Tuesday, June 12, 2012
Posted by: Joy Ingram
Malcolm Butler, MD, Medical Director, Columbia Valley Community Health Services
[Dr. Butler was the winner of the 2012 NWRPCA Summit Award for outstanding leadership of a quality improvement project]
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Though bloodletting was a favored therapeutic intervention since the time of the Mesopotamians, it was Galen, a student of Hippocrates, who popularized it among physicians. The procedure was based on the collective human life experience of catharsis – that purging oneself of some offensive element will lead to improved wellbeing. Stool, urine, gas, emesis, pus from pimples and boils - all feel better out rather than in. In the ancient world blood was believed to grow like hair, and if not purged it would collect within our bodies and stagnate. The fact that blood circulated and was important to preserve wasn’t introduced until the 18th century. Thus a foundational concept of health and medical treatment taught to every physician trained between the time of Hippocrates and the US Civil War was almost comically flawed. As physicians, we are trained by those who come before us, and we follow in their footsteps.
In this article I will argue that the use of opioids in the management of chronic pain makes as much sense as bloodletting. It has become a standard of practice, and it does far more harm than good. I will share our trip down the opioid rabbit-hole and how we are now trying to improve our practice and the safety of our patients by limiting our use of opioids.
Prior to the 1990s, “chronic pain” was not a broadly recognized concept in medicine. We knew that cancer patients suffered from intractable pain, and that most adults had issues like back pain, arthritis pain, and recurrent headaches, and some few patients seemed to have pain like fibromyalgia that persisted without any evidence of tissue damage or other internal derangement. In the mid 1990s we were told that we were doing an inadequate job of treating pain. We were being needlessly stingy with opioids. Esteemed speakers at medical conferences preached for more appropriate (liberal) use of opioids in pain management.
Then, in 1996, Purdue Pharmaceuticals introduced Oxycontin as a safe, long-acting opioid that would avoid the euphoric rush of short-acting opioids, and thus could be used chronically without fear of addiction or misuse. A new wonder drug had been developed “just in time” to meet our new needs. Whether by happy accident or by design, new pressures to aggressively treat all forms of pain made Oxycontin the best selling opioid on the face of the earth by 2001.
At Columbia Valley Community Health (CVCH), the community health center where I practice, we were early adopters of this newly recommended practice. We are champions of the down- trodden. We serve those whom others have shunned. So we laughed at the timidity of other physicians who were reluctant to use opioids to manage all types of pain. Though we were afraid of Oxycontin, which by this time had proven to be easily crushed and injected by those seeking to abuse it, we championed the concept that a long-acting opioid ought to be safe for chronic use.
We were also early adopters of methadone in the management of chronic non-malignant pain. It was generic, cheap, had been around forever, and was used to treat opioid addiction (so it could hardly cause addiction, right?). We believed that patients with chronic pain deserved to have a background dose of a long acting opioid like methadone, and then some short-acting opioids on hand for breakthrough pain. A “controller” medication and a “rescue” medication is a pharmaceutical model widely used in the treatment of asthma, rheumatoid arthritis, and diabetes, so it fit nicely into our primary care brains.
This movement toward more aggressive pain management was so strong that the Joint Commission (an accrediting body for quality medical practice) created a standard: every patient should be asked about their pain at every visit so that it could be appropriately addressed. At CVCH we are Joint Commission accredited, so the “pain scale” became a vital sign just like blood pressure and temperature.
We knew we were on to something, because our providers became very popular. We had patients seeking out our brand of compassionate, forward thinking care from far and wide. In fact, we became popular like a picnic is to yellow-jackets – patients couldn’t get enough of us, and these turned out to be some tough and very needy patients - lots of Labor and Industries cases, lots of patients with multiple prior back surgeries, lots of permanently disabled low functioning depressed unemployable patients - to the point where it became overwhelming.
We used to joke, in the black humor of the back office, that these pain patients were like psychic leaches who could suck the life force out of a provider. I personally used to emerge from an exam room with a chronic pain patient, hold my hands out to my nurse with my palms turned up, exposing the underside of my wrists to her, and say: “cut me now.” No matter how much I listened and empathized and cared, and no matter how many opioids I prescribed, they never got better. They always needed more – more of me, more medication, more studies. They cheated and lied to me and got more opioids from different doctors. They sold their drugs on the street. They lost them and demanded more. By the time that “chronic pain syndrome” was recognized with its own ICD-9 diagnostic code around 2003, chronic pain management had become a leading dissatisfier among primary care providers.
We decided that if we were going to survive, something had to change. We created a structured, standardized program for our patients who needed opioids to manage their pain. Every patient receiving more than #50 tablets of opioids per month signed a consent which explained the dangers of opioids and the “rules” of our program. We required them to participate in educational group visits. We required random Urine Drug Screens (UDS) to ensure they were not in trouble with other drugs, and even more importantly, to ensure they were actually swallowing the drugs we were prescribing (because if the opioids we were prescribing were not in our patient’s urine, then they were in someone else’s urine.)
We limited the total daily dose of opioids our providers are allowed to prescribe to a given patient. We prescribed opioids only in a 28-day supply, to ensure that refills never came due on a weekend. We never refilled opioids by phone or on the weekend. We required a substance abuse evaluation for all the patients we were considering starting on chronic opioids.
We created an “Opioid Oversight Committee” to help our providers cope with challenging situations (“My dog was having seizures and the vet told me to give the dog my medication. What was I supposed to do, just let my dog die?”). A PCP, a Walk-In provider, a pharmacist and a psychologist sit on the committee and review difficult cases, providing recommendations back to the primary care provider who has requested help.
Yet even with our carefully structured pain program, even with a program which exceeded published recommendations for cautious opioid prescribing, our patients were not getting better. Our staff still found pain patients the most challenging patients in their day. We watched as physicians in local communities built up huge panels of pain patients on elephantine doses of opioids, and then left town in the dead of night, releasing hundreds of opioid-dependent patients onto the streets in search of a compassionate provider. We were left as the bad guy, explaining that although we were willing to try to help, we couldn’t possibly prescribe even 1/10th the dose their prior fly-by-night physician was prescribing. We watched as patients were admitted to the hospital for some unrelated problem (perhaps a heart attack or asthma attack) and were placed on the dose which they had been prescribed, and promptly stopped breathing – because in fact they had not been taking anything close to that dose, but rather had been selling most of their opioids to afford their rent.
In 2006 the State of Washington published guidelines for the use of opioids in the management of chronic pain. Our pain program already met or exceeded all of these standards. Arguably we had one of the most advanced pain programs in the state.
As part of CVCH’s in-house quality program, I review every patient mortality in our practice. We care for around 20,000 patients, and every year between 40 and 60 of these patients die. They die of heart attacks and suicides and car accidents and pneumonias. I review these cases to ensure we have done everything that could have been done to recognize and appropriately manage these issues. In 2010 I realized that 23% of our mortalities were accidental opioid overdoses. Of the 43 patients who died in 2010, 11 of them were found dead, and the coroner reported: “Accidental death related to the combined effects of . . .” and listed all of the drugs discovered on a post mortem toxicology screen, at least one of which was an opioid. A quarter of our patients who died in 2010 might not have died if we had not been prescribing opioids to them.
That was when we stood up to the challenge of change.
As safety net providers we are are well versed in hunkering down under the challenge of adversity. So the work was hard – all of our work is hard. So the patients could be nasty – we don’t do this because it is easy. So they don’t get better – few of our patients get better. But we weren’t killing any of our other patients.
We took on the challenge of “the discontinuation of inappropriate opioid prescribing.” My research confirmed our experience that opioids had become one of the foremost public health challenges in our nation. Consider these statistics:
- The US has 5% of the world’s population, yet consumes 85% of the world’s prescription opioids.
- Accidental opioid overdoses are now the leading cause of death in adults between the ages of 35 and 55 (above cancer, suicide, car accidents, heart attacks, smoking, HIV, etc).
- One quarter of high school students have used prescription opioids to try to get high. (Prescription opioids, taken from mom’s or grandpa’s medicine cabinet, are put into a fish bowl by the door at the party, and then the fish bowl is passed around and everyone takes a handful.)
- ERs now see as many cases related to prescription drug abuse as to illegal drug abuse.
- High school students now look forward to having their wisdom teeth taken out because they know they will end up with a prescription for opioids afterwards.
With this information, and with our devastating mortality statistics, we convened a meeting of the medical leadership within our little valley (population 60,000). We identified three prime areas of focus:
- This is a public health issue. It is about keeping patients safe. It is NOT about which providers are the nicest or most compassionate. In fact, in this instance, the best practice is the hardest practice – it means setting limits and saying NO.
- Everyone in town must be on the same page as to how we will prescribe opioids; otherwise patients will just migrate downhill to the providers who are willing to continue the dangerous prescribing practices of old.
- “Everyone” means surgeons and dentists and vets and ER docs and primary care docs and schools and the public health district and pharmacists and law enforcement.
- There are no published standards around the recommended volumes of opioids for acute pain. (How many Percocet should be prescribed after a C-section, or an ankle fracture?)
- There is no easy method to dispose of opioids that are no longer needed.
- It is illegal to return them to your doctor or your pharmacist.
- It is inappropriate to flush them down the toilet (bad for the fishies).
I put together a PowerPoint presentation, and with the blessing of our local poly-specialty group and our local hospital, I began to spread the gory details of the public health crisis. I gave at least 20 talks to groups ranging from the hospital to the Medical Society to the Kiwanis to the local surgeons to the Dental Society; and in every case there was stunned silence - followed shortly by a swelling enthusiasm for change. Providers were doing back flips of appreciation. Out of a total audience of several hundred, I received only one letter of protest and disapproval.
I had given providers permission to say NO.
Remember, we were only doing what we were told to do. Just as Galen had been taught by Hippocrates that bloodletting was safe and effective medicine, we had been taught that opioids could be used safely in the management of chronic pain. Yet at some level we all were waking up to the truth that we were causing more of a problem than we were curing. Even with what was arguably the most sophisticated pain program in the state, we were failing to keep our patients safe. Somehow we all wanted to be able to step out of the craziness that opioids had brought to our lives, but the standard of practice required us to ask every patient about their pain and then to treat it.
We moved away from the use of long-acting opioids; they are just too dangerous and confusing for patients. We lowered our total ceiling dose of opioids well below the state guidelines. We refused to prescribe opioids for patients on benzodiazepines or patients on medical marijuana – you may have one, or the other, but not both, not by my pen. We no longer start patients afresh on chronic opioids for their chronic non-malignant pain. We set standards for the volume of opioids to prescribe for acute pain. Our local ERs stopped refilling opioid prescriptions. And now we are working on setting up opioid disposal stations in our local sheriff’s offices.
Setting new practice standards outside of academia is a challenge. We don’t have the funding or the tools to conduct randomized double- blind clinical trials to prove what is best practice. We are overwhelmed just meeting the demands of the underinsured. So what we do, in the real world of safety-net medicine, is to study the best available information, make a change, and then observe our outcomes while reading and listening to the academics for evidence that supports or rejects our position.
Here is what we have learned:
- After 15 years of trying to follow published standards of high quality pain management,
- There is NO evidence that opioids improve outcomes in chronic pain.
- There is good evidence that opioids impair social function, contribute to behavioral comorbidities, and decrease function.
- Opioids are excellent for acute pain but are just the wrong tool for chronic pain.
- It makes about as much sense to treat chronic pain with alcohol as with opioids. Both will help pain in the short run. Both will cause new and more difficult challenges in the long run.
- By asking every patient about pain at every visit, we had “medicalized” pain.
- Pain is a normal component of everyday life – it is not an anomaly requiring treatment.
- Pain is a protective reflex. It galvanizes us to improve and change. Removing it does the opposite, allowing us to become victims and to stagnate.
- As we have weaned our patients down on their opioids – nothing has changed. The patients who were working while taking 400mg a day are still working when taking 100mg a day. Those who were lying on the couch while taking 400mg a day are still lying on the couch while taking 100mg a day.
- There appears to be a dose above which more opioids don’t improve function in chronic pain – and it must be pretty low, as we still haven’t found it.
- As we have decreased the volumes of opioids we prescribe, bad behavior of all types has decreased within the clinic. Whereas the OOC used to review 6 cases per month, we now review 2 cases every 3 months.
- Chronic pain is a mélange of nociceptive pain, emotional pain, boredom, and anhedonia – all of which feel better on opioids, and all but one of which are made worse by chronic opioids.
- Acute pain is almost entirely nociceptive pain, and is well managed with opioids.
- Chronic pain is amplified and prolonged by the use of opioids.
In 2011 I again reviewed our mortality data. After a year of difficult interventions between primary care providers and their pain patients; after a year of hate mail from disgruntled patients; after a year of community organizing and newspaper articles, our opioid related mortalities had dropped by 50%. In 2010 23% of our mortalities were accidental opioid overdoses. In 2011 only 11% of our mortalities were accidental opioid overdoses. That 11% still represented 7 lives lost. That 11% still screams at me that we have NOT done an adequate job treating the real culprits of emotional distress and chemical dependency. But after a year of leading a charge against the established norms, after a year of decrying the wrongheadedness of our modern bloodletting, we have solid evidence that we have improved the safety of our patients.
My challenge to you is to do the same.
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