Is CMS proposal violating their own anti discriminatory policies ?

Posted on March 30, 2018 by Pharmaciststeve

CMS proposes to force patients off effective opioid doses without their physician’s approval

Nondiscrimination

https://www.cms.gov/about-cms/agency-information/aboutwebsite/cmsnondiscriminationnotice.html

Nondiscrimination Notice

CMS doesn’t exclude, deny benefits to, or otherwise discriminate against any person on the basis of race, color, national origin, disability, sex, or age in admission to, participation in, or receipt of the services and benefits under any of its programs and activities, whether carried out by CMS directly or through a contractor or any other entity with which CMS arranges to carry out its programs and activities.

How to file a complaint:

If you believe you’ve been subjected to discrimination in a CMS program or activity, there are 3 ways to file a complaint with the U.S. Department of Health and Human Services, Office for Civil Rights:

Online
By phone: Call 1-800-368-1019. TTY users can call 1-800-537-7697.
In writing: Send information about your complaint to:

Office for Civil Rights
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 2020

This non-discrimination policy applies to both CMS/HHS and all the vendors/providers to  Medicare/Medicaid pts. The article in the above link suggest that CMS is going to “dump” these discriminatory policies on to the insurance companies, PBM, and pharmacies to implement and fulfill..

 

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The anticipation of unrelieved pain could induce patients to avoid needed surgical procedures

Posted on March 30, 2018 by Pharmaciststeve

New Attitudes Toward Pain Amid the Opioid Crisis

https://www.medscape.com/viewarticle/893926

Backpedaling on Opioid Use

To correct what they believe was an overly zealous approach to pain control that put patients at risk for opioid addiction, some physicians are now telling their patients to expect to have some pain. A recent article on Medscape explains that “Doctors at some of the largest US hospital chains admit they went overboard with opioids to make people as pain-free as possible, and now they shoulder part of the blame for the nation’s opioid crisis. In an effort to be part of the cure, they’ve begun to issue an uncomfortable warning to patients: You’re going to feel some pain.”

Nurses—and some physicians—have a wide range of views on the issue. Some believe that patients are being overmedicated, but others worry that we are taking a step backward and patients will suffer. In the discussion after the article Hospitals Hone New Message in Wake of Opioid Epidemic: Expect Pain, nurses described their own experiences with undertreated pain and their reluctance to undergo needed medical procedures out of fear that they will have uncontrolled pain.

The Fifth Vital Sign Initiative

“The fifth vital sign approach has backfired on us all,” wrote one reader, who was not alone in this assessment. Many readers suggested that the “pain as the fifth vital sign” initiative—introduced by the American Pain Society in 1996—is at least partly to blame for the current opioid crisis. This concept stresses that assessment of pain is as important as measurement of the standard four “vital signs,” and that clinicians must act when patients report pain.[2]

 

“I don’t remember many addiction problems until ‘pain as a fifth vital sign’ subtly implied that pain was an avoidable part of life, if only insensitive doctors would prescribe more drugs,” one reader commented. Another wrote:

Making pain a vital sign caused more harm than any benefit, unless of course someone is traversing toward end-of-life or symptom-based palliative care, either owing to a terminal illness or severe physical disability. More objective pain assessments should be utilized in the acute care setting as opposed to a subjective Likert scale (ie, numerical pain scale based on 1-10).

“The Joint Commission should share some of the responsibility for the opioid epidemic. For a long time, citations were imposed on facilities for not doing enough to manage patients’ pain. As a matter of fact, they came up with the slogan that pain should be the fifth vital sign,” another commented, erroneously.

The Joint Commission addressed these misconceptions in an April 18, 2016, statement on pain management, clarifying their position:

The only time that The Joint Commission standards referenced the fifth vital sign was when they provided examples of what some organizations were doing to assess patient pain. In 2002, The Joint Commission addressed the problems in the use of the fifth vital sign concept by describing the unintended consequences of this approach to pain management and how organizations had subsequently modified their processes.

Their current standard: “The hospital assesses and manages the patient’s pain,” allowing organizations to develop and implement their own policies.

The Joint Commission does not require pain to be treated until the pain score declines to zero. Instead, they require individualized care that is tailored to specific patient needs. Furthermore, these pain treatment strategies “may include pharmacologic and nonpharmacologic approaches.”

Data from the National Institute on Drug Abuse disproves the belief that the Joint Commission’s pain standards caused a steep rise in opioid prescriptions. The number of opioid prescriptions actually increased steadily during the 10 years before the release of the standards in 2001, when insufficient pain management began to be recognized as a widespread problem. The Joint Commission writes:

It is likely that the increase in opioid prescriptions began in response to the growing concerns in the United States about undertreatment of pain and efforts by pain management experts to allay physicians’ concerns about using opioids for nonmalignant pain. If there was an uptick in the rate of opioid use, it appears to have occurred around 1997-1998, two years prior to release of the standards.

 

The Downside of Unrelieved Pain

Many nurses remember a time when patients’ pain was inadequately treated, driving some patients with chronic pain to suicide, and they fear we might return to those days. One of these older nurses summarized this view: “We had to fight for good pain control in the 1970s to keep patients moving after surgery, thereby avoiding complications. We seem to be going back in time rather than taking appropriate steps to address the real issues at play here.”

 

Another reader said, “This opioid epidemic cannot be solved by going back to the previous paradigm. It is a multifaceted problem.”

 

Pain makes it harder for postoperative patients to get up and move around, take deep breaths, and cough—all necessary for their recovery. One nurse noted, “You heal better when your muscles aren’t tense because of pain. That doesn’t mean you need to send a patient home with a script for Percocet with several refills.”

 

Several readers commented on the risks for kidney and liver damage and gastrointestinal bleeding associated with excessive acetaminophen or nonsteroidal anti-inflammatory (NSAID) use.

 

A physician said, “Centers for Disease Control and Prevention statistics show that there were 20,000 overdose deaths in 2010, and over 30,000 in 2016. At the same time the number and dosage of narcotic prescriptions were decreasing. It is wrong to indict my postop patients for the problem.”

 

Many nurses related their own experiences with pain that wasn’t properly addressed. One said she was given no pain medication when she broke her elbow, and another said she had been “in terrible agony” in an emergency department with a kidney stone and was given only a muscle relaxer. “It did nothing, and it made me think they thought I was drug-seeking,” she wrote.

 

Another nurse said that when she went to the emergency department with “crushing pain” from a herniated disc, she was sent home with naproxen. “The pendulum has swung, but too far,” she continued.

 

After gastrointestinal surgery, one nurse said, “I cried until I was finally given narcotic pain medicine a few hours postoperatively. I was all for the new initiative to use a nerve block, gabapentin, intravenous acetaminophen, and Toradol (ketorolac). But it wasn’t enough. I even had to beg for pain meds upon discharge.”

 

Readers expressed concern that the anticipation of unrelieved pain could induce patients to avoid needed surgical procedures. On nurse whose pain was not adequately managed after knee replacement surgery explained, “The thought of pain relief being unavailable to me because somebody else might be addiction-prone makes me cringe. If I have to experience that degree of pain, I will never work up the courage to have the other knee replaced.”

 

Another reader who anticipates surgery in the near future commented, “I am terrified that the hospital will decide that a couple of acetaminophen tablets will suffice.”

 

Achieving a Balance

Some nurses who think that opioids are overused talked about refusing opioids for pain relief and how they had successfully used other methods to manage pain, including massage, chiropractic care, meditation and visualization, Epsom salt baths, and distraction. And several readers suggested cannabidiol oil or marijuana as alternatives to opioid medications.

 

Readers said that patients need to have realistic expectations about pain, and not to expect no pain. An emergency department nurse wrote, “I have learned to tell the patient asking for pain meds that ‘the ability to feel pain means you are alive.’ Not feeling anything at all seems abnormal.”

 

One nurse said that she “was taught that pain meds were to take the edge off the pain, not to make the patient pain-free. If a patient is pain-free and something is wrong, no one would know.”

 

“Patients think they have the right to feel no pain; it’s very unrealistic. We need to have a balance,” another commented.

 

Nurses on both sides of the issue said that steps to improve the quality of pain management must include patient education about realistic expectations; alternative treatments; and effective use of nonopioid medications, such as acetaminophen and NSAIDs. Good observation skills and interviewing techniques are also important, others pointed out.

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Palliative care is a right of all people in pain

Posted on March 30, 2018 by Pharmaciststeve

Palliative care is a right of all people in pain

www.kevinmd.com/blog/2018/03/palliative-care-right-people-pain.html

In 2017, The Lancet published a report on the international lack of palliative care. It is a tale of woe documenting the sorry state of unrelieved global suffering. Everywhere “people live and die with little or no palliative care or pain relief.” It describes the “access abyss” in which the poor live and die in extreme suffering without receiving pain-relieving medications. They describe the world in which most of humanity lives in as a world of hurt.

The report cites poor public health planning and poor physician understanding of pain relief as the major causes the multinational shortfall of palliative care:

1. International health policy investments have focused on infectious diseases. The lack of pain relief at the end of life is due to the neglect of non-communicable diseases where the need for palliative care is highest.

2. Opiophobia is the “prejudice and misinformation about the appropriate medical use of opioids.” Opiophobia worries more about the addiction of the living than the palliation of the dying.

There is an astounding maldistribution of pain relievers expressed as morphine equivalent opioids (MEOs). Of the 68,000 pounds of MEOs distributed worldwide, only 225 pounds is dispensed in low-income countries. In Haiti, only 5mg of MEOs per patient are available, leaving 99 percent of the palliative care needs unmet. In America, MEOs are a staggering 55,000 mg/patient! This meets >3000% of USA needs vs. <6% of MAO needs in Haiti which leaves almost everyone there suffering from serious health-related suffering (SHS) in pain. SHS is suffering that “cannot be relieved without medical intervention that compromises physical, social, or emotional functioning.”

It is not only the poor countries’ poor who needlessly experience SHS but also the rich countries’ poor and, frequently, the rich countries’ rich. In poorer nations, poor access to “inexpensive, essential and effective intervention” to relieve their physical torment. In America, there are frequent reports that despite the 55,000 mg/patient of MEOs many live with unrelieved SHS. For the authors, this is “a medical, public health, and moral failing.” America’s patients enduring unpalliated SHS are also in this world of hurt.

Relief of unnecessary physical pain is a right of all patients in all places. It is not a lack of drugs but a lack of appreciation that pain is an agony for the sick and their loved ones, that pain destroys the person as well as the body, and that mitigating unnecessary suffering is an ethical obligation. The global lack of pain relief is a hurtful healthcare failing on a distressingly worldwide scale.

At the center of this hurting world is the painfully skewed maldistribution of pain-relieving medications. The WHO has estimated that 80 percent of the world’s population has no meaningful access to MEOs. The International Narcotics Control Board reported that in 2014 a mere 17 percent of the world’s population consumed 92 percent of all MEOs. This disparate distribution of opioids is grimly illustrated by the fact that while over 12 million people died in pain for lack of opioids between 2016 and 2017, over 64,000 Americans died from an excess of them. In a poignant counterpoint to The Lancet report, just seven days after it was published, the U.S. declared the “opioid crisis in the USA to be a public health emergency.”

This globalization of pain is old news. In 2012, the New England Journal of Medicine published an editorial entitled “Painful Inequities – Palliative Care in Developing Countries” detailed the global burden of pain and the global initiatives to relieve. Back then, 150 countries were identified where “morphine is simply not available.” The conclusion about this human catastrophe was, “People dying in pain are generally invisible.”

The Global Access to Pain Relief (GAPRI). GAPRI has estimated that as many as 5 billion people live with “little or no access to pain medications.” This included >5 million terminal cancer patients. Their website is harrowing to peruse.

The American Cancer Association’s Treat the Pain Program has the ambitious goal “to make effective pain medicines universally available by 2020.” The ACA works with governments and international health partners to raise international awareness that the poor feel the same pain as the wealthy. Pain is everywhere on our planet, but pain medications are not.

Unrelieved global pain is not only a “medical, public health, and moral failing,” it is more disgracefully an economic failure. The cost of meeting the global need for pain-relieving opiates is approximately $145 million which is “equivalent to a very small fraction (0.002 percent) of total public health expenditure.” The money is not spent because the problem is not seen. The world-wide unrelieved suffering is appallingly invisible. The farther the problem is from our homes, the farther it is from our consciousness and consciences.

This is not merely an income or geographic problem. Many in the wealthy nations despite being awash in opiates suffer just like those in poorer countries, but the poor of the world suffer more intensely, much longer and in much greater despair. The poor often have no physicians to champion their plight. They are often so ill, in so much pain and so politically disenfranchised that they are powerless to advocate for themselves.

If we are to preserve the dignity of the dying of our world, we must palliate their suffering. Palliative care is a right of all people in pain at home and abroad. The unrelieved pain locally and globally is unfathomable to contemplate and unspeakable to endure. This problem is “generally invisible” only because we choose not to see what The Lancet has revealed. We need to examine their revelations with our eyes wide-opened and see that many people who share our planet live in a world of hurt. Those living in this world of hurt need better pain relief. Attempting to meet these needs will not only preserve the dignity of the dying but our dignity as their fellow human beings as well.

Michael A. Salvatore is a palliative care physician.

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As a physician, I urge caution as we cut back opioids

Posted on March 29, 2018 by Pharmaciststeve

http://thehill.com/blogs/pundits-blog/healthcare/326095-as-a-physician-i-urge-other-doctors-to-cut-back-on-prescribing

Recently I met with a woman, a casualty of our nation’s clumsy efforts to curb its opioid crisis. Her story shows how a myopic fascination with numeric targets, which caused so much harm as our prescribing went up, is likely to cause just as much harm as it comes back down.

A 60 year-old kidney transplant recipient, she required a slew of medications to protect her transplanted kidney. She also took over 100 milligrams daily of an opioid for painful arthritis. Amid national calls to reduce opioid prescriptions, one doctor after another lowered her doses in simple 50 percent steps.

None of them documented any problem caused by her pain pills. None sought her consent. Predictably, she fell apart, as did her adherence to other medications, including ones to protect her kidney. Life spiraled out of control. Ultimately, the threat of losing her kidney compounded the uncontrolled pain of her arthritis. Whether she will keep her costly transplant, or go back on dialysis, is not yet known.

Clumsy new opioid policies are practically designed to ensure her story is not unique. The pressure on physicians is already intense. It comes from legislators, law enforcement, insurers, and leaders who equate prescribed opioids with illicit heroin.

Accordingly, doctors cut doses unilaterally and shun pain patients. Last month, two national agencies entered the fray, with the National Committee for Quality Assurance and the Centers for Medicare and Medicaid Services proposing escalate the pressure. One (CMS), will restrict insurance coverage based on dose. The other (NCQA), proposed a quality measure to flag physicians as engaged in bad practice if they let doses remain high, regardless of how well or poorly the patient is doing.

It will surprise many to learn that such plans were not endorsed by the Centers for Disease Control and Prevention (CDC) in 2016, whose review found no data to support the unilateral dose reductions that CMS and NCQA will incentivize.

In its 7th recommendation, the CDC urged that care of patients already receiving opioids be based not on the number of milligrams, but on the balance of risks and benefits for that patient. That two major agencies have chosen to defy the CDC ignores lessons we should have learned from prior episodes in American medicine, where the appeal of management by easy numbers overwhelmed patient-centered considerations.

In years past, we erred when observational data led agencies such as NCQA to demand strict control of blood sugar in all diabetes patients. Subsequent trials showed that harmed many patients, and helped only some. Similarly, millions of postmenopausal women were thrown onto estrogen because observational data suggested it prevented heart attacks. Later trials showed we were causing heart attacks, not preventing them.

Even the run-up in opioid prescribing emerged from an unhealthy enchantment with a single number, the pain score, at the expense of common sense. The cardinal lesson is this: prior to imposing simple numeric targets on all patients, we should require prospective trials showing benefit. That’s what we lack for unilateral opioid dose reductions.

As physicians today execute a hard shift on opioids, I plead for caution. Patients with chronic pain report enormous suffering, some committing suicide as they see their lives turned upside down by doctors pressured to reduce.

A rising tide of concern has emerged among academic physicians who have dedicated their work to fighting addiction, including some who worked on the CDC Guideline itself. They see that clinical practice has sprung ahead of data, that it has begun to look like someone has shouted fire in a crowded theater, creating a social stampede.  This does not reflect the cautious, patient-centered care urged by the CDC.

To be sure, unrestrained opioid prescriptions are dangerous. A run-up in prescribing from 2000 through 2011 fueled a spread of addiction and overdose, sometimes to pills we prescribed, and often to opioids illicitly distributed. In 2015, 33,091 Americans died from overdose. The percentage of patients prescribed an opioid who develop addiction is hard to pin down, but the CDC estimates 0.7 percent (at lower doses) to 6.1 percent (at higher doses).

Without oversight and guidelines urging caution, more will be harmed. However, this prudent check on uncontrolled prescriptions need not create a whole new population of chronic pain patients who suffer from overly-prescriptive and oversimplified recommendations that force all prescriptions below a uniform milligram limit.

Eighty professionals, including four who worked on the CDC Guideline, signed a public letter to NCQA, raising the alarm about this entirely predictable downside of new dose-curtailing policies, as did 83 who signed a letter to CMS a few weeks ago.

Among them were leading scholars in addiction medicine, pain and health care quality improvement. We can listen to these experts, or we can let more patients suffer. Now is a good time to remember how easy numbers sometimes make for bad care.

Stefan G Kertesz, MD, is a physician in internal medicine and addiction medicine on faculty at the University of Alabama at Birmingham School of Medicine. Views expressed are his own and do not represent formal positions held by any of his employers. Follow @StefanKertesz.

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The Opioid Epidemic in 6 Charts Designed To Deceive You

Posted on March 29, 2018 by Pharmaciststeve

https://www.acsh.org/news/2017/10/12/opioid-epidemic-6-charts-designed-deceive-you-11935

I do not know Dr. Andrew Kolodny,  personally, and, aside from one brief phone call last year, I have had no contact with him. Therefore I cannot know his motivation for becoming a driving force behind “opioid reform”— a concept which would border on hysterically funny if not for the tragedy that it is causing in this country. 

Dr. Kolodny, a psychiatrist, is the executive director of Physicians for Responsible Opioid Prescribing (PROP)—a group that played a significant role in creating the disastrous CDC Guideline for Prescribing Opioids for Chronic Pain (2016). The CDC ended up incorporating much of PROP’s recommendations, which were supposedly designed to help the US mitigate the damage done by opioid (1) drugs, despite the fact that the “evidence” contained in the recommendations had been carefully scrutinized and found unsupportable by FDA scientists. 

Since I cannot read his mind, I have no way of knowing whether Kolodny’s efforts are an honest, but misguided, attempt to help, or something else.

But I can read his writings, and based on “The opioid epidemic in 6 charts,” recently published in The Conversation, honesty is not the word that first pops into my mind. Yes, Dr. Kolodny does present 6 charts to explain his version of what I will now call “The Fentanyl Crisis,” (2) but even a quick read of his editorial reveals that it appears to be designed to confuse rather than clarify matters. Let’s take a look. 

Trick #1: Manipulative and misleading statistics.

“Drug overdose deaths, once rare, are now the leading cause of accidental death in the U.S., surpassing peak annual deaths caused by motor vehicle accidents, guns and HIV infection.”

This sentence, the very first of the editorial, doesn’t pass the sniff test. Why?

  • The term “drug overdose deaths” (there are about 60,000 annually) is now standard jargon used to characterize fatalities from all drugs of all sorts, anticoagulants, antidepressants, aspirin, cocaine, etc. But most people will read what Kolodny wrote and arrive at the conclusion that 60,000 people were killed by prescription pain medications. They were not. All opioids together (including heroin) killed 30,000 people. The number of deaths from prescription opioids—the target of the current crusade— was about 17,000— half the number killed by accidental falls.  Are we having an “accidental fall epidemic?” Why not? Accidental falls are killing twice as many people as prescription pain medicines. 
  • The figure 60,000 is, of course, inaccurate, but so is 17,000. This is because opioid overdose deaths are frequently the result of combination with other drugs, especially benzodiazepines, which potentiate the effect of the opioid action. In 2015 almost half (7,500) of the overdose deaths from opioids also involved benzodiazepines (Figure 2). When you include other drugs that are taken with opioids, especially alcohol and cocaine, It can reasonably be assumed that the number of deaths from opioid pills alone will be much lower, perhaps in the neighborhood of 5,000—ten-times lower the 60,000 that Kolodny implies, and roughly the same as bicycle and bicycle-related deaths. This is what the hysteria is about? 

Figure 2. Opioid involvement in benzodiazepine death, And also benzodiazepine involvement in opioid deaths.

 

  • Comparing the number of drug overdose and motor vehicle deaths is pointless, arbitrary and manipulative. What’s more, these unrelated numbers can be interpreted in either of two ways. Annual deaths from auto accidents peaked in 1972—before seatbelt laws were in effect—and decreased by 41% as of 2011. What was responsible for the switch? Was it rising drug ODs? Decreasing auto accidents? Both? Does it matter? No, it doesn’t. It’s a stupid comparison.
  • A comparison to deaths from HIV is similarly meaningless. HIV deaths have declined because of antiretroviral drugs. 

This same sentence could be rewritten to be just as accurate, but send an entirely different, albeit, still pointless message:

“Life in the US  is now significantly safer. The number of annual deaths from automobile accidents, AIDS, and guns is now lower than that from drug overdoses, even when illegal street drugs, such as heroin, are included.”

Trick #2: Telling a half-truth.

“The effects of hydrocodone and oxycodone on the brain are indistinguishable from the effects produced by heroin. “

Yes, they are. But Kolodny omits a vital bit of information — potency. While the physiological effect of hydrocodone on the brain may be the same as heroin (the two drugs hit the same receptors), the functional difference between the two drugs is night and day. The magnitude of the effect is conveniently omitted from this “equation.” Heroin packs a much more powerful punch than hydrocodone, especially at doses that are used by addicts. People can become addicted to heroin (or even die) from a single injection. It is virtually impossible for one hydrocodone pill to kill or addict anyone. The two drugs don’t even belong in the same sentence, even though they happen to belong to the same class of drugs. 

Trick #3: The absence of evidence is not the evidence of absence.

“In cases [of long-term use], opioids are more likely to harm patients than help them because the risks of long-term use, such as addiction, outweigh potential benefit. Opioids have not been proven effective for daily, long-term use.”

  • Trick #3 actually consists of a trick and maybe even a lie. Opioids may not have been proven to be effective for long-term use, but this is because such studies have not been done. This does not mean that opioids have been proven ineffective, even though the wording of this sentence implies this.
  • The “lie” about addiction potential of opiates is perfectly obvious to anyone who has read the literature on addiction. The risk of addiction is very low for pain patients (less than 1%) who take pain medicine to control their pain. Overwhelmingly, addiction arises from recreational, not therapeutic use of these drugs. 

Trick #4: Blame the drug companies.

“The increase in opioid prescription was fueled by a multifaceted campaign underwritten by pharmaceutical companies. Doctors heard from their professional societies, their hospitals and even from state medical boards that patients were suffering needlessly because of an overblown fear of addiction.”

  • This tactic is appallingly unoriginal. There is no better way to shore up a weak argument than to introduce an “enemy.” And if there is one failsafe enemy, it is the pharmaceutical industry. There is little doubt that there was malfeasance taking place, especially involving companies that were pushing the idea that certain drugs were safer than they really were. Purdue, the makers of OxyContin was fined $653 million for its former actions. Other companies are now being investigated. But this is now irrelevant. Assigning blame may score some points with the readers, and provide fodder for trial attorneys, but does absolutely nothing to keep a single OD victim alive. Whatever certain companies did two decades ago is partly responsible for starting today’s fentanyl OD epidemic, but it has nothing whatsoever to do with keeping it going.

Trick #5: Twist the truth

“Why did this happen? A common misconception is that so-called “drug abusers” suddenly switched from prescription opioids to heroin due to a federal government “crackdown” on painkillers. There is a kernel of truth in this narrative.”

Yes, there is, barely. But it is only a small part of the story. What Kolodny cites as a common misconception is probably a result of his twisting what I have written in previous articles (See: No, Vicodin Is Not The Real Killer In The Opioid Crisis and Heads In The Sand — The Real Cause Of Today’s Opioid Deaths). Except I never said this. The reasons for opioid abuse are multifactorial, but there is no question that epidemic began to escalate in 2010, not from any crackdown, but from an improvement in the formulation of abuse-resistant OxyContin and the unintended consequences that followed. This is indisputable:

From this point on, there was a “shortage” of pills, both because of market forces and government intervention. The difficulty in getting pills was clearly responsible for some/most of the switch to heroin. Koldony’s statement itself was a “kernel of truth.” And a rather small kernel at that.

Now let’s look at what is really going on. Figure 3 makes this crystal clear. Despite seven years of increasing “vigilance,” the number of deaths caused by prescription pain medications remains unchanged, yet total opioid overdose deaths have increased dramatically. The reason is obvious. Virtually all of the additional overdose deaths since can be accounted for by increased use of heroin/fentanyl. Prescription pain medicines are much more difficult to get than 7 years ago, and the only result has been suffering by pain patients and no benefit. It could be no other way. Pills are not the primary driver of overdose deaths. They never were. 

Figure 3. The futility of limiting prescription pain medication. The result was more deaths from heroin/fentanyl and nothing else.

Trick #6: Ignore what doctors are saying.

“Here’s another reason not to believe the narrative about a “crackdown” on painkillers leading to a sudden shift to heroin: There hasn’t been a crackdown on prescription opioids.”

To say that there hasn’t been a crackdown on opioid prescriptions is to ignore reality.  Pharmacy chains are imposing bureaucratic barriers on filling prescriptions and denying prescription refills. The US Association of Attorney’s General is lobbying US Insurance providers to revise their formularies to emphasize non-opioid medications in preference to opioids. The Veterans Administration has been directed by Congress to make the CDC prescription guidelines mandatory rather than voluntary.  Hospitals and pain management practices all across America are discharging patients and forcibly tapering down the dose levels of those they retain.

And Kolodny’s statement also contradicts what every single physician I have spoken with has said. (See: Pain In The Time Of Opioid Denial: An Interview With Aric Hausknecht, M.D.). I’m not sure what Kolodny means by “crackdown,” but when doctors are receiving “friendly” warning letters from departments of health and law enforcement agencies, that’s not merely a crackdown. It’s Kristallnacht. 

In closing, although I have questioned whether the intentions of Kolodny and his acolytes are well-meaning or not, it really doesn’t matter to the six million people who are cut off from pain treatment in this country. The resulting “opioid pain refugee crisis” is a national disgrace. As is the undue influence granted to a handful of ideologues, well intended or not. As public policy goes, this may be as cruel as it gets. 

Notes:

(1) The term “opioids” is scientifically meaningless. Technically, “opioid” means a drug that interacts with the same receptors as morphine, etc., regardless of whether the drug is derived from a natural source, for example, poppy. Opiates are a subset of opioids; they are drugs that are found in plants (e.g., codeine) or semi-synthetic derivatives of them. Heroin, which does not occur naturally, is considered to be an opiate because it is made from morphine, which does. Fentanyl considered to be an “opioid” because it is not an opium derivative. These classifications are a distinction without a difference. The term “opiates” is more than sufficient to describe drugs with morphine-like properties. The word “opioid” should be dropped from the English language. 

(2) There is no such thing as an opioid crisis. It is a fabricated term. People who are now dying from overdoses are now (most of the time) dying from fentanyl and its chemical cousins. A far better and more accurate term is “the fentanyl crisis.” 

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The Myth of an Opioid Prescription Crisis

Posted on March 29, 2018 by Pharmaciststeve

https://www.cato.org/policy-report/septemberoctober-2017/myth-opioid-prescription-crisis

According to the New York Times, drug overdoses are now the leading cause of death for Americans under age 50. Opioid overdoses, in particular, have been on the rise in recent years, killing over 30,000 people in 2015. In response, many have called for stricter regulations on prescription opioids. But are doctor-prescribed drugs truly the cause of the increase in overdoses? At a Capitol Hill Briefing in June, Arizona surgeon and Cato senior fellow Jeffrey A. Singer argued that regulators, in their rush to interfere in the patient-doctor relationship, are actually causing more problems than they’re solving.

THE SCIENCE OF OPIOIDS
Many people in the policy world really don’t understand the science of opioids, so let’s begin by clearing up a few myths. First, it’s important to understand that the long-term use of opioids, unlike alcohol, really doesn’t have deleterious effects on the body. That’s why we place people on methadone maintenance, for example, sometimes for their whole lives. And so far there’s no conclusive evidence that long-term use of opioids has any effect on cognitive faculties or on the brain itself.

Second, I want to clear up misconceptions about heroin. Heroin is a brand name. The chemical name is diacetylmorphine. Its generic name is diamorphine. It was invented by Bayer in the late 1800s and given the brand name of heroin, which is a derivation of a German word that has to do with “strength.” It’s still on the formulary and used by doctors and pain patients in a lot of developed nations, including the United Kingdom, Canada, and others. It was banned in this country in 1924 because the head of the Narcotics Bureau at the time was convinced that it corrupted moral character. And despite appeals by the physicians at the time to leave it legal because there weren’t that many pain medications available, it was banned. So of course, as any economist will tell you, within a very short period of time heroin became the number one substance for opioid addicts — because what would you rather sell on the black market: something that’s totally banned, or something there are other ways to get?

Heroin is about three times more potent than morphine; and methadone, which we give people on methadone maintenance — we’ll get more into that later — is also two and a half to three times more potent than morphine. Dilaudid, which is legal and which we give to patients for whom morphine is not working, is three to four times more potent than heroin. And fentanyl, also legal, is 50 times more potent than morphine.

Another commonly held misconception is that if you take one hit of heroin, you’re hooked. That’s absolutely not true. If it is, then why isn’t that the case with morphine or Dilaudid or any other legal opioids we give people? In fact, as early as the 1960s, studies done in the New England Journal of Medicine and International Journal of Group Psychotherapy identified heroin users who were true recreational users. They used it on occasion, on weekends. They had productive lives and were not addicted, just occasional users.

And although we often hear the words “addiction” and “physical dependence” used interchangeably, there is a difference. A recent article in the New England Journal of Medicine by Nora D. Volkow points out that, on the molecular level, physical dependence is when you actually develop withdrawal symptoms when the drug is taken away, so you need to be tapered off — as opposed to addiction, which is a behavioral disorder, in which you actually seek the drug. You will make major sacrifices in your lifestyle that have negative consequences for you because it’s so important to you to take the drug.

That’s a lot different from physical dependence. I’m a surgeon, and most of our patients who come to the office dependent on opioids want to be off them, so we help them slowly taper off. An addict, on the other hand, doesn’t want to be off them, which is why you have a high recidivism rate when you’re treating drug addicts.

ARE OVERDOSES A PRESCRIPTION PROBLEM?
The National Survey on Drug Use in Health has found that the nonmedical use of prescription opioids such as oxycodone and hydrocodone actually peaked in 2012. Total opioid use was actually lower in 2014 than in 2012. Despite that, opioid overdose deaths have increased. There were 33,000 deaths in 2015.

An overwhelming majority of those deaths, however, are people who used mixtures of drugs. In 2013, New York City found that 94 percent of the people who died from heroin or other opioids had mixed drugs in their system. These were not necessarily chronic pain patients. And also, for the first time, this year more people died from heroin overdoses than from prescription opioid overdoses.

According to Chinazo Cunningham at Albert Einstein College of Medicine, who helped develop the 2016 Centers for Disease Control and Prevention (CDC) guidelines, the number of prescription opioid overdoses is actually stabilizing, but opioid overdose rates have not plateaued because heroin use is dramatically increasing. So that’s important to understand — that the big cause of overdose problems now is heroin. We’re also seeing heroin use become much more prevalent in people in upper socioeconomic groups, and among suburban and rural white individuals.

According to the National Survey on Drug Use and Health, only one-quarter of people who take opioids for nonmedical reasons get them by obtaining a prescription. So the sequence that everybody thinks exists, in which a patient gets narcotics for pain, gets hooked, and then eventually dies from an overdose, is not your typical story. In fact, a 2014 JAMA (Journal of the American Medical Association) study of 136,000 patients treated for opioid overdoses in emergency rooms found that just 13 percent of them were chronic pain patients. And the CDC cites a study showing that the opioid-related overdose rate for people who are on chronic pain medicine under the guidance of a doctor is 0.2 percent.

New addictions in people who take opioids for pain, in general, are uncommon. The most rigorous comprehensive review, from the Cochrane Library, found that the addiction rate of people put on prescription opioids was about 1 percent. It’s very rare that a doctor prescribes a painkiller for a patient in pain who then gets hooked and becomes a heroin addict.

THE TRUE CAUSE OF THE PROBLEM
Both the CDC and the Texas A&M College of Pharmacy report that what they are seeing, however, is that as pain patients who are physically dependent and are in pain are gradually cut off pain medicine by their doctors, who are getting pressured to stop prescribing, a lot of them go on to seek pain medicine through the illicit drug market. And of course when they go to the illicit drug market, they often buy counterfeit opioids, and they don’t know what they’re laced with. Oftentimes they’re laced with fentanyl. And many of them are buying heroin, because heroin is, according to the CDC, about one-fifth the price of street obtainable prescription opioids.

Also driving the opioid problem is the promotion of tamper-resistant opioids. The Food and Drug Administration (FDA) is encouraging pharmaceutical companies to develop drugs that are tamper-resistant — in other words, you can’t use them for anything other than the medicinal use for which they were prescribed.

Mark Twain has been quoted as saying that history may not repeat itself, but it rhymes. Many people may be aware that back during the days of alcohol prohibition, ethanol was still allowed to be produced for industrial use. But the government required that the manufacturers put in what was called denatured alcohol — they put ingredients in it to make it unpalatable, so that bootleggers couldn’t steal vats of ethanol and sell it on the black market. But bootleggers are pretty resourceful people, and they soon found out how to distill those impurities out and still sell it. So in 1926, the government required industrial ethanol manufacturers to add methyl alcohol, or methanol, also called wood alcohol, which can make you blind when you drink it. (That’s where the expression “drinking himself blind” comes from.)

So they put methyl alcohol and benzene in the ethanol, and that, despite attempts, could not be distilled out. At least 10,000 deaths are documented since 1926 from people who were drinking bootlegged alcohol that contained methanol and benzene.

That was the alcohol prohibition years’ version of tamper-resistant alcohol, and it resulted in unintended consequences. I’m sure nobody wanted to see people die. But the same thing is happening today with tamperresistant drugs.

For example — in 2010, OxyContin was converted to a tamper-resistant package. And when people couldn’t crush it any more to snort it, they figured out how to boil it, turn it into an injectable form, and then inject it. A study published in the Canadian Medical Journal in 2015 found that “In Ontario and the US, overall rates of opioid-related deaths have continued to rise since the long-acting formulation of oxycodone (OxyContin) was replaced with a tamper-resistant formulation… Rather, there is increasing evidence that individuals shift to other opioids, including uncontrolled formulations such as heroin.” In JAMA Psychiatry in 2015, Cicero and Ellis found that nonmedical users of OxyContin switched to other opioids, or to heroin, after the tamper resistant reformulation of OxyContin replaced regular OxyContin in 2010.
 

In June, the FDA asked the manufacturer of Opana ER to pull it off the market. Opana is the brand name for oxymorphone, stronger than oxycodone. It used to be very popular, when it was obtained in the black market, to crush it and snort it. The manufacturers then made it so that it was not crushable, so people figured out how to boil it and inject it. And then an outbreak of HIV was reported in the Indianapolis area from people sharing dirty needles to inject Opana ER. I understand what tamper-resistant measures are trying to do, but instead they’re actually creating a lot of these problems.

At the same time, all but one state (Missouri) have adopted PDMPs, or prescription drug monitoring programs. These programs give us doctors a report card — in the case of Arizona, it’s every quarter — of where you stand with respect to all of your colleagues in your specialty as to how many prescriptions you wrote for oxycodone, hydrocodone, and so forth. It is not broken down by how many patients you saw, just how many prescriptions you wrote. And it ranks you in ranges from normal to outlier, to extreme outlier.

That casts a chilling effect on doctors. Nobody wants to be seen as an outlier. It pressures doctors to cut back on prescribing, and then their legitimately suffering patients are driven to the illegal market where they get laced opioids, or they go to cheaper heroin and, of course, that is where the overdoses occur. A study just came out in May from the University of Pennsylvania that examined the effect of PDMPs from 1999 to 2014, and they found that PDMPs were not associated with reductions in drug overdose mortality rates, and may be related to increasedmortality from illicit and other unspecified drugs.

So what can we do from a policy standpoint? I’m an advocate of what’s known as harm reduction: if we can’t stop people from using these drugs, at least let’s do what we can to make sure they don’t harm themselves. An example of harm reduction is methadone maintenance, which has been around for decades. You basically replace an addiction to heroin with an addiction to methadone in the form of a pill, which prevents withdrawal but doesn’t give you the euphoria. It’s sort of like the opioid version of a nicotine patch.

Another policy being used in several countries is — and this may sound weird — heroin maintenance programs. Now remember, heroin is diamorphine, which is a pharmaceutical that is available and used in many developed countries. In 1994, Switzerland started a heroin maintenance program.

There are criteria to join it to make sure you’re not trying to game the system, but you declare yourself a heroin addict; you come into a clinic in the morning; you’re given pharmaceutical-grade diamorphine with a clean needle and syringe; a nurse is there watching you; you inject yourself; and then you leave. You sign in and sign out. They’ve found that many addicts, once they aren’t spending their whole day looking for their connection, get a job, some get married and have a family, and as they resume a more conventional lifestyle a significant number of them actually detox themselves off. A smaller program like this in the United Kingdom has been going on for about 10 years. In Vancouver, British Columbia, one just began in December 2016. Since heroin is a banned substance in this country, we would need to pass legislation to allow a few heroin maintenance pilot programs.

Another form of harm reduction, from the clinician’s standpoint: Instead of pressuring doctors through things like these prescription drug monitoring boards to decrease the amount of prescriptions we give to our patients, why don’t you just let us be doctors? That’s our job. When I have a patient who has recovered from major trauma surgery, and I know he’s physically dependent, and he’s asking me for another refill of oxycodone, and I think this has been going on a little longer than it should be — what I do ethically, as part of my profession, is have a discussion with my patient and see if I can get the patient to go along with my tapering him off. Sometimes patients are in denial. If they’re addicted, I can refer them to someone who has more expertise in treating addiction.

But if I’m faced with the decision between giving this guy another prescription under the condition that he’ll see me in two weeks so we can talk about this again, or cutting him off and risking that he’ll go get some counterfeit Percocet and maybe die of an overdose because it contained fentanyl or carfentanil — I think you should leave that judgment call to me, the doctor. If we can keep people on methadone maintenance, why can’t I decide, under close supervision, to keep a person on oxycodone maintenance? There’s no difference, chemically. My advice would be to stop interfering in the patient-doctor relationship — you’re actually making it worse.

In summary, our opioid overdose problem is not a product of the patient-doctor relationship. It’s a product of drug prohibition, because it’s the illegal market that has led to all these impurities and to people getting substances that kill them. We need to address drug prohibition, not the patient-doctor relationship.

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An Accurate Blood Test for Fibromyalgia

Posted on March 29, 2018 by Pharmaciststeve

https://www.healthcentral.com/article/an-accurate-blood-test-for-fibromyalgia

The journey to an accurate diagnosis of fibromyalgia can be long and arduous — just ask Lady Gaga, who was only diagnosed after four years of suffering from chronic pain. Even worse, patients are often told that the pain is “all in their heads.” Now, however, there’s a blood test for fibromyalgia, FM/a, that can lead to a quicker diagnosis and treatment. HealthCentral interviewed Frederick G. Behm, M.D., Frances B. Geever Professor and Head of Pathology at the University of Illinois at Chicago College of Medicine, who performed studies of the blood test, for his take on the state of fibromyalgia today.

 

HealthCentral: Why is it so difficult to diagnose fibromyalgia?

Dr. Behm: There are several reasons, the first being that fibromyalgia may not be just one disorder. It could be multiple disorders that have overlapping symptoms. The symptoms also tend to be nonspecific — patients often can’t tell doctors where they hurt. They just hurt all over. In addition, up until recently there have been no lab or radiology tests to confirm the clinical diagnosis of fibromyalgia, so people would go to many doctors without finding relief, or they would try all sorts of home remedies that didn’t work.

Because the diagnosis is so elusive, we believe that fibromyalgia is underdiagnosed and affects far more than the four million people who are said to have it in the United States. In fact, we think it may exceed the number of people with adult-onset diabetes. It’s also a worldwide problem.

 

HC: What are the tip-off symptoms of fibromyalgia?

Dr. Behm: The main symptoms are chronic pain that is widespread throughout the body, severe fatigue that prevents the person from functioning in daily life, an inability to sleep, muscle tenderness that is vague and moves, headaches, visual problems like blurry eyesight, depression, memory problems, and not being able to think clearly. These are all very nonspecific to fibromyalgia and can mimic other disorders. However, if you have three or four of these symptoms, particularly widespread pain, and you’re a woman (women are more likely than men to have fibromyalgia), you might ask that your healthcare provider evaluate you for fibromyalgia.

HC: What is the FM/a test and how is it helping in diagnosis?

Dr. Behm: The FM/a blood test looks for markers in the immune system that demonstrate an abnormal pattern that is unique to fibromyalgia patients. Results of the test are based on a 1 to 100 scoring system, and people with fibromyalgia have scores higher than 50. We did a study of the test in my lab here at the University of Illinois College of Medicine Chicago where we looked at blood samples from people with and without fibromyalgia, although we didn’t know who did or did not have the disorder until the test results had been completed. We were pleasantly surprised to find the test was very accurate: It was able to identify over 90 percent of patients with fibromyalgia, which is pretty spectacular in terms of accuracy for a medical test.

 

HC: How should people with widespread pain approach getting a diagnosis and treatment? Who should they see?

Dr. Behm: Most people start by seeing a primary care provider such as an internist or a family doctor. From there, they might be referred to a rheumatologist. They might also receive a referral to a psychologist or a psychiatrist if they are depressed or the healthcare provider thinks they might benefit from talk therapy. And now patients can ask their doctor for the FM/a test, which was approved for use in 2012 and is becoming more widely available in the U.S. This test is the only one available that can confirm the immunologic process characteristic of fibromyalgia is going on in a person. The challenge is for fibromyalgia groups to get the word out that there is a test that can be performed.

As for treatment, there really is no good therapy. We can treat symptoms with pain medications including opioids, but those can be habit-forming. Antidepressants and anticonvulsants help other people, but it’s really very hit-or-miss for most people with fibromyalgia, which is frustrating. We need better treatments. Still, getting a confirmed diagnosis of fibromyalgia can be reassuring — at least patients know the problem isn’t just in their heads.

HC: Are there other advances coming down the pike for fibromyalgia diagnosis and treatment?

Dr. Behm: Our lab and a lab at the University of California Los Angeles began a new study this year looking at the genes of people with fibromyalgia compared to people without it to see if there are any genetic clues to tell us what is going on in this disease process. We will need several thousand patients to thoroughly study the genetic profile, so if you are interested in participating you can go to the website fmtest.com to find out more. We are also looking at the composition of the bacteria in the gut — what’s called the gut microbiome. We know there is an interplay between the immune and nervous systems in fibromyalgia, so we suspect there may be alterations in the gut microbiome we can identify to find new treatments.

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CMS proposes to force patients off effective opioid doses without their physician’s approval

Posted on March 29, 2018 by Pharmaciststeve

http://thehill.com/opinion/healthcare/380805-cms-proposes-to-force-patients-off-effective-opioid-doses-without-their

Centers for Medicare and Medicaid Services (CMS) is proposing a limit on the amount of opioids a physician can prescribe to a patient. This limitation, that may take effect on Jan.1, 2019, would be unrelated to the patient’s past experience or need. It would render pharmacists unable to fill prescriptions that CMS has defined as “high” or long-term dosages unless an appeal is approved.

CMS defines long-term opioid therapy as opioid use for more than 90 consecutive days and high-dose usage as at least 90 mg morphine equivalent dosage (MED) per day. However, this definition has never received substantial scientific support.

The history of dose investigation shows that opinions about what constitutes the appropriate amount of opioids have changed through the years. To begin, a paper published 15 years ago in the New England Journal of Medicine suggested most people do not benefit from opioids administered above 180 mg per day. This article ignited a heated debate. However, it focused on efficacy, not the risk of overdose or addiction at higher doses.

 

Four years later, guidelines created in Washington State from a different set of factors suggested 120 mg as a daily ceiling dose (that figure was subsequently lowered to 90 mg MED). However, this team later published a paper stating dose was not a significant factor for overdoses, but concomitant sedative-hypnotics such as benzodiazepines and muscle-relaxants were common in most overdoses.

In 2009, the joint guideline of the American Pain Society and American Academy of Pain Medicine performed a scientific review of the literature and arrived at 200 mg per day as a typical dose. Any number above that would be considered a “high” dose.

The creators of this guideline write, “Theoretically, opioids have no maximum or ceiling dose, but there is little evidence to guide safe and effective prescribing at higher doses, and there is no standardized definition for what constitutes a ‘high’ dose. By panel consensus, a reasonable definition for high dose opioid therapy is >200 mg daily of oral morphine (or equivalent), based on maximum opioid doses studied in randomized trials.”

The point is that the CMS proposal does not consider the variable factors other than dose that affects the incidence of overdose deaths. It assumes there is one dosage that is correct for all patients, and that number is immutable.

A study found that in the absence of benzodiazepines, the risk of death from an opioid overdose does not substantially increase until the dose exceeds 200 mg MED. Preventing overdose requires vigilance in prescribing at all dose levels as well as knowledge of the drivers of overdose, such as dangerous drug combinations, that are independent of dose.

In setting goals for opioid dose reductions, CMS may influence other payers to create similar restrictions on prescriptions. Some insurers would likely welcome the intervention. However, the result will likely be involuntary dose reductions that may be enforced without regard to individual condition or a physician’s recommendation.

Doctors fear the consequences of making a different therapeutic decision than the prescriptive directives of government agencies. They see their colleagues being pursued by the DEA for prescribing high doses of medications. Some of their colleagues have retired; others have been held responsible for patients’ overdoses and have been incarcerated.

Therefore, many of them are abandoning patients on higher doses, forcing them into discontinuation or drastic reduction of doses. The unintended consequence is that some patients may turn to street drugs and expose themselves to the dangers of illicit drugs and the criminal justice system. Other patients may choose suicide over unmanaged pain.

Despite the CMS’s claim, the proposal does not set a standard of care; a de facto standard of care will bleed into legal and regulatory proceedings for prescribing an opioid. Any deviation will threaten a doctor’s ability to practice medicine. The needs of the patients will not be taken into consideration.

The CMS dose ceilings will lead to coverage and reimbursement restrictions imposed outside the chronic pain population. Currently, state laws built on federal agency guidelines are beginning to interfere with the delivery of palliative, cancer, and end-of-life care. Minnesota requires Medicaid patients above 120 mg MED to go through pre-authorization.

This places a burden on patients and providers that results in barriers to care for patients who are at the end of life or who have life-limiting illnesses. Thus, the practice of individualized medicine is at risk of curtailment through policies crafted with heavy input from entities with a financial interest in dictating treatment coverage options and limitations.

CMS writes, “Lower [quality measurement] scores demonstrate less long term, high-dose opioid prescribing, resulting in a lower likelihood of adverse events associated with opioid use and, thus, higher quality care.”

On the contrary, there is evidence that a decline in opioid prescribing over the past five years has coincided with a surge of overdose deaths. Furthermore, the risk for suicides of patients left without sufficient pain relief or support during opioid discontinuation or dose reduction is real.

Finally, such actions will not reduce opioid deaths related to heroin and illicit fentanyl which is the source of most overdose deaths. In fact the opposite effect may occur. People in pain may be pushed to illicit channels causing more deaths. Solutions that are not aimed at the true current cause of overdose deaths will more likely lead to unfortunate and preventable sad outcomes.

Lynn R. Webster, MD is a vice president of scientific affairs for PRA Health Sciences and consults with Pharma. He is a former president of the American Academy of Pain Medicine. Webster is the author of “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.” You can find him on Twitter: @LynnRWebsterMD. 

 

Here is a quote from CMS’ website:

Nondiscrimination Notice

CMS doesn’t exclude, deny benefits to, or otherwise discriminate against any person on the basis of race, color, national origin, disability, sex, or age in admission to, participation in, or receipt of the services and benefits under any of its programs and activities, whether carried out by CMS directly or through a contractor or any other entity with which CMS arranges to carry out its programs and activities.

https://www.cms.gov/about-cms/agency-information/aboutwebsite/cmsnondiscriminationnotice.html

And just how is CMS expecting to get around their own non-discriminating rules ?  Maybe like CDC.. these guidelines do not bear the weight of law and DOES NOT SET A STANDARD OF CARE…  could they be “dumping” this on the insurance insurance and the pharmacy industry to create a “opiate desert” ?

This may be the FINAL CALL to the chronic pain community to get their ass in gear… those that believe that if they kept their head low enough it would not bother them… This appears that CMS  is planning on CARPET BOMBING the chronic pain community.  You will not be able to get/keep your head low enough.  It is probably now too late to vote the bums out… because – if that could happen – the “new class of Congress” would be taking office as this is proposed to go into effect…

The only option that the chronic pain community may now have is to get their pennies and dollars together to create a legal defense fund and try to force CMS to observe their own anti-discriminating policy and or go after any provider that elects to discriminate against those in the chronic pain community

 

 

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Is the opiate conversion tables putting prescribers at risk of malpractice claims ?

Posted on March 29, 2018 by Pharmaciststeve

Below is the “warnings” from one of the many opiate conversion tables that are available to calculate MME’s… they all have – or should have – the same or similar warning to those who are expected to be using them to stay within the CDC and other daily opiate guidelines and/or state laws.  I am also including 4 statements from the CDC guidelines that provides the prescriber with latitude in providing a pt’s doses above the CDC daily MME limits.  Also a link to a published article by Dr Tennant concerning the importance of the CYP-450 enzyme deficiencies testing and opiate dosing for individual pts.

IMO… these three issues pretty much establish what is – or should be – a standard of care and best practices in treating chronic pain pts.

If a pt is being forced to reduce their opiate dosing and it is important for the pt to inquire as to which formula/table the prescriber is using to calculate these MME equivalents. The one below is just one of many out there, but… they all come up with the same/similar conversion figures and NONE OF THEM… are 100% accurate for each and every pt, may not be accurate for ANY PT ?

I am sure that no prescriber would use a piece of equipment that is known to be less than accurate and base the pt’s therapy on the results from that equipment, but isn’t that exactly what these prescribers are doing by blindly following these opiate conversion tables and ignoring the warning that comes with these conversion tables as to their accuracy and reliability ?

While I am not an attorney, I would think that any prescriber that is blindly using these opiate conversion tables maybe setting themselves up for some legal issues… maybe malpractice, maybe pt abuse, maybe unprofessional conduct, maybe failing to meet best practices and standard of care.  Only time will tell as things progress.

Before using this application, please review these important points:

https://globalrph.com/medcalcs/opioid-pain-management-converter-advanced/
bullet Published equianalgesic ratios are considered crude estimates at best and therefore it is imperative that careful consideration is given to individualizing the dose of the selected opioid. Dosage titration of the new opioid should be completed slowly and with frequent monitoring. 

bullet Factors that must be addressed during the conversion process include: Age of the patient or presence of coexisting conditions. Use additional caution with elderly patients (65 years and older), and in patients with liver, renal, or pulmonary disease. 

bullet Conversion ratios in many equianalgesic dosing tables do not apply to repeated doses of opioids.

bullet The amount of residual drug in the patient’s system must be accounted for. Example: fentanyl will continue to be released from the skin 12 to 36 hours after removal of the patch. Residual effects from discontinued long-acting formulations should also be assessed before converting a patient to a new opioid.

bullet The use of high but ineffective doses of a previous opioid may result in overestimation of the converted opioid. 

bullet Ideally, methadone conversions (especially patients who were previously receiving high doses of an opioid) should only be attempted in cooperation with a pain specialist or a specialist in palliative medicine. 

bullet Meperidine should be used for acute dosing only and not used for chronic pain management (meperidine has a short half-life and a toxic metabolite: normeperidine). Its use should also be avoided in patients with renal insufficiency, CHF, hepatic insufficiency, and the elderly because of the potential for toxicity due to accumulation of the metabolite normeperidine. Seizures, confusion, tremors, or mood alterations may be seen. In patients with normal renal function, total daily doses should not exceed 600mg/24hrs. 

Here is four quotes from the CDC opiates guidelines:

https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

“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.”

 

https://www.practicalpainmanagement.com/treatments/pharmacological/opioids/cytochrome-p450-testing-high-dose-opioid-patients

Severe, chronic pain patients who seek opioid dosages above normal standards should now be tested for genetic cytochrome P450 deficiencies.

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Trying to find objective evidence to justify treating subjective disease ?

Posted on March 29, 2018 by Pharmaciststeve

In my experience of reviewing thousands of patient histories for chronic pain management in greater than 15 states, including extensive physician chart notes, the overwhelming majority of prescribers of opioids in chronic pain management [excluding cancer related pain, palliative care and sickle cell anemia (because there exists bonafide clinical evidence in the safety and effectiveness in these conditions)], the results are this: The vast majority of prescribers are NOT following evidence based medicine as a general guideline, not even close. This includes pain management specialists. But don’t worry, the PBM’s have their market shares/rebates to protect for their bottom line, so chances are, the prior auths will get a approved. And if not, they’re making plenty of money on their market shares/rebates of buprenorphine products. Win-Win for them.

Opioids Don’t Treat Chronic Pain Any Better Than Ibuprofen: Study

The above comment was made by someone who identified themselves as a PharmD.  It was one of several comments on a post that referenced the above Newsweek article.  From what this PharmD stated at the end of the comment he/she does reviewing of pt’s records for a insurance or PBM company.  I had a “flashbulb” moment in reading these words..

This “expert” is looking for clinical/objective evidence to justify the treatment for a SUBJECTIVE DISEASE.  He/she is reading physician’s notes on a pt’s subjective disease issues…  So those notes is the prescriber’s interpretation of what the pt stated as to their pain, the intensity of their pain, etc, etc… There is no objective means of measuring the pt’s intensity of pain and highly unlikely that the prescriber will adequately translate the pt’s body language into the pt’s medical record.

This is similar to two people exchanging emails, texts, messages and there is a misunderstanding by one side of the “conversation” because the conversation is basically a TWO DIMENSIONAL conversation… whereas, if the conversation had been in real time – face to face – and “body language” was part of the conversation… the misunderstanding may not have happened.

With the increased use of electronic medical records, is it time for prescribers to start recording the office visit of those pts dealing with subjective diseases and perhaps “forcing” those “experts” who are outsiders reviewing pt’s medical records to go past the typical two-dimensional pt chart reviews ?

I was right, I found out where this PharmD works  https://www.welldynerx.com/ 

and from their website:   

WellDyneRx took early steps to combat the opioid epidemic

In 2014, WellDyneRx clinicians decided they needed to take steps to curb opioid abuse. Through a multifaceted approach, members are managed via real-time cumulative morphine equivalent dose (MED) point-of-sale (POS) edits and prior authorizations for targeted high-risk medications.

EXPLAINS A LOT !!

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