www.statnews.com/2017/02/24/opioids-prescribing-limits-pain-patients/

Amid a rising toll of opioid overdoses, recommendations discouraging their use to treat pain seem to make sense. Yet the devil is in the details: how recommendations play out in real life can harm the very patients they purport to protect. A new proposal from the Centers for Medicare and Medicaid Services to enforce hard limits on opioid dosing is a dangerous case in point.

There’s no doubt that we needed to curtail the opioid supply. The decade of 2001-2011 saw a pattern of increasing prescriptions for these drugs, often without attention to risks of overdose or addiction. Some patients developed addictions to them; estimates from the Centers for Disease Control and Prevention range from 0.7 percent to 6 percent. Worse, opioid pills became ubiquitous in communities across the country, spread through sale, theft, and sharing with others, notably with young adults.

The prescribing tide has turned: Private and governmental data show that the number of prescriptions for opioids has been falling since 2012. Reassuringly, federal surveys show that misuse of pain relievers bottomed out in 2014-15.

Nevertheless, the CDC produced a guideline in 2016 that recommended shorter durations for opioid prescriptions and the use of non-drug treatments for pain. It also suggested keeping opioid doses lower than the equivalent of 90 milligrams of morphine. As the guideline acknowledged, its recommendations reflected weak scientific evidence. Problematically, it was silent on how to care for patients already receiving doses higher than the 90 milligram threshold.

To its credit, the guideline endorsed treating patients as individuals, not numbers. A CDC official wrote to one patient that the guideline “is not a rule, regulation, or law. … It is not intended to take away physician discretion or decision-making.”

Unfortunately, these mitigating features were undermined by intemperate publicity that vilified opioids for pain. Opioids for pain “are just as addictive is heroin,” proclaimed CDC Director Dr. Tom Frieden. Such statements buttress a fantasy that the tragedy of opioid overdoses and deaths will be solved in doctors’ offices, primarily by upending the care of 5 to 8 million Americans who receive opioids for pain, even when most individuals with opioid addiction did not start as pain patients.

The progression of the guidelines from “voluntary” to “enforceable” has culminated in a draft policy from CMS. It would block all prescriptions above the CDC threshold of 90 milligrams unless complex bureaucratic barriers are surmounted. Many pharmacy plans are already enforcing this approach. Under that plan, many patients suffering with chronic pain would lose access to the medicines they are currently taking, all in the name of reversing a tide of death increasingly defined by non-prescribed opioids such as heroin and fentanyl.

The logic of doing this is untested. There have been no prospective clinical studies to show that discontinuing opioids for currently stable pain patients helps those patients or anyone else. While doing so could help some, it will destabilize others and likely promote the use of heroin or other drugs. In effect, pain patients currently taking opioids long-term have become involuntary participants in an experiment, with their lives at stake.

Turning the voluntary guidelines into strict policy is unfortunate for three reasons.

Second, we have alternatives to bureaucratic controls. These include promoting and paying for treatments that de-emphasize pills. Important work by the Department of Veterans Affairs shows how to identify patients with elevated risk for harm from opioids and how to mitigate the risks.

Third and most troubling is the increasingly inhumane treatment of patients with chronic pain. Fearing investigation or sanction, physicians caring for patients on long-term opioids face a dire choice: to involuntarily terminate prescriptions for patients who are otherwise stable, or to carry on as embattled, unprotected professionals, subject to bureaucratic muscle and public shaming from every direction.

In this context, we cannot be surprised by a flurry of reports, in the press, social media, and the medical literature describing pain patients entering acute withdrawal, losing function, committing suicide, or dying in jail. The CMS policy, if adopted, will accelerate this trend.

Many of our colleagues in addiction medicine tell us they are alarmed by the widespread mistreatment of pain patients. We receive anecdotes every week from physicians and pharmacists, most of them expert in addictions, describing pain patients who have involuntarily lost access to their pain medications and as a result have been reduced from working to bedridden adults, or who have become suicidal.

This loss of access occurs several ways. A pharmacy benefit program may refuse to cover the prescription because it has already enacted the changes that CMS is proposing to make mandatory. A physician may feel threatened by employers or regulators, and believes his or her professional survival depends on reducing opioid doses — involuntarily and without the patient’s consent — to thresholds that the CDC itself described as voluntary and not mandatory. Or state regulators have imposed such burdensome requirements that no physician in a given region can sustain prescriptions for their patients. Such patients are then “orphaned,” compelled to seek treatment from other physicians across the country.

Given the expertise in addiction among these physicians, it should be particularly worrisome that they believe the present pill-control campaign has gone too far. And yet, the ethics are clear: It should never be acceptable for us to countenance the death of one patient in the avowed service of protecting others, even more so when the projected benefit is unproven.

Surgeon General Dr. Vivek Murthy made an underappreciated declaration in a recent interview with the New England Journal of Medicine. “We cannot allow the pendulum to swing to the other extreme here, where we deny people who need opioid medications those actual medications. … We are trying to find an appropriate middle ground,” he said.

As addiction professionals, we agree wholeheartedly.

Stefan G. Kertesz, MD, and Adam J. Gordon, MD, are physicians in both internal medicine and addiction medicine. Dr. Kertesz is an associate professor of preventive medicine at the University of Alabama at Birmingham School of Medicine; Dr. Gordon is a professor of medicine at the University of Pittsburgh School of Medicine and editor of the journal Substance Abuse. The views expressed here are their own and do not reflect positions held by their employers.

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https://www.pharmacytoday.org/article/S1042-0991(18)30491-2/fulltext

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US puts Canada on IP priority watch list

https://gulfnews.com/business/economy/us-puts-canada-on-ip-priority-watch-list-1.2213130

Washington: The Trump administration on Friday labelled 36 countries as inadequately protecting US intellectual property rights, keeping China on a priority watch list and adding Canada over concerns about its border controls and pharmaceutical practices.

The US Trade Representative’s annual report on global IP concerns is separate from the ‘Section 301’ report on Chinese technology transfer practices that has led the world’s two largest economies to threaten each other with tariffs.

The so-called ‘Special 301 Report on Intellectual Property Rights’ calls out China for its “coercive technology transfer practices” and “trade secret theft, rampant online piracy, and counterfeit manufacturing”.

It was the 14th straight year that China was placed on the ‘Priority Watch List’.

The report was met with objections from the Chinese commerce ministry, which said the United States lacks objective standards and fairness.

“The Chinese side opposes this, and urges the US to earnestly fulfil its bilateral commitments, respect the facts, and objectively, impartially, evaluate with positive intentions the efforts made by foreign governments including China in the area of intellectual property rights and the results achieved,” the ministry said in a statement on its website on Saturday.

US Trade Representative Robert Lighthizer is due to travel to China next week along with other senior Trump administration officials for talks on US demands for changes in Beijing’s trade and intellectual property policies.

President Donald Trump has threatened up to $150 billion (Dh551 billion) in tariffs on Chinese goods, and China’s Ministry of Commerce has threatened to retaliate in equal measure.

A USTR official declined to comment on Lighthizer’s specific message to his Chinese counterparts next week, but said US officials “anticipate engaging with them meaningfully on all these issues.”

The biggest surprise in Friday’s report was the decision to move Canada from the lower-level ‘Watch List’ to the same priority list as China. USTR cited Canada’s “poor border enforcement,” especially for counterfeit goods shipped through America’s northern neighbour, and concerns about intellectual property protections for pharmaceuticals.

US pharmaceutical companies have long complained that generic versions of drugs still under US patent protection flood in from Canada at much cheaper prices.

Nafta talks

The increased criticism of Canada was revealed as Canadian Foreign Minister Chrystia Freeland was locked in intense negotiations with Lighthizer over updating the North American Free Trade Agreement (Nafta).

Washington has demanded that a modernisation of the 1994 pact include stronger IP protections.

Lighthizer, Freeland and Mexican Economy Minister Ildefonso Guajardo are trying to work out a number of stumbling blocks in the Nafta talks, including auto content rules.

The office of Canadian Innovation Minister Navdeep Bains, who launched an intellectual property strategy on Thursday, did not immediately respond to a request for comment.

Ottawa is pledging to create an independent body to oversee patent and trademark issues, “which will ensure that professional and ethical standards are maintained.”

Colombia also was added to the Priority Watch List for failing to revise its copyright laws as required under a free trade agreement with the United States.

Saudi Arabia and the UAE were added to the Watch List. Concerns about pharmaceutical intellectual property protections, pirated software and counterfeit goods were factors in those decisions, USTR said.

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In Memory Of

Jennifer E. Adams age 41 of Helena

December 20, 1976 – April 25, 2018

Every DEATH starts with “DEA”

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Blue Cross Warns Patients They May Be On Hook For Their ER Visit

https://www.nbcdfw.com/news/local/Blue-Cross-Warns-Patients-They-May-Be-On-Hook-For-Their-ER-Visit-481000741.html

Thousands of Texans may want to think twice about their next trip to the emergency room.

The largest health insurer in the state, Blue Cross Blue Shield of Texas, will notify some policy holders they’ll be responsible for paying the entire bill of an emergency room visit for reasons that are determined to not be life threatening or serious. 

In a memo, the company says “some of our members are using the emergency room (ER) for things like head lice or sprained ankles.”

It goes on to say, “doing so not only drives up costs for our members, but uses limited ER resources for conditions that are not serious or life threatening. We want to make health care affordable for our members.” 

Starting June 4th, fully-insured groups or retail HMO members may be required to pay for the entire ER bill if they go to an-of network ER as a convenience for a condition they don’ think is serious or life-threatening.

President of the DFW Hospital Council W Stephen Love says misuse of the ER has been a problem for some time and leads to higher health care costs.

He says the other problem is confusion about where to get immediate health care. Many people go to out-of-network, freestanding emergency rooms, under the impression they’re going to in-network urgent care clinics.

“If you walk into a freestanding ER and said, ‘do you accept insurance?’ most would say yes. The real question you should be asking is, ‘do you take insurance that’s in network and will I not be billed out of network?’ Sometimes, people don’t know enough to ask those detailed type questions,” Love said.

Dallas freelance hair and makeup artist Cheryl Smith purchased a Blue Cross HMO plan, which she says, requires with monthly premiums higher than her monthly mortgage payments.

Smith feels the policy change creates an extra burden on the consumer to decide what’s considered a covered “emergency.”

“I’m paying for this but I’m scared to use it because I don’t think our insurance company is going to have our back on this,” says Smith.

Dallas Morning News Business of Healthcare Reporter Sabriya Rice takes an in-depth look at the changes here.

To learn more about BCBS emergency care, visit its SmartER Care website.

It would appear that BC is putting the decision as to what is an emergency and requires a trip to the ER and what doesn’t not … on NON MEDICALLY TRAINED GENERAL PUBLIC and if the person does not evaluate their condition correctly could be given a bill for hundreds or THOUSANDS OF DOLLARS.

Recently it was stated that 60% + of the population could not afford a $500 emergency cost and/or a $1000 emergency medical bill. According to this, a person going to ER, who it is determined – after the fact – did not have a “real health emergency” … could throw the family’s financial status into a financial crisis ?

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https://www.facebook.com/jonelle.elgaway/videos/1686814994740377/

 

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Walmart May Need Humana Patients To Fill Emptying Retail Space

https://www.forbes.com/sites/brucejapsen/2018/04/27/walmart-may-need-humana-patients-to-fill-emptying-retail-space/#c414b92c6d34

As online shopping continues to eat away at traditional brick and mortar retailers, Walmart may need Humana health plan enrollees to fill its store with patients in need of healthcare services.

That’s a theory floated in a report from Credit Suisse’s A.J. Rice and colleagues who said they recently hosted a former Walmart executive who offered the longtime healthcare analyst and his team thoughts on how a partnership with Humana would help the retail giant.

“(Walmart) would like to see more of overall healthcare spending take place in its locations, while making sure on the other hand that it protects its current related activities, particularly in the midst of a changing landscape,” Rice and Credit Suisse associates wrote in a note last week. “As the need for traditional retail space has evolved due to the proliferation of online shopping , there is a perception that some space within the footprint of an average store could be used to offer new and non-traditional services, such as healthcare.”

Humana releases its first quarter earnings next week when the insurer could face questions from Wall Street analysts about recent Walmart speculation. Humana has more than 14 million people in its health plans.

Filling available space with health services is already part of the strategy of Walgreens Boots Alliance and CVS Health. CVS is working its way through an acquisition of Aetna, the nation’s third-largest health insurer, and both parties say they want to develop more healthcare services that would be covered by the health plan for its more than 20 million members.

Walgreens is “opening up more space” for healthcare services such as the attached urgent care centers run by UnitedHealth Group’s MedExpress that connect primary care with the corner drugstore. The partnership has grown to 15 locations.

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http://www.timesnews.net/Law-Enforcement/2018/04/27/Kingsport-Pharmacist-pays-100-000-in-civil-penalties

 

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http://www.foxnews.com/opinion/2018/04/25/greg-gutfeld-opioids-facts-and-fallacies.html

I realize that every time I discuss the opioid crisis with someone, I find that they often don’t know all the facts. And maybe, neither do I. But I try.

So, my goal here is to present all the stuff that I’ve read recently, with links. And I quote the articles, extensively, so you can see what I see, and not depend on my words alone.   

But I must note: this article below is biased. The sources I’m using were sent to me by people upset by the media narratives regarding opioids. So the perspective here is not “fair and balanced,” but rather balancing the other narratives already out there.

Am I 100 percent certain that all of this is correct? Nope.

But I think it’s important to hear the other side, before we start punishing the wrong people.

So here are the facts:

As opioid prescriptions decline, deaths related to opiods spike.

“The opposing trends show the folly of tackling the ‘opioid crisis’ by restricting access to pain medication,” writes the great Jacob Sullum, in Reason Magazine. Sullum offers the reader a graph, showing that death does not decline with a drop in prescriptions. “To the contrary, it has risen sharply in recent years, driven by dramatic increases in deaths involving heroin (orange) and illicit fentanyl…”

 “The crackdown on pain pills not only has not reversed the upward trend in opioid-related deaths,” adds Sullum, “It is contributing to it by driving nonmedical users into the black market, where the drugs are more dangerous because their purity and potency are inconsistent and unpredictable.”

Opioid use isn’t the problem. Drug abuse, involving multiple drugs, is.

Check out this fact: the California Department of Health & Human Services published a paper looking at toxicology data from Marin County — particularly those people who had died from any drug. And the average number of drugs found in all overdoses was six. Not one… but six!!

In short, deaths from opioids often involve other substances. Meaning, this is about chronic abuse of multiple drugs – not a cancer or pain patient trying to get through the day. 

What this also means, is that the numbers you often hear about opioid deaths aren’t really as large as you think. If you remove illegal drugs like heroin and fentanyl, the new numbers may be much lower. How low? Hard to tell, since the reporting is so murky.

Roughly only one percent of patients become addicted to painkillers

If you listened to politicians and the media – an overdose begins with a construction worker who injures his neck. He has surgery, and then is put on pills. Quickly he becomes a junkie, runs out of pills and turns to street drugs. He’s found dead.

Not really. Fact is, pain patients rarely become addicted. According to Reason Magazine, “A 2018 study found that just 1 percent of people who took prescription pain medication following surgery showed signs of “opioid misuse,” a broader category than addiction.”

And the mag adds, “Even when patients take opioids for chronic pain, only a small minority of them become addicted. The risk of fatal poisoning is even lower—on the order of two-hundredths of a percent annually, judging from a 2015 study.”

And here’s this from Politico, which has a slightly higher percentage of addiction: “According to a 2016 national survey conducted by the Substance Abuse and Mental Health Services Administration, 87.1 million U.S. adults used a prescription opioid—whether prescribed directly by a physician or obtained illegally…Only 1.6 million of them, or about 2 percent, developed a “pain reliever use disorder,” which includes behaviors ranging from overuse to overt addiction.”

Still, despite these facts, we hear “opioid epidemic,” which might serve to hurt cancer and pain patients, by restricting access. The “epidemic” label scares doctors with threats of investigation, monitoring of pharmacists, while creating limits on how many pills can be given. This, potentially, punishes the lawful.

Does this remind you of anything? Yep – the debate over guns. Friends of mine who are gun rights advocates will demand a drug ban. They can’t see their own hypocrisy. Whether its guns or medications (both products with inherent risks), you don’t punish the lawful, for the lawless. Instead you try to tag the abuser or the criminal, and leave the law-abiders alone.

Take a look at another piece from CATO, which suggests the war on “drugs,” is really a war on “patients.” And we’re letting it happen because we’re so used to blaming, rather than fixing.

Here’s the nugget: “A January 2018 study in BMJ by researchers at Harvard and Johns Hopkins examined 568,000 opioid naïve patients prescribed opioids for acute and postoperative pain from 2008 to 2016 and found a total “misuse” rate (all “misuse” diagnostic codes) of just 0.6 percent. And researchers at the University of North Carolina reported in 2016 on 2.2 million residents of the state who were prescribed opioids, where they found an overdose rate of 0.022 percent.”

Reformulating prescription pills doesn’t help either.

Roughly 8 years ago, the popular opioid OxyContin was remade to make it harder to abuse. What happened?

Heroin use soared. Between 2001 and 2010, there were roughly 2000 to 3000 deaths by heroin. But then it shot up to 10,000 from 2010 to 2015.  Implication: the overdoses were not caused by pills, but perhaps a scarcity of pills.

“During the ensuing five years, OxyContin abuse dropped and the strict restrictions we now see on opioid pills began to take hold. The result? Between 2010-2015 opioid overdose deaths in the US increased by 65%, roughly 13,000. And…that increase was entirely due to injectable drugs like heroin or fentanyl. “

Equating the potency of opioids with heroin creates hysteria that hurts patients

It’s true that basic opioid pills and heroin actually hit the same brain receptors. But heroin doses used by addicts packs way more punch than opioids. And while it’s practically impossible for one hydrocodone pill to kill you – a heroin user can die from one injection. By conflating these two types of drugs, we make it sound like pills are as immediately lethal as what comes from the syringe.

They may belong to the same class of drugs, and “drug overdose deaths” groups these drugs together, but it’s a messy classification.

To quote ASCH:

“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?”

“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.”

The best way to save lives is for patients to be able to predict the potency of the drug delivery system.

When I drink wine, I know when to stop. The modulated alcohol delivery creeps up on your own system, giving you time to slow down, and stop.

When I used to smoke, I understood what I needed to get me to “that point.” How many cigarettes did I need to make me feel good? Generally, one or two. The fact that nicotine was divided into 20 uniform delivery systems (a pack of cigs), allowed me to figure out how far I wanted to go, before getting nauseous. By reducing prescriptions of opioids, you force people into the wild west of street meds, where no one knows what potency they’re getting. One pill could end it all, for you, on the street (but not from the pharmacy).

As Reason puts it, the increases in deaths are “related to heroin and illicit fentanyl, which are more dangerous than legally produced opioids because their potency is unpredictable.”  

The CDC and others are exaggerating the numbers of overdoses by pills.

I’ll just quote this from Circa: “According to a recent article written by CDC officials in the American Journal of Public Health, death certificate data does not always differentiate between illegally and legally obtained drugs, so a fatal overdose involving illicitly manufactured fentanyl could have been counted as a legal opioid prescription death. 

Because of this, the total deaths from prescription opioids would have appeared to be over 32,000 in 2016, but the numbers were probably closer to about 17,000, and the CDC said they changed their method of calculating these deaths in 2015 to account for the increased availability of illicit fentanyl.”

Inflated numbers have created a panic about prescription opioids, leading to an environment where chronic pain patients are targeted.

Pain patients are committing suicide because their paid meds are being taken from them.

This is from Vice:

“I’ve seen a published list that heavily emphasizes publicly reported events, which includes between 20 and 30 suicides,” says Stefan Kertesz, associate professor of preventive medicine at the University of Alabama.”

 “”Widespread suicidal ideation should be seen as a signal of a major risk,” he says.”

The government is now running interference between doctor and patient.

Currently, 17 states have laws that restrict opioid prescriptions; there are more to come.   Florida Gov. Rick Scott just proposed a three-day limit on prescribed opioids; Massachusetts limits patients to a 7-day supply, and so on.

This is not entirely logical, when you consider surgical recovery. All post-surgical pain is different — as is patient response to meds.  

This is from the Las Vegas Review-Journal: “For example, the effect of a drug on an individual is directly related to the weight of the patient. No dose of any drug will produce the same effect in a 100-pound woman as in a 300-pound man.”

Even more, drug metabolism differs. “It has been shown that the metabolism of opioids can vary as much as 15-fold from one individual to the next. This means that the same dose of a medicine could be too high for one person while at the same time being too low for another, regardless of weight.” 

The New York Times is just making it worse.

In a recent piece, the paper says that the only people who should have access to opioids, are those who are going to die anyway. Forget anyone with gunshot wounds, broken legs, or surgery pain! Nope, you can only have the drug, if you’re doomed. I’d swear right now, but it would only make work for the copy editor.

So, as boring as this article might be — I tried to corral research you might not have seen, and slapped it together, so you can at least hear the other side.

It’s not an elegant piece. It’s not funny. But I hope it’s helpful.

I also realize that there are people who are gaming the system – using legitimate meds to feed a recreational addiction.

That’s life.

If you create something effective, there will always be an accompanying, corrupting influence. You create a currency, there will be counterfeiting. Humans are like that. There are a great many drugs that could help so many people, but we ban them because we fear abuse (MDMA is one such substance – one that could help in a number of conditions). So let’s focus on targeting the problems, and not the patients. 

If this vaccine becomes a reality and a “former addict” has to under go surgery or is in a accident or failed surgery and becomes a chronic pain pt… are they just going to be SCREWED  when it comes to pain management ?

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http://www.narconon-suncoast.org/blog/narcan-resistant-fentanyl-found-in-pennsylvania.html

This year has brought a lot of bad news in the world of drugs and drug addiction. First, it was elephant tranquilizers being found in batches of heroin across the nation. Then, the number of deaths related to Fentanyl shot through the roof. And finally, we had fake Xanax make its way around Florida, killing at least 9 people. Drug use is scary these days and it’s astounding that anyone in their right mind would choose to use drugs. It seems like you never know what you’re gonna get. Now, we have another huge problem looming on the horizon and it looks completely dismal.

In Pittsburgh, PA a type of Narcan-resistant Fentanyl has been found in batches of heroin and it’s already causing numerous overdoses and deaths. Apparently, it’s hundreds of times more powerful than morphine and called Acryl-Fentanyl. There is a distinct difference between Fentanyl, Carfentanil and Acryl-Fentanyl. Believe it or not, Fentanyl and Carfentanil actually have legitimate, medical uses. Fentanyl is an extremely strong painkiller that’s usually given to patients before or after surgery and for those who are terminally ill. Carfentanil is, well, an elephant tranquilizer and has veterinary purposes. But Acryl-Fentanyl has no known purpose for even existing… and it’s highly troubling that it’s been synthesized.

You got it, Acryl-Fentanyl is synthesized, which means it’s artificially created and has no natural origin (remember, heroin’s natural origin is a poppy plant). Not only is it manmade, but it’s being created in China, like most other research chemicals and synthetic drugs and being smuggled into the United States.

DEA Special Agent In-Charge, David Battiste said, “If Acryl-fentanyl is introduced into the population, it can have devastating effects. You would have to reuse Narcan if you are revived from Narcan at all.”

That’s right folks, this stuff is completely resistant to Narcan. Like Special Agent Battiste said, it’s unlikely that Narcan will reverse its effects and, if it does, it will take multiple, multiple doses. We’re already having enough of a problem with the strength of opiates these days. Narcan is struggling to keep up and continue to save the lives of those who overdose. Acryl-Fentanyl is going to make this problem a whole lot worse and this is only the tip of the iceberg when it comes to the devastating effects this drug is going to have on our society.

Opiate abuse has reached an all-time high, creating an all-time low for our society. Instead of curbing the problem and reducing use and abuse of painkillers and heroin, the problem only seems to be growing at exponential rates. Instead of halting the importing of these drugs into the country, they just keep flowing in. Want to know why? It’s because we consume this garbage. Manufacturers in China know, in my opinion, that they can keep making ultra-strong and deadly drugs and we’re going to consume it. And not only consume it, but consume it in mass quantities because the world knows that the United States has a completely unquenchable thirst for drugs.

If anyone you know is struggling with painkiller addiction or heroin abuse, get them help now! The opiate problem is getting so bad, you never know who’s going to die. Instead of waiting for that fateful day, get an addict you care about the help that they most desperately need. Before it’s too late.

 

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