CDC Made Few Changes in Opioid Guidelines

By Pat Anson, Editor

The Centers for Disease Control Prevention (CDC) has made few changes in its draft guidelines for opioid prescribing, three months after they were widely criticized by pain patients and healthcare providers.

The agency still maintains that “non-pharmacological therapy” and non-opioid pain relievers are the “preferred” treatments for chronic pain, while admitting there is little evidence to support many of its recommendations. The guidelines also fail to address other issues, such as the lack of insurance coverage for many of the treatments the CDC advocates.

The proposed guidelines for primary care physicians were publicly released for the first time today as the CDC opened a 30-day public comment period on them. You can make a comment by clicking here.

The dozen guidelines can be found in a 56-page report, along with the reasoning behind them. You can see the report by clicking here.

“This guideline provides recommendations that are based on the best available evidence that was interpreted and informed by expert opinion. The clinical scientific evidence informing the recommendations is low in quality,” the report states.

“To inform future guideline development, more research is necessary to fill in critical evidence gaps. The evidence reviews forming the basis of this guideline clearly illustrate that there is much yet to be learned about the effectiveness, safety, and economic efficiency of long-term opioid therapy.”

The CDC was roundly criticized for the way it prepared and handled the initial release of the guidelines in September to a select online audience.  The agency never made the guidelines available on its website or in any public form outside of the webinar, and only a 48-hour public comment period was allowed afterwards. The CDC also came under fire for secretly consulting with “experts” that included special interest groups and addiction treatment specialists, but few pain patients or pain physicians.

After getting feedback from critics, the CDC said it would make changes in its recommendations, but only a few changes can be found in the dozen guidelines released today:

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks to the patient.

2. Before starting opioid therapy for chronic pain, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should not initiate opioid therapy without consideration of how therapy will be discontinued if unsuccessful. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.  

3. Before starting and periodically during opioid therapy, providers should discuss with patients known risks and realistic benefits of opioid therapy and patient and provider responsibilities for managing therapy.

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

5. When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, should implement additional precautions when increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should generally avoid increasing dosage to ≥90 MME/ day

6. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, providers should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three or fewer days usually will be sufficient for most nontraumatic pain not related to major surgery.

7. Providers should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Providers should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, providers should work with patients to reduce opioid dosage and to discontinue opioids.

8. Before starting and periodically during continuation of opioid therapy, providers should evaluate risk factors for opioid-related harms. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, or higher opioid dosages (≥50 MME), are present.

9. Providers should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving high opioid dosages or dangerous combinations that put him or her at high risk for overdose. Providers should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

10. When prescribing opioids for chronic pain, providers should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

11. Providers should avoid prescribing opioid pain medication for patients receiving benzodiazepines whenever possible.

12. Providers should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

Most of the dozen guidelines are strongly recommended by the CDC, even though the evidence used to support them was considered “limited” or there was “very limited confidence in the effect” of the recommendations.

Changes in Draft Guidelines

Some changes were made in guideline #5, which warns physicians to avoid giving patients high doses of opioids. The new guideline suggests that patients already taking high dosages “should be offered the opportunity to re-evaluate their continued use of opioids at high doses,” instead of having their medication abruptly changed to a lower dose.

However, no mention is made of a CYP450 genetic test, which can determine if a patient may need high doses of opioids.

“The CYP450 omission is disturbing since 20 percent of the population has some defect. How can you have a prescribing policy without CYP450 testing?” asked Gary Snook, a Montana man who needs extremely high doses of opioids to relieve pain from adhesive arachnoiditis. “It makes me wonder, are these doctors really qualified to put forth this draft that will have such an impact on so many that live in severe 24/7 pain? I think not!”

One significant change, in guideline #10, acknowledges that the results of urine drug tests are often wrong or misinterpreted. It recommends drug testing before opioid therapy begins and then annually, but random drug testing is discouraged. The guideline also recommends that providers not test for substances such as marijuana, which may not affect the efficacy of pain management.  

If there are “unexpected results” from a urine drug test, the guideline says patients should not be terminated from a doctor’s practice, but should be counseled or offered treatment for substance abuse.

Pain Patients Urged to Comment

“I feel it's critical that members of the pain community, or people whose loved ones suffer from chronic pain, to take this rare second chance to refer to each of the guidelines and make their feelings known,” said Kim Miller, a pain patient and advocate..

“I feel it's important to keep your feelings out of comments to official government entities. Professionals are more receptive to calm remarks.  There's no need to be inflammatory; other agencies, law firms, and numerous medical providers have already expressed their disappointment and disapproval of the previous draft guidelines.  At this point, sticking to the facts is all that's necessary.”

The CDC is emphasizing the revised guidelines are voluntary and “intended to improve communication” between doctors and their patients.

Debra Houry, MD, the CDC official who oversaw development of the guidelines, even put out a Tweet, saying, “Patients & providers should decide together how to best treat long-term chronic pain.”

But critics say the guidelines, when adopted, could quickly become a standard of practice for state medical boards and professional healthcare societies, giving physicians little choice but to comply with them.

“These ‘guidelines’ are not looked at merely as suggestions,” Miller said. “When the CDC suggests there's no need for concern, after all these are only guidelines, it couldn't be further from the truth.  The pain community must be sure to give these guidelines very serious consideration, your medical providers will be.”

After the public comment period ends, the CDC says the guidelines will be reviewed by a scientific advisory group, which will then appoint another working group to refine the guidelines further.  The agency has not released a timetable or said if outside consultants who helped draft the initial guidelines will still be part of the process.

The CDC was criticized for consulting with five board members of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which runs a chain of addiction treatment centers. Critics say PROP has a conflict of interest when it advocates that pain patients be given greater access to addiction treatment.

Will CDC Start Listening to Chronic Pain Patients?

By Pat Anson, Editor

Friday’s announcement by the Centers for Disease Control and Prevention (CDC) that it will reconsider and delay implementing its controversial draft guidelines for opioid prescribing throws open a process that’s been largely concealed from the public.

But will it lead to changes in the guidelines themselves? And will the agency start listening to pain patients who fear losing access to opioid pain medication?

There are many different opinions from experts and activists who’ve been closely following the debate.

“A delay will not stop the inevitable, nor will a few months serve as a cooling blanket for the medical professionals and patients that are outraged by the approach CDC has taken on these guidelines.  CDC’s behavior was so outlandish that is caused an avalanche of pushback,” said Jeffrey Fudin, a pharmacist and founder of Professionals for Rational Opioid Monitoring & Pharmacotherapy (PROMPT).

“It is heartening to see that CDC has decided to do now what it really should have done in the beginning, and I hope the result is a set of recommendations that everyone can support,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

“Some have said that this delay is a victory for ‘the opioid lobby,’ but I think it’s not really a victory for anyone; it might be a victory for tried-and-true methods of developing practice guidelines, and a victory for transparency, but a delay in producing reasonable, workable guidelines actually does everyone a disservice. That could have been prevented, had CDC used a proper process from the beginning.”

The process that CDC used in developing the guidelines was unusually secretive and one-sided for a public agency. As Pain News Network has reported, the CDC handpicked outside advisers dominated by special interest groups and addiction treatment specialists, most of whom were determined to rein in opioid prescribing. The CDC’s panel of experts and stakeholders included five board members of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which operates a chain of addiction treatment centers. Few patient advocates and pain physicians were included in the process.

Not surprisingly, the resulting draft guidelines discourage primary care physicians from prescribing opioids for chronic pain. “Non-pharmacological therapy” such as exercise and cognitive behavioral therapy were recommended instead, along with non-opioid drugs such as over-the-counter pain relievers.

The guidelines were unveiled to a select online audience in September and only a brief 48-hour window was allowed for public comment. That sparked an outcry from the pain community. In a survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation, large majorities complained that non-opioid treatments didn’t work for them or were not covered by insurance. Others predicted the guidelines would cause even more addiction and overdoses, not less.

The CDC largely ignored the complaints and said it would continue with plans to implement the guidelines in January, as planned.

Only in recent weeks, when the CDC started getting “feedback” from others did the agency reconsider. It was threatened with a lawsuit by the pro-business Washington Legal Foundation and officials from other federal agencies mocked the guidelines as “ridiculous” and “an embarrassment to the government.”

“CDC appreciates the feedback we have received to date, which has informed and strengthened the document thus far, and we look forward to receiving further input to improve the way opioids are prescribed,” said Debra Houry, MD,  the CDC official in charge of developing the guidelines, in an email Friday to stakeholders.

The agency now says it will reopen the public comment period for 30 days, starting on Monday, December 14th. The draft guidelines will also be reviewed by a scientific advisory panel, which will appoint a new work group to consider changes, a process that could take several months or more.

“I think it's a good idea to get broader input. Some have been critical of CDC, but the criticism has swirled primarily around the process itself, particularly the need for more input. More input can't hurt. It's my sense that the draft guidelines themselves have generally been well-received,” said David Juurlink, MD, a PROP board member who served on one of the CDC’s advisory committees. 

“Regarding the Washington Legal Foundation, I note that they've lobbied previously on behalf of Exxon Mobil, Philip Morris and Purdue Pharma. People can infer from this what they will.”

Jeff Fudin thinks the review process is yet a smokescreen.

“It seems to me that CDC is forming more committees and more layers to shield liability and hide behind their transgressions.  Rather than do this, I’d like to see a committee formed to examine how CDC’s actions around the guidelines happened in the first place, including but not limited to the choice of committee members and all potential conflicts and alliances among participants. Only after we understand how the CDC went awry can a fair scientific board be put in place to avoid a snowball of transgressions,” Fudin said in an email to Pain News Network. 

“The CDC realizes that they created a fire storm with their politically driven guidelines,” said Lynn Webster, MD, past president of American Academy of Pain Medicine. “It is good that they have heard the crescendoing opposition to what they have done.  We will have to see if it is just a maneuver to appease the concerns or if they are truly interested in working to be more inclusive and scientific in developing the guidelines.

“There are two fundamental concerns with the proposed guidelines.  The first is the secretive process and inclusion of advisers who are biased and prejudicial against opioids.  The other major concern is that the recommendations do not match the level of evidence.  This is what is most bizarre from the CDC, since the CDC is supposed to be a scientific body which uses best evidence in proposing health recommendations for the country. They failed to follow this principle in this case.”

Another bizarre part of the process is that – outside of September’s webinar -- the CDC has never made the guidelines available on its website, in a news release, or in any public forum. That will finally change on Monday when the draft guidelines are published in the federal register.

Controversy Grows over Journal Article on Pain Treatment

By Pat Anson, Editor

It’s not uncommon for colleagues in the medical profession to disagree. Egos and different medical backgrounds can sometimes lead to heated discussions about the best way to treat patients. But those arguments are usually kept private. 

That is why it is so unusual for a prominent pain physician to publicly call for another doctor to resign or be fired from her faculty position at a prestigious medical school.

“I believe she should resign her academic post,” says Forest Tennant, MD, referring to Jane Ballantyne, MD, a professor at the University of Washington School of Medicine, who recently co-authored a controversial article in the New England Journal of Medicine (NEJM) that said reducing pain intensity should not be the goal of doctors who treat chronic pain. The article also suggests that patients should learn to accept their pain and move on with their lives.

“For somebody in her position as a professor at a university to call for physicians to quit treating pain – or pain intensity – whether acute, chronic, whether rich, poor, disabled or what have you, is totally inappropriate. And it’s an insult to the physicians of the world and an insult to patients. And frankly, she should not be a professor.” Tennant told Pain News Network.

“To suggest that physicians should no longer treat pain intensity and let patients suffer goes beyond any sort of decency or concern for humanity.”

Tennant is a pain management specialist who has treated patients for over 40 years at his pain clinic in West Covina, California. He’s authored over 300 scientific articles and books, is editor emeritus of Practical Pain Management, and is highly regarded  in the pain community for accepting difficult, hard-to-treat patients that other doctors have given up on.

dr. forest tennant

Tennant was surprised the influential, peer-reviewed New England Journal of Medicine, which reaches over 600,000 people each week, even published the article.

“I know that they’re biased and they’ve got all their medical device people there and all their academia and all that, but I think they have a responsibility also. They are supposedly representing medicine,” says Tennant. “Why do I have a medical degree if I’m not supposed to treat pain intensity? Give me an answer to that. She didn’t have an alternative did she?”

dr. jane ballantyne

Exactly what Ballantyne and co-author Mark Sullivan, MD, meant to say is open to interpretation. Pain News Network has been unable to get comment from either about the controversy.

They began their article by saying “pain that can be relieved should be relieved,” but then veer off in another direction, stating that chronic pain should not be treated with opioid pain medication.

“Is a reduction in pain intensity the right goal for the treatment of chronic pain? We have watched as opioids have been used with increasing frequency and in escalating doses in an attempt to drive down pain scores — all the while increasing rates of toxic drug effects, exposing vulnerable populations to risk, and failing to relieve the burden of chronic pain,” they wrote, dismissing the pain intensity scales that are widely used by physicians to measure pain levels.

“We propose that pain intensity is not the best measure of the success of chronic-pain treatment. When pain is chronic, its intensity isn't a simple measure of something that can be easily fixed.”

Ballantyne and Sullivan offered no alternative “fixes” for pain treatment, other than patients learning to live with pain and sitting down for a chat with their doctors.

“Nothing is more revealing or therapeutic than a conversation between a patient and a clinician, which allows the patient to be heard and the clinician to appreciate the patient's experiences and offer empathy, encouragement, mentorship, and hope,” they wrote.

Angry Comments from Readers

The article infuriated both patients and physicians, including dozens who left angry comments on the NEJM website.

“Great job. I will be going into the coffin business thanks to these believers that people should suck it up. How NEJM even recognizes these people as doctors and not quacks is beyond me,” wrote Michael Shabi, who identified himself as a family practice physician.

“I take just enough narcotic pain meds to cut the edge off of my pain to be coherent enough to love my wife and respond to your constant misinformation. I have had 21 neurological surgeries and procedures and live in constant pain. So why in the heck do you people have such a problem in hearing us?” asked pain patient Kerry Smith.

“Only an idiot might conclude that one can dismiss the effects of living with a healthcare problem that reminds you of its presence with every move you make,” wrote Terri Lewis, PhD, a specialist in rehabilitation.

Both Ballantyne and Sullivan have lengthy careers in medicine and have been active in organizations that discourage the use of opioids. 

According to the University of Washington website, Ballantyne received her medical degree from the Royal Free Hospital School of Medicine in London and trained in anesthesiology at John Radcliffe Hospital in Oxford. She moved to Massachusetts General Hospital in Boston in 1990 and then to the University of Washington in 2011, as a Professor of Education and Research and as Director of the UW Pain Fellowship. 

Last year Ballantyne was named president of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which operates a chain of addiction treatment centers. She also serves as an expert adviser to the Centers for Disease Control and Prevention (CDC) as it develops controversial new guidelines that discourage primary care physicians from prescribing opioids. Ballantyne is one of five PROP board members who are advising the CDC on the guidelines.

Sullivan is a Professor of Psychiatry and Behavioral Sciences -- also at the University of Washington School of Medicine -- and is executive director of Collaborative Opioid Prescribing Education (COPE), a program that educates healthcare providers about safe opioid prescribing practices. He is also a PROP board member.

Sullivan has authored several research articles on opioids, including a recent one warning about the co-prescribing of sedatives and opioids.

“He’s not as well known,” says Tennant. “He doesn’t carry the public influence that she does. She’s sitting on federal committees, advising CDC that pain patients should not be treated and the intensity scale should not be used. I cannot imagine anyone making that statement. I can’t imagine the New England Journal of Medicine publishing it. The atrocity here is just awful.

dr. mark sullivan

“Any semblance of decency left among physicians in PROP, if that’s what they believe, then I think the whole organization ought to close its doors. I didn’t know they were going to say we didn’t want pain treated at all. They said they wanted to use opioids responsibly. Well, that’s fair. But that’s not what she said.”

Tennant is urging the pain community to contact Paul Ramsey, the CEO of UW Medicine and Dean of the School of Medicine to ask that Ballantyne be fired. He’s gotten a few takers, including Becky Roberts, who suffers from arachnoiditis.

“I do not feel she should be teaching new medical students. Professor influence is big when you are a student. I am sure if any one of them read her article, most were probably shocked,” Roberts said in an email to Pain News Network.

“They did not get into medicine because they are uncaring. Compassion for other human beings is why they went to medical school. To help heal human beings is their goal. I really do think she needs to be removed from that position. How long has she been teaching this kind of logic?”

The UW School of Medicine has about 4,500 students enrolled in undergraduate, professional, and post-graduate programs. 

Can Marijuana Help Treat Heroin Addicts?

By Pat Anson, Editor

There’s a new twist to the rising use of heroin in the United States – and what can be done to help addicts in recovery.

A recent study by researchers at Columbia University found that medical marijuana improves the treatment outcome of heroin addicts. Patients who were given dronabinol -- a prescription drug that contains THC, the active ingredient in marijuana -- had lower withdrawal symptoms compared than those given a placebo. In addition, patients who smoked marijuana regularly during the outpatient phase of treatment had fewer sleeping problems, less anxiety and were more likely to finish treatment.

"One of the interesting study findings was the observed beneficial effect of marijuana smoking on treatment retention," the researchers concluded.

"Participants who smoked marijuana had less difficulty with sleep and anxiety and were more likely to remain in treatment as compared to those who were not using marijuana, regardless of whether they were taking dronabinol or placebo."

The Columbia study appears in the journal Drug and Alcohol Dependence.

According to High Times, several other studies have reached similar conclusions. Studies at the New York Psychiatric Institute found that opiate addicts who consumed marijuana intermittently were less likely to start using opioids again, compared to those who never used marijuana or used it habitually.

Earlier this year, researchers at the RAND Corporation and the University of California, Irvine reported similar results in a study for the National Bureau of Economic Research – going so far as to suggest that marijuana is a good substitute for opioid pain medication.

“Many medical marijuana patients report using marijuana to alleviate chronic pain from musculoskeletal problems and other sources. If marijuana is used as a substitute for powerful and addictive pain relievers in medical marijuana states, a potential overlooked positive impact of medical marijuana laws may be a reduction in harms associated with opioid pain relievers,” they wrote. “We find that states permitting medical marijuana dispensaries experience a relative decrease in both opioid addictions and opioid overdose deaths compared to states that do not.”

And what happens in states where regulations make it harder to obtain prescription opioid medication?

There were unintended consequences in Washington, one of the first states in the country to impose strict new guidelines on opioid prescribing. From 2008 to 2014, the number of deaths from prescription opioids in Washington fell from 512 to 319. But over the same period, the number of heroin deaths almost doubled, to nearly 300.

But the surge in heroin use wasn’t confined to Washington. According to the National Survey on Drug Use and Health, the number of heroin users nationwide rose from 161,000 in 2007 to 289,000 in 2013, an increase of nearly 80%. During the same period, the U.S. Centers for Disease Control and Prevention (CDC) reported the number of poisoning deaths involving heroin rose from 3,041 to 8,257, an increase of 172%.

“There is no robust evidence that recently enacted policies regarding prescription opioids are responsible for large-scale shifts to heroin,” the CDC’s Courtney Lenard recently told Alcoholism & Drug Abuse Weekly. Only about 1 in 25 people who use prescription opioids recreationally start using heroin within five years, she said.

Should Patients Learn to Live with Chronic Pain?

By Pat Anson, Editor

Chronic pain patients should learn how to live with their pain and pain relief should not be the primary focus of doctors who treat them, according to two influential physicians in a commentary published in the New England Journal of Medicine.

“Is a reduction in pain intensity the right goal for the treatment of chronic pain?” ask Jane Ballantyne, MD, and Mark Sullivan, MD. "We have watched as opioids have been used with increasing frequency and in escalating doses in an attempt to drive down pain scores — all the while increasing rates of toxic drug effects, exposing vulnerable populations to risk, and failing to relieve the burden of chronic pain at the population level."

“We propose that pain intensity is not the best measure of the success of chronic-pain treatment. When pain is chronic, its intensity isn't a simple measure of something that can be easily fixed," they wrote in answer to their question.

Ballantyne is President of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to end the overprescribing of opioid pain medication. She is also a member of the “Core Expert Group” the Centers for Disease Control and Prevention (CDC) is consulting with in drafting new guidelines for opioid prescribing.

Sullivan is a professor of Psychiatry and Behavioral Sciences at the University of Washington School of Medicine, and is executive director of Collaborative Opioid Prescribing Education (COPE), a program that educates healthcare providers about safe opioid prescribing practices.

In their commentary, Ballantyne and Sullivan say it’s a mistake for doctors to treat chronic pain sufferers the same way they would treat patients who are terminally ill or have short-term acute pain. They also recommend that doctors be less reliant on pain scales, such as the Wong-Baker pain scale, to measure pain intensity.

“Reliance on pain-intensity ratings tends to result in the use of opioid treatment for patients with mental health or substance abuse problems who are least likely to benefit from opioid treatment and most likely to be harmed by it,” they wrote.

“Borrowing treatment principles from acute and end-of-life pain care, particularly a focus on pain-intensity scores, has had unfortunate and harmful consequences. The titrate-to-effect principle fails when pain is chronic, because our best chronic-pain treatments don't produce an immediate or substantial change in pain intensity.”

Instead of relying on opioids for pain relief, Ballantyne and Sullivan say chronic pain patients need “multimodal treatment” that includes physical and behavioral therapy. They also stress that patients should learn to accept pain and get on with their lives.

“Many of the interdisciplinary and multimodal treatments recommended in the National Pain Strategy use coping and acceptance strategies that primarily reduce the suffering associated with pain and only secondarily reduce pain intensity. Willingness to accept pain, and engagement in valued life activities despite pain, may reduce suffering and disability without necessarily reducing pain intensity,” they wrote.

Ballantyne is one of five PROP board members who are advising the CDC about its opioid prescribing guidelines. Those guidelines, which recommend “non-pharmacological” and non-opioid treatments for chronic pain, are scheduled to be finalized in January 2016. A draft version of the guidelines was released in September and can be found here.

In a survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation, 9 out of 10 said more people will suffer than be helped by the guidelines. Large majorities also predicted that doctors would prescribe fewer or no opioids, there would be more suicides in the pain community, and that the guidelines will result in more addiction and overdoses, not less.

Will CDC Guidelines Promote Addiction Treatment?

By Alison Knopf, Editor of Alcoholism & Drug Abuse Weekly

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

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

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

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

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

SAMHSA Working With CDC

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

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

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

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

Guidelines Not Mandatory

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

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

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

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

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

Most Americans Touched by Opioid Abuse

By Pat Anson, Editor

Over half of Americans say they know someone who has abused, been addicted to, or died from an overdose of opioid pain medication, according to a new survey by the Kaiser Family Foundation.

The survey also found a surprising awareness among many Americans that it is easier for abusers to get access to opioids than it is for pain sufferers. Three out of four (77%) believe it is easy for people to get access to prescription opioids without a prescription.  

“The perception among the public is that the balance is currently in the abuser’s favor. More of the public says it’s easy for people to get access to painkillers not prescribed to them than say it is easy for people who medically need them,” the Kaiser report says.

Over half (58%) of Americans believe it is very easy or somewhat easy to get prescription opioids for medical purposes.

Over a third (40%) believe it is somewhat difficult or very difficult for a patient to get an opioid prescription.

Kaiser surveyed over 1,350 Americans adults by telephone in mid-November for its monthly tracking poll. For the first time the survey included questions about the public’s awareness and attitude about painkiller abuse.

The survey found that whites were far more likely than African-Americans or Hispanics to have a “personal connection” to the abuse of opioids. Nearly two thirds (63%) of whites said they know someone who has abused, been addicted to, or died from an overdose of painkillers. That compares to 44% of African-Americans and 37% of Hispanics.

That finding appears to support evidence of a surprising spike in the death rate of middle aged white Americans that was uncovered by two Princeton University researchers. They estimate that nearly half a million white baby boomers died early between 1999 and 2013, coinciding with a spike in the prescribing of opioid painkillers. Financial stress, pain and disability are also believed to have played a role in the those deaths.

Other findings in the Kaiser survey:

• 16% of Americans know someone who has died from a prescription opioid overdose
• 9% know a family member or close friend who died from an opioid overdose
• 27% know someone who has been addicted to opioids
• 2% admit they are addicted to opioids  
• 45% know someone who has taken an opioid not prescribed for them
• 6% admit taking an opioid not prescribed for them

The survey also found that the public was divided over the role government should have in addressing prescription painkiller abuse. Over a third (36%) believe the federal government should be primarily responsible, while 39% believe state government and 16% believe local government should be responsible for solving the problem.

FDA Speeds Approval of Naloxone Nasal Spray

By Pat Anson, Editor

It usually takes years for the Food and Drug Administration to approve a new medication.

But it took less than four months for the agency to give the okay to Narcan, the first FDA approved nasal spray containing naloxone, an emergency life-saving medication that can stop or reverse the effects of an opioid overdose.

Opioids – both legal and illegal – can suppress breathing and cause sleepiness. When someone overdoses on an opioid they may fall asleep and be hard to wake, and their breathing can become shallow or even stop – leading to brain damage or death. If naloxone is administered quickly, it can counter the overdose effects, usually within two minutes.

“Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, MD, acting commissioner of the FDA. “While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose.”  

image courtesy of adapt pharma

Until now, naloxone was only approved in injectable forms, usually in a syringe or auto-injector. Many first responders and emergency room physicians felt a nasal spray formulation of naloxone would be easier and safer to deliver.

Narcan does not require assembly and delivers a consistent, measured dose of naloxone. It can be used on adults or children, according to the FDA, and is easily administered by anyone. The drug is sprayed into one nostril while the patient is lying on their back, and can be repeated if necessary.

The FDA granted fast track review of Narcan in July after a getting a new drug application from a unit of Adapt Pharma, which is based in Ireland.  In clinical trials, a single 4 mg dose of Narcan delivered the same levels of naloxone in about the same amount of time as an injection.

“We heard the public call for this new route of administration, and we are happy to have been able to move so quickly on a product we are confident will deliver consistently adequate levels of the medication – a critical attribute for this emergency life-saving drug,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

The use of Narcan in patients who are opioid dependent may result in severe withdrawal symptoms, such as body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, sweating, nausea or vomiting, shivering and abdominal cramps.

Adapt Pharma says Narcan will be available after the first of the year and will initially have a “public interest price” of $75 for a package of two doses when ordered by public health  organizations.  The company has not disclosed pricing for other purchasers using private insurance or paying in cash.

“Anyone who uses prescription opioids for the long term management of chronic pain, or those who take heroin, are potentially at risk of experiencing a life-threatening or fatal opioid overdose where breathing and heart beat slow or stop,” the company said in a statement.

Study Calls for End to ‘Permissive’ Opioid Prescribing

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Women More Likely to Get Addicted to Pain Meds

Pat Anson, Editor

Over half the women being treated for addiction at methadone clinics in Canada say their first experience with opioids was a pain medication prescribed by a doctor, according to a new study.

Researchers at McMaster University in Hamilton recruited over 500 men and women being treated for opioid dependence at 13 clinics in Ontario. The aim of the study, which is published online in the journal Biology of Sex Differences, was to identify any significant gender differences between men and women attending the clinics. Participants provided researchers with detailed information about their health and lifestyle, as well as urine tests to measure their use of illicit and legal drugs.

Compared to men, women were found to have more physical and psychological health problems, more childcare responsibilities, and were more likely to have a family history of psychiatric illness.

While over half the women (52%) and about a third (38%) of the men reported doctor-prescribed painkillers as their first contact with opioids, only 35% of participants said they suffered from chronic pain during the study period.

"It's not clear why women are disproportionately affected by opioid dependence originating from prescription painkillers - it could be because they're prescribed painkillers more often due to a lower pain threshold, or it might simply be because they're more likely than men to seek medical care,” said lead author Monica Bawor of McMaster University.

“Whatever the reasons, it's clear that this is a growing problem in Canada and in other countries, such as the U.S., and addiction treatment programmes need to adapt to the changing profile of opioid addiction."

Only about a third (36%) of the study participants were employed or had completed a high school education (28%).

Men were more likely than women to be employed, and were more likely to smoke cigarettes. Men were also more likely to report having smoked marijuana, although rates of marijuana use were relatively high among both men and women, Nearly half (47%) said they had used marijuana in the month prior to the study.

"Most of what we currently know about methadone treatment is based on studies that included few or no women at all. Our results show that men and women who are addicted to opioids have very different demographics and health needs, and we need to better reflect this in the treatment options that are available,” Bawor said.

"A rising number of women are seeking treatment for opioid addiction in Canada and other countries yet, in many cases, treatment is still geared towards a patient profile that is decades out of date - predominantly young, male injecting heroin, and with few family or employment responsibilities."

Compared to studies from the 1990s, the average age of patients being treated for opioid addiction is older (38 vs. 25 years of age), and patients also started using opioids at a later age (25 vs. 21 years). There was a 30% increase in the number of patients becoming addicted to opioids through doctor-prescribed painkillers.

The number of opioid painkiller prescriptions has doubled in Canada over the last two decades. According to the World Health Organization, Canada consumes more opioid painkillers per capita than any other country.

Are Opioids or Economics Killing White Americans?

By Pat Anson, Editor

Opinions are all over the map about a recent study by two Princeton University researchers, who estimate that nearly half a million white Americans died in the last 15 years due to a quiet epidemic of pain, suicide, alcohol abuse and opioid overdoses.

The husband and wife research team of Angus Deaton and Anne Case were careful not to point a finger at any one cause, but speculated that financial stress caused by unemployment and stagnant incomes may be behind the rising mortality of middle-aged whites. The deaths were concentrated in baby boomers with a high school education or less.

But some were quick to blame the “opioid epidemic.”

“An opioid overdose epidemic is at the heart of this rise in white middle-age mortality,” wrote psychiatrist Richard Friedman, MD, in an editorial that appeared in the New York Times under the headline “How Doctors Helped Drive the Addiction Crisis.”

“Driving this opioid epidemic, in large part, is a disturbing change in the attitude within the medical profession about the use of these drugs to treat pain,” said Friedman. “It is physicians who, in large part, unleashed the current opioid epidemic with their promiscuous use of these drugs; we have a large responsibility to end it.”

And what should doctors do to end the epidemic?

Friedman said there was “strong evidence” that Motrin, Tylenol and other nonsteroidal anti-inflammatory drugs (NSAIDS) were “safer and more effective for many painful conditions than opioid painkillers.”

The Fresno Bee took a more nuanced view of what it called “the epidemic of pain and heartbreak.”

“If ever a set of numbers cried out for deeper examination, it is this one. Human frailty may be epidemic, but surely it is also no surprise that a generation raised with the expectation of a secure future might sink into depression, hostility, illness, anguish and rage when that future fails to transpire,” The Bee said in an editorial. “Whether the solution is better jobs, cheaper schools, more mental health care or less reliance on painkillers, the distress of America’s white working class has become a public health crisis.”

“White Americans who used to be able to support a family are now struggling even in dual income households, and there's a corresponding loss in stature and self-esteem. They are turning to prescription opioids in greater numbers than minorities,” said the Baltimore Sun. “The transition to a 21st (century) economy is literally killing some people, and the United States can ill afford to ignore this disturbing development.”

Overseas news outlets also tended to blame the rising death rate on a “ruthless economy.”

“These people are dying because history has unexpectedly thrown them on the scrapheap,” said The Guardian. “White baby boomers had high expectations of the future, yet many of them have lived to discover that they will be worse off than their parents.”

“(The) findings should awaken Americans to the price we pay for pursuing economic policies that enrich the few at the expense of the many,” said David Cay Johnston in a column for Al Jezeera America. “The harsh reality is that our economy is in many ways stuck in 1998 and that for poorly educated Americans, the economy has become a living nightmare with no expectation of a brighter tomorrow. The rise in drug and alcohol poisonings as well as the rising tide of suicides should not surprise. But these trends should disturb.”

What do you think? Is the economy to blame for the increasing number of deaths? Or is it opioids?

CDC: We Need Safer, More Effective Pain Relief

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

By Debra Houry, MD, Guest Columnist

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Feds Unveil Opioid Mapping Tool

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Opioid Use Stabilized in U.S. Decade Ago

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

What’s Killing Middle-Aged White Americans?

By Pat Anson, Editor

A quiet epidemic of chronic pain, suicide, alcohol abuse and drug overdoses has killed a “lost generation” of nearly half a million middle aged white Americans in the last 15 years, according to a startling new study by Princeton University researchers.

Using data culled from a variety of sources and reports, researchers found a disturbing increase in the death rate for whites aged 45 to 54. Between 1999 and 2013, the mortality rate for middle aged whites rose by 2% annually, a reversal from previous decades when their death rate declined by an average of 1.8% a year.

The spike in mortality is estimated to have led to the early deaths of 488,500 white Americans, a figure comparable to the number of deaths caused by the AIDS epidemic.

 “This change reversed decades of progress in mortality and was unique to the United States; no other rich country saw a similar turnaround,” researchers Anne Case and Angus Deaton wrote in the study published in the Proceedings of the National Academy of Sciences. “This increase for whites was largely accounted for by increasing death rates from drug and alcohol poisonings, suicide, and chronic liver diseases and cirrhosis.”

No other race or ethnic group saw such an increase in mortality. African-Americans, Hispanics and those aged 65 and older continued to see their mortality rates fall.

The rising death rate for middle-aged whites was accompanied by declines in physical health, mental health and employment, as well as increases in chronic joint pain, neck pain, sciatica and disability.

It also coincided with a sharp increase in the prescribing of opioid pain medication, and seems likely to fuel a chicken and egg debate over which came first.

“The epidemic of pain which the opioids were designed to treat is real enough, although the data here cannot establish whether the increase in opioid use or the increase in pain came first. Both increased rapidly after the mid-1990s. Pain prevalence might have been even higher without the drugs, although long-term opioid use may exacerbate pain for some, and consensus on the effectiveness and risks of long-term opioid use has been hampered by lack of research evidence,” wrote Case and Deaton.

“Pain is also a risk factor for suicide. Increased alcohol abuse and suicides are likely symptoms of the same underlying epidemic, and have increased alongside it, both temporally and spatially.”

“The findings are astonishing, and a testament to the enormous toll opioids are taking in the U.S.,” said David Juurlink, MD, who heads the Division of Clinical Pharmacology and Toxicology at the University of Toronto. “It is very difficult to argue against cause-and-effect here. In my view it is a damning indictment of the widespread use of opioids for chronic pain, and should cause prescribers and patients alike to reflect on the role of these drugs, which have essentially no evidence behind them.”

Juurlink, who is a board member of Physicians for Responsible Opioid Prescribing (PROP), is advising the Centers Disease for Disease Control and Prevention (CDC) about its draft guidelines for the prescribing of opoids. He says it’s no coincidence that deaths in middle-aged whites rose just as opioid prescribing increased.

“It is an unarguable fact that opioids play a causal role in a good many of these deaths. People have drunk alcohol to excess for millenia, and have taken benzodiazepines needlessly for decades. And yet we see a striking surge in poisoning deaths coincident with surging opioid sales,” Juurlink wrote in an email to Pain News Network.

“As for suicide, you can put me on the record as speculating that opioids trigger suicide in some patients, and perhaps quite a high number. I raise this point because it's sometimes asserted that opioids can prevent suicide in patients with chronic pain. There is no evidence that this is true, but there are ample grounds to assert that they might in fact be a component cause.”

Another recent study published in JAMA found that drug overdose deaths associated with opioids nearly doubled in the last decade, rising from 4.5 deaths per 100,000 people in 2003 to 7.8 deaths per 100,000 in 2013.

But others says opioids are the not the cause of rising deaths, but more a symptom of a deeper problem.

“I can tell you absolutely that opioids do not lead this dysfunction.  Abuse, addiction, disability, and suicide are symptoms of a failing healthcare system,” says Terri Lewis, PhD, a rehabilitation specialist and patient advocate. “This population of white Americans has also been largely uninsured or underinsured.  They turn to self medication practices that involve alcohol because that is what is available.  Their acute care is often dependent on emergency room services where there is no continuity or recovery model in place.”

Deaths Hit Least Educated Hardest

The Princeton study found that death rates related to drugs, alcohol and suicides rose for middle-aged whites at all education levels, but the largest increases were seen among those with the least education. For those with a high school degree or less, deaths caused by drug and alcohol poisoning rose fourfold; suicides rose by 81 percent; and deaths caused by liver disease and cirrhosis rose by 50 percent.

“All cause” mortality rose by 22% for this least-educated group. Those with some college education saw little change in overall death rates, and those with a bachelor's degree or higher actually saw death rates decline.

The researchers speculated that financial stress may have played a role in the rising death rate. Median household incomes of whites began falling in the late 1990s, and wage stagnation hit especially hard those with a high school or less education.

“These were folks who were also disproportionately represented in the downturn of the economy and loss of jobs from rural communities,” says Lewis. “When the economy failed, their disability and reduced level of functioning did not allow them to migrate into other locations or jobs – their educational levels and physical limitations simply imposed too much of a barrier.  The loss of employment put many onto the disability roles.” 

The rise in mortality occurred in all regions of the U.S., although suicide rates were marginally higher in the South and West than in the Midwest and Northeast. In each region, death by way of accidental drug and alcohol poisoning rose at twice the rate of suicide.

In all age groups researchers said there were marked increases in deaths related to drug and alcohol poisoning, suicide and chronic liver disease and cirrhosis. The midlife group differed only in that the number of deaths was so large that it changed the direction of their overall mortality.

If that trend is not reversed, researchers warn, there will be an enormous cost to the healthcare system. 

“A serious concern is that those currently in midlife will age into Medicare in worse health than the currently elderly. This is not automatic; if the epidemic is brought under control, its survivors may have a healthy old age. However, addictions are hard to treat and pain is hard to control, so those currently in midlife may be a ‘lost generation’ whose future is less bright than those who preceded them,” they said.