A Pain Patient's Perspective on Opioid Prescribing

By Barby Ingle, PNN Columnist

It is essential to prescribe pain treatments that are appropriate and effective for each patient. I say that based on my own experiences as a patient, as well as thousands of others I have spoken with over the years as a friend and advocate.

Patients who need opioids, benzodiazepines, antidepressants and other medications should have access to them -- just as a heart patient has access to medication that keeps their heart functioning or a diabetic needs access to insulin.

People living with pain should also be offered individualized treatment. That could be anything from physical therapy and analgesics to surgical procedures and alternative therapies like acupuncture. I have tried over 100 different types of pain treatment; some have worked and others have not. It often made me feel like a guinea pig. Unnecessary surgery hurt me most in the end.

There are many public education campaigns underway to prevent addiction and overdoses by reducing the use of prescription opioids. These campaigns are repeated in the media, but the information does not always include facts or is presented in a misleading way.

For example, there is the DEA’s “One Pill Can Kill” campaign, which is aimed at raising awareness about a surge in counterfeit pills made with illicit fentanyl and other street drugs. Another is the CDC’s “Rx Awareness” campaign, which shares the stories of people whose lives were impacted by prescription opioids. The overall theme is that opioids are “addictive and dangerous.”  

Although well-intentioned, these campaigns have a tendency to demonize FDA-approved medications that have a lot of science and research behind them. Most people are unaware that fentanyl has been used safely and effectively for decades to treat severe pain and as an analgesic in millions of surgeries. Saying “one pill can kill” to a pain patient who has improved their life with a legally prescribed medication is disheartening.

I have seen this misinformation firsthand over the years and how it has put a damper on opioid prescribing. Physicians should prescribe opioids for pain when appropriate, but many are afraid to do so because of potential sanctions and legal threats. As a result, many providers won’t prescribe opioids or will only do so minimally and as a last resort.

Individualized Treatment

I believe each patient is different and should be treated as such. We need providers to operate on the assumption that each individual is unique and requires something different, even when they have the same disease or injury as someone else.

Physicians today can use pharmacogenomics to see if a patient’s DNA can affect how they respond to a treatment or what is chemically right for them. The dosage, brand, procedure and frequency will vary depending on each patient. I often bring my pharmacogenomics information to communicate more effectively with my providers, which benefits us both.

I also know that doing what is least invasive first and then progressing to other options is essential. Sometimes, surgery is the best option. Sometimes, opioids or other pain medications should be used first. Every medical provider should work at finding the treatment that most effectively suits the patient.

It is a considered best practice to prescribe opioids to someone in severe pain from sickle cell disease. Yet, when many sickle cell patients go to the ER or are admitted to a hospital, they are denied opioids because of hospital policy. What is the point of having a trained medical providers on staff if you won’t let them treat a patient the way they should be?

Denying pain relief is not only cruel, it can be the worst practice for everyone involved. For example, a man in severe chronic pain committed suicide after a doctor at a Kentucky pain clinic cut his opioid dose in half. The man’s family filed a lawsuit and won a $7 million judgement against the doctor and clinic.  

Ultimately, it should be the patient's responsibility to weigh the risks and benefits of any treatment, after getting input from their provider and conducting due diligence. Unfortunately, there are many obstacles standing in the way of that. One of the biggest is finding a doctor willing to prescribe pain medication. In addition, there are insurance restrictions, the cost of medication, and other logistical issues such as transportation to appointments.

Here in Arizona, patients must see their provider every month to renew a prescription for a controlled substance. Policies like that were put in place to “protect” pain patients, but only added extra costs, burdens and stigmas to them.

Patient-Physician Communication

How can we change the narrative about opioid prescribing? We can start by emphasizing the importance of effective communication between physicians and patients, even those as young as elementary school. Early education on how to talk to medical professionals and advocate for yourself is vital. I see this as one of the most critical things for patients to do.

Communication and trust are essential. Patients need to know when to take medication, how much to take, and what the potential side effects are. They also need to be able to express how the medication is working and what their symptoms are. Patients should feel comfortable asking questions and discussing their pain management plan. Physicians need to listen, provide feedback and give advice when needed.

Individualized treatment plans should be tailored to the patient’s age, gender, medical history, lifestyle and other factors.  That will help ensure that the treatment is effective and also reduce the risk of adverse reactions and potential complications. Collaborative decision-making makes patients feel more comfortable, confident in their treatment plan, and more likely to follow it.

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and the founder and former President of the International Pain Foundation. You can follow Barby at www.barbyingle.com. 

Supreme Court Case May Decide Future of Opioid Prescribing

By Pat Anson, PNN Editor

Over a dozen patient and physician advocacy groups have filed legal briefs with the U.S. Supreme Court in support of two doctors appealing their convictions for criminal violations of the Controlled Substances Act.

The nation’s high court has consolidated the cases of Dr. Xiulu Ruan of Alabama and Dr. Shakeel Kahn, who practiced in Wyoming and Arizona. Both doctors were sentenced to lengthy prison terms after being convicted on a variety of charges – including the prescribing of high doses of opioid pain medication to patients “outside the usual course of professional practice.”

Oral arguments will be heard by the Supreme Court on March 1, with a decision expected later in 2022. Monday was the deadline for interested parties to file “amicus curiae” briefs on the case, which could have a significant impact on opioid prescribing practices nationwide if the appeals are successful. Many doctors have stopped or reduced their prescribing of opioids because they fear being prosecuted under the Controlled Substances Act (CSA).

“It is no exaggeration to say that CSA prosecutions of physicians have already impaired the treatment of chronic pain,” Ruan’s attorneys said in their appeal. “In response to the opioid crisis, fear of prosecution has increasingly prompted pain management doctors to avoid or reduce opioid prescriptions, even when those decisions leave chronic pain patients without recourse.”

A successful appeal would mean Ruan and Kahn could ask for new trials, along with dozens of other doctors convicted of similar charges under the CSA.

“It will also avoid what I see as the chilling effect that it’s had on lots of doctors who are not doing anything even remotely suspicious, but are afraid that they are going to get caught because they prescribe a higher dose, and so they’re dropping people from care or tapering them,” said Kate Nicholson, Executive Director of the National Pain Advocacy Center (NPAC).

NPAC, along with other advocacy groups and the U.S. Chamber of Commerce, are asking the high court to clearly state how the practice of medicine should be regulated under the CSA. Some argued it is best left to state medical boards, not federal prosecutors or law enforcement.

“Patients with pain, addiction, or both desperately need appropriate care and treatment. If practitioners are held strictly liable under (the CSA), patient abandonment will become ever more common as practitioners act to avoid scrutiny,” Jennifer Oliva and Kelly Dineen, professors of health law and policy, said in their brief. “Progress in medical care in these areas can only recover if the regulation of medical practice is returned to the province of the states except in narrow circumstances.”

‘Good Faith’ Practice

At issue in the Ruan/Kahn case is what constitutes the “standard of care” and “usual course of professional practice” under the CSA. Doctors traditionally have been given wide latitude in determining what’s appropriate for a patient, as long as they act in “good faith” with a medical purpose. But that laissez-faire approach came to an end as the overdose crisis intensified and doctors came under more scrutiny for their opioid prescribing practices. 

“No other country criminalizes physician behavior like the federal prosecutors have done in the US. This is especially the case as these prosecutions are all based on a whim with an ‘expert’ opinion rendered by a hired government expert and orchestrated by a new generation of overzealous and unchecked federal prosecutors pointing fingers at wealthy doctors as greedy drug pushers and fraudsters,” Physicians Against Abuse argued in its brief.

“Doctors are just a ‘sitting duck’ for these federal prosecutors who raid medical offices and unlike the career drug pusher on the streets who gets caught and charged with one or two counts, federal prosecutors pile up count after count because doctors are required to keep records and those records are used against them in these out of control prosecutions against physicians.”  

Pain Clinic ‘Factory’

Complicating Ruan’s appeal is that he often gave patients Subsys, an expensive and potent fentanyl spray that was only approved by the FDA for breakthrough cancer pain. Ruan prescribed Subsys “off label” to patients who didn’t have cancer, which made him an easy target for federal prosecutors who were building a massive fraud and bribery case against Insys Therapeutics, the manufacturer of Subsys.

In his new book, “The Hard Sell: Crime and Punishment at an Opioid Startup,” author Evan Hughes depicts Ruan as a greedy and ruthless physician who was more interested in acquiring luxury cars and Insys stock than he was in treating patients. According to Hughes, Ruan and his business partner ran their pain clinic and adjoining pharmacy like a factory.

“Instead of collecting a mere $200 or so for an office visit, Couch and Ruan treated each patient as a profit center, an opportunity to bill for tests and procedures in-house, or to refer out to some other provider who would cut them in on the business. They reinvested to grow their factory, buying new machines that added lucrative capabilities,” Hughes wrote.

In addition to the charges against him under the CSA, Ruan was convicted of taking kickbacks from Insys in exchange for prescribing “massive quantities” of Subsys. Ruan was one of the top prescribers of Subsys in the United States.

Kahn was convicted of more than 20 counts involving excess prescribing of oxycodone and other controlled substances, and running a criminal enterprise that resulted in the death of a patient. When federal agents raided his properties in Wyoming and Arizona, they found firearms and over $1 million in cash.

Advocates hope the Supreme Court will overlook the seedier aspects of both cases and rule in a way that clearly defines the rights of doctors under the CSA to prescribe medications they deem appropriate.

“I think our biggest concern is having the correct standard moving forward so that doctors have space to practice medicine appropriately and patients stop suffering,” Nicholson told PNN. “My guess is that they’ll do something to clarify, but how objectively or subjectively they go, I think that’s anyone’s guess.”  

How to End the ‘Opioid Paradox’

By Pat Anson, PNN Editor

Three public health and pain management experts are calling for a major shift in strategy to combat the U.S. opioid crisis, one that doesn’t just focus on pill counts and punishing doctors deemed to be “overprescribing” opioids.

In an op/ed recently published online in Anesthesiology, the official journal of the American Society of Anesthesiologists, Editor-in-Chief Evan Kharasch, MD, Editor J. David Clark, MD,  and former U.S. Surgeon General Jerome Adams, MD, said current policies are failing to address what they call the “opioid paradox” --- how opioid overdose deaths have risen to record levels even as opioid prescribing has fallen to 20-year lows.

SOURCE: ANESTHESIOLOGY

“Overall, the nation’s response to the oral opioid crisis has been to tighten patient supplies and impose institutional and practitioner quality indicators based on pill counts. Governments, payers, and pharmacies have assumed authority for limiting opioid prescribing, often in indiscriminate ways, based on misinterpretation of Centers for Disease Control guidelines or based on no real guidance at all,” they wrote.

“Pill counts have become de facto standards employed by healthcare organizations to highlight their success in reducing opioid use, yet there is no discussion of how those reductions are affecting patient outcomes. One crucial problem is that agencies mandating policy restrictions do not measure, nor are they accountable for, patient outcomes. Mandated opioid prescribing limits may be too low to adequately control pain, or too high to reduce oversupply.”

The three authors say more novel and comprehensive approaches are needed to better manage the supply of prescription opioids, prevent diversion and address the opioid paradox.

“It involves immediate action to address opioid use, storage, return, and harm reduction, with a specific focus on patients and communities,” they explained.

Reduce Demand

In recent years, federal and state agencies, healthcare organizations and insurers have created new guidelines for treating pain – many of which take a one-size-fits-all approach to opioid prescribing that doesn’t take into account an individual patient’s needs.   

“Legislative, regulatory, and insurer limitations on opioid prescribing alone have not met their intended goals and are considered unlikely to achieve them. One reason is that they impose tight restrictions on an extremely heterogeneous patient population,” the authors said.

Rather than limiting or withholding opioids after surgery – which has become increasingly common --  Drs. Kharasch, Clark and Adams urge anesthesiologists and surgeons to provide patients with enough opioids for adequate pain relief, because undertreated acute pain can turn into chronic pain and become a risk factor for opioid misuse.

Smaller opioid doses may be effective in treating postoperative pain, the authors said, if they are combined with multimodal strategies that also employ non-opioid medications and therapies. So too may the use of longer-acting opioids such as methadone, which can result in less postoperative pain and relief that lasts for weeks or months after a single dose.

Proper Disposal of Leftover Pills

Hundreds of millions of opioid pills are dispensed to patients but go unused each year, according to the authors. Most leftover pills are kept by patients and few are safely stored. Only a fraction are disposed of properly or returned.

"The current difficulty of returning prescription opioids contrasts markedly with the ease of obtaining them. This is illogical and unsafe," Drs. Kharasch, Clark and Adams said.

They believe pharmacies that dispense opioids should be required to provide patients with instructions for proper return and disposal; the addresses and telephone numbers of disposal stations; and a pre-addressed, prepaid envelope for returning unused pills. Disposal stations should be available year-round, not just on “Prescription Drug Take Back” days.

Another novel approach would be opioid “buy-back” programs, similar to the gun buy-backs used by law enforcement agencies to get unneeded firearms off the street. One pilot compensation program for opioids found that 30% of surgery patients were willing to participate in buy-backs, selling their leftover opioids for up to $50.

Partial Fills

Kharasch, Clark and Adams also suggest more partial filling of opioid prescriptions. A 2016 federal law allows both patients and clinicians to request partial filling of prescriptions for hydrocodone, oxycodone and other strong Schedule II opioids. Partial filling for schedule III–V weaker opioids has been permitted for decades, but is not widely practiced.

According to one estimate, 36 million postoperative opioid prescriptions could be partially filled each year. One hurdle for partial fills is the extra paperwork and cost to pharmacies, estimated at $15 for each prescription.

“Partial opioid fills could be the single most effective intervention to deplete America’s medicine cabinets of unused prescription opioid pills, shrink the opioid pool, improve the prescription opioid ecosystem, and prevent misuse, diversion, and death,” the authors said. 

Kharasch, Clark and Adams place an emphasis on reducing diversion, even though less than one percent of legally prescribed opioids are diverted, according to the DEA. Partial fills may reduce leftover pills in medicine cabinets, but they won’t do anything to prevent the wholesale theft of opioids from hospitals, pharmacies and the pharmaceutical supply chain.

The authors also buy into the myth that most street drug users start with prescription opioids, and that pain patients denied opioids “switch to illicit drugs” and fentanyl-laced counterfeit pills.

But Kharasch, Clark and Adams do have some interesting ideas about addressing the opioid paradox – chief among them the long overdue recognition that current opioid reduction strategies have been a complete failure.

“Attempts to solve the problem by restricting patient supply alone have not succeeded, and the prescription opioid pool remains large. Additional novel efforts to shrink the pool are needed, both by diminishing demand (reducing pain through better treatment) and by facilitating opioid disposal and return,” they concluded.

Walmart Sues Feds Over Prescribing Regulations

By Pat Anson, PNN Editor

In an unusual move, Walmart has filed a lawsuit against the Department of Justice and Drug Enforcement Administration, asking a federal court to clarify the “roles and legal responsibilities of pharmacists and pharmacies” in filling opioid prescriptions.

“We are bringing this lawsuit because there is no federal law requiring pharmacists to interfere in the doctor-patient relationship to the degree DOJ is demanding, and in fact expert federal and state health agencies routinely say it is not allowed and potentially harmful to patients with legitimate medical needs,” the company said in a statement.

Walmart and other pharmacy chains are defendants in multiple class action lawsuits alleging the companies helped fuel the opioid crisis by dispensing opioids irresponsibly. They have also been fined tens of millions of dollars by the DEA for lax controls on opioid prescriptions. According to ProPublica, federal prosecutors in Texas even sought criminal charges against Walmart, but were overruled by top officials at the Department of Justice.

Walmart is the largest retailer in the world and operates over 5,000 in-store pharmacies in the United States. The company said it filed suit against the DOJ and DEA because it was caught “between a rock and a hard place” over opioid prescribing.    

“Unfortunately, certain DOJ officials have long seemed more focused on chasing headlines than fixing the crisis. They are now threatening a completely unjustified lawsuit against Walmart, claiming in hindsight pharmacists should have refused to fill otherwise valid opioid prescriptions that were written by the very doctors that the federal government still approves to write prescriptions,” Walmart said.

“At the same time that DOJ is threatening to sue Walmart for not going even further in second-guessing doctors, state health regulators are threatening Walmart and our pharmacists for going too far and interfering in the doctor-patient relationship. Doctors and patients also bring lawsuits when their opioid prescriptions are not filled.”

‘Corresponding Responsibility’

Under current law, pharmacists have a “corresponding responsibility” when filling prescriptions – a legal right to refuse to fill prescriptions they consider unusual or improper. Most pharmacists will call the prescribing doctor to double-check before turning away a patient, but Walmart and other pharmacies have gone even further by blacklisting doctors deemed to have questionable prescribing practices.  

That’s what happened to a nurse practitioner at an Arizona pain clinic, who received a letter from Walmart in 2018 saying it would no longer fill her prescriptions – even though there was no indication any of her patients had been harmed by opioids.

“In reviewing your controlled substance prescribing patterns and other factors, we have determined that we will no longer be able to continue filling your controlled substance prescriptions,” the letter states.

“It was very humiliating. I was upset about it,” said nurse practitioner Carolyn Eastin. “We’ve already had patients who can’t get prescriptions there.”

A former Walmart pharmacist told PNN the company closely monitors opioid prescriptions and the doctors who write them.

“They had assembled prescription numbers for every doctor who had filled prescriptions at my store. They knew the exact number of medications ordered and sold down to the tablet. They knew what drugs the doctors wrote for and what percentage of the total each drug they wrote for," the pharmacist explained.

In its statement, Walmart said its pharmacists “refused to fill hundreds of thousands of opioid prescriptions they thought could be problematic” and had “blocked thousands of questionable doctors from having their opioid prescriptions filled.” The company also said it frequently assisted law enforcement agencies in “bringing bad doctors to justice.”

Caught in the middle of this are pain patients with legitimate prescriptions that are not getting filled. In August, two patients filed class action complaints against Walgreens, Costco and CVS alleging they were discriminated against by the pharmacies.

As PNN has reported, Sen. Elizabeth Warren (D-MA) and other members of Congress are urging the DEA to update a regulation that would allow pharmacists to only partially fill an opioid prescription. Patients would have to return a second time to get the rest of their medication.

Federal Prosecutors Warn Top Opioid Prescribers in Wisconsin

By Pat Anson, PNN Editor

Wisconsin’s two U.S. Attorneys have sent letters to 180 physicians, physician assistants and nurse practitioners in the state warning them that their opioid prescribing practices could result in prosecution.

None of the prescribers have been charged with a crime and it’s not clear if any are under investigation or have been linked to overdoses. Copies of the letters were not released and the recipients were not identified.

According to a news release, the letters warn doctors that they are prescribing opioids at “relatively high levels” that could lead to addiction and that “prescribing opioids without a legitimate medical purpose could subject them to enforcement action, including criminal prosecution.”

“We know that for many, addiction began with opioids prescribed by a medical professional,” said Matthew Krueger, U.S. Attorney for the Eastern District of Wisconsin. “By sending these letters, we are asking medical professionals to join the fight against addiction and ensure they prescribe no more opioids than are necessary.”

“Opioid addiction has touched the lives of far too many families in our state,” said Scott Blader, U.S. Attorney for the Western District of Wisconsin. “Medical professionals play a pivotal role in stemming the flow of legal opioids into unlawful channels.”

According to a spokeswoman, the 180 recipients of the warning letters were selected based on a review of Medicare prescription drug claims, which found that they prescribed opioids above the CDC’s highest recommended dose of 90 MMEs (morphine milligram equivalent). 

“They were identified through Medicare data for two years,” Myra Longfield, a public information officer in the Western District of Wisconsin, told PNN. “And from that data, practitioners were identified where they prescribed on average 90 MMEs (or more) per patient per day. That’s the threshold where the CDC and the Wisconsin Medical Examining Board say there is no real evidence to suggest that above that amount has any better effect on chronic pain.” 

The 2016 CDC opioid guideline is voluntary and only intended for primary care physicians. Longfield said warning letters were not sent to pain management physicians, oncologists or those working in hospice or palliative care, where higher opioid doses may be needed to control pain. 

Chilling Effect on Prescribers

Federal prosecutors in Georgia and Massachusetts have sent similar warning letters to high prescribers. While the intent is to urge caution, critics say the letters are likely to intimidate other doctors.

“This will have a totally chilling effect. The abuse of statistics is pathetic. It would only be an ignorant person that would take the top prescribers and say that they are endangering lives,” said Mark Ibsen, MD, a Montana doctor who nearly lost his medical license over allegations that he overprescribed opioids.  

“After they lop off the top prescribing doctors, guess what that leaves? More top prescribing doctors. Until there are none. Soon we will be seeing tattoos on physicians, similar to POWs.”

“This is an egregious overreach and will lead to more deaths not fewer,” said Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine. “Using the CDC guidelines as a goal post is not what even the CDC recommended. Most opioid addictions do not begin with a legal prescription of opioids. It usually starts long before exposure to a prescription opioid. The major problem is with illegal opioids smuggled in from Mexico and China. 

“I am worried for tens of thousands of patients in Wisconsin. Many of them will be at risk of suicide or seek illegal drugs, where the real harm exists. Sad. Very Sad.”

Last year, the American Medical Association adopted resolutions opposing the “misapplication” and “inappropriate use” of the CDC guideline. The resolutions by the AMA House of Delegates warn that “no entity should use MME thresholds as anything more than guidance” and that physicians should not be disciplined or prosecuted for prescribing opioids at levels above those recommended by the CDC. The AMA said some patients “can benefit from taking opioids at greater dosages” and “such care may be medically necessary and appropriate.” 

Most opioid overdoses in the United States are now linked to illicit fentanyl and heroin, not prescription opioids. In Wisconsin, 916 people died of opioid overdoses in 2017. Most of those deaths involved either heroin or fentanyl.

FDA Expands Safe Prescribing Program for Opioids

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration will require that educational training in pain management and safe opioid prescribing be offered to all healthcare providers under a major expansion of the agency’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) program.

REMS is also being expanded to include immediate-release (IR) opioids such as hydrocodone, oxycodone and morphine. Until now, REMS regulations only applied to extended-release and long-acting (ER/LA) opioid analgesics, such as OxyContin and Exalgo. Warning labels will be updated for all IR opioids, which account for about 90 percent of opioid pain medications.

“Many people who become addicted to opioids will have their first exposure in the medical setting,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements.”

The REMS program was first established in 2012. It required manufacturers of ER/LA opioids to pay for continuing education programs for prescribers only. Updated educational content must now also be provided to nurses, pharmacists and other healthcare providers who seek it. The training will cover broader information about pain management, including alternatives to opioids for the treatment of pain.

The training is not mandatory, but the FDA is considering whether to require continuing educational programs in pain management and safe prescribing.

“The agency believes that all health care providers involved in the management of patients with pain should be educated about the safe use of opioids so that when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving these medications, they can help ensure the proper product is selected for the patient and used with appropriate clinical oversight,” the agency said.

“I think these changes to the REMS are very good and long overdue,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management. “We know that the IR opioids are much more highly sought-after, versus ER/LA opioids, for purposes of abuse, and there is absolutely no reason why they (and their manufacturers) should be exempt from this requirement.  

“I’m not concerned, at this stage, about this change causing primary care providers to back off on prescribing, given that participation in the program is still completely voluntary for healthcare providers. If this voluntary status changes, and FDA finds a way to make REMS education mandatory, I will be concerned that some providers will opt out of prescribing opioids altogether.”

The FDA’s action greatly expands the number of opioid products covered by REMS from 62 to 347 opioid analgesics. The updated warning labels will strongly encourage providers to complete a REMS education program, and to counsel patients and caregivers on the safe use of opioid medication.

“Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines,” said Gottlieb.

Opioid prescriptions in the United States fell sharply during the first half of 2018 and now stand at their lowest levels since 2003, according to data released last month by the FDA. The trend appears to be accelerating as many doctors lower doses, write fewer prescriptions or simply discharge pain patients.

While opioid prescriptions decline, overdoses continue to rise. According to preliminary data from the CDC, nearly 49,000 Americans died from opioid overdoses in 2017, over half of them due to illicit fentanyl, heroin and counterfeit drugs, not prescription opioids.

Mayo Clinic: Opioid Prescribing Has Not Changed

By Pat Anson, Editor

Numerous studies have shown that opioid prescriptions are falling. The trend started in 2011 and appears to have accelerated since the release of the CDC’s 2016 opioid prescribing guidelines.

The volume of opioid medication filled last year fell by 12 percent, the largest decline in 25 years, according to the IQVIA Institute.  Prescriptions for hydrocodone – once the most widely prescribed drug in the country – have fallen by a third since their peak. Even the CDC has reported that opioid prescriptions have dropped by about 5% each year between 2012 and 2016.

Anecdotally, many patients tell us opioids are harder, if not impossible, to obtain. Nearly half of the 3,100 patients PNN surveyed last year said they were getting a lower dose. And one in four said they were no longer prescribed opioids.

But according to Mayo Clinic researchers, opioid prescribing hasn't changed that much and remains at high levels. In a study published in the British Medical Journal (BMJ), they report that opioid prescriptions for Medicare and privately insured patients have remained relatively stable over the past few years. And the average daily dose of opioids is well above what it was 10 years ago.

“If you’re hearing the message that prescription opioid use is starting to decline, I think we need to counter that message and say in most populations it really isn’t moving very much.” says lead author Molly Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Our data suggest not much has changed in prescription opioid use since about five years ago.”

Why the discrepancy? Jeffrey says most of the previous studies only looked at market-level data – the amount of opioids that drug makers reported producing and selling. She and her colleagues dug a little deeper, looking at insurance claims for 48 million U.S. patients between 2007 and 2016.  

Over that 10-year period, the rate of opioid use by privately insured patients remained relatively flat at 6 to 7 percent. The average daily dose for that group, about two pills of 5-milligram oxycodone, remained the same.

The rate of opioid use by Medicare patients 65 and older peaked at 15% in 2010 and decreased slightly to 14% by 2016. Their average daily dose, three 5 mg pills of oxycodone, also remained relatively unchanged.

Rates of opioid use by disabled Medicare patients also haven't changed much, peaking at 41% in 2013 and falling to 39% in 2016. Their average daily dose remains relatively high, about eight 5 mg oxycodone pills. 

“Our research of patient-level data doesn’t show the decline that was found in previous research,” says Jeffery. “We wanted to know how the declines were experienced by individual people. Did fewer people have opioid prescriptions? Did people taking opioids take less over time? When we looked at it that way, we found a different picture.”

The Mayo study includes an interesting disclaimer. While the researchers looked at data from patient insurance claims, they never surveyed or spoke to any patients about their opioid use. The researchers said they would “engage” with patients in future blog posts and press releases.

You can share your views with Molly Jeffery by email at jeffery.molly@mayo.edu or @mollyjeffery on Twitter.

10 Myths About the Opioid Crisis

By Roger Chriss, Columnist

There is no shortage of false statements being made about opioids. As the overdose crisis worsens, old and debunked claims reappear, while new claims rise up alongside them. Pundits, politicians and even physicians are perpetuating them, despite all evidence to the contrary.

So let’s set the record straight in order to promote an informed dialog about opioid medication, chronic pain, and the opioid crisis.

Myth 1: America has 5% of the world’s population but uses 80% of the world’s opioids.

Numerous politicians, such as Missouri Sen. Claire McCaskill and former New Jersey Gov. Chris Christie, as well as many journalists, have made this statement. It is demonstrably false.

In fact, the U.S. only uses about 30% of the world’s opioid supply. That estimate includes the addiction treatment drugs methadone and buprenorphine, both of which are opioids.

Myth 2: 80% of heroin addicts began by abusing prescription opioids.

This myth is pernicious because it is based on a kernel of truth. The number is correct but the implication is wrong. Only 4 to 6% of people who misuse prescription opioids go on to use heroin. And the number of people who start heroin without taking prescription opioids first has been rising in the past year.

Myth 3: Addiction starts with a prescription.

This claim persists despite decades of data to the contrary. A 2010 study found that only one-third of 1% of chronic pain patients without a history of substance abuse became addicted to opioids during treatment. Most abuse begins when people take medication that was not prescribed to them, using pills that were stolen, purchased illegally, or obtained from friends and family members.  

Myth 4: Opioid use leads to pain sensitization or ‘opioid induced hyperalgesia.’

Addiction treatment specialists like to repeat the claim that long-term opioid use makes patients hypersensitive to pain. But hyperalgesia is poorly understood and often confused with opioid tolerance. One study found that chronic pain patients on opioids had no difference in pain sensitivity when compared to patients on non-opioid treatments.    

Myth 5: Opioid overdoses are killing 64,000 people per year.

Nearly 64,000 Americans died from drug overdoses last year, according to the CDC, so that part is true. But opioids were involved in only about two-thirds of those deaths – and most of those overdoses involved heroin and illicit fentanyl.

Myth 6: Reduced opioid prescribing will end the overdose crisis.

Reduced prescribing is clearly not working.The number of opioid prescriptions has been in steady decline since 2010, yet fatal overdoses have risen sharply ever since.

Myth 7: Medical cannabis will cure the opioid crisis.

This is a recurring myth, made popular again in 2017. Unfortunately, not only does the recent data show that medical cannabis is not helping in states where it is legal, the underlying assumption of this myth is that chronic pain care is driving the opioid crisis. This is not the case.

Myth 8: Banning opioid medication will fix the opioid crisis.

This was put forth again early in 2017 by New Hampshire attorney Cecie Hartigan. Setting aside the problem of banning illegal drugs like heroin and fentanyl analogues (they are already banned), opioids are simply too medically useful to give up. Moreover, prior experience with drug bans, from Prohibition to the current overdose crisis, shows that bans do not stop misuse or addiction.

Myth 9: There are lots of ways to treat chronic pain

This myth has become increasingly popular as states, medical facilities, and health insurers pursue policies to reduce opioid prescribing. Although some of these methods, from physical therapy to spinal cord stimulators, may prove helpful, that misses the fundamental point. Chronic pain disorders are so horrible that all effective options, including opioid therapy, need to be on the table.

Myth 10: Opioids are ineffective for chronic pain.

This is the biggest myth of all. There is an abundance of high-quality research showing that opioids can be effective for some forms of chronic pain. Here’s a partial list of recent studies:

• Benefits and Risks of Opioids in Arthritis Management

• Opioids for chronic pain: new evidence, new strategies, safe prescribing

• The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain

• Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects

Adding to these studies is a recent review in Medscape, in which Charles Argoff, MD, a professor of neurology at Albany Medical College, said that “in multiple guidelines and in multiple communications, we have a sense that chronic opioid therapy can be effective."

New myths appear regularly, but these persist despite all efforts to counter them. Like an ear-worm or viral meme, they cannot be eliminated. The only defense is knowledge.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

Trump Commission Seeks More Limits on Rx Opioids

By Pat Anson, Editor

President Trump’s opioid commission released its final report Wednesday, an ambitious list of over four dozen recommendations aimed at treating addiction, preventing overdoses, and further restrictions on opioid prescribing.   

“This crisis can be fought with effective medical education, voluntary or involuntary changes in prescribing practices, and a strong regulatory and enforcement environment,” the commission said in its report.

The president established the commission in March to give him a list of recommendations to combat drug addiction and the overdose crisis. 

“Our people are dying. One hundred seventy-five people a day, every day, are dying in the United States from this epidemic,” said commission chairman Gov. Chris Christie of New Jersey, one of five politicians who served on the six member panel.

“If a terrorist organization was killing 175 Americans every day on American soil, what would you be willing to pay to make it stop? I think we’d be willing to do anything and everything to make it stop. And that’s the way we now need to see this, because this is an attack from within. We are killing ourselves.”

The commission’s 131-page report did not spell out how much money would be needed to implement the panel’s wish list of 56 recommendations.

Chief among them was to get drug makers and the National Institutes of Health to work together developing new non-opioid painkillers and addiction treatment medications.

“It is inexcusable that the major pharmaceutical companies in this country have stood on the sidelines during this crisis. And they have,” said Christie.

New Prescribing Guideline to Supplement CDC's

The commission is also recommending that a new set of guidelines for opioid prescribing be developed to “supplement” the guideline released last year by the Centers for Disease Control and Prevention.  It was not immediately clear if the new guidelines would replace, weaken or strengthen the CDC’s recommendations, or simply expand their use throughout the healthcare system.

“An updated set of guidelines for prescription pain medications should be established by an expert committee composed of various specialty practices to supplement the CDC guideline that are specifically targeted to primary care physicians,” the report says.

The commission recommended that federal regulators require patients to give informed consent about the risks and alternatives to opioid painkillers before the medication is prescribed to them. The panel also called for a new “national curriculum and standard of care” for opioid prescribers, and that pharmacists be trained to recognize and deny “inappropriate prescriptions.”

The commission urged the federal government to work with states to improve the toxicology data on overdose deaths by developing uniform forensic drug testing. Critics say the current data now being used by federal agencies is flawed or cherry-picked. 

“We do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths,” the report says.

No Limit on Opioid Supply for Acute Pain

The commission did not recommend that supply limits be placed on opioid prescriptions for short term pain, as many expected. Several states have already enacted 5 or 7-day limits on opioids for acute pain. The panel also did not endorse the development of marijuana-based medications, which many pain sufferers are now using as an alternative to opioids.

Most of the commission’s other recommendations deal with cracking down on drug traffickers and the illicit drug market, expanding the drug court system, and increasing access to addiction treatment.

Gov. Christie refuted criticism of President Trump for declaring the overdose crisis a public health emergency, instead of a national emergency. Only $57,000 in federal funding is currently set aside to deal with a public health emergency.

“The president did exactly what I asked him to. I wanted this to be a public health emergency because I wanted HHS (Department of Health and Human Services) to administer the funds, not FEMA (Federal Emergency Management Agency). No offense to FEMA. They’re busy with some other things and it’s not there area of expertise,” Christie said.

“Now it’s incumbent upon Congress to step up and put money in the public health emergency fund, so the president can utilize that. And that should happen without delay in the view of the commission.”

In addition to Christie, commission members include Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Florida Attorney General Pam Bondi, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman.

In its fifth and final hearing, the commission heard testimony from several people who lost loved ones to opioid addiction and overdose. The panel never asked for or received testimony from pain sufferers, patient advocates or pain management physicians.

Painful Opioid Statistics

By Roger Chriss, Columnist

The opioid crisis continues to worsen, and media coverage continues to be overly simplistic.

Vox recently reported the U.S. “absolutely dwarfs” all other countries in opioid prescriptions, in a story headlined “America’s huge problem with opioid prescribing, in one quote.”

"Consider the amount of standard daily doses of opioids consumed in Japan. And then double it. And then double it again. And then double it again. And then double it again. And then double it a fifth time. That would make Japan No. 2 in the world, behind the United States," Stanford psychiatry professor Keith Humphreys told Vox.

Although Humphreys’ statement is accurate, it is a misleading oversimplification that omits important context, including the rising rate of heroin and fentanyl-related deaths, and the shifting landscape of opioid prescribing.

First, this statistic represents an average (or mean). It does not include the variance, a measure of how many people use what quantity of opioids. The average person in the U.S. does not use any opioids at all. But people suffering from opioid addiction may use a large quantity of opioids every single day of the year.

In statistical work, reporting an average without the variance is considered sloppy at best, misleading or manipulative at worst.

Humphreys’ statement also fails to distinguish between the legal and illegal use of “pharmaceutical opioids,” a convenient term to refer to legally manufactured opioids, regardless of whether they are used for valid medical purposes, or diverted, shared or sold.

In other words, the much higher number of pharmaceutical opioids in the U.S. compared to Japan reflects both medical use and misuse.  

Further, this statistic assumes that Japan’s level of pharmaceutical opioid consumption is somehow better. In fact, Japan has a well-documented history of undertreating pain because of fears about opioid addiction. Pain is so poorly treated in Japan, according to The New York Times, that the government launched a campaign in 2007 urging patients to request pain relief, with hospital posters urging patients to “Tell Us About Your Pain.”

Japan continues to struggle with high levels of chronic pain. A 2015 review found a “high prevalence and severity of chronic pain, associated factors, and significant impact on quality of life in the adult Japanese population."

The Vox article also fails to point out that opioid prescribing in the U.S. peaked in 2010 and has been declining ever since. Yet opioid addiction and overdose deaths have been steadily rising, fueled largely by illegal opioids such as heroin and illicit fentanyl.

Vox is not alone in oversimplifying a complex problem. CNBC, for example, reported last year that “80 percent of the global opioid supply is consumed in the United States.”

Many others have repeated that claim, including Missouri Sen. Claire McCaskill, who recently tweeted that, "We have 5% of world population. 80% of opioids."

PolitiFact ran a fact check on McCaskill’s numbers and found them “greatly exaggerated.”

“While the United States is clearly the largest consumer of opioids, it, at most, accounts for roughly 30 percent of global consumption. We rate McCaskill’s claim False," PolitiFact said.

This is a significant issue in the opioid crisis. While some journalists, politicians, and even physicians name villains, people suffering from opioid addiction continue to get substandard treatment. And people who benefit from opioid therapy are struggling more and more to find physicians willing to prescribe and pharmacies willing to fill opioid prescriptions so they can have a reasonable quality of life.

No one is suggesting that the U.S. needs more opioids, particularly in the acute care setting. Opioids should be prescribed with close monitoring by physicians with experience in pain management. The research literature and public health studies agree that over-prescribing occurred, especially in pill mills and dubious pain clinics. In addition, drug theft and diversion are huge problems.

So while a statistic that invokes multiple doublings for comparative purposes sounds impressive, its context is much more important. We need to focus on the crisis as it really is, without exaggeration, if we hope to have meaningful progress ending it.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

A Pained Life: Pennsylvania’s Opioid Law Ignores Us

By Carol Levy, Columnist

Recently I received an email update from my state senator. He wanted to let me know about  efforts in the Pennsylvania legislature to address the "opiate crisis.”

I have written before that I believe some of what has been proposed throughout the country makes sense, a prescription monitoring database, for instance. Much of what is being considered in Pennsylvania also makes sense to me:

• Labels on opioid prescription bottles warning of their addictive nature
• Written consent from parents in order for their children to receive prescription opioids
• A safe opioid prescribing curriculum in Pennsylvania’s medical schools to better educate future doctors about proper opioid prescribing practices
• Insurance plans to provide access and share the cost of abuse-deterrent opioids
• Mandatory reporting of all heroin and opioid overdoses where naloxone was administered
• Implementation of opioid prescribing guidelines developed by a state task force
• Healthcare providers to discuss the risks of opioid addiction and overdose with patients and to receive written consent from a patient before prescribing them

But there are two provisions of the law I find very concerning, one being a requirement that coroners and medical examiners report the death of any person resulting from a drug overdose.

One of the issues surrounding the reporting of deaths arising from opioids is that other medical conditions, such as the use of alcohol or illegal drugs, are often ignored and the death is counted as an opioid overdose.

That is not only poor research, but gives a false picture of what is the effectual cause of the death. Ignoring those other factors means ignoring other issues that the law needs to be addressing.

The second issue I have with the law is alarming: limiting the prescription of opioids to seven days. This ignores chronic pain sufferers and the long-term need for opioid medication, which is often our only or last available treatment.

The change we saw, in many states, was requiring a visit to the doctor for a new prescription every 6 months to needing one every 3 months. That was bad enough.  I recall needing to go only once a year, but that was in the 1970's and 80's.

If you have trouble moving, tolerating the weather or other issues, being forced to go see the doctor every three months is an issue. In addition, co-pays rise, insurance companies pay more for extra visits and may raise your rates as a result, and the cost to the state and federal government through increased Medicaid/Medicare billing soars.

I decided to research this. I found that New York State has imposed a 7-day limit on prescriptions, but the law contains exceptions for those with chronic pain or who are receiving hospice or palliative care for life threatening illnesses. Unfortunately, Pennsylvania legislators have decided to ignore those in chronic pain. The bill includes exceptions only for hospice and patients receiving palliative care.

The government has acted as doctor in many other instances; such as women's health care, declaring some drugs illegal, and allowing certain medications and procedures while denying others. I understand that. There needs to be limitations and oversight.

But this is not oversight or limitation.  This is a frenzied and illogical response to an “epidemic” that is not caused or perpetuated by those of us with chronic pain, but is nevertheless being taken out on us.

Politicians who point at us and claim they are handling the crisis are ignoring the real culprits, which is those who abuse drugs illegally.

The question has to be asked. 

How in the world does this law address the opioid epidemic, as opposed to merely blaming and punishing those with chronic pain?

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

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

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

CDC Maintains Secrecy Over Opioid Guidelines

By Pat Anson, Editor

The Centers for Disease Control and Prevention (CDC) is refusing to disclose what outside advisors it consulted with during the drafting of its controversial opioid prescribing guidelines for physicians. The proposed guidelines, which were released this week, have angered many pain patients who think they could lead to sharp reductions in the prescribing of opioids for both acute and chronic pain.

“The anonymity of the reviewers engaged in this process is important during the ongoing development of these guidelines, as it allows reviewers to provide honest and independent comment and feedback,” said Courtney Lenard, a health communication specialist in the CDC’s National Center for Injury Prevention and Control. The panel of advisors is known within the CDC as the Core Expert Group.

“The Core Expert Group includes a limited number of CDC scientific staff, primary care professional society representatives, state agency representatives, experts in guideline development methodology, and other subject experts,” said Lenard.

Pain News Network has learned through a reliable source that about 15 people are in the Core Expert Group, only one of which is a physician with expertise in pain management.

The other members were “physicians and non-physicians, many of whom have been involved in efforts to rein in (opioid) prescribing.”

“Input from the pain management community in developing the guideline was, essentially, non-existent,” said the source, who identified Jane Ballantyne, MD, a professor of Anesthesiology and Pain Medicine at the University of Washington as the sole member with pain management expertise.

“As a member of the Core Expert Group, I have been asked not to comment on the (final) guideline until it is released,” said Ballantyne in an email to Pain News Network.

Ballantyne last year was named President of Physicians for Responsible Opioid Prescribing (PROP), a controversial organization that has lobbied Congress and criticized the Food and Drug Administration for not doing more to limit opioid prescribing.

The CDC and PROP appear to have a close working relationship -- a link to PROP literature recommending “cautious, evidence-based opioid prescribing” can be found -- unedited -- on the CDC’s website.

Asked if he was also a member of the CDC’s Core Expert Group that drafted the guidelines, PROP founder Andrew Kolodny said that he had no comment. Kolodny, who is chief medical officer for Phoenix House, which operates a chain of addiction treatment clinics, also said he would have no comment on the guidelines themselves.

Phoenix House was recently the subject of a highly critical report by Reuters, which claimed that in recent years the publicly funded institution “has consistently failed to provide the quality of care necessary to help addicts kick the habit.”

CDC Guidelines for Prescribing

Now that the draft guidelines have been released, the CDC plans to consult with a “Stakeholder Review Group” that includes over a dozen professional organizations involved in the field of pain management. Only two “stakeholders” – the American Chronic Pain Association and the American Cancer Society – represents pain patients.  A full list of the Stakeholder Review Group will be listed at the end of this article.

Secrecy has surrounded the development of the CDC's guidelines from their inception and continues today. The CDC refused to provide an advance copy of the guidelines before they were released Wednesday during an online “webinar.” Even after their release, only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on the guidelines after a 48-hour window of opportunity.

“Given the public health need to respond to the prescription overdose epidemic, it was critical to identify a public participation method and comment period that was rapid and efficient so that comments could be immediately provided to peer reviewers for their consideration,” explained the CDC’s Lenard in an email.

The first prescribing guideline recommends “non-pharmacological therapy” as the “preferred” treatment for chronic non-cancer pain, and states that opioids should only be prescribed if the benefits of reducing pain outweigh the risk of addiction and overdose.

Other guidelines recommend urine drug testing of all patients who are prescribed opioids, both for illicit drugs and prescribed medications. Smaller doses and quantities of opioids are also recommended – including a “three or fewer days” supply of opioids for most types of acute pain. The guidelines also recommend that benzodiazepines not be prescribed concurrently with opioids. A complete list of the guidelines can be found here.

“We’re concerned about some of the provisions in here, and by the fact that such guidelines issued by CDC are often accepted, sometimes rather uncritically, by state health departments and licensing boards, and thus quickly become standards of practice,” said Bob Twillman, Executive Director of the American Academy of Pain Management, which is one of the stakeholder groups that will be consulted by the CDC.

“I was generally satisfied with the proposed guidelines,” said Pete Jackson, president of Advocates for the Reform of Prescription Opioids, who lost his teenage daughter to a single dose of OxyContin in 2006.

“My main concern at this stage is how the federal government will reconcile these guidelines with the FDA REMS guidelines for long-acting opioids, which were voluntary guidelines issued a few years ago by FDA and have not been effective at deterring the overprescribing,” Jackson told Pain News Network. “Hopefully the CDC's guidelines will supersede the wholly inadequate FDA guidelines.  I would also like to see the CDC implement a very intensive training program to support the implementation of their new guidelines."

Pain Patients Worried

Pain patients – including many who already find it difficult to get opioids for pain relief – are angered and worried by the CDC’s recommendations.

“This terrifies me. I take two Norco per day, it barely keeps my pain at tolerable levels so I can do fun things like shower and get out of bed. I already jump through hoops to get my prescriptions every month.” said Cynthia Mittel. “To arbitrarily take away my only chance to have a life halfway worth living is evil and very short-sighted! Government at its finest. Guess we'll all be getting our drugs off the street now!”

“This is such a slap in the face to the millions of pain sufferers in this country," wrote Sue B. "We are not addicted to opioids! We need them in order to live. Would you think of putting these strict guidelines on insulin? It is not our fault drug abusers use our meds, our lifelines, to sell and get high, yet we are constantly punished.”

“We are not treated properly now. We get drug tested and insulted now. I cannot believe this is even coming up after the last change in guidelines,” wrote Kryste Southwick.  “Why do junkies have more meaning than chronic pain patients? Why are you stripping us of what little lives we can have? Do your research people. If this happens there will be A LOT of suicidal blood on YOUR hands.”

“This is wrong of the CDC to try and force their guidelines in people who live with chronic pain. I am monitored by my rheumatologist for my pain medication. I do not abuse my medication nor am I addicted to them,” said Suzanne Stevenson. “These guidelines the CDC want to impose are wrong and unfair to so many people. What right does the CDC have in this matter? None!”

Many have wondered why the CDC is acting as the lead agency in creating the prescribing guidelines – a role traditionally played by the Food and Drug Administration. The FDA has yet to release a statement about the CDC guidelines or say what role – if any – it had in drafting them.

"CDC and FDA are federal partners and collaborate on many different issues and at many different levels, prescription drug overdose being one of them. FDA has been involved in the review process of the guidelines and we will continue to work with them on this prescription drug overdose epidemic," said the CDC's Lenard.

CDC officials have long been critical of opioid overprescribing and have repeatedly cited a study that claims over 16,000 Americans are killed annual by overdoses linked to pain medications.

"CDC’s top focus in developing these guidelines is improving patient safety and reducing the risk that any more patients will die from an overdose related to mixing medications, using alcohol while on treatment, or taking a dangerous dose of opioids," said Lenard.

"We want to provide tools that primary care physicians can use to help determine when and how to safely initiate, maintain, and discontinue use of opioid therapy for chronic pain outside the setting of end-of-life care.  We understand that pain is a complex problem and that some patients will require treatment with a pain specialist. These guidelines are not intended to guide that care. We want patients currently on opioid therapies to work with their doctors to stay safe while managing their pain."

According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

The CDC said it will now consult with the “stakeholders” group --and will then submit the guidelines to a peer review panel  -- before releasing a final version in January, 2016.

Members of the stakeholders group include the following: American Academy of Neurology; American Academy of Pain Management; American Academy of Pain Medicine; American Academy of Pediatrics; American Academy of Physical Medicine and Rehabilitation; American Cancer Society; American Chronic Pain Association; American College of Medical Toxicology; American College of Obstetrics and Gynecology; American Geriatrics Society; American Hospital Association; American Medical Association; American Pain Society; American Society of Addiction Medicine; American Society of Anesthesiologists; American Society of Hematology; American Society of Interventional Pain Physicians; and Physicians for Responsible Opioid Prescribing.

The Dangerous Game of Forced Opioid Reduction

By Forest Tennant, MD, Guest Columnist

A colleague who I highly respect just informed me of a woman with intractable angina who had multiple, inserted coronary splints and required a high daily dose of morphine. Without warning, her insurance company arbitrarily decided she did not need opioids. As one might expect, the forced cessation of opioids led to her death.

The forced reduction and/or cessation of daily opioids in stabilized patients have, in some corners of our country, reached the point of unscientific and inhumane hysteria. The craze to fight opioid abuse and force opioid dosages below 100 to 120 mg of morphine equivalents a day (MEQ) is now harming some patients who have been doing quite well on stable, daily opioid dosages. Some of the rhetoric and tac­tics being used to force opioid reduction are farcical if they weren’t so tragic in their consequences.

First, who is doing the forcing? There are multiple culprits: insurance companies, state legislators, regulators, and suppli­ers. Some of the tactics to force opioid reduction are indirect, such as limiting the amount of opioids a pharmacy can stock. Others are blatant, such as states that require physicians to seek a pain consultation if they continue to prescribe over a threshold MEQ level, even to patients who have been well maintained for a considerable time period. For example, in Washington State, a 120 mg/d MEQ threshold will trigger the prescribing physician to conduct, or refer the patient for, a pain consultation (exceptions and exemptions do exist). As noted by Stephen J. Ziegler, PhD, JD, “in some states, these thresholds appear in regulations, making the actions required actions, while in other states the thresholds appear in guidelines, making the actions merely recommended.”

Insurance companies are currently the most dangerous “forcers.” Neither patient, pharmacist, nor physician is pre­pared when a stable, opioid-maintained patient goes to fill a long-standing opioid prescription only to be told their insurance company has suddenly decided the patient should immediately cut their opioid daily dose by 30% to 70%, or even stop it altogether. The saddest aspect of this dan­gerous practice is that the motive is clearly greed, although the reduction may be accompanied by an “out-of-the-blue” statement that the forced reduction is for the patient’s safety. For example, insurance companies have recently informed long-standing, opioid-maintained patients that they have suddenly and capriciously decided they will no longer cover brand name opioids, injections, patches, compounded for­mulations, or a daily dosage above a specific level.

Insurance companies and some state guidelines are spitting out two illogical excuses for the forced reduction of opioids. One is that opioids dosages above 120 mg or so of MEQ are unsafe. Show me a study that indicates tissue toxicity of opioids at dosages over 120 mg in patients who have been maintained at a stable dosage for over 1 year. Patients who have been titrated up to dosages above 120 mg of morphine and periodically monitored by competent physicians almost always experience improved health and function, not the reverse. I have several patients who have been safely main­tained on high opioid dosages and led quality lives for over 20 years!! Why force these folks into sickness, suffering, and possibly death by suddenly and capriciously claiming their life-saving medication is dangerous?

The other straw-dog is “hyperalgesia.” Would someone please tell me how I’m to define and diagnose hyperalge­sia in a patient who has been well maintained on a stable opioid dosage—high or low—for over a year? Hyperalgesia has become a label and excuse to force down opioid dos­ages. Reputable and credible pain practitioners are not even sure it exists in a human who is well maintained on opioids. Whenever I see a patient who is on opioids and claims their opioids aren’t working as well as they used to, I take a hor­mone profile. Once I replace any deficient hormones, the patients’ opioids resume working.

My demand is for someone to send me the consensus doc­ument that tells me how to objectively diagnose hyperalge­sia in patients who have been well maintained on opioids over 90 days. What’s more, if hyperalgesia exists, what harm does it do? If we really believe that hyperalgesia is a problem with high-dose opioids, we must remove all intrathecal opi­oid pumps because these devices deliver a MEQ directly to the CNS receptors that is far in excess of any dosage we can achieve by peripheral administration!!

Readers of Practical Pain Management well know that severe, constant pain has far more risks than any stable, daily opioid dosage. Severe pain adversely affects the cardiovas­cular, endocrine, immune, and neurologic systems. It sends patients to bed in agony to lead a short, suffering life. There is no need to take these risks in a caring, concerned soci­ety, as a minute extract from the opium plant can prevent these complications and the pathetic, miserable death that a forced opioid reduction can bring.

So what do we do at this point? First, physician’s need to correct any false comments about the imagined dan­gers of stable, on-going opioid dosages. Whenever possible, pain practitioners should attempt to prescribe non-opioid pharmaceuticals that have come forward in recent years. In the latter category, I place ketamine, anti-epileptic agents (gabapentin, pregabalin, etc), and neurohormones (oxyto­cin, human chorionic gonadotropin, and progesterone). I’ve cut my patients’ opioid use by about 50% over the past 5 years by use of these new agents. I also recommend obtain­ing an opioid serum level in patients who take over 100 mg of MEQ. The presence of a reasonable opioid serum level indicates that the patient is ingesting opioids and is func­tioning well with a high opioid dosage.

Lastly, and most important, families of patients who must take a high daily opioid dosage need to become publicly active as advocates for their loved one. Unfortunately, but realistically, patients who must take a high opioid dosage always have a debilitating condition such as arachnoiditis, CRPS, traumatic brain injury, post-encephalitis headache, or facial neuropathy, and are too ill to fend for themselves. But their family can. Its time families demand the right of their suffering loved ones to obtain opioids, and their direct and blunt communication should go to State Medical Boards, insurance companies, wholesale suppliers, and their elected representatives.

Also, pain patients and family members should start joining the emerging nationwide organizations that are now forming to fight back. While we physicians have little public voice left, families of pain patients can, should, and will be heard.

Dr. Forest Tennant is pain management specialist in West Covina, California who has treated chronic pain patients for over 40 years. He has authored over 300 scientific articles and books, and is Editor Emeritus of Practical Pain Management.

This column is republished with permission from Practical Pain Management.

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.

Pain Education Improves Opioid Prescribing

By Pat Anson, Editor

A safe opioid prescribing course --- aimed at filling in gaps in pain education at many medical schools -- can help reduce the abuse and misuse of opioids, according to a new study published in the journal Pain Medicine.

Boston University School of Medicine launched its Safe and Competent Opioid Prescribing Education (SCOPE) program in 2013, offering live or online courses in chronic pain and safe opioid prescribing practices.

A survey of over 10,000 doctors who took the SCOPE program found that two months after the training about two-thirds of participants reported greater confidence in their prescribing practices, and 86 percent improved how they prescribed opioids and monitored patients.

"Our program improved knowledge, attitudes, confidence and clinical practice in safe opioid prescribing," said corresponding author Daniel Alford, MD, associate professor of medicine at Boston University School of Medicine and course director of the SCOPE of Pain program.

SCOPE was the first program to receive funding from the Food and Drug Administration’s Risk Evaluation and Mitigation Strategy (REMS), which requires opioid manufacturers to fund continuing education programs in pain management.

"While education cannot be the only strategy to combat this national crisis, it can help improve clinician behaviors and be a major part of the solution,” said Alford.

An earlier survey of physicians by Boston University found that many lacked confidence in managing patients on opioids. Over a quarter (28%) said they had not completed certified medical education (CME) in safe opioid prescribing. Many also said they lacked the time or staff to implement an opioid monitoring system for patients, such as drug testing and pill counts.

Only a quarter of the doctors surveyed said they were very confident about their ability to safely manage chronic pain with opioids.

Pain education for doctors – or the lack of it – is such a concern that the National Pain Strategy considers it a top priority.

“Many health professionals, especially physicians, are not adequately prepared and require greater knowledge and skills to contribute to the cultural transformation in the perception and treatment of people with pain,” a draft version of the report states. “Core competencies in pain care are not fully developed and generally do not inform undergraduate curricula in health professions schools or graduate training programs, even those in pain medicine.”

A 2012 study published in the Journal of Pain  called pain education in the U.S. and Canada “lackluster” and warned that unless steps were taken to improve the training of pain physicians, “the crisis in pain care and resultant deaths from opioid abuse will only spiral upwards.”

The study of 117 U.S. and Canadian medical schools found that less than 4% required a course in pain education and only one in six schools offered a pain elective. A large number of U.S. medical schools do not have any pain courses and many of those that do have less than five hours of classes.

Many Doctors Not Confident Prescribing Opioids

By Pat Anson, Editor

Nearly two-thirds of physicians who prescribe opioids say they are not confident or only somewhat confident about managing patients on opioid painkillers, according to the results of a new survey that found widespread gaps in education about opioid safety.

"This indicates a critical need for provider education addressing this issue. It is important our medical community is given the training it needs to confidently manage chronic pain while significantly reducing prescription opioid misuse, overdose and diversion," said Daniel Alford, MD, of Boston University School of Medicine.

Boston University and Haymarket Medical Education conducted an online survey of nearly 800 physicians who are registered with the Drug Enforcement Administration to prescribe Schedule II and III controlled substances.

Over a quarter (28%) said they had not completed certified medical education (CME) in safe opioid prescribing. Many also said they lacked the time or staff to implement an opioid monitoring system for patients, such as drug testing and pill counts.

"It's troubling that so many physicians say implementing safe opioid prescribing systems is not a priority, even though this is an acute issue. We've created a situation where some physicians are comfortable not doing anything about it,” said Alford.

Only a quarter of the doctors surveyed said they were very confident about their ability to safely manage chronic pain with opioid pain medication. Four out of ten said they don’t even prescribe opioids.

 “Lack of knowledge regarding some narcotics. Concerns of dealing with patients who appear to be drug seeking. Lack of time to follow some of these patients closely,” said one doctor who was not confident about prescribing opioids.

“Lack of training. Fear of providing access to patients who might abuse opioids,” said another.

Pain education for doctors – or the lack of it – is such a concern that the recently released National Pain Strategy considers it a top priority.

“Many health professionals, especially physicians, are not adequately prepared and require greater knowledge and skills to contribute to the cultural transformation in the perception and treatment of people with pain,” a draft version of the report states. “Core competencies in pain care are not fully developed and generally do not inform undergraduate curricula in health professions schools or graduate training programs, even those in pain medicine.”

A 2012 study published in the Journal of Pain  called pain education in the U.S. and Canada “lackluster” and warned that unless steps were taken to improve the training of pain physicians, “the crisis in pain care and resultant deaths from opioid abuse will only spiral upwards.”

The study of 117 U.S. and Canadian medical schools found that less than 4% required a course in pain education and only one in six schools offered a pain elective. A large number of U.S. medical schools do not have any pain courses and many of those that do have less than five hours of classes.