Senators Pressed DEA to Cut Rx Opioid Supply

Posted on November 13, 2017 by Pharmaciststeve

Next year ( Nov 2018) 34 Senators are up for re-election

https://www.painnewsnetwork.org/stories/2017/11/13/senators-pressured-dea-to-cut-rx-opioid-supply

A group of 16 U.S. senators played an influential role in getting the Drug Enforcement Administration to make further cuts in the supply of opioid pain medication, the latest example of how politicians have inserted themselves into the healthcare choices of Americans.

As PNN reported, the DEA published an order last week in the Federal Register that cut the 2018 production quotas for Schedule II opioid painkillers by 20 percent. It’s the second year in a row the DEA has ordered steep reductions in the supply of opioids. The move affects several commonly prescribed medications that millions of pain patients rely on for relief, such as oxycodone, hydrocodone, morphine and codeine.

The DEA acted even after drug makers and patients warned the agency that the cuts were so severe they could lead to shortages of pain medication. Under federal law, the DEA sets production quotas for manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more.

The 16 senators – 15 Democrats and one independent – have been urging the DEA for months to go even further to reduce the risk of opioid painkillers being abused.

“As the gatekeeper for how many opioids are allowed to be sold legally every year in the United States, we commend DEA on taking initial steps last year to lower production quotas for the first time in a generation,” Democratic Sen. Dick Durbin of Illinois wrote in a letter to DEA Acting Administrator Chuck Rosenberg on July 11.

“However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic.”

SEN. DICK DURBIN

SEN. DICK DURBIN

Durbin’s letter was co-signed by 15 of his Senate colleagues: Sherrod Brown (D-OH), Amy Klobuchar (D-MN), Edward Markey (D-MA), Joe Manchin (D-WV), Dianne Feinstein (D-CA), Claire McCaskill (D-MO), Patrick Leahy (D-VT), Tammy Baldwin (D-WI), Jeanne Shaheen (D-NH), Kirsten Gillibrand (D-NY), Catherine Cortez Masto (D-NV), Maggie Hassan (D-NH), Richard Blumenthal (D-CT), Al Franken (MN) and Angus King (I-ME).

Durbin followed up with a personal meeting with Rosenberg at DEA headquarters on August 3. The meeting was also attended by Senators Brown, Shaheen, Manchin, Markey and Hassan.

“I commend Administrator Rosenberg for acknowledging that the DEA can do more to keep dangerous painkillers off our streets,” Durbin said in a statement after the meeting.  “In today’s meeting, I asked him to continue this effort and further lower the opioid quotas for 2018.  Fewer pills on the market means less addiction and, hopefully, fewer deaths.”   

rosenberg (left) meeting with durbin and other senators

rosenberg (left) meeting with durbin and other senators

“In today’s meeting, I asked him to continue this effort and further lower the opioid quotas for 2018.  Fewer pills on the market means less addiction and, hopefully, fewer deaths.”   

The August 3 meeting is important, because the very next day the DEA announced it would publish a notice in the Federal Register that it was planning a 20% reduction in Schedule II opioids for 2018.

The notice opened up a 30-day public comment period on the DEA’s proposal. Over a hundred people wrote in, most of them pain sufferers who warned the DEA it was going too far.

“The quotas for 2017 caused some shortages at pharmacies. I do not understand the reasoning behind more aggressive production quotas for 2018. People I know who are long term chronic pain patients have gone to the pharmacy for their prescription and are told that it will be a week or 10 days to fill the prescription,” wrote Marjorie Zimdars-Orthman. “It is cruel to implement quotas that will cause pharmacy shortages.”

“This is just beyond insane. Far too many people are already suffering and committing suicide due to not being able to get proper pain management,” said Eric Busch. “Even those that find a doctor willing to actually treat the pain humanely and write a prescription, might not be able to fill said prescription if there are artificial quotas and shortages.”

“How can the government ensure that these quotas will not adversely affect pain patients?” asked Brian Teer, whose wife has suffered from chronic pain for nearly 20 years. “I implore you to consider the medical needs of unfortunate patients like my wife, who face the burden of untreated intractable pain. Please do not reduce the production of the very medications that she needs to continue living. Please do not take her life.”

The DEA said three unidentified drug makers also made comments, warning that the 2018 quotas for codeine, fentanyl, hydrocodone, methadone, morphine, oxycodone and oxymorphone “were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States.”   

The only comment left in support of the 2018 production quotas included a second letter from Durbin and his colleagues, warning that opioid supplies “remain far too high.”

“Given everything we now know about the threat posed by opioids and DEA’s downstream efforts to tackle this problem, there is no adequate justification for the volume of opioids approved for the market,” the letter said.

In the end, the DEA sided with the 16 senators, ruling that the 2018 opioid quotas were “sufficient” to meet the needs of patients. The agency dismissed the comments from pain sufferers as medical complaints that were “outside of the scope” of its final order.

“These one hundred and six comments did not provide new discrete data for consideration, and do not impact the original analysis involved in establishing the 2018 aggregate production quotas,” wrote Robert Patterson, who became acting head of the DEA after Rosenberg resigned unexpectedly in September.

Opioid Quotas Should ‘Continue to Come Down’

Sen. Durbin and his colleagues are apparently not done yet, and may seek to rein in the supply of opioids even further in 2019.

Durbin recently joined with Sen. Markey in introducing the Opioid QuOTA Act, a bill that seeks more transparency from the DEA in disclosing how it sets opioid production quotas. The legislation would require the agency to list on its website the production quota for each opioid manufacturer, information that the DEA now considers confidential.

“The public deserves the right to know which drug companies are manufacturing these opioids, how many they are producing each year, and their justification for asking the DEA to approve their ever-increasing quota requests,” Durbin said in a statement.

“Our work will not be done until these quotas continue to come down, doctors become more judicious in their prescribing, drug companies stop misleading the public about their products, and we do more to help those who are currently addicted get treatment.”

Along with Durbin and Markey, the legislation is co-sponsored by Senators Manchin, Brown, Shaheen and Hassan – the same group of senators that met with the DEA administrator in August and pressed him to make further cuts in the opioid supply.

 

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Can Jeff Sessions Wreak RICO Ruin on America’s Cannabis Industry?

Posted on November 13, 2017 by Pharmaciststeve

www.marijuanapolitics.com/can-jeff-sessions-wreak-rico-ruin-americas-cannabis-industry/

Attorney General Jeff Sessions remains a sworn enemy of all things marijuana. Alarmingly, a half-century old law may now give him the power to soon devastate medical marijuana and the thriving American marijuana businesses. The 1970 Racketeer Influenced and Corrupt Organizations Act (RICO) was designed to attack organized crime, the mafia. Since then vaguely written act has metastasized into any easy,  too easy, way for prosecutors to score wins, with horrendous punishment inflicted upon the prosecuted. Now the RICO law gives Jeff Sessions an easy, too easy, way to bust the robust American cannabis industry.

Even without RICO, Jeff Sessions has, as attorney general, a range of powerful prosecutor tools for his vendetta against cannabis.

Foremost is marijuana’s misplaced but long-standing status as a Schedule I drug, highly dangerous and without medical use, the most restrictive and punitive classification. This horrendous legal blunder has lasted decades. The best hope for change was under the last presidency, but it did not happen. Please see Obama Leaves Behind a Marijuana Nightmare. Marijuana as Schedule I gives Jeff Sessions enormous powers to destroy the lives of Americans involved with cannabis medically or as entrepreneurs.

  • Schedule I confers strict mandatory minimum sentencing, often decades of prison time, along with enormous fines.
  • Schedule I makes cannabis business people pariahs to the banking system, forcing risky, cash-based business practices.
  • Schedule I triggers nightmare IRS 280e tax treatment, disallowing common business deductions.

Another key weapon treasured by Jeff Sessions is asset forfeiture, the taking of citizen’s cash and property of the police and prosecutors. Asset forfeiture allows the DEA and other police to simply take money and property without even making an arrest, simply by declaring the cash to be drug-related. Sharing schemes with the feds allow local and state police to send such lucre to the DEA whereby most of it is returned to the agency who took it, allowing them to spend it as they please while avoiding state laws restricting asset forfeiture.

 

Another discretionary tool available to the attorney general is the direction given to 93 US attorneys and their 5,000 assistant attorneys. As one of his first acts in office Sessions mandated his attorney army to always pursue the harshest treatment of drug defendants.

Potent as these weapons are, RICO adds a dangerous legal opportunity for Sessions to harm the lives of those he chooses. The Racketeer Influenced and Corrupt Organizations Act was written to powerfully assist the prosecution of people working together in what the government considers crimes.

Conservative radio host Hugh Hewitt recently chided Jeff Sessions for his lack of aggressiveness regarding the rapid spread of marijuana legalization. Perhaps unaware of the banking restrictions in place, Hewitt asked,

A lot of states are just simply breaking the law. And a lot of money is being made and banked. One RICO prosecution of one producer and the banks that service them would shut this all down. Is such a prosecution going to happen?

But one prosecution that invokes a supremacy clause against one large dope manufacturing concern, and follows the money as it normally would in any drug operation and seizes it, would shut, would chill all of this. But I haven’t seen on in nine months, yet. Is one coming?

Supposedly a conservative, Hewitt should be ashamed of himself for such anti-Federalist, anti-states rights, and anti-business sentiments.

L. Gordon Crovitz, writing for Reason.com explains some of the prosecutorial advantages of RICO:

With the vague crime of RICO, prosecutors have enormous power to bring cases against targets simply because they are in some way unpopular.

The act is prized by prosecutors and mourned by civil libertarians. It allows the additions of federal crimes on top state charges for ‘predicate acts.’ Growing or transporting marijuana is such a predicate act. The addition of these federal RICO charges add long prison terms, tripled fines, and other crippling punishments.

As scary as Session’s ability to use RICO as a club is the fact that states, even individuals, can use RICO to attack activities they dislike, activities including growing marijuana. The Cannabist documents a recent case where horse farm neighbors complained–and sued through RICO–that the smell of marijuana reduced their property value. 10th U.S. Circuit Court of Appeals in Denver ruled may present big RICO problems. Alicia Wallace reports, “In remanding that case to district court, the judges left the door open for something that legal experts and case attorneys say could rattle the legal marijuana industry: that private-property owners could potentially bring federal racketeering claims against neighboring marijuana grows and dispensaries.”

Whatever their form, RICO laws are a danger to cannabis entrepreneurs. Stay tuned to see how Jeff Sessions and perhaps anti-cannabis citizen groups put them to use. 

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‘My only other option is to die’: N.S. woman dismayed by pain clinic closure

Posted on November 13, 2017 by Pharmaciststeve

‘My only other option is to die’: N.S. woman dismayed by pain clinic closure

http://atlantic.ctvnews.ca/mobile/my-only-other-option-is-to-die-n-s-woman-dismayed-by-pain-clinic-closure-1.3672496

A Nova Scotia woman says if the Dartmouth Pain Clinic closes, she will be left with two options: seek her medication illegally on the streets, or end her own life.

Dawn Rae Downton has been living with chronic pain due to sacroiliitis, a form of inflammatory arthritis, for more than two decades and has been a patient at the Dartmouth Pain Clinic for nearly 10 years. On Thursday, a message on the answering machine at the clinic told patients it would be closing for good on Dec. 31.

“I had a very good pain physician there. He knew how to treat me, he knew that it was appropriate to treat me with fentanyl,” she said.

She says her physician at the pain clinic told her in July that he would be retiring in another three to four years, so it was a shock to hear in October that he planned to close his practice at the end of this year.

“Since then, I’ve looked for anyone – a (general practitioner) who will prescribe, another pain specialist. I’ve looked through Nova Scotia, I’ve looked across the country, I’ve looked into the United States,” she said.

Despite her search she has not been able to find help. Her family physician dropped her as a patient this year, and Downton says it’s because she is an opioid patient.

“My only options are now to go to the street to a street dealer. Not sure if I can afford that, not sure if I will get what I’m hoping to get, rather than something deadly. My only other option is to die,” she said. “And that’s a good option, because if I went back to the kind of pain that I had before I was seen by a pain clinic and put on fentanyl, I just couldn’t tolerate it. It would be pointless to go back to that kind of life.”

“I was unable to stand, to walk, to sit, to lie down and especially not to sleep, there was so much pain involved,” she said.

Downton says she waited nearly four years to get into a pain clinic. Doctors tried to treat her pain with non-medicinal therapies, including acupuncture, mindfulness, and physiotherapy. She says she also tested a number of pharmaceutical options, but nothing worked. As a last resort, she was put on fentanyl patches.

“And they gave me back my life,” she said. “So to be facing a situation now where I don’t have adequate pain meds leaves me with an intolerable life.”

The Nova Scotia Health Authority says a new pain specialist will start working in a private practice in Dartmouth in January. Another specialist is being recruited. It’s not clear how many of the Dartmouth Pain Clinic patients they will take on. In fact, the NSHA is unable to say how many patients the clinic has.

“We are doing our utmost and we are going to try to increase our capacity so we can look after these patients,” said Dr. Romesh Shukla, the chief of anesthesiology for the NSHA’s central zone.

Dr. Shukla says the Dartmouth Pain Clinic’s specialist, Dr. Robert Paterson, may continue to see patients after the closure date.

“He’s going to try to take some time to look after (patients) appropriately so that patients are looked after, whether it’s medication or other treatment he’s providing,” Dr. Shukla said.

For now, the wait list at the Pain Management Unit at the Queen Elizabeth II Health Sciences Centre in Halifax will grow. According to the NSHA, there are 850 patients on the Halifax Pain Clinic waitlist, and the 550 patients from the Dartmouth waitlist will be added to that.

The health authority says because patients are triaged for priority and based on new approaches to managing pain, patients are expected to be seen within 14 to 18 months.

However, if you are looking for experts learn more about Philip Naiman Physiotherapy here as they are know for innovative ways to curb the pain caused by an injury. One of the physicians at the Halifax Pain Clinic has told patients today that the wait list was between 13 and 16 months before the Dartmouth patients were added, and it is now more than two years.

Terry Bremner is an advocate for patients with chronic pain. He’s raised concerns before about patients feeling squeezed because of pressure on physicians to stop prescribing opioids.

Nova Scotia’s College of Physicians and Surgeons endorses a national guideline for prescribing opioids for chronic pain patients that was written this year. It recommends against the use of opioids.

Bremner says news of closure of the Dartmouth clinic is devastating, especially during National Pain Awareness Week, and he warns it will make it more difficult for patients to get care.

“We’re very complex individuals and we take up more time in the doctors’ offices, so the GPs want to pass us along to someone that specializes,” he said. “And that’s where we come into our wait times and these wait times are unacceptable.”

 Dawn Rae Downton has been living with chronic pain due to sacroiliitis, a form of inflammatory arthritis, for more than two decades and has been a patient at the Dartmouth Pain Clinic for nearly 10 years.

 

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The FACES OF PAIN … normally INVISIBLE to all but the pt’s family

Posted on November 13, 2017 by Pharmaciststeve

https://youtu.be/RjrJnriz6y8

https://youtu.be/0CuFEgnz8yA

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Imagine this: A functioning addict… not committing crimes

Posted on November 13, 2017 by Pharmaciststeve

https://www.wsbtv.com/news/2-investigates/prescription-heroin-the-alternative-approach-to-opioid-addiction/643637593

ATLANTA – As deaths continue to escalate from the opioid and heroin crisis across the country and here in Georgia, Channel 2 Action News visited an addiction clinic doing something you may say is unthinkable: giving heroin to addicts.

Despite the controversy, studies and patients experiences back up the success of the approach.

MONDAY AT 6: Miami, Biloxi, NYC: APD spent thousands to recruit in popular tourist destinations

The idea behind it is simple: If addicts are going to use heroin, why not give it to them in a safe environment?

[READ: Georgia among the top states with opioid overdose deaths]

The drugs are not contaminated, addicts don’t turn to crime and they can start to rebuild their lives.

Such treatment may seem irrational, even dangerous, but it’s gaining attention as the U.S. and Georgia battle an epidemic of overdose deaths.

Of the 1,300 overdose deaths in Georgia, in 2015, 900 of them were due to opioids and heroin.

[READ: Fulton County to sue drug manufacturers in fight against opioid epidemic]

Channel 2’s Tom Regan flew to Vancouver, Canada to see the heroin-assisted-treatment program at Providence Crosstown Clinic. The treatment is directed at hard-core heroin addicts who don’t benefit from other medications like methadone and suboxone.

With nurses standing by with naloxone, the clinic said it’s never had a fatal overdose.

2 Investigates take a look at the program’s success and if the approach could work in the United States, and here in Georgia, to fight the opioid crisis, Monday on Channel 2 Action News at 5 p.m.

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CDC guidelines: fewer opiates being prescribed… pt’s pain levels UP… suicides UP

Posted on November 13, 2017 by Pharmaciststeve

2017 CDC SURVEY RESULTS

Thank you for your interest in our survey on the impact of the CDC’s opioid prescribing guidelines. The online survey of 3,108 pain patients, 43 doctors and 235 other healthcare providers was conducted between February 15 and March 11, 2017 by Pain News Network and the International Pain Foundation (iPain).

Questions Q3 through Q10 were answered by pain patients only, while Q11 through Q19 were answered by doctors and healthcare providers.

Thanks to everyone who participated in this valuable survey.

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NY Post Spreads DEA Disinformation Regarding Kratom

Posted on November 12, 2017 by Pharmaciststeve

NY Post Spreads DEA Disinformation Regarding Kratom

www.inquisitr.com/4617297/ny-post-spreads-dea-disinfo-regarding-kratom/

The New York Post recently published an article regarding kratom that relied heavily on blatant misinformation supplied by the DEA. The article claimed 10 percent of the 23,000 respondents to the call for public comments claimed they supported the DEA ban. They relied on a claim of 15 attributable deaths related to kratom that has bee debunked numerous times. There was also an “anonymous source” who alleged serious withdrawal symptoms related to kratom. Kratom is a Southeast Asian plant related to coffee used for hundreds of years as a folk medicine that many consider to be a life-saver.

The claim that 10 percent of users experienced ill effects from kratom is in conflict with the analysis performed by the American Coalition of Free Citizens. The ACFC findings revealed the actual number to be just under 1 percent. The ACFC’s analysis found 99.1 percent of the 23,000 respondents were in favor of kratom. Only 113 of the 23,000 supported the DEA’s proposed extra-judicial ban. In addition, 48 percent of the respondents were veterans, law enforcement officials, health care professionals and scientists. This population of the respondents came out in favor of kratom and against a ban with a support level of 98.7 percent. Twenty-one percent of the filers who indicated age were 55 or older. Many users of kratom prefer the plant to prescribed pain medication because it is more effective and doesn’t have the same side effects of intoxication and addiction that pain pills do. The 90 percent figure offered by DEA spokesperson Melvin Patterson that the NY Post offers is completely fabricated.

Of the “15 cases of death attributed to kratom,” Dr. Babin cites academic papers regarding a forensic study that revealed 9 deaths attributed to kratom were connected to ingestion of the research chemical o-desmethyl-tramadol. Other deaths involved presence of other drugs in combinations that were more likely to prove fatal. To date, no deaths connected to kratom or its active constituents has occurred even in laboratory animals either due to respiratory depression, lethal overdose or other causes.

The New York Post also makes a point to mention how kratom can bind to the same receptors as opioids. This isn’t misinformation, per se, but it would be more honest to point out that milk, dairy products, and cheese have been shown to bind to opiate receptors as well. The coffee plant has also been shown in studies to result in “potent opiate receptor binding activity.” The coffee plant is actually closely related to kratom. Both are members of the Rubiaceae family. The difference is, caffeine overdose actually does lead to a small number of deaths per year, unlike kratom.

In addition to false claims regarding the percentage of people who experienced withdrawal symptoms from kratom and false claims regarding deaths attributable to kratom, the NY Post reported an “anonymous source” who experienced serious withdrawal from kratom involving vomiting. Multiple studies have confirmed that kratom doesn’t cause physical dependence and withdrawal symptoms are mild and comparable to caffeine withdrawal.

As for kratom being responsible for deaths, recently two coroners were debunked by lawyer and molecular biologist Dr. Jane C. Babin, PhD, molecular biology, Purdue University, and JD, University of San Diego School of Law. Dr. Karl V. Ebner, PhD, is a consultant at KETox Forensic Toxicology Consulting and author of numerous depositions, reports, and opinions related to drug and alcohol-related cases. Dr. Ebner concurred that Dr. Babin’s report “very troubling indications” of incorrect attribution of death to kratom, once again.

When the DEA attempted a ban of kratom at the end of the legislative season the kratom community leaped into full force in record time. 142,000 signatures were received on a White House petition to reverse the ban and three separate actions by congressional representatives were also issued including an official letter of objection to the Office of Management and Budget by Rep. Mark Pocan (D-Wis.) and Rep. Matt Salmon (R-Ariz.) signed by 51 members of the House of Representatives, a Dear Colleague objection led by Sen Orrin Hatch (R-Utah) and a letter of opposition to the DEA from Sen. Cory Booker (D-N.J.), Sen. Kirsten Gillibrand (D-N.Y.) and Sen. Ron Wyden (D-Ore.).

Pharmacologist Dr. Christopher McCurdy and several other experts in the field of pharmacology, ethnobotany and drug addiction addressed their concerns about how a proposed ban could “cripple painkiller research” and shut down a valid alternative used by thousands. CNN‘s Dr. Sanjay Gupta has theorized kratom could help end the opioid crisis. Last year, Dr. Babin wrote to DEA’s Office of Diversion Control to note that their initial conception of the plant was based on “contradictory opinions, incomplete knowledge of the most current scientific evidence and without input from the public on their experience with kratom.”

As for the addictive nature of kratom, Dr. Jack Henningfield is a professor at Johns Hopkins University and one of the foremost researchers on addiction performed a comprehensive 8-factor analysis on the addictive potential of kratom. According to Dr. Henningfield, “It’s important to understand that although kratom has some mild effects similar to opioids, its chemical make-up is different, and it appears overall much safer, with apparently relatively small effects on respiration. In fact, kratom’s analgesic effects and impact on energy, combined with its favorable safety profile supports continued access by consumers to appropriately regulated kratom products while research on its uses continues.”

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Montana leads the nation in suicides per capita

Posted on November 12, 2017 by Pharmaciststeve

Montana needs a pain patient bill of rights

http://helenair.com/opinion/letters/montana-needs-a-pain-patient-bill-of-rights/article_4fd8c999-ae65-5cab-9d78-0c7f65290c95.html

“But pain patients are particularly vulnerable. They die by suicide at twice the rate of the general population. In 2014, 28,000 took their lives.” (http://www.painmedicinenews.com/Policy-and-Management/Article/11-17/Opioid-Crisis-Continues-to-Pressure-Physicians-But-Patients-Bear-the-Pain/45054)

This article points out the crisis — currently invisible — of suicides in pain patients. Given that Montana leads the nation in suicides per capita, would it not be prudent to take whatever measures we can to prevent them?

 

There are several high profile suicides that have been noted in the press (Bryan Spece, Bob Mason). Many, of course, are not found in the press, but the agony for their families is no less. Perhaps you could call for hearings on this very subject. Get to what is so, and respond appropriately.

As you already know from all the hundreds of emails and articles I have sent you, and from this article above, palliative care of the 100,000,000 pain patients in America is disappearing, and that would be 100,000 patients in montana. (See the IOM report on pain in America 2011 for the data).

In Montana, as I have noted before, opiate refugees actually have been seeing doctors outside the state, and killing themselves as access has been withdrawn. This is a public health crisis right under our noses, and I am again sounding the alarm today. Please look into this.

As you know, the Board of Medicine takes no policy actions, just punitive ones. They have cast a pall over pain care by punishing doctors for “over-prescribing,” though no one has ever defined that term. And no one has been sanctioned for “under prescribing,” which must exist if over-prescribing does!

“The Board seeks to assure that no Montanan requiring narcotics for pain relief is denied them because of a physician’s real or perceived fear that the Board of Medical Examiners will take disciplinary action based solely on the use of narcotics to relieve pain. Although improper use of narcotics, like any improper medical care, will continue to be a concern of the Board, the Board is aware that treatment of malignant and especially nonmalignant pain is a very difficult task. The Board does not want to be a hindrance to the proper use of opioid analgesics. Treatment of the chronic pain is multifactorial, and certainly treatment with modalities other than opioid analgesics should be used, usually before long-term opioids are prescribed. Use of new or alternative types of treatment should always be considered for intractable pain periodically, in attempts to either cease opioid medications or reduce their use.”

 

This was the board’s policy on pain management until it disappeared from the BOME’s website somewhere around 2013, with no fanfare and no notice to physicians in the state. The MMA has been notified of this issue, and unfortunately has not acted either, as they are controlled more by specialty intervention doctors. This is a sad truth. I learned from MMA leadership courses that “What Don’t We Know?” Is a useful question to use to manage crises.

This problem can be solved by increasing safety in medicine (like was done with cars), sharing knowledge and using good evidence. Since legislators and federal agencies have made this a political issue, I again bring it to your attention.

We need a pain patient bill of rights in Montana, patterned on those of other states and compassion toward the 100,000 patients in pain in our state, as well as the 10-15,000 pain refugees that suffer daily here.

Sincerely,

And in good health, 

Mark Ibsen, MD

Helena

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There are dozens of cases of reported suicides after pain patients had their doses reduced

Posted on November 12, 2017 by Pharmaciststeve

Cracking Down on Opioids Hurts People With Chronic Pain

https://tonic.vice.com/en_us/article/8x5m7g/opioid-crackdown-chronic-pain-patients-suicide

Before he broke his back in a 1980s accident that ultimately triggered years of chronic pain, Jay Lawrence had to make a split-second decision. He was on a bridge with a car in front of him and the brakes on his truck had failed. “He saw a baby seat in the car and he hit the bridge,” says his widow, Meredith Lawrence. She lost her husband to suicide earlier this year after his doctor abruptly decided to cut down his opioid pain medication.

 “He had this great big personality,” she says, describing how Jay loved to be around people and constantly insisted on helping her, even when he was in severe pain.

But in March, Jay Lawrence shot himself with a gun that he insisted she purchase for him. He was 58. They were together in a park in Tennessee, near where, just two years earlier, they had renewed their wedding vows. When he died, Meredith was holding his hand. Afterwards, she called the police and was arrested for assisting a suicide (she’s now on probation).

Jay had warned his wife that there might come a day when the pain became too much for him. He’d had three back surgeries, countless steroid shots and nerve blocks, an electrical stimulator, a morphine pump, and several different types of prescription and non-prescription pain medications. He’d become resigned to the fact that he wasn’t going to regain function, but on good days he could make Meredith coffee before she went to work and help tend to their menagerie of nine cats and two dogs.

Then, in February, his doctor decided he would no longer prescribe the dosage of opioids that allowed Jay this small modicum of function. Since the introduction of the Centers for Disease Control and Prevention’s guidelines for opioid prescribing in 2016, physicians who have chronic pain patients on doses higher than the equivalent of 90 milligrams of morphine a day are under increasing scrutiny, by both civil and criminal authorities.

 Though Jay had not misused the drugs or shown any signs of trouble, he was told that his dose would immediately be cut from 120 milligrams of morphine to 90 and would drop again within two weeks. “I will not do this,” Meredith says he told her. And so, when she couldn’t find another doctor for him and saw that his mind was absolutely made up, she agreed to help. “He was the most stubborn person I ever met,” she says.

“It was either that or I would come home and find him,” she says, adding that she didn’t want that to be her last memory of him and certainly did not want him to die by himself.

“This would not have happened if they’d just left him alone,” she says.

Unfortunately, Jay is far from alone in being subjected to an involuntary opioid dose reduction. Since the guidelines were rolled out, 70 percent of more than 3,000 chronic pain patients who participated in an online survey by Pain News Network reported that doctors had either reduced or simply cut off their medications.

And Jay is also far from the only person to have taken their life in response: several dozen similar cases have been documented by a growing and furious group of pain patient advocates and doctors (who are not funded by pharmaceutical companies), and who are starting to organize in the aftermath of the crackdown.

The stories are nearly unbearable to read: descriptions of various forms of intense agony, mitigated to some extent with medication, which is then stopped regardless of the patients’ pleas. And then, death: often by shooting, sometimes by overdose.

 

“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, who is trying to raise alarm over the problem with the CDC and other health authorities. Kertesz says he receives numerous emails and social media posts from patients who are suffering and thinks the government needs to fund research to specifically track the outcomes of these patients. “Widespread suicidal ideation should be seen as a signal of a major risk,” he says.

Although the guidelines were intended to be voluntary and to apply only to general practitioners—not pain specialists—they’ve been widely interpreted as a mandate. Doctors who have patients on doses that exceed the guidelines receive letters from insurers and medical boards suggesting that they cut back; state Medicaid policies have been implemented that actually do mandate a maximum legal opioid dose and pharmacies like CVS are imposing their own limits on what they will dispense. The National Committee for Quality Insurance will now rate healthcare organizations on whether they keep doses below the limit—despite a protest letter signed by multiple experts involved in developing the CDC guidelines.

All of this is occurring despite wide individual variation in opioid metabolism (meaning a high dose for one patient will be a low dose for another), tolerance (over time, higher doses can become necessary), pain condition (again, immensely variable) and a complete lack of research showing that forcibly lowering opioid dose is safe or effective.

 

“It remains the case that there is no evidence that mandated prescribing reduction results in better outcomes for patients,” say Kertesz. While some data suggests that some patients improve with voluntary dose reductions—higher doses may sometimes paradoxically increase pain, a phenomenon known as hyperalgesia—none shows that forcible tapers do more good than harm in pain care. A recent study in the The International Journal of Drug Policy found that there was no reduction in addiction rates, either.

“A gradual taper is something every patient on high-dose opioids for chronic pain should be encouraged to do, and doctors owe it to these patients to explain why a taper makes sense,” says David Juurlink, professor of medicine at the University of Toronto, who is a major proponent of decreasing the use of opioids for chronic pain. However, he says, “As much as high-dose opioid therapy is a bad idea, tapering abruptly without the patient’s buy-in makes things worse. I discourage the practice at every opportunity.”

Juurlink says he would never cut opioid dosage as abruptly as was done in Jay’s case. “I would not take someone from 120 to 90 in two weeks, unless he a) really wanted to, and, critically, b) understood that it might be tough, and that I’d take him back up to 120 if things got bad and we’d go more slowly next time.”

In the climate of fear induced by the opioid crisis, however, doctors are focused on self-preservation. Patients report coming into doctor’s offices and seeing signs advising them that medication doses are being dropped, for everyone, no exceptions. “The popular discourse presents opioids as lethal and physicians as no better than heroin dealers,” says Kertesz, “The result of this is that no public authority has been willing to articulate a safe harbor for physicians to protect their patients who need opioids.”

 

These patients need exactly that: some kind of certificate or validation that their doctors are permitted to prescribe for them and they are patients in good standing. The CDC also needs to make a public statement saying that its guidelines cannot be used to prosecute doctors who prescribe higher doses in good faith.

The goal of lowering dosage is supposed to be to protect patients from the overdose death risk associated with high doses. But lowering numbers on a chart isn’t saving lives—and some of these patients could even be overdosing because they’ve had a dose reduction, or fear one.

“Jay said that people need to be held accountable for this,” Meredith says, “My job is to put a face to this problem. Real families are being hurt here. And I’m finding more and more people and hearing more and more stories.”

The CDC, the DEA, and other regulators who oversee our response to the opioid crisis must take heed. Cutting off opioids used by addicted people hasn’t protected them—it’s merely shifted them to more dangerous street supplies like heroin and fentanyl, further increasing the death rate. For pain patients, these suicides and the stories of those whose pain has worsened as their opioids were take away suggest that they, too, are being harmed. Who is being helped here? The operation cannot be a success if the patients die.

If you or someone you know is considering suicide, help is available. Call 1-800-273-8255 to speak with someone now or text START to 741741 to message with the Crisis Text Line.

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CVS, Other Pharmacies Update Safety Rules to Prevent Harmful Drug Interactions

Posted on November 11, 2017 by Pharmaciststeve

CVS, Other Pharmacies Update Safety Rules to Prevent Harmful Drug Interactions

www.lawfirmnewswire.com/2017/11/cvs-other-pharmacies-update-safety-rules-to-prevent-harmful-drug-interactions/

Leading national pharmacy chains have updated their safety measures to prevent dangerous drug interactions that could harm patients.

The sweeping changes are the result of a Chicago Tribune investigation that found 52 percent of pharmacies in the Chicago area dispensed risky drug combinations without warning patients about potentially harmful interactions. CVS failed to caution consumers 63 percent of the time, the highest rate among the 255 independent and chain pharmacies tested.

After the report was published in December 2016, CVS upgraded the computer system at its 9,700 stores nationwide to improve patient safety. Pharmacists must now warn patients or consult with the prescribing doctor when an alert shows up for serious drug interactions. The computer system prevents pharmacists from selling medication until they take the required action. Around 30,000 pharmacists and 50,000 technicians received training on the new safety protocol.

“Pharmacies are finally taking steps in the right direction to make significant improvements that address the growing risk of people taking multiple medications that could potentially have harmful, and even fatal, effects,” commented Briskman Briskman & Greenberg medical malpractice attorney Paul Greenberg. “Patients have a right to know about dangerous drug interactions, and it is the pharmacist’s duty to provide that information to them.”

Walgreens announced that it conducted additional training on dangerous drug interactions with the company’s 27,000 pharmacists. Costco, Kmart and Wal-Mart have also updated their computer systems and trained their pharmacists in order to boost patient safety.

While national pharmacy chains have adopted new measures to reduce the number of people hospitalized each year due to dangerous drug interactions, local chain Jewel-Osco did not provide any details about changes implemented after last year’s Tribune report. Investigators found the Chicago pharmacy failed to warn consumers about dangerous medications 43 percent of the time.

According to a statement Jewel-Osco released to the Tribune, “Technological and operational adjustments have been made to assist and monitor our pharmacists as they perform their jobs to ensure patient safety.” The pharmacy did not specify the changes involved. Mariano’s, another local pharmacy chain, now requires all of its pharmacists to undergo training in drug interactions, drug allergy contraindications and other patient safety concerns.

Since all of these pharmacies have “updated their computer software” and “retrained” their Rx dept staff… does this suggest that they knew or should have known all along …that their prescription filling processes was failing to protect pts from known drug interaction(s)  and it took a “damning expose” pointing out the inadequacies of all of these systems/processes and the risk that they were putting the pts that put their trust in these pharmacies to protect them against adverse drug interactions to get them to make changes… that should have been in place … in the first place ?

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