What Is Polypharmacy?

How should polypharmacy be defined? In a list-serve in which I participate psychiatrists commented thus in relation to a case under consideration:

Dr. P: "My definition of "Polypharmacy" would apply to any inappropriate use of any medication."

Dr. R says the term is pejorative.

Dr. M says, "I don't mean to use the term "polypharmacy" in a pejorative way, simply that there are several meds
And it makes it difficult for me to know what is or is not helping..."

Here's my definition, written years ago.

Other thoughts? I think there is also a question of what should be the threshold. I can't see that as some arbitrary number of drugs, though.

An Ethics Odyssey V

Current Status (continued from An Ethics Odyssey IV)

As of April 27, 2010 the initial question regarding possible fee-splitting remains unanswered and the WSPA investigation of the informed consent issue appears to be in limbo, possibly awaiting review by APA. The Illinois committee issued a final determination in a letter dated July 7, 2009 indicating application of the educational sanction but with no mention of an option for the complainant to appeal. The Queens County committee may have been the only one to suggest that the conduct was clearly not unethical, indicating in a letter dated October 20, 2008 that the complaint was dismissed. Aside from WSPA (and possibly IPS) no other committee appears to have taken up the informed consent question.

Ethics Committee Report Card

DB	Date initiated	Date determined	Determination	Communi-cation	Perfor- mance
WA	1.9.2007	NA	None/pending	F	F
FL	4.17.2007	NA	Raised bogus question of illegal activity	C	F
TX	4.17.2007	11.14.2007	Presumed ethical because of informed consent	D	D
GA	4.17.2007	9.17.2007	Different financial arrangement	A	A
NJ	4.17.2007	6.18.2007	Psychiatrist no longer licensed… did not accept any fees	A	NA
Queens Cnty, NY	4.17.2007	10.20.2008	No ethics violation.	B	A
Illinois	1.21.2008	NA	Determination only implied.	A	A-
S CA	1.21.2008	3.10.2008	Raised bogus question of illegal activity; did not respond to questions.	F	F
HI	4.17.2007	2.3.2008	Wrong psychiatrist with similar name	A	NA

Conclusions

This admittedly difficult group of cases has indeed revealed weaknesses in APA’s procedures for handling ethics questions. APA and the local committees have failed to answer a straightforward ethics question posed by a member in good faith after more than two years time. If members cannot expect timely responses to such questions, they may choose to take their chances with conduct that an ethics committee may determine to be unethical after the fact. This places patients and physicians at unacceptable risk and should be remedied immediately.

Unnecessary delay in addressing such a question may adversely affect the member financially by forcing the member to delay making a decision that could have resulted in increased income. This also may create the appearance of anti-competitive activity. If committee members fear that allowing another member to provide a new treatment will take business away from them, they erect temporary road blocks. This could also hurt our patients by delaying availability of needed and effective treatment.

Delay in addressing these questions resulted to a large degree from the WSPA ethics committee’s requirement that the matter be handled as an investigation. The committee should have answered the questions I posed as soon as it gained access to the necessary documents, or the APA ethics committee should have answered the question, as did the Queens County comittee. Delay and avoidance of answering the questions served no legitimate purpose. WSPA subsequently issued a statement to the effect that the ethics committee, as a matter of policy, will no longer take up questions regarding ethics, but will only investigate actual complaints. While I am disappointed, I support this decision. These questions should be addressed by the APA ethics committee.

The quality of response to referrals of potential ethics problems differs markedly from committee to committee. While the Illinois committee’s response appears exemplary Florida and Southern California appear to have used the baseless ploy that their might have been some kind of illegal activity to avoid investigating the cases at all. Texas would appear to believe that informed consent obviates any concern about ethical conduct even without clear evidence that informed consent was obtained, and APA upheld their decision. APA needs a mechanism for assuring consistent quality of investigation across all local committees and should remedy this problem immediately.

It appears likely that determinations will differ among local committees. Texas appears to have determined there has been no violation, but it is not clear that the practice in question actually was used by their members. WSPA pretended to address the question but did not. Only Queens County and Illinois may have come to a real determination. What is considered unethical in Illinois should not be considered ethical in Texas. Nor should this require appeal to APA. APA needs a mechanism for assuring consistency in ethical determinations throughout the association and should establish procedures needed to achieve this goal immediately.

Dr. Adler’s meeting and conversations with representatives of the company gave the appearance that his committee may have assisted this for-profit corporation in crafting their contract. This is not an appropriate role for a professional association ethics committee because of the possibility of conflict of interest or role conflict. Furthermore, he should not have informed company representatives about my “inquiries to the Washington State Psychiatric Association (WSPA) and to a news reporter.” Although the “complainant” has no duty of confidentiality, the committee should consider communications to an ethics committee by the complainant privileged, particularly with regard to a third party like the company. His request that I as the complainant agree to non disclosure after I raised questions about his contacts with the company and reference to the “Martini Doctrine” was not justified. Perhaps the APA ethics committee should address this kind of conduct in formal guidelines.

The company appears to have performed admirably. Their secrecy requirement probably served a legitimate need to protect their investment. When questions were raised, they responded appropriately, apparently bending over backward to assure that their doctors can provide the protocol ethically. However, their charges of harassment and threats of litigation to avoid further referrals of ethical questions by their legal counsel was gratuitous and may have constituted attempted interference with the ethics determination process by intimidation. There remains as well the question of whether the treatment protocol works.

The use of agreements requiring secrecy poses a challenge for APA ethics policy. Members should not be able to avoid scrutiny of their professional activities for compliance with ethics guidelines simply by agreeing with a third party to keep those activities secret. The APA ethics committee should advise members not to enter into such an arrangement unless it specifically allows them to reveal the agreement to an ethics committee. The committee should also advise members not to enter into agreements that do not allow them to provide full informed consent to their patients.

The risks, costs, time and other factors associated with ethics investigations may exceed what is reasonable to expect from members of a district branch or state association. APA should consider increasing the level of indemnification of members investigating ethics complaints and providing more support including access to legal counsel.

The problems with the APA’s system for addressing ethics in the profession described above provide evidence that the system needs to be fixed. Delay in action to correct these problems will hurt our profession.

(Financial interest disclosure: The author owns stock in the company discussed above. One share, valued 4.6.2010 at $0.21.)

DSM-V: A Brief Conversation With Allen Frances

Having come across his email address I could not resist posing a question, and he honored me with a reply, alas another question. I thought the conversation might deserve public exposure.

My question:

"It has seemed to me that in general DSM criteria from 3 on have been necessary but not sufficient to make a dx. The clinician must make a judgement that the pt is ill, THEN use the DSM to classify that illness.

Would it help to emphasize that fact?"

Before I record Frances' response let me elaborate. Many years ago, during a deposition, an attorney pulled out the DSM and walked me through the criteria for some disorder one by one. I had to admit most if not all seemed to be met, at least at first glance, but I still opined that the patient did not suffer from the disorder. This raised a question I might have thought would have an obvious answer: According to the DSM, if the patient meets all the criteria, does that imply they have the illness? I have looked in vein for an answer. This led me to the conclusion that, especially given the Cautionary Statement at the beginning of the book, the proper way to apply the criteria might involve a trained clinician (not an attorney) first making the judgment that the patient suffers from a mental illness, and referring to the diagnostic criteria only to classify the illness, ie to determine which diagnosis fits best.

It seems to me that inclusion of a clear statement on this issue could improve DSM-V.

I figured if anyone knows the answer it must be Dr. Frances. His response:

"Do you mean by ill that the patient has clinically significant distress or impairment?" 

Gee thanks, doc. I think he may be trying to use this as a teachable moment. I believe this question is beside the point, but of course it is very critical.

"Clinically significant distress or impairment," in my opinion, does not qualify as the definition of a mental disorder. Rather it is a threshold. I find it hard to imagine making a diagnosis of mental disorder in the absence of clinically significant distress or impairment, but I hold out the possibility it might be appropriate in some cases. I'm still wondering why he asks. Maybe he just wants to know whether the process I describe above consists of first determining that there is clinically significant distress or impairment, then applying the criteria. Fair enough.

But that is not what I do. I believe there is more to identification of a diagnositc entity than distress or impairment. A disorder must somehow hold together and have a life of its own. It can't just mean feeling really bad or not functioning 100% when things are going rough for example (or did I just define adjustment disorder?).

The term "clinically significant" bothers me too. Does that just mean the problem was so bad the patient sought professional help, or that someone else thought they should seek professional help?

A lot of this debate struggles with determining just how clear the dividing line between normal and sick should be. We lose if we say everyone is sick all the time, or that everyone has an excuse for doing bad things or failing a responsibility. We also lose if we keep those who need it from accessing treatment.

If Dr. Frances responds again, I will post here.

DEA Suboxone Audit Update VIII

Continued from: Worst Experience of My Career: a Follow Up

After numerous phone calls and broken promises, as well as assistance from my congressman, I received a letter from Mark Caverly, Chief the the Liaison and Policy Section, Office of Diversion Control, DEA, responding to my request for a description of the buprenorphine record and stock inspection process when conducted under Administrative Inspection Warrant.

Although Mr. Caverly provided no such description, he did shed some light on what a physician might expect. I am left with the overall impression that the process differs little from an inspection conducted after a physician has signed Form 82, the chief difference being that the inspection is conducted without the physician's permission.

The most egregious aspect of the inspections from the physician's (an patients' present at the office) seems unchanged from the "permitted" inspection: agents will appear unannounced, thus unnecessarily disrupting medical care under the illusion that this will prevent physicians from preparing in advance, so the agents can catch offenders red handed. Because of this I see little advantage in declining to sign Form 82 when agents appear at your office.

Mr. Caverly failed to answer most of the rest of my questions:

"Will agents force entry if the physician is not present?"

He seems to have missed the fact that this is a yes or no question. He simply cited a statute with no reference to forced entry. The statute does refer to a "right" (Shouldn't that be authority?) to "enter such premises... in a reasonable manner," whatever that means.

"Will agents serve the warrant during regular business hours?"

The cited statute also specifies that inspections should be conducted at "reasonable times," whatever that means. Again, he does not seem to recognize a yes or no question.

"If the physician is present when the agents serve the warrant, and is prepared to provide access to the required records, will the audit be conducted as it would have been with Form 82 (Notice of Inspection) consent?"

Once more he evades a yes or no question. He simply tells us that the same records must be made available rather than addressing how the inspection will be conducted.

"Will agents be more or less likely to confiscate records than they would be with Form 82 consent?"

He evades this question as well but does tell us that the physician will be provided with a receipt for any records seized pursuant to the authority of the Administrative Inspection Warrant, and that the records will be returned when the process is completed.

"To what extent does national policy govern the process, and how much latitude and discretion does DEA afford local field offices?"

Once more his answer is uninformative and completely fails to address the question. It would be wonderful to see one of these people cross examined in court where they can't get away with such evasiveness. And these are public servants?

An Ethics Odyssey IV

 (Continued from An Ethics Odyssey III)

More District branches, State Associations

Since no district branch or state association had yet answered my original question, and months had passed since my original round of letters, I wondered whether there might be some new players where inquiries might bare fruit. Another search of the company and APA Web sites revealed members apparently associated with the protocol in two more areas. On January 21, 2008 I wrote letters to the Illinois Psychiatric Society and the Southern California Psychiatric Society.

Southern California

William Arroyo, chair of the ethics committee of the Southern California Psychiatric Society responded with a letter dated March 10, 2008. He referred to my “allegations of illegal fee-splitting” which would require the committee to “reach a legal conclusion of whether the law has been violated before there can be a determination of whether unethical activity has been alleged by you.”

I read on, hoping in vein for clarification:

“The SCPS lacks the authority and the resources to determine such a legal issue.”

This seems obvious.

“Hence it can not determine that there has been an allegation of unethical behavior.”

There clearly has not been an “allegation of unethical behavior.”

“Until such time that a court of law has determined that the ‘fee splitting’ you allege is illegal, the SCPS cannot issue an opinion on the ethical nature of this allegation.”

Dr. Arroyo seems to believe “the courts” can make ethics determination.

“Accordingly, the SCPS is not in a position to proceed with your letter of complaint and must decline to take further action. The SCPS will gladly review any new information related to this matter in the future.”

He went on to inform me that I could appeal to APA, but the letter confused me to such a degree that I was not sure what I might appeal. I wondered whether he had understood my original letter at all.

I got the sense SCPS did not want to pursue this, but I replied anyway, explaining that I had not alleged anything and certainly had not considered that any illegal activity had taken place. After a few weeks without a response from SCPS I did in fact write a letter of appeal to APA whose ethics committee upheld this “non-determination.”

Illinois

I received a letter dated February 7, 2008 from David H. Baron, MD chair of the Illinois Psychiatric Society ethics committee acknowledging receipt of my letter. He explained the process in detail and asked me to provide further information. He enclosed a copy of the APA publication “Information for Complainants on the Ethics Process.” He provided the email address of a contact person in the IPS office.

Correspondence back and forth followed. I was asked whether I might be able to travel to Chicago for a meeting, but I pointed out that this was probably not necessary given that I had little actual knowledge of the critical facts surrounding the question. On June 23 I participated in a conference call with a committee. IPS left me with the greatest confidence that the investigation would be handled professionally and responsibly.

In a telephone conversation on September 10, 2008 Meryl Sosa of IPS told much of the investigation was completed with consideration of the evidence to occur soon. In a subsequent conversation she told me IPS had submitted the committee’s determination to the APA ethics committee for final approval.

Back to the Fee Splitting Question

Dr. Adler wrote on January 31, 2008: “Since the physicians have signed an NDA [non disclosure agreement] they may be in a bind regarding responding to our initial inquiry. We might need to contact the company asking them if the circumstances as conveyed to us are true. Unless they can definitively show otherwise, we would have to assume there is fee-splitting.” He appeared to put the burden of proof on the doctors.

Having heard no more from Dr. Richie I wrote the third psychiatrist to hold the position of WSPA President during this protracted process, Ray Hsiao, MD, on April 20, 2008 via email asking whether I might get a status report. Dr. Hsiao forwarded to Dr. Adler who forwarded to Dr. Richie. Still no response from WSPA, but it appears that I got the attention of the company again.

In a letter dated May 8, 2008 an attorney claiming to represent the company, apparently prompted by my inquiry to the Illinois Psychiatric Society, accurately pointed out that I “did not contact [the company] prior to filing [my] complaint.” She also accurately pointed out that I could have raised concerns with the company, which in fact I had. Then she got off track. She voiced the mistaken impression that company representatives could have somehow provided “information” to allay my concerns about the financial arrangement. “… you now have actual knowledge that your complaints are without merit and baseless.” Although she went on to cite determinations from the Georgia and Texas cases, she seems to have overlooked the questions raised in Washington. And she overlooked the fact that neither of those cases directly addressed the question. “Your actions evidence a malicious effort on your part to harass and intimidate these psychiatrists, and to tortiuosly [ie, We will sue you if you don’t stop.] interfere with [the company’s] professional business relationship with them.”

Her assertions grew wilder: “Moreover, your actions show a complete lack of respect for the several psychiatrists against whom you have filed complaints, in patent violation of the APA guidelines.” There are no such guidelines. In fact one could argue that members of APA have a duty to report possible ethical misconduct. I will readily admit to having a complete lack of respect for more than a few psychiatrists, but probably none of those associated with the protocol can accurately claim membership in that group. And of course no one from APA to this day has accused me of this “patent violation.”

I wrote the attorney promptly, describing my still futile efforts to get my professional association to assure me that any agreement into which I might enter with her client would meet ethical muster and assuring her that I felt no animosity for her client company. Alas she could only respond with another threatening letter (July 10). But then, to paraphrase Tigger, “That’s what attorneys do best.”

The important question raised by the role played by this attorney is whether the psychiatrist might be held responsible for using the threat of litigation to discourage an ethics investigation. I raised this issue with the Illinois committee.

Embarrassed Government Officials

In the fall of 2007 reports of controversy over a program using the protocol at a local clinic emerged. The clinic reportedly abandoned use of the protocol in the spring of 2008 amid questions of conflict of interest in government officials and questions about cost and evidence of effectiveness. In a telephone conversation a psychiatrist who had provided the treatment there told me another psychiatrist called him with questions about the protocol. He told me he was unsure of the psychiatrists name, but added that the caller did not identify himself as pursuing an ethics inquiry. Could this have been the mysterious Dr. Richie?

WSPA, Continued

Finally, action! Dr. Adler wrote a letter dated May 16, 2008 in which he attributed the “delay in reviewing this matter” to “negotiations to obtain contracts from” the company. He addressed the matter of the financial arrangement first:

“… if the member in question were not direct licensees, but only clinicians operating the… protocol for an employer, then our review of the contracts indicate that the member psychiatrists are not participating in fee-splitting or its equivalent.”

On first read I thought the committee had determined the financial arrangement to be ethical. Then I read more carefully. It reminded me of a line from an old Harry Belafonte Calypso song, “It was clear as mud but it covered the ground.” It appears that Dr. Adler carefully worded the statement to avoid revealing information about the members’ relationships with the company. This I respect. But because he implied that none of the psychiatrists named was a party to the arrangement in question he never addressed the original question. Nor did he promise to address it later.

Dr. Adler did proceed to express concern on the part of the committee regarding informed consent. He went on to indicate initiation of investigation of the members to determine whether consent to treatment was informed consistent with ethics guidelines and promised “the entire process” might take “a year or more to complete”

What disturbed me most, however, was the wording of the letters WSPA sent to each of the listed physicians. Each letter stated that [the author] “filed a complaint… alleging that you have acted unethically.” This of course was far from the truth. I wrote to each of the psychiatrists myself correcting the mistake, and I wrote to WSPA to ask that the association likewise write letters correcting and apologizing for the error. Dr. Hsiao wrote back agreeing only to “inform the respondents of your ‘formal complaint’ as outlined in your letter.”

Continued: An Ethics Odyssey V

WSPA Spring Meeting in Seattle

Stephen Michael Thielke, MD, incoming president of the Washington State Psychiatric Association programmed this years meeting around a theme of technology.

WSAP President Elect Robert Hilt, MD led off with a presentation describing experience of delivering child psychiatry services to remote underserved areas of the state, emphasizing the program's telepsychiatry services in a model providing for remote offices staffed and equipped through the program. I disagree with Dr. Hilt's definition of telepsychiatry excluding the telephone which makes teleconferencing look inadequate relative to face to face contacts. In fact we should emphasize that teleconferencing with video is superior to telephone contact which has been an essential part of standard of care for providing medical services for almost as many years as the technology has existed.

Jacob Sperber, MD spoke next on "The Impact of Interactive Digital Social Media on Psychiatry." However, most of the several authors he quoted have published in other fields, like media and sociology, and it soon became clear that he talked not about psychiatry in general but rather about psychoanalytic psychotherapy. He argued that psychiatry, as though it were some kind of monolithic organization, espouses intimacy as a value, and that psychiatrists should oppose activities, such as social networking, that threaten to impair our capacity for intimacy. I strongly disagree with this position. Social networking clearly has potential for good as well as harm, but psychiatrists should stick to treating mental illness rather than promoting values which, at least in this case, are probably based on psychoanalytic views of what should be considered normal. With his views Dr. Sperber would likely have risen to a high position in the old Soviet Union.

Sperber also argued that digital social networking promotes "multiplicity," in that users portray themselves in different ways in different settings on the Web. That may be true, but we would be pretty boring if each of us always acted the same regardless of the situation. And you don't need the Internet to act differently just for fun, or for some other purpose. I guess if Dr. Sperber's mother told him she cried for the cop to get out of a traffic ticket he would want her to sign up for a several years on the couch.

After lunch VA psychiatrist Kenric Hammond, MD described the electronic medical record system that has evolved over many years at the VA. He focused on the problem of copying and pasting of text and encouraged increased use of narrative vs. check boxes. He also suggested hypertext technology might provide a superior alternative, allowing the provider to refer elsewhere in the record rather than copying the same text. Having reviewed many pages of records from VA clinics and hospitals myself I agree the system begs for improvement. I might suggest a system in which each provider could select modules to customize data entry. It appears to me that the tail too often wags the medical dog. EMR's should bend to the style of the physician rather than dictate how the physician works. On the other hand the EMR, properly designed, might also lead to improved care. The proposed use of hypertext, however, will create change in how forensic record reviews proceed. If the reviewer wants an accurate picture the linked document must be readily accessed from the link. This could apply pressure for abandoning paper copies in favor of electronic. This could be good.

Finally librarian Valerie Lawrence told us how to access journals and other resources available to all WA licensed physicians, and attorney Jacqueline Melonas described risk management considerations in communicating with patients via digital media.

iPad. Ho Hum.

I have been using a tablet PC for over 7 years.

I can write on it.

It even recognizes my handwriting.

It's really a computer.

I can read books with it, watch movies on it, surf the Web with it.

iPad? Not.