“winged junkies ” ?

'These birds have become so smart that they don’t make any noise when they swoop on the fields,' one farmer said.

Druggie parrots plunder poppy fields to feed opium addictions

http://www.foxnews.com/world/2017/03/24/druggie-parrots-plunder-poppy-fields-to-feed-opium-addictions.html

Junkie parrots are plundering poppy fields to feed their opium addictions.

They have learned not to squawk and fly silently into fields to nab the drug-laden pods.

Video shows them retreating to high branches to gorge on the plants, grown under state control.

Farmers now claim they are getting warnings from the Indian government’s narcotics department – which controls opium farming – over their reduced yields.

This phenomenon was first reported in 2015, but this year it has spread across to other regions for the first time.

Sobharam Rathod, an opium farmer from Neemach, India, estimates parrots are stealing around ten percent of his crop and he has been given a warning.

He said: “Usually, the parrots would make sound when in a group.

“But these birds have become so smart that they don’t make any noise when they swoop on the fields.

“The birds start chirping when they fly away with opium pods.

“We have tried every trick possible to keep the birds at bay but these addicts keep coming back even at the risk of their life.

“Like we keep an eye on them, but they also keep an eye on us.

“The moment you lower your guard the army of parrots silently swoop onto your field and take away the bulbs.”

In 2015 drug raiding parrots were reported in Chittorgarh in the state of Rajasthan.

But this year they have been found making a huge dent in crops 40 miles away in Neemach in the state of Madhya Pradesh.

According to farmers, the numbers of birds raiding their fields are increasing with every passing year.

TV documentary on pain treatment funded by doctor with industry ties

TV documentary on pain treatment funded by doctor with industry ties

www.statnews.com/2017/03/24/pain-documentary-public-television/

Public television stations across the country have begun airing a documentary about pain treatment produced by a doctor with significant financial ties to the manufacturers of opioid medications — a fact not disclosed in the program.

“The Painful Truth” chronicles the plight of several patients struggling to find effective treatment for chronic pain. Throughout the 57-minute-long program, politicians, federal agencies, and others are depicted as having overreacted to the epidemic of opioid-related overdoses; the documentary suggests pain specialists have been discouraged from prescribing opioids to patients who genuinely need them.

The program accuses the US Drug Enforcement Agency of unfairly targeting pain doctors and putting a “bounty” on pain clinics the agency aims to shut down.

“The political culture has declared war against opioids and those who prescribe them,” the narrator of the program says. “The DEA is the army. The pain patients are the civilians caught in the middle.”

The producer, Dr. Lynn Webster of Utah, and several of the experts he quotes in the program, have long-standing and extensive financial relationships with pain medicine makers. When asked why these relationships are not disclosed to viewers, Webster told STAT that he did not receive any drug industry funding for the documentary. He said it was funded entirely by himself and his wife.

“I am cognizant of that issue, but I think I dealt with it as carefully as I could,” he said in an interview. If viewers want to know whether any of the individual doctors associated with the documentary have financial relationships with pharmaceutical makers, Webster said they can search for that information on the web.

Webster has been paid by dozens of pharmaceutical companies for research, consulting, advisory board positions, speaking engagements, and travel expenses. From 1990 to 2010, Webster operated a pain clinic in Salt Lake City. In 2003, he cofounded a research facility that operated out of the same building as his pain clinic. He has focused on research since closing the clinic in 2010, most recently as vice president of scientific affairs at PRA Health Sciences.

Not referenced in the documentary is the role of pharmaceutical companies that misleadingly marketed opioids by downplaying addiction risks and convinced doctors to prescribe the potent painkillers for conditions the drugs are not approved to treat. Physicians who treat pain patients are described as victims — of overzealous authorities and coldhearted insurance companies. Also criticized is the Centers for Disease Control and Prevention, which last year issued voluntary guidelines that advise doctors that the use of non-opioid treatment is preferred for chronic pain. An undercurrent of resentment regarding media coverage of opioid addiction runs throughout the program.

“There are dozens of important stories about people with opioid addiction almost daily but rarely is there a story about people in pain,” Webster said in an email to STAT.

The program is being distributed by the National Educational Telecommunications Association, which makes the documentary available to public television stations across the country. Public television stations pay an annual fee to NETA for the rights to broadcast the programming it offers. “The Painful Truth” was brought to NETA by MontanaPBS, which acts as the presenting station and helps Webster and his co-producer market the program to other stations.

The documentary was first offered on March 1 and has been booked for broadcast in 20 markets. It is scheduled to air in the country’s largest market when it runs on WNYE in New York City Monday and has already aired on stations in Ohio, Montana, New Mexico, and Georgia, according to the documentary’s website. It can be viewed online on the PBS website.

Aaron Pruitt, director of content at MontanaPBS, said he was “not aware” of any financial connections between Webster and companies that make opioid pain relievers. “If there is some evidence of that, I have seen nothing,” he said. After being directed to public disclosures of those relationships, Pruitt wrote in an email, “As far as I can tell, he has been working with companies to find safer, less addictive treatments for patients.”

In a pitch to television stations offered the documentary, the distributors write that “NETA and MontanaPBS have carefully reviewed The Painful Truth, and the credentials of Dr. Webster. We have found Dr. Webster to be one of the country’s experts on pain treatment, a past president of the American Academy of Pain Medicine, and an advocate for the safe prescription of opioids.”

Pruitt said he and the director of programming at NETA did look into a DEA investigation of Webster’s pain clinic after several patient deaths. Government officials never disclosed what they were investigating. Webster said he received a letter informing him the investigation was closed with no action taken. The US attorney’s office in Utah was quoted in 2014 confirming there would be no prosecution of Webster.

Some of Webster’s industry relationships are detailed in the federal government’s Open Payments database. From 2013-2015, Webster was listed as the principal researcher on just over $9 million worth of contracts with pharmaceutical companies, including Pfizer Inc., Mallinckrodt LLC, Bristol-Myers Squibb Co., Jazz Pharmaceuticals Inc., and Orexo US, Inc.

While much of the research is opioid-related, the nature of the work ranges from a study of a medication to treat opioid dependence to examining the abuse potential of certain opioids. Webster said the research money is paid to whatever research company he is working for and he is not privy to details of contracts with the drug makers.

Webster has also received direct payments from industry — more than $100,000 from several companies in the 2013-2015 period reported on the government website. He received $11,400 in consulting fees and other compensation from Insys Therapeutics, an Arizona company whose marketing of a powerful prescription opioid called Subsys is the subject of numerous investigations. He was also reimbursed by the company for travel to Las Vegas, Miami Beach, and Chicago.

He was paid $3,000 by Zogenix Inc. for speaking at a non-accredited medical education event related to the company’s controversial opioid painkiller Zohydro ER, which it later sold to another company. He has received $6,000 for consulting for Depomed Inc., which makes a long-acting opioid pain medication.

The government database does not include all of Webster’s recent financial relationships with industry, and his work for pharmaceutical companies in prior years is not disclosed on the site. Webster has in earlier years reported industry relationships in medical journal articles and at speaking engagements, but the amounts and specific nature of payments are not public.

For instance, Webster reported in 2010 that he was a member of the advisory board at Purdue Pharma, the manufacturer of OxyContin, whose aggressive marketing of the prescription painkiller has been blamed for helping seed the opioid addiction crisis. Three company executives pleaded guilty to charges Purdue fraudulently marketed the drug by falsely claiming it was less addictive.

Webster also reported being a consultant for Cepahlon Inc., which at the time sold a fentanyl product called Actiq. Cephalon, which was acquired by Teva in 2011, paid a $425 million fine to resolve allegations it improperly marketed Actiq and two other drugs.

Webster was the president in 2013 and 2014 of the American Academy of Pain Medicine, which has received significant funding from pharmaceutical companies.

Among the physicians featured in the documentary is Dr. Russell Portenoy, who helped write a 1996 consensus statement on behalf of two pain societies that has been criticized for allegedly playing down the risk of addiction and overdose with opioids when prescribed to treat chronic pain. Portenoy was a frequent lecturer on the topic, although he later acknowledged that some talks he gave about the risk of opioid addiction were not true.

Both Portenoy and Webster are named as defendants in ongoing lawsuits filed by three counties in New York alleging they were part of a conspiracy with drug makers to deceptively market opioids as safe and effective in the treatment of chronic pain. The doctors, in a court filing, strongly denied the charge and called it an attack on their free speech rights to express medical opinions.

Webster said he attempted to include differing views of opioid treatment in his documentary and reached out to a member of Physicians for Responsible Opioid Prescribing, a group that has called for more cautious use of the medications. He declined to identify the person he contacted, but said it was by email and he never received a response.

Jane Ballantyne, the president of PROP and a professor of pain medicine at the University of Washington, said she was never contacted by Webster and doesn’t know of other members of her group who were. She has not viewed the documentary.

“The message should be that opioid treatment of chronic pain is the exception not the rule,” she wrote in an email. “Lynn Webster would like it to be the rule, I think — and so would pharma who keep pushing that way.” Ballantyne said she did not have any financial relationships with industry. In 2015, she reported receiving consultancy fees from a law firm that has sued prescription opioid makers.

“The Painful Truth” is critical of the DEA and features a doctor who was found innocent of charges related to illegal prescribing following a federal government investigation. Webster said he has served as an expert witness or consultant in more than a dozen cases on behalf of pain doctors charged with improper prescribing of opioids. His own case with the DEA and his expert witness work for doctors is not disclosed in the documentary.

“There is a lot in the media and press about the bad doctors and the overprescribing and the pill mills,” Webster said in an interview. “What there isn’t, and the reason for the documentary, is to bring something out that is not well-known. That is there are doctors being accused of wrongdoing when there is probably not justification. And that has had a negative impact on the ability of physicians and their interest and willingness to treat people in pain whether with an opioid or not.”

A former DEA agent is shown in the documentary saying the agency is often “used as a bogeyman.” A DEA spokesman, Russell Baer, said the allegation in the documentary that the agency has placed a bounty on pain clinics or that agents receive bonuses for successfully going after pain doctors is “false.” Baer said he “took offense” to that allegation and the accusation in the documentary that the agency views pharmaceutical companies and pain doctors as “the enemy.” He said the DEA actively works with both drug manufacturers and prescribers to find ways to address the opioid epidemic.

The patients featured in “The Painful Truth” include some who are fearful of losing access to opioid treatment, as well as those who say some doctors have refused to treat them and pharmacies have balked at filling their prescriptions. The apprehension among some pain patients that they won’t be able to get opioids has been reported in several media outlets, including STAT.

Webster acknowledged that several of the patients in his documentary are “miserable” even while taking opioids, and the documentary makes the point that better treatments are desperately needed. For now, however, he said opioid medications are often the best of several flawed options.

“With all of the focus on opioid addiction, we are forgetting many people with pain who have benefited,” he said. “It’s the only thing that keeps them from suicide.”

 

Opioid & Heroin Town Hall in the Skype Live Studio

Opioid & Heroin Town Hall in the Skype Live Studio

www.youtube.com/watch?v=99ZT94iu9gU

 

DEA Approves Syndros, a Pharma Cannabis Solution, for Schedule II Status

DEA Approves Syndros, a Pharma Cannabis Solution, for Schedule II Status

http://www.westword.com/marijuana/dea-approves-syndros-a-cannabis-solution-from-insys-for-schedule-ii-status-8904122

The Drug Enforcement Administration has awarded a Schedule II classification for a cannabis solution.

Cannabis itself is classified under Schedule I, the same classification as heroin, and marijuana advocates have long hoped that the DEA would lessen the drug’s classification to a Schedule II. While Schedule II substances still have a high potential for abuse, dependence and addiction, there are fewer restrictions on research — an area in which cannabis and marijuana products have encountered many roadblocks.

The pharmaceutical drug company Insys waited two years for the approval of Syndros, an oral remedy containing THC; this week the DEA finally gave the okay. Syndros is approved to treat nausea and vomiting, which many cancer patients suffer during chemotherapy.

Kevin Gallagher, director of compliance in government affairs at Craft Concentrates and a board member of the Cannabis Business Alliance, notes that many cancer patients already use medical marijuana to help with the same conditions that Syndros targets.

“When I was working [at a dispensary], I got to see a lot of cancer patients. These cancer patients really loved getting a mixture of CBD and THC — they would smoke it for immediate relief but take various edibles, tinctures, what have you, to really get their body feeling well,” Gallagher says. “You get that body high. You get that body release. You get that pain relief. In my experience, with cancer patients, they would come in, and some would be in for the first time. They couldn’t keep anything down, they’re going through chemotherapy, and they try cannabis for the first time. They come back a few days later and you can see there’s a smile on their face for the first time in however many weeks or months. They can actually start eating again. The nausea is much less severe, so you can really see how it really changed their lives.”

He would watch as patients begin to attain some kind of normal life, even at the most difficult and trying time they’d experienced, Gallagher adds.

“These pharmaceutical companies still think they’re going to win the battle in creating essentially fake cannabis and having to even compete with the real cannabis industry, but they’re not looking at the effects of certain terpenes or certain cannabinoids,” he says.

Another aspect of cannabis that Gallagher says pharmaceutical companies will never be able to control is home growing. Pharmaceutical-grade medicine can use very few of the substances that can be added to liquids, salves and food, or taken directly from the plant. But home growers can.

“They can just make a lot of these products at their homes,” Gallagher points out. “They don’t need to go to a doctor or go to a pharmacy to get a prescription. They can truly make a lot of this at home….This is a completely unique substance that is so readily available, and it’s so easy to take advantage of its healing nature, so it’ll be very interesting to see how that plays out.”

While Gallagher watches how the relationship between pharmaceutical companies and the cannabis industry evolves, Tom Angell, founder of the Marijuana Majority, has already identified an area where the two are already intersecting: He followed the money.

In his daily newsletter, the Marijuana Moment, Angell notes that Insys donated half a million dollars to the campaign against legalizing marijuana in Arizona. Arizona was one of nine states with cannabis legalization on the ballot last November; it was the only one that didn’t pass it. Insys is based in Arizona, he points out.

“It doesn’t really surprise me…. It’s typical big pharma,” Gallagher says. “This pharmaceutical company also produces fentanyl. You can see where that company lies. They don’t care at all about cannabis, right? This drug isn’t even derived from cannabis; it’s derived from dronabinol. It just seems like they’re trying to compete to make a more concentrated form, so they don’t want Arizona and other [states] to have legal cannabis because they don’t want to compete with real cannabis. They just want patients to take their drug that was cooked up in a lab that has nothing to do with cannabis.

“As soon as you see that this company is making fentanyl, you can see [that] what they’re more interested in is how many patents they can distribute the drug to and get a lot of money out of it,” he adds. “They obviously don’t care about a patient’s health, because they’re trying to continue prohibition in Arizona, and likely other states as well.”

Lawsuit blames improper marketing of potent opioid for woman’s death

Lawsuit blames improper marketing of potent opioid for woman’s death

IMO.. this family will probably win this lawsuit.  This drug allows the pt to administer the Fentanyl via a sublingual route. Which allows the drug to be absorbed at a rate similar to a IV injection.  Fentanyl administered like this has a rapid onset and a 30-60 minutes of pain relief.  Giving a pt this medication as their primary pain management opiate does nothing more/less than put the pt on a very violent “pain roller coaster”.  Depending on the pt’s CYP450 opiate metabolism status.. A pt could be using this medication every 30-60 minutes OR LESS in the attempt to maximize their pain management. On top of all this… the Subsys medication is EXTREMELY EXPENSIVE.

www.statnews.com/2017/03/24/opioid-insys-improper-marketing-lawsuit/

The family of a New Jersey woman who died after using a prescription version of the potent opioid fentanyl filed a wrongful death lawsuit Thursday against the drug’s maker, her doctor, and a specialty pharmacy that provided the drug.

The lawsuit, filed in a New Jersey state court, alleges 32-year-old Sarah Fuller was the victim of a nationwide push by Insys Therapeutics to entice doctors to prescribe its Subsys fentanyl spray for patients for which the drug was not suitable.

“Insys infiltrated the medical community with lies, misinformation, kickbacks and financial rewards which led to a large span of the medical community to prescribe Subsys for off-label indications for which there was no proven safe use,” according to the complaint. Insys did not respond to a request for comment.

Subsys is approved by the US Food and Drug Administration for patients with cancer who suffer from breakthrough pain that doesn’t respond to other treatments, though physicians are permitted to prescribe drugs for unapproved, or “off-label” uses. Fuller did not have cancer, and her doctor nevertheless prescribed it to her. At the time of her death, she was taking a heavy dose of the drug around-the-clock.

The lawsuit also accuses a specialty pharmacy company, Linden Care of Woodbury, N.Y., of abetting the effort by Insys to push the use of Subsys in patients who did not have cancer. The lawsuit claims the pharmacy company, which shipped Subsys to Fuller via FedEx, should not have dispensed the drug to her. Fuller’s family claims the pharmacy company did not have possession of the original prescription as required and was mandated by a special federal program to only dispense the drug to patients with breakthrough pain due to cancer.

“Insys needed a pharmacy to turn a blind eye to what it was doing and dispense Subsys throughout the country,” the complaint alleges. Linden Care declined comment.

Fuller became a patient of Dr. Vivienne Matalon in August 2014. At the time, Fuller was not taking any narcotic medications for the pain caused by two auto accidents. By October, according to the complaint, Matalon had Fuller on a regimen of oxycodone and OxyContin. In January 2015, Fuller and her father met with Matalon at her office. Also in the room was an Insys saleswoman, who was there to convince Fuller that Subsys would help treat her neck and back pain, the lawsuit charges.

She was prescribed the drug, and within three weeks, her dosage was tripled in strength. In October 2015, Fuller was admitted to the hospital, suffering from “hyper-sedation,” according to the lawsuit. She was immediately taken off Subsys and at discharge was told to discontinue use of it, along with weaning herself off OxyContin. Despite Matalon being notified by the hospital of the event and the instructions for Fuller, the lawsuit claims the doctor again prescribed Subsys for Fuller.

On March 25, 2016, Fuller died as a result of taking Subsys and the anti-anxiety medication alprazolam, the lawsuit charges. Both were prescribed by Matalon.

In the wake of the Fuller case, the New Jersey attorney general accused Matalon of “indiscriminately” prescribing Subsys and she agreed to a suspension of her medical license while her conduct is investigated by the state medical board. Attempts to contact Matalon’s attorney for comment were unsuccessful.

The disease killing white Americans goes way deeper than opioids

The disease killing white Americans goes way deeper than opioids

https://www.washingtonpost.com/news/wonk/wp/2017/03/24/the-disease-killing-white-americans-goes-way-deeper-than-opioids/?utm_term=.7cef4bba53e2

In rich countries, death rates are supposed to decline. But in the past decade and a half, middle-aged white Americans have actually been dying faster. Princeton economists Anne Case and Angus Deaton first pointed out this disturbing trend in a 2015 study that highlighted three “diseases of despair”: drugs, drinking and suicide. 

On Thursday, the pair released a deeper analysis that clears up one of the biggest misconceptions about their earlier research.

The problem of dying whites can’t only be blamed on rising rates of drug overdoses, suicides and chronic alcoholism, they say. More and more, middle-aged white Americans are dying for all kinds of reasons — and the underlying issue may have less to do with opioids and more to do with how society has left behind the working class.

“Ultimately, we see our story as about the collapse of the white, high school educated, working class after its heyday in the 1970s, and the pathologies that accompany that decline,” they write.

On the streets of Chillicothe, Ohio: ‘Shooting heroin is like drinking beer’

Chillicothe, Ohio is grappling with an addiction epidemic driven by opioids like heroin. But some here aren’t letting overdoses rule. (Lee Powell/The Washington Post)

This is slightly different than what they said in their first paper, where they emphasized that the trend of rising white mortality was “largely accounted for by increasing death rates from drug and alcohol poisonings, suicide, and chronic liver diseases and cirrhosis.” That’s technically correct — but by focusing only on the increase in death rates, Case and Deaton distracted from the larger picture.

The alarming fact isn’t just that middle-aged whites are dying faster, but also that mortality rates have been dramatically declining in nearly every other rich country. The United States is getting left behind.

In the last 15 years, a chasm opened up between middle aged whites in America and citizens of European countries like France, Germany and the United Kingdom. While white death rates in America rose slightly, death rates in those other countries continued to plummet. In comparison to what happened in Europe, the situation for American whites starts looks much more dire — and it’s a bigger problem than opioids or suicides can explain. It’s not just about what went wrong in America, but what stopped going right.

Fifteen years ago, middle-aged whites in the United States were neck and neck with their German counterparts. Now, middle-aged white Americans are 45 percent more likely to die than middle-aged Germans.

As Case and Deaton show, the gap in mortality between white middle-aged Americans and middle-aged Germans is about 125 deaths per 100,000 people now. Every year, of 100,000 Germans between the ages of 45 and 54, about 285 die. In the United States, it’s more than 410.

Out of those 125 additional American deaths, only about 40 might be explained by the spike in deadly drug use, drinking and suicides. And the rest? It’s hard to say. In their latest paper, Case and Deaton say that heart disease is part of the problem. While other countries have cut down heart disease deaths by over 40 percent in the past 15 years, heart disease remains a significant killer for white middle-aged Americans.

There’s still much left unexplained, but the latest data tell a larger — and more troubling — story. Most of the increase in white deaths is concentrated among those who never finished college. These are the same people who have been pummeled by the economy in recent decades. It’s gotten more difficult for them to find jobs, and what jobs they do come across nowadays don’t pay as well.

Yet, it’s not entirely a matter of income either. Some of these same economic trends — driven by globalization and automation — afflicted countries like the U.K. and Germany, where the death rate has been dropping. Besides, according to a Washington Post analysis of recent Census Bureau data, white American men without a college degree still earn 36 percent more than their black counterparts. But the death rate among less-educated black Americans has actually been decreasing. In recent years, the two groups have converged — they are dying at about the same rate — even though white Americans still earn more.

So the theory comes back to despair. Case and Deaton believe that white Americans may be suffering from a lack of hope. The pain in their bodies might reflect a “spiritual” pain caused by “cumulative distress, and the failure of life to turn out as expected.” If they’re right, then the problem will be much harder to solve. Politicians can pass laws to keep opioids out of people’s hands or require insurers to cover mental health costs, but they can’t turn back the clock to 1955.

An End to PBM Pick-Pocketing

An End to PBM Pick-Pocketing

https://morningconsult.com/opinions/end-pbm-pick-pocketing/

Usually when your pocket has been picked, you discover the loss pretty quickly. But many of America’s more than 22,000 independent community pharmacies are finding their reimbursements for prescription drugs reduced well after the patient hands over the co-pay and leaves with their medicine. The technical term for this transaction is a “retroactive pharmacy direct and indirect remuneration (DIR) fee.” That’s one way of putting it.

DIR fees pick the pockets of community pharmacies and their patients.

Pharmacies dispense medication and are reimbursed, only to have a portion of that reimbursement then “clawed back” by pharmacy benefit managers weeks or months after the transaction. There’s often no way to anticipate the fees, and pharmacists are seldom provided sufficient justification for the clawback.

A medication on which the pharmacy looks to break even or even turn a modest, fair profit at the time it’s dispensed can become a loss weeks after the fact when the PBM claws back a portion of the proceeds. And those losses? Well, you can’t make up for those in volume, as they say. It’s a maddening way to have to operate a business.

Pharmacies’ pockets aren’t the only ones picked. Patients get fleeced, too. DIR fees distort the accuracy of drug cost information on the Medicare Plan Finder — the only publicly available resource accessible to Part D beneficiaries who rely on this information to make critical decisions about their health care. In addition, DIR fees increase beneficiary out-of-pocket costs for needed medications and in doing so push seniors more quickly into the “donut hole”— the point at which they are responsible for 100 percent of their prescription drug costs until they reach the catastrophic coverage threshold when the taxpayers pay 80 percent of the cost In other words, Part D beneficiaries who need and use their drug plan are punished the most by DIR fees.

PBMs are health care’s shadowy middlemen, exerting tremendous control over which prescription drugs a health plan will cover and how much the pharmacies that dispense them will be reimbursed. Unfortunately for patients, pharmacies and taxpayers, PBMs have long avoided both the spotlight and the typical marketplace constraints of meaningful regulatory oversight or transparency.

This explains, at least in part, how they can clawback funds from a pharmacy so readily: no one seems to be telling them they can’t. Operating in that virtual black box enables them to extract money from the prescription drug supply chain and profit mightily — all while prescription drug prices spiral out of control.

Now, there’s a move afoot to catch the pickpocket. Bipartisan legislation has been introduced in both the U.S. Senate and House to prohibit retroactive pharmacy DIR fees. If The Improving Transparency and Accuracy in Medicare Part D Drug Spending Act (S.413 / H.R. 1038), is enacted, PBMs will no longer be able to employ pharmacy DIR fees retroactively. All of the criteria for reimbursement would be determined at the point of sale, assuring that Medicare patients are properly charged.

To be clear, the proposed legislation does not eliminate or cut pharmacy DIR fees. Instead, it ensures that all charges are included when PBMs determine the pharmacy’s reimbursement for a senior’s prescription drug. No pick-pocketing after the fact.

Congress can stop this pick-pocketing and stand up for patients and independent pharmacies by passing S. 413 and H.R. 1038.

Palm Beach County and Martin County leaders ask Governor Scott to declare public health emergency

Palm Beach County and Martin County leaders ask Governor Scott to declare public health emergency

 

I got a phone call today from a pt on the west coast

I got a phone call today from a pt on the west coast

This particular 50 y/o pt has been on a substantial benzo dose for a couple of decades to treat anxiety/panic attacks and this pt also has some cardiac arrhythmia issues.

This pt has been patronizing a particular CVS store for all these years and the pt sees a very high profile psychiatrist.

The two 50 something male pharmacists at this CVS has been taking care this pt’s needs for all these years.

In steps into this symbiotic relationship a 30 something female Pharmacist/District Manager {PDM) that “ORDERED” the two pharmacists in the store to no longer fill this particular pt’s benzo prescriptions.

Apparently this PDM’s SOP is the overwhelming use of threats, fear and intimidation.. apparently her idea of “motivating employees”.

One of the staff Pharmacists has told the pt that – and rightly so – that she has no authority to dictate to another pharmacist if prescriptions are to be filled or not filled… but… fears of ending up becoming one of CVS’s  “infamous floater”…

For those of you who are not familiar with how the typical CVS floater is treated… they are often scheduled 12-14 hr shifts and often have to drive 2 hr each way to the store they are assigned to.  So these Pharmacists are lucky if they can get 4-5 hrs sleep… which many believe that a “Tired Pharmacist … is a Dangerous Pharmacist”, but this is how CVS saves paying unemployment and hopefully avoids age discrimination lawsuit.. by getting a Pharmacist to quit or they keep working under such hostile work environment that they end up making a medication error and harming a pt or worse…. which means that the Pharmacist violates corporate policies and procedure and justifies firing the pharmacist.

Apparently this PDM has agreed to allow the pt to have another 30 days supply… to allow her time to figure things out.

Remember… part of the practice of medicine is the starting, changing, stopping a pt’s medication… so.. IMO.. this PDM decides that the pt can’t have any more medication… Is she guilty of attempting to practice medicine without an appropriate license ?  Pharmacists are not granted “prescriptive authority” under their pharmacy practice act.

This pt has already had a discussion with an attorney and I advised the pt the 5-6 different legal issues that may be involved with the actions of this PDM.

An Opioid Quality Metric Based on Dose Alone?

An Opioid Quality Metric Based on Dose Alone?

80 Professionals Respond to NCQA

 
 

Introduction: As the US comes to grips with a crisis of opioid overdose and addiction, many professionals have assessed that excessive opioid prescribing, based on weak data, helped us reach this point. Efforts to reduce prescribing while optimizing care for patients with pain, and expanding access to addiction treatment, are of cardinal importance. How we advance these objectives depends partly on changing our shared understandings of what it means to deliver good care. It also depends on policies, resources and formal methods to assess if we are doing a good job. The 2016 Guideline on Prescribing Opioids for Chronic Pain from the Centers for Disease Control and Prevention (CDC) represents one such effort.

In early 2017, a new and consequential proposal was made by the National Committee for Quality Assurance (NCQA), which seeks to advance health care quality through measurement and accreditation. NCQA’s highly influential performance measures help purchasers and consumers to assess whether health care quality is good or bad. When NCQA issued a draft set of standards related to opioids in 2017, they requested public comment. One of the measures counts the percentage of health plan members receiving opioid doses greater than the equivalent of 120 milligrams of morphine (MME), with a lower percentage counting as evidence of better care.

The premise, focused on dose, is similar to recent proposal from the Centers for Medicare and Medicaid Services. The concern about dose as an important risk factor for adverse opioid outcomes is well-justified. But well-justified concerns do not always translate into fault-free performance targets, particularly when doing so entails clinical practices not yet tested in scientific trials, and not endorsed by the CDC Guideline. Eighty doctoral level clinicians from across the country, mostly academic physicians, have endorsed the letter submitted to NCQA on March 22, 2017. They include four who had roles assisting the Centers for Disease Control and Prevention in development of the 2016 CDC Guideline, and five who edit scholarly journals in addiction medicine or pain. This document represents the opinion of signers, and not that of any agency for which they work. We welcome your feedback here or on Twitter, including two of the authors (@StefanKertesz @SubstanceAbuseJ) as well as NCQA itself (@NCQA).

Mary Barton, MD, MPP Vice President, Performance Measurement

National Commission for Quality Assurance

1100 13th Street, NW Suite 1000 Washington, DC, 20005

March 22, 2017

Dear Dr. Barton:

We write to register strong objection to the proposed “Opioid High Dosage” HEDIS measure, focused on minimizing the number patients receiving greater than 120 morphine milligram equivalents. As doctoral-level professionals in pain, in medicine and allied fields, we believe this measure will incentivize care that violates principles in the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. As a result, it will pose a serious risk to some patients currently receiving opioids. Many signatories to this letter have expertise in addiction medicine (signified “A” next to signature), or pain medicine (“P”). Persons among us who assisted the Centers for Disease Control and Prevention (CDC) in the 2016 Guideline are designated “C”. Many of us play professional roles in helping patients at high doses to taper, in mitigating opioid risk, in minimizing new opioid starts and in restraining dose escalation. Given these commitments, we understand that our strong objection to the proposed NCQA measure may come as a surprise.

To explain this objection, we must distinguish between the language of the CDC Guideline itself, and the perverse care decisions that the NCQA “Opioid High Dosage” binary measure will incentivize.

The CDC Guideline cites observational evidence associating higher opioid doses with increased adverse outcomes, including overdose. Such data justify restraint in opioid initiation (Recommendation 1) and dose escalation, with particularly careful reassessment of “evidence of individual benefits and risks” when considering increasing dosage to ≥50 mg/day and avoiding or carefully justifying decisions to titrate to ≥90 mg/day (Recommendation 5). However, the CDC Guideline did not prohibit dose escalation. Nor did it propose that any dose above a numeric threshold was “bad care”. Rather it insisted on “individual assessment of risk and benefit” as the primary basis for decision making related to both opioid dose titration and opioid dose reduction. For patients already receiving high opioid daily dosages, the CDC guideline states that “clinicians should discuss their safety concerns with the patient, consider tapering to a safer dosage (see Recommendations 5 and 7), and consider offering naloxone (see Recommendation 8).” High dose alone is not an indication for tapering or discontinuation.

On this basis, most of us wish to see an evolution toward fewer opioid starts and fewer patients at high doses. The proposed NCQA measure indulges no such subtleties. It will incentivize rapid efforts to minimize the number of patients whose current opioid dose exceeds 120 MME. The most efficient action to optimize measure performance would involve dose reduction for patients at >120 MME, regardless of patient acceptance, the mix of benefits and harms specific to the individual patient, or the potential harms of rapidly tapering patients prescribed high doses for many years. This is happening in many health systems today, despite the lack of any evidence to assess its impact on risk to patients, and the reality that the CDC Guideline did not endorse this approach.

Of particular concern, widespread unilateral dose reductions that would be incentivized by this HEDIS measure contradict Recommendations 5 and 7 of the CDC Guideline, both of which emphasize individualized assessment and decision making. Recommendation 5 applies only to new opioid starts. Recommendation 7 suggests working with patients on an individual basis to taper opioids when benefits are not sustained or when risks outweigh benefits. High dose is cited as simply one indicator of risk in the discussion of tapering. The proposed “Opioid High Dosage” measure eviscerates the CDC Guideline of these patient-centered considerations.

Put simply, the “Opioid High Dosage” measure will accelerate a reconfiguration of care that has never been tested in prospective trials and that could actually increase risk to individual patients, as illustrated by scholarly and popular reports of acute withdrawal (with death), protracted abstinence syndrome, and suicide associated with incautious unilateral opioid discontinuation or unrelenting pain.

Finally we must underscore that institutional embrace of binary quality measures based on promising epidemiologic data has sometimes proven a mistake in retrospect. This has occurred with aggressive targets for glucose, blood pressure and lipid control. Even the widespread embrace of opioids itself (an effort to optimize pain scores) reflected extrapolation from limited data in ways that courted risk to patients.

We urge NCQA to recognize that binary metrics developed in the absence of compelling controlled trials are often treacherous. And there is little to justify a HEDIS measure that contradicts the language found in CDC Guideline Recommendations 5 and 7.

We recommend that NCQA abandon the Opioid High Dosage measure until trial data and expert review permit a more appropriate consideration of this issue. We are willing to assist you in identifying alternate measures that involve lower risk to patients.

This letter includes 80 signatories, with 4 who had formal roles assisting the Centers for Disease Control and Prevention in development of the 2016 CDC Guideline. Signers include 5 who edit scholarly journals in addiction medicine or pain, 60 with academic affiliations, 33 with special expertise in addictions, and 23 with special expertise in pain. Also, several signers have focused their careers on measuring and improving quality of care.

Disclaimer: Views expressed here are those of the signers alone, and do not represent formal positions of any employing or affiliated organization, university, or United States Federal Agency.

(A): Addiction Professional (P): Pain Professional (C ): Assisted the CDC in Opioid Guideline Development as Reviewer, Core Expert, or Author

Signatories

Stefan G. Kertesz, MD, MSc (A) University of Alabama at Birmingham School of Medicine

Adam J. Gordon, MD, MPH (A) University of Utah, Editor-in-Chief, Substance Abuse

Erin E. Krebs, MD, MPH (P, C) University of Minnesota Medical School

Joanna L. Starrels, MD, MS (A, P, C) Albert Einstein College of Medicine & Montefiore Medical Center

Chinazo Cunningham, MD, MS (A, C) Albert Einstein College of Medicine & Montefiore Medical Center

Matthew J. Bair, MD, MS Indiana University School of Medicine (P, C)

Richard Saitz MD MPH, DFASAM, FACP(A) Boston University School of Public Health, Senior Editor, Journal of Addiction Medicine

Jalie A. Tucker, PhD, MPH (A), University of Florida, Gainesville, Strategic Advisor, Addiction

Jeffrey H. Samet, MD, MPH (A) Boston University School of Medicine, Board, Addiction Medicine Foundation & Editor-in-Chief, Addiction Science & Clinical Practice

Michael E. Schatman, Ph.D (P)Tufts University School of Medicine, Editor-in-Chief, Journal of Pain Research

Peter D. Friedmann, MD, MPH, DFASAM, FACP (A) University of Massachusetts Medical School-Baystate, Deputy Editor, Journal of Substance Abuse Treatment

William M. Tierney, MD, MACP, Dell Medical School, University of Texas at Austin, Past President, Society of General Internal Medicine

Robert M Centor, MD, University of Alabama of Birmingham School of Medicine, Master, American College of Physicians, Past President, Society of General Internal Medicine

Nancy L. Keating, MD, MPH, Harvard Medical School and Brigham and Women’s Hospital

Max Michael, MD, Dean, University of Alabama at Birmingham School of Public Health

Ken Freedman, MD, MS, MBA (A) Tufts University School of Medicine, Boston, MA

Jane M. Liebschutz, MD MPH, (A,P) Boston University School of Medicine

Julia Lindenberg MD, Beth Israel Deaconess Medical Center

Terrence Shaneyfelt MD, MPh, University of Alabama at Birmingham School of Medicine

Name Redacted

Laurie Gordon, MD, New York, NY

David E. Pollio, PhD (A), Chair, Department of Social Work, University of Alabama at Birmingham

Daniel Pomerantz MD MPH FACP, Albert Einstein College of Medicine, New York

Toshiko Uchida, MD, FACP, Northwestern University Feinberg School of Medicine

John D. Goodson, MD, FACP. Harvard Medical School, Massachusetts General Hospital

Daniel P. Alford, MD, MPH, FACP, DFASAM (A, P) Boston University School of Medicine, Boston Medical Center

Carol K. Bates, MD, FACP, Harvard Medical School and Beth Israel Deaconess Medical Center

Lynn Webster, MD (P) Vice President, PRA Health Science and Past President, American Academy of Pain Medicine

Marcus A. Bachhuber, MD, MS, Montefiore Medical Center/Albert Einstein College of Medicine

James DeMicco, PharmD, Hackensack, New Jersey

Joseph W. Frank, MD, MPH (P) VA Eastern Colorado Health Care System and University of Colorado School of Medicine

Kimber P. Richter PhD, MPH (A) University of Kansas School of Medicine

Saul J. Weiner, MD, University of Illinois at Chicago School of Medicine

Michael Banks, MD, Orothwest

Michael Fingerhood MD FACP (A), Johns Hopkins University School of Medicine

Josiah D. “Jody” Rich, MD, MPH (A), Warren Alpert Medical School of Brown University

Signatory’s name redacted by request

Monika M. Safford, MD, Weill Cornell Medicine, New York, NY

Lauren Broyles, PhD, RN (A), Grant Writer’s Seminars and Workshops, VA Pittsburgh Healthcare System

Gerald Cochran, MSW, PhD (A), University of Pittsburgh, School of Social Work, School of Medicine

Ryan Kraemer, MD, University of Alabama at Birmingham School of Medicine

Thomas S. Huddle, MD, PhD, University of Alabama at Birmingham School of Medicine

Terri A, Lewis, PhD, NCoC, Southern Illinois University-Carbondale, Rehabilitation Institute

David Nagel, MD (P) private practice, author, “Needless Suffering; How Society Fails Those with Chronic Pain.”

Stephen J. Ziegler, PhD, JD, Indiana University-Purdue University, Dept of Public Policy

Janey C. Peterson EdD, MS, RN (P), Weill Cornell Medicine, New York, NY

Stephen A. Paget, MD (P) Hospital For Special Surgery, Weill Cornell Medicine, New York, NY

Diana Coffa, MD (P) (A), University of California, San Francisco, CA

Paula J. Lum, MD MPH FASAM (A), University of California, San Francisco, CA,

Tim Lahey, MD MMSc, Dartmouth’s Geisel School of Medicine

Diane S. Morse, MD (A), University of Rochester School of Medicine

Elvin Geng, MD MPH, University of California, San Francisco School of Medicine

Emma Stanton, MD MBA (A), Beacon Health Options

Thomas E. Reznik, MD, MPH (P), Providence VA Medical Center and Warren Alpert Medical School of Brown University

Barbara Herbert MD FASAM (A) Senior Medical Advisor, Column Health, Arlington Mass

Ingrid Binswanger, MD, MPH, MS (A) University of Colorado School of Medicine, Aurora, CO

Michael F. Bierer MD MPH (A) Harvard Medical School Boston MA

Howard Hoffberg, MD, (P) Rehabilitation and Pain Management Associates, Baltimore MD

Signatory’s name redacted by request

Thomas Sachy, MD, MSc, (P) (A) Georgia Pain and Behavioral Medicine, Gray, GA

Kevin R. Riggs, MD, MPH, University of Alabama at Birmingham School of Medicine

Calie Santana, MD, MHS, Internal Medicine, WESTMED Medical Group

Stephen Martin, MD, EdM (A) University of Massachusetts Medical School

Monica Gandhi MD, MPH, Professor of Medicine and Ward 86 Clinic Director, UCSF

Janet Grochowski, PharmD, Clinical Pharmacist, Positive Health Program (Ward 86), UCSF

Zackary Berger, MD, PhD, Johns Hopkins School of Medicine

Royce C. Lin MD, University of California, San Francisco School of Medicine

Sarah E. Wakeman, MD, FASAM (A), Massachusetts General Hospital, Harvard Medical School

Thomas Sachy, MD, MSc, (P) (A), Georgia Pain and Behavioral Medicine

Paul Arnstein, RN, PhD, FAAN (P)

David S. Craig, PharmD, Moffitt Cancer Center, Tampa FL

Michael J, Brennan, MD (P) The Pain Center of Fairfield, Fairfield CT

Sri Nalamachu, MD (P), Overland Park, KS

Jayne Pawasauskas, PharmD, BCPS (P) University of Rhode Island College of Pharmacy

Jeffrey Fudin, B.S., Pharm.D., DAAPM, FCCP, FASHP (P), President and Director, Scientific and Clinical Affairs, REMITIGATE, LLC

Debra F. Hobbins, DNP, APRN, LASUDC, CARN-AP, Anchorage, AK

Shelley Trazkovich, M.D (A) (P), Reisterstown, Maryland

James Patrick Murphy, MD, MMM, FASAM (A,P); Murphy Pain Center; Univ of Louisville Sch of Medicine; Past Pres, Greater Louisville Medical Soc

Anika Alvanzo, MD, MS, FASAM, FACP (A), Johns Hopkins University School of Medicine

Teresa Bryan, MD, University of Alabama at Birmingham School of Medicine

 
 
 
 
 
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