How Have the CDC Opioid Guidelines Affected You?

By Pat Anson, Editor

Next month will mark the one year anniversary of opioid guidelines released by the Centers for Disease Control and Prevention – guidelines that discourage primary care physicians from prescribing opioids for chronic non-cancer pain.

At the time of their release, the CDC estimated that as many as 11.5 million Americans were using opioid medication daily for pain relief. Many of those patients now say their doses have been abruptly lowered or they are unable to obtain opioids at all.

That could be a good thing, depending on your point of view about the nation’s so-called “opioid epidemic.” Former CDC director Thomas Frieden, MD, has called the guidelines an “excellent starting point” to stop an epidemic fueled by “decades of prescribing too many opioids for too many conditions where they provide minimal benefit.”

Many pain patients disagree, saying they’ve used opioids safely and effectively for years. They say the guidelines have had a chilling effect on many of their doctors and are being implemented in ways that go far beyond what the CDC intended.  

“Last year, when the CDC ‘recommendations’ came out, the entire building of the only doctor's office I can go to decided they were rules, and cut me from 210 mg/day morphine to 90 mg. Now they say they can only give me 60 mg/day,” wrote Eli, one of hundreds of patients we’ve heard from in the past year.

“I'm in so much pain I can't properly care for myself, nor get to town for supplies when I need them. I've become increasingly more disabled and dependent on others.”

“My pain management doctor told me that the CDC required that all morphine be taken away from all Americans,” wrote a California woman who suffers from severe back pain. “He even stated that surgeons were sending home their post-surgery patients with Motrin, nothing else.

“What are you people in the CDC doing? Don't you realize how paranoid doctors can get? You may think using the term ‘guideline’ will help them understand what you are trying to do, but you have created a bunch of neurotic paranoids. Stop it. Do something before you kill all of us.”

“I am a 76 year old intelligent woman who is not an addict or an abuser, yet I am denied relief from unremitting pain even after 20 years of trying every drug and treatment modality available,” wrote Roberta Glick. “I am at a total loss as to what to do, how to fight, etc.  My physician is a strong supporter.  He is not the problem. He also is a victim of misguided CDC attempts to curb drug addiction.”

Are the CDC guidelines voluntary or mandatory? Have they improved the quality of pain care? Are patients being treated with safer and better alternatives? Most importantly, are soaring rates of opioid abuse and addiction finally being brought under control?

Those are some of the questions Pain News Network and the International Pain Foundation (iPain) are asking in an online survey of patients, doctors and other healthcare providers.

“I strongly believe that as these guidelines are implemented by doctors and hospitals around the country there are important lessons to learn from those who are affected by them,” says Barby Ingle, president of iPain and a PNN columnist.

“I hope that pain patients and providers participate in this survey so that we can begin to show how deep the impact actually is to the chronic pain community one year later.” 

The online survey consists of less than a dozen multiple choice questions, which should take only a few minutes to complete. Please take time out of your busy day and complete the survey by clicking here.

The survey findings will be released on March 15th, the first anniversary of the CDC guidelines. By taking the survey, you can also sign up to have the results emailed to you.

A Deadly Mix: Opioids and Alcohol

By Pat Anson, Editor

Taking one oxycodone tablet together with alcohol significantly raises the risk of respiratory depression and possible death, according to a new study by Dutch researchers. Elderly people were more likely to experience this complication, researchers found.

The study, published in the journal Anesthesiology, is one of the first to address the effect of alcohol and opioids on respiratory depression, which causes breathing to become extremely shallow or stop altogether.

"Unfortunately, we're seeing more fatalities and people in emergency rooms after having misused or abused legally prescribed opioids, like oxycodone, while having consumed alcohol," said lead author Albert Dahan, MD, a professor of anesthesiology at Leiden University Medical Center in the Netherlands.

"Respiratory depression is a potentially fatal complication of opioid use. We found alcohol exacerbated the already harmful respiratory effects of opioids."

Dahan and his colleagues studied the effects of oxycodone and alcohol on breathing in 12 healthy young volunteers (ages 21 to 28) and 12 elderly volunteers (ages 66 to 77). On three separate occasions, the volunteers were given one 20 mg oxycodone tablet combined with an intravenous infusion of ethanol (alcohol).

The amount of alcohol was increased until blood-alcohol levels reached 0.5 g/L on the second visit and 1.0 g/L on the third visit, as measured through the volunteers' breath. A man would need to consume about 5 alcoholic drinks to reach the latter level.

Taken alone, one oxycodone tablet reduced respiratory ventilation – the amount of air the volunteers breathed per minute -- by 28 percent. Adding 1.0 g/L of alcohol caused ventilation to further decrease by another 19 percent - a total decrease of 47 percent.

The combination of alcohol and oxycodone also caused a significant increase in the number of times volunteers temporarily stopped breathing. This was especially true in the elderly volunteers, who were more likely to experience repeated episodes where they temporarily stopped breathing.

"We hope to increase awareness regarding the dangers of prescription opioids, the increased danger of the simultaneous use of opioids and alcohol, and that elderly people are at an even greater increased risk of this potentially life-threatening side effect," said Dahan. "Ultimately, people should know that it is never a good idea to drink alcohol with opioids."

Although warning labels for oxycodone and other opioids caution against using them with alcohol, it’s common for the two to be mixed. A recent study by the Centers for Disease Control and Prevention found that alcohol was involved in about 15 percent of drug overdoses, including deaths associated with oxycodone, hydrocodone, morphine and fentanyl. 

New Guidelines Offer Little Relief for Back Pain

By Pat Anson, Editor

“Take two aspirin and call me in the morning” doesn’t cut it anymore for low back pain. In fact, very little does.

One in four adults will experience low back pain in the next three months, making it one of the most common reasons for Americans to visit a doctor. But when it comes to treating low back pain, the American College of Physicians (ACP) says the evidence is weak for many pharmaceutical and non-drug therapies.

In fact, the best treatment for acute low back pain may be none at all.

"Physicians should reassure their patients that acute and subacute low back pain usually improves over time regardless of treatment," said Nitin Damle, MD, president of ACP. "Physicians should avoid prescribing unnecessary tests and costly and potentially harmful drugs, especially narcotics, for these patients."

An ACP review committee analyzed dozens of clinical studies to arrive at new guidelines for treating acute back pain (pain lasting less than 4 weeks), subacute back pain (pain lasting 4 to 12 weeks) and chronic back pain (pain lasting more than 12 weeks).  

The ACP recommends that doctors start with non-drug therapies, such as exercise and superficial heat with a heating pad, along with massage, acupuncture, spinal manipulation (chiropractic), tai chi, and yoga. The evidence for the effectiveness of exercise and superficial heat was considered moderate, while the evidence for the other non-drug treatments was considered low quality.

Only when non-drug treatments have failed does the ACP recommend medication for chronic low back pain, starting with non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and aspirin. Tramadol (a mild acting opioid) and duloxetine (Cymbalta) are recommended as second line therapies. The ACP says physicians should only consider stronger opioids as a third line therapy when all other treatments have failed.

The evidence for the effectiveness of NSAIDs and opioids was classified as moderate, while the evidence for acetaminophen, benzodiazepines and systemic steroids was considered low-quality.

"For the treatment of chronic low back pain, physicians should select therapies that have the fewest harms and costs, since there were no clear comparative advantages for most treatments compared to one another," Damle said.

The ACP guidelines say surprisingly little about the documented risks associated with NSAIDs, such as cardiovascular and gastrointestinal problems. The guidelines refer only vaguely to “moderate quality evidence” that NSAIDs have “adverse effects.”

Short-term use of opioids for low back pain was linked to increased nausea, dizziness, constipation, vomiting, somnolence and dry mouth. Interestingly, addiction and overdose were not listed as potential risks because they were not studied.

“Studies assessing opioids for the treatment of chronic low back pain did not address the risk for addiction, abuse, or overdose, although observational studies have shown a dose-dependent relationship between opioid use for chronic pain and serious harms,” the guideline states.

The ACP guidelines were released one week after Australian researchers released their own evaluation of NSAIDs in treating back pain. Their study found that NSAIDs reduced pain and disability somewhat better than a placebo, but the results were not statistically important (see “Ibuprofen No Better Than Placebo for Back Pain”).

The ACP calls itself the largest medical specialty organization in the United States. ACP members include 148,000 internal medicine physicians (internists), related sub-specialists and medical students.

The new guidelines are published in the Annals of Internal Medicine.

Sex, Poverty and Education Linked to Chronic Pain

By Pat Anson, Editor

If you are female, poor and never finished high school, you are much more likely to suffer from chronic pain than other Americans, according to a new study published in the journal Pain.

“Women, the less educated, and the less wealthy experience not only more pain, but also more severe pain, as well as greater disability, said Hanna Grol-Prokopczyk, an assistant professor of sociology at the University of Buffalo.

Grol-Prokopczyk studied over 12 years of data from nearly 20,000 Americans aged 51 and over, who participated in the national Health and Retirement Study from 1998 to 2010.

Her research uncovered some unexpected findings about chronic pain in the United States.

She found that the severity and frequency of pain is increasing in older adults. People who were in their 60’s in 2010 reported more pain than people who were in their 60’s in 1998.

“There are a lot of pressures right now to reduce opioid prescription,” says Grol-Prokopczyk. “In part, this study should be a reminder that many people are legitimately suffering from pain. Health care providers shouldn’t assume that someone who shows up in their office complaining of pain is just trying to get an opioid prescription.

“We have to remember that pain is a legitimate and widespread problem,” she added.

The study is among the first to measure chronic pain by degree. Participants were asked whether their pain was mild, moderate or severe, and if they were “often troubled with pain.” Participants were followed for over 12 years, as opposed to most studies that follow patients over a much shorter period.

“I found that people with lower levels of education and wealth don’t just have more pain, they also have more severe pain,” she says. “I also looked at pain-related disability, meaning that pain is interfering with the ability to do normal work or household activities.  And again, people with less wealth and education are more likely to experience this disability.”

About one out of every four people who didn’t finish high school said their pain was severe, while only 10 percent of those with college graduate degrees did so.

About 8 percent of African Americans and Hispanics said their pain was severe, compared to about 5 percent of whites.

“If you’re looking at all pain – mild, moderate and severe combined – you do see a difference across socioeconomic groups. And other studies have shown that.  But if you look at the most severe pain, which happens to be the pain most associated with disability and death, then the socioeconomically disadvantaged are much, much more likely to experience it,” said Grol-Prokopczyk.

More research needs to be done to understand why pain is so unequally distributed in the population, and Grol-Prokopczyk says it’s critical to keep the high burden of pain in mind as the nation grapples with an overdose epidemic.

“We don’t have particularly good treatments for chronic pain. If opioids are to some extent being taken off the table, it becomes even more important to find other ways of addressing this big public health problem,” she said. “If we as a society decide that opioid analgesics are often too high risk as a treatment for chronic pain, then we need to invest in other effective treatments for chronic pain, and/or figure out how to prevent it in the first place.”

How We Can Stop Medicare’s ‘Big Brother’ Opioid Policy

By Rick Martin, Guest Columnist

How many readers who leave comments on PNN are doing more than just commenting?

Change takes work if the pain community is going to stop the Centers for Medicare and Medicaid Services (CMS) from making the CDC’s opioid prescribing guidelines mandatory for millions of Medicare patients, including a ban on daily doses higher than 90 mg morphine equivalent (see “Medicare Planning to Adopt CDC Opioid Guidelines”).

We don’t need CMS and the insurance industry dictating what medication a physician can prescribe for pain or the appropriate amount of medication needed (see "Insurers Behind Medicare's 'Big Brother' Opioid Policy").

In my opinion, this is what needs to be done:

We have to start a chain letter.

I propose a form letter that everyone can copy and paste, forward, fax and mail to friends, family, caregivers, bloggers, Facebook, Twitter, and any other viable means of communication.  

You have to send it to at least 10 people. And ask them to send it to 10 people they know.

The letter also needs to be sent to patient advocacy groups like the U.S. Pain Foundation, American Chronic Pain Association, International Pain Foundation and the Alliance for Balanced Pain Management, a coalition of advocacy groups. They can post it in their newsletters and alert their members to what CMS is doing. This is the only way to reach a huge amount of people in a short amount of time. 

Here are their email addresses:

• U.S. Pain Foundation:  contact@uspainfoundation.org 
• American Chronic Pain Association:  acpa@theacpa.org 
• International Pain Foundation:  info@internationalpain.org 
• Alliance for Balanced Pain Management:  info@alliancebpm.org

We need to rein in CMS from dictating how we should live and the ability of our physicians to treat us. It won’t be easy. It took me 27 letters to the CDC to get a response from Dr. Debra Houry, who helped draft the agency’s guidelines.  

CMS is only accepting emailed public comments to their proposal until March 3, 2017. They will publish the final rules on April 3, so there is not much time. We must all act NOW.

Here is what I am emailing to CMS at this email address: AdvanceNotice2018@cms.hhs.gov

To Whom It May Concern:

I oppose the Centers for Medicare and Medicaid Services’ plan to align its policies with the CDC Guideline for Prescribing Opioids for Chronic Pain.

The CDC guideline is voluntary and gives physicians discretion in determining what is right for their patients. However, your policy as presently drafted will make the guidelines mandatory for all doctors, patients and pharmacists, and impose a ceiling on the highest dose of opioids that can be prescribed. That was never the CDC’s intent. 

On June 1, 2016, Dr. Debra Houry, Director of the CDC’s National Center for Injury Prevention
and Control, wrote the following:

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain. Specifically, the Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”

The following are additional quotes from the CDC Guideline itself:

"Clinicians should consider the circumstances and unique needs of each patient when providing
care.”

"Clinical decision making should be based on a relationship between the clinician and patient,
and an understanding of the patient's clinical situation, functioning, and life context."

"The Guideline provides recommendations for primary care providers who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care and end-of-life-care."

Your policy does not provide an exception for palliative care, only patients receiving cancer treatment or end-of-life care. In my opinion, that is a blatant omission.

The facts are also available showing there has been collusion between the insurance industry and CMS in drafting your new “Opioid Misuse Strategy.”

For all of these reasons and more, CMS should not adopt or align your agency’s policies with the CDC Guideline, as it is apparent you have misinterpreted them.

Sincerely,

Rick Martin

Feel free to copy my letter or make changes to express your own views. It also might be helpful to attach a copy of Dr. Houry’s letter in your email. If anyone wants a copy of her letter, click here to download it.

Time is running out if we want to put a stop to this.

Rick Martin is a retired pharmacist in Nevada who was disabled by chronic back pain.

Pain News Network invites other readers to share their opinions and stories with us.  Send them to:  editor@PainNewsNetwork.org. 

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.

Ibuprofen No Better Than Placebo for Back Pain

By Pat Anson, Editor

When it comes to treating back pain, anti-inflammatory drugs such as ibuprofen work no better than a placebo, according to new Australian study.

Researchers at the University of Sydney conducted a meta-analysis (a study of studies) of 35 clinical trials involving over 6,000 people with back pain, and found that non-steroidal anti-inflammatory drugs (NSAIDs) provide little benefit. The study was published in the Annals of the Rheumatic Diseases.

“NSAIDs are effective for spinal pain, but the magnitude of the difference in outcomes between the intervention and placebo groups is not clinically important. At present, there are no simple analgesics that provide clinically important effects for spinal pain over placebo,” wrote lead author Gustavo Machado, PhD, of The George Institute for Global Health. “There is an urgent need to develop new drug therapies for this condition.”

Back pain is the world’s leading cause of disability, with about 80 percent of adults experiencing back pain at some point in their lives.

Opioids are usually not prescribed for simple back pain, leaving patients little alternative but over-the-counter pain relievers such as NSAIDs, a class of drugs that includes both aspirin and ibuprofen. NSAIDs are known to raise the risk of gastrointestinal and cardiovascular problems.

The Australian study found that NSAIDs reduced pain and disability somewhat better than a placebo or dummy medication, but the results were not statistically important.

"NSAIDs do not provide a clinically important effect on spinal pain, and six patients must be treated with NSAIDs for one patient to achieve a clinically important benefit in the short-term," wrote Machado. “When this result is taken together with those from recent reviews on paracetamol (acetaminophen) and opioids, it is now clear that the three most widely used, and guideline-recommended medicines for spinal pain do not provide clinically important effects over placebo.”

The study did not evaluate non-pharmacological treatments for back pain, such as exercise, physical therapy or chiropractic care.

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are found in so many different products -- such as ibuprofen, Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

Misuse of Opioid Medication a Worldwide Problem

By Pat Anson, Editor

We hear often about the recreational or “non-medical” use of prescription drugs, particularly opioids, in the United States and Canada. But a new study published in the journal World Psychiatry suggests the abuse and misuse of opioids is a problem around the world.

Researchers at Columbia University's Mailman School of Public Health studied surveys of teenagers and young adults in Europe, Latin America, Asia, Middle East and the U.S.  They found that from 2000 to 2014, there was a 200 percent increase worldwide in overdose deaths due to opioids.

“Data on high school or university students from the Middle East or Arab world indicate that nonmedical use of prescription drugs warrants closer attention,” said lead author Silvia Martins, MD, associate professor of Epidemiology at Columbia University's Mailman School of Public Health.

“In Beirut, Lebanon, past-year nonmedical use of any prescription drugs was 21.6% among private university students and 10% among high school students. In both populations, prescription opioids were the drugs most commonly used nonmedically. In Saudi Arabia, a recent school-based survey showed a lifetime prevalence of 7.2% for the nonmedical use of any prescription drug.”

The growing misuse of opioid medication in some countries comes at a time when there is less misuse in the United States. A recent large survey found that 4.8% of American high school seniors had misused an opioid pain reliever in the past year, down from a peak of 9.5% in 2004. In the past five years, misuse of opioid pain medication by American 12th graders has declined by 45 percent.

Martins and her co-author say the availability of prescription opioids can vary widely from one country to another. Societal attitudes about medications and the misconception that they are “safe” can also contribute to misuse.

“The biggest challenge is balancing a country’s need to make available prescription drugs to those in need (i.e., those with chronic pain), while simultaneously curbing diversion and nonmedical use,” Martins wrote. “Another challenge is controlling the top most reported sources of supply, including parents, doctors and friends.”

A recent DEA report said the diversion of prescription opioids in the U.S. has fallen dramatically in the last few years, with less than one percent of legally prescribed opioids being diverted. The prescribing and abuse of opioid medication is also declining, along with the number of admissions to treatment centers for painkiller addiction. Despite these trends, which are rarely reported in the mass media, overdoses from heroin and other illegal opioids are soaring.

The DEA is planning to cut the supply of opioids even further in 2017, by reducing the supply of hydrocodone and other Schedule II opioids by 25 percent or more.

Trump Administration Promises Relief to Patients

By Pat Anson, Editor

A spokesman for the Trump administration pledged this week that the Department of Health and Human Services (HHS) would provide relief to patients who are "being harmed by the status quo.”

Matt Lloyd, a former top aide to Vice President Mike Pence, recently assumed the job of chief spokesman for HHS, the federal department that oversees the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services (CMS).

Lloyd made his comment in an unusual statement emailed to reporters after CMS released a report Friday that showed the number of Americans who signed up for insurance during Obamacare’s annual enrollment period had fallen to 9.2 million. That’s down from 9.6 million the year before.  

“Obamacare has failed the American people, with one broken promise after another. As noted in the report today from CMS, premiums in the ACA marketplace have increased 25 percent while the number of insurers has declined 28 percent over the past year,” Lloyd said.

MATT LLOYD

“We look forward to providing relief to those who are being harmed by the status quo and pursuing patient-centered solutions that will work for the American people.”  

Ironically, Lloyd made his statement two days after CMS invited public comment on the agency’s plans to have Medicare adopt the CDC’s opioid prescribing guidelines – a move that could affect thousands of patients who use opioids for pain relief. The CDC guidelines are voluntary and only intended for primary care physicians, but CMS wants to apply them to all doctors who prescribe opioids for non-cancer pain. A strict daily limit on opioids would also be set at 90 mg of a morphine equivalent dose.

Doctors and patients who don’t follow the proposed CMS policy could face punitive action, such as being dropped from Medicare coverage and insurance networks. CMS has estimated that over 15,000 Medicare beneficiaries who receive high doses of opioids for pain relief could be impacted  

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare.

The agency’s “Opioid Misuse Strategy” was developed during the final months of the Obama administration, but could be quickly adopted by the new administration.  CMS is only accepting public comments on its proposals until March 3 and plans to publish the final rules by Monday, April 3, 2017.

Comments on the CMS rule change should be mailed to:  AdvanceNotice2018@cms.hhs.gov.

Comments can be emailed to Matt Lloyd at: Matt.Lloyd@hhs.gov.

Medicare Planning to Adopt CDC Opioid Guidelines

By Pat Anson, Editor

The Centers for Medicare and Medicaid Services (CMS) has announced plans to fully implement the opioid prescribing guidelines released by the Centers for Disease Control and Prevention, which recommend that doctors not prescribe opioid medication for chronic non-cancer pain.

CMS is taking the CDC’s voluntary guidelines one step further, however, by mandating them as official Medicare policy and taking punitive action against doctors and patients who don’t follow them.

“When CDC released its guideline, I predicted that policymakers and payers would quickly move to convert CDC's voluntary recommendations into mandatory regulations, and my prediction appears to be coming true, both with CMS and with private payers,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

As Pain News Network has reported, CMS is adopting a “Big Brother” approach to fighting opioid abuse by developing a strategy that will encourage pharmacists to report doctors who may be overprescribing opioids and patients who may be abusing them. Information about these “potential opioid overutilizers” would be shared with insurance companies, which would be empowered to “prevent opioid overuse at point of sale at the pharmacy.”

CMS contracts with dozens of private insurance companies – known as sponsors -- to provide health insurance to about 54 million Americans through Medicare and nearly 70 million in Medicaid.

“To address the opioid epidemic, CMS has implemented a medication safety approach by which sponsors are expected to reduce beneficiary overutilization of opioids and maintain access to needed medications,” the agency said in a statement.

Saying it wanted to “better align” its policies with the CDC guidelines, CMS is proposing a daily ceiling on prescribed opioids at 90 mg morphine equivalent dose (MED). Any dosage above that level would be considered excessive. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged.

Insurers would be expected to police pharmacies, doctors and patients who do not follow CMS policies, potentially dropping them from Medicare coverage and their insurance networks.

“Under the Part D opioid overutilization policy, sponsors are expected to implement appropriate plan-level claim controls at POS (point of sale) for opioids, use improved retrospective drug utilization review to identify beneficiaries at high risk for an adverse event due to opioids, and perform case management with the identified beneficiaries’ prescribers followed by beneficiary-specific POS edits to prevent Part D coverage of opioid overutilization,” CMS said.

Such a policy change would have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved. The Veterans Administration is the only other federal agency to adopt the CDC guidelines – and many veterans have complained that they are no longer able to obtain adequate pain relief at VA facilities.

Critics of the CMS strategy say it is even more draconian than the CDC guidelines, which are intended only for primary care physicians.

“CDC's ‘soft limit’ of 90 MED in treating chronic pain was a recommendation aimed at treatment of some people with chronic pain by primary care specialists. CDC stated that all of its recommendations were voluntary, and in this case, further provided prescribers with the option to use a higher dose if indicated by a careful risk/benefit analysis,” Twillman said in an email to PNN.

“In light of these limitations, it seems inappropriate for CMS to ask Part D providers to institute opioid dosing limits for people with pain who don't have cancer or are receiving hospice care, and for all prescribers, both primary care and specialists. 

Strategy Developed by Insurance Industry

The agency’s proposed “Opioid Misuse Strategy” was released publicly in early January.  It closely follows a 62-page “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of private insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud. 

The white paper, however, goes far beyond fraud prevention by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed. 

The number of Medicare patients who “overutilize” opioids is relatively small – just 15,651 beneficiaries in 2015 – which represents just 0.13% of Part D opioid users.

CMS is seeking public comment on the proposal in its 2018 Advance Notice and Draft Call Letter, which outlines a number of other changes the agency is making to its Medicare Advantage and Part D prescription drug programs. Comments will be accepted through March 3rd, with final versions published on April 3, 2017.

Comments can be emailed to: AdvanceNotice2018@cms.hhs.gov. 

Flu and NSAIDs Increase Heart Attack Risk

By Pat Anson, Editor

With the cold and flu season in full swing, many people take over-the-counter pain relievers like Advil and Aleve to ease their aches and pains, and to help them sleep.

What many don’t know is that they may be increasing their risk of a heart attack.

In a study of nearly 10,000 people hospitalized in Taiwan after a heart attack, researchers found that patients who took non-steroidal anti-inflammatory drugs (NSAIDs) during an acute respiratory infection tripled their risk of an acute myocardial infarction (heart attack).  The study was published in the Journal of Infectious Diseases.

Respiratory infections and NSAIDs were both already known to raise the risk of cardiovascular problems, but this was the first time they were studied together.  

"Physicians should be aware that the use of NSAIDs during an acute respiratory infection might further increase the risk of a heart attack," said lead author Cheng-Chung Fang, MD, of National Taiwan University Hospital.

“This approach should raise clinical concern because NSAIDs use during ARI (acute respiratory infection) episodes is highly common in real-world practice.”

Fang and his colleagues found that using NSAIDs while having a respiratory infection was associated with a 3.4-fold increased risk for a heart attack. The risk was 7.2 times higher when patients received NSAIDs intravenously in the hospital.

Another commonly used pain reliever, acetaminophen, which eases pain in a different way than NSAIDs do, was not evaluated in the study. But researchers say it may be a safer alternative, at least in terms of cardiac risk, for relief from cold and flu symptoms.

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are found in so many different over-the-counter products -- such as ibuprofen, Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

In 2015, the U.S. Food and Drug Administration ordered warning labels for all NSAIDs to be strengthened to indicate they increase the risk of a fatal heart attack or stroke. The revised warning does not apply to aspirin. The FDA said people who have a history of heart disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk.

European researchers released an even stronger warning last year, saying there was no solid evidence that NSAIDs are safe.

Exactly how the pain relievers damage the heart is unclear, but a recent study on animals at the University of California, Davis found that NSAIDs reduced the activity of cardiac cells and caused some cells to die.

We Need to Admit Opioid Medications Are Dangerous

By Fred Kaeser, Guest Columnist

If chronic pain patients want continued access to opioid medications, we're going to have to admit they can be dangerous

There, I said it.

This has been bothering me for some time now, the apparent inability of many opioid medication users to admit that opioids can be dangerous. Read through the comments here at PNN or any other chronic pain forum and you'll hear a continuous drumbeat from many that opioids are safe when used for chronic pain. No ifs, ands, or buts.

The truth is no one really knows how safe or unsafe long-term opioid use is. No one knows because those studies have never been done.

But what many of us chronic pain patients do know is that popping a 10 mg oxycodone or its equivalent will pretty much do the job for us for a few hours or more.

And for many of us, it will do the job better than any other complimentary or alternative pain modality you can throw at us.

Of course, there are those who will tell us that opioid medications are dangerous. If you happen to be one of the 2.2 million people suffering from opioid medication addiction (OMA) you know they're dangerous. If you're one of the 4 million or so parents whose son or daughter suffers from OMA, you know they're dangerous. And if you're one of the nearly 30,000 parents whose son or daughter died last year from an opioid medication interaction, you really know they're dangerous.

So, opioid medications are dangerous – to them. But what about us chronic pain patients? If you are genetically predisposed to addiction, opioid medication is potentially dangerous to you. But even if you're not predisposed, opioid addiction is still possible. If the addiction rate is just 1% (which some believe), that means for the 11 million Americans who use opioid medication daily, they're dangerous for 110,000 of us. And if you believe the addiction rate is 10%, they're dangerous for 1.1 million of us.

Ever experience opioid withdrawal? Some of us have. How did you like going through that? Many would admit that was pretty dangerous. And if we didn't think it was, we sure thought that it sucked. And how about opioid medication misuse? Misuse our medications and risk respiratory distress or some other negative consequence? It can all be pretty dangerous.

Why do we need to admit opioids are dangerous?

Because to the average Joe and Jane America, we’ll seem pretty stupid if we don't. Policy makers and most of America have bought into the idea that opioids (legal and otherwise) pose a huge problem. If we don't jump on that bandwagon and work together to see how this problem can be effectively handled, we're only going to be left further behind. That train left the station and it isn’t coming back.

Continue to resist admitting that opioid medications can be dangerous, and all those that believe they are will continue to turn a deaf ear when we say we need them for pain relief. We only sound like the addict who is equally convinced that they need their drugs.

We can no longer afford to be seen as part of the problem. It is time that we are seen as part of the solution. And that starts with an open and honest dialog about the dangers of opioids, along with a similar dialog as to how chronic pain sufferers gain a quality of life when we take our medications responsibly -- which is the case the vast majority of the time.

We can argue that chronic pain patients should continue to have access to opioid medication, while at the same time agreeing that they can be dangerous and have created a problem for many in our society.

We can continue to lobby and fight for our right to adequate pain relief, while at the same time lend our efforts in the fight to minimize and reduce the horrors of addiction and death.

By doing so we will enhance our plight in the eyes of those that do not know what it is like to suffer daily the burdens of debilitating chronic pain.

By doing so we will be seen as reasonable and responsible in wanting to thwart the opioid problem. And even though we suffer, we are willing to fight for the greater good.

Most of us are pretty good at standing up and saying we deserve the medications that serve us so well. We can still do that when we also admit that they can be very dangerous.

Fred Kaeser, Ed.D, is the former Director of Health for the NYC Public Schools. Fred suffers from osteoarthritis, stenosis, spondylosis and other chronic spinal problems. He taught at New York University and is the author of What Your Child Needs to Know About Sex (and When): A Straight Talking Guide for Parents.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org.

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.

Lyrica and Cymbalta Advised for Diabetic Neuropathy

By Pat Anson, Editor

New guidelines by the American Diabetes Association for the treatment of diabetic neuropathy strongly discourage the use of opioids to treat nerve pain, while recommending pregabalin (Lyrica) and duloxetine (Cymbalta).

Nearly 26 million people in the United States have diabetes and over half have some form of neuropathy, which often causes a painful stinging or burning sensation in the hands or feet.  Nerve pain is often the first symptom that prompts people to seek medical care before getting a diabetes diagnosis.

Researchers at the University of Michigan led a group of internationally recognized endocrinologists and neurologists, and teamed up with the American Diabetes Association (ADA) to craft a new position statement on the prevention, treatment and management of neuropathy. The ADA last released a statement on diabetic neuropathy in 2005.

"Our goal was to update the document so that it not only had the most up-to-date evidence, but also was easy to understand and relevant for primary care physicians," said lead author Rodica Pop-Busui, MD, a professor of internal medicine at Michigan Medicine Division of Metabolism, Endocrinology and Diabetes.

"Treatment of neuropathy pain is specifically relevant because, unfortunately, there has been much overprescribing of narcotics for neuropathic pain."

Although opioids like oxycodone and tramadol are effective in relieving nerve pain, they are not recommended by the ADA as a first, second or even a third-line treatment.

“Despite the demonstrated effectiveness of opioids in the treatment of neuropathic pain, there is a high risk of addiction, abuse, sedation, and other complications and psychosocial issues even with short-term opioid use. For these reasons, opioids are not recommended in the treatment of painful DSPN (distal symmetric polyneuropathy) before failure of other agents that do not have these associated concerns,” the guideline states.

Instead of opioids, the ADA recommends either pregabalin (Lyrica) or duloxetine (Cymbalta) as an initial treatment for neuropathic pain. Gabapentin (Neurontin) can also be considered.

PNN readers often complain of side effects from all three drugs – such as depression, fatigue, nausea, headache and weight gain -- yet the ADA statement only vaguely warns that their “adverse effects may be more severe in older patients.”

"Lyrica did help with my nerve pain but the side effects were intolerable and the withdrawal was absolute hell," said Laura.  "I gained 20 pounds in a month and was even more of a zombie than when I was on gabapentin. I had no personality, no interest in anything, and had completely lost motivation to do anything."

"I have been on Cymbalta a couple of years. It has helped overall with depression, anxiety and pain. I also can't miss a dose or try to quit cold turkey," wrote Rebecca Williams. "I become very dizzy, nauseated, night sweats, crazy dreams, electrical zaps in my head. I don't know how I would ever get off of it because the withdrawal symptoms are unbearable."

The ADA guidelines recommend that physicians try different therapies to prevent or slow the progression of diabetic neuropathy, most of which focus on controlling high blood sugar (glucose), which can cause irreversible damage to small nerve fibers. Insulin, regular exercise and a low-calorie, low-fat diet can help regulate glucose levels.

To see the ADA’s recommendations, click here.

Insurers Behind Medicare’s ‘Big Brother’ Opioid Policy

By Pat Anson, Editor

The insurance industry appears to have played a major role in the development of a new strategy by the federal government to combat the abuse of opioid pain medication.

As Pain News Network has reported, the plan calls on pharmacists to report suspicious activity by doctors who prescribe opioids to Medicare and Medicaid patients (see “Medicare Takes ‘Big Brother’ Approach to Opioid Abuse”). Individual profiles of patients, their behavior, and opioid use would also be created and shared among insurance providers.

The plan was outlined earlier this month by the Centers for Medicare & Medicaid Services (CMS) in the agency’s proposed “Opioid Misuse Strategy.” 

The CMS plan closely follows a 62-page “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of private insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud. 

The white paper, however, goes far beyond fraud prevention by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed.  It states that all physicians should follow the opioid prescribing guidelines released by the Centers for Disease Control and Prevention, even though the guidelines are voluntary and explicitly state they are not intended for all prescribers.

The white paper was drafted largely by insurance companies – called “Partner Champions” -- including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation.

“These HFPP Partner Champions have committed themselves to the creation of an HFPP White Paper that describes the best practices for serious consideration by all healthcare payers and other relevant stakeholders to effectively address and minimize the harms of opioids,”  the white paper states.

“Through coordinated action, payers, including members of the HFPP, have the opportunity to dramatically influence and reduce opioid misuse in the U.S. Simple actions performed systematically across a large group of stakeholders can considerably decrease the toll of prescription opioid misuse and OUD (opioid use disorder) in the U.S.”

Physicians and Patients Left Out

No other stakeholders in healthcare, such as physicians, pharmacists, hospitals or patients, were involved in a “special session” of the HFPP last October that led to the drafting of the white paper.

“It’s concerning that CMS appears to have developed a policy proposal regarding opioid prescribing solely on the basis of advice from a group dominated by the insurance industry, without asking for input from affected healthcare professional groups,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, an organization of physicians who specialize in pain care.

“We have to be mindful of the vested interests of insurance companies in this issue. Some advocates have argued that pharmaceutical manufacturers have wielded outsized influence in previous policy decisions, but there has been precious little focus on the influence of payers, which seems obvious in this case.”

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in state-run Medicaid programs.

“Who exactly are the individuals who put this information together for CMS… and what is their true aim?” asks Ingrid Hollis, the mother of a chronic pain patient. “It looks to me like collusion between insurance companies and federal agencies to cut costs.

“Senior citizens and those disabled with progressive painful diseases or injuries deserve better treatment than this. To single this community out for draconian policies based on what looks like purely profit motives in the name of ‘harm reduction’ is inhumane. Who is truly being harmed here?”

“When they describe insurance companies involved in their efforts as ‘Champions,’ it calls to mind comic book and movie heroes like Superman.  Superman was noble, his motives pure.  I don't think of profit-conscious insurers as being noble or pure in motive,” said Anne Fuqua, a disabled nurse, pain patient and patient advocate. 

“Involving insurance companies in setting policies that directly or indirectly impact prescribing and/or reimbursement presents a conflict of interest.”

Stewards, Stockers and Demanders

Under the proposed CMS policy, information about doctors and patients who’ve been red flagged by pharmacists for suspicious prescribing would be shared through a CMS database with all insurers. The companies would then be empowered to “investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.” Violators could be dropped from insurance networks or lose their coverage.    

The HFPP white paper goes further, recommending that insurers develop profiles of each patient and classify them in one of three groups based on their behavior:

1. “Stewards” (patients who follow guidelines)
2. “Stockers” (patients who stockpile unused medications)
3. “Demanders” (patients who ask for medication)

“Segmenting patients by intentions/behaviors with regards to opioid prescriptions could help payers better target messages and disseminate tailored communications that are most salient to the recipient,” the white paper states.

“For example, stewards may be those who are more likely to adhere to the CDC guideline and seek non-pharmacologic or non-opioid pharmacologic therapies for chronic pain and stockers may be those who are likely to ask for an opioid prescription/have received an opioid prescription for chronic pain in the past.”

A data analysis of patients and doctors, according to the white paper, could also be used by insurers to develop computer models to identify “problematic actors and schemes” and “deny payments for prescriptions that do not conform to general prescribing practices.”

“The HFPP strongly encour­ages collaborative efforts to develop and widely disseminate effective strategies to identify: patients at risk of opioid misuse or OUD, providers whose opioid prescribing patterns fail to comply with quality indicators (such as the CDC Guideline for Prescribing Opioids for Chronic Pain), and methods that are particularly ef­fective at preventing or treating OUD,” the white paper states.

But critics say the profiling of patients and doctors, as well as the sharing of data from prescription drug monitoring programs (PDMPs), amounts to an invasion of privacy.

“PDMP data contains some of the most sensitive health information that is produced.  When PDMPs were introduced, confidentiality protections were stressed and prescribers and pharmacists could review the information,” says Anne Fuqua.

“Now, CMS is discussing their plan to provide open access to insurers participating in their database.  They flip between arguments that this will help insurers make sure people get needed treatments for addiction and fraud detection.  It's clear that detection of fraud and conserving on drug costs is the primary focus.”

Non-Opioid Treatments Encouraged

Like the CDC guidelines, the white paper discourages the use of opioid pain medication, and recommends that over-the-counter pain relievers such as aspirin, acetaminophen and ibuprofen be used as an alternatives, as well as “non-pharmacological” treatments like cognitive behavioral therapy and chiropractic care. Addiction treatment drugs such as buprenorphine and methadone are strongly recommended for anyone showing signs of opioid use disorder.

“Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with non-pharmacologic therapy and non-opioid pharmacologic therapy,” the paper states.

Critics say the recommendations – and threats of sanctions against those who don’t follow them -- could interfere with the doctor-patient relationship.

"Proposals, like CMS' Opioid Misuse Strategy, aimed at combatting the prescription drug abuse crisis, while important, must be careful to not leave patients with a legitimate medical need without access to the treatments they and their doctors have determined are the best course of care,” the Alliance for Patient Access, a national network of physicians, said in a statement to PNN.

“Patient access can be impeded when physicians and patients feel threatened that they are being watched, may be reported, or their personal information shared by pharmacists and insurers. When that happens patients suffer and the physician-patient relationship, one based on trust, is strained.” 

“It should not be a surprise that insurance companies have been aggressively opposing the use of branded opioids. Their fiduciary responsibility is to their shareholders, not to patients,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “Decisions by insurance companies are causing many patients to suffer. This is not right.”

“Patients and doctors don’t want insurance companies and other parties determining what is best for them.  Doctors have a medical degree, the experience, the knowledge and treatment plans are determined by the medical condition they are treating,” says Ingrid Hollis.

“They act in the best interest of the patient, and have pledged the Hippocratic Oath of ‘Do no harm.’ Can the same be said of the bean counters in the insurance industry? Insurance is interested in cost cutting and maximizing profits.  Doctors are trying to save lives.”

CMS has not said when it plans to implement its Opioid Misuse Strategy or if public hearings would ever be held on them. The agency has only said that in coming weeks it would release “statements reflecting the agency’s Medicare and Medicaid goals.”

The HFPP white paper was released publicly for the first time Tuesday on the CMS website, without any explanation of its broader meaning or impact on Medicare and Medicaid policies.

An HFPP infographic urging people "to fight healthcare fraud, waste and abuse" was also released on the government-run website, without any indication that it was largely developed by the insurance industry.

Pain Patients Sound Off on Opioid Cutbacks

By Pat Anson, Editor

In our last newsletter, we asked readers if their doctors had recently reduced or stopped prescribing opioid pain medication, and to share their stories with us.

We heard back from dozens of people, all of them angry and frustrated with the state of pain care and the government agencies that regulate pain medication in the U.S.

“We are disgusted with the DEA and uneducated callous physicians' war on chronic pain patients and their doctors. Suicides are skyrocketing and lives are being destroyed,” wrote Connie Potter, a registered nurse in New Mexico.  “The number of people I see whose lives are worthless and destroyed is appalling.” 

Connie said that her husband, who suffers from severe back pain, dystonia and fibromyalgia, is being prescribed about a third of the pain mediation he used to get.

“No one wants to give pain meds in southern New Mexico. My friend with acute MS (multiple sclerosis) has had his already pathetic meds dosages halved,” she said.

Many pain sufferers are being told by doctors that they are required to reduce or eliminate opioid prescribing, even though guidelines released last year by the Centers for Disease Control and Prevention are voluntary, not mandatory.

“I was told in November that as of January 1, 2017 my medication would be reduced by half because the government is mandating this across the United States,” wrote 46-year old Cindy, who has suffered from back and pelvic pain since childhood. 

“I am still trying to grasp how this could happen!  I am every doctor's dream patient. I do whatever they ask whatever they suggest - anything!  How the hell am I supposed to make it through a day of work when I can't sit? This is crazy!  Do I seriously not have any recourse?”

“These doctors don't give a s*** anymore, all they care about (is) lowering their opiates prescriptions, so they don't have to deal with the backlash from our stinking government,” said David Cole, who has perineural neuropathy.

“I've been using opioids for the last 14 years to control to my pain and manage my life,” wrote Eli. “Then came the infamous CDC 'recommendations' and in March of 2016 I was cut down 50% on my dosage. Was difficult to do it, and couldn't have pulled it off without the help of cannabis.”

Even though medical marijuana is legal in California, where Eli lives, most doctors don’t want to prescribe opioids to someone using cannabis. So he's been tapered again to a lower dose. And he may be on his last refill.  

“My life began falling apart when they cut my dose in half, and hasn't been the same since. I've grown much more dependent on help from others and can barely shop. This anti-opioid madness has got to stop," he says.

Treated Like Addicts

Many readers say they are tired of being treated like criminals or addicts.

“Being treated like an incompetent, drug seeking/selling, whiny and lazy hypochondriac by non-medical and/or elected individuals is not an issue I anticipated,” wrote Ellen Rames, who is disabled at the age of 65. “It feels like the eyes of judgment are on me every day. It shouldn't be this way.”

“Twenty five years of taking opioids without a problem and now I feel like criminal trying to get them,” said Kaye Ingram, a disabled coal miner. “I (am) just sick of being piss tested every month and being threatened.”

“I'm tired of being treated like a druggie or addict when I ask for relief,” said Mike Schmidt, who has chronic pain after 15 surgeries on his neck and back. At the age of 72, the retired drug and alcohol counselor says he’s not worried about addiction.

“I have always taken medication at the prescribed dosage or less,” says Schmidt.  “I found morphine to be an effective pain relief for me after trying different medications and not liking the side effects.”

“It angers me to no end that I can't get decent sleep and that I spend most days in a chair because some people abuse medications that I legitimately need, and for which I have a proven record of responsible use,” said G.D. King, who has suffered from chronic back pain for over 25 years.

“Clearly I understand that the government doesn't want citizens dropping dead willy-nilly from overdoses.  But the fact that these deaths are the result of abusive and/or illegal activity for which I must pay a very steep personal price does not incline me toward sympathy for those who engage in these activities.”

Illegal activity is what some patients are considering to get pain relief.

“Pot isn't legal where I am so guess I'd have to break the law, or well, heck, since heroin is easier to get than a legitimate pain prescription, I guess that might be another choice.  Do these people have any common sense?” asked Donna.

Suicide is seen as an alternative by some.

“The government needs to get out of our doctor’s offices and our pharmacies and quit attempting to practice medicine by lumping all persons into the same category.”

“I feel that there needs to be more reporting on the suicide rate among chronic pain sufferers.  These people who are pushing for stopping opioid use to prevent overdose and death from opioids are only trading one form of death for another,” said Sam, a retired counselor who has worked with suicidal clients.  “I support euthanasia and the legalization of physician assisted suicide for the terminally ill, but I think it should also be allowed for those who suffer chronic pain that are not getting relief.”

Others believe the campaign against opioids is more about corporate profits, not healthcare or preventing addiction.

“This is strictly a dollars and cents issue, with the insurance companies not wanting to fulfill their contractual obligations. I know firsthand, as my insurer cut me off completely in 2016,” wrote Russ. “My family already is prepared that when I die because of their incompetence, the major lawsuits will begin unabated against any agency or company that was implicit in this conspiracy, and a conspiracy it is.

“The government needs to get out of our doctor's offices and our pharmacies and quit attempting to practice medicine by lumping all persons into the same category.”

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‘Confusing’ Email Warns of Drug Shortages in Florida

By Pat Anson, Editor

The Florida Department of Health is apologizing for a “confusing” email sent Friday that warned of possible prescription drug shortages in the state due to the recent suspension of a wholesale drug distributor.

Earlier this week, the McKesson Corporation agreed to pay a record $150 million fine for failing to track and report suspicious orders of opioid pain medication and other controlled substances.   As part of the settlement with the Drug Enforcement Administration, McKesson suspended sales of controlled substances from wholesale distribution centers in Colorado, Ohio, Michigan and Florida.

Late Friday morning, the Florida health department sent an email with the subject line “Emerging Health Threat” to pharmacists in the state warning of possible drug shortages.

“The DEA recently suspended McKesson Corporation’s sales of controlled substances from distribution in Florida. This suspension could impact your patients’ ability to fill their prescriptions and you may want to advise them about the potential implications. As a practitioner, you should be aware of the possibility of drug shortages and consider alternative treatment options when prescribing controlled substances.”

About six hours later, the health department sent out a second email, apologizing for the first one:

"A recent message that was sent out regarding the DEA’s suspension of McKesson Corporation’s sales of controlled substances from distribution in Florida was found to be confusing. This suspension will impact one distribution center in Florida and impacts only the handling of hydromorphone. The Florida Department of Health and Division of Medical Quality Assurance apologize for any confusion that may have resulted from that message.”

There was no explanation for why the first “confusing” email was sent or why there was such an abrupt change in tone in the second one. No press release was issued by the health department warning of possible drug shortages in Florida. 

A spokesperson for McKesson confirmed that the suspension of its Florida distribution center will only impact hydromorphone, an opioid medication sold under the brand names Dilaudid and Exalgo.

"We do not anticipate our pharmacy customers will experience any negative impacts as a result of the temporary suspension," wrote Kristin Hunter in an email to PNN.

"The Lakeland, FL distribution center will be suspended for one year from distributing hydromorphone ONLY (not ALL controlled substances). There will be no change to the distribution of non-controlled pharmaceutical and over-the-counter products. Customers that typically receive controlled substances from an affected distribution center are now being served by one of the other 28 DCs (distribution centers) in McKesson’s network with no interruption in service."

This is the second time McKesson has been accused of violating the Controlled Substances Act. In 2008, the company paid a $13.25 million fine after it failed to identify and report suspicious orders for opioid pain medication from independent and small pharmacies. 

As part of a settlement with the DEA, the company agreed to implement a system to detect such orders.

However, the DEA says McKesson “did not fully implement or adhere to its own program” and continued to supply pharmacies with “an increasing amount of oxycodone and hydrocodone pills, frequently misused products that are part of the current opioid epidemic.”

From 2008 to 2013, the company processed over 1.6 million orders for controlled substances in Colorado, but reported only 16 of them as suspicious, according to the DEA.

A pharmacist told WFTX-TV in Naples that suspending distribution centers and potentially disrupting the supply of opioids isn’t helpful because it only makes it harder for chronic pain patients to get their medications.

 "It's a terrible way of policing, essentially what they're going to try do is, rather than go in and physically shut down what they call 'pill mill physicians' or 'dirty doctors' they cut the supply," said Fort Myers pharmacist T. J. Depaola, who says some patients unable to get medication turn to the black market for pain relief.

"You have patients that were being treated for chronic pain; all of a sudden they couldn't get meds, they went to heroin because that's the closest thing to what they were on before."

Finding pain relief in Florida is already difficult. Because of the state’s crackdown on pill mills, many doctors are now unwilling to prescribe opioids and patients report pharmacies are often reluctant to fill legitimate prescriptions.  

A pharmacist who asked to remain anonymous told Pain News Network that many Florida pharmacies already operate under a strict quota system, in which they are allotted a certain number of painkillers per month. He predicted McKesson’s suspension will have a snowball effect, driving patients from one pharmacy to another in search of a dwindling supply of opioids.

“With the DEA restriction on McKesson hydromorphone supplied pharmacies, and with a shift of patient population to pharmacies using alternative suppliers, the latter pharmacies will now exceed the (quota) sooner and exhaust the supplies sooner. It is crazy,” he said.

Further tightening the supply are plans by the DEA to reduce the amount of almost every Schedule II opioid pain medication manufactured in the U.S. by 25 percent or more in 2017. The quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, is being reduced by a third. The DEA said it was cutting the opioid supply to prevent diversion and because of declining demand for painkillers.