Second Guessing the Medical Board II

(Continued from Part I)

Diagnosis and Medication

MQAC provides minimal information about diagnosis and treatment:

• After his initial evaluation in March Dr. Roys diagnosed Major Depression, rule out Bipolar Disorder.
• Dr. Roys stopped venlafaxine because it no longer worked and prescribed lamotrigine.
• In June he prescribed ziprasidone.
• The documents state that in August Dr. Roys "was aware" that the patient "was taking clonazepam" and advised her to taper and discontinue the drug while prescribing mirtazapine.
• During an encounter on August 16 the patient complained of increased anxiety and depressed mood and "was increasingly suicidal." Dr. Roys recommended reduction in lamotrigine dose by half, and prescribed diazepam 10 mg four times daily as needed, a quantity of 120 (a standard one month supply if taken regularly).
• On September 3 the patient took an overdose of "primarily" "all of her" diazepam. Since the document fails to specify whether this meant 120 or 2 capsules/tablets the actual number requires imagination.
• After less than one week in the hospital the patient was discharged back to Dr. Roys' care with a diagnosis of "major depression" on lamatorigine, mirtazapine and trazodone.
• Dr. Roys continued the lamotrigine "along with various other medications."

MQAC criticizes Dr. Roys as follows:

• Inadequate documentation of his rationale for his treatment of her depression.
• "prescribing her Lamictal and stopping her antidepressant."
• Prescribing a large amount of diazepam.
• Failure to document the rationale for treating the patient as "having bipolar depression instead of uipolar depression."

Analysis

Believing as I do that most psychiatric disorders can be adequately treated without benzodiazepines, I applaud Dr. Roys for recommending Patient A stop her clonazepam. But the statement that he was "aware" of her using the drug suggests that she obtained it from another physician or from the street rather than by his prescription. MQAC neglects to address this key question suggestive of noncompliance, mismanagement by another provider, or even an undiagnosed substance use disorder.

I might say that I agree with MQAC's criticism of his decision to then treat Patient A with diazepam. However, the Board appears to regard such prescribing as quite legitimate, provided the amount prescribed remains below some unspecified number of dose units. If the Board agreed with me it would sanction half the physicians in the state. Indeed, MQAC would have us believe that the number prescribed increases the risk of an overdose. Insofar as 2 dose units taken at once represent an overdose how can one argue with that logic? In fact this is a cheap shot, a pejorative ploy to prejudice the reader. Only the patient determines how many pills she actually takes and when. Can MQAC really be so naive as to think that patients always take their medications as prescribed? Even this case gives the lie to that notion. 

The Board would deceive the reader into confusing the risk of overdose with the risk of suicide attempt. In fact he number of pills prescribed does nothing to affect the risk of sucide attempt. How cynical of MQAC to insinuate that the number of doses prescribed caused the suicide attempt while neglecting to propose a "safe" number of doses. Could this be because there is no safe number? Any patient can accumulate a dangerous quantity of any prescription drug unbeknownst to the physician. In fact, one could applaud Dr. Roys for providing the patient with a relatively safe means with which to attempt suicide. But MQAC has covered that base. The documents suggest that combining the diazepam with alcohol or other CNS depressant would increase the lethality of the drug. This is true but entirely irrelevant since there is no evidence the patient did so. Such pejorative, gratuitous statements do not belong in such a document. (Combining diazepam with rat poison would also increase its lethality. So what?) It is perhaps surprising that the Board failed to fault Dr. Roys for not telling the patient that adding alcohol would make for a more lethal cocktail. After all, was it not his duty to provide informed consent thus educating her as to how to kill herself? 

In fact, this patient like all of us had at her disposal numerous and sundry methods for attempting suicide.

Why did Dr. Roys' start diazepam instead of clonazepam during that August encounter. Did he think the latter would be more helpful for the severe anxiety described. Or did the patient imply that she would surely kill herself if he did not provide the requested drug? The Board does not seem to consider that question relevant.

I also wonder about the Board's interest in whether Dr. Roys diagnosed unipolar or bipolar depression. Some authorities believe recurrent depressive episodes represent a variant of bipolar disorder and should be treated as bipolar disorder. Psychopharmacotherapy is a process of auditioning drug after drug, combination after combination, until something works or the patient begins to see the process as futile. There is nothing in the information provided by the board to suggest that Dr. Roys neglected an effective drug or combination or that any of the drugs he prescribed might have adversely affected the patient (provided the patient chose to comply with the ordered regime). Overlake Hospital's psychiatrist seem to have continued more or less the same regimine, only adding trazodone and presumably stopping the diazepam. Kudos to Overlake for bucking the fashion and dropping the bipolar diagnosis, but Patient A needed effective treatment more than she needed the correct diagnosis.

In the documents MQAC claims Geodon (ziprasidone) is "indicated in bipolar disorder" "to help reduce anxiety" Not exactly: Geodon's FDA label approves the drug for treating

"acute manic or mixed episodes associated with Bipolar Disorder, with or without psychotic features" 

MQAC cites no evidence for a mixed or manic episode, in fact describing chronic depressed mood and anxiety rather than mood episodes. The document also criticizes Dr. Roys for "prescribing her Lamictal and stopping her antidepressant" but fails to specify the "antidepressant" to which it refers while also apparently failing to appreciate that psychiatrists often prescribe lamotrigine as an antidepressant. Does MQAC criticize Dr. Roys for discontinuing venlafaxine which stopped working? Does MQAC believe mirtazapine is not an antidepressant?

The documents criticize Dr. Roys for failures in documentation. Medical documentation as an end in itself should only be criticized for failure to serve a purpose in advancing the patient's care. Dr. Roys' putative failure to document rationale for his diagnosis or treatment may damage his ability to defend his choices, but does nothing to adversely affect the patient's care, either by Dr. Roys or any future provider.

In my next installment I address questions surrounding scheduling, coordination of treatment and reimbursement.

Second Guessing the Medical Board

When state medical licensing boards started posting on the Web the documents associated with discipline of physician misconduct physicians worried about the negative impact on their reputations and practices. But these documents also make public the work of the boards, leaving that work open to scrutiny, analysis, and criticism.

It only occurred to me to embark on such a critique after the name of a physician in my community appeared in the regular Washington Medical Quality Assurance Commission (MQAC -- pronounced M Quack) publication. I wondered whether readers might appreciate my analysis. Whether that includes Dr. Roys or MQAC is yet to be determined.

Links to documents related to Case M2009-897 appear in order from last to first on the linked Web page.

Disclosures

I met David Roys, MD 15-20 years ago, but never knew him well or worked closely with him. I have worked as a consultant for MQAC in the remote past, reviewing patient records for the most part, although I may have examined a physician or two for them. I practice in the same community as Dr. Roys, so you might rightly consider us competitors. Robert Small, MD may have been pro tem psychiatric member of  MQAC at the time of this case. If I recall correctly Dr. Small trained in child psychiatry. I knew him when we both belonged to the medical staff of a local psychiatric hospital (presumably Overlake), and I believe we both worked as consultants for a managed care operation. I believe Dr. Small continued his career on the payer side by working for a health insurance company, perhaps as medical director. He seems to have managed to keep a very low profile on the Web. I have been a member of the Overlake Hospital medical staff for approximately 25 years.

Disclaimers

Understand that my sole source of information about this case is the five documents alluded to above. I have not reviewed medical records or discussed the case with Dr. Roys, his attorney, or anyone from the Board. Board attorney James Mclaughlin provided limited information as to who may have written the documents and Dr. Small's possible involvement. I can draw conclusions only about MQAC documents, not about Dr. Roys' handling of the case or MQAC's decisions. It is not my intention to help or hurt Dr. Roys or anyone associated with the case. It is my intention to shed light on the disciplinary process to the extent that the reports accurately reflect that process. It does occur to me that MQAC might find my analysis useful in future cases and that either side might find my analysis useful if litigation follows the complaint, as it often does. So be it. If such litigation should involve a jury trial, any prospective juror who has read this might use the fact to disqualify herself from duty.

Case Summary

According to MQAC documents, a psychotherapist refers a patient to the Respondent psychiatrist (Dr. David Roys) after failed treatment for an apparent depressive disorder with another physician. Dr. Roys makes some changes in the regime, including stopping the clonazepam, wondering whether the patient might suffer from Bipolar Disorder. After nearly 6 months the patient reports continued depressed mood with thoughts of suicide. Dr. Roys prescribes diazepam, but patient and doctor do not schedule a follow up appointment, possibly for financial reasons. Soon thereafter the patient attempts suicide (presumably) with overdose of "her medications, primarily the diazepam," is admitted to hospital, discharged back to Dr. Roys, then finds a new psychiatrist and files a complaint with MQAC (not necessarily in that order).

Sanctions

MQAC charged Dr. Roys under RCW 18.130.180 Unprofessional Conduct: "Incompetence, negligence or malpractice which results in injury to a patient or creates an unreasonable risk that a patient may be harmed." MQAC criticizes Dr. Roys' management of the case as follows:

• Prescribing too much diazepam given the purported level of suicide risk.
• Prescribing that was ineffective for treating the "noted depression."
• Stopping antidepressant medication even absent sufficient evidence for Bipolar Disorder.
• Treating the patient's anxiety without "fully addressing" (whatever that means) her depression.
• Failure to provide a "well structured care and monitoring plan."
• Asking the patient to return "only when she felt the need."
• Prescribing a drug (diazepam) that had "propensity for abuse."
• Failure to document coordination with the psychologist "to better tailor the medication plan with the mental health issues of Patient A that the psychologist was dealing with."

Points for Analysis

I will address the following issues from the official documents in this and future installments:

• Writing style and grammar
• Benzodiazepines
• Diagnosis and medication regime
• Documentation
• Scheduling of appointments
• Coordination of treatment
• Suicide attempt
• Reimbursement
• Possible unintended consequences of MQAC's expressed and implied positions

Style

In a word I find the documents, particularly the Statement of Charges and Amended Statement of Charges, sloppy, particularly given their importance. It may seem petty to criticize the authors, for example, for capitalizing generic drug names like diazepam which are not proper nouns, but the ambiguity in many statements leaves me wondering whether the statement reflects MQAC's views or whether MQAC actually knows what it wants to say or indeed understands the issues.

The Amended Statement of Charges includes several "amendments" to the original Statement. The original refers to the referring professional as a psychologist, but this individual becomes a "therapist" in the Amended Statement. Was this a physical therapist, massage therapist, or a psychotherapist? If, as I suspect, he or she was a psychotherapist I hardly think it would break the MQAC budget to add those extra six letters.

Both Statements allude to whether the patient "was bi-polar." Not only is there no hyphen in the term, but Patient A may have had bipolar disorder; it is incorrect to say that she was bipolar. The patient may have taken antidepressant medications, not "anti-depression" medications. According to the Statement paragraph 1.7 the patient "manifested serious depression and anxiety." Apparently we are not to confuse this with comical depression or anxiety.

In paragraph 1.8 the report indicates that Dr. Roys told the patient to return "as needed." We see this term recorded later as "prn," an abbreviation of the Latin pro re nada which physicians usually reserve for prescriptions. Since we learn later that the patient's budget may have affected the frequency with which she wanted to visit Dr. Roys, and that MQAC criticized Dr. Roys handling of this matter, one wonders whether this pejorative language accurately reflected the event.

Paragraph 1.11 uses the legal term "grounds" to describe the patient's motivation for transferring care to a new psychiatrist. The author should have chosen a more appropriate word; legal jargon is gratuitous. This paragraph also refers to Dr. Roys as "not resolving" the patients symptoms. Doctors do not resolve symptoms; they treat them. Symptoms and illnesses might, however, resolve with treatment, or indeed without treatment.

With paragraph 1.12 the author takes us abruptly from laying out the facts to criticizing Dr. Roys' handling of the case leaving me with the impression that MQAC has failed to discriminate between facts and charges. I believe this shift justifies a separate, appropriately labeled, section in the report. The original Statement criticizes Dr. Roys' treatment as "not effective," seeming to insinuate that ineffective treatment is negligent treatment. Since psychiatric illness frequently fails to respond to standard treatments the author acted correctly in dropping this statement from the amended version. Also correctly omitted from the amended report is the ambiguous criticism of Dr. Roys' in paragraph 1.13 for not "fully addressing her depression." Psychiatrists do not "address" depression. We treat it.

The ambiguity continues in 1.14 of both statements which refer to a "well structured care and monitoring plan." In this paragraph in the original statement the author states Dr. Roys "was asking her to return only when she felt the need." This language leaves me wondering when and how often he "was asking," and more importantly, given the pejorative tone, whether MQAC criticizes Dr. Roys for what he did (was asking) or for what he should have done. Paragraph 1.14 in the amended statement provides little more clarity in stating that Dr. Roys "on several occasions did not schedule appropriate follow-up visits." Does MQAC want us to understand that he did schedule inappropriate visits? How does MQAC differentiate between appropriate visits and inappropriate visits? Perhaps we should focus instead on the fact that he did not schedule (the visits). If so, all physicians should indeed fear board sanction. In fact I myself have spent this entire morning not scheduling visits of any kind, appropriate or inappropriate.

The original statement criticizes Dr. Roys for prescribing a "large amount of Diazepam (Valium) which had the propensity for abuse." Was it the amount that had the propensity for abuse, or was it the diazepam? If the latter, does MQAC expect us to believe that some diazepam has a propensity for abuse and other diazepam does not? Does not all diazepam have a propensity for abuse? Is that not why it is a controlled substance? The author correctly omitted this language from the amended statement.

Paragraph 1.15 in the original statement is a near total disaster. In it the author criticizes Dr. Roys' records for failing to "reflect the kind of coordination with Patient A's psychologist that would be required in monitoring the patient, to better tailor the medication plan with the mental health issues of Patient A that the psychologist was dealing with." Fortunately for us readers the author clarifies this mess, at least partly, in the amended report.

One can only hope that MQAC was less sloppy in adjudicating this case than these documents reflect.

In my next installment I will address questions surrounding medication, especially the benzodiazepines clonazepam and diazepam.

BehaveNet needs help with terms and definitions

Psychostimulant, analeptic, stimulant, CNS stimulant, wakefulness promoting: Are they all synonyms? If not, what might distinguish one from another? Would you classify the same group of drugs in all of them?

Anorectic, anorexiant, anorexigenic: same questions

Hypnotic, soporific: any difference?

The EMR and Litigation

Years ago in my work as expert witness I realized that the paper versions of EMRs documenting care at early adopters like HMOs and the VA seemed awkward and poor representations of the actual computer record. A few days ago a prominent hospitalist friend observed at a grand rounds on EMR that these systems have become so complex and unique that each may require training and even certification for the physicians who use them, a significant problem for docs who cover hospitals with different EMRs.

Will these facts affect future litigation? Will an expert need certification to be a credible witness in a case where records are electronic? Will it suffice to provide the expert a stack of printed records, or must access be granted to the EMR itself, perhaps even in the courtroom, to achieve a valid picture of the record? If so, how will we provide the expert an accurate picture of the record at the relevant point in time?

WA Rx Monitoring Program Flawed

First thing yesterday morning two messages appear in my inbox. A few minutes later I am searching the controlled substance records for the patients on my schedule for the next few days. Health Information Designs provides the service via a Web interface that looks like a throwback to the 1990's and features data entry windows that do not line up with their labels. The "practitioner/pharmacist query" page features a check box for "Prescriber Search by DEA." Does HID intend that DEA agents should be able to use this to search for providers like me? Or did they mean "Prescriber Search by DEA Number?"

Undaunted by the amateurish interface I conduct my first queries. Bingo. I discover more than one non-physician has prescribed controlled substances I consider contraindicated for a patient I treat for addiction without contacting me to coordinate care. I strike more pay dirt:

• One buprenorphine maintenance patient had already told me his dentist had prescribed a -codone for a dental procedure.
• I discovered another physician had prescribed zolpidem to a buprenorphine patient without consulting me.
• I discovered another physician had prescribed eszopiclone unbeknownst to me.

Now what? Should I test each patient by asking if there's anything they want to tell me? Should I discharge the filthy liars? And how often should I check the database?

I am inclined to avoid the drama, but let each patient know that I can now discover what other docs (and non-docs) prescribe. Since these other providers also have access to the records there will exist no illusion that the patient can keep them in the dark.

Out of a total of 18 patients I was unable to find any record of 7 patients. In one case I had entered the wrong birth date, but in several cases I myself have prescribed controlled substances regularly for months. This means that a negative query can result from entering the name or birth date incorrectly, but it could also result when no controlled substances were prescribed. So a positive result tells you something, and a negative tells you nothing. This flaw merits urgent attention.

I inquired about the problem via email to HID. The response:

Your search may be too narrow and will only pull specified information. I am able to help you with a search if you are available. Also your search should be used as a tool in addition, to the information you know is true and it allows the prescriber/pharmacist to make a better decision about health care. When used this will prove a very useful tool when used in conjunction with good sense and caring health providers like you.
Thanks,
Ayana Lewis
Technical Support Specialist
Prescription Drug Monitoring Program
Health Information Designs, Inc.

If anyone out there can interpret that for me, please comment.

When I called HID for that promised help I predictably encountered Ayana's voice mail, so I called back to navigate the menus. The states are divided alphabetically with menu choices, but I waited in vain for Washington. I guess I could have extrapolated from Vermont (8), but I chose to call once more and try my luck with an operator. With minimal hold time I spoke with a representative who ultimately did not seem to grasp the gravity of the problem or offer any hope for correction. I have since contacted the State of WA and am expecting a return call.

On the positive side for the interface: security. Not only must I use a username and password to access my account, but I must register the devices (computers) I intend to use.

An unexpected positive consequence: Patients in the past have refused to allow me to coordinate care with other providers for fear I will reveal their addiction history. Since this strategy will no longer keep the secret I can expect more cooperation in the future.

The patient I "caught" above (or I could more accurately say I caught the providers of the prescriptions) admitted to the problem, allowing us to develop a new plan, including giving me permission to contact those providers and read them the riot act. Overall this program will likely help a lot of people and save more than a few lives.