WARNING: Before we go any further, I am going to lay my cards on the table, and state my biases. I have suffered from age 12 for 48 years with 2 intractable pain conditions, for which I have been prescribed opioids on both an acute and chronic basis for 38 of those years. At age 12, I suffered my first classic migraine. From age 12 to age 18, I was treated in the ER roughly 6 times each year with Demerol as a rescue medication for acute migraine headaches. Over the next 6 years, as an undergraduate and during my first two years of medical school, I was prescribed oral oxycodone (Percodan) to self manage my migraines, 12 tablets every 6 months. The sleep deprivation of clinical rounds caused my migraine frequency to peak, and when the faculty of my medical school was unable to treat my frequent migraine headaches, I was forced to leave medical school after the third year. I was opioid free between 1985 and 1996, but after many workups, my headache specialist started me on 30 mg OxiContin per day. This controlled my migraines from 1996 through 2008. In 2008 my car was struck by another car and hit a tree at 45 mph. I suffered 15 broken bones, including 3 fractured vertebrae. I was discharged from the hospital 22 days later on 600 Milligram Morphine Equivalents (MMEs). That dose was titrated down to about 120 over two years, and I was maintained on that 120 MME dosage through 2018. This year my current pain management physician titrated me to 85 MME, due to the current CDC Guideline. I will discuss further my beliefs surrounding opioids; however, I wanted to provide a disclosure.
No one doubts that the number of drug overdose death rate has increased dramatically since 1999. And because some number of those deaths involve opioids, whether or not the opioid was the causative agent, the increase has been labeled the opioid epidemic.
Drug overdose deaths (DOD) have steadily increased from 1999 through 2017. In 1999, there were 6.1 DOD per 100,000 standard population; in 2016 that rate had risen to 19.8 per 100,000. The rates for all age groups above 15 years of age increased over that time frame. For some age groups, the increase was much larger than others (See figures 1 and 2).
The Centers for Disease Control and Prevention (CDC) has been one of the lead agencies in describing, defining, and combating the opioid epidemic. Why? Two factors (at least): their name (Disease Prevention) and their constitution i.e. a collection of epidemiologists. The CDC uses epidemiological methods to describe and characterize outbreaks of sickness. I remember receiving the CDC Morbidity and Mortality Weekly Report (MMWR) from my first week of medical school in 1980. Do they treat patients? Rarely, but they do crunch numbers and characterize epidemics.
We know that people are dying due to drug overdoses that include opioids because the CDC has produced report after report with thousands of statistics on these opioid overdoses. And not just the CDC. The White House Office of National Drug Control Policy (ONDCP) and the Drug Enforcement Agency also release statistics about the number of deaths due to opioids, and the number of prescriptions for opioid medications that are being written. One little problem: The statistics don't always agree. In fact, the agencies can't even agree on the trends. And this is a big problem, because if we can't determine how many people are dying, what drugs they are dying of, and where they got their drugs, how can we fix the problem?
As an example, on December 8, 2016, the Obama White House's ONDCP stated that 17,536 Americans dies in 2015 from overdoses involving prescription opioids, a 4% increase over the previous year. However, on December 16, 2016, the CDC stated in that weeks MMWR that the number of drug overdoses due to prescription opioids was actually 12,700 in 2015. When the Pain News Network, (PNN) a pain management advocacy newsletter, contacted the CDC for comments on the disparity, they were given a third statistic: 15,281, for 2015. The PNN column also noted that the CDC failed to mention that the DEA had reported that the prescribing and abuse of opioid pain medication (as opposed to illicit opioids) is falling, and that less than 1% of prescription opioids are diverted.
Part of the reason is the methodology involved: the CDC's epidemiologists consult death reports for cause of death. And death reports, by the CDC's own grading system, are not of uniform or even high quality. The CDC states that only 28 states provide "high quality reporting" on overdose deaths. Also, death certificates do not necessarily reflect the cause of death, merely conditions that exist as death. As an example, a patient that dies of cancer who received morphine from their oncologist would constitute an "opioid involved death". Another problem with the statistics involves heroin: heroin is rapidly metabolized to morphine, and therefore some illicit drug deaths may be reported as prescription drug deaths, or double counted as both prescription and heroin deaths.
The CDC developed voluntary guidelines for prescribing opioids for chronic pain. These guidelines were intended to be for family practitioners, the class of physicians who treat the vast majority of chronic pain patients in the US, and who receive little training in the use of opioids for chronic pain. In addition, these guidelines were intended for new chronic pain patients, and weren't supposed to be applied to already established patients. But due to the public outcry over the opioid epidemic, the CDC guidelines have been adopted by some state legislatures and/or state licensing boards, causing those guidelines to become hard and fast rules for all chronic pain patients.
So, we know we have an opioid epidemic, although we don't know how bad it is, because we don't even know how good the statistics are. Some say that the epidemic occurred because of opioids being prescribed for pain. Others point to big pharma, saying that the drug companies pushed the opioids on people. Others point to irresponsible doctors, and others at pill mills.
All of these play some little role. But there is a bigger role, one that isn't talked about much. And we will never control and "solve" the opioid crisis if we don't talk about the cause.
Pain is a human condition. Every person is exposed to pain, from an early age. We touch as stove and learn to avoid heat in response to the pain of a burn. We skin a knee and learn to run a bit more carefully to avoid the pain of falling down. A woman experience childbirth and learns that a new child comes after the pain of labor. But for some of us, either the painful condition is never cured, or the pain doesn't go away after the trauma is supposedly healed. These are what constitutes chronic pain. How prevalent is chronic pain? Unfortunately, just like the statistics for the opioid crisis, there is lack of agreement.
The CDC issued a report that estimated that in 2016 20.4% of Americans (66 million) suffered chronic pain most or every day for 6 months, and 8.0% (26 million) suffered high-impact chronic pain, where high-impact chronic pain was pain most or every day that prevented functioning in work or family surroundings for 6 months of 2016. By comparison, in 2011 the National Institutes of Medicine issued its report Relieving Pain In America which found that more than 100 million Americans suffered from chronic pain every year.
It is unfortunate that chronic pain does not receive the attention it deserves. Why is that? There are class, cultural, economic and personal reasons for that. And these in turn shed light on why we have an opioid epidemic.
Let's start with class: If you are upper middle or upper class, odds are you don't have a job that will lead to your becoming crippled with chronic pain. Oh, you may suffer some back pain from sitting at a desk too long. But crippled? Hardly. But if you are lower or lower middle class? Much more likely. And crippled means hurting.
I am including a block from an article by Lauren Hough, published in Huff Post, who worked for 10 years as a cable tech:
We weren’t allowed to discuss pay. But we weren’t allowed to smoke pot and most of us did. We weren’t allowed to work on opiates either. We were all working hurt. I can’t handle opiates. But if I’d wanted them, there were plenty of guys stealing them from customer’s bathrooms. I could’ve bought what I needed after any team meeting.That’s the thing they don’t tell you about opiate addiction. People are in pain because unless you went to college, the only way you’ll earn a decent living is by breaking your body or risking your life — plumbers, electricians, steamfitters, welders, mechanics, cable guys, linemen, fishermen, garbagemen, the options are endless.
They’re all considered jobs for men because they require a certain amount of strength. The bigger the risk, the bigger the paycheck. But you don’t get to take it easy when your back hurts from carrying a 90-pound ladder that becomes a sail in the wind. You don’t get to sit at a desk when your knees or ankles start to give out after crawling through attics, under desks, through crawl spaces. When your elbow still hurts from the time you disconnected a cable line and your body became the neutral line on the electrical feeder and 220 volts ran through your body to the ground. When your hands become useless claws 30 feet in the air on a telephone pole and you leave your skin frozen to the metal tap. So you take a couple pills to get through the day, the week, the year. If painkillers show up on your drug test, you have that prescription from the last time you fell off a roof. Because that’s the other thing about these jobs, they all require drug tests when you get hurt. Smoke pot one night, whether for fun or because you hurt too much to sleep, the company doesn’t have to pay for your injury when your van slides down an icy off-ramp three weeks later. I chose pot to numb my head and body every night. But it was the bigger risk.
I probably should’ve stolen pills. It would have made up for the fact I was making less than every tech I asked. They don’t like you talking about your pay for a reason. Some had been there longer. Most hadn’t. I was the only female tech because really, why the fuck was I even doing that job? Because I didn’t go to college. I joined the Air Force.
Why do you think that there are more opioid overdoses in the Mid-West and Appalachia? Florida, Massachusetts, New Hampshire and Maine: where are fisherman located? What about coal miners: Kentucky, West Virginia, Ohio.
Let's talk economics. Which classes are less likely to have good medical insurance? Let's go back to the great recession. What states had the most foreclosures? Take a look and compare:
It sure isn't a perfect match. But I could probably show correlation, at least for a large number of states. Yet the CDC would have you believe that the opioid epidemic is because of physicians prescribing too many opioids, or big pharma pushing too many. I'm sorry, but the reasons are much more nuanced.
My belief is we don't treat chronic pain patients well enough. There are many alternative treatments for pain than just opioids. Pain experts such as Dr. Lynn Webster, in his book The Painful Truth, talk about these. I have been fortunate to have received many of these, including injections, topical NSAIDs and lidocaine, psychiatric therapy, physical therapy, and opioids. Very few chronic pain patients have medical insurance that pays for the range of therapies needed for a balanced approach to chronic pain. And there are far too few pain management physicians for the number of chronic pain patients that exist. And it is getting worse, because the mis-guided approach of American regulatory bodies are driving both pain management physicians and other practitioners out of the pain management practice.
As I mentioned in my warning at the beginning, I studied medicine for three years, until my first chronic pain condition forced me to leave medicine. At that time, around 1980-1983, the use of opioids was very limited, even to cancer and terminal patients. In 1989, Texas passed the Texas Intractable Pain Act. This act provided a safe harbor for physicians to treat pain from a condition that had no cure, provided they documented the condition and their determination that the condition could not be cured or alleviated by existing medical means. Prior to the act, physicians were being disciplined by the Texas Medical Board because giving an opioid to a patient on a continuing basis made them "habitual users". By 1996, the Intractable Pin Act was modified to allow physicians to prescribe opioids to pain patients that had been abusers, so long as the prescription was to alleviate their pain that the prescriber had a duty to monitor and document.
In Texas, the Intractable Pain Act (Chapter 107, Texas Occupational Code) has been subsumed by the pain management rules codified at Chapter 170.3, Title 22, Texas Administrative Code. Chapter 170 describes those "guidelines" that the physician must meet to legally treat chronic pain in the state of Texas. Rule 170.3 states:
A physician's treatment of a patient's pain will be evaluated by considering whether it meets the generally accepted standard of care and whether the following minimum requirements have been met:
- Evaluation of the patient.
- Treatment plan for chronic pain. The physician is responsible for a written treatment plan that is documented in the medical records. The medical record must include:
- Informed consent. It is the physician's responsibility to discuss the risks and benefits of the use of controlled substances for the treatment of chronic pain with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is without medical decision-making capacity. This discussion must be documented by either a written signed document maintained in the records or a contemporaneous notation included in the medical records. Discussion of risks and benefits must include an explanation of the:
- Agreement for treatment of chronic pain. A proper patient-physician relationship for treatment of chronic pain requires the physician to establish and inform the patient of the physician's expectations that are necessary for patient compliance. If the treatment plan includes extended drug therapy, the physician must use a written pain management agreement between the physician and the patient outlining patient responsibilities, including the following provisions:
- Periodic review of the treatment of chronic pain.
- Consultation and Referral. The physician must refer a patient with chronic pain for further evaluation and treatment as necessary. Patients who are at-risk for abuse or addiction require special attention. Patients with chronic pain and histories of substance abuse or with co-morbid psychiatric disorders require even more care. A consult with or referral to an expert in the management of such patients must be considered in their treatment.
- Medical records. The medical records shall document the physician's rationale for the treatment plan and the prescription of drugs for the chief complaint of chronic pain and show that the physician has followed these rules. Specifically the records must include:
Wow! That seems like a lot. But it is not... I will flesh out the lower levels in a moment. But look, there's nothing here about 90 MMEs maximum a day, or a maximum of 7 days of opioid medication, or other of the guidelines from the CDC. What these seven items constitute are basic standards of care we would want any physician to give us before they treat us with any treatment.
We want our physician to evaluate our symptoms. We want the doctor to tell us how they will treat our problem, and document it. We want them to explain the treatment, in sufficient detail so that we understand and can make an informed decision. We want to give out agreement, or not be treated at all. We want the doctor to periodically evaluate whether the treatment is helping, and not just keep giving us the same treatment if it isn't. We expect the treatment plan to be updated if necessary. If the treatment isn't working, and the primary physician needs help, we expect to be referred or have the physician consult with a doctor that can. And we expect all of this to be properly documented.
That is a minimum standard of care I was taught as a first year medical student. Every first year medical student is taught this. It's a no-brainer.
Rule 170.3 fleshes these items out in detail:
- Evaluation of the patient.
- A physician is responsible for obtaining a medical history and a physical examination that includes a problem-focused exam specific to the chief presenting complaint of the patient.
- The medical record shall document the medical history and physical examination. In the case of chronic pain, the medical record must document:
- the nature and intensity of the pain;
- current and past treatments for pain;
- underlying or coexisting diseases and conditions;
- the effect of the pain on physical and psychological function;
- any history and potential for substance abuse or diversion; and
- the presence of one or more recognized medical indications for the use of a dangerous or scheduled drug.
- Prior to prescribing dangerous drugs or controlled substances for the treatment of chronic pain, a physician must consider reviewing prescription data and history related to the patient, if any, contained in the Prescription Drug Monitoring Program described by §§481.075, 481.076, and 481.0761 of the Texas Health and Safety Code and consider obtaining at a minimum a baseline toxicology drug screen to determine the presence of drugs in a patient, if any. If a physician determines that such steps are not necessary prior to prescribing dangerous drugs or controlled substances to the patient, the physician must document in the medical record his or her rationale for not completing such steps.
- Treatment plan for chronic pain. The physician is responsible for a written treatment plan that is documented in the medical records. The medical record must include:
- How the medication relates to the chief presenting complaint of chronic pain;
- dosage and frequency of any drugs prescribed;
- further testing and diagnostic evaluations to be ordered, if medically indicated;
- other treatments that are planned or considered;
- periodic reviews planned; and
- objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function.
- Informed consent. It is the physician's responsibility to discuss the risks and benefits of the use of controlled substances for the treatment of chronic pain with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is without medical decision-making capacity. This discussion must be documented by either a written signed document maintained in the records or a contemporaneous notation included in the medical records. Discussion of risks and benefits must include an explanation of the:
- diagnosis;
- treatment plan;
- anticipated therapeutic results, including the realistic expectations for sustained pain relief and improved functioning and possibilities for lack of pain relief;
- therapies in addition to or instead of drug therapy, including physical therapy or psychological techniques;
- potential side effects and how to manage them;
- adverse effects, including the potential for dependence, addiction, tolerance, and withdrawal; and
- potential for impairment of judgment and motor skills.
- Agreement for treatment of chronic pain. A proper patient-physician relationship for treatment of chronic pain requires the physician to establish and inform the patient of the physician's expectations that are necessary for patient compliance. If the treatment plan includes extended drug therapy, the physician must use a written pain management agreement between the physician and the patient outlining patient responsibilities, including the following provisions:
- the physician may require laboratory tests for drug levels upon request;
- the physician may limit the number and frequency of prescription refills;
- only the primary pain management physician or another physician covering for the primary pain management physician in compliance with Chapter 177, Subchapter E of this title (relating to Physician Call Coverage Medical Services), may prescribe dangerous and scheduled drugs for the treatment of chronic pain. For any prescriptions issued for medications to treat acute or chronic pain by a person other than the primary pain management physician or covering physician, the terms of the agreement must require that at or before the patient's next date of service, the patient notify the primary pain management physician or covering physician about the prescription(s) issued. The terms of the agreement must require that such notice include at a minimum the name and contact information for the person who issued the prescription, the date of the prescription, and the name and quantity of the drug prescribed;
- only one pharmacy designated by the patient will be used for prescriptions for the treatment of chronic pain, with an exception for those circumstances for which the patient has no control or responsibility, that prevent the patient from obtaining prescribed medications at the designated pharmacy under the agreement. For such circumstances, the agreement's terms must require that at or before the patient's next date of service, the patient notify the primary pain management physician or covering physician of the circumstances and identify the pharmacy that dispensed the medication; and
- reasons for which drug therapy may be discontinued (e.g. violation of agreement).
- Periodic review of the treatment of chronic pain.
- The physician must see the patient for periodic review at reasonable intervals in view of the individual circumstances of the patient.
- Periodic review must assess progress toward reaching treatment objectives, taking into consideration the history of medication usage, as well as any new information about the etiology of the pain.
- Each periodic visit shall be documented in the medical records.
- Contemporaneous to the periodic reviews, the physician must note in the medical records any adjustment in the treatment plan based on the individual medical needs of the patient.
- A physician must base any continuation or modification of the use of dangerous and scheduled drugs for pain management on an evaluation of progress toward treatment objectives.
- Progress or the lack of progress in relieving pain must be documented in the patient's record.
- Satisfactory response to treatment may be indicated by the patient's decreased pain, increased level of function, and/or improved quality of life.
- Objective evidence of improved or diminished function must be monitored. Information from family members or other caregivers, if offered or provided, must be considered in determining the patient's response to treatment.
- If the patient's progress is unsatisfactory, the physician must reassess the current treatment plan and consider the use of other therapeutic modalities.
- The physician must periodically review the patient's compliance with the prescribed treatment plan and reevaluate for any potential for substance abuse or diversion. In such a review, the physician must consider reviewing prescription data and history related to the patient, if any, contained in the Prescription Drug Monitoring Program described by §§481.075, 481.076, and 481.0761 of the Texas Health and Safety Code and consider obtaining at a minimum a toxicology drug screen to determine the presence of drugs in a patient, if any. If a physician determines that such steps are not necessary, the physician must document in the medical record his or her rationale for not completing such steps.
- Consultation and Referral. The physician must refer a patient with chronic pain for further evaluation and treatment as necessary. Patients who are at-risk for abuse or addiction require special attention. Patients with chronic pain and histories of substance abuse or with co-morbid psychiatric disorders require even more care. A consult with or referral to an expert in the management of such patients must be considered in their treatment.
- Medical records. The medical records shall document the physician's rationale for the treatment plan and the prescription of drugs for the chief complaint of chronic pain and show that the physician has followed these rules. Specifically the records must include:
- the medical history and the physical examination;
- diagnostic, therapeutic and laboratory results;
- evaluations and consultations;
- treatment objectives;
- discussion of risks and benefits;
- informed consent;
- treatments;
- medications (including date, type, dosage and quantity prescribed);
- instructions and agreements; and
- periodic reviews.
All of these things strike me as reasonable and necessary to treat a patient with dangerous drugs. Again, nowhere is there a list of MMEs or days of opioids prescribed. These kinds of arbitrary, one size fits all regulations are bad, and they get in the way of the physician crafting a pain management program that is tailored for the patient.
In fact, the CDC guidelines, or any regulation based on a maximum amount of morphine equivalents is bad medicine, for a variety of reasons that I will cover in a future post.







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