Tragedies prompt sedation rule changes September 30, 2009
By: Laird Harrison, Senior Editor
Sometimes it takes death to move a bureaucracy. Or two. When Chicago elementary school principal Georgette Watson died during root canal therapy in 2007, it was the second time in as many years that a sedated patient had died in a Chicago dental office. So last week Illinois published draft rules that would more closely align its rules with ADA guidelines. But in the two years since the ADA issued its new guidelines, few other states have fallen in line, according to Sean Boynes, D.M.D., an assistant anesthesiology professor at the University of Pittsburgh School of Dental Medicine.
"Last time I checked, there were four that had done it in some way, shape, or form," Dr. Boynes said.
“The rules we filed aim to prevent the tragic outcomes that occurred in recent years.”
— Brent Adams, Illinois Division of
Professional Regulation
One reason is that the new popularity of oral conscious sedation techniques had already prompted many states to revise their regulations in the years leading up to the ADA's 2007 guidelines. "They don't want to spend the resources reviewing it again," he said.
Another issue is that some states don't like the ADA guidelines. For example, the guidelines define "supplemental dosing" for minimal sedation as 1.5 times the FDA's maximum recommended dose. Some states may be concerned about the liability issues of endorsing doses greater than what the FDA recommends.
But other states seem to march to the pulse of a different oximeter. Some require permits for oral conscious sedation, while others don't. Some categorize sedation by the administration route; others by the patient's state of consciousness. Some states don't require any permit at all, Dr. Boynes said.
The result is a hodgepodge of regulations that create challenges for dental educators trying to prepare their students to practice in any state and headaches for any dentist who wants to move a practice across state lines. "It's very convoluted," Dr. Boynes said. "If you're trying to train someone, what standard do you pick?"
More training demanded
Despite the conflicting paths of different states, some broad trends have emerged, said Dr. Boynes, who has published an overview of state regulations and is working on an article identifying changes. In general, states are requiring more training. Specifically:
In 2004, states required a mean of 50 hours training for a conscious sedation permit and 1.02 years of advanced education for a general anesthesia permit, Dr. Boynes found. By contrast, in 2008, states required a mean of 60 hours for a conscious sedation permit and 1.98 years for a general anesthesia permit, he said. Since 2004, the number of dental boards requiring advanced cardiac life support certification for permit status increased from 10 states to 38 (as of 2008). Likewise, the number of dental boards requiring office inspections for anesthesia permit applicants increased from eight in 2004 to 49 in 2008. The number of boards requiring continuing education for anesthesia permit renewal increased from two in 2004 to 21 in 2008. The number of states requiring permits for oral conscious sedation increased from four in 2004 to 24 in 2008, but the average number of hours of training for these permits declined from 38.3 in 2005 to 27.3 in 2008.
Perhaps because of the increased requirements, the number of permit holders for the various categories of anesthesia and sedation decreased from 14,649 in 2004 to 10,068 in 2006. But the number increased again to 11,974 in 2008, possibly because more courses became available.
A contentious process
The experience of Colorado illustrates how requirements can end up so different from state to state. In Colorado, the Board of Dental Examiners this year proposed regulations that would have required dentists to get 60 hours training if they wanted to practice "minimal sedation."
After undergoing fierce criticism from some local dentists and a prominent blogger, the board is now proposing 16 hours of training, in line with the ADA's guidelines. The public has until today (September 30) to comment in writing on the new proposal. A public hearing will take place October 21.
"We're just waiting to see how things are going to unfold at that rulemaking hearing," said Maulid Miskell, the board's program director.
The new proposed rules would change the categories of sedation and anesthesia. Under the current system, different standards of training apply depending on whether the dentist uses general anesthesia and/or deep sedation, parenteral conscious sedation, or enteral conscious sedation. How much training was required for each of these types of sedation was unclear, which was one reason for revising the rules, according to Miskell.
More in line with the ADA guidelines, the new categories are local anesthesia, analgesia, anxiolysis (which licensed dentists can use without additional training); minimal sedation (for which 16 hours training are required); moderate sedation (for which 60 hours are required); deep sedation, and general anesthesia (for both of which an accredited residency or ADA-approved postdoctoral training program is required).
Deaths in Illinois
Meanwhile, Illinois dentists wishing to moderately or deeply sedate their patients would have to get more training than previously required -- and so would their staff -- in proposed regulations published last week by the Illinois Division of Professional Regulation.
The changes were prompted by the sedation deaths of two Chicago patients, a 5-year-old girl in 2006 and a 46-year-old school principal in 2007.
"The rules we filed aim to prevent the tragic outcomes that occurred in recent years," said Brent Adams, acting secretary of financial and professional regulation, in a news release. "We want to make sure dentists, dental hygienists, and dental assistants understand what is required of them during dental care."
The regulations would attempt to spell out more exactly what dentists must do, said Dave Marsh, director of government relations for the Illinois Dental Society. "They have taken out the subjectivity," he said.
But most dentists are already doing what the regulations would require. "This rule may be a little overkill, trying to deal with every possible scenario," he said. And dentists would be able to continue practicing what their current permits allow.
Like Colorado, Illinois is proposing to change the sedation categories. But Illinois is using only three categories: minimal, moderate, and deep (which also includes general anesthesia).
The new regulations would not affect dentists who practice minimal sedation, formerly called anxiolysis, in which patients take a mild tranquilizer such as Valium. But dentists applying for permits to practice moderate sedation (formerly called conscious sedation, with "altered consciousness; signs of sleep") would have to get 75 hours of training, up from 60 in the current regulations. The training would have to include advanced airway management, a more demanding course than the cardiopulmonary resuscitation in the current regulations.
During minimal sedation, the regulations also require the presence in the treatment room of two other staff members, who could either be dental assistants or dental hygienists. Dentists, hygienists, and assistants working on this level of sedation would have to be certified in basic life support for healthcare providers or an equivalent course. And they would have to get nine hours of anesthesia continuing education per renewal cycle, plus a current advanced cardiac life support or pediatric advanced life support certificate.
The dentists would also have to have specific equipment, including a defibrillator, emergency backup suction equipment, a laryngoscope, and an advanced airway device to isolate the trachea and facilitate positive pressure oxygen administration.
Dentists wanting to practice deep sedation in Illinois would have to meet requirements similar to those in the proposed Colorado rules.
The comment period for the Illinois regulations began September 24 and continues for 45 days. The Joint Committee on Administrative Rules then has another 45 days to make changes, after which time the rules go into effect.
A better way?
Since states aren't rushing to adopt the ADA guidelines -- or any other national standard -- Dr. Boynes recommends another option: a new sedation specialty. "Dentists should be able to perform anxiolysis," he said. "But once you get to moderate, that's where the specialty should come in."
He would grandfather current permit holders into the specialty so that a corps of licensed practitioners could train the next generation. But anyone else who wanted to administer more than nitrous or a single dose of oral sedation would have to pass board exams. "You could have uniform training programs," Dr. Boynes said.
But don't expect that to happen tomorrow.
Copyright © 2009 DrBicuspid.com
Related Reading Dentists' licenses suspended in sedation death Chicago dentists settle out of court in sedation death Maine dental board challenges oral sedation safety Critics blast proposed Colorado sedation rules AAOMS: Only trained practitioners should administer anesthesia
Last Updated lh 9/30/2009 12:42:21 PM
FORUM COMMENTS
5 comments so far ...
10/6/2009 8:05:00 AM
Stefan |
University of Toronto has already implemented a dental anaesthesia specialty 2 years ago. Its a 3 year program and currently only accepts 2 or 3 candidates per year. More info:
http://www.utoronto.ca/dentistry/academic/graduate/AnaesthesiaIntro.html
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10/6/2009 1:48:52 PM
Laird Harrison |
Thanks for this information. Dr. Boynes was suggesting that an anesthesia dental specialty be recognized by the American Dental Association.
Laird Harrison
Senior Editor
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10/7/2009 6:27:56 PM
rootdoc57 |
Maybe we should train undergraduates in basic anesthesia techniques. After all we developed anesthesia techniques and we have lost control of our own destiny. |
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12/5/2009 7:24:54 PM
DMLDDSPA |
AAOMS has traditionally been opposed to the creation of a dental anesthesiology specialty FWIW. I believe there was an attempt back in the 90's but it was squashed. I personally think a dental anesthesia specialty would be a good idea.
DML
quote:
ORIGINAL: Laird Harrison
Thanks for this information. Dr. Boynes was suggesting that an anesthesia dental specialty be recognized by the American Dental Association.
Laird Harrison
Senior Editor
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12/5/2009 8:24:22 PM
sioux |
Thank you for this article. It certainly supports my assertions that there are no set rules on this practice - as well as the fact that the only real concern is shown over deaths in the chair. Imagine how many victims are experiencing the psychological effects of these drug/chemical combinations, symptoms that remain unreported, because no one is owning up to the drug's known side effects, much less checking for them 1-4 weeks after the appointment. If you could see the change in my daughter, you'd know that there is a thing as bad as death, and that is to lose one's mind in one's prime.
One other note, my dental board has pretty much adopted ADA guidelines .75 mg limit, and DOCS training- .75 limit, and at the same time, says not to exceed the MRD - .5 limit -- go figure. Then the chief officer tells me that these are just "guidelines" - that a dentist can use his "professional judgement." Ok, I say, then can she use her professional judgement as to whether or not to get licensed, because that's on the rules list as well. you see what I mean about the so-called "laws" governing this practice.
This is my last post. I have a daughter to care for and have to find a way to keep from losing my house after having to give up my job and my retirement fund to care for her -- after she was dosed with what Goodchild and Donaldson wrote was appropriate in some case - 1 mg. So, I can see how these venerable scientists might have influenced the "professional judgment" of the fool who poisoned my daughter, becaue he apparently could not read the drug label himself.
Don't any of you practicing oral sedation or promoting it through "scientific" journals ever kid yourself for one damned minute into thinking triazolam is safe.
Now, more discussion as to how the drug came to be perceived that way in the first place:
Excerpts/info from the paper I rec'd today. Everything that Upjohn did in the 80s and 90s, Pharmacia is doing today, just covertly, using the same methods, brainwashing just about everybody.
The info is supportive of my theories about distortions presented and repeated often by a group of so-called scientists promoting the off-label use of triazolam as a dental sedative, basically ignoring the drug’s most serious side effects and it’s history of questionable ethics – which Goodchild & Donaldson characterize as “colorful” in their “Hallucinations and Delirium in the Dental Office Following Triazolam Administration.” Anesth Prog. 2005 Spring; 52(1): 17–20. (there ya go Leslie, in case you wanna read it.)
I had wrtten Berger for this info and just received it today. It is written by a former public relations manager for Upjohn (the original manufacturer, now merged with Pharmacia & Monsanto), Bruce K. Berger, titled: “The Halcion Affair: Public Relations and the Construction of Ideological World View.”
Berger prefaces his example of how Upjohn dealt with the “crisis” over serious concerns, beginning in 1979, about the safety of its prize product, Halcion, one the company had had high hopes for pulling it out of years of “modest” yield, with a discussion about the character of organizational public relations, ie ideology, and the three aspects of ideology. He identifies these three as “distortion, legitimation, and terrain of struggle.”
Beginning with distortion (my favorite), Berger explains it has its roots with Marx, who “…saw classes producing ideologies (i.e., self-interested and thereby partial images or representations of the world and of particular politcial, social, religious, and aesthetic belief, attitudes, and opinions). The image Marx used was camera obscura (Kamenka, 1983), an inverted image, which produced a distorted or disguised view of reality, or false consciousness, which was grounded in the appearance of things so that it was perceived to be natural, inevitable, and necessary….” Just like the use of triazolam as a dental sedative, right?
Berger explains that even though the idea of “…a dominant ideology linked to class is not widely accepted today, ideology as masked power and a producer of distortion, and the subsequent acceptance of distorted perspective by others as reality or meaningfulness, continues to be relevant….- playing out “…in a scientific-technocratic ‘background ideology’ … that takes on a legitimizing power, veils practical problems, and distorts the communication process.” Isn’t it great to have an academic definition of bullshit?
Now don’t forget, all of this is a preface to how Upjohn responded to reports of serious side effects to triazolam.
Berger goes on: “Althusser (1990) called ideology the ‘beautiful lie,’ which distorts in two ways: ‘It works on the consciousness of the exploited to make them accept their condition as “natural”; it also works on the consciousness of members of the dominant class to allow them to exercise their exploitation and domination as “natural” (p.28).”
It’s kinda like the Lucifer Effect, isn’t it?
Berger elaborates, explaining that “Distortion occurs ‘primarily in the way in which ideology inhibits examinations of reality’….by veiling contradictions or excluding them from discussion, covering up self-interests, and creating a consensus of how the world is.”
Going on to the second aspect of ideology, as Berger describes it, “…legitimation, entails a process of establishing justification and noncoercive consent for existing authority”…and does it by “…bridging the gap between authorities’ claims to legitimacy and individuals’ beliefs in such legitimacy.”
Berger’s third aspect, terrain of struggle, is a little harder for me to explain. He explains it, basically, as how world view is ever-changing, subject to “competing definitions,” and that terrain of struggle “denotes places or sites of contest,” over which the mass media has powerful and growing control. “The mass media also administer the public sphere…, which results in distortion of the legitimation process itself, so that ‘legitimations consist of interpretations, of narrative presentations or… of systematized explanations and chains of arguments’…rather than critical debate, reflection, and examination.”
Next Berger explains how all of these concepts related to how Upjohn handled its crisis – (apparently not caring about the crises it caused a large number of innocent, unsuspecting human beings- my opinion, not Berger’s)
Once Cees Van Der Kroef (the Dutch scientist who reported his observations of frequent and serious side effects in his patients taking Halcion), notified Upjohn and Dutch health authorities of his concerns, Berger explains that he then took them to the Dutch media (though Duke explained that the media got a hold of his draft inadvertantly). And the media coverage that followed ended with Dutch authorities suspending Halcion.( John Abrahams elaborates, explaining that the Dutch first asked Upjohn to lower the dose, and only after Upjohn refused, did the Dutch suspend the drug.)
Anyway, Upjohn responded with, according to Berger, “An intensive and comprehensive organization public relations program…to construct a favorable, scientific world view for the product.”
Fair enough, but then Berger goes on to describe the nature of that program, explaining that “’Winning the Halcion war’ became a high priority for the company because the CNS drugs were then projected to contribute $300 to $400 million dollars in annual sales during the decade.”
So Upjohn developed its “company-constructed world view, which subsequently would anchor and frame all Halcion-related communications (e.g., news releases, advertisements, medical and governmental presentations, and interviews)” – summarized as follows:
“Halcion is a safe and highly effective prescription medication when properly
prescribed and administered. It possesses significant advantages over alternative
therapies in treating serious medical conditions, as proven in comprehensive
clinical trials conducted by leading physicians and involving thousands of patients in countries worldwide.”
Geez, that has a familiar ring to it.
Berger goes on to explain that this was the story Upjohn stuck to as time went on and as the drug’s safety and Upjohn’s license were “contested in several dozen countries.” This story was “respresented consistently and persistently by company personnel and various ‘experts’ in thousands of print and electronic media interviews, numerous meetings with health regulatory officials in various countries, public and private conferences with researchers and physicians, discussions and briefing sessions with hospital pharmacy and formulary personnel, sales calls with physicians and pharmacists, speeches to community and consumer groups, briefings with financial analysts, and in the company’s own ongoing employee and shareholder communications. At each of these sites, this core Halcion posisiton was repeated, elaborated, and articulated in a manner deemed most appropriate for the relevant others at the site.”
Berger details the specific tactics used, such as:
“Swift response to all ‘negative’ news stories…,” pointing out “journalistic ‘inaccuracies…,” and attempting to “deaden interest in an ‘old’ story.”
“One-on-one briefings with ‘hostile’ journalists,” hooking them up with “third-party ‘experts’ or ‘leading’ science writers to gain ‘fuller’ understanding.”
“Rigorous media training of company CNS researchers, conducted by former television network experts, to prepare researchers for media interviews. Researchers were taught how to ‘bridge’ from questions that might be raised to so-called ‘safe islands’ (i.e., key messages in the company position so that the Upjohn content of interviews was invariably a litany of key messages). As the crisis deepened, similar media training was provided to third-party experts who were believed capable of conveying the company’s position with greater credibility.”
“The sales force was armed regularly with documents,” ( “documents that positioned recent positive stories or health regulatory developments as ‘news’”) “for dissemination to physicians, pharmacists, and researchers to demonstrate a long trail of support of the company’s position and the safety of the product.”
Berger apparently didn’t have the details that John Abraham later exposed about the “staging “ of the “private seminar involving a dozen international CNS experts,” brought in to review the data on Halcion in New York in response to the reaction in the Netherlands. Berger didn’t mention that one of those experts who subsequently “pronounced Halcion a safe and effective product when properly prescribed and administered” said later he would not have signed the letter to that effect (that was thereafter published in the Lancet) if he had known facts that Upjohn had failed to disclose. Berger does however reveal something that Abraham left out, or didn’t know. “The company provided handsome honoria” to these “experts.”
After that seminar, Upjohn staged yet another, and much larger conference in Europe, with physicians, CNS experts, and “several dozen ‘leading’ science writers. Again, Halcion was ‘favorably’ review by the experts, some of whom were conducting ongoing research for the company or had conducted clinical trials with Halcion. Scientific documents produced out of this meeting by organizational public relations personnel were used for years with science writers, journalists, physicians, pharmacists, researchers, and government authorities to document and support the company’s position.”
Portraying attacks by scientists like van der Kroef, (and certainly Oswald, whom Berger does not mention) and by the media as “unfair” and the scientists’ reputations as “questionable,” Upjohn portrayed itself as a victim of vicousness, determined to “…use every means to defend its product and its century-old reputation.”
Not only did Upjohn NOT discontinue this dangerous drug, whose safety it was misrepresenting all over the world, it added yet another dangerous drug to the market, Xanax. Berger explains that Xanax, “because of its close relation to Halcion…, also drew criticism from media, medical, and regulatory representatives. Thus, the education plan broadened the Halcion position and supported activities to inclued wide distribution of multilingual consumer pamphlets, entitled The Turth About Tranquilizers; a series of physician bylined discussion papers for use with journalists; a cassette series, targeted to radio stations and containing prerecorded 2-min interviews with medical experts on pivotal benzodiazepine issues; and a revitalized spokesperson program, involving media training for additional scientists and researchers and aggressive placement of these experts in radio and television interviews.”
“These actual public relations practices and processes provide various points of entry for discussion of distortion, legitimation, and terrain of struggle, “ says Berger. “Considering distortion first, the official company position played a critical framing and limiting role: It outlined the company’s interpretation and perspective of the Halcion affair and demarcated what was important and what was not, and what was and was not true, for audiences both outside and inside the company.” And it used any criticisms to rally employees together for the cause. “Those individuals who in some manner successfully defended or advanced the positon often were recognized or rewarded; some who were less successful, or less supportive of the consensus, experienced reassignment or other disincentives.”
“The aspect of legitimation in constructions of world view also is strikingly evident in Upjohn’s public relations practices as demonstrated in the company’s preoccupation with naturalizing its poisiton through the building of coalitions with leading science writers, the staging of conferences with medical experts, the ongoing production of supportive medical and scientific documents, and the persistent discrediting of Van Der Kroef and the ‘misleading’ and ‘sensational’ news coverage of the ‘false’ dangers of Halcion.”
I have to say, Leslie, you and others have been very well trained in your roles.
Despite all the efforts to prevent it, Halcion was suddenly and unexpectedly suspended for use in The Netherlands, which prompted Upjohn to react with a resolve to fight the “Halcion war” on two fronts: “in the media and in the offices of regulatory decision makers.”
“The legitimation authority in each” front, explained Berger, “was considered to be ‘science.’ In the broadest sense, the scientific, technical approach itself may often serve as the legitmating authority in developed, Western nations (Habermas, 1992c). However, science operated at four very specific levels in the Halcion affair.” Upjohn, Berger continues, used the results of its tests to decide to go to market, and also used them as the “scientific documentation for review and approval by appropriate medical and regulatory experts in each country. In turn, these research and test results, as well as the proclamations and opinions of medical and scientific experts, then formed the basis for the Halcion position and subsequent ongoing communication with journalists, medical writers, and health authorities. Finally, the strength of Upjohn’s science, in combinations with the regulatory decisions of national health authorities, provided the framework within which individual patients and their physicians discussed sleep disorders and ultimately selected an appropriated medication. At each level of decision making—company, national health ministry, media editorial, and individual patient or physician-the authority of science played a pivotal role.”
Though he implies it, Berger, for some reason, never points out the extent to which Upjohn’s premarketing tests were flawed from the get-go (as Abraham documents very well), leaving this multi-billion-dollar marketing machine based on these trials itself flawed, if for no other reason.
“Thus, “ Berger goes on, “Upjohn’s position and public relations practices called attention to the weight, significance, and overwhelming safety record of its extensive patient clinical trials, as well as the positive attestations of recognized CNS experts and leading science writers.” (Kinda like the equivalent of Berthold, Dionne, Silverman, Donaldson, Goodchild, and others on the Oral Sedation scene.) “Against this broad international alliance of scientific experts and data, the allegations of a single Dutch physician and the ‘media-driven’ reactions of a few ‘pressured’ authorities, portrayed as politically motivated actors, were characterized consistently as scientifically insignificant and even disinformative. In fact, public relations personnnel categorized and repackaged adverse publicity about the drug and fed it back to media personnel, claiming it provided a disservice to their readers: Rather than ‘helping’ their readers, the publicity was harmful and frightening to those patients who most needed Halcion.”
Much like those poor dental phobics who just couldn’t get along without it now – isn’t it? Give me a break!
To know more about the “terrain of struggle issue” and the entire article itself, please contact Bruce Berger at the College of Communications and Information Studies, The University of Kentucky.
This information is taken from his paper titled: “The Halcion Affair: Public Relations and the Construction of Ideological World View,” found in Journal of Public Relations Research, 11(3), 185-203.
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