Friday, September 5, 2008

Medications and Driving - Informed Consent?

The WSJ Health Blog highlighted a second case out of Massachusetts where a patient and their prescribing physicians (five of them) are being sued for a motor vehicle accident that occurred while the patient/driver was taking opioids. The reason the physicians are being sued is for negligence in education or counseling to the patient regarding driving and opioids. To my knowledge the pharmacy or pharmacists dispensing the medication are not involved in the lawsuit.

The Massachusetts Supreme Court ruled in favor of the plaintiff in a similar lawsuit against a prescribing physician in December.

Some quick details of each of the cases.

Dec 2007 Ruling
: 75 year old male with COPD and lung cancer on oxycodone, Zaroxolyn, prednisone, Flomax, potassium, Paxil, oxazepam, and furosemide. While driving his car, he killed a 10 year old boy. PCP sued successfully.

Aug 2008 Case:
77 year old female with breast cancer. Medications are not revealed at this time. Killed physician and secretary inside radiation oncology clinic with car while trying to park. 5 MD's including PCP are defendants.

Opioids are a common class of medications in the palliative care toolkit for symptom control and thus our field needs to be aware of potential legal consequences of our frequent prescription tendencies. This is particularly relevant because opioids and many other common palliative care medications can cause cognitive impairments. Cases like this make me think there will be an even greater barrier to prescribing these medications appropriately and effectively. Clinicians are already crunched for time, and to include counseling for avoidance of driving for EVERY possible medication that could cloud thinking would be an impossible task.

And there are way too many questions:

  • Where does the liability stop?
  • Is the pharmacist liable?
  • Is the weekend on-call doctor who sees the patient in the hospital while they are already on medications that may alter mental status liable, because they did not say anything?
  • How about the drug maker for not having clear warnings on the insert (that no patient reads)?
  • If we start blanket counseling does that mean I should counsel the comatose patient in the ICU on ativan and morphine drips just in case they survive and still need these medications post discharge?
  • How do we determine which drug classes to apply this to since lasix was implemented in the first case?
  • How would hospice agencies be affected?
  • What about the hospice nurse who actually sees the patient and knows they are driving as opposed to the physician who may presume the patient is home/bed bound while on hospice?
I am not saying the medical community should have no role , but what is reasonable, and what is effective in preventing horrible tragedies such as these two cases? Taking away driving privileges has always been a source for consternation in families and in the medical community and there is no simple rule or guideline to follow. Does anyone have a good journal article to help clarify the role of the medical professional in discussing driving responsibilities with patients?

10 comments:

dethmama said...

Holy moly! Another thing to worry about! And yes, this could indeed affect the prescribing of pain meds for the hospice patient.
So then what... A patient, in uncontrolled pain, crashes his car. Now we sue for under-prescribing?

PharmacistMike said...

One interesting side is the pharmacist responsibility. Precedence has been set in many cases in which the pharmacist is only responsible to follow the doctors prescription and give the patient the correct medication. One interesting case involved drug interactions, which is still left to the physician to warn the patients. One pharmacy did get sued for failing to warn of a drug interaction but that was only because they advertised to their customers that part of their service was to monitor for drug interactions. It seems that pharmacists, since not really considered practitioners, need only to follow what the doctor orders, unless they know it is going to definitely harm the patient. This is not how pharmacists practice but just how the courts judge the profession.

Christian Sinclair, MD said...

Be sure to check out the comments on the original WSJ Health Blog and Kevin MD's post. There are some interesting opinions on this out there.

Anonymous said...

My physician is VERY clear to me when he is prescribing medications about NOT driving, or if driving may be okay, he says, "Before you try your car, try dirving your bike in an empty parking lot. See how that works out for you."

Look, I think what underlies my statement is that my doctor and I have a trusting partnership at work. We have taken the time to be honest with one another. He says crappy things I don't want to hear, and I require that he be up to date on information or he knows he going to get the riot act.

Since I am the child of lawyers and judges, I have deep sympathy for his position. As a patient who is in pain or needs treatment, I have no patience whatsoever for doctors who are more interested in treating the health of their medical licences than in the health of their patients, and boy, there's a plethora of the former, and a scarcity of the latter.

And while the issue of informed consent is facinating, the issue of informed physicians is likely more the problem.

Why do I say that? Because the relationship between physician and patient is an interesting mix of art and science. A doctor who is fantastic at the science and stinks on the art of their relationship with a patient, is still getting a %50 on the overall test. And when I was in school, that was a flunking grade.

What lies at the heart of medications and driving is a basic question, is your patient telling you the absolute truth when they tell you what medications they are on? I seriously doubt it.

Between specialists, hospital visits, and dental visits, age of patient and symptom, it's far more likely than not, that you are missing at least one or more medications.

There are some things to be done. Encourage your patient to use one pharmacy, and one only.

Lean on your elected representatives and those in the statehouse to stop treating doctors as drug dealers.

Do a better job a unionizing and creating a political arm for doctors to get politics out of medicine. And I'm not talking about the AMA, folks. They are in the business of sickness, not wellness.

While this may be a palliative medicine blog, clearly meant to be for and by doctors, let me tell you as a lay person, there is a voice missing from your blog. And that voice is something along the lines of , "How are our patients experiencing their palliative treatments, and, if they are lucky, their options for treatment?"

I can answer that for you. It sucks out here. Patients are dizzy from all of the buck passing, the families are in despair from trying to ease the suffering of a loved one, and all of them feel that doctors have a different agenda than patient treatment.

Bottom line: Pain is the number one complaint for which people see doctors. And you people suck at managing the one complaint with which you are faced. Imagine this success rate applied to any other profession. You'd be on food stamps.

You want feedback. You got it.

This blog is the closest I have seen to a group of physicians understanding that there's a real problem out there. But where are the rest of the members of your profession?

oh, right, they are busy tending to their medical licenses and hiding from state and federal authorities instead of telling them all to go screw themselves.

I wonder what would happen if the AMA, as a group, took on the government, which thinks they know how to treat patients better than doctors.

Until that day, it's hard to see the situation as anything other than it is: sad for patients, and a pathetic reflection of the medical profession.

Oh, and for every story of mine, there are literally thousands of others out there with stories. And those stories are far, far more heart wrenching than mine.

Give that some thought.

Anonymous said...

To the previous poster,
It is interesting that for someone who accuses an entire profession of "hiding" and the like, you chose to represent yourself as anonymous. As a child of lawyers and judges, you should know that the problem of undertreated pain and suffering is much larger than just the medical profession. Why not call up your elected official and ask them what they are doing about tort reform? That would be more productive than ranting on a blog. Or how about collaborating with some of the "thousands of others" you described to form a patient advocacy group in support of physicians who do a good job. Because, guess what, most of us physicians are too busy and dedicated to our patients to worry about organizing, to the point of neglecting our own health and families. As a palliative care doc, I will put my license on the line and risk financial ruin for the patients who I know need my care; unfortunately, there are many more others who would abuse such compassion for their own interests. As you pointed out, the doctor-patient relationship depends on a modicum of truthfulness. It is good that you have a trusting relationship with your physician; maybe the best thing you can do is to show up when it is your doctor's day in court.

Anonymous said...

To the previous poster who responded to me.

Interesting that you think all I have done to solve this problem is rant on a blog. I've been working as an activist for nearly 20 years to get healthcare reform.

Of course tort reform is a part of the healthcare reform issue, and the link between the two is demonstrable in stories such as the informed consent one.

As far as contacting my representatives, I call one (or more) of my representatives every single day. Every. Single. Day. Today's call was to Harry Reid asking why the hell they aren't scheduling a vote on S-CHIP before the election. I began a program called Five Minutes a Day for Democracy to teach civics and activism and increase public participation in our democracy. I teach organizing to citizens who want to do more than just bitch on a blog.

But I'd like to point out that your response to my criticism was just one more form of killing the messenger, and you seemed to miss this part of my post:

This blog is the closest I have seen to a group of physicians understanding that there's a real problem out there. But where are the rest of the members of your profession?

You are already a palliative physician, but where's the outrage from your profession as a whole?

I'm supposed to organize a support group for doctors who are competent? For crying out loud, you already have a lobbying group: the AMA. Are they doing the job you need them to do?

As for this quote:Because, guess what, most of us physicians are too busy and dedicated to our patients to worry about organizing, to the point of neglecting our own health and families.

No, most of the physicians aren't. You are, but you are rare. And don't put your life management issue on me. Climb off the cross and own your choices. Your choices aren't my fault.

But let's look at the case you make. You make what amounts to a strawman argument: Our patients suffer because lawyers are so mean, and doctors are completely helpless because they have no control over their choices, so they don't do anything affirmative to change the system.

So what, fix the damn tort laws and everything will be hunky dory? That's silly. Insurance companies will still be in charge and committing murder by spread sheet, drug companies will still be advertising inappropriately in the media, and the DEA will still be targeting doctors because doctors are only packing stethoscopes, not guns. Much safer than going after real drug pushers.

Tort reform isn't at the heart of the relationships that doctors have with their patients. How much time you can spend with a patient, and the quality of information you are able to get on intake is much closer to the heart of informed consent.

I appreciate that the "as the child of lawyers and judges" line in my original post makes me an irresistible target for your martyred complaints about frivolous lawsuits and the need for tort reform. That's okay, I can take it. But let's not pretend that tort reform will make the problem of doctors widespread undertreatment of the number one complaint of the patients they contract to treat go away.

I'm not the enemy, Doctor. I'm the consumer of your product, and I'm giving you feedback on your product. Is the appropriate response to blame me for the problems caused by your faulty manufacturing process?

In other situations, the consumer could boycott a substandard product, but they can't really do that in this case, can they? How would a consumer even know that the product sucks until it's too late?

The issue is about who has the greatest power to effect the greatest change.

And it's not the patients who have most of the power. It's the doctors. And until and unless you folks stand up with one voice and say, "Nobody makes medical decisions for patients except trained and licensed physicians", nothing will change. And the few, like you and my doctor, who do care deeply (sometimes to the point of self-harm) will continue to pay the price for the moral failings of your fellow doctors, who won't risk their wallets for their principles.

Sorry if you don't like what you hear, but if your response is any indication, why would any patient tell you what they really think? It's not going to be easy to have informed consent when a doctor only wants the information to flow one way.

What chance do you have at establishing a trusting relationship if your doctor excoriates you for speaking the truth about your own experience as a patient and the opinions you form about healthcare as a result? And how does that affect the ability of physicians to administer the best possible treatment for their patients?

[BTW: I posted anonymously here because I have trust issues with doctors who take criticism of their profession as a personal judgment. Go figure.]

Drew Rosielle MD said...

1. Regarding the exchange between the anonymous commentors: please read our comments policy regarding keeping comments non-personal. I've decided to leave these comments up because they raise important issues but they are on the borderline of what's acceptable by our policy.
2. Christian I don't know of any good references out there or really anything defining a 'standard of care' for this issue. I think, reasonably, we should be discussing with all out patients on opioids and other potentially sedating drugs driving risks (especially when we're starting a new drug or increasing a dose), and documenting we did that. I don't know what else to say about it other than that.
3. Re: our anonymous commentors: I'd recommended Dr. Andy DeLuca's excellent (and terrifying/angry-making) site War On Doctors:
http://doctordeluca.com/wordpress/

Anonymous said...

Drew: I am the first anonymous commentor. Many thanks for your patience and flexibility. Thanks for your link to the Deluca piece. On related note, several items below your cited article, is a piece that contains a reference to the class action lawsuit filed by PRN v.Washington.

While the brief is 125 pages, it is well written and an excellent summary of the public health risk posed by the widespread under treatment of pain. It's nicely organized and a good place to find some standard referencing and research citations on this issue.

What I find most interesting about this case, though, is that it has been brought by a physician in his standing as jus tertii. This is the same standing that allowed the legal breakthrough of Griswold v. Connecticut, and it the manner in which I was calling upon physicians to take action, not just on behalf of your patients, but in your own interest as well.

While tort reform remains a valid point of consideration and provides ample fodder for discussion, the ability of a physician, in fact ANY physician to use their legally recognized standing within the court as jus tertii, may be the best and quickest resolution to this issue.

In any event, this case certainly makes for interesting reading, and provide a new area for exploration wherein doctor and patients can partner to effect the positive change they both seek.

Drew Rosielle MD said...

1) Anon can you explain exactly was jus tertii is?

2) Re: War on Doctors blog: it's Alex DeLuca, not Andy (sorry Alex).

Anonymous said...

Sure, Drew. Happy to help--Let me quote from the suit itself, so folks can go and read from the original sources material how this functionally operate in the justiciability of a case.

Jus tertii is a standing doctrine wherein a physician against whom action has been or could be taken (for treating patients) can assert a sufficiently direct threat of personal detriment as to constitute a justiciable controversy. See Doe v. Bolton, 410 U.S. 179, 188-89 (1973); see also Eppersom v. Arkansas, 393 U.S. 97(1968);
Griswold v. Connecticut, 381 U.S. 479, 481 (1965).

The physician is the one against whom the underlying licensure statutes directly operate, and the physician is the party targeted by the challenged State Guidelines.

To clarify further, the basis of the suit is not the doctor's property interest in protecting his license, but the doctor's interest in being able to treat his patient.

And here is the link to the pdf file of the lawsuit. The passage quoted for the definition can be found on p.39, as footnote 76. Apologies to the readers, as I should have included this as a direct link in the previous post.

I should also include a disclaimer: I am not a lawyer. I am just hopelessly surrounded by them. I am an activist and national political consultant who works to get bad laws changed and good programs funded. (Hey, someone in the family had to be the rebel.) :)

 
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