The 7 Golden Rules of Opioid Prescribing for Patients

By Jeffrey Grolig, MD, JD, Guest Columnist  

“Don’t do it!” is the advice often given to brand new physicians about whether to specialize in pain medicine. Increasing numbers of doctors are being fined, disciplined or arrested due to scrutiny caused by the nation’s opioid crisis. Every single opioid prescription, even the mildest painkiller, is being tracked, and prescription drug database searches tell the DEA and state board investigators who to watch.  

The unfortunate innocent victims of this crisis have been those legitimate patients who suffer in chronic pain, with up to 100 million in the United States alone. Each time a physician or pharmacy is attacked, thousands of pain patients must pay the price.

A pharmacy in my northern California town recently closed after the owner was charged with 200 counts of failing to properly keep records. Each count carries a $20,000 fine.

A local physician’s license was restricted for failure to warn in writing about the risks of combining sleeping pills with opioids. This family physician had already spent $56,000 in legal fees for previous documentation lapses.

A pulmonary specialist with English as his second language was arrested for prescribing codeine-containing cough syrup to four undercover DEA agents posing as patients. He is facing 20 years in prison and $2 million in fines.   

I still accept pain patients, but my background as an attorney compels me to use “universal precautions,” something I advise every physician who prescribes opioids to do. This boils down to following what I call “The 7 Golden Rules of Opioid Prescribing.” If you, as the patient, understand that your doctor must follow these 7 golden rules, it will make it much easier for you to obtain excellent pain management, including opioids.  

I developed the 7 golden rules by analyzing the most common documentation lapses of doctors who were disciplined or prosecuted. I included them when I wrote the “Physician Primer: Prescribe Like a Lawyer” to empower doctors to think and practice like a lawyer and not lose their careers over simple documentation errors.

If you write a cover letter like the one below to your current or prospective physician, touching on each and every one of these 7 golden rules, your pain control will vastly improve, I promise. 

Dear Doctor,

#1 I have a legitimate medical reason for needing opioids. My medical diagnosis is… (be specific: examples include diabetic neuropathy, failed spine surgery, spinal stenosis, CRPS, etc.). Attached is my MRI report (or EMG, CT, X-ray, Bone Scan, lab test, etc.) proving this.  

#2 I am not now, nor have I ever been addicted to prescription medication, illegal drugs or alcohol.   

#3 I have no depression, psychosis or bipolar disorder.  

#4 I understand all the risks of opioids and related medications, as well as my options for all non-opioid alternative treatments.  

#5 I am not taking benzodiazepines and drinking alcohol.  

#6 I have attached my last 12 months of medical records (not applicable if you have been with the same physician for one year).  

#7 These records reflect that I am an honest, compliant and responsible patient.  

Respectfully,  

Pain Patient

If you do not meet these criteria, it means you are in a higher risk category and would be better managed at a university medical center or a teaching hospital. To my knowledge, the DEA or state medical board has never raided a teaching hospital or university medical center. 

The best way a patient can signal to me they are responsible and low risk is to write a letter covering each of the 7 golden rules, attached to one year’s worth of medical records. This essentially does my work for me, and it makes it easy for me to decide whether or not to accept the patient.

If your doctor still won’t budge, hand him my free “Primer Flyer,” a pamphlet that explains risk management, that’s available on my website: ​ThePhysicianPrimer.com​.

If all else fails, have him watch my YouTube video on The 7 Golden Rules of Opioid Prescribing for Doctors. 

Jeffrey W. Grolig, MD, JD, is a board-certified specialist in Physical Medicine & Rehabilitation. He has taught at UC Davis Medical Center in both the departments of Family Practice and Physical Medicine & Rehabilitation. Dr. Grolig has formerly worked as a licensed attorney and has authored 6 books.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

New Federal Task Force to Address Opioid Prescribing

By Pat Anson, Editor

The federal government is forming another advisory panel to study and develop "best practices" for treating acute and chronic pain. And for the first time, the feds are seeking nominations from the public for members to serve on the panel, who would represent pain patients and pain management experts.

The Pain Management Best Practices Inter-Agency Task Force was authorized by the Comprehensive Addiction and Recovery Act of 2016 – also known as the CARA Act – a landmark bill signed into law last year to address the nation's addiction and overdose crisis.

While much of CARA is focused on preventing and treating opioid addiction, the law also calls for the Department of Health and Human Services (HHS) to form a task force to recommend solutions to “gaps or inconsistencies” in pain management policies among federal agencies.

Currently, the Centers for Disease Control and Prevention, Food and Drug Administration, Centers for Medicare and Medicaid Services, Department of Veterans Affairs, and the Department of Defense all have different regulations and guidelines for opioid medication.

“This Task Force represents a critical piece of HHS’s five-point strategy to defeat the opioid epidemic, which includes advancing the practice of pain management,” HHS Secretary Tom Price said in a news release.

“Top experts in pain management, research, addiction and recovery can help us reassess how we handle the serious problem of pain in America.”

The task force could have as many as 30 members representing a broad spectrum of interests in pain management, according to a notice being published in the Federal Register:

The members of the Task Force shall include currently licensed and practicing physicians, dentists, and non-physician prescribers; currently licensed and practicing pharmacists and pharmacies; experts in the fields of pain research and addiction research, including adolescent and young adult addiction; experts on the health of, and prescription opioid use disorders in, members of the Armed Forces and veterans; and experts in the field of minority health.

The Members of the Task Force shall also include… representatives of pain management professional organizations; the mental health treatment community; the addiction treatment community, including individuals in recovery from substance use disorder; pain advocacy groups, including patients; veteran service organizations; groups with expertise on overdose reversal, including first responders; State medical boards; and hospitals.

Members will also be appointed to represent Veterans Affairs, Department of Defense, Office of National Drug Control Policy, and “relevant HHS agencies.” The latter most likely includes the FDA and CDC. The Drug Enforcement Administration, an agency in the Department of Justice, will apparently not have a representative on the task force.

Pain patients and pain management experts have been poorly represented – and in some cases excluded – from previous federal advisory panels that addressed opioid prescribing and addiction. Some panel meetings were also closed to the public.

President Trump’s opioid commission, for example, includes three governors, a former congressman, and a Harvard professor who has been a longtime critic of opioid prescribing. No patients, pain management experts or practicing physicians were appointed, and the commission only heard testimony from addiction treatment advocates during its one public meeting.

That was better than the CDC, which held no public hearings while preparing the initial draft of its opioid prescribing guideline in 2015. As PNN has reported, the “Core Expert Group” and various stakeholders that advised the CDC were dominated by special interest groups and addiction treatment specialists, including five board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Only after a public outcry and threats of a lawsuit did the agency delay the release of the guideline, seek public comment and form a new advisory panel.

Are you interested in becoming a member of the new task force on pain management or know someone who might?

Information on how to nominate individuals – including self-nominations -- can be found by clicking here. Applications are due by Wednesday, September 27. All nominations must be submitted via email to the attention of Vanila Singh, MD, Chief Medical Officer at PainTaskforce@hhs.gov.

Members of the task force who are not government employees will receive per diem pay and reimbursement for travel expenses. All task force meetings will be open to the public.

CDC Guideline: A Good Start that Needs Improvement

By Stefan Kertesz, MD, Guest Columnist

President Obama began his 2016 State of the Union address by referencing an American epidemic of opioid overdoses. He was right to do so. The Centers for Disease Control report that 2014 saw a record of 18,893 deaths related to opioid overdose, a category that includes both medications and heroin. Given a rising tide of deaths, it is only sensible to look closely at how opioids come into distribution. There is more than one path. Doctors write prescriptions, and the pills may be consumed properly or improperly. Or they can be sold, given to friends, or stolen. Heroin is incredibly cheap and potent these days. It’s often laced with other drugs and can cause overdose in ways that users can’t predict.

A major portion of the public health response has focused on doctors and their prescriptions (disclosure: I’m a primary care doctor trained in internal medicine and addictions). Most public health authorities believe a major contributor to the rising tide of overdoses has something to do with the prescriptions for opioids we write. Our tendency to write prescriptions for pills like hydrocodone or morphine rose precipitously from 2000 to 2011.

Everyone knows a story of someone who wheedles pills out of credulous physicians. Barring a few so-called pill mills (which alone cannot account for the rise in prescriptions), most doctors writing prescriptions for opioid pills do so in response to a patient with severe chronic pain. There are an estimated 100 million Americans with chronic pain, and between 5 and 8 million take opioids for that pain.

It stands to reason that among the patients who have received opioid prescriptions, surely some (or many) should not have received them. Many doctors have decided to prescribe less, starting in 2012, according to national data.

If prescribing went down while overdoses went up these past few years, it’s fair to say that there is room for argument about precisely how doctor’s prescriptions relate to overdoses. But few would argue there is no relationship at all. Thus, great hopes are pinned on the notion that getting doctors to prescribe differently (and less) for their patients with pain will be key.

Last year the Centers for Disease Control, after consulting an extensive array of experts and interest groups, prepared a draft guideline for doctors on prescribing opioids. In December they placed notice in the Federal Register seeking public commentary. By deadline on January 13, over 4,300 comments were received.

There is a reason this document excites so much passion. In part, organizations such as the American Cancer Society project this guideline will not be voluntary, but will carry force of law.

The hope is to prevent development of addiction and overdose that devastates countless families. Yet, there are those 5 to 8 million patients who receive opioids, some of whom believe that they are at risk of losing access to a crucial medication that is helping manage their pain, improve their quality of life and overall function. As medical boards, insurers and government agencies enforce this guideline, prescribing differently from the topline recommendations is likely to become onerous, leaving many patients in the lurch.

If you listen to this conversation between this 70-year old coal miner who suffered 18 major injuries, and a chief advocate (addiction specialist Dr. Andrew Kolodny) for the reduction of opioid prescribing, you feel the tension. You will hear the distress of a man who fears being confined to bed from his pain, and the concern of an addiction doctor who believes opioid pills have done harm, not good, even perhaps to the man to whom he is speaking.

The experts convened by the CDC include many I know and respect. They have taken a fairly strong stand. They conclude that the literature shows no evidence of enduring benefit from opioids, and that measurable harms are tied closely to dose. They urge careful assessment of risk and benefit. They urge aggressive use of urine drug testing to identify patients who take opioid medication differently from intended or use illicit drugs.

In 56 pages, they say a lot more. My primary care patients include several with chronic pain, and my practice lines up pretty closely with precisely what the guideline recommends. And despite that, I feel this guideline is not yet ready, not given the power we project it to have.

For reasons I shared with the CDC, I think it reaches a bit beyond the available science in some places, neglects it in others, and misconstrues how best to translate it in the care of our patients. It risks making opioids less available to patients who are benefiting from them. It is not far from where it needs to be, but it needs improvement.

Friends, some of them national leaders in primary care, addiction and pain medicine, have urged me to publish this concern broadly.

For people interested in learning more about these concerns, I offer them in linked piece at Medium.com. I offer it to show that one can take a different stand without rejecting the science or the underlying public health commitment that I fully share with the honorable drafters of the CDC’s draft Guideline. For the readers who believe I am right, or perhaps have also misconstrued the science, I welcome your thoughts.

Stefan Kertesz, MD, is an Associate Professor at the University of Alabama at Birmingham School of Medicine. Opinions expressed are solely his own and do not represent positions of any agency of the U.S. Federal Government or the State of Alabama.

This column is republished with permission by the author. It originally appeared in Medium.com, along with the comments submitted by Dr. Kertesz to the CDC about the guideline.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Montana Doctor’s License to Be Suspended

By Pat Anson, Editor

The Montana Board of Medical Examiners voted unanimously Thursday to suspend the medical license of Dr. Mark Ibsen for unprofessional conduct, the latest chapter in a three year investigation into Ibsen’s opioid prescribing practices. A final order on the board’s ruling still needs to be drafted and voted on again. Ibsen has said he will appeal the decision.

The medical board accepted almost all of the recommendations made in a proposed order by Michael Fanning, Special Assistant Attorney General to the Montana Department of Labor and Industry, but it refused to consider lengthy allegations that Ibsen has “destructive psychological and behavioral issues.”

Ibsen was one of the last doctors in Montana willing to prescribe opioid pain medication to new patients, including many who drove hundreds of miles to see him. While that made Ibsen a folk hero of sorts in the pain community, it also attracted the attention of investigators who thought he was overprescribing opioids, and raising the risk of addiction and overdose.

“Opioid deaths are frighteningly common with one source estimating one death for every 500 opioid prescriptions written in America,” Fanning wrote in his 62-page proposed order, without citing a single case where Ibsen’s prescribing practices led to someone’s death or injury.

The case against Ibsen largely centered on nine pain patients and the incomplete records he kept on their treatment.

MARK IBSEN, MD

“Dr. Ibsen’s charts did not contain satisfactory evidence that he attempted more conservative care short of chronic opioid therapy,” Fanning wrote. “While the charts include occasional references to mental or behavioral health and rare references to interventional services, there was no consistent evidence that the more conservative option had been attempted and failed before continuing opioid therapy.”

Ibsen’s charts also did not include records of a written or oral contract with patients about their opioid use, which is a common requirement in pain management. Fanning said Ibsen also overlooked “red flags” in a patient’s behavior that could indicate signs of opioid abuse or diversion.

Last year a hearing officer recommended that Ibsen be put on probation for 180 days, but Fanning went much further, asking the board to suspend Ibsen’s medical license indefinitely. The board spent over seven hours reviewing the case and over 6,000 documents admitted as evidence before making its decision.  

“I just want to say that nothing has made me feel more ashamed to say that I am a Montanan born and raised than this kangaroo court in action,” said Gary Snook, who suffers from Arachnoiditis, a painful and disabling spinal cord disorder caused by botched spinal injections. He now gets medical treatment in California.   

“I am appalled by the total lack of understanding of the treatment of pain by these doctors. No wonder Montana has one of the highest disability rates in the nation,” Snook said in an email to Pain News Network.

“Overreaching is far too gentle a term for what occurred here. It felt like a witch hunt,” said Terri Lewis, PhD, a rehabilitation specialist and patient advocate.  “No doubt Dr. Ibsen, like many, has flaws, but holding this physician to a standard of perfection which exists in neither law nor practice makes no sense.  Maybe they will assign him a scarlet ‘O’ to wear on his chest.

“This is signal in the noise of our public confusion about the management of chronic pain.  This hearing process provides a good deal of insight into the conditions of care, or lack thereof, that both clinicians and patients find so challenging and threatening.”

One board member – who voted to suspend Ibsen’s license -- praised Ibsen for his compassion toward patients and said she hoped he would apply to have his license reinstated if he submits to professional oversight..

Publicity about the case and financial problems forced Ibsen last month to close his Urgent Care Plus clinic in Helena. Ibsen was arrested in November, not for opioid prescribing, but for a misdemeanor domestic assault charge. He has pleaded not guilty.

Doctor's License May Be ‘Suspended Indefinitely’

By Pat Anson, Editor

The Montana Department of Labor and Industry is recommending that the medical license of Mark Ibsen, MD, be suspended indefinitely by the state Board of Medical Examiners for unprofessional conduct.

Ibsen has been at the center of a long-running debate in Montana over the prescribing of opioid pain medication. State investigators say Ibsen overprescribed opioids, kept poor records and risked the health of his patients, while supporters say he is one of the few doctors left in the state willing to treat chronic pain patients. The Board of Medical Examiners is scheduled to meet Thursday to decide Ibsen's fate.

“Opioid deaths are frighteningly common with one source estimating one death for every 500 opioid prescriptions written in America,” wrote Michael Fanning, Special Assistant Attorney General to the Montana Department of Labor and Industry.

But in his 62-page proposed order, Fanning dos not cite a single case where Ibsen’s prescribing practices led to someone’s death. Instead he focuses on Ibsen’s alleged emotional instability and poor record keeping.

“Dr. Ibsen’s charts did not contain satisfactory evidence that he attempted more conservative care short of chronic opioid therapy,” Fanning wrote. “While the charts include occasional references to mental or behavioral health and rare references to interventional services, there was no consistent evidence that the more conservative option had been attempted and failed before continuing opioid therapy.”

Fanning also said Ibsen overlooked “red flags” in a patient’s behavior that could indicate signs of opioid abuse or diversion, such as multiple requests for early refills of prescriptions, seeing multiple doctors, and multiple lost medications. Ibsen’s charts also did not include records of a written or oral contract with some patients about their opioid use.

Fanning’s proposed order also includes references to “erratic and unprofessional behavior” by Ibsen reported by a former spouse and medical associates. One psychological profile of Ibsen said he suffers from bipolar disorder and narcissism, and that Ibsen “fails to accept responsibility, projects blame onto others and believes that others have conspired against him.”

mark ibsen, md

The state medical board is under no obligation to accept Fanning’s recommendation of indefinite suspension of Ibsen’s license. Last year the board rejected a proposed order from a hearing officer that Ibsen be put on probation for 180 days.

"I don't think I've had fair treatment in three years with the board of medicine. They've rewritten the evidence and are redefining reality," Ibsen told Pain News Network. "I haven't been treated fairly at all. They continue to accuse me of horrible and heinous things for people that I've helped. And there's been no one harmed by anything that I've done."

Ibsen has become something of a hero to pain patients, not only in Montana, but around the country. Many have trouble finding a doctor willing to prescribe opioids.

"I've become quite an advocate for the downtrodden pain patients. I promote medical marijuana as an exit strategy for people on opiates. I may be upsetting the status quo," said Ibsen.

Publicity about his case and financial problems recently forced Ibsen to close his Urgent Care Plus clinic in Helena. Ibsen was arrested in November, not for opioid prescribing, but for a misdemeanor domestic assault charge. He has pleaded not guilty.

Under Fanning's proposed order, Ibsen would be eligible to have his medical license reinstated, provided he was under "perpetual monitoring" by a professional assistance program. Ibsen says he will appeal if his license is restricted.

Will CDC Guidelines Promote Addiction Treatment?

By Alison Knopf, Editor of Alcoholism & Drug Abuse Weekly

The quick answer to the question “Will treatment providers be able to treat patients coming in addicted to opioids because they have been thrown off their pain medications next year?” is no. The treatment system can’t even treat all the patients who need help now. But this question is on the minds of federal policymakers as the federal Centers for Disease Control and Prevention (CDC) works on its forthcoming guidelines for physicians on prescribing opioids, due out next January (see ADAW, Nov. 16).

While the pain community is creating the loudest noise about the forthcoming guidelines, charging that they are not addicts and don’t want to be lumped in with them, the treatment community has on the one hand seen the benefits of decreasing the amount of prescription opioids available, but also seen the downside: patients who are dependent or addicted, who cannot successfully taper off the pain medications, will switch to heroin. Many started as legitimate pain patients.

But for some, when their doctors felt they no longer needed the pain medication, or thought the patient was doctor-shopping, or simply decided to go along with the calls to reduce the amount of prescriptions for opioids, it was difficult to stop, and they sought illicit sources of opioids.

The CDC confirmed to ADAW that there will be a guideline that “addresses treatment for opioid use disorder.” The draft guidelines leaked in September specifically recommended that an opioid agonist (methadone or buprenorphine) be arranged for patients who need treatment for an opioid use disorder. The CDC said the guidelines are continuing to be revised. Below is the wording of that recommendation from the September draft:

“Providers should offer or arrange evidence-based treatment (usually opioid agonist treatment in combination with behavioral therapies) for patients with opioid use disorder.”

SAMHSA Working With CDC

But how the primary care physician determines whether a patient has an opioid use disorder is unclear. The Substance Abuse and Mental Health Services Administration (SAMHSA) expects there to be a change in prescribing practices — that’s the whole point of the guidelines. But according to Robert Lubran, director of the Division of Pharmacologic Therapies at SAMHSA’s Center for Substance Abuse Treatment (CSAT), it’s up to the physicians who are prescribing the medications to come up with a referral plan for their patients.

“I go back to what Westley Clark always said,” Lubran told ADAW, referring to the former director of CSAT. “He said the physician has to have an exit strategy for a patient he isn’t going to be prescribing opioids for anymore.” The physician has to determine if the patient is dependent on or addicted to the medication. Dependence is a normal result of regular opioid intake, addiction is pathological, but both will result in withdrawal symptoms when opioids are stopped suddenly. Someone who is dependent can be slowly tapered off the opioids and endure the craving that ensues. Someone who is addicted cannot stop and will seek opioids from another source.

“There has to be a place where the doctor can refer someone when the doctor determines that the patient can’t be safely tapered down because they are addicted,” said Lubran. A treatment provider specializing in opioid use disorders, such as an opioid treatment program (OTP) or office-based opioid treatment (OBOT), would be a good solution, he said. “We’re working with the CDC to make sure the guidelines include information on where to refer these patients,” Lubran told ADAW.

“We’re already struggling on the traditional medicine side with how a patient goes from being a pain patient to being an addict,” said Lubran. “They discharge them, but what about referrals? More states and counties need to be involved in recommendations for care,” said Lu, adding that insurance companies need to be involved as well.

Guidelines Not Mandatory

Mark Parrino, president of the American Association for the Treatment of Opioid Dependence (AA-TOD), said that as far as he knows, OTPs have not been involved in the development of the CDC guidelines. However, he expressed skepticism about the effect of the guidelines. “Will there be a reaction by physicians? Will this really change their practice patterns? Will there necessarily be a wholesale dumping of patients who are getting pain medications? I would hope not. But if that is the result, I would ask how we are going to know whether these patients will show up in treatment, or go into the street for drugs?”

Furthermore, said Parrino, these are just guidelines from the CDC. “Doctors aren’t even required to read the stuff,” he said. “They’ll issue a big press statement, yes. But it’s like package inserts. Do you really think every physician will be watching their computer for the guide-lines, saying ‘Now I need to change my medical practice?’”

The CDC itself says as much. “It is important to note that, like other CDC guidelines, including prevention and treatment of sexually treated diseases, the guidelines are intended to support informed clinical decision-making but are not mandatory (that is, physicians are not required to follow these guidelines),” according to Courtney Lenard of the CDC’s press office. The CDC’s guide-line is meant to “help primary care doctors provide safer, more effective care for patients with chronic pain” and at the same time “help reduce use, abuse and overdose from these powerful drugs,” the CDC’s press office told us last week. “The guideline is intended for primary care providers who treat adult patients (age 18 and older) for chronic pain in outpatient settings, and is not intended for patients who are in active cancer treatment, palliative care or end-of-life care.”

Asked if restrictions on prescription opioids will lead to increased use of heroin, however, the CDC continued to stick to the federal official answer, which is: No. “There is no robust evidence that recently enacted policies regarding prescription opioids are responsible for large-scale shifts to heroin,” said Lenard, adding that only 1 in 25 people who use prescription opioids nonmedically start using heroin within five years. However, she added that this “translates into a major and growing epidemic of heroin use given how widespread the misuse of prescription opioids has become.” Stopping the misuse of prescription opioids is the best way to stop the heroin epidemic, according to the CDC.

This article is republished with permission of Alcoholism & Drug Abuse Weekly, which provides news and analysis of federal and state public policy developments, private sector business developments, and provider issues and innovations in addiction treatment.

Should Johns Hopkins be Policing the Nanny State?

By Terri Lewis, Guest Columnist

I was copied a response to the recently issued document, "The Prescription Opioid Epidemic: An Evidence-Based Approach" published by Johns Hopkins Bloomberg School of Public Health. 

The 46-page document is full of pronouncements about what the proper course of action should be to rein in the abuse of opioids by people who experience unrelenting chronic pain on a daily basis.  The document is replete with terms like addict, addiction, surveillance, monitoring,  intervention, adherence, and conformance distributed across seven topical areas, all claiming to address the current evidence for the need to ramp up the nanny state:

#1: Prescribing Guidelines
#2: Prescription Drug Monitoring Programs
#3: Pharmacy Benefit Managers and Pharmacies
#4: Engineering Strategies
#5: Overdose Education and Naloxone Distribution
#6: Addiction Treatment
#7: Community-Based Prevention

Nowhere, does this document even remotely address the fact that the onset of chronic pain is often an iatrogenic event that occurs as the result of medical harm or insufficiently delivered medical care. 

Nowhere, does this document address the financial and practical impact of these pronouncements on the ability of persons who have lost everything to illness to conform to protocols that turn healthcare delivery into a policing activity.

Everywhere, these protocols engender the further victimization, the institutionalization of marginalization, and stigmatization of the chronically ill as unworthy, incapable of protecting themselves, and potentially harmful to themselves and others because of the characteristics of their illness imposed disabilities. 

Every dollar that is proposed for expenditure in this document should be going to research designed to prevent and minimize the impact of chronic pain -- not punish it.  But this document, from a major public health training institution, completely fails to address the prevention and reduction of chronic pain as a public health issue of significant importance, and is focused instead on counting adherence, conformance and compliance activities that will (a) not lead to improved personal outcomes for consumers who live with chronic pain and (b) rob consumers of precious resources with which to live. 

These pronouncements reflect an ignorance of astounding proportion in understanding who persons with chronic pain actually are and the conditions under which they are forced to live.  Who does this document serve?  Who are we trying to protect?  

I am outraged.

And then this.  Into my email came a response to this smug, sanctimonious document from a woman in California who suffers from interstitial cystitis -- acquired through medications she received after treatment for shoulder and spinal injuries at the hands of her medical provider.  It's too good not to share:

To the misguided folk at Johns Hopkins Bloomberg School of Public Health:

This is my contribution to your little Town Hall hand-wringing session.

So, I guess you are jumping on the anti-opiate frenzy bandwagon.  Just another organization that feels compelled to point at anyone who takes opiates, and call us all "addicts" and not even considering those of us who suffer from severe CHRONIC PAIN (the kind That Never Ends) due to circumstances totally beyond our control.  My pain is not caused by any flaw in my character.  People like myself who see our doctors religiously and always take our medication responsibly.  What, are you being financially rewarded by punishing us?  What did we ever do to you?  Or are you just trying to Thin the Herd?  I guess Chronic Pain Patients' Lives DON'T Matter.

I'm talking to you.  I'm one of those people, who suffer from illnesses and or injuries that have already stolen our quality of life away from us, and pain that causes as much, and sometimes more, pain than cancer.  People who suffer from pain that only opiate prescription medication can dull.  And people like you, whom I will never meet, want to take that away from me.  A patient who has NEVER EVER ABUSED HER MEDICATION.  Not ONCE.  I am a 60 year old lady who worked her entire adult life and never once did anything to invite nor cause the condition that causes me terrible TERRIBLE pain.

My pain saga started with chronic tears to both my rotator cuffs, and a herniated cervical spine.  All from a desk job involving typing and mousing and staring at a computer monitor for years and years and years.  This activity has destroyed the tendons in both my shoulders and neck and herniated my spine.  And while that pain was bad enough, I figured it would eventually end.  I never envisioned that the pain would remain after my shoulders were carved up and stitched back together.  It was during my recovery from this surgery, that I began to experience the horrors of an incurable illness known as Interstitial Cystitis.

On bad days it feels like someone is taking a blowtorch to my genitalia.   In fact, Interstitial Cystitis is considered the Third Worst Pain in all of medicine.  Imagine, if you will, the sensation of hot lava being blasted through your bladder, vagina, colon and pelvic parts.  All the time.  Having the urge to urinate every 15 minutes -- or more often than that -- on bad days.  I am basically chained to a toilet.  And because the pain is ALWAYS much worse at night, I suffer from severe insomnia.  It is impossible to fall asleep or stay asleep with pain this bad.  My urologist opined that I would be better off if I suffered from Bladder Cancer, because there is at least a chance of recovery from that illness.

The only FDA authorized treatment for this condition is Elmiron, and it doesn't work on every patient.  In fact, it only works on maybe 25% of patients who suffer from this horrible condition.  It did nothing to help me with any of my symptoms but cause my hair to fall out and raise my liver enzymes to a dangerous level.  That's all our modern medical machine could do for me medically.  They sure as hell cannot cure this illness yet.  The only thing that medicine CAN offer is pain relief.  The only chance in hell I have of ever having a life without this horrible, searing, burning, aching, stabbing pain is if The Good Lord decides to send me into remission.  All a doctor can really do for me to help me is provide me with pain relief.

The only medication I take that takes the edge off of this pain is Norco.  I tried the Fentanyl patch, but it caused me to develop an intestinal blockage.  For obvious reasons, I had to discontinue that medication.  And while I intensely dislike taking ANY medication, I dislike the awful pain worse.  I have NEVER abused my medication.  I never take more than I am prescribed.  I do everything and anything that is asked of me, whether it involves blood tests and/or pissing into a cup.

So why am I going to be punished?  Answer me that question.  I just found out that my pain medication is going to be cut drastically OR terminated at my next visit to my pain doctor, which is this Friday.  It is not being taken away because I have ever abused my medication, or lied, or deceived, or stolen, or sold it.  I can only assume that my pain doctor is just too afraid of the DEA and the paperwork headache.  It will be easier for him to just dump me as a patient, and limit his practice to injections which make him more money anyway.  Well, guess what?  Injections have never done a thing to help my pain, and I have had quite a few.  I have had TENS units, Physical Therapy, Massage and Ultrasound.  I have tried just about everything that exists to reduce the horrendous pain I experience 24/7.  The only medicine with the fewest side effects that helps reduce pain is Norco.

We are a vulnerable part of the population who are being deprived of compassionate and adequate care to help us live our lives with a semblance of normalcy.  We are being punished for the irresponsible actions of people who would be addicted whether or not it was via opioids or anything else.  All of this noise is just that:  NOISE.  Mark my words:  all this brouhaha will not make one iota of difference in the epidemic you speak of.  People who are addicts will always find a way to get high.  That is what addicts do.  However, what your actions WILL do is cause an increase in suicides of people suffering from terrible TERRIBLE pain, who can no longer get medication that enables them to have something resembling a quality of life, and be semi-productive citizens. 

Yes.  The pain of illnesses like mine can and does drive good people to commit suicide if they can't get pain relief.  Or maybe these same people turn to other drugs they would never EVER consider if they received the compassionate care we are all entitled to.  That is what you will see start to happen.  I am sure that some of this surge in heroin use is by people who are in such terrible pain that they are desperate, and their doctors will not help them because of fear of the DEA and organizations like yours.  And then what will happen?  More "meetings" and "studies" and "head-scratching" about the spike in suicides?  How can you be so obtuse?

No one is speaking up about us. No one is helping us.  Chronic pain patients are being marginalized and treated like addicts, when we are not.  We can barely function because pain robs us of the ability to function, and we are already exhausted from this daily fight.  I guess we are easy targets.  Few of us possess the strength to march on numbers in Washington or anywhere else.  I know I couldn't.  I am so ill that I can barely leave my house.

I know what happens to me when I don't take my pain medication:  I experience much more severe pain.  I don't drool, or hallucinate, or stumble, or vomit, or shiver, or do anything but just cry buckets and buckets of tears, and huddle in a corner of my bed in the fetal position with bags of ice stuffed into my underwear to try and numb the horrible, searing pain of this illness.  And I guarantee that if any of you people making these horribly unjust decisions suffered from the condition I suffer from, that you would be begging for drugs to take the pain away.  I'm willing to stake what few dollars I still possess on that fact, because guess what?  This illness has also rendered me destitute and incapable of working at my job.  I can't even sit in a chair very long because of the pain.

So, in summary, what you are doing is KILLING US.  You, and 60 Minutes, and the CDC and the DEA and every other soulless agency that is carping about this.  If I weren't so sick from this horrible illness, and what it has done to my life, I would be laughing because of the incredible stupidity being displayed by a bunch of suits I will never meet.  Dumping every single person who takes opiates into a category you call "addiction" and shoving us off in the same leaky boat.  Yes.  You are killing us.

Name withheld to protect her privacy

For the record, this person also found out last week that her beloved husband of 20 years is in the throes of stage 4 kidney failure as a result of 5 years of treatment from a physician for arthritis -- resulting in an unidentified drug-drug interaction that has, unbeknownst to the physician, destroyed his patient's kidneys because he failed to monitor his patient or pay attention to known drug-drug interactions.

So who needs to be monitoring and surveilling here?  Who?  Does the public really need protection from persons with chronic pain who can barely leave their homes?  Or do persons in pain need protection from the public purveyors of unsound, impractical, and misguided policies? 

God spare us from the nanny state.

Terri Lewis, PhD, is a specialist in Rehabilitation practice and teaches in the field of Allied Health.  She is the daughter and mother of persons who have lived with chronic pain.

This column was reprinted with permission from the author.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Study Calls for End to ‘Permissive’ Opioid Prescribing

By Pat Anson, Editor

A major study released by the Johns Hopkins Bloomberg School of Public Health is calling for new guidelines in the prescribing of opioid pain medication, including the repeal of “permissive and lax prescription laws and rules.”

The report also calls for sweeping changes in the way opioid prescriptions are dispensed and monitored, and would encourage insurance companies to provide information to federal regulators about “suspicious” pharmacies, prescribers and patients.

The Johns Hopkins report (which can be seen here) grew out of discussions that began last year at a town hall meeting on prescription opioid abuse hosted by the Bloomberg School and the Clinton Foundation. It was prepared primarily by a group of public health researchers, physicians, law enforcement officials and addiction treatment specialists.  

“A public health response to this crisis must focus on preventing new cases of opioid addiction, early identification of opioid-addicted individuals, and ensuring access to effective opioid addiction treatment, while at the same time continuing to safely meet the needs of patients experiencing pain,” wrote G. Caleb Alexander, MD, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness at the Bloomberg School.

“It is widely recognized that a multi-pronged approach is needed to address the prescription opioid epidemic. A successful response to this problem will target the points along the spectrum of prescription drug production, distribution, prescribing, dispensing, use and treatment that can contribute to abuse; and offer opportunities to intervene for the purpose of preventing and treating misuse, abuse and overdose.”

The report calls on federal and state agencies, state medical boards and medical societies to require "mandatory tracking of pain, mood and function" at every patient visit, as well as patient contracts and urine drug tests.  Patients prescribed high doses of opioids would be required to consult with a pain management specialist.

“It sounds like an aggressive government intrusion into the practice of medicine and is punitive towards providers willing to help people in pain. It certainly is a threat.  Every physician in America should be concerned if these recommendations are adopted,” said Lynn Webster, MD, past President of the American Academy of Pain Medicine.

“I am amazed that one of our finest educational institutions in America failed to address the source of the prescription drug abuse problem in their report.  Not once did the report discuss the lack of safe effective treatments for pain.  They almost totally ignored the needs of people in pain.  Yet it is number one public health problem in America. Their focus was myopic and represents a narrow and prejudicial view of people in pain.”

One of the more controversial recommendations in the report would expand access to prescription drug monitoring programs (PDMPs) to private insurance companies and pharmacy benefit managers (PBMs). Access to those databases, which track prescriptions for opioids and other controlled substances, are currently restricted to regulators, law enforcement and physicians.

"It is a very bad idea to allow law enforcement or even payers to have access to PDMPs without a cause approved by a judge.  This is personal medical information that should be protected," said Webster in an email to Pain News Network.  

Under the Johns Hopkins plan, insurers would be encouraged to report suspicious prescribing activity to federal regulators and the Center for Medicare and Medicaid Services (CMS).

“Allowing managed care plans and PBMs access to PDMP data will improve upon their current controlled substances interventions that have been shown to positively influence controlled substances utilization,” the report states. “All PBMs should provide a list of suspicious pharmacies, prescribers and beneficiaries to the National Benefit Integrity Medicare Drug Integrity Contractor (MEDICs). Using the actionable PBM data they are receiving, MEDICs should be reporting potential providers for removal to the CMS.” 

The report also calls for mandatory use of PDMPs by prescribers and pharmacies, more training for medical students in pain management, expanded federal funding of addiction treatment, and greater access to naloxone, a drug that can reverse the effect of an opioid overdose.

“What’s important about these recommendations is that they cover the entire supply chain, from training doctors to working with pharmacies and the pharmaceuticals themselves, as well as reducing demand by mobilizing communities and treating people addicted to opioids,” said Andrea Gielen, director of the Johns Hopkins Center for Injury Research and Policy at the Bloomberg School and one of the report’s signatories.

“Not only are the recommendations comprehensive, they were developed with input from a wide range of stakeholders, and wherever possible draw from evidence-based research.”

One of the ”stakeholders” and a signatory of the Johns Hopkins report is Andrew Kolodny, MD, founder of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to end the overprescribing of opioids. Kolodny, who has collaborated with Dr. Alexander on other prescribing studies, is chief medical officer of Phoenix House, a non-profit that operates a chain of addiction treatment centers. According to a note on PROP's website, "PROP is a program of Phoenix House Foundation."

Kolodny has referred to opioid pain medication as “heroin pills” and has called for expanded access to buprenorphine, a weaker opioid widely used to treat both addiction and pain.

The Johns Hopkins report would greatly expand the use of buprenorphine by ending the 100 patient limit on the number of people that DEA licensed physicians can treat with buprenorphine at any one time. It would also require federally funded addiction treatment programs, such as those offered by Phoenix House, to allow patients access to buprenorphine.

Although praised by Kolodny and many addiction treatment specialists as a tool to wean addicts off opioids, some are fearful buprenorphine is already overprescribed and misused. Addicts have learned they can use buprenorphine to ease their withdrawal symptoms and some consider it more valuable than heroin as a street drug.

"The 100 patient limit is going to be lifted. It is going to create buprenorphine pill mills and increase the abuse of heroin. You will have more doctors getting the DEA exemption as they would not be subject to visit by DEA inspectors checking on the patient limit," said Percy Menzes, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis, Missouri area.

Over three million Americans with opioid addiction have been treated with buprenorphine. According to one estimate, about half of the buprenorphine obtained through legitimate prescriptions is either being diverted or used illicitly.

CDC: We Need Safer, More Effective Pain Relief

(Editor’s Note: Debra Houry is director of the CDC's National Center for Injury Prevention and Control, which is developing new opioid prescribing guidelines that the agency plans to adopt in January 2016. We have many questions about the guidelines and the manner in which they are being drafted, and asked for an interview with Dr. Houry. She declined, as did CDC Director Tom Frieden. Dr. Houry did offer to write a column about the guidelines for our readers and we agreed to publish it.)

By Debra Houry, MD, Guest Columnist

At CDC I see the numbers.  The numbers of people dying from an overdose of opioid pain medications.  And, many of these unintentional deaths were in patients taking medications for chronic pain.

But to me, it’s not about numbers.  It’s about the people.  I’m concerned about stories we’ve heard at CDC from people like Vanessa and Carl, who were both prescribed opioid pain medications after car crashes. Vanessa was 17 years old when she was prescribed opioids the first time, and within several years, she was abusing IV drugs and was afraid she was going to die with a needle sticking out of her arm. Carl became addicted quickly and suffered from withdrawal when he tried to stop. He became a drug dealer to get access to the drugs that would prevent the unbearable withdrawal symptoms caused by his opioid addiction. Thankfully both Vanessa and Carl got into treatment and have been in recovery for several years now.

As an ER doctor I’ve cared for people like Carl and Vanessa suffering from traumatic injuries or in chronic pain. I’ve also had to be the one to tell families that they lost a loved one to an overdose of prescription opioids.  I see the risks. It worries me when patients return because their opioid medications are no longer effective at relieving their pain, and they need larger and larger doses.  Although opioids are powerful drugs that are important to manage pain, they have serious risks, with multiple side effects and potential complications, some of which are deadly.

But I want patients for whom the benefits outweigh the risks, to be able to get these important pain medications. And, I need to be able to treat pain more safely and effectively so that people can have relief without the risk of abuse, overdose or death.

Since 1999, we’ve seen a dramatic increase in the amount of opioid pain medications prescribed in the U.S. and at the same time overdose deaths from these medications have quadrupled.  The evidence is becoming clearer that overprescribing these medications leads to more abuse and more overdose deaths. Guidelines that help doctors and other health care providers work with their patients to determine if and when opioid medications should be given as part of their overall pain management strategy need to be updated.  

Most of the existing guidelines have focused safety precautions on high-risk patients, and have recommended use of screening tools to identity patients who are at low risk for opioid abuse. However, opioids pose a risk to all patients, and currently available tools cannot rule out risk for abuse or other serious harm outside of end-of-life settings.  

We must find a better way to treat pain so that diseases, injuries or pain treatments themselves don’t stop people from leading full and active lives. That is why CDC is working with doctors, other health care providers, partners, and patients on urgently needed guidelines based on the most current facts about safer and effective pain treatment. In a national health crisis like this one, our priorities are clear. First, take swift action to protect and save lives. Second, use world class science and proven processes to determine further improvements. And third, use the facts to prevent this situation from happening in the future.

The upcoming CDC guidelines will provide recommendations on providing safer care for all patients, not just high-risk patients. The guidelines will also incorporate recent evidence about risks related to medication dose and encourage use of recent technological advances, such as state prescription drug monitoring programs.

The guidelines are intended to help providers choose the most effective treatment options for their patients and improve their patients’ quality of life. Currently, 44 Americans die each day as a result of prescription opioid overdose. By providing the tools to help physicians make informed prescribing decisions, we can improve prescribing and help prevent deaths from prescription opioid overdose.

Thank you to the many Pain News Network readers who took the time to share your thoughts with us.  As we move forward, we will continue to look for opportunities to work with you on the critical issue of safer, effective pain management.

Debra Houry, MD, is a former emergency room physician and professor at Emory University School of Medicine in Atlanta. In 2014, she was named director of the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention.

Dr. Houry can be emailed at vjz7@cdc.gov and reached on Twitter at @DebHouryCDC.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

For a look at the first draft of the CDC’s opioid prescribing guidelines, click here.

Feds Unveil Opioid Mapping Tool

By Pat Anson, Editor

Big Brother is watching your doctor. And now you can watch too.

In a graphic display of just how closely the government is tracking the prescribing of opioid pain medication, the Centers for Medicare & Medicaid Services (CMS) has released an interactive online map that allows ordinary citizens to follow opioid prescribing trends across the United States.

The map not only permits users to see the number and percentage of opioid prescription claims for each state filed under Medicare Part D – but to drill down on the data to counties, ZIP codes and even prescribers. Over 31 million people are enrolled in Medicare Part D, which subsidizes the cost of prescription drugs for Medicare beneficiaries.

“The opioid epidemic impacts every state, county and municipality. To address this epidemic, while ensuring that individuals with pain receive effective treatment, we need accurate, timely information about where the problems are and to what extent they exist,” said CMS Acting Administrator Andy Slavitt. 

“This new mapping tool gives providers, local health officials, and others the data to become knowledgeable about their community’s Medicare opioid prescription rate.”

The data used in the mapping tool is from Medicare Part D prescription drug claims in 2013, when over 80 million claims for opioids were filed at a cost of $3.7 billion.

The names of Medicare patients are not included in the online map, but prescribers can be looked up by name.

“By openly sharing data in a secure, broad, and interactive way, CMS and the U.S. Department of Health and Human Services (HHS) believe that this level of transparency will inform community awareness among providers and local public health officials,” the CMS said in a statement.

That kind of easy access to prescribing data -- without any context -- is chilling to Mark Ibsen, a Montana doctor who stopped prescribing opioid pain medication to patients because he feared prosecution or losing his medical license.

"Let's keep threatening data bases on car dealers and the crashes that happen, or pharmacies and who dies from their meds, or oncologists and what they prescribe, or police officers and who they have shot, or people we have dated and where they live," Ibsen said in an email to Pain News Network.

"Whatever useless data we can, thinking because it may be useful, using it, regardless of ANY forethought about harm, unintended consequences, or impact on prescribers, patients, business or law enforcement. This has gotten so carried away. I'm done. Whatever evil idea is going on, whoever thought this up, needs to be reeled in."

A look at the national map shows that Alabama, Oklahoma and Nevada have the highest rates of opioid prescribing for Medicare Part D beneficiaries. Over 7 percent of the claims in those states were filed for opioid pain medication, compared to a national average of 5 percent.

Counties and ZIP Codes can have much higher rates, as the map below shows. ZIP code 89081 is north of Las Vegas, near Nellis Air Force Base. Over 34% of the Medicare claims filed by two prescribers in that ZIP code were for opioids.

“The opioid abuse and overdose epidemic continues to devastate American families,” said CDC Director Tom Frieden, MD. “This mapping tool will help doctors, nurses, and other health care providers assess opioid-prescribing habits while continuing to ensure patients have access to the most effective pain treatment. Informing prescribers can help reduce opioid use disorder among patients.”

The CDC is trying to rein in opioid prescribing by issuing guidelines for primary care physicians, who prescribe most of the nation’s opioids. Those guidelines, which are expected to be released in January, encourage doctors to prescribe non-opioid pain relievers and “non-pharmacological” treatments for chronic non-cancer pain.

A recent survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation found that 90 percent are worried they will lose access to opioid pain medication if the guidelines are adopted. Many also believe the guidelines will lead to more addiction and overdoses, not less.

Opioid Use Stabilized in U.S. Decade Ago

By Pat Anson, Editor

The use of prescription drugs has soared in the United States since the turn of the century, with nearly six out of ten adults taking a prescribed medication at least once in the last 30 days, according to a new survey.

But while the use of blood pressure medication, statins and anti-depressants rose sharply from 1999 to 2012 -- the use of opioid pain medication appears to have stabilized and gone into decline over a decade ago.

“Although increased use of narcotic analgesics may raise concern about their potential misuse or abuse, it should be noted that use stabilized after 2003-2004. This flattening trend may reflect increased awareness of prescription opioid drug misuse or abuse, although underreporting of these drugs may have increased with awareness regarding their potential for abuse,” wrote lead author Elizabeth Kantor, PhD, formerly of the Harvard T.H. Chan School of Public Health, who is now with the Memorial Sloan Kettering Cancer Center.

The study findings are published in JAMA, the official journal of the American Medical Association.

The use of opioids rose from 3.8% of adults in 1999 to 5.7% in 2004, according to the study. Since then they have begun to decline slightly. The use of non-opioid pain relievers also appears to have leveled off. 

The data for the survey was compiled differently than most other studies of prescription drugs, which rely on pharmacy databases and insurance claims, not on actual use of the drugs.

The survey involved nearly 38,000 adults across the U.S. and was collected during household interviews.  Participants were asked if they had taken a prescription drug during the last 30 days. If they responded “yes” they were asked to name the medication or to show the drug’s container.

Although other studies have indicated that opioid prescribing is in decline, the Centers for Disease Control and Prevention (CDC) claims there is an “urgent need for improved prescribing practices.” It plans to issue new prescribing guidelines for primary care physicians in January that would limit the quantities and doses of opioids for both acute and chronic pain.  A complete list of the guidelines can be found here.

The opioid hydrocodone was once the most widely prescribed medication in the U.S. But hydrocodone does not appear in the list of top ten drugs used by participants in the survey, nor does any other opioid. The most commonly used prescribed medication in 2011-2012 was simvastatin, followed by lisinopril, levothyroxine, metoprolol, metformin, hydrochlorothiazide, omeprazole, amlodipine, atorvastatin, and albuterol.

“Eight of the 10 most commonly used drugs in 2011-2012 are used to treat components of the cardiometabolic syndrome, including hypertension, diabetes, and dyslipidemia. Another is a proton-pump inhibitor used for gastroesophageal reflux, a condition more prevalent among individuals who are overweight or obese. Thus, the increase in use of some agents may reflect the growing need for treatment of complications associated with the increase in overweight and obesity,” said Kantor.

The researchers found that prescription drug use increased from 51% of adults in 1999-2000 to 59% in 2011-2012. The prevalence of polypharmacy (use of five or more prescription drugs) nearly doubled, from 8% to 15% of those surveyed.

CDC Updates Opioid Prescribing Guidelines

By Pat Anson, Editor

The U.S. Centers for Disease Control and Prevention (CDC) is “still revising and making lots of changes” to its controversial draft guidelines for opioid prescribers, according to a source who listened to a CDC conference call today updating “stakeholders” about the guidelines.

But CDC officials gave few specifics on what modification have been made, and said the dozen guidelines will remain under a strict embargo until they are released in January.

“Overall, they tried hard to give the sense that they really listened and responded to our comments. But, of course, all they did was talk in generalities about changes that have been made, and we won’t see it again until it’s published,” the source told Pain News Network.

The draft guidelines ignited a storm of controversy in the pain community when they were released last month. The CDC is recommending “non-pharmacological therapy” and non-opioid pain relievers as preferred treatments for chronic non-cancer pain. Smaller doses and quantities of opioids are recommended for patients in acute or chronic pain.  A complete list of the guidelines can be found here.

A survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation found that many are worried about losing access to opioid pain medications if the guidelines are adopted. Nearly 93 percent believe the guidelines would be more harmful than helpful to pain patients. Many also believe they will not decrease the use of illegal drugs but actually increase them, causing even more addiction and overdoses.

On today’s call, CDC officials said their most important goal was to maintain access to opioids for pain patients. They also emphasized that the guidelines are voluntary for primary care physicians, who treat the vast majority of pain patients. Language such as “usually” and “whenever possible” are being added to a number of guidelines to give prescribers more flexibility, according to the source.

One guideline that has raised serious concern would put an upper limit on opioid prescribing to a daily dose of 90 mg of morphine equivalent. One stakeholder during the call said that threshold was “arbitrary” and “perhaps dangerous.” CDC officials said the language in that guideline was modified extensively to emphasize that is intended for new patients, not patients who are already taking opioids at or above that dosage level.

The CDC said it received over 1,200 comments on the guidelines during a 48 hour window when it accepted comments from stakeholders and the public last month.  Although as many as 11.5 million Americans are on long term opioid therapy, public participation has been minimal in the guidelines development. Only two patient advocacy groups were included among the dozens of stakeholders and special interests invited to listen to today's conference call. A complete list of the stakeholders will be listed at the end of this article.

The CDC’s update came as the Obama Administration announced new efforts aimed at addressing prescription drug abuse. Over 40 organizations representing doctors, dentists, nurses, physical therapists and educators announced that over half a million of their members would  complete opioid prescriber training in the next two years. In addition, several media outlets, the National Basketball Association, Major League Baseball and other companies said they would donate millions of dollars for public service announcements about the risks of prescription drug misuse.

Call for Congressional Investigation

Meanwhile, the American Academy of Pain Management (AAPM) is urging the House Energy and Commerce Committee to look into how the CDC developed the opioid guidelines. In a letter to committee chairman Rep. Fred Upton (R-MI), the AAPM said the process used in developing the guidelines was “deeply flawed” by secrecy and a lack of transparency, as well as potential conflicts of interest with many of the outside advisers the CDC consulted with.  

“We urge you to strongly encourage CDC to withdraw this draft guideline and, should they decide to start over, to engage in a process that is more transparent and inclusive of the needs and views of all clinicians and patients—both those with pain and those who misuse opioid pain relievers,” wrote Bob Twillman, PhD, Executive Director of AAPM.

“Unless these questions are adequately addressed, the organizations with clinicians who strive to treat chronic pain, and in fact do so with opioids, will not support them but will, by necessity, be forced to actively oppose them.”

Washington Post Calls Guidelines “Promising”

Secrecy surrounding the CDC guidelines has been one reason they haven’t gotten much coverage in the mainstream news media. One example is the Washington Post, which has yet to run a story on the guidelines or the controversy surrounding their development.

But that oversight didn’t stop the Post’s editorial board from weighing in on the issue. In an editorial headlined “The CDC’s promising plan to curb America’s opioid dependence,” the Post said the guidelines would turn opioid prescribing “in an appropriately more cautious direction.”

The editorial also dismissed a letter from the American Cancer Society opposing the guidelines, saying its concerns about cancer patients being denied pain relief were “overstated.”

“It’s true, as the cancer society letter notes, that the CDC guidelines are more than mere suggestions and will influence ‘state health departments, professional licensing bodies or insurers.’ That is precisely why they can be so beneficial,” the Post said.

“Until now, government, medicine and the private sector have too often underestimated the risks, individual and societal, of widespread opioid prescription. The CDC has the prestige and authority to correct the balance. After incorporating valid comments from the cancer society and other interested parties, the CDC plans to publish in early 2016, and we see no reason to delay.”

CDC's Stakeholder Review Group:

American Academy of Neurology; John Markman, MD
American Academy of Pain Medicine; Edward C. Covington, MD
American Academy of Pain Management; Bob Twillman, PhD
American Academy of Pediatrics; Roger F. Suchyta, MD, FAAP
American Academy of Physical Medicine and Rehabilitation; Christina Hielsberg
American Cancer Society; Mark Fleury, PhD
American Chronic Pain Association; Penney Cowan
American College of Medical Toxicology, David Juurlink, BPharm, MD, PhD
American College of Obstetrics and Gynecology; Gerald “Jerry” F. Joseph, Jr, M.D.
American Geriatrics Society; Mary Jordan Samuel
American Hospital Association; Ashley Thompson
American Medical Association; Barry D. Dickinson, PhD
American Pain Society; Gregory Terman MD, PhD
American Society of Anesthesiologists; Asokumar Buvanendran, M.D.
American Society of Addiction Medicine; Beth Haynes, MPPA
American Society of Hematology; Robert M. Plovnick, MD, MS
American Society of Interventional Pain Physicians; Sanford M. Silverman, MD
Physicians for Responsible Opioid Prescribing; Andrew Kolodny, MD

CDC Should Listen to Pain Patients

By Shaina Smith, Guest Columnist

In the wake of the release of the Centers for Disease Control and Prevention's opioid prescriber guidelines, patient advocacy groups and chronic pain patients have been anything but silent. For U.S. Pain Foundation, the process by which the guidelines were crafted seems to have left out a significant part of the equation: chronic pain patients.

When it comes to patient care, we are not alone in this battle to advocate on behalf of those who cannot speak. There are like-minded organizations working diligently to ensure the basic rights of the chronically ill. What we are finding within the nonprofit realm, however, is that higher commanding entities, formed to support the health and well-being of patients, are creating additional hurdles for those they should be helping.

Closed door conversations without consideration of the impact such discussions and decisions can have do not create improved methods that will be embraced by pain warriors. On the contrary, they work against the patient and will cause potential harm.

Working alongside U.S. Pain Foundation volunteers known as Pain Ambassadors, I hear too often chilling and heart-wrenching stories about insurance companies bickering over who will cover what prescription (if they have insurance at all), along with state laws that create additional roadblocks to fair treatment and access.

When I learned of these guidelines, I immediately thought of all those individuals who have already messaged me, begging that we come up with a plan to provide fair access to the treatment they were seeking. After reading the survey results generated by Pain News Network and the Power of Pain Foundation, it is clear that the window for providing fair access and treatment for chronic pain patients is closing.

But there is always hope and ways we can unite our voices to gain back a sense of balance in the way patients are treated by healthcare providers, regulators and lawmakers.

Perhaps the most alarming statement made by over 2,000 participants who completed the survey was that the vast majority feel the CDC guidelines would be more harmful to patients than helpful. This statement is supported throughout the survey results; many fear there will be a rise in pain patients committing suicide, and believe the guidelines will not resolve the misuse and abuse issue at all.

The results are not surprising. While the war on drugs has taken the media’s attention by the horns, patient advocacy organizations like U.S. Pain Foundation have been fighting their own battles on behalf of the brave pain survivor; seeking fair and timely treatment, access to integrative and prescription therapies (not exclusive to opioids) and fighting societal stigmas.

Although we are grateful for lawmakers taking a stance to promote easier access to treatment through the elimination of unjust practices such as step therapy and specialty tiers; there are still many proposals written with good intentions that will potentially cause negative impacts to the 100 million Americans living with chronic pain.

Sadly, the CDC guideline for opioid prescribers is one such proposal. It aims to alleviate misuse and abuse, and attempts to be an educational tool for healthcare providers, but also attempts to take the place of a patient’s treatment plan crafted by that patient and their doctor.

U.S. Pain Foundation has for years prided itself in becoming involved in proposed legislation to ensure the patient-doctor relationship is not hindered by regulations that second-guess the doctor’s initial findings, diagnosis and treatment plan for each patient. We will champion for similar models as the CDC continues revising its prescriber guidelines.

In reading the survey results, it is clear that there are many variables which were not considered in the guidelines. One such variable would include insurance coverage for additional treatments if a patient’s doctor follows the guidelines and decides to no longer prescribe opioid medications.

When asked if their health insurance covered non-pharmacological treatments such as acupuncture, massage and chiropractic therapy, 54% of survey participants stated their insurance did not cover such treatment. I shake my head while reading these answers as I find it hard to believe that in this day and age we are still fighting for basic patient rights to access modalities that may lessen a person’s suffering.

Patients Worried What Their Doctors Will Do

Where are pain patients to turn if these guidelines are put in place and they are not even given alternative means to offset their discomfort?

It is inevitable that many primary care physicians or pain specialists will become fearful if they decided to continue prescribing opioids once the guidelines are in full effect. The survey results clearly reflect a large group of worried pain sufferers whose gut reaction is telling them that their doctors will prescribe opioids less often or not at all if the guidelines are implemented.

Moving forward, the nation can learn from the failed attempt at including the voices of those who would be directly impacted by guidelines. When I say failed, I am speaking of the lack of communication between the CDC and organizations that are fighting access issues on a daily basis. I am speaking of the pain patient who was not privy to join in the CDC’s webinar and has not been given a clear understanding of the CDC’s intent.

The CDC should see the concerns spelled out in the survey and the impact the prescriber guidelines could have on patients. Had the chronic pain community been more involved with the development of the guidelines, less concern would be shared among advocacy groups and patient-centered organizations within the United States.

How each proposed guideline may impact a person’s mother, father, chronically ill child, grandmother, sister, husband or friend should have been expressed and explored further. The CDC should have included patient advocates and pain survivors to lend their expertise during the development stages of the prescriber guidelines.

After reviewing the survey results, U.S. Pain Foundation’s National Director of Policy and Advocacy Cindy Steinberg said, “The overwhelming feeling of survey respondents appears to be that the CDC is discriminating against people with pain.”

“Chronic pain sufferers are very worried that if these CDC guidelines go forward, they will not be able to access a treatment that they can rely on,” she added. “They are concerned that these guidelines will be very harmful for them and that they will lead to a lot more suffering for people with pain.”

U.S. Pain Foundation supports all treatment options that will lessen a person’s suffering. Reducing options, which will be the case as healthcare professionals will likely follow guidelines implemented by the CDC, only exacerbates an already existing battle for chronic pain patients.

Pain warriors are unfortunately made to feel that their pain is not real, their attempt at finding relief makes them drug seekers, and they should fail first at other options before receiving the care agreed upon by their doctors. Everyday obstacles faced by chronic pain patients, including me, cause added stress and hardships.

The CDC should consider the already struggling pain survivors before moving forward with guidelines that would impose additional adversity on the pain patient.

Shaina Smith is Director of State Policy & Advocacy and Director of Alliance Development for U.S. Pain Foundation Inc.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

CDC Cites ‘Urgent Need’ for Prescribing Guidelines

By Pat Anson, Editor

In the wake of growing criticism over its draft guidance for opioid prescribing, the Centers for Disease Control and Prevention (CDC) has released a new study it claims is proof of an “urgent need for improved prescribing practices.”

The agency released its first multi-state report from a federal surveillance system that analyzes data from eight states’ prescription drug monitoring programs (PDMP).

The report, published in the Morbidity and Mortality Weekly Report (MMWR) Surveillance Summary,  tracked prescribing patterns during 2013 in California, Delaware, Florida, Idaho, Louisiana, Maine, Ohio and West Virginia -- about a quarter of the U.S. population.

The report found that prescribing patterns varied widely by state, not just for opioid pain medications, but for stimulants and benzodiazepines, a class of anti-anxiety drugs.

Louisiana ranked first in opioid prescribing, and Delaware and Maine had relatively high rates of prescribing extended-release (ER) opioids. Delaware and Maine also ranked highest in opioid dosage and in the percentage of opioid prescriptions written. California had the lowest prescribing rates for both opioids and benzodiazepines.

In most states, only a small minority of prescribers are responsible for most opioid prescriptions. The report also found that people who obtained opioid prescriptions often received benzodiazepine prescriptions as well, despite the risk for adverse drug interactions.

The wide variance between states was cited as a reason to bring more uniformity to prescribing practices.

“A more comprehensive approach is needed to address the prescription opioid overdose epidemic, including guidance to providers on the risks and benefits of these medications,” said Debra Houry, MD, director of CDC’s National Center for Injury Prevention and Control.

“Every day, 44 people die in American communities from an overdose of prescription opioids and many more become addicted,” said CDC director Tom Frieden, MD. "States are on the frontline of witnessing these overdose deaths.  This research can help inform their prescription overdose prevention efforts and save lives.”

Last month the CDC unveiled a dozen draft guidelines for primary care physicians who prescribe opioids. The guidelines recommend “non-pharmacological therapy” and non-opioid pain relievers as preferred treatments for chronic non-cancer pain. Smaller doses and quantities of opioids are recommended for acute or chronic pain.  A complete list of the guidelines can be found here.

Critics faulted the CDC for developing the guidelines in secret and with little input from patients or pain management experts.

Earlier this month, the California Medical Association sent a highly critical letter to Frieden and Houry saying it had “significant concern” about the secretive nature the agency used in developing the guidelines, which it said were “not appropriate nor transparent.”

“It is deeply concerning that the details behind the 12 recommendations are being made available to some unknown organizations and individuals for review and comment, but not to the general public. The information available to the public was so limited and the time to comment so brief, that it created the perception that the end result has already been determined,” wrote Luther Cobb, MD, President of the California Medical Association, which represents over 40,000 healthcare providers.

“The public must also be able to assess the potential biases and the opioid prescribing expertise for those involved in the creation of the guidelines. The public needs to know who was involved as well as their qualifications and conflicts.”

Cobb called on the CDC to publicly release all materials and recommendations used to develop the guidelines and to allow for a public comment period of 90 days.

The CDC accepted public comments for just 48 hours after releasing the guidelines during an online webinar last month.  As Pain News Network has reported, over 50 invitations to the webinar were sent to groups representing physicians, insurance companies, pharmacists, anti-addiction advocacy groups and other special interests. Only two patient advocacy groups – the American Cancer Society and the American Chronic Pain Association (ACPA) – were invited.

Patients Predict More Drug Abuse Under CDC Guidelines

By Pat Anson, Editor

Guidelines for opioid prescribing being developed by the Centers for Disease Control and Prevention (CDC) will worsen the nation’s drug abuse problem and cause even more deaths, according to a large new survey of pain patients. Many also fear they will lose access to opioids if the guidelines are adopted.

Over 2,000 acute and chronic pain patients in the U.S. participated in the online survey by Pain News Network and the Power of Pain Foundation. Over 82 percent said they currently take an opioid pain medication.

When asked if the CDC guidelines would be helpful or harmful to pain patients, nearly 93% said they would be harmful. Only 2% think the guidelines for primary care physicians will be helpful.

Nearly 90% of patients said they were “very worried” or “somewhat worried” that they would not be able to get opioid pain medication if the guidelines were adopted.

“Over 2,000 pain patients participated in our survey – an indication of just how seriously many of us take the CDC’s proposed guidelines,” said Barby Ingle, president of the Power of Pain Foundation.

DO YOU THINK THE CDC GUIDELINES WILL BE HELPFUL OR HARMFUL TO PAIN PATIENTS?

“We are the ones feeling the pain daily, minute by minute. We are the ones who these guidelines will affect. Even if the guidelines are not law, other agencies, providers and insurance companies will adopt them. There is already an issue with patients receiving proper and timely care across the country, and this will add to the crisis in pain care that already exists.”

The draft guidelines released last month by the CDC recommend “non-pharmacological therapy” and other types of pain relievers as preferred treatments for chronic non-cancer pain. Smaller doses and quantities of opioids are recommended for patients in acute or chronic pain.  A complete list of the guidelines can be found here.

Although the goal of the CDC is to reduce the so-called epidemic of prescription drug abuse, addiction and overdoses, a large majority of pain patients believe the guidelines will actually make those problems worse – while depriving them of needed pain medication.

“I've been closely monitored by a pain management specialist and successfully taken opioids for over 10 years with no abuse or addiction issues,” said one patient. “They have saved my life, independence, and improved my quality of life and daily function. Now I'm terrified of going back to the pain I endured for years.”

“Some pain patients may turn to the streets for relief, if they can afford it,” said another.

“Attempted suicide, pain and withdrawal symptoms would be a major epidemic,” predicts one patient.

“The level of functioning afforded me through pain medication will greatly diminish or disappear, along with an unbearable increase in pain levels. I will either seek pain relief via medical marijuana or consider ending my life,” said one patient.

 “This is absurd. Why is it assumed that anyone who has a prescription for opiate medication is going to sell it or become addicted?” asked another patient.

When asked to predict what impact the guidelines will have on addiction and overdoses, over half said they would stay the same and over a third said they will increase. Less than 5% believe the CDC will achieve its goal of reducing addiction and overdoses.

"There will be a higher incidence of abuse and addiction. People will continue to find ways to get the medication that works for them. Without appropriate supervision, abuse, addiction and overdose will actually increase," said one patient.

"I have a friend who eventually became addicted to heroin when NY state made it hard for her to get tramadol. It was easier for her to get street drugs for her back injury pain," said another.

WHAT IMPACT WILL THE CDC GUIDELINES HAVE ON ADDICTION AND OVERDOSES?

"I believe the CDC should stick to their title, Centers for "Disease" Control. There are many areas of research desperately needed much more than new rules to control a doctor's ability to properly treat and manage chronic pain patients," one respondent said.

Asked what would happen if the guidelines were adopted – and given the choice of various scenarios – large majorities predicted more suffering in the pain community, as well as suicides, illegal drug use and less access to opioids. Only a small percentage believe patients will exercise more, lose weight and find better alternatives to treat their pain.

• 90% believe more people will suffer than be helped by the guidelines
• 78% believe there will be more suicides
• 76% believe doctors will prescribe opioids less often or not at all
• 73% believe addicts will get opioids through other sources or off the street
• 70% believe use of heroin and other illegal drugs will increase
• 60% believe pain patients will get opioids through other sources or off the street
• 4% believe pain patients will find better and safer alternative treatments
• 3% believe fewer people will die from overdoses
• 1% believe pain patients will exercise more and lose weight

CDC officials and many addiction treatment experts contend that opioids are overprescribed – leading to diversion and abuse -- and that other types of pain medication or therapy should be “preferred” treatments for chronic pain.

But over 58% of the patients who were surveyed disagree or strongly disagree with the statement that opioids are overprescribed. Less than 16% agree or strongly agree that opioids are overprescribed.

Many patients said they were already having trouble obtaining opioid prescriptions.

"People are UNDER MEDICATED not getting relief. I do not believe addiction is a factor, I think people are not getting what they need, period!" wrote one patient.

"It's already very difficult to get any prescription pain meds that actually help reduce pain. With these changes many will suffer. Why should people who truly have chronic pain be penalized due to others abuse of their meds?" asked another patient.

DO YOU AGREE THAT OPIOIDS ARE OVERPRESCRIBED?

"It is already difficult to get my prescriptions that I have been safely using for years. If these additional restrictions of prescriptions, need for monthly doctor visits, etc. are put into place. I will only suffer more," wrote another patient. "Legitimate pain patients are not the problem, yet are greatly impacted by guidelines such as this. I ask that the CDC PLEASE consider unintended consequences for legitimate patients before they implement these recommendations. This could be tragic."

To see what pain patients are saying about the effectiveness of therapies recommended by the CDC, click here.

For a complete look at all of the survey result, visit the "CDC Survey Results" tab at the top of this page or click here.