one of the websites actually guaranteed delivery of this deadly fentanyl into our communities, but only if the fentanyl was shipped through the Postal Service

Posted on December 28, 2020 by Pharmaciststeve

Mail Disruptions Loom as CBP Lags on Implementation of Opioid-Importation Law

https://www.hstoday.us/subject-matter-areas/customs-immigration/mail-disruptions-loom-as-cbp-lags-on-implementation-of-opioid-importation-law/

International mail could be disrupted after the first of the year as deadlines haven’t been met as CBP and USPS try to comply with the STOP Act that aims to stem the flow of opioids like fentanyl into the United States, agency officials told senators.

In 2018, the Senate Homeland Security Subcommittee on Permanent Investigations issued a report detailing how online drug dealers based in China were exploiting a loophole in international mail that allowed packages to be shipped into the United States without advance electronic data (AED) through the U.S. Postal Service.

“Our report described how, during our investigation, subcommittee staff emailed with six websites located in China that advertised fentanyl for sale on the open internet,” said Chairman Rob Portman (R-Ohio) at a hearing last Thursday. “When asked, all six of these websites told us they preferred to ship through the international arm of the Postal Service because of this loophole.

In fact, one of the websites actually guaranteed delivery of this deadly fentanyl into our communities, but only if the fentanyl was shipped through the Postal Service.

So our own federal government was complicit in providing this poison into our communities.”

Based on the recommendations in that report, in October 2018 the Synthetics Trafficking and Overdose Prevention Act, or STOP Act, was passed by Congress, requiring AED on all packages entering the U.S. beginning in 2021. The Postal Service and CBP submitted a joint strategic plan for implementation to Congress in March 2019.

“The STOP Act required CBP to finalize regulations regarding how packages would be dealt with that had no AED, by October 2019. Those regulations weren’t even submitted to the Office of Management and Budget for review until August of 2020,” Portman said. “We were told those regulations have now been passed back to the Customs and Border Protection, CBP, people with comments, but we still don’t know when they will be final.”

The legislation required USPS to collect AED on 70 percent of all international packages and 100 percent of packages from China by the end of 2018, but in January 2019 those numbers were only 57 percent and 76 percent, respectively.

By January of this year, 67 percent of international packages coming into the U.S. had AED, but during the COVID-19 pandemic that has slipped to 54 percent as of October. When USPS must begin rejecting packages without AED as of Jan. 1, 2021, that could mean the Postal Service turns away about 4 million pieces of mail a month. “I can’t imagine other countries won’t retaliate by blocking at least some of the packages that the Postal Service sends abroad,” said Ranking Member Tom Carper (D-Del.).

“In my opinion, the Postal Service, and come January 20, the new administration will have been put in an impossible position. And this is all coming at a time when trends with respect to how drugs like fentanyl are getting here are changing,” Carper said. “According to CBP, significantly more drugs may be coming through land ports of entry along our southern border. And at the same time, seizures in the international mail have declined.”

Robert Cintron, vice president of logistics at the United States Postal Service, said seizures of opioids in international mail have dropped 93 percent this year, with an increase in fentanyl and other drugs coming into the United States via the Mexico border.

“From fiscal year 2017 to January, 2020, the AED percentage trend steadily increase. But AED progress reversed as the global pandemic impacted international shipments. Once international mail recovers, we expect AED will resume its upward trajectory,” Cintron said.

“We have made strides in AED compliance but on January 1, 21 days from now, it is probable and foreseeable that a portion of international packages will lack AED. This places us in a difficult position. If inbound shipments, even by professional moving services like Big T are not accompanied by AED, we face the prospect of disrupting inbound mail,” he added. “On the other hand, applying alternative procedures may require burdensome and labor-intensive procedures.”

Cintron said USPS looks to CBP “for guidance on whether it can afford remedial measures.”

Thomas Overacker, executive director of cargo and conveyance security in the Office of Field Operations at U.S. Customs and Border Protection, called AED “the backbone of CBP’s targeting efforts” that can “effectively interdict illicit goods, segment risk and facilitate legitimate trade.”

In fiscal year 2018, CBP seized 91.2 pounds pounds of fentanyl in incoming mail from China, compared to just over a pound in fiscal year 2020. The amount of fentanyl seized at ports of entry on the southwest border rose 54 percent from fiscal year 2019 to 2020, while the amount seized between ports of entry increased 258 percent.

“Nevertheless, China continues to present a unique set of challenges. It remains a major source country of chemical precursors, narcotic manufacturing equipment such as pill presses, other controlled substances, fraudulent documents, and counterfeit merchandise,” Overacker said. “The explosive growth of e-commerce and direct to consumer shipping, especially directly from foreign sellers, has resulted in exponential growth in the number of actors in the international supply chain.”

Overacker said CBP is “confident” that the regulation requiring AED for international mail “will be published soon.” The interim rule required USPS to collect a dollar processing fee for inbound express mail service and give half of that to CBP to enhance capabilities at international mail facilities.

“CBP, DHS Science and Technology, ONDCP and the U.S. Postal Inspection Service sponsored a contest called the Opioid Prize Challenge, offering a $1.55 million prize to develop a solution that could detect minute quantities of opioids and other specific contraband in the mail stream,” he said. “The prize winner was announced, last December, and CBP has awarded contracts to purchase and deploy this technology as part of an overall strategy to modernize mail processing capabilities, including a multimillion-dollar renovation for our international mail facility at the JFK International Airport.”

Portman chided CBP for being more than a year late on the deadline to finalize regulations on the refusal of packages. “There is no good solution, thanks to the reality that you do not have the regulations in effect and the reality that we have not been successful in requiring 100 percent AED, as required by law,” the senator said.

Cintron said that “absent any alternatives, the Postal Service is prepared to refuse any of the shipments coming into the country” come Jan. 1. “There will be some disruption, but we are, absolutely, prepared to do it,” he said.

“For us, AED is what we use to assess risk,” Overacker said. “Provided that the volumes are manageable, we think we can set, we can mitigate risk by doing enhanced scanning, use of canines or even physical inspection.”

“But that would be something that’s on the ground at the international service enters and our international mail facilities, for those personnel to determine what is manageable volume, depending on the, what the environment is like, coming January 1st,” he added. “And we will have to make day-to -day decisions on that, based on the volume of mail without AED or the volume of mail that is co-mingled.”

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Ohio Attorney General Dave Yost says email shows OptumRx was overcharging the state – and knew it

Posted on December 27, 2020 by Pharmaciststeve

According to this article https://community.aarp.org/t5/Medicare-Insurance/Avoid-Optum-RX-Worthless/m-p/2360940 OptumRx is the entity along with United Health that is endorsed by AARP .  One  has to wonder if the royalties that AARP gets from allowing United Health/OptumRx to use AARP’s name and AARP’s endorsement is more important than the actual good service that is provided to AARP members ?

Ohio Attorney General Dave Yost says email shows OptumRx was overcharging the state – and knew it

https://www.dispatch.com/story/news/healthcare/2020/12/27/ohio-dave-yost-says-pbm-optumrx-overcharges-shown-email-bureau-of-workers-compensation-suit/4028221001/

Ohio Attorney General Dave Yost’s office says it may have uncovered evidence in a court battle to show that a pharmacy benefit manager knowingly overcharged a state agency. 

Among hundreds of thousands of emails obtained from PBM OptumRX as part of the litigation was one that appears to acknowledge that the multibillion-dollar corporation was not following the terms of its contract with the Ohio Bureau of Workers’ Compensation.

Starting with its predecessor, a company called Catamaran that OptumRX acquired, the PBM administered prescription drugs for workers injured on the job. In all, OptumRX overcharged the bureau on more than 1.3 million claims for generic medications, the lawsuit says.

The contract, in effect from mid-2009 until the fall of 2018, called for the PBM to charge the lowest of four potential prices for generic drugs, including a measure from the Centers for Medicare and Medicaid known as the Federal Upper Limit, or FUL for short.

A key portion of an Ohio Bureau of Workers' Compensation contract with its pharmacy benefits manager is contained on Page 103 of a 110-page document. To establish the cost for generic drugs, the PBM is supposed to use the lowest of four prices. But an email from the PBM indicates it was not considering one of those four: the Federal Upper Limit (FUL) as established by the Centers for Medicare and Medicaid.

But in a series of May 2015 emails marked as “confidential,” John Spankroy, director of public sector account management for Catamaran, said the Federal Upper Limit was never applied, despite the contract. 

He told Susan McCreight, senior director of public sector account management, “Per BWC contract we are supposed to be using pricing logic that includes lower of FUL for generics. None of the BWC price schedules has FUL as a cost source.” 

In a separate email, Spankroy told Bryce Owens, the Illinois-based PBM’s manager for pricing and analytics, “We do not see FUL included as a cost source option.”

Spankroy also acknowledged: “BWC is not aware of this (yet).”

This email from a top official at the pharmacy benefit manager Catamaran - later taken over by OptumRX - says the PBM is not adhering to a contract with the Ohio Bureau of Workers' Compensation requiring use of a factor called the Federal Upper Limit to help determine the cost of generic prescriptions drugs to the state.

“The admission is highly relevant” to the central issue in the legal dispute: “whether OptumRX was required to follow the pricing terms included in the BWC contract,” said Yost’s legal team in a Dec. 16 court filing.

But Andrew Krejci, who is with Optum’s corporate communication office, says the  federal FUL requirement was never part of the PBM’s agreement with the state.

“The plain language of the contract demonstrates that the lesser-of reimbursement methodology, which was agreed upon and utilized by the parties over the course of their almost decade-long relationship, incorporated three reimbursement options and CMS FUL was never one of them,” OptumRx said in a court filing.

More: Drug middleman fires back in workers’ comp suit

Krejci said, “We are honored to have delivered access to more affordable prescription medications for the Ohio Bureau of Workers’ Compensation and Ohio taxpayers. We believe these allegations are without merit.”

The bureau dropped OptumRX more than two years ago after a consultant determined the PBM was vastly overcharging the state.

The same consultant later discovered that PBMs — including OptumRX — in Ohio’s Medicaid program, which pays for health care of the poor and disabled, were charging three to six times the standard rate, enabling them to take home nearly $250 million in a single year.

According to the lawsuit, which seeks unspecified damages, OptumRx overcharged the bureau on 57% of 2.3 million prescription claims from injured Ohio workers between January 2014 and September 2018.

The case is before Judge Michael Holbrook of Franklin County Common Pleas Court.

drowland@dispatch.com

@darreldrowland

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chuckle to say goodbye to 2020

Posted on December 27, 2020 by Pharmaciststeve

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Under pressure, CDC delays release of opioid prescribing guidelines

Posted on December 26, 2020 by Pharmaciststeve

When Joe Biden is sworn in as our 46th President, he had stated over and over again that he believes in doing what SCIENCE dictates should be done in regards to health issues. This article is FIVE YEARS OLD, but many outside of the CDC said that their opiate dosing guidelines “flies in the face of science” … Is this the point that the community should start reaching out to him and insisting that he does an EXECUTIVE ORDER to RESCIND the CDC opiate guidelines, because they did not follow the science and when he was VP in the Obama/Biden Administration.

Under pressure, CDC delays release of opioid prescribing guidelines

https://www.statnews.com/pharmalot/2015/12/15/cdc-opioid-painkiller/

Under mounting criticism, the Centers for Disease Control and Prevention has delayed plans to next month release controversial opioid prescribing guidelines for primary care physicians. Instead, the guidelines will now be issued sometime later in the year, but an agency spokeswoman did not mention a specific time frame.“The guideline is a priority for our agency,” the CDC spokeswoman wrote us. “Given the lives lost and impacted every day, we have an acute sense of urgency to issue guidance quickly.”

On Monday, the CDC released its draft guidelines for opioid prescribing, but now says the recommendations will be subject to further review, which will also incorporate public comments, resulting in the delay of the release.

The delay was first signaled yesterday when the CDC unexpectedly disclosed that public comments on its proposal would be accepted through Jan. 13. However, the agency will also tap the National Center for Injury Prevention and Control’s Board of Scientific Counselors, a federal advisory committee, to review the guidelines and public comments. Its first meeting is scheduled for Jan. 7.

The postponement follows complaints from representatives of other federal agencies and consumer advocacy groups that the CDC guidelines were based on weak evidence and would unfairly restrict some patients from obtaining needed pain relief. The agency was also chastised for using a “secretive” process to formulate the guidelines, which some critics argued had violated federal law.

The guidelines were assembled earlier this year in response to a long-running epidemic of opioid abuse and misuse. Every day, 52 Americans die from overdoses of opioid painkillers. And so, the CDC convened a group of outside experts to draft guidelines for primary care physicians, since family doctors and internists write the vast majority of prescriptions for these drugs.

The CDC guidelines call on doctors to prescribe opioids only after other therapies have failed. The proposal also suggests physicians start their patients on short-acting opioids instead of extended-release, long-acting opioids, and initially prescribe the lowest possible effective dosage. The overall theme is to bolster physician awareness of abuse problems and encourage greater monitoring.

But critics charge the guidelines will be far too restrictive, making it difficult for some patients to be treated with the most effective options. There is also concern that the guidelines, which are not binding, will be widely adopted by state legislatures and government agencies.

These objections began percolating after the CDC disclosed the guidelines last fall. Earlier this month, the National Institutes of Health’s Interagency Pain Research Coordinating Committee met and decided to file an objection to the CDC. In particular, many of the participants expressed concern that the CDC relied on what was termed weak evidence for some of its recommendations.

“It flies in the face of science,” Myra Christopher of the Center for Practical Bioethics, a nonprofit patient advocacy group, said at the meeting. The organization, by the way, is one of at least three patient groups that participated in the meeting and receive industry funding. Meanwhile, the Center for Practical Bioethics receives at least some of its funding from pharmaceutical firms, including Purdue Pharma, a spokesperson from the drug maker said. The Center for Practical Bioethics did not respond to questions.

“CDC’s plan to issue its guideline in January was thwarted by a well-organized, industry-funded effort,” said Dr. Andrew Kolodny, chief medical officer at Phoenix House, a nonprofit that runs alcohol and drug abuse treatment and prevention programs, and the head of Physicians for Responsible Opioid Prescribing, an education and advocacy group. A PROP member helped draft the guidelines.

Separately, a member of the CDC’s Core Expert Group, which helped the agency draft the guidelines, explained that the agency’s decision to rely on weak evidence reflected a stark reality. There is a lack of sufficient evidence to properly evaluate long-term opioid use or compare the drugs with other options, according to this group member.

Nonetheless, officials from other federal agencies also complained. The level of evidence cited to support the guidelines “is low to very low and that’s a problem,” said Sharon Hertz, who heads the FDA Division of Anesthesia, Analgesia and Addiction Products. And Richard Ricciardi, a health scientist at the Agency for Healthcare Research and Quality, called this “an embarrassment to the government.”

A CDC spokeswoman noted that other federal agencies were “a part of the review process and cleared the guidelines.” Nonetheless, the remarks by Hertz, in particular, were a reminder that the FDA and CDC are sometimes at odds over balancing pain relief and reducing abuse. The FDA, for instance, this summer approved a long-acting version of OxyContin for children as young as 11 years old.

Meanwhile, the CDC delay apparently reflects a desire to comply with the Federal Advisory Committee Act, which governs how expert groups are formed to provide official advice. The Washington Legal Foundation, a nonprofit that has often sided with the pharmaceutical industry in marketing matters, last month wrote the CDC to argue the agency violated the law.

The CDC is “certainly moving in right direction now,” said Richard Samp, the WLF’s chief counsel.

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Walmart fights back against DOJ opioid lawsuit and action begs question about why DEA isn’t doing its job

Posted on December 24, 2020 by Pharmaciststeve

This article by Steve Forbes, it seems to have been composed by a person who really can’t make up their mind as to which side of the war on drugs/pts they want to be on.  Whatever law firm that Walmart has hired, it would seem like they have done a lot of wide & deep research concerning the  shenanigans that the DEA has done over the decades to put on the image that they are really interested and dedicated in fighting/winning the war on drugs/pts.

About one year ago, the Alaska Board of pharmacy sent a letter to all pharmacies/pharmacists  State, Pharmacy Board tell pharmacies: ‘Fill legitimate opioid prescriptions’

If Walmart comes out ahead on this lawsuit, could be a significant indicator that the denial of pain pendulum is starting to swing in  the opposite direction.  There is a phrase in the Controlled Substance Act  – “corresponding responsibility” … it has been interpreted by the DEA and Pharmacy Boards that it means that both the prescriber and pharmacist are responsible for a controlled substance being prescribed or dispensed to a person without a valid medical necessity.  I have often stated that this phrase should be a “two-way street” … to date there has been little concern if a dose DOES NOT GET INTO THE RIGHT HAND… the only concern is if a dose GETS INTO THE WRONG HAND.  It would appear that everyone involved has little concern if a legit pt does not get their medically necessary medication… it is just collateral damage that ALL WARS HAVE… something like deaths from “friendly fire” !

One thing that I did not see in this article and it may have been in the filed lawsuit – about the discrimination and civil rights violations that the DEA is causing to untold hundred of thousands or millions of chronic pain pts. If Walmart prevails, this could be one small step for chronic pain pts… in  getting adequate pain management. It could also be the genesis of a tsunami of law firms and lawsuits against many healthcare organizations and practitioners.

Walmart fights back against DOJ opioid lawsuit and action begs question about why DEA isn’t doing its job

https://www.foxbusiness.com/politics/walmart-doj-opioid-lawsuit-dea

It’s a story that unfortunately never gets old: Career bureaucrats failing in their mission to address a major public policy issue try to shift the blame, shirk the responsibility and scapegoat the innocent.

In the case of the opioid epidemic, those bureaucrats are at it again. Despite the massive failure of the Drug Enforcement Agency (DEA) to recognize and deal with the enormous growth in the production of opioids (which is literally their job – to regulate production levels), and despite their crisis-fostering failure to end prescribing by problematic doctors (again, literally their job), the DEA is targeting pharmacists and pharmacies for blame.

Enter the Department of Justice with a headline-seeking, deep-pocket-targeted pending lawsuit.

But for once, one of their targets is fighting back.       The Wall Street Journal reported in late October that Walmart had filed a preemptive lawsuit against the Department of Justice and the Drug Enforcement Agency ahead of a potential opioid-related suit by the DOJ.

In a suit filed last month in federal court, Walmart, which runs over 5,000 pharmacies, argued that DOJ lawyers are planning to target them without being able to cite any actual law or rules that they are violating.

The company is seeking a declaration from a federal judge that the government has no legal basis for such a lawsuit.

Walmart, as it argues in its filing, is caught between a rock and a hard place on the issue of filling opioid prescriptions.

On one hand, federal government lawyers have targeted them for filling customer prescriptions from certain doctors,  arguing that pharmacists at Walmart should have inserted themselves into the doctor-patient relationship and refused to fill legitimate (no evidence of fraud or forgery) prescriptions despite having no knowledge of the patients’ medical history, treatment or illness.

On the other hand – as Walmart extensively details – if they refuse to fill legitimate prescriptions, they risk having their licenses revoked. In fact, many states have already taken action against Walmart for refusing to fill opioid prescriptions.

All pharmacies lose whichever choice they make.

Walmart is asking the court to resolve these conflicting demands by declaring that the Controlled Substance Act “does not require pharmacists to second-guess a registered and licensed doctor’s decision that a prescription serves a legitimate medical purpose.”

As Walmart said in its lawsuit, “[i]n the shadow of their own profound failures, DOJ and DEA now seek to retroactivity impose on pharmacists and pharmacies unworkable requirements that are not found in any law and go beyond what pharmacists are trained and licensed to perform.”

In their threatened action against Walmart, some DOJ career lawyers have identified hundreds of doctors whose written prescriptions they claim shouldn’t have been filled by Walmart pharmacies.

Yet, 70% of these very doctors continue to be actively registered with the DEA. So, government officials cannot even take action against the doctors they claim are writing suspicious prescriptions, but they threaten private companies for not stopping those very same doctors.

DEA needs to do its job and crack down on doctors abusing their privileges, not target pharmacies for not doing the job DEA failed to do.

These threats are made worse by the fact that these government officials cannot point to any laws or official DEA guidelines that are being violated.

According to Walmart, the claims are based instead on alleged “violations” of informal letters and PowerPoint presentations. It should also be noted that by their own rules, DOJ is not allowed to base a case on such unofficial guidance.

The full power of federal law enforcement should not be unleashed on the basis of bureaucratic presentations!

Walmart is asking the court to declare that DOJ and DEA “must follow their own regulations and may not base any enforceable legal positions on the alleged violation of agency guidance rather than obligations found in a statute or duly promulgated rule or regulation.”

Clearly, the likely action by the Justice Department is not about addressing the real issue or enforcing the law, it is about shifting blame – and finding deep-pocketed targets to shake down.

Walmart should be commended for calling their bluff and taking steps to ensure that those responsible for fighting this crisis implement clear rules and regulations for pharmacists across the nation.

The opioid addiction crisis has been crying out for leadership by our government agencies and it’s time put an end to their blame games and hold them accountable for real action.

Walmart’s turn to the court is a bold and important move by the company to stop this intimidation effort.  Pharmacies and pharmacists – whether Walmart or small corner pharmacy – deserve clarity, resolution and simple justice.

Steve Forbes is chairman and editor-in-chief of Forbes. 

 

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Excedrin recalled over faulty packaging, child poisoning concerns

Posted on December 24, 2020 by Pharmaciststeve

Excedrin recalled over faulty packaging, child poisoning concerns

https://www.foxnews.com/health/excedrin-recalled-faulty-packaging-child-poisoning-concerns

Multiple brands of the over-the-counter headache medication Excerdrin are facing a recall after many bottles were found to have holes in the bottom, prompting child poisoning concerns. 

The U.S. Consumer Product Safety Commission on Wednesday announced that some 433,600 units of Excedrin products are subject to the recall, including Excedrin Migraine Caplets, Excedrin Migraine Geltabs, Excedrin Extra Strength Caplets, Excedrin PM Headache Caplets, and Excedrin Tension Headache Caplets. 

One of the recalled products.

One of the recalled products. (CPSC)

The holes in the affected bottles could pose child safety issues, as “children could access and swallow the contents, posing a risk of poisoning,” per the recall announcement. “These products contain the substances aspirin and acetaminophen, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act (PPPA).”

The recall, which involves 50, 80, 100, 125, 200, 250 and 300-count bottles of the above-listed Excerdrin brands, were sold at pharmacies, department stores, grocery stores and beyond from March 2018 to Septemeber of this year. The products were also sold online. 

ALMOND KRINGLE SOLD AT TRADER JOE’S FACES RECALL OVER UNDECLARED PECANS

Those who purchased one of the affected bottles may be eligible for a refund. Consumers who find a hole on the bottom of the bottle can contact the manufacturer, GSK Consumer Healthcare, for information on how to obtain a prepaid shipping label to initiate the refund. 

LEAN CUISINE RECALLS SELECT FROZEN CHICKEN MEALS AFTER COMPLAINTS OF PLASTIC IN PRODUCT

“Bottles without a hole can be retained and used as directed,” per the recall announcement. 

For a full list of recalled items, click here.

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Congress set to ban surprise medical billing in year-end spending package

Posted on December 21, 2020 by Pharmaciststeve

Congress set to ban surprise medical billing in year-end spending package

https://www.foxbusiness.com/economy/congress-set-to-ban-surprise-medical-billing-in-year-end-spending-package

Congress is poised to include a ban on “surprise” medical bills as part of its massive year-end spending package that lawmakers are expected to vote on Monday.

In a joint statement Sunday night, House Speaker Nancy Pelosi and Senate Minority Leader Chuck Schumer confirmed that “bipartisan, bicameral legislation that will end surprise billing for emergency and scheduled care” will be part of $1.4 trillion spending bill, which also includes an additional $900 billion in coronavirus relief money.

“We’re very proud that surprise billing is a part of this,” Pelosi said Sunday night.

The long sought-after legislation will protect insured patients from receiving expensive medical bills when they inadvertently receive out-of-network care. Americans of all stripes support the effort: A survey published Friday by the Kaiser Family Foundation found that 80% of adults support abolishing the practice.

Although lawmakers in both parties had been pushing for a plan to fix the issue for years — with the support President Trump, who had made it a key campaign priority — the effort drew fierce opposition from powerful lobbying groups representing the health care industry, who questioned how much the insurer would have to pay the doctor once the patient was removed from the equation.

A previously announced deal called for health insurers and providers to negotiate most billing disputes or bring their complaints to a mediator. The final legislation moves even further in favor of doctors and hospitals by preventing the arbiter from using the lower payment rates paid by Medicaid and Medicare programs, according to Politico, which obtained a copy of the bill summary.

Lawmakers also diluted a measure that would have required health insurers to disclose information to employers about their drug costs and rebates through their contracts with middlemen known as pharmacy benefit managers. The legislation now calls for insurers to submit more general information on medical costs and prescription rug spending, according to Politico.

Rep. Richard Neal, chairman of the House Ways and Means Committee, called the proposal a “win for patients and their families that will improve America’s health care system.”

An earlier clash between Neal, who had previously blocked proposals to stop surprise medical billing, and three other committees — House Energy and Commerce, House Education and Labor and Senate Health, Education, Labor and Pensions — threatened to derail the reform efforts. After securing changes that were friendlier to doctors and hospitals, however, Neal agreed to support the proposal.

 

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Oregon State Advocates FIght to Reverse Opioid Guidelines That Hurt Chronic Pain Patients

Posted on December 21, 2020 by Pharmaciststeve

Oregon State Advocates FIght to Reverse Opioid Guidelines That Hurt Chronic Pain Patients

https://www.msn.com/en-us/health/medical/oregon-state-advocates-fight-to-reverse-opioid-guidelines-that-hurt-chronic-pain-patients/ar-BB1c7zOj?li=BBnba9O

a close up of items on a table: Medicines pills scattered on a prescription pad with a pen © The Mighty Medicines pills scattered on a prescription pad with a pen

The climate allowed drastic policies and guidelines, which limited or eliminated chronic opioid therapy for legacy patients (intractable pain patients benefiting from long-term opioid therapy). Because of this, many were harmed and some lost their lives to suicide.

Untreated or under-treated pain has resulted in an increase in suicides. Rates among Veterans have shown a significant increase, with chronic pain being one of the main contributors. And in Oregon, doctor-assisted suicides have increased by 25% due to untreated pain. This is a far cry from the statement from 2007 stating that Oregon leads the nation in pain control for patients.

Well-respected experts, chronic pain patients and advocates objected to the drastic paradigm shift and the significant harms asserting the swing was not based on evidence nor was it aligned with the standard of care or best practices. In the past year, nationally, the pendulum has begun to swing back to a neutral position giving suffers hope.

Some changes that could benefit people with chronic pain include:

1. The CDC Clarified Its Guidelines

In April 2019, the CDC clarified its guidelines, stating that they had been misapplied resulting in forced opioid tapers and tapering too quickly, which both caused patient harms. Its guidelines, which were only meant to aid primary care doctors in initial doses of opioid pain analgesics for new opioid patients, were misapplied to limit doses pain specialists could prescribe and restrict dosages for legacy patients.

2. The FDA Acknowledges Harm of Forced Opioid Tapers

April 9, 2019, the Food and Drug Administration (FDA) issued a statement acknowledging harms (including suicide) from forced opioid tapers. The FDA only gives instruction for opioid tapering when the taper is mutually agreed upon between patient and doctor.

3. AMA Opioid Task Force Supports Chronic Pain Patients

April 24, 2019, Patrice Harris, MD, president-elect of the American Medical Association (AMA) Opioid Task Force came out in support of legacy patients by releasing a statement applauding the CDC’s clarification of its guidelines stating they have been “widely” misapplied, preventing physicians from providing the best care to patients.

4. Human Rights Watch Advocates Against Forced Opioid Tapers

Humans Rights Watch (HRW), an international organization that reports on human rights violations, became involved with the opioid epidemic in response to the huge outcry of harm. After investigating, the HRW released a report supporting legacy patients and asserted there is an obligation to respond to this health need and to “refrain” from forced (non-consensual) opioid tapers. Furthermore, HRW stated, “Under the ICESCR’s right to health framework, state parties have an obligation to ‘respect, protect, and fulfill the right of chronic non-cancer pain patients to appropriate pain management.”

5. Washington State Clarifies Opioid Prescribing Guidelines

Oregon’s geographical neighbor, Washington state, has been doing damage control this past year from its previously released rules for opioids. It issued statements and released documents stating that under-treating or refuse to treat pain is just as bad as over-treating. Sept. 20, 2019 it released a letter as its latest attempt at reversing the damage.

In spite of all this, in Oregon, policymakers forge forward forcing many chronic pain patients to question their safety in the midst of known harms from dangerous opioid tapers.

For over a year, advocates have vigilantly voiced concerns at chronic pain task force meetings and now taper task force meetings, through communication with Oregon’s governor, and the state’s senior health policy advisor, testifying at the task force meetings, meeting with the chief medical officer of the Oregon Health Authority, and written comments from experts and patients. There has been one major request­, for evidence-based individual medical care based on each patient’s unique needs, separating those with substance use issues from chronic pain patients and applying different remedies as is appropriate.

Here are just some of the efforts to curb Oregon’s anti-opioid stance, which may be applicable in your own state:

The Human Rights Watch was specifically concerned about harmful policies, proposals and guidelines in Oregon so they wrote a personal letter to the governor of Oregon, along with others, to object to the actions taken against legacy patients. Oregon Medical Association and American Medical Association issued a letter opposing a proposal to force taper some patients off of their opioids. Doctors and experts wrote a letter to the Oregon governor, and others, opposing a proposal that included some forced tapers and to request an evidence-based approach to pain care in Oregon.

However, these requests have fallen on deaf ears. They continue to lump those with substance use issues and chronic pain patients and offer a single remedy, or list of remedies. For example, this was evident, once again, in Taper Task Force meeting material. Not only is there only one taper protocol, the decision to taper or “when to consider tapering” is the same irrespective of whether a person is utilizing opioid medications for pain or if they are struggling with addiction. There is no allowance to return a patient to their previously stable dose of pain analgesics.

The task force also attempted to broaden the inclusion of pain patients into the category of an addiction diagnosis by selectively using DSM5 diagnosis criteria for opioid use disorder (OUD). The task force left out the critical qualifier repeatedly asserted in the DSM5 that states, those using opioids “under appropriate medical supervision.” This means compliant chronic pain patients cannot be diagnosed with OUD.

In addition, the guidelines seem to enlarge an addiction category to include many non-addicted legacy patients by the guideline’s criteria for complex persistent opioid dependence (CPOD). The difference between OUD and CPOD are startling. To be diagnosed with CPOD one only has to have the desire to take opioids for pain, without opioid cravings, no compulsive use, and no harmful use, the patient takes opioids “exactly” as prescribed, and has no social disruption other than from experiencing pain. This is an incredible description and includes all model chronic pain patients.

Amid pressure from advocates and patients, Oregon’s Taper Task Force added a clarifying statement to its updated materials, stating not all patients need to be tapered. But then the rest of the guideline goes on to recommend providers consider a taper for those who meet certain criteria, easily met by the majority of legacy patients. These criteria include:

The patient is on a daily opioid dose of 50–90 MED or higher. The patient has medical risk factors that can increase risk of adverse outcomes, including overdose (e.g., lung disease, sleep apnea, liver disease, renal disease, fall risk, medical frailty). The patient is taking other medications that increase the risk of drug-drug interactions or the risk of overdose, such as benzodiazepines or other sedating medications (e.g., Benadryl, gabapentin). The patient’s history indicates an increased risk for substance use disorder (SUD) (e.g., past diagnosis of SUD, SUD-related behaviors, family history of SUD).

To put this in other words, the majority of legacy patients are on 50 MED or higher of opioids, so that one criterion alone encompasses a huge percentage of patients. In addition, the rest of the criteria includes advanced age (medical fragility — the term they use to describe older people), people who have allergies (take Benadryl) people who have anxiety disorders or need awake oral surgery or any other twilight surgery (benzodiazepine), those who have nerve pain (gabapentin), and those who don’t have SUD, but who have a family member who has it (have an uncle who has SUD, even though you don’t). After including all these, there will be few chronic pain patients who won’t fall within the recommendation to consider tapering.

Why is the narrative the same in Oregon when other states and nationally there’s been some movement?

The task force membership includes a large percentage of addiction specialist who are allowed to make policy for chronic pain patients even though they do not have specific knowledge on this population. The task forces membership doesn’t include chronic pain patient representatives without a substance use disorder The task force recycles many of the same members or representatives from the same organization over and over Those with substance use disorder and chronic pain patients are lumped together and given the same guidelines The public commenting process is often confusing and not transparent There’s been no collection of data on patient harms for current forced taper policies but claim success based solely on the fact that the patients were tapered. Despite agreeing to revisit the guideline this fall, we have yet to see a plan to do so

Despite the evidence and efforts to the contrary, Oregon doesn’t seem to be curbing their anti-opioid sentiment even with the knowledge that it will cause patient harms.

The taper task force guidelines will be enforced for all Oregonians regardless of insurance (Medicaid, private or self-pay). Oregon is a scary place for legacy patients.

 

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What are the ingredients of Pfizer’s covid-19 vaccine?

Posted on December 19, 2020 by Pharmaciststeve

What are the ingredients of Pfizer’s covid-19 vaccine?

https://www.technologyreview.com/2020/12/09/1013538/what-are-the-ingredients-of-pfizers-covid-19-vaccine/

Facebook said on December 3 that it would remove posts with false claims or conspiracy theories about what’s in the covid-19 vaccines that everyone’s counting on.

In the face of rumors suggesting that Bill Gates has installed tracking microchips in the shots, or that the inoculations contain luciferase, a glowing chemical from fireflies whose name makes some people think of the devil, the company suggested it would be policing such claims by making reference to the “official vaccine ingredient list.”

What’s actually on the official ingredient list? This week an elderly UK woman became the first person outside of a trial to get the newly approved vaccine developed by Pfizer and BioNTech, and the US could greenlight the same inoculation as soon as Thursday, December 10. Along with the regulatory actions over the last week have come the most detailed disclosures yet of the new vaccine’s makeup.

Here, for instance, is what the US Food and Drug Administration says is in Pfizer’s vaccine:

  • Active Ingredient
    • nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2
  • Lipids
    • (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis (ALC-3015)
    • (2- hexyldecanoate),2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
    • 1,2-distearoyl-snglycero-3-phosphocholine (DPSC)
    • cholesterol
  • Salts
    • potassium chloride
    • monobasic potassium phosphate
    • sodium chloride
    • basic sodium phosphate dihydrate 
  • Other
    • sucrose

Reading the ingredient list is like looking at the side of a cereal box, except that you need a degree in organic chemistry to understand it. We got help from various scientists and biotech entrepreneurs to understand what each of the ingredients does and make some educated guesses about others.

The mRNA

Pfizer’s vaccine is the first on the market that consists of actual genetic information from a virus in the form of messenger RNA, or mRNA, a type of molecule whose usual job is to transport copies of genetic instructions around a cell to guide the assembly of proteins. This information can be understood better if you visit Shenandoah Biotech and understand the technical terms and the science behind protein recombination. Imagine an mRNA as a long ticker tape carrying instructions. It’s fairly delicate stuff, and that’s why Pfizer’s vaccine needs to be kept at around -100 °F (-73 °C) until it’s used.

The new vaccine, delivered as a shot in the arm muscle, contains an RNA sequence taken from the virus itself; it causes cells to manufacture the big “spike” protein of the coronavirus, which the pathogen uses to glom onto a person’s cells and gain entry. On its own, without the rest of the virus, the spike is pretty harmless. But your body still reacts to it. This is what leaves you immunized and ready to repel the real virus if it turns up.

The mRNA in the vaccine, to be sure, isn’t quite the same as the stuff in your body. That’s good, because a cell is full of defenses ready to chop up RNA, especially any that doesn’t belong there. To avoid that, what’s known as “modified nucleosides” have been substituted for some of the mRNA building blocks.

But Pfizer is holding back a little. The spike gene sequence can be tweaked in small ways for better performance, by means that include swapping letters. We don’t think Pfizer has said exactly what sequence it is using, or what modified nucleosides. That means the content of the shot may not be 100% public.

The lipids

The Pfizer vaccine, like one from Moderna, uses lipid nanoparticles to encase the RNA. The nanoparticles are, basically, tiny greasy spheres that protect the mRNA and help it slide inside cells.

These particles are probably around 100 nanometers across. Curiously, that’s about the same size as the coronavirus itself.

Pfizer says it uses four different lipids in a “defined ratio.” The lipid ALC-0315 is the primary ingredient in the formulation. That’s because it’s ionizable—it can be given a positive charge, and since the RNA has a negative one, they stick together. It’s also a component that can cause side-effects or allergic reactions. The other lipids, one of which is the familiar molecule cholesterol, are “helpers” that give structural integrity to the nanoparticles or stop them from clumping. During manufacturing, the RNA and the lipids are stirred into a bubbly mix to form what the FDA describes as a “white to off-white” frozen liquid.

Salts

The Pfizer vaccine contains four salts, one of which is ordinary table salt. Together, these salts are better known as phosphate-buffered saline, or PBS, a very common ingredient that keeps the pH, or acidity, of the vaccine close to that of a person’s body. You’ll understand how important that is if you’ve ever squeezed lemon juice on a cut. Substances with the wrong acidity can injure cells or get quickly degraded.

Sugar

The vaccine includes plain old sugar, also called sucrose. It’s acting here as a cryoprotectant to safeguard the nanoparticles when they’re frozen and stop them from sticking together.

Saline solution

Before injection, the vaccine is mixed with water containing sodium chloride, or ordinary salt, just as many intravenously delivered drugs are. Again, the idea is that the injection should more or less match the salt content of the blood.

No preservatives

Pfizer makes a point of saying its mixture of lipid nanoparticles and mRNA is “preservative-free.” That’s because a preservative that’s been used in other vaccines, thimerosal (which contains mercury and is there to kill any bacteria that might contaminate a vial), has been at the center of worries around over whether vaccines cause autism. The US Centers for Disease Control says thimerosal is safe; despite that, its use is being phased out. There is no thimerosal—or any other preservative—in the Pfizer vaccine. No microchips, either.

The vaccine is still known by the code name BNT162b, but once it’s authorized, expect Pfizer to give it a new, commercial name that conveys something about what’s in it and what it promises for the world.

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Michigan Libertarian rep introduces bill to end civil asset forfeiture

Posted on December 18, 2020 by Pharmaciststeve

Michigan Libertarian rep introduces bill to end civil asset forfeiture

https://www.foxnews.com/us/amash-bill-end-civil-asset-forfeiture

A Michigan congressman introduced a bill Thursday to end civil asset forfeiture, which allows police to seize a person’s property on the suspicion that it was used in a crime. 

“Civil asset forfeiture is a due process violation, and it always has been,” Rep. Justin Amash, L-Mich., said Thursday. “Its history is riddled with injustices not because it’s a valid practice that gets misused, but because its central premise—denying people their procedural rights—is inherently flawed.”

Police counter that they need civil asset forfeiture to fight criminal organizations, but often the people who have their property seized are never charged with a crime. 

DESPITE PROMISES TO CUT BACK, FED AND STATE GOVERNMENT PRESS ASSET FORFEITURES

The Greenville News examined civil asset forfeiture cases in South Carolina and found that a fifth of the 4,000 people who had property seized never were charged with a crime, and another fifth were charged but never convicted. 

Nationwide, $68.8 billion was seized from Americans over the last 20 years, according to an Institute for Justice report released this month. 

Large criminal enterprises and drug kingpins typically are not targeted in these cases; the institute found that the average currency forfeiture is just $1,276. 

Since hiring an attorney to contest the forfeiture can be expensive, people who had property seized only sought its return in 22% of cases. 

SEN. PAUL, SCOTT BULLOCK: CIVIL FORFEITURE HAS RUINED COUNTLESS LIVES

In one 2016 case, the tour manager for a Burmese Christian musical act had $53,000 of concert proceeds seized during a routine traffic stop in Oklahoma. The money was for Christian refugees and Thai orphans. Muskogee County District Attorney Orvil Loge told the Washington Post that he dropped the case after negative press coverage and calls from “a lot of citizens” who were upset about the case. 

In 2017, Tennessee police officers seized a disabled Vietnam veteran’s BMW because his son was accused of driving the car to the site of drug deals. The American Civil Liberties Union took up his defense and eventually got the property back. 

“I took an oath to defend our Constitution when I served in the military,” the veteran told ACLU. “I have the highest respect for law enforcement, but the Fourth Amendment has to mean something. Police officers can’t just take people’s property for no reason.”

CLICK HERE FOR THE FOX NEWS APP

Civil asset forfeiture is illegal in three states, and 11 more require a criminal conviction to seize a person’s property, according to the National Conference of State Legislatures.

Amash said he hopes to make the practice illegal nationwide. 

“By ending [civil asset forfeiture], my bill helps fulfill Congress’ obligation to stop rights violations at both the state and federal level, and it ends a practice that contributes to the frayed relationship between law enforcement and the public,” Amash said Thursday. 

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