validate the patient identity before proceeding. This kind of problem led to incorrect medication orders and in one case an unnecessary chest x-ray. Twenty-four percent of incidents were linked to data-input mistakes. For example, one nurse recorded blood glucose results for the wrong patient due to typing the incorrect patient identification number to access the record.  [Many of these are likely due to what NIST has termed "<a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">use error</a>" - user interface designs that will engender users to make errors of commission or omission - as opposed to "user error" i.e., carelessness - ed.] Most of remaining event reports were related to data-transfer failures, such as a case where a physician’s order to stop anticoagulant medication did not properly transfer to the pharmacy system. The patient received eight extra doses of the medication before it was stopped. [Due to outright software, hardware and/or network problems and defects - ed.]</blockquote> I've been writing about such issues since 1998, not because I imagined them.  As a CMIO I saw them firsthand; as teacher and mentor I heard about them from colleagues; as a writer I heard about them via (usually unsolicited) emails from concerned clinicians; as an independent expert witness on health IT harms I've heard about them from Plaintiff's attorneys, but not from the Defense side of the Bar as yet.  Of course the reasons for that are understandable -  albeit disappointing. In fact, robust studies of a serious issue - the actual risks of paper towards harm causation - and further, whether any of the issues are remediable without spending hundreds of billions of dollars on IT - seem scarce.  I've asked the PA Patient Safety Authority about the possibility of using data in the Pennsylvania Patient Safety Reporting System (PA-PSRS) database, just as they did for EHR-related medical events, to determine incidence of paper-related medical events.  They are pondering the issue. As an aside, I note that it would be ironic if the relative risks of both IT and paper were not really robustly known.  (I note that in a PubMed search on "<a href="http://www.ncbi.nlm.nih.gov/pubmed/?term=risks+of+paper+medical+records" target="_blank">risks of paper medical records</a>", not much jumps out.)  IT hyper-enthusiasts will not even debate the issue of studying whether a good paper system might be safer for patients in some clinical environments than bad health IT. Considering the tremendous cost and unknown risk of today's health IT (and perhaps the unknown risk of paper, too), would it not make more sense, and be consistent with the medical Oath, to leave paper in place where it is currently used - and perhaps improve its performance - until we "get the IT right" in controlled, sequestered environments, prior to national rollout? In other words, as I've asked before on these pages, should we not slow down the IT push and adhere to traditional (and hard-learned) cautions on medical research? Even asking such questions brings forth logical fallacies such as straw arguments (e.g., UCSF's <a href="http://community.the-hospitalist.org/" target="_blank">Bob Wachter</a> in a recent discussion I initiated with several investigative reporters: "...where we part ways is your defense of paper and pencil. I understand advocacy, and you have every right to bang this particular drum"), ad hominem attacks, etc. <blockquote class="tr_bq">... It is not enough for physicians and other health care leaders to shop carefully for IT systems, the report said. Ensuring that systems such as computerized physician order entry and electronic health records work safely has to be a continuing concern, said Karen P. Zimmer, MD, MPH, medical director of the ECRI Institute PSO. “Minimizing the unintended consequences of health IT systems and maximizing the potential of health IT to improve patient safety should be an ongoing focus of every health care organization,” she said.</blockquote> I recommended that clinicians take matters into their own hands if their leaders do not, as at the bottom of my post <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">here</a>.  This advice bears repeating: <blockquote class="tr_bq">... When a physician or other clinician observes health IT problems, defects, malfunctions, <a href="http://www.tinyurl.com/hostileuserexper">mission hostility</a> (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting): (DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.) <ul><li>Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "<a href="http://www.jpands.org/vol9no3/huntoon.pdf">disruptive physician</a>" and/or or being subjected to sham peer review (<a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">link</a>).</li></ul><ul><li>Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal"> at this link</a>. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger <a href="http://hcrenewal.blogspot.com/search/label/Dr.%20Scott%20Monteith">Dr. Scott Monteith</a> in a comment to me about this post.)</li></ul><ul><li>Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at <a href="http://www.jointcommission.org/report_a_complaint.aspx">http://www.jointcommission.org/report_a_complaint.aspx</a> . Also consider writing the JC senior officers (<a href="http://www.jointcommission.org/about_us/joint_commission_officers.aspx">link to officer's list</a>), whose awareness of HIT issues I can personally attest to via our correspondences.</li></ul><ul><li>Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at <a href="https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm">https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm</a>. An example of such an adverse event report I filed myself (when the involved hospital refused) is <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1729552">at this link</a> in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.</li></ul><ul><li>Inform the State Medical Society and local Medical Society of your locale.</li></ul><ul><li>Inform the appropriate Board of Health for your locale.</li></ul><ul><li>If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "<a href="http://www.qipa.org/Home.aspx">Quality Insights of PA</a>."</li></ul><ul><li>Inform a personal attorney.</li></ul><ul><li>Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.</li></ul><ul><li>As clinicians are often forced to use health IT, at their own risk even when "certified" (<a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">link</a>), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:</li></ul><blockquote>"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.] We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice. With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at <a href="http://www.jointcommission.org/assets/1/18/SEA_42.PDF" style="font-style: italic;">http://www.jointcommission.org/assets/1/18/SEA_42.PDF</a>, the IOM report on HIT safety at <a href="http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF" style="font-style: italic;">http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF</a>, and the FDA Internal Memorandum on H-IT Safety Issues at <a href="http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology" style="font-style: italic;">http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology</a>. CMO __________ (date, time) CIO ___________ (date, time) CMIO _________ (date, time) General Counsel ___________ (date, time) etc."</blockquote><ul><li>If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.</li></ul><ul><li>As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.</li></ul></blockquote> These recommendations still stand, although after this recent story, my caution about retaliation should be re-emphasized: <blockquote class="tr_bq">The Advisory Board Company Feb. 14, 2013 <a href="http://www.advisory.com/Daily-Briefing/2013/02/15/Jury-Hospital-CEO-framed-physician-by-planting-gun" target="_blank">Hospital Framed Physician; Planted a Gun </a></blockquote> -- SS

Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI "Deep Dive" Study of Health IT "Events"

FDA's Center for Devices and Radiological Health director Jeffrey Shuren MD JD voiced the opinion a few years ago that what FDA knows a...

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Another Reason for Hope? - Concern about Excessive Executive Pay in Health Care Goes Mainstream

Another recent case suggested that the problem of excess, disproportionate <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">compensation of health care executives</a> is becoming more of a mainstream concern.  The Case of Eastern Connecticut Health Network The case appeared in the Manchester (CT) Journal-Inquirer (<a href="http://www.journalinquirer.com/articles/2013/02/22/politics_and_government/doc51263d0334cdf093796210.txt">link</a> requires subscription).  Here are the basics: <blockquote class="tr_bq">ECHN Inc., which owns Mancester Memorial and Rockville General hospitals, reported to the IRS last year that the company paid its president and CEO, Peter J Karl, a total of $1,042,200 in salary and fringe benefits.  That's a 30.7 percent increase over Karl's compensation reported in the previous year,.... ECHN also reported that six other top executives were paid between $254,640 and $591,090, representing increases of as much as 20.6 percent. </blockquote> ECHN is yet another relatively small non-profit hospital system with a million dollar plus CEO. For comment on this, I turn back to the Journal-Inquirer article.  One person the reporter interviewed <blockquote class="tr_bq">says the big salaries and bonuses paid to top officials at Eastern Connecticut Health Network are part of a national scandal over executive compensation propelled by the 'pursuit of talent for short-term gains.' 'The hospital industry is emblematic of what's happened in executive compensation in the United States, where the multiple of the lowest- paid employee to get to the salary of the highest-paid employee has just exploded over the last 30 years,'....</blockquote> Furthermore, the person interviewed noted that hospital executives were bemoaning decreases in payments to their institutions by state government "while making 10 to 20 times as much money as" the state governor makes.  In this case, the CEO, Mr Karl's "compensation package was 6.9 times [Governor Daniel P] Malloy's salary of $150,000." A second person interviewed said <blockquote class="tr_bq">Salaries have gotten to the point where they have skyrocketed and are out of control.</blockquote> He also raised an issue about conflicts of interest affecting the ECHN board <blockquote class="tr_bq">he agreed with state health care advocate, Victoria Veltri, who told the Journal Inquirer last week that nearly $1 million in business deals between ECHN and five members of its board of trustees require further scrutiny</blockquote>Criticism from the Mainstream I have been coy about who the commentators were, but bear with me. So we see in this one somewhat obscure newspaper article about one small regional hospital system points that we have been raising for years about the perverse incentives generated by excess executive compensation in health care.  We have frequently discussed how such compensation is often completely untethered to the organizations' financial results, much less its positive effects on patients' and the public's health.  Compensation often rises faster than inflation, faster than revenue (and sometimes when revenue declines and deficits loom), and even when the organization is facing financial, clinical, or ethical challenges.  Thus it often seems that the primary goal of the organization has become enriching top executives (look <a href="http://hcrenewal.blogspot.com/2013/02/non-profit-hospital-executive-salaries.html">here</a> for a recent example).  As the first commentator noted above, this seems to arise out of the business school dogma that puts short-term revenue ahead of all other goals (which we discussed <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">here,</a> and can be termed <a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a>.) But our concerns do seem to be getting more mainstream.  The first commentator above was actually the Governor of Connecticut, Dannel P Malloy, himself.  The second commenter was Connecticut state Senator Steve Cassano.  So prominent politicians are beginning to see the perversity of excess executive compensation in health care at a time of still burgeoning health care costs and still threatened health care access and quality.  So maybe some more people will listen this time when we repeat....  Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Another Reason for Hope? - Concern about Excessive Executive Pay in Health Care Goes Mainstream

Another recent case suggested that the problem of excess, disproportionate compensation of health care executives is becoming more of a mai...

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Reason for Hope? - Novartis Rescinds Vasella's Golden Parachute

Enormous compensation of hired health care executives, out of all proportion, if related at all to whether their work had any positive effect on patients' or the public's health, has long been a <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">concern</a> on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.  For example, back in 2006, we posted repeatedly (look <a href="http://hcrenewal.blogspot.com/2006/10/another-really-big-one-bites-dust-ceo.html">here</a> for links) about the billion dollar plus fortune amassed by the then CEO of UnitedHealthcare which vividly contrasted with the company's avowal to "make health care more affordable." We have posted many such stories.  Yet maybe there is a whiff of change in the air.  For the first time that I can recall, a gigantic pay package to a top health care executives has been rescinded after public protest. Novartis' Golden Parachute for Vasella This is how the New York Times <a href="http://www.nytimes.com/2013/02/19/business/global/for-daniel-vasella-of-novartis-78-million-to-keep-secrets.html">described</a> the huge golden parachute that was initially proposed: <blockquote class="tr_bq">A plan by Novartis<a class="meta-org" href="http://topics.nytimes.com/top/news/business/companies/novartis_ag/index.html?inline=nyt-org" title="More information about Novartis A.G"></a>, one of Switzerland’s biggest drug makers, to pay its departing chairman $78 million to keep him from sharing his knowledge with competitors has added fuel to an already heated debate about executive pay. <div itemprop="articleBody">The announcement of the payment to the chairman, Daniel Vasella, was made last Friday, just two weeks before a Swiss referendum to give shareholders more power to determine executive compensation. Mr. Vasella, who had previously said that he would step down as chairman at Novartis’s annual shareholder meeting on Friday, is to receive the sum, 72 million Swiss francs, over six years. </div><div itemprop="articleBody"> </div>In a statement, Mr. Vasella said that 'it has been very important to Novartis that I refrain from making my knowledge and know-how available to competitors and to take advantage of my experience with the company.'</blockquote> Unprecedented Resistance by Shareholders, Politicians and the Public The plan to provide this "golden parachute" met stunning resistance from Swiss citizens and company shareholders.  As the Times reported, <blockquote class="tr_bq"><div itemprop="articleBody">Swiss lawmakers and shareholder activists criticized the company over the weekend for not making the amount public earlier. They also contended that the planned payment was just the latest of several bad decisions by Novartis on executive pay. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Ethos, a Swiss group of investors, on Monday called on Novartis to immediately cancel the contract with Mr. Vasella and take back any money already paid. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Christophe Darbellay, president of the Christian Democratic People’s Party, told a Swiss newspaper, SonntagsZeitung, that Mr. Vasella’s compensation was 'beyond evil.' Simonetta Sommaruga, the Swiss federal justice minister, told another newspaper, SonntagsBlick, that the payment was an 'enormous blow for the social cohesion of our country' and that such 'help-yourself mentality' was damaging confidence in the economy. </div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Even Swiss identified as pro-business or right-wing joined in the criticism.  As <a href="http://www.swissinfo.ch/eng/swiss_news/Vasella_s_extra_pay_stirs_up_emotions.html?cid=35006618">reported</a> by the Swiss Broadcasting Company, </div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">Philipp Müller, president of the centre-right Radical Party which traditionally has close links with the business community, is quoted as saying Vasella was 'taking liberal Switzerland to the henchman'. Other politicians described the latest figure as 'disgusting' and denounced the recklessness of top managers. The director of the Swiss Business Federation, which has been leading the fight against the initiative, said he was surprised by the 'dimension of the payment' to Vasella.</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">A Golden Parachute Despite a Past Record of Misadventures </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Maybe there would have been even more outrage if those in Switzerland had known about Novartis' track record of misadventures, at least in the US, while Vasella had been leading it.  In particular,</div><div itemprop="articleBody">-  In 2011, as we noted <a href="http://hcrenewal.blogspot.com/2011/12/legal-settlements-have-become-so-common.html">here</a>, a company subsidiary paid $150 million to settle charges by several US states that it had misrepresented pricing information</div><div itemprop="articleBody">-  In 2010, as we noted <a href="http://hcrenewal.blogspot.com/2010/10/novartis-settles-but-wait-theres-more.html">here</a>, the company settled US federal civil and criminal charges in connection with its marketing of multiple drugs for $422.5 million.  The charges included giving kickbacks to physicians disguised as speakers' honorariums and fees for serving on advisory boards.  </div><div itemprop="articleBody">-  In 2010, as we noted <a href="http://hcrenewal.blogspot.com/2010/05/novartis-settles-again.html">here</a>, the company settled separate US charges that it made false claims to support off-label marketing of its drug tobramycin for cystic fibrosis for $72.5 million.  </div><div itemprop="articleBody">- In 2008, as we noted <a href="http://hcrenewal.blogspot.com/2008/07/bad-week-in-court-for-us-health-care.html">here</a>, the company settled charges in the US state of Alabama that it defrauded Medicaid for $33.7 million. However, these legal escapades were not mentioned in the recent media coverage of the proffered and then withdrawn parachute.  </div><div itemprop="articleBody"> </div><div itemprop="articleBody"> </div><div itemprop="articleBody">The Company Backs Down. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Nonetheless, what was really surprising was that the outrage made the company back down.  <a href="http://online.wsj.com/article/SB10001424127887323495104578313670408396876.html">Per</a> the Wall Street Journal, </div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">Novartis AG on Tuesday abandoned a 72-million-Swiss-franc ($78 million) exit package for its chairman, bowing to pressure from shareholders and Swiss politicians after four days of increasing criticism.</div><div itemprop="articleBody"> </div>The Swiss drug maker said its board and Chairman Daniel Vasella<a class="topicLink" href="http://topics.wsj.com/person/V/Daniel-Vasella/4329"></a> agreed to cancel a six-year noncompete and related-compensation agreement designed to prevent him from joining or advising rivals and which would have paid him 12 million francs a year. The agreement was scheduled to take effect on Friday, when Dr. Vasella, 59 years old, is planning to leave the Basel-based company at its annual shareholder meeting</blockquote> Furthermore, <blockquote class="tr_bq">In the Novartis statement on Tuesday, Dr. Vasella acknowledged that his offer hadn't soothed public opinion: 'I have understood that many people in Switzerland find the amount of the compensation linked to the noncompete agreement unreasonably high,' he said. </blockquote> In addition, as Reuters noted, Vasella actually admitted he made "mistakes," <blockquote class="tr_bq">'The fierce reaction and reproaches that were made as a consequence of the many-sided discussions about my compensation did leave its mark on me,' 59-year-old Vasella said in his opening address to 2,688 shareholders gathered at Novartis's annual general meeting in Basel. 'I made two avoidable mistakes: the first was to even negotiate this contract. And the second to believe that giving up this individual payment to charities would be considered as something positive by society.'</blockquote> Of course, it is hard to believe that Novartis had previously paid him as lavishly as it did  - the New York Times had reported that his pay just prior to resignation was 12.4 million francs, "about $13.4 million a year" -  without securing an agreement to protect trade secrets.  Many businesses routinely add confidentiality clauses, trade secret protection, and non-compete clauses to contracts of many employees.  Thus adding a $78 million golden parachute ostensibly just to protect trade secrets and defection to the competition seems like impossibly gilding the lily.  Furthermore, if Novartis really thought that Vasella was likely to run to another firm at the drop of a hat, it would have made no sense to entrust someone thought to be at risk of such disloyalty with top leadership positions. Reason for Hope At least Chairman Vasella admitted "mistakes," and at least the ridiculous pay package was rescinded. This incident does show that it is possible for public and shareholder outrage over gargantuan payments to executives to have some effect.  That seems like real progress, and a reason to hope.  Of course, executives of public for-profit corporations are supposed to be working for shareholders.  Thus their general impunity from shareholders' control up to now remains inexplicable.  Furthermore, executives of pharmaceutical companies and other health care corporations seemingly should be responsible for putting patients' and the public's health ahead of their own enrichment.  Thus their ability up to now to ignore public concern about their companies' actions, and to avoid personal responsibility for their companies' bad actions also remains inexplicable. But progress may now be possible.  In and outside of Switzerland, shareholders of publicly-held for-profit health care corporations should demand accountability from the executives who are supposed to be working for them.  In and outside of Switzerland, health care professionals, policymakers, and the public at large should demand accountability from leaders of health care organizations for the effects of their organizations on patients' and the public's health.

Reason for Hope? - Novartis Rescinds Vasella's Golden Parachute

Enormous compensation of hired health care executives, out of all proportion, if related at all to whether their work had any positive effec...

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