“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
“In situations for which the evidence is limited, it is particularly important not to extend the implementation beyond the guideline’s statements and intent. And yet in some cases, the guideline has been misimplemented in this way,” Deborah Dowell, MD, MPH, of the CDC, and colleagues wrote.
The following inconsistencies with the guidelines were recently identified by a consensus panel, researchers wrote:
Applying the guideline to patients engaging in active cancer treatment, experiencing acute sickle cell crises or post-surgical pain and/or those participating in medication-assisted treatment for opioid use disorder;
Ceasing opioids that have already been prescribed at doses of 90 morphine milligram equivalents a day or more; and
Abrupt tapering or sudden stopping of opioid use.
The CDC Guidelines for Prescribing Opioids for Chronic Pain are not consistently followed, putting patient health and safety at risk, according to a perspective recently published in The New England Journal of Medicine.
Source:Adobe
The NEJM report is not the first to suggest possible misuses of the CDC opioid guidelines. Healio Primary Care Today reported earlier this year that though the CDC guidelines were not meant to be model legislation for states to act on, 28 states did so.
In a separate press release, the AMA said it “welcomed” the findings reported by Dowell, et al.
“The AMA appreciates that the CDC recognizes that patients in pain require individualized care and that the agency’s 2016 guidelines on opioids have been widely misapplied. The guidelines have been treated as hard and fast rules, leaving physicians unable to offer the best care for their patients,” Patrice A. Harris, MD, the organization’s opioid task force chair said in a statement.
She added that reversing the harm by such inaccuracies will be a “challenge,” and suggested some steps for facilitating the process. “The AMA is urging a detailed regulatory review of formulary and benefit design by payers and [pharmacy benefit managers] to ensure that patients have affordable, timely access to medically appropriate treatment, pharmacologic and non-pharmacologic. The nation’s physicians will work with CDC so our patients receive comprehensive, multidisciplinary, multimodal pain care based on medical science and effective clinical practice.”
Dowell and colleagues wrote in the NEJM piece that clinicians are encouraged to use the CDC’s pocket guide to assist them in tapering methods, its app and website that provide motivational interviewing tips, and its information about nonopioid treatments for pain.
Physicians are also encouraged to bookmark Healio’s Opioid Resource Center. This collection of news articles and features covering multiple medical specialties provides the latest information on the opioid crisis including treatment strategies, FDA decisions regarding treatments and other important, related announcements.
The CDC is “working to identify ways to integrate recommendations into medical education and to support best practices among the next generation of medical professionals,” Dowell and colleagues wrote. – by Janel Miller
Disclosures : The authors report being among the authors of the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain.
Jeff DickSince spine surgery I have chronic pain but I refuse to take opioids. I don’t even take Tylenol. That means I have difficulty understanding how people can get hooked. It’s a good thing I will never be in a position to make the rules. I would prohibit a second refill of any addictive drug. If the patient is in that much pain something is physically wrong. Rather that mask the pain, fix the damn problem.
Steve AriensI guess all chronic pain pts are lucky that you are not in the position to make the rules… unfortunately, we have way too many in the position to make the rules – that are as ignorant as you are about human health and treatment. what medical science knows about the human system is greatly dwarfed by what it doesn’t know… and apparently you are a good example … our medical science cannot fix STUPID !
Jamie HubertJeff Dick 1) You have a VERY narrow world view.
2) You have no comprehension of how the country’s or worlds medical and financial systems work.
3) Every BODY is different. …See More
Jeff DickWow, the bleeding hearts are out tonight. You all seem absolutely anxious to get millions of people addicted just so they won’t have to feel a little pain. Your preference is turn them into a dependent zombie. Your cure, is many times worse than the disease.
The above is comments from someone who believes that NO ONE should have more than one Rx of opiates regardless of their pain. I put the link to his facebook page on the top of this page. Apparently our health care system will never make any attempt to cure STUPID ?
State is placing persons who are involuntarily committed to treatment – the section 35 process – in jail or prison even though no charges have been levied against them
Sheriff Nick Cocchi, left, on his way to visit men civilly committed for drug or alcohol abuse at the Hampden county jail in Ludlow, Massachusetts. Photograph: Josh Wood/The Guardian
The scene plays out every day in Massachusetts, thousands of times a year.
A loved one is addicted to opioids. Their life is spinning out of control as they use more and more. Their family panics. Rehab can be unaffordable – and it may require waiting for a spot. But they need to get their loved one somewhere they can’t use before it’s too late.
It’s about now that they might consider section 35, a process in Massachusetts by which persons abusing drugs or alcohol can be involuntarily committed to treatment for up to 90 days after a family member, guardian, law enforcement officer or doctor petitions a judge. Many states have similar laws in place and have turned to them in battling the opioid crisis gripping the nation.
But in Massachusetts, involuntarily committed men can end up in jail or prison even though no charges have been levied against them.
That’s how Jim, a 29-year-old student, arrived at the Hampden county jail in the western Massachusetts town of Ludlow in March after overdosing on opioids. Despite being forced into jail with no charges, he told the Guardian he was glad to be there.
“I’ve never been in trouble with the law, but it was absolutely necessary for a cop to come to the house, put me in handcuffs and take me here,” he said.
Eight days into his stay, he said jail was “the best thing that’s probably ever happened to me”.
As Massachusetts struggles against an opioid crisis that kills five times as many people than automobile accidents every year in the state, the placement of civilly committed men in correctional facilities has emerged as one of the most controversial tactics to confront addiction in the state – and one not seen anywhere else in the nation.
To proponents, the section 35 process is seen as lifesaving, putting people in a place where they absolutely cannot get drugs and where they cannot simply walk out. But its detractors say that forced rehabilitation does not work, that putting men in correctional facilities is unconstitutional and that putting patients in prison settings is detrimental to recovery and increases the risk of relapse once patients are released.
Women were once held in correctional facilities in Massachusetts for addiction, but after an ACLU lawsuit, the state ended the practice in 2016.
But the state has ramped up its incarceration of civilly committed men. According to Prisoners’ Legal Services, a not-for-profit that has been a key opponent of the practice, Massachusetts places more than 2,000 men involuntarily committed for substance abuse in correctional facilities per year.
The Hampden county jail wing looks like a jail, but the people here are patients, not inmates, and have been charged with no crime. Photograph: Josh Wood/The Guardian
In March, PLS filed a lawsuit against the department of correction and department of public health on behalf of 10 unnamed patients being held at the Massachusetts Alcohol and Substance Abuse Center (Masac), a facility operated by the DoC in the town of Plymouth.
The lawsuit charges that holding the men in correctional facilities is unconstitutional, constitutes unlawful discrimination on the basis of gender and disability and is overall detrimental to recovery. They also describe an abusive environment where patients are “routinely” humiliated by correctional officers (COs) and where patients lack access to opioid substitution medications such as Suboxone.
“These people are being shamed and stigmatised on the basis of a disease that’s acknowledged as a disability,” said Bonnie Tenneriello, PLS staff attorney.
One of the unnamed plaintiffs said officers called patients pussies, bitches, junkies and crackheads while telling him that his “mother is a whore”.
Another plaintiff described how during detox, his roommate urinated and defecated on himself, but that nobody cleaned it up.
Others described being too afraid to call their employers or loved ones as all phone calls coming from the facility inform the person being called that they are receiving a call from a correctional facility.
PLS says patients have been sent to solitary confinement for seemingly minor offences like smoking a cigarette, not answering questions or taking extra milk with their meals.
“All of that is counter-therapeutic, all of that is traumatising, all of that is telling people you are not a full citizen, you are not to be trusted, you are a bad person,” said Tenneriello of placing patients in correctional facilities.
A cell – or bedroom – in the wing for civilly committed men at the Hampden county jail. While the facility is locked, cells remain unlocked. Photograph: Josh Wood/The Guardian
‘It’s a jail mentality’
Joel Kergaravat, 36, was hooked on heroin and crystal meth when his mother petitioned him to be sectioned last summer. They both thought that sectioning him would mean rehab, but instead he was put in restraints and loaded into a hot van for a long drive to Masac.
His experience at Masac appeared to mirror allegations laid out in the lawsuit.
Once he got to Masac, he did not have access to detox medications. “It’s barbaric not to give people that medication, because you’re basically vomiting and shitting yourself for six days,” he said. “That’s what happens. It’s not pretty.”
Inside, he said guards were abusive. He felt the place was unsanitary and unclean and worried about getting sick. Patients would get into fistfights.
“It’s a jail mentality,” he said. “They have you in a prison setting so people act accordingly.”
When he got out, he was traumatized. He got back on drugs and at one point tried to kill himself by overdosing – a result, he says, of his experience at Masac.
“If you’re going to force people into treatment, that’s fine, put them into treatment,” he said. “You can’t just rename a prison or a section of a prison and call it treatment.”
A sheriff champions section 35
The Hampden county sheriff, Nick Cocchi, might be the biggest proponent of section 35 in the state.
Cocchi views his mission as a rehabilitative one. His COs don’t carry weapons of any kind and those on the section 35 wing don uniforms consisting of polo shirts – an attempt to look less guard-like. He keeps a folded, ageing piece of paper in his pocket that lists the names of those that have died at the jail in the 26 years he has been working there. When western Massachusetts residents call him and send him Facebook messages pleading for advice about loved ones who have been trapped by addiction, he invites them to his office, even if it is a weekend. Men who have previously been sectioned call him up when they are relapsing.
Cocchi says that when done right, forced rehab works.
His enthusiasm about section 35 was born out of a desire to provide treatment closer to home for residents of western Massachusetts.
“You serve no purpose taking somebody two and a half hours from home, detoxing them and then saying ‘here’s a bus ticket to get back to where you’re going.’ Where’s the support?” he said. “There’s no support. And when there’s no support, there’s relapse.”
Sheriff Nick Cocchi says that done right, forced rehab works. If Massachusetts stops allowing correctional facilities to hold men civilly committed for drug and alcohol abuse, he says it will ‘devastate’ the state. Photograph: Josh Wood/The Guardian
He said the kind of abusive treatment outlined against Masac in the lawsuit brought by PLS doesn’t happen at his jail. He said that there need to be reforms to the section 35 process, but that his facility is “second to none” in the state.
Recently the gregarious sheriff brought the Guardian into the section 35 wing, walking in with a five-month-old bull mastiff puppy named Brooklyn.
“What’s up guys?” he beamed at the patients – or “clients” as they are referred to in the jail administration’s parlance. “I don’t want anyone to panic – this is not a drug sniffing dog!”
The wing appeared clean and orderly. The patients wore a uniform of brown pants and yellow or blue T-shirts with inspiring mottos like “recovery works” and “one day at a time” on them. They appeared friendly with the sheriff and the COs, stopping them to share their thoughts and concerns about their time on the unit.
Several patients eagerly lined up to speak to the Guardian about their experience at the jail, all saying positive things. Many were optimistic that being closer to home, having counseling about their discharge plan and having access to advice after they were out would mean it would be easier to stay off drugs or alcohol once released.
Some had spent time at Masac in Plymouth and said their current surroundings were much better.
Jim, the 29-year-old student who was sectioned after an overdose, said: “The COs don’t treat you like inmates, they treat you like a patient essentially.”
The wing has only been receiving section 35 patients since May, but Cocchi says he is confident that statistics will eventually show that his program has a higher success rate than any other treatment facilities.
“There’s also a group out there that says forced treatment doesn’t work – when you force someone to go into treatment, it doesn’t work,” he said. “That is absolutely false.”
If people trying to put an end to correctional facilities holding civilly committed men are successful, Cocchi says “they will devastate the commonwealth of Massachusetts, specifically western Massachusetts right now … And I will not lay down on that.”
‘Setting them up to die’
But opponents of jailing section 35 patients say that even if the abuses laid out against Masac are not present at a correctional facility, keeping civilly committed men there is wrong and dangerous.
“No matter how well run any prison might be, we’re saying that it’s a disease,” said Tenneriello, the PLS attorney. “Putting people in prison because they have a disease is fundamentally wrong”
Leo Beletsky, an associate professor of law and health sciences at Boston’s Northeastern University is an expert on the opioid epidemic and sits on the state’s section 35 commission.
He points to studies, like one by the Massachusetts department of public health, that show that persons recently released from incarceration are 120 times more likely to die of an opioid overdose than members of the general public.
“By putting people in correctional settings, we’re essentially setting them up to die,” he said.
Physician Sarah Wakeman, an addiction medicine specialist and medical director of the Substance Use Disorders Initiative at Boston’s Massachusetts general hospital, said those leaving forced rehab are at particular risk for overdosing given they did not want to be there in the first place and have lowered their tolerance.
To Wakeman, more focus needs to be placed on making sure that voluntary treatment for substance abuse is more readily accessible.
“The reality is that tough love is not a useful intervention to help a person suffering from addiction,” she said.
Beletsky said the section 35 system remains popular as it is much easier to access than voluntary treatment programs.
“Section 35 in many ways is the path of least resistance for getting into treatment,” he said. “It’s immediate, it’s free, it requires no navigation.”
It “illustrates how broken our systems of care are,” he said. “In many ways it’s easier to put somebody away than have them access normal healthcare.”
In 1917 the DOJ declared that opiate addiction was a CRIME and not a DISEASE and any prescriber treating/maintaining a opiate addiction would be jailed.
So it would appear that that declaration did not bear the weight of law.. or these people would have been jailed and charged with a CRIME.
This program seems to parallel what is – and has been done – with the Civil Asset Forfeiture Act where 85% of the people who have had their assets confiscated and no charges were ever filed and most people are lucky to get MAYBE half of the dollars confiscated and if other assets that were confiscated and liquidated (sold at auction) may get little or nothing of what the assets were actually worth.
There are several states that have involuntary mental health admission – in CALF it is referred to as a 5150 and in FL it is referred to as the Baker Act, but the involuntary mental hold is 72 hrs.
Generally “abstinence rehab” has a 5% success rate because pts who have been provided opiates for a long period of a couple of months and are cut off of their medication – of course – does into withdrawal because their prescriber did not properly wean the pt off their opiates and the fact that they are suffering withdrawal symptoms they are told that they are addicted., and when they are properly weaned off their opiates… they turn out that they were never actually “addicted”.
I find it interesting that ACLU sued the state over the same treatment for woman and the state loss and the state discontinued this treatment ONLY FOR WOMEN. What happened to EVERYONE IS EQUAL ? and is supposed to be treated equally ?
Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level. A small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches. The 50 mcg/h patches that were included in cartons labeled 12 mcg/h are individually labeled as 50 mcg/h. This transdermal system is manufactured by 3M Drug Delivery Systems, St. Paul, MN.
Application of a 50 mcg/h patch instead of a prescribed 12 mcg/h patch could result in serious, life threatening, or fatal respiratory depression. Groups at potential increased risk could include first time recipients of such patches, children, and the elderly. To date, Alvogen Inc. has not received any reports of adverse events related to this issue.
The product is indicated for the management of pain in opioid tolerant patients and is packaged in primary cartons of five individually wrapped and labeled pouches. The affected Fentanyl Transdermal System lots include:
Lot 180060 of Fentanyl Transdermal System, 12 mcg/h, expiration date 05/2020.
Lot 180073 of Fentanyl Transdermal System, 12 mcg/h, expiration date 06/2020.
The mislabeled product is packaged in a 12 mcg/h primary carton. These lots of Fentanyl Transdermal System were distributed Nationwide to the pharmacy level.
See images example for lot 180073.
Alvogen Inc. is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products. Pharmacies are requested not to dispense any product subject to this recall. Patients that have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement.
Questions regarding this recall should be directed to Alvogen Customer Complaints by calling 866-770-3024 or sending an e-mail to pharmacovigilance@alvogen.com from Monday to Friday from 9:00 am to 5:00 pm EST. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Federal prosecutors charged drug distributor Rochester Drug Cooperative and its former CEO with drug trafficking charges Tuesday — the first criminal charges for a pharmaceutical company and executives in the nation’s ongoing opioid crisis.
The charges signify a groundbreaking move by the government to try to combat the opioid epidemic, which kills 130 Americans every day, according to the Centers for Disease Control and Prevention. For the first time, a pharmaceutical company and white collar executives were charged like street dealers and traffickers.
“This prosecution is the first of its kind: executives of a pharmaceutical distributor and the distributor itself have been charged with drug trafficking, trafficking the same drugs that are fueling the opioid epidemic that is ravaging this country. Our Office will do everything in its power to combat this epidemic, from street-level dealers to the executives who illegally distribute drugs from their boardrooms,” U.S. Attorney Geoffrey S. Berman said in a statement.
The U.S. Attorney’s Office for the Southern District of New York charged Rochester Drug Cooperative (RDC), one of the country’s largest distributors of opioids, with “knowingly and intentionally” violating federal narcotics laws “by distributing dangerous, highly addictive opioids to pharmacy customers that it knew were being sold and used illicitly,” according to a press release.
RDC was also charged with failing to properly report thousands of suspicious orders of oxycodone, fentanyl and other controlled substances to the Drug Enforcement Agency (DEA), officials said.
The DEA has been investigating for years whether RDC failed to comply with pharmaceutical reporting laws. The company has previously paid to resolve claims it failed to properly report the theft of opioids.
According to court records, from 2012 through 2016, RDC filled more than 1.5 million orders for controlled substances from its pharmacy customers, but reported just four suspicious orders to the DEA. In reality, there were at least 2,000 suspicious orders in those four years, federal prosecutors said.
Despite being briefed by company employees, top executives allegedly ignored “red flags” like cash payments and customers traveling from out of state to buy opioids.
“Today’s charges should send shock waves throughout the pharmaceutical industry reminding them of their role as gatekeepers of prescription medication,” DEA Special Agent in Charge Ray Donovan said in a statement. “DEA investigates DEA Registrants who divert controlled pharmaceutical medication into the wrong hands for the wrong reason. This historic investigation unveiled a criminal element of denial in RDC’s compliance practices, and holds them accountable for their egregious non-compliance according to the law.”
In the opioid industry, RDC is a middleman that buys controlled substances from manufacturers and sells them to individual pharmacies. As one of the nation’s 10 largest drug distributors, it delivered to more than 1,300 pharmacies and took in over $1 billion in revenue during the relevant five-year period, officials said.
RDC agreed to a non-prosecution consent decree and agreed to pay a $20 million penalty. It will be monitored by the government for the next five years.
“We made mistakes,” Jeff Eller, a company spokesperson said in a statement. “RDC understands that these mistakes, directed by former management, have serious consequences.”
“One element of the opioid epidemic is a dramatic increase in the volume of prescriptions for opioids and all narcotics,” the RDC statement continued. “With that dramatic volume increase came an increase in our business, resulting in an increase in orders we should have identified as suspicious order, which we failed to report to DEA.”
The company’s former chief executive, Laurence Doud III, surrendered to federal agents and appeared in Manhattan federal court late Tuesday. He was handcuffed and wore a dark suit as he was led up the stairs of the courthouse by federal agents.
Doud, 75, of New Smyrna, Florida, was charged with one count of conspiracy to distribute controlled substances and one count of conspiracy to defraud the United States. He faces a minimum of 10 years, if convicted.
Separately, William Pietruszewski, 53, RDC’s former chief of compliance, pleaded guilty earlier this month to participating in a narcotics distribution conspiracy from January 2012 to March 2017. He also pleaded guilty to conspiracy to defraud the United States and one count of willfully failing to file suspicious order reports with the DEA.
He has agreed to cooperate with the investigation.
Prosecutors say RDC employees told Doud and Pietruszewski that some of the company’s customers were “very suspicious,” and went so far as to describe some pharmacy clients as a “DEA investigation in the making” or “like a stick of dynamite waiting for [the] DEA to light the fuse.”
But in the relevant five year period, RDC, under Doud’s leadership, increased its sales of oxycodone and fentanyl “exponentially,” prosecutors said.
“From 2012 to 2016, RDC’s sales of oxycodone tablets grew from 4.7 million to 42.2 million – an increase of approximately 800 percent – and during the same period RDC’s fentanyl sales grew from approximately 63,000 dosages in 2012 to over 1.3 million in 2016 – an increase of approximately 2,000 percent. During that same time period, Doud’s compensation increased by over 125 percent, growing to over $1.5 million in 2016,” the U.S. Attorney’s office said.
RDC was also among the drug distributors named last month in a civil lawsuit by the New York Attorney General’s office, which alleged fraud, willful misconduct and gross negligence.
Between 2010 and 2018, the company sold more than 143 million oxycodone pills to customers in New York alone, the state’s attorney general’s lawsuit said.
“At this time, it would not be appropriate to comment on ongoing litigation,” Eller told ABC News in a statement.
Opioid manufacturers are facing over 1,700 lawsuits over their role in the current crisis. Paul Hanly, co-lead counsel for the plaintiffs in the federal litigation, which he said includes 2,000 cases, welcomed the move by U.S. prosecutors.
“The charges make the civil case against RDC easier to try and provide a potential road map to evidence that may prove the civil claims against other distributors,” Hanly told ABC News on Tuesday.
lynnwebstermd.com When Will Forced Tapering of Opioids End? Lynn Webster, M.D. 6-8 minutes When Will Forced Tapering of Opioids End?
20th April, 2019
By Lynn Webster, M.D.
This article, in a slightly edited form, first appeared on Pain News Network on April 17, 2019.
“Larry” recently wrote to me asking for advice. He describes himself as “virtually crippled totally” after having his opioid medication cutback.
“I am being forced tapered and the PA I now have will not budge one inch on the weaning, as he calls it. I hate him. I have never had a more callous doctor in my life,” Larry wrote.
“What does one do in my situation? Blow my brains out? A[n] intentional overdose? I have two beautiful dogs that depend on me and a son who needs me. I have to stay here on planet Earth although I want out of here so bad I beg God to kill me every morning noon and night. It is my daily prayer.”
Unfortunately, Larry is only one of many patients who are struggling to be heard by their providers. Physicians are under government pressure to adhere to the CDC’s 2016 opioid prescribing guideline.
Although the CDC designed its guideline as voluntary, government agencies interpreted it as a mandate instead. The Drug Enforcement Administration has pursued doctors who prescribe a level of opioids that exceeds the guideline’s recommended daily limit of 90 MME (morphine milligram equivalent), even when no patients have been harmed.
According to Maia Szalavitz, writing for Tonic, Dr. Forest Tennant was one of the few physicians who still were willing to prescribe high-dose opioids for the sickest pain patients. The DEA raided his California office and home, allegedly because the agency had reason to believe some of his patients were selling their medication.
There simply was no evidence of that. But as a result of the raid, Dr. Tennant retired from clinical practice.
Szalavitz wrote that the raid “terrifies pain patients and their physicians, who fear that it could lead to de facto prohibition of opioid prescribing for chronic pain and even hamper end-of-life care.”
Dr. Mark Ibsen in Montana had his license suspended by the state medical board for allegedly overprescribing opioids. According to Dr. Ibsen, the DEA warned him “he was risking his livelihood and could end up in jail if he kept prescribing.” A judge later overturned the board’s decision.
As Dr. James Patrick Murphy, a Kentucky-based pain and addiction specialist, told the Courier-Journal, “many well-intended doctors are unfairly arrested ‘all the time’ in the hunt for those who recklessly contribute to patients’ addictions and fatal overdoses.”
As of this writing, The American University Law Journal plans to publish an alarming article by Michael Barnes, JD, about the raids on America’s top physicians.
Although few physicians are incarcerated for prescribing high dosages of opioids, many of them are threatened with losing their licenses to practice medicine. Doctors and pharmacists told a POLITICO survey that they felt enormous pressure to limit their prescriptions for painkillers. Their fear of the consequences of noncompliance with the CDC guideline exceeded their responsibility to treat patients with severe pain. Second Thoughts About CDC Guideline
On April 1, the attorneys general of 39 states and territories wrote a letter on behalf of the National Association of Attorneys General to Dr. Vanila Singh of the U.S. Department of Health and Human Services. The letter expressed concern with the draft report of the Pain Management Best Practices Inter-Agency Task Force, which recommends changes in the CDC guideline to end the forced tapering of patients.
The attorneys general said “it is incomprehensible that officials would consider moving away from key components of the CDC guideline.” Additionally, they expressed their hope that the report would be revised “to clearly state that there is no completely safe opioid dose.”
Yet on April 9, the Food and Drug Administration issued a medical alert warning doctors not to abruptly discontinue or rapidly taper patients on opioid medication, because it was causing “serious harm” to patients, including uncontrolled pain, psychological distress and suicides.
Now it seems the CDC may be moving in the same direction.
Dr. Daniel Alford, a Professor of Medicine at Boston University, wrote a letter to the CDC asking it to address the misapplication of its guideline with a “public clarification.” He was writing on behalf of Health Professionals for Patients in Pain, and 300 healthcare professionals signed his letter.
The CDC’s response, published on April 10, echoed the FDA’s statement. CDC Director Dr. Robert Redfield observed that the CDC guideline “offered no support for mandatory opioid dose reductions in patients with long-term pain.” He reinforced the fact that the guideline was voluntary and that doctors should use their knowledge of their patients to determine which dosages were appropriate for them.
Dr. Redfield wrote that “CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms.” And he agreed that “patients suffering from chronic pain deserve safe and effective pain management.”
STAT News points out that the overzealous enforcement of the CDC guideline was indeed causing patients harm. “Denying opioids to patients who have relied on them — sometimes for years — may cause some to turn to street drugs, thereby increasing their risk of overdose,” STAT warned.
According to The Washington Post, “Many patients have claimed that long-term use of the drugs is all that stands between them and unrelenting pain, and that they can take the medication without becoming dependent or addicted.”
The CDC and the FDA now admit the guideline has been misapplied and mainstream media outlets are beginning to pick up the story. The question is: Will the DEA stop pursuing doctors who treat pain patients with levels of opioids that exceed the guideline’s recommendations?
For Larry and other pain patients who have been forcibly tapered, the answer may be a matter of life and death.
“The guideline is intended to ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function.”
“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.”
“This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.”
The entire CDC guidelines are some 90 odd pages. What “key components” of the CDC guidelines are they focused on 90 MME ? – out of 90+ pages. I particularly like this quote from these 39 “medical experts” to clearly state that there is no completely safe opioid dose… there is no really “safe dose” of ANY MEDICATION… they are trying to force our body to do something that it naturally wants to do.
The CDC guidelines completely ignores the fact that we have a test .. CYP-450 opiate metabolism test – a simple cheek swab – that will determine if a pt is slow, normal, fast, ultra fast metabolizer and the pt’s dose may have to be increased and/or frequency of the dose increased and/or BOTH !
These same guidelines IGNORE that all of the opiate conversion programs have a footnote stating – the same or similar – that the results of using these conversion programs – ARE CRUDE ESTIMATES AT BEST and should not be used as black/white pt dosing .. only as a starting point.
Some of us believe that the CDC did not have the statutory authority to even generate and publish these guidelines. Maybe that is why the then head of the CDC Tom Frieden shortly after they were released made a public statement that these guidelines were just RECOMMENDATION and DID NOT HAVE THE AUTHORITY/WEIGHT OF LAW. Could that have been a “back door” admission that the CDC did not have the legal authority to publish these guidelines ? After all the CDC’s primary charge is dealing with contagious diseases.
But then when you assembly a committee to develop these guidelines that each has a personal interest in treating substance abusers, what would one expect but a final product that primarily deals with . It also seems suspicious that this committee met behind closed doors and the CDC tried to keep the committee members anonymous .
So in the end we have 39 state AG’s who wish to continue honoring “guidelines” as LAW that were created by a Fed agency that may not have had the statutory authority to generate them in the first place and they may well be unconstitutional.
Also it seems to be a quote from these AG’s “it is incomprehensible that officials would consider moving away from key components of the CDC guideline”.. so it would appear that these AG’s prefer to only chose a favorite sentence, paragraph or page out of the 90+ page document to be the “key components” that they wish to have adhered to.
It would not be the first time that a legislative body will have passed a bill that gets signed into law and remains on the books and is enforced until someone challenges the constitutionality of the law in the courts. In our legislative system, there is no process to validate the constitutionality of a bill before it gets signed into law.
U.S. agencies warn doctors not to abruptly cut off the medications for long-time users
Ever since U.S. health authorities began cracking down on opioid prescriptions about five years ago, one vulnerable group has suffered serious collateral damage: the approximately 18 million Americans who have been taking opioids to manage their chronic pain. Pain specialists report that desperate patients are showing up in their offices, after being told by their regular physician, pharmacy or insurer that they can no longer receive the drugs or must shift to lower doses, no matter how severe their condition.
Abrupt changes in dosage can destabilize patients who have relied for many years on opioids, and the consequences can be dire, says Stefan Kertesz, an expert on opioids and addiction at the University of Alabama at Birmingham School of Medicine. “I’ve seen deaths from suicide and medical deterioration after opioids are cut.”
Last week, after roughly three years of intensive lobbying and alarming reports from the chronic pain community, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) took separate actions to tell clinicians that it is dangerous to abruptly curtail opioids for patients who have taken them longterm for pain. The FDA did so by requiring changes to opioid labels specifically warning about the risks of sudden and involuntary dose tapering. The agency cited reports of “serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide” among patients who have been inappropriately cut off from the painkillers.
One day later, CDC director Robert Redfield issued a clarification of the center’s 2016 “Guideline for Prescribing Opioids for Chronic Pain,” which includes cautions about prescribing doses above specific thresholds. Redfield’s letter emphasized that these thresholds were not intended for patients already taking high doses for chronic pain but were meant to guide first-time opioid prescriptions. The letter follows another recent clarification sent by the CDC to oncology and hematology groups, emphasizing that cancer patients and sickle cell patients were largely exempt from the guideline.
Taken together, these actions represent a significant victory for the chronic pain community. “The combination of the FDA and CDC speaking out reconfigures the conversation going forward in a very, very helpful way,” says Kertesz, who was one of five doctors associated with the advocacy group Health Professionals for Patients in Pain (HP3) who received Redfield’s letter.
Tougher rules on opioid prescriptions from federal and state authorities, health insurance companies and pharmacies, were an understandable response to the nation’s “opioid crisis,” an epidemic of abuse and overdose that led to a 345 percent spike in U.S. deaths related to legal and illicit opioids between 2001 and 2016. Since 2016, most fatal overdoses have involved illegally produced fentanyl sold on the street, according to CDC data, but past research has shown that many victims got started with a prescription opioid such as oxycodone.
The CDC’s 2016 guideline was aimed at reining in irresponsible prescribing practices. (The agency’s own analysis showed that prescriptions for opioids had quadrupled between 1999 and 2010.) The guideline stressed that the first-line treatments for chronic pain are non-opioid medications and non-drug approaches such as physical therapy. When resorting to opioids, the guideline urged doctors to prescribe “the lowest effective dosage,” to carefully size up risks versus benefits when raising doses above 50 morphine milligram equivalents (MME) a day, and to “carefully justify a decision” to go to 90 MME or above.
That advice on dosage was widely misinterpreted as a hard limit for all patients. Kertesz has collected multiple examples of letters from pharmacies, medical practices and insurers that incorrectly cite the guideline as a reason to cut off long-term opioid patients.
Frank Gawin, a retired psychiatrist in Hawaii, is one of many chronic pain sufferers ensnared by that kind of mistake. For 20 years he took high-dose opioids (about 400 MME daily) to manage extreme pain from complications of Lyme Disease. Gawin, an expert on addiction himself, was well aware of the risks but notes that he stayed on the same dose throughout those 20 years. “It helped me profoundly and probably extended my career by 10 to 15 years,” he says. About five months ago, his doctor, a pain specialist he prefers not to name, informed Gawin and other patients that she would be tapering everyone below 80 MMEs because she was concerned about running afoul of medical authorities. Gawin has not yet reached that goal, but his symptoms have already returned with a vengeance. “As I am talking to you, I am in pain,” he said in a phone interview. “I’m having trouble concentrating. I’m depleted. I’m not myself.”
Last week’s federal actions could go a long way in informing physicians not to cut off patients like Gawin. Of particular value, say patient advocates and experts, is the emphasis on working together with patients on any plan to taper the drugs. “It’s finally about patient consent,” says Andrea Anderson, former executive director of the Alliance for the Treatment of Intractable Pain, an advocacy group. She notes that the FDA urged doctors to create an individualized plan for patients who do wish to taper and that the agency stated that “No standard opioid tapering schedule exists that is suitable for all patients.”
The CDC is relying on pain advocacy groups to get the word out about its clarification. Any formal update to the guideline will await the results of a systematic review of chronic pain research currently underway, said Debbie Dowell, chief medical officer of the CDC’s Injury Center, in an email; Dowell is the lead author of the 2016 guideline.
Gawin hopes the federal actions will persuade his doctor that forced tapering is wrong for him. “The only way I can see getting back to normal,” he says, “is to get back to the medication that worked for me.”
A Washington state lawmaker has provoked the ire of nursing professionals after saying that some nurses “play cards” for a “considerable” portion of their shifts.
State Sen. Maureen Walsh, R-Walla Walla, was debating a bill on Tuesday that would require uninterrupted meal and rest breaks for nurses and would also provide mandatory overtime protections for them.
Walsh pushed for an amendment that would exclude hospitals with fewer than 25 beds from the provision, arguing that such small facilities struggle to provide 24-hour care as it is.
“I would submit to you that those (small hospital) nurses probably do get breaks,” Walsh said, according to The Olympian. “They probably play cards for a considerable amount of the day.”
Walsh’s remarks were posted to a blog by the Washington State Nurses Association, receiving so many hits that the site crashed.
The ill-received comments also inspired plenty of social media mockery; the hashtags #maureenwalsh and #nursesplaycards went viral.
Walsh’s comments even drew backlash from comedian Kathy Griffin who said her mother worked in a hospital for decades.
The bill specifically requires that nurses and some other staff, such as surgical and diagnostic radiologic technologists, be given uninterrupted meal and rest periods, except when there is an unforeseeable circumstance.
If a rest break is interrupted before 10 complete minutes, an additional 10-minute break is required. The measure would also prohibit health care facilities from using what the nurses’ association considers a legal loophole to require overtime.
Ultimately the bill was passed with Walsh’s amendment. It previously passed the House without it but both bills will have to be reconciled before it can be signed into law.
I read this article recently about a veteran killing himself in a VA waiting room and it brought me back to a recent conversation that we’ve been having on the National Pain Report about suicide.
And so, I spent some looking at the comments sections on the stories and was struck—again—by the increasing feelings of hopelessness and isolation that are permeating many people who have chronic pain.
The system is failing them.
When I was talking with Terri Lewis, Ph.D. recently about the topic, she said something that has stuck with me.
“Every person has a plan for exiting the planet when they’ve had enough. Remarkably, communities and health systems don’t have a plan.”
Hard to argue.
Reader Dave Brooks wrote about the importance of loved ones.
“The thought (of taking his life) has crossed my mind more than once. I keep going knowing my children always tell me they love me when I have a chance to talk to them… Always!!!
Elizabeth R. spoke about the fear that many are feeling in a place where they shouldn’t be fearful—their doctors’ offices.
“If We patients tell our doctors the truth about our pain and how it really affects us despite our efforts to manage it, we will be punished.”
A reader named Lindsey is at her wit’s end.
I have my suicide plan and materials ready. It gives me peace of mind. I have cancer also and am six months overdue on my surgery. I have so much pain that I KNOW I would never survive recovery on 2 or 3 days off extra pain relief
David Hickle expressed the fear that the government not only hasn’t been listening, it won’t.
“Our government isn’t going to listen all they are doing is buying their time covering their ass until they betray the American citizens, I don’t trust anyone anymore in the USA or humanity because whatever anyone says is a load of crap.”
When you consider that 22 veterans—at least some of them with chronic pain– are taking their lives EACH DAY and that many people who have chronic pain are telling us they are considering suicide, it tells you—or at least tells me—that this health care system is failing people.
