The insane crackdown on pain medication

https://nypost.com/2018/05/24/the-insane-crackdown-on-pain-medication/

If you have chronic, agonizing pain, your troubles are about to get worse. New state and federal regulations will make it nearly impossible to get the prescription painkillers you need.

Grandstanding politicians are imposing one-size-fits-all limits on how much medication patients can receive and for how long.

Pols claim they’re combating the opioid crisis, but these draconian limits will harm millions with chronic pain and do zip to curb overdose deaths. Before the 1990s, pain was frequently under-treated, and patients suffered horribly. Since then, doctors have been trained to routinely ask patients about their pain and treat it.

Now, politicians are undoing that progress. Patients will be forced to tough it out again.

Seniors on Medicare get harmed the most. New Medicare regulations will refuse to pay for high-dose, long-term prescriptions for chronic-pain sufferers starting Jan. 1, 2019, with only a few exceptions, such as cancer patients.

Never mind that this age group is the least likely to overdose. And never mind that some 1.6 million seniors on Medicare Part D will be affected. Facts be damned.

Politicians parrot a false narrative that millions of people are becoming drug addicts because of prescriptions their doctor gave them for pain.

Not true. Emergency-room records reveal that very few overdose victims were being treated by a doctor for chronic pain, according to the Journal of the American Medical Association–Internal Medicine. That’s not how they got hooked.

True, there are doctors who unscrupulously operate pill mills, dispensing prescriptions to anyone who asks, but those bad apples are not causing the tragic surge in overdose deaths. Only about 1 percent of patients prescribed opioids for chronic pain become addicted — according to a systematic survey of peer-reviewed medical studies. Even 1 percent is too much, but it doesn’t justify harming millions of patients who need pain relief.

Politicians should be battling dealers, not doctors. Illegal drugs cause nearly all overdose deaths, not drugs patients get from their doctor. Fentanyl (a man-made heroin-like drug), heroin and cocaine play the biggest roles in overdose deaths in New York City, according to the city’s health data. Fewer than one in five overdose victims even had a prescription drug in their system, and it was virtually never the only drug.

Yet Mayor Bill de Blasio wrongly blames the city’s overdose death toll on prescription painkillers.

Nationwide also, fentanyl poses the biggest threat. Overdose deaths from fentanyl and other manmade street drugs soared 100 percent in one year, while overdoses linked to prescription opioids hardly increased or in many areas declined.

Patient advocates are alarmed at the new laws and regulations limiting what their doctors can prescribe. Nearly half the states, including New York, Connecticut and New Jersey, have acted. Though many limit only prescriptions for short-term pain relief, not chronic pain, they’re having a chilling impact. Doctors fear legal trouble, and are cutting off patients. Some of these turned-away patients, like 52-year-old bed-ridden Debra Bales, who had taken painkillers for years, resort to suicide in desperation.

Ohio Gov. John Kasich boasts that his state will erect new hurdles before a doctor can prescribe an opioid painkiller. Doesn’t Kasich know that prescription-opioid overdoses are at a six-year low in his state, while deaths from heroin and other illicit drugs are soaring? Target the real problem, governor.

Good advice for de Blasio, the ultimate grandstander. He’s brandishing a lawsuit against pharmaceutical companies and boasts millions in new spending on the opioid crisis, but refuses to put any of that money into law enforcement.

That’s a mistake. The facts behind overdose deaths show the city should be clamping down on the pushing and shooting up going on in plain sight in parks and public places. Nationwide, pols should be going after dealers instead of seniors and other chronic-pain sufferers who use, but do not abuse, meds.

Betsy McCaughey is a senior fellow at the London Center for Policy Research.

More than 11 million Americans prescribed wrong dose of common drugs, scientists say

https://www.whio.com/news/national/more-than-million-americans-prescribed-wrong-dose-common-drugs-scientists-say/teBg0N0pHLxaFdjFnDtoHK/

More than 11 million people in the United States may have been given the wrong prescription dose for common drugs, according to scientists from the Stanford University School of Medicine.

>> Read more trending news

The researchers analyzed the reliability of updated pooled cohort equations, guidelines often used as online web tools that help doctors determine a patient’s risk of stroke or heart attack.

When patients walk into the doctor’s office, their risks are automatically calculated using PCEs and uploaded to electronic health records. Based on the data, doctors decide whether to prescribe aspirin, blood pressure or statin medications — and how much.

>> Related: Long-term aspirin use may reduce your chances of getting cancer, study says

But experts in the medical community have long debated whether the equations are based on outdated data and may be putting patients at risk.

Stanford professor and lead researcher Sanjay Basu is one such expert. According to his team’s analysis, Basu noted one of the main data sets used for PCEs had information on people who would be 100-132 years old in 2018, so probably dead.

“A lot has changed in terms of diets, environments and medical treatment since the 1940s,” Basu said in a university article. “So, relying on our grandparents’ data to make our treatment choices is probably not the best idea.”

>> Related: Heart attack sufferers more likely to survive if doctor is away, study says

The data also didn’t have a sufficient sample of African-Americans, suggesting physicians may have been inaccurately assessing the group’s risks of heart attacks or strokes as too low.

Basu and his team believe the statistical methods, in addition to the data sets, also need to be upgraded to improve the accuracy of risk estimates.

The findings were published in the Annals of Internal Medicine on June 5.

Survey Finding Chronic Pain Community Energized and Angry

www.nationalpainreport.com/survey-finding-chronic-pain-community-energized-and-angry-8836472.html

“They are amazing and they are pissed.”

That is how Terri Lewis Ph.D. described the early responses she has been receiving from a survey we are promoting on the National Pain Report.

The survey–which Dr. Lewis developed– is designed to capture data from the chronic pain community that can be shared with the FDA at its July 9 Public Meeting for Patient-Focused Drug Development on Chronic Pain

Dr. Lewis is keeping the survey open until June 17, at which time she’ll cut off the survey to prepare her findings for the meeting in July.

If you haven’t taken the survey yet, you may do so by clicking here.

At this point persons from all 50 states have responded, “some states far more than others,” she said.

As has been the case since the survey started, the respondents have been mostly women (80%) and over 40 years old, but she’s seeing a small increase in the number of people under 17.

In fact, the largest group of respondents is in the 50-to-59 year old range, which she points out is in sharp contrast to the JAMA article released last week that asserts the largest amount of opioid related deaths occur in people in their twenties.

“There are only a few respondents from minority groups, although the number has been picking up of late,” she added.

Dr. Lewis points out that a big number of people who are responding would otherwise be in the prime of their working and economic lives were it not for injury and illness that they endure. Public Meeting for Patient-Focused Drug Development on Chronic Pain
“They are very unhappy with the system they have to rely on.  They are extraordinarily negatively impacted by shrinking footprint of healthcare and public policy,” she pointed out.

Many of the respondents have been dealing with their illnesses and injuries for many years and had achieved some degree of stability of care until the opioid wars destabilized their provider system.

“Their disruptions are not disruptions of their own making – they are systemic in nature and for the most part imposed through public policy with the opioid wars and insurance changes.” she said.

“These are simply sick people, invisible to the system, who have been left to cope on their own,” Dr. Lewis added.

The goal of the survey is to bring the story of the chronic pain community to the FDA in July. 

Let your voice be heard.

Follow Dr. Lewis on Twitter: @tal7291

Follow us on Twitter @NatPainReport

Follow the author on Twitter @edcoghlan

Example of the “EXCELLENT HEALTH CARE” available in Montana ?

DEA Agent – “a marijuana medical expert” talks to community about the uses of MMJ

DEA Agent Wants To Separate Facts From Myths Regarding Medical Marijuana

http://www.newson6.com/story/38376205/dea-agent-wants-to-separate-facts-from-myths-regarding-medical-marijuana

TULSA, Oklahoma –

On June 26, 2018, Oklahomans will vote whether to legalize medical marijuana.

The head of Oklahoma’s Drug Enforcement Administration office said he wants people to separate the facts from the myths, so he speaks to church groups and organizations about State Question 788.

4/12/2018 Related Story: Medical Marijuana Could Bring Great Benefits, Challenges For Oklahoma

The DEA says at no time in history have people been allowed to decide what medicine is by popular vote. Assistant special agent in charge, Richard Salter, believes the bill is disguised as medical but is actually about recreational use.

Salter has created a 45-minute presentation that he’s given more than two dozen times. He says people need to know the facts, rather than simply believe what they see on social media or commercials.

5/3/2018 Related Story: Colorado Elderly Lining Up For Medical Marijuana

“I think Oklahoma will be the first state, if this passes, to have no qualifying medical condition. That means you go to the doctor and say, ‘Even though there’s nothing wrong with me, I’d like a medical marijuana card,’” Salter said.

He said the amounts of pot allowed under the law are a lot.

“Allows a person to possess three ounces on their person outside their house, which is the equivalent of 168 joints or marijuana cigarettes. And, in their house, possess another eight ounces, another 448 joints, and that’s not including the 72 ounces of edibles, which is four-and-a-half pounds of brownies,” he said.

Salter said people could also have six full-grown plants and six seedling plants. He said one plant in California alone produced 100 pounds of marijuana.

He said the CBD oil, which is one extract of the plant does and doesn’t produce a high, can help with childhood epilepsy and has been legal in Oklahoma for three years and FDA is thinking of approving it.

“If that’s helpful to epileptic children, that’s great, it’s a good thing, but that doesn’t mean you have to legalize the entire plan and everything that goes along with it,” Salter said.

You can read the full law below:

 

Let’s order a round of respect: for both patients and physicians

https://www.kevinmd.com/blog/2018/06/lets-order-a-round-of-respect-for-both-patients-and-physicians.html

To complement Aaron Lacy’s post on treating colleagues with respect, I’d like to expand that concept to include treating patients with respect too. That means if a patient says she’s freezing, and adding insult to injury, has been sick as well,  adjust the thermostat a little, please, even if you as the doctor isn’t cold. When a stray cat came to our door in the dead of winter, my husband made a warm little spot for him in the garage. If it’s good enough for a cat, it should be good enough for person.

Mr. Lacy brought up many good points, one of which is to not embarrass a colleague, especially in front of others. That courtesy should be extended to a patient as well. If I say that I eat 1200 calories a day, but my 20 extra pounds of pudge won’t budge, don’t look at me as if I just said I was from Mars. I’m not, nor did I eat a Mars® candy bar, but I know how to count, and I eat about 1,200 calories a day. I was willing to wear a video camera to prove my actions, but when he told me that he had friends who went to Emory, my alma mater, I didn’t ask him to prove it. I took him at his word. If it was good enough for me to believe him, it should have been good enough for him to believe me.

Too many cooks spoil the medical office.  There have been times when I am instructed to leave a message with one person, who is going to relay that information to another person. However, that second person never gets the message, causing a lot of miscommunication and misunderstandings all the way around. After several phone messages, all was fine, but talk about the game, “telephone,” (where messages get misunderstood).

Doctors’ offices state that if you don’t pay within a certain period of time, you’ll be charged interest. What about when I’ve had to wait over 60 days for a refund? Do I get to charge interest? I’d be interested to know.

As Mr. Lacy pointed out, if you make a mistake, own up to it. Fingers will eventually point to you anyway. He also implored colleagues not to be mean. That should be part of everyone’s core. I mean it. We shouldn’t have to contend with rude attitudes.

How else can a doctor show respect to a patient? Maybe by knocking on the door. I mean, we’re not going to turn you away, but that 2-second knock humanizes us a little, so, knock knock Doc.

Of course, respect works both ways. I call my doctors Drs. So-and-so, but I don’t mind if they call me by my first name, but some people do.  I know medicine can be a calling, and you should be aware that calling a patient by a preferred name goes hand in hand with your profession. For me, just don’t say, “Hey Dude, “(although Dudette Barnett sounds OK).  Some new patient forms ask what name you’d like to be called, but that wasn’t always the case. Doctors would call my 85-year-old mom by her first name. She rolled with it, but I’d suggest starting with Mr. or Mrs., to avoid any misses.

Patients usually follow doctors’ orders, so let’s order a round of respect, all the way around.

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.