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Off Label Use of Meds:
Is the EP Liable for IV Haldol? 
 
 
A 68-year-old male was brought to the emergency department several times over the past month after being found intoxicated in public. On one occasion, he was found sleeping in the bathroom at a restaurant. On another occasion he was sleeping in the ATM lobby of a bank. On a third occasion, he was trying to break into a neighbor's home, believing it was his own home.

On each visit to the ED, the patient became impatient, then tried to leave the hospital. He was then escorted back to his room and became violent. On his second ED visit, he swung at a nurse and told her that if she touched him, he would "knock her block off." The patient required restraints on each of his previous visits. He struggled in the physical restraints and was therefore given intravenous haloperidol and lorazepam for chemical sedation. By the morning, the patient was relatively calm and was discharged with his son-in-law.

On his fourth visit for drunkenness with an alcohol level of 398, the patient once again tried to stumble out of the emergency department. The security guard and physician escorted the patient to bed while he yelled loudly. He then pushed the security guard, was placed in physical restraints and was then given intravenous haloperidol and lorazepam. Roughly 15 minutes later, the patient stopped breathing. ACLS was performed and when the patient was attached to the monitor, he was found to be in torsades de pointes. He received cardioversion and a normal rhythm was restored. He was admitted to the intensive care unit.

The following day, the patient woke with facial spasms which were thought to be a stroke caused by the patient's arrhythmia. Eventually, these spasms were diagnosed as tardive dyskinesia and persisted for several months after his discharge.

The patient's family consults an attorney who filed suit against the emergency physician for giving Haldol intravenously, which is a route unapproved by the FDA. Such "off label" use of Haldol was alleged to have caused both the patient's arrhythmia and the patient's dyskinesia. The plaintiff's pharmacology expert stated that the patient's age and alcohol abuse increased the possibility that the patient would have an adverse event when given intravenous Haldol, and that, to a reasonable degree of medical certainty, the patient's tardive dyskinesia will last for the rest of his life.
 
Did the emergency physician's actions meet the standard of care?
Should the emergency physician be liable for the patient's injuries?
 
 

Comments   

# ED physicianTom Richardson 2008-05-16 20:02
Don't ever do anything if you can't defend it---but this you can. While an "off label" use of haldol, never the less, it is a known and well described in literature dosing form. If you are having trouble with this kind of patient in this manner, you are trying to protect both him and staff. That being said, a patient this intoxicated you have to also go at a little "gently."--mixi ng drugs with alcohol can certainly cause respiratory depression if we give them or a patient gives them The arrythmia can happen IM or IV--which is what I would argue, as can the EPS he presented with, and I am not aware of any articles stating the incidence to be higher with IV dosing.
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# questionJim Rosenthal 2008-05-16 20:18
In the writeup of the case, you didn't specify doses. Were the two drugs given in similar doses to the prior events, or was the dose increased?

The usual reason for dosing drugs IV as opposed to IM is for quicker onset of action, better control of effect and side effects; also the presence of an IV makes it easier to reverse drugs, at least the ones that are reversible. I think the standard of care is well met in this instance, and that the patient would have had EPS whether he had received Haldol IV or IM. I can't see that the route of administration matters at all.

A better question might be this: if the patient was physically restrained, did he require IV restraint as well? One or the other might be more advisable. However, I still don't think that there's a violation of SOC.

I do have another comment. This writeup is similar to many I've seen in which the reader is presented a case of a bad outcome in the ED. In many of these writeups, the patient is a deliberately unsympathetic individual who suffers a bad outcome and then of course files a suit. This is possibly deceitful and biased; most med mal suits are not filed by plaintiffs who might be charitably described as unsympathetic individuals. I'll be watching this space to see how future putative plaintiffs are described by Dr. Sullivan. If they are all depicted as this fellow was, it won't reflect well on whoever is writing these cases for presentation.
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# Emergency PhysicianDan Bledsoe 2008-05-16 21:58
I do agree with Jim's points about the unsympathetic portrayal of many of the SOC patients. The patient's unpleasant mein and chronic alcoholism should not play into the primary question this column seeks to address, "Was the standard of care met?"

Of course, the patient's history may come into play during the discussion of compensatory damages for lost wages and will certainly play into the jury's sympathy factor in determining punative damages.

That said, SOC was met in my opinion. IV Haldol is part of emergency medicine practice. However, there will be many who will testify to its dangers (real or imagined). In the true alcoholic who is in mutritional jeopardy, using Haldol and other QT prolonging drugs is more dangerous due to the magnesium depletion that accompanies the nutritional depletion and diuresis of alcoholism.

I would say that it will not be in a distant future that IV Haldol will not be SOC anymore as our practice evolves to meet ISMP standards.
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# Giving patients a fair shakeEditor 2008-05-16 22:46
Thank you for the great comments so far. To address Dr. Rosenthal's concern, I would point to the previous columns in the Standard of Care section of the web site. I believe they paint patients in a fair light.
That said, we appreciate readers continuing to hold us to the highest standard. Keep it coming!
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# Emergency PhysicianCarl Kraemer MD 2008-05-17 01:19
The question of if off label use of a medication constitutes a breach of standard of care I feel the answer is no, especially not in a drug as well studied in the geriatric and alcoholic population as Haldol. There is a statement that concerns me that there may have been a breach in the standard of care. The case states "ACLS was performed and when the patient was attached to the monitor, he was found to be in torsades...". If the patient had been restrained and sedated and not monitored with a cardiac monitor and pulse ox, then the standard of care was breached as the likelihood of arrhythmia was not addressed. If the patient was on a monitor and an arrhythmia was missed then the standard of care was breached. If the patient was appropriately sedated and monitored and checked upon, then any complication is a complication from neccessary care and not a breach of the standard of care.
Reply
# monitoringJim Rosenthal 2008-05-17 01:37
I agree with Dr Kraemer. Persons who are given IV sedation which could depress respiration ought to be on a monitor and it is a good question. Was the patient in fact on a monitor?
Reply
# ED AttendingKarl Harnish 2008-05-17 02:48
SOC once removed:

Why has the ED become the police's SOC for Drunk and Disorderly ? In each of these cases, this fellow could have slept off his drunk in the jail. I am tired of the police offering drunks the choice of jail or the ED, forcing us to deal with someone who's family doesn't want to deal with, and giving us the headache of waiting until his ET-OH is low enough we can let him walk out on his own.

If we have to use any kind of restraint - physical or chemical - he's is probably "medically cleared" for jail. Do not pass go!
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# ED Attendingtom benzoni 2008-05-17 03:41
I feel Routine of Care was met, as well as Standard of Care.
Torsades is a class effect of the atypicals.
Torsades also occurs in many other circumstances, like anoxia and electrolyte disorders.
Additionally, torsades' presence or absence is notoriously difficult; I have witnessed cardiologists disagreeing among themselves over like dysrhythmias.
Presence of EPS is a common occurrence with cerebral anoxia.
All that said, I don't like benzo/alcohol combinations, either medical or in overdoses. Benzos alone are pretty safe OD's but can be deadly when mixed with other CNS depressants, like ETOH.
Conclusion: exemplary care on the part of the EP in getting tranquilizers in, cuffs off and cops out. Losing control of one's ship only adds the rescuers to the pile of those needing rescue.
Reply
# Michael Nerenberg MD 2008-05-17 07:38
Absolutely the SOC was met by the EP.
It is too bad the plaintif's so called expert can't be disciplined for his miserable testimony.
It is an unfortunate fact of life, I guess, that the ED has become the defacto drunk tank. Same at my shop. I suspect it happened do to diabetics dying in drunk tanks before the advent of glucometers. We tried to change EMS protocol to allow the medics to not bring them. The medics would, however, rather not fight with the police over this.
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# Standard of CareJeffrey Proudfoot, DO 2008-05-17 10:13
I chafe somewhat with the way "standard of care" gets tossed around by our legal brethren as if there is a SOC for every action/procedur e/medication and diagnosis that we perform, give or make. If there is a SOC to be addressed here it is---is the physician fulfilling his duty to treat the patient while taking steps to protect both the patient and his staff from the patient's intoxicated state. The methodologies available to achieve this are myriad as the number of drugs and types of restraints availble to ED physicians. Patient had the same treatment previously with no adverse effects. Each physician uses the methods he/she is most comfortable/exp erienced with that has given the best results in the past.The argument over route of administration is specious at best--it's certain that had the medication been given IM plaintiff would still file and make the same claim. Of course the patients age and substance abuse put him at increased risk for many different adverse outcomes, some foreseeable and some not.
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# R C Dobson MD FACEP 2008-05-17 15:26
I believe none of the persons responding have any business making a judgment about the standard of care given the information provided. As a physician with 25 years (and requested review of > 1000 malpractice claims against EM physicians)one of the leading causes of suits against docs is other physicians jumping to conclusions prior to reviewing ALL of the information needed to formulate a justifiable opinion. One needs to look at ALL the original records, depositions, and know (not just think one knows because one is a physician) what the literature actually says. Additionally, what a reasonable and prudent physicians would do in most instances is a range of actions, not just a single thing and one must consider (as well as be aware of the existing other schools of thought) all of those as acceptable even if it is not what one would do personally. It is amazing how often physicians think they know what a physician should do, yet when a group is actually polled they are surprised at the range of actions suggested by reasonable and prudent physicians. This type of exercise - the providing a clinical sketch and asking MDs to decide the SOC is a disservice to all. The column shouldn't be eliminated, but should state clearly every time that there isn't sufficient information to form a valid SOC. The column should ask instead for Comments about factors that should be taken into account in ultimately reaching a decision about the SOC AFTER all the information available had been reviewed.
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# S S Pearson MD BCEM 2008-05-17 19:56
Chill Randall! the SOC, like the soap opera, fulfills our need to know someone else has it worse than we do...wrong place(busy ED)..wrong time(to use a drug off-label)= BAD OUTCOME...there but for the love of God...
Reply
# MDJoseph Soler MD 2008-05-19 01:07
I believe the EP met the Standard of Care. It should also be noted that Haldol least prolongs the QT interval compared to all similar agents of its class, thus less chance of Torsades.
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# MDRicardo Machado 2008-05-20 05:37
Although there are approved IV medications that would do as good a job as or better than the use of intravenous Haldol is widespread and it safety well recognized. As long as the patient was closely monitored standard of care was met. Nonetheless, I strongly agree with Dr Harnish, if the patient is aggressive enough to require sedation to stay calm in the ER, he doesn't need the ER to begin with and should be discharged to jail.
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# MDWilliam Parker 2008-05-23 07:30
The repiratory depressant effect of Lorazepam is additive with ETOH (Haldol is likely not). For this reason, I usually avoid giving benzos to acutely intoxicated patients. Haldol, of course, may have pro-arrythmic effects... but I order it frequently.
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# SOCMario C. Villegas, MD 2008-05-24 21:07
This is a lawyer's wet dream..... damed with we do and damed if we don't. For the record, I feel that SOC was met but it dosen't matter what we think. It's what the lay person jury thinks or feels that matters. Careful about just discharging to jail, because if anything and I mean anything, goes wrong you will be liable. If you are lucky maybe not "100%" but you "should of known that it was a possiblity that whatever happens could happen and could of been prevented.... just like the last "expert" said it could of...
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# PA StudentAndrea 2008-05-29 14:26
Quick Question... I'm a PA student and in one of our classes it was mentioned that a provider should administer diphenhydramine any time Haldol is administered to decrease the possibility of extrapyramidal symptoms such as tardive dyskinesia. Would that have helped in a case such as this?
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# Mitchell Heller, M.D. 2008-06-04 16:29
In that a great many Emergency Physicians routinely administer Haldol or a Haldol/Benzo cocktail intravenously under similar circumstances, the Standard of Care is clearly met in this case.

Chemical restraint (i.e. sedation) is always a requirement in an agitated pt. Leaving an agitated pt in physical restraints without adequate sedation is a recipe for disaster.

I agree with those who comment that the sedated pt should be monitored. Certainly, a restrained pt should be under direct visual observation at all times. Pulse-ox and EKG monitoring are prudent measures as well.

I was taught (and practice) that benzos alone are a superior choice to major-tranquili zers like Haldol for intoxicated or delirious pts. The overall side effect profile for benzos is superior to and safer than drugs like Haldol. Also, it has never been clear to me why other physicians use combinations of drugs rather than adequate doses of a single agent. Nevertheless, I recognize that many others have different opinions on this and practice this way with proven safety.
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# Ron Dobson MD, FACEP 2008-06-05 03:55
For PA Andrea (Commented May 29)
I'm unaware of any peer-reviewed, statistically valid literature that says that concomitant or prophylactic use of diphenhydramine decreases the incidence of tardive dyskinesa. That said, the downside to doing so would seem small, even though it is polypharmacy.
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# No More Drunk Tankjohn, md 2008-06-12 05:08
I do believe that the reason the ED is used so much for "medical clearance" is the same reason that this case was ever filed. Liability. For the 1 in a thousand intoxicated patient that aspirates in the jail cell or took a knock to the head while being arrested and developed a subdural the government's answer has been, and still is, send them to the ER for 'medical clearance'. They have neatly made their problem, our problem, and plaintiff's attorneys have loved every minute of it.
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