1BOM posted a link to a Forbes article on the issue of blockbuster drugs. Journalists are typically slow to pick up on this because it takes the element of scandal out of any relationship between physicians and the pharmaceutical industry. After all, aren't physicians clueless about pharmaceutical advertising and mindless cogs in Big Pharma's attempts at hegemony? The tone of the article is that Big Pharma is now increasing the drug prices for therapies targeting fewer conditions. No thanks to Big Pharma for all of the innovation currently used by the generic pharmaceutical companies. As an example, I bought a bottle of montelukast (90 tablets) a month ago for $9. It is the Singulair product list as Merck's 2010 blockbuster drug in the Forbes article. As far as I can tell, it is the only effective treatment for an asthma attack that has caused me to take oral prednisone, inhaled glucocorticoids of various types, nebulizer treatments, inhaled ipratropium, and various inhaled beta agonists for the past four months. I didn't see the US government or the academic community inventing montelukast. In fact, I don't see the US government or the academic community doing much about the fact that the average asthmatic is still wheezing and there is no effective approach to preventing the spread of respiratory viruses that are a major cause of this problem. I guess their solution is to partner with managed care and suggest that pay-for-performance is going to save us all. Maximum treatment with everything except montelukast has done nothing for me. What would pay-for-performance do?
Maybe that is why doctors who I have seen always ask: "Are you sure you NEVER have smoked?" That seems to happen after the usual: "I like to treat asthmatics because I can do so much for them!" If that is true why are most asthmatics still wheezing? I think it is fair to say that the only reason I am wheezing less at this point is due to Merck. The necessary CME disclosure at this point is that I do not own any pharmaceutical company stock, but I am quite willing to admit it when I see a good product defined as one that works for me. Since the focus of this blog is on psychiatry - I also get direct feedback from patients that the medication I prescribe has had some of the same effects. That is even in the case of medications that I never prescribe - paroxetine and fluoxetine, in people I see for consultation. And for all of the clinical trials obsessed out there - I suppose I could just say or think: "I guess this person is unfamiliar with the meta-analyses critical of antidepressant efficacy." or at least: "I guess this person has never been on the Internet and read about the horrendous side effects of these medications." But being the foolish psychiatrist I am, I am likely to think that a person with severe depression requiring hospitalization, severe postpartum depressions with psychosis and suicide attempts, or severe disabling depression may have actually found an effective medication that works for them. I am much less impressed by the work of statisticians than the experience of my patients, especially when their lives are back on track.
In terms of the cost of psychiatric medications, this is really an old issue. It was years ago when I noticed that people could pick up citalopram for $4 a month at Wal-Mart. I had to point the wide availability of generic antidepressants in a response to a Washington Post article. I guess the DSM-5/Big Pharma conspiracy is not looking too good now. Sure there are new antidepressants, but there is no reason why they should be first line drugs. Anyone with an first time PHQ-9 elevation is going to get an inexpensive SSRI.
All of the critics of Big Pharma were naturally slow to pick up on it, especially the antipsychiatry crowd because it means that the moral high ground is lost. They can no longer devalue everything that psychiatrists do based on the alleged Big Pharma connection with a handful of psychiatrists. Of course they can keep the conspiracy theories going about some missing clinical trial results of a now generic drug that is over thirty years old. They can conflate that as having something to do with psychiatry despite the fact that the major regulators like the FDA have done nothing about the drug based on post marketing surveillance. They can blame psychiatry for the overprescribing of primary care physicians and the institutionalized overprescribing of managed care systems. The antipsychiatrists will certainly continue to hate psychiatry and the critics will still have an axe to grind with particular psychiatrists. But at least I won't have to tolerate a smug blogger proclaiming that they were "Keeping psychiatry honest since 2007." I have actually done very well maintaining my honesty without the help of a self promoting blog and the psychiatrists I know have done the same.
And wait a minute - what about the real epidemic that has been actually killing more than 10,000 people per year for over a decade? Plenty of generics there and plenty of ways to take way too much acetaminophen.
The other problem with the Big Pharma conspiracy theories has been a general naivete about capitalism and marketing. Advertising is good for the New York Times, but not a medical journal or meeting. Physicians need to be cloistered from market influences. They could be corrupted in a way that is inimical to the interests of patients. Direct advertising of toxic medication to consumers is a much preferred route. As far as the "me too drug" argument goes, let me illustrate the problem with that argument by my trip to the convenience store today. I ran out of grape juice today. I only drink Welch's 100% grape juice, diluted at a ratio of about 5:1 with carbonated water. I drink about 576 fluid ounces of the stuff per month. Rather than go to a supermarket, I went to a convenience store because it was closer. On the shelf were a vast array of chemical drinks and sodas of no nutritional value, small bottles priced at what I could buy 64 ounces of pure unsweetened grape juice for. The comparisons were overwhelming. Self proclaimed nutritional drinks that had no calories, no protein, and plenty of artificial sweeteners. Natural juice "beverages" or "cocktails" that had vanishingly low amounts of actual juice. All of these products basically knock offs of fruit juice, but, heavily marketed, neatly packaged, much more expensive, and having the occasional nutrient value of added vitamins. Does a "me too" pharmaceutical have less value than a "me too" soft drink? There is no comparison.
I also had the association to my Peace Corps experience. In the country where I served in Africa, there was a place called the Northern Frontier Zone. There was a police outpost there and you had to sign a register acknowledging that the local government was not responsible for your safety once you crossed into that territory. One of the best ways to get there was to hitchhike on large trucks carrying Coca-Cola. You just had to get comfortable laying on cases of Coke. Over the years, I have drank as much Coke as anybody - but for the purposes of this post and the focus on advertising and marketing consider what I am saying here. In 1975, Coke was widely available in remote African villages and the Northern Frontier zone. For most people it was more widely available than clean water. Since then. they have sold increasing amounts of the product. The world is dominated by American cola manufacturers. Are "me too" pharmaceutical products less valuable than Coca-Cola? I would suggest that they are probably not and they are marketed a lot less vigorously. Unless I have missed it there has been no complaint about Coke's world domination, although I sincerely hope that a psychiatrist is never photographed drinking a can.
I might be biased by a good four months of decreased wheezing, but I hope the general message on the Forbes article gets out and clears some of the air. In psychiatry, there are many more important things to focus on than conspiracy theories that really don't apply to the vast majority of psychiatrists. You can't take physicians out of their historical mandarin role and instead blame them for colluding with Big Pharma. It may have been a political strategy to get them out of that role and suggest that politicians (of all people) should assume that role.
The work psychiatrists do is tough and demanding. No psychiatrist who I have ever talked with expects a pat on the back.
Getting out of our face is a pretty modest wish.
George Dawson, MD, DFAPA
Supplementary 1: I also have no financial interest in any of the other products mentioned here including Welch's grape juice or Coca-Cola. I used the real names because they are historically accurate.
Saturday, May 17, 2014
Thursday, May 15, 2014
The Spectrum Of Caring About Medication Information
With over half of Americans on prescription drugs and many on significant polypharmacy, not a lot is known about the decisions to take a medication or the associated informed consent issues. There is always a question about whether a productivity based, low quality medical environment will result in more prescriptions or less. There is the ever present marketing issue and regulatory decisions by the FDA that often seem to be market based. The CDC came out with recent data on this phenomenon today including some excellent information on potential overprescribing - see the antidepressant and antibiotic slides (click to enlarge any graphic).
I thought I would look at how medication information seems to be used by patients. I try to condense this issue down to a graphic to capture what I think are the essential elements to consider in terms of the information requirements that people need to make decisions about medications. There is a full spectrum of considerations from people who don't want to know anything about a medication to those who want as close to a medical level of knowledge as possible. The one area of this table that I know for certain is that we all start out in a common place and that is not wanting to take a medication at all. As I have pointed out here several times, searching for a medication that will work for a problem is often fueled by desperation. Medication side effects and a lack of efficacy of medications is common. The graphic is based on my direct observations about medications and how people decide that they will use them. I eliminated the scenarios that involve addiction for the purpose of a more simplified scenario, but could develop that if anyone is interested. (click to enlarge)
In 30 years of practice I have encountered all of the scenarios listed in the above table at one point or another. As an intern on the Internal Medicine service, I recall a young man who I had just admitted to the ICU for acute asthma. We gave him the usual glucocorticoids, theophylline, and albuterol nebulizers. Within and hour he wanted to leave. His respiratory status was slightly improved at the time but my resident, attending, and I did not think it was a good idea. He signed out AMA with the complaint that is was just too boring to stay in a hospital despite his flare up of asthma and continuou wheezing.
I have also had plenty of experience at the other end of the spectrum. They are generally complicated situations involving treating physicians or other professionals or the relatives of professionals, people with severe complicated problems that have not responded to any of the usual therapies, people taking highly interactive or toxic medications, or people with personality structures (innate or acquired) that require a lot of information or the idea that better decisions are predicated on the maximum amount of information. Many of these folks also have ideas about physicians and expectations of how much time they are able to spend with physicians.
If I had to guess about the distribution of people I have talked with most of them would probably lie in column 5 (from the left). The distribution of people on both ends of the table is low. I think that the most important aspect of this spectrum for a physician is recognizing the approach that the patient is taking and trying to complement that. That involves being more available to people who don't want a lot of information up front in the event that they have experiences with the medication that they might want to ask about. Even in the case of refusal of medication, people change their mind especially when dealing with illnesses that are clearly disruptive and potentially life-threatening. Some people may come back and demand to know why nobody forced them to take a medication in the first place even when they refused it initially.
Television ads for new medications seem to take a high pressure approach to column 6 with a very rapid speech about severe and potentially life threatening complications. The ads obviously lack depth for the person described in this column, but they have a degree of transparency about severe effects. I would wonder if a person speaking more slowly about the side effects would have more impact.
The other lesson that is often lost is that there is no correct way to consider information for an informed consent decision about medication. Physicians consider rational thinkers to look at the probabilities of the risks versus the benefits and make a decisions. That is what much of the medication information educational material is based on. In fact, medication decisions are very personalized. The response of the population in general does not dictate the response of the individual. The affected person may have no interest at all in a new medication that is offered but they may recall detailed information about their response or the response of their family members to medications. They may also have had very adverse experiences with medications, physicians, and other medical personnel. People develop medical comorbidities at different rates and that will also be an important aspect of the decision making process. The only decision-maker who is really problematic in this table is a person who takes an empirical approach and then does not report any side effects thinking that they will "get used to" the medication. I think a lot of those ideas may originate with physicians who have inflexible approaches because in my experience people rarely get used to side effects and some side effects are harbingers of potentially severe problems.
There are also important questions about the overprescribing issue. In at least some of those cases, physicians are often dealing with patients who may be receiving information like: "You don't have signs of a bacterial infection" but processing it as: "I believe in antibiotics and need to take antibiotics to get better".
I think this is all an important aspect of the informed consent process. The informational aspects of informed consent need to include how much information a person is willing to consider is the first step. The analysis of that data follows.
George Dawson, MD, DFAPA
Sunday, May 11, 2014
Near Riot In A 24 Hour Pharmacy
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
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
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
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