Pain Doesn’t Belong on a Scale of Zero to 10

Pain Doesn’t Belong on a Scale of Zero to 10

https://www.medpagetoday.com/opinion/second-opinions/110926

The real answer is long, complicated, and not measurable in this one-dimensional way

Over the past 2 years, a simple but baffling request has preceded most of my encounters with medical professionals: “Rate your pain on a scale of zero to 10.”

I trained as a physician and have asked patients the very same question thousands of times, so I think hard about how to quantify the sum of the sore hips, the prickly thighs, and the numbing, itchy pain near my left shoulder blade. I pause and then, mostly arbitrarily, choose a number. “Three or four?” I venture, knowing the real answer is long, complicated, and not measurable in this one-dimensional way.

Pain is a squirrely thing. It’s sometimes burning, sometimes drilling, sometimes a deep-in-the-muscles clenching ache. Mine can depend on my mood or how much attention I afford it and can recede nearly entirely if I’m engrossed in a film or a task. Pain can also be disabling enough to cancel vacations, or so overwhelming that it leads people to opioid addiction. Even 10+ pain can be bearable when it’s endured for good reason, like giving birth to a child. But what’s the purpose of the pains I have now, the lingering effects of a head injury?

The concept of reducing these shades of pain to a single number dates to the 1970s. But the zero-to-10 scale is ubiquitous today because of what was called a “pain revolution” in the ’90s, when intense new attention to addressing pain — primarily with opioids — was framed as progress. Doctors today have a fuller understanding of treating pain, as well as the terrible consequences of prescribing opioids so readily. What they are learning only now is how to better measure pain and treat its many forms.

About 30 years ago, physicians who championed the use of opioids gave robust new life to what had been a niche specialty: pain management. They started pushing the idea that pain should be measured at every appointment as a “fifth vital sign.” The American Pain Society went as far as copyrighting the phrase. But unlike the other vital signs — blood pressure, temperature, heart rate, and breathing rate — pain had no objective scale. How to measure the unmeasurable? The society encouraged doctors and nurses to use the zero-to-10 rating system. Around that time, the FDA approved oxycodone hydrochloride (OxyContin), a slow-release opioid painkiller made by Purdue Pharma. The drugmaker itself encouraged doctors to routinely record and treat pain, and aggressively marketed opioids as an obvious solution.

To be fair, in an era when pain was too often ignored or undertreated, the zero-to-10 rating system could be regarded as an advance. Morphine pumps were not available for those cancer patients I saw in the ’80s, even those in agonizing pain from cancer in their bones; doctors regarded pain as an inevitable part of disease. In the emergency room where I practiced in the early ’90s, prescribing even a few opioid pills was a hassle: It required asking the head nurse to unlock a special prescription pad and making a copy for the state agency that tracked prescribing patterns. Regulators (rightly) worried that handing out narcotics would lead to addiction. As a result, some patients in need of relief likely went without.

After pain doctors and opioid manufacturers campaigned for broader use of opioids — claiming that newer forms were not addictive, or much less so than previous incarnations — prescribing the drugs became far easier and were promoted for all kinds of pain, whether from knee arthritis or back problems. As a young doctor joining the “pain revolution,” I probably asked patients thousands of times to rate their pain on a scale of zero to 10 and wrote many scripts each week for pain medication, as monitoring “the fifth vital sign” quickly became routine in the medical system. In time, a zero-to-10 pain measurement became a necessary box to fill in electronic medical records. The Joint Commission on the Accreditation of Healthcare Organizations made regularly assessing pain a prerequisite for medical centers receiving federal healthcare dollars. Medical groups added treatment of pain  to their list of patient rights, and satisfaction with pain treatment became a component of post-visit patient surveys. (A poor showing could mean lower reimbursement from some insurers.)

But this approach to pain management had clear drawbacks. Studies accumulated showing that measuring patients’ pain didn’t result in better pain control. Doctors showed little interest in or didn’t know how to respond to the recorded answer. And patients’ satisfaction with their doctors’ discussion of pain didn’t necessarily mean they got adequate treatment. At the same time, the drugs were fueling the growing opioid epidemic. Research showed that an estimated 3% to 19% of people who received a prescription for pain medication from a doctor developed an addiction.

Doctors who wanted to treat pain had few other options, though. “We had a good sense that these drugs weren’t the only way to manage pain,” Linda Porter, PhD, director of the National Institutes of Health’s Office of Pain Policy and Planning, told me. “But we didn’t have a good understanding of the complexity or alternatives.” The enthusiasm for narcotics left many varietals of pain underexplored and undertreated for years. Only in 2018, a year when nearly 50,000 Americans died of an overdose, did Congress start funding a program — the Early Phase Pain Investigation Clinical Network, or EPPIC-Net — designed to explore types of pain and find better solutions. The network connects specialists at 12 academic specialized clinical centers and is meant to jump-start new research in the field and find bespoke solutions for different kinds of pain.

A zero-to-10 scale may make sense in certain situations, such as when a nurse uses it to adjust a medication dose for a patient hospitalized after surgery or an accident. And researchers and pain specialists have tried to create better rating tools — dozens, in fact, none of which was adequate to capture pain’s complexity, a European panel of experts concluded. The Veterans Health Administration, for instance, created one that had supplemental questions and visual prompts: A rating of 5 correlated with a frown and a pain level that “interrupts some activities.” The survey took much longer to administer and produced results that were no better than the zero-to-10 system. By the 2010s, many medical organizations, including the American Medical Association and the American Academy of Family Physicians, were rejecting not just the zero-to-10 scale but the entire notion that pain could be meaningfully self-reported numerically by a patient.

In the years that opioids had dominated pain remedies, a few drugs — such as gabapentin and pregabalin for neuropathy, and lidocaine patches and creams for musculoskeletal aches — had become available. “There was a growing awareness of the incredible complexity of pain — that you would have to find the right drugs for the right patients,” Rebecca Hommer, MD, EPPIC-Net’s interim director, told me. Researchers are now looking for biomarkers associated with different kinds of pain so that drug studies can use more objective measures to assess the medications’ effect. A better understanding of the neural pathways and neurotransmitters that create different types of pain could also help researchers design drugs to interrupt and tame them.

Any treatments that come out of this research are unlikely to be blockbusters like opioids; by design, they will be useful to fewer people. That also makes them less appealing prospects to drug companies. So EPPIC-Net is helping small drug companies, academics, and even individual doctors design and conduct early-stage trials to test the safety and efficacy of promising pain-taming molecules. That information will be handed over to drug manufacturers for late-stage trials, all with the aim of getting new drugs approved by the FDA more quickly.

The first EPPIC-Net trials are just getting underway. Finding better treatments will be no easy task, because the nervous system is a largely unexplored universe of molecules, cells, and electronic connections that interact in countless ways. The 2021 Nobel Prize in Physiology or Medicine went to scientists who discovered the mechanisms that allow us to feel the most basic sensations: cold and hot. In comparison, pain is a hydra. A simple number might feel definitive. But it’s not helping anyone make the pain go away.

Optum to pay $20M to settle improper prescription allegations

Optum to pay $20M to settle improper prescription allegations

https://www.beckershospitalreview.com/legal-regulatory-issues/optum-to-pay-20m-to-settle-improper-prescription-allegations.html

OptumRx will pay $20 million to settle allegations it improperly dispensed some opioid medications, the Justice Department said June 27. 

The settlement resolves an investigation into if OptumRx improperly filled certain opioid prescriptions between 2013 and 2015. The Justice Department alleged the pharmaceutical benefit manager improperly dispensed opioids in combination with other drugs, including benzodiazepines and muscle relaxants, from its mail-order pharmacy operations in Carlsbad, Calif. 

Opioids prescribed alongside benzodiazepines and muscle relaxants are commonly referred to as “trinity” prescriptions. These prescriptions raise red flags that the drugs may not be for legitimate medical use, and could lead to the diversion of controlled substances, the Justice Department said. In its investigation, the department alleged OptumRx dispensed trinity prescriptions without resolving red flags. 

OptumRx does not admit liability as part of the settlement. The company has instituted policies to reduce the number, dose and duration of opioids distributed, according to the Justice Department, and instituted more robust procedures to identify prescriptions for dangerous combinations of drugs or doses. Optum closed its Carlsbad mail-order operations during the course of the investigation, according to the Justice Department. 

OptumRx is a pharmaceutical benefit manager owned by UnitedHealth Group. 

The PBM industry using its monopolistic stasis to crush their competition and generate excessive profits

It is easy to see from this graphic why independent pharmacies are going out of business and why the insurance/pbm industry wants to get all pts to move their Rxs over to their mail-order pharmacy.

According to the graphic the mail-order pharmacy got paid as much as $4,000+ more than the community pharmacy got paid to fill the same Rx.

On every Rx, the mail-order pharmacy got paid SUBSTANTIALLY more than the community pharmacy was paid.

One particular Rx the community pharmacy was paid abt $2,000 LESS THAN THE COST OF THE MEDICATION FROM THE DRUG WHOLESALER. It does not take an MBA or a PhD in business management to figure out that selling products for substantially less than it costs to buy the product from a wholesaler, is not a good business plan to help ensure the business has a profitable/sustainable future.

YOU WILL HAVE TO CLICK ON THE GRAPHIC TWICE TO GET IT TO BE MORE READABLE

Arkansas is suing PBMs Express Scripts and Optum, accusing them of fueling the state’s opioid crisis

I have been waiting for this to happen! This is the last part of various entities that have “touched” opioids in some manner that have not been sued for “contributing” to our fabricated opioid crisis.

By suing Express Scripts, they are indirectly suing Cigna – the insurance company that owns Express Scripts. In suing Optum, they are indirectly United Healthcare because Optum is part of that huge healthcare organization.

Are they not suing Caremark this time, because CVS Health owns that PBM, and they have already sued/fined CVS Health for billions?

Could all this activity going after any entity that is involved with the manufacturing, prescribing, dispensing, wholesaling, and paying for opioids? Because the 1999 Tobacco Settlement Agreement annual payments to states will start to be reduced in 2025 and years going forward. It has been claimed that abt 3% of all the billions paid out to the states since 1999 has been used for the stated purpose of the agreement. The vast majority of the dollars paid out have been put in the state’s coffers to be used as the state’s bureaucrats wished.

 

Arkansas is suing pharmacy benefit managers Express Scripts and Optum, accusing them of fueling the state’s opioid crisis

https://fortune.com/2024/06/25/arkansas-suing-pharmacy-benefit-managers-express-scripts-optum-opioid-crisis/

Arkansas on Monday sued two pharmacy benefit managers that oversee coverage for insurers, employers and other large clients, accusing them of fueling the opioid crisis in the state.

Attorney General Tim Griffin filed the lawsuit against Express Scripts Inc. and Optum Inc., and their subsidiaries, in state court.

Pharmacy benefit managers run prescription drug coverage for big clients that include health insurers and employers that provide coverage. They help decide which drugs make a plan’s formulary, or list of covered medications. They also can determine where patients go to fill their prescriptions.

Griffin’s lawsuit said the companies benefitted from the opioid crisis “by negotiating favorable deals with opioid manufacturers and by not taking sufficient action to curb excessive opioid prescriptions.”

“For at least the last two decades, defendants had a central role in facilitating the oversupply of opioids,” the lawsuit said. “Defendants ignored the necessary safeguards in order to ensure increased opioid prescriptions and sales.”

In a statement, Optum said it has taken steps to fight the opioid epidemic and would defend itself against Arkansas’ suit.

“Optum did not cause the opioid crisis or make it worse, and we will defend ourselves in this litigation,” the company said in a statement. “Optum takes the opioid epidemic seriously and has taken a comprehensive approach to fight this issue, including the Opioid Risk Management Program available to all Optum Rx clients, to address opioid abuse and promote patient health.”

Express Scripts did not immediately respond to a request for comment.

According to the lawsuit, opioids were the most commonly prescribed class of controlled substances in Arkansas in 2022, and Arkansas had the second-highest opioid prescribing rate in the nation that year.

State and local governments have filed thousands of lawsuits over the toll of the opioid crisis. The claims have included asserting that drugmakers, wholesalers, pharmacy chains and other businesses engaged in deceptive marketing and failed to stop the flow of the powerful prescription painkillers to the black market.

Many of the major cases have been settled, with proposed and finalized agreements to provide more than $50 billion –- with most of it to be used to fight the opioid crisis. A federal judge who is overseeing federal lawsuits over opioids is lining up cases involving pharmacy benefit managers for trials, possibly a precursor to settlements.

In recent years, opioid overdoses have been linked to about 80,000 deaths annually in the U.S. The majority of those lately have involved fentanyl and other potent drugs produced illicitly in labs and often used to lace other illegal drugs.

Top Law Firms in US Opioid Lawsuits to Get Hundreds of Millions in Fees

Top Law Firms in US Opioid Lawsuits to Get Hundreds of Millions in Fees

https://www.usnews.com/news/top-news/articles/2024-06-07/top-law-firms-in-us-opioid-lawsuits-to-get-hundreds-of-millions-in-fees

A court-appointed panel on Friday recommended how to divvy up a pool of $2.13 billion in legal fees from nationwide drug industry settlements over the U.S. opioid crisis, with top firms set to receive hundreds of millions of dollars.

The panel gave national firm Motley Rice the largest share, with 18.6% of the funds, or $396 million. Other firms with large shares include New York-based Simmons Hanly Conroy, with 11.4%, or $244 million; California-based Robbins Geller Rudman & Dowd, with 8.2%, or $174 million; and California-based Lieff Cabraser Heimann & Bernstein, with 5.65%, or $120 million.

The $2.13 billion fee pool comes out of settlements totaling more than $46 billion that drugmakers, distributors and pharmacies have reached to resolve lawsuit by local and Native American tribal governments accusing them of fueling an epidemic of opioid addiction.

The money was set aside as a so-called common benefit fund, to compensate law firms for work they did that benefited all of the plaintiffs in the litigation.

U.S. District Judge Dan Polster, who has overseen the sprawling opioid litigation since 2017, also ruled Friday that firms have until June 21 to appeal the panel’s recommendations before they become final.

The fees stem from settlements with drugmakers Johnson & Johnson, AbbVie and Teva Pharmaceutical Industries; distributors Cencora, McKesson and Cardinal Health; and pharmacies CVS, Walgreens Boots Alliance and Walmart.

They do not include a settlement of up to $6 billion with bankrupt OxyContin maker Purdue Pharma, which is funded by that company’s Sackler family owners in exchange for a shield from future lawsuits. The U.S. Supreme Court is currently weighing whether that settlement is legal.

Opioid settlements, including both the nationwide deals and separate agreements negotiated by individual states, now total well over $50 billion. However, many state and local governments have yet to develop detailed plans for how they will spend the money to remedy the harms caused by opioids.

More than 800,000 people died of opioid overdoses from 1999 through 2023, according to data from the U.S. Centers for Disease Control and Prevention. Plaintiffs in the lawsuits say that drugmakers downplayed the drugs’ risks, and distributors and pharmacies ignored red flags that they were being diverted into illegal channels.

 

WHO and Eli Lilly caution patients against falling for fake versions of popular weight-loss drugs

WHO and Eli Lilly caution patients against falling for fake versions of popular weight-loss drugs

https://apnews.com/article/wegovy-zepbound-ozempic-mounjaro-counterfeit-8302657de25a0c9c343abe20802d35a7

The World Health Organization and drugmaker Eli Lilly and Co. are warning people to be wary of fake versions of popular weight-loss and diabetes medicines.

WHO said Thursday that it has fielded several reports of fake semaglutide — the active ingredient in Novo Nordisk’s Wegovy and Ozempic — in all geographic regions of the world since 2022.

Lilly said in an open letter that it was “deeply concerned” about growing online sales and social media posts involving phony or compounded versions of tirzepatide, the active ingredient behind its drugs Mounjaro and Zepbound.

The Indianapolis-based company said it was the only lawful supplier of those drugs, and it does not provide tirzepatide to compounding pharmacies, wellness centers or online retailers.

Lilly said fake versions of its drugs frequently advertised or sold online are never safe to use.

Novo Nordisk has issued similar warnings in the past about its medications.

WHO said patients can protect themselves by using prescriptions from licensed physicians to buy the medications. The agency said patients also should avoid buying the drugs from unfamiliar sources.

Lilly said any products marketed as tirzepatide and not Mounjaro or Zepbound were not made by the drugmaker and are not approved by the U.S. Food and Drug Administration.

US Drug Shortage Reaches a Decade High: US Pharmacopeia Reports

US Drug Shortage Reaches a Decade High: US Pharmacopeia Reports

There were 125 drug shortages by the end of 2023

https://www.theepochtimes.com/health/us-drug-shortage-reaches-a-decade-high-us-pharmacopeia-reports-5665830

Drug shortages are the highest in a decade, with 2023 topping the charts, according to United States Pharmacopeia’s first annual Drug Shortage Report (USP).

“The number of drug shortages has increased over a decade, with 125 active drug shortages monitored by FDA at the end of 2023. … This high number of shortages is a direct result of persistent market vulnerabilities,” the report authors wrote. “According to our analysis, over a quarter of drugs in shortage were new drug shortages (34 products) in 2023.”

USP is a nonprofit organization that sets quality standards for medication, dietary supplements, and food ingredients worldwide.

The report, published in early June, notes that the average drug shortage lasts more than three years and affects multiple types of drugs. Almost 25 percent of those drugs have been on shortage lists for over five years, and six drugs, including epinephrine injections, have been in short supply for a decade. Injectable generic medications have been hit hardest, comprising more than 53 percent of new drug shortages.

These drug shortages indicate vulnerability in the market and affect patient care.

“Unexpected shocks can break the system and disrupt the supply of quality medicines,” Anthony Lakavage, senior vice president for Global External Affairs at USP, said in a news release. “This worrisome trajectory leads to more frequent drug shortages, prolonged scarcity, and more people at risk of not getting the medicines they need, when they need them.”

What’s Causing the Shortage?

The report states that fundamental supply and demand are likely to blame for the drug shortages but adds that the problem in the United States is exacerbated by manufacturing complexity (e.g., sterile injectables). For instance, drug classes like antibiotics need dedicated facilities, and some active ingredients require complicated chemical synthesis.

Some of the other reasons for the shortages include:

  • Race to the bottom: Most of the drugs in short supply cost less than $5 to make. Many of these cheap drugs are solid oral and sterile injectable medicines. The authors found that 66 percent of solid oral medications in shortage cost less than $3, and nearly one-third of the injectables in shortage cost less than $2. From 2022 to 2023, the number of discontinued drugs increased by 40 percent. Almost half of these are solid oral medications that cost less than $4. The report suggests tightening margins have pushed some manufacturers to pull out of the market.
  • Geographic concentration: The United States produces 44 percent of injectable medication, while India produces 56 percent of solid oral medication. These concentrations of production increase supply-chain vulnerability. A well-known example of injectable drugs is semaglutide weight-loss drugs, which were in short supply during the fall and winter of 2023. These medications often require complex chemical synthesis and take more time to manufacture. They also often require more steps in the manufacturing process.
  • Quality concerns: Unrelated but still problematic quality concerns have also slowed production. The report shows that in 2023, the U.S. Food and Drug Administration (FDA) inspected facilities accounting for 40 percent of drug production for having “objectionable conditions.”

“Quality comes at a price,” Vimala Raghavendran, vice president for Informatics Product Development at USP, said in the press release. “The economics of generic drugs often leave manufacturers with razor-thin margins, making it challenging to prioritize investment in modern machinery or to elevate standards of quality. Without sufficient profitability, the cycle of innovation and improvement becomes difficult to sustain.”

The Solution

U.S. Pharmacopeia, which touts itself as an independent, science-based nonprofit focused on building trust in the supply of safe medication, has joined with other national health care organizations in a call to action for the long-term, systemic solutions to the U.S. pharmacy drug shortage.

“As we navigate the complex landscape of drug shortages, it is paramount to shift the market into a stable state,” Mr. Lavakage said.

The coalition called upon policymakers to promote lower-priced drugs and a sustainable, high-quality supply chain. Its suggestions were to:

  • “Coordinate supply chain resilience and reliability efforts”
  • “Increase supply chain visibility”
  • “Establish a vulnerable medicines list”
  • “Align the market to incentivize a quality and adequate supply chain”
  • “Bolster manufacturing capacity”
  • Fund “research to better understand market interactions”

Map shows the PHARMACY DESERTS that the PBM industry is creating


you must click on the RED HYPERLINK BELOW to get the map up and displaying. It shows all the pharmacies that have closed over the last DECADE. Clearly demonstrates the PHARMACY DESERTS that the insurance/PBM is causing.

Mapping U.S. Pharmacy Closures

 

January 2014 to March 2024

 

Community pharmacies are accessible locations for health and wellness in the United States.

Nearly  90% of people living in the United States live within 5 miles of a pharmacy , and practically  80% of the U.S. population can reach a pharmacy by driving 10 minutes or less . However, when a community pharmacy closes, patient access to essential medications and other health and wellness services like vaccinations could lessen.

Pharmacists and pharmacy corporations may close their pharmacy businesses for many different reasons. But when a pharmacy thrives, local communities can access care that helps them get well and stay well.

“The community pharmacy is a foundational piece of our American health system. We must protect pharmacies from closures for the health and wellness of our communities.”

Lucas A. Berenbrok

Pharmacy closures are a threat to public health. The map below illustrates pharmacy locations that have closed between January 2014 and March 2024. Pharmacy closure dates and addresses were obtained from dataQ ®  a product of the National Council for Prescription Drug Programs (NCPDP).

This map progressively displays pharmacy locations that closed between January 2014 and March 2024.

Esri, TomTom, FAO, NOAA, USGS | Esri, US Census Bureau
Powered by Esri
1/1/2014

1/1/2014

Use the play ⏵︎ and pause ⏸︎ buttons to start and stop animation at any time. Pharmacy closures will appear progressively over time. Use the + and – buttons to zoom in and out of areas of interest. Click on location points to explore characteristics of closed pharmacies.

Limitations

The map shows locations of pharmacies that closed between January 2014 and March 2024. Because pharmacy closures are voluntarily reported to NCPDP by the store, closures not reported to NCPDP do not appear on this map and reported closure dates may not match  dates published by the media . In few cases where pharmacy ownership changed, an active pharmacy may appear as closed on the date previous ownership reported closure to NCPDP. To report a case, email  pharmacymaps@pitt.edu .

Conclusion

Community pharmacies serve as essential access points for health care in the United States. Pharmacy closures threaten population and individual access to medications and other health and wellness services.

 

 

Lost Chances to Treat Overdose Survivors Documented in New Medicare Study

Could this study be used to rationalize/justify less prescribing of opioids to folks on Medicare? There are 65 million people on Medicare of which 9 million are on Medicare Disability. So about 14% of Medicare folks are disabled. The 137,000 sample was ~ 0.2% of the Medicare population. The article states that ~ 30% of the sample was Medicare folks on disability or ~ 41,100.  If the Medicare disabled were fairly represented in the population sample, there would have been ~ 274 folks.

Could the design of this study intentionally have 150 times the percentage of disabled Medicare folks than is typical of the Medicare population as a whole?

I keep reading this article like U.S. government researchers found 53% of overdose survivors received opioid painkillers – Does this mean that they were prescribed FDA opioids are bought illegal opioids on the street?

About 80% of them had been treated for acute or chronic pain, and nearly half had prescriptions for opioids before the overdose  Does this mean that 20%  had never been prescribed FDA opioids and little more than HALF had been using STREET OPIOIDS?

The word “prescriptions” was only used THREE TIMES IN THE ENTIRE ARTICLE! The word “PAIN” was only used FOUR TIMES IN THE ENTIRE ARTICLE!

Lost Chances to Treat Overdose Survivors Documented in New Medicare Study

https://www.medpagetoday.com/painmanagement/painmanagement/110702

Findings also highlight the difficulty of managing chronic pain

A new study documents lost opportunities to treat drug overdose survivors covered by the Medicare program — and illustrates the difficulty of managing chronic pain.

Overdose survivors “should be at the front of the line for the full range of medications and counseling and support,” said Brian Hurley, MD, president of the American Society of Addiction Medicine, who was not involved in the research.

Instead, those on Medicare who survived a drug overdose in 2020 were much more likely to later receive opioid painkillers than any medication to treat addiction — and some went on to die of an overdose, according to the study findings in JAMA Internal Medicine

U.S. government researchers found 53% of overdose survivors received opioid painkillers while 4% received treatments such as buprenorphine. Only 6% filled prescriptions for the overdose antidote naloxone. Within a year of their overdose, 17% experienced a second nonfatal overdose and 1% died of an overdose.

The researchers looked at nearly 137,000 Medicare beneficiaries who survived an overdose in 2020, when the emergence of COVID-19 scrambled drug treatment efforts.

The group included about 30% who qualified for Medicare because of a disability rather than their age. About 80% of them had been treated for acute or chronic pain, and nearly half had prescriptions for opioids before the overdose.

In some situations, it might be appropriate to continue to prescribe opioids after an overdose, but “these patients should be closely monitored, provided naloxone,” and have plans in place to reduce overdose risk, said lead author Capt. Christopher Jones, PharmD, DrPH of the Substance Abuse and Mental Health Services Administration.

Gaps in treatment for overdose survivors exist throughout the U.S. healthcare system and predate the pandemic, said Michael Barnett, MD, of the Harvard T.H. Chan School of Public Health, who was not involved in the new study, but found similar results among Medicare patients from 2016-2019.

“The health system is very poor at connecting people to life-saving medication after they overdose,” Barnett said. “It’s a health system problem. And it’s also a problem of stigma and public education that many people may not be interested in or may not trust medications for opioid use disorder.”

In 2020, Medicare expanded coverage to include methadone to address a longstanding treatment gap. Methadone is the oldest, and experts say, the most effective of the three approved medications used to treat opioid addiction. It eases cravings without an intense high, allowing patients to rebuild their lives.

Medicare still does not cover residential addiction treatment, another gap that should be closed, Hurley said.

drug products containing acetaminophen may cause severe skin reactions

drug products containing acetaminophen may cause severe skin reactions

https://dps.fda.gov/omuf/ordersearch/order_otc000035

Summary

FDA is issuing this proposed administrative order to amend the requirements for internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter (OTC) human use, as currently described in Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (OTC Monograph M013).

This proposed order, if finalized, will amend OTC Monograph M013 to require the addition of a warning to the labeling of OTC internal analgesic, antipyretic, and antirheumatic drug products containing acetaminophen. The warning would alert consumers that the use of acetaminophen may cause severe skin reactions.

You may submit comments for Proposed Administrative Order OTC000035 electronically in OTC Monographs@FDA beginning on June 14, 2024.  See the Proposed Administrative Order for instructions. The Scientific Review Supporting Proposed Administrative Order OTC000035 can be viewed under the Supporting Documents.