Would You Support a Boycott of CVS?

By Pat Anson, Editor

One of the most talked about issues in the pain community over the last two weeks has been CVS Health’s announcement that its pharmacists would soon start restricting doses of opioid pain medication and limit the supply of opioids for acute pain to 7 days.

The policy only applies to customers enrolled in CVS Caremark’s pharmacy benefit management program, but it quickly triggered an online backlash from pain patients – including many who called for a boycott of CVS.

“I refuse to patronize companies that practice medicine without a license,” wrote Jeannette on PNN’s Facebook page.

“Don’t go there anymore. Hit them in their pocketbook,” wrote Lauren.

“I very rarely use a CVS and will never go there for prescriptions or anything else,” said Jackie.

“I left CVS years ago for Walgreens and I’m guessing many more will be doing so,” wrote Amanda.

"CVS has some nerve. The use of opioids, or any other drug, really, is up to the doctor and his or her patients, not a pharmacist. This is a terrible precedent, which will drive an even bigger wedge between physicians and patients,” cardiologist Arthur Kennish, MD, told the American Council on Science and Health.

The CVS boycott soon had its own hashtag on Twitter.

“Wrong way to handle, CVS! I will join the #BoycottCVS. You make it more difficult for the sick w/ no impact on the crisis,” Stephanie tweeted.

The online outrage even spilled over onto CVS’ Facebook page, where many negative posts were apparently deleted by the company.

“CVS Pharmacy, why did you take down all your Posts and comments regarding your big announcement over overriding doctor's orders and limiting patients' rights to their pain medication?” asked Lauri. “Where did they all go?”

People are so passionate about this issue that we started an online poll asking if they would support a boycott of CVS. Click here if you’d like to participate.

Would a Boycott Work?

But while there’s plenty of online enthusiasm for a boycott, it’s unlikely to be effective without the support of patient advocacy groups.  An informal survey of pain organizations by PNN found most were critical of CVS’ decision, but opposed to a boycott.

“I think boycotting CVS is not a good idea. I think a better idea is working with them for better care and finding the good in what they are doing and amplifying the bad.  They want better education, they want better disposal, and many other things we all fight for,” said Paul Gileno, President of the U.S. Pain Foundation.  “I don't think a boycott would work or be effective and can come across in a negative way. We need a loud conversation with CVS.”

“I don’t typically like boycotts” said Barby Ingle, President of the International Pain Foundation and a PNN columnist. “But if enough people have a bad experience or don’t like the CVS policies, they will see a drop in the market and will have to reevaluate what their policies will be.

“I wouldn’t call it a boycott, I would call it a shift in patients understanding that we have power and that we can choose to go to the healthcare places that fulfill our needs. Unless CVS changes their practices, I can see them continuing to lose business.”

Penney Cowan of the American Chronic Pain Association did not respond to a request for comment.

One patient advocate who gave full support for a boycott was Cynthia Toussaint, the founder of For Grace, a non-profit that supports women in pain.

“The lack of patient advocacy support for the boycott is totally surprising,” Toussaint wrote in an email. “We’ve all been beating the ‘don’t get between a doctor and a patient’ drum for years, and now that we can put our names behind that, we’re being sheepish.

“For Grace is ON BOARD with the boycott! This is chilling news for the pain world - and I hope our support helps many people. We understand CVS’s very real concern about the opioid crisis, but this new policy is too heavy handed and will greatly harm the chronic pain community!”

CVS is not the first pharmacy to restrict access to opioid medication. In 2013, Walgreens gave its pharmacists a “secret checklist” to help them screen patients with opioid prescriptions. Any red flags, such as a prescription written by a new doctor or a patient paying in cash, could result in a prescription not being filled. The policy was implemented after Walgreens was fined $80 million by the Drug Enforcement Agency for violating the rules for dispensing controlled substances.

CVS has also been fined hundreds of millions of dollars for violations of the Controlled Substances Act and other transgressions, many of them involving opioid medication.

A Florida pharmacist who was fired this year by Sam’s Club for not following the company's opioid policy says pharmacies are driven by profit, not patient care, and a boycott is unlikely to change their bottom line. 

“Patients won't need to boycott. CVS doesn't want the business anyway,” says Karl Deigert, who was fired after complaining that patient rights were being violated at Sam’s Club, which is owned by Walmart.  “Corporations are only acting in their own best interest and have no concern for the patient. Patients can save their breath and energy as any complaints filed will fall on deaf ears. 

“Overzealous corporate policy makers have no desire or interest to protect the patients' well-being. Their policy making is self-serving to protect their assets from DEA scrutiny and monetary penalties. The corporations and the majority of retail pharmacists simply do not care to help the chronic pain patient population.”

The new opioid policy at CVS doesn’t go into effect until February 1, 2018. But CVS Caremark is already tightening the rules for some opioid prescriptions. 

A Caremark client who has been getting fentanyl pain patches at CVS for years was recently notified by letter that new limits are being placed on the patches “to help ensure that your use of opioid medication for pain management is safe and appropriate.” 

But is it really about safe and appropriate use?

The letter goes on to say the patient will still be able to get the fentanyl patches, but without prior authorization they “will have to pay 100 percent of the cost.”

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.

Fake Fentanyl Pills Found in 40 States

By Pat Anson, Editor

Counterfeit painkillers and fake medications made with illicit fentanyl have killed Americans in at least 16 states, according to a new report that found the highly dangerous pills have spread from coast to coast.

“We have documented the spread of counterfeit pills made with illegal fentanyl throughout 40 states. There is documentation that counterfeits made with fentanyl have killed Americans in at least 16 of those states. The other 24 states probably have deaths attributable to counterfeits made with fentanyl, but because of limited awareness of the problem, those deaths may not have been investigated for counterfeit drugs,” said the report by the Partnership for Safe Medicines (PSM) a coalition of pharmacy groups and other healthcare organizations.

The report is based on a review of court records, statements by law enforcement and public health agencies, and news reports.

Fentanyl is 50 to 100 times more potent than morphine. It is legally available in lozenges, patches and other medications to treat severe pain, but in recent years illicit fentanyl has become widely available on the black market, where it is often mixed with heroin or used in the production of counterfeit drugs.

Many addicts looking for a high or pain sufferers looking for relief have no idea what they’re buying. Experts say a single dose of fentanyl as small as two or three milligrams can be fatal.

“Up until now, it’s been difficult to grasp the scope and pervasiveness of the counterfeit drug problem,” said Dr. Marvin Shepherd, chairman of the PSM Board and former director of the Center for Pharmacoeconomic Studies at the University of Texas at Austin’s College of Pharmacy. “We’ve had a number of examples of counterfeit pill seizures and tragic fentanyl-related deaths, but this report paints a picture of a nation under siege from fake and lethal drugs coming across our borders.”

Massachusetts, Pennsylvania, New Jersey, Ohio and several states now report they have more people dying from overdoses of illicit fentanyl than from prescription opioids. 

Most of the illicit fentanyl is manufactured in China and smuggled into the U.S. by drug cartels. In August, the Mexican military found over 140 pounds of powdered fentanyl hidden inside a tractor trailer rig at a checkpoint near Yuma, Arizona. The shipment, which had an estimated street value of $1.2 billion, also included nearly 30,000 counterfeit tablets made with fentanyl.

The fake pills are often designed to look like oxycodone or the anti-anxiety drug Xanax, and are hard to distinguish from the real thing.

“They’re relatively cheap (to make) and the profit margin is phenomenal,” said Lisa McElhaney, President of the National Association of Drug Diversion Investigators, during a recent seminar for pain management providers. “You’re talking about such a miniscule amount (of fentanyl). But it has such a heavy potency and purity level that it is fatal.”

McElhaney said the black market in prescription drugs used to be dominated by legally-made medications that were stolen or diverted from medicine cabinets, pharmacies or drug manufacturers. She now believes most of the pills sold on the street are counterfeit.

counterfeit oxycodone pills

“I would say 99% of what we are seeing on the street, bought and sold, is product from China, India, Mexico, or from second or third-hand distributors. It is not pharmaceutical grade, FDA approved fentanyl,” she said.

While the DEA and other law enforcement agencies have been warning of the fentanyl problem for years, federal health officials have been slow to recognize or even address it – focusing instead on limiting the use of opioid pain medication.

For example, the Centers for Disease Control and Prevention recently launched a new marketing campaign, using videos, online advertising, billboards, newspapers and radio ads to raise awareness about the risks of prescription opioids. The campaign completely ignores the role of fentanyl and heroin in the overdose crisis, because the CDC didn't want to risk “diluting” its primary message.

“Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging,” the CDC explained.

Politicians are also focused on prescription opioids. Several states have adopted or are considering laws that limit opioid prescriptions for acute pain to only a few days’ supply – a move that President Trump’s opioid commission appears to be considering as a recommendation in its final report.

“This is a prevention measure… to limit the number of drugs that are out there for improper diversion and to make sure that we don’t inadvertently turn people into addicts by giving 30, 60, 90 pills the first time,” said commission chairman Gov. Chris Christie of New Jersey, whose state has adopted a five day limit on new opioid prescriptions.

This week the Pharmaceutical Research and Manufacturers of America -- an organization that represents virtually every major drug maker – told the commission that it would support a 7-day limit on opioid prescriptions for acute pain.  

CVS Defends Rx Opioid Policy

By Pat Anson, Editor

CVS Health has released new details about its plan to limit the dose of opioid pain medication and restrict new prescriptions for acute pain to a 7-day supply.

The new policy, which was announced last week, immediately sparked an online backlash from chronic pain patients, who fear they will no longer be able to refill their opioid prescriptions at CVS or will have to do it weekly.

“It's crazy what's going on. Every week going to doctors and pharmacists paying that extra money. This is a crime on the sick,” wrote Amy in a Facebook post.

“Even for new patients, this doesn't make sense,” wrote Jennifer in another online post. “After surgery some patients need these medications for longer than 7 days. Driving to the doctor to get a new script, then to the pharmacy to get more medication is not conducive to healing.”

“How can they single out medications and refuse when the doctor writes them for 30 days?” wrote Hazel. “Everyone should boycott them, not only for prescriptions but shopping there for anything. This is getting ridiculous!”

Asked to comment on these and other concerns, CVS Health emailed a statement to PNN answering a series of questions we had about its new opioid policy. We were not allowed to interview anyone at CVS directly.

The questions and answers below were edited for clarity:

PNN: Many of your customers with chronic pain believe they'll have to go to a CVS pharmacy four times a month to get their refills. Can you clarify that for them? 

CVS: The seven day quantity limit on opioid prescriptions, going into effect on February 1, 2018 for CVS Caremark's pharmacy benefit management (PBM) clients, applies only to prescriptions written for acute conditions, such as a minor surgery or dental procedure, that generally last only for a short duration. 

We recognize that there are patients with a legitimate need for pain medication, and our approach is carefully designed to ensure that those patients can access their medication in an appropriate manner.  We are dedicated to ensuring our retail and PBM approaches do not negatively affect patients who are in need of their chronic pain medication.   

PNN: What happens when a patient recovering from surgery needs opioid medication for more than 7 days? Do they go back to their doctor and get a new prescription?

CVS: Our program encourages safe and appropriate utilization of opioids by managing utilization in a manner consistent with the Guideline set forward by the CDC.  Our efforts to ensure safe and appropriate opioid use are designed to improve the quality of care and health outcomes for patients.  If a prescriber feels patient care should exceed these limits, the prescriber can request an exception. 

PNN: What about limiting opioid prescriptions to 90mg morphine equivalent (MME) doses? Some pain patients are prescribed more than that.

CVS:  The CDC recommends that clinicians prescribe the lowest effective opioid dose and use caution when prescribing opioids at any dosage.  Further, the Guideline indicates physicians should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day. 

We are aligning our standard utilization to these limits for all patients who are not in active cancer treatment, palliative care, or hospice care.  However, if a prescriber feels patient care should exceed these limits, the prescriber can request an exception. 

PNN: You say you are following the CDC guideline, but the guideline is voluntary and only intended for primary care physicians treating chronic pain. You are making them mandatory for all doctors and all patients for all types of pain.

CVS: Given the toll opioid misuse has taken on our country, we believe it is appropriate to align our utilization management of opioids for our members with the Guideline set by the CDC.  Our efforts to ensure safe and appropriate opioid use are designed to improve the quality of care and health outcomes for patients.  Notably, if a prescriber feels patient care should exceed these limits, the prescriber can request an exception. 

PNN: Many patients complain that there's already a tendency by some pharmacists to refuse to fill opioid prescriptions to avoid hassles, extra work, etc. and to send them away without their medication. How will CVS make sure its pharmacists abide by your rules and not invent new ones?

CVS: Our opioid utilization management program will be consistently executed as a coverage determination across all pharmacies in our PBM retail network.  Pharmacists at CVS Pharmacy, or any of the other retail pharmacies in our network, will not be making independent medical judgments about the appropriateness of opioid prescribing or the length of such prescribing. Additionally, the program we have recently announced does not impact prescriptions filled for CVS Pharmacy retail customers who are not covered by the CVS Caremark PBM.   

Our pharmacists are committed to providing the highest level of care for their patients.  At our retail pharmacies, we are also strengthening counseling for patients filling an opioid prescription with a robust safe opioid use education program highlighting opioid safety and the dangers of addiction. 

'Cookie Cutter' Approach to Pain Care

CVS is not the first pharmacy to adopt rules that limit the dispensing of opioids, but it is the first major chain to set a 7-day limit on prescriptions for acute pain. Given recent trends, it is probably not the last.

Several states have already adopted laws that limit opioids to a few days' supply for acute pain. And yesterday a major pharmaceutical organization announced its support for a 7-day limit on new opioid prescriptions.  

Critics say this “cookie cutter” approach to pain care ignores the fact that when acute pain is poorly treated or untreated, it can turn into chronic pain in a matter of months or even weeks.

And chronic pain can worsen or cause other life-threatening health problems, including high blood pressure, stroke, heart attack, depression and suicide ideation.

Each patient is also different. A large new study published this week in JAMA Surgery looked at the different lengths of time patients needed opioid medication while recovering from 8 common surgical procedures.

While a 7-day supply of opioids was adequate for most patients recovering from an appendectomy, hysterectomy, hernia repair and other common surgeries, an analysis of over 215,000 surgery patients found that about 20 percent of them needed at least one refill of their prescription. Orthopedic and neurological procedures were the most likely to require a refill, and Medicare patients were the most likely group to need opioids for more than 7 days after a surgery.

“Although 7-day limits on initial opioid pain medication prescriptions are likely adequate in many settings, and indeed also sufficient for many common general surgery and gynecologic procedures, in the postoperative setting, particularly after many orthopedic and neurosurgical procedures, a 7-day limit may be inappropriately restrictive," wrote lead author Louis Nguyen, MD, of Brigham and Women’s Hospital, Harvard Medical School.

But not everyone finds fault in the cookie cutter approach. In an editorial also published in JAMA Surgery, a leading surgeon wrote that “any effort” to reduce the frequency of opioid prescriptions was a good thing.

“Unfortunately, we have reached a point that 100% elimination of pain has become not only the goal but the expectation. If a surgeon allows a patient to expect a pain-free recovery, he or she will see refill requests increase,” wrote Selwyn Rogers, MD, chief of surgery at the University of Chicago Medicine Trauma Center.

“Alternatives to narcotics should be recommended and incorporated as the foundation of pain management. It does not take much time to explain the use of acetaminophen and ibuprofen and then follow up with a stronger option if the pain is not adequately relieved. It is also useful to prepare the patient to expect some discomfort, realize that complete relief of all pain is impossible, and that the cost of trying is not worth it.”

Chronic Pain in the Workplace

By Lana Barhum, Columnist

Unless you have lived with chronic pain, you cannot begin to fathom the physical and psychological torture many people in pain go through.  Chronic pain is an issue so often ignored in the workplace.

About a year ago, I wrote an article about “presenteeism,” which basically is the act of attending work while you are sick.  But presenteeism isn’t just showing up for work when you have a cold or the sniffles, it is showing up to work every day despite pain, fatigue and other symptoms that come with chronic pain and illness.

Presenteeism was recently researched by the Global Corporate Challenge (GCC), which found that while employees with chronic health conditions took an average of just four sick days a year, they confessed to being unproductive at work an average of 57.5 days a year.

The GCC report estimated that the cost of presenteeism was 10 times higher than absenteeism. Absent workers cost employers in the United States, United Kingdom and Australia about $150 billion a year, but those who came to work and were not fully productive cost them $1,500 billion.

The study’s authors noted the importance of companies to improve productivity by putting their focus on reducing presenteeism.

I am not sure employers know or even care how many of their people are dealing with chronic pain challenges.  And if they do, what expectations do they have of these employees? Do they even understand the difficulties of being productive when you are physically hurting?

Chronic Pain and Lost Productivity

According to another report from the Institute of Medicine Committee on Advancing Pain Research, Care and Education, chronic pain is costing the U.S. economy between $560 to $635 billion annually in healthcare costs and lost productivity. While many employees who live with pain continue to work, they struggle to be productive. 

One possible solution – opioid pain medication – is no longer easily accessible, even for pain patients who don’t misuse prescription drugs and who want to have normal, productive lives.

Research has shown that about two million Americans misuse opioids, and a good chunk of them wind up in emergency rooms. But that statistic ignores the millions of people that need pain medications and don’t abuse them.

Too many prescribing guidelines -- and fear of DEA oversight -- keep our doctors from writing prescriptions for pain medication, even for medicines that are relatively safe and have low risk of addiction.  Guidelines and insurance reimbursement policies have basically taken discretion away from responsible doctors in managing patient pain care.

Some chronic pain sufferers won’t even ask their doctors about pain medication because of the stigma attached to opioid misuse and abuse. Up until recently, I was one of them. I wouldn’t ask my doctor for medication to manage my pain because of that very stigma.  But my pain levels got so bad I had no other choice.  And my doctor, like so many others, was wary of writing a prescription and didn’t give in until I was practically begging. She explained she trusted my judgment, but was limited in her options due to government guidelines.

Working with Pain

The biggest concern I have on an almost a daily basis is how long I will be able to continue working. Will my boss get tired of the mistakes I make on the days I am hurting and my focus is off due to pain and lack of sleep? While my employers know I live with pain from rheumatoid arthritis and fibromyalgia, they really don’t care – most likely because my disability is invisible, but also because it isn’t their problem – it is mine.  

I am not sure most employers or coworkers understand the overwhelming and difficult responsibility of holding down a full-time job when you live with chronic pain.  Even if your employer provides accommodations – like workspace adjustments and options to work from home on occasion – the basic requirements of the job can still be great when you are hurting.

In an ideal world, employers would offer options for pain management on the job -- in the form of wellness programs and workplace accommodations – so we could work at full capacity.  Employees who feel supported will seek out all available help, feel better, and function better on the job. 

But most employers have yet to recognize the crucial role they play in helping to manage the pain epidemic in this country.  They see chronic pain as a personal problem, rather than a business dilemma.   Until that changes, we are on our own to suffer in silence and figure out how to work better, despite the pain that we endure. 

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother who lives with rheumatoid arthritis and fibromyalgia. Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit her website.

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.

Drug Makers Support 7-Day Limit on Rx Opioids

By Pat Anson, Editor

A leading organization of pharmaceutical companies announced today its support for a 7-day limit on opioid prescriptions for acute pain.  

The announcement -- made during a meeting of President Trump’s opioid commission – marks a significant shift for the industry and is likely to speed up efforts to have limits imposed nationwide on opioid medication for short-term pain.

“PhRMA is announcing for the first time our support to limit the supply of opioids to 7 days for acute pain management. Too often, individuals receive a 30-day supply of opioid medicines for minor treatments for short-term pain,” said Stephen Ubl, President and CEO of PhRMA, the Pharmaceutical Research and Manufacturers of America.  

“Overprescribing and dispensing can lead to patients taking opioids longer than necessary and excess pills falling into the wrong hands.”

PhRMA is a trade organization that represents over 3 dozen pharmaceutical companies, including AstraZeneca, Bayer, Allergan, Bristol-Myer Squibb, Eli Lilly, Johnson & Johnson, Merck, Pfizer, Teva, Novartis, GlaxoSmithKline, and Purdue Pharma.

“Our announcement is candidly an unprecedented step for the industry. We’ve always supported physician autonomy and the preservation of the physician-patient relationship, but as you know, given the scope of this (opioid) crisis,we believe this is the right thing to do,” Ubl said.

“I want to thank you and the industry for stepping forward," said commission chairman Gov. Chris Christie of New Jersey. “This is a prevention measure… to limit the number of drugs that are out there for improper diversion and to make sure that we don’t inadvertently turn people into addicts by giving 30, 60, 90 pills the first time. And so the fact that the pharmaceutical industry is willing to step up and acknowledge that there is something that needs to be done is an important first step.”

New Jersey, Ohio, New York and several other states have already implemented or are considering laws to limit the number of days opioids can be prescribed and dispensed for acute, short-term pain. This week Florida Gov. Rick Scott announced that he would support legislation for a 3-day limit on opioids for acute pain in his state. Strict conditions would have to be met to get a 7-day supply.   

A bill introduced in the U.S. Senate earlier this year would require doctors nationwide to limit the initial supply of opioids for acute pain to seven days, a prescription that could not be renewed.  The bill by Sen. John McCain and Sen. Kirsten Gillibrand was referred to the Senate Judiciary Committee in April, but has gone no further.

CVS Health announced last week that it would limit opioid medication for acute pain to 7 days in all of its pharmacies nationwide, starting February 1.

CVS will also limit opioid doses for both acute and chronic pain to 90mg morphine equivalent units, and patients would be required to try immediate release formulations before using extended release opioids.

‘Moonshot’ Needed for New Pain Treatments

Today’s meeting of President Trump’s opioid commission focused largely on expanding access to addiction treatment and developing new ways of treating chronic pain without the use of opioid medication. During the two-hour meeting, there was hardly any mention of illegal opioids or the scourge of heroin and illicit fentanyl now sweeping the country.

"Our nation needs a moonshot commitment to the development of non-opioid pain treatments. We need new therapies and we need them fast," said Jim Campbell, MD, President of Centrexion Therapeutics. "The abuse of opioids costs lives, but the other equally important issue is the problem of untreated pain. Untreated pain leads to lost work, depression, lack of sleep, social withdrawal and may even lead to suicide."

Commission member Patrick Kennedy, a former congressman in recovery from addiction, said the problems of pain, addiction, depression and suicide are all intertwined, and need better advocacy.

“Clearly, depression is rampant. The opioid crisis was driven by a depression crisis. And while we’re talking about the opioid crisis and overdose deaths, suicide is getting right up there, to the height of the AIDS epidemic itself,” said Kennedy. “Because these illnesses are so stigmatized, the advocacy is really anemic. There’s no one out there shaking the trees as if this were HIV and AIDS, like we saw in those crises.”

To watch a replay of the commission meeting, click here.

FDA Targets Rogue Online Pharmacies

By Pat Anson, Editor

The Food and Drug Administration is cracking down on over 500 online pharmacies that illegally sell potentially dangerous, unapproved versions of prescription drugs, including opioid pain medication, antibiotics and injectable epinephrine products. So far the crackdown doesn’t appear to be very effective, as many of the websites the FDA targeted remain online.

The FDA recently partnered with Interpol and other international law enforcement agencies in a global operation called Pangea X. The goal was to identify the makers and distributors of illegal prescription drugs and shut them down.

“These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances. Consumers go to these websites believing that they are buying safe and effective medications, but they are being deceived and put at risk,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

“The ease with which consumers can purchase opioid products online is especially concerning to me, given the immense public health crisis of addiction facing our country. Some of the websites sold unapproved versions of multiple prescription opioids directly to U.S. consumers. This easy and illegal availability of these controlled substances fuels the misuse and abuse of opioids.”

The FDA sent 13 warning letters to the operators of 401 websites informing them they were illegally selling unapproved prescription drugs.

screen shot from american pharmacy group website

One such letter went to the American Pharmacy Group in Silver Spring, Maryland, warning the company about selling an unapproved combination of hydrocodone and acetaminophen in 10/500mg doses.

The FDA asked drug manufacturers in 2011 to limit the strength of acetaminophen in prescription drugs to 325mg because of the risk of severe liver injury.

“There are currently no approved drug applications… for the hydrocodone products that contain 500 mg of acetaminophen offered for sale on your websites,” the FDA letter warned.  “Offering hydrocodone products for sale on your websites is particularly concerning given the potential for abuse and dependency, especially amid the growing epidemic of opioid abuse in the U.S.”

The FDA letter was dated September 19, 2017. But today a website affiliated with American Pharmacy Group was still selling the hydrocodone/acetaminophen combination in the 10/500mg dose as a “muscle relaxant.” A bottle of 30 pills could be purchased for $269 with 2-5 day delivery.  

In an online chat with “John” the pharmacy manager, I asked if a prescription was needed to get the painkiller.

“No you no need prescription no,” was his reply.

“Really? I don’t need a prescription to get that?” I asked

“No,” he answered again.

John then referred me to a “new” online pharmacy, one that was not on the list of 21 websites the FDA identified as being affiliated with American Pharmacy. It’s apparently easier to put a new website up than it is for federal agents to take an old one down.

In adddition to warning letters, the FDA seized nearly 100 website domain names, such as buyhydrocodoneonline.com, canadian-pharmacy24x7.com and buyklonopin.com.

As part of Pangea X, FDA inspectors also screened packages suspected of containing illegal drugs at international mail facilities (IMFs) in Chicago, Miami and New York. Those screenings resulted in nearly 500 parcels being seized.

“Our work to fight illegal online pharmacies is not over,” said Gottlieb. "We’ve recently tripled the staff we have in the IMFs to improve our ability to inspect packages that are suspected of containing illegal drugs, and we have doubled the number of cybercrime and port of entry special agents for the Office of Criminal Investigations,” Gottlieb said.

Interpol said it seized over $51 million in illicit and counterfeit medications during Operation Pangea X. Over 400 people were arrested worldwide, with 3,584 websites shut down.

ER Patients Less Likely to Use Opioids Long Term

By Pat Anson, Editor

Patients who are prescribed opioid pain medication for the first time in hospital emergency rooms are less likely to become long term opioid users than patients in other settings, according to a large new study by researchers at the Mayo Clinic.

"Our paper lays to rest the notion that emergency physicians are handing out opioids like candy," said lead author Molly Moore Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Most opioid prescriptions written in the emergency department are for shorter duration, written for lower daily doses and less likely to be for long-acting formulations."

Jeffrey and her colleagues analyzed data for 5.2 million opioid prescriptions filled in emergency rooms from 2009 to 2015.

They found that only 1.1% percent of “opioid naïve” patients with private insurance progressed to long term opioid use. That compares to 2% of patients in non-emergency settings. Long term use was defined as someone getting 10 or more refills or more than a 120 day supply of opioids in a year.

About 3 percent of Medicare beneficiaries used opioids long term after getting them in an ER, with disabled Medicare patients the most likely ER patients to progress to long term use (13.4%).

Only 3.3% of opioid doses for privately insured patients in the ER exceeded 90mg morphine equivalent units (what the CDC considers a high daily dose). That compares to 7.2% of doses in non-emergency settings.  The duration of prescriptions was also lower for ER patients.

"Less than 5 percent of opioid prescriptions from the ER exceeded 7 days, which is much lower than the percentage in non-emergency settings. Further research should explore how we can replicate the success of opioid prescribing in emergency departments in other medical settings," said Jeffery, whose study is published online in the Annals of Emergency Medicine.

The use of opioid medication in hospital emergency rooms has become a contentious issue for both patients and physicians, with many patients complaining that they are profiled and labeled as drug seekers when they seek treatment at an ER for pain.

“I refuse to go to the ER for pain. Unless I feel I'm absolutely dying, I will not go. It isn't worth being made to feel like I'm only ‘putting on a show’ or I'm a junkie just trying to get high,” one pain sufferer told us.

In a survey of over 1,250 pain patients last year by PNN and the International Pain Foundation, 80 percent said they had felt labeled as an addict or drug seeker by hospital staff. Asked if doctors were reluctant to prescribe opioid medication while they were hospitalized, over two-thirds said it happens often or sometimes. To see the complete survey results, click here.

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

Some hospitals, such as Temple University Hospital in Philadelphia, have adopted guidelines that discourage opioid prescribing to ER patients. The voluntary policy quickly won broad support from Temple’s physicians.

In a survey by the hospital, only 13% of Temple’s ER doctors thought patients with legitimate reasons for opioids were denied appropriate care. A large majority – 84% of the doctors -- did not believe patients were denied appropriate pain relief.

“Emergency physicians have identified themselves as targets for patients who seek opioids for nonmedical purposes, yet it can be difficult for clinicians to distinguish drug seeking behavior from legitimate need,” said Daniel del Portal, MD, Assistant Professor of Clinical Emergency Medicine at the Lewis Katz School of Medicine at Temple University.

The 4 H’s That Can Help Lower Pain Levels

By Barby Ingle, Columnist

One of my goals in this continuing series on alternative pain care is to help people find an effective treatment that they hadn’t considered before. Even we help just one person, it makes it all worthwhile.

I understand that not all treatment options work for everyone. I am also very aware that some patients would rather only do what is “traditional” for their chronic condition. But what if you could get even more relief by adding another therapy or combining multiple treatment options? I believe a treatment I received took me from a wheelchair to walking, but I know that I would have done even better by adding a multi-modal approach to my pain care.

This segment of my series will cover the 4 H’s: hypnotherapy, hyperbaric therapy, holistic living and herbal therapy.

Hypnotherapy

Hypnotherapy is used in chronic pain treatment to create a subconscious change in patients. It will not “cure” a patient of their pain or physical challenges, but it can help form new responses, thoughts, attitudes, and behavior patterns to help cope with constant pain.

Hypnotherapy is a complementary therapy that utilizes suggestive techniques that patients can use to alter their state of consciousness. Using skilled relaxation techniques, the hypnotherapist makes appropriate suggestions to relax our conscious thoughts in order to focus on the subconscious ones.

There are multiple approaches to hypnotherapy, so learning about the different types may be helpful. A few of them include cognitive behavioral therapy, Ericksonian therapy, neuro-linguistic programming, cortical integrative therapy, and past life regression.

There is wide endorsement for hypnotherapies that can be used in habit breaking, stress-related challenges, and treating long-term conditions. We have a hypnotherapist on the iPain board of directors and the National Institute for Health and Care Excellence has also endorsed hypnotherapy for multiple uses.

But there is still a need for more testing and research to provide more concrete evidence that hypnotherapy can help and be used in tandem with traditional treatments.

Not everyone responds to hypnotherapy, as our susceptibility and commitment to the process varies from patient to patient, as do the treatments. It could be a single hypnosis session for issues like smoking cessation or it could be weekly visits for chronic pain.

Costs can vary between $50-150 per session. Some insurance companies will cover hypnotherapy, so it’s a good to check with them before making an appointment. If you want to feel more comfortable about hypnosis before trying it, I suggest that you talk to the therapist first and do some research online. If you need help finding a hypnotherapist in your area, you can start by clicking here.

Hyperbaric Therapy

Hyperbaric oxygen therapy is painless to participate in. It was originally created for deep-sea divers to help them overcome decompression sickness, but has also been used for decades to treat infections, severe burns and carbon monoxide poisoning. More recently it has been found to help people with fibromyalgia and other chronic illnesses.

Many chronic pain patients have trouble with vascular constriction and getting proper oxygen throughout the body, especially to areas that most affected by pain.

Hyperbaric therapy helps improve oxygen levels, which reduces nerve pain, fights infections, and promotes cell growth and wound healing.

Patients undergoing hyperbaric oxygen therapy sit in a pressurized room or tube. The higher air pressure allows lungs to gather more oxygen than they would normally, resulting in 10 to 15 times the normal amount of oxygen being brought to each cell.

This stimulates cell healing and provides vital nutrients to cells that are not functioning correctly. When our cells are not getting the proper amount of oxygen and nutrients, we lose energy, tissue becomes malnourished, and it delays or prevents healing.

Most patients using hyperbaric therapy will require a few rounds of treatment over several weeks to get results. The cost can be quite high, but if you can get your provider to test your vascular constriction with a Doppler Study or another measuring device, your insurance may pay for this treatment.

Holistic Living

Holistic living is more of a lifestyle approach than a treatment, because it is aimed at improving the mind, body and spirit. Once we bring harmony into our lives physically, mentally, spiritually and emotionally, we create a balance that can make the tough times of living with chronic pain more bearable.

The good news is you can start consciously living in a holistic manner at any time. Taking one step at a time is the way to get on the path of self-improvement. Living holistic is about being conscious of all aspects of who you are and the choices you make.  

Holistic living also makes use of massage, acupuncture, acupressure, herbal medicine and other healing options. These are typically out of pocket expenses, so access to them can be limited. But with YouTube, Zubia and other online platforms, it’s easy to find videos – like the one below --to help learn how to live holistically on your own.

Herbal Therapy

Herbal therapy was first introduced to me back in college when I had a cheerleading injury and a friend took me to Chinatown to see a doctor who had been treating her.

I thought it was such a strange experience. He looked at my eyes, my fingers and my tongue. What could he see? What was he looking for? I could hardly understand him, but when he was done, we headed into a room with all kinds of herbs and plants stored in bins.

He walked around the room, chose some items for me, and wrote out on a piece of paper what to do. I took the stuff back to my dorm room and made it into a tea that I drank a little of each day. It was to help with inflammation from my injury.

Some people, including my friend, just ate the herbs and plants. But I didn’t like the taste, so making the tea was easier for me to get it down.

Just because an herb or plant is in its natural state doesn’t make it right for all of us. You should check with an herbalist who has some training in this area. Herbs can interact with some over-the-counter and prescription medications. And be sure to tell your healthcare providers about any herbal medications you are taking.

This month’s spotlight on H’s that can help with pain care are meant to be idea starters. As always, I look forward to hearing from those of you who have tired any of these modalities and whether it improved your general health and to chronic pain specifically.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website. 

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

CDC Launches New Campaign Against Rx Opioids

By Pat Anson, Editor

The Centers for Disease Control and Prevention has launched a new awareness campaign to combat the abuse of prescription opioids, a marketing effort driven by surveys and focus groups that completely ignores the increasing role of heroin and illicit fentanyl in the nation’s overdose crisis.

The Rx Awareness campaign uses videos, online advertising, billboards, newspapers and radio ads designed to increase awareness “about the risks of prescription opioids and stop inappropriate use.” The campaign will initially run for 14 weeks in Ohio, Kentucky, Massachusetts, and New Mexico, with a broader release expected as additional states receive funding through CDC programs. No estimate of the cost of the campaign was released.

“The U.S. Department of Health and Human Services (HHS) is committed to using evidence-based methods to communicate targeted messages about the opioid crisis and prevent addiction and misuse in every way we can,” HHS Secretary Tom Price, MD, said in a statement. 

But little "evidence" is actually presented in the Rx Awareness campaign, which primarily uses slogans and emotional, “real-life accounts” of people recovering from opioid addiction or who have lost loved ones to a prescription opioid overdose.

“Prescription opioids can be addictive and dangerous,” a woman says in an online banner ad.

“One prescription can be all it takes to lose everything,” a man says in another ad.

Although addictive behavior typically starts during adolescence, the Rx Awareness campaign is targeting adults aged 25-54 who have used prescription opioids at least once either medically or recreationally.

“We learned that adults between the ages of 45 and 54 had not yet been targeted by a broad-reaching campaign. This information was reinforced by surveillance data indicating that the population with the highest fatality rate from opioid overdoses was non-Hispanic white adults ages 45–54,” the CDC said in an unusually detailed explanation of the marketing research behind the campaign.

“We also found a need for communication efforts to deliver primary prevention messages to younger audiences ages 25–35, who are less likely to experience chronic pain but may be exposed to opioids for other reasons, such as having a sports injury or undergoing a dental procedure.”

The four states initially being targeted all have soaring rates of opioid overdoses, but in recent years most of the deaths have been linked to heroin and illicit fentanyl, not prescription opioids. 

The latest report from the Massachusetts Department of Public Health, for example, shows prescription opioids were involved in only 15 percent of opioid-related overdose deaths in the state during the first quarter of 2017. Fentanyl was involved in 81 percent of the Massachusetts deaths and heroin in 39 percent of them. 

But fentanyl and heroin are not even addressed in the Rx Awareness campaign, because the CDC didn't want to risk “diluting” its primary message.

“The campaign does not include messages about heroin. Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging. Heroin is a related topic that also needs formative research and message testing,” the CDC said.

One of the video testimonials featured in the campaign is the story of Steve Rummler, a Minnesota man with chronic back pain who became addicted to painkillers. Rummler died of a heroin overdose at the age of 43.

His mother Judy, who appears in the video, founded the non-profit Steve Rummler Hope Foundation, an anti-opioid activist group. The Rummler foundation is the “fiscal sponsor” of Physicians for Responsible Opioid Prescribing (PROP), a designation that allows PROP to collect tax deductible donations using the foundation’s non-profit status. PROP founder Andrew Kolodny, MD, is listed as a member of the Rummler foundation's medical advisory committee, as is PROP President Jane Ballantyne, MD.

The CDC said it developed the videos and other campaign material using a “mixed-method design integrating data from in-depth interviews and a quasi-experimental, one-group retrospective post-then-pretest (RPTP) survey was used to assess target audiences’ responses to campaign messages.”

In the other words, the campaign is driven by marketing research -- not Secretary Price's "evidence-based methods." The CDC said most participants in focus groups thought the campaign material was "attention grabbing, believable and meaningful." Many also said they would share the video testimonials with others.   

“This campaign is part of CDC’s continued support for states on the frontlines of the opioid overdose epidemic,” said CDC Director Brenda Fitzgerald, MD. “These heartbreaking stories of the devastation brought on by opioid abuse have the potential to open eyes – and save lives.”

5 Things to Know About Epidural Steroid Injections

By Margaret Aranda, MD, Columnist

Some patients with neck and back pain report that their doctor requires them to get epidural steroid injections (ESI's) before they are prescribed opioid pain medication. Many do not realize that the procedure or any use of drugs for spinal injection is not FDA approved and is considered "off label."

Some patients benefit from ESI’s, while others gain no pain relief or suffer serious complications. In 2014, the FDA warned that injection of corticosteroids into the epidural space of the spine may result in rare but serious neurological events, including "loss of vision, stroke, paralysis, and death."  

A 2015 commentary by FDA scientists in The New England Journal of Medicine urged doctors to carefully select patients to identify those who might benefit from spinal injections and to minimize serious risks.

Probably the worst epidural steroid catastrophe was the 2012-13 outbreak of fungal meningitis, caused by contaminated steroids produced at the New England Compounding Center. As many as 13,000 patients nationwide were exposed to the fungus, mostly through epidural injection, resulting in 751 meningitis infections and at least 64 deaths.

Let's take a step back to assess why epidural steroids may or may not be a good idea. The rationale behind the procedure comes from the anti-inflammatory effect of steroids on the nerves.

Chronic inflammation in nerves can lead to pain, numbness, and muscle weakness. Nerve injury causes microscopic changes in nerve anatomy, including tissue swelling or edema, an increase in fibrous tissue and, in the worst case, nerve death through something called Wallerian degeneration. In cases like traumatic brain injury or stroke, the nerve damage can be permanent.

There are now about 9 million epidural steroid injections performed annually in the U.S and the number of procedures appears to be growing.

During a standard epidural injection, the doctor may inject into the epidural space a contrast dye using x-ray guidance (fluoroscopy) to make sure the dye is going into the correct location.  Others may use a more blind approach, called the "loss of resistance" technique, with a syringe of air that injects itself into the epidural space as it enters. There is a "pop" when the needle penetrates the epidural space.

After the air or dye is injected and the needle located, a second syringe containing  the steroid is injected. Afterward, the patient is observed for signs of pain relief and complications.

Many studies show that about 50% of patients feel better. If there is no pain relief after one ESI, a second attempt is usually in order. If partial relief is exhibited, a series of three injections in two weeks may be performed.

There is controversy over the rate and frequency of epidurals for pain. Typically, a “cycle” of epidurals is done, but if there is no pain relief after two injections, some doctors recommend that a different treatment be used. Some patients report getting as many as two or three dozen epidurals in a single year.  Critics say that raises the risk of a misplaced needle causing “cumulative trauma” and serious complications such as adhesive arachnoiditis.

If you doctor recommends that you get an epidural steroid injection, here are five things you need to know:

1. Drugs Used: The two most common drugs for ESI are a local anesthetic (lidocaine or bupivacaine) and/or a corticosteroid (betamethasone, dexamethasone, hydrocortisone, methyl-prednisolone, triamcinolone). 

The local anesthetic offers immediate numbing and pain relief. It also verifies whether the injection was done in the right place and gives an idea of how the steroid may act to decrease inflammation. After the anesthetic wears off, the steroid kicks in for an effect that may last varying times, sometimes for a short period and sometimes forever.

Patients and doctors need to know whether there was immediate pain relief from the local anesthetic. The doctor should ask, "Does the pain feel better?" to assess the temporary anesthetic effect.

If the answer is yes, then the steroid should provide more pain relief. If the answer is no, the steroid is much less likely to have any clinical effect. There is no indication to repeat the procedure if there is no decrease in pain. Doing so would unnecessarily expose a patient to serious complications or death.

2. Injection Sites: The most common injections are into the neck (cervical) and into the lower back (lumbar). Less commonly, epidural injections are placed into the upper back (thoracic) or to the bottom tip of the spine in the sacral area (caudal). The needle can go either straight into the middle of the spine (interlaminar), or enter from the left or right side (transforaminal). 

In general, the closer the injection is placed to the head, the greater the risk of serious complications if the needle accidentally hits a nerve or artery, an air bubble causes an embolism, or if the injection goes into the spinal fluid.

3. Minor complications: Adverse events can occur within minutes or up to 48 hours after an injection. Minor complications are generally not life-threatening and usually go away with little to no treatment.

Some patients get an "epidural headache" when the needle is inserted too far into the dura, causing a leak of cerebrospinal fluid. This is a stressful and painful headache, but it usually completely resolves. Other minor complications include facial flushing, fainting, hypertension (high blood pressure) and increased pain.

4. Serious complications: No one really knows the complication rate of epidural steroid injections, due to under-reporting by doctors and the lack of standard guidelines.

Normally, the steroid will flow into the epidural space above and below where it was injected, but it can also flow into unintended places like the subdural or intrathecal spaces, cranial nerves, brain stem, and lower midbrain.

For example, if the injection accidentally goes into the spinal fluid, the procedure becomes a spinal block, not an epidural block. This may lead to potentially life-threatening complications. If this happens during an injection to the neck, it can spread upward, toward the top of the head and into the brain, leading to serious complications. 

Severe complications from an injection can include arachnoiditis, allergic reactions, stroke, brain edema, cauda equina syndrome, seizures, vasculitis, blindness, and death.

5. Off-Label Use: The FDA places epidural steroids in the category of "off-label" use that falls within the practice of medicine and is not FDA-approved. The FDA requires all glucocorticoid steroid warning labels to state:

The safety and effectiveness of epidural administration of corticosteroids have not been established and corticosteroids are not approved for this use… serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids.”

The FDA website also warns patients to seek emergency medical attention if they experience any unusual symptoms, such as loss of vision or vision changes, tingling in the arms or legs, sudden weakness or numbness, dizziness, severe headache or seizures.

If you have concerns regarding the use of epidural steroid injections, talk to your doctor.

Dr. Margaret Aranda is a Stanford and Keck USC alumni in anesthesiology and critical care. She has dysautonomia and postural orthostatic tachycardia syndrome (POTS) after a car accident left her with traumatic brain injuries that changed her path in life to patient advocacy.

CVS to Limit Opioid Prescriptions

By Pat Anson, Editor

CVS Health has announced plans to further restrict the filling of opioid prescriptions at its pharmacies by limiting the dose and supply of opioids for acute pain to seven days. The new policy only applies to customers enrolled in the CVS Caremark pharmacy benefit management program, which provides pharmacy services to over 2,000 health and insurance plans.

CVS said its opioid policy would “give greater weight” to the Centers for Disease Control and Prevention's opioid prescribing guideline, which discourages doctors from prescribing opioids for chronic pain.

“The CDC Guideline should become the default approach to prescribing opiates, a scenario in which physicians would have to seek exceptions for those patients who need more medication or longer duration of therapy,” Troyen Brennan, MD, CVS’ Chief Medical Officer wrote in a post on Health Affairs Blog.

But the new CVS policy actually goes beyond the voluntary recommendations of the CDC guideline, which was only intended to give advice to primary care physicians who treat chronic pain.

Beginning February 1, CVS will limit all opioid prescriptions for acute pain to seven days. For both acute and chronic pain, opioid doses must not exceed 90mg morphine equivalent units and patients will be required to try immediate release formulations, before using extended release opioids.

The policy will apply to all 90 million CVS customers enrolled in commercial, employer or Medicaid health plans. CVS operates 9,700 pharmacies and 1,100 walk-in medical clinics nationwide.

In announcing the policy, CVS rejected complaints that it and other healthcare providers were adopting a “heavy-handed, cookie cutter” approach to patient care – decisions best left between a patient and their doctor.

“To be sure, prescriber autonomy and respect for the physician-patient relationship are of paramount importance. However, there is little evidence to show that past opioid prescribing habits are necessary or appropriate, and there is a great deal of evidence that they have produced significant harm,” said Brennan.

“We see firsthand the impact of the alarming and rapidly growing epidemic of opioid addiction and misuse,” said Larry Merlo, CEO of CVS Health. 

“With this expansion of our industry-leading initiatives, we are further strengthening our commitment to help providers and patients balance the need for these powerful medications with the risk of abuse and misuse.” 

Opioids Have Been Costly for CVS

Patient safety may not be the only factor behind CVS’ decision to limit opioid prescriptions. In recent years, the company has been fined hundreds of millions of dollars for violations of the Controlled Substances Act and other transgressions, many of them involving opioid medication.

As PNN has reported, CVS recently agreed to pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of the painkiller hydrocodone by employees.

In 2016, CVS also paid a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged opioid prescriptions. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight different CVS stores. Another forger obtained over 200 prescriptions for hydrocodone and methadone by forging the name of an emergency room physician.

And in 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

As a result of these and other fines, CVS pharmacists were already under pressure to be wary of filling opioid prescriptions. Many started calling doctors to make sure the prescriptions were legitimate and some even refused to fill the prescriptions of longtime customers.

Alcohol Sales Continue

CVS was widely praised for its decision to stop selling cigarettes a few years ago, a move that cost the company $2 billion in lost tobacco sales.  According to Marketplace, the company has also removed transfats from its branded food products and reduced displays of candy near its cash registers.

The healthier offerings apparently do not apply to alcohol, however, a substance that causes far more addiction, death and health problems than opioid medication. This week an advertising flier for CVS stories in California prominently displays a selection of inexpensive beer, wine and hard liquors.

CVS did not respond to a query from PNN about whether it intends to limit the amount and frequency of alcohol purchases, as it is planning to do for opioid pain medications.    

CVS Health (NYSE: CVS) stock has fared poorly in the past year and company insiders have sold nearly $100 million in shares. Among the sellers, according to Barrons, was CEO Merlo – who has sold $26 million in shares so far in 2017, including $20 million in September alone.

Is Medical Marijuana Causing More Fatal Crashes?

By Rochelle Odell, Columnist

Medical marijuana’s role in fatal auto accidents is a subject that’s rarely addressed by those who support full legalization of cannabis. But I found numerous articles about it online and all show there is cause for concern.

An NBC News story warned that “Pot Fuels Surge in Drugged Driving Deaths” back in 2014, the year after Colorado became the first state to legalize recreational marijuana:

“During each shift at her drive-through window, once an hour, Cordelia Cordova sees people rolling joints in their cars. Some blow smoke in her face and smile.

Cordova, who lost a 23-year-old niece and her 1-month-old son to a driver who admitted he smoked pot that day, never smiles back. She thinks legal marijuana in Colorado, where she works, is making the problem of drugged driving worse.”

“Drugged driving” is a term I had not heard before. Police agencies and medical professionals usually refer to it as driving under the influence or operating a vehicle while intoxicated. It is a perfect description, not only for marijuana, but for any substance that alters your ability to safely operate a vehicle.

The NBC News story quotes researchers at Columbia University, who looked at toxicology reports on over 23,000 dead drivers in six states were medical marijuana was legal. Cannabis was detected in the bodies three times more often in 2010 than in 1999.  

"This trend suggests that marijuana is playing an increased role in fatal crashes, said Dr. Guohua Li, co-author and director for Injury Epidemiology and Prevention at Columbia University Medical Center.

But alcohol was the most common mind-altering substance detected, appearing in the blood of nearly 40 percent of the drivers who died in 2010.

Research on this subject can be somewhat contradictory. A second study at Columbia found that states with medical marijuana laws had an 11 percent decrease in traffic fatalities. They also found there were fewer alcohol related accidents, suggesting that some younger drivers were substituting marijuana for alcohol.

Marijuana, like opiates and alcohol, should never be consumed by someone intending to drive. Even cannabidiol (CBD) based medications, which marijuana supporters tout as safe, may contain trace amounts tetrahydrocannabinol (THC), the chemical ingredient in cannabis that makes people high.

I am not an active proponent of medical marijuana, although I realize there are those who benefit from its use. But cannabis is not always the "magic bullet" when it comes to pain relief, and not all pain patients support it.

I tried CBD medication for three weeks and it did nothing for my pain. Being asthmatic precludes me from smoking or vaping, and I have been told using edibles in the amount required to achieve pain relief would require a large amount. Medical marijuana is also costly and can be cost prohibitive for those of us on fixed incomes.

I did vote for full legalization last year when it was on the California ballot. I also believe those who buy it from medical marijuana dispensaries have a right to know where it is cultivated, along with what pesticides, fertilizers or other harmful substances may have been used in its cultivation. People are going to use marijuana whether it is legal or illegal, so state and federal governments should legislate accordingly.

Studies show that Colorado, Oregon and Washington State have all seen an increase in car crashes since they fully legalized marijuana, although the number of fatal crashes has remained about the same. A recent analysis by the Denver Post found the number of drivers in Colorado who tested positive for marijuana after fatal crashes has risen by 145 percent since 2013.

Like everything else, we can draw our own conclusions from these statistics. I only ask that readers who are medical marijuana users check your state’s laws before smoking or vaping, consuming CBD, or ingesting the popular edibles.

THC is a known psychoactive and can affect your ability to safely operate a vehicle. CBD can also show up in toxicology reports and will reflect on the driver if they’re involved in an accident. Please educate yourself and be sober from any substance, legal or illegal, before driving.

Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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 Opioid Commission Delays Final Report

By Pat Anson, Editor

The chairman of President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis has asked for – and apparently been granted – a one month delay in releasing the panel’s final report.

In a letter posted on the White House website, New Jersey Gov. Chris Christie said the commission’s “research and policy development are still in progress,” and that he was extending the deadline from October 1 to November 1.

Christie said the opioid commission would hold its third public hearing September 27 at the White House. A notice published in the Federal Register indicates the meeting will focus on pain management and the diversion of opioid pain medication.

“The meeting will consist of statements to the Commission from invited government, nonprofit, and business organizations regarding Innovative Pain Management and Prevention Measures for Diversion followed by discussion of the issues raised,” the statement says. No list of attendees is included.

Christie’s letter also says the opioid commission will visit an Ohio medical center to learn about “innovative pain management strategies” and will meet in New Jersey with representatives of the pharmaceutical industry “to talk about partnership opportunities with the National Institutes of Health and the Food and Drug Administration.”

Until now the focus of the opioid commission has been on treating opioid addiction. An interim report released in July recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioid medication, and increased efforts to detect and stop the flow of illicit fentanyl into the country. There are no specific recommendations aimed at reducing access to prescription opioids or providing different forms of pain management.

Bondi Joins Commission

Another possible sign of a shift in the commission’s direction is the recent appointment of Florida Attorney General Pam Bondi to the panel. Bondi is now listed as member of the commission on the White House website,  although there has been no official announcement by the Trump administration. She is the fifth politician appointed to the six member panel.

Bondi played a prominent in shutting down on Florida’s pill mills several years ago, but critics say she has been slow to acknowledge that the opioid crisis has shifted away from prescription painkillers to street drugs like heroin and illicit fentanyl. Many pain patients in Florida still have trouble finding pharmacies willing to fill their opioid prescriptions.

Bondi recently joined other state attorneys general in asking pharmaceutical companies for information about their marketing, production and distribution of opioids.

“Florida citizens continue to become addicted to opioids and die daily -- meanwhile, prescription drug manufacturers, distributors and the medical profession all point fingers at each other as the cause of this national crisis,” Bondi said in a statement. “This far-reaching multistate investigation is designed to get the answers we need as quickly as possible. The industry must do the right thing. If they do not, we are prepared to litigate.”

Bondi also recently joined the National Association of Attorneys General in asking the insurance industry to do more to reduce opioid prescriptions and combat opioid abuse.

“Insurance companies can play an important role in reducing opioid prescriptions and making it easier for patients to access other forms of pain management treatment. Indeed, simply asking providers to consider providing alternative treatments is impractical in the absence of a supporting incentive structure,” the attorneys general said in a letter to an insurance industry trade group.

“Insurance companies thus are in a position to make a very positive impact in the way that providers treat patients with chronic pain.”

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

The Trump administration has still not officially declared that the opioid crisis is a national emergency – something the President said he would do in August.  

CDC Releases More Faulty Research About Opioids

By Pat Anson, Editor

A new study by researchers at the Centers for Disease Control and Prevention estimates that opioid overdoses have shaved two and a half months off the average life span of Americans – a somewhat misleading claim because the study does not distinguish between legally obtained prescription opioids and illegal opioids like heroin and illicit fentanyl.

The research letter, published in the medical journal JAMA, looked at the leading causes of death in the U.S. from 2000 to 2015. Overall life expectancy rose during that period, from 76.8 years in 2000 to 78.8 years in 2015, largely due a decline in deaths from heart disease, cancer, stroke, diabetes and other chronic health conditions.

But deaths due to Alzheimer’s disease, suicide, liver disease, drug poisoning and opioid overdoses rose, collectively causing a loss of 0.33 years in life expectancy – most of it due to opioids.

“This loss, mostly related to opioids, was similar in magnitude to losses from all the leading causes of death with increasing death rates,” wrote lead author Deborah Dowell, MD, of the CDC’s National Center for Injury Prevention and Control.

“U.S. life expectancy decreased from 2014 to 2015 and is now lower than in most high-income countries, with this gap projected to increase. These findings suggest that preventing opioid related poisoning deaths will be important to achieving more robust increases in life expectancy once again.”

Dowell was also one of the lead authors of the CDC’s 2016 opioid prescribing guidelines, which discourage physicians from prescribing opioids for chronic pain. She and her two co-authors in the JAMA study --  both of them CDC statisticians -- do not explain why they failed to distinguish between black market opioids and legal prescription opioids, a dubious use of statistics akin to lumping arsonists in the same category as smokers or Boy Scouts learning to build campfires.  

They also fail to even mention the scourge of heroin and illicit fentanyl sweeping the country, which now accounts for the majority of opioid overdoses in several states.  

But Dowell and her co-authors don't stop there. The say the actual number of deaths caused by opioids is “likely an underestimate” because information on death certificates is often incomplete and fails to note the specific drug involved in as many as 25% of overdose deaths. This is another disingenuous claim, because it fails to explain why the data on the other 75% of overdoses is faulty too. 

Epidemic of Despair

Other researchers have also tried to explain the disturbing decline in American life expectancy – which began over adecade ago for middle-aged white Americans. Princeton researchers Anne Case and Angus Deaton were the first to document that trend,  when they estimated that nearly half a million white Americans may have died early because of depression, chronic pain, suicide, alcohol and drug abuse, and other health problems – an epidemic of despair linked to unemployment, poor finances, lack of education, divorce and loss of social connections.

The evidence was right there for Deborah Dowell and her co-authors had they looked for it. The JAMA study found that over 44,000 Americans committed suicide in 2015, a 66% increase from 2000, and over 40,000 died from chronic liver disease or cirrhosis, another 66% increase. Opioid overdoses during that same period rose to 33,000 deaths. 

Which is the bigger epidemic?

As PNN has reported, the CDC ignored early warnings from its own consultant that the agency’s opioid guidelines were being viewed as “strict law rather than a recommendation,” causing many doctors to stop prescribing opioid pain medication. Chronic pain patients also feel “slighted and shamed” by the guidelines, and are increasingly suicidal or turning to street drugs. We’ve also reported that the CDC has apparently done nothing to study the harms or even the possible benefits the guidelines have caused since they were released 18 months ago.

Instead of going back in time and selectively mining databases to fit preconceived notions about opioids, perhaps it is time for the CDC to take a giant step forward and see what its opioid guidelines have actually done.