Let’s talk about pain

A while back I published several articles on pain and opioid use.  I wrote these article to shed light on the other side of the pain and opioid use debate that seemed to me to be very one-sided.  And while opioid abuse has undoubtedly destroyed many lives, what concerned me most was the focus on opioid abuse without equal time being given to the estimate 25.3 million Americans suffering from chronic pain (8/11/15 NIH press release).

That said you can find my articles on the issue here

Nov. 2011 – Working Nurse Magazine – Chronic Pain: What nurses don’t know about pain management WNM Chronic Pain1 copy

Sept. 2012 – Working Nurse Magazine – The Great Opioid Debate: Balancing the need for pain management with the potential for abuse — WNM The Great Opioid Debate1 copy

May – Apr. 2014 – Working Nurse Magazine — The Opioid “Epidemic”: Why we need to dial back the sensationalism and find common-sense solutions — WNM Opioid Epidemic1 copy

Once a year more than 2,000 people gather in Las Vegas to attend a five-day conference on all things pain related. The attendees aren’t just researchers, but all types of healthcare providers and patients as well. I started attending PainWeek nearly three years ago and each year I return with even greater knowledge about pain and more specifically the latest in treatment for my condition — Complex Regional Pain Syndrome; a condition I developed as a direct result of my work related injury.

This year’s conference had several session regarding workers’ compensation and I had the opportunity to attend Dr. Matthew P. Foster’s session on “Pain Management in Workers’ Compensation: Overview of Spend, Utilization, and Treatment Guidelines”. The room filled up quickly, leaving only a few empty seats.

Dr. Foster’s presentation moved quickly explaining how workers’ compensation treatment and drug prescription moved from whatever, without questions, that the doctor ordered for the injured worker to more and more states adopting guidelines that were either created by the state or that followed the Office of Disability Guidelines (ODG) or that followed the recommendations of the American College of Occupational & Environmental Medicine (ACOEM) or that followed some combination.

His presentation showed that by using treatment guidelines, most states had shown some “control” over the rising costs of workers’ compensation, with the exception of State of New York (which has created its own treatment guidelines). One area where treatment guidelines seem to have the greatest impact was in the approval of opioid treatment for injured workers suffering extreme and/or chronic pain. Many insurance companies and their adjusters have used these guidelines, not such as a guide but much more like something which to adhere to very strictly without wiggle room. Nowhere is this more apparent than with prescription opioids.

It was during the question and answer section of Foster’s presentation that members of the audience brought up very similar tales of adjusters using guidelines to basically “cut off” the injured worker from any opioid medication beyond what the “guidelines” suggest. A common thread was the following: the earliest the insurance company will allow a patient refill of their opioid prescription is 28 days (2 days before the patient’s current script ends), when the patient turns in a new script at the 28 days mark some insurance companies then ask for 7 to 10 days to authorize the new opioid script thus leaving the patient without opioid medication to cover for that time period placing the patient at risk for withdrawal, not to mention the emotional and psychological impact the fight every month to fill their physician order medication has on the injured worker. Meanwhile in California a great many of the utilization review physicians are from ER specialty a discipline that doesn’t prepare the physician to take care of patient for the long term, an observation that I shared with the audience and with which the audience agreed.

So in short when it comes to opioid prescriptions the injured worker is basically made powerless by the very program that’s been put in place to “help the injured worker return to pre-injury condition as quickly as possible”.

Thanks to several high profile news articles and news reports a heightened awareness of opioid pill mills and the doctors that run them came into the awareness of not only the American people, but various government agencies, as well. This was not such a bad thing, but what was never addressed by the news articles (many covered in the Los Angeles Times) were the thousands of patients living with chronic pain that were finding benefit from opioids and the conscientious doctors that made a point to monitor their patients for compliance.

The constant focus on those who die from opioid abuse and the doctors that prescribe opioids willy-nilly overlooks the reality that many more people have benefited from opioid use and do so without abusing the medication. The 2012 LA Times series on opioid abuse and deaths has been referenced in nearly all opioid cautionary articles since the series first ran with the factoid that between 2006 and 2011 there were 3,733 opioid-related deaths in four Southern California counties (Los Angeles, Orange, San Diego and Ventura). Though 3,733 is a staggering number of opioid-related deaths, the LA Times reporter failed to provide perspective; such as, during this same period of time there was a total population of 16.9 million people (as of June 2011) in the abovementioned counties and these opioid-related deaths though tragic represents .0002% of the population – my question then how does this make a raging epidemic?

Also missing in many of the reports of opioid abuse is how many individuals were not only addicted to opioids but to other drugs (both legal and illicit), and alcohol. Little effort was done on the part of the experts and reporters alike to deduce which came first the opioid abuse or the alcohol/illicit drug use. Actually in the LA Times series, it was noted that in many of the deaths that were reported as being opioid-related could only be assumed, since at the time of death the death wasn’t identified as an opioid-related death.

While the LA Times did a relatively good job at highlighting deaths related to opioid-abuse they did a disservice by not providing context and by failing to present stories from those living with chronic pain for which opioid use is the only treatment. Instead as a response to the LA Times and other similar articles various agencies and regulatory bodies began to discuss ways to “curb” the opioid epidemic. Meanwhile, few if anyone was talking about what could be done to provide support to those living with chronic pain for which opioid treatment was the only option or one very important part of their therapy to alleviate the constant, chronic pain– because that would be too easy! While the LA Times targeted California for its pill mill and opioid-related deaths (remember 3,733 people died), they failed to mention that California had the lowest person to opioid rate of all 50 states. They failed to address how insurance, in particular Workers’ Compensation, seemed reticent to provide alternative treatment for people living with chronic pain. For example, Workers’ Compensation puts a cap on the number of physical therapy (PT) sessions an injured worker can have, in total, over the course of an injury. This doesn’t mean that a Workers’ Compensation adjuster can’t approve more (PT), but far too many adhere to the strict guideline; even if PT is the recommended course of treatment for recovery from a particular procedure, so all too often doctors have to rely on opioid treatment in lieu of PT.

While it may seem as though states regulatory agencies have done little to curb opioid abuse a map/document produced by Progressive Medical outlined with some thoroughness state opioid rules by restriction, and though this document was published in 2013 it provides a good snapshot of these restrictions by state and can be found here – OpioidRulesByRestriction + MAP_10-15-13_FINAL.

So with so many people and agencies focused on the “problem of opioid-abuse” no one seems willing to advocate and address the needs of people living with chronic pain for which opioid treatment is the only option. There’ve been a few groups that have spoken out, but their voices are often muted by the screams of those who seem intent of removing opioids completely from all formularies. Prescription Drug Monitoring Programs (PDMP) such as California’s Controlled Substance Utilization Review and Evaluation System (CURES) programs have shown little effectiveness. Meanwhile, CURES has a very low utilization by California physicians and pharmacists. Meanwhile few states, including California’s CURES updates in real-time. Oklahoma is one of the few states whose program updates with very little lag-time which allows both prescribing physicians and pharmacists to access the Oklahoma PDMP in real time which helps weed out pill shoppers and helps in the identification of possible pill mills.

Draconian measures will not solve the challenge of opioid-related deaths or abuse or those running pill mills. What’s needed is a balance and sane approach. Doctors need to be well educated on when opioid use is optimum, how to detect possible doctor shopping, non-compliance and so forth. In turn patients and their families need to be educated on appropriate opioid use and provided tools to be both compliant with treatment protocol and to be aware of possible signs of opioid dependency. For example patients who are in extreme pain may not be cognizant that they just took their Vicodin because when a patient is in a state of extreme pain they experience time differently. I should know I had to endure an Ilizarov external fixator for a time and if not for a note that I kept at my bedside where I would document each time I took the Vicodin that had been prescribed to me there would’ve been times when I could’ve sworn that two hours had already passed since my last dose. I can’t recall one occasion where physician, nurse practitioner or nurse ever recommended a method to track when medication, especially opioids, that had been taken.

On the upside conferences such as PainWeek offer caregivers, practitioners and patients alike an opportunity to learn about the various manifestations of pain and the different modalities to treat pain. I’ve truly enjoyed attending PainWeek these past two years and I am looking forward to more networking this year.

I long ago stopped using Consumer Reports as my go to source for whether a specific product was a good or bad buy, but I was astonished to read their recent article – “Special Report: The danger of painkillers” – published in their September 2014 issue. Their special report once again tried to stoke the flames of fear over opioid use and abuse. The article cites the staggering statistic of almost 17,000 people a year die from overdoses of opioids. While 17,000 people dying every year is indeed an eye-opening number that pales in comparison to the 35,000 who died in automobile accidents in 2013. Consumer reports goes even further to cite that for every death from opioid overdoses 30 people are admitted to the ER for complications of opioid abuse. So after doing the math that’s approximately 510,000 people admitted to the ER for opioid abuse while the National Safety Council “estimated that nearly 3.8 million people suffered crash injuries that required medical attention”. And if you consider that there are nearly 319 million people living in the United States, though 17,000 people dying of opioid abuse is tragic and sad these deaths represent not even 1% of the total population.

Does this mean these deaths should be ignored or minimize, by no means! However, in my opinion I feel that the folks at Consumer Reports should be ashamed of themselves for failing to put the statistics into perspective; but just like the Los Angeles Times they seem to have chosen the approach of fear mongering over ethical journalism. Consumer Reports even dragged out the Zohydro ER “controversy” demanding that the FDA withdraw their approval of Zohydro ER Consumer Reports mentions in their report that attorney generals from 28 states have written the FDA demanding that the FDA reconsider their decision and withdraw their approval of Zohydro ER, as well as the two bills (HR 4241- https://www.govtrack.us/congress/bills/113/hr4241 and S 2134 – https://www.govtrack.us/congress/bills/113/s2134) in Congress that if passed would ban the sale of Zohydro. GovTrack, a excellent source to keep track of legislation both at the federal and state level gives HR 4241 and S 2134 a 2% and 1% (respectfully) chance of being passed by Congress, but don’t you just love it when Congress decides to practice medicine! I know I do.

The Consumer Report article also fails to mention that what separates Zohydro ER from the rest of the opioid pack is that it contains no acetaminophen (aka Tylenol). Why is this important? Simply put, for people living with chronic pain and chronic liver issues, such as Hepatitis C, liver disease and so forth, opioids can prove problematic since acetaminophen is very hard on ones liver, thus any opioid that can provide relief from chronic pain without added acetaminophen is a safer option for those patients in the long run. And Consumer Reports failure to report this very important difference only convinces this person that the folks at Consumer Reports have strayed far afield from their core mission.

Meanwhile, if you’re interested in hearing the FDA’s rationale from their “own lips” then point your browser here – http://www.biocenturytv.com/player/3476140971001

Rule of thumb when you submit a letter to the editor you should always follow-up to ensure that your letter has been received. This policy has served me well over the years, that is until I tried to follow-up on two letters to the editor that I sent in response to two article the Boston Globe had run on the acetaminophen-free opioid, Zohydro ER .

I felt compelled to respond because I was getting tired of reading and hearing the same incorrect statements being repeated time and time again by various media outlets. Primarily the mischaracterization that Zohydro, which is a hydrocodone, was somehow 10 to 50 times more potent (take your pick) than hydrocodone, no one seemed to question this illogical statement – because how can hydrocodone be more potent than itself? Of course, the mistake so many have made was in trying to compare “regular” Vicodin (hydrocodone with acetaminophen, aka Tylenol) to Zohydro ER (a hydrocodone with no acetaminophen and in which the medication is released over a period of time). So while the maximum recommended dosage of Vicodin can range from 40mg to 60mg depending on the type of Vicodin the maximum recommended dosage of Zohydro ER cannot exceed 50mg twice in a 24-hour period. So Zohydro ER is never 5 times let alone 10 times more potent, as cited so incorrectly by our erstwhile media.

Also another common omission by so many media outlets is that Zohydro is the first and only extended-release hydrocodone that doesn’t contain acetaminophen. This is in contrast to other opioids (even immediate release varieties) that contain either acetaminophen or some other additional ingredient. Having an opioid that contains no acetaminophen is an important tool in the pain management toolkit for people living with severe chronic pain. Of course, there’s the consideration of the abuse factor, but this pales in comparison to the estimated 6 million people living with severe chronic pain, whose voice is being drowned out by the nearly rabid and hysterical outcries of those involved with addiction issues.

As both a person living with severe chronic pain and a registered nurse, I can understand the reticence of those confronted with the issues of addiction. However I also find them unwilling to consider the needs of individuals living with intractable, severe and chronic pain. Many severe, chronic pain suffers have had to depend on opioids containing acetaminophen (done solely to “curb” the potential abuse of these same opioids) that there is a real risk of liver damage, which is why access to Zohydro ER is so critical.

Meanwhile this person wonders why no one answers the phone at the Boston Globe? How can the good people of Boston expect fair and balanced reporting if the Boston Globe only chooses to report one side of the story? Then again this is one of the main reasons so many newspapers are losing readership these days, they can’t bother to pick up the phone and, they can’t bother to report fairly both sides of the story. I guess yellow journalism is alive and well.

Finally after multiple calls and messages left to numerous individuals at the Boston Globe over many, many days — miracle of miracle the writer Milton Valencia answered his phone when I called. But when I expressed my concerns about what I believed were inaccuracies in his two articles on Zohydro ER, he suddenly had to go because he was on a deadline and anyway it didn’t really matter since he spoke with the folks at Zogenix (the makers of Zohydro ER) and they had no issues with his coverage.

You can read the two Boston Globe articles BG Judge blocks Massachusetts ban on painkiller Massachusetts and Mass. sued over restrictions on painkiller Zohydro and my letters to the editor L BG Zohydro5 and L BG Zohydro 140611b.

Here’s my latest article in Working Nurse Magazine —

One of nurses’ most important and underappreciated duties is advocating for our patients. While much of that advocacy takes place at the bedside, we are also in a unique position to address the larger issues that affect the practice of nursing and medicine.

The latest issue that demands our attention is the controversy over prescription opioids and the efforts of the Medical Board of California to crack down on these dangerous but necessary medications.

THE PERILS OF STATISTICS

If you listen to the fearless pundits of the Fourth Estate, deaths related to prescription drugs are a national crisis. According to the Centers for Disease Control and Prevention, 38,329 Americans died of drug overdoses in 2010 and about 60 percent of those deaths involved prescription medications, many of them opioids.

Back in 2012, the Los Angeles Times ran a four-part investigative report on the human cost of opioid abuse and the role of some physicians in overprescribing painkillers. The story reported that between 2006 and 2011, there were 3,733 deaths related to opioid use in just four Southern California counties: Los Angeles, Orange, San Diego and Ventura. That story and others like it have put pressure on the Medical Board of California to respond to the growing “epidemic.”

I put the word “epidemic” in quotes because the outcry is somewhat out of proportion to the reality. As alarming as the number of opioid-related deaths sounds in isolation, the L.A. Times report failed to contextualize that statistic in terms of the combined population of those four counties (16.9 million as of July 2011), the population of California as a whole (37.7 million) or the number of deaths due to other causes during the same period. For example, according to the California Highway Patrol, car crashes killed 18,416 Californians between 2006 and 2011: almost five times the death toll of the headline-grabbing opioid menace.

PSE AND THE METH EPIDEMIC

I don’t mean to diminish the significance of those deaths or suggest that there isn’t a problem, but it’s important not to let alarmism triumph over common sense. While the number of collision-related deaths may indicate a need for better traffic safety, no one is seriously suggesting closing our freeways or restricting how far commuters are allowed to drive!

Unfortunately, when it comes to drugs, such overreaction is the rule rather than the exception. For instance, many of us are familiar with the federal Combat Methamphetamine Epidemic Act of 2005 (CMEA), which sought to stem the rise of methamphetamine abuse by restricting the sale of products containing the nasal decongestant pseudoephedrine (PSE).

PSE is not a prescription drug in most states, but the CMEA limited how much PSE a customer could buy at one time, mandated behind-the-counter placement in stores, required photo identification for purchase and forced sellers to maintain logbooks of sales and customer information. Those measures have had little impact on the meth epidemic. At a conference this February, DEA Office of Diversion Control Deputy Assistant Administrator Joseph Rannazzisi admitted that “NEITHER of these systems [tracking or rescheduling PSE] will have ANY impact on methamphetamine availability in the United States.” [emphasis in the original]. In short, these restrictions  have not curbed the meth supply, but have added a considerable bookkeeping burden for retailers while inconveniencing millions of cold and allergy sufferers.

The effects of the state medical board’s response to the outrage over opioid-related deaths may be far worse. Some of the suggestions I heard at a recent meeting of the board’s Prescribing Task Force left me wanting to tear out my hair in frustration.
the role of alcohol

California’s medical community has good reason to be embarrassed by the L.A. Times expose, which linked a substantial number of overdose deaths in Southern California to a surprisingly small number of doctors.

The story also raised serious questions about the medical board’s effectiveness in responding to complaints about excessive or reckless prescriptions. The board seldom suspends a doctor’s prescribing authority even if he or she is being actively investigated or has already been disciplined for reckless prescribing.

Given all that, you might expect that the Prescribing Task Force’s focus would be on improving the medical board’s oversight of its own members. Instead, I listened to hour after hour of experts proposing new restrictions on patients. The suggestions ranged from requiring patients to sign a contract with their physician prior to receiving prescription opioids to forcing all patients to submit to pill counts and random urine tests. Such measures would be tantamount to treating patients like criminals!

There were more sensible proposals calling for greater patient education, but overall, I was dismayed by the lack of clear-headed perspective on the issues involved. For example, one expert pontificated at length about the evils of opioid abuse without once mentioning the role of alcohol in many painkiller overdose cases. When I asked him about it, he replied that he would touch on that point at the end of his presentation, suggesting that he considered alcohol a trivial footnote rather than a significant contributing factor in many overdose deaths.

PUTTING PATIENTS LAST?

As a nurse and as one of the estimated 100 million Americans living with some degree of chronic pain, I am well aware of both the power and the dangers of opioid painkillers. There’s no argument that opioids carry a high potential for abuse and can kill if misused.

However, I’ve also witnessed the consequences of overzealous protocols that prevent patients from getting needed medication. If you suffer chronic pain, draconian limits on how much painkiller you’re allowed do not protect you; they just reduce your ability to function and increase the chances that you’ll find some other way to self-medicate — possibly with lethal consequences.

Tools like pill counting or contracts may be appropriate in certain cases, but imposing such restrictions on all patients would only have a chilling effect on the provider-patient relationship. If our approach to patients defaults to suspicion and mistrust, we only discourage our patients from communicating openly with us about issues like abuse and addiction.
comprehensive approach

So, what should be done? A better solution would include all of the following:

  • Improved education for patients about the dangers and proper use of opioids, including the risk of adverse interactions with alcohol or other drugs.
  • Better educating physicians and their healthcare teams about the signs of opioid abuse, including how to recognize potential risk factors like addictive personalities.
  • Fully implementing a real-time prescription drug monitoring program that can flag suspected prescription shoppers and physicians who may be recklessly prescribing opioids or running “pill mills.” California’s CURES (Controlled Substance Utilization Review and Evaluation System) could be but currently isn’t used for that purpose due to a lack of resources and interest.
  • More effective sanctions for doctors whose prescription history suggests a pattern of reckless or inappropriate prescribing.
  • Finding and funding alternative treatments for chronic pain and conditions that cause it. If you remove the source of the pain, you also remove the need to treat it with opioids.

Obviously, many of these are long-term solutions. In the short term, it’s important that nurses get involved in the debate. The Prescribing Task Force’s next meeting is in May. (See www.mbc.ca.gov for a schedule.) The meetings are open to the public and I urge readers to attend and participate.

This is an issue that directly affects many of us, our loved ones and our patients. We should not sit idly by while the medical community devises quick-fix solutions that may ultimately do more harm than good.

Genevieve Clavreul’s earlier article on this topic, “The Great Opioid Debate of 2012,” was published in WN127, Sept. 3, 2012.

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Scott Glover and Lisa Girion, “Dying for Relief: A Times Investigation,” Los Angeles Times:

Part 1 (“Legal Drugs, Deadly Outcomes,” 11 Nov. 2012)

Part 2 (“Reckless Prescribing, Lost Lives,” 9 Dec. 2012)

Part 3 (“Rogue Pharmacists Feed Addiction,” 20 Dec. 2012)

Part 4 (“Unused Tool Could Help State Flag Deadly Doctors,” 30 Dec. 2012)

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CDC, “Drug Overdose in the United States: Fact Sheet,” last updated 10 February 2014. The fact sheet says 60 percent of 2010 overdose deaths were pharmaceuticals, of which 75 percent involved opioids and 30 percent involved benzodiazepines.

Physicians for Responsible Opioid Prescribing, “Cautious, Evidence-Based Opioid Prescribing.”

The American Academy of Pain Management, cites 100 million chronic pain sufferers in America, per Institute of Medicine Report, “Relieving Pain in America.”

Transforming Prevention, Care, Education and Research (Washington, D.C.: The National Academies Press, 2011.