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 Say Non-Opioid Therapies Often Don’t Work

By Pat Anson, Editor

Pain treatments recommended by the Centers for Disease Control and Prevention (CDC) as alternatives to opioids often do not work and are usually not covered by insurance, according to a large survey of pain patients.  Many also believe the CDC’s opioid prescribing guidelines discriminate against pain patients.

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. Most said they currently take an opioid pain medication.

When asked if they think pain patients are being discriminated against by the CDC guidelines and other government regulations, 95% said they “agree” or “strongly agree.”  Only 2% said they disagree or strongly disagree.

The draft guidelines released last month by the CDC 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 patients in acute or chronic pain.  A complete list of the guidelines can be found here.

“Many non-pharmacologic therapies, including exercise therapy, weight loss, and psychological therapies such as CBT (cognitive behavioral therapy) can ameliorate chronic pain," the CDC states in internal briefing documents obtain by PNN.

DO THE CDC GUIDELINES AND OTHER GOVERNMENT REGULATIONS DISCRIMINATE AGAINST PAIN PATIENTS?

“Several nonopioid pharmacologic therapies (including acetaminophen, NSAIDs, and selected antidepressants and anticonvulsants) are effective for chronic pain. In particular, acetaminophen and NSAIDs can be useful for arthritis and low back pain, and antidepressants such as tricyclics and SNRIs as well as selected anticonvulsants are effective in neuropathic pain conditions and in fibromyalgia.”

Most patients who were surveyed said they had already tried many of these non-opioid treatments and had mixed results, at best.

“Does the CDC really believe that a pain patient on long term opiates hasn't already tried everything else possible?” asked one patient.

“The CDC says don't do something but comes up with NO viable, realistic alternatives. Tylenol, etc., are unrealistic. Exercise is unrealistic when you are in too much pain to move! “ said another patient.

“Anti-anxiety meds are just as addictive. Over the counter pain medicines are not strong enough to cover the pain in a patient with chronic pain. And there are hundreds of pain patients who can't take NSAIDs because of an allergic reaction. Same thing with steroids,” wrote another.

When asked if exercise, weight loss or cognitive behavioral therapy had helped relieve their pain, only about a third of the patients surveyed said they “helped a lot” or “helped a little.” Nearly two-thirds said they “did not help at all.”

Over half said non-opioid medications such as Lyrica, Cymbalta, Neurontin, anti-depressants and anti-anxiety medications “did not help at all.”

Over the counter pain relievers such as acetaminophen and NSAIDs were even less helpful. Three out of four patients said they “did not help at all.”

“We must be mindful of the treatment options that the CDC guidelines stress over opioids,” said Barby Ingle, president of the Power of Pain Foundation. “For instance in my case, taking NSAIDS for an extended period (a little over 1 year) caused internal bleeding and ulcers which lead to being hospitalized, a surgical procedure, and months of home nursing and physical therapy that could have been avoided.

HAVE EXERCISE, WEIGHT LOSS, OR COGNITIVE BEHAVIORAL THERAPY HELPED RELIEVE YOUR PAIN?

“It is important to include a multi-disciplinary approach to care. We have to use non-pharmacological treatments and non-opioid medications in conjunction with more traditional treatments. Using chiropractic care, nutrition, good dental health, better posture, meditation, aqua therapy, etc., can go a long way in the management of chronic pain conditions.”

But the survey found that many of those treatments are simply out of reach for pain patients because they’re not covered by insurance.

When asked if their health insurance covered non-pharmacological treatments such as acupuncture, massage and chiropractic therapy, only 7% said their insurance covered most or all of those therapies.

About a third said their insurance “covers only some and for a limited number of treatments” and over half said their insurance does not cover those treatments. About 4% do not have health insurance.   

“I tried acupuncture and massage, paying out of my pocket, but neither helped. In fact, they hurt. I tried Lyrica, Savella, and Cymbalta. No luck. I do warm water aerobics three days a week WHEN I CAN TAKE MY OPIATES FIRST,” wrote one patient.

Although the CDC didn’t even raise the subject of medical marijuana in its guidelines, many patients volunteered that they were using marijuana for pain relief and that it worked for them.

DOES YOU INSURANCE COVER ALTERNATIVE TREATMENTS SUCH AS ACUPUNCTURE, MASSAGE AND CHIROPRACTIC THERAPY?

“Alternative medicine is needed. I am a huge advocate of medicinal marijuana, in addition to opioids to treat my disease,” wrote a patient who suffers from CRPS (Chronic Regional Pain Syndrome).

“If cannabis was legal and accessible, it would greatly lessen the need for prescription pain medication,” said another patient.

“I should be able to get the proper medical marijuana legally. I have tried it from a friend and it helps tremendously. However, I will not purchase it because it is illegal. I pray every day I can get it someday,” said a patient who suffers from lupus, arthritis and other chronic conditions.

The survey found patients were evenly divided on whether they should be required to submit to urine drugs tests for both prescribed medications and illegal drugs.

"In order to receive my monthly pain medication, I must submit to a urine screen and a pill count each and every month. I must (whether they work or not) agree to have steroid injections every few months. While I don't have any problem to submitting to urine screenings or pill counts, I do not like having injections that provide no help. I am trapped playing this game,” said a patient.

“99.9% of pain patients are responsible adults but are treated like toddlers who need constant supervision. Pain patients are sicker, fatter, and poorer because they are pumped full of chemicals and steroids. Forced to be experimental guinea pigs or forced to suffer if they say NO,” said another patient.

DO YOU THINK PATIENTS PRESCRIBED OPIOIDS SHOULD BE REQUIRED TO HAVE URINE DRUG TESTS?

"As both a chronic pain patient and a provider I get to view this issue from multiple perspectives. Of course opioids aren't the first line treatment for chronic pain, and when they are used they shouldn't be the only treatment. They are one part of a larger toolkit for managing chronic pain," wrote a registered nurse practitioner.

"There are many fortunate people who are able to manage their pain without medication, or even recover from pain completely using some of the wonderful new interventions we now have available. But there are large numbers of patients out there who have tried all the other medications and dietary changes and injections and PT (physical therapy) modalities and mindfulness. And they are still left with pain that only responds to opiates."

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.

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.

CDC’s Prescribing Guidelines and the ‘Cone of Silence’

By Stephen Ziegler, PhD, Guest Columnist

A recent effort by the Centers for Disease Control and Prevention (CDC) to reduce prescription drug overdose may actually lead to increases in pain, injury, and death from opioids by over-relying on the use of dosage levels in prescribing policies.  

Last month, in a webinar that reminded me of Get Smart’s "Cone of Silence", the CDC introduced draft guidelines for the prescribing of opioid pain medication.

The actual guidelines themselves were not made available in advance, nor do they appear on the CDC website.

However, attendees fortunate enough to successfully log into the webinar could hear the guidelines read to them by the CDC (and perhaps see the guidelines if the technology was working).

While the secrecy associated with the release of the draft guidelines raises several concerns, so do the guidelines themselves, especially the guideline relating to dosage which states: “Providers should implement additional precautions when increasing dosage to 50 or greater milligrams per day in morphine equivalents and should avoid increasing dosages to 90 or greater milligrams per day in morphine equivalents.”

Although dosage is a legitimate concern, there are a myriad of problems associated with the adoption of arbitrary dosage thresholds in prescribing guidelines. In fact, the CDC is not alone; many states throughout the U.S. continue to adopt a variety of dosage thresholds that, once reached, will trigger specific actions or recommendations.

And while those subsequent recommendations or actions may be consistent with good medical practice, the use of arbitrary dosage triggers are problematic because:  1) there may be good reasons for not waiting until a daily dose is reached before taking certain actions; 2) there is no direct cause and effect relationship between dosage and overdose in legitimate pain treatment; 3) converting to morphine equivalency is an error-prone process that can lead to over-dosing, under-dosing, and even under-treated pain; 4) arbitrary dosage thresholds fail to consider individual patient characteristics; 5) many prescribers may consider the threshold a ceiling and will seek to avoid approaching it to avoid regulatory scrutiny and thereby under-medicate and under-treat pain; and, 6) poly-pharmacy and poly-substance abuse, not dosage standing alone, plays a far more significant role in unintentional overdose.

In the October issue of Pain Medicine, I discuss these and other concerns regarding the proliferation of dosage thresholds across the United States and their potential to increase pain and opioid-related mortality.

Prescription drug overdose is a local and national problem, but so too is the under-treatment of pain. While the CDC has paid a lot of attention to preventing prescription drug overdose, they also need to start paying attention to the other epidemic: the 100 million Americans who are impacted by chronic, long-term pain. What we need are balanced approaches, and any prescribing guideline that is veiled in secrecy, or fails to consider the unintended consequences on the treatment of pain, has no place in clinical practice or public policy.

Stephen J. Ziegler, PhD, is an Associate Professor of Public Policy at Indiana University-Purdue University in Fort Wayne, Indiana. Dr. Ziegler conducts research, provides continuing medical education, and consults on the topics of opioid risk management and the impact of drug regulation and enforcement on the treatment of pain. He has been published in several peer reviewed journals and serves as a reviewer for several journals such as the Journal of Opioid Management, Pain Medicine, Cancer, and the Journal of Medical Ethics.

Prior to obtaining his law degree, Dr. Ziegler worked as a police detective and as a Task Force Officer for the U.S. Drug Enforcement Administration.

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.

Orthopedic Surgeons Advised to Limit Opioids

By Pat Anson, Editor

The American Academy of Orthopaedic Surgeons (AAOS) has joined the chorus of physician organizations calling for greater efforts to address the “growing opioid epidemic” in the U.S.

The AAOS Board of Directors has adopted an Information Statement on Opioid Use, Misuse and Abuse in Orthopaedic Practice that calls for limits on opioid prescribing and improved efforts to educate physicians, caregivers and patients about opioid misuse.

Orthopaedic surgeons are the third highest prescribers of opioids behind medical doctors and dentists, according to the AAOS.

"A culture change has created the current opioid epidemic, and only a culture change -- led by physicians unafraid to limit opioid prescriptions -- will solve the epidemic," said David Ring, MD, a member of the AAOS Patient Safety Committee. "It's up to us to treat pain with less dependence on opioids. This information statement outlines the steps and strategies to help get us there."

Among the recommendations:

Standardized opioid prescribing policies that set ranges for acceptable amounts and duration of opioids for various surgical and non-surgical conditions and procedures. Opioids should not be prescribed for pre-operative and non-surgical patients.

Patients at greater risk for opioid use, such as those with symptoms of depression and poor coping strategies, should be identified and treated for these conditions prior to elective surgery.  

Surgeons should practice empathetic and effective communication. Patients are more comfortable and use fewer opioids when they know their doctor cares about them.

Partnerships need to be established among hospitals, employers, patient groups, state medical and pharmacy boards, law enforcement agencies, pharmacy benefit managers, insurers and others to combat opioid abuse.

Improved opioid tracking. A single nationwide tracking system would allow surgeons and pharmacists to see all prescriptions filled by a given patient.  

Physicians should be stricter about prescribing opioids and monitor their effectiveness..

Health care providers must recognize that patients with terminal illnesses and “other appropriate conditions” should have access to opioids.

The recommendations also call for an “opioid culture change.”

“Making opioids the focus of pain management has created many unintended consequences that often put both patients and their families at increased risk of addiction and death. Peace of mind is the strongest pain reliever. Studies have found that opioids are associated with more pain and lower satisfaction with pain relief,” the AAOS guidelines state.

The AAOS represents over 40,000 physicians and health care providers in osteopathic and orthepaedic medicine. It is one of 27 physician organizations that have joined the American Medical Association’s Task Force to Reduce Opioid Abuse.

Opioid Abuse Down; Deaths Up in U.S.

By Pat Anson, Editor

A new study has found conflicting trends in the abuse and misuse of opioid pain medication in the U.S.

From 2003 to 2013, the “nonmedical” use of prescription opioids decreased in American adults from 5.4 percent to 4.9 percent. At the same time, however, rates of opioid abuse and opioid related deaths increased.

Drug overdose deaths associated with prescription opioids rose sharply during those ten years, from 4.5 deaths per 100,000 people to 7.8 deaths per 100,000 in 2013.

The study, which was published in JAMA, the official journal of the American Medical Association, is certain to fuel further debate about opioid pain medication and whether further efforts are needed to limit its prescribing.

"We found a significant decrease in the percentage of nonmedical use of prescription opioids, as well as significant increases in the prevalence of prescription opioid use disorders, high-frequency use, and related mortality,” the study says.

“Furthermore, the increases identified in this study occurred in the context of increasing heroin use and heroin-related overdose deaths in the United States, supporting a need to address nonmedical use of prescription opioid and heroin abuse in a coordinated and comprehensive manner."

“The most disturbing statistic is the increase in mortality per 100,000,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “Unfortunately the data doesn't help sort out if the deaths are occurring in patients or non-patients.  It is important to know because the required interventions will differ depending on the reasons for overdose within both groups.  

“For example the definition of ‘nonmedical use’ is defined as use without a prescription or with a prescription for how the opioid makes the individual ‘feel’.  Of course an opioid is supposed to make people feel better.  Is that nonmedical use or is it therapeutic use defined as nonmedical use?”

It didn’t take long for critics of opioid prescribing to weigh in. JAMA also published an editorial that immediately pointed a finger at patients, not addicts.

“Most opioids misused by patients originate from prescription medication. Most patients who overdose on prescription opioids are taking their medications differently than prescribed or are using opioids prescribed to someone else. These 2 main types of nonmedical opioid use represent a major cause of morbidity and mortality,” wrote Lewis Nelson, MD; David Juurlink, MD, and Jeanmarie Perrone, MD.

"The chronic, relapsing nature of opioid addiction means most patients are never 'cured,' and the best outcome is long-term recovery. The lifelong implications of this disease far outweigh the limited benefits of opioids in the treatment of chronic pain, and in many cases the risks inherent in the treatment of acute pain with opioids.”

“Oh my goodness, this is terrible,” said Janice Reynolds a chronic pain sufferer and patient activist. She said the editorial was full of “myths and “lies” that discount the use of opioids to relieve pain.

“There is, despite their claims, much research which supports its use,” Reynolds said in an email.

Coincidentally, all three authors of the editorial – Nelson, Juurlink and Perrone – are members of panels developing opioid prescribing guidelines for the Centers for Disease Control and Prevention (CDC). Currently those guidelines 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 also recommended for acute or chronic pain.  A complete list of the guidelines can be found here.

Nelson is a member of the CDC's "Core Expert Group," a panel that advised the CDC on initial development of the opioid guidelines.

Juurlink, who is considered a “stakeholder” by the CDC, is a board member of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to reduce the overprescribing of opioids.

Perrone has an even more important role with the CDC, serving on a three member peer review panel that will help finalize the opioid guidelines. Another member of the peer review committee, David Tauben, MD, is also a PROP board member.

The CDC has informed Pain News Network that the peer reviewers were asked to disclose any conflicts of interest, including any financial, professional or other interest relevant to their work -- and nothing was found to warrant removal from the peer review panel.

"PROP (Physicians for Responsible Opioid Prescribing) is considered a professional membership organization and wasn’t considered a conflict of interest unless  there was a financial and promotional relationship identified," said Shelly Diaz, a CDC spokesperson.

"The Peer Reviewers  disclosed no financial interests or other  promotional relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. When reviewers  reported interests related to intellectual property, other (travel, gifts), public statements and positions, or additional information provided, their statements were carefully reviewed by the CDC guideline development staff to determine if the interests would have an effect on the suggestions."

Study: Long-Term Opioid Use Often Ineffective

By Pat Anson, Editor

Less than half the people on long-term opioid therapy achieve relief from chronic pain, according to a new survey that found opioids even less effective in younger women. However, most respondents still considered opioids to be very or extremely helpful.

Over two thousand women and men enrolled in group health plans in Washington State and northern California were surveyed about their long-term use of opioids. The study, published in the Journal of Women’s Health, is believed to be the first to look at differences in the effectiveness of opioids between the sexes.    

Only about 20 percent of the patients on long term opioid therapy were classified as having a favorable “global pain status” – which is a measure of overall pain and function. Nearly 28% had an intermediate status and over 52% had an unfavorable global pain status.

Women between the ages of 21 and 44 were much more likely than men in the same age group to have an unfavorable status (66% vs. 40%). That finding is significant because younger women face unique risks from opioid use, such as reduced fertility and risks to a developing fetus during pregnancy.

"Given the high rates of chronic opioid use in women along with evidence of poor relief from pain and concerning risks, particularly in reproductive-aged women, we need more effective and safer options for managing pain in this population," Susan Kornstein, MD, Editor-in-Chief of the Journal of Women's Health and  Executive Director of the Virginia Commonwealth University Institute for Women's Health.

Over half the women and men with “unfavorable” pain status were depressed, unemployed, laid off or not working for health reasons.

“Our observational data indicate that for typical COT (chronic opioid therapy) patients in community practice the probability of experiencing good pain control and favorable levels of functioning is relatively low,” the study found. “However, regardless of global pain status, in every age–sex group, the majority of patients rated opioids as very or extremely helpful in relieving pain.”

Researchers admitted they could not assess whether pain and function had improved or deteriorated from the time patients began using opioids. They also could not explain why opioids appear to be more effective in men than women.

“Women tend to have greater pain severity, and are more likely to be prescribed opioids to treat their pain.  However, opioids work less well in women,” said Beth Darnall, PhD, a pain psychologist, clinical associate professor at Stanford University and author of Less Pain, Fewer Pills.

“Rather than stopping medications that are not working well, often the opioid prescriptions are continued and the dose increased—this can set women up to have more side effects and even greater pain.”

Darnall, who has studied the medical and psychological risks of long-term opioid use by women, says safer alternatives to opioids need to be found.

“For many years there was a common perception that opioids were a ‘solution’ to pain. We must continue to look beyond opioids to comprehensive treatments that have low risks for patients. Such treatments may include acupuncture, pain psychology, self-management, physical therapy, and occupational therapy.  A primary problem is lack of access to these low-risk, effective treatments.”

CDC Should Consider Marijuana as Alternative to Opioids

By Ellen Lenox Smith, Columnist

Presently in our country, those that are successfully using opioids for pain relief are feeling dirty and lost -- largely due to fears about addiction and  overdoses. Pain patients often have to cope with physicians who are reluctant to prescribe opioids and pharmacies that are sometimes unwilling to fill their prescriptions.

The Centers for Disease Prevention and Control (CDC) is considering new guidelines that would encourage doctors to shift even further away from prescribing opioids, leaving the patient with little effective medication to turn to.

Why is the CDC not even considering the use of medical marijuana to help these people in need?

The Boston Herald recently reported that hundreds of opioid addicts are being treated successfully in Massachusetts with medical marijuana.

“We have a statewide epidemic of opioid deaths,” said Dr. Gary Witman of Canna Care Docs, which issues medical marijuana cards in seven states. “As soon as we can get people off opioids to a non-addicting substance — and medicinal marijuana is non addicting — I think it would dramatically impact the amount of opioid deaths.”

Witman is treating about 80 patients at a Canna Care clinic who are addicted to opioids, muscle relaxants or anti-anxiety medications. After enrolling them in a one-month tapering program and treating them with cannabis, Witman says more than 75 percent of the patients have stopped taking the harder drugs. Medical marijuana gave them relief from pain and anxiety — and far more safely than opioids.

Patients across the country are also learning they can use cannabis for pain relief, decreasing or even eliminating their use of opioids.  Marijuana works far better than other substitutes since it is not synthetic and does not cause organ damage or deaths like opioids can in some circumstances.

Medical marijuana works naturally on what is known as the “endocannabinoid system,” binding to neurological receptors in the brain that control appetite, pain sensation, mood and memory.

Here in Rhode Island, my husband and I have witnessed the amazing transition of pain patients on opioids that chose to transition to medical marijuana.  Most that turn to cannabis do so to eliminate the side effects of opioids and concerns about their long term use. They still achieve pain relief but know they are gaining that relief in a safer manner -- no organ damage, no teeth getting destroyed, no concerns of addiction and no deaths.

Marijuana may still be illegal at the federal level, but it is legal in 23 states and the District of Columbia, and millions of people are discovering its therapeutic benefits. The CDC should consider adding medical marijuana to the list of “non-opioid” therapies in its guidelines.

Ellen Lenox Smith and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition. 

For more information about medical marijuana, visit their website.

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.

Medical marijuana is legal in 23 U.S. states and the District of Columbia, but is still technically illegal under federal law. Even in states where it is legal, doctors may frown upon marijuana and drop patients from their practice for using it.

How the CDC Gets Opioids So Wrong

By Crystal Lindell, Columnist

Look, I get it. I really do. Heroin is just such an easy thing to be against. I mean, it’s a drug. It’s a bad drug. It’s illegal. And people literally die after using it.

What’s not to hate?

But here’s the problem. Somewhere in this conversation about how heroin is bad, people started thinking that all opioids are bad. Even the legal ones. The ones that help people. The ones that actually save lives.

And thus, we have now ended up with another government agency trying to regulate medications that so many of us need. Not medications we want. Or that we think might be good. Medications we need.  

Last month the Centers for Disease Control and Prevention (CDC) released new draft guidelines that would -- if adopted-- sharply reduce the prescribing of opioids for both chronic and acute pain in the U.S. It’s mostly an effort to curb heroin use and non-medical use of opioids. Which, again, I get. Those are easy things to hate.

The CDC has since come out and said they would review the guidelines and look at public input, before finalizing them. But what changes, if any, they’ll make is unclear.

Among the 12 guidelines are recommendations like doctors should only prescribe opioids as a last resort, and chronic pain patients should have comprehensive treatment plans that go beyond just handing them a bottle of hydrocodone.

As someone who literally needs daily morphine to take showers, I’m extremely wary about the recommendations. And I’m also extremely weary of how the CDC chose to announce them.

They revealed all of them during an online webinar, which I wasn’t able to attend live. Seeing as how it’s 2015 though, I assumed I’d be able to watch it later on demand via my computer. Alas, although the CDC recorded the webinar, it didn’t make it available to watch on demand. I even went so far as to reach out to their marketing person and ask for the slides or a special link, but I never got a response. The whole thing seems pretty shady.

Thankfully, Pain News Network editor Pat Anson did attend the webinar and was able to detail all 12 guidelines. The best way to explain how wrong the CDC is about all this is just to take them one by one. You can see the official language here, but I’m just going to use laymen’s terms to sum them up:

1. If possible, use “non-pharmacological therapy" and non-opioid pain relievers for treating chronic pain. Use opioids as a last resort.

First of all, because of all the stigma associated with opioids, many doctors are already doing this. But it’s to the detriment of those suffering. When I first got sick, the doctors tried to give me prescription-strength Aleve. It literally did nothing for me. And eventually I was in so much pain that I would lay in bed at night and plan out how I wanted to take a knife to my wrists in the bathtub. That’s not hyperbole, that’s the truth.

Eventually, the doctors gave me a really low dose of hydrocodone. It did nothing for me either, and it wasn’t until I tried doubling the dose, and then doubling that dose, that I realized I didn’t have to live every second of every day feeling like someone had just dropped a cinder block on my ribs and then stabbed me with a butcher knife.

Also, I’m guessing that by “non-opioids” they mean nerve medications like Cymbalta and Lyrica, which people have somehow started to believe are a one-to-one swap for opioids, without all the side effects. But that’s just not the case. Nerve medications come with their own set of horrible side effects and withdrawal symptoms, and many people, like myself, find that they don’t actually help treat the pain.

It took way too long for me to get the medications I needed. And requiring doctors to try everything else first will only exacerbate that. You wouldn’t tell someone who just go out of surgery that they should try acupuncture before giving them pain pills. And you shouldn’t do it with someone in chronic pain either.

2. Establish a treatment plan.

Well, duh. Doctors should be doing this even if they aren’t prescribing opioids.

Unfortunately, doctors aren’t neglecting to create treatment plans because they want to give away opioids like candy, they’re neglecting to create treatment plans because they don’t have the time or the patience to have these kind of in-depth conversations.

3. Discuss the risk and benefits of opioids with patients.

Again, duh. But this should apply to all prescription medications. There’s nothing special about opioids.

4. Favor short-acting opioids over extended-release/long acting opioids.

This is the recommendation that makes it most obvious that they didn’t actually consult with any chronic pain patients. Anyone who uses opioids will tell you how much better extended release pills are than short-acting, quick hit opioids.

That’s because extended release pills don’t result in that insane cycle that a typical hydrocodone dose will give you — a burst of pain relief, followed by a crash that leaves you begging for death, and reaching for more meds before it’s time for your next dose.

One of the best decisions I ever made was to go on eight-hour time release morphine. The steadiness of the dose has helped me maintain the same dosage for almost two years. And by avoiding the insane lows that come with short-acting opioids, my pain stays at a more manageable level.

5. Prescribe the lowest possible effective dose, and implement additional precautions when increasing the dosage to 50 mg (morphine equivalent) or more per day. Also, avoid going over 90 mg a day.

I’m just going to say it. I’m on as much as 60 mg of opioids on the daily. There. Now you know. I take a lot of drugs.

But you know why I take that many drugs? Because every day when I wake up it feels like I just got whacked in the chest with a baseball bat, and then hit by a freight train, and then thrown off a bridge. Every day. Again, that is not hyperbole. That is my life. And proposing arbitrary limits on how much medication you think I need to deal with is infuriating.

6. Long-term opioid use usually begins with treating acute pain. So, when opioids are used for acute pain, doctors should give out the lowest possible dose of short-acting opioids and they should only prescribe enough for three days or less.

Look, I’ve had surgery. And it took me a serious week to recover from having my gallbladder out. And I needed that hydrocodone every single day I was on it — all seven days. I’m glad the folks at the CDC can hop out of bed three days after having their stomach cut open, but we aren’t all so lucky.

7. Doctors need to check in with any patients on long-term opioids.

Again, duh. And again, this is something that should apply to any person on any drugs.

8. Doctors should go over the pros and cons of the drugs. Also, they should give patients naloxone if there’s a chance of things going wrong with the opioids.

Okay. Look. It’s always a good idea to go over the pros and cons of any drug. I’m not sure how many times I have to write this, but yes, doctors should do this with EVERY drug.

As for naloxone, I don’t personally feel like I need it because I only use my opioids responsibly. But if a doctor thinks it’s a good idea, I’m not going to argue about it. The key word there though is “doctor.” I don’t believe the CDC needs to be involved.

9. Doctors should review the patient’s history of controlled substances.

I mean, yeah, I guess if someone just got out of rehab for heroin that should probably be a red flag. But I don’t think someone with trigeminal neuralgia should be denied treatment because one time in high school they got caught with pot.

10. Providers should drug test everyone on long-term opioids.

Look, this is already pretty much policy across the country. While my doctor doesn’t do it to me, I did sign a contract saying he could. And, yes, it does kind of suck.

For example, what if you’re being under medicated and need some Mary Jane? What if you just don’t want to feel like a common criminal every time you go to the doctor? Or what if you already just peed? It sucks. And it just adds to the stigma that so many opioids patients already deal with.

11. Doctors should not prescribe opioids and benzodiazepines together.

If your doctor is doing this, find a new doctor. This is basic “these medications don’t mix” stuff.

12. Doctors should offer treatment for people with opioid use disorder (aka addiction to opioids).

Yes. Yes they should. It’s called medical care.

So there they are, all 12 guidelines. Most of them can be summed up as, “Doctors need to talk to their patients more.” And like I said, that’s a philosophy that could apply to all doctors, all patients, and all drugs.

It’s quite obvious from reading through these guidelines that the CDC didn’t really consult with anyone in chronic pain who is using opioids responsibly — and that’s really the worst part about all this.

Look, it’s not like I’m saying you should be able to get time-release morphine over the counter. I get that there has to be some regulation. And I truly do believe that doctors should do a better job explaining various drugs to patients before they hand them a script for hydrocodone.

But I think doctors need to do a better job explaining all drugs. And when the CDC releases uneducated guidelines like this without input from as many as 11.5 million Americans who are on long term opioid therapy, all they’re doing is perpetuating an unfair stigma that does more harm than good.

People who don’t know any better are always making off-handed remarks to me about how, “You need to get off all those drugs.” And I always stop whatever I’m doing to explain to them that it’s “all those drugs” that give me the ability to live my life. Would they rather I laid on the couch all day contemplating suicide? Because that is the alternative.

Again, no hyperbole. That’s just my life.

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

Are the CDC Opioid Guidelines Really Voluntary?

By Pat Anson, Editor

When is a medical guideline voluntary and when does it become a “standard of practice” that doctors are expected to follow?

That is one of the key questions in the ongoing debate over controversial guidelines for opioid prescribing unveiled last month by the Centers for Disease Control and Prevention (CDC).

The draft guidelines 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 also recommended when the drugs are used to treat acute or chronic pain.  A complete list of the guidelines can be found here.

The CDC says the guidelines are needed to help primary care providers. Many lack adequate training in pain management and opioid prescribing, yet they treat the vast majority of chronic pain patients.

“It’s important to note that CDC is not a regulatory agency, unlike the Food and Drug Administration.  Physicians are not required to use the guideline, instead it is intended to support informed clinical decision making regarding the provision of safer, more effective pain treatment for patients,” said Courtney Leland, a spokesperson for the CDC.

But the CDC’s own internal documents make clear that the agency’s ultimate goal is for the guidelines to be widely adopted.

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings,” the agency says in briefing papers obtained by Pain News Network.  “CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.”

“Clearly the intent of CDC is that the guideline be distributed to and adopted by state public health entities and certifying organizations as if it had the legal authority of a regulation,” a representative with the American Cancer Society wrote in a recent letter to CDC Director Tom Frieden.  

The letter said the American Cancer Society “cannot endorse the proposed guidelines in any way” because they “have the potential to significantly limit cancer patient access to needed pain medicines.”

Experts and patient advocacy organizations say the guidelines – voluntary or not – could quickly be adopted by state licensing boards and have a chilling effect on doctors who prescribe opioids.

“If a healthcare provider receives correspondence from the CDC, the assumption can be made that more often than not, the healthcare provider will consider such correspondence relevant and necessary to follow so as to not face any backlash from the CDC or similar agency,” said Shaina Smith, Director of State Policy and Advocacy for the U.S. Pain Foundation, one of the nation’s largest patient advocacy organizations.

“A guideline coming from CDC will be viewed as having a stronger pedigree than a guideline coming from a professional society or other source, and will thus be more likely to be adopted as reflecting a standard of practice, or adopted as a rule by state licensing boards,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

Once in place, Twillman says a guideline or rule could be used in court by a disgruntled patient to challenge the competency of their doctor.

“If a prescriber is sued, one of the things that will be raised at trial is whether or not the prescriber demonstrated that the care provided conforms to the standard of practice. Standard of practice is a bit of an ill-defined term, but I can guarantee you that one question that would be asked in making this determination is, ‘Did you, or did you not, provide care that conforms to the most up-to-date and evidence-based guidelines?’ Any prescriber who can’t show that the care in question conformed to guidelines is going to be in a world of hurt,” Twillman wrote in an email to Pain News Network.

“It can get further complicated because guidelines also come up in disciplinary hearings by licensing boards and other agencies. Again, the same question will be asked, and again, a prescriber whose treatment does not conform to guidelines will be in jeopardy.”

Guidelines Can Become Laws

Twillman says there are precedents for guidelines to turn into laws. Such was the case in Washington State in 2007, when the Agency Medical Director’s Group (AMDG) adopted what was then the nation’s toughest guidelines for physicians who treat pain and prescribe opioids. In 2010, Washington’s Governor signed many of those same guidelines into law, the first in the world to set specific dosing levels for opioids.

Interestingly, two key members of the AMDG were Drs. Gary Franklin and David Tauben, who now sit on CDC panels that are helping to develop and draft the agency’s opioid guidelines. A third CDC panelist, Dr. Jane Ballantyne, has spoken at several hearings in favor of the AMDG guidelines.

Ballantyne and Franklin are the President and Vice-President, respectively, of an advocacy group called Physicians for Responsible Prescribing (PROP), which seeks to reduce the overprescribing of opioid pain medication. Tauben is a board member of PROP, as are two other CDC panelists providing input on the opioid guidelines.

The CDC says it is only fulfilling its mandate to protect the public from a serious health issue.

“Although CDC has not previously issued guidelines on opioid prescribing, we have consulted on and supported guideline development by professional organizations,” said the CDC’s Leland, citing as an example guidelines developed by the American College of Emergency Physicians on the use of opioids in hospital emergency rooms.

“CDC is the nation's health protection agency, operating to strengthen our nation’s public health systems. One way we do this is by developing and issuing guidelines and recommendations on any number of health issues, including those guiding clinical practice,” Leland added. “Prescription drug abuse and overdose is a serious public health issue and improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse, or overdose.”

Leland says the agency is currently revising its draft opioid guidelines – after getting input from healthcare providers and some patients – and remains on track to finalize and release the guidelines in January 2016.

Benzos May Increase Dementia Risk

By Pat Anson, Editor

Anti-anxiety drugs often prescribed to chronic pain patients increase the risk of dementia and Alzheimer's disease when used long term, according to clinicians with the American College of Osteopathic Neurologists and Psychiatrists.

Benzodiazepines --  also known as benzos -- include brand name prescription drugs such as Valium, Ativan, Klonopin and Xanax. They were approved by the U.S. Food and Drug Administration to treat psychiatric conditions, but are also prescribed "off label" to treat bipolar disorder, insomnia, post traumatic stress disorder, and chronic pain.

A Canadian study of 9,000 patients found those who had taken a benzodiazepine for three months or less had about the same dementia risk as those who had never taken one.

But taking benzos for three to six months raised the risk of developing Alzheimer's by 32 percent, and taking them for more than six months boosted the risk by 84 percent.

Similar results were found by French researchers studying more than 1,000 elderly patients.

"Current research is extremely clear and physicians need to partner with their patients to move them into therapies, like anti-depressants, that are proven to be safer and more effective," saidHelene Alphonso, DO, Director of Osteopathic Medical Education at North Texas University Health Science Center in Fort Worth.

The case for limiting the use of benzodiazepines is particularly strong for patients 65 and older, who are more susceptible to falls, injuries, accidental overdose and death when taking the drugs. The American Geriatric Society in 2012 labeled the drugs "inappropriate" for treating insomnia, agitation or delirium because of those risks.

"It's imperative to transition older patients because we're seeing a very strong correlation between use of benzodiazepines and development of Alzheimer's disease and other dementias. While correlation certainly isn't causation, there's ample reason to avoid this class of drugs as a first-line therapy," said Alphonso.

In its draft guidelines for the prescribing of opioid pain medication, the Centers for Disease Control and Prevention (CDC) recommends that opioids and benzodiazepines not be prescribed concurrently whenever possible. A CDC study found that about 80% of unintentional overdose deaths associated with opioids also involved benzodiazepines. Nearly 6,500 people died from overdoses involving benzodiazepines in 2010.

Opioids, benzodiazepines and muscle relaxants are all central nervous system depressants. Mixing the drugs is potentially dangerous because their interaction can slow breathing and raise the risk of an overdose death.

In a study of over 35,000 patient visits for acute and chronic pain, recently published in the journal Pharmacoepidemiology and Drug Safety,  researchers found that the prescribing of benzodiazepines was three to four times more likely when opioids were also prescribed.

Over a third of the patients prescribed opioids for chronic musculoskeletal pain were given a sedative. And patients with a history of psychiatric and substance abuse disorders were even more likely to be co-prescribed opioids and sedatives.

"Multi drug use is the trailing edge of the opioid epidemic," said Mark Sullivan, MD, a professor of psychiatry and behavioral sciences at the University of Washington School of Medicine. "We are making progress on decreasing opioid prescribing, but co-prescribing of opioids and sedatives has not decreased.

"Patients who are on long-term combined opioid and benzodiazepine therapy are often on a treadmill. They feel relief when they take their medications and withdrawal when they stop, so they continue this combined therapy, even though many function poorly and some will die as a result."

Over 50,000 visits to emergency rooms in 2011 involved a combination of benzodiazepines and opioids, according to the Substance Abuse and Mental Health Services Administration (SAMHSA)

Pain Meds Top Concern of Work Comp Industry

By Pat Anson, Editor

The use of opioid pain medication is the number one issue faced by the worker’s compensation industry, according to a new survey that calls the long-term use of opioids in the U.S. an “extremely significant problem” for insurers and employers.

The annual survey of nearly two dozen insurers, state worker compensation agencies and self-insured employers was conducted by CompPharma, a consortium of pharmacy benefit managers that helps members develop procedures to control work comp costs.

The survey found that drug spending by the worker compensation industry increased by 6.4% last year, the first increase since 2009. Pharmacy spending in work comp cases was estimated at between $5 and $7 billion in 2014.

“During the past several years long-term opioid use has become the single biggest concern identified by respondents. While program managers and work comp executives have long known about the relatively high usage of narcotics in work comp, the depth and breadth of understanding of the issue continues to increase. Throughout the survey, respondents mentioned narcotics, opioids, addiction, specific drugs, dependency, and related terms, even when responding to other questions,” CompPharma said in a report on the survey.

Asked to rate the severity of the opioid problem on a scale of one to five, respondents gave it an average ranking of 4.75, which was called “a clear indicator of the level of the industry’s anxiety over a problem that it was somewhat slow to fully grasp.”

Payers also expressed concern about the cost of new opioids and abuse deterrent opioids, which are formulated to make it more difficult for the drugs to be snorted or injected.

“They say follow the money well here you go,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “If patient well-being and safety were the concern of payers they would rapidly adopt abuse deterrent formulations and lobby Congress to find safer and more effective therapies.  Neither are occurring.”

Webster said the cost of opioids was the “genesis for the anti-opioid movement” and claimed the work comp industry was fueling efforts to limit opioid prescribing.

“We need to ask why cost to payers trumps patients reporting effectiveness,” Webster said in an email to Pain News Network.  “There should be a Senate investigation to see if this has been an orchestrated attack.  If so it should be criminal.” 

Payers who were surveyed said they had developed a variety of ways to limit the cost of opioids or make them harder to get.

“Respondents noted several approaches to controlling cost, with a more diverse range of solutions and more specificity in solutions than we’ve previously seen. The majority of the respondents implemented programs, upgraded approaches, hired staff, or altered DUR (drug utilization review) processes pertaining to opioids. This shows how seriously these respondents take the issue,” the report states.

Payers were also concerned about physicians dispensing opioid pain medications out of their own offices, which often cost more than opioids obtained at a pharmacy.

“Physician dispensing also drastically and artificially inflates the cost of workers’ compensation pharmacy costs. Physician-dispensed prescriptions typically cost three to ten times the amount of the same prescription filled by a retail pharmacy. More recent studies point to longer claim duration, more claimants prescribed opioids for longer periods, higher overall medical costs, higher indemnity expense, and poorer outcomes associated with claims with physician-dispensed drugs,” the report said.

The survey also found a greater willingness on the part of the work comp industry to utilize urine drug testing. Four years ago, half of the survey respondents said they were using drug tests to monitor employees who had filed work comp claims. The 2014 survey found that three-quarters of respondents have implemented or will implement a drug testing program.

CDC Opioid Guidelines Being Revised

By Pat Anson, Editor

In the wake of growing criticism by pain sufferers and patient advocacy groups, the Centers for Disease Control and Prevention (CDC) is revising its controversial guidelines for primary care physicians who prescribe opioids.

“CDC is currently in the midst of the scientific process and the draft guidelines document is still being revised, without final language that we can disseminate at present. At each step of this process, we’ve incorporated feedback and revisions have been made.  We do not want clinicians using these guidelines until they are finalized,” said Courtney Leland, a CDC spokesperson in an email to Pain News Network.

The extent of the revisions is unclear and the agency says it is still on track to finalize the guidelines in January, 2016.

The draft guidelines released last month 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 who continue using the drugs for acute and chronic pain.  A complete list of the guidelines can be found here.

“Prescription drug abuse and overdose is a serious public health issue and improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse, abuse, or overdose,” said Leland.

Many pain patients are worried the guidelines could further restrict their access to opioid pain medications. The CDC has also been criticized for a lack of transparency in developing the guidelines and for seeking little public input.

In a letter to CDC Director Tom Frieden, the American Cancer Society called for the guidelines’ development to be suspended until numerous issues are addressed.

“We believe the proposed guidelines have the potential to significantly limit cancer patient access to needed pain medicines. We have concerns about the lack of evidence on which the guidelines were based, the methodology used to develop the guidelines, and the transparency of the entire process,” wrote Christopher Hansen, President of the American Cancer Society Cancer Action Network.

“Our concerns are so serious that we cannot endorse the proposed guidelines in any way and suggest suspending the process until the methodological flaws are corrected and more evidence is available to support prescribing recommendations.”

Hansen’s letter was also addressed to Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention and Control, which is developing of the guidelines.

In an email Monday to a “Stakeholders Review Group” composed mainly of physician organizations, Houry invited the groups to listen to a conference call on October 21 to update them on the drafting of the guidelines.  

“As a reminder, the recommendations in the document you reviewed are pre-decisional, draft, and confidential. We ask that you refrain from sharing them widely at this point because they are not yet final, will change based on the feedback we received through the various comment processes, and we do not want clinicians to refer to the guidelines until we complete the peer review, revisions, and clearance process,” Houry wrote.

Secrecy had surrounded the development of the guidelines from the beginning and continues today. Only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on them.

Even the number of public comments the agency has received about the guidelines is unclear. In her email to stakeholders, Houry said there were “more than 250 comments.” But Pain News Network was told there were “more than 1,200 comments from patients, health care professionals, and members of organizations.”

When asked to explain the discrepancy, a CDC spokesperson said the agency had actually received just 167 emails during the public comment period, “but note that this is just the number of emails and doesn’t necessarily equate with the number of comments incorporated within each of the email messages.”

As many as 11.5 million Americans are on long term opioid therapy. The American Cancer Society called on the CDC to give those patients and the public a better chance to review and comment on the guidelines.

“We have concerns that the attempts to solicit public input on the draft guidelines were cursory and did not allow adequate opportunity for thoughtful responses. While a public webinar was held to discuss the recommended guidelines, it was not well advertised and many interested parties were denied access because the webinar lacked sufficient capacity,” Hansen wrote in his letter to the CDC.

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.

“U.S. Pain Foundation was disappointed to have learned that the CDC drafted the proposed prescriber guidelines on opioid medications without, in the organization’s opinion, appropriately notifying the pain community at-large,” said Shaina Smith, Director of State Policy and Advocacy for the U.S. Pain Foundation, one of the nation’s largest patient advocacy organizations. “U.S. Pain feels it was not afforded the opportunity to participate in these important discussions which could have a significant impact on the lives of individuals with pain.

“Despite the CDC stating that 55 diverse organizations were invited to join the webinar's discussion, none of the collaborating patient advocacy organizations U.S. Pain works alongside were granted an invitation. Furthermore, pain patients were not alerted of this opportunity until after the guidelines were made available to the public.”

Repeated calls and emails to Penney Cowan, executive director of the American Chronic Pain Association (ACPA), for comment on the guidelines were not returned.

"We apologize, but Ms. Cowan has been traveling extensively and will not be back in the office until Oct 20th.  She indicated that she does not have time in her schedule to discuss this," a spokesperson for ACPA explained in an email.

High Use of Opioids by Older Adults with COPD

By Pat Anson, Editor

Canadian researchers have found significantly high rates of opioid use among older adults with chronic obstructive pulmonary disease (COPD), according to a large study published in the British Journal of Clinical Pharmacology. Over half of the patients received a new opioid prescription after their COPD diagnosis.

"The new use of opioids was remarkably high among adults with COPD living in the community," said Nicholas Vozoris, MD, a respirologist at St. Michael's Hospital in Toronto. "The amount of opioid use is concerning given this is an older population, and older adults are more sensitive to narcotic side effects."

The study is based on records for more than 120,000 adults in Ontario age 66 and older with COPD, a progressive lung disease that makes it harder to breathe. COPD causes coughing, wheezing, shortness of breath, chest tightness and other symptoms. Most people who have COPD smoke or used to smoke, according to the National Institutes of Health.

Between 2003 and 2012, 70 per cent of the COPD patients who lived in their own home were given a new opioid prescription, while about 55% of those living in long-term care facilities received a new opioid prescription. Many were given multiple opioid prescriptions, early refills, and prescriptions that lasted more than 30 days.

Opioids might be prescribed more frequently among older adults with COPD to treat chronic muscle pain, breathlessness and insomnia.

"Sometimes patients are looking for what they think are quick fixes to chronic pain and chronic breathing problems," said Vozoris. "And physicians sometimes believe that narcotics may be a quick fix to COPD symptoms."

Common side effects of opioids in older adults include falls and fractures, confusion, memory impairment, fatigue, constipation, nausea, vomiting and abdominal pain. Vozoris says opioids may also negatively affect lung health by reducing breathing rates and volume, which can result in decreased blood oxygen levels and higher carbon dioxide levels.

"This is a population that has chronic lung disease, and this drug class may also adversely affect breathing and lung health in people who already have chronically compromised lungs," he said.

Most of the opioid prescriptions were written by family physicians, usually for pain medications that combine an opioid with acetaminophen.

"Patients and prescribers should reflect on the way narcotics are being used in this older and respiratory-vulnerable population," said Dr. Vozoris. "They should be more careful about when narcotics are used and how they're being used."

A study published in Clinical Interventions in Aging warned about the risk of “polypharmacy” in older adults, who often take multiple medications written by different providers.

“The elderly population is especially challenging when one has to consider all of the pharmacodynamic changes that occur with normal aging. The side effect profile of opiates is similar for all age groups; however the elderly population is at a greater risk for these side effects given their comorbidities and high incidence of polypharmacy. Using opiates appropriately and at the most efficacious dosage for the severity and type of pain becomes crucial in the elderly,” the study said.