I thought that we were the “UNITED STATES”… not the 50 colonies of Washington DC ?

DEA Agent: Pot Still Illegal Despite State, City Laws

https://www.newsmax.com/politics/dea-enforce-marijuana-canibus/2018/06/10/id/865248/

The Drug Enforcement Administration will keep enforcing the federal law against marijuana — despite New York Mayor Bill de Blasio’s reported plan to decriminalize pot, a federal agent declared.

In an interview with radio host John Catsimatidis aired Sunday on “The Cats Roundtable,” James Hunt, DEA agent in charge of New York, said marijuana possession is “still against the law federally.”

The remarks begin at the 7:18-minute mark.

“The federal government is very clear on it,” Hunt said. “There’s been a lot of research. The Supreme Court has ruled there is no medical necessity for marijuana. It’s still a Schedule 1 substance, not approved by the [Federal Drug Administration]”

“We will not stop enforcing the laws because Congress makes these laws,” Hunt added. “If people are so worried about the marijuana laws, they should appeal to their congressman and change the law.

“But as long as it’s illegal, the federal government, we will enforce the laws.”

According to the New York Daily News, de Blasio will tell the New York Police Department to stop arresting people for public pot smoking — and launch a task force to officially prepare the city for the outright legalization of marijuana in New York.

Sessions: ‘Drug Overdoses Finally Started to Decline’ – if you only look at certain stats ?

www.painnewsnetwork.org/stories/2018/6/11/sessions-overdoses-finally-started-to-decline

There are signs – very tentative signs –  that the U.S. is making progress in the so-called opioid epidemic. Attorney General Jeff Sessions alluded to some of them in a speech on Friday.  

“New CDC preliminary data show that last fall, drug overdoses finally started to decline.  Heroin overdose deaths declined steadily from June to October, as did overdose deaths from prescription opioids,” Sessions said at the Western Conservative Summit in Denver.

Overdoses from heroin and prescription opioids did indeed fall by about 4 percent during that five-month period, but what Sessions failed to mention is that deaths from illicit fentanyl and other synthetic opioids rose by 12 percent – more than making up for whatever gains were made in reducing deaths from heroin and painkillers. 

From October 2016 to October 2017, the CDC estimates that 68,400 Americans died from drug overdoses, a 12% increase from the previous 12-month period.

So overdoses have not “finally started to decline” as Sessions claims. And the Attorney General, who once urged chronic pain sufferers to take two aspirin and “tough it out,” continues to blame prescription opioids for much of the nation’s drug problems.

“This (Justice) Department is going after drug companies, doctors, and pharmacists and others that violate the law,” Sessions said. “Since January 2017, we have charged more than 150 doctors and another 150 other medical personnel for opioid-related crimes.  Sixteen of those doctors prescribed more than 20.3 million pills illegally.”

 ATTORNEY GENERAL JEFF SESSIONS

ATTORNEY GENERAL JEFF SESSIONS

The Drug Enforcement Administration, which Sessions oversees, is also seeking a rule change that could lead to further tightening of the nation’s supply of opioid medication — in addition to the 45% in production cuts the DEA ordered over the last two years. The DEA wants to change the rules so it can arbitrarily punish drug makers who fail to prevent their opioid products from being diverted and abused.  

Sessions ‘Socially Irresponsible’

“I think they’re attacking it from the wrong end, to be candid with you,” says Tony Mack, the CEO and chairman of Virpax Pharmaceuticals. “Who is going to end up suffering is the real patients that have chronic pain and can’t get a hold of these opioids.”

Although Virpax is focused on developing non-opioid pain medication, Mack has a wealth of experience in opioid pharmaceuticals, having worked for Purdue Pharma, Endo and Novartis. In an unusually blunt interview for a drug company executive, Mack told PNN that Sessions’ focus on prescription opioids was “socially irresponsible.”

“I believe Attorney General Jeff Sessions needs to sit down and talk to some of these physicians who are pain specialists and understand that what he’s doing is going to put the chronic pain patient, the post-operative patient, and the patient that comes to the emergency room in serious jeopardy,” Mack said. “I think that Jeff Sessions is not educated well. I think he is picking on something that sounds good politically but doesn’t make sense socially. It’s socially irresponsible.”

Mack says pain patients would be caught in the middle if the DEA changes the opioid production rules and, for example, tells Purdue Pharma to stop selling OxyContin, its branded formulation of oxycodone.

“If you cut off that particular company, since they have more oxycodone out there than anyone, what will happen is patients will have to go to morphine or have to go to fentanyl,” Mack told PNN. “You’re not going to give patients the choices that they need to have in order to manage their pain. Not every single opioid works the same way for every single person. They all work differently.”

Mack thinks the DEA’s earlier production cuts have contributed to nationwide shortages of IV opioid medications, which are used to treat hospital patients recovering from surgery and trauma.

“Absolutely, I do,” he said. “It’s just a domino effect to me. You’re going to send more patients home or you’re going to be postponing surgeries until they get opioids because they can’t do (surgeries) without it. It would be inhumane.”

Mack says efforts to limit opioid prescribing and production may have backfired, giving patients little choice but to turn to the black market for pain relief.

“I think they’re trying to throw the baby out with the bathwater here. They’re not thinking it through,” Mack said. “They’re probably going to increase the amount of (illegal) drugs out there. And patients aren’t going to try and get help, because they’re going to be on heroin. Not on a prescription medication. They’re going to be shooting up heroin.”

The continuing focus on opioid medication also ignores a little known fact: A recent study by the Substance Abuse and Mental Health Services Administration (SAMHSA) found that psychotherapeutic drugs used to treat depression, anxiety and other mental disorders are now involved in more overdoses than any other class of medication. They include antidepressants, benzodiazepines, anti-psychotics, barbiturates and attention deficit hyperactive disorder (ADHD) drugs such as Adderall. Over 25,000 overdoses in 2016 involved psychotherapeutic drugs. That compares to 17,087 deaths linked to opioid medication.

Surgeon General talks new campaign to combat opioid crisis

https://www.nbcnews.com/nightly-news/video/surgeon-general-talks-new-campaign-to-combat-opioid-crisis-1250753603836

 

all laws/rules have UNINTENDED CONSEQUENCES

Pharmacy benefit managers target opioid crisis

www.capitolweekly.net/pharmacy-benefit-managers-opioid-crisis/

“One critical step championed by PBMs is requiring electronic prescribing (e-prescribing) of controlled substances in Medicare. E-prescribing of controlled substances helps ensure each prescription is written by a legitimate prescriber and filled by a legitimate pharmacy.”

H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act

https://www.congress.gov/bill/115th-congress/house-bill/4275

Summary: This bill requires the Drug Enforcement Administration (DEA) to develop and disseminate training programs and materials on: (1) the circumstances under which a pharmacist may refuse to fill a controlled substance prescription suspected to be fraudulent, forged, or indicative of abuse or diversion; and (2) federal requirements related to such refusal.

 

These two policies or proposed laws could have some unintended consequences for Pharmacists and Boards of Pharmacy. The first from the PBM’s.. they are stating their belief that a e-prescribed (electronically transmitted) Rx would ENSURE that the prescription is written by a legitimate prescriber. So for a Pharmacist to refuse to fill such a prescription would legally be limited to getting a “bad” PMP report on the pt… showing that the pt is a prescriber/pharmacy shopper, drug allergy or drug interaction with other medications that the pt is taking. There could be a possible questions about a high dose, but if a pt has been previously taking a “high dose” without any health consequences.. it is really not something that the pharmacist should question.  Because of the pt’s tolerance after taking a opiate for an extended period of time… there is no way to really determine what would be a “troublesome/lethal” dose.

So a Pharmacist declining to fill a prescriptions because of his/her “feeling” of “I’m not comfortable”.. no real facts… might be something that the Board of Pharmacy (BOP) may be forced to address.. if the pt files a complaint to the BOP. Also if the pharmacist uses the excuse “Don’t have inventory”… all pharmacies have to maintain a PERPETUAL INVENTORY on C-II’s..  and not sure how much it would cost but an attorney could probably get access to that inventory to prove if the pharmacy had sufficient inventory on the specific day/time.

Will the BOP consider taking actions against a pharmacist for lying to a pt resulting in a denial of care and/or would the employer condone or look the other way on lying to pts and denial of care or would they discipline the pharmacist and/or fire him/her ?

Like all other new laws/regulations, they will be defined/clarified thru our courts and legal system.

 

 

 

half of all states experiencing a 30 percent rise in suicides

Like you, we woke up to the news that celebrity chef Anthony Bourdain had taken his own life. Days earlier, we’d awoken to similar headlines about fashion designer Kate Spade.

Someone not surprised by the news? The Centers for Disease Control. On Thursday, the CDC released a study that found suicide rates have increased in nearly every state since 1999, with half of all states experiencing a 30 percent rise in suicides.

More troubling, only about half of the people who died by suicide had a known mental health condition.

Over One-Third of HCV Patients Denied DAA Tx by Payers

https://www.medpagetoday.com/infectiousdisease/hepatitis/73368

Highest among commercial insurers, increased over study period

More than a third of chronic hepatitis C (HCV) patients were denied access to direct-acting antiviral (DAA) treatment by their insurance provider, researchers found.

Among patients prescribed DAAs, 35.5% (95% CI 34.5%-36.5%) had their prescriptions denied by their insurer, reported Charitha Gowda, MD, of Ohio State University College of Medicine in Columbus, and colleagues.

Not only that, but the proportion of hepatitis C patients whose DAA prescriptions were denied by their insurance company increased over a period of 16 months, the authors wrote in the study online in Open Forum Infectious Diseases.

The authors noted that despite the benefits of HCV therapy, research in Clinical Infectious Diseases indicates that the high cost of DAAs has led public and private insurers to restrict access to these medications, and that insurers required “varying criteria for reimbursement” such as “evidence of advanced liver fibrosis, consultation with a specialist, and/or abstinence from alcohol or illicit drug use,” according to studies in Hepatology and Journal of Hepatology.

While advocacy efforts, threatened lawsuits, and greater price competition led some insurers to ease these restrictions, the Gowda and co-authors said their aim was to examine how access to DAAs has changed.

The team examined data from patients filling a prescription for DAAs from Diplomat Pharmacy Inc., which was described by the authors as providing “specialty pharmaceuticals” to patients across the U.S.

From January 2016 to April 2017, the system received prescriptions from 9,025 patients for DAAs — 4,702 covered by Medicaid, 2,502 covered by commercial insurance, and 1,812 covered by Medicare. Patients were a median 57 years old, and 38.4% were women. Over half were prescribed sofosbuvir/ledipasvir with or without ribavirin.

The authors noted that denial of treatment was more common among patients with commercial insurance (52.4%) compared with those with Medicaid (34.5%) or Medicare (14.7%, P<0.001 for both). The incidence of absolute denial increased across the study period, from 27.7% in the first quarter to 43.8% in the last quarter (test for trend, P<0.001).

Out of 45 examined states where a DAA prescription was submitted, eight states contributed 90% of prescriptions. Pennsylvania had the highest proportion (31.5%), followed by California (23.6%) and Michigan (14.3%). However, when the researchers examined the overall incidence of absolute DAA denial in these eight states, Maryland had the highest incidence (51.5%), followed by Delaware (49.1%), New Jersey (47.2%), and Pennsylvania (45.7%).

The authors emphasized the important clinical implications of the findings — namely that “persons denied access to HCV therapy remain at risk for the development of hepatic fibrosis, cirrhosis, liver decompensation, and hepatocellular carcinoma,” as well as ongoing HCV-associated inflammation that could lead to extrahepatic complications.

The team also pointed out the potential public health impact — i.e., that lack of access to DAAs could impede the goal of HCV elimination. The researchers cited a recent report from the National Academies of Sciences, Engineering, and Medicine that recommended that “public and private insurers should remove restrictions to DAAs that are not medically indicated and offer treatment to all chronic HCV-infected patients,” which is also consistent with guidelines from the American Association for the Study of Liver Diseases/Infectious Diseases Society of America.

Healthcare/Insurance… just your basic FOR PROFIT BUSINESS

Half of hepatitis C patients with private insurance denied life-saving drugs

https://medicalxpress.com/news/2018-06-hepatitis-patients-private-denied-life-saving.html

The number of insurance denials for life-saving hepatitis C drugs among patients with both private and public insurers remains high across the United States, researchers from the Perelman School of Medicine at the University of Pennsylvania reported in a new study published in the journal Open Forum Infectious Diseases. Private insurers had the highest denial rates, with 52.4 percent of patients denied coverage, while Medicaid denied 34.5 percent of patients and Medicare denied 14.7 percent.

The data was revealed through a prospective analysis of over 9,000 prescriptions submitted to a national specialty pharmacy between January 2016 and April 2017.

Direct-acting antiviral drugs (DAAs) – once-a-day pills that first became available in the United States in 2014—are highly effective, with a 95 percent cure rate and few side effects for with chronic C, but expensive. Because they can cost between $40,000 and $100,000, both private and public insurers have restricted access to the medications, approving the drugs only for patients with evidence of advanced liver fibrosis and/or abstinence from alcohol or illicit use, for example.

More recently, some of those restrictions had been relaxed because of vocal stakeholders and leaders, class action lawsuits, and greater drug price competition that experts believed would help increase the overall approvals by insurers. However, analysis of the data suggests otherwise.

“Despite the availability of these newer drugs and changes in restrictions in some areas, insurers continue to deny coverage at alarmingly high rates, particularly in the private sector,” said study senior author Vincent Lo Re III, MD, MSCE, an associate professor of Infectious Disease and Epidemiology. “It warrants continued attention from a public health standpoint to have more transparency about the criteria for reimbursement of these drugs and fewer restrictions, particularly in private insurance and certainly to continue the push in public insurance, if we want to improve hepatitis C drug access across all states.”

The reason for the higher than expected denial rate is unclear, the authors said, but may be due to the varying restrictions on reimbursements that exist among the states. It’s likely there were more attempts to treat patients who have less advanced liver fibrosis, have not met sobriety restrictions, or have not had consultation with a specialist, they wrote.

The team analyzed prescriptions from 9,025 patients between January 2016 and April 2017 submitted to Diplomat Pharmacy Inc. throughout 45 states. Among those patients, 4,702 were covered by Medicaid; 1,821 by Medicare; and 2,502 by commercial insurance. In all, 3,200 (35.5 percent) were denied treatment.

The denial rates appear to be increasing, as well. The overall incidence of denials across all insurance types increased during the study period from 27.7 percent in the first quarter to 43.8 percent in the final quarter. In addition, a Penn study from 2015 found that just five percent who had Medicare received a denial, while 10 percent who had private insurance did.

That same study also found that 46 percent of Medicaid patients were denied coverage, compared to the current study’s 35.7 percent. A statement from the Centers for Disease Control and Prevention in 2015 indicating that restrictions violated federal law prompted class action suits and legal action against Medicaid, which likely contributed to the public insurer easing its criteria across some states and improved approval rates, the authors said. Still, Medicaid denials increased over the study period.

“From a clinical standpoint, patients with chronic hepatitis C who are denied therapy can have continued progression of their liver fibrosis and remain at risk for the development of liver complications, like cirrhosis, hepatic decompensation, and liver cancer,” Lo Re said. “In addition, chronic hepatitis C promotes not only liver inflammation, but systematic inflammation, which can lead to adverse consequences on organ systems outside of the , such as bone, cardiovascular, and kidney disease. Further, untreated patients can continue to transmit infection to others.”

A recent report from the National Academies of Science, Engineering, and Medicine determined that at least 260,000 chronic hepatitis-infected patients must be treated yearly to achieve elimination of the virus in the United States by 2030. To reach that goal, they recommended that public and remove restrictions to the hepatitis C drugs that are not medically indicated and offer treatment to all C-infected patients. Those recommendations are also consistent with guidelines from the American Association for the Study of Liver Diseases and Infectious Diseases Society of America.

“Eliminating hepatitis C in the U.S. is a feasible goal,” Lo Re said, “but that’s going to be hard to achieve if payers are not reimbursing for the treatment.”

Explore further: Insurance denials for new hepatitis C drugs remain high nationwide, study suggests

I will believe this when the CDC and DEA make similar statements and take action.

FDA Commissioner Says FDA Will Listen to Chronic Pain Patients About Opioids

www.themighty.com/2018/05/fda-chronic-pain-patients-opioids/

In a blog post published on Monday, Scott Gottlieb, the Food and Drug Administration commissioner, said the FDA is listening to opioid-related concerns from patients with chronic pain.

“We’ve heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life,” Gottlieb wrote.

Over a year ago, the FDA created the Opioid Policy Steering Committee with the goal of reducing exposure to opioids, preventing more addictions and developing and cultivating the use of medications to treat opioid addiction. This committee received public input from patients who use opioids to manage their chronic pain.

Now, the FDA is asking for input from chronic pain patients again to learn more about the “impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments.”

Gottlieb said the FDA wants to “strike the right balance” between making policies that give patients who need opioids the proper accessibility and preventing opioid exposures that lead to new addictions.

Most patients with chronic pain do not develop an addiction. While studies vary on percentages, one study stated that less than 1 percent of those who take opioids long-term develop an addiction. Another study said 8 to 12 percent of people with chronic pain develop an addiction. This study also said that misuse (but not addiction) of opioids among chronic pain patients can be between 21 to 29 percent.

The FDA is considering coming up with a strategy in the next few months to encourage medical professional societies to create evidence-based guidelines on how to prescribe medications for acute medical needs and assess prescribing behavior as well as adding new prescribing information to opioid labels.

Gottlieb wrote:

We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.

The Centers for Disease Control and Prevention published guidelines for prescribing opioids for chronic pain in 2016. The guidelines were not well received by patients, who said the guidelines led to less doctors prescribing opioids for their pain.

Gottlieb also said the FDA will be developing guidance documents for the most efficient path for developing drugs that can be used to treat various types of pain. This is an effort to promote more drug innovation for pain.

Patients with chronic pain can attend the FDA’s “Patient-Focused Drug Development for Chronic Pain” meeting on July 9 from 10 a.m. to 4 p.m. Patients can attend in person in Maryland or through a webinar by registering online.

Healthcare is just a FOR PROFIT BUSINESS… MORE PROFITS… results in poorer outcomes for pts ?

https://www.medpagetoday.com/publichealthpolicy/opioids/73289

After Medicaid Privatization, Steep Cuts in Care

The Dallas Morning News launched a series they’re calling “Pain and Profit,” which looks at how companies paid by the state to handle Medicaid issues fall short. The first installment explored the case of a baby named D’ashon Morris who needs assistance to breathe. In the months before his first birthday, D’ashon began pulling out his trach tube. Despite evidence that it was a constant problem, the company supervising his care ruled that he did not require around-the-clock care. Physicians called it a matter of life and death.

It didn’t matter. He didn’t get the care. His tube dislodged one night; he’s now brain dead. The second piece, highlighting care to poor adults, published Monday.

When Opioids Are Discouraged, Pain Gets Short Shrift

Physicians’ growing discomfort prescribing opioids — and the federal government’s efforts to curb prescription rates — has left those in chronic pain in the lurch, the Washington Post reports. Some are flying across the country to find a prescription, while others are turning to unregulated substances such as kratom.

“I am seeing many people who are being harmed by these sometimes draconian actions amid this headstrong rush into finding a simple solution to this incredibly complicated problem,” said Sean Mackey, chief of Stanford University’s Division of Pain Medicine. “I do worry about the unintended consequences.”

Do we need to educate the professionals?

Do we need to educate the professionals?

www.nationalpainreport.com/do-we-need-to-educate-the-professionals-8836437.html

Some professionals claim to be “experts”; however, few are experts in the entire scope of their chosen field of study. Most likely they will end up being “specialists” in certain subsets of their profession. Either because they have become interested in one or more subsets, or that is where there is a need to provide services.

Has anyone noticed that there are seemingly endless array of personal injury attorneys appearing on TV, offering to sue someone because someone has gotten injured or died?

Most seem to focus on trucking/vehicles accidents, nursing home neglect, and other areas where there is some entity with a “deep pocket” to sue.

I have heard or read from countless chronic pain patients, about them contacting an attorney to sue over patient abuse/neglect/discrimination – and all have been turned down.

They are being turned down because in our legal system, the “value of life” of a person who is handicapped/disabled, elderly, unemployable, retired, is about the same as the value of the family pet… nearly ZERO. Likewise, if a law firm did take such a case, most states have a rather low cap on settlements… To a point where there is no financial upside for the law firm for winning the case.

But the “the times they are a changing”… An increasing number of various healthcare entities are seemingly taking it upon themselves to practice medicine. Some of those entities are insurance companies, PBM’s, large hospital corporations, chain pharmacies and other such entities.

They are creating edicts that their employed prescribers, pharmacists and others are to limit/restrict controlled medications – regardless of what the patient’s personal prescriber deems necessary.

Beside attempting practicing medicine without a license, they are discriminating against a protected class of people under the Americans with Disability Act, Civil Rights Act and numerous other legal issues.

What do these healthcare businesses have in common with the entities that these personal injury attorney normally sue?  DEEP POCKETS!!!

Now is the time for chronic pain patients to start contacting law firms and point out to them – EDUCATE THEM… all the patient abuse, neglect and discrimination that is going on at the hands of these corporate entities that are called “healthcare companies” – and individually these companies are harming hundreds, thousands or tens of thousands of chronic pain patients.

With 20 to 30 million intractable chronic pain patients in our country, the total number of patients being affected is really not known. All we know is that whatever the number is today, it is GROWING.

OR… you can keeping contacting President Trump, members of Congress, signing petitions and creating hundreds of Facebook pages… and how has that been working for you?