Opioid-addicted baby at center of class action lawsuit in Southern Illinois

Posted on March 5, 2018 by Pharmaciststeve

 

http://www.bnd.com/news/local/article202972584.html

March 05, 2018 07:33 AM

Updated 5 hours 23 minutes ago

The family of a baby born addicted to opioids filed a class action lawsuit Wednesday against 20 pharmaceutical companies they accused of being negligent and responsible for the mother’s addiction to opioids and heroin.

The lawsuit tells the story of a baby, only identified by his initials T.W.B. He was born March 21, 2017, and spent the first days of his life in “excruciating pain” as he was weaned from his opioid addiction, inherited from his mother.

“Baby T.W.B. will require years of treatment and counseling to deal with the effects of prenatal exposure,” the lawsuit says. “Baby T.W.B. and his mother are victims of the opioid crisis that has ravaged Illinois, causing immense suffering to those born addicted to opioids and great expense to those forced to deal with the aftermath.”

Alton residents Deric and Ceonda Rees, the baby’s grandparents, filed the lawsuit Wednesday in the U.S. District Court of Southern Illinois. Ceonda Rees declined to comment, saying she had been advised not to discuss the lawsuit.

The baby was diagnosed with Neonatal Abstinence Syndrome, which can cause breathing and feeding problems, and require a longer hospital stay while they are experiencing withdrawal symptoms.

baby twb.jpg

The family of baby T.W.B. is suing pharmaceutical companies, alleging neglect. This photo was included in the lawsuit, which was filed Wednesday in Southern Illinois.
Provided

Taking opioids during pregnancy can also cause babies to be born with birth defects, according to Stanford Children’s Health. The number of babies born with this disease has increased fivefold since 2000, according to the National Institute on Drug Abuse.

At birth, Baby T.W.B. shook, refused to feed and cried excessively as he arched his back from the pain, according to the lawsuit. It was difficult to soothe him, and his development was delayed.

The baby’s mother became addicted to opioids when she was prescribed them for a broken ankle and broken hand as a young teenager. Her addiction to prescription opiates functioned as a gateway to heroin addiction, according to the lawsuit. The lawsuit alleges the mother consumed drugs made and distributed by each of the 20 defendants, including Dilaudid, Percocet, Oxycodone and Hydrocodone.

The lawsuit accuses the pharmaceutical companies of creating an environment where opioids freely flow due to “false, negligent and unfair marketing/unlawful diversion of prescription opioids.”

The Reeses asked for equitable relief and medical monitoring to identify developmental issues that will “almost inevitably appear as they age,” and fund services and treatment.

nasinfographic.jpg

National Institute on Drug Abuse

“Baby T.W.B.’s experience is part of an opioid epidemic sweeping through the United States, including Illinois, that has caused thousands of infants great suffering and continuing developmental issues,” the lawsuit says.” This epidemic is the largest health care crisis in U.S. history.”

A similar lawsuit was filed in Louisiana on Tuesday.

The pharmaceutical companies included in the lawsuit released the following statements:

  • Janssen Pharmaceuticals, Inc.: “We recognize opioid abuse and addiction are serious public health issues, and are committed to being part of the ongoing dialogue and to doing our part to find ways to address this crisis. Our actions in the marketing and promotion of these medicines were appropriate and responsible. The labels for our prescription opioid pain medicines provide information about their risks and benefits, and the allegations made against our company are baseless and unsubstantiated. In fact, our medications have some of the lowest rates of abuse among this class of medications.”
  • Purdue Pharma: “We are deeply troubled by the prescription and illicit opioid abuse crisis, and we are dedicated to being part of the solution. As a company grounded in science, we must balance patient access to FDA-approved medicines, while working collaboratively to solve this public health challenge. Although our products account for less than 2 percent of the total opioid prescriptions, as a company, we’ve distributed the CDC Guideline for Prescribing Opioids for Chronic Pain, developed three of the first four FDA-approved opioid medications with abuse-deterrent properties and partner with law enforcement to ensure access to naloxone. We vigorously deny these allegations and look forward to the opportunity to present our defense.”
  • Allergan: “It is important to put into perspective Allergan’s role regarding opioids. Allergan’s three legacy opioid products – Norco, Kadian and Fiorinal with Codeine — account for less than 0.04 percent of all opioid products prescribed in 2017 in the U.S. These products came to Allergan through legacy acquisitions and have not been promoted since 2013, in the case of Kadian and Fiorinal, and since 2003, in the case of Norco. Allergan has a history of supporting — and continues to support — the safe, responsible use of prescription medications. This includes opioid medications, which when prescribed and used responsibly, play an appropriate role in pain relief for millions of Americans.”
  • Teva Pharmaceuticals: “Teva is committed to the appropriate use of opioid medicines, and we recognize the critical public health issues impacting communities across the U.S. as a result of illegal drug use as well as the misuse and abuse of opioids that are available legally by prescription. To that end, we take a multi-faceted approach to this complex issue; we work to educate communities and healthcare providers on appropriate medicine use and prescribing, we comply closely with all relevant federal and state regulations regarding these medicines, and, through our R&D pipeline, we are developing non-opioid treatments that have the potential to bring relief to patients in chronic pain. Teva also collaborates closely with other stakeholders, including providers and prescribers, regulators, public health officials and patient advocates, to understand how to prevent prescription drug abuse without sacrificing patients’ needed access to pain medicine.”
  • Endo Pharmaceuticals and Endo Health Solutions declined to comment.
  • Amerisource, Cardinal Health and Johnson & Johnson did not respond for comment.

Notice that they are not suing any prescriber or doctor… did this woman get all her opiate from the street or friends  and all 20 of these companies are: responsible for the mother’s addiction to opioids and heroin. The last time I looked… no AMERICAN PHARMA COMPANY LEGALLY PRODUCES HEROIN and the GRANDPARENTS ARE DOING THE SUING… and ONLY ONE SET OF GRANDPARENTS !!! 

Apparently the Mother of this baby… COULD CARE LESS…  Nothing in the article states or suggests that the Mother is now sober ?

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Sessions greenlights police to seize cash, property from people suspected of crimes BUT NO CHARGED !

Posted on March 4, 2018 by Pharmaciststeve

https://www.washingtonpost.com/world/national-security/sessions-greenlights-police-to-increase-seizures-of-cash-and-property-from-suspected-criminals/2017/07/19/3522a9ba-6c99-11e7-96ab-5f38140b38cc_story.html?

The Justice Department announced a new federal policy Wednesday to help state and local police take cash and property from people suspected of a crime, even without a criminal charge, reversing an Obama administration rule prompted by past abuse by police.

Deputy Attorney General Rod J. Rosenstein said the Justice Department will include more safeguards to prevent the kind of problems that have been documented in the past. Police departments will be required to provide details to the Justice Department about probable cause for seizures, and federal officials will have to more quickly inform property owners about their rights and the status of the seizures.

“The goal here is to empower our police and prosecutors with this important tool that can be used to combat crime, particularly drug abuse,

” Rosenstein said at a news briefing. “This is going to enable us to work with local police and our prosecutors to make sure that when assets are lawfully seized that they’re not returned to criminals when there’s a valid basis for them to be forfeited.”

[Jeff Sessions’s Justice Department turns a $65 million asset forfeiture spigot back on]

Two years ago, then-Attorney General Eric H. Holder Jr. barred state and local police from using federal law to seize cash and other property without criminal charges or warrants. Since 2008, thousands of police agencies had made more than 55,000 seizures of cash and property worth $3 billion under a Justice Department civil asset forfeiture program, which allowed local and state police to make seizures and then share the proceeds with federal agencies.

 

A Washington Post investigation in 2014 found that state and local police had seized almost $2.5 billion from motorists and others without search warrants or indictments since the terrorist attacks of Sept. 11, 2001. The Post series revealed that police routinely stopped drivers for minor traffic infractions, pressed them to agree to searches without warrants and seized large amounts of cash when there was no evidence of wrongdoing.

Police then spent the proceeds from the seizure with little oversight, according to the Post investigation. In some cases, the police bought luxury cars, high-powered weapons and armored cars.

“You’re never going to eliminate allegations of abuses,” Rosenstein said, “never going to eliminate mistakes 100 percent. But I think this new policy is going to position us very well to make sure there are very few credible allegations of abuse, and where there are we’re going to make it a priority to follow up.”

The new policy from Attorney General Jeff Sessions authorizes federal “adoption” of assets seized by state and local police when the conduct that led to the seizures violates federal law. Rosenstein said that the department is adding safeguards to ensure that police have sufficient evidence of criminal activity when property is seized. Property owners will receive notice of their rights within 45 days, which is twice as quickly as required by current law. Law enforcement agencies will be required to provide officers with more training on asset forfeiture laws, he said.

State and local law enforcement officials supported the change, but Democratic and Republican lawmakers were skeptical.

Rep. Darrell Issa (R-Calif.) called Sessions’s policy “troubling” and said it would “expand a loophole that’s become a central point of contention nationwide.”

 “Criminals shouldn’t be able to keep the proceeds of their crime, but innocent Americans shouldn’t lose their right to due process, or their private property rights, in order to make that happen,” Issa said in a statement.

[Jeff Sessions’ defense of civil asset forfeiture, annotated]

Holder tweeted that Sessions’s policy was “another extremist action” and said the Obama administration policy was “a reform that was supported by conservatives and progressives, Republicans and Democrats.”

Kanya Bennett, legislative counsel for the American Civil Liberties Union, called the action “outrageous.”

“We are talking about people who have not been convicted of a crime and are often not given a day in court to reclaim their possessions,” Bennett said. “Civil asset forfeiture is tantamount to policing for profit, generating millions of dollars annually that the agencies get to keep.”

At a meeting with county sheriffs on Feb. 7, President Trump made clear to law enforcement officials that he is a strong supporter of the civil asset forfeiture program and told the Justice Department to rescind the Obama administration restrictions.

On Wednesday, Sessions defended the reversal at a meeting with representatives from the Fraternal Order of Police, the National Sheriffs’ Association, the Major Cities Chiefs Association and other law enforcement officials who back the new policy.

“Civil asset forfeiture is a key tool that helps law enforcement defund organized crime, take back ill-gotten gains and prevent new crimes from being committed, and it weakens the criminals and the cartels,” Sessions said.

But the ACLU’s Bennett said, “The problem is that we are not talking about criminals.”

“We are talking about Americans who have had their homes, cars, money and other property taken through civil forfeiture, which requires only mere suspicion that the property is connected to a crime,” she said.

I thought that Session was functioning with a  70’s & 80’s mindset – early war on drugs period… Our judicial system declared opiate addiction was a CRIME not a DISEASE… in 1917… So apparently Session’s mindset is back 100 yrs ago in what was referred to as our country’s “Prohibitionist Period”.. That is before alcohol was prohibited and while women still did not have the RIGHT TO VOTE…

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Kennedy-Gingrich Anti-Opioid Group Funded By Maker Of Opioid Addiction Medication

Posted on March 4, 2018 by Pharmaciststeve

Kennedy-Gingrich Anti-Opioid Group Funded By Maker Of Opioid Addiction Medication

https://khn.org/morning-breakout/kennedy-gingrich-anti-opioid-group-funded-by-maker-of-opioid-addiction-medication/

Braeburn Pharmaceuticals, which won approval last year to market an implant that continuously dispenses the opioid addiction medicine buprenorphine, entered into an agreement to make a $900,000 charitable donation to Advocates for Opioid Recovery. Media outlets report on the crisis out of California, Ohio, Pennsylvania, Missouri, New Hampshire and Massachusetts as well.

Stat: Mystery Solved: Addiction Medicine Maker Is Secret Funder Of Kennedy-Gingrich Group A company that sells a new opioid-addiction medication is a secret funder of an advocacy group fronted by Newt Gingrich and Patrick Kennedy that is pushing for more government funding and insurance coverage of such treatments. Gingrich, the former Republican House speaker and a Trump confidant, and Kennedy, a former congressman and son of former US Senator Edward Kennedy, are paid advisors to Advocates for Opioid Recovery. They have generated a flurry of media attention in those roles, including joint interviews with outlets ranging from Fox News to the New Yorker. (Armstrong, 3/3)

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A Former Federal Peer Reviewer’s Analysis of the Draft CDC Guidelines

Posted on March 4, 2018 by Pharmaciststeve

www.nationalpainreport.com/a-former-federal-peer-reviewers-analysis-of-the-draft-cdc-guidelines-8828910.html

In my former life prior to chronic pain and illness I had many important and fascinating jobs.  One was as a peer reviewer for the United States National Institutes for Health (NIH), Center for Mental Health Services (CMHS), and Substance Abuse and Mental Health Services (SAMHSA); and New York State’s Education Department, Office of Mental Health, and Office of Alcohol and Substance Abuse Services.  I reviewed multi-million dollar grants, provided consumer input to agencies, and served on publication committees and focus groups.  When the opportunity arose to comment on the draft “CDC Guideline for Prescribing Opioids for Chronic Pain”, I looked forward to reawakening my peer reviewer skills to objectively identify the strengths and weaknesses of the document.

Unfortunately, I found it near impossible and beyond frustrating to review this document in an objective manner.  The guideline is not organized like a typical guideline or tool kit.  It is nothing more than a literature review of the harms and risks of opioids.  It is not objective, therefore, I found it impossible to be objective.  It was biased which made me completely biased (in the other direction).  Reading this document left me scared—really scared.  It left me wondering what happened to the United States and to the rights of patients?  How could this be?  No consumer groups or chronic pain patients were included in their peer review or “experts” process.  A huge no no.  Here is the comment I posted on the CDC site (I omitted my introduction):

As a consumer and citizen, I request you halt further activity regarding these guidelines until a consumer board can be developed—one that is solely made up of chronic pain patients who have experienced primary care access issues to opioid medication.  I also request you conduct focus groups of chronic pain patients who are on opioids.  Only then will you have guidelines that serve the public, the primary care doctors, and the chronic pain patients.

It is imperative a section in the guideline be created detailing how adequate pain control is a fundamental right of every patient.  Point to the Joint Statement from 21 Health Organizations and the Drug Enforcement Administration, “Promoting pain relief and preventing abuse of pain medications: A critical balancing act” which states “Effective pain management is an integral and important aspect of quality medical care, and pain should be treated aggressively… Preventing drug abuse is an important societal goal, but it should not hinder patients’ ability to receive the care they need and deserve” (http://www.deadiversion.usdoj.gov/pubs/advisories/painrelief.pdf).  In addition, in this section provide a thorough review of the risks of untreated chronic pain, i.e. suicides, depression, unemployment, lower quality of life, etc.

Throughout this document it is mentioned there are no adequate long term studies that prove opioid medication is effective, leading the reader to believe opioid medication never helps patients long term, which is not true.  If you conducted a focus group of chronic pain patients you would understand the complexities of opioid pain management and long term effect.  It became clear to me this document was written in a biased manner when I read the “Effectiveness of Alternative Treatments” section.  It boasted these treatments effective under 6 months.  Nowhere in this document did I see a similar positive citation for opioid treatment for short term use though hundreds exist.  The writers excluded the fact these alternative treatments, like opioids, had no proven long term benefits.  Furthermore, the alternative pharmacological agents, i.e. gabapentin, SSRIs, NSAIDs, etc. are touted as excellent treatments with little to no risks.  The writers should have included information on the hundreds of possible side effects, some very serious, each of these drugs carry.  The risk of death, overdose and suicide is very real for some of these medications and literature citations stating as such was discluded.

The statistics in the Background section do not delineate criminal activity from actual chronic pain patients in a pain management type setting.  It also does not define whether in overdoses there were additional drugs or alcohol contributing to the overdose (polydrug overdose) and whether these overdoses were legitimate pain patients or illegally obtained prescriptions.  These guidelines should not include such statistics.  This is not a paper about criminal activity and misuse.  Only statistics for actual pain patients should be included.

Information must be included describing the fact primary care doctors may be the only opioid prescriber in their area as most pain management doctors no longer manage chronic pain with opioids and specialists refuse to prescribe.  Primary care doctors have by default become pain management doctors.  As such, pain patients should not be punished for this trend.  I did like that you included a few sentences encouraging physicians to be compassionate.  Please expand on this.  Most of us are treated like a nuisance and criminal.  Include information on the difference between physical dependence, tolerance, and addiction/misuse of opioid medications.

Information about actual pain conditions is slim, which is disconcerting.  The fact you include cataracts as a painful condition and not severely painful conditions like chronic pancreatitis, complex regional pain syndrome, shingles, back and spine issues, trigeminal neuralgia, endometriosis, adhesion pain, kidney stones, and more shows the lack of familiarity of the team of writers with true chronic pain populations.

Teach patients basic opioid safety—keeping the opioids locked away and out of teenagers’ hands.  Many patients are naïve to think their teens would never consider experimenting with their meds or visitors won’t snoop through a medicine cabinet.  Providing real-world information will prevent unnecessary overdoses NOT limiting chronic pain patients their pain medication.  Also, the naloxone section should be removed or limited to a sentence.  True chronic pain patients rarely experience overdose and should be dealt with by emergency personnel.

—End of comment—

The CDC is clearly not the appropriate agency to spearhead opioid prescribing guidelines.  They are good at authoring literature reviews on ebola and trying to find cures for diseases.  They are NOT equipped to publish guidelines of this manner.  This is not an epidemic and they are incapable of being objective.  A document like this must be objective and unbiased.

Brooke Keefer is a mom to three sons ages 28, 19, and 4 and has a 2 year old granddaughter. Brooke has a Bachelor of Science degree in Mathematics from the State University of New York at Albany. For over 15 years she worked as a not-for-profit director, lobbyist, advocate, and a grants writer, manager, and reviewer in the field of children’s mental health. Brooke suffers from several painful conditions—sphincter of oddi dysfunction (a defect in the pancreatic/biliary valves), chronic pancreatitis, and fluoroquinolone toxicity syndrome (long term adverse reaction of the nervous system to Levaquin). Though these have disabled her, she writes health articles, advocates for patient rights, and runs the Sphincter of Oddi Dysfunction Awareness and Education Network website, www.sodae.org.

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Eric Chase had cocaine, marijuana, alprazolam (commonly known as Xanax), and the opioid drugs, fentanyl and cyclopropyl fentanyl, in his system.

Posted on March 4, 2018 by Pharmaciststeve

http://people.com/tv/eric-bolling-son-death-ruled-accidental-overdose-included-opioids/

Six weeks after former Fox News host Eric Bolling‘s only child, 19-year-old Eric Chase Bolling, was found dead on Sept. 8, his cause of death has been revealed.

“Just received some tragic news from Coroner in Colorado. Eric Chase’s passing has been ruled an accidental overdose that included opioids 1,” the mourning father, 54, revealed on Twitter Thursday.

The Boulder County Coroner’s report, obtained by PEOPLE on Thursday, lists the cause of death as “mixed drug intoxication” and ruled it as an accident. The post-mortem toxicology report, which was completed on Sept. 11, revealed Eric Chase had

cocaine, marijuana, alprazolam (commonly known as Xanax), and the opioid drugs, fentanyl and cyclopropyl fentanyl, in his system. “History of drug abuse and white powdery substance discovered at the scene,” stated the report.

Fentanyl, the same drug that also killed music icon Prince, is classified as a Schedule II drug by the federal government and its medical uses are typically pain management following surgery or for chronic pain. Cyclopropyl fentanyl is a synthetic opioid that is chemically similar to fentanyl but is not intended for human or animal use.

Fentanyl is 50 times stronger than heroin, up to 100 times stronger than morphine.

“Adrienne and I thank you for your continued prayers and support. We must fight against this national epidemic, too many innocent victims,” Bolling wrote in a follow-up tweet along with a photo of his son, who was studying economics at the University of Colorado, Boulder.

On the day of his son’s death, Bolling tweeted: “Authorities have informed us there is no sign of self harm at this point. Autopsy will be next week. Please respect our grieving period.”

Facebook

The sad news came hours after news broke that Bolling, who anchored Fox News’ Cashin’ In. and also co-hosted Fox News Specialists and The Five, had been removed from his job at Fox News following allegations that he harassed colleagues.

Also on Thursday, President Donald Trump declared the opioid epidemic a national public health emergency. Trump called for “really tough, really big, really great advertising” to “teach young people not to take drugs,” according to the New York Times.

Since 2000, the number of deaths from opioids — which includes painkillers and heroin — in the U.S. has risen more than 137 percent, according to TIME.

Bolling’s friends and former Fox News co-workers expressed their condolences on social media Thursday.

“So sorry brother for your awful loss. warm regards to your family from me and mine,” tweeted Geraldo Rivera.

Earlier this week, former Fox News host Bill O’Reilly apologized to Bolling in a tweet after he implied in a recent interview that Bolling’s son’s death was a suicide: “Apologies to Eric Bolling and prayers for him and his family. The message I tried to send was that allegations harm kids. Nothing more.”

 

I fell sorry for this family,  their child officially died of mixed drug intoxication… of six difference substances…  and  History of drug abuse and white powdery substance discovered at the scene.

How can you claim that this was an accident… when this kid intentionally ingested six difference substances most/all are illegal substances. No one – with absolute certainty – could state that this was a accident… college kids do commit suicide…

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New insurer policies kick in as doctors, patients adjust to Nevada’s new opioid law

Posted on March 4, 2018 by Pharmaciststeve

https://thenevadaindependent.com/article/new-insurer-policies-kick-in-as-doctors-patients-adjust-to-nevadas-new-opioid-law

Nevada’s new law to combat the rising number of opioid deaths has drawn a public outcry from doctors and patients who say it is styming access to necessary medications, but recent changes to insurer and pharmacy management policies have largely flown under the radar in the conversation.

Several insurance companies, responding to both public pressure to combat the opioid epidemic as well as guidelines issued by the Centers for Disease Control and Prevention, instituted changes nationwide at the beginning of the year, limiting the initial prescription of opioids for acute pain to seven days and requiring prior authorization for long-acting opioids. The biggest pharmacy benefit managers, responsible for negotiating drug prices between manufacturers, insurance companies and pharmacies, also have recently put limits on initial fills of opioid prescriptions.

The policy changes take effect amid a larger conversation in Nevada about how to balance laws and regulations aimed at preventing opioid overdoses with ensuring that patients who actually need pain medication receive it in a safe and responsible way. Proponents of the new opioid law attribute the initial pushback against it to doctors being uninformed about how to follow it, a problem that can be solved through education, while others say the law is inherently flawed and in need of fixing.

The insurance company and pharmacy benefit manager (PBM) policies are yet another method of combating opioid deaths. But they also are creating another layer of paperwork and rules for doctors to follow as they navigate compliance with the new Nevada law and can complicate things for patients.

“There are unintended consequences with these artificial restrictions,” said Dr. Jim Marx, a pain specialist in Las Vegas.

For instance, Aetna started limiting the quantity of opioids prescribed for acute pain and post-surgery to a seven-day supply starting Jan. 1. Any prescription greater than seven days requires prior authorization, to ensure providers are not overprescribing in an acute pain setting, an Aetna spokeswoman said.

“Physicians and members can always appeal denials for prescriptions, including for opioids,” said Aetna spokeswoman Anjie Coplin in an email.

Aetna also requires prior authorization for all long-acting opioids in order to ensure the medicines are being appropriately used, Coplin said. The prior authorization process takes into account whether the patient is undergoing treatment for cancer or receiving end-of-life care. Long-acting opioids can be covered for up to six months at a time for chronic pain, but lifetime coverage can be granted for end-of-life or cancer diagnoses.

Health Plan of Nevada and Sierra Health and Life, two United Healthcare subsidiaries providing insurance in Nevada, started requiring prior authorization for patients on their commercial plans taking long-acting opioids or those cumulatively taking more than 180 morphine equivalent doses starting on Jan. 1. Medicaid patients on Health Plan of Nevada have been subject to prior authorization for long-acting opioids since July.

Starting Thursday, commercial customers on the two plans and Medicaid patients on Health Plan of Nevada are now only able to receive initial prescriptions of opioids for up to seven days and no more than 49 morphine equivalent doses on their first prescription if they are new to opioid therapy. (There are no restrictions on a second prescription as long as it doesn’t meet the other criteria for prior authorization.)

Other insurance companies started rolling out limits over the last couple of years. Anthem Blue Cross Blue Shield started limiting initial prescriptions of short-acting opioids to seven days for some drugs in October 2016, and all short-acting opioids were subject to the limit in July. Anyone covered by Anthem can only receive a maximum of a 14 day supply for short-acting opioids in a 30-day period without prior authorization. The company also implemented a prior authorization process for long-acting opioids in September 2016 for initiation of therapy.

Pharmacy benefit managers have also adopted their own policies as far as the drugs they’ll cover. CVS Caremark, one of the three largest pharmacy benefit managers, started limiting initial prescriptions of opioids for acute pain for patients who are new to therapy starting Feb. 1. The new policy also limits daily dosages and requires that immediate-release formulations or drugs be given before extended-release versions are prescribed. Doctors can ask for exemptions for certain patients and employers and insurers are allowed to opt out of the new policy.

Express Scripts, another of the big three, started limiting patients new to opioid therapy to a seven-day supply on a short-acting opioid on Sept 1. OptumRx now limits members naive to opioid therapy to 49 morphine-milligram equivalent per day, with up to two seven-day fills in a 60-day timeframe starting July 2017.

The policy changes come as a reaction to guidelines issued by the CDC in 2016 as far as appropriate prescribing of opioids for both acute and chronic pain. They also come amid increased focus on the role that insurance companies and pharmacy benefit managers have played in the opioid crisis.

The limits on opioids seem like a good idea at face value, Marx said, but don’t always work out the way you think they’re going to in practice.

Marx gave the example of a chronic pain patient who takes 200 morphine milligram equivalents (MME) a day. Because patients who take higher amounts of opioids at one time are more likely to become addicted, doctors like to use as low a dose as possible as many times a day that a patient requires it. However, he said he’s run into situations where pharmacy benefit managers will approve two 100 MME doses but not four 50 MME ones.

“They want the patient to take one big pill, presenting a situation where the patients are presented with larger doses of medication, less times a day, and more likely to develop a liking for that medication,” Marx said.

Prescribers also have to be cognizant of the fact that although Nevada’s new opioid law allows them to write initial prescriptions for up to 14 days, a patient’s insurance may only pay for seven days.

Larry Pinson, executive secretary of the Board of Pharmacy, said that he hasn’t heard of issues between insurance companies, PBMs and pharmacists in response to the new policies because whether or not the prescription can be filled is usually decided right on the spot in the pharmacy. But he said it makes sense for insurers to set their own policies on opioids.

“I think in the long run, if you look at it empirically, it makes sense for insurance companies to look at those sorts of things,” Pinson said. “What good is it going to do to pay for narcotics for forever if someone gets addicted?”

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Chronic, Noncancer Pain Boosts Suicide Risk

Posted on March 3, 2018 by Pharmaciststeve

Chronic, Noncancer Pain Boosts Suicide Risk

https://www.medscape.com/viewarticle/804832

Certain types of noncancer pain conditions are associated with an increased risk for suicide, a new study suggests.

A study conducted by investigators at the University of Michigan in Ann Arbor showed that psychogenic pain, back pain, and migraine, but not arthritis or neuropathy, were associated with an increased risk for suicide.

Although some of this risk appears to be due to co-occurring mental health problems, there may be something about the experience of pain that also contributes directly to suicide risk, lead author Mark A. Ilgen, PhD, told Medscape Medical News.

“Treatment providers, particularly those who work in pain treatment settings, should be aware of these risks and consider mental health and suicide risk assessments in their patients,” Dr. Ilgen said.

 

Previous research suggests that individuals with pain may be at increased risk for suicidal thoughts and behaviors, but it is likely that “not all pain is created equal” in terms of its association with suicide, and that the association between pain and suicide could vary, depending on the type of pain patients experience, Dr. Ilgen said.

The study was published online May 22 in JAMA Psychiatry.

Arthritis Most Common Dx

In the current study, the investigators sought to understand the degree to which specific pain conditions related to suicide risk. The investigators also wanted to understand whether pain remained an important predictor of suicide, even after controlling for other mental health conditions that are associated with both pain and suicide risk.

The team looked at treatment records of all patients (n = 4,863,036) who were seen in the Veterans Health Administration system in fiscal year 2005 and who were alive at the start of fiscal year 2006.

They then examined the association between baseline clinical diagnoses of the following pain-related conditions: arthritis, back pain, migraine, neuropathy, headache or tension headache, fibromyalgia, and psychogenic pain, as well as the extent to which each of these conditions predicted risk for suicide in fiscal years 2006 to 2008.

Arthritis was the most common diagnosis, occurring in 2,076,514 patients (42.7%), followed by back pain, in 1,111,187 (22.8%). Psychogenic pain was the least frequent diagnosis, occurring 18,145 patients (0.4%). Suicide occurred in 4823 (0.01%) in the subsequent fiscal years.

After controlling for demographic and other factors, including age, sex, and Charlson score, the researchers found that except for arthritis and neuropathy, each pain condition was associated with an elevated risk for suicide.

 

Psychogenic pain was associated with the greatest risk for suicide death (hazard ratio [HR], 2.61; 95% confidence interval [CI], 1.82 – 3.74).

 

Back pain was associated with a 33% increased risk for suicide death (HR, 1.33; 95% CI, 1.22 – 1.45), migraine with a 68% increased risk (HR, 1.68; 95% CI, 1.28 – 2.20), headache or tension headache with a 38% increased risk (HR, 1.38; 95% CI, 1.17 – 1.64), and fibromyalgia with a 45% increased risk (HR, 1.45; 95% CI, 1.16 – 1.81).

When these analyses were further controlled for concomitant psychiatric conditions, these associations between pain conditions and suicide death were reduced.

 

However, significant associations remained for back pain (HR, 1.13; 95% CI, 1.03 – 1.24), migraine (HR, 1.34; 95% CI 1.02 – 1.77), and psychogenic pain (HR, 1.58; 95% CI, 1.11 – 2.26).

 

Controversial Diagnosis

 

“Psychogenic pain is listed within the ICD-9 [International Classification of Diseases, Ninth Revision] coding system and characterizes pain that is caused by psychological instead of purely physical factors,” Dr. Ilgen explained.

Dr. Mark Ilgen

“This is a diagnosis that is used relatively infrequently within the VA, and there is considerable disagreement among pain and mental health professionals about the validity and utility of this diagnosis,” he said.

 

Because of the type of data that were analyzed in this study, it is impossible to tell what treatment providers were thinking when they used the diagnosis of psychogenic pain, Dr. Ilgen added.

 

“Still, this diagnosis had the strongest association with suicide of any of the pain disorders that we examined. It is my guess that a diagnosis of psychogenic pain is given to patients with pain that is poorly understood and that may be particularly difficult to treat. Also, there is the possibility that patients with this diagnosis are particularly frustrated with their care and hopeless about the resolution of their pain condition. I do not interpret our findings to indicate that ‘psychogenic pain,’ as it is defined in the ICD-9, is directly causing suicide, rather, that there is something about being diagnosed with this condition that is associated with a particularly poor prognosis.”

 

Need for Screening and Treatment

 

Commenting on this study for Medscape Medical News, Colonel (retired) Elspeth Cameron Ritchie, MD, chief medical officer for Washington, DC, Department of Mental Health and an expert on suicide in the military and veterans population, called it important, although not a surprise.

 

“It’s not a revelation because anecdotally, we have known that pain is a risk factor for depression and for suicide. But it is looking at a very large population, and this adds to its importance,” she said.

 

Dr. Ritchie, who retired from the army 2 years ago, said she saw this firsthand.

 

“Pain was a major risk factor. Many service members, after 12 or 20 years of service, have a lot of aches and pains. So in the military, pain is a risk factor.”

 

She added that for her, the “take-home message” is that clinicians should be evaluating suicide risk in all patients with pain.

 

“The standard questions for evaluating risk for suicide are, ‘Have you given away your possessions?’ and ‘Have you made a will?,’ but it’s not a standardized question in the psychiatric setting to ask about pain, and it absolutely should be.”

 

Also, asking about pain is not enough. Clinicians should make sure that patients with pain are getting appropriate treatment, she added.

 

The study was sponsored by the Veterans Health Administration. Dr. Ilgen and Dr. Ritchie report no relevant financial relationships.

 

JAMA Psychiatry. Published online May 22, 2013. Abstract

Filed under: General Problems | 1 Comment »

FDA: PROP’s request on high dose opiates – PUT ON HOLD ?

Posted on March 3, 2018 by Pharmaciststeve

 

Filed under: General Problems | 4 Comments »

Opinion: Medicare Considering Opioid Restrictions – Comment on Docket by Monday 3/5

Posted on March 3, 2018 by Pharmaciststeve

www.nationalpainreport.com/opinion-medicare-considering-opioid-restrictions-comment-on-docket-by-monday-3-5-8835679.html

Most of us knew this had been coming; however, it doesn’t make it any easier to swallow.  This is probably one of the most important tasks you will be asked to do as a chronic pain patient or for pain patients.  We know there have been literally hundreds of ‘Calls to Action’ over the years, but this is it.  Medicare is considering limiting coverage for opioid dosages over 90 MME and putting a 3, 5, or 7-day cap on new prescriptions for acute pain.  There is a proposed 7-day supply to be provided while you seek an exemption to an over 90 MME prescription.  Medicare is also proposing adding extra flags for Gabapentin, Lyrica and Benzos in combination with opioids.  Final approval is given to your insurance carrier, not your doctor.  We must ask for a legacy exemption for those already stabilized above 90 MME.

We have until Monday to badger as many people as we can to comment on the federal docket.  Pain patients are now joining their State Pain Advocacy Groups, created several months ago for direct action and advocacy.  These groups are a little different than your typical advocacy groups, as they discourage personal stories, memes, medical talk and surgical photos.  We are focusing on the collective and not individual experiences, though they are the most important part of this.  We will comment on federal dockets, attend legislative hearings, talk with reporters/policy makers and even protest at the nationwide ‘Don’t Punish Pain’ rallies on April 7, 2018.

We must bombard Capitol Hill with calls, faxes, Tweets and emails and meet with them if we can.  Not only do we need to let them know how medically fragile and chronically ill we are, and that we depend on these medications for our very existence, but we have to PROVE to them we are not functioning addicts.  They must see us speaking as one, with clear speech and clear eyes.  We must be rational, calm, cool and collected – not an easy thing to be when you are fighting for your life along with daily fatigue, illness and disability.

Please comment on the federal docket that closes on Monday, March 5th, 2018.  Use these steps as a guide, but please do not copy them verbatim, as Medicare will disregard duplicate comments.  Join your state pain advocacy group – it’s your state name and ‘Pain Advocacy Group’ on Facebook – the website is under construction.  We will never ask for money from chronically ill pain patients, as most don’t have any to spare.  Ask how you can help in your state group, as there’s so much to be done.  We are just at the beginning of what we fear will be a very long battle.  It’s way past time for us to be advocating together – if we wait until our pain relief has been completely taken away, it could be nearly impossible to fight.  Please know that we are all just one appointment away from losing access to pain medication – whether it’s your doctor unwilling or unable to prescribe, your insurance denying coverage or your pharmacist being out of supply or refusing to fill.  It’s happening and it’s real.  Come join us – we need you now!

Here are some tips on how to comment on the federal regulations:

  1. https://www.regulations.gov/document?D=CMS-2017-0163-0007
  2. Click Blue Box ‘COMMENT NOW’
  3. You may want to write your comment in a document and then copy/paste in case the site glitches or it’s too long and you need to attach it as a doc – ‘Choose files’ – if you need to upload it.
  4. Name/City/Sate/Zip/Country/email or submitting on behalf of 3rd party – we can submit your comment anon for you/CONTINUE.
  5. I am a Medicare/Medicaid patient or future patient – or have a private insurer which often follows Medicare policies.
  6. I am a pain patient diagnosed with (diagnosis) for (how many?) years. I tried( ______ ) – list all the non-opioids (n-saids, Tricyclic anti-depressants, SSRIs, SNRIs, Steroids, anti-epileptics, etc.) you tried BEFORE opioids and include all the different therapies/treatment/surgeries (i.e., PT, OT, Aqua T, Chiro, Osteo, injections, devices, procedures, CBT/mindfulness, acupuncture, acupressure, massage, biofeedback, Medical Cannabis, creams, TENs, MENS, natural remedies, etc.) but they all failed to heal/help or adequately control my pain, so I require opioid pain medications. Opioids help me by managing my pain and (_____) – talk about improved function that opioids help with – working, chores, childcare, travel, entertainment, etc.
  7. If Medicare/Medicaid/private insurer refuses to pay and if I do not have access to my medication over 90 MME/any dosage I will (____) – explain how your life will change – lose your job, income, home, car, entertainment, not be able to care for family/house, etc.
  8. Explain you have been a model, compliant patient, and if you have a pain contract – include how often you have UAs, pill counts, secure you medications and if you use one pharmacy, avoid alcohol, cannabis, etc. Mention it is unlikely your condition will improve and the effects of time and aging will make things worse. Opioids and pain management were a last resort option.
  9. Proposed policies are not supported by proven studies, everyone genetically metabolizes medications differently, the CDC guidelines were written outside the rules by non-pain management physicians, some who may have professionally or personally profited from the outcome.
  10. These policies could: create more chronic pain by not treating acute pain, scare more doctors out of pain treatment, create more demand for urgent care, increase the rate of expensive and possibly dangerous procedures, more disability claims/unemployment, and need for social services.
  11. Force involuntary tapers, withdrawals, risk of suicide, high blood pressure, stroke risk, and cardiac issues.
  12. I am disabled, NOT over 65 and pain medication helps me PREVENT falls by stabilizing my pain.
  13. My medical care and decision making should be left to my doctor, who understands my complicated and complex case, not CMS/Medicare.
  14. A 7-day supply while seeking an exemption to 90MME would cause extreme stress, paperwork burden for my doctor, extra copays at pharmacy/doctor, plus another trip to doctor/pharmacy when you are in pain.
  15. A 7-day limit on prescriptions for new patients would be a physical and financial hardship – doesn’t take into account injury, size, metabolizing, genetics or other factors.
  16. I take _____ (Benzos, Gabapentin, Lyrica) safely – I do not mix them with alcohol, other substances and use as directed.  Explain what might happen if these were to be discontinued.
  17. Prescribing has been going down for over 5 years while ODs to illicit heroin/Fentanyl coming in from Mexico/China is skyrocketing – deaths will continue to rise, as this crisis is NOT an over prescribing issue.

Valorie Hawk lives in Washington and has experience working with Congress. She can be reached by Email: C-50painadvocacygroups@outlook.com and you can follow her on Twitter   @C50painadvocacy

Filed under: General Problems | 4 Comments »

President Trump says drug dealers may deserve ‘ultimate penalty’

Posted on March 2, 2018 by Pharmaciststeve

http://www.wpxi.com/news/national/president-trump-says-drug-dealers-may-deserve-ultimate-penalty/709651660

WASHINGTON (AP) – President Donald Trump said Thursday the “ultimate penalty” may be in order for drug dealers because the nation’s drug problem will never be solved without a show of strength and toughness.

The comments were Trump’s most explicit on the matter to date. He previously has alluded to death for drug dealers by noting that some countries are “very harsh” with drug dealers. Trump also has said he knows the answer to the drug crisis, but he isn’t sure the country is “ready for it yet.”

In remarks Thursday at a White House summit on the opioid epidemic, Trump said drug dealers and pushers kill hundreds of people but that that most don’t go to jail.

“You know, if you shoot one person, they give you life, they give you the death penalty. These people can kill 2,000, 3,000 people and nothing happens to them,” he said, referring to drug dealers.

“Some countries have a very, very tough penalty – the ultimate penalty. And, by the way, they have much less of a drug problem than we do,” Trump continued. “So we’re going to have to be very strong on penalties.”

Trump also held out the possibility of initiating federal lawsuits against opioid makers and distributors. He also said his administration will be “rolling out a policy” on opioids in the coming weeks that will be “very, very strong.” Neither he nor his aides provided any details.

Trump said he had spoken with Attorney General Jeff Sessions about suing opioid makers. Sessions announced this week that the Justice Department will support local officials in hundreds of lawsuits against opioid makers and distributors.

Addressing potential federal litigation, Trump said: “I think it’s very important because a lot of states are doing it, but I keep saying, if states are doing it, ‘Why isn’t the federal government doing it?’ So that will happen. So that will happen.”

Trump’s wife, Melania, opened the summit. She said many people are grieving loved ones lost to the opioid crisis and “we need to change that.”

She read from a letter from Betty Henderson, a Florida woman who lost her 29-year-old son, Billy, to drugs last September. Henderson appealed to Mrs. Trump for help “in claiming these lost souls before drugs take them from this earth.”

Opioids, including prescription opioids, heroin and fentanyl, killed more than 42,000 people in this country in 2016, more than any year on record, according to the Centers for Disease Control and Prevention. Trump has declared that fighting the opioid epidemic is a priority for the administration but critics say the effort has fallen short.

Trump in the past has addressed the issue of tough penalties for drug dealers and pushers.

In January, Trump said: “We’ve never had a problem with drugs like we do, whether it’s opioid or drugs in the traditional sense. It’s never been like it is.

“And we are going to do everything we can. It’s a very difficult situation, difficult for many countries,” Trump said. “Not so difficult for some, believe it or not. They take it very seriously and they’re very harsh. And those are the ones that have much less difficulty. “

Trump raised the issue later that month as he signed legislation giving Customs and Border Protection agents new resources to stop the illicit drug flow. He suggested that he’d like to take a more aggressive approach to the drug crisis – but said the country isn’t ready for what he has in mind.

“So we’re going to sign this. And it’s a step. And it feels like a very giant step, but unfortunately it’s not going to be a giant step, because no matter what you do, this is something that keeps pouring in,” he said.

“And we’re going to find the answer. There is an answer. I think I actually know the answer, but I’m not sure the country’s ready for it yet,” he added. “Does anybody know what I mean? I think so.”

Pres Trump, when it comes to the opiate crisis and the war on drugs.. is so out of his league and he is depending on the advice of that numb-nuts AG Sessions who is still in the 70’s or 80’s in trying to fight the war on drugs… nothing like trying to deal with 21st century crooks with 20th century policies and processes.

Everyone who has three brain cells holding hands that when you take out a drug dealer… there are two or three waiting in the wings to step up and take over selling the product to meet the demands for the product in the general population of our society.

We already have the highest percent of our population in jails/prisons of any civilized society on the globe… most for non-violent drug offenses…  Perhaps Trump and Sessions need to be given an abbreviate education in Economics 101 and the law of supply and demand.

Is it time for a valid THIRD POLITICAL PARTY ?

 

 

 

Filed under: General Problems | 2 Comments »

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