Wednesday, March 31, 2010

An Ethics Odyssey I

My series of posts addressing the APA Ethics Committee’s opinions documents problems with the national committee’s approach to ethics questions and complaints, but local, district branch and state association, ethics committees do much of the work of handling ethics complaints. Not only does this uncompensated work require substantial amounts of time, but it also involves liability exposure with only limited protection. I believe this story will demonstrate some of the basis for my opinion that APA should do more, if not all, of this work.

During the last months of 2006 I began to consider purchasing a license to provide a proprietary treatment for patients addicted to alcohol, cocaine, and methamphetamine. There was little or no proof that the treatment worked, but given the devastation associated with methamphetamine addiction in particular it seemed this novel protocol using flumazenil, hydroxyzine, and gabapentin (all off-label and off-patent) might be worth trying provided the patient understood that the protocol might not work.

Representatives of the company informed me that I could purchase a license to provide the protocol in my office, but before spending thousands of dollars to use this patented treatment regimen I wanted to make sure my professional liability (malpractice) carrier would cover me and that the financial arrangement would not be considered unethical as some sort of fee-splitting arrangement or kickback to the company. The representatives told me I would collect a fee of thousand of dollars from the patient. One representative wrote in an email January 25, 2007 email, “As the patient comes to your practice for the treatment, our site manager notifies our corporate office who will invoice you for the license fee and the aftercare money of $1500. If the patient stays in your Outpatient tx program, you will bill us for the visits up to $1500. If you refer the patient to an IOP, that group will bill [the company] for their services.” I would then pass along to the company “$7450 for stimulant patients and $6400 for alcohol dependent” patients. This sounded enough like fee-splitting or a kickback to me that I wanted my colleagues in my professional association, the American Psychiatric Association, to assure me that it would meet ethical muster.

Professional Liability

By January 24, 2007 I asked my professional liability carrier about coverage, and by March I had an answer, but first an insurance underwriter raised the question of informed consent in an email: “Informed consent is extremely important as this is an unproven treatment using medications for off-label use. It would be appreciated if you could please provide a copy of the informed consent that you plan to use in your practice. ”

At this stage I had no access to the informed consent form, and I knew that, at least until publication of the applications for US Patents on the protocol, details of the protocol, even the drugs administered, were not divulged to the public. I, too, felt that informed consent would be critical, especially that I should be free to tell the patient what drugs I administered to them or that APA would consider ethical any constraints on that freedom.

The malpractice carrier ultimately declined to cover my use of the protocol in my office, citing what they believed to be an unacceptable risk of seizures associated with intravenous administration of flumazenil, a benzodiazepine receptor antagonist, but told me I could purchase coverage for this activity in a hospital setting such as an outpatient surgery department for a 25% surcharge added to my existing premiums.

The hospital of whose medical staff I am a member declined to allow me to provide the treatment in their outpatient surgery department on the grounds that there was too little evidence of effectiveness, but I decided to pursue the ethics questions anyway, knowing that I could ask the hospital again later and hoping that the requisite evidence of effectiveness might be forthcoming.

Informal ethics question

During my 20 years of membership in the Washington State Psychiatric Association I had twice before submitted questions to the ethics committee. In both cases a few telephone discussions led to consideration of my question at a meeting or two, then I received a letter with a clear determination, and an expression of gratitude for posing an interesting question.

But complications in resolving this ethics questions surfaced early. I first posed the question to WSPA ethics committee chair, Richard Adler, MD, in an email dated January 9, 2007. He asked me to submit the question via the WSPA president, but I knew that the licensing company, a publicly owned for-profit corporation, appeared to want to license physicians all over the country. It occurred to me that while my local APA association (WSPA) might find the financial arrangement ethical, another state association or district branch might determine that it was unethical. I reasoned that if the American Psychiatric Association ethics committee should consider the question so every psychiatrist in the country would know whether there might be an ethics problem.

APA

I contacted the APA ethics committee with the question in an email dated January 10, 2007. The APA ethics committee said they would not consider the question until the next yearly meeting in May, 2007, with an opinion to follow as late as mid summer. I provided her with the names of four psychiatrists listed on the company Web site as providing the treatment in my state.

A January 17, 2007 email indicated the question had been forwarded to APA ethics chair Wade Myers, MD, but he asked me for more information and wrote in a January 20, 2007 email to WSPA ethics chair Richard Adler, MD asking him whether he might be able to “assign a couple members of your Committee to review his concerns and provide him with some written feedback, hopefully within a couple of weeks if possible. I think it is ideal to have local WPSA [sic] MDs review this situation as they will best understand the professional landscape in your state and how it interfaces with this issue.” APA Medical Director and CEO James Scully, MD agreed in a letter dated May 2, 2007.

Non-Disclosure Agreement

The secrecy surrounding this company’s proprietary protocol also presented a problem for an ethics determination. The company apparently and understandably wanted to prevent an unlicensed (by the company) provider from copying the protocol, competing with licensed providers for a much lower fee and depriving the company of profits on its investment in the patents. When I asked a representative for a look at the licensing agreement, he forwarded my request to the company. Another representative of the company, in an email dated January 18, 2008, indicated I would have to sign the company’s “Confidentiality and Non-Disclosure Agreement” (NDA) which I understood would restrain me from revealing the contents of the agreement to anyone else. I realized this would also present a problem for the ethics committee since they might need to examine the exact wording of the agreement to make an ethics determination. If I agreed to non-disclosure, I would not be able to reveal the licensing agreement to the ethics committee. It seemed that at least one member of the ethics committee would have to sign the NDA and read the licensing agreement before the committee would be able to pass judgment.

On January 30, 2007 Dr. Adler forwarded a copy of my earlier email to then WSPA President Jason MacLurg, MD. In this message I had described the financial arrangement and raised the question of ethics related to informed consent. Dr. Adler informed Dr. MacLurg “As is the protocol, you do the initial review on ethics complaints.” On February 1 Dr. Adler wrote that the committee would be “discussing the matter this evening at our Ethics Committee meeting.”

Adler to the Company

Dr. Adler initiated contact with the company. He wrote in a February 2 email to the company:
“We received a complaint alleging that the arrangements related to [the protocol]:
“(1) reflect fee-splitting in that the clinician is provided referrals and a fee is paid for each patient treated and,
“(2) the patient is not provided information on the exact nature of the medication(s) used prior to signing a contract, thus precluding true informed consent.
“To address this ethics complaint it would probably be helpful to have relevant documents provided for review--such as the contract with providers, informed consent form, NDA.  Should you require written assurances about the limitations on the use of the material, I would be happy to sign an appropriate agreement.”

Dr. Adler was right to ask to be allowed to see the agreement, but he had taken some liberty with my original question. I had not complained or “alleged” at all. I had raised some questions. This was to prove a harbinger of things to come. He wrote on February 23 that he “signed an agreement with [the company] and they are sending us ALL relevant materials for review.” He added, “I anticipate 7-10 calendar days would be a good time frame,” but did not say for what.

“Seven to ten calendar days” stretched into weeks. I received no response from Dr. Adler to my phone calls and email. The “lead investigator” assigned to the case, a Dr. William Richie, left a message for me, but I was not able to get through to him until a Saturday in March during the annual meeting of the WSPA, which I attended, but he did not. I had little to offer in the way of additional information, but he promised a determination by March 30.

On April 3, 2007 I wrote newly elected WSPA president Robert Williams, DO, to ask for an explanation for the delay. I attended a meeting of the WSPA Executive Committee where I expressed my dismay at the delay and lack of communication. On April 13 Dr. Adler copied me on an email to Dr. Richie indicating his intent to “make this inquiry and keep all parties informed of the status.”
Dr. Richie replied to Dr. Adler the same day: “Based on this data, (and my interpretation of In re: C. Robert Crow, M.D., and later affirmed by the Fifth District Circuit Court in, Crow v. Agency for Health Care Administration) my preliminary assessment is that the ethics committee may have basis to consider a full case investigation, as the arrangement is apparently not “limited solely to fees generated by the physician from his own professional services and those services provided by individuals under his own direct supervision without reliance on fees generated from ancillary services,”.  (Those ancillary services being the referral service of [the company].) ”

Adler responded the following day: “the situation appears to represent a breach of ethics and [the author] stated last evening that he is aware of specific WSPA members who operate under these conditions/agreements.” Not exactly. To this day I have no direct knowledge of the actual financial arrangement of any physician providing the protocol.

In a letter dated April 16, 2007 I listed the names of four psychiatrists whose names I found on the company Web site said to provide the protocol in Washington State. I asked the committee to investigate whether any of them might be involved in an unethical financial arrangement as part of any license agreement with the company. I received acknowledgement in a letter from the WSPA office dated May 16 which also indicated the office forwarded copies of my letter to Drs. Adler and Williams.

Then I waited.

Continued: An Ethics Odyssey II

Wednesday, March 24, 2010

Independent Treatment: The Whole Truth

Every article I have read in the psychiatric literature about "split treatment" (The psychiatrist prescribes medication while another professional provides psychotherapy.) reveals a bias against this practice. The article by Drs. Mossman and Weston (Splitting Treatment: How to limit liability risk when you share a patient's care Current Psychiatry 9:3) continues the tradition. While purporting to help psychiatrists avoid malpractice suits related to independent treatment, this article will likely send plaintiffs' attorneys scurrying to the authors' doors for expert testimony to support antiquated theories based in myth. I hope to provide the whole truth, which may appeal more to defense attorneys, not to mention patients.

Mossman and Weston would have you believe the story started "not long ago," when "insight-oriented psychotherapy was the primary treatment" provided by psychiatrists. Not so. The truth is that psychiatry's dalliance with psychotherapy has probably spanned less than half the time since psychiatry's birth; is already a thing of the past; and 100 years from now will probably be viewed as a little blip. There have probably always been many psychiatrists who eschewed psychological treatment approaches, preferring ECT or medication, but psychiatrists only became enamored of psychotherapy with the introduction of psychoanalysis by Freud, who was himself a neurologist.

The terminology betrays the bias in discussions of this subject. "Split treatment" implies inferiority to "whole" treatment (without foundation). More accurate, less pejorative terms include "joint treatment" (which the authors do mention at least once), "collaborative" and "independent" treatment. The authors use these latter terms to designate types of "split-care relationships," but I argue that these terms may in fact be synonymous with split treatment. Collaborative care implies coordination, but still the non-psychiatrist provides the psychotherapy. This term has also been used to designate treatment models in which a primary care physician, rather than a psychiatrist, provides medical management. The term "med check" likewise demeans the medication management or psychopharmacology visit.

Independent care, rather than designating a type of split care, accurately and without bias describes the reality: When a psychiatrist prescribes medication, and a psychotherapist provides psychotherapy, each is an independent, presumably licensed or registered, professional. Neither assumes responsibility for the actions of the other, regardless of who wears the deepest malpractice pockets. What Mossman and Weston fail to mention is that each of these professionals may be "treating" something different. The psychiatrist may prescribe paroxetine for panic disorder while the family psychotherapist treats marital conflict or parenting problems. Yet another psychotherapist, a psychologist perhaps, may provide cognitive behavior therapy for the panic disorder, but even when the two professionals thus treat the same problem for the courts to hold either responsible for the actions of the other is a grievous error. Frequently the psychiatrist may treat a "brain disease" with medication or rTMS while the psychotherapist helps with life problems, related or unrelated to the psychiatric -- or other -- illness.

Another erroneous assumption in the Mossman Weston article, and indeed most discussions of independent treatment is that the duration of the two treatments coincides. In fact many psychiatric conditions require lifelong medication either for symptom control or for prevention. Psychotherapy, however, usually stops after certain goals are reached. This may apply especially to cognitive behavior therapy. No patient should have to continue 45-50 minute sessions indefinitely to satisfy the needs of the psychiatrist who has become stuck in the rut of psychotherapy. And psychiatrists who require all patients to be "in" psychotherapy for the duration of treatment have an obligation to inform each patient that other psychiatrists may require only short medication management visits.

Did I mention the patient? I read the Mossman Weston article twice or more and found no mention of what the patient wants. I regularly encounter patients in my practice who do not want psychotherapy. We must respect what the patient wants, even if ultimately we must guide some patients in a different direction. Some patients, too, want only psychotherapy. And even if the patient wants both, how many psychiatrists can provide skilled psychopharmacological treatment as well as excelling at a variety of different psychotherapies. The patient who needs CBT in addition to medication deserves the best CBT psychotherapist, and that will not likely be the psychiatrist. The patient with a substance use disorder may need a chemical dependency counselor. The patient has a right to choose which psychiatrist and which psychotherapist or counselor from whom he or she wishes to obtain treatment.

Myth: Psychiatrists are the best psychotherapists. Psychologists, social workers and others can possess skills in psychotherapy equal to or better than many psychiatrists. Medical school may provide essential foundations for a psychopharmacology practice, but not for psychotherapy.

Myth: The psychiatrist should judge the competence or credentials of the psychotherapist. This is absurd. No medical school, internship or residency trains any physician in how to "credential" a professional of another discipline. Would this be expected of a primary care provider in the same situation? I think not. Mossman and Weston say "find out if the potential collaborator is credentialed." Even they, however, do not tell us what they mean by credentialed. Would a drivers' license suffice? If the patient's hairdresser or massage therapist provides advice or comfort, must the  psychiatrist confirm registration or licensure? This raises another question. Suppose the patient wants to use a clergyman as a counselor, a Rabi or priest perhaps. Should the psychiatrist then check with God about this individuals "credentials?" Should she "respectfully inquire" about malpractice insurance? The irony in this is that how the courts view this issue may hinge on whether this counselor bills the patient for services. And yet psychotherapists in training programs may provide service at no charge, not to mention other givers of advice in the context of completely informal relationships. Must the psychiatrist then inquire about financial arrangements? What about an alcoholic patient's AA sponsor? I say it's none of our business, and none of our responsibility.

Myth: "Psychiatrists have a duty to ensure that their patients receive good care." The psychiatrist only has a duty to provide good care himself unless there exists a formal supervisory relationship as in a clinic.

Logistical problems: From time to time a patient will have the audacity to consult a non-physician psychotherapist, counselor, or, the latest thing, life coach, without obtaining the psychiatrists permission. Now the abused psychiatrist must decide whether to punish the patient by discharging them on the spot (while carefully avoiding the appearance of abandonment of course), contact the psychotherapist to coordinate care, or ignore this new problem. Perhaps the psychiatrist should add language to the already encyclopedic policy statement each patient probably glances at before tossing in recycling, language demanding that the patient inform the psychiatrist before daring to consult any other professional. Then there is the matter of staying in contact. Assuming the psychotherapist has the courtesy to return phone calls, remember that patient authorization for release of information may expire after 90 days. This means you must make sure that each such patient reactivate written authorization at least that often even when stable treatment dictates visits only a few times per year. It also means that at the very time when communication would seem must critical, when the patient fails to keep an appointment or return calls, providers may not have a way to obtain authorization.

Liability wrongly attached to independent treatment is not a problem for the psychiatrist to solve by knowing through which hoops to jump to avoid liability, but for the courts to solve by attending to reality and obtaining competent expert testimony that supports reality, instead of sour grapes psychiatrists who can't stop living in the past and give up an unjustified bias in favor of integrated treatment. We had enough of a problem with scarcity of psychiatrists before health care reform that psychologists and nurses were able to convince legislatures to give them prescribing privileges. With millions of Americans newly able to afford psychiatric care we should make it easier, not harder, for psychiatrists to focus on what only they are able to do best, psychoparmacotherapy, and leave the psychotherapy to non-physicians.

See also: The Real Reasons Psychiatrists Want to Provide Psychotherapy

Tuesday, March 23, 2010

Commentary on Opinions of APA Ethics Committee VIII

Continued from Commentary on Opinions of APA Ethics Committee VI with more miscellaneous items:

 G.1.b. (1977, 2001? page 31): Execution and assisted suicide
This opinion states, with regard to psychiatrist participation in execution: "... the physician-psychiatrist is a healer, not a killer..." But now at least two states allow "death with dignity" or assisted suicide in which a terminal patient might conceivably ask a psychiatrist to provide a prescription for a lethal dose of drug. Perhaps more likely the psychiatrist's "participation" might consist only of determining whether the terminal patient is competent to decide to end his or her life under such a statute.

When I asked the committee for an opinion the chairman responded thus (personal communication 10.26.2009):
"I read with interest about this relatively new statute (passed in November 2008) on line. As you know, the ethics surrounding a physician providing patient care in any given setting are unique. The physicians who participate in your death with dignity procedures are truly in a position to best comment on the ethics involved, given they have firsthand experience and can best judge the competing interests that weigh into the decision to participate or not for any given case. I would encourage them to write or otherwise communicate about the ethics of this area so we can all learn from their experiences. I have attached the AMA CEJA opinion on this area which you have probably seen, and I know that not all physicians agree with this view, one that has been greatly debated."

"Opinion 2.211 - Physician-Assisted Suicide
Physician-assisted suicide occurs when a physician facilitates a patient’s death by providing the necessary means and/or information to enable the patient to perform the life-ending act (eg, the physician provides sleeping pills and information about the lethal dose, while aware that the patient may commit suicide).

"It is understandable, though tragic, that some patients in extreme duress--such as those suffering from a terminal, painful, debilitating illness--may come to decide that death is preferable to life. However, allowing physicians to participate in assisted suicide would cause more harm than good. Physician-assisted suicide is fundamentally incompatible with the physician’s role as healer, would be difficult or impossible to control, and would pose serious societal risks.

"Instead of participating in assisted suicide, physicians must aggressively respond to the needs of patients at the end of life. Patients should not be abandoned once it is determined that cure is impossible. Multidisciplinary interventions should be sought including specialty consultation, hospice care, pastoral support, family counseling, and other modalities. Patients near the end of life must continue to receive emotional support, comfort care, adequate pain control, respect for patient autonomy, and good communication. (I, IV)

"Report: Issued June 1994 based on the reports "Decisions Near the End of Life," adopted June 1991, and "Physician-Assisted Suicide," adopted December 1993 (JAMA. 1992; 267: 2229-33); Updated June 1996."

I believe this is a cop out. APA should decide now whether to rubber stamp the AMA position and issue an opinion as to whether psychiatrists can ethically participate in competence evaluations for assisted suicide. Member psychiatrists and their patients deserve no less. APA should also address the ethics of participation in such competence evaluations where the psychiatrist might allow personal beliefs to influence the determination.

N.6.b. (1985, page 69): Admission of a patient to the hospital where he or she is employed
The opinion correctly states that no ethical question arises, but fails to point out that the patient's wishes should weigh heavily in the decision.

N.6.c. (1988, page 69): Continuity of care from office to hospital
The psychiatrists at a local mental health center do not have or want privileges at the local hospital. The committee opines that for these psychiatrists to refuse to care for "their" patients at the hospital might constitute abandonment rather than an ethical question. Abandonment is very much an ethical matter, but even in 1988 psychiatrists in many communities restricted their practices to office work, and rightly so. Continuity of care may have advantages for the patient, but there are also many advantages for the patient in accepting care from a different psychiatrist in the hospital, not the least of which is a built in second opinion.

O.2.b. (1978, page 70): Who's in charge here anyway?
The committee answers a question about whether an ethical psychiatrist can list his or her practice in a "professional" directory correctly as yes, but then recommends taking up any question about what might be considered "adverstising" with the "local medical society." Another cop out. The committee should take responsibility for addressing questions like this without deferring to some other unnamed organization. Advertisement show themselves even when you do not want them to. You must know what you are looking for to find a practice in a directory. Directory listing clearly does not constitute advertising.

D.4.f. (1987, page 24): Ethics of "completing forms"
According to this opinion it is not only unethical to decline to complete an insurance form but, at least in the case of a so-called "simplified" insurance claim form (Dose anyone even know what that is?), it is also unethical to charge for the time. This opinion belongs on the scrap heap. Completing a form is really a euphemism for whatever purpose the form serves. Insurance claim forms related to a contract between patient and physician. The physician's only obligation should be to the patient and should be restricted to providing diagnosis and medical care. I would argue that for the physician to take responsibility for obtaining benefits for the patient might be UNethical. The physician should certainly make it known to the patient up front if her policy is to not assist with insurance claims or to charge a fee for completing them. The patient can decide whether to accept the psychiatrist's terms of treatment, so-called "local custom" notwithstanding.

Skypiatry by the Sense

Or, What's the Sense in Skypiatry?

Despite the fact that physicians have talked to patients on the telephone for years, even sometimes charging a fee for the contact, risk managers have criticized patient contact via Skype or similar technology citing the fact that, while the psychiatrist can see and hear the patient, she will not be able to smell the patient. It occurs to me that this position fails to account for several other senses, and since it appears that each sense should add value to the interaction I propose a fee schedule for, let's say, Psychiatric Medication Management, by the sense:
  • Hearing the patient: $50
  • Seeing the patient: $40
  • Smelling the patient: $30
  • Tasting the patient: $20
  • Feeling the patient (tactile -- not empathy): deduct $20 for boundary violation. Naughty psychiatrist!
  • Empathy (That could be the sixth sense.): $20
Incidentally, physicians have practiced successfully while blind or deaf. Do you know of anyone has has been denied admission to medical school or medical licensure because of congenital or other anosmia?

    Monday, March 22, 2010

    Ritchie v. Krasner: Unnecessary Case; Unfortunate Verdict

    I found this case interesting in two respects. Reports have emphasized its implications for malpractice exposure in independent medical examiners, but it also illustrates some of the avoidable costs of a defective health care system.

    Facts:

    Ritchie claimed injury at work. The first providers to treat him, including a Dr. Robinson and a chiropractor,  requested an independent orthopedic exam authorized by Paula Insurance, the worker's compensation carrier. Orthopedic surgeon Krasner, the examiner, opined to Paula that Ritchie had suffered only a strain and needed no more treatment for any industrial injury. Paula terminated worker's comp benefits, and Ritchie failed to seek further care for 8 months despite continued symptoms, until he qualified for medical insurance, when his own physician, a Dr. Solomon, diagnosed spinal cord injury and recommended surgery. Residual symptoms were blamed on the delay, so Ritchie sued, first for malpractice, but then died of "accidental" overdose, so his family added wrongful death. The jury verdict awarded $5 million to the plaintiff against several defendants, including Krasner, who appealed. The Arizona appellate court affirmed the verdict (appellate opinion).

    Duty:

    Ordinarily doctors who conduct independent examinations for employers and insurance companies are not considered to owe a duty to the examinee, who is not their patient. In fact, often the questions asked of the doctor have little to do with practice of medicine. For example in worker's comp cases like this one examiners are routinely asked whether the cause of the illness or injury was work related. Such a question is rarely if ever relevant in medical practice.

    In its opinion the court acknowledges that in many cases of independent examination a duty to the examinee may not exist, but upheld the finding of duty in this case apparently because Ritchie claimed that he relied upon Krasner's opinion in "deciding" not to pursue treatment with his own providers. According to the opinion "Krasner’s report prevented Jeremy [Ritchie] from seeking treatment either because he relied on Krasner’s report or because Paula relied on the report, causing it to terminate Jeremy [Ritchie]’s workers’ compensation coverage.(¶28) But it appears that Ritchie's ultimate diagnosis was delayed, not because he did not seek treatment, but because he delayed seeking treatment either because coverage by AHCCCS was delayed (because he did not qualify financially) or because Ritchie chose to spend his money on something other than a physician or health insurance. He did in fact seek another medical opinion, this time from his own physician, as soon as he obtained medical benefits under AHCCCS.

     Ritchie's failure to obtain benefits was not the responsibility of Kranser or any other physician. If Krasner was negligent in opining that there was no industrial injury, for that aspect of his services his only duty, and his only dereliction of that duty, was to Paula. Only Paula should have cause of action against Krasner for such negligence. One wonders why Ritchie did not name Paula in the suit. ERISA? Some other sort of immunity?

    Although the opinion may not have addressed the issue directly it appears that the appellate court allowed that Krasner's duty flowed through Paula to him by way of denied benefits. This was wrong. Doctors have no duty to obtain benefits for an individual, regardless of the nature of the relationship. The role of a physician is to diagnose and treat illness. Krasner's liability should have been limited to what would have occurred had Ritchie had access to care. This issue has become a problem in states where treating physicians must claim that a condition was work related in order to obtain reimbursement. Even though most states exclude mental-mental or stress claims, physical-mental claims (mental disorders arising out of physical injuries) commonly arise creating role conflicts for psychiatrists. Independent examiners, not treating psychiatrists, should determine causality.

    Damages:
    The jury may have erred in finding that Krasner's presumed negligence was the proximate cause of Ritchie's death. Ritchie's history of alcoholism and other substance abuse suggests that he had already established a pattern of ignoring directions in taking drugs he knew or should have known would be dangerous in overdose. He may also have been able to obtain the same drugs illicitly. Furthermore, it is likely that he used the drugs, or used too high a dose of the drugs, not to treat injury-related pain, but to get high. Once more this could not reasonably be blamed on Dr. Krasner. The logic in the appellate argument applying a foreseeability test is flawed. It is in fact also foreseeable that "from time to time" anyone to whom opiate agonists are prescribed will lie to physicians to obtain drugs or use the drugs to get high. This does not require negligence on the part of the prescribing physician. It is also of course foreseeable that any individual with or without a history of addiction will "from time to time" (¶26) overdose on any of a variety of drugs (obtained from any source) and die. What is particularly unjust in this case is that Ritchie's family and attorneys should receive a $5 million award while others whose family members died of overdose of the same or similar drugs receive not a penny simply because the decedent did not have the consideration to visit a doctor beforehand.

    Implications for independent examiners (Good news and bad news):

    The good news: HIPAA requires covered entities to provide records to examinees. Insurers often demand that examiners refrain from releasing reports, and some state statutes support that position. Examining physicians are caught in the middle. This appellate opinion suggests that independent examiners should inform examinees of important findings. In my experience most examinees obtain copies of reports eventually anyway. Making release of such records standard practice would simplify the work of independent examiners.

    Of course while this sounds simple in theory, attempting to establish policies for putting this into practice raises more questions. Physicians may no longer be caught in the middle, but given that a physician intends to share a finding with an examinee, how will this be accomplished without establishing a physician-patient relationship, further muddling the line between the two roles? This could lead to reduced credibility and objectivity in examiners and, worse, sloppy attempts to fulfill the role of treating physician. Will it be sufficient to provide a copy of the report to the examinee? Standard of care may require that the physician meet face to face with a patient to deliver bad news about diagnosis, and answer questions. How will examiners accomplish this? Who should pay for the contact? How should it be documented? Will this create added duty? and added liability? Will it suffice to recommend that the examinee seek follow up care with another physician who may have access to the examiner's report?

    The remedy for independent examiners:
    • Warn all examinees not to rely upon the opinion. 
    • Warn all examinees to obtain second opinions from their own physicians.
    Unintended consequences:
    • Professional liability premiums and worker's comp insurance premiums will increase. 
    • The cost of independent examinations will rise. 
    • Physician's fees will increase. 
    • Physicians will seek to avoid entanglement in similar cases by whatever means they can.
    Ironies:

    Had Mr. Ritchie applied for insurance after his injury and described his symptoms on the application, the insurer might deny coverage because of the preexisting illness or, if he concealed the symptoms, argue that he should have sought medical care for his symptoms in canceling his policy or denying coverage for a preexisting condition. Is it fair to apply a different rule where Dr. Krasner is concerned? Hardly.

    As I write this Congress moves toward health care reform which could prevent cases like this. This case might never have occurred were it not for the fact that Ritchie lost his coverage, presumably while losing his job. He would not have had to prove an industrial cause of his symptoms in order to obtain care from his own physician.

    Independent examiners for worker's compensation should not have to determine whether a worker will have medical insurance or not. They should determine only who will pay: the industrial fund or ordinary health insurance.

    Wednesday, March 17, 2010

    A Working Definition for Self Medication

    (See: Hien, et al, Do Treatment Improvements in PTSD Severity Affect Substance Use Outcomes? A Secondary Analysis From a Randomized Clinical Trial in NIDA’s Clinical Trials Network Am J Psychiatry 2010; 167:95-101)

    Most discussions of self medication fail to address whether it is use or disordered use that is supposed to “treat” an underlying illness. One notion of self-medication would suggest that effective treatment of the illness would lead to abstinence. An alternative notion suggests that effective treatment of the illness might, for example, leave an alcoholic capable of controlled, rather than uncontrolled, drinking. No generally accepted rigorous definition of self-medication exists currently.

    It is not necessary to invoke a self medication hypothesis or model to explain the findings in this study. And in fact the findings also support the opposite conclusion. If high intensity of symptoms occur during times when there is heavy substance use, this suggests that at best the substance fails to treat the symptoms, and perhaps that it exacerbates the symptoms.

    The authors present no data regarding the relationship of the date of trauma to the onset of substance use or disordered substance use. If substance use (disorder) predates the trauma, it is more likely that the substance use contributed to exposure to trauma.

    It is challenging for an addict or alcoholic to achieve abstinence even in the absence of mental disorder. The study supports the idea that effective treatment of co-occurring mental disorder should enhance recovery from SUD. However, the study does not address ethical or logistical considerations in attempting to treat a mental disorder in a patient who regularly uses substances of abuse, particularly where those substances may interact adversely with pharmaceuticals or where they might seem likely to exacerbate symptoms of the mental disorder. It should be noted that of all the drugs listed as used by participants in the study only “sedatives” (and barbiturates, which are themselves sedatives) would seem likely to provide any benefit to the symptoms of PTSD, and these were among the least used of the drugs listed. Also, cocaine, among the most used substances, would seem likely to exacerbate any anxiety disorder, including PTSD. There is certainly no evidence from any clinical trial of which I am aware that cocaine might have any therapeutic effect for treating PTSD. These two facts combined with the fact that sedatives might be more easily obtained than cocaine, weigh strongly against a self-medication model.

    The authors of this paper like many other authors use the term self medication without defining it. The usual implied definition seeks to explain the patient’s “reason” for using the drug. However, we know that addiction is about how drugs are used, not why, and that the purpose of use, e.g. to get high, may have little to do with the rationalization, e.g., to relax.

    Khantzian’s original self-medication hypothesis related not to Axis I, but to Axis II, and not even necessarily to a disorder. He suggested that the choice of drug of someone who was addicted might be explained as compensating for undesired personality traits. This hypothesis did not address how the drug was used. Furthermore, this hypothesis only made sense for those addicted to a single substance, the mythical drug of choice.

    Proposed operational definition

    I propose first the “SEE” test. The degree to which the substance use in question fulfills these criteria determines the degree to which self medication has occurred:
    •     Specificity: The drug’s beneficial effect is specific to the symptom. For example general anesthesia will remove awareness of almost any symptom, but does not meet the specificity test. (Rarely a characteristic of drugs of abuse which produce a state of euphoria rather than removing a symptom.)
    •     Efficacy: The drug attenuates or removes symptoms (Rarely a characteristic of drugs of abuse, many of which cause or exacerbate symptoms, depending on dose.)
    •     Economy: The drug is used only after symptoms have started, and only in amounts necessary to control symptoms (not usually a characteristic of disordered substance use). Persistent drug use in the absence of symptoms fails this arm of the test.
    Next we apply this SEE test to what might be called types or stages of self medication:

        Primary (na├»ve) self-medication: The patient has never used the drug before, but based on information from another source, or simply because no other treatment is available, chooses to experiment. For example, Joe develops a headache and finds only a bottle of fluoxetine in the medicine cabinet, so he tries one tablet. The headache gets slightly worse. He never uses the drug again.
        This type is of little relevance to disordered substance use.

        Secondary self-medication: The patient has used the drug before with some benefit and decides to try it a second time based on that experience. For example, Judy develops a headache. The last time she experienced a headache she tried acetaminophen and the headache improved markedly after about 20 minutes. This second use of the drug produces a similar result.
        This type again is of little interest related to substance use.

        Tertiary self-medication: The patient has used the drug multiple times in the past and begins to use it regularly. Now we must consider three subtypes:

    a)    S(+) E(+) E(+): A patient with recurrent back pain has an old bottle of oxycodone used several times in the past for a variety of painful conditions or injuries. It was first prescribed after a dental procedure. She takes the drug for several days according to dosing directions on the bottle. She finds the side effects mildly unpleasant and stops taking the drug when she realizes the pain has remitted.

    This patient medicated herself in a way that one could argue was appropriate even though it was not recommended by a physician. Is this disordered use? It certainly was not used to get high. To call this self medication may be valid but is trivial.

    b)    S(+) E(+) E(-): Another patient with chronic back pain like the patient above begins taking oxycodone from a bottle prescribed for her father before he died of cancer. After taking the drug regularly for weeks she notices diminished effect so she increases the dose. She too dislikes the side effects, especially after she begins to experience withdrawal symptoms when she tries to do without the drug, even though the pain has remitted. She flushes the remaining pills down the toilet resolving never to use them again, and does well after several days of intense, but diminishing, withdrawal discomfort. Several months later an oral surgeon prescribes the same drug after a procedure. After the first dose, recalling her previous negative experience, she switches to ibuprophen. This patient was physiologically dependent on the drug but not addicted.

    This is the first case in which use of the drug after resolution of symptoms serves the purpose of “self medicating” not a separate illness or symptom, but rather symptoms that directly result from absence of the drug (which we call withdrawal. Again this use of the term seems trivial.

    c)    S(-) E(-) E(-): Our next patient suffers from chronic nausea. He looks through his friend’s medicine cabinet, finding only an old bottle of oxycodone. He recalls the last time he used the drug he became mildly nauseated, but what stands out in his mind is the recollection of intense euphoria that dominated any negative effect. He takes the drug, and despite worsening nausea, and once more experiencing euphoria, continues to take it regularly. Like the patient in b) he soon finds he must increase the dose of the drug but never quite experiences the level of euphoria of the first few uses. He also experiences withdrawal symptoms so intensely that when he exhausts his supply he visits a local emergency room where he feigns severe headache in order to obtain another prescription. He was physiologically dependent and addicted.

    This patient like patient b) has reverted to secondary self medication of withdrawal symptoms, but his purpose in using is only to reduce withdrawal symptoms or in the hope of attaining euphoria. This clearly meets the definition of disordered use, regardless of whether the term self medication applies. Because the drug causes nausea it is illogical to say he is medicating that symptom.

    It is critical to understand that in the case of “tertiary self-medication” any combination of a, b, and c is possible, that is a patient may be “treating” real symptoms effectively, becoming physiologically dependent, and also seeking a euphoric effect. I have not proposed an S(+) E(-) E(-) case because specificity requires efficacy.

    To judge the extent to which application of the term self medication to the study we would need to know more about the patterns of use and the effect of the drugs used. In general, however, it appears that the use described fails the SEE test. There is no evidence for Specificity as the patients used a variety of drugs with varied effects, but all can produce a high. There is no evidence for Efficacy for any of the drugs in treating post-traumatic stress disorder. In fact it is more likely that use of the drugs exacerbated the illness. There is no evidence for Economy as the authors failed to demonstrate that use was restricted to the amount necessary to control the symptoms.

    What this study does demonstrate is that it may not be necessary to stop substance use before treating PTSD. The study does not support a self medication model with any useful definition. It does not support the notion that treating the underlying illness can lead to controlled substance use or that the SUD is not a separate disorder. Mention of self medication in this study was gratuitous. Pending a more rigorous definition the term is either trivial or meaningless and should be abandoned in discussions of disordered substance use.

    Jack London knew almost 100 years ago the irrelevance of the "reason" for using to the addiction itself:

    "It is the way of John Barleycorn. When good fortune comes, they drink. When they have no fortune they drink to the hope of good fortune. If fortune be ill, they drink to forget it. If they meet a friend, they drink. If they quarrel with a friend and lose him, they drink. If their lovemaking be crowned with success, they are so happy they needs must drink. If they be jilted, they drink for the contrary reason. And if they haven't anything to do at all, why they take a drink, secure in the knowledge that when they have taken a sufficient number of drinks the maggots will start crawling in their brain and they will have their hands full with things to do. When they are sober they want to drink; and when they have drunk they want to drink more.
    Jack London, John Barleycorn or Alcoholic Memoirs

    Tuesday, March 16, 2010

    Commentary on Opinions of APA Ethics Committee VII

    Continued from Commentary on Opinions of APA Ethics Committee VI these next items do not easily fall together in a category:

    E.2.d. (2001, page 27): Healing from reporting professional misconduct?
    In this case a psychiatrist asks whether it would be ethical to report sexual misconduct of another psychiatrist to the licensing board over the objection of the patient. Not an easy question, the answer may depend on reporting statutes, but I object to the committee's opinion that the treating psychiatrist suggest that the patient report the misconduct "as part of a healing process." As in many of these cases the opinion appears to presume that the current treatment involves psychotherapy, but makes no mention of treatment modality. Even assuming a psychotherapy context it seems presumptuous to suggest that reporting might contribute to healing. Potential also exists for further harm. The opinion make no mention of diagnosis. Should the psychiatrist devote visit time to pushing this presumably separate issue? But what bothers me most is that while the psychiatrist should keep this patient's welfare foremost, reporting seems more likely to satisfy the psychiatris's own needs and possibly protect other patients in the future. I believe simply informing the patient of the option might constitute the most ethical course.

    N.4.b. (1988, page 66):
    In this case the psychiatrist want to know whether there might be an ethical problem with asking the phone company to intervene with an ex-patient who harasses with abusive calls. I agree with the committee that as a last resort the psychiatrist can ethically enlist the phone company's assistance, but with the proviso that the psychiatrist does not have to tell the phone company that the individual named was a patient. This opinion, however, begs for an update to the day of voice mail and stalking. New technologies may enable the victim of such harassment to block the calls, but the psychiatrist may want to consider other steps to ensure safety.

    A.2.b. (1978, page 8): Investment advice from the psychiatrist
    This psychiatrist wants to know whether an ethical problem exists with accepting a "finder's fee" after providing investment advice. The opinion correctly identifies an ethical problem with the implied exploitation, but incorrectly attributes this to giving advice, rather than the real exploitation: accepting a fee. The suggestion that this would be a "strange form of psychotherapy," however, is gratuitous. While we might characterize many methods of psychotherapy as strange, first, the question makes no mention of psychotherapy, and second, there is no suggestion that giving investment advice was part of the treatment at all. This question involves dual roles: that of treating physician and that of investment adviser. We can presume the goal of the latter would be to obtain money for the patient (not to mention the fee for the psychiatrist). The opinion here may conflict with other opinions where the committee has endorsed a similar role of obtaining money for the patient by "completing forms" or assisting in a disability or other claim. Of course the psychiatrist should not accept a "finder's fee" in connection with either of these roles, but I would argue that even without such a fee ethical problems exist. One can no more be treater and investment adviser than treater and lover.

    N.4.e. (1993, page 67): Do records go to the patient after the psychiatrist dies?
    The committee opines in this case that after the death of a psychiatrist executors should refuse to provide treatment records to a patient requesting them. This opinion may conflict with law, including HIPAA, which may require such release unless there is reason to believe the patient or someone else might be endangered as a result. Unfortunately the executors probably cannot make such a determination, and probably should not access the records anyway. To fully comply with the law may require that a professional review the records and the request, and/or attempt to convince the patient to agree to have the records forwarded to a new treating professional who might assist with such a determination.

    N.6.a. (1978, page 68): Unethical to refuse Medicaid?
    A retiring psychiatrist cannot find new providers to assume the care of patients covered only by Medicaid. The committee states, "Your colleagues might wish to consider their roles as ethical providers in assisting you and your patients in your time of need." This statement seems to imply that refusing to accept a patient covered by Medicaid might be unethical. This conflicts with Section 6 which indicates a physician shall be "free to choose whom to serve." If we took it upon ourselves to serve all those who cannot afford it we physicians would enter that group as well.

    I.4.b. (1998, page 41): Insurer audit by "appropriate" clinician
    This opinion addresses some of the ethical issues surrounding audit of patient charts by insurers (managed care companies). The opinion omits the fact that clinicians must allow such an audit only if they have contracted with the payer. Agreeing to certain terms of such contracts raises ethical issues as well. The opinion here states that the audit should take place in the psychiatrist's office and implies that the psychiatrist should insure that only "appropriate clinicians" see the records. This of course assumes that the insurer has not demanded that the psychiatrist send them a copy of the records in which case the psychiatrist will not be able to observe who sees the records. But suppose the audit does take place in the office. What constitutes an "appropriate clinician." Review of such records does not constitute clinical activity, and even if it did, how does the committee propose that a psychiatrist verify the credentials of the reviewer. The best way to avoid this predicament is to eschew contracts with insurers, but for those who choose to agree to their terms it is not within the capability of a practicing psychiatrist to verify the credentials of anyone who happens to work for an insurer.

    C.6.a. (1990, page 20): How to determine competence of replacements
    A psychiatrist leaving a hospital want to know whether it is ethical to turn over patients to a psychiatrist whose "competency" (I think they meant competence.) is unknown to her. I get the feeling another agenda might be hiding here. I suspect the hospital, right or wrong, may want this psychiatrist to leave, and the psychiatrist is trying to make a case against the hospital. The committee's easy answer is to advise the hospital to seek competent replacements. Is that it? And what choice does this psychiatrist have? Wait indefinitely until this competent replacement appears? And how does this psychiatrist determine this individual is competent? That job belongs to the medical staff or the hospital itself, not the departing psychiatrist.

    D.2.b. (1993, page 22): Public perception counts.
    The question and answer here count less than the justification. The committee invokes the importance of the "public's perception of psychiatry" in supporting the opinion. While this may not seem as relevant to ethics on the surface as, for example, sex with a patient, in my opinion it goes to the heart of professional ethics. For our patients to trust us to provide treatment they must perceive that we behave ethically.

    Commentary on Opinions of APA Ethics Committee VIII

    Saturday, March 13, 2010

    Treat Physical Pain Safely With Buprenorphine

    "Authorities: Haim had illegal prescription" reads the headline on msnbc.com. Other news media regularly feature stories about deaths from overdose with legally prescribed narcotic analgesics like hydrocodone, the narcotic analgesic in Vicodin, and oxycodone, the narcotic analgesic in Oxycontin, Percodan and Percocet. At high enough doses these drugs can make you stop breathing and die.

    Doctors, long familiar with prescribing these drugs, are damned if they do, damned if they don't. When medical boards threatened to revoke our licenses for prescribing them too freely, we cut back. Then we were accused of withholding indicated analgesics and allowing our patients to suffer needlessly. But even if the doctor happens by some stroke of luck to get it just right the patient can take too much and die, even unintentionally.

    What doctors (or patients) need is an analgesic that is effective but safe, one that attenuates pain but will not get you high or euphoric, but especially one that, even if you took the whole bottle, would not kill you.

    I wish I could tell you FDA approval of such a drug was just around the corner, or maybe that I could announce that FDA just approved it, but in fact the FDA approved just such a drug, buprenorphine, in 1981 as Buprenex. Buprenex, now available as generics, comes only as a parenteral (injectable) preparation, but FDA approved a formulation that dissolves under the tongue in 2002. Although only approved for treating opiate dependence doctors can prescribe it to treat pain off label quite legally.

    Why don't more physicians prescribe buprenorphine for injuries or post-surgical pain? Even though I have prescribed the drug for treatment of opiate addiction since it became available in 2003 I only realized within the past year or so that physicians can prescribe it legally off label. I suspect few other physicians realize this, but even if I were to tell them they would be reluctant to try something unfamiliar. I also believe many patients would object to having to take the drug sublingually, and most patients dislike the flavor. Of course the good thing about all that is the fact that often NSAID's like ibuprofen adequately control pain in those situations, and the bad taste might push many patients to take a drug from that class rather than the narcotic.

    I hope I haven't missed something in this, but I plan to start encouraging my colleagues (and maybe even my dentist) to consider prescribing buprenorphine for pain instead of the -codone's. It might save some lives.

    Friday, March 5, 2010

    EHR's and APA

    @dr_bob (http://www.dr-bob.org/) suggested psychiatrists might embrace an EHR (EMR) provided or sponsored by the Amereican Psychiatric Association. I said that might scare some of us away. He countered with the question of whether low cost might be an incentive.

    I see 2 issues here. First the EHR: I learned a little Fortran in '69 at a summer job at NASA when the equivalent of pressing enter was to put a rubber band around a stack of punch cards, drive them across the base to the data reduction center, and drop them off at the IBM 360. With luck you got a printout the next day. I started patching together my own ersatz EHR around '84 after I bought my first PC. Now I use, on a Tablet PC I can hold in my lap and write upon while sitting with a patient, a combination of MS Word, GoldMine (contact management), iscribe (soon to be allscripts, online prescribing), efax, and Dragon. For evaluations and forensic reports I use Audiacity to create an mp3 which I encrypt before I ftp the file to New Delhi for transcription. I have templates for reports. I use Excel for keeping track of time and Access for record reviews on forensic cases. My billing software is still on an old DOS PC. I frequently synchronize my computer with my office manager's desktop, and her desktop with my (now obsolete) Palm Treo. I still do not trust the digital version of my records; I print a new page every time I add a progress note or paste in lab results and put it in a manila folder. I use Skype for some patient contacts. I do not "bill electronically" so I am not a covered entity under HIPAA.

    I tried to "upgrade" to an EHR around 1988. I spent hours researching the product to make sure it would do everything I wanted it to. It took only about 2 days of use for me to discover that it was a total flop and revert to my existing system.

    I could write pages about features, capabilities, bells and whistles, but the critical element for me that I doubt I will find in an EHR is this: My contact management software holds not only all my patient contact information, but also all my business, forensic, and personal contact information. I have everything in one place, two if you count the smart phone, practically all the time and everywhere I go. But after I mistakenly sent an email intended for a friend to the executive director of my state psychiatric association I decided I would not even keep a record of any patient's email address, much less communicate with patients via email.

    So let me know when they write an EHR that allows me to keep all my non-patient contact info in the same place as my patient contacts. I also want it to be "in the cloud" and to be fully integrated with a smart phone like the iphone or Nexus One.

    Now for APA: I'm disenchanted with the organization. I told Dr. Bob I probably would quit were it not for the cheap professional liability insurance, and for the opportunity to torment the risk managers there. I believe APA is stuck in the 1950's, still thinking of psychiatrists as "therapists" and of psychoanalytic theory as a core competency in psychiatry. And when I made inquiries about the professional liability insurance underwriting debacle several years ago someone in the APA administration had the audacity to refuse my questions based on a policy of not releasing that information "to the public."

    So I don't want to get any more "hooked on" APA than I already am. On the other hand the idea that large numbers of practicing psychiatrists might have the same EHR appeals to me. And of course the cheaper the better.

    Skypiatry Hint

    Thinking it would make my Skype user-name easier to remember for patients I started it with the letters "dr" and followed with my name. Then a patient pointed out that her husband, who does not know that she suffers from a mental illness, might see the user-name on the computer, arousing his curiosity.

    I plan to change my user-name, which appears to require that I start from scratch with a new account, probably a different email address. It will be worth the trouble.

    I suggest if you set up an account yourself that you pick a user-name that has not association with your profession.

    Thursday, March 4, 2010

    Homeopathic Cure for Drowning

    I understand that to produce a homeopathic remedy requires several steps:

    1) Get some of the stuff that causes the illness
    2) Dilute it 10:1 with water.
    3) Succuss (shake) it .
    4) Repeat #2
    5) Repeat #3
    6) Continue repeating 2 & 3 until you end up with what is well shaken water. Maybe 10 times.

    So you find someone who just drowned. The offending agent will usually be whatever water they drowned in. There should be plenty nearby. Get maybe a cup or bottle full. Now you must dilute it with -- you guessed it -- water. Once more you will find plenty readily at hand. Now dilute that water with more water and shake it thoroughly. Take a small amount of the resulting liquid and dilute it with more water, again shaking (sorry, succussing) it vigorously. Repeat this process 10(?) times before administering a sufficient amount to the victim. Here's the rub: If the victim is not conscious, you should not try to get them to swallow the water or even place any water in his mouth. If the victim is conscious, he may not need this treatment, but if he is thirsty maybe you could let him have a few small sips.

    Disclaimer: I am not a homeopathic physician. Before you attempt to use this treatment on a drowning victim consult a licensed, registered or certified homeopathic physician.

    Wednesday, March 3, 2010

    Buprenorphine Pill Counting: Make Believe Medicine

    I just found this in PCSS on Adherence, Diversion and Misuse of Sublingual Buprenorphine:

    "Pill counts: Having the patient bring in the bottle for a pill count at every visit helps to monitor the rate at which the pills are being consumed.

    "Unannounced monitoring: Both urine testing and pill counts can be done ‘randomly’. The patient is contacted and must appear to give a urine test and have a pill count within a specified time, for example 24 hours after a phone call. Of course, pill counting can also be subverted, and anecdotal reports of “pill renting” are common."

    Sounds like a great idea. Anybody can count, even doctors. Your OBOT patient dutifully brings the bottle for their last buprenorphine prescription. If you prescribed just enough to get the patient through that visit, the bottle should be empty. If the bottle still contains pills you admonish the patient for non-compliance and/or reduce their dose accordingly. If you ordered enough to last beyond that visit, you can count the remaining pills to make sure just enough remain to last through the appropriate date. If too many remain you again admonish and reduce, but if too few remain, you can say "gotcha" and discharge the patient for presumption of diversion or, heaven forbid, for taking more than prescribed.

    Even the PCSS seems to acknowledge that patients are not stupid by admitting that you may more likely catch the patient in such a transgression by calling them back unexpectedly to appear 24 hours after a phone call, and that what they call "pill renting" may occur. The unexpected call back should catch the patient who has sold all or most of the prescription soon after purchase. But as the guidance suggests the enterprising "patient" need only "rent" or purchase the necessary number of pills to present for counting, and sell them again.

    The problems with this strategy extend far beyond pill renting, however. To paraphrase the adage, addicts of a feather flock together.  I suspect the pretend patient who sells all or most of her buprenorphine can easily find enough to rent or buy back, but I have also treated many patients along with friends, spouses, siblings, parents and children. Let's say both husband and wife want buprenorphine, but only one has insurance. The husband gets treatment, claiming to need 16 mg daily, but shares half the pills with the wife. No need to rent or buy back anything. The pills may still be in the same bottle.

    I hope I do not need to explain that having too many pills will not likely occur. All the patient must do is leave the requisite number of pills elsewhere when you do the count. If this happens you should evaluate your patient for dementia.

    If you insist on pretending that random call  backs for pill counting tells you anything at all, consider that the likelihood of catching a diverter diminishes rapidly with time. The longer you wait, the lower the count should be, and the fewer pills the patient will have to come up with to avoid detection.

    Now consider some other factors: The fact that you should inform your patient of the possibility of pill counts at the start of treatment all but eliminates the likelihood of surprise. Then consider the excuses for not getting back to the office for the count (I'm lucky if I can get some of my patients to keep regularly scheduled appointments.):

    "I can't miss work/school."
    "I have to take care of the kids/grandma/grandpa."
    "My car broke down."
    "I'm sick."
    "I'm traveling out of town/state/country."

    or the excuses for having too few pills:

    "The dog ate them."
    "My brother stole them."
    "The doorman/police/customs confiscated them."
    "I dropped them down the toilet/drain/sink/well/man hole."

    "so could you please order me a replacement prescription. I'm so glad you called."

    And suppose your patient lives 3 hours from your office.

    There's more: Pharmacists are trained and licensed to count pills. Physicians are not. Physicians diagnose and treat illness. Law enforcement officers and agents should pursue diversion. Is there a CPT code for counting pills? Does any third party payer reimburse for counting pills? This is not to say that physicians should write unlimited prescriptions for controlled substances. We should not. For my part I make it clear to patients that I will not order replacement prescriptions unless the patient provides me with a receipt from law enforcement stating the number of pills confiscated. Then I attempt to account for the possibility the confiscated pills may be returned to the patient later. Several patients have left my practice after I refused to replace "lost" prescriptions. But of course they, like the patient you discharge for failing the pill count test, will find another source, legal or illicit, for buprenorphine.

    I never cease to be amazed at the willingness of physicians to do whatever is demanded of them (getting paid for or not) without thinking. Sign this form. Sure. Sign this contract. OK. I don't even need to read it. Count pills. Any time. Reminds me of my all time favorite lawyer joke, which I believe may be misdirected. After all, lawyers only advocate; they don't decide the verdicts:

    Why do we use lawyers instead of rats for medical research?
    -Lawyers are  more plentiful.
    -You can develop an emotional attachment to a rat.
    -There are still a few things you can't get a rat to do.

    It seems to me the last reason at least might apply to many of us in the medical profession more than to lawyers.

    I have seen no evidence that pill counts impact diversion. The logistical problems outweigh any potential impact. Physicians should abandon this futile pretense, leaving diversion control to law enforcement, and pill counting to pharmacists.

    Tuesday, March 2, 2010

    Worst Experience of My Career: a Follow Up

    Previous post: Agents in the Waiting Room: To Warn or Not

    In DEA Suboxone Audit: Worst Experience of My Career As a Physician I relayed a first hand account of an audit of an OBOT physician by DEA agents.

    [I am postponing the bulk of this post indefinitely at the request of the physician, but stay tuned]

    The bottom line: Because of these audits opiate addicts will find it more difficult to obtain effective treatment. They will likely continue to obtain drugs illegally, in many cases provided by those physicians DEA should target. Some of them will die. And DEA agents will have more job security.

    Audits should be conducted by administrative personnel who know how to conduct themselves with respect in a physician’s office, not law enforcement personnel, who instead should pursue suspected criminals. DEA should schedule audits. If DEA wants to collect information about trends in drug use, they should look elsewhere. Patients should be informed and have an opportunity to object if agents attempt to force access to records without a court order. I might consider refusing access to identified records in the absence of a court order. Physicians should consider refusing to provide information in writing or orally that does not relate to the stated purpose of the audit.

    Illinois attorney Glen Crick wrote about DEA inspections with a focus on requests to surrender registration:

    http://www.cricklaw.com/docs/Request_to_Surrender_DEA_Registration.pdf

    You have a right to obtain legal counsel. But according to yet another physician, Agent Nice denounced Dr. Brave for retaining an attorney. Patients in your waiting room have a right to know these are law enforcement agents. Physicians should make sure to have a witness such as an office manager present during the audit: Agents may lie about what happened during their investigation at your office. Do not trust what a DEA agent tells you during an audit.

    Maybe you or another physician will qualify for one of these:


    or speak out from your bumper. Better yet, send one as a gift to your favorite DEA agent. I sent one to R. Gil Kerlikowske at the Office of National Drug Control Policy: