Genetic Testing for Opioid Use Disorder Heads to FDA Advisors

https://www.medpagetoday.com/painmanagement/opioids/101314

To date, no FDA-cleared or approved devices are indicated for identifying genetic risk of OUD

On Thursday, members of the FDA’s Clinical Chemistry and Clinical Toxicology Devices Advisory Committee will meet to discuss AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD).

AvertD detects the presence or absence of 15 single nucleotide polymorphisms (SNPs) to help identify adults with an increased genetic risk of OUD. It’s intended to be used in combination with clinical evaluations and patient assessments when oral prescription opioids are being considered to treat acute pain.

The device currently is marketed to physicians and their patients and is paid for either by insurance or by the patient directly at $199.

Currently, no FDA-cleared or approved devices are indicated for identifying genetic risk for OUD. A version of AvertD with 11 of the 15 SNPs now included in the device was granted FDA breakthrough device designation in March 2018.

More recently, the device was assessed in a multi-site observational study that evaluated 385 people after their initial exposure to prescription oral opioids.

The FDA declined SOLVD’s initial de novo classification request for AvertD in August 2021. That decision was upheld on appeal in January. In June, SOLVD resubmitted a de novo request after collecting additional information about study participants to respond to the FDA’s concerns.

Now, the FDA is seeking input from its advisory committee before rendering its final decision.

SOLVD reported overall study results demonstrating a sensitivity of 82.76% (95% CI 76.31-88.05) and specificity of 79.23% (95% CI 73.06-84.54). “However, numerous factors impact the interpretation of test performance and raise uncertainty about the applicability of the observed clinical study test results to the intended use population,” the FDA wrote in its briefing documents ahead of the meeting.

“A device that detects genetic variants that may be associated with OUD could be potentially beneficial in combating the opioid epidemic,” the agency observed.

But genetic risk may not be the biggest factor in predicting OUD risk, the FDA pointed out, noting that “the genetic associations of individual candidate genes identified so far explain only a small portion of OUD risk.” In addition, many individuals with risk factors may never develop the disease, the FDA said.

Unlike risk assessment tools for chronic pain that include routine screening like patient history questionnaires and urine drug tests, genetic tests may have different emotional ramifications and stigmas associated with them, the FDA noted. Risks associated with false-positive and false-negative results also need to be considered, the agency said.

Research studies have also indicated that the 15 SNPs detected by the AvertD are not specific to OUD and may be associated with several other disorders of addiction and mood, the FDA added.

But the over-arching question for the advisory panel on Thursday will focus on the clinical study and whether study participants adequately represent the intended-use population. The FDA voiced a number of potential concerns, including variances in the case report forms used to collect study data, confidence that the study fully excluded people whose index oral opioid exposure was either illicit or for treatment of chronic pain, and the demographic makeup — race, ethnicity, age, and sex — of participants.

In its pre-meeting documents, SOLVD addressed these points and provided additional analyses to support that AvertD study results apply to the intended-use population.

SOLVD also noted that prescribing guidelines call for individual benefit-risk assessments to determine whether opioids are appropriate to manage acute pain.

“Thus, AvertD would fit into current clinical flow, with the principal benefits being providing information to patients and providers to make more informed choices about prescribing opioids for acute pain,” the company wrote.

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Congressman Escalates War With PBMs – one of only 2 Pharmacist in Congress/House

They are hurting healthcare affordability and quality, says Rep. Buddy Carter

https://www.medpagetoday.com/pharmacy/pharmacy/101124

SAVANNAH, Ga. — Representative Buddy Carter, BSPharm (R-Ga.), a pharmacist and former pharmacy owner, on Friday escalated his longstanding battle against pharmacy benefit managers (PBMs), releasing a report critical of the industry and calling for changes in the PBM rebate system.

“What we’re trying to achieve in healthcare is accessibility, affordability, and quality,” Carter said at a press conference in the parking lot of a pharmacy here. “PBMs are hurting accessibility, affordability, and the quality of healthcare.”

Carter issued a report entitled “Pulling Back the Curtain on PBMs: A Path Towards Affordable Prescription Drugs.” The report included stories from patients who had experienced difficulties in accessing their medications due to PBM rules or excessively high drug costs.

The report also urged support for a regulation issued by the Trump administration — but delayed by the Biden administration — that would force drug company rebates to be passed along to patients at the point of sale, rather than being absorbed by the PBMs. And it urged support for legislation now in Congress, such as the Pharmacy DIR Reform to Reduce Senior Drug Costs Act and the Drug Price Transparency in Medicaid Act, that would curb some PBM authorities and force them to be more transparent about their pricing strategies.

At the press conference, speakers — several of whom also appear in Carter’s report — outlined the issues they were having receiving their medications. Jessica Wofford, a nurse who has had Crohn’s disease for 15 years, said that her monthly 1-ml injection of ustekinumab (Stelara) is $24,900. “My insurance company is wonderful in that they will pay $17,000 of this, leaving the rest of the $7,000 to me to figure out how I’m going to pay for it.”

Wofford said she is enrolled in two copay assistance programs to help make up the difference. “I’m enrolled in the second one because I maxed out of the first one in March of this year … And the problem with these kinds of medications is that they’re authorized by your insurance, [but] your insurance will only authorize this through one particular specialty pharmacy. You cannot shop these medications; you cannot go online, unfortunately, and find better prices.”

Terry Wilcox, CEO and founder of Patients Rising NOW, a group of patients advocating for better access to treatment, said that she recently went to a pharmacy to pick up ear drops for her son. “They said, ‘That’ll be $210.'” When Wilcox said the price wasn’t usually that high and that the GoodRx app quoted a price of $80, the pharmacy told her she couldn’t pay that price because it wouldn’t count toward her deductible.

“I was like, ‘Why would I want to pay two and a half times more for something just so that it can count towards my deductible? I want this,'” she said. “So I ended up paying that price. But that’s the shenanigans you go through.”

Elisa Comer, a healthcare administrator, said “there should never be a case where a pharmacist or physician has to tell a mother she can’t [access] medication for a child with juvenile arthritis,” sending the child back into a wheelchair for the next year and a half. “These are true stories,” said Comer. She said that she herself fought so hard with PBMs one year that “I had to give up and go off my medication.”

“I have a message for you PBMs out there: we’re on to you and we’re coming for you,” she said. “These are hills that we are willing to die on. And we’re tired of you hijacking our healthcare. And a word for my chronic illness family — you stay the course, you stay in there and fight. ‘Let’s roll.'” Her last remark a quote from Todd Beamer, a passenger on one of the hijacked September 11, 2001 flights, who said “Let’s roll” before he and some fellow passengers stormed the pilots’ cabin in an effort to derail the hijackers.

Asked for their response, the Pharmaceutical Care Management Association, a trade group for PBMs, sent a statement saying that “Americans consistently reject the use of blame game tactics, especially when real patients’ health and lives are at stake. This is especially true when it comes to blaming PBMs, the one entity reducing costs in the healthcare system.”

“An overlooked reality is that, for the majority of Americans, average patient out-of-pocket costs are actually decreasing thanks to PBM’s [sic] proven ability to negotiate discounts from pharmacies and drug manufacturers on behalf of patients,” the statement said. “Without the affordability and care coordination provided by PBMs, patients’ access to their medications will be limited. We urge other members of the prescription drug supply and payment chain to put down their swords, and join us in making prescription drugs more affordable for more Americans.”

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Pharmacy benefit managers inflate drug prices and decrease competition while consumers pay the price. Does the FTC have the medicine to fix it?

Pharmacy benefit managers inflate drug prices and decrease competition while consumers pay the price. Does the FTC have the medicine to fix it?

Many have never heard of a pharmacy benefit manager, mega-profitable companies that control what consumers pay for prescription drugs. The FTC’s new probe needs to go far to change the status quo.

One in four people struggle to afford their medications, and eight in 10 people say the cost of prescriptions is unreasonable. Do we really understand why?

The answer: pharmacy benefit managers, or PBMs. If you’re not in healthcare, you’ve likely never heard of these conglomerates, even though some are in the Fortune 10. They impact consumers by controlling and driving up drug prices. After pressure from provider and pharmacy groups, and on the heels of the bipartisan Pharmacy Benefit Manager Transparency Act, the Federal Trade Commission launched a long-overdue investigation into the anti-competitive, anti-consumer practices of the major PBMs, including CVS Caremark, OptumRx, and Express Scripts, who control 80% of the prescription drug market.

How do PBMs work? It’s complicated, on purpose. But the crux is this: PBMs negotiate “rebates” with drug manufacturers to ostensibly lower the price of drugs for consumers on commercial health plans. If you’re a drug manufacturer and don’t pay the rebate, you’re likely excluded from the PBM’s benefit plans. It’s a pay-to-play scheme, and a common practice in this market, leading to allegations that at least one PBM forcibly steered patients to more expensive drugs. Another way PBMs grow profits is adding margin to the price they pay the pharmacy versus what they charge the health plans and patients, a practice known as “spread pricing.” The PBM keeps the spread while raising drugs prices, and any savings comes out of the pockets of pharmacy owners.

What’s more, PBMs operate completely in the dark. There’s no transparency on rebates they get from drug manufacturers, why they cover some drugs but not others, and how they reimburse pharmacies for filling prescriptions. These practices have so inflated the cost of drugs that no one even knows what the real cost is, making all parties in the chain – pharmacists, employers, providers, consumers – completely disempowered. If you’re not mad yet, get ready: PBMs increase their control through bundling, or more precisely, “tying.” The three biggest PBMs are owned by or operate medical payers – CVS/Caremark now owns Aetna, ExpressScripts is now operated by Cigna, and OptumRx is a subsidiary of UnitedHealth Group. They use their newfound drug profits to subsidize their health plan premiums – the argument for vertical integration being, “we’re lowering the cost of healthcare.”

I call it moving money from the left pocket to the right. But the real strategy here is more nefarious. By leveraging their market power in the drug business, bundling this very profitable business with the lower margin medical insurance business becomes an effective tool for blocking new market entrants that would disrupt their lucrative model. The winner is the vertically integrated oligopoly; the loser is consumers.

These conglomerates not only control what drugs are covered and what you pay for them, but even where you can buy them – whether you can use your local community pharmacy or the mail order pharmacy they own and operate. The result is that consumers have been steered away from essential community pharmacies and toward PBM-owned pharmacies, further restricting competition and increasing the PBM’s profits.

Because PBMs have created market distortion in price and prevented a more efficient market from developing, people can’t shop for the drugs they need. Co-pays are sometimes more expensive than paying in cash, patients increasingly can’t afford their medication, and pharmacies are struggling to survive.

So, what can be done? FTC, we look to you: you must nail PBMs on price transparency and tying, bringing real change to the industry through the following requirements:

• PBMs must disclose to their customers the actual net prices paid and rebates they receive for employer health plans.
• Make it illegal to limit a patient’s choice of pharmacy providers to the PBM’s owned pharmacy.
• Enforce existing prohibitions on price tying and bundling when used as a device to block competition.
• Continue expanding patients’ right to their data, with severe penalties making the cost greater than the rewards for protecting their existing business model.

Anything less will continue the pain at the pharmacy counter. Only through transparency can change come. When people know the price of their drugs and can compare prices across pharmacies and co-pay vs. cash, they can finally take control of their prescription drug experience – and make the right choices for their health.

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back in June 2020  

Trump slashes cost of insulin for Medicare enrollees to $35 a month

This plan would have limited the cost of insulin to Medicare folks to $35/month, starting in Jan 2021

Yes, Biden stopped a Trump order to lower insulin costs, but it would not have helped most diabetics

President Biden took office in Jan, 2021 reversed Trump EO because it would not help that many people… only those on Medicare

The Inflation Reduction Act caps costs for Medicare patients on insulin. Where the push for broader relief stands

In Aug 2022, President signed into law this bills that will provide a copay limit of $35/month on Insulin for Medicare folks – and will not start until 2023.  33% of Medicare folks require insulin to treat their diabetes  And because of this action by President Biden each one of those Medicare folks had to pay – on average –  $446/yr … for their insulin for a EXTRA TWO YEARS

Insulin Rationing Common Among Patients With Diabetes

https://www.medpagetoday.com/endocrinology/diabetes/101257

— More than a million Americans may be engaging in the risky practice, researchers said

More than a million Americans with diabetes may be skipping insulin doses or delaying purchase of the drug because of its expense, said authors of a new study.

Based on data from 982 insulin users participating in the CDC’s 2021 National Health Interview Survey (NHIS), 16.5% reported some form of rationing the drug (95% CI 13.8%-19.6%), according to Adam Gaffney, MD, of Harvard Medical School in Cambridge, Massachusetts, and colleagues.

If that finding is representative of all Americans with diabetes, it could mean more than 1 million patients are rationing insulin with potentially harmful consequences, the researchers wrote in a brief report published in Annals of Internal Medicine.

The survey asked adult insulin users with type 1 or 2 diabetes if they had skipped insulin doses, took less than needed, or delayed buying insulin in the past 12 months to save money. Gaffney’s team considered any positive response an indication of rationing. The most common form of rationing was delayed purchase (14.2%), followed by taking less than needed (10.6%), and skipping doses (9.6%), the study found.

“Several factors likely underlie our findings. Insulin prices in the United States are far higher than in other nations. Moreover, pharmaceutical firms have increased insulin prices year upon year, even for products that remain unchanged,” Gaffney and colleagues said.

“Previous research, media reports of deaths due to insulin omission, and the established pathophysiology of diabetes indicate that cost-related nonadherence to insulin can have serious, even fatal outcomes,” they noted.

Insulin rationing varied among subgroups. Among adults 65 or older, 11.2% reported rationing, compared with 20.4% of younger persons. Among those with higher incomes, 10.8% reported rationing, compared with 19.8% of middle-income and 14.6% of low-income persons. Among Black participants, 23.2% rationed insulin, compared with 16.0% of white and Hispanic individuals.

Rates of rationing were highest among the uninsured (29.2%), followed by those with private insurance (18.8%), other coverage (16.1%), Medicare (13.5%), and Medicaid (11.6%), the study found.

Gaffney’s group also investigated whether rationing was associated with feeling “overwhelmed by the demands of living with diabetes” in the past month. Survey responses were dichotomized as “sometimes, usually, or always” versus “rarely or never.” After adjustment for sociodemographic variables, there was a significant association with feeling overwhelmed (prevalence ratio 1.48, 95% CI 1.20-1.76).

In an email to MedPage Today, Gaffney said, “Physicians should be aware of the financial barriers their patients face and prescribe less expensive versions of drugs, assuming it is clinically appropriate and there are multiple, equally effective alternatives.”

“But often there is not, which is yet one more reason why we need fundamental reform in how we procure and provide prescription medications,” he added. “Cost barriers are a tax on illness: we don’t need copays or deductibles on insulin, truly nobody uses more than they need. In my opinion, insulin — like all essential medications — should be free for all.”

Insulin prices are higher in the United States than other countries in part because the federal government does not use its purchasing power to negotiate lower prices, Gaffney said. “So we pay pharmaceutical companies twice as much for their drugs as other high-income nations. Second, we lack a universal healthcare system with full coverage of medications, so patients pay significant amounts out-of-pocket, or even the full sticker price if they are uninsured. It is a dysfunctional system that has caused patient deaths.”

In a statement accompanying the study, the investigators said the findings have implications for ongoing policy debates. The 2022 Inflation Reduction Act capped Medicare enrollees’ copays for insulin at $35 per month. The initial draft of that bill would also have capped insulin costs for people with private insurance, they said.

That provision wasn’t included in the final legislation, however. “As a result, neither the privately insured nor the uninsured — the groups who the new study found most often rationed insulin — have any protection from insulin costs, which can average $1,000 per month or more,” Gaffney’s group asserted.

Limitations of the study included the self-reporting of outcomes and diagnoses, the researchers noted. In addition, the NHIS did not collect data on potential consequences from insulin rationing, such as organ damage or hospitalizations for ketoacidosis.

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CDC 2022 Opioid Prescribing Guideline: Tapering

https://www.practicalpainmanagement.com/resources/clinical-practice-guidelines/cdc-2022-opioid-prescribing-guideline-tapering

Guideline Analysis: A look at the updated recommendations regarding the opioid tapering process and MME cutoffs.

In this analysis, we break down the various aspects of the proposed revisions to the CDC Guideline on Opioid Prescribing for Chronic Pain to help clinicians, patients, and caretakers alike understand their nuances and to provide expert review of their applicability, potential benefits, and potential concerns. Specifically, we examine an integral part of the 2016 original and 2022 revised guidelines: recommendations on opioid tapering.

Opioid tapering has historically been, and continues to be, one of the most controversial aspects of the original 2016 CDC prescribing guideline, and, thus, has become a crucial topic to examine in the proposed 2022 guidelines (expected to be finalized and released by the end of this year).

The concept of tapering does not exclusively apply to opioids, as it describes the general process of lowering any amount of medication in a gradual way to avoid potential precipitation of withdrawal and to ensure that a patient’s condition does not worsen without said medication. However, with opioids in particular, inappropriate reasons to taper or the use of an inappropriate tapering process can be associated with detrimental cognitive, physical, and emotional issues, all of which should be avoided when possible.

Prior to making the decision to taper an opioid, it is essential to establish an appropriate reason to taper in the first place. There could be several clinical reasons for initiating a taper:

• lack of efficacy
• attempt at opioid rotation
• development of adverse events
• abhorrent use/misuse

MME Limits

Each of the reasons to taper noted above are specifically noted in the 2016 CDC Guideline on Prescribing Opioids for Chronic Pain,¹ however, to the dismay of several expert clinicians, researchers, organizations, and stakeholders,²⁻⁵ the recommendation seemed to emphasize achieving a dosing threshold of 90 morphine milligram equivalents (MME) or lower per day. In addition, the 2016 recommendation advised to “consider tapering opioids to a lower dosage or to taper and discontinue opioids” if the patient is at ≥ 90 MME/day.

While the authors of the CDC guideline did not outright recommend blind and blanket tapering for those on opioids at ≥ 90 MME/day, unfortunately, because of the framing of the recommendations, several states enacted legislation while third-party payers created policies revolving around cutoffs utilizing the 90 MME/day threshold.¹˒⁶ These regulations resulted in blind tapering, reductions, and, in some cases, abrupt discontinuation of opioids across many patient populations who had been maintained on stable opioid therapy.²⁻⁸

Tapering Process

Regarding the process of how to taper, the 2016 guidelines were more vague, although their recommendations were more in line with the literature and best practice of the time.⁹ The CDC guideline authors did note that clinicians should collaborate with the patient on a tapering plan and that, if the patient agreed to taper, and that taper should remain slow, gradual, and even require pauses to allow for “gradual accommodation.”¹

They also recommended patients be monitored closely for anxiety, among other symptoms that may result from a taper.¹

Regarding the pending update to the CDC opioid prescribing guideline, there seems to be a greater emphasis by not only the authors but also by relevant stakeholders and the review panel, on gradual, patient-centered tapers.¹⁰

MME Limits

Despite what the authors indicate regarding MME/day cutoffs, there is a section in the draft update that discusses the plateauing of analgesia at opioid dosing of around 50 MME/day based on evidence with a level of “type 2” quality.¹⁰ While there is no mention of using 50 MME/day as a new dosing cutoff, the inclusion of 50 MME/day to describe evidence of efficacy is concerning, to say the least.

Tapering Process

There has been no significant change in recommendations for appropriate reasons to taper.¹⁰ Additionally, similar to the 2016 guideline, the 2022 draft update recommends a vague but gradual approach to opioid tapering, recommending specifically against blanket tapers or abrupt discontinuation.¹⁰ The authors of the updated document (who, of note, are the same authors of the 2016 guideline aside from one new contributor) also make a specific note, highlighted in the summary, that the guidelines are not “a law, regulation, and/or policy that dictates clinical practice or [serves as] a substitute for FDA-approved labeling.” This distinction is especially important to consider given that more than 170 policy changes made between 2016 and 2018 related to opioid-dosing cutoffs and MME/day thresholds, many of which were directly in response to the 2016 guidelines.⁶˒¹⁰

In fact, the 2022 draft update confirms the misapplication of the 2016 recommendations (specifically with regard to policies) concerning “opioid tapers and abrupt discontinuation without collaboration with patients; rigid application of opioid dosage thresholds.”¹⁰ The 2022 authors agree, as they did in a 2019 article published in the New England Journal of Medicine,⁷ that misapplying these recommendations in particular may have contributed to physical and psychological patient harm, undertreated pain, withdrawal symptoms, and suicidal ideation and behavior.¹⁰ They indeed recommend against the strict utilization of dosing thresholds based off of MME/day cutoffs.¹⁰

Like other revisions to the new guidelines, it does appear that the CDC has attempted to clarify and highlight important concerns that arose after the vast implementation of their 2016 opioid prescribing guidelines around opioid tapering. We commend the CDC for confirming the appropriate reasons to taper, for emphasizing patient-centered decisions regarding tapering, and for emphasizing that tapers be enacted with a gradual and careful approach.

However, there has not been a consensus update by pain management specialists based on clinical trials or sound scientific data regarding specific tapering recommendations such as duration, reduction amount, or frequency of reduction, and, thus, there remains significant discomfort and disparity among clinicians regarding how to adequately taper a patient off of opioids.¹¹˒¹²

Further, as noted, the CDC’s discussion that “type 2” evidence does not support dosing of opioids greater than 50 MME/day because of lack of association with significant efficacy and increased risk of adverse events when used in chronic pain.¹⁰ While the CDC recommends against the use of rigid dosing cutoffs, the language around their concerns with doses greater than 50 MME/day reads similar to the language used in 2016 guideline on 90 MME/day. The latter was a major reason cited by providers for tapering stable patients off opioids.¹¹ To reduce these concerns, it would be prudent for the CDC to specifically recommend against the use of 50 MME/day as a potential dosing cutoff going forward.

Overall, opioid tapering continues to be a difficult therapeutic aspect entwined within the use of opioids, not only because of the difficulties in identifying appropriate reasons/individuals to taper, but then to develop a tapering strategy with the patient. The CDC’s draft update to the opioid prescribing guideline attempts to provide some clarity on all of these aspects, however, remains vague in tapering strategies and allows for ambiguity around potential tapering in individuals on certain opioid doses.

No matter the final language, the authors believe it is pertinent that opioid tapering occurs in only appropriate situations, where patient physical and psychological harm is minimized, and where the tapering process remains individualized.

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Stable, Long-term Opioid Therapy Safer Than Tapering?

https://flashnews11.com/health/medicine/stable-long-term-opioid-therapy-safer-than-tapering/

Discontinuing secure, long-term opioid remedy is probably not obligatory for sufferers who present no indicators of misuse ― and it may even be safer than tapering or abrupt discontinuation, new analysis suggests.

Investigators analyzed knowledge for nearly 200,000 sufferers who didn’t have indicators of opioid use dysfunction (OUD) and have been receiving opioid remedy. The investigators in contrast three dosing methods: abrupt withdrawal, gradual tapering, and continuation of the present secure dosage.

Results confirmed a better adjusted cumulative incidence of opioid overdose or suicide occasions 11 months after baseline amongst members for whom a tapered dosing technique was utilized, in contrast with those that continued taking a secure dosage. The danger distinction was 0.15% between taper and secure dosage and 0.33% between abrupt discontinuation and secure dosage.

“This study identified a small absolute increase in risk of harms associated with opioid tapering compared with a stable opioid dosage,” Mark LaRochelle, MD, assistant professor of drugs, Boston University School of Medicine, Massachusetts, and colleagues write.

“These results do not suggest that policies of mandatory dosage tapering for individuals receiving a stable long-term opioid dosage without evidence of opioid misuse will reduce short-term harm via suicide and overdose,” they add.

The findings have been published online August 12 in JAMA Network Open.

Benefits vs Harms

The investigators word that the Centers for Disease Control and Prevention (CDC), in its 2016 Guideline for Prescribing Opioids for Chronic Pain, “recommended tapering opioid dosages if benefits no longer outweigh harms.”

In response, “some health systems and US states enacted stringent dose limits that were applied with few exceptions, regardless of individual patients’ risk of harms,” they write. By distinction, there have been “increasing reports of patients experiencing adverse effects from forced opioid tapers.”

Previous research that recognized harms related to opioid tapering and discontinuation had a number of limitations, together with a give attention to discontinuation, which is “likely more destabilizing than gradual tapering,” the researchers write. There can be “a high potential for confounding” in these research, they add.

The investigators sought to fill the analysis hole by drawing on 8-year knowledge (January 1, 2020, to December 31, 2018) from a big database that features adjudicated pharmacy, outpatient, and inpatient medical claims for people with business or Medicare Advantage insurance coverage encompassing all 50 states, the District of Columbia, and Puerto Rico.

Notably, people who had obtained a prognosis of substance use, abuse, or dependence or for whom there have been indicators in line with OUD have been excluded.

The researchers in contrast the three remedy methods throughout a 4-month remedy technique project interval (“grace period”) after baseline. Tapering was outlined as “2 consecutive months with a imply MME [ morphine milligram equivalent] discount of 15% or extra in contrast with the baseline month.”

All estimates have been adjusted for potential confounders, together with demographic and remedy traits, baseline yr, area, insurance coverage plan kind, comorbid psychiatric and medical situations, and the prescribing of different psychiatric medicines, corresponding to benzodiazepines, gabapentin, or pregabalin.

Patient-Centered Approaches

The remaining cohort that met inclusion standards consisted of 199,836 people (45.1% males; imply age, 56.9 years). Of the overall group, 57.6% have been aged 45–64 years. There have been 415,123 qualifying long-term opioid remedy episodes.

The largest share of the cohort (41.2%) have been receiving a baseline imply MME of fifty – 89 mg/day, whereas 34% have been receiving 90 – 199 mg/day and 23.5% have been receiving no less than 200 mg/day.

During the 6-month eligibility evaluation interval, 34.8% of the cohort have been receiving benzodiazepine prescriptions, 18% had been recognized with comorbid anxiousness, and 19.7% had been recognized with comorbid depression.

After the remedy project interval, most remedy episodes (87.1%) have been thought of secure, 11.1% have been thought of a taper, and 1.8% have been thought of abrupt discontinuation.

Eleven months after baseline, the adjusted cumulative incidence of opioid overdose or suicide occasions was lowest for many who continued to obtain a secure dose.

The danger variations between taper vs secure dosage have been 0.15% (95% CI, 0.03% – 0.26%), and the danger variations between abrupt discontinuation and secure dose have been 0.33% (95% CI, −0.03% to 0.74%). The danger ratios related to taper vs secure dosage and abrupt discontinuation vs secure dosage have been 1.15 (95% CI, 1.04 – 1.27) and 1.34 (95% CI, .97 – 1.79), respectively.

The adjusted cumulative incidence curves for overdose or suicide diverged at month 4 when evaluating secure dosage and taper, with a better incidence related to the taper vs secure dosage remedy methods thereafter. However, when the researchers in contrast secure dosage with abrupt discontinuation, the occasion charges have been related.

A per protocol evaluation, wherein the researchers censored episodes involving lack of adherence to assigned remedy, yielded outcomes just like these of the primary evaluation.

“Policies establishing dosage thresholds or mandating tapers for all patients receiving long-term opioid therapy are not supported by existing data in terms of anticipated benefits even if, as we found, the rate of adverse outcomes is small,” the investigators write.

Instead, they encourage healthcare techniques and clinicians to “continue to develop and implement patient-centered approaches to pain management for patients with established long-term opioid therapy.”

Protracted Withdrawal?

Commenting for Medscape Medical News, A. Benjamin Srivastava, MD, assistant professor of scientific psychiatry, Division on Substance Use Disorders, Columbia University Medical Center, New York State Psychiatric Institute, New York City, known as the examine “an important contribution to the literature” that “sheds further light on the risks associated with tapering.”

Srivastava, who was not concerned with the analysis, famous that earlier research exhibiting an elevated prevalence of antagonistic occasions with tapering included members with OUD or indicators of opioid misuse, “potentially confounding findings.”

By distinction, the present examine investigators particularly excluded sufferers with OUD/opioid misuse however nonetheless discovered a “slight increase in risk for opioid overdose and suicide, even when excluding for potential confounders,” he mentioned.

Although causal implications require additional investigation, “a source of these adverse outcomes may be unmanaged withdrawal that may be protracted,” Srivastava famous.

While abrupt discontinuation “may result in significant acute withdrawal symptoms, these should subside by 1–2 weeks at most,” he mentioned.

Lowering the dose with out discontinuation might result in sufferers’ getting into into “a dyshomeostatic state characterized by anxiety and dysphoria…that may not be recognized by the prescribing clinician,” he added.

The mind “is still being primed by opioids [and] ‘wanting’ a higher dose. Thus, particular attention to withdrawal symptoms, both physical and psychiatric, is prudent when choosing to taper opioids vs maintaining or discontinuing,” Srivastava mentioned.

The examine was funded by a grant from the CDC and a grant from the National Institute on Drug Abuse (NIDA) to one of many investigators. LaRochelle obtained grants from the CDC and the NIDA through the conduct of the examine and has obtained consulting charges for analysis paid to his establishment from OptumLabs outdoors the submitted work. The different investigators’ disclosures are listed within the unique article. Srivastava stories no related monetary relationships.

JAMA Netw Open. Published on-line August 12, 2022. Full article

Batya Swift Yasgur, MA, LSW, is a contract author with a counseling observe in Teaneck, NJ. She is an everyday contributor to quite a few medical publications, together with Medscape and WebMD, and is the creator of a number of consumer-oriented well being books in addition to Behind the Burqa: Our Lives in Afghanistan and How We Escaped to Freedom (the memoir of two courageous Afghan sisters who advised her their story).

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Philips Respironics Alerts Customers Worldwide of Updated Instructions and Labeling of Specific Sleep Therapy Masks That Contain Magnetic Headgear Clips Due to Potential Risk of Serious Injury

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/philips-respironics-alerts-customers-worldwide-updated-instructions-and-labeling-specific-sleep

Company Announcement

These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Pittsburgh, Pennsylvania – Royal PhilipsExternal Link Disclaimer’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body. The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry.

This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing such magnetic clips to inform them of the updated instructions and labeling. All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication described below. This represents a new and industry-leading practice.

Contraindication: As per Nobles Health Care Product Solutions, Use of the mask is contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to:

• Pacemakers
• Implantable cardioverter defibrillators (ICD)

• Neurostimulators

• Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
• Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt)
• Aneurysm clips
• Embolic coils
• Intracranial aneurysm intravascular flow disruption devices
• Metallic cranial plates, screws, burr hole covers, and bone substitute devices
• Metallic splinters in the eye
• Ocular implants (e.g., glaucoma implants, retinal implants)
• Certain contact lenses with metal
• Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
• Magnetic denture attachments
• Metallic gastrointestinal clips
• Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)

• Implantable ports and pumps (e.g., insulin pumps)

• Hypoglossal nerve stimulators
• Devices labeled as MR (Magnetic Resonance) unsafe
• Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field

Patients should stop using the affected mask if the implant/medical device is contraindicated against the mask magnets. Patients should consult their physician immediately to determine if another mask can be used for their therapy. In the interim, switch to a non-magnetic mask if available, for continued therapy. Patients should properly dispose of the mask that has magnets after an alternative is obtained.

These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Warning: Magnets with a magnetic field strength of 400 mT are used in the mask. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 15 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks.

Impacted masks include: See Image Below

More than 17 million masks containing magnetic clips have been distributed by Philips Respironics to date. As of August 30, 2022, Philips Respironics has received 14 reports of patients suggesting that the mask magnets may have impacted their medical devices including pacemaker interference, pacemaker failure leading to replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillator (AICD), seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues.

Patients with questions may contact Philips Respironics’ customer service at 1-800-345-6443, (Monday – Friday; 8:30 AM ET to 8:00 PM ET) for more information about non-magnetic mask options. Patients may also contact their Durable Medical Equipment (DME) provider, which supplied the masks affected by this notice.

Any adverse events experienced with the use of masks containing magnetic clips should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

This voluntary medical device corrective action has been reported to the regulatory agencies in the countries where these masks are available.

An FAQ can be found hereExternal Link Disclaimer.

FDA Safety Communication

FDA News Release 

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Suicide Notes Offer ‘Unique Window’ Into Motives, Risks in the Elderly

https://www.medscape.com/viewarticle/982132

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https://www.fda.gov/drugs/news-events-human-drugs/morphine-milligram-equivalents-current-applications-and-knowledge-gaps-research-opportunities-and

There is a BOAT LOAD of PDF’s in this hyperlink…  since this was a two day virtual seminar… it might take someone a couple of days to try and digest all this information.

Here is a link to a one of my blog posts that includes a what is basically the genealogy of the MME system and how it has no science nor double blind clinical studies behind it to support this clinical conclusions… and MAY only have some minor applications to pts dealing with acute/decreasing post-op pain… BUT … HAS NO VALID APPLICATION TO CHRONIC PAIN THERAPY

Was/is the CDC 2016 guidelines built on a “false foundation ” and created a covert genocide on a protect class of people ?

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Tricare to reduce number of network pharmacies for its beneficiaries this month

https://www.stripes.com/theaters/us/2022-10-11/tricare-prescriptions-pharmacy-express-scripts-7659239.html

A new contract from prescription-drug benefit manager Express Scripts will force nearly 15,000 pharmacies out of the Tricare network by the end of this month, according to a spokeswoman for a small pharmacies’ association.

The new contract will remove 14,963 pharmacies from the network by Oct. 24, leaving approximately 41,000 pharmacies.

A proposed contract Express Scripts sent to participating pharmacies in August lowered their reimbursement rates below even their own costs, Anne Cassity, vice president of federal and state government affairs at the National Community Pharmacists Association, told Stars and Stripes by phone Sept. 22. She said association members had never before seen anything like it.

“We saw a massive reduction in reimbursements to the tune of far below even acquisition price for our pharmacies,” Cassity said. “So, they would be underwater on every prescription that they dispense for a Tricare beneficiary.”

Many small, local pharmacies had to refuse the new contract, she said.

“This is going to have a huge effect, especially in rural areas where it’s generally independent pharmacies,” Cassity said.

Express Scripts, a pharmacy benefit management company based in St. Louis, handles annual pharmacy contract negotiations on behalf of Tricare. It also provides a mail order prescription service for Tricare beneficiaries. The company has 27,000 employees and annual revenue of over $100 billion, according to job-search website Zippia.

In August 2021 the Department of Defense awarded a $4.3 billion contract to Express Scripts that incentivized the company to reduce the size of the Tricare retail pharmacy network, according to email and phone conversations with National Community Pharmacists Association spokeswoman Andie Pivarunas.

“Express Scripts began notifying impacted beneficiaries in mid-September 2022,” Tricare spokesman Peter Graves told Stars and Stripes by email Sept. 30.

“Anyone with a prescription at a pharmacy that is transitioning out of the network should transfer it to a new network pharmacy to avoid paying the full cost of the prescription up front or having to file a claim for reimbursement,” Graves said.

Doris Parker, 66, of Alexandria, Va., the wife of a retired service member, used to receive Kisqali, a cancer medication, through the Express Scripts mail-order service, she told Stars and Stripes by phone on Sept. 26.

“About three or four months after I started taking it, they decided they aren’t going to send it to me anymore,” she said.

Parker turned instead to a local pharmacy, but in September was told by Express Scripts that the pharmacy would be dropped from the Tricare network, she said.

Tricare denies its new contract will have a huge, negative impact on beneficiaries living in rural areas.

“The Tricare retail network will continue to meet or exceed Tricare’s standard for pharmacy access,” Graves said. “[Defense Health Agency] expects nearly 95% of beneficiaries will maintain access to at least two network pharmacies within 15 minutes from their home, and over 99% will have access within 30 minutes.”

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