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Friday, October 1, 2010
Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?
In my July 2010 post "Meaningful Use Final Rule" I pointed out the cart-before-the-horse problem of creating "meaningful use" rules for health IT before usability issues were resolved:
From the HIMSS EHR Usability Task Force, June 2009:
Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available. Achieving the healthcare reform goals of broad EMR adoption and �meaningful use� will require that efficiency and usability be effectively addressed at a fundamental level.
These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations.
Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the risks entailed.For crying out loud, talk about putting the cart before the horse...Something's very wrong here...
Here we go again.
"Ready ... fire ... aim" seems the postmodern approach to healthcare IT:
Institute to study HIT patient safety for ONC
Mary Mosquera
Government Health IT, Thursday, September 30, 2010
The Institute of Medicine (IOM) announced it will conduct a year-long study for the Office of the National Coordinator for Health IT to identify best policies and practices for improving healthcare safety when using electronic health records.
The IOM, an arm of the National Academy of Sciences, will examine prevention of health IT-related errors, rapid reporting of patient safety concerns [To whom? The vendor, as now, so they can sit on the problems until it suits them to fix it? In the face of contractual gag clauses, I'm not sure where else such reports can go - ed.] and methods to promote safety-enhancing features of electronic health records (EHRs), said Dr. David Blumenthal, the national health IT coordinator.
The IOM will also make recommendations about the potential effects of government policies and private sector efforts to make the most of patient safety and avoid medical errors through health IT.
[In reading the hype right up to the ONC Director Blumenthal and the POTUS, one would get the impression that medical error-prevention was an inherent, deterministic characteristic of this 100% beneficent technology, so much so that simply putting it in will revolutionize medicine. Now, we all of a sudden need to study its safety? - ed].
... �This study will draw on IOM�s depth of knowledge in this area to help all of us ensure that HIT reaches the goals we are seeking for patient safety improvement,� Blumenthal said.
Earlier this year, the Health IT Policy Committee, a federal advisory group, conducted hearings about patient safety and EHRs. It recommended creating a national database to which healthcare providers can report patient data errors and unsafe conditions they encounter using EHRs.
[To reiterate, there is a major problem with this proposal: "providers" cannot do this with contractual gag clauses in effect. It also seems such databases belong at the state level, since the control of medicine traditionally resides in the states, but these days the Federal government seems to know no bounds - ed.]
The committee also urged the establishment of a patient safety organization to analyze the reports and share information from the database to make healthcare a learning system.
So, in the midst of a National Program for Health IT in the United States (NPfIT in the U.S.), with tens of billions of dollars earmarked for health IT already (money we don't really have, but it can be printed quickly, or borrowed from China) the IOM is going to study health IT safety, prevention of health IT-related errors, etc. ... only now?
Perhaps these studies should have been initiated, say, ten years ago, or at least before the beneficence of health IT and its capacity to revolutionize medicine was openly promoted by the past and current Administrations (the current one going so far as to institutionalize penalties for non adopters)?
A move like this suggests someone's blown the whistle on the purveyors of the NPfIT in the U.S. They are now attempting to cover their tracks regarding this glaring deficiency (unknown risk) in an already-initiated, extremely expensive national program based on equivocal studies and literature, an increasing amount of which is now refuting the grandiose claims made about health IT. The purveyors would seem to have a figurative gun at their heads causing them to ask the IOM for assistance at this rather late date in the scheme of things (could that gun be named Grassley?)
A tidbit of common sense regarding IT, all too lacking in today's national leadership:
- You should not need year-long IOM studies to study the safety of supposedly safe devices already slated for national rollout.
Finally, the sudden interest in health IT safety suggests the HITECH act on health IT with its timelines and penalties, 'smuggled' in under the auspices of the ARRA, is premature. HITECH's timelines should be delayed delayed until this technology and its safety is truly understood (or it should be repealed entirely and redone in a non-cavalier fashion).
-- SS
10/2/10 addendum:
I recall that we already have the 2009 National Research Council HIT study. It reported that HIT in its present form does not support physician cognitive needs and that our approaches to HIT are "insufficient" to achieve stated goals...
The U.S. National Research Council�s "Current Approaches to U.S. Health Care Information Technology are Insufficient" is here. A full report on an investigation of healthcare IT lack of progress is here (PDF).
From the NRC/NAS/IOM sites:
"The National Research Council (NRC) functions under the auspices of the National Academy of Sciences (NAS), the National Academy of Engineering (NAE), and the Institute of Medicine (IOM)." ... "The IOM is the health arm of the NAS."
The National Research Council report on HIT was basically buried. HITECH happened anyway.
ONC seems to now be going back to the same source(s), presumably for either a glowing report, or a report that it can safely ignore.
Finally:
That HIT effectiveness issues, safety issues, admittedly poor usability but "meaningful use" criteria crafted anyway, lack of clinician cognitive support requiring years of multidisciplinary research to correct, etc. - have had no inhibitory effect on grandiose, autocratic and highly expensive plans for national HIT also suggest political agendas far beyond "improving patient care."
-- SS
Novartis Settles..., But Wait, There's More
Back in January, 2010, we posted about Novartis' settlement of charges that it promoted its anti-seizure drug, Trileptal, (Oxcarbazepine) for off-label uses, agreeing to plead guilty to one charge of violating the US Food, Drug and Cosmetic Act. This week, the full story of the settlement just came out, and yes, but wait, there's more. Per the New York Times article by Duff Wilson, the story is not only about Trileptal:
And the issue was not solely off-label marketing:
While the allegations were much more broad than those originally announced, the penalties were the usual suspects:
Also,
However,
Back in June, we posted about how US law enforcement was supposedly going to start getting tougher with the people who authorized, directed or implemented wrong doing by health care organizations. Back then, federal officials said that executives would be held accountable, and forced to leave their jobs or even be disbarred from working in the industry.
However, here we are, four months later, and even a case that mushroomed from involving allegations of off-label promotion of one drug to off-label promotion of six drugs, allegations of kickbacks to physicians, and allegations that top management knew about what was going on results in no negative consequences to any individuals.
So it still seems that if misdeeds, such as promotion of drugs for off-label uses, and giving kickbacks to doctors disguised as honoraria for talks, consulting fees, and meals and travel payments, are done under the auspices of a large health care organization, no one is ultimately responsible for them. The organization may have to pay what appears to be a big fine, but one that pales against the profits to be made from the misdeeds.
So, if an ordinary person commits fraud, he or she is likely to have to pay a big fine and go to jail. If a physician commits fraud, he or she is likely to have to pay a big fine and go to jail, and incidentally to lose his or her medical license. But if a corporate executive authorizes a fraudulant practice, he or she is likely not to pay any penalty (but may well have already collected a big bonus).
We have repeated endlessly that by limiting penalties to only modest increases in the costs of doing business for organizational malfeasance in health care, we just encourage more bad behavior. But with each new example like this, I agree more that the fundamental problem has become corporatism, (or Corpocracy, as Robert A G Monks put it). Government and corporate leaders find that they have more in common with each other than with the little people. Or as Barry Ritholtz just blogged:
Furthermore,
The Swiss drug giant Novartis is paying $422.5 million to settle criminal and civil investigations into the marketing of the antiseizure medicine Trileptal and five other drugs, federal officials said on Thursday.The other drugs were:
Diovan, a hypertension drug that is the company�s top-selling product, at $6 billion last year; Sandostatin, a drug to treat a growth hormone disorder that had worldwide sales of $1.2 billion last year; Exforge, a hypertension drug that sold $671 million; Tekturna, a blood pressure medicine that sold $290 million; and Zelnorm, a medicine for irritable bowel syndrome and constipation that was later withdrawn from the United States market.
And the issue was not solely off-label marketing:
Federal prosecutors accused Novartis of paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. But aside from pleading guilty to one misdemeanor charge of mislabeling in an agreement that Novartis announced in February, the company denied wrongdoing.
While the allegations were much more broad than those originally announced, the penalties were the usual suspects:
The settlement includes a $170 million criminal fine and $15 million in criminal forfeiture by Novartis Pharmaceuticals, its United States subsidiary.
Also,
Novartis settled the investigation into the other drugs for $237.5 million.
However,
Prosecutors said top management at Novartis had approved illegal marketing from July 2000 to June 2004. No individual, however, was named or charged.
Back in June, we posted about how US law enforcement was supposedly going to start getting tougher with the people who authorized, directed or implemented wrong doing by health care organizations. Back then, federal officials said that executives would be held accountable, and forced to leave their jobs or even be disbarred from working in the industry.
However, here we are, four months later, and even a case that mushroomed from involving allegations of off-label promotion of one drug to off-label promotion of six drugs, allegations of kickbacks to physicians, and allegations that top management knew about what was going on results in no negative consequences to any individuals.
So it still seems that if misdeeds, such as promotion of drugs for off-label uses, and giving kickbacks to doctors disguised as honoraria for talks, consulting fees, and meals and travel payments, are done under the auspices of a large health care organization, no one is ultimately responsible for them. The organization may have to pay what appears to be a big fine, but one that pales against the profits to be made from the misdeeds.
So, if an ordinary person commits fraud, he or she is likely to have to pay a big fine and go to jail. If a physician commits fraud, he or she is likely to have to pay a big fine and go to jail, and incidentally to lose his or her medical license. But if a corporate executive authorizes a fraudulant practice, he or she is likely not to pay any penalty (but may well have already collected a big bonus).
We have repeated endlessly that by limiting penalties to only modest increases in the costs of doing business for organizational malfeasance in health care, we just encourage more bad behavior. But with each new example like this, I agree more that the fundamental problem has become corporatism, (or Corpocracy, as Robert A G Monks put it). Government and corporate leaders find that they have more in common with each other than with the little people. Or as Barry Ritholtz just blogged:
The new dynamic, however, has moved past the old Left Right paradigm. We now live in an era defined by increasing Corporate influence and authority over the individual. These two 'interest groups' � I can barely suppress snorting derisively over that phrase � have been on a headlong collision course for decades, which came to a head with the financial collapse and bailouts. Where there is massive concentrations of wealth and influence, there will be abuse of power. The Individual has been supplanted in the political process nearly entirely by corporate money, legislative influence, campaign contributions, even free speech rights.
This may not be a brilliant insight, but it is surely an overlooked one. It is now an Individual vs. Corporate debate � and the Humans are losing.
Furthermore,
There is some pushback already taking place against the concentration of corporate power: Mainstream corporate media has been increasingly replaced with user created content � YouTube and Blogs are increasingly important to news consumers (especially younger users). Independent voters are an increasingly larger share of the US electorate. And I suspect that much of the pushback against the Elizabeth Warren�s concept of a Financial Consumer Protection Agency plays directly into this Corporate vs. Individual fight.
But the battle lines between the two groups have barely been drawn. I expect this fight will define American politics over the next decade.
Keynes vs Hayek? Friedman vs Krugman? Those are the wrong intellectual debates. Its you vs. Tony Hayward, BP CEO, You vs. Lloyd Blankfein, Goldman Sachs CEO. And you are losing . . .
Epinephrine Use to Treat Food Allergy or Insect Sting Reactions
State laws vary in regards to whether non-medical personnel may administer epinephrine to a person experiencing anaphylaxis due to an allergic reaction. Recently, the WMS (Wilderness Medical Society) addressed this issue. The organization has taken the position that:
Ideally, a person with a known allergy that may lead to an anaphylactic reaction carries their own medication and self administers if necessary. That is not always possible though, especially for children experiencing a reaction. The laws need to protect helpers who may need to assist someone in a life-threatening situation.
Read the full WMS position and know the laws in your state.
- outdoor instructors authorized to treat anaphylaxis should be trained to administer epinephrine
- legislative change on the federal level should establish uniform protection in all 50 states
Ideally, a person with a known allergy that may lead to an anaphylactic reaction carries their own medication and self administers if necessary. That is not always possible though, especially for children experiencing a reaction. The laws need to protect helpers who may need to assist someone in a life-threatening situation.
Read the full WMS position and know the laws in your state.
Cool Technology of the Week
For years, I've said that the ideal computing device for clinicians is simple:1. Under 1 pound
2. 8-12 hour battery life
3. 5x7 inch form factor that can fit into an white coat pocket
4. Easy to disinfect (medicine is messy)
5. Can be dropped 5 feet onto carpet without significant damage
I predict that the iPad and the plethora of new similar devices are going to be the emerging clinical platform of choice for healthcare in 2011.
The latest announcement from RIM, the Playbook, seems to address my requirements list very well - it's small, lightweight, and advertised as stable/reliable/secure/enterprise ready.
Of course, it will be interesting to watch how the developer marketplace responds given that its operating system (QNX) is not Android nor the iPhone/Ipad iOS.
However, since all my applications are browser-based, in many ways we do not care what device users choose as long as it is secure.
Nirvana for clinical computing devices is finally arriving. That's cool
