Wednesday, May 5, 2010

What do you get? Boney fingers.

There's a song out there someplace that says "What do you get if you work your fingers to the bone? Boney fingers."

And so I sit here, after working my fingers, etc. for several hours. I'm working on a complaint to my state medical board concerning the actions/inactions of my pdoc (my psychiatrist). I decided to post it here for two reasons: (1) I have nothing to hide and (2) I want an archive of my work available on the 'net in case my computer goes down.

Remember, this is a letter to the Medical Board of California.

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You have a great deal more medical education, experience and expertise than I, but I don't know if you are a psychiatrist who has prescribed Lithium before. If so, please skip down to "My Story." If not, please don't be offended if I begin with an analogy, a children's story I hope you know called "Goldilocks and the Three Bears."

I have spent many hours in the last few months learning how psychiatrists prescribe Lithium. I know the story will be relevant.

In the story, Goldilocks first finds three bowls of porridge. She tries them, saying of each, "That's too hot," "That's too cold, “and "Just right." And then she finds three beds and when she tries them says, "That's too hard," "That's too soft," and "Just right." I actually don't remember how the rest of the story goes but I *do* know how it relates to prescribing Lithium.

You see, Lithium has a very narrow therapeutic range. If you prescribe a dose just a little too high, it's toxic -- perhaps fatally so. Most complaints and malpractice claims about Lithium involve giving patients overdoses of the drug. I'll discuss the Standard of Care to prevent overdosing below.

Prescribing too low a dose of Lithium, on the other hand, is like leaving a light switch in the "Off" position. Until you reach the threshold at which Lithium becomes therapeutic, and the switch changes to "On," it literally does nothing at all. Let me add the words "nada" and "zilch" for emphasis. Unlike some medications, there is no benefit at all if the patient takes a dose even a little bit too low.

Lithium is strange that way. Only the therapeutic dose is "Just right." Deciding the dose on the basis of body mass isn't a good idea. While "So many milligrams per kilo" is an effective guideline with many medications, how the body metabolizes Lithium varies among patients. When writing the first prescription for Lithium, psychiatrists don't start by aiming for a therapeutic dose; they start lower and use a protocol to build to it over a period of time.

I promised to tell you how a psychiatrist avoids overdosing a patient. It's the same way a psychiatrist avoids *under*dosing. It’s the method the psychiatrist uses to titrate the patient to a therapeutic dose: start low, test the level in the blood, increase if indicated, and repeat. This is called "Therapeutic Drug Monitoring" (TDM) -- sometimes called "Therapeutic Drug Management" -- and is the absolute standard in prescribing Lithium. I will explain a good deal more about TDM below but the key elements of the procedure are (1) the frequency of tests and (2) the nature of the tests the psychiatrist orders.

My Story
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My Story will consist of the following 5 elements: (1) my recollection of events, (2) emails my psychiatrist and I exchanged, (3) "Progress Notes" he wrote during and after each session, (4) the paraphrased statements of other psychiatric professionals I have seen (and contact information for them), and (5) miscellaneous other things to complete the picture (such as Medication Information Sheets on Lithium, lab slips and lab results). Everything I'll be saying is absolutely true.

I'm sorry if I will sometimes use the wrong medical terminology or syntax, but this is not my area of expertise. I hope you will bear with me and understand the points I'm trying to make. I apologize, as well, for the length of the narrative. I wanted to be thorough.

Along the way, I will state what my research has shown to be universally accepted medical facts, practices and standards. While I will provide a few supporting citations, the number of citations will by no means be exhaustive, merely definitive. If you need more verification, please ask a psychiatrist, read peer-reviewed journals (of psychiatry, pharmacology, therapeutics) from this country or anywhere abroad, consult the NIH, or take whatever steps you like to confirm what I say is, in fact, accepted both in the USA and around the world.

What you will find below is that my psychiatrist, Dr. XXX of the Amen Clinic in Fairfield, California, completely violated the Standard of Care with regard to prescribing Lithium. He attempted to intervene in my suicidal depression by prescribing Lithium, but botched the "TDM" protocol I will describe in two significant ways that allowed me to be undermedicated. I took the equivalent of a placebo for nearly two months. I hope I needn't point out that prescribing a placebo as medication to treat a suicidal patient is *not* indicated.

The results were devastating. I am lucky to be alive.

I say this neither to be dramatic nor to employ hyperbole. You will see an easily demonstrable and incontrovertible fact; Dr. XXX's actions and inactions nearly cost me my life. Such negligence should neither be sanctioned nor condoned. It should not, in fact, be allowed. Under similar circumstances, another patient might die.

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In the scheme of things, this seems like a small point, but I'm angry about it.

I brought my wife with me to Fairfield on DATE. She sat in the waiting area for the first ### minutes while I met with Dr. XXX, then he and I asked her to join us. Almost the first words he said concerned my desire to commit suicide. My wife knew I had been severely depressed but I had never told her I was considering suicide. In my mind, telling her would have been overly dramatic, or cruel, or impolite. It had never crossed my mind to discuss the subject with her. Sharing that information, when she could do nothing to help, to my way of thinking, was just *wrong.* Those thoughts and feelings were reserved for my psychiatrist, who would hold them in confidence. It took Dr. XXX about 5 seconds to violate that confidence.

Although she did her best to hide her reaction, in our car driving home she told me she had been unpleasantly surprised and saddened to hear the news. And I will admit to being surprised, as well. While I *may* have signed a consent form authorizing Dr. XXX to violate my confidentiality, I certainly don't remember having done so.

Isn't some large, mostly herbivorous, semi-aquatic mammal supposed to protect a patient's privacy? (The Hippo or something?)

Unless Dr. XXX can produce something I signed to the effect that he could share with my spouse things I had said to him within the bounds of doctor-patient privilege and with the expectation of confidentiality, I think his having violated my privacy warrants censure, at least. I'll leave that up to you.
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Therapeutic Drug Monitoring [or "Therapeutic Drug Management"] (TDM) of Lithium
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As we've heard, a dosage of Lithium only slightly above the therapeutic level is toxic, perhaps deadly. So TDM is the standard method of insuring safety and efficacy. Here are the steps:

1. Start with a low dose.
2. A few days later, when the patient's body has had time to stabilize to that dose, test the serum blood level of Lithium.
3. If the level is less than therapeutic (according to widely published standards, but adjusted by the doctor's clinical observation of the patient and the patient's feedback), increase it.
4. Repeat steps 2 and 3 until a therapeutic level is reached.
5. Keep patient on that dose, monitoring every few months.

The key points are:

A. Don't wait too long after beginning at any given dose before testing. This is especially true if your intention is to prevent suicide. Obviously, the soonest practicable timeframe to reach efficacy is desirable. A suicidal patient ought not wait for whatever benefit Lithium at a therapeutic level provides. You needn't be hasty, but be prudent about it.

A steady-state level is widely accepted to be achieved within a period of 4-5 days. That’s when to test.

B. The level upon which any change of dosage is determined is universally known to be a "trough level" reading. What does that mean and why is it so? Because you don't want a random number and you *certainly* don't want a peak number (reflecting the spike in that follows the patient ingesting the medication). The *only* level you should consider is the trough level, which is obtained by having the patient take his/her evening dose, wait 12 hours after the evening dose, then get the blood work done *before* his/her morning dose.

After reading vast amounts of information available on the Internet (not on the blog of some bipolar patient, mind you, but articles from universities, medical journals, professional associations, textbooks, clinical guidelines and the like), let me sum it up this way: I can provide you with hundreds, perhaps thousands, of citations that attest to trough level blood testing being the standard for TDM and TDM being the standard for prescribing Lithium.

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I've been considering possible reasons why Dr. XXX didn't tell me to get a "trough level" test. Try as I might, I can think of only three.

Reason #1. He had never prescribed Lithium before. In that admittedly unlikely event, he would have to gather prescribing information from various sources. The epocrates information sheets he gave me were intended for patients, not doctors, but they never mentioned "trough level" blood tests. I think, at the very least, he would have consulted journals of psychiatry and/or pharmacology before writing a prescription. Certainly the protocol for TDM would be mentioned in those publications. If, of course, he wrote a prescription without knowing the protocol for establishing an efficacious dosage, he was seriously negligent, but I find this difficult to believe.

Reason #2. The same is true if he *had* prescribed Lithium before, but it had so long ago that he forgot the correct procedure. Again, if he didn't knowing how, he shouldn't have been prescribing. Doing so would have been negligent. But, again, I find this possibility hard to believe.

I am obliged, however, to mention that you will see emails he and I exchanged following my 5150 stay, from which a reasonable man might infer he *didn't* know about the trough level TDM protocol. There are a few ways to interpret them, but some interpretations are disturbing.

Reasons #1 and #2, above, seem particularly unlikely because Bipolar Disorders and Depressive Disorders are common comorbidities of ADHD. Dr. XXX works at a clinic specifically known for treating patients who go there because they have ADHD. While I haven't asked, I should think Lithium is a medication that would be prescribed frequently at his clinic. In fact, the customized lab slip he sent to me following my 5150 experience of January 19-20 had a pre-printed box just for Lithium Level, so one would think it is a test they would order regularly.

[One *might* interpret the emails he and I exchanged immediately following the 5150 to mean he had no clue how to prescribe Lithium. That interpretation, however, is only one of many that are possible. When we get there, I’ll let you decide.]

Which leaves us with only Reason #3.

Reason #3. He simply forgot to tell me what a trough level test is and that I should get one. I suppose I'd be more concerned if #1 or #2 were true. A prescribing physician not knowing what he's doing would be an alarming state of affairs. The possibility of simply forgetting to tell me, however, is also very disturbing. He knew I was seriously suicidal. This was, very much, a "life or death" situation. We discussed Lithium (in his office???),(via XXX emails), he sent me a lab slip that said nothing about trough level testing. In short, there were many, many times he could simply have said, "Take your evening dose, then wait 12 hours before the test, but before your morning dose."

If establishing the correct dose was critical to my staying alive, why wasn't he concerned about getting the blood work right? And why wasn't he concerned about getting it right *right away*?

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