Pharmacy Closures Disproportionately Affect Vulnerable Americans

https://www.uspharmacist.com/article/pharmacy-closures-disproportionately-affect-vulnerable-americans

Columbus, OH—How do so-called pharmacy deserts disproportionately affect U.S. residents living in regions with low healthcare practitioner supply and high social vulnerability?

That was the question raised in a recent research letter published in the Journal of the American Medical Association Network Open. “Retail pharmacy chains have been closing thousands of locations throughout the US, possibly playing a role in health care gaps,” the Ohio State University authors wrote. “Similar to the concept of food deserts, areas in which medications are harder to obtain have been deemed pharmacy deserts.”

The study team sourced data through 2020 from TelePharm Map on communities located 10 or more miles from the nearest retail pharmacy. Counties were stratified as high pharmacy desert density if the number of pharmacy deserts per 1,000 inhabitants was in the 80th percentile or higher.

At the same time, the researchers obtained social vulnerability index (SVI) and healthcare practitioner data from the Agency for Toxic Substances and Disease Registry and the Area Health Resources File.

The study calculated the density of primary care practitioners (PCPs; including family medicine, general practice, general internal medicine, general pediatrics physicians) as the number of PCP per 10,000 inhabitants.

The results indicated that, among 3,143 counties reviewed, 1,447 (46%) had at least one pharmacy desert, of which 818 (56.5%) were categorized as having low and 629 (43.5%) as having high pharmacy desert density, respectively.

“Counties with a high vs. low pharmacy desert density had a higher SVI (high SVI: 238 [38.0%] vs. 294 [36.0%]; low SVI: 194 [31.0%] vs 246 [30.0%]; P = .006),” according to the article. “Areas with a high pharmacy desert density had lower median [IQR (interquartile)] PCP density (3.65 [1.12-5.96]) vs. regions with low (5.01 [3.21-7.53]) or no pharmacy (4.86 [3.10-7.40) desert density (P <.001).”

On multivariate analysis, after controlling for age and sex, the researchers determined that both high SVI (odds ratio [OR], 1.35; 95% CI, 1.07-1.70; P = .01) and low PCP density (OR, 2.27; 95% CI, 1.80-2.86; P <.001) were associated with a higher likelihood for a county to have a high pharmacy desert density.

“In the U.S. CVS announced plans to close 900 stores in the next 3 years, and Rite Aid filed for bankruptcy,” the authors wrote. “As pharmacies close, more and more individuals are left without easy access to medications, with disproportionate consequences for certain communities. Patients in higher SVI counties with a lower PCP density had a 30% to 40% higher likelihood to reside in regions with pharmacy deserts.”

The researchers noted that their findings underscore how disparities compound to create barriers to access basic healthcare, noting the association between SVI and the number of chronic conditions.

“For example, diabetes and hypertension tend to be more prevalent among black patients living in rural areas,” the authors wrote. “Poor access to pharmacies is often associated with lower medication adherence. Patients in socially vulnerable communities may lack the means to travel to other pharmacies or may have limited access to broadband internet to find telepharmacy options. Furthermore, pharmacies often offer diagnostic, preventive, and emergency services.”

Complicating the situation is that high pharmacy desert density counties tend to also have a lower PCP density. “Patients residing in these regions face increased barriers to accessing primary health care needs,” the authors concluded.

The authors suggested that in future studies, weighted regression and inverse probability weighting could provide more insights into disparities in healthcare access.

That high SVI and low PCP density that were associated suggested that “people already at highest risk of being neglected by the health care system are most likely to be affected by pharmacy closures. More efforts are needed to maintain access to pharmacies in underserved communities.”

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Guess how much the insurance/PBM industry was DEMANDING in a kickback/rebate/discount from Lilly for them to paid for this medication for one of their beneficiaries?

Eli Lilly selling Zepound vials at 50% discount: 4 notes

https://www.beckershospitalreview.com/pharmacy/eli-lilly-selling-zepound-vials-at-50-discount-4-notes.html

Eli Lilly has started selling single-dose vials of its blockbuster weight loss drug Zepbound for roughly half of its usual monthly list price. 

Patients with a prescription who are paying out of pocket can now purchase a month’s supply of the drug through LillyDirect ( https://lillydirect.lilly.com/ )— the company’s direct-to-consumer platform that launched in January. Eli Lilly is offering a four-week supply of 2.5-milligram and 5-milligram single-dose vials for $399 and $549, respectively. The list prices for GLP-1 weight loss drugs are typically around $1,000 a month.

“This new option helps millions of adults with obesity access the medicine they need, including those not eligible for the Zepbound savings card program, those without employer coverage and those who need to self-pay outside of insurance,” Eli Lilly said in an Aug. 27 news release.

Three more notes:

• Zepbound typically comes in a single-dose autoinjector pen. The new vials will require patients to administer the medicine using a needle and syringe. The drugmaker said the vials will expand the supply of Zebound in the U.S. because they are simpler to produce than the autoinjector pens.
• Eli Lilly added a self-pay pharmacy channel to its LillyDirect website, where patients with a valid prescription can purchase the vials. The drugmakers said this will ensure patients receive “genuine” Zepbound amid a rise in counterfeit and compounded products, which use the same active ingredient as brand-name drugs but are not tested or regulated by the FDA.
• The move stands to raise pressure on Novo Nordisk surrounding the prices of its GLP-1 drugs, analysts told Bloomberg. The drugmaker’s Ozempic is listed at $969 per month in the U.S., and Wegovy at $1,349 per month. The company’s CEO, Lars Fruergaard Jørgensen, is set to testify on the drug’s prices at a Senate Health, Education, Labor and Pensions Committee hearing Sept. 24. Mr. Jørgensen recently told NBC News the two drugs can reduce overall costs associated with obesity care.

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Feds Killed Plan To Curb Medicare Advantage Overbilling After Industry Opposition

https://kffhealthnews.org/news/article/medicare-advantage-overbilling-diagnostic-codes-cms-killed-rule/

A decade ago, federal officials drafted a plan to discourage Medicare Advantage health insurers from overcharging the government by billions of dollars — only to abruptly back off amid an “uproar” from the industry, newly released court filings show.

The Centers for Medicare & Medicaid Services published the draft regulation in January 2014. The rule would have required health plans, when examining patient’s medical records, to identify overpayments by CMS and refund them to the government.

But in May 2014, CMS dropped the idea without any public explanation. Newly released court depositions show that agency officials repeatedly cited concern about pressure from the industry.

The 2014 decision by CMS, and events related to it, are at the center of a multibillion-dollar Justice Department civil fraud case against UnitedHealth Group pending in federal court in Los Angeles.

The Justice Department alleges the giant health insurer cheated Medicare out of more than $2 billion by reviewing patients’ records to find additional diagnoses, adding revenue while ignoring overcharges that might reduce bills. The company “buried its head in the sand and did nothing but keep the money,” DOJ said in a court filing.

Medicare pays health plans higher rates for sicker patients but requires that the plans bill only for conditions that are properly documented in a patient’s medical records.

In a court filing, UnitedHealth Group denies wrongdoing and argues it shouldn’t be penalized for “failing to follow a rule that CMS considered a decade ago but declined to adopt.”

This month, the parties in the court case made public thousands of pages of depositions and other records that offer a rare glimpse inside the Medicare agency’s long-running struggle to keep the private health plans from taking taxpayers for a multibillion-dollar ride.

“It’s easy to dump on Medicare Advantage plans, but CMS made a complete boondoggle out of this,” said Richard Lieberman, a Colorado health data analytics expert.

Spokespeople for the Justice Department and CMS declined to comment for this article. In an email, UnitedHealth Group spokesperson Heather Soule said the company’s “business practices have always been transparent, lawful and compliant with CMS regulations.”

Medicare Advantage insurance plans have grown explosively in recent years and now enroll about 33 million members, more than half of people eligible for Medicare. Along the way, the industry has been the target of dozens of whistleblower lawsuits, government audits, and other investigations alleging the health plans often exaggerate how sick patients are to rake in undeserved Medicare payments — including by doing what are called chart reviews, intended to find allegedly missed diagnosis codes.

By 2013, CMS officials knew some Medicare health plans were hiring medical coding and analytics consultants to aggressively mine patient files — but they doubted the agency’s authority to demand that health plans also look for and delete unsupported diagnoses.

The proposed January 2014 regulation mandated that chart reviews “cannot be designed only to identify diagnoses that would trigger additional payments” to health plans.

CMS officials backed down in May 2014 because of “stakeholder concern and pushback,” Cheri Rice, then director of the CMS Medicare plan payment group, testified in a 2022 deposition made public this month. A second CMS official, Anne Hornsby, described the industry’s reaction as an “uproar.”

Exactly who made the call to withdraw the chart review proposal isn’t clear from court filings so far.

“The direction that we received was that the rule, the final rule, needed to include only those provisions that had wide, you know, widespread stakeholder support,” Rice testified.

“So we did not move forward then,” she said. “Not because we didn’t think it was the right thing to do or the right policy, but because it had mixed reactions from stakeholders.”

The CMS press office declined to make Rice available for an interview. Hornsby, who has since left the agency, declined to comment.

But Erin Fuse Brown, a professor at the Brown University School of Public Health, said the decision reflects a pattern of timid CMS oversight of the popular health plans for seniors.

“CMS saving money for taxpayers isn’t enough of a reason to face the wrath of very powerful health plans,” Fuse Brown said.

“That is extremely alarming.”

Invalid Codes

The fraud case against UnitedHealth Group, which runs the nation’s largest Medicare Advantage plan, was filed in 2011 by a former company employee. The DOJ took over the whistleblower suit in 2017.

DOJ alleges Medicare paid the insurer more than $7.2 billion from 2009 through 2016 solely based on chart reviews; the company would have received $2.1 billion less if it had deleted unsupported billing codes, the government says.

The government argues that UnitedHealth Group knew that many conditions it had billed for were not supported by medical records but chose to pocket the overpayments. For instance, the insurer billed Medicare nearly $28,000 in 2011 to treat a patient for cancer, congestive heart failure, and other serious health problems that weren’t recorded in the person’s medical record, DOJ alleged in a 2017 filing.

In all, DOJ contends that UnitedHealth Group should have deleted more than 2 million invalid codes.

Instead, company executives signed annual statements attesting that the billing data submitted to CMS was “accurate, complete, and truthful.” Those actions violated the False Claims Act, a federal law that makes it illegal to submit bogus bills to the government, DOJ alleges.

The complex case has featured years of legal jockeying, even pitting the recollections of key CMS staff members — including several who have since departed government for jobs in the industry — against those of UnitedHealthcare executives.

‘Red Herring’

Court filings describe a 45-minute video conference arranged by then-CMS administrator Marilyn Tavenner on April 29, 2014. Tavenner testified she set up the meeting between UnitedHealth and CMS staff at the request of Larry Renfro, a senior UnitedHealth Group executive, to discuss implications of the draft rule. Neither Tavenner nor Renfro attended.

Two UnitedHealth Group executives on the call said in depositions that CMS staffers told them the company had no obligation at the time to uncover erroneous codes. One of the executives, Steve Nelson, called it a “very clear answer” to the question. Nelson has since left the company.

For their part, four of the five CMS staffers on the call said in depositions that they didn’t remember what was said. Unlike the company’s team, none of the government officials took detailed notes.

“All I can tell you is I remember feeling very uncomfortable in the meeting,” Rice said in her 2022 deposition.

Yet Rice and one other CMS staffer said they did recall reminding the executives that even without the chart review rule, the company was obligated to make a good-faith effort to bill only for verified codes — or face possible penalties under the False Claims Act. And CMS officials reinforced that view in follow-up emails, according to court filings.

DOJ called the flap over the ill-fated regulation a “red herring” in a court filing and alleges that when UnitedHealth asked for the April 2014 meeting, it knew its chart reviews had been under investigation for two years. In addition, the company was “grappling with a projected $500 million budget deficit,” according to DOJ.

Data Miners

Medicare Advantage plans defend chart reviews against criticism that they do little but artificially inflate the government’s costs.

“Chart reviews are one of many tools Medicare Advantage plans use to support patients, identify chronic conditions, and prevent those conditions from becoming more serious,” said Chris Bond, a spokesperson for AHIP, a health insurance trade group.

Whistleblowers have argued that the cottage industry of analytics firms and coders that sprang up to conduct these reviews pitched their services as a huge moneymaking exercise for health plans — and little else.

“It was never legitimate,” said William Hanagami, a California attorney who represented whistleblower James Swoben in a 2009 case that alleged chart reviews improperly inflated Medicare payments. In a 2016 decision, the 9th Circuit Court of Appeals wrote that health plans must exercise “due diligence” to ensure they submit accurate data.

Since then, other insurers have settled DOJ allegations that they billed Medicare for unconfirmed diagnoses stemming from chart reviews. In July 2023, Martin’s Point Health Plan, a Portland, Maine, insurer, paid $22,485,000 to settle whistleblower allegations that it improperly billed for conditions ranging from diabetes with complications to morbid obesity. The plan denied any liability.

A December 2019 report by the Health and Human Services Inspector General found that 99% of chart reviews added new medical diagnoses at a cost to Medicare of an estimated $6.7 billion for 2017 alone.

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New Painkiller Could Bring Relief to Millions—Without Addiction Risk

https://www.scientificamerican.com/article/new-pain-medication-suzetrigine-prevents-pain-signals-from-reaching-brain/

The medication initially known as VX-548 blocks sodium channels in nerves, blocking pain signals before they reach the brain

hen doctors ask Sara Gehrig to describe her pain, she often says it is indescribable. Stabbing, burning, aching—those words frequently fail to depict sensations that have persisted for so long they are now a part of her, like her bones and skin. “My pain is like an extra limb that comes along with me every day.”

Gehrig, a former yoga instructor and personal trainer who lives in Wisconsin, is 44 years old. At the age of 17 she discovered she had spinal stenosis, a narrowing of the spinal cord that puts pressure on the nerves there. She experienced bursts of excruciating pain in her back and buttocks and running down her legs. That pain has spread over the years, despite attempts to fend it off with physical therapy, anti-inflammatory injections and multiple surgeries. Over-the-counter medications such as ibuprofen (Advil) provide little relief. And she is allergic to the most potent painkillers—prescription opioids—which can induce violent vomiting.

Today her agony typically hovers at a 7 out of 10 on the standard numerical scale used to rate pain, where 0 is no pain and 10 is the most severe imaginable. Occasionally her pain flares to a 9 or 10. At one point, before her doctor convinced her to take antidepressants, Gehrig struggled with thoughts of suicide. “For many with chronic pain, it’s always in their back pocket,” she says. “It’s not that we want to die. We want the pain to go away.”

Gehrig says she would be willing to try another type of painkiller, but only if she knew it was safe. She keeps up with the latest research, so she was interested to hear earlier this year that Vertex Pharmaceuticals was testing a new drug that works differently than opioids and other pain medications.

That drug, a pill called VX-548, blocks pain signals before they can reach the brain. It gums up sodium channels in peripheral nerve cells, and obstructed channels make it hard for those cells to transmit pain sensations. Because the drug acts only on the peripheral nerves, it does not carry the potential for addiction associated with opioids—oxycodone (OxyContin) and similar drugs exert their effects on the brain and spinal cord and thus can trigger the brain’s reward centers and an addiction cycle.

In January Vertex announced promising results of clinical trials of VX-548, which it is calling suzetrigine, showing that it dampened acute pain levels by about one half on that 0-to-10 scale. The company is applying for U.S. Food and Drug Administration approval for the drug this year.

Other pain drugs that target sodium channels are now being developed, some by firms motivated by Vertex’s success. Navega Therapeutics, led by biomedical engineer Ana Moreno, is even using molecular-editing tools such as CRISPR to suppress genes involved in chronic pain. “We are definitely hopeful that we can replace opioids, and that’s the goal here,” she says.

One in five U.S. adults—51.6 million people as of 2021—is living with chronic pain. New cases arise more often than other common conditions, such as diabetes, depression and high blood pressure. Yet pain treatments have not kept pace with the need. There are over-the-counter pills such as aspirin, acet­aminophen (Tylenol) and nonsteroidal anti-inflammatories (NSAIDs) such as Advil. And there are opioids. The glaring inadequacy of existing medications to alleviate human suffering has fueled the ongoing opioid epidemic, which has led to more than 730,000 overdose deaths since its start.

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‘This is organized crime’: Pharmacy board blasted for alleged corruption, retaliation at public hearing

https://1819news.com/news/item/this-is-organized-crime-pharmacy-board-blasted-for-alleged-corruption-retaliation-at-public-hearing

The Alabama State Board of Pharmacy (ABOP) was subjected to a nearly two-hour grilling by lawmakers on Thursday after a recent report that found multiple “significant problems” with the board’s operations and perceived retaliatory practices against licensees.

The Alabama Examiners of Public Accounts report was compiled before Thursday’s Sunset Committee meeting. At this meeting, lawmakers scrutinize licensing boards that require legislative approval for their continued existence.

SEE: ‘Atrocious management practices and governance’: Alabama Pharmacy Board in hot water after litany of ‘significant issues’ found in examiners’ report

At Thursday’s meeting, multiple lawmakers, advocates and lawyers noted that the report did not paint a flattering picture of ABOP.

Initially, ABOP executive secretary Donna Yeatman addressed the committee, giving what seemed like a preemptive exculpation of the board’s reputation, offering a commendatory description of the board and its practices, especially through the COVID-19 pandemic.

“The board takes seriously its responsibility to ensure the safety of Alabama patients,” Yeatman said. “We are confident that every citizen in Alabama can rely on this board, as every action this board takes, every rule they write or amend, and every disciplinary action is driven by the board’s mandate to protect the citizens of Alabama.”

The report from the state examiners found several instances of “significant issues” with ABOP, including how it reported income, over-fining, levying non-specified fees, charging non-licensed entities, meeting minutes that are inconsistent with board actions, violations of Alabama’s Open Meetings Act, failure to file oaths of office with the secretary of state’s office, failing to deposit receipts promptly, violating the state’s open-bidding rules, inaccurate invoicing, overpaying vendors over the contracted amount and unlawfully procuring supplies and services.

Yeatman briefly addressed the issues in her prelude, agreeing with the examiners’ findings on some of the more minor issues and disagreeing with the examiners on more significant ones.

Regarding the anonymous pharmacists, Yeatman stated that since the questionnaire respondents were only a small portion of the state’s pharmacists, she believed “the overwhelming majority” were happy with the board and its actions.

Several members of the public also spoke. Some praised the board and its mission and policies, while others slammed ABOP with charges ranging from fleecing taxpayers to excessive and punitive fines meant to line board members’ pockets.

Jamie Moncus, a Birmingham attorney, represented a pharmacist named Billy East, and according to Moncus, East, a pharmacy employee, had his license unlawfully stripped by ABOP for a DEA statute that applied to the pharmacy, not an individual pharmacist. Moncus claimed he attempted to appeal the decision before Yeatman and two board attorneys, which was met only with laughter.

“I soon found out they were never interested in applying the law,” Moncus said. “They were never interested in the truth at all. They were all about grudges.”

Moncus also accused the board of charging witnesses intended to exculpate East to prevent them from testifying. He said the attorney general had to intervene and drop the charges to restore East’s license. East sued the board, and that lawsuit can be found below.

Attorney Joseph Kreps, who boasted of representing people before the board for nearly 20 years, gave the most impassioned and fierce condemnation of ABOP, accusing it of lining its pockets through punitive and arbitrary fees and fines levied against pharmacists.

“The pharmacy board’s funds are hidden from view,” Kreps said. “in 2023, licensing fees collected by this agency hit $4.4 million, with nearly $4 million of that spent on administrative salaries and benefits alone. These board members are paid. They are making a fortune being on this board. It’s wrong. They pocketed a combined $325,000 in salary and per diem payments, and travel expenses were more than $210,000. They extort $1 million annually from these licensees through unlawful fines and junk fees. Late fees surged almost 1,500% from 2013 to 2022.”

He continued, “They don’t care anything about the licensees. The only thing they care about is collecting money and funneling it into their own pockets.”

In one instance in the examiners’ report, a company failed to report an ownership change in an allowable timeframe. The Board offered the company two options: Option one was for the company to sign a consent agreement, which is a reportable offense, and pay a fine of $2,000 per permit for a total of $4,000. Option two was for the company to sign a deferral agreement, which is a non-reportable offense, and pay an administrative cost of $5,000 per permit for a total of $10,000.

“That is extortion,” Kreps said. The other issue I would say is — these board members are prosecuting and collecting illegal fines and illegal fees, junk fees, and they’re funneling that money to themselves.”

“This is not the regulation of a profession. This is organized crime, in my opinion, and it’s extortion. And it’s all in black and white,” he continued.

Lawmakers on the committee asked Yeatman extensive questions regarding the examiners’ report, seeking clarification on the serious issues found. Their questions were answered. However, multiple lawmakers expressed serious concerns about the report and ABOP’s actions while acknowledging the importance of the board’s regulatory role.

“This is one of the worst reports, and I haven’t been on the Sunset Committee very long, but it’s one of the worst reports, if not the worst one I’ve seen,” said State Sen. Sam Givhan (R-Huntsville). “I would recommend that the board start working post haste to remedy these issues.”

State Rep. Kerry Underwood (R-Tuscumbia) said the optics of the board’s actions give the appearance of “pay-to-play.”

“I know that this is the Sunset Committee, but there is a lack of sunlight in your program, in your department and in your board,” said State Rep. Matt Simpson (R-Daphne.). “I’m not saying you’re sweeping things under the rug. There is an appearance of; if you were sweeping things under the rug, there is nothing that we would be able to see these things.”

State Sen. Keith Kelley (R-Anniston) emphatically stated that if this report had come against a less significant board, it would have been “lights out,” meaning the legislature would likely vote not to renew that agency.

“Whenever I look at this, to say I’m concerned is an extreme understatement,” Kelley stated.

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Calley & Casey Means: How Big Pharma Keeps You Sick, and the Dark Truth About Ozempic and the Pill

I’ll admit that I did not watch this entire video – at least not right now – but I have saved this to my hard drive because I have seen where “things” have disappeared from the web – never to be seen again and other things that may still be out there on the web when the Zombie apocalypse happens and/or hell freezes over.. whichever happens first.  I did watch enough to know that what they are talking about is not that far misaligned in what I have been talking about for years concerning how our healthcare system is mostly HARMING PTS. I started this blog abt 12 yrs ago and found this under the “about tab” on my blog is the last sentence under text on that blog page — Now retired, Steve no longer has to have allegiance to any entity other than to those patients whose healthcare system is failing to provide proper care.

Casey Means was a Stanford-educated surgeon. Her brother Calley was a lobbyist for pharma and the food industry. Both quit their jobs in horror when they realized how many people were being killed by the systems they participated in. This is an amazing story.

Watch Calley’s first interview with Tucker here:    • Big Pharma Is Fooling You Again, and …  

Chapters: 0:00 Intro 0:54

Who Are Casey and Calley Means? 10:32

Seed Oils and the Lies of the Food Pyramid 22:20 Vaccines for Newborns 34:41

Why Is the Medical Industry Ignoring This? 44:38

The Spiritual Crisis 52:23

Chemicals Linked to Cancer and Early Puberty 1:00:13

Ozempic 1:15:35

The Birth Control Pill 1:30:12

The Rise of Dementia 1:36:27

Why Obamacare Is Harmful and How to Fix the Medical Industry 1:50:55

Infertility 2:05:21

Michelle Obama’s Weaponization of Sugar in Schools 2:10:24 What Should We Be Eating?

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Lilly documented her journey through the medical system and it took me a long time before I could even look through things without going to pieces! Fun fact is mostly Stacey but Lilly too both worshipped Steve Ariens & read every article he ever wrote Steve just said, they just have good taste as Steve played no small roll in their care! Stacey and Lilly both have passed and were best friends and after Stacey’s brain surgery she got a horrible infection and Lilly did her hair and nails while her scalp was an open wound & in a medical coma! Both died of brain cancer! These 2 girls stole my heart and also lead to alot of phone calls because they caused trouble at Vanderbilt Children’s Hospital I’m trying to get her small documentary out but I can only do small pieces at a time ! The anniversary of their deaths is slowly approaching and I always get grouchy and think what a waste of 2 fine child advocates This year I hope I have Lilly and Stacey’s story out so folks can understand what children in pain go through! These 2 wonderful human beings should never be forgotten and their steadfast dedication to helping other small children should never be forgotten! These 2 kids taught me more in 2 years than one can learn in a lifetime! One thing they did give me is hope our younger generation can bring an end to this madness!
Bob Sheerin
Child Advocate
American Pain and Disability Foundation

To help other child like Lilly and Stacey donate to
Www.4apdf.org

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Safety and Risk Assessment of No-Prescription Online Semaglutide Purchases

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2821882

The popularity of branded semaglutide is surging, with widespread media coverage, viral social media exposure, and celebrity endorsements.¹ Although Wegovy (Novo Nordisk) is approved for long-term weight management, Ozempic (Novo Nordisk) (only approved for type 2 diabetes) is often used off-label for this purpose. Global regulatory agencies, including the US Food and Drug Administration (FDA), European Medicines Agency, and World Health Organization (WHO), have warned about fake versions driven by patient demand, high cost, and shortages. Illegal online pharmacies, which operate without valid licenses and sell medicines like semaglutide without prescription, represent a consumer risk for ineffective and dangerous products.

In this qualitative study, we conducted risk assessment of semaglutide online sourcing (Figure and eAppendix in Supplement 1). We followed the SRQR reporting guideline.

First, we conducted structured searches on Google and Bing to catalog websites advertising semaglutide without a prescription in July 2023. Websites meeting inclusion criteria were selected for a product test buy protocol.² Two 0.25-mg per dose prefilled pens or equivalent semaglutide injection vials were ordered from each website. Upon product receipt, authors (A.R.A., and A.F.) used the International Pharmaceutical Federation’s (FIP) checklist for visual inspection to assess potential counterfeiting or falsification risks, compared with genuine Ozempic brand 1-mg semaglutide solution for injection in a prefilled pen.³ Products were then tested for quality, including sterility and microbiological contamination, according to European Pharmacopoeia and US Pharmacopeia guidelines. Quantification of active ingredients was performed using liquid chromatography–mass spectrometry (LC-MS). Test purchases and analytical testing were performed August from 2023 to March 2024.

Search engine monitoring generated 1080 hyperlinks, with 317 (29.35%) for online pharmacies. Nearly one-half (134 sites [42.27%]) belonged to illegal pharmacy operations; 763 links were websites not offering products for sale, including 615 news and informational websites and 148 telemedicine websites requiring consultation to obtain prescription before purchase.

Six online vendors classified as not recommended or rogue by LegitScript and/or National Association of Boards of Pharmacy and offering parenteral semaglutide products were included in test buys. Three websites offered prefilled 0.25-mg per dose semaglutide injection pens, and 3 sold vials of lyophilized semaglutide to be reconstituted to solution for injection (1-3 mg). All vendors referred to weight loss and obesity on their product page. Prices for the smallest dose and quantity ranged from US $113 to $360 (mean [SD], US $218.5 [$93.6]) (Table).

Test purchases were confirmed via email and WhatsApp. Of 6 products purchased, only 3 were received. Three vendors selling Ozempic injections engaged in nondelivery scams requesting extra payments (range, US $650-$1200) to purportedly clear customs, confirmed as fraudulent by customs agencies. Although genuine Ozempic scored the full 22 points on the FIP checklist, test purchased products scored 8 or 9 with clear discrepancies in regulatory registration information, accurate labeling, and evidence products were likely unregistered or unlicensed.

Upon quality testing, one sample had elevated presence of endotoxin (8.95 EU/mg) indicating possible contamination, although no viable microorganisms were detected. LC-MS revealed the presence of semaglutide in all samples, but with considerably lower purity levels (7%-14% vs advertised 99%). The measured semaglutide content substantially exceeded the labeled amount in each sample by 29% to 39%, meaning that users could receive up to 39% more semaglutide per injection. These risk factors indicate likely falsification that does not meet legitimate product quality standards.

This qualitative study found that semaglutide products are actively being sold without prescription by illegal online pharmacies, with vendors shipping unregistered and falsified products. Two websites evaluated were sent FDA warning letters for unlawful sale of unapproved and misbranded semaglutide.^4,5 US poison centers have reported a 1500% increase in calls related to semaglutide, highlighting the need for enhanced pharmacovigilance including for online sourcing harms.⁶ Study limitations include limited sample of products tested due to nondelivery scams. Furthermore, although tested products represent some accessible semaglutide products sold online, higher priced offerings were excluded, limiting generalizability of the findings.

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