Arthritis Patients Are Being Denied Methotrexate Post-Dobbs. Are People With Cancer Next?

Posted on July 31, 2022 by Pharmaciststeve

Arthritis Patients Are Being Denied Methotrexate Post-Dobbs. Are People With Cancer Next?

https://www.forbes.com/sites/victoriaforster/2022/07/18/arthritis-patients-are-being-denied-methotrexate-post-roe-are-people-with-cancer-next/

After the U.S. Supreme court overruled Roe v Wade last month, ripples have been felt throughout U.S. healthcare, with doctors claiming that the new restrictions threaten lives.

As part of this, in States where abortion is banned or now more severely restricted, multiple people with arthritis and other rheumatoid conditions have reported that they can no longer get their prescriptions filled, forcing them to try to find other medications to help manage their conditions.

Most of the people reporting they have been denied refills of their medication are women and there are suggestions that this is violating federal anti-sex discrimination laws. On the 14th of July, the Department for Health and Human Services said it was investigating the reports and communicating with pharmacies to remind them of their duties.

“We are committed to ensuring that everyone can access health care, free of discrimination. This includes access to prescription medications for reproductive health and other types of care,” said Xavier Becerra, Health and Human Services Secretary said on the 14th in a statement.

Methotrexate can be used to terminate pregnancies and is the most common drug used to treat ectopic pregnancy, where the fetus develops outside of the womb and is non-viable, as well as life-threatening for the pregnant individual. But methotrexate can also be used in therapy for certain types of cancer, working by reducing the amount of a nutrient called folate a cell can use, preventing it from growing and replicating itself.

“Methotrexate is an essential drug for oncologists,” said Julie R. Gralow, MD, FACP, FASCO, Chief Medical Officer of the American Society of Clinical Oncology (ASCO). “It is an essential chemotherapy agent for the treatment of multiple cancers including both adult and pediatric acute lymphoblastic leukemia and osteosarcoma,” Gralow added.

Methotrexate is also used to treat certain types of lymphoma, cancers which have spread from elsewhere to form tumors on the meninges-thin layers of tissue which cover the brain and occasionally breast and head and neck cancers. But so far, at least, prescribing issues affecting patients with arthritis do not appear to be affecting patients with cancer who need treatment with methotrexate.

“We have certainly heard concerns about this possibility, but we have not yet heard of a case where a patient with cancer has been denied methotrexate. We are communicating regularly with our members so that we have the most current information about the realities of delivering cancer care,” said Gralow.

However, it is not only methotrexate which may get caught up with the new anti-abortion laws in several states. Many cancer treatments are not compatible with pregnancy and on difficult occasions where a pregnant individual is diagnosed with cancer, one choice is to elect to have an abortion to allow treatment to proceed.

“ASCO’s singular focus is assuring every individual with cancer is able to receive high quality, equitable, evidence-based cancer care. For pregnant patients with cancer, the option to terminate a pregnancy is an important component of high-quality cancer care. We will continue to do everything within our means to ensure patients have access to equitable, evidence-based cancer care,” said Gralow.

The Supreme Court decision is still very recent and many of the ripple effects of the ruling have yet to be felt. Gralow says that ASCO is regularly reaching out to their volunteers and state societies to better understand what is happening on the ground in states where abortion is now banned or strictly limited.

“Patients must be able to trust their doctors. We are concerned that the Dobbs ruling creates uncertainty and confusion that can undermine this trust and the doctor-patient relationship, threatening patient access to potentially lifesaving, life-extending, or palliative treatment,” said Gralow.

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Critics say Mark Cuban’s pharmacy isn’t tackling the big issue: brand-name drugs

Posted on July 30, 2022 by Pharmaciststeve

when I first started working in a pharmacy – the summer of 1967 – there was no DEA, there were no PBM’s.  Nearly all the Rx meds were brand name and everyone pay CASH for their prescriptions. The average Rx price was in the $4.00 range. Of course, the Brand Name Pharmas did all the R&D on new meds – as they do today.  Generic companies do little/no R&D for new medications. If one took the average Rx price back in 1967 and apply the Consumer Price Index and/or Cost of Living Adjustment to that price.  All things remaining the same, the average Rx price today should be in the $30 range – instead of pushing $70 as they are today, with 85%-90% of all Rxs being generics.

If somebody has taken the time, I have not seen it published.  The two biggest changes in prescription market between 1967 and today is that today the PBM industry controls abt 90% of the pricing of all prescriptions and – to a certain degree – what medications the pt gets their insurance to pay for and the 85%-90% of all Rxs dispensed is now generics.  I would suspect that one would find that the increase of the average Rx price would track the increase in the per-cent of all prescriptions that the PBM industry paid for over that time frame.

So, how does the part of the pharma industry in charge of footing the bill for all the R&D of new meds pay for all that expense when their meds are only 10%-15% of all prescriptions ?  Charge a ARM & a LEG for a brand name med, don’t forget the PBM’s will  demand up to 75% of the AWP (Average Wholesale Price) as a discount, rebate and/or kickback from the Pharma. The graphic below, demonstrates in what pockets  the $$ you pay for your Rx really goes.

One pt I saw posted the other day on FB, that they called customer service for goodrx and they answered OptumRx customer service – part of United Health insurance. Yep, it appears that the 4-5 major PBM’s are behind those CASH DISCOUNT Rx CARDS.

 

 

Critics say Mark Cuban’s pharmacy isn’t tackling the big issue: brand-name drugs

https://www.beckershospitalreview.com/pharmacy/critics-say-mark-cuban-s-pharmacy-isn-t-tackling-the-big-issue-brand-name-drugs.html

Mark Cuban’s pharmacy, Cost Plus Drug Co., has hundreds of drugs marked at discounted prices, but some pharmacy experts say there’s a larger problem that needs fixing, CNBC reported July 28. 

The online pharmacy launched in January with about 100 drugs, and by its one-year anniversary, plans to have more than 1,500 medications, according to the company’s website. The business model, which allocates for a $3 pharmacy dispensing fee, $5 shipping fee and a 15 percent profit margin with each order, aims to uproot the pharmaceutical industry, which has faced criticism for years about its opaque business practices. 

Gabriel Levitt, the president of PharmacyChecker, a company that monitors the cheapest drug prices, told CNBC there’s more to be done.

“As much as I support the venture, what they’re doing does not address the big elephant in the room,” Mr. Levitt said. “It’s really brand-name drugs that are increasing in price every year and forcing millions of Americans to cut back on medications or not take them at all.”

Brand-name drugs are 80 percent to 85 percent more expensive than generics since brand-name drugs have to repeat clinical tests to prove efficacy, according to the FDA. Cost Plus Drug Co. only offers generics. Mr. Cuban told CNBC he hopes to sell brand-name medications “within six months,” but added that it’s a tentative timeline.

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CVS Health: Being sued again for alleged OVER CHARGING ON RX PRICES ?

Posted on July 28, 2022 by Pharmaciststeve

CVS siphoned millions from ‘safety net’ hospitals – New York lawsuit

https://www.reuters.com/business/healthcare-pharmaceuticals/new-york-attorney-general-sues-cvs-health-violating-antitrust-laws-2022-07-28/

NEW YORK, July 28 (Reuters) – New York on Thursday sued CVS Health Corp (CVS.N) for allegedly forcing hospitals that serve low-income patients to pay millions of dollars to access discounted prescription drugs, violating state antitrust law.

In a lawsuit filed in state court in Manhattan, New York Attorney General Letitia James said CVS group abused its market power by requiring hospitals and clinics to use a CVS subsidiary, Wellpartner, to fill prescriptions for discounted drugs at CVS pharmacies.

“While safety net health care providers are tackling public health crises and helping underserved communities, CVS is robbing them out of millions of desperately needed funds that could improve patient care,” James said in a statement.

“These allegations are without merit and we will defend ourselves vigorously,” CVS said in a statement.

The lawsuit centers on so-called safety net providers, which are eligible for discounted drugs because they serve predominantly lower-income patients under a federal program known as 340B.

Most providers contract with outside companies to administer their 340B programs, which requires extensive recordkeeping to comply with federal rules. CVS bought Wellpartner, a third-party 340B administrator, in 2017.

James’ lawsuit said that CVS then began refusing to contract with providers that did not use Wellpartner to obtain 340B benefits. Because 340B rules forbid providers from steering patients away from particular pharmacies, the providers were forced either to start using Wellpartner, or to forego 340B discounts when patients chose to fill their prescriptions at CVS.

Many providers already had contracts with other 340B administrators, but most switched to Wellpartner for all their 340B prescriptions, even those not filled at CVS, because it was not economical to pay two contractors, the lawsuit said.

James is seeking a court order blocking CVS from requiring providers to use Wellpartner, and an unspecified amount of money damages.

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Promised lower out of pocket cost for Rx meds – reality or an illusion ?

Posted on July 28, 2022 by Pharmaciststeve

This appears to be another bill/law that Congress plans on passing, when they don’t understand what they are really dealing with.  All out pt meds are provided by Part D and/or Medicare-C (advantage).  Which are all FOR PROFIT INSURANCE COMPANIES.  The Feds pay these companies a fixed $$/pt/month and the insurance company has got to figure out — how to spend less than they are paid for my the feds to provide medications to Medicare folks.  The PBM industry already negotiates prices with the pharmas and as the graphic below demonstrates the Insurance/PBM industry keeps the “lion’s share” of those discounts to pad their bottom lines. The top 5 PBM’s are owned by insurance companies, if those PBM’s are forced to share those discount/rebates/kickbacks with pts, I expect that pts will see higher premiums, deductibles and co-pays.  Even perhaps they will be forced to use the PBM’s mail order facility are in the case of CVS Health – be forced to have their Rxs filled at one of their community/retail pharmacies or their mail order.  Other PBM may “make a deal” with one of the chain pharmacies where the pts can get their Rxs filled and get some coverage by Part D or Medicare-C..  This article mentions some undefined “certain prescription drugs” that they will be seeking LOWER PRICES ON.

What tax hikes are in the Manchin-Schumer reconciliation bill?

https://www.foxbusiness.com/politics/what-tax-hikes-are-manchin-schumer-reconciliation-bill

Prescription drug pricing reforms: $288 billion

Under the bill, the government would have the power to negotiate with drugmakers in order to lower prices for certain prescription drugs. The proposal would cap what seniors on Medicare pay out of pocket for drugs each year at $2,000.

If pharmaceutical companies raise the prices of their drugs more than the rate of inflation, pharmaceutical companies would be required to rebate Medicare.

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Vancouver BC: Free Pharma Fentanyl for addicts – and chronic painers get ?

Posted on July 27, 2022 by Pharmaciststeve

Fentanyl From the Government? A Vancouver Experiment Aims to Stop Overdoses

https://www.nytimes.com/2022/07/26/health/fentanyl-vancouver-drugs.html

VANCOUVER, British Columbia — The place where Chris gets his fentanyl is bright and airy, all blond wood and exposed brick. The staff is friendly and knowledgeable about the potency of the pills he can crush, cook and inject.

Soft pop music played, and an attendant spritzed a bit of Covid-cautious spray on his seat before he settled into a booth on a recent afternoon with a couple of red-and-yellow pills, a tourniquet, a tiny candle and a lighter.

“The best thing about this is the guarantee: I can come in here four times a day and get it,” Chris said. He no longer spends all of his waking hours in a frantic scrabble of panhandling and “other stuff” to scrape up the cash to pay a dealer. He won’t get arrested — and he won’t overdose and die using a drug that is not what it is sold as.

This fentanyl dispensary is legal, and Canada’s public health system finances it.

It is the latest and perhaps most radical step in a city that has consistently been at the leading edge of experiments in “harm reduction,” an approach to reducing deaths and severe illness from illicit drugs by making the drugs safer for people who use them. Harm reduction, even in basic forms such as the distribution of clean needles, remains deeply controversial in the United States, although the concept has been gaining fitful support as overdoses rise, including from the Biden administration.

Biden’s Drug Czar Is Leading the Charge for a ‘Harm Reduction’ Approach
Experts describe the president’s drug control strategy as the most progressive since Richard Nixon appointed the nation’s first drug czar in 1971.
July 26, 2022

But the breadth of Vancouver’s services and interventions is almost unimaginable in the United States, less than an hour’s drive to the south. Supervised injection sites and biometric machines that dispense prescription hydromorphone dot the city center; naloxone kits, which reverse overdoses, are available free in every pharmacy; last year, a big downtown hospital opened a safer-use site next to the cafeteria, to keep patients who are drug users from leaving in order to stave off withdrawal.

And since April, Chris, a wiry, soft-spoken 30-year-old who wanted to be identified by only his first name to protect his privacy, has received pharmaceutical-grade fentanyl through the dispensary, which sells to those who can pay and provides free drugs through the program’s operational budget to those who cannot.

The new program aims to provide a safer alternative to the fentanyl available on the streets, where the supply is increasingly lethal and is responsible for most of the overdose epidemic that was declared a public health emergency here six years ago.

Dr. Christy Sutherland, a board-certified addiction medicine specialist who set up the program, said its goal was, first, to keep people from dying, and, second, to help bring stability to their lives so that they may think about what they might want to change.

Chris started using pills recreationally in his teens, then moved to heroin. But the heroin supply in Vancouver was taken over about a decade ago by fentanyl, an opioid that is 50 to 100 times as potent and thus far more profitable for the cartels that sell it.

Credit…Jackie Dives for The New York Times
Chris has been using illicit drugs since he was a teenager. “The best thing about this is the guarantee: I can come in here four times a day and get it,” he said.
Wistaria Burdge, right, a nurse, helped Ken Elliott apply a bandage after injecting heroin at the Crosstown Clinic.
Credit…Jackie Dives for The New York Times

Overdose deaths have surged in British Columbia since the start of the Covid pandemic, as they have across the rest of North America. Some 2,200 people died of overdoses in the province last year, among the 115,000 lives lost to drugs in Canada and the United States during that time. The mounting toll has spurred communities to search for new solutions, and this city has tried more of them, faster, than anywhere else.

Vancouver’s experiments have government support and are paid for by the public health system on the expectation that they will save not only lives but also taxpayer dollars — in reduced emergency services and hospitalizations.

But there is concern from both the general public and some addiction medicine specialists here. They say that the latest efforts go too far, diverting resources from proven treatments to experiments that have not been shown to reduce drug use or save lives, and risking an increase in the numbers of both users and deaths. Supplying drugs is for criminals, not health clinics, they say.

“These are highly potent substances that produce quite a bit of harm,” said Dr. Launette Rieb, an addiction medicine physician who has worked for decades with drug users in Vancouver. “When access increases, costs go down and perception of risk goes down.”

Evidence of the effectiveness of these interventions in saving lives is limited, she said.

A clinical trial in Vancouver found that providing injectable heroin to patients who had not responded to other forms of treatment helped them reduce their use, stay tied to health care and improve their quality of life, compared with users who were given methadone. Another found a similar benefit from prescribed hydromorphone. Research on the fentanyl program has just begun but will track whether it shows a similar benefit, which could justify expanding it.

In June, British Columbia received an exemption from federal drug laws that will allow the province to decriminalize individual possession of up to 2.5 grams of hard drugs, starting early next year. The police will no longer confiscate small amounts of drugs, and no user will be required to seek treatment to avoid arrest, but drug trafficking and production will still be crimes.

The decriminalization is a significant step beyond Canada’s legalization of cannabis use in 2018. Proponents say it should be a first move toward a regulated government supply of all drugs as the best way to respond to growing toxicity, which is the immediate cause of overdose deaths.

The lobby of the Vancouver Area Network of Drug Users, a peer support organization.
Credit…Jackie Dives for The New York Times
Injection booths at St. Paul’s Hospital in Vancouver, the first hospital in Canada to offer an overdose prevention site in-house.
Credit…Jackie Dives for The New York Times

Fentanyl has largely displaced heroin and the opioid painkillers Dilaudid and OxyContin as the illicit drug most used in Vancouver, a shift underway throughout North America. It is also often cut into other drugs, including non-opioid prescription medications such as the attention deficit disorder medicine Adderall, which is sold on the street as a stimulant. Its potency and users’ inability to know what they are buying or how strong it will be have led to the huge surge in overdoses.

Dr. Sutherland, an effervescent, fast-talking 41-year-old, is the medical director of a social service agency called the PHS Community Services Society. It serves the Downtown Eastside, a neighborhood that has long been the site of intense drug use and advocacy by and for drug users. It was home to North America’s first needle exchange, first supervised injection site and first prescription heroin program.

Dr. Sutherland said she was tired of responding to overdoses on the sidewalk outside her clinic, knowing that if she could go back in time 10 minutes and give people safer drugs, she wouldn’t be trying to save their lives.

She began her medical practice working with homeless people. She said that those patients, and others living on the social margins, shifted her thinking on drug use from “Drugs are bad and are outlawed to keep people safe” to seeing addiction as a disease that she could help people overcome. Now she takes it one step further with a view that is gaining traction in British Columbia: There will always be people who use drugs, so all drugs — not just alcohol and tobacco — should be regulated by the government and sold in a controlled, legal market.

“Treatment and recovery is not the answer to a toxic drug supply. Getting rid of the toxic drug or giving alternatives to the toxic drug supply is,” she said. “You can start there and talk about treatment and recovery down the road a bit.”

It’s not realistic to think that people will abstain from substances, she said, and so the role of the state should be to keep substances safe and take access out of the hands of organized crime.

Dr. Christy Sutherland, the medical director of the PHS Community Services Society, at the Columbia Street Community Clinic in Vancouver.
Credit…Jackie Dives for The New York Times
Medication and injection supplies for a patient. Patients can buy drugs with a prescription or obtain them through a taxpayer-funded drug program.
Credit…Jackie Dives for The New York Times

Back in 2010, Dr. Sutherland began prescribing what is called opiate agonist therapy, or medication-assisted treatment, to patients who were using street drugs. That includes methadone, Suboxone and Kadian, long-acting opioids that satiate the craving for an opiate without providing the high. She helped stabilize many users and connect them with treatment to stop using altogether. But some intended to keep using, and the therapy failed for others, and Dr. Sutherland concluded that what those users needed was safer drugs.

So she started to provide a replacement for the street drugs, first Dilaudid, then fentanyl patches, and, now, the fentanyl capsules. Her project purchases the fentanyl from a pharmaceutical manufacturer, and a local pharmacy compounds it, with dextrose and caffeine as buffers. The pills are sold at $10 a hit, priced to match the street rate exactly.

Dr. Sutherland writes a prescription for the drug, and patients buy it; if they can’t pay, the program covers the cost.

When nurses enroll new participants in the program, they increase the dose over days to find exactly what the patients need to replace what they use on the street. Participants use the drugs under supervision at first, to make sure they have the amount they need to avoid withdrawal (and no more, so that there is no risk they will sell excess on the street). Then, they can take the drugs off-site to use.

Chris has been a daily user of illicit drugs since he was a teenager. He receives 30,000 micrograms of fentanyl at the dispensary each day. That is vastly more than would kill a nonuser — a doctor would typically prescribe about 50 micrograms temporarily to manage pain — but, after years of use, it is what Chris needs to feel a quick rush of euphoria and prevent withdrawal. He said he hoped to return to working soon and then would start buying from the program, the way he would patronize a liquor store.

Dr. Sutherland expects that patients such as Chris may gradually reduce the amount they use, because they’re not worried about how they will score the next hit to keep the agony of withdrawal — being “dope sick” — at bay.

Lisa James personifies the anticipated benefit of programs like this. Ms. James, who is 53, spent 18 years addicted to heroin. For the first eight, every day began the same grim cycle: She’d go out in the morning and steal from stores, then pass the merchandise to her boyfriend, who would resell it and use the money to buy heroin. He’d bring it home, where she was waiting anxiously, already nauseated and twitchy with dope sickness.

“Doctors would all say the same thing, ‘Go to detox and go to meetings,’” Ms. James said. “And when you’re that far down in it, that’s like a lifetime away. You can’t even imagine getting through two days, never mind going into detox.”

Erin Elliot, left, and Lisa Santucci, both nurses, prepared drugs for distribution to patients at the fentanyl clinic.
Credit…Jackie Dives for The New York Times
Lisa James obtains prescription heroin every day from the Crosstown Clinic.
Credit…Jackie Dives for The New York Times

Ms. James failed repeatedly at treatment. What turned her life around wasn’t quitting heroin but rather receiving pure medical-grade heroin from the Crosstown Clinic, which is run by the British Columbia health care system and provides the drug free of charge. When she was taken on as a client there a decade ago, Ms. James stopped stealing, stopped hustling and was able to set down the constant terror of wondering if she would be able to buy the next hit. She got a job, and the Crosstown staff helped her find an airy apartment in the suburbs to share with her daughter.

She may one day stop using heroin, she said, but she doesn’t need to decide that now. “With this program, even if I have to keep using something to stay off street drugs, I’m willing to do that,” she said. “I feel really lucky to live here.”

But critics of this and other safer-supply initiatives reject this idea, arguing that opioid use disorder is a brain disease and one that can be effectively treated. Dr. Annabel Mead, a Vancouver addiction specialist, said her initial hesitancy about safer-supply programs — should a doctor whose first rule is “do no harm” give out highly addictive drugs? — had been reinforced by the growing number of children she sees at B.C. Children’s Hospital who have overdosed.

She said that a hydromorphone dispensing program, set up to try to help people with addictions to isolate during Covid lockdowns, was partly to blame for a surge in teen use: Drug users prescribed Dilaudid are selling pills to young people and using the money to buy fentanyl that has the potency they are used to, she said.

In the meantime, she added, the province is spending too little on abstinence-based treatment; there is a nine-month waiting list for the main residential women’s treatment program. Many skeptics of safer supply here argue that treatment that aims to help people stop using is being shortchanged, but British Columbia’s 2021 budget designated $330 million for new treatment and recovery services for substance use, which was an increase. The total far outweighs the spending on safer supply.

Some people say the steps in Vancouver don’t go far enough. The Crosstown Clinic has 116 people on its prescription heroin and Dilaudid programs. Dr. Sutherland thinks she can supply about 100 people with fentanyl, for now. Several hundred people are also receiving safer drugs through their pharmacy under prescribing guidelines that the provincial government loosened in the first days of the pandemic, when supervised injection sites were closed.

Donald MacPherson, director of the Canadian Drug Policy Coalition and a professor at Simon Fraser University, says Vancouver’s harm-reduction projects don’t go far enough. “Incrementalism kills,” he said.
Credit…Jackie Dives for The New York Times
An overdose prevention site at the Vancouver Area Network of Drug Users.
Credit…Jackie Dives for The New York Times

But there are more than 85,000 people at risk of overdose in British Columbia every day, from daily users on the street to occasional users who don’t live anywhere near a supervised injection site.

“Harm-reduction services are like a candle for lighting something, a tiny intervention into this monstrous toxic cesspool of fentanyl and its analogues,” said Donald MacPherson, director of the Canadian Drug Policy Coalition and professor at Simon Fraser University.

He added, “We need to do something big.” The rate of death demands much more sweeping intervention, he said. “The incremental is no good. No more pilot projects.”

Dr. Bonnie Henry, British Columbia’s health officer, said there was little choice but to move incrementally.

“Incrementalism is the only way it’s going to work,” she said. “We have to evaluate it, and the evaluating has to be done independently by somebody who’s not committed to seeing it fail or to seeing it succeed.”

At the same time, she is part of a community that includes government, researchers, doctors and drug users, all trying to envision what a new, safe, regulated market could look like. “People don’t deserve to die because of the toxicity of the street supply,” she said. “So how else can we help?”

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Study Shows Widespread Mislabeling of CBD Content Occurs for Over-the-Counter Products

Posted on July 27, 2022 by Pharmaciststeve

Study Shows Widespread Mislabeling of CBD Content Occurs for Over-the-Counter Products

https://www.newswise.com/articles/study-shows-widespread-mislabeling-of-cbd-content-occurs-for-over-the-counter-products

Newswise — In a new study, Johns Hopkins Medicine researchers tested more than 100 topical cannabidiol (CBD) products available online and at retail stores, and found significant evidence of inaccurate and misleading labeling of CBD content. The study also revealed that some of these nonprescription products contained amounts of delta-9-tetrahydrocannabinol (THC), the main active ingredient in cannabis that can cause a “high,” including some products that claimed to be free of THC. 

The study, published July 20 in JAMA Network Open, further found that some of the CBD products made therapeutic claims not approved by the U.S. Food and Drug Administration (FDA). To date, the FDA has only approved one prescription CBD product to treat seizures associated with rare epilepsy disorders, and two prescription THC products for nausea and vomiting associated with chemotherapy and for loss of appetite and weight loss associated with HIV/AIDS. 

“Misleading labels can result in people using poorly regulated and expensive CBD products instead of FDA approved products that are established as safe and effective for a given health condition,” says study lead author Tory Spindle, Ph.D., assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine. 

According to the National Institutes of Health’s National Center for Complementary and Integrative Health, CBD and THC are the most commonly known compounds in the plant Cannabis sativa. A key difference between the two is that THC can produce a psychoactive “high” effect at high doses, whereas CBD doesn’t. 

Under the Agriculture Improvement Act of 2018 (the Farm Bill), CBD products that contain less than 0.3% of THC are not considered federally illegal substances. This has made CBD products particularly popular and widely available to consumers virtually anywhere, but it also makes it difficult for the FDA to address unapproved claims and mislabeling. However, Spindle notes, “Recent research has shown that people who use CBD products containing even small amounts of THC could potentially test positive for cannabis using a conventional drug test.” This has not been determined for topical CBD products, but the authors are currently studying it. 

For the study, the research team purchased 105 CBD topical products — including lotions, creams and patches — online and at brick-and-mortar retail locations in Baltimore, Maryland, in July and August 2020. Products were tested using a technology called gas chromatography-mass spectrometry to identify the actual amount of CBD and THC they contained. 

Only 89 (85%) of the 105 tested products listed the total amount of CBD in milligrams on the label. Of the 89 products, 16 (18%) contained less CBD than advertised, 52 (58%) contained more CBD than advertised and 21 (24%) were accurately labeled. On average, the in-store products contained 21% more CBD than advertised and the online products contained 10% more CBD than advertised, though CBD label accuracy varied widely across products. 

THC was detected in 37 (35%) of the 105 products, though all were within the legal limit of 0.3%. Four (11%) of those 37 were labeled as “THC free,” 14 (38%) stated they contained less than 0.3% THC and 19 (51%) did not reference THC on the label. 

Of the 105 products, 29 (28%) made a therapeutic claim, mostly about pain/inflammation, 15 (14%) made a cosmetic/beauty claim (e.g., that they alleviate wrinkles or nourish/improve skin) and 49 (47%) noted they were not FDA approved. The other 56 (53%) products made no reference to the FDA. “It’s important to note that the FDA has not approved CBD products to treat any of the conditions advertised on the products we tested,” says Spindle, who also is a faculty member at the Johns Hopkins Cannabis Science Laboratory. 

“The variability in the chemical content and labeling found in our study highlights the need for better regulatory oversight of CBD products to ensure consumer safety,” says Ryan Vandrey, Ph.D., professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine and the study’s senior author. Such regulation, the authors believe, would ensure CBD products meet established standards for quality assurance so consumers can make informed decisions about product selection and are not misled by unproven therapeutic or cosmetic claims. The study authors also caution that people should check with their health care practitioner before starting any CBD regimen. 

In addition to Spindle and Vandrey, other researchers who contributed to the study include Dennis Sholler and Edward Cone from the Johns Hopkins University School of Medicine, Timothy Murphy and Mahmoud ElSohly from ElSohly Laboratories, Ruth Winecker from RTI International, Ronald Flegel from the Substance Abuse and Mental Health Services Administration (SAMHSA) and Marcel Bonn-Miller from the Canopy Growth Corp. 

This research was supported by the Substance Abuse and Mental Health Services Administration (SAMHSA). 

COI: Tory Spindle has served as a consultant for Canopy Health Innovations, Ryan Vandrey has been a consultant or received honoraria from Canopy Health Innovations, MyMD Pharmaceuticals, Mira1a Therapeutics, Syqe Medical Ltd. and Radicle Science, and Marcel Bonn-Miller is employed by the Canopy Growth Corp. The other authors declare no conflicts of interest. 

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PBM industry HEADLINES: more abt bottom line health than healthcare of their beneficiaries ?

Posted on July 26, 2022 by Pharmaciststeve

Filed under: General Problems | 1 Comment »

New York Requests Public Comments Regarding PBM Patient-Steering

Posted on July 26, 2022 by Pharmaciststeve

Filed under: General Problems | 3 Comments »

An example of what/how a national health insurance will care for high acuity pts ?

Posted on July 24, 2022 by Pharmaciststeve

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More than 600 Southern California grocery store pharmacists authorize strike

Posted on July 23, 2022 by Pharmaciststeve

https://www.foxla.com/news/more-than-600-southern-california-grocery-store-pharmacists-authorize-strike

LOS ANGELES – More than 600 pharmacists and pharmacy workers at Ralphs, Vons, Albertsons and Pavilions stores in Southern California could walk out following an “overwhelming” membership vote to authorize union leadership to call for a strike.

No dates have been set for a strike and negotiations with the stores have continued.

United Food and Commercial Workers (UFCW), which represents workers across seven locals, has filed Unfair Labor Practice charges against the stores with the National Labor Relations Board, claiming they have engaged in “unlawful and unfair treatment.” The accusations include retaliation against pharmacists who engage in union activity, attempting to bribe pharmacists with bonuses rather than negotiating wage increases and hiring temporary workers to undermine union activity.

The seven locals make up the largest union grocery contract in the country.

 (Photo by Tim Boyle/Getty Images)

“Southern California’s essential pharmacists have made their voices heard with this vote,” the union locals said in a joint statement Friday. “This vote gives union leaders the authorization to call for a strike and lays the groundwork to allow more than 600 pharmacists across California to stand up to protect their rights and ensure they have the ability to effectively serve their patients and communities.”

John Votava, a spokesperson for Ralphs, told CNS the store is continuing to negotiate in good faith and that the strike authorization does not mean there will be a strike or work stoppage.

“Our company is committed to continue to negotiate in good faith with the union locals until an agreement is reached that meets the needs of our pharmacy associates and ensures our customers have access to affordable medicines while keeping stores competitive,” Votava said.

Votava called the Unfair Labor Practice allegations a “fear tactic UFCW can use to call a strike and cause disruption for our company, associates and communities.” He said the National Labor Relations Board has not investigated the claims.

“Ralphs follows the law and has not been notified of any wrongdoing,” Votava said.

Albertsons, which owns Pavilions and Vons, did not respond to a request for comment.

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