Measurement Based Care
Measurement based care is generally perceived to improve the outcomes of various psychiatric conditions by routinely bringing the same assessments to everyday treatment world the as those used in the clinical trials of the interventions being prescribed. When scientists talk of studies of clinical interventions the first two terms you need to know are independent variables and dependent variables. An independent variable is the intervention; it does not depend on any other action other than being given to the subject (patient). The dependent variable is what is measured and hypothesized by the investigator to be a result of the intervention (independent variable). For example, if a patient is given Prozac (fluoxetine) then the investigator hypothesizes there should be a reduction in depression. This begs the question; how do we know the depression has been reduced? Better yet, how much depression was present at the beginning of treatment and how much depression is remaining after a period of treatment? A carpenter would not cut a board without first measuring the board to see if the board were long enough to yield his desired length and then measure at least twice to cut his desired length. Yet, everyday physicians and clinicians of all stripes that treat mental illness make metaphorical cut after cut without knowing much of anything except the name of the metaphorical saw he or she is using. In the United States only about 18% of psychiatrists and 11% of psychologists routinely administer rating scales to their patients. The clinicians that use clinical judgement alone detect only 21% of their patients that have deterioration and who have increased symptom severity. The clinicians detect even fewer patients who are not deteriorating but are simply not improving. When the clinician fails to detect a deterioration or even more commonly a failure to respond optimally to treatment, then the patient continues to be ill, or at least more ill than necessary, due to lack of adjustment in the treatment plan. In addition to the lack optimal patient outcomes there is also a lack of optimal clinician outcomes. Clinicians that do not observe the systematic results of their interventions have no way of knowing that the interventions were not successful and to what level they were not successful. The clinician does not get the feedback that allows him or her to adjust treatment strategies and grow in clinical knowledge and skill. Measurement based care (mbc) has been defined as “enhanced precision and consistency in disease assessment, tracking, and treatment to achieve optimal outcomes”. Symptom rating scales are the starting point for the evaluation of clinical effectiveness. For the mbc to be effective the symptom feedback must be clinically actionable. Perhaps we should coin a phrase here: “you don’t need to measure what you can’t treat, and you can’t treat what you can’t measure”. For the rating scale to be useful (valid) it must be a current assessment, it must be interpretable, and it must be readily available during the clinical encounter. Screening tools are now mandated in many electronic health records as part of the Byzantine Federal regulations promulgated upon the medical community. Most commonly, the PHQ-9 is given at a yearly screening exam. This is a 9-symptom rating scale of depressive symptoms. It is not a diagnosis, that requires clinical judgement, in addition to point-in-time data. Screening alone is insufficient to improve outcomes without system in place to monitor treatment response. Mbc requires that symptom severity must be assessed frequently to be effective. This assessment must be done in concurrently with the clinical encounter. For example, if the rating scale is administered quarterly in the first month of the quarter but the patient is seen quarterly in the third month of the quarter then the rating scale is useless. (I am sure it is only a matter of time before some insurance company or managed care company comes upon this bright idea to institute this useless strategy under the heading of quality improvement). I have been practicing management-based care in my clinic for the last 30 years. My goal from the outset was to be able to demonstrate the effectiveness of the treatments rendered. Of course, there are numerous variables other than the independent variable of the medication prescribed that may impact the treatment outcome (in statistics, we call these confounds). These confounds only apply to comparisons between patients, within the same patient the confounds remain the same and the comparison of the same rating scale outcomes over time and interventions is both reliable and valid. There are many rating scales available for clinical use and are simple and easy to administer or have the patient self-administer. I will review these, perhaps, in the next blog. At my office we use the SCL-90 for the diagnostic screening, although I am thinking of changing to the Mini-Neuropsychiatric Assessment, and the Basis-32 and a Review of Systems (ROS) both at baseline and with each follow-up visit. The Basis-32/ROS covers all the symptoms on the MADRS, PHQ-9, and GAD-7, and most of the symptoms on the Ham-D. In addition, it has a robust section for social functioning assessment. If the need arises for further clarification, I will complete a MADRS, AIMS, PANSS or Columbia Suicide Scale. I hope this has given you some background information of why you and I do what we do at your clinical visit. References available upon request. The author does not wish to represent the findings of others as his.
From the beginning there has been a chasm between the way that psychopharmacologists refer to and think about psychiatric medication as opposed to the FDA, the lay press, and the marketing arms of the pharmaceutical companies. The FDA generally approves a medication for a disease indication according to the Anatomical Therapeutic Chemical (ATC) classification system. For example, we have anti-depressants, anti-anxiety medications, and anti-psychotics. However, all of these “classes” of medications may be utilized for one or more of the “indications” in the ATC system. The FDA regulations require that in order to obtain a new “indication” that the compound must show benefit in 2 of 3 clinical trials. The pharmaceutical company run 2-3 Phase 3 clinical trials to obtain each indication. This is the reason that the company will most often pursue a single indication for a given medication. Clinicians utilize the medication “off label” to treat other conditions in which clinical trials apart from the drug company demonstrate safety and efficacy. That is how we get to the point where when I prescribe an “anti-depressant” for an anxiety disorder, as is recommended for a first line treatment, I get the statement, “I’m not taking that, I’m not depressed”.
The Neuroscience-Based Nomenclature (NbN) was designed to describe a drug based on its pharmacology and mechanisms of action so that the treating physician has a clear alternative when selecting a treatment or altering a therapeutic regimen. The NbN was adopted first in Europe and has moved to the United States. The cause has been championed internationally by Dr. Stephen Stahl of La Jolla, California. This nomenclature has now been adopted by several of the leading journals of neuroscience and pharmacology. Most recently, this list was joined by the prestigious American journal, Biological Psychiatry. As an acolyte of Dr. Stahl, I have utilized the mechanism of action model to describe psychotropic medication for many years.
At this point I am going to digress slightly and stress a fact that is all too often misunderstood and distorted, i.e., the mechanism of action describes only what the medication does at the level of the cell. This does not translate to the medication addressing the causation of the illness, even though the use of the medication alleviates the symptoms of the illness. In a crude analogy, just because we can fix a broken arm with a cast does not mean that a lack of fiberglass tape leads to a broken arm. This reasoning is how we get the phrase, “chemical imbalance”. There is not and never was a “chemical imbalance” leading to depression. This was a marketing phrase.
The NbN includes four additional dimensions beyond the basic pharmacology: 1. Approved indications; 2. Efficacy and side effects; 3. Practical note (a summary of the most relevant clinical information); 4. Neurobiology (includes preclinical and clinical data and highlights preclinical findings of value to physicians).
A full description of the NbN can be found at www.nbn2r.com .
What is a diagnosis
What is a diagnosis.
A frequently asked question is, “well doc, what is my diagnosis?” My usual answer is, “you are kind of a mixed bag”. Let me explain.
As I have probably said in a previous post, “all psychiatrists have physics envy”. That is to say, we all wish to have some mathematical model that will explain the human condition so that we can simply plug in the appropriate variables and out pops the correct answer or explanation. Although physics and chemistry determine all of biology and therefore our brain and its emergent property the mind, at the emergent level of the mind we cannot deal in that level of precision. What we can say about the mind is that it is noisy and non-linear. With this as background, what then is a diagnosis?
A diagnosis is a constellation of symptoms, both subjective and observed, that tend to cluster together as a behavioral state that impairs normal daily functioning. These states have been known since humans have been human and talking about other humans. Over the span of recorded human history, they have gone by different names and different explanations have been given for their existence. These states if left untreated tend to have a distinct course of symptom evolution over time. This is true of all medical illnesses. The exact makeup of the symptom clusters has varied over the course of human history. Our current diagnostic schema is determined by a committee of the American Psychiatric Association (which happens to own the copyright to this schema). The naming has nothing to do with the underlying biology (illness). If you are now thinking this is no way to practice medicine, you would be correct.
Let us take the example of PTSD. Please be advised that I am shamelessly reciting facts presented by my colleague, Dr. Amit Etkin, for this example. His videos on this subject can be found on You Tube. In DSM 3, the previous iteration of our diagnostic schema, (the diagnostic manual devised by the above referenced committee) there were 80,000 different combinations of symptoms that will yield a diagnosis of PTSD. Just a few years later this same committee revised the criteria for PTSD (DSM-4). Now there are 600,000 combinations of symptoms that will lend a diagnosis of PTSD. To complicate matters further, there is only a 50% overlap in these combinations between the two different versions of the same PTSD diagnosis. The biology of PTSD surely did not change during this time and neither did the emergent properties of the biology. What changed was the way the committee decided to slice and dice these emergent properties. If about now, you are thinking of the story of the blind men feeling the elephant, you would be correct.
With this is background, a few more facts can be stated about psychiatric diagnosis.
In general, a psychiatric diagnosis is not “one thing”. Take for example, major depression. The diagnosis includes disorders of sleep (too much or too little), appetite changes (too little or too much), decreased energy, decreased motivation, psychomotor agitation or retardation, decreased concentration and indecisiveness. We know from functional imaging studies and neurophysiology, that for the most part, each of these symptoms is controlled by a different neural pathway. In addition, you can see that within a given pathway the changes may be in totally different directions. Given this, I find it amazing that sometimes a single intervention will address all these changes. More often, multiple interventions are required to fully address all the various changes in the various pathways.
Psychiatric diagnoses often overlap. One example of this is the diagnosis of depression and anxiety. There is an old saying in psychiatry that one can be anxious without being depressed but one cannot be
depressed without being anxious. More often than not, that is born out in the clinic. Let us look at one of the most used rating scales of major depression, the Hamilton Depression Rating Scale. The first three items address mood, guilt and suicide, all exclusively depressive symptoms. The next three questions address insomnia which is disordered in many different conditions including anxiety. The next question addresses work and activities and the next question addressed psychomotor retardation. The anchor points of these questions favor the disability being in the depressive spectrum. The next seven questions address some form of psychic or somatic manifestation of anxiety. The remainder of the scales addresses various varieties of depression such as melancholic and psychotic.
As you can see from this one example, and there are many more, a psychiatric diagnosis is seldom either/or but more likely “and”.
Sapien Labs developed the Mental Health Quotient. This is an online rating scale of mental well being that spans across the various diagnoses (transdiagnostic). You may take the rating scale at the Sapien Labs website. The researchers broke the sample into a clinical group that was being treated for any diagnosis and a group that was “at risk” based on their responses to the rating scale. Both groups displayed “severe” symptoms.
In the clinical group, the percentage of the group with one or more diagnoses were approximately as follows: no diagnosis (dx)=5%, 1 dx=13%, 2 dx=12%, 3dx=11%, 4dx=14%, 5dx=12%, 6=10%, 7dx=8%, 8dx=8%, 4dx=9%, 10dx=1%.
In the at-risk group with severe symptoms, 60% had no diagnosis and 20% had 1 diagnosis, 9% had 2 diagnoses.
Once again, if you are thinking this is not a good way to practice medicine, you are correct. What this practice is doing to improve on this situation will be addressed in future posts.
An article with the above title appeared in the Friday, December 6, 2019 Wall Street Journal. The article is written by the Jewish psychoanalyst Erica Komisar of New York City. She draws her conclusions from her reading of the scientific literature, her experience treating anxious and depressed children, and her Jewish faith and community. Her advice transcends any particular faith. I recommend her article to you.
Ms. Komisar cites a 2018 study in the American Journal of Epidemiology that looked at how being raised in a household with religious or spiritual beliefs affects mental health compared to an equal size non- religious control group. The children that attended a religious service one a week or more scored more highly on tests of mental wellbeing and a lower risk of mental illness. These children also had a lower probability of drug use and early sexual behavior. The children also had a higher rate of volunteering, a greater sense of mission, and a greater ability to forgive. From a purely secular point of view, these attributes alone might be worth “faking it to you make it”.
Ms. Komisar then goes on to address what she sees at the root of much of the increased anxiety and depression in today’s children, existential nihilism. When there is no meaning to a life beyond the here and now day to day survival, no ultimate meaning and purpose beyond our existence, then a person is ripe for not only depression and anxiety but also despair. This has been addressed by numerous authors including, most notably, Dr. Fiktor Frankl. Therefore, I ask almost all my patients, “what is your reason for getting out of bed each morning, what is your meaning and purpose in life, what is the hope that keeps you going?”
Having this transcendent anchor point external to ourselves, but with personal meaning to the induvial believer as well as the community of believers, allows us to answer the big questions common to all children and to provide solace in their time of anxious questioning. This hopeful belief system allows us to talk frankly to our children about death. I will quote directly from Ms. Komisar’s article: “The idea that you simply die and turn to dust may work for some adults, but it doesn’t help children. Belief in heaven helps them grapple with this tremendous and incomprehensible loss. In an age of broken families, distracted parents, school violence and nightmarish global-warming predictions, imagination plays a big part in children’s ability to cope.”
Ms. Komisar states she is often asked by parents how they can instill gratitude and empathy in their children. These are virtues found in all religious traditions, even those without a deity or belief in an afterlife such as Zen Buddhism. Ms. Komisar states in her article: “It’s rare to find a faith that doesn’t encourage gratitude as an antidote to entitlement or empathy for anyone who needs nurturing. These are the building blocks of strong character. They are also protective against depression and anxiety.”
Finally, Ms. Komisar points out that religion provides a natural community. Ms. Komisar expresses this beautifully in the following passage: “The idea that hundreds of people can gather together and sing joyful prayers as a collective is a buffer against the emptiness of modern culture. It’s more necessary than ever in a world where teens can have hundreds of virtual friends and few real ones, where parents are often too distracted physically or emotionally to soothe their children’s distress.”
I will leave you with the final paragraph of Ms. Komisar’s article: “Today the U.S. is a competitive, scary and stressful place that idealizes perfectionism, materialism, selfishness and virtual rather than real human connection. Religion is the best bulwark against that kind of society. Spiritual belief and practice reinforce collective kindness, empathy, gratitude and real
connection. Whether children choose to continue to practice as adults is something parents cannot control. But that spiritual or religious center will benefit them their entire lives.”
Currently available antidepressants, at least in their initial action, exert their antidepressant effect by influencing monoamine levels in the brain. Despite increasing the monoamine levels within the first day, the clinical manifestation of the antidepressant effect may be delayed by days to weeks. Approximately one third of major depressed patients will have a 50% or more reduction in symptoms with the first agent prescribed. Although the total number of patients responding increases with subsequent medication trials, the proportionate response to each new drug is much less than to the original drug. This series of trials may take months to years. This scenario has led to the search for a medication that rapidly reduces depressive symptoms. Esketamine seems to fulfill those criteria.
The brain’s response to any medication is much more complex than increasing as certain neurotransmitter. Esketamine does not raise monoamine neurotransmitters. Instead, esketamine binds to the post-synaptic NMDA glutamate receptor blocking glutamate neurotransmission. There are a few other biochemical happenings at the receptor level that are necessary for this to effectively occur, but that is a bit in the weeds for this article. Another result of this binding is the activation of the mTOR pathway. This is a pathway that eventually leads to increased BDNF and increased synapse formation. Pay no attention to the acronyms, just know it’s a good thing to happen. Wikipedia can give you a fuller explanation. This is amazing in two ways. First, that protein formation (needed for the building of synapses) can be elicited and seen occurring within 2 hours of administration is remarkable. This occurs with typical antidepressants but may take weeks. Second, the BDNF increase and the onset of new synapse formation correlates with a decrease in depressive symptoms and suicidal ideations. A medication that can be administered intranasally in a psychiatrist’s office and reduce suicidal ideations and decrease depression within 2 hours is a large leap forward in psychiatric treatment.
Serendipity and Urine Drug Screens
A not unusual occurrence in medicine is that while looking for one thing we find another. This happens all the time at the drug discovery level with many of our drugs being developed for one disease while looking for a cure for another disease. A classic example is the development of the tricyclic antidepressants. All the antidepressants can trace their lineage in one way or another back to isoniazid. Isoniazid was being developed as a treatment for tuberculosis. When this drug was given to severely depressed patients at state hospitals, many of the patients had a remission of their depression. As is often said, the rest is history.
With the urine drug screens we have seen another bit of medical serendipity, although not nearly to the level of importance as the above example. About one year ago the state board of medical licensure mandated point of service urine drug testing when a physician writes a prescription for benzodiazepines (Xanax, Ativan, Valium, Klonopin, etc.), opiates (oxycodone, Norco, Hydrocodone, etc.), or stimulants (Adderall, Ritalin, etc.). The reasoning that led to this decision seems to be that people that are prescribed one addictive substance such as an opiate are often prescribed another addictive substance by the same or different physician (the VA study). These patients have an increased risk of fatal drug interactions leading to respiratory depression and death. In addition, patients who are addicted to heroin or other opiates obtained either legally or illegally are often using other drugs, particularly benzodiazepines, that increases the risk of a fatal overdose.
At the time of the promulgation of these regulations, I argued strongly to the medical board that the routine urine drug testing of patients prescribed benzodiazepines was unlikely to discover patients using opiates not already noted in the PMP (a computerized data base of all controlled substances prescribed to a patient nationwide). The physician is mandated to check the PMP each time a controlled substance is prescribed. Now, about one year into this experiment some clear patterns have emerged. The first is that my reasoning regarding opiates and benzodiazepines has been confirmed. However, a totally unexpected pattern and area of concern has been manifest.
Since the institution of the above regulations, the federal government has passed the Farm Bill. In this bill was the legalization of the production of industrial hemp. In addition, proliferation of states with legalized “medical” marijuana has exploded, making marijuana products, even in states without such laws, more readily available. What we have discovered at my clinic over the past year is that the number of urine drug screens positive for opiates who had a negative PMP has been very low. However, patients positive for THC, the psychoactive component of marijuana, has been large. In addition, over the past two or three months, we have seen a dramatic rise in the number of THC positive urines who claim to have only used CBD products. Why is this clinically relevant? Please read the next blog post.
CBD and the Medical Patient
Medical marijuana and recreational marijuana are derived from Cannabis Indica or Cannabis Sativa. The important ingredient is the resin produced by the flower. CBD products are derived from the flower of a Cannabis Sativa strain with a different genetic profile than the marijuana Cannabis Sativa. In the following paragraphs I will illustrate why I am concerned about the rise in CBD and THC usage, especially in patients with a psychiatric condition.
First, a major caveat: No one under the age of 25 or a patient with schizophrenia and possibly bipolar disorder should use compounds that contain THC.
There are two CB (cannabinoid) receptors in human tissues. These are found throughout the body including the brain (CNS or central nervous system). These receptors are CB1 and CB2. In the brain CB receptors are instrumental in neuronal maturation and especially in the expansion and pruning process that occurs starting at about age twelve years and culminating at around age 25 years. Use of marijuana in this age group has been associated with an early onset of schizophrenia. Despite the speculation that CBD may be beneficial in schizophrenia and other conditions, there are virtually no medical studies (especially, double blind, placebo-controlled studies, the gold standard) of any cannabis product on any medical condition.
Cannabis products contain approximately 108 cannabinoids and 420 other compounds. CBD preparations are notable for their relative lack of THC (the content is supposed to be about 0.5%). However, this is not a guarantee of any type of purity. Commercially available CBD is still a mixture of a vast number of CBDs and other compounds. Although marketed as CBD or cannabidiol the preparation is far from pure cannabidiol. The reason that this is possible is because the FDA does not regulate the content, purity, safety, or investigate any clinical claim of CBD effectiveness. CBD does not even have to pass the over the counter drug review at the FDA. The over the counter drug review is much less stringent than the review of a prescription medication.
From a purely pharmacologic standpoint and for the sake of our conversation at the level of the brain, the major difference
In the November 2018 edition of Psychiatric Services Mary Brunette, MD, et. al., published a brief update on this timely question above. In the following blog post the reader should assume the material is taken directly from that review. Secondary references are contained within the article and the interested reader is referred to that article for further attribution and more in depth inquiry.
Thirty-three states and the District of Columbia have substantially reduced barriers for the sale and use of marijuana either through the legalization of medical and/or recreational marijuana or the decriminalization of the possession and use of marijuana. In Washington state 20,000 pounds of marijuana are produced each month. In addition, the marijuana industry has developed an array of products and delivery methods such as smoking, edibles, and concentrates. In addition, the industry profiles customers and heavily advertises to consumers. This all raises the question inferred in the title of this blog.
To borrow a phrase from an old Buick commercial, "this ain't your daddy's marijuana". When I was in college the THC content (the component in marijuana that gives you a high, the other component of marijuana CBD does not have euphoric/sensation altering properties) was anywhere from virtually non-existent to about 4%. Today the average street marijuana has a THC content of about 12% while the CBD component has decreased leading to a more rapid and potent high. Through genetic manipulation that would be the envy of Gregor Mendel and post harvest manipulation, we now have various products that vary the THC and CBD to produce custom products that allegedly have varying psychological effects. A sample of the offerings in Washington State include, Gorilla Glue Ethanol Shatter, with 75.8% THC potency; Billy Club Sativa, with 19.04% THC and <.05% CBD potencies; and Shark Shock Flower, with 9.21% THC and 11.8% CBD potencies. Marijuana is no longer, and perhaps never was, one entity but a variety of products with varying potencies, THC:CBD ratios, and CNS and peripheral nervous system effects.
What does this mean for the person with a serious mental illness such as schizophrenia or bipolar disorder? Psychiatrists have known for several decades that potent THC can cause psychotic symptoms in psychotic and non-psychotic individuals. When used heavily in adolescence THC increases the risk of developing schizophrenia. In patients that already have schizophrenia, THC worsens the symptoms and course of the illness. Heavy THC usage is associated with an increased risk of developing mania and depression, and in patients with a pre-existing mood disorder is associated with exacerbations of depression and mania. There is a common folk knowledge that marijuana is helpful in the treatment of PTSD but there is not a single controlled prospective published study of marijuana for this condition and retrospective, uncontrolled studies have been mixed.
Whether CBD is helpful for people with certain mental illnesses is unknown. (Part of the reason for the unknowing is that marijuana is illegal at the federal level. The DEA classifies marijuana as a schedule I drug. Researchers find grant money non-existent and all the marijuana that is used must be obtained from the farm at Ole Miss which is a strain from the 1960's). There was a study published in 2018 using a preparation of CBD without THC that reduced psychotic symptoms among people with schizophrenia. Beyond that, we do not have much evidence on which to hang our clinical hat.
In conclusion, outside of schizophrenia, bipolar disorder and use in adolescence, the evidence for benefit or harm from marijuana is anecdotal and conflicted owing to a lack of quality, prospective, controlled studies. Our current understanding is that marijuana is not universally good nor universally bad. However, it is not inconsequential. For patients in my clinic, I address marijuana use as another clinical factor that should be addressed with the patient. We do know the physiological effects of THC and CBD. We also know the the physiologic effects of the FDA approved medication we use every day in the clinic. In devising with the patient a treatment plan we must take all of this into consideration.
The simple answer is that the medical board requires it. The full explanation is a bit longer and more involved. Let me see if I can elaborate without too much editorializing.
This all started with the 'opiate crisis". I put opiate crisis in quotation marks because whether or not there has been (the number of opiate related deaths seems to have peaked about 1-2 years ago) a crisis very much depends on where one lives. The story of America's opiate epidemic has been told in an excellent book, Dreamland: The True Tale of America's Opiate Epidemic by Sam Quinones. There are many individuals, corporate entities, and regulatory agencies that acted in their own self interest without regard for the longterm impact on patients and society at large. A short list of these entities include certain pharmaceutical companies, especially Perdue Pharma, an enterprising group of Mexican nationals, corrupt pill mills, the Joint Commission on the Accreditation of Hospitals, and the American citizenry's insatiable appetite for addictive psychoactive substances. Most of this is documented in the above referenced book.
Perdue Pharma developed and aggressively marketed the powerful narcotic Oxycontin. Oxycontin is about 1.5 times as potent as Morphine. Having a potent narcotic is welcome relief to those suffering for acute severe pain such as after surgery, major trauma or cancer pain. Compared to fentanyl, oxycontin is a lightweight in morphine equivalents. Fentanyl is 70 to 100 times as potent as morphine. Fentanyl is used multiple times each day in the operating and procedure rooms. If that were the end of the story all would be well.
Enter the Joint Commission on the Accreditation of Healthcare Organizations (JACHO). In the 1990's JACHO declared pain to be the 5th vital sign (after temperature, heart rate, blood pressure, and respiratory rate). This was not based on any scientific findings but was more of a compassionate public relations campaign foisted on the healthcare community. You will notice that the four standard vital signs are objectively measurable and reproducible both within the same patient and between patients. Pain, on the other hand is a totally subjective experience with a very strong emotional component. One might argue that psychiatrists deal with largely subjective symptoms and still manage to relieve suffering through the judicious use of medication. One difference is that for the major psychiatric disorders, excluding attention deficit disorder, the medication is largely non-addictive and not fatal in overdose. (Tricyclic antidepressants are the major exception to the fatality statement, and benzodiazepines to the addictive statement).
Oxycontin was supposed to have a coating that made it difficult or impossible to have it rapidly absorbed. Patients with addictions soon learned that this coating was easily removed and the oxycontin could be ingested or injected resulting in an immediate "high". To summarize: We have a potent opiate that can be injected for an immediate high, it is readily available not just for hospital use but for routine outpatient use, aggressively marketed to physicians and hospitals as a largely non-addictive or at least not likely to be abused pain reliever, a disorder, pain, which had previously been regarded as a symptom, the disorder is wholly subjective and not independently verifiable, and the leading accreditor of healthcare organizations (and if you don't have this accreditation you are out of business) telling the healthcare community they must aggressively treat pain as they would an elevated blood pressure or fever without regard to the underlying cause. What could possibly go wrong?
The rest of the story developed rapidly. Pill mills sprouted in Florida (why do scams of this sort seem to arise in Florida?) and West Virginia. Other areas had this pill mills but these areas were ground zero. The price of oxycontin on the street rose. A group of enterprising Mexican nationals saw a market niche and began importing tar heroin from Mexico. They had excellent customer service, prompt delivery, and they were able to undercut the price of oxycontin or white heroin from Asia. People began to die.
But I still don't understand why I have to take a UDS if I'm just taking Xanax 0.5 mg twice a day. The lethal dose of Xanax by itself is so large you would likely choke to death on the volume before you died from the drug. Also, if I'm a pain patient taking Percocet,
(a popular combination of oxycodone and acetaminophen) I would die from liver failure from the acetaminophen before dying from the oxycodone component. What gives?
Drug addicts don't use just one drug, they use drugs in combination. Among opiate addicts the favorite combination is an opiate with a benzodiazepine, most often Xanax or Klonopin. The opiate decreases respiratory drive and agitation associated with a decreased oxygen level and the benzodiazepine decreases arousal. The user is likely to die at lower blood levels of each drug when they are combined.
In 2016 the Centers for Disease Control (CDC) promulgated practice guidelines strongly recommending against the practice of combined prescriptions. About this same time, most states instituted the Prescription Monitoring Program (PMP), a computerized data bank of all controlled substances that is searchable by patient. Most states medical boards or legislatures have mandated the checking of the PMP and strongly recommend following the CDC guidelines. This approach is rational and will make the prescribing physician aware of any other controlled substance prescribed by another physician so that appropriate clinical decisions can be made with he patient.
As far as I can tell, through accessing data bases of drug laws in other states, Mississippi is the only state that requires a UDS for a routine benzodiazepine or other controlled substance prescription. If the physician follows the CDC guidelines and accesses the PMP before each benzodiazepine prescription, then the only patients that the UDS will "catch" are those that are taking opiates from friends, family or abusing heroin or buying opiates off the street. Experience with this screening will tell if this slice of the public is as large of a public health concern as the medical board has indicated.
Prior Authorizations for Medication
Sorry for the long absence from the blog site. The previous posts have explained various aspects of my practice or provided what may be referred to as helpful hints for mental health. I now plan to move to a more wide ranging group of topics. Today's topic concerns the rise in prior authorization requests.
Psychiatry has been particularly hard hit by medication prior authorization requests. This topic has been widely discussed in professional circles but perhaps not so often between physicians and patients. As the immediate past president of the Mississippi Psychiatric Association, a former member of the American Psychiatric Association Assembly (the legislative body of the APA) and an active member of the Mississippi Medical Association, I have debated and advocated for prior authorization reform. We were able to get a uniform prior authorization request for the various Medicaid programs, but have been less successful with the various commercial insurance companies. The most likely reason for this is that prior authorization ( hereafter referred to as pa) do not come from your insurance company directly but from a pharmacy benefits management company (pbm).
Nationally, pa requirements have become a major topic of concern. How big is the issue? Last year the Cleveland Clinic spent about 10 million dollars on prior authorization requests. An AMA survey of 1,000 practicing physicians found that on average medical practices spend two business days per week per physician to comply with pa protocols. One third of practices employ staffers who do nothing all day but process pa requests. On average, a practice will complete 29.1 pa requests per physician per week that requires 14.6 hours to process. About half of the requests are for medical services while the other half is for prescriptions.
Pa request originate with the pbm. Pbms make their profit by billing the insurance company, receiving rebates from the pharmaceutical manufacturers, and discounts from the pharmacies. The goal for the insurance company is to pay the pbm as little as possible, the goal of the pbm is to make as much profit as possible. Pbms can increase profit by: 1. obtaining greater rebates from the manufacturer, 2. paying the pharmacy less for the medication, 3. receiving payment from the insurance company for medication coverage and limit the patient's utilization of the medication and therefore pocket the difference as profit. Number 3 is where the prior authorization comes in to play. By excessive, onerous and burdensome prior authorization requests the pbm drives down medication utilization.
In the past, the pbms largely focused on expensive medication services delivered in hospital outpatient services, infusion centers and chemotherapy delivered in physicians clinics. These have generally been chemotherapy agents for cancer or rheumatologic diseases. In both of these areas the pa is requested from the party that is delivering the service and being paid for the service.
In the case of a pa request from a pharmacy, the physician is being asked to devote additional time and effort to obtaining a service (dispensing a medication) for which the physician is not compensated, but the pharmacy and pbm are being compensated. The fee that the patient and the patient's insurance company pays to the physician at the time the clinical service is delivered at the office covers only the face to face time, effort, and clinical decision making at the time of the consultation (coding guidelines and CMS guidelines). In the past, the pbm companies targeted only new medication that were many times more expensive than existing medication. Over the past year there has been a move to require prior authorization for generic and relatively inexpensive medication. We have received pa requests for Benadryl, Cogentin (on the market since the 1960's), Elavil (on the market since the 1950's) and other similar medication.
We often hear from patients something along the lines of "the pharmacy said you just have to authorize the medication". If it were that simple. Completing a pa usually consists of either logging onto the pbm website or filling out a pa form. The pa usually requires such things as a diagnosis, length of treatment, other medications that have been utilized to treat the condition, including doses and dates, reasons for not continuing these medications, and the reason the requested medication is the only one that will treat the condition (and then only if FDA indicated and not "off label"). In addition, a pbm may require that you be prescribed and fail to respond to two other medications before the requested medication will be allowed. As you can see, this is not a simple request but requires going through your entire medical record. Because there is clinical reasoning involved it can only be completed at the highest level by the physician. The medication is then almost routinely denied. The most common denied medications in my practice are second generation antipsychotics, controlled release stimulants, and newer antidepressants.
While I and my staff are always wiling to advocate for the best possible care for my patients, advocacy is not without cost. Insurance companies do not reimburse the physician or physician staff for the time, effort, and clinical judgement involved in completing a pa. The insurance company pays only for direct face to face medical care delivered at the time of the clinic visit. Therefore, if you wish the office to complete an pa and advocate with your pbm on your behalf you will be charged for the service.
Philosophically, I am a capitalist and do not begrudge companies realizing the profits they can generate. I also have to deal with my own personal physician and pharmacy benefits and purchase insurance coverage for my family and employees. In my roles above I have advocated for my fellow physicians and our patients with insurance executives and government officials. I believe that transparency and sunlight are essential for good working agreements, such as those between you, me, your insurance company, pharmacy and pbm (my guess is you didn't know there were so many people involved in our transaction). I hope this post has gone some small distance in making the pharmacy benefits coverage provided by your insurance company a little more transparent and enlightened.
Andrew Bishop, MD FAPA