Topical and systemic ototoxicity: medicolegal considerations.
We are all well aware of the consequences of the ever-escalating number of lawsuits and the disproportionately large awards to some plaintiffs--the rising costs of liability insurance, the reluctance of some specialists to continue performing high-risk procedures, etc.
Not all lawsuits are frivolous, of course. Some have great merit, but they are the exception.
In order for a lawsuit to stand, the plaintiff must demonstrate that the standard of care has not been met because of a breach of duty by a physician that resulted in an injury to the plaintiff or a failure to disclose information and obtain informed consent.
I disagree with the notion that it takes a lawsuit to change our behavior. There is no insurmountable reason why we can't take the initiative to prevent lawsuits. The keys are educating all staff personnel, establishing safety protocols, and setting up a quality assurance department. As you know, physicians can be liable for the actions of other staff. For example, how many physicians prep patients for ear surgery? How many physicians are even in the room when the nurse preps a patient? So it is imperative that we have established protocols for all operating room personnel, as well as for those involved in postoperative care, particularly floor nurses, audiologists, and pharmacists. These protocols must cover the use of all potentially ototoxic drugs.
While obtaining informed consent, the physician must explain all the risks of a particular procedure and the alternative treatments. We must disclose all the possible vestibulotoxic and ototoxic effects of any medication we use. If a patient is unable to provide informed consent, we should involve a responsible family member in choosing from among the options. It is easy to forget to do this.
I began practicing in 1991. At that time, my philosophy was, "Practice medicine for the sake of medicine and not for the sake of the lawyers." I felt that if I did a good job, that would be enough and I would be protected. By 2000, I felt the need to think a bit differently, and my philosophy became, "Practice medicine for the sake of medicine and be cognizant of the lawyers." Now, in 2006, my advice is, "Practice medicine for the sake of medicine, but do not be a fool; always think of the lawyers."
Dr. Ramzi T. Younis: I wish to add a comment about the importance of documentation. We can be susceptible to liability if we are relying on evidence that we don't have. If something is not written down, does it actually exist? I would not want to take such a chance.
Also, I advise physicians to remember the four Cs: communication, caring, clarification, and commitment. Communication is first on the list. The importance of communication with patients seems obvious, but how often do we let it slip? A failure to communicate well can ruin a perfect surgery. A common complaint in many lawsuits is that following surgery, the physician was arrogant, inattentive, unapproachable, or absent. It is not enough to just dash off a prescription. It is important to keep our patients close to us, especially if there is a chance of a postoperative complication.
It is also important to communicate with staff and keep them informed and in the loop. We should not give our own staff any reason to speak against us in a lawsuit.
The dynamics of medicolegal proceedings
Dr. Billy Giles: Working with our Joint Underwriters Association and their attorneys, I have found it very difficult to find information on the details of malpractice cases. The information is not accessible with the popular Internet search engines. It is available via private search engines, but they are expensive to access and the information is incomplete.
There are groups of personal injury lawyers that specialize in "gentamicin poisoning" cases. Two other groups in this country specialize in malpractice cases involving neomycin. If a patient sees a local attorney complaining that gentamicin caused a hearing loss, the local attorney will contact the lawyers who specialize in gentamicin cases, and they will provide assistance for a percentage of the fee. They will even supply the expert witness. This is what we're up against.
Another problem is that accused physicians are not always judged by a jury of our peers. The defense attorney wants as many educated people as possible on the jury, and the plaintiff's attorney wants uneducated people. The plaintiff's attorney automatically dismisses the most educated men--automatically. Defense attorneys also have the right to issue peremptory challenges, of course, but it's difficult to place highly intelligent people on such a jury. Jury selection experts know what kind of socioeconomic, demographic, and racial/ethnic makeup they want. It can be nasty business, and many physicians have become very cynical.
At any rate, a defendant is going to have a very hard time with a jury, uneducated or not, when the plaintiff's attorney says, "Now let me get this straight. You knew that this drug was bad for the ears, and you put it in there anyway. Isn't that right? Isn't that right?"
The exact number of these gentamicin and neomycin cases is impossible to determine--for example, suits that are settled out of court don't always become part of the public record--but I suspect these cases are more prevalent than we think they are.
If you lose such a case, I am fairly sure you will not use an ototoxic drug again. You will switch to a quinolone once and for all. But why wait? Even if you have never heard of someone losing such a case, it does not make sense to use an aminoglycoside in an open eardrum.
Dr. Ann Edmunds: That's right. If you use the safest drug available, liability becomes a nonissue.
Methods of educating staff
Dr. Ian Witterick: How many times have we as teachers been confronted with a situation in which we were not sure what to do? How many times have we flown by the seat of our pants, usually doing to our learners what our old teachers did to us? I direct continuing medical education (CME) programs, and I know how useful it is to be able to turn to a set of guiding principles based on evidence--or at least on successful long-term experience.
Adult learning theorist Malcolm Knowles came up with various theories on the art and science of helping adults learn. (2) His program is based on five assumptions:
* Adults are independent and self-directing.
* They have accumulated a great deal of experience.
* They value learning that integrates with the demands of everyday life.
* They are more interested in immediate problem-centered approaches to learning than in general-subject-centered approaches. For example, they would rather learn the specifics of how to deal with an individual case of tube otorrhea than listen to a general discussion of tubes.
* They are motivated to learn by internal drives more than by external ones.
If we can establish an effective learning climate, learners will feel safe and comfortable expressing themselves, and they will become actively involved in the planning of what they will learn and how they will learn it. In short, learners diagnose their own problem and prescribe their own treatment.
Dr. Witterick: How long does it take for a major breakthrough in medicine, documented by several level I randomized clinical trials, to make its way into everyday clinical practice? The best way to express this is to look at the case of the anticoagulant streptokinase. In 1982, administration of streptokinase was shown to improve survival in patients undergoing an acute myocardial infarction. (3) However, it took more than 10 years before streptokinase infusion became routinely accepted therapy. (4) Think about that. A therapy that was shown to save lives with level I evidence still took more than a decade to become standard practice.
Ranking the different education strategies
Dr. Witterick: As physicians and teachers, we have moral and ethical obligations to our residents, our fellows, and to practicing otolaryngologists in the community and in academia. With respect to something like the proper use of ototopical medications, we have educational obligations to family physicians, pediatricians and, of course, to our patients and the public in general. But how do we do this? How do we persuade others to come around to our way of thinking? How do we bend the tree?
We have evidence to evaluate different methods of educating healthcare personnel and the public. Meta-analyses have been conducted on the effectiveness of CME lectures and workshops, talks by local opinion leaders, practice guidelines, personal visits to healthcare providers (educational outreach visits), and mass media interventions.
CME lectures and workshops. Thomson O'Brien et al analyzed the results of 32 randomized trials or quasi-experimental studies (N = 2,995) of the effect that CME meetings have on clinical practice and healthcare outcomes. (5) The authors found that didactic lectures alone were unlikely to have any significant impact on practice. Interactive workshops, with or without didactic lectures, were a significantly more effective method of education, and they had a moderate to moderately large impact on clinical practice.
Local opinion leaders. The same researchers examined 8 randomized trials involving approximately 300 healthcare professionals responsible for patient care. (6) Local opinion leaders were designated as such by their colleagues as educationally influential. According to the meta-analysis, the value of using these leaders to disseminate information and influence clinical practice was mixed, and no conclusions could be drawn. The large number of variables made this a difficult issue to study.
Practice guidelines. Graham et al examined the Canadian Medical Association's database of practice guidelines developed or endorsed by Canadian organizations. (7) They then mailed questionnaires to the developers of all guidelines that had been entered into the database between June 1996 and December 1999. Data were received on 730 unique guidelines developed by 75 organizations. These data revealed that the most common methods of disseminating the guidelines were direct mailings to the issuing organization's members (80% of all guidelines), publishing guidelines in journals or newsletters (76%), and direct mailing to persons other than the organization's members (73%). Other methods included electronic dissemination (62%) and CME and other educational activities (50%). Information on 47% of guidelines was disseminated to patients and other members of the public.
It is interesting, and perhaps surprising, that only 5% of these guidelines have undergone any evaluation to determine what impact they have on health outcomes. Clearly, that rate must improve.
Unfortunately, family physicians say they are inundated with clinical practice guidelines, and I don't believe that they or pediatricians are likely to pay much attention to the American Academy of Otolaryngology-Head and Neck Surgery's guidelines on ototopical drug therapy.
Educational outreach visits. This type of educational effort includes visits to physicians' offices by pharmaceutical sales representatives (detailing) and by others interested in promoting healthy behavior (e.g., smoking cessation counselors). An analysis of 18 studies of approximately 1,900 physicians revealed that these visits do have a positive effect on medical practice, particularly prescribing patterns. (8) However, the cost-effectiveness of these visits has not been well studied.
Mass media interventions. Grilli et al examined 15 studies of mass media promotional campaigns and 5 studies of straight news coverage of health issues. (9) Unfortunately, the methodology of most of these studies was poor, and the results might have been skewed by publication bias. Nevertheless, all but one of these studies showed that using the mass media was an effective way of disseminating healthcare information.
Prof. Michael Hawke: Three times, Dr. Rutka and I have sent out warning notices to every surgeon in Canada to inform them about the risk of using certain antiseptics as a prepping agent prior to ear surgery, but I don't believe they paid any attention.
Dr. Harvey Coates: In the late 1970s, an Aboriginal child was undergoing a bilateral myringoplasty in our hospital. He was prepped with chlorhexidine, and he became profoundly deaf in both ears. That unfortunate circumstance really got the message across throughout Australia.
Dr. David W. Proops: What we are up against is cognitive dissonance. We surgeons are particularly prone to it. We hold onto our dear beliefs. In the United Kingdom over the past decade, they've been trying to conquer cognitive dissonance by having surgeons attend regular audits. But these audits have totally failed. The audits are delivered by the residents, but the good old boys refuse to believe them, and they make all sorts of rationalizations to discount what they've just been told. I don't know what we can do about this. I think it's just the nature of the type A male surgeon, but in the United Kingdom today, 60% of all new medical graduates are women, so I wonder if this will change the way physicians will communicate and accept new ideas in the future.
(1.) Gergen D. America's legal mess. U.S. News and World Report Aug. 19, 1991:72.
(2.) Knowles MS. The Modern Practice of Adult Education: From Pedagogy to Andragogy. Chicago: Follett Publishing, 1980.
(3.) Stampfer MJ, Goldhaber SZ, Yusuf S, et al. Effect of intravenous streptokinase on acute myocardial infarction: Pooled results from randomized trials. N Engl J Med 1982;307:1180-2.
(4.) Ryan TJ, Anderson JL, Antman EM, et al. ACC/AHA guidelines for the management of patients with acute myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). J Am Coll Cardiol 1996;28:1328-1428.
(5.) Thomson O'Brien MA, Freemantle N, Oxman AD, et al. Continuing education meetings and workshops: Effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2001;(2): CD003030.
(6.) Thomson O'Brien MA, Oxman AD, Haynes RB, et al. Local opinion leaders: Effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2000;(2):CD000125.
(7.) Graham ID, Beardall S, Carter AO, et al. The state of the science and art of practice guidelines development, dissemination and evaluation in Canada. J Eval Clio Pract 2003;9:195-202.
(8.) Thomson O'Brien MA, Oxman AD, Davis DA, et al. Educational outreach visits: Effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2000;(2):CD000409.
(9.) Grilli R, Ramsay C, Minozzi S. Mass media interventions: Effects on health services utilisation. Cochrane Database Syst Rev 2002;(1): CD000389.
Panel discussion based on presentations by Zorik Spektor, MD, FAAP; Billy Giles, MD; and Ian Witterick, MD
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|Publication:||Ear, Nose and Throat Journal|
|Date:||Oct 1, 2006|
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