Rising Stimulant Deaths Show that We Face More than Just an Opioid Crisis

https://www.drugabuse.gov/about-nida/noras-blog/2020/11/rising-stimulant-deaths-show-we-face-more-than-just-opioid-crisis

Although we often talk about individual drugs and drug use disorders in isolation, the reality is that many people use drugs in combination and also die from them in combination. Although deaths from opioids continue to command the public’s attention, an alarming increase in deaths involving the stimulant drugs methamphetamine and cocaine are a stark illustration that we no longer face just an opioid crisis. We face a complex and ever-evolving addiction and overdose crisis characterized by shifting use and availability of different substances and use of multiple drugs (and drug classes) together.

Source: Office of Intramural Training & Education, NIH

Overdose deaths specifically from opioids began escalating two decades ago, after the introduction of potent new opioid pain relievers like OxyContin. But actually, drug overdose deaths have been increasing exponentially since at least 1980, with different substances

(link is external) (e.g., cocaine) driving this upward trend at different times. Overdose deaths involving methamphetamine started rising steeply in 2009, and provisional numbers from the CDC show they had increased 10-fold by 2019, to over 16,500. A similar number of people die every year from overdoses involving cocaine (16,196), which has increased nearly as precipitously over the same period.

Although stimulant use and use disorders fluctuate year to year, national surveys have suggested that use had not risen considerably over the period that overdoses from these drugs escalated, which means that the increases in mortality are likely due to people using these drugs in combination with opioids like heroin or fentanyl or using products that have been laced with fentanyl without their knowledge. Fentanyl is a powerful synthetic opioid (80 times more potent than morphine) that since 2013 has driven the steep rise in opioid overdoses.

During the last half of the 1980s, when cocaine surged in popularity, many overdoses occurred in people combining this drug with heroin. The recent rise in deaths from co-use of stimulants and opioids seems to reflect a similar phenomenon. According to a recent examination of barriers to syringe services programs published in the International Journal of Drug Policy

(link is external), staff at some programs report that increasing numbers of individuals are injecting methamphetamine and opioids together. Some also report that individuals are switching from opioids to methamphetamine because they fear the unpredictability of opioid products that may contain fentanyl (even though methamphetamine may be laced with fentanyl too).

A 2018 study by researchers at Washington University in St. Louis and published in Drug and Alcohol Dependence

(link is external) found that methamphetamine use has increased significantly among people with an existing opioid use disorder (OUD). People with OUD in their study reported substituting methamphetamine for opioids when the latter are hard to obtain or are perceived as unsafe, or that they sought a synergistic high by combining them. People who purposefully combine heroin and cocaine or methamphetamine report that the stimulant helps to balance out the soporific effect of opioids, enabling them to function “normally.” However, the combination can enhance the drugs’ toxicity and lethality, by exacerbating their individual cardiovascular and pulmonary effects.

Much more research is needed on the co-use of stimulants and opioids as well as how their combination affects overdose risk. Unfortunately, death certificates do not always list the drugs involved, and when they do, they may not always be accurate about which drugs principally contributed to mortality, making it difficult to know exactly the role opioids and stimulants play in mortality when people deliberately or unknowingly take the two together.

Overdose is not the only danger. Persistent stimulant use can lead to cognitive problems as well as many other health issues (such as cardiac and pulmonary diseases). Injecting cocaine or methamphetamine using shared equipment can transmit infectious diseases like HIV or hepatitis B and C. Cocaine has been shown to suppress immune-cell function and promote replication of the HIV virus and its use may make individuals with HIV more susceptible to contracting hepatitis C. Similarly methamphetamine may worsen HIV progression and exacerbate cognitive problems from HIV.

The use of methamphetamine by men who have sex with men has been found to be an important factor in the transmission of HIV in that population. According to a new study in the Journal of Acquired Immune Deficiency Syndromes

(link is external) by researchers at the City University of New York and the University of Miami, more than a third of the gay and bisexual men in their sample who acquired HIV in a 12-month study period reported that they used methamphetamine both before and during that period. Among the variables examined, methamphetamine use was the single biggest risk factor for becoming HIV positive, pointing to use of this drug as an important target for intervention in this group. Another NIH-funded study by a team at the University of California San Francisco School of Nursing published in the Journal of Urban Health in 2014 found that delivering cognitive-behavioral therapy for SUD as a harm reduction measure reduced stimulant use and sexual risk-taking behavior in a sample of men who have sex with men.

For now, the best available treatments for stimulant use disorders are behavioral interventions. Contingency management, which uses motivational incentives and tangible rewards to help a person attain their treatment goals, is the most effective therapy, particularly when used in conjunction with a community reinforcement approach. Despite its effectiveness for treating both methamphetamine and cocaine use disorders, contingency management is not widely used, stemming in part from a policy limiting the monetary value of incentives allowable as part of treatment.

Currently, there are no approved medications for the treatment of stimulant use disorders, but hopefully that will change in the not-too-distant future. Multiple NIDA-funded research teams have been hard at work, in some cases for many years already, testing new medication targets as well as immunotherapies for methamphetamine addiction, such as vaccines.

Linda Dwoskin, a NIDA-funded researcher at the University of Kentucky College of Pharmacy, is developing compounds that will alter the function of  molecules called vesicular monoamine transporters that affect how neurons recycle dopamine and that are targets for methamphetamine’s activity, in order to reduce craving and relapse in people addicted to the drug. (Her two-decade quest to develop a medication for methamphetamine addiction is chronicled in a multi-part series in NIDA Notes—the most recent installment is here.)

Apart from medications, another novel approach being tested to treat several substance use disorders is compounds that recruit the body’s own immune system against specific types of drugs, or the direct delivery of antibodies to neutralize a drug’s effects. A team at the University of Arkansas for Medical Sciences and the biotech company InterveXion Therapeutics is currently conducting Phase 2 trials of a monoclonal antibody capable of holding methamphetamine in the bloodstream and disabling its entry into the brain. (A recent NIDA Notes series also details this research program.)

Unfortunately, the COVID-19 pandemic and its associated stresses have made the need for new prevention and treatment approaches more urgent. Researchers at the Department of Health and Human Services and Millennium Health recently published in JAMA

(link is external) that since the beginning of the national emergency in March there has been a 23 percent increase in urine samples taken from various healthcare and clinical settings testing positive for methamphetamine nationwide, a 19 percent increase in samples testing positive for cocaine, and a 67 percent increase in samples testing positive for fentanyl. Another recent study of urine samples by researchers at Quest Diagnostics, published in Population Health Management, found significant increases in fentanyl in combination with methamphetamine and with cocaine during the pandemic. 

Efforts to address stimulant use should be integrated with the initiatives already underway to address opioid addiction and opioid mortality. The complex reality of polysubstance use is already a research area that NIDA funds, but much more work is needed. The recognition that we face a drug addiction and overdose crisis, not just an opioid crisis, should guide research, prevention, and treatment efforts going forward.

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Critical Care Nurses Add Their Perspective To Pain Management in the ICU

https://www.painmedicinenews.com/Policy-and-Management/Article/05-20/Critical-Care-Nurses-Add-Their-Perspective-To-Pain-Management-in-the-ICU/58188

Managing patients’ pain isn’t just for doctors; it takes a whole care team. However, much of the current literature isn’t from a nurse’s perspective.

To fill this void, the Association of Critical Care Nurses released a symposium of articles in its journal Advanced Critical Care, addressing the challenges and knowledge gaps in pain treatment in acute and critically ill patients.

“Pain management remains a daily challenge to care teams because high levels of pain are often reported by patients, and a significant proportion of acute and critically ill patients cannot communicate,” wrote the journal’s editor Céline Gélinas, PhD, RN, an associate professor in the Ingram School of Nursing at McGill University, in Montreal, in her introduction. “Adequate treatment of acute pain, based on a multimodal analgesic approach, is essential to provide appropriate pain relief to patients, optimize recovery and prevent chronic pain development.”

Providers need to zero in on pain from the start of whatever critical treatment a patient receives, according to the research presented in the symposium’s first article (AACN Adv Crit Care 2019;30[4]:335-342), especially in patients suffering from chronic pain. Those patients may have hypersensitive neurons, study author Barbara St. Marie, PhD, AGPCNP, an assistant professor at the University of Iowa’s College of Nursing, in Iowa City.

“They may be hypersensitive to pain,” Dr. St. Marie said. “When patients don’t have their acute pain well managed, there may be a persistence [in pain] that lasts longer and requires more opioids.”

Nonverbal Assessment of Pain

As many providers know, it can be difficult to assess patients’ pain overall, but especially so with those who have trouble communicating or are not able to communicate their pain verbally. “Many ICU patients may not be able to self-report due to their critical care condition and related treatments, which may alter their consciousness and ability to interact,” Dr. Gélinas said.

Behavioral scales and observational techniques can fill the gap, according to the authors of another article in the symposium (AACN Adv Crit Care 2019;30[4]:365-387). The researchers reviewed a total of 106 articles, analyzing 13 behavioral pain assessment tools for various noncommunicative populations. After investigating the tools’ characteristics, such as reliability and feasibility, the researchers endorsed the Behavioral Pain Scale, the Behavioral Pain Scale Nonintubated and the Critical-Care Pain Observation Tool. “They have shown robust psychometric properties in discriminating between painful and nonpainful procedures and correctly classify patients,” Dr. Gélinas said. “They can guide appropriate decisions for pain treatment and evaluation of analgesia effectiveness.”

Withdrawal and Opioid Use Disorder

The power of observation can also aid in avoiding iatrogenic withdrawal syndrome resulting from discontinuing opioids and/or benzodiazepines after prolonged patient use, according to another study in the symposium (AACN Adv Crit Care 2019;30[4]:353-364). The investigators note that “research to date is scant” on the subject, but providers must recognize the warning signs.

“[Iatrogenic withdrawal syndrome] is preventable with appropriate monitoring. Nurses must be aware of the signs and symptoms of withdrawal, which may affect the central nervous, gastrointestinal and sympathetic nervous systems,” Dr. Gélinas said.

Some patients at risk include those with opioid use disorder (OUD). These patients can be especially challenging in a critical care setting, but managing symptoms well, sometimes with medication-assisted treatments such as buprenorphine, can be achieved (AACN Adv Crit Care 2019;30[4]:335-342).

“To provide the best care, nurses must recognize withdrawal and craving and discuss concerns of these symptoms with the multidisciplinary team, including those in addiction medicine,” Dr. St. Marie said. “Nurses play a vital role in assessments, especially identifying those at risk for psychological health care needs.”

However, there is a lack of guidelines on treating OUD patients in critical care, Dr. St. Marie explained. “Many of the gaps in clinical practice guidelines cover managing patients with an active disease of addiction with acute or chronic pain, or helping patients protect the work they’ve done in recovery,” she said.

“Another gap is helping those in recovery with medications for OUD when they have acute or chronic pain. Establishing expert panels to search literature for evidence and write guidelines is going to be important to our patients,” Dr. St. Marie added.

Nonpharmacologic Treatments

As the opioid crisis has forced more judicious uses of various pain medicines, more research is supporting nonpharmacologic methods for pain relief (AACN Adv Crit Care 2019;30[4]:388-397). Analyzing the current literature, the researchers found music and massage therapies are being used most often in critical care settings, as well as an increase in combining several therapies at the same time. Bundled interventions—such as massage, music, relaxation and cold therapy—have been proven to reduce pain in some patients, Dr. Gélinas said.

“Some nonpharmacologic interventions reduce pain by 1 or 2 points on a 0-10 numeric rating scale in ICU patients,” she explained. “They can be administered by nurses following appropriate training. The selection of interventions should take into account the patient’s preferences and clinical condition.”

One source of nonpharmacologic support for patients can be including family members in the treatment process (AACN Adv Crit Care 2019;30[4]: 398-410). Although again, the literature was lacking, an assessment of 11 articles found that family members can be beneficial in helping to express a patient’s pain experience and choosing nondrug interventions—if they feel comfortable doing so.

“An important gap that deserves attention is the role of family members in assessing and managing pain. Family members should be encouraged to participate in the delivery of nonpharmacologic interventions if they feel comfortable,” Dr. Gélinas said. “It is suggested that family members get involved in the identification of pain behaviors in loved ones, [especially those] unable to self-report.”

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https://youtu.be/E6ifjSAkTTs

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FDA Alert: Certain Lots of Sportmix Pet Food Recalled for Potentially Fatal Levels of Aflatoxin

https://www.fda.gov/animal-veterinary/outbreaks-and-advisories/fda-alert-certain-lots-sportmix-pet-food-recalled-potentially-fatal-levels-aflatoxin

Fast Facts

• FDA is alerting pet owners and veterinary professionals about certain Sportmix pet food products (see list below) manufactured by Midwestern Pet Foods, Inc. that may contain potentially fatal levels of aflatoxin. 
• FDA is aware of at least 28 deaths and 8 illnesses in dogs that ate the recalled product. 
• This is an ongoing investigation. Case counts and the scope of this recall may expand as new information becomes available.
• Aflatoxin is a toxin produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxin can cause illness and death in pets.
• Pets experiencing aflatoxin poisoning may have symptoms such as sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes or gums due to liver damage), and/or diarrhea. In severe cases, this toxicity can be fatal. In some cases, pets may suffer liver damage but not show any symptoms.
• Pet owners should stop feeding their pets the recalled products listed below and consult their veterinarian, especially if the pet is showing signs of illness.  The pet owner should remove the food and make sure no other animals have access to the recalled product.
• FDA is asking veterinarians who suspect aflatoxin poisoning in their patients to report the cases through the Safety Reporting Portal or by calling their local FDA Consumer Complaint Coordinators. Pet owners can also report suspected cases to the FDA.

What is the Problem?

On December 30, 2020, Midwestern Pet Food, Inc. announced a recall of certain lots of Sportmix pet food products after FDA was alerted about reports of at least 28 dogs that have died and eight that have fallen ill after consuming the recalled Sportmix pet food. Multiple product samples were tested by the Missouri Department of Agriculture and found to contain very high levels of aflatoxin. Aflatoxin is a toxin produced by the mold Aspergillus flavus and at high levels it can cause illness and death in pets. The toxin can be present even if there is no visible mold.

FDA is issuing this advisory to notify the public about the potentially fatal levels of aflatoxin in pet food products that may still be on store shelves, online, or in pet owners’ homes. 

FDA is conducting follow-up activities at the manufacturing facility.

This is a developing situation and the FDA will update this page with additional information as it becomes available.

What are the Symptoms of Aflatoxin Poisoning in Pets?

Pets are highly susceptible to aflatoxin poisoning because, unlike people, who eat a varied diet, pets generally eat the same food continuously over extended periods of time. If a pet’s food contains aflatoxin, the toxin could accumulate in the pet’s system as they continue to eat the same food. 

Pets with aflatoxin poisoning may experience symptoms such as sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes, gums or skin due to liver damage), and/or diarrhea. In some cases, this toxicity can cause long-term liver issues and/or death. Some pets suffer liver damage without showing any symptoms. Pet owners whose pets have been eating the recalled products should contact their veterinarians, especially if they are showing signs of illness. You can find more pet safety tips at pet blog sites like HouseholdPets.co.uk

There is no evidence to suggest that pet owners who handle products containing aflatoxin are at risk of aflatoxin poisoning. However, pet owners should always wash their hands after handling pet food. 

What Products are Involved?

On December 30, 2020, Midwest Pet Food, Inc. announced a recall of nine total lots of Sportmix pet food products. FDA and the Missouri Department of Agriculture are working with the firm to determine whether any additional products may have been made with the same ingredients containing potentially fatal levels of aflatoxin. As new information becomes available, this product list may continue to expand.

The list of recalled dry pet food products announced by Midwestern Pet Food, Inc. on December 30, 2020 is:

• Sportmix Energy Plus, 50 lb. bag
  • Exp 03/02/22/05/L2
  • Exp 03/02/22/05/L3
  • Exp 03/03/22/05/L2
• Sportmix Energy Plus, 44 lb. bag
  • Exp 03/02/22/05/L3
  • Sportmix Premium High Energy, 50 lb. bag
  • Exp 03/03/22/05/L3
• Sportmix Premium High Energy, 44 lb. bag
  • Exp 03/03/22/05/L3
  • Sportmix Original Cat, 31 lb. bag 
  • Exp 03/03/22/05/L3
• Sportmix Original Cat, 15 lb. bag
  • Exp 03/03/22/05/L2
  • Exp 03/03/22/05/L3

Lot code information may be found on the back of bag and will appear in a three-line code, with the top line in format “EXP 03/03/22/05/L#/B###/HH:MM”

The affected products were distributed to online retailers and stores nationwide within the United States. 

What Do Retailers Need to Do?

Don’t sell or donate the affected pet food products. Contact the manufacturer for further instructions. The FDA also encourages retailers to contact consumers who have purchased recalled products, if they have the means to do so (such as through shopper’s card records or point-of-sale signs). 

What Do Pet Owners Need to Do?

If your pet has symptoms of aflatoxin poisoning, contact a veterinarian immediately. Even pets without symptoms may have suffered liver damage, so you may want to contact your veterinarian if your dog has eaten any of the recalled products. Provide a full diet history to your veterinarian. You may find it helpful to take a picture of the pet food label, including the lot number.

Don’t feed the recalled products to your pets or any other animal. Contact the company listed on the package for further instructions or throw the products away in a way that children, pets and wildlife cannot access them. Sanitize pet food bowls, scoops, and storage containers using bleach, rinsing well afterwards with water, and drying thoroughly.

There is no evidence to suggest that pet owners who handle products containing aflatoxin are at risk of aflatoxin poisoning. However, pet owners should always wash their hands after handling any pet food.

You can report suspected illness to the FDA electronically through the Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. It’s most helpful if you can work with your veterinarian to submit your pet’s medical records as part of your report. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.

What Do Veterinarians Need to Do?

The FDA urges veterinarians treating aflatoxin poisoning to ask their clients for a diet history. We also welcome case reports, especially those confirmed through diagnostic testing. You can submit these reports electronically through the FDA Safety Reporting Portal or by calling your state’s FDA Consumer Complaint Coordinators. For an explanation of the information and level of detail that would be helpful to include in a complaint to the FDA, please see How to Report a Pet Food Complaint.

The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and parties involved in the investigation. The agency will update this page as more information becomes available. 

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https://youtu.be/SKI9m8me6WM

Chronic pain comes in ALL forms and fashions. What hurts for one may be just fine for another. The sheer number of parts which construct & form our human body as we know it is quite mind-boggling. From the largest organ of our body; the skin to our bones, the muscles, nerves, glands, organs, 5 senses, ligaments, brain, eyes, legs, arms, feet … you name it — I could go on and on. It is just fascinating.
So when a body part fails to function as it should, and begins to cause pain, most around us don’t know (or don’t wanna know) how to deal with it. We need more empathy. By creating this short video, I hope it moves you enough to video your OWN pain, and tell the CDC EXACTLY what chronic pain FEELS like. Because apparently they don’t have a clue. Go to: www.VideoYourPain.com Advocate for your rights to proper pain medications!

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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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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.

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).”

“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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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/

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