What Will Trump Election Mean for Pain Care?

By Pat Anson, Editor

The day after one of the biggest political upsets in American history, millions of chronic pain patients are wondering what a Donald Trump administration will mean for them.

President-elect Trump has repeatedly vowed to “immediately repeal and replace Obamacare,” but has not clearly defined what he would replace the Affordable Care Act with. Trump has also supported reductions in the supply of oxycodone, hydrocodone and other Schedule II opioids.

But perhaps the biggest change will be in leadership positions at federal agencies that set health care policies. That happens whenever a new administration takes office, but the changing of the guard this time will almost certainly mean the departure of several politically appointed administrators who played key roles in setting policies that many pain sufferers consider anti-patient.   

Health and Human Services (HHS) Secretary Sylvia Burwell – who presided over key policy decisions such as the CDC’s opioid prescribing guidelines and Medicare’s decision to drop pain questions from patient surveys – will be replaced.

Also likely to depart are CDC director Dr. Thomas Frieden, FDA commissioner Dr. Robert Califf, acting DEA administrator Chuck Rosenberg, and Surgeon General Dr. Vivek Murthy. All have endorsed policies harmful to pain patients.  

Murthy recently sent letters to over 2 million physicians urging them “not to prescribe opioids as a first-line treatment for chronic pain.”

Rosenberg has called medical marijuana "a joke" and recently tried to criminalize kratom as a Schedule I controlled substance, a move the DEA withdrew after widespread opposition from the public and some members of Congress.

In his short time as FDA commissioner, Califf has overruled some of the FDA’s own experts in endorsing the CDC guidelines and has instituted a series of policies at FDA aimed at reducing opioid prescribing.

Frieden’s departure from the CDC will likely lessen the influence of Physicians for Responsible Opioid Prescribing (PROP) at the agency. PROP founder Dr. Andrew Kolodny has a long association with Frieden, having worked for him when Frieden was commissioner of New York City’s Health Department. PROP President Dr. Jane Ballantyne continues to serve as a consultant to CDC, despite complaints that she has a conflict of interest.

The new heads of the CDC and DEA will be appointed by president-elected Trump, while the HHS Secretary, FDA commissioner, and the Surgeon General are nominated by the president and confirmed by the Senate.

According to Politico, one of the front runners to be nominated by Trump as HHS Secretary is Dr. Ben Carson, a former Republican presidential candidate and retired brain surgeon, who Trump has called a “brilliant” physician.

"I hope that he will be very much involved in my administration in the coming years," Trump said at a campaign rally.

Other names being mentioned for HHS Secretary are Florida Gov. Rick Scott, former House Speaker Newt Gingrich, and Rich Bagger, a pharmaceutical executive on leave from Calgene who is the executive director of Trump's transition team.

None of this means that a Trump administration will reverse any of the pain care policies at CDC, FDA and other federal agencies. Like most Republicans, Trump wants to reduce government regulations, not increase them. But as PNN reported last month, the president-elect has already indicated he supports measures to limit the supply of opioids.

“DEA should reduce the amount of Schedule II opioids -- drugs like oxycodone, methadone and fentanyl -- that can be made and sold in the U.S. We have 5 percent of the world’s population, but use 80 percent of the prescription opioids,” Trump said in prepared remarks at a campaign rally in New Hampshire. “I would also restore accountability to our Veterans Administration. Too many of our brave veterans have been prescribed these dangerous and addictive drugs by a VA that should have been paying them better attention.”

Trump wants the FDA to speed up the approval of opioid pain medication with abuse deterrent formulas. And he wants to increase the number of patients that a doctor can treat with addiction treatment drugs like buprenorphine (Suboxone).

"The FDA has been far too slow to approve abuse-deterring drugs. And when the FDA has approved these medications, the rules have been far too restrictive, severely limiting the number of authorized prescribers as well as the number of patients each doctor can treat," he said.

The president-elect has also pledged to stop the flow of fentanyl and other illegal drugs into the country.

“We will close the shipping loopholes that China and others are exploiting to send dangerous drugs across our borders in the hands of our own postal service. These traffickers use loopholes in the Postal Service to mail fentanyl and other drugs to users and dealers in the U.S.” Trump said.

“When I won the New Hampshire primary, I promised the people of New Hampshire that I would stop drugs from pouring into your communities. I am now doubling-down on that promise, and can guarantee you – we will not only stop the drugs from pouring in, but we will help all of those people so seriously addicted get the assistance they need to unchain themselves.”

Trump has personal dealings with addiction, having lost a brother to alcoholism at age 43. Watching the long downward spiral of his older brother Fred led Trump to a life-long aversion to alcohol, drugs and tobacco.

Fentanyl Deaths Rise Again in Massachusetts

By Pat Anson, Editor

Nearly three out of four opioid overdoses in Massachusetts have been linked to fentanyl, far outnumbering the number of deaths associated with prescription pain medication, according to a new report from the Massachusetts Department of Public Health. 

Massachusetts was the first state to begin using blood toxicology tests to look specifically for fentanyl, a powerful synthetic opioid that is more potent and dangerous than heroin. Toxicology tests are far more accurate than the death certificate codes used by the Centers for Disease Control and Prevention to classify opioid-related deaths. 

Over 1,000 confirmed cases of unintentional opioid overdoses were reported in Massachusetts in the first nine months of 2016. During the third quarter (July-September), 74 percent of the deaths where a toxicology screen was available showed a positive result for fentanyl.

Almost all of those deaths are believed to involve illicit fentanyl, not pharmaceutical fentanyl that is prescribed to treat severe pain.

“The data released today are a sobering reminder of why the opioid crisis is so complex and a top public health priority,” said Secretary of Health and Human Services Marylou Sudders. “This is a crisis that touches every corner of our state, and we will continue our urgent focus expanding treatment access.”

Only about 20 percent of the overdose deaths in Massachusetts were associated with prescription opioids such as hydrocodone and oxycodone, a trend that has held fairly steady since 2014, even as the number of opioid prescriptions in the state has declined.

Massachusetts department of public health

 "I think this points to the fact that cutting scripts for legitimate pain patients and blaming doctors for overdose deaths is pointing fingers in the wrong direction and harming a lot of innocent people living with debilitating pain while doing nothing to reduce overdose deaths – a critical goal,” said Cindy Steinberg of the U.S. Pain Foundation, a patient advocacy group. “People living with the disease of chronic pain and those living with the disease of substance use disorder are two different populations of people with little overlap.

“If we are committed to doing all we can to stop overdose deaths then the only way we can do that is to really understand what exactly is causing them. The fact that illicit fentanyl is the cause points to the need for increased law enforcement efforts to interdict the supply coming into Massachusetts.”

According to the Drug Enforcement Administration, chemicals used to make illicit fentanyl are being smuggled in from China and Mexico. Illicit fentanyl is usually mixed with heroin or cocaine, and it is also appearing in counterfeit pain medication sold on the black market. The drug is so potent that a single pill could be fatal.

Rhode Island is also using blood toxicology tests to help determine the true nature of the opioid epidemic. The most recent data from that state shows that about two out of three opioid overdoses are linked to fentanyl.  Since 2012, overdoses from prescription opioids have fallen by about a third in Rhode Island.

“The shifts in prescription and illicit drug overdose deaths also began roughly when more focused efforts were undertaken nationally to reduce the supply of prescription drugs,” the Rhode Island Department of Health said in a statement.

The CDC uses death certificate codes – not toxicology tests -- in its reports on opioid overdoses. The codes do not indicate the cause of death, only the conditions or drugs that may be present at the time of death. Because of limitations in the data, many overdoses involving illicit fentanyl and heroin are being reported by the CDC as prescription opioid deaths.

Does Canada Need ‘Enforceable’ Opioid Guidelines?

By Pat Anson, Editor

Canada should adopt nationwide “enforceable guidelines” to limit the prescribing of opioid pain medication and doctors should be sanctioned if they fail to follow them, according to a new commentary in the Canadian Medical Association Journal.

The head of the Chronic Pain Association of Canada called the proposed guidelines “another sad effort to punish people with pain.”

Like the United States, Canada has been hit by a wave of opioid overdoses – deaths increasingly attributed to heroin and illicit fentanyl, not pain medication. According to one estimate, over 1,000 Canadians have died so far this year from fentanyl overdoses.

But, like its neighbor to the south, Canada has been trying to fix the opioid problem by restricting access to pain medication.

“This crisis is only getting worse, and Canada urgently needs to implement effective measures aiming at and addressing the underlying drivers of the opioid epidemic,” writes lead author Benedikt Fischer, PhD, of the Centre for Addiction and Mental Health at the University of Toronto.

Fischer and his two co-authors specialize in addiction, mental health and epidemiology, not in pain management.

“Evidence of the therapeutic effectiveness of prescription opioids for pain is rather limited. Data show some benefits for treatment of acute pain, but evidence to support using opioids to treat long-term chronic pain is weak and insufficient,” they wrote.

Only in passing do Fischer and his colleagues even mention the rising number of deaths in Canada being blamed on illicit fentanyl – a synthetic opioid 50 to 100 times more potent than morphine.   

They propose several measures similar to the opioid prescribing guidelines released by the U.S. Centers for Disease Control and Prevention:

• Prescribe opioids in “the lowest possible dose and for the shortest possible duration”
• Establish prescription drug monitoring systems across Canada
• Develop a “national surveillance system” for opioid-related overdoses and emergency room visits
• Expand access to opioid addiction treatment

One key difference from the so-called “voluntary” guidelines of the CDC is a recommendation that Canada adopt “enforceable guidelines” that would allow for opioids to be prescribed only as “an exceptional treatment” and only when there is “good scientific evidence” for their use.

The guidelines would be similar to professional medical standards recently adopted in British Columbia and Nova Scotia, which make physicians in those provinces liable for professional, civil or even criminal sanctions if they don’t follow them.

Critics say the guidelines are having a chilling effect on both patients and prescribers.

“Limiting prescriptions of opioids will do absolutely nothing to stop this problem and just the notice of intent has already made the problem for pain sufferers worse,” said Barry Ulmer, executive director of the Chronic Pain Association of Canada.

“They are forcing patients on high doses to come off their medications, stopping family doctors from actually working with patients who have been in their care for years, and even giving names of patients on high doses to the police as potential dealers. One doctor had his practice visited by police with 3 names of patients and took their files for investigation.”

Like the United States, Ulmer says the debate over opioids in Canada is being led by addiction treatment specialists, not by pain management physicians.

As an example, he cites this month’s National Opioid Conference in Ottawa, which is being hosted by Canada’s Minister of Health. The invited keynote speaker is David Juurlink, MD, an academic toxicologist at Sunnybrook Health Sciences Centre in Toronto, who is also a board member of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played an influential role in drafting the CDC guidelines.

“It is not a conference on opioids, but an addiction conference or more probably an effort to restrict opioids or just prohibit them,” said Ulmer. “It is clear what direction they are going in when they invite Juurlink to be the keynote speaker and have not invited some of the preeminent doctors who are experts in the use of opioids. Tantamount to medical malpractice. They don’t want to talk about the illicit problem because that destroys their whole argument.”

Health Canada is currently conducting a review of Canada’s opioid prescribing guidelines, which have not been updated since 2010. The Centre for Addiction and Mental Health in Toronto – Canada’s largest addiction treatment hospital -- released a report today urging Health Canada to pull all high-dose opioid medications off the market, according to The Globe and Mail.

Medicare Pain Questions Being Dropped in 2017

By Pat Anson, Editor

Hospital patients will no longer be asked about the quality of their pain care under new rules released this week by the Centers for Medicare and Medicaid Services (CMS) for 2017.

Medicare uses a funding formula that rewards hospitals that provide good care and are rated highly in patient satisfaction surveys. Critics claimed that three questions in the survey asking patients about the quality of the pain care created a financial incentive for doctors to prescribe opioid pain medication to boost their hospital’s scores.

The three questions being dropped, which don’t even mention opioids, are as follows:

During this hospital stay, did you need medicine for pain?

During this hospital stay, how often was your pain well controlled?

During this hospital stay, how often did the hospital staff do everything they could to help you with your pain?

CMS said it was still developing and field testing alternative pain questions to replace the ones being eliminated.

“Today’s final rule would address physicians’ and other health care providers’ concerns that patient survey questions about pain management in the Hospital Value-Based Purchasing program unduly influence prescribing practices," CMS said in a statement.

"While there is no empirical evidence of such an effect, we are finalizing the removal of the pain management dimension of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey… to eliminate any financial pressure clinicians may feel to overprescribe medications.”

The American Medical Association (AMA), one of the groups that lobbied CMS to drop the pain questions, applauded the move.

"CMS understands that these policies effect how physicians practice medicine and how patients receive treatment," said AMA President Andrew Gurman, MD, in a statement. "By listening to our concerns, CMS made clear that patient care was the top priority. We look forward to continuing to work with CMS to improve patient health and enhance access to affordable quality care."

CMS was under intense political pressure to drop the pain questions. Twenty-six U.S. senators sent a letter to Health and Human Services Secretary Sylvia Mathews Burwell claiming “physicians may feel compelled to prescribe opioid pain relievers in order to improve hospital performance."

Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group,also said the patient survey "fosters dangerous pain control practices."

But a top Medicare official disputed those claims in an article published in JAMA, saying “nothing in the survey suggests that opioids are a preferred way to control pain.”

Pain patients have long complained about the poor quality of their treatment in hospitals. In a survey of over 1,250 patients by Pain News Network and the International Pain Foundation, nine out of ten said patients should be asked about their pain care in hospital satisfaction surveys. Over half rated the quality of their pain treatment in hospitals as poor or very poor, and over 80 percent said hospital staffs are not adequately trained in pain management. 

What Grade Should Your State Get for Pain Care?

By Pat Anson, Editor

Millions of Americans who suffer from chronic pain are having trouble finding doctors, obtaining pain medication, and getting health insurance to cover their treatment. So imagine their surprise when a recent study gave passing grades to all 50 states for their pain care policies and said there was “an overall positive policy environment across the nation.”  

“We saw that report and were disgusted. At a time when chronic pain patients across the country are losing their medications and treatments to manage their pain, giving no state a grade below a 'C' is insulting,” said Amanda Korbe, who suffers from Reflex Sympathetic Dystrophy (RSD) and is a founder of Patients Not Addicts, a patient advocacy group.

“Achieving Balance in State Pain Policy” was released over the summer by the Pain and Policy Studies Group at the University of Wisconsin School of Medicine. The report looked at state laws and regulations in 2015 that governed drugs, prescribing and pain care practices.

“This evaluation is meant to identify relevant language in each state’s legislation or regulatory policies that have the potential to influence appropriate treatment of patients with pain, including controlled medication availability,” the study says.

The study gave 13 states an “A” for the quality of their pain care policies:  Alabama, Georgia, Idaho, Iowa, Kansas, Maine, Michigan, Oregon, Rhode Island, Vermont, Virginia, Washington and Wisconsin.

Thirty-one states were given B’s and the rest got C’s. No state was given a failing grade. A complete list of grades for all 50 states and Washington DC can be seen at the end of this story.

“I know that as an Oregon chronic pain patient, I can say my state does not deserve an 'A' right now. We have too many under treated patients, and too many that can't get care at all. For those of us that can't get proper pain management, these high grades are a slap in the face. It invalidates our experiences and struggles to get proper pain management,” said Korbe.

“Would pain management be in such a sorry state if these ‘grades’ actually meant anything? I personally think they are worthless,” said Janice Reynolds, a retired nurse, pain sufferer and patient advocate in Maine, which received an “A” grade.  

Rather than look at state policies and regulations, Reynolds said the study would be more meaningful if it examined whether opioids were being prescribed appropriately, if patients were having a difficult time finding providers, and if untreated pain was leading to more suicides.

“Every state would get a D or F if this was done,” she said.

Study Looked at Pain Policy, Not Practice

“To really look at this comprehensively, it requires a broader analysis to really get an understanding of things,” admits Aaron Gilson, PhD, the lead researcher for the study, which was funded by the American Cancer Society.

Gilson told Pain News Network the study only looked at state policies and regulations as they exist on paper – not how they were being implemented or even if they were effective.

“There’s not necessarily a 100% correlation between policies and practice. The policies in and of themselves don’t create barriers to pain management that we’ve identified. The grade that each state earned is really based on policies that can improve pain management for patients when put into practice,” he said.  

“Sound policy that's not implemented is only words wasted,” says Anne Fuqua, a pain sufferer and patient advocate, whose home state of Alabama was given an “A” grade.

“I'd give Alabama a 'C' for being better than the worst states like Ohio, Kentucky, Tennessee, Florida, West Virginia, Washington, and Oregon.  On paper the policy is excellent and it deserves the 'A' it gets. It just needs to be implemented.”

The study also didn’t look at insurance reimbursement issues or how doctors are responding to federal policies such as the CDC’s opioid prescribing guidelines, which were not released until this year and are having a chilling effect on both patients and doctors.    

Gilson said the methodology used to prepare the next pain care policy report – which was first released in 2000 – probably needs to be updated.

“That’s the first order of business in terms of continuing to do this, to really understand how policies have changed,” Gilson said. “I think it’s really time to examine the criteria that we use to see to what extent we might be missing policy because we’re not looking at the right thing, because barriers are erected in other ways than when we constructed this type of evaluation 16 years ago.”

Patient Survey Underway

One way to better understand those barriers is to simply ask patients what they are experiencing.

“Legitimate patients report the entire move to reduce (opioid) production and restrict prescribing is having a profoundly negative impact on their treatment protocols. Understanding how they are being impacted is important,” says Terri Lewis, PhD, a patient advocate and researcher.

Lewis is conducting a lengthy and detailed 29-question survey of pain patients to see how they are being impacted by efforts to reduce opioid prescribing. To take her online survey, click here.

Lewis will be able to breakdown the data state-by-state to get a real indication of how pain care policies and practices are being implemented.

“We will get that patient voice into this conversation,” she says. “Reports from patients are important and add value to the public conversation.  Reports will be analyzed and compared to months long data collection to look at trends, the impact of increasing restrictions, the fear of physicians to treat patients in this climate, and the influence of other factors like insurance restrictions and red flagging. This is a complex problem.”

SOURCE: PAIN & POLICY STUDIES GROUP, UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE

Unwilling to Suffer in Silence over Opioid Guidelines

By David Hendry, Guest Columnist

As an Army combat veteran, certified public accountant, law-abiding citizen and also a 70-year old arthritic, I am outraged by the restrictions imposed on primary care physicians for prescribing opioid pain medication.

The Centers for Disease Control and Prevention’s opioid guidelines are officially "voluntary" but have primary care physicians plainly scared about losing their licenses. My own physician, who has provided me with a low dose of Norco (and I have never asked for an increased dose), has suddenly found a host of reasons to discontinue it.

I listened carefully to this man I have known for years. He is not a very good liar. He is scared.

The "voluntary" guidelines seem to be saying to doctors: "Cooperate. We would not want anything to happen to your medical license, would we?"

That is the phrasing and logic of an extortionist.

How did Norco and heroin get lumped into the same set of statistics? I have even heard someone say, "Norco is a gateway drug to heroin.”

In fact, heroin has been a problem for decades. Actions to reduce its use have been ineffective and heroin has nothing to do with mild doses of relief for painful medical conditions that will never go away.

DAVID HENDRY

And how did I get statistically lumped in with addicts and criminals? The New England Journal of Medicine article "Reducing the Risks of Relief" acknowledges the opioid problem, but it is clear that there is not enough scientific evidence for such a "one size fits all" rule.

It is inhumane to remove pain relief and offer nothing as a replacement. Over-the-counter medications have their own problems and now we are told to go back to them? If they were effective, we would not need stronger medications.

The callous decision-makers (we're from the government and we are here to help!) exemplify the words of Francois de La Rochefoucauld: "We all have enough strength to endure the misfortunes of others."

We need a class action lawsuit to restore a reasonable balance between "pill mills" and the responsible use of narcotic pain relief. The class of people injured by the CDC guidelines and subsequent state-by-state actions include people like me, my wife (who suffers from post-polio syndrome), wounded veterans, and many others.

We are law-abiding Americans who recognize government over-reach and are unwilling to suffer in silence just because of a bureaucrat's decision.

David Hendry lives in Arizona. He has been a Chief Financial Officer and CEO for several mid-sized businesses. He also has a Master’s Degree in Health Care Management and a Master's in Education. David enjoys tennis, the outdoors and teaching, and is a proud Army combat veteran.

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.

Indians Manager Battles Back from Chronic Pain

By Pat Anson, Editor

Cleveland Indians manager Terry Francona – who has led the Indians to their first World Series since 1997 -- has struggled for decades with chronic pain from knee, wrist and shoulder injuries.

His story is an inspirational one to pain sufferers who have also dealt with the stigma associated with chronic pain and the use of opioid pain medication.

Francona may be the front runner for American League manager of the year, but it wasn’t too long ago that he was barely able to walk after complications from knee replacement surgeries left him in severe pain with blood clots and staph infections.

His managerial career also seemed finished after rumors surfaced that he abused pain medication while managing the Boston Red Sox.

Francona was upfront about his health problems and use of painkillers like oxycodone and Percocet in his book with Dan Shaughnessy; “Francona: The Red Sox Years.”

“I think I probably should have died with all that happened,” Francona said of one extended hospitalization in 2002, when his right leg almost had to be amputated.

“There were a couple of nights in the hospital where I was thinking, I can’t take this anymore.  The nurses would come running in because I’d stop breathing. I was in bad shape. There were people around who did not think I was going to make it. I know I came real close to losing the leg.”

Pain medication helped him survive the ordeal.

TERRY FRANCONA

“I lived on it at that time,” Francona recalled in the book. “When I left the hospital, I was on heavy-duty drugs, and it was tough.”

Francona recovered and resumed his career as a baseball coach. In 2004, he was hired as manager of the Red Sox and led the team to its first World Series title in 86 years. They added a second title in 2007. Through it all, Francona was still in pain and taking so much medication he would sometimes joke about it. He also started hoarding pain pills.

When one of Francona’s adult daughters found a bottle in his home with 100 Percocet pills, she convinced her father to see a pain management specialist and enter a confidential drug treatment program managed by Major League Baseball.  

That was in 2011, the year Francona’s marriage and his career as Red Sox manager unraveled at the same time. A team that many predicted would win yet another World Series suffered an historic collapse. Stories surfaced about players drinking beer, eating fried chicken and playing video games in the clubhouse during games. Anonymous sources pinned much of the blame on Francona, who was unceremoniously dumped by the Red Sox at the end of the season.

“Team sources said Francona… appeared distracted during the season by issues related to his troubled marriage and to his health,” reported the Boston Globe. “Team sources also expressed concern that Francona’s performance may have been affected by his use of pain medication.”

Francona felt betrayed by the team and by the insinuation that he was an addict.

“I don’t have a drug problem, that’s pretty obvious. I don’t drink that much, but I joke about it a lot. Anybody that knew me knew that I had taken more painkillers in ’04, because my knees were shot,” he said.

Francona was hired as manager by the Indians in 2012 and has guided them to four consecutive winning seasons. The Indians swept Francona’s old club – the Red Sox – to win the American League’s divisional series this month. They went on to beat the Toronto Blue Jays to win the American League pennant and now face the Chicago Cubs in the World Series.

This is Francona’s 16th year managing in the big leagues. At 57, he doesn’t talk much about his health problems – preferring instead that the attention be focused on his players. In addition to pain medication, Francona reportedly takes blood thinning medication and wears compression sleeves on his legs to improve blood circulation.  

Fewer Pain Meds but More Overdoses in Massachusetts

By Pat Anson, Editor

Opioid prescribing fell by 15 percent for members of Blue Cross Blue Shield of Massachusetts after the insurer adopted policies that discourage the dispensing of opioid pain medication, according to a new analysis by the Centers for Disease Control and Prevention.

The CDC’s Morbidity and Mortality Weekly Report found that 21 million fewer opioid doses were dispensed to Blue Cross Blue Shield members from 2012 to 2015. But the new policies failed to slow the growing number of opioid overdose deaths in Massachusetts, which more than doubled during the same period.

The CDC said it will "take time" before overdoses start to decline.

“Reducing the level of opioid prescribing is a long term strategy to limit exposure to these drugs. Mortality outcomes would not be expected to change for several years after implementation, and impact would be complicated by the increasing supply of illicit opioids,” Courtney Lenard, a CDC spokesperson, said in an email to Pain News Network.  

"Long-term strategies like the one outlined in the report take time to make an impact and therefore no immediate impact can be expected during the first several years of program implementation. Assessing what happened before and after the policy at the mortality level is inappropriate."

Blue Cross Blue Shield (BCBS) of Massachusetts is the state’s largest insurer, with about 2.8 million members.

In 2012, the insurer adopted policies that discourage opioid prescribing by requiring doctors to develop treatment plans that consider non-opioid therapies; requiring pre-authorization for all opioid prescriptions after an initial 30 day supply; and limiting some pain patients to use of a single pharmacy.

The effect was immediate, with an average monthly decline of 14,000 prescriptions for both short and long-acting opioids.

Although cancer patients were exempt from the policies, there was a 9% decline in opioid prescriptions to BCBS members with a cancer diagnosis. The CDC attributed that to a “sentinel effect” in which doctors implement the same policies for all of their patients regardless of diagnosis.

“I think oncologists were becoming more thoughtful and maybe more vigilant about how much narcotics they were prescribing and I think that’s why we saw that decrease in cancer patients,” said Tony Dodek, MD, associate chief medical director for BCBS of Massachusetts. “We’ve only received one complaint about the program in terms of people having access to necessary pain medications.”

Like the CDC, Dodek said it may take years before the stricter prescribing policies start to have an impact on overdoses. So far the signs are not encouraging.

Opioid overdoses in Massachusetts rose from 698 deaths in 2012 to 1,659 deaths in 2015. The trend has continued in the first six months in 2016, with nearly a thousand opioid overdoses reported. Two-thirds of this year’s deaths were related to fentanyl, a synthetic opioid that is increasingly appearing on the black market. Illicit fentanyl is often combined with heroin and cocaine, or used in the manufacture of counterfeit pain medication.

MASSACHUSETTS DEPARTMENT OF HEALTH

“It’s not surprising to me that overdoses have not gone down because there is still a lot of drugs in circulation,” said Dodek. “What we did was slow the supply of new medication that’s in circulation. The fact is there is already way too much medication sitting in people’s medicine cabinets at home and that is what was available to start this epidemic.”

The Drug Enforcement Administration has said the U.S. is being “inundated” with counterfeit painkillers and there are anecdotal reports of some patients turning to street drugs for pain relief as opioid medication has become harder to get. But Dodek says it is recreational users – not pain patients – who are resorting to the black market.

“Any pain patient isn’t having access problems to getting opioids,” he said. “Those who may be using it for recreational purposes or for diversion probably are having a more difficult time (getting prescriptions). We still need to figure out what to do about illicit drugs, but I think decreasing the amount of prescriptions drugs will only be a good thing in the end.”

And what about the effect on pain patients as these policies are adopted? The CDC report ends with this telling statement:

“Finally, it is not known from these data how patient pain and function were affected by limiting access to opioid prescriptions.”

Half of New York Overdoses Blamed on Fentanyl

By Pat Anson, Editor

Nearly half of the overdose deaths in New York City since July have been linked to fentanyl, according to a new report that adds to the growing body of evidence that illicit fentanyl is now driving the nation’s opioid epidemic – not prescription pain medication.

In an advisory sent to healthcare providers, New York’s health department said 47 percent of the city's confirmed overdose deaths since July 1 have involved fentanyl. That compares to 16% of overdoses involving fentanyl in all of 2015. So far this year, 725 people have died from drug overdoses in New York.

“Data suggest that the increased presence of fentanyl is driving the increase in overdose fatalities,” the alert said. “While fentanyl is most commonly found in combination with heroin-involved overdose deaths, fentanyl has also been identified in cocaine, benzodiazepine, and opioid analgesic-involved overdose deaths.”

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. Because of its potency, healthcare providers are being warned that additional doses of naloxone – which reverses the effects of an opioid overdose – may be needed when fentanyl is involved.

Fentanyl is available legally by prescription in patches and lozenges to treat more severe types of acute and chronic pain, but illicitly manufactured fentanyl has become a scourge across the U.S. and Canada, where it is often mixed with heroin and cocaine or used to make counterfeit pain medication.

Unsuspecting buyers, including some pain patients who were unable to get opioid medication legally, often have no idea the drug they’re getting from a dealer or friend could contain a lethal dose of fentanyl.

dea image of fentanyl

In addition to New York City, several states in the Northeast and Midwest have reported that fentanyl is now involved in about half of their overdose deaths.

The sharp increase in fentanyl-related deaths has coincided with new restrictions on the prescribing of opioid pain medication. In the past year, the Drug Enforcement Administration has issued two public safety alerts about fentanyl, but the Centers for Disease Control and Prevention has remained relatively quiet about the problem – focusing instead on opioid prescribing guidelines that were released in March of this year.  

Those guidelines have led many doctors to reduce doses or stop prescribing opioids altogether, but they have failed to make a dent in the number of Americans dying from overdoses. There have also been anecdotal reports of a rising number of suicides by patients unable to get opioid medication.

“I know five people who have committed suicide from being denied pain medication by doctors after the CDC came out with their ridiculous statements of the ‘epidemic’ of prescription opioid use,” says Nina Stephens, a Colorado woman who suffers from chronic pelvic pain. 

“Doctors are so afraid of getting in the middle of this epidemic mess with the FDA that they have decided to stop prescribing opioids to their patients, even those patients who are in desperate chronic pain. We are now treating our patients worse than dogs when it comes to pain.”

Stephens says she has to drive 4 hours each month to see a doctor who is still willing to prescribe opioids. A local pain management doctor just 20 minutes away said he would take Stephens off opioids and give her epidural injections instead, which she refused.

“I am truly afraid that soon I will have to drive even farther to find a doctor who will still be willing to prescribe pain pills to me each month or I will have to start looking at the black market.  Maybe a veterinarian would be willing to start treating me?  No wonder the suicide rate is going up so dramatically!” Stephens wrote in an email to PNN.

Canada’s Fentanyl Crisis

Counterfeit fentanyl pills started appearing in British Columbia about two years ago and have since spread throughout Canada. The fentanyl crisis is so severe a two-day conference was held in Calgary this week for healthcare providers and law enforcement.  There were 153 deaths associated with fentanyl in Alberta province during the first six months of 2016.

Some attendees want Alberta to declare a public health emergency – as British Columbia did in April. But Alberta’s Minister of Justice says the current fentanyl situation doesn’t warrant such a declaration.

“None of those powers will assist us in this case but they do give the government a significant ability to violate civil liberties,” said Kathleen Ganley. “We think it’s important we use those powers that have significant impact on Albertans only where they would be helpful to us.”

On display at the conference was an illegal pill press seized by law enforcement that is capable of producing 6,000 fentanyl laced pills per hour.

“Some of the tablets we’ve been seizing in Calgary have ranged from 4.6 milligrams to 5.6 milligrams per tablet—which is very high obviously, considering a lethal dose is two milligrams,” said Calgary police Staff Sgt. Martin Schiavetta in Calgary Metro.

Trump and Clinton Pursue Same Policies in Pain Care

By Pat Anson, Editor

Chronic pain patients hoping for a dramatic change in federal pain care policies as a result of the presidential election are likely to be disappointed.

Both Donald Trump and Hillary Clinton favor more restrictions on opioid prescribing, as well as expanded access to addiction treatment programs, which are essentially the same policies being pursued by the Obama administration.

At a rally in New Hampshire this weekend, Trump outlined for the first time his strategy to combat the nation’s so-called opioid epidemic.

“DEA should reduce the amount of Schedule II opioids -- drugs like oxycodone, methadone and fentanyl -- that can be made and sold in the U.S. We have 5 percent of the world’s population, but use 80 percent of the prescription opioids,” Trump said in prepared remarks.

“I would also restore accountability to our Veterans Administration. Too many of our brave veterans have been prescribed these dangerous and addictive drugs by a VA that should have been paying them better attention.”

Trump said the Food and Drug Administration has been “too slow” in approving opioid pain medication with abuse deterrent formulas. And he said he would “lift the cap” on the number of patients that a doctor can treat with addiction treatment drugs.

donald trump

But the Republican nominee seemed confused about the difference between abuse deterrent formulas and addiction treatment drugs like buprenorphine (Suboxone).

"The FDA has been far too slow to approve abuse-deterring drugs. And when the FDA has approved these medications, the rules have been far too restrictive, severely limiting the number of authorized prescribers as well as the number of patients each doctor can treat," he said.

There are no limits on doctors for prescribing abuse deterrent drugs, but there are for the buprenorphine. In August, the Obama administration nearly tripled the number of patients that a doctor can treat with buprenorphine.

Trump also seemed unaware that the DEA recently said it would reduce the production quota for many opioids by 25 percent or more.

Trump claimed the Obama administration has worsened the nation’s drug problem by commuting the sentences of drug traffickers and by releasing “tens of thousands” of drug dealers early from prison. He also pledged to stop the flow of illegal drugs into the country.

“We will close the shipping loopholes that China and others are exploiting to send dangerous drugs across our borders in the hands of our own postal service. These traffickers use loopholes in the Postal Service to mail fentanyl and other drugs to users and dealers in the U.S.” said Trump.

“When I won the New Hampshire primary, I promised the people of New Hampshire that I would stop drugs from pouring into your communities. I am now doubling-down on that promise, and can guarantee you – we will not only stop the drugs from pouring in, but we will help all of those people so seriously addicted get the assistance they need to unchain themselves.”

Like Trump, Hillary Clinton has also promised to expand access to addiction treatment, but in more detail. Her Initiative to Combat America's Deadly Epidemic of Drug and Alcohol Addiction would allocate $10 billion in block grants to states to help fund substance abuse programs.  

Clinton also wants doctors to undergo training in opioid prescribing before they are licensed to practice and to require that they consult prescription drug databases before writing prescriptions for controlled substances.

One area where Clinton differs with Trump is that she puts less emphasis on law enforcement. Saying she wants to “end the era of mass incarceration,” Clinton has called for low-level drug offenders to get treatment and not just be locked up.

“For those who commit low-level, nonviolent drug offenses, I will reorient our federal criminal justice resources away from more incarceration and toward treatment and rehabilitation. Many states are already charting this course — I will challenge the rest to do the same,” Clinton wrote in an op/ed published in the New Hampshire Union Leader.

hillary clinton

In their public statements, neither Trump or Clinton have given any indication that they believe that  federal policies affecting pain care, such as the CDC’s opioid prescribing guidelines, have gone too far. If anything, they want to go further.

Clinton has endorsed a proposed tax on opioid pain medication sponsored by West Virginia Sen. Joe Manchin (D). If approved, the so-called Lifeboat Act would raise $2 billion annually to fund addiction treatment programs. The tax would be the first federal tax on a prescription drug ever levied on consumers.  

During a roundtable discussion about opioid overdoses in West Virginia, Clinton called the tax “a great idea” and said it was “one of the reasons why I am such an admirer of Sen. Manchin.”

Pain News Network has asked the Trump campaign where the Republican nominee stood on the opioid tax. We have yet to get a response.

Tips for Managing Your Meds

By Barby Ingle, Columnist

When it comes to managing medication, the more you know about your medical condition the better equipped you’ll be to understand which drugs to take, the side effects to watch for, and when to take them. It is also a great idea for your caregiver to know.

There are many times when I am not doing well and my husband will say, “You seem dizzy. Have you taken XXX yet? When was the last time you took it?”

Or he’ll say, “We are going to go out later to get groceries, so take your pill now so you won’t be sleepy when we go and you will be more comfortable.”

Having someone there to help me is great, because sometimes I feel so awful that I cannot remember to take my medication or even what I have taken. I have overdosed on different medications a few times because I forgot I had already taken a dose.

Here are some tips I’ve learned to manage my medications safely:

1)  Use a pill organizer to keep track of your medications. I have a pill box for a two week supply separated into morning and night pills.

2)  Keep medications without childproof caps away from children or lock them up, especially if you have opioid pain medications.

3)  Take your pills at the same time each day, especially when medications are time-released versions. This helps to keep the level of medication consistent in your body.

4)  Know why you are taking each medication, how best to take them (before or after eating), and any side effects that you may experience. Find out what your doctor wants you to do for each medication and verify it with your pharmacist.

5)  Be sure to never break or split time-release pills. Breaking the seal can be very dangerous as your body can receive the dose of the whole pill too quickly and it can become deadly.

6)  Carry a list of your medications and doses at all times in your purse or wallet. You should also update your pharmacy records to include all of the drugs that you take, including any over-the-counter medications. I use Walgreen's and they have a great online site that allows me to update it from home.

7)  Do not drive under the influence of medication that affects your cognitive thinking. It is also a good idea not to drive while taking medications that cause drowsiness or when you are distracted by pain.

8)  If a medication is making you sick or causing side effects that you cannot tolerate, talk to your physician about adjusting the dose or changing the medication. If side effects include trouble breathing, a rash or more severe symptoms, head to a local emergency room for immediate assistance.

9)  Read prescription labels and inserts carefully. They contain important information such as the medication’s name, dosage, prescribing doctor, and expiration dates. This can help you avoid taking a medication for too long or having adverse effects from long-term use.

10)  If you are a drinker, be sure to discuss with your provider or pharmacist if it is safe to drink with any of the prescriptions or over-the-counter medications you are taking.

11)  If you have more than one doctor prescribing medications, be sure to tell all of them what you are taking, so they can be alert to possible interactions and complications. I had to do this for myself and have not had these issues since.

12)  If you decide you no longer want to continue a medication, get your provider’s guidance before you stop taking it. Some medications can be stopped immediately, but many require you to titrate or taper off them.

13)  If you discontinue a medication, be sure to dispose of it properly and immediately. You should also dispose of medication once the expiration date has passed. The FDA has a list of disposal recommendations you can see by clicking here.

Some medications such as inhalants have hazardous material disposal requirements. Follow the specific disposal instructions on the drug label. If no instructions are given, you can crush and mix medications with coffee grounds, cat litter, or food scraps. Then seal them in a bag or a container (such as a margarine tub or jar) and discard them in the regular trash.

Many pharmacies and law enforcement agencies have “Drug Take Back” events that you can participate in. Find out more from your local pharmacist or police station.

Following these tips will keep you, your loved ones and your community safer.

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) 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.

Chronic Pain Patients to Rally at White House

By Pat Anson, Editor

Only a few months are left in the Obama administration -- and much of the nation’s attention is focused on the bruising battle between Hillary Clinton and Donald Trump over who will be the next president.

But some activists in the pain community are determined to make some noise of their own. They’re planning to hold a Rally Against Pain on the Ellipse south of the White House on Saturday, October 22.

The goal is to draw attention to the millions of chronic pain sufferers who are losing access to opioid pain medication because of a series of actions by the Obama administration to restrict opioid prescribing as a way to fight the national epidemic of drug abuse and addiction.

“We kind of feel like it was this administration that made this mess,” says Lana Kirby, a Florida paralegal, chronic pain sufferer and patient advocate who organized the rally.

“I mean the harm that is happening every single day. For them to let it go and know that it’s going on, to let it go anyway and leave it for the next administration, that’s not the right thing to do.”

Since the Centers for Disease Control and Prevention released it opioid prescribing guidelines in March, Kirby says many patients she counsels in support groups have had their doses reduced or cutoff entirely. Some have been abandoned by physicians who are no longer willing to treat pain patients because they fear harassment or prosecution for prescribing opioids.   

“It’s just one story after another. You can’t really offer these people any hope or help,” says Kirby. “Just about everybody I know in at least 50 percent of the states have either had their medicine discontinued or cut back to minimal levels.

“The way things keep going with all these restrictions, you wonder where it is going to end and what their overall plan is.”

The biggest jolt to the pain community may be yet to come. The Drug Enforcement Administration recently announced plans to reduce the production of hydrocodone, oxycodone and many other opioids by 25 percent or more in 2017. As PNN has reported, some experts in hospice care are worried the cuts could be so severe that terminally ill patients may not be able to get the pain medication they need.

Publicly, the DEA claims the cuts are necessary because of declining demand for opioids. But patient advocates say the real decline is in opioid prescribing -- not in demand -- and the administration is ignoring the impact its policies are having on pain sufferers.

“They only tell you what they want the public to hear because they want the general public to be against opioids of any kind. And they’re doing it very successfully,” says Kirby.

“No other president in American history has done more to destroy the hopes, lives and natural rights of people in pain then President Obama and his administration,” says David Becker, a social worker and patient advocate who will be one of the speakers at the October 22 rally.

“The FDA, CDC, DEA, and DHHS have made it clear that we are not qualified to have an opinion about pain care or our own good. They are as tyrannical as any despot ever was,” adds Becker. “The people involved with the Rally Against Pain are feeling the moral shock that leads to social movements and social movement organizations. We stand with Lincoln in knowing that silence is sin when protest is needed.”

Kirby is expecting about 300 protestors to appear at the rally – a small number compared to the estimated 100 million Americans who suffer from chronic pain. She says many supporters who want to attend are disabled or in too much pain to make the trip.

The rally was organized by volunteers through Facebook and other social media without the participation of well-funded advocacy groups like the U.S. Pain Foundation and the American Chronic Pain Association. Even so, it could turn out to be largest protest ever held by pain patients.

Kirby says she didn’t want to hold the rally next year -- after the new administration takes office -- because too many pain patients are suffering or even suicidal.

“More people will be gone by then. More people will not be functioning. Things are only going to get worse. If we don’t do something and get some attention right away, things are going to be very bad,” she said.

For more information about the rally and how you can participate, click here.

The VA’s Opioid Policy Hurts Veterans Like Me

(Editor’s note: In 2015, Congress passed and President Obama signed into law legislation that requires the Veterans Administration to adopt the CDC’s “voluntary” opioid guidelines, which discourage the prescribing of opioids for chronic pain. Over the past year, the VA has implemented the guidelines throughout its healthcare system, which provides medical services to 6 million veterans -- over half of whom suffer from chronic pain. One of them is Ron Pence.)

By Ron Pence, Guest Columnist

I am a Vietnam veteran who turned to the VA health system in 2001, when I started having pain from polymyositis and chronic arthritis, the worst kind of arthritis caused by autoimmune disease. My own body was attacking my joints and muscles. They said CPK enzyme levels in my blood were very high and in danger of shutting down my kidneys.

Back then the VA cared about vets. I was started on pain meds and they moved me up the ladder as the pain increased.

The head of rheumatology started me on morphine because he said it was the only drug he had to offer. He was right. After 3 pain management visits, 3 more doctors agreed I was on the correct needed dose. X rays of the arthritis in my back ruled out chiropractic care.

I was on the same dose of morphine for 9 years. It worked well enough for me to function and to live alone. The VA promised to continue my opiate therapy as long as I did not break their rules.

After 5 years or so they came out with a new contract and forced us to sign it. I was told either sign it or you don’t gets your meds. I was never accused of breaking their rules and never have. I pointed out the new contract was totally in favor of the VA doing as they please and was signed under duress.

RON PENCE

Now out of the clear blue they cut my dose in half over two months and they may cut it completely because I refuse to take terrible and dangerous psychiatric drugs with the worst side effects. Just search the Internet for “Cymbalta side effects” and you’ll see what I mean.

The VA is really pushing these drugs that I would not give to a dog. They are a lobotomy in a pill. I WILL DIE BEFORE TAKING THEM. They take away your ability to think, speak and make decisions; and come with side effects such as permanent blindness, kidney stones and suicide, even in non-depressed people with no mental problems. Even trying to get off this drug under a doctor's care can end in death for some people. Besides that, it’s nothing more than a sugar pill for the pain.

Why start something like that when what I was taking had no side effects for me and was working fine? I am sure the pills they are pushing will end in a lot more deaths and terrible disabilities and suffering.

My companion almost died after taking Enbril. The VA doctors write prescriptions for Enbril, Humira, etc. as if they were candy. Four shots a month cost $2,000. Far more dangerous than opiates, but someone lines their pockets and the drug companies make over $10 billion a year on them. There is more here than meets the eye.

The CDC in Atlanta says their opioid prescribing guidelines are just that, guidelines. Doctors at the VA must not be smart enough to know what a guideline is. They’re pushing very dangerous, expensive and destructive drugs to replace opioids. Pray and try to find a substitute that works. Doctors sit and lie about what the guidelines say. The stress of not knowing if you are going to be cut off completely is as bad as the pain.

Since the big cutback in my pain medication, I am far less functional. Just standing up 30 seconds to snatch my clothes out of the washer puts me in hollering pain and I fall back into my wheelchair. Cutting the meds even makes it hard to get on the toilet. I am 70 and live alone. My family brings me food to keep me from starving most of the time. I have lost over 90 pounds.

This is going to mean the nursing home for a lot of people like me and I cannot stand the thought of living or existing in a nursing home. Karma is going to get a lot of people making these bad decisions.

I don’t take complaints to Washington because I am old and an 8 mile trip to Walmart wipes me out for a couple of days. This is a fight for the younger guys.

We are in one of the most advanced countries in the world medically, yet the doctors and politicians will not use that knowledge to ease pain and suffering. We have to find a solution.

Ron Pence lives in Florida. Ron enlisted in the Air Force in 1963 – at the age of 17 -- and served his country for 6 years.

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 represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

DEA Opioid Cuts Could Affect Terminally Ill Patients

By Pat Anson, Editor

Steep cuts in the production of opioid pain medication planned by the U.S. Drug Enforcement Administration could worsen drug shortages and affect pain patients receiving end-of-life hospice care.

“Yes, I think that’s absolutely possible. And very, very concerning,” says Judi Lund Person, VP of Regulatory and Compliance for the National Hospice and Palliative Care Organization.

The DEA announced earlier this week that it is reducing production quotas for almost every Schedule II opioid pain medication next year by 25 percent or more. The quota cuts include opioids such as hydrocodone, oxycodone, fentanyl, hydromorphone and morphine – many of which are used to give pain relief to patients in palliative and hospice care.

The DEA said the cuts are needed to prevent the diversion and abuse of opioids, and because opioid prescribing has been in decline for several years.

But Person says some patients in palliative care – who are generally disabled and chronically ill, but still living at home  – are already having trouble getting their opioid prescriptions filled.

“We’ve had patients who’ve had a lot of trouble finding a pharmacy that carries certain opioids,” she said

Person is worried that the DEA’s production cuts will also make it difficult for hospices to obtain opioids for terminally ill patients. Her organization, which represents about 4,000 hospice facilities in the United States, is still examining the possible impact of the opioid cuts.

“What does that do for patients at the end of life who need these drugs? That, I think, is one of our biggest questions,” Person told PNN.

“Living and working in the Washington area, the pressure is on so much around the opioid addiction crisis, and looking for any and all opportunities to see if we can correct that. It doesn’t surprise me in any way that this is happening. Now, what we’ll do about it and how we switch over to other drugs that will be available is a completely different question. I don’t know what we’ll do.”

Person says there are 1.4 million Medicare patients in hospice care and several million more receiving palliative care.

Many chronic pain patients who are not in palliative or hospice care say opioids are already hard to get, because many doctors are reluctant to prescribe them and some pharmacies claim they’re out of stock.

“I am really, really scared about my future and others. So many others are already suffering needlessly. How many more are going to be thrown under the bus?” asks Rich Martin, a Nevada pharmacist who was forced into early retirement by chronic back pain. “I take hydrocodone for my rescue doses, 5 times a day, and I almost always use them unless I am totally sedentary. I think hydrocodone is being reduced by 36 percent. 

“Opioids across the country have already been reduced or stopped parabolically downward. This whole quota thing could collapse to where there is indeed inadequate opioids for treatment of legitimate pain patients.  Then pharmacies may actually be telling the truth when they say they are out of opioids.”

The DEA says its opioid quotas are sufficient to provide “adequate and uninterrupted supply for legitimate medical need,” and could be adjusted if problems develop.

“DEA may revise a company’s quota at any time during the year if change is warranted due to increased sales or exports; new manufacturers entering the market; new product development; or product recalls,” the DEA said in a press release.

“This is a step in the right direction,” Sen. Dick Durbin (D-Illinois) said in an interview with WGN Radio. Durbin was among a group of senators that urged the DEA to lower the quota for opioids.

“Clearly there is more (opioids) than is necessary to alleviate pain. I’m the glad the DEA stepped up. It’s the first time.”

GAO Questions DEA’s Competency

Many Americans may not be aware of the significant role DEA plays in regulating the nation’s drug supplies. Drug manufacturers apply to the DEA every year to produce opioids and other controlled substances, and the agency determines how many – the quota – each drug maker can produce.

But in a recent series of highly critical reports, a congressional watchdog agency questioned the DEA’s competency in regulating pharmaceutical drugs.

In March 2015, the DEA was criticized in a lengthy report by the Government Accountability Office (GAO) for its inability to deal with drug shortages, a problem so serious it was called “a risk to public health.”

The GAO said that between 2001 and 2013, there were 87 “critical” shortages of controlled substances, over half of them pain relievers. There were also shortages of anti-anxiety medications, sedatives, and stimulants. 

“The shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the GAO report states.

A second GAO report in July 2015 faulted the DEA for heavy-handed tactics during pharmacy investigations. Many pharmacists said they were worried about being fined or having their licenses revoked, and blamed the DEA for poor communication and unclear rules. 

“In the absence of clear guidance from DEA some pharmacies may be inappropriately delaying or denying filling prescriptions for patients with legitimate medical needs,” the GAO report said. 

What has the DEA done in the last year to correct these problems? 

Of the 11 recommendations made by the GAO to improve the quota system and prevent drug shortages, the DEA has fully implemented only two of them.

One of the problems the DEA failed to address is the timeliness of its release of production quotas. Under guidelines set in 2006, the DEA is supposed to set quotas for controlled substances on or before May 1 of each year, to give drug manufacturers enough time to adjust their production schedules for the following year.

“DEA officials attributed this lack of compliance to inadequate staffing and noted that the agency’s workload with respect to quotas had increased substantially,” the GAO said in a report this summer.

“We could not confirm whether DEA’s lack of timeliness in establishing quotas had caused or exacerbated shortages because of concerns about the reliability of DEA’s data, among other things. However, by not promptly responding to manufacturers’ quota applications, we concluded that DEA may have hindered manufacturers’ ability to manufacture drugs that contain schedule II controlled substances that may help prevent or resolve a shortage.”

The quotas for 2017 were released on October 5 -- the 10th straight year that DEA has missed the quota deadline.

DEA Cutting Opioid Supply in 2017

By Pat Anson, Editor

It’s going to get even harder for chronic pain patients in the United States to get prescriptions refilled for hydrocodone, oxycodone, morphine and other opioids classified as Schedule II controlled substances.

The Drug Enforcement Administration has announced plans to reduce the amount of almost every Schedule II opioid pain medication manufactured in the U.S. by 25 percent or more. The 2017 quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, is being reduced by a third.

The DEA’s order, which is being published in the Federal Register, comes just seven months after the Centers for Disease Control and Prevention released guidelines that discourage primary care physicians from prescribing opioids from chronic pain. The guidelines have had a chilling effect on many patients and their doctors, who have reduced opioid doses or stopped prescribing them altogether.

Opioid prescribing was falling years before the CDC and DEA acted. According to IMS Health, hydrocodone prescriptions in the U.S. plunged by 22 percent from nearly 120 million in 2014 to 93.5 million in 2015.

The “established quota” for hydrocodone in 2017 is being reduced to 58.4 million prescriptions under the DEA order.

“The purpose of quotas are to provide for the adequate and uninterrupted supply for legitimate medical need of the types of schedule I and II controlled substances that have a potential for abuse, while limiting the amounts available to prevent diversion,” the DEA said in a press release.

“Once the aggregate quota is set, DEA allocates individual manufacturing and procurement quotas to those companies that apply for it.  DEA may revise a company’s quota at any time during the year if change is warranted due to increased sales or exports; new manufacturers entering the market; new product development; or product recalls.”

The DEA has been under growing political pressure to reduce the supply of opioids. A group of U.S. senators sent a letter to the agency this summer demanding that opioid quotas be reduced.

“We urge DEA to utilize its existing quota setting authority, to the fullest extent possible, to combat this epidemic,” said the letter from Senators Dick Durbin (D-IL) Sherrod Brown (D-OH), Edward Markey (D-MA), Amy Klobuchar (D-MN), Angus King (I-ME), and Joe Manchin (D-WV).

“Fourteen billion opioid pills are now dispensed annually in the United States – enough for every adult American to have a bottle of pills. Certainly, the pharmaceutical industry is at fault for decades of misleading information about their products and the medical community bears responsibility for its role in over-prescribing these dangerous and addictive drugs, but we remain deeply troubled by the sheer volume of opioids available – volumes that are approved by DEA.”

Although opioid pain medication is routinely blamed by politicians, federal agencies and the media for the nation’s so-called opioid epidemic, recent studies in several states have found that most drug overdoses are actually caused by illegal opioids such as heroin and bootleg fentanyl. There are also increasing signs that pain patients unable to get opioids legally are turning to pain medication sold on the streets, some of it counterfeit and laced with fentanyl.

Efforts to restrict the supply of opioids may only be making things worse.

Law enforcement agencies in West Virginia recently said a federal crackdown on opioids – dubbed the Bluefield Pill Initiative -- may have contributed to a recent spike in heroin cases, according to the Bluefield Daily Telegraph.

“We are seeing an increase in heroin because pills are in fewer quantity,” said Sgt. J.S. McCarty, who heads a local crime task force. “Without pills an opioid addict’s only choice is heroin.”