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Trump Administration Seeks Public Comments On Marijuana Reclassification
Posted on October 10, 2018 by Pharmaciststeve
Trump Administration Seeks Public Comments On Marijuana Reclassification
The federal government wants your input on whether marijuana should be reclassified under global drug treaties to which the U.S. is a party.
Marijuana leaf in front of a globe against blue background
Specifically, the U.S. Food and Drug Administration (FDA) is asking for public comments about the “abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use” of cannabis and several other substances now under international review.
Under current U.S. federal law as well as global drug policy agreements, marijuana is classified in the most restrictive category of Schedule I. At home, that means it is considered illegal and not available for prescription, while research on its potential benefits is heavily restricted. Cannabis’s international status means that nations who are signatories of drug control treaties are not supposed to legalize it, though that hasn’t stopped Canada and Uruguay from doing so.
Public comments on marijuana’s effects and legal status “will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs,” Leslie Kux, FDA’s associate commissioner for policy, wrote in a Federal Register filing published on Wednesday. “WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs.”
WHO’s Expert Committee on Drug Dependence (ECDD) is meeting in Geneva next month to consider the classification of marijuana and other substances, and is now seeking to “gather information on the legitimate use, harmful use, status of national control and potential impact of international control,” the United Nations body said in a notice excerpted in the FDA filing.
Earlier this year, ECDD determined that cannabidiol (CBD), a component of marijuana shown to have medical benefits without intoxicating properties like other cannabinoids such as THC, should not be scheduled under international drug control conventions.
“CBD has been found to be generally well tolerated with a good safety profile,” the UN body found in its critical review. “There is no evidence that CBD as a substance is liable to similar abuse and similar ill-effects as substances…such as cannabis or THC, respectively. The Committee recommended that preparations considered to be pure CBD should not be scheduled.”
The body also agreed to undergo an in-depth critical review of the marijuana plant and its resins and extracts, as well as THC itself. That new review is what triggered the FDA’s request for public comment on Wednesday.
The Trump administration sought public comments from interested parties in advance of an earlier UN pre-review on marijuana as well.
“Any comments received will be considered by [the U.S. Department of Health and Human Services] when it prepares a scientific and medical evaluation for drug substances that is responsive to the WHO Questionnaire for these drug substances,” the new FDA notice says. “HHS will forward such evaluation of these drug substances to WHO, for WHO’s consideration in deciding whether to recommend international control/decontrol of any of these drug substances.”
Legalization advocates are hopeful that a hard look at the data on marijuana’s effects will inevitably lead to a pro-reform conclusion.
“A careful review of the relevant science does not now, nor has it ever, supported a hard-line approach to cannabis scheduling. Cannabis’s abuse potential relative to other substances, including legal substances like alcohol, tobacco and prescription medications, does not warrant its continued criminalization under either U.S. or international law,” Paul Armentano, deputy director of NORML, said in an email. “By any rational assessment, cannabis prohibition is a disproportionate public policy response to behavior that is, at worst, a public health concern. But it should not be a criminal justice matter and international laws should no longer classify it as such.”
Mason Tvert, a spokesman for the Marijuana Policy Project, agreed.
“The time has come for marijuana to be removed from the federal drug schedules. There is no longer any doubt that it has significant medical value, and the science is clear that it is less harmful than many legal medical products,” he said. “While marijuana is not harmless — few, if any, products are — it poses less harm than alcohol to consumers and to society. The U.S. led the world into the quagmire of cannabis prohibition, so it should lead the world out of it by descheduling cannabis and implementing a more evidence-based policy.”
That said, the feds aren’t planning to make any cannabis recommendations to the UN panel ahead of its review meetings next month.
“Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in mid-2018,” the Federal Register notice says. “Any HHS position regarding international control of these drug substances will be preceded by another Federal Register notice soliciting public comments.”
In addition to marijuana and its components, the WHO committee is also reviewing several synthetic cannabinoids, fentanyls and other substances.
FDA has hinted that international rescheduling of marijuana and its components could influence changes to its legal status here at home.
This month, FDA publicly released a letter it sent to the Drug Enforcement Administration (DEA) earlier this year suggesting that CBD should be completely removed from federal control.
Cannabidiol has a “negligible potential for abuse” and has a “currently accepted medical use in treatment,” the agency found.
But, because of international drug treaty obligations, FDA conceded that the substance needs to be scheduled, concluding that it should be placed under the least-restrictive category of Schedule V.
“If treaty obligations do not require control of CBD, or if the international controls on CBD change in the future, this recommendation will need to be promptly revisited,” FDA wrote in its analysis to DEA.
That document, dated in May, preceded the WHO’s determination that CBD should not be globally scheduled, and was part of the federal government’s approval and rescheduling last month of CBD-based drug Epidiolex, which is used for severe epilepsy disorders. It is not clear why the U.S. government subsequently decided to place FDA-approved CBD medications in the federal Schedule V, with an appeal to global treaties that the UN now says shouldn’t schedule the substance.
For now, FDA is accepting public comments on marijuana and the other substances currently under UN review via the web until October 31. Interested parties can also submit written comments via mail.
Ultimately, WHO will make a scheduling recommendation for marijuana to UN Secretary-General António Guterres, who oversaw the enactment of drug decriminalization as Portugal’s prime minister, a policy he has touted in his current capacity.
Tom Angell publishes Marijuana Moment news and founded the nonprofit Marijuana Majority. Follow Tom on Twitter for breaking news and subscribe to his daily newsletter.
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Trump said that Americans usually come together during times of suffering
Posted on October 9, 2018 by Pharmaciststeve
Trump says it will be hard to unify country without a ‘major event’
Hours before his first State of the Union, President Donald Trump said Tuesday that he wants to unite the country amid “tremendous divisiveness” and hopes he can do so without a traumatic event affecting Americans.
Trump spoke about creating a more united country during a lunch with a number of television news anchors. Trump said the United States has long been divided, including during the impeachment of former president Bill Clinton. Trump also said that Americans usually come together during times of suffering.
“I would love to be able to bring back our country into a great form of unity,” Trump said. “Without a major event where people pull together, that’s hard to do. But I would like to do it without that major event because usually that major event is not a good thing.”
The president also said the country’s divisions date back to both Republican and Democratic administrations, citing the scandals that led to Clinton’s impeachment by the House in 1998.
“I want to see our country united. I want to bring our country back from a tremendous divisiveness, which has taken place not just over one year, over many years, including the Bush years, not just Obama.” he said.
Trump went on to say that uniting people would also be hard because of issues like health care, because some people want “free health care paid by the government” and others want “health care paid by private, where there’s great competition.”
The comments came as the president was putting the finishing touches on his first State of the Union address Tuesday night.
According to a White House official, Trump’s speech will be about 50 minutes long, and was written with help from H.R. McMaster, the national security advisor, Rob Porter, the White House staff secretary, Gary Cohn, the chief economic advisor, Stephen Miller, the senior policy advisor, and Ross Worthington and Vince Haley, who are both speechwriters.
Is 100 million chronic pain pts without any medication/treatment … is that enough suffering ?
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AMENDMENT TO THE SENATE AMENDMENT TO H.R. 6- opiate recovery act
Posted on October 9, 2018 by Pharmaciststeve
AMENDMENT TO THE SENATE AMENDMENT TO H.R. 6
Anyone interested in the details of the Senate bill that passed the Senate recently by 99 to 1 … the bill is ONLY 660 pages
SHORT TITLE: This Act may be cited as the 2 ‘‘Substance Use–Disorder Prevention that Promotes 3 Opioid Recovery and Treatment for Patients and Communities Act’’ or the ‘‘SUPPORT for Patients and Communities Act’’.
Shouldn’t we all be ecstatic that Congress is wanting to help a few million opiate substance abusers (addicts) get clean – that FEW REALLY WANT TO GET CLEAN ?
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www.cawnation.com Diabetes & Myths 10/09/2018 8 PM EDT
Posted on October 9, 2018 by Pharmaciststeve
www.cawnation.com
THE DOCTOR’S CORNER
w/ DR. KLINE & JONELLE ELGAWAY
Tonight! 8pm est
Topic: Diabetes/Myths
Tune in:
www.cawnation.com and click “listen”
OR
listen and chat live on NEW YT Channel:
“The Doctor’s Corner” direct link
https://www.youtube.com/channel/UCQk7ewfPvTfo3pleSzvth7A
Please call in with comments or questions at
(415) 915-2291.
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You should be MAD AS HELL AND NOT GOING TO TAKE IT ANYMORE
Posted on October 8, 2018 by Pharmaciststeve
My regular readers should have noticed that the number of post that I have been doing – starting with last month – have been about HALF – previous months and I have been making many more OPINIONATED PIECES… This is INTENTIONAL on my part…
There are 435 House Members and 33 in the Senate that are up for re-election next month… only 9 House members voted against the 70 odd opiate bills recently and ONLY ONE Senator voted NO in the Senate Mike Lee ( R-UT) .
We are registered in FL to vote… and Senator Bill Nelson ( D-FL) is on my HIT LIST… he voted against the Medicare Part D program, he voted the recent tax cuts – that Rep Pelosi referred to the $1000 as “crumbs”, he voted for the recent opiate bill and against Judge Kavanaugh… he has been in the senate for THIRTY YEARS .. He is 76 and – IMO – it is time for some term limits… I am not real thrilled that his opponent is current Fl Governor Rick Scott… but once against the election seems to be the lesser of the evils.
All those Senators and Representative VOTED AGAINST YOU AND YOUR PAIN MANAGEMENT and in favor of substance abusers getting treatment…it won’t be long before they will impose a opiate Rx tax to pay for the therapy for those substance abusers… who, for the most part …. don’t want to get clean.
Letter to bureaucrats haven’t moved the needle…. talking to the media -when they would talk to you – hasn’t moved the needle… having a few people picketing some office or bldg… more of the same…
those bureaucrats in Washington… 98% expect to get re-elected no matter what they have done or not done during their 2 or 6 yr term… you send them a letter about denial of care and most likely they will send you back a letter – maybe – about the opiate crisis.
The chronic pain community needs to get their ass in gear and get their act together… just stop whining, bitching, moaning on FB… you may have missed the date to register to vote, if not register to vote. you can vote my mail… hopefully you can afford a single postage stamp to mail your ballot back in..
Going forward, I am going to keep expressing my opinion on a more regular basis on my blog… some might say that I can’t be MORE OPINIONATED 🙂
At this point in time, I really don’t have a dog in this fight… Barb’s pain is being managed the best possible… of course, that could change at anytime. We don’t have any “horror stories” about denial of care… It is up to the chronic pain community to get their asses in gear and get the job done.
There is suppose to be 100 + million chronic painers and most have spouses and kids – hopefully of voting age… collectively the chronic pain community has the numbers to “control” any/all who get elected to ANY OFFICE.
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I didn’t want heavy painkillers after surgery — but my hospital pushed opioids on me anyway
Posted on October 8, 2018 by Pharmaciststeve
I didn’t want heavy painkillers after surgery — but my hospital pushed opioids on me anyway
Hospitals want to keep their patients happy, but too often doctors treat pain like a disease and push opioids even when people explicitly say no.
This is a story about how the health care industry effectively forces patients into opioid use. I know, because this recently almost happened to me. And it could have cost me my life.
A few weeks ago, I had a major abdominal surgery. I have had two similar surgeries before, which taught me how well I tolerated both pain — and painkillers. Pain, while uncomfortable, was not unbearable. Far worse were the drugs, which caused uncontrollable nausea, dizziness, vomiting and overall malaise. That was not something I was keen on dealing with again, least of all following a stomach surgery. Before my procedure, I made sure to have these requests documented in my medical records.
That’s where the trouble started.
During the month before my surgery, every professional I met with did their utmost to assure me that this time would be different. This time, they emphasized, I should expect the very worst in terms of pain. Time and again, I gave them the same answer I had given in my initial consultation and had written in my medical file: “I prefer not to use any heavy narcotics outside of the necessary anesthesia.” And time and again, I was met with the same slack-jawed expression and incredulous response.
Oh no, they all assured me. No, no, no — I really didn’t understand just how painful this surgery would be.
I really did, I insisted, and began to explain that I had had similar surgeries — only to be immediately cut off and told that my prior surgeries hadn’t been anywhere near as serious as this one, and that I was going to need something quite strong to make the pain go away.
Make the pain go away. As though the pain itself were a disease or disorder. The physicians were emphatic, as though my future pain was more of an issue than the current tear in my abdomen.
“I understand I’m going to be in pain,” I repeated, equally emphatically, and now to the point of frustration. “The pain is not the issue.”
My surgeon was the only individual who did not disregard my decision to manage without prescription painkillers, and in my file noted that my post-discharge pain management plan would consist of standard, over-the-counter Tylenol.
That note was later updated to read Tylenol 3 — with codeine — by the hospital staff. No one believed that I could manage without something stronger. Sure enough, upon discharge, I was given a prescription for 40 tablets of codeine.
Forty.
Pain is a symptom, not a disease
Later I sat at home, the flimsy piece of dull blue paper trembling in my hands, its 4 and 0 scrawled out in sharp black ink. Forty tablets of codeine. For what? For an otherwise healthy woman, who had insisted on her preference of not using anything stronger than over-the-counter Tylenol? A woman who had made sure her choice was indicated in her medical file?
Why had it been so difficult for me to not obtain narcotics? In my head, I replayed the events of the past 18 or so hours: Over the course of a one-night hospital stay, I had been offered and denied narcotics at least half a dozen times. It began immediately following my surgery. Not long after I had awakened, a nurse entered my room and attempted to administer Dilaudid through an IV. When I stopped her, I learned I had already been given Dilaudid once, while unconscious.
I began to dread the thought of falling asleep.
Every few hours, another nurse would appear and attempt another dose of Dilaudid. When I explained effects that these painkillers tended to cause for me, one nurse seemed to listen at first, then replied that the staff would give me the Dilaudid to manage my pain, and then give me yet another drug, an anti-emetic, to cope with the nausea.
Even my indirect interactions with the hospital were marked by the medical industry’s near-militant insistence on eviscerating pain. All the questionnaires I received before and after my surgery were all centered around pain management. On the wall of my hospital room, a stark white sign blared in large block letters: “Pain management is a patient right. Please tell us about your pain.”
Pain management was a patient right. Painkiller refusal, it seemed, was not.
“It’s about you, our patient,” the sign added, in smaller script underneath. But was it? Too often, the incentive structure that pervades the industry sets things up so that health care professionals work harder to serve drug companies and hospitals than actual patients and policyholders.
There are other incentives at work, as well. Patient satisfaction scores now play a role in hospital reimbursement rates. As an Annals of Family Medicine study reported this year, patients who are prescribed high doses of opioids were more likely to report high satisfaction with care — meaning higher rates of Medicare reimbursements for their providers.
Similarly, in 2014 a Patient Preference and Adherence survey indicated that nearly half of doctors admitted to prescribing inappropriate narcotic medication because of the incentive to acquire higher satisfaction scores. The misalignment can have deadly consequences.
Incentive should be to save lives, not sell drugs
Three days after my surgery, I experienced a sharp, persistent pain in my right calf. In the emergency room, an ultrasound located a blood clot just below my right knee. Post-surgical clots can quickly travel through the body and into the lungs, where a pulmonary embolism could have catastrophic consequences for a patient.
I reflected on my experiences and had the chilling thought: Had I taken my (filled, but still unused) prescription for 40 Tylenols with codeine, would I have been able to identify the pain in my leg? If I had regarded pain as a disease rather than a symptom, and tried to eradicate the pain rather than treat its causes, would I be sitting here today?
We in the medical industry have a chance — and a duty — to use our expertise toward eradicating something far worse than pain: an epidemic that destroys lives, eats through money, and endures through a perverse incentive structure to which no one in my field is fully immune. If we all took a bold step to commit to change and refuse the siren song of kickbacks, reimbursements and misaligned rewards, wouldn’t the lives we save be incentive enough?
Emma Passé has 14 years experience in the insurance industry. She is currently at Employee Benefit Management Services, Inc., an independent Third Party Administrator (TPA) where she helps employers and their employees incentivize higher value care at lower costs.
You can read diverse opinions from our Board of Contributors and other writers on the Opinion front page, on Twitter @usatodayopinion and in our daily Opinion newsletter. To respond to a column, submit a comment to letters@usatoday.com.
When I started reading this article… I thought to myself … what sort of “nut” went down this path and then wrote about it… If you read the credentials of the person who wrote this article she ... has 14 years experience in the insurance industry. She is currently at Employee Benefit Management Services, Inc., an independent Third Party Administrator (TPA) where she helps employers and their employees incentivize higher value care at lower costs.
Note the LOWER COST as part of her job description and also notice this statement in this article:
If we all took a bold step to commit to change and refuse the siren song of kickbacks, reimbursements and misaligned rewards, wouldn’t the lives we save be incentive enough?
My money is on that she gets a bonus on how much she CUTS THE $$$ that are paid out by the companies that hire her employer… and she can justify her “no opiates” because she was able to get thru it… FIRST HAND EXPERIENCE !!… Money can be a GREAT MOTIVATOR and the size of your bonuses going forward depends on you toughing it out a few days of pain post surgery… GREAT MOTIVATOR..
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WHEN SIZE MATTERS
Posted on October 8, 2018 by Pharmaciststeve
It would appear that the nomenclature surrounding the use/abuse of opiates is changing once again… They have seem to finally figure out that we don’t have a EPIDEMIC.. because addiction is not contagious. They have also seem to be moving away from using both terms addiction and dependency and now they are just using the term “substance use disorder”…
So anyone using/abusing opiates or controlled substances are now being labeled as having a SUBSTANCE USE DISORDER…
Is a “disorder” … a disease…. a mental health issue… or a moral failing ?
It would appear that the number of Face Book pages devoted to pain and/or disease issues with pain associated with it.. that keep expanding almost exponentially
The common thread among all those Face Book pages is a lot of whining, bitching and moaning and if anyone believes that anyone that are perpetuating this covert genocide are following any of these FB pages… and or cares what is said on these FB pages … are kidding themselves.
A handful or two have tried to be a lighting rod to organize some demonstrations across the country and/or collect facts about how the bureaucracy is harming the chronic pain community.
Maybe everyone should take a step back and look at the number of protestors that showed up this past week against Kavanaugh getting confirmed by the Senate. Kavanaugh still got confirmed and all those hundreds of people on the capital steps MAY HAVE changed the mind of TWO SENATORS to vote NO – MAYBE…
And just like the few people that showed up for the various demonstrations last month in various cities… some got some TV coverage and some got some unwanted notice with people setting up free needles and/or encouraging people to have Narcan handy. Then there was one TV station that included the piece about the denial of pain care… they included something about the opiate crisis and/or free needles and the use of Narcan.
If you cannot control the message… because you can’t get the full attention of the messenger, you never know what is going to show up on the nightly news.
Is it time for pts to start filing complaints en mass ?
The American with Disability act is at the federal level and many states have a similar law.
If you are on Medicare or Medicaid then www.cms.gov or 800-Medicare
If you have other health insurance there is a state insurance commissioner. Every complaint filed against an insurance company gets posted on the insurance commissioner’s webpage – and STAYS THERE… Seeing the number of complaints against an insurance company on the insurance commissioner’s website … does not make any insurance company happy.
If you have company insurance and it is a ERISA plan (company is self insured) .. the “insurance company” is just paying out the employer’s money and there is normally someone in the employer company who can tell the “insurance company” to just cover the service and PAY THE BILL.
Each state has a Pharmacy Board, Medical Board, Nursing Board or Dental Board or other such boards… and while they may dismiss your complaint.. they have to put in the healthcare practitioner’s file…
Having complaints en mass .. then it will be time for pts to take their issue to their state or fed legislators… they passed the laws that these agencies are refusing to enforce. Presuming that there is a volume of ignored or dismissed complaints … the legislators may not be very pleased with what is going on in regards of enforcement of the laws they passed.
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The board said she shouldn’t just cut me off though
Posted on October 8, 2018 by Pharmaciststeve
So, I am on hd opioids. My pharmacist, whom I’ve been with for years, won’t fill my prescription because 60 minutes spooked her. I get it filled weekly. She gave me one week. Is that abandonment? Any advice?
I’ve been in stable dose for 15 years
Can I share what you said with her?
I don’t want to live anymore. They have this so wrong
Cause it’s a very high number
It’s sad cause I’m finally getting my life together now I’m gonna suffer
My pharmacist said that she doesn’t want to be on the news.
She said it once you’re on the news your guilty
My doctor is ok and my insurance approved the Med for another year
I don’t think I’ll find a pharmacist to fill it in this climate!
I saw my doctor….he was so nice
He called her and politely gave it to her. She didn’t fully back down but is willing to try long acting medication
What is happening in this country! It’s sad. Isn’t there a middle ground?
I just read about all of the suicides. Where’s the coverage!?!?
It made me tear up
I met with my pharmacist. I told her what you said. She didn’t like it! Ha ha. She told me she called the pharmacy board and they couldn’t advise her one way or another cause they haven’t made decisions but she is proceeding to switch me to long acting and force a taper.
It’s so crazy. My doctor isn’t calling for that my pharmacist is! My meds are approved through my insurance another year
The board said she shouldn’t just cut me off though.
It is hard for me to face having to go from pharmacy to pharmacy begging like a dog and feeling like sub human
I guess I’ll try the forced taper and reevaluate
This has all made me feel as if I’m doing something wrong
This isn’t a pharmacist practicing medicine without a license – where really is that line ? … and she called the BOP and they could not advise her one way or the other… so apparently the BOP either has not addressed this issue… either because they could not come up with a “pair” or a backbone between the lot 🙂 Maybe they have had complaints and have ignored or just dismissed them because there was no law firm involved. So much for the BOP’s primary charge to protect the health/safety of the general public.
Is this because NO PTS have filed complaints against any pharmacists in this state – not sure what state this pt lives in.
If this pt does decides to file a complaint against this pharmacist with the BOP… what is the pharmacist going to do… force the pt off of his opiates as a retaliatory reaction ?
Maybe it is time for pts to start filing complaints with the BOPs EN MASSE… force the BOP to make a decision that will apply to all pharmacists… if the BOP refuses to address the issue, then it is time to contact your state’s legislators.. they are the ones that passed the laws that the BOP is suppose to enforce…but.. failing to do so.
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Coercion or practicing medicine without a license ?
Posted on October 7, 2018 by Pharmaciststeve
“After using Walmart pharmacy many years to fill my opiod prescriptions, they will no longer fill any opiod prescription solely because my pain management doctor does not have me on a program to wean me off all opiod medications.”
Some people think that this is practicing medicine without a license, but in reality is that the pharmacist is trying coerce the prescriber to change the prescription. If the prescriber “caves” to the request/demand of the pharmacist then the prescription order is being done by a legal prescriber.
If the Pharmacist just flat out REFUSED to fill the prescription without VALID FACTS to justify the denial. Then the Pharmacist could be guilty of denial of care and not following the prescriber’s orders.
Also under the Controlled Substance Act no one can prescribe/de-prescribe a controlled substance without doing in person physical exam of the pt and since Pharmacists do not have the education/training or legal authority to do a physical exam of the pt. So unilaterally changing a pt’s controlled med.. could also be a violation of the Control Substance Act.
Some Pharmacists believe that they can refuse to fill a prescription for ANY REASON… everyone is entitled to their own opinion BUT .. no one is entitled to their own FACTS… and refusal to fill a prescription should be based on facts that filling the prescription will harm the pt. Pharmacist seem to continue to believe this “I can deny anything” because no one has sued them for denying care without a valid/factual reason.
If the Pharmacist arbitrarily decided to changed the directions and quantities on the prescription without consent of the prescriber and decide that the pt was going to be weaned off the opiate(s).. then that would be practicing medicine without a license.
Normally, chronic pain pts collectively takes a “boat load of medications”, so if a Pharmacist is only having a concern about weaning a pt off of a controlled med and none of their other medications then one could argue that could be a discrimination. Generally, the vast majority of pts being prescribed a controlled substance have one or more health issues that would qualify the pt as being part of the protected class under the Americans with Disability Act.
Discrimination under that act is considered a civil rights violation, much like if a pharmacist refused to fill a prescription because he/she did like the color of the pt’s skin, sexual orientation or some other reason that has nothing to do with proper medical care.
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