ER Doctors Lobby to Silence Pain Patients

By Pat Anson, Editor

A professional organization for emergency room physicians has joined in a lobbying effort to stop asking hospital patients about the quality of their pain care.

At issue is a Medicare funding formula that requires hospitals to prove they provide good care through patient satisfaction surveys. The formula rewards hospitals that are rated highly by patients, while penalizing those that are not. 

In a letter to Health and Human Services Secretary Sylvia Mathews Burwell, the head of the American College of Emergency Physicians (ACEP) claims that asking patients about their pain care could lead to overprescribing of opioid pain medication. To see the letter, click here.

“Patient experience/satisfaction surveys are important, particularly regarding issues of treating patients with dignity and respect, but questions about pain have resulted in unintended consequences and the pursuit of high patient-satisfaction scores may actually lead health professionals and institutions to practice bad medicine by honoring patient requests for unnecessary and even harmful treatments,” wrote Jay Kaplan, MD, President of ACEP, which represents over 30,000 emergency room physicians in the U.S.

“Any questions which provide an opportunity for patients to express dissatisfaction because they didn’t get the drugs they sought, provide disincentives for physicians to prescribe non-opioid analgesics which will negatively affect their scores.”

Only two questions are asked about pain in the 32-question survey known as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS):

During this hospital stay, how often was your pain well-controlled?

During this hospital stay, how often did the hospital staff do everything they could to help you with your pain?

In his letter, Kaplan states “there is no objective diagnostic method that can validate or quantify pain” and until one is developed, both pain questions should be dropped from the survey.

“We are concerned that the current evaluation system may inappropriately penalize hospitals and physicians who, in the exercise of medical judgment, opt to limit opioid pain relievers to certain patients and instead reward those who prescribe opioids more frequently,” Kaplan wrote. “We urge the Department to undertake a robust examination of whether there is a connection between these measurements and potentially inappropriate prescribing patterns, and, until that is completed, we urge you to remove pain questions from the various CAHPS surveys.”

Kaplan’s letter is similar to one sent to Secretary Burwell in February by Sen. Susan Collins (R-Maine) and 25 of her colleagues in the U.S. Senate. To see that letter and the senators who signed it, click here.

“The evidence suggests that physicians may feel compelled to prescribe opioid pain relievers in order to improve hospital performance on quality measures,” wrote Sen. Collins.

Both Collins and Kaplan cite only one piece of “evidence” – a 2013 magazine article in The Atlantic  -- that mentions a small study of “drug seeking behavior” by emergency room patients. The article's author, who is a physician, also mentions anecdotal comments from colleagues and concludes “this problem is widespread.”  

Pain News Network and the International Pain Foundation recently conducted a survey of over 1,250 pain patients and found that what is actually widespread in hospitals is poor pain care. Over half the patients surveyed said the quality of their pain treatment was poor or very poor and over 80 percent said hospital staffs are not adequately trained in pain management. Nine out of ten patients said they should be asked about their pain care in hospital satisfaction surveys.

“Before eliminating patients' right to critique their pain care, a better idea would be to ask doctors what they know about pain!” wrote one patient. 

When Pain News Network provided ACEP with the survey results, a spokesperson declined to comment on the findings.

A top Medicare official recently wrote an article in JAMA defending the HCAHPS survey.

"It has been alleged that, in pursuit of better patient responses and higher reimbursement, HCAHPS compels clinicians to prescribe prescription opioids. However, there is no empirical evidence that failing to prescribe opioids lowers a hospital’s HCAHPS scores," wrote Lemeneh Tefera, MD, Quality Measurement and Value-Based Incentives Group, Centers for Medicare & Medicaid Services.

"Although opioids are sometimes appropriate, depending on the underlying cause, other nonpharmaceutical approaches and multiple nonopioid pain medications are available to treat pain. Nothing in the survey suggests that opioids are a preferred way to control pain. On the other hand, good nurse and physician communication are strongly associated with better HCAHPS scores."

“I find this notion that we would stop asking patients how well their pain was controlled in the hospital appalling,” said Cindy Steinberg, National Director of Policy and Advocacy for the U.S. Pain Foundation. “I find it perverse that we would be more concerned with whether doctors in a hospital setting felt ‘pressure’ to provide pain relief than whether patients felt the hospital staff did all they could to help them with their pain. What ever happened to the focus on ‘patient-centered’ care?"

DEA Warns of Fake Fentanyl Pain Pills

By Pat Anson, Editor

In the wake of nine deaths and dozens of overdoses in the Sacramento, California area in recent weeks, the U.S. Drug Enforcement Administration has issued a public safety alert about illicit fentanyl being disguised as opioid pain medication and sold on the black market.

Fentanyl is a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses. Fentanyl is available by prescription to treat more severe types of chronic pain, but illicitly manufactured fentanyl is fast becoming a scourge across the U.S. and is blamed for thousands of fatal overdoses.

White fentanyl powder is usually mixed with heroin or cocaine to give those drugs an extra kick, but in Sacramento the drug was disguised as counterfeit Norco pills, a legal opioid pain medication that combines hydrocodone with acetaminophen.

“Public Health and Law Enforcement officials believe that the pills containing Fentanyl were likely sold on the street under the guise of being legitimate hydrocodone.  Additionally, the pills are marked to mimic the authentic hydrocodone product. However, the Sacramento County Department of Health and Human Services reports that test results show that some of the tested pills did not contain hydrocodone, but rather fentanyl,” the DEA said in a statement. 

IMAGE OF COUNTERFEIT NORCO

“The DEA urges the public not to take a prescription drug unless prescribed by your own physician and obtained from a reputable pharmacy."

One of the overdose victims in California was David Alfaro, a 53-year old man who suffered chronic pain from a leg injury, according to a report by KCRA-TV.

"He bought what he thought was Norco, and it ended up being fentanyl -- and it killed him," said Marinda Conway, Alfaro’s common law wife. "He wasn't a heroin addict that was looking to substitute his addiction by buying street pills. He wasn't an opioid addict by any means.”

Conway said a single fake Norco pill was enough to kill Alfaro, although autopsy results are pending.

"This has been my fear with the new CDC guidelines that more people with pain will have less access to prescription medications; therefore taking matters into their own hands, self-medicating with medications bought on the street," said Paul Gileno, president of U.S. Pain Foundation, referring to recently adopted government guidelines that discourage primary care physicians from prescribing opioids for chronic pain.

"The CDC never thought about the unintended consequences from limiting access to legitimate patients needing care whose clinicians now feel unable to prescribe or treat appropriately. My worst nightmare is the possible repercussions looming in the future due to these hindering guidelines," Gileno said.

In a survey last fall of over 2,000 pain patients by Pain News Network,  70 percent predicted that use of heroin and other illegal drugs would increase if the CDC guidelines were adopted.

The DEA says illicit fentanyl is primarily manufactured in Mexico and China before being smuggled into the U.S. Because of the nature of the drug, it’s impossible to tell if fentanyl was prescribed legally and used for medical reasons or manufactured illegally and used recreationally. The CDC admits many fentanyl overdoses may have been misclassified as deaths caused by prescription painkillers.

White House Steps Up Anti-Opioid Campaign

By Pat Anson, Editor

The Obama administration has unveiled a series of new initiatives aimed at treating addiction and educating doctors about prescription opioid abuse – amid growing signs the nation’s drug abuse epidemic is being fueled more and more by illegal opioids such as heroin and illicit fentanyl.

The new campaign, unveiled at the National Rx Drug Abuse and Heroin Summit in Atlanta, expands on a $1.1 billion funding proposal the President sent to Congress last month to address the nation’s growing drug problem.

One change that could greatly expand access to addiction treatment is a proposed rule by the Department of Health and Human Services (HHS) to double the number of prescriptions that a doctor can write for buprenorphine, an opioid used to treat addiction. Doctors currently are limited to 100 buprenorphine patients, but the new rule would expand that to 200 patients. The number of doctors trained and licensed to prescribe buprenorphine will also be increased.

HHS and the Substance Abuse and Mental Health Services Administration (SAMHSA) will also release over $100 million to expand access to addiction treatment.

"Expanding access to medication-assisted treatment for opioid-use disorders has been a top priority for this administration. Research clearly shows that this approach, when combined with behavioral therapies, is more effective at sustaining recovery and preventing overdose," said Michael Botticelli, director of the White House Office of National Drug Control Policy.

The policy changes and funding support stand to greatly benefit addiction treatment centers such as Phoenix House, whose medical director has lobbied for expanded access to buprenorphine treatment. Andrew Kolodny, MD, is also the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP) which had five board members, including Kolodny, advising the CDC about its new opioid prescribing guidelines.

While buprenorphine is considered a “safer” opioid and has long been used to treat addiction (under the brand name Suboxone), it is prized by some addicts and can be abused. A 2013 study by SAMHSA found a ten-fold increase in the number of emergency room visits involving buprenorphine. Over half of the hospitalizations were for non-medical use of buprenorphine – meaning many users took the drug to get high.

“One of the most effective medications for opioid addiction is a drug called buprenorphine or Suboxone,” said Kolodny in an interview on C-SPAN last October.

A request to Phoenix House and Kolodny for comment on the HHS buprenorphine proposal went unanswered.

The White House also announced this week that 60 medical schools will require students to take some form of prescriber education, modeled after the CDC’s opioid guidelines, in order to graduate.

The lack of pain education in medical schools has long been recognized as a problem. A 2012 study published in the Journal of Pain called pain education "lackluster" in the U.S. and Canada. Few schools required a course in pain education and many did not have any pain courses.

A recent survey by Pain News Network and the International Pain Foundation (IPain) found that 8 out of 10 patients feel that hospital staffs are not adequately trained in pain management. Over half rated the quality of their pain care in hospitals as either poor or very poor.

Some fear the new White House plan is focused more on addiction treatment and limiting access to opioids than it is on educating doctors about pain management.  

“What remains astonishing is the total deafness to the needs of people in pain. It is as if people in pain don't exist and that they are not important,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“Focusing on opioid prescribing education in medical schools without also educating medical students about pain medicine is only going to further stigmatize people in pain and those who develop addictions. This is a true Back to the Future nightmare.  We will be practicing 1950's medicine for the most prevalent public health problems in America.  Absolutely astounding to me.”  

Six Fatal Fentanyl Overdoses in California

While the Obama Administration was announcing its new plan, health officials in Sacramento, California confirmed that six people died and over two dozen were hospitalized this month after ingesting a black market version of Norco, a widely prescribed opioid painkiller.

Legitimate Norco pills are a combination of hydrocodone and acetaminophen, but the “street” Norco was laced with fentanyl, a much more potent and potentially deadly opioid. Fentanyl is odorless and cannot be easily distinguished from other drugs.

“Some who have taken it stated that they were told that it was Norco.  However, results just released indicate that some of the pills that were retrieved have been tested and show that they did not contain Hydrocodone or Acetaminophen. The lab was able to identify the pills as containing Fentanyl instead.  This indicates that they are really Fentanyl pills that have been made to look like Norco,” the Sacramento County Division of Public Health said in a statement.

Fentanyl deaths have been rising around the country – at least 22 died from fentanyl overdoses in the Cleveland, Ohio area this month alone and dozens of deaths have been reported in West Virginia.

Last year the Drug Enforcement Administration issued a nationwide alert about the abuse, diversion and illegal manufacture of fentanyl. Thousands of people are believed to have died from fentanyl overdoses, but because of the nature of the drug it is impossible to tell whether it was prescribed legally and used for medical reasons or manufactured illegally and used recreationally. The CDC admits many fentanyl overdoses may have been misclassified as deaths caused by prescription painkillers.

Meanwhile, a report this week in Maine’s Portland Press Herald suggests that there is a correlation between rising heroin use and reduced access to prescription opioids. In recent years the number of people being treated for heroin addiction has nearly tripled in Maine, at a time when the number of prescriptions written for opioids dropped by 45 percent.

How Opioid Prescribing Guidelines Use Pseudoscience

By Michael Schatman and Jeffrey Fudin, Guest Columnists

Recently, we (along with our colleague, Dr. Jacqueline Pratt Cleary) published an open access article in the Journal of Pain Research, entitled “The MEDD Myth: The Impact of Pseudoscience on Pain Research and Prescribing Guideline Development.”

In this work, we address the issue of how governmental and managed care opioid guideline prescribing committees use the flawed concept of morphine-equivalent daily dose (MEDD or MME) to arbitrarily place limits on the amount of opioids that a clinician “should” prescribe to any patient with chronic pain -- as if all patients were identical. 

The article cites excellent research that exposes the invalid concept of MEDD – and while guideline authors are fully aware of that lack of evidence, they are hypocritically fine with using MEDD as a device to thwart chronic opioid use. In the case of opioids for chronic non-cancer pain, there is at least some evidence.  But for MEDD, there is no evidence.   

One reason the MEDD concept is not legitimate is pharmacogenomic differences – that is, due to each of our unique genetic compositions, various individuals and geographical groups metabolize some opioid analgesics differently.  These differences are often enormous. 

For example, it may require Person “A” 20 milligrams of hydrocodone to achieve adequate pain relief, while Person “B” (of the same gender and weight) may require 60 milligrams of the same drug for the same type of chronic pain condition.  Does this make Person “B” an addict?  Of course not.

We believe that by arbitrarily limiting the “appropriate” amount of an opioid that a physician should prescribe to a patient (which all recent guidelines – including the CDC’s guideline – call for), physicians feel compelled to limit the amount of opioid analgesic therapy that they prescribe – irrespective of the amount of relief that a patient with chronic pain receives. 

Is this good pain medicine practice?  Hardly.  However, in the eyes of the anti-opioid zealots who have dominated recent opioid prescribing guideline committees, their agenda of taking opioids out of the picture altogether for patients with chronic pain is evidently more important than is patient well-being.

Aside from the pharmacogentic issues, we also have conversion issues because of simple mathematics.  We cite data that clearly shows there are no universally accepted opioid equivalents.  Even if there were no issues with genetic variability, there is still no consensus on how to mathematically convert one opioid to another. For example, the state of Washington may decide on a different MEDD equivalent than the one New York state chooses.

Will the anti-opioid zealots admit that they have a non-scientifically-based agenda to take opioids out of the American chronic pain management discussion?  No – because if they were to do so, they would be seen as cruel or uncaring.  Rather, they emphasize that their concerns are for the well-being of patients and society.  Their logic suggests that if clinicians stop prescribing opioid analgesics altogether, then the unfortunate number of opioid-related overdoses and deaths will decrease dramatically. 

Not surprisingly, they lack the data that supports this assertion, yet the data are clear that when this happens, heroin use increases proportionally. 

As scientists and practitioners who work with patients with chronic pain every day, we see the damage in which these guidelines result.  For example, while the guidelines are described as “voluntary” by the committees that write them, that is clearly not the case.  Although the zealots deny the existence of a chilling effect on prescribing, there are data that suggest that progressively fewer physicians are willing to prescribe opioids since these non-evidence-based guidelines have surfaced.  Despite being touted as voluntary, physicians fear regulatory sanction should they disobey them, and accordingly are taking opioids out of their treatment armamentaria. 

Are we suggesting that opioid therapy be considered the first-line treatment for chronic pain?  Certainly not.  Chronic opioid therapy should be considered only when other available treatments have proven ineffective. However, given the for-profit health insurance industry’s business ethic of cost-containment and profitability, insurance access to many treatments that may be superior to opioid therapy are out of reach for the vast majority of Americans. We also have to remember that 20% of Americans live in underserved areas in which more sophisticated and safer treatment options are completely inaccessible.

We are concerned about this ethical imbroglio, as it is extremely damaging to our patients who suffer from the disease of chronic pain.  To quote from our article, opioid prescribing guideline committees’ continued utilization of the antiquated and invalid concept of MEDD is “scientifically, ethically, and morally inexplicable.”

As a result of this highly unethical practice, “impressionist lawmakers and anti-opioid zealots are basing clinical policy decisions on flawed concepts that ultimately could adversely affect positive outcomes for legitimate pain patients.”

It’s difficult enough to suffer from chronic pain under the best circumstances.  What patients with pain and society in general certainly don’t need is a group of smug inexperienced pain policymakers, politicians, and managed care administrators impacting public policy by evoking pseudoscience. There is sufficient good science being published that demonstrates that their reliance upon the MEDD myth is highly disingenuous.

Michael E. Schatman, PhD, is a clinical psychologist who has spent the past 30 years working in multidisciplinary chronic pain management. Until recently, he served as the Executive Director of the Foundation for Ethics in Pain Care in Bellevue, WA.

Dr. Schatman is Editor-in-Chief of the Journal of Pain Research and Director of Research for the U.S. Pain Foundation.

Jeffrey Fudin, PharmD, is a Clinical Pharmacy Specialist and Director at the Pharmacy Pain Residency Programs at the Stratton Veterans Administration Medical Center in Albany, NY.  

Dr. Fudin is Diplomate to the American Academy of Pain Management and a Fellow of both the American College of Clinical Pharmacy and the American Society of Health-system Pharmacists. 

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

Pain Patients Say Non-Opioid Meds ‘Do Not Help at All’

By Pat Anson, Editor

In recent weeks, several efforts have been launched to scale back the use of opioid pain medication in hospitals and emergency rooms.

The American Pain Society (APS) released new guidelines for post-surgical pain that encourage physicians to limit the use of opioids, and to give acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), gabapentin (Neurontin), or pregabalin (Lyrica) to patients suffering from postoperative pain. Cognitive behavioral therapy and transcutaneous elective nerve stimulation (TENS) were also recommended by the APS for post-operative pain.

Similar measures were endorsed by an expert panel at the Jefferson College of Population Health in Philadelphia, which warned that relieving a patient’s post-surgical pain with opioids could lead to addiction.

“Clearly, giving patients what they want, or think they need, is not always in their best interest,” wrote lead author Janice Clark, RN, Jefferson College of Population Health.

But most pain patients aren’t getting what they want or what they need in hospitals -- pain relief --  according to an extensive survey of over 1,250 acute and chronic pain patients by Pain News Network and the International Pain Foundation (IPain).

Over half rated the quality of their pain care in hospitals as poor or very poor, and six out of ten patients said their post-surgical pain was not adequately controlled.

And many hospitals are already very reluctant to give patients opioids. Over half (53%) the patients in our survey say they were refused opioid pain medication while hospitalized.   

“If you end up in the emergency room you will NEVER be given opioid based pain meds. They use NSAIDs. That usually isn't good enough,” said a patient who suffers from rheumatoid arthritis and spinal stenosis.

“This obsession with preventing pain sufferers from receiving adequate care is cruel and unusual. Would you deny a diabetic access to medication to control their condition?”

WERE YOU EVER REFUSED OPIOID PAIN MEDICATION WHILE HOSPITALIZED?

“They didn't want to hand out an opiate but were sure happy to go get me some Xanax,” said a patient who was hospitalized for an undiagnosed heart problem, as well as back and rib pain. “Welcome to the American standard of schooling and healthcare.”

“I went to the ER for a broken arm, and they took x-rays and told me it was broken. I asked for pain meds, even asked for non-narcotic meds, and got NOTHING, not even an aspirin with a broken arm, nothing while they put a cast on it and nothing to fill when I left,” said another patient.

“The pharma companies are using everything they can to increase the drug costs and these newer drugs are less effective and much more expensive. Soon they'll be suggesting we not use anesthesia for amputations,” said another pain sufferer.

Patients overwhelmingly agreed in our survey that non-opioid medications and therapies were ineffective in relieving pain. Nearly two-thirds (65%) said they “did not help at all” and nearly one in four said they only “helped a little.”

Just 11% said non-opioid treatments were very effective or somewhat effective at relieving pain.

“If they intend to use ‘preferred treatments’ like NSAIDs and Lyrica/Neurontin, they should have a reason for using these more dangerous, less effective meds,” wrote one patient.

“They should know that Lyrica and Neurontin can take months to build in the patient's system in order to be effective, and that NSAIDs can cause heart problems, gastric bleeding, and other side effects which can cause a host of new problems for the patient.”

“Tylenol won't help me and I'm allergic to NSAIDs. Why not do something about the real druggies that ruined it for the real patients? They get their medicines! I won't go to the ER unless I'm dying!” wrote another patient.

WAS NON-OPIOID PAIN MEDICATION OR THERAPY EFFECTIVE IN RELIEVING YOUR PAIN?

“Advil or Tylenol just don't cut it. It's ridiculous that you would not be treated for chronic pain in and out of hospital setting,” said another pain sufferer.

“I'm not surprised there's a perception that pain care is poor, in hospital or out,” said David Juurlink, MD, an internist and clinical pharmacologist at Sunnybrook Health Sciences Centre in Toronto.

“It's important that patients understand that one major reason for this is that our available pain medications (principally acetaminophen, NSAIDs and opioids, but various other drugs as well), simply don't work well for many types of pain. I see this firsthand every day, and it highlights the need for research into novel drug therapies that treat pain safely and effectively,” said Juurlink, who is also a board member of Physicians for Responsible Opioid Prescribing (PROP) and was a consultant to the CDC during development of its opioid prescribing guidelines.

“It's especially important that people not conflate ‘poor pain care’ with ‘reluctance to use opioids,’ because opioids really are no better than our other options for treating pain -- chronic pain in particular -- and they can make pain worse in a very short period of time. This phenomenon (opioid-induced hyperalgesia) is something we're just starting to understand, but it's one of many reasons why patients can have pain that persists or even worsens despite therapy. It's one more reason why doctors and patients need to de-emphasize the role of opioids in managing pain.”

One patient in our survey wishes hospitals would allow medical marijuana to be used an alternative to opioids.

“It would be better and safer if cannabis was allowed in treating pain in hospitals,” they said. ”I don't use opioids every day because I use cannabis instead. When I am in hospital I am forced back on opioids and go through withdrawal when I leave the hospital. This would not be the case if I could keep using cannabis instead.”

Still another patient discovered a novel way to get opioids in the hospital: don’t ask for them.

“I ended up learning to ask for non-opioid painkillers. That way when the painkillers they gave me didn't work, they would actually suggest them,” he said.

To see the complete survey results, click here.

A Pained Life: The Good and Bad about CDC Guidelines

By Carol Levy, Columnist

The Centers for Disease Control and Prevention begins the summary of its new opioid guidelines by stating: “This guideline provides recommendations for primary care providers who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.”

I have issue with some of the guidelines. Other parts I think are common sense, although I know many will disagree with me.

That being said, the guidelines negate themselves when they state they are not aimed at those receiving palliative care, which is described as: “Palliative care is specialized medical care for people with serious illnesses. It focuses on providing patients with relief from the symptoms and stress of a serious illness. The goal is to improve quality of life for both the patient and the family.”

That definition clearly includes those with chronic pain illnesses and disorders. As such it does not make sense to go after us as the main culprits of the alleged opioid epidemic.  I write alleged because there seems to be much controversy whether the epidemic exists, its cause, and the medications involved, some of which are either gotten illegally or are themselves illegal, such as heroin.

These are the guidelines:

1) Non-pharmacologic therapy and non-opioid medication are preferred for chronic pain. If opioids are used, they should be combined with non-opioid drugs and therapy as appropriate.

2) Before starting opioids for chronic pain, clinicians should establish treatment goals, including realistic goals for pain and function, and consider how opioid therapy will be discontinued if benefits do not outweigh risks.

3) Before starting and periodically during opioid therapy, clinicians should discuss known risks and realistic benefits of opioid therapy.

4) When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting opioids.

5) When opioids are started, clinicians should prescribe the lowest effective dosage.

6) Long-term opioid use often begins with treatment of acute pain. Clinicians should prescribe the lowest effective dose of immediate-release opioids and no greater quantity than needed for the expected duration of severe pain. Three days or less will often be sufficient; more than seven days will rarely be needed.

7) Clinicians should evaluate benefits and harms within 1 to 4 weeks of starting opioids or dose escalation, and should evaluate benefits and harms every 3 months. If harm outweighs benefits clinician should work with patients to taper opioids to lower dosages or discontinue.

8) Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms.

9) Clinicians should review the patient’s history of controlled substance prescriptions.

10) When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually.

11) Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently.

12) Clinicians should offer or arrange evidence-based treatment.

Most of these guidelines seem to be to be based on common sense; however I take great umbrage at the recommendation about urine drug testing. I do not know of any other patient group where a patient is presumed guilty or felonious. It casts cast a black mark on every person who has a chronic pain disorder and for whom opiates are prescribed.

The guidelines also miss the mark by not differentiating between patients for whom physical and alternative therapies can help and those they cannot. For instance, trigeminal neuralgia and other cranial neuropathies will get no benefit whatsoever from those kinds of therapies. Lupus, multiple sclerosis, chronic regional pain syndrome (CRPS/RSD), and many other conditions are also not responsive or greatly responsive to physical therapy, targeted injections and other types of nonopiod therapies.

Suggesting other forms of therapy for a population that is not helped by them is not palliative, in any sense of the word.

However, I think we hurt ourselves when we jump on a bandwagon and say the whole idea of guidelines are hurtful to our community. We need to look at them clearly.

It should be pro forma that the doctor talk to his patient about the harms and benefits of any prescribed treatment. It should be standard practice for a doctor to evaluate if the treatment is helping or not, and make any necessary changes.

It is only logical that the medical community treat the chronic pain community as they would any other; with professionalism, common sense, decency, and thoughtful help.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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

Pain Patients Tired of Being Labeled as Addicts

By Pat Anson, Editor

If there’s one thing that gets a pain patient frustrated or angry, it’s being labeled as an addict or a “drug seeker” in search of opioids.  So imagine hearing that from a doctor or nurse at a hospital where you’ve gone for treatment because your pain is out of control or unbearable.

But it happens all the time.

“I refuse to go to the ER for pain. Unless I feel I'm absolutely dying, I will not go. It isn't worth being made to feel like I'm only ‘putting on a show’ or I'm a junkie just trying to get high,” one pain sufferer told us. “In every situation I've experienced in going to the ER with a complaint (of) pain, I've been made to feel less than human and was automatically met with suspicion.”

“I was screamed at and humiliated by the front desk nurse in front of a whole lobby of people for having pain and no medication or treatment. Had nowhere to go and didn’t know what else to do. She was so angry at me, I was shocked. I couldn’t believe it,” said another pain patent.

“My husband experienced a ruptured appendix at home,” wrote one woman. “His hospital experience was a nightmare! I had to stay at the hospital 24/7 just to make sure that his pain was kept under control. He was ridiculed, humiliated and not believed to the point that he was ready to walk out.”

Those are some of the typical responses we received in a survey of over 1,250 acute and chronic pain patients by Pain News Network and the International Pain Foundation (IPain).  Nearly three out four patients surveyed said they currently take an opioid pain medication.

When asked if they ever felt labeled as an addict or drug seeker by hospital staff, nearly half (46%) said they often were and over a third (34%) said it happens sometimes. Only 20% of pain patents said they had not been labeled.

“I was treated like a drug seeker and humiliated in front of the staff and patients. This has happened several times,” wrote one pain sufferer.

“I was insulted, berated, and humiliated by hospital staff while seeking help for my chronic pain conditions,” said another.

DID YOU EVER FEEL YOU WERE LABELED AS AN ADDICT OR "DRUG SEEKER" BY HOSPITAL STAFF?

“I have panic attacks about going to the hospital because I have been treated so badly,” wrote one woman. “I've heard nurses say, ‘She's only here for the free meds.’ I've had nurses and doctors yell at me when I explain my pain symptoms and ask for something simple like a pillow, or an IV in a different spot. I've been told, ‘You’re in a hospital. You are supposed to be uncomfortable!’”

“Doctors have called me a liar when it comes to why I have previously been in the ER or hospital. I have been told I am no better than a street addict,” wrote a patient who has pancreatitis and lupus.

“The nurses that treated me saw on the state Rx monitoring website I was taking opioids (although I had already told them). They shut the curtain and told me to take a nap! I was not seen by a doctor and was told I was a drug seeker,” wrote a patient who was seeking treatment for abdominal pain. “I got up and left and a couple weeks later was diagnosed with diverticulitis and a serious infection that could have killed me. I had 2 1/2 feet of my intestine taken out.”

Asked if doctors were reluctant to give them opioid pain medication while they were hospitalized, 38% of pain patients said it happens often and 36% said sometimes. Only 26% said no.

“I had a doctor in an emergency room situation one time during an episode I was having, who actually stood in the open doorway of my room, I was still in the ER, and yelled at me as loud as he could, that he wasn't giving me any pain medicine,” said one patient.

“I understand why opioids are scary to prescribe and I do understand that there are a lot of people just looking to get high. But doctors and hospitals discriminate (against) all of us with real medical problems and it’s inhumane,” wrote another.

WERE DOCTORS RELUCTANT TO GIVE YOU OPIOID PAIN MEDICATION WHILE YOU WERE HOSPITALIZED?

“The nurses and doctors need to understand the difference between the 98% who are not drug seeking and be able to address the patients’ needs who present in front of them,” said Barby Ingle, president of IPain.  “Treatment based on misconceptions and poor pain understanding is not ethical or appropriate. We must create policies that support the pain patient and their individual needs.”

Even patients who do not take opioid medication said they were labeled as addicts or drug seekers --  just as often as those who take opioids.

“I am really sick of being looked at as if I am there for dope meds. Not all of us is addictive or crazy about pain meds,” wrote one patient.

“I am not a bad person. I am sick. I did not do this to myself, it was done to me in childhood trauma. I was abused, please don't abuse me more,” pleaded another patient.

“Everyone needs to be treated with compassion, respect, and have their concerns listened to. This is not happening. We need to start holding people accountable for how they treat people in pain,” says Janice Reynolds, a pain sufferer and retired palliative care nurse.

“I would encourage everyone when you have been to the ER or in the hospital to write a letter to the CEO of the hospital, the vice president of nursing, and the medical and nursing managers of the department you were in.  Tell them how you were treated, how they made you feel, what happened that didn’t work, and try to get names and write them down.  Do this for good treatment as well as bad treatment,” Reynolds wrote in an email Pain News Network.

“I have actually done this and while one letter may not be effective, you are a costumer and if they get several letters they may start seeing there is a problem.  I know at the hospital I worked at, we were always told about a positive or negative comment which mentioned us by name.”

Another way to lodge a complaint – or compliment – is in patient satisfaction surveys, which Medicare requires hospitals to conduct to prove they provide quality care. Medicare rewards hospitals that are rated highly by patients, while penalizing those who do not. 

However, Maine Sen. Susan Collins (R) and 25 of her colleagues in the U.S. Senate have sent a letter to Health and Human Services Secretary Sylvia Mathews Burwell asking that Medicare stop asking patients about their pain care because that could lead to opioid overprescribing.

“We are concerned that the current evaluation system may inappropriately penalize hospitals and pressure physicians who, in the exercise of medical judgment, opt to limit opioid pain relievers to certain patients and instead reward those who prescribe opioids more frequently,” the letter states.

Pain patients say that’s nonsense. When we asked if patients should still be asked about their pain care in hospital satisfaction surveys, over 92% said yes and less than 3% said no.

“I find this notion that we would stop asking patients how well their pain was controlled in the hospital appalling,” said Cindy Steinberg, National Director of Policy and Advocacy for the U.S. Pain Foundation. “Dropping these questions from the Medicare survey sends the message that pain relief is no longer part of a quality-of-care measure that hospital staff need be concerned about. Controlling patients’ pain is just not that important any more.  Is this really where we want to go?

SHOULD PATIENTS BE ASKED ABOUT THEIR PAIN CARE IN HOSPITAL SATISFACTION SURVEYS?

“We have moved from the war on drugs to the war on pain patients and now to the war on the very concept of appropriately treating pain.  This is a shameful perspective that condones a cavalier and uncaring attitude toward the pain and suffering of fellow human beings.  I wonder what the Senators who signed this letter would say about the responsibility for doctors and nurses in hospitals to relieve pain if it was their loved ones or themselves who was experiencing unrelieved pain in the hospital?”

A request to Sen. Collins’ office for an interview or statement on the survey findings went unanswered.

To see the complete survey results, click here.

Tomorrow we'll see how pain patients feel about non-opioid medications and whether they are effective in providing pain relief.

Pain Patients Fed Up with Poor Treatment in Hospitals

By Pat Anson, Editor

Eight out of ten pain patients feel hospital staff have not been adequately trained in pain management and over half rate the quality of their pain care in hospitals as either poor or very poor, according to a new survey.

Over 1,250 acute and chronic pain patients participated in the online survey by Pain News Network and the International Pain Foundation (IPain). The survey findings -- supported by the comments and experiences of hundreds of pain patients -- amount to a stinging indictment of hospital pain care in the United States.

It’s not uncommon for pain patients to suffer from a variety of chronic conditions and diseases, and many told us they've been hospitalized several times. 

Asked to rate the overall quality of their medical care in hospitals, pain patients were fairly even-handed in their ratings. About a third said it was good or very good, 37% said it was fair and 29% said it was poor or very poor.

But some said they were so badly treated and traumatized by the experience, they’re afraid to go back.

“It's so bad that I will not seek treatment in an ER or hospital unless I really feel like my life is in jeopardy. They do not get it, they do not listen, and they do not care,” is how one pain patient put it.

“I refuse to go to ER. It will end up killing me because I know how sick I am, but I would rather die than deal with ignorant, condescending doctors and nurses,” wrote another.

HOW WOULD YOU RATE THE OVERALL QUALITY OF YOUR MEDICAL CARE IN HOSPITALS?

Several healthcare providers also wrote to us, admitting pain patients were often treated poorly.

"Many of my colleagues would refuse to medicate patients in pain, especially women in pain. They had many misconceptions that women were attention seeking, or exaggerating their pain. They also believed that even short term opioid therapy would 'create' addiction," wrote a nurse.

"I am a nurse anesthetist as well as a patient with fibromyalgia and severe arthritis," said another nurse. "The USA does a horrible job treating chronic pain. Too many suffer and too many commit suicide because of this."

When asked to rate only the quality of their pain treatment, the survey results were decidedly negative. Over 52% said their pain treatment in hospitals was poor or very poor, 25% rated it fair, and only 23% said it was good or very good.

Many patients complained that their pain went untreated or under-treated, even though pain was usually the primary reason they were admitted to a hospital. 

“I was at the ER once crying because I was in so much pain and I had a nurse tell me to shut up and cut the act. Never been treated so inhumanely,” said one pain patient.

“I've had to fight for proper pain management every time I've been in a hospital in the last 10 years. The DEA created this problem and the CDC is only reinforcing it. It's a travesty,” wrote another.

HOW WOULD YOU RATE THE QUALITY OF YOUR PAIN TREATMENT IN HOSPITALS?

“If I were an animal and was treated the way I was after surgery my owner would have been arrested for cruelty to an animal. As a human being, don't I deserve to be treated at least as well as an animal?” asked another pain sufferer.

"I've stopped going to hospitals even if I feel I'm having another stroke or heart attack, due to the horrific lack of pain control," wrote a patient who has multiple autoimmune diseases. "I'd rather die than be judged or be left writhing in pain."

"Pain is under-treated and at times downright ignored. I believe that this is leading to the cause of chronic pain in some patients," wrote another patient.

There is some evidence to support the claim that untreated or under-treated acute pain can turn into chronic pain. A study published in the Lancet warned that “an alarmingly high number of patients develop chronic pain after routine surgery.”

Yet when pain patients were asked in our survey if their pain was adequately controlled after surgery or treatment in a hospital, nearly two-thirds (64%) said no and only 34% said yes. 

“There is research demonstrating that the intensity of acute postoperative pain correlates with the risk of going on to develop chronic pain. This suggests that aggressive early therapy for postoperative pain is critical for preventing the pain from turning chronic,” says Cindy Steinberg, National Director of Policy and Advocacy for the U.S. Pain Foundation.

IF YOU EXPERIENCED PAIN AFTER A SURGERY OR TREATMENT IN A HOSPITAL, WAS IT ADEQUATELY CONTROLLED?

“Minimizing and deemphasizing the focus on controlling acute pain in hospital settings is likely going to set us up for potentially dramatic increases in the number of Americans with long term chronic pain.”

By treating acute pain so poorly, could our hospitals and emergency rooms be mass-producing future chronic pain patients?

And, if so, what can be done to stop it?

One solution – overwhelmingly supported by respondents to our survey – is better education in pain management for doctors, nurses and other healthcare providers.

Asked if they feel hospital staff are adequately train in pain management, nearly 83% of pain patients said no and just 9% said yes.  

“All staff should be educated and able to understand the difference between opioid dependency and opioid abuse," wrote one pain patient. "Over the last decade I have witnessed the quality of care for pain management plummet, and I have also observed increased chronic mistreatment of pain patients.”

"I am a nurse. Anyone who has chronic pain is labeled automatically as a drug seeker. The under-education about chronic pain is alarming. The way truthful patients are treated is just deplorable," wrote another pain sufferer.

OVERALL, DO YOU FEEL HOSPITAL STAFF ARE ADEQUATELY TRAINED IN PAIN MANAGEMENT?

"I think that hospital staff members are trained to be afraid of pain patients. They know what is necessary to treat pain, even chronic pain, but the fear that is instilled in them by oversight committees, the DEA, and Congress that all opiod pain prescriptions lead to drug addiction has led them to be afraid of treating pain patients. Education is the key," wrote another pain sufferer.

“In my 20+ years of having CRPS (Chronic Regional Pain Syndrome), I have never been to an ER where the staff even knew what it was,” wrote one of several readers who lamented that doctors and nurses are often ignorant about CRPS and RSD (Reflex Sympathetic Dystrophy).

“I have experienced this myself. The nurses didn’t understand my pain conditions and how my body reacted. They didn’t understand that I had additional needs," said Barby Ingle, president of IPain, who suffers from RSD. "I have recently had a provider ask, 'Does it really hurt that bad?' while doing a procedure on me under local anesthesia. I was screaming, crying, and moving so much that a normal patient gets 7 anesthetic shots. For me it took 28 and those were extremely painful.

“For a pain patient to go to a hospital for pain care and still have their pain unaddressed, under-treated, or misunderstood is clear evidence that we need better education for hospital staff."

The lack of pain education in medical schools is not new. A 2012 study published in the Journal of Pain  called pain education "lackluster" in the U.S. and Canada. The study of 117 medical schools found that less than 4% required a course in pain education and many did not have any pain courses.

Despite that, opioid prescribing guidelines released this month by the Centers for Disease Control and Prevention only briefly mention the agency will "work with partners to support clinician education" and even that vague promise is only focused on reducing opioid use. The same is true for the Food and Drug Administration, which recently announced several sweeping changes in its opioid policies, none of which address physician education.  

Only the recently adopted National Pain Strategy (NPS) acknowledges that "most health care professions’ education programs devote little time to education and training about pain and pain care," and suggests several ways to improve them.  But it's unclear how the NPS will ever be implemented, since it has no budget and relies on major policy changes involving medical schools, accreditation groups,  healthcare providers, and regulatory agencies. 

"I think it’s true that many hospital providers are poorly educated about pain management, and, especially if the patient’s condition is complex, understanding what is going on and finding a good solution can be very challenging,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management, who believes providers need more empathy, as well as education.

"In my experience, I found that hospitalized patients were much more satisfied if they just felt like someone understood them and their pain, expressed a sense of caring, and made a strong effort to help. For those patients, even if you weren’t able to get their pain controlled for a little while, they really appreciated the fact that someone believed them and was trying to help. Sometimes, it’s as much about caring for the person with pain as it is treating the person with pain."

To see the complete survey results, click here.

New Anti-Opioid Campaigns Launched

By Pat Anson, Editor

Two provocative anti-opioid campaigns were launched this week -- one aimed at educating parents and the other warning physicians about the risks associated with opioid pain medications.

A report by the National Safety Council claims that 99 percent of doctors are prescribing opioid pain medication longer than the three-day period recommended by the Centers for Disease Control and Prevention. Nearly a quarter (23%) of the doctors surveyed said they prescribe at least a month's worth of opioids to their patients.  

Guidelines for primary care physicians released last week by the CDC state that three days or less supply of opioids “often will be sufficient” for acute pain caused by trauma or surgery, and that 7 days supply “will rarely be needed.”

The small survey of 201 family medicine and internal medicine physicians by the National Safety Council (NSC) did not distinguish between acute and chronic pain in their questions, making the findings somewhat misleading.

“For what period of time do you ordinarily prescribe opioid pain medication?” is what the doctors were asked.

Acute pain was the most common reason (87%) opioids were prescribed, but doctors said they prescribe opioid pain medication for many other conditions that the NSC considers inappropriate, including:

• 72% Chronic back pain
• 63% Chronic joint pain
• 55% Dental pain
• 55% Neuropathic pain
• 32% Fibromyalgia
• 28% Chronic headaches

The NSC’s report on the survey findings also claim that acetaminophen and ibuprofen are far more effective at providing pain relief than opioids and that doctors “overestimate the efficacy of opioids and underestimate the impact of safer alternatives.”

"Opioids do not kill pain; they kill people," said Donald Teater, MD, medical advisor for the National Safety Council. "Doctors are well-intentioned and want to help their patients, but these findings are further proof that we need more education and training if we want to treat pain most effectively."

The NSC survey also found that 99% of the doctors “have seen patients with pill-seeking behavior or evidence of drug abuse,” but handled the situation in very different ways:

• 44% Continued to treat the patient, but without opioids
• 38% Referred patient to addiction treatment
• 10% “Fired” the patient
•    5% Treated patient for addiction themselves
•    1% Refilled the opioid prescription
•    1% Never had a patient abuse opioids

Nearly 90% of doctors said it was difficult or very difficult to refer a patient for addiction treatment. Most blamed their patients, saying they were unwilling or uncooperative. Lack of insurance for addiction treatments and long waiting lists were two other reasons often cited.

The National Safety Council is a nonprofit organization focused on preventing injuries and deaths. It is funded largely through corporate donations and the insurance industry. The NSC has long had an aggressive campaign against opioids and claims they are the root cause of the prescription drug overdose epidemic.

“Opioids are being overprescribed. And it is not children reaching in medicine cabinets who have made drug poisoning the #1 cause of unintentional death in the United States. Adults have been prescribed opioids by doctors and subsequently become addicted or move from pills to heroin,” the NSC says on its website.

"Would you give your child heroin?"

Linking opioid pain medication to heroin is the focus of an advertising campaign launched this week, called "You Decide Before They Prescribe."

Created by the Partnership for a Drug-Free New Jersey, the campaign encourages parents to tell their doctors to prescribe alternative pain medications instead of opioids to their children.

“Would you give your child HEROIN to remove a wisdom tooth?” asks a new billboard unveiled in New York’s Times Square. "Ask your dentist how prescription drugs can lead to heroin abuse."

Similar ads will appear on trains and buses in New Jersey, and the organization eventually hopes the campaign will spread nationwide.

"40% of New Jersey parents still walk into a physician's office not understanding the link between prescription pain medicine and heroin – that opioids are a synthetic version of heroin," said Angelo Valente, Executive Director of Partnership for a Drug-Free New Jersey.

“The majority of New Jersey parents strongly agree that physicians should be legally required to discuss the risk of developing either a physical or psychological dependency on the prescription pain medication with patients prior to prescribing it." 

PARTNERSHIP FOR DRUG-FREE NEW JERSEY

Montana Doctor to Seek ‘Medical Asylum’

By Pat Anson, Editor

A doctor whose license was suspended indefinitely by the Montana Board of Medical Examiners for over-prescribing opioids plans to seek “medical asylum” in other states or even overseas.

The Montana medical board issued its 80-page final order suspending Dr. Mark Ibsen’s license on Tuesday, the latest chapter in a three year investigation into Ibsen’s opioid prescribing practices. Ibsen was accused of over-prescribing pain medication to nine patients and keeping inadequate medical records on them, even though investigators did not cite a single case where Ibsen’s practices led to someone’s death or injury. Ibsen disputes the charges and will file an appeal.

(Update: District Court Judge James P. Reynolds on Thursday issued a temporary restraining order that prohibits the Montana Board of Medical Examiners from suspending Ibsen's license for 30 days.)

“I was kind of hoping for a Hail Mary. I was hoping they’d come to their senses, but they didn’t,” Ibsen said.

The board left the door open for Ibsen to someday get his license reinstated if he takes a class on medical record keeping and is under the supervision of another physician. Ibsen says the terms for reinstatement are “impossibly vague” and impractical, but he doesn’t intend to give up medicine.

“I’ll go wherever I can get a license. I’m considering myself a medical refugee and I’m seeking medical asylum, whether it’s in New Zealand or Australia or Canada or one of the United States,” he told Pain News Network.

In May, Ibsen plans to go to India and do volunteer work.

dr. mark ibsen

“I do have an agreement to travel with a mission to northern India in Zanskar province, with a group that’s going to help the Dali Lama open up a hospital there,” he said. “I’m going be bringing an ultrasound for them, hopefully train them how to use it, and I’m going to screen kids for congenital heart disease and rheumatic heart disease. There’s a lot of strep infections in that area. And I’ll be doing general medicine.”

Ibsen said he last visited India in 1989 and is not worried about needing a license to practice medicine there.

“I’ll treat the underserved and people who don’t get care anyway. The Indian government is not at the level of regulating licenses of volunteers,” he said.

Ibsen was one of the last doctors in Montana willing to prescribe opioids to new patients and became something of a folk hero in the pain community, treating patients that other doctors had abandoned.

In December, financial problems forced Ibsen to close his Urgent Care Plus clinic in Helena. Since then, various efforts to reopen it under new management have fallen through. Ibsen is not sure what will become of the clinic.

“Right now the business is dead and rotting,” he said.

FDA Orders Stronger Warning Labels for Opioids

By Pat Anson, Editor

The U.S. Food and Drug Administration is strengthening the warning labels on the nation’s most widely used opioid painkillers. The FDA is adding a “black box” warning to immediate release (IR) opioid pain medications, such as hydrocodone and oxycodone, stating that they pose serious risks of misuse, abuse, addiction, overdose and death.

The FDA will also require additional safety labeling changes on all other opioid medications, warning they can interact with antidepressants and migraine medications, or cause impotence and infertility.

The actions are the latest in a series of steps taken by the Obama administration to combat the so-called epidemic of opioid abuse and addiction by reining in the use of opioid pain medications. Last week the Centers for Disease Control and Prevention released new guidelines that discourage primary care physicians from prescribing opioids for chronic pain,

The updated warning will state that IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (non-opioid analgesics or opioid combination products) are inadequate or not tolerated. Dosing information will also provide clearer instructions about the initial recommended dosage, dosage changes during therapy, and a warning not to abruptly stop treatment in a physically dependent patient.

A sample of the new black box warning label can be seen here:

"Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” said Robert Califf, MD, FDA commissioner.

“Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”

Califf, a cardiologist who was recently confirmed by the U.S. Senate, has also pledged to prioritize development of non-opioid alternatives for pain and to convene an expert advisory committee before approving any new drug applications for opioids that do not have abuse deterrent properties. 

In 2013, the FDA ordered labeling changes only for extended release opioids, a move that angered some politicians and addiction treatment specialists, who wanted stronger warning labels on all opioids. At the time, the agency said there was not enough evidence to support stronger warnings for IR opioids, which are intended for use every four to six hours.

Today’s action sweeps that earlier objection away.

“The broad set of actions announced today is reflective of the FDA’s efforts to improve informed prescribing of opioids across the board,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, who opposed IR labeling changes three years ago.

“We have been and will continue to evaluate all new data to ensure that labels of opioid drugs contain appropriate prescribing information about the benefits and risks of prescription opioids,” she said.

As part of the new boxed warning on IR opioids, the FDA will requires a statement that chronic use of opioids by pregnant women could result in neonatal opioid withdrawal syndrome (NOWS), which may occur in a newborn exposed to opioids for a prolonged period while in utero.

“We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with IR opioid products,” said Douglas Throckmorton, M.D., deputy center director of regulatory programs, FDA’s Center for Drug Evaluation and Research.

Last week, the head of the American College of Obstetricians and Gynecologists (ACOG), disputed that claim in a response to the CDC guidelines, saying they overstated the risk to pregnant women and newborns.

“Neonatal abstinence syndrome is the most established risk to newborns from use of opioids in pregnancy, but it is expected and treatable, and does not appear to pose permanent risks to the neonate,” said ACOG president Mark DeFrancesco, MD.

“However, evidence shows that withdrawal from opioid use during pregnancy may be associated with complications including fetal demise.  While some studies have suggested an association between birth defects and other adverse outcomes with opioid use in pregnancy, the absolute risk of these problems is low and data demonstrating a causal connection are lacking.”

Sen. Edward Markey (D-Mass) applauded the label changes by the FDA, but said they should have come sooner.

“Today’s announced changes to the labels of opioid products will finally reflect what we have known about these drugs for decades - they are dangerous and addictive and can lead to dependency, overdose and death,” said Markey in a statement. “Whether it's immediate or extended release, or abuse-deterrent, the labels given by the FDA have done little to prevent opioid addiction. Unfortunately, it has taken FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone.”

Markey said the FDA also needs to convene an external advisory committee whenever it considers a new opioid for approval, something Califf has promised to do.

Doctors Have Mixed Reaction to CDC Guidelines

By Pat Anson, Editor

Although generally supportive of the CDC’s new opioid prescribing guidelines, some doctors are worried that patients who need opioid pain medications may lose access to them.

The voluntary guidelines, which discourage the prescribing of opioids for chronic pain, are intended for primary care physicians, but are widely expected to have a ripple effect throughout the healthcare system and on anyone who prescribes opioids.

"If these guidelines help reduce the deaths resulting from opioids, they will prove to be valuable. If they produce unintended consequences, we will need to mitigate them. They are not the final word," said Patrice Harris, MD, the board chair-elect of the American Medical Association, the nation’s largest medical group.

Like many other medical organizations that submitted public comments on the CDC guidelines, the AMA said it had concerns about the poor quality of scientific evidence supporting several of the recommendations. But the dozen guidelines are largely unchanged from a draft version that was released last September.

“We remain concerned about the evidence base informing some of the recommendations; conflicts with existing state laws and product labeling; and possible unintended consequences associated with implementation, which includes access and insurance coverage limitations for non-pharmacologic treatments, especially comprehensive care; and the potential effects of strict dosage and duration limits on patient care,” said Harris, who chairs the AMA Task Force to Reduce Opioid Abuse.

The lack of clinical evidence was also pointed out by other physicians.

 “There are few well-controlled clinical studies on opioid-prescribing methods for chronic pain. While the guidelines will be updated as new data become available, concerns may be raised that appropriate access to opioids could be negatively affected by federal guidelines based on admittedly weak data,”  wrote William Renthal, MD, of the Department of Neurology at Brigham and Women’s Hospital in an editorial in JAMA Neurology.

The head of the American College of Obstetricians and Gynecologists (ACOG) said he was concerned the guidelines overstate the risks of opioids for women during pregnancy and after labor.

“ACOG agrees with the CDC that opioid should only be used for treatment of pain when alternatives are not appropriate or effective, but we also know that there are times, including during pregnancy and the postpartum period, when such use is both appropriate and safer than the alternative,” wrote ACOG president Mark DeFrancesco, MD. “Opioids may be needed to treat acute pain such as from cesarean delivery, kidney stones, sickle cell crisis or trauma in pregnancy, or as part of an established plan to treat problems associated with substance use disorders.”

DeFrancesco said the risk of birth defects and other problems caused by opioids was low and research demonstrating a connection was lacking.

“We are concerned that some of the CDC's patient education communications regarding use of opioids during pregnancy could discourage women from needed, appropriate care by overstating the risk of rare complications associated with opioid use during pregnancy and by understating the potential risk associated with opioid discontinuation, “ he said.

Two pediatric physicians are concerned the guidelines are only intended for patients 18 and older and do not address pain or opioid use by children.

“Unfortunately, the exclusion of children from the national discussion on pain is not new,” wrote Neil Schechter, MD, of Boston Children’s Hospital and Gary Walco, PhD, of Seattle Children’s Hospital in an editorial in JAMA Pediatrics. “Data clearly show that poorly treated pain in the young has deleterious long-term consequences on the development of pain systems and related responses, as well as psychological well-being. Furthermore, the long-term impact of pain on a developing organism may be quite different than on an adult and may suggest more aggressive, or at least different, interventions.”

Schechter and Walco urged the CDC to provide ”an explicit and definitive statement that this guideline should not be applied to those younger than 18 years of age for fear of untoward consequences.”

The Alliance for Balanced Pain Management (AfBPM), a coalition of patient groups and professional societies, said it was concerned about opioid dosing limits and the CDC recommendation that three days or less supply of opioids “often will be sufficient” to treat acute pain from surgery or trauma.

“When the CDC suggests the exact number of days and the precise dosing limit, the agency may be inserting itself too far, interfering with physician care of patients who live day to day with serious pain,” said Brian Kennedy, Alliance for Patient Access and a member of the AfBPM Steering Committee. “These guidelines mark a milestone in the national conversation about how we treat pain, both chronic and acute. Multimodal approaches to pain treatment make use of non-opioid treatments and have tremendous value for patients, but we shouldn’t tie physicians’ hands when it comes to treatment options.”

 “The data will never be perfect. The measures will never be perfect. The guidelines will never be perfect. And neither will clinicians and their performance,” wrote Thomas Lee, MD, of Press Ganey and Harvard Medical School in a JAMA editorial. “But by acknowledging these imperfections and trying to get better with the tools available, physicians can more effectively reduce the suffering of patients.”

1 in 6 Seniors Take Risky Drug Combinations

By Pat Anson, Editor

One in six older adults now regularly use potentially deadly combinations of prescription drugs, over-the-counter (OTC) medications and supplements, a two-fold increase over a five-year period, according to new research published in JAMA Internal Medicine.

Researchers at the University of Illinois at Chicago surveyed over 2,200 Americans between the ages of 62 and 85 and found that over half (54%) were taking some type of pain reliever in 2011.

Over 40 percent used aspirin; nearly 14% took non-steroidal anti-inflammatory drugs (NSAIDs); and about 11% used an opioid analgesic.

Only 44% were using a pain reliever in 2006.

Researchers identified 15 potentially life-threatening drug combinations of the most commonly used medications and supplements. Statins, anti-platelet drugs such as aspirin, and supplements (specifically omega-3 fish oil) accounted for the vast majority of interacting drug medications, some of which worsen cardiovascular problems. Opioids were not listed among the 15 risky combinations.

Nearly 15% of older adults regularly used at least one of the dangerous drug combinations in 2011, compared to 8% five years earlier.

"The risk seems to be growing, and public awareness is lacking," said Dima Mazen Qato, an assistant professor of pharmacy systems at the University of Illinois.

"Many older patients seeking to improve their cardiovascular health are also regularly using interacting drug combinations that may worsen cardiovascular risk. For example, the use of clopidogrel in combination with the proton-pump inhibitor omeprazole, aspirin, or naproxen -- all over-the-counter medications -- is associated with an increased risk of heart attacks, bleeding complications, or death.”

As Pain News Network reported, European researchers also warned last week that aspirin and some types of NSAID’s could be harmful to patients with heart or kidney problems. The researchers said NSAIDs, in particular, raise cardiovascular risk and there is no "solid evidence" the drugs are safe.

"When doctors issue prescriptions for NSAIDs, they must in each individual case carry out a thorough assessment of the risk of heart complications and bleeding. NSAIDs should only be sold over the counter when it comes with an adequate warning about the associated cardiovascular risks,” said Christian Torp-Pedersen, a professor in cardiology at Aalborg University in Denmark.

In opioid prescribing guidelines released last week, the Centers for Disease Control and Prevention recommends "nonopioid pharmacologic therapy" such as acetaminophen and NSAIDs as the "preferred" treatments for chronic pain. Only briefly do the CDC guidelines even mention that NSAIDs have been associated with cardiovascular risks or that acetaminophen may cause liver failure. Instead, the 52-page guideline focuses on the risks of opioid addiction and abuse.

Over half of the risky drug combinations in the University of Illinois study involved over-the-counter medications or dietary supplements.

Feds Quietly Release National Pain Strategy

By Pat Anson, Editor

The U.S. Department of Health and Human Services (HHS) on Friday quietly released the National Pain Strategy, a comprehensive and ambitious “roadmap” to improve the quality of pain care in the United States. The 83-page report was overshadowed by the opioid prescribing guidelines released by the Centers for Disease Control and Prevention just a few days earlier.

Development of the National Pain Strategy (NPS) began over five years ago after the Institute of Medicine released a report calling for a “cultural transformation” in pain care, prevention, research, and education. Although the NPS was being closely watched by researchers, academics, regulators and professional societies, many long-suffering pain patients will be surprised to hear the U.S. even has a national pain strategy.

The Department of Health and Human Services (HHS) did little to publicize the NPS, issuing a single news release that wasn’t even posted on its own website 24 hours later.  There was no press briefing for reporters to explain why the NPS was developed or what its objectives are.

The announcement wasn't even made by HHS Secretary Sylvia Mathews Burwell, but by a lower ranking aide.

“Chronic pain is a significant public health problem, affecting millions of Americans and incurring significant economic costs to our society,”  Karen DeSalvo, MD, acting assistant secretary for health at HHS, said in the news release. “This report identifies the key steps we can take to improve how we prevent, assess and treat pain in this country.”

The major goals of the NPS are:

• Develop new methods to prevent and manage pain.
• Improve pain education of physicians
• Develop “integrated, interdisciplinary, patient-centered” pain management teams
• Provide better insurance coverage of pain treatment options
• Reduce barriers to pain care, especially for stigmatized and underserved populations.
• Increase public awareness and patient knowledge of treatment options and risks

The 800-pound gorilla of pain management – opioid pain medicine – is only briefly mentioned in the NPS, and not in a positive way.

“Evidence suggests that wide variations in clinical practices, inadequate tailoring of pain therapies to individuals, and reliance on relatively ineffective and potentially high risk treatments such as inappropriate prescribing of opioid analgesics, or certain surgical interventions, not only contribute to poor quality care for people with pain, but also increase health care costs,” the report says.

“Treatments that are ineffective, whose risks exceed their benefits, or that may cause harm for certain subgroups need to be identified and their use curtailed or discontinued.”

“We need to ensure that people with pain get appropriate care and that means defining how we can best manage pain care in this country,” said Linda Porter, PhD, director of the National Institute of Health’s Office of Pain Policy and co-chair of an interagency committee that helped develop the report.

“To achieve the goals in this report, we will need everyone working together to create the cultural transformation in pain prevention, care and education that is desperately needed by the American public,” said Sean Mackey, MD, who heads the Division of Pain Medicine at Stanford University and is co-chair of the interagency committee.

Still unclear is how the NPS will ever be implemented, since it relies on major policy changes and coordinated action involving medical schools, healthcare providers, insurers, government agencies, Congress and the White House. No estimate is provided on how much it will cost or where funding will come from.

“The NPS is riddled with vague terms and objectives -- which render the whole effort too subject to interpretation,” says David Becker, a patient advocate and author of “Quotes on Pain.” “I find it fascinating that despite the outcry from individuals regarding very specific concerns and problems, they are intent on imposing population based public health solutions on individuals. They can’t see the trees for the forest. And their plan is to help some nameless faceless pain sufferers with a very homogenized approach.

“The whole report reminds me of a Seinfeld episode when he says his show is all about nothing. The NPS is about some vague objectives -- even though the underlying philosophy, politics, privileges -- are only too clear. I guess those privileged pain specialists just don’t wish to be pinned down too much about what their pig in the poke is all about.”

The NPS was quickly endorsed by the American Pain Society (APS), a professional group that focuses on pain research.

“The National Pain Strategy gives the nation a blueprint for aggressive action to expand access to effective pain care,” said APS President Gregory Terman, MD. “Pain is a serious and often neglected public health problem that is draining our health care resources. It is responsible for inestimable lost wages, impaired worker productivity, and extracts a tragic personal toll on patients and their families.”  

Terman and several other APS members were involved in drafting the National Pain Strategy, as well as the CDC’s opioid prescribing guidelines.

“We believe several high impact policy initiatives will emerge from implementation of the National Pain Strategy, especially in helping primary-care physicians, who see that vast majority of pain patients, become more knowledgeable about pain mechanisms, pain assessment, and safe use of analgesic medications,” Terman said.

CDC Guidelines Urge Doctors Not to Test for Marijuana

By Pat Anson, Editor

One of the less publicized provisions in the Centers for Disease Control and Prevention’s opioid prescribing guidelines is a recommendation that doctors stop urine drug testing of patients for tetrahyrdocannabinol (THC), the psychoactive ingredient that causes the “high” for some marijuana users. The guidelines also discourage doctors from dropping patients if marijuana is detected.

Urine drug screens are conducted almost routinely by pain management physicians and other opioid prescribers for a variety of drugs, both legal and illegal.

Some doctors use a positive result for THC as an excuse to discharge patients from their practices, even in states where medical marijuana is legal.

While the CDC guidelines encourage physicians to conduct urine drug tests before starting opioid therapy and at least annually afterwards, they draw the line at THC.

“Clinicians should not test for substances for which results would not affect patient management or for which implications for patient management are unclear. For example, experts noted that there might be uncertainty about the clinical implications of a positive urine drug test for tetrahyrdocannabinol (THC).” the guidelines state.

"Clinicians should not dismiss patients from care based on a urine drug test result because this could constitute patient abandonment and could have adverse consequences for patient safety, potentially including the patient obtaining opioids from alternative sources and the clinician missing opportunities to facilitate treatment for substance use disorder."

As Pain News Network has reported, “point-of care” (POC) urine drug tests, the kind widely used in doctor’s offices, frequently giving false positive or false negative results for drugs like marijuana, oxycodone and methadone. One study found that 21% of POC tests for marijuana produced a false positive result. The test was also wrong 21% of the time when marijuana is not detected in a urine sample.

Not mentioned in the CDC guidelines is evidence that opioid overdose rates declined by nearly 25 percent in states where medical marijuana was legalized.

"We applaud the CDC's reasoned approach to the use of urine testing and its drawbacks when used on pain patients," said Ellen Komp, Deputy Director of California NORML. "Considering that opioid overdose deaths are significantly lower in states with medical marijuana programs, we are sorry the agency apparently didn't read the letter Elizabeth Warren recently sent to its chief calling for marijuana legalization as a means of dealing with the problem of opiate overdose."

That letter by Sen. Warren encouraged the CDC to adopt the guidelines and its restrictive approach to opioids “as soon as possible,” but also encouraged the agency to further study the impact legalization of medical and recreational marijuana could have on opioid overdose deaths.

The annual cost of drug testing in pain management is estimated at $2 billion per year. While POC tests are relatively cheap, more expensive laboratory testing can cost thousands of dollars and is often not covered by insurance.