This is a true story.
Not too many years ago, my father-in-law and mother-in-law came to town for Thanksgiving. They had to drive about 6 hours to get here and in their haste to leave town, they forgot some of their medications. We were able to get the scripts filled at a 24 hour pharmacy, but the pharmacist said: "You can come down and wait - but it will take a while." I drove down around midnight and there were about 15 people standing there. "Not too bad I thought" and took a seat. Over the next 30 minutes the crowd started to build. This was the Wednesday night before Thanksgiving, but we were already into Thursday. I could see the pharmacist and noted he was a PharmD. He was also working furiously. He was literally filling prescriptions at the rate of 1 - 2 every 5 minutes while taking telephone calls. I noticed at the 30 minute mark he was starting to break a sweat. The next time I looked up there were over a hundred people there, pushing back through the aisles.
The pharmacist's work ethic was not enough to appease the crowd and it was getting ugly. It started out with the kind of atmosphere you find on an airplane when a passenger does something to delay take-off. A lot of irritable people grumbling under their breath and rolling their eyes for the most part, but the occasional well enunciated expletive. "Great" I thought: "Here is a guy who has a PharmD working as fast as anyone can work and it is not fast enough for the growing mob." To make matters worse, a very crabby middle-aged women sat down right next to me. As the crowd got angrier, she started to ridicule them. It was hard to believe at first, but she would lean over to me like we were best friends and make incredibly crude remarks at the people in the front of the crowd. Even though she leaned toward me, she projected her statements right at the front row. I thought about whether I should intervene and talk with her but instead, I just dissociated and hoped that my prescription would come up soon and I could get out of there. Besides, the angry young men in the crowd had already made the decision that there was probably nothing to be gained from arguing with an irritable middle-aged woman much less pummeling her.
I thought back to the pharmacists I knew well. Working mostly in a hospital setting you get to know a lot of pharmacists. They are a critical part of just about very level of care that involves medications. They participate in Pharmacy and Therapeutics (P&T) Committees and provide most of the hard data for discussion. They sign off on all physician orders and call that physician if there is a problem. They provide education for physicians, patients, and nursing staff. These days they monitor and change the orders on warfarin and some antibiotic therapies and do the phrmacokinetics. In many cases they work with Infectious Disease teams on monitoring antibiotic and fungal resistance as well as antibiotic selection for drug resistant bacterial infections. They used to work in teams with inpatient units and discuss drug interactions and pharmacokinetics. For years they would come in person to my unit to trouble shoot all things in person on my unit every day.
At least until managed care decided that pharmacists should just crank out prescriptions. Clinical pharmacists disappeared from their consulting roles. Initially just a few units. We still had a pharmacist to consult with, but eventually that person (who specialized in psychopharmacology) also disappeared. I would drop by the pharmacy to pick up scripts and see my old colleagues all working furiously - just like the PharmD I was watching through the window in the 24 Hour Pharmacy. They were so busy filling prescriptions they barely had time to look up.
For anyone who thinks that only physicians have been marginalized by the management that goes along with managed care, it really goes across the board. Pharmacists, nurses, and clerical workers are all put on the same production plan. I always wonder how we survived doing things in a collegial manner before all of the management geniuses showed up. Is it an artifact of managed care that there now seem to be billions of prescriptions more than before we were in a managed care environment? Is it the logical outcome of of widget production? The prescriptions in the 1980s all got filled and I still talked with the clinical pharmacists in person every day. There were no near riots in the pharmacy. When physicians and pharmacists are talking and networking - the quality of care is better. As an interesting sidebar, I consulted my most recent text on management of healthcare systems (copyright 2008) and there was no mention of pharmacy services or pharmacists, but plenty of references to the pharmaceutical industry.
Back to the all night pharmacy. My name was finally called and it was not a moment too soon. The woman in the seat next to me had just made a loud and incredibly crude remark to the mob. Several people had noticed and seemed ready to say something. I turned to her and said:
"If I told you that you had to be cool would you know what I meant."
"Yeah - I suppose so"
"Well good because you really need to be cool here. You are starting to make some of those people angry and they are already angry about waiting at 1AM to pick up prescriptions."
I picked up my prescription and left. As far as I know there were no further incidents. At least I did not read about anything in the papers.
I was burned out from my job at the time. I think I was covering an entire 20 bed inpatient unit. I had taken a week off to recover.
But I was very glad to not be a pharmacist.
George Dawson, MD, DFAPA
Sunday, May 11, 2014
Saturday, May 10, 2014
Blaming Psychiatrists For Decreased Access - The Ultimate Political Manipulation?
I was trying to mind my own business this morning and focus on my usual PowerPoints but then I happened across the musings of 1BOM and and some of his associations to an article on the fact that psychiatrists accept insurance at lower rates than other physicians. Interestingly, the authors look at some correlates of this phenomenon and then jump to the following conclusion:
"Nonetheless, our findings suggest that policies to improve access to timely care may be limited because many psychiatrists do not accept insurance."
The only way a sentence like this gets into a journal article is with the necessary qualifiers "suggest" and "may". Certainly the press and the detractors of psychiatry won't pay much attention to the qualifiers. I am sure that some managed care executives also see this as a reason for celebration. At a time when they literally have psychiatry on the run because of poor reimbursement, rationing, and invasive management practices - what better "research" to back up more managed care practices? It is not the onerous business practices after all, it is those pesky psychiatrists who refuse to accept whatever we want to pay them.
The authors of this article seem to ignore the historical context of 30 years of rationing psychiatric care to the point that inpatient care is generally of very limited value, psychotherapy-at least the research based kind is scarcely available, and psychiatrists trying to function in an outpatient settings are continuously harassed by insurance reviews or restrictions. Many public systems of care previously under the oversight of psychiatrists are now being run by administrators with no mental health training who have no shortage of ideas about how systems based care should be implemented. The authors provide an introduction to this research that contains the following paragraph:
"The Centers for Disease Control and Prevention estimates that a quarter of adults in the United States report having a mental illness at any given time and about half will experience mental illness during their lifetime. In the wake of the Connecticut school shooting and other recent mass shootings, policy makers and the public have called for increased access to mental health services. For example, President Obama’s “Now Is the Time” proposal, released in January 2013, called for better mental health services, including programs to identify diagnosable mental health problems early so that patients can be referred for treatment, and increased training of mental health professionals."
"Psychiatrists play an important role in the diagnosis and treatment of patients with mental illnesses particularly because of their training and ability to prescribe medications."
Supplementary 1: The issue of "financial viability" of my closed clinic came up on the 1BOM discussion. In my experience financial viability is just more managed care rhetoric. Like cost effectiveness it needs to be rejected outright. The most obvious evidence is the collaborative care model. Here we have a model that is strongly promoted by managed care and now the APA that is telling us that there are essentially unlimited resources to see what are called "med management" visits. They are after all eliminating any actual diagnostic process and putting people on medications as soon as possible. I am quite sure that some of the patients with complex problems that I assessed are now getting a PHQ-9 and placed on antidepressants. I have already posted that (based on 2005-2010) data that antidepressants are already being overprescribed. Collaborative care will result in a proliferation of additional "prescribers" to increase that number. For that questionable low quality service, the patient will probably be charged around $50 for (at the maximum) a 10 or 15 minute visit. In fact, in my health plan it can occur over the telephone with no actual patient visit. If I was in private practice I would probably charge $300-350 for a 60-90 minute evaluation that look at all of the patients medical, psychiatric, and medical imaging data. The final product is a diagnosis or list of diagnoses rather than a PHQ-9 score and there would be an intelligent discussion with the patient about what to do. If medications were prescribed there would be a detailed discussion of the risk, benefit, and likelihood of success. There would also be a detailed discussion of how to avoid rare but serious side effects and when the medication should be stopped and when I should be called if there were problems.
If you want to say that "financial viability" is a legitimate metric that exists outside of the mind of an managed care MBA, I would clearly disagree. My plumber, electrician, and chimney sweep don't hesitate to charge me $200 to show up and then add charges on top of that. The information content and technical skill they use to fix or install things does generally not reach the level that I would use in my 60-90 assessment. Financial liability in a managed care system is basically anything outside of high volume low quality work that the company can profit from. It is an artifact of cartel pricing that seriously discounts the skills of physicians. The only reason my tradesmen are financially viable is that they don't have a cartel fixing their prices, forcing them to put out a high volume, low quality product and skimming their profits.
I hope that more and more physicians stop taking managed care insurance and put the financial viability theory to a test. It certainly has not put tradespeople out of business and they are easily charging on par what physicians charge for reasonable medical care. We can also learn a lot from our dental colleagues who are usually subject to severe insurance limitations. I guess that by the managed care definition, dentists are also not financially viable?
My dentist by the way charges way more than I would charge in private practice.
Supplementary 2: A reader suggested that I was erroneously saying that managed care hit mental health services harder than the rest of medicine. The following excerpt from a report by Floyd Anderson, MD describes the results of the Hay Group report on this issue in the 1990s:
"More recently, the National Association Of Psychiatric Health Systems - Hay Group found that from 1988 to 1997 that a total value of health care benefits for over 1,000 large U.S. employers declined by 10%; general health care benefits declined by 7%, but behavioral health benefits declined by 54%. As a proportion of total health benefit costs, behavioral health benefits decreased from 6% to 3% during that period. This same study found that between 1993 and 1996, the use of outpatient behavioral health services dropped 25%, but use of outpatient general health services increased 27%. Inpatient psychiatric admissions between 1991 and 1996 declined by 36%, compared with a 13% decline for general health admissions during that same period. Mental Health Economics reported in September of 1999, “Despite the robust economy of the past five years, and the growing awareness of disparity between mental health care benefits and general health care coverage, the value of employer-provided mental health care benefits has declined by over 50% since 1988.”
That occurred in the context of overall health care expenses increasing. And do you really need a report? It may be hard to believe, but mental health services were delivered outside of jails at one point in time.
"Nonetheless, our findings suggest that policies to improve access to timely care may be limited because many psychiatrists do not accept insurance."
The only way a sentence like this gets into a journal article is with the necessary qualifiers "suggest" and "may". Certainly the press and the detractors of psychiatry won't pay much attention to the qualifiers. I am sure that some managed care executives also see this as a reason for celebration. At a time when they literally have psychiatry on the run because of poor reimbursement, rationing, and invasive management practices - what better "research" to back up more managed care practices? It is not the onerous business practices after all, it is those pesky psychiatrists who refuse to accept whatever we want to pay them.
The authors of this article seem to ignore the historical context of 30 years of rationing psychiatric care to the point that inpatient care is generally of very limited value, psychotherapy-at least the research based kind is scarcely available, and psychiatrists trying to function in an outpatient settings are continuously harassed by insurance reviews or restrictions. Many public systems of care previously under the oversight of psychiatrists are now being run by administrators with no mental health training who have no shortage of ideas about how systems based care should be implemented. The authors provide an introduction to this research that contains the following paragraph:
"The Centers for Disease Control and Prevention estimates that a quarter of adults in the United States report having a mental illness at any given time and about half will experience mental illness during their lifetime. In the wake of the Connecticut school shooting and other recent mass shootings, policy makers and the public have called for increased access to mental health services. For example, President Obama’s “Now Is the Time” proposal, released in January 2013, called for better mental health services, including programs to identify diagnosable mental health problems early so that patients can be referred for treatment, and increased training of mental health professionals."
I really cannot think of a more politically naive statement about the state of mental health in this country or the likelihood that things are going to change. It is certainly clear to me that we have a standard strategy for mass shootings in this country that does not involve addressing the widespread availability of firearms or lack of availability of a functional mental health system. The public also seems quite content to accept the idea that violence and aggression are random acts and cannot be addressed from a psychiatric perspective. The usual photo-op involves politicians showing up, suggesting some serious political work (that never comes to fruition), praising the heroes and then suggesting that we must all move on. Occasionally there is the suggestion that people were just "in the wrong place at the wrong time". It is really nothing more than political helplessness in the service of career politicians and special interests. Torrey and Jaffe have taken a close look at what is wrong with the idea of a President's initiative on violence and aggression and there are many problems. Transmuting all of these chronic problems into psychiatrists not wanting to accept inferior reimbursement or the additional free work required for insurance business is ridiculous.
In the next paragraph the authors resort to a familiar stereotype of psychiatrists:
It is well known that 80% of all medications for mental health indications are prescribed by primary care physicians. Furthermore we are currently caught up in the latest managed care technology referred to as collaborative care that will greatly increase that percentage. That will be true because of an expected rapid increase in access to antidepressant prescriptions and also because in some models - psychiatrists will not actually see patients or write prescriptions. The real risk of eliminating psychiatrists is the diagnostic capability. There are many interests who benefit by not considering the importance of eliminating that skillset. Let me illustrate how that happens. For many years, I worked in a Geriatric Psychiatry and Memory Disorders Clinic. It was staffed by myself, by a neurologist, and an RN who specialized in geriatrics. We offered a service to primary care specialists and the community as a resource for diagnosing a full spectrum of cognitive disorders, dementias, and mental health disorders in geriatric populations. We also offered some research protocols and treatment with what was then state of the art medications for Alzheimer's disease. We also offered a full spectrum of referrals for psychosocial resources and residential care for patients that we saw and assessed. We were told at one point that reimbursement for our services did not cover the cost of nursing services for out clinic. Our nurse was an absolutely critical piece because she would gather information on the functional capacity, behavioral problems, and known medical problems of all patients coming in to the clinic. She would often gather this information from more than one informant. That would amount to about 8 hours of telephone work for one 4 hour clinic. Most of the time was provided free gratis because she believed in what we were doing. In order to possibly improve the financial status of the clinic, we started to travel out to nursing homes and see people there in person. That model was not useful because we received dramatically less reimbursement consulting in a nursing home setting. We also had unreimbursed travel time with each visit and the cost of transportation. Eventually administrators told us we had two choices - shut down the clinic or eliminate the nurse. It was an easy decision for the neurologist and myself. We barely had enough time to do all of the documentation associated with our services much less all of the collateral contacts. So we shut down the clinic.
This is a classic example of how quality mental health services are rationed and put out of business. Our clinic was well known for quality care. Years later I was still being asked about why we shut our doors. It is literally a function of how much information that you collect and analyze. In order to make the necessary diagnoses the full spectrum of functional capacity, cognitive, psychiatric, medical imaging, and laboratory data needs to be reviewed or ordered for the first time and analyzed. We would see people who were told by other physicians that "there is nothing else we can do for you" and they were wrong. There can alway be a debate about how much comprehensive services that utilize the full training and ongoing education of physicians is worth. It is definitely worth more than a 5 or 10 minute visit, a prescription and a Mini-Mental State Exam score.
1BOM list some associated arguments about the issue of whether psychiatrists should accept whatever insurance companies decide to reimburse. The most interesting of these is that the field can be parsed into basically psychotherapy and neurosciences. Further analysis suggests that if psychiatrists want to provide psychotherapy they should accept whatever standard reimbursement a "non-medical" therapist should accept. It is almost as if non-medical psychotherapy is an option in the training of psychiatrists. That attitude is certainly counter to the fact that psychotherapy is an integral part of psychiatric training both as a treatment modality and as a necessary technique for studying the therapeutic alliance. There are similar illogical arguments about transferring the neuroscience and neuropsychiatric aspects of psychiatry to neurologists. Dr. Nardo in his wisdom points out that basically neurologists don't want it. That is why they went in to Neurology in the first place. It seems that other specialists seem to know the demarcation of the speciality better than some psychiatrists do.
The overall problem here is very familiar to me. It is the reason I started writing this blog in the first place. Everybody has been bombarded by business and managed care propaganda for decades. One the the strategies contained in that propaganda is that medicine and psychiatry no longer define themselves. Business defines medicine. That is why all of my colleagues freaked out in the 1990s. They heard that "things are different now" and did not know what to do about that. Even today, the first reaction to the propaganda is to cannibalize your own specialty before thinking clearly about what this all means. Managed care closed down my clinic because they said my valued nurse colleague was not "cost effective". Closing that clinic eliminated the availability of two experts who were providing services that were not replaced. Does that mean we have no need for geriatric psychiatrists, nurses, or neurologists? The headlines today would suggest otherwise.
We will all remain in the limbo of politicians telling us we need increased access and insurance companies decreasing access in order to increase their profitability. And that has nothing to do with the fact that psychiatrists need to be trained in neurology, neuroscience, medicine, and psychotherapy. Not accepting insurance is the ultimate affirmation that business does not define medicine or psychiatry.
George Dawson, MD, DFAPA
1: Bishop TF, Press MJ, Keyhani S, Pincus HA. Acceptance of insurance by psychiatrists and the implications for access to mental health care. JAMA Psychiatry. 2014 Feb;71(2):176-81. doi: 10.1001/jamapsychiatry.2013.2862. PubMed PMID: 24337499.
1: Bishop TF, Press MJ, Keyhani S, Pincus HA. Acceptance of insurance by psychiatrists and the implications for access to mental health care. JAMA Psychiatry. 2014 Feb;71(2):176-81. doi: 10.1001/jamapsychiatry.2013.2862. PubMed PMID: 24337499.
Supplementary 1: The issue of "financial viability" of my closed clinic came up on the 1BOM discussion. In my experience financial viability is just more managed care rhetoric. Like cost effectiveness it needs to be rejected outright. The most obvious evidence is the collaborative care model. Here we have a model that is strongly promoted by managed care and now the APA that is telling us that there are essentially unlimited resources to see what are called "med management" visits. They are after all eliminating any actual diagnostic process and putting people on medications as soon as possible. I am quite sure that some of the patients with complex problems that I assessed are now getting a PHQ-9 and placed on antidepressants. I have already posted that (based on 2005-2010) data that antidepressants are already being overprescribed. Collaborative care will result in a proliferation of additional "prescribers" to increase that number. For that questionable low quality service, the patient will probably be charged around $50 for (at the maximum) a 10 or 15 minute visit. In fact, in my health plan it can occur over the telephone with no actual patient visit. If I was in private practice I would probably charge $300-350 for a 60-90 minute evaluation that look at all of the patients medical, psychiatric, and medical imaging data. The final product is a diagnosis or list of diagnoses rather than a PHQ-9 score and there would be an intelligent discussion with the patient about what to do. If medications were prescribed there would be a detailed discussion of the risk, benefit, and likelihood of success. There would also be a detailed discussion of how to avoid rare but serious side effects and when the medication should be stopped and when I should be called if there were problems.
If you want to say that "financial viability" is a legitimate metric that exists outside of the mind of an managed care MBA, I would clearly disagree. My plumber, electrician, and chimney sweep don't hesitate to charge me $200 to show up and then add charges on top of that. The information content and technical skill they use to fix or install things does generally not reach the level that I would use in my 60-90 assessment. Financial liability in a managed care system is basically anything outside of high volume low quality work that the company can profit from. It is an artifact of cartel pricing that seriously discounts the skills of physicians. The only reason my tradesmen are financially viable is that they don't have a cartel fixing their prices, forcing them to put out a high volume, low quality product and skimming their profits.
I hope that more and more physicians stop taking managed care insurance and put the financial viability theory to a test. It certainly has not put tradespeople out of business and they are easily charging on par what physicians charge for reasonable medical care. We can also learn a lot from our dental colleagues who are usually subject to severe insurance limitations. I guess that by the managed care definition, dentists are also not financially viable?
My dentist by the way charges way more than I would charge in private practice.
Supplementary 2: A reader suggested that I was erroneously saying that managed care hit mental health services harder than the rest of medicine. The following excerpt from a report by Floyd Anderson, MD describes the results of the Hay Group report on this issue in the 1990s:
"More recently, the National Association Of Psychiatric Health Systems - Hay Group found that from 1988 to 1997 that a total value of health care benefits for over 1,000 large U.S. employers declined by 10%; general health care benefits declined by 7%, but behavioral health benefits declined by 54%. As a proportion of total health benefit costs, behavioral health benefits decreased from 6% to 3% during that period. This same study found that between 1993 and 1996, the use of outpatient behavioral health services dropped 25%, but use of outpatient general health services increased 27%. Inpatient psychiatric admissions between 1991 and 1996 declined by 36%, compared with a 13% decline for general health admissions during that same period. Mental Health Economics reported in September of 1999, “Despite the robust economy of the past five years, and the growing awareness of disparity between mental health care benefits and general health care coverage, the value of employer-provided mental health care benefits has declined by over 50% since 1988.”
That occurred in the context of overall health care expenses increasing. And do you really need a report? It may be hard to believe, but mental health services were delivered outside of jails at one point in time.
Thursday, May 8, 2014
Paroxetine For Hot Flashes - A Potential Problem
This opinion piece caught my eye in the New England Journal of Medicine this week for a number of reasons. First off, it involves my least favorite antidepressant, so I am always interested in why there may be broadened indications. I stopped prescribing paroxetine well over 20 years ago because of what I considered to be an unfavorable pharmacokinetic and side effect profile. In this case there is a potential interaction that could decrease the efficacy of tamoxifen - a medication used to treat breast cancer. In my capacity as a consultant, I frequently encounter people who are already on paroxetine and will continue it if that is their preference. I do encounter people with side effects and either transition them off of the medication or onto something else depending on the clinical scenario. Second, FDA decision-making is always interesting to follow and that is also true in this case. Like the recent Zohydro decision, the FDA decided to go against the recommendation of its scientific committee and approve the specified name brand product for hot flashes. Third, the remarketing for generics as brand name drugs with slightly different formulations is another interesting aspect of FDA regulation and in this case that is also true. The product in this case is Brisdelle, a 7.5 mg tablet of paroxetine. Paroxetine is currently available as a generic drug as 10, 20 , 30 and 40 mg immediate release tablets and 12.5, 25 and 37.5 mg controlled release preparations. Some of the 10 mg tablets are scored allowing for an approximation of the approved product. Another interesting pint is that this action is apparently over a year old according to this FDA release.
The scientific evidence comes down to two randomized, double-blind, placebo controlled trials of 1184 women. Baseline moderate to severe hot flashes were occurring at a rate of about 10 per day. The effects observed during the trial were described as modest with an overall decrease in these hot flashes by about 0.9 per day by week 12 in one study and 1.7 per day in the other. Despite that slight effect, the women on active drug reported a meaningful difference at the end of the study and again at 6 months.
In balancing the risk rewards of this study and the regulatory decision, the FDA Reproductive Health Drugs Advisory Committee voted 10-4 against approving Brisdelle. The authors speculate that modest efficacy and existing warnings about suicidality swayed the Advisory Committee in this vote. I thought it was interesting that the authors consider the safety profile of paroxetine to be well established. Paroxetine seems to be one of the most complained about medications on the Internet and a favorite of critics who consider themselves as watchdogs of the pharmaceutical industry. In the case of Brisdelle, the formulation had side effects that did not exceed placebo. Anyone used to prescribing selective serotonin reuptake inhibitor (SSRI) type antidepressants is aware of a possible significant discontinuation syndrome. The authors suggest that Brisdelle does not need to be tapered if discontinued but the package insert from the web site suggests potential problems including potential discontinuation symptoms and symptoms in neonates exposed to the medication.
The authors discuss the importance of a non-hormonal agent to treat hot flashes, especially give the impact on lifestyle and risks of stroke, coronary artery disease, thromboembolism, and breast cancer. The only current FDA approved treatment is hormonal therapy in the form of estrogen or estrogen-progestin. The problem is that using SSRIs or SNRIs for hot flashes is already a fairly widespread practice and it is backed up to some degree by double blind controlled trials where approval by the FDA was not the goal of the study. I did a Medline search of controlled clinical trials for hot flashes and came up with this rough collection. If you look up the specific studies you will find some positive and some negative. I did not look for meta-analyses. The most interesting opinion was naturally the one that matched mine and I found it in this study. In this study the authors correctly conclude that potent CYP2D6 inhibitors should be avoided in women taking tamoxifen and the recommendation to avoid paroxetine is being ignored. Using a database from the Netherlands paroxetine remains a widely prescribed antidepressant.
The last reference reflects my opinion on paroxetine in general and certainly for this specific problem. It is also an example of how the FDA could consciously avoid problems rather than sending them out into the free market and waiting for the post marketing surveillance. That is acceptable in the case of serious conditions with no current therapies. But this is a case of alternate therapies with scientific backing being readily available and experts in the field recommending not to use paroxetine. I also have a concern about the impact that remarketing a generic drug with an unusual dose on the generic drug market in general. I am thinking about the precedent of generic doxepin being remarketed as Silenor in unique dosages of 3 and 6 mg. Most pharmacies have generic doxepin 10 mg tablets as the smallest available dose size with a liquid form that can be ordered for additional dose adjustments. My impression is that the prescribing of doxepin in low doses has increased in general with the recognition that low doses can be used for insomnia. Doxepin is primarily a substrate for CYP enzymes, but at some point could probably accumulate with higher doses. If the same thing happens with paroxetine it may result in standard antidepressant doses being prescribed for hot flashes. That could lead to more complications and potentially more drug interactions.
George Dawson, MD, DFAPA
1: Ronald J. Orleans, M.D., Li Li, Ph.D., Myong-Jin Kim, Pharm.D., Jia Guo, Ph.D., Mahboob Sobhan, Ph.D., Lisa Soule, M.D., and Hylton V. Joffe, M.D., M.M.Sc. FDA Approval of Paroxetine for Menopausal Hot Flashes. N Engl J Med 2014; 370:1777-1779.
2: Binkhorst L, Mathijssen RH, van Herk-Sukel MP, Bannink M, Jager A, Wiemer EA, van Gelder T. Unjustified prescribing of CYP2D6 inhibiting SSRIs in women treated with tamoxifen. Breast Cancer Res Treat. 2013 Jun;139(3):923-9. doi: 10.1007/s10549-013-2585-z. Epub 2013 Jun 13. PubMed PMID: 23760858.
The scientific evidence comes down to two randomized, double-blind, placebo controlled trials of 1184 women. Baseline moderate to severe hot flashes were occurring at a rate of about 10 per day. The effects observed during the trial were described as modest with an overall decrease in these hot flashes by about 0.9 per day by week 12 in one study and 1.7 per day in the other. Despite that slight effect, the women on active drug reported a meaningful difference at the end of the study and again at 6 months.
In balancing the risk rewards of this study and the regulatory decision, the FDA Reproductive Health Drugs Advisory Committee voted 10-4 against approving Brisdelle. The authors speculate that modest efficacy and existing warnings about suicidality swayed the Advisory Committee in this vote. I thought it was interesting that the authors consider the safety profile of paroxetine to be well established. Paroxetine seems to be one of the most complained about medications on the Internet and a favorite of critics who consider themselves as watchdogs of the pharmaceutical industry. In the case of Brisdelle, the formulation had side effects that did not exceed placebo. Anyone used to prescribing selective serotonin reuptake inhibitor (SSRI) type antidepressants is aware of a possible significant discontinuation syndrome. The authors suggest that Brisdelle does not need to be tapered if discontinued but the package insert from the web site suggests potential problems including potential discontinuation symptoms and symptoms in neonates exposed to the medication.
The authors discuss the importance of a non-hormonal agent to treat hot flashes, especially give the impact on lifestyle and risks of stroke, coronary artery disease, thromboembolism, and breast cancer. The only current FDA approved treatment is hormonal therapy in the form of estrogen or estrogen-progestin. The problem is that using SSRIs or SNRIs for hot flashes is already a fairly widespread practice and it is backed up to some degree by double blind controlled trials where approval by the FDA was not the goal of the study. I did a Medline search of controlled clinical trials for hot flashes and came up with this rough collection. If you look up the specific studies you will find some positive and some negative. I did not look for meta-analyses. The most interesting opinion was naturally the one that matched mine and I found it in this study. In this study the authors correctly conclude that potent CYP2D6 inhibitors should be avoided in women taking tamoxifen and the recommendation to avoid paroxetine is being ignored. Using a database from the Netherlands paroxetine remains a widely prescribed antidepressant.
The last reference reflects my opinion on paroxetine in general and certainly for this specific problem. It is also an example of how the FDA could consciously avoid problems rather than sending them out into the free market and waiting for the post marketing surveillance. That is acceptable in the case of serious conditions with no current therapies. But this is a case of alternate therapies with scientific backing being readily available and experts in the field recommending not to use paroxetine. I also have a concern about the impact that remarketing a generic drug with an unusual dose on the generic drug market in general. I am thinking about the precedent of generic doxepin being remarketed as Silenor in unique dosages of 3 and 6 mg. Most pharmacies have generic doxepin 10 mg tablets as the smallest available dose size with a liquid form that can be ordered for additional dose adjustments. My impression is that the prescribing of doxepin in low doses has increased in general with the recognition that low doses can be used for insomnia. Doxepin is primarily a substrate for CYP enzymes, but at some point could probably accumulate with higher doses. If the same thing happens with paroxetine it may result in standard antidepressant doses being prescribed for hot flashes. That could lead to more complications and potentially more drug interactions.
George Dawson, MD, DFAPA
1: Ronald J. Orleans, M.D., Li Li, Ph.D., Myong-Jin Kim, Pharm.D., Jia Guo, Ph.D., Mahboob Sobhan, Ph.D., Lisa Soule, M.D., and Hylton V. Joffe, M.D., M.M.Sc. FDA Approval of Paroxetine for Menopausal Hot Flashes. N Engl J Med 2014; 370:1777-1779.
2: Binkhorst L, Mathijssen RH, van Herk-Sukel MP, Bannink M, Jager A, Wiemer EA, van Gelder T. Unjustified prescribing of CYP2D6 inhibiting SSRIs in women treated with tamoxifen. Breast Cancer Res Treat. 2013 Jun;139(3):923-9. doi: 10.1007/s10549-013-2585-z. Epub 2013 Jun 13. PubMed PMID: 23760858.
Sunday, May 4, 2014
Dangerous Medication - Part 3 - A Risk-Averse Approach To Prescribing Bupropion
Bupropion is a widely prescribed antidepressant. It is a safe and effective medication according to the FDA. It can be safely prescribed with a high level of success. It is probably more widely prescribed with the advent of guidelines suggesting that it is an augmenting agent for situations where antidepressant monotherapy is ineffective. It may also end up being used with another antidepressant if a patient is interested in using it for smoking cessation and in an off label manner for attention deficit hyperactivity disorder and to treat sexual dysfunction associated with SSRI type antidepressants. Bupropion does have a unique position in antidepressant pharmacotherapy. With the increased focus on electrocardiogram abnormalities, it is probably the antidepressant that is least likely to affect the QTc interval.
Bupropion is generally well tolerated, but there are some people who develop increased anxiety, agitation and insomnia. This people generally need to stop taking the medication or reduce the dose. A small number of people will develop mild to moderate hypertension and depending on the situation, the medication should be discontinued or the hypertension treated. The largest problem I see with this medication is deciding when to stop and start it based on its contraindications. The FDA package insert (from the FDA website using the brand name) on the matter is clear:
CONTRAINDICATIONS
WELLBUTRIN is contraindicated in patients with a seizure disorder.
WELLBUTRIN is contraindicated in patients treated with ZYBAN® 13 (bupropion hydrochloride) Sustained-Release Tablets, or any other medications that contain bupropion because the incidence of seizure is dose dependent.
WELLBUTRIN is also contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in such patients treated with WELLBUTRIN.
WELLBUTRIN is contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).
The concurrent administration of WELLBUTRIN and a monoamine oxidase (MAO) inhibitor is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with WELLBUTRIN.
WELLBUTRIN is contraindicated in patients who have shown an allergic response to
bupropion or the other ingredients that make up WELLBUTRIN Tablets
The package insert goes into some of the evidence for these contraindications, but the details seem fairly clear to me. So why is it that the following happens?
1. Patients who are not aware of the fact that bupropion can cause seizures.
2. Patients who are prescribed this medication in spite of the contraindications.
3. Patients with a past history or an active eating disorder taking this medication.
4. Patients who are regularly drinking alcohol +/- sedative hypnotics taking this medication.
5. Patients who have had generalized tonic clonic seizures taking this medication and the medicine is still prescribed.
I could go into much greater detail about some of the most extreme situations where this occurs, but I think it would be more instructive if I just cut to a few basic recommendations for the safe use of this medication:
1. Do not prescribe it in the presence of contraindications.
2. Do not prescribe it to anyone who has a known problem with alcohol or sedative abuse problems. In fact, obtain a new history for those disorders at the time you are obtaining informed consent for the prescription and revisit the contraindications every time you increase the dose since the seizure risk increases with dose increases.
3. Discontinue bupropion immediately if you are treating the patient for alcohol or sedative hypnotic withdrawal. Have a serious conversation with that person about seizure risk an the FDA contraindications before restarting it. People provided with that information quickly reassess the need for the medication and whether or not it has been helpful.
4. Discuss the warnings with the patient if they have medical comorbidity that is flagged in the package insert such as:
Hepatic Impairment: WELLBUTRIN should be used with extreme caution in patients with severe hepatic cirrhosis. In these patients a reduced dose and/or frequency is required, as peak bupropion, as well as AUC, levels are substantially increased and accumulation is likely to occur in such patients to a greater extent than usual. The dose should not exceed 75 mg once a day in these patients.
and:
The risk of seizure is also related to patient factors, clinical situations, and concomitant
medications, which must be considered in selection of patients for therapy with WELLBUTRIN.
Patient factors: Predisposing factors that may increase the risk of seizure with bupropion use include history of head trauma or prior seizure, CNS tumor, the presence of severe hepatic cirrhosis, and concomitant medications that lower seizure threshold.
Clinical situations: Circumstances associated with an increased seizure risk include, among others, excessive use of alcohol or sedatives (including benzodiazepines); addiction to opiates, cocaine, or stimulants; use of over-the-counter stimulants and anorectics; and diabetes treated with oral hypoglycemics or insulin.
Concomitant medications: Many medications (e.g., antipsychotics, antidepressants, theophylline, systemic steroids) are known to lower seizure threshold.
5. Seriously weigh the seizure risk of adding any medication that might lower the seizure threshold to any person who is stable on bupropion and keep that person involved of the possible seizure risk. Do a detailed and individualized risk assessment for prescribing medications to any patients.
6. Document the vital signs of any patient on bupropion and the trend.
7. Do not prescribe bupropion again to anyone who has had a seizure while taking it.
I have seen bupropion prescribed in the context of all of the contraindications and warnings without seizures or other complications. Risking a low frequency but serious complication is not the optimal way to prescribe it. The other consideration is that the risk assessment needs to be done on an individualized basis. A general number quoted as an average side effects from clinical trials obviously would not apply to a patient with multiple risk factors or a patient who reliably gets side effects every time he or she takes the drug. Population based care sounds good when it is promoted by managed care companies or government agencies, but this is a good example of where that concept fails. As I think about all of the high risk ways I have seen bupropion prescribed, I go back to the recent post on overprescriber biases and how that influences the process. No physician trained in psychopharmacology would have these deficits on a purely cognitive level, but in the case of treatment resistant depression and a contraindication the situation may become higher risk.
That is an ideal time for consultation or referral rather than taking a chance.
If you are reading this from the patient perspective, I encourage reading the Medline Plus handout on any medication that you are taking. The FDA approved package insert is usually available on the Internet, even in the case of most generics. I would exercise caution if you decide to study it. In a previous post, I point out that a lot of people really don't want to know about detailed side effects in advance because they fear developing them by mere suggestion or they might avoid taking a useful medication entirely. Some package inserts have specific "Information to the patient" that is usually designed to communicate important information.
George Dawson, MD, DFAPA
Bupropion is generally well tolerated, but there are some people who develop increased anxiety, agitation and insomnia. This people generally need to stop taking the medication or reduce the dose. A small number of people will develop mild to moderate hypertension and depending on the situation, the medication should be discontinued or the hypertension treated. The largest problem I see with this medication is deciding when to stop and start it based on its contraindications. The FDA package insert (from the FDA website using the brand name) on the matter is clear:
CONTRAINDICATIONS
WELLBUTRIN is contraindicated in patients with a seizure disorder.
WELLBUTRIN is contraindicated in patients treated with ZYBAN® 13 (bupropion hydrochloride) Sustained-Release Tablets, or any other medications that contain bupropion because the incidence of seizure is dose dependent.
WELLBUTRIN is also contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in such patients treated with WELLBUTRIN.
WELLBUTRIN is contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).
The concurrent administration of WELLBUTRIN and a monoamine oxidase (MAO) inhibitor is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with WELLBUTRIN.
WELLBUTRIN is contraindicated in patients who have shown an allergic response to
bupropion or the other ingredients that make up WELLBUTRIN Tablets
The package insert goes into some of the evidence for these contraindications, but the details seem fairly clear to me. So why is it that the following happens?
1. Patients who are not aware of the fact that bupropion can cause seizures.
2. Patients who are prescribed this medication in spite of the contraindications.
3. Patients with a past history or an active eating disorder taking this medication.
4. Patients who are regularly drinking alcohol +/- sedative hypnotics taking this medication.
5. Patients who have had generalized tonic clonic seizures taking this medication and the medicine is still prescribed.
I could go into much greater detail about some of the most extreme situations where this occurs, but I think it would be more instructive if I just cut to a few basic recommendations for the safe use of this medication:
1. Do not prescribe it in the presence of contraindications.
2. Do not prescribe it to anyone who has a known problem with alcohol or sedative abuse problems. In fact, obtain a new history for those disorders at the time you are obtaining informed consent for the prescription and revisit the contraindications every time you increase the dose since the seizure risk increases with dose increases.
3. Discontinue bupropion immediately if you are treating the patient for alcohol or sedative hypnotic withdrawal. Have a serious conversation with that person about seizure risk an the FDA contraindications before restarting it. People provided with that information quickly reassess the need for the medication and whether or not it has been helpful.
4. Discuss the warnings with the patient if they have medical comorbidity that is flagged in the package insert such as:
Hepatic Impairment: WELLBUTRIN should be used with extreme caution in patients with severe hepatic cirrhosis. In these patients a reduced dose and/or frequency is required, as peak bupropion, as well as AUC, levels are substantially increased and accumulation is likely to occur in such patients to a greater extent than usual. The dose should not exceed 75 mg once a day in these patients.
and:
The risk of seizure is also related to patient factors, clinical situations, and concomitant
medications, which must be considered in selection of patients for therapy with WELLBUTRIN.
Patient factors: Predisposing factors that may increase the risk of seizure with bupropion use include history of head trauma or prior seizure, CNS tumor, the presence of severe hepatic cirrhosis, and concomitant medications that lower seizure threshold.
Clinical situations: Circumstances associated with an increased seizure risk include, among others, excessive use of alcohol or sedatives (including benzodiazepines); addiction to opiates, cocaine, or stimulants; use of over-the-counter stimulants and anorectics; and diabetes treated with oral hypoglycemics or insulin.
Concomitant medications: Many medications (e.g., antipsychotics, antidepressants, theophylline, systemic steroids) are known to lower seizure threshold.
5. Seriously weigh the seizure risk of adding any medication that might lower the seizure threshold to any person who is stable on bupropion and keep that person involved of the possible seizure risk. Do a detailed and individualized risk assessment for prescribing medications to any patients.
6. Document the vital signs of any patient on bupropion and the trend.
7. Do not prescribe bupropion again to anyone who has had a seizure while taking it.
I have seen bupropion prescribed in the context of all of the contraindications and warnings without seizures or other complications. Risking a low frequency but serious complication is not the optimal way to prescribe it. The other consideration is that the risk assessment needs to be done on an individualized basis. A general number quoted as an average side effects from clinical trials obviously would not apply to a patient with multiple risk factors or a patient who reliably gets side effects every time he or she takes the drug. Population based care sounds good when it is promoted by managed care companies or government agencies, but this is a good example of where that concept fails. As I think about all of the high risk ways I have seen bupropion prescribed, I go back to the recent post on overprescriber biases and how that influences the process. No physician trained in psychopharmacology would have these deficits on a purely cognitive level, but in the case of treatment resistant depression and a contraindication the situation may become higher risk.
That is an ideal time for consultation or referral rather than taking a chance.
If you are reading this from the patient perspective, I encourage reading the Medline Plus handout on any medication that you are taking. The FDA approved package insert is usually available on the Internet, even in the case of most generics. I would exercise caution if you decide to study it. In a previous post, I point out that a lot of people really don't want to know about detailed side effects in advance because they fear developing them by mere suggestion or they might avoid taking a useful medication entirely. Some package inserts have specific "Information to the patient" that is usually designed to communicate important information.
George Dawson, MD, DFAPA
Saturday, May 3, 2014
For The Last Time - Collaborative Care Is Not Psychiatric Care
I decided to post my response to the pro-collaborative care post “Experiences in Implementing Collaborative Care” by Sanchez on this blog so that it would be more readable and contain active links. In reading this blogpost and the accompanying links it is apparent to me that these models have little to do with psychiatry. The link to the article by Sanchez and Adorno describes a psychiatrist who is in clinic for direct consultation with patients for 4 hours per week and is otherwise available for curbside consultation. Contrary to some of the initial responses this requires no special training on the part of psychiatrists. Psychiatrists currently do that every day. The other element that jumps out of this material is that this is behavioral health or in other words managed care. Take the psychiatrist out of the picture and you have a method for providing more detailed primary care and supportive services to patients with mild if any psychiatric illness. Given managed care’s lack of physician time with patients this is certainly a good idea. It might actually save psychiatrists time when they find themselves explaining medications and drug interactions for medications prescribed by primary care physicians. Promoting this as psychiatric care and suggesting that this is the future of psychiatry (see Worcester) is a clear mistake. At the level of large healthcare organizations, it allows them to say that they are providing “behavioral health care” while the needs of patients with severe mental illnesses are neglected and their care is shifted to another system that may include a local jail.
I was trained to do collaborative care in the Assertive Community Treatment (ACT) model of Test and Stein in 1987. For three years following residency, I did collaborative care with a case management team out of a community mental health center. We provided comprehensive medical and psychiatric care to every person on the team and that included determining medical needs and making referrals for testing and treatment if I felt the patient’s medical problems were not being addressed. In that model of care, the psychiatrist is a physician coordinating medical and psychiatric care for people with severe mental illnesses and significant medical comorbidity. All of the care comes from a personal relationship with each patient. The psychiatrist sees the patient frequently and knows them well. We were tremendously successful in helping people stay out of hospitals, helping them live independently, providing 24/7 crisis coverage, reducing the total amount of medications prescribed, and getting them medical care for significant problems that were misdiagnosed or that they had refused to get care for. As far as I know, the community psychiatry models are being taught in most residency programs and the number of these programs has increased significantly since I was trained.
The problem with current models of collaborative care is that the psychiatrist does not or provides minimal medical or psychiatric care. One central question is – what model are we talking about? The original model in a JAMA article points out that the psychiatrist does not see the patient at all but reviews rating scales. The new model from a group consulting to the American Psychiatric Association (APA), has put the psychiatrist in the role of seeing the occasional patient, probably similar to the link to the Sanchez and Adorno article. The remaining links are less specific.
The responsibilities outlined in both the AMA and APA models are not really psychiatry. Instead they can be seen as an extension of a process initiated 20 years ago by managed care companies to ration access to psychiatrists and psychiatric care. Everybody reading this knows what that means. We currently have no useful inpatient treatment besides crisis care based on “dangerousness” criteria. The largest psychiatric hospitals in the country are county jails. We have limited to no access to detox facilities despite being in the midst of an opiate epidemic. Access to psychiatrists is rationed and it is not uncommon to be told that a psychiatrist will be available for a 10-15 minute discussion of medications only. Psychotherapy that resembles the psychotherapy delivered in research studies is rarely if ever provided. In their place we have models where patients fill out a checklist and get placed on a medication as soon as possible. That is occurring in the context of clear evidence that in many cases antidepressants already exceed the actual diagnosis of major depression. It also occurs in the context that depression screening has no evidence basis and in most cases screening equates with diagnosis.
The current models of collaborative care can easily be done without a psychiatrist. I think that is really the point. Anybody can look at a PHQ-9 score and an antidepressant algorithm and put somebody on an antidepressant. It is ironic that when psychiatrists and other physicians are being told that it is important to go through maintenance of certification procedures in addition to continuing medical education that the federal government and professional organizations have recommended such a low standard. On the other hand it does seem like the logical conclusion of the marginalization of psychiatry and psychiatric services by the insurance industry and federal and local governments.
What is a proactive position for psychiatry? First, recognize that this model is not the model for providing psychiatric services. If anything it highlights the well known fact that there are two tiers of care for mental illnesses. Psychiatrists have adapted to managed care rationing by refusing to accept insurance and changing to a cash only basis. I recently saw this compared to how dental care is rationed and I think that is an accurate comparison. Excellent dental care is available but the odds are the patient will pay for it. Second, this form of rationing will probably continue the current managed care tradition of rationing psychiatric services. It will not lead to any improvement in the availability of inpatient services, detoxification services, or psychotherapy for people with severe mental illnesses. It will allow these companies to advertise collaborative care along with all of the other business services that are marketed as improvements to their patients. Third, there is the undeniable connection between PHQ-9 scores and medication exposure at a time when the FDA has issued a warning on a widely prescribed antidepressant. Fourth, with the widespread use of the PHQ-9 and availability of administrative data it is just a matter of time before somebody publishes papers based on the data showing a marked increase in the prevalence of depression. Some researchers and many clinicians equate a PHQ-9 score with a diagnosis of depression. Fifth, psychiatrists need to remain focused on providing a high standard of care to people with severe mental illness, neuropsychiatric problems, and people with significant medical comorbidity. There are many internists and family physicians who are very competent in prescribing antidepressants and using typical augmentation strategies. They are also using fewer benzodiazepines to treat anxiety disorders. That constitutes a first line of medical care from the primary care side for mental illness in this country.
Collaborative care should not be confused with psychiatric care and psychiatrists should not be confused about this being a new model for them to follow.
George Dawson, MD, DFAPA
References:
Sharon Worcester. Future of psychiatry may depend on integrated care. Clinical Psychiatry News. April 2014. page 1.
The Model of Psychiatric Care for the Future
Collaborative Care – Even Worse Than I Imagined
I was trained to do collaborative care in the Assertive Community Treatment (ACT) model of Test and Stein in 1987. For three years following residency, I did collaborative care with a case management team out of a community mental health center. We provided comprehensive medical and psychiatric care to every person on the team and that included determining medical needs and making referrals for testing and treatment if I felt the patient’s medical problems were not being addressed. In that model of care, the psychiatrist is a physician coordinating medical and psychiatric care for people with severe mental illnesses and significant medical comorbidity. All of the care comes from a personal relationship with each patient. The psychiatrist sees the patient frequently and knows them well. We were tremendously successful in helping people stay out of hospitals, helping them live independently, providing 24/7 crisis coverage, reducing the total amount of medications prescribed, and getting them medical care for significant problems that were misdiagnosed or that they had refused to get care for. As far as I know, the community psychiatry models are being taught in most residency programs and the number of these programs has increased significantly since I was trained.
The problem with current models of collaborative care is that the psychiatrist does not or provides minimal medical or psychiatric care. One central question is – what model are we talking about? The original model in a JAMA article points out that the psychiatrist does not see the patient at all but reviews rating scales. The new model from a group consulting to the American Psychiatric Association (APA), has put the psychiatrist in the role of seeing the occasional patient, probably similar to the link to the Sanchez and Adorno article. The remaining links are less specific.
The responsibilities outlined in both the AMA and APA models are not really psychiatry. Instead they can be seen as an extension of a process initiated 20 years ago by managed care companies to ration access to psychiatrists and psychiatric care. Everybody reading this knows what that means. We currently have no useful inpatient treatment besides crisis care based on “dangerousness” criteria. The largest psychiatric hospitals in the country are county jails. We have limited to no access to detox facilities despite being in the midst of an opiate epidemic. Access to psychiatrists is rationed and it is not uncommon to be told that a psychiatrist will be available for a 10-15 minute discussion of medications only. Psychotherapy that resembles the psychotherapy delivered in research studies is rarely if ever provided. In their place we have models where patients fill out a checklist and get placed on a medication as soon as possible. That is occurring in the context of clear evidence that in many cases antidepressants already exceed the actual diagnosis of major depression. It also occurs in the context that depression screening has no evidence basis and in most cases screening equates with diagnosis.
The current models of collaborative care can easily be done without a psychiatrist. I think that is really the point. Anybody can look at a PHQ-9 score and an antidepressant algorithm and put somebody on an antidepressant. It is ironic that when psychiatrists and other physicians are being told that it is important to go through maintenance of certification procedures in addition to continuing medical education that the federal government and professional organizations have recommended such a low standard. On the other hand it does seem like the logical conclusion of the marginalization of psychiatry and psychiatric services by the insurance industry and federal and local governments.
What is a proactive position for psychiatry? First, recognize that this model is not the model for providing psychiatric services. If anything it highlights the well known fact that there are two tiers of care for mental illnesses. Psychiatrists have adapted to managed care rationing by refusing to accept insurance and changing to a cash only basis. I recently saw this compared to how dental care is rationed and I think that is an accurate comparison. Excellent dental care is available but the odds are the patient will pay for it. Second, this form of rationing will probably continue the current managed care tradition of rationing psychiatric services. It will not lead to any improvement in the availability of inpatient services, detoxification services, or psychotherapy for people with severe mental illnesses. It will allow these companies to advertise collaborative care along with all of the other business services that are marketed as improvements to their patients. Third, there is the undeniable connection between PHQ-9 scores and medication exposure at a time when the FDA has issued a warning on a widely prescribed antidepressant. Fourth, with the widespread use of the PHQ-9 and availability of administrative data it is just a matter of time before somebody publishes papers based on the data showing a marked increase in the prevalence of depression. Some researchers and many clinicians equate a PHQ-9 score with a diagnosis of depression. Fifth, psychiatrists need to remain focused on providing a high standard of care to people with severe mental illness, neuropsychiatric problems, and people with significant medical comorbidity. There are many internists and family physicians who are very competent in prescribing antidepressants and using typical augmentation strategies. They are also using fewer benzodiazepines to treat anxiety disorders. That constitutes a first line of medical care from the primary care side for mental illness in this country.
Collaborative care should not be confused with psychiatric care and psychiatrists should not be confused about this being a new model for them to follow.
George Dawson, MD, DFAPA
References:
Sharon Worcester. Future of psychiatry may depend on integrated care. Clinical Psychiatry News. April 2014. page 1.
The Model of Psychiatric Care for the Future
Collaborative Care – Even Worse Than I Imagined
Tuesday, April 29, 2014
Prior Authorization - A Legal Document?
As part of the continuous harassment that is prior authorization, I recently received a form in the mail. It was a repeat of one that I had already signed and faxed in. The only difference was this boilerplate attached to the bottom"
"I attest that the medication requested is medically necessary for this patient. I further attest that the information provided is accurate and true, and that documentation supporting this information is available for review if requested by the claims processor, the health plan sponsor, or, if applicable, a state or federal regulatory agency. I understand that any person who knowingly makes or causes to be made a false record or statement that is material to a claim ultimately paid by the United States government of any state government may be subject to civil penalties and treble damages under both the federal and state False Claims Acts. See, e.g., 31 U.S.C. §§ 3729-3733."
I suppose I should be grateful that the PBM in this case did not attach the 14 page federal statute. And that's right, this statute is a Civil War era statute that I am sure no legislator at the time or since then would have applied to the practice of medicine. What are the implications?
1. First is the clear alliance of PBMs with the federal government. There is no clear separation of where a private for profit business ends and the government begins. I have never sent out a form or a letter with a warning that governments at any level might enforce my recommendations or services. In fact, I have complained numerous times to government officials and agencies about managed care companies at several levels only to be politely told "We can't help you." Probably because they are tripping over one another to help out the managed care cartel.
2. Secondly (and this is a recurrent theme), we have the illusion that health care companies are policing doctors and holding them accountable. That's right - the same industry that is basically one of the largest taxes on most Americans and the same industry that has dismantled mental health care and transferred the mental health care of millions of Americans to correctional facilities. There is also an implicit threat very similar to the threat I wrote about during the billing and coding era.
3. The propaganda effect - practically all managed care intrusions into the practice of medicine are designed to shift financial and clinical risk to physicians. That would includes all of the other managed care schemes like report cards, capitation, pay-for-performance, utilization review, managed formularies and all other schemes to shift risk onto doctors. The net effect of this propaganda has been to adopt the propaganda as somehow being normative. The worst effect is that these insurance companies and MBAs push the propaganda as though it is scientific fact. It not only lacks scientific merit but they frequently do not know how to analyze the data. The best example I can think of is using the PHQ-9 to "measure" depression treatment in the state of Minnesota. This is not only an invalid application of the screening tool, but the state clearly does not have any way to analyze the longitudinal data in any scientific manner.
The blizzard of propaganda from the managed care industry has been a positive for them. It has such a deleterious effect on physician morale that nobody seems to be up for a fight. They have actually launched a new wave of propaganda that is very similar to the initial wave that was used to justify managed care in the first place. We are now seeing "collaborative care" studies that claim very positive results. Medicine and psychiatry in particular seem desperate in the face of managed care propaganda. One of the front page headlines in this month's Clinical Psychiatry News was:
Future of psychiatry may depend on integrated care.
I would submit that it does but not for the reasons claimed in the article. Integrated care will result in psychiatrists with considerable less knowledge than they currently have and they will be totally marginalized without a clear set of problems to treat. The only reason psychiatrists have not been put out of business so far is that we successfully treat a set of problems that nobody else does.
Standing around in a primary care clinic looking at PHQ-9 scores and monitoring the rapid and random prescription of antidepressants by nonpsychiatrists seems like a job for an MBA rather than an MD.
I am sure at the proper time, some business type will come to that conclusion and psychiatry in managed care systems will politely disappear.........
George Dawson, MD, DFAPA
"I attest that the medication requested is medically necessary for this patient. I further attest that the information provided is accurate and true, and that documentation supporting this information is available for review if requested by the claims processor, the health plan sponsor, or, if applicable, a state or federal regulatory agency. I understand that any person who knowingly makes or causes to be made a false record or statement that is material to a claim ultimately paid by the United States government of any state government may be subject to civil penalties and treble damages under both the federal and state False Claims Acts. See, e.g., 31 U.S.C. §§ 3729-3733."
I suppose I should be grateful that the PBM in this case did not attach the 14 page federal statute. And that's right, this statute is a Civil War era statute that I am sure no legislator at the time or since then would have applied to the practice of medicine. What are the implications?
1. First is the clear alliance of PBMs with the federal government. There is no clear separation of where a private for profit business ends and the government begins. I have never sent out a form or a letter with a warning that governments at any level might enforce my recommendations or services. In fact, I have complained numerous times to government officials and agencies about managed care companies at several levels only to be politely told "We can't help you." Probably because they are tripping over one another to help out the managed care cartel.
2. Secondly (and this is a recurrent theme), we have the illusion that health care companies are policing doctors and holding them accountable. That's right - the same industry that is basically one of the largest taxes on most Americans and the same industry that has dismantled mental health care and transferred the mental health care of millions of Americans to correctional facilities. There is also an implicit threat very similar to the threat I wrote about during the billing and coding era.
3. The propaganda effect - practically all managed care intrusions into the practice of medicine are designed to shift financial and clinical risk to physicians. That would includes all of the other managed care schemes like report cards, capitation, pay-for-performance, utilization review, managed formularies and all other schemes to shift risk onto doctors. The net effect of this propaganda has been to adopt the propaganda as somehow being normative. The worst effect is that these insurance companies and MBAs push the propaganda as though it is scientific fact. It not only lacks scientific merit but they frequently do not know how to analyze the data. The best example I can think of is using the PHQ-9 to "measure" depression treatment in the state of Minnesota. This is not only an invalid application of the screening tool, but the state clearly does not have any way to analyze the longitudinal data in any scientific manner.
The blizzard of propaganda from the managed care industry has been a positive for them. It has such a deleterious effect on physician morale that nobody seems to be up for a fight. They have actually launched a new wave of propaganda that is very similar to the initial wave that was used to justify managed care in the first place. We are now seeing "collaborative care" studies that claim very positive results. Medicine and psychiatry in particular seem desperate in the face of managed care propaganda. One of the front page headlines in this month's Clinical Psychiatry News was:
Future of psychiatry may depend on integrated care.
I would submit that it does but not for the reasons claimed in the article. Integrated care will result in psychiatrists with considerable less knowledge than they currently have and they will be totally marginalized without a clear set of problems to treat. The only reason psychiatrists have not been put out of business so far is that we successfully treat a set of problems that nobody else does.
Standing around in a primary care clinic looking at PHQ-9 scores and monitoring the rapid and random prescription of antidepressants by nonpsychiatrists seems like a job for an MBA rather than an MD.
I am sure at the proper time, some business type will come to that conclusion and psychiatry in managed care systems will politely disappear.........
George Dawson, MD, DFAPA
Friday, April 25, 2014
Expanding The Market For Legal Marijuana
I caught a story about the marketing of legal marijuana on public radio yesterday that was predictable in its content. It is always interesting to observe human behavior when it comes to selling a potentially addictive intoxicant. Suddenly - people with no interest or aptitude for science and medicine become "master growers" and gurus of the medical effects of marijuana. It takes on an eery analogy with the business types who have taken over medicine. Money gives you immediate legitimacy whether you know anything or not. And really - how much do you have to know to grow and sell pot? Feign a little concern and market it to everybody - just like tobacco.
In all of the agitation about "medical marijuana" and the gnashing of teeth in state legislatures across the land, I guess nobody was anticipating that there will now be a branding and marketing emphasis on weed. How do you determine if 30% or your audience is minors? The MPR story illustrates how some dealers want to differentiate their product by the people who use it. They want to make sure that they are attracting more than "stoners". Put it in an upscale store and market it like fine wine. Having gone from Cheech and Chong comedy albums and movies in the 1970's to weed as a serious product is a mind expanding experience for people from my generation. Besides getting used to the concept there are probably a couple of other things for consideration.
The issue of crime and marijuana production is real. As a student of reality TV, there are clearly growers and dealers out there who have questionable ethics and seem to do more than just drop prices to compete with one another. The people on reality TV seem to carry firearms and steal from one another at the minimum. It makes sense to me that with an increasing concentration of people who expect to get wealthy from selling weed, that this kind of activity will increase. The 2009 letter from the Department of Justice on potential federal prosecution in states where medical marijuana is legal addresses this to some extent:
Typically, when any of the following characteristics is present, the conduct will not be in clear and unambiguous compliance with applicable state law and may indicate illegal drug trafficking activity of potential federal interest:
• unlawful possession or unlawful use of firearms;
• violence;
• sales to minors;
• financial and marketing activities inconsistent with the terms, conditions, or purposes of state law, including evidence of money laundering activity and/or financial gains or excessive amounts of cash inconsistent with purported compliance with state or local law;
• amounts of marijuana inconsistent with purported compliance with state or local law;
• illegal possession or sale of other controlled substances; or
• ties to other criminal enterprises.
It seems to me that the DOJ anticipated some of this activity with medical marijuana. I have not seen any specific guidance on legal marijuana for non-medical purposes.
What about the economic effects? Will marijuana dispensaries become as common as liquor stores and if so does the economics of liquor stores have any implications? Lotterman points out that liquor stores are intensely competitive businesses and no one seller has enough leverage to increase the price. Demand is also inelastic and that means that the amount purchased does not vary significantly with any initial price increases. Inelastic demand also occurs with food and emergency medical services. Buyers tend to not postpone purchases based on price - at least initially. As a result the businesses have low margins due to competition but fairly high volume and it does not take much to impact their profitability. The article is written about the potential impact of of a law that keeps liquor stores open on Sunday. Lotterman also talks about the cost to society of keeping the liquor stores open on Sunday. I think that marijuana dispensaries and the dispensaries of whatever other drug the politicians legalize will eventually resemble the liquor store scenario with a proliferating collection of low margin businesses. It will take a while for the market to get to that level, largely due to the folklore associated with the product at this point in time.
Why is this model important? Two reasons really. The first is the current marketing angle. The marijuana entrepreneurs want to expand the market including expanding it to people who are not using the product. Secondly will be the level of availability. If we are looking at the liquor store model, each establishment will have to move a large amount of product to stay in business. That will involve a range of product analogous to expensive wines and liqueurs in fancy bottles to the inexpensive vodka that is the mainstay of alcoholism. Few people will get rich, In many ways it will be similar to the Freakonomics analysis of why it is hard to get rich selling crack cocaine. In the end, high volume low margin business benefits the few and not the many who may end up taking the risks. It is the ideal low cost mechanism for maximizing exposure of the product to the most people.
I expect the learning curve on all of this to be high. As I have watched the reality TV shows about this phenomenon as well as the dramatic adaptations like the television series Weeds it is clear that the goldrush myths are alive and well. The product is hyped as being benign and it will be widely marketed. It doesn't take a lot of imagination to predict that there will be crime activity associated with the overall process. The idea that addictive intoxicants can be removed from the sphere of criminal activity so that we can all enjoy the benefits of getting high and spending the increased tax revenues is a recurrent fantasy. There is significant criminal activity associated with the legal drugs - alcohol and tobacco and they have their own agency to deal with those problems.
George Dawson, MD, DFAPA
Edward Lotterman. The Cost of Sunday Liquor Sales. March 16, 2014.
Luke Runyon. To Keep The Business Growing, Vendor's Rebrand Pot Stoner's Image. Minnesota Public Radio. April 21, 2014. (listen to the link).
Steven D. Levitt, Stephen J. Dubner. Why do drug dealers still live with their moms? in Freakonomics, Harper Perennial, New York, 2005, 2006, 2009: 85-113.
Supplementary 1: I intentionally avoided any reference to the medical costs of cannabis even though we know more about that now than at any point in history. There have been some high profile stories recently but the most believable one should come from long time cannabis advocate Tommy Chong during an interview on TMZ a few weeks ago. I personally saw the video in real time where he comments that pot is not for everybody and that some people should avoid it. That is a paraphrase. I thought the actual video would be out there but it is not. Probably too much at odds with his other videos.
Supplementary 2: Public domain photos of marijuana courtesy of U.S. Department of Justice Drug Enforcement Administration.
Supplementary 3: It will be an interesting twist if cannabis is marketed as anything but a drug. That will be the difference between direct-to-consumer pharmaceutical ads where the consumer is rapidly advised of a string of significant side effects (including the possibility of death in some cases) and some ads contain the phrase: "this drug is not for everybody" and an ad for an alcoholic beverage that says "drink responsibly". The latter by definition will result in broader exposure for a larger number of people.
Supplementary 4: I was just (4/30/2014) informed by a reader from Colorado that medical marijuana is still the preferred product there because the taxes on it are lower.
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