Hospitals Sue Drug Makers Over Cost of Treating Opioid Addiction

In recent weeks, hundreds of hospitals have joined the fight against the opioid epidemic by filing suits against the highly addictive drug’s makers and distributors.

In recent weeks, hundreds of hospitals have joined cities and counties across the country in the fight against the opioid epidemic by filing suits against the highly addictive drug’s makers and distributors, in an effort to recoup the cost of treating uninsured opioid users for addiction. This comes on the heels of thousands of suits filed in state and federal court, aiming to hold Perdue Pharma, Johnson & Johnson, McKesson Corp. and others in the pharmaceutical industry responsible for the more than 400,000 opioid-related deaths that have occurred since 1999.

According to court documents, hospitals estimate treating opioid-related addiction costs an average of $107,000 per person, and the total costs to U.S. hospitals in just one year exceeded $15 billion.

“The expense of treating overdose and opioid-addicted patients has skyrocketed, straining the resources of hospitals throughout our state,” Lee Bond, Chief Executive Officer of Singing River Health System in Mississippi, said in a statement.

So far, suits have been filed in Arizona, Florida, Kentucky, Mississippi, Tennessee, Texas, and West Virginia, with more likely to follow in other states around the country.

The lead defendant in the suits, Purdue Pharma, has thus far not responded to requests for comment.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Landmark Decision Holds Drug Maker Responsible In Opioid Crisis

An estimated 130+ people die every day from opioid-related drug overdoses, and now a landmark decision in Oklahoma is holding one drug maker responsible.

An Oklahoma judge has ruled that pharmaceutical company Johnson & Johnson deceptively marketed opioids, which helped fuel the state’s opioid crisis, a crisis that claimed the lives of more than 6,000 people, and must pay $572 million to the state.

The landmark decision, which was handed down by Judge Thad Balkman on Monday, is the first of its kind, in which a pharmaceutical company is being held directly responsible for one of the worst drug epidemics in American history.

“Defendants caused an opioid crisis that is evidenced by increased rates of addiction, overdose deaths and neonatal abstinence syndrome in Oklahoma,” Judge Balkman said in the ruling.

Johnson & Johnson immediately released a statement in which it was said that the company “plans to appeal the opioid judgment in Oklahoma.”

The case and the subsequent ruling have undoubtedly been closely watched by plaintiffs in other opioid lawsuits, of which there are currently more than 2,000 pending.

It is estimated that more than 130 people die every day in the United States from opioid-related drug overdoses.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Surgeons’ Opioid-Prescribing Habits are Dangerous, Persistent

As the opioid crisis escalated into an epidemic across the U.S., thousands of surgeons continued to hand out far more pills than needed.

Julie Appleby, Kaiser Health News and Elizabeth Lucas, Kaiser Health News

As opioid addiction and deadly overdoses escalated into an epidemic across the U.S., thousands of surgeons continued to hand out far more pills than needed for postoperative pain relief, according to a KHN-Johns Hopkins analysis of Medicare data.

Many doctors wrote prescriptions for dozens of opioid tablets after surgeries — even for operations that cause most patients relatively little pain, according to the analysis, done in collaboration with researchers at Johns Hopkins Bloomberg School of Public Health. It examined almost 350,000 prescriptions written for patients operated on by nearly 20,000 surgeons from 2011 to 2016 — the latest year for which data are available.

Some surgeons wrote prescriptions for more than 100 opioid pills in the week following the surgery. The total amounts often exceeded current guidelines from several academic medical centers, which call for zero to 10 pills for many of the procedures in the analysis, and up to 30 for coronary bypass surgery.

While hundreds of state and local lawsuits have been filed against opioid manufacturers, claiming they engaged in aggressive and misleading marketing of these addictive drugs, the role of physicians in contributing to a national tragedy has received less scrutiny. Research shows that a significant portion of people who become addicted to opioids started with a prescription after surgery.

In sheer numbers, opioid prescribing in the U.S. peaked in 2010, but it remains among the highest in the world, according to studies and other data.

In 2016, opioids of all kinds were linked to 42,249 deaths, up from the 33,091 reported in 2015. The opioid-related death rate jumped nearly 28% from the year before, according to the CDC.

Yet long-ingrained and freewheeling prescribing patterns changed little over the six years analyzed. KHN and Johns Hopkins examined the prescribing habits of all U.S. surgeons who frequently perform seven common surgical procedures and found that in the first week after surgery:

  • Coronary artery bypass patients operated on by the highest-prescribing 1% of surgeons filled prescriptions in 2016 exceeding an average of 105 opioid pills.
  • Patients undergoing a far less painful procedure — a lumpectomy to remove a breast tumor — were given an average of 26 pills in 2016 the week after surgery. The highest-prescribing 5% of surgeons prescribed 40 to 70 pills on average.
  • Some knee surgery patients took home more than 100 pills in the week following their surgery.

Those amounts — each “pill” in the analysis was the equivalent of 5 milligrams of oxycodone — are many times what is currently recommended by some physician groups to relieve acute pain, which occurs as a result of surgery, accident or injury. The analysis included only patients not prescribed opioids in the year before their operation.

“Prescribers should have known better” based on studies and other information available at the time, said Andrew Kolodny, co-director of opioid policy research at Brandeis University and director of the advocacy group Physicians for Responsible Opioid Prescribing.

While the dataset included only prescriptions written for patients on Medicare, the findings may well understate the depth of the problem, since doctors are more hesitant to give older patients the powerful painkillers because of their sedating side effects.

Surgeons’ prescribing habits are significant because studies show that 6% of patients who are prescribed opioids after surgery will still be taking them three to six months later, having become dependent. The likelihood of persistent use rises with the number of pills and the length of time opioids are taken during recuperation.

Also, unused pills in medicine cabinets can make their way onto the street.

Dr. Marty Makary, a surgical oncologist at Johns Hopkins, admits that he too once handed out opioids liberally. Now he is marshaling a campaign to get surgeons to use these powerful painkillers more consciously and sparingly. “I think there’s an ‘aha’ moment that many of us in medicine have had or need to have,” he said.

But old habits are hard to kick.

KHN contacted dozens of the surgeons who topped the ranks of opioid prescribers in the 2016 database. They hailed from small, community hospitals as well as major academic medical centers. The majority declined to comment, some bristling when questioned.

Look Up Opioid Prescribers: Search KHN Database By Doctor, Hospital

Some of those surgeons were critical of the analysis, saying it didn’t take into account certain essential factors. For example, it was not possible to determine whether patients had complications or needed higher amounts of pain medication for another reason. And some surgeons had only a handful of patients who filled prescriptions, making for a small sample size.

But surgeons also indicated that the way they prescribe pain pills was less than intentional. It was sometimes an outgrowth of computer programs that default to preset amounts following procedures, or practice habits developed before the opioid crisis. Additionally, they blame efforts in the late 1990s and early 2000s that encouraged doctors and hospitals to consider pain as “the fifth vital sign.” A major hospital accrediting group required providers to ask patients how well their pain was treated. Pharmaceutical companies used the fifth vital sign campaign as a way to promote their opioid treatments.

Makary, who oversaw the analysis of the Medicare dataset, said that, while opioid prescribing is slowly dropping, to date many surgeons have not paid enough attention to the problem or responded with sufficient urgency.

Dr. Audrey Garrett, an oncologic surgeon in Oregon, said she was “surprised” to hear that she was among the top tier of prescribers. She said she planned to re-evaluate her clinic’s automated prescribing program, which is set to order specific amounts of opioids.

KHN will analyze data for 2017 and subsequent years when it becomes available to follow how prescribing is changing.

Prescribing Patterns Highlight What’s At Stake 

The analysis examined prescribing habits after seven common procedures: coronary artery bypass, minimally invasive gallbladder removal, lumpectomy, meniscectomy (which removes part of a torn meniscus in the knee), minimally invasive hysterectomy, open colectomy and prostatectomy.

Across the board, the analysis showed that physicians gave a large number of narcotics when fewer pills or alternative medications, including over-the-counter pain relief tablets, could be equally effective, according to recent guidelines from Makary and other academic researchers.

On average, from 2011 to 2016, Medicare patients in the analysis took home 48 pills in the week following coronary artery bypass; 31 following laparoscopic gallbladder removal; 28 after a lumpectomy; 41 after meniscectomy; 34 after minimally invasive hysterectomy; 34 after open colon surgery; and 33 after prostatectomy.

According to post-surgical guidelines spearheaded by Makary for his hospital last year, those surgeries should require at most 30 pills for bypass; 10 pills for minimally invasive gallbladder removal, lumpectomy, minimally invasive hysterectomy and prostatectomy; and eight pills for knee surgery. It has not yet published a guideline for open colon surgery.

The Johns Hopkins’ doctors developed their own standards because of a dearth of national guidelines for post-surgical opioids. They arrived at those figures after reaching a consensus among surgeons, nurses, patients and other medical staff on how many pills were needed after particular surgeries.

Hoping to reduce overprescribing, Makary is preparing to send letters next month to surgeons around the country who are among the highest opioid prescribers under a grant he received from the Arnold Foundation, a nonprofit group whose focus includes drug price issues. (Kaiser Health News also received funding from the Arnold Foundation.)

Even if the prescription numbers have fallen since 2016, the amounts given today are likely still excessive.

“When prescribing may have been five to 20 times too high, even a reduction that is quite meaningful still likely reflects overprescribing,” said Dr. Chad Brummett, an anesthesiologist and associate professor at the University of Michigan.

Brummett is also co-director of the Michigan Opioid Prescribing Engagement Network, a collaboration of physicians that makes surgery-specific recommendations, many of them in the 10- to 20-pill range.

“Reducing unnecessary exposure is key to reducing the risk of new addiction,” said former Food and Drug Administration commissioner Scott Gottlieb. In August 2018, when Gottlieb was at the agency’s helm, it commissioned a report from the National Academy of Sciences on how best to set opioid prescribing guidelines for acute pain from specific conditions or surgical procedures. Its findings are expected later this year.

“There are still too many 30-tablet prescriptions being written,” said Gottlieb.

Healers Sowing Disease?

Naturally, surgeons rankle at the idea that they played a role in the opioid epidemic. But studies raise serious concerns.

Transplant surgeon Dr. Michael Engelsbe, director of the Michigan Surgical Quality Collaborative, points to the study showing 6% of post-op patients who get opioids for pain develop long-term dependence. That means a surgeon who does 300 operations a year paves the way for 18 newly dependent people, he said.

Many patients do not need the amounts prescribed.

Intermountain Healthcare, a not-for-profit system of hospitals, clinics, and doctors in Utah, began surveying patients two years ago to find out how much of their prescribed supply of opioids they actually took following surgery.

“Globally, we were overprescribing by 50%,” said Dr. David Hasleton, senior medical director.

But Intermountain approached individual doctors carefully. “If you go to a prescriber to say, ‘You are overprescribing,’ it never goes well. A common reaction is, ‘Your data is wrong’ or ‘My patients are different than his,’” said Hasleton.

For the analysis, KHN attempted to contact more than 50 surgeons whose 2016 numbers ranked them among the top prescribers in each surgical category.

One who did agree to speak was Dr. Daniel J. Waters, who 13 years ago had his chest cut open to remove a tumor, an operation technically similar to what he does for a living: coronary artery bypass.

“So I have both the doctor perspective and the patient perspective,” said Waters, who practices in Mason City, Iowa.

In 2016, Waters’ Medicare bypass patients who filled their prescriptions took home an average of nearly 157 pills each, according to the KHN-Johns Hopkins analysis.

“When I went home from the hospital, 30 would not have been enough,” said Waters of the number recommended by the Hopkins team for that surgery.

But he said he has recently curbed his prescribing to 84 pills.

Nationally, the average prescription filled for a coronary artery bypass was 49 pills in 2016 and had changed little since 2011, the analysis shows.

Others who spoke with KHN said they had developed the habit of prescribing copiously — sometimes giving out multiple opioid prescriptions — because they didn’t want patients to get stuck far from the office or over a weekend with pain or because they were trying to avoid calls from dissatisfied, hurting patients.

In the KHN-Johns Hopkins data, the seven patients of Dr. Antonio Santillan-Gomez who filled opioid prescriptions after minimally invasive hysterectomies in 2016 received an average of 77 pills each.

A gynecologic oncologist, Santillan-Gomez said: “I’m in San Antonio, and some of my patients come from Laredo or Corpus Christi, so they would have to drive two to three hours for a prescription.”

Still, he said, since e-prescribing of opioids became more widespread in the past few years, he and other surgeons in his group have limited prescriptions to 20 to 30 pills and encouraged patients to take Tylenol or other over-the-counter medications if they run out. E-prescribing can not only help track patients getting opioids but also reduce the problem of patients having to drive back to the office to get a written prescription.

Dr. Janet Grange, a breast surgeon in Omaha, Neb., said that in her experience, opioid dependence had not been a problem.

“I can absolutely tell you I don’t have even 1% who become long-term opioid users,” said Grange.

The analysis showed that Grange had 12 opioid-naïve Medicare patients who had a lumpectomy in 2016. Eight of them filled prescriptions for an average of 47 pills per patient.

She called Johns Hopkins’ zero-to-10-pill pain-control recommendation following that procedure “miserly.”

The Pendulum Swings

Some of the higher-prescribing surgeons in the KHN-Johns Hopkins analysis reflected on their potential contribution to a national catastrophe and are changing their practice.

“That is a shocking number,” said oncologist Garrett, speaking of the finding that 6% of patients who go home with opioids will become dependent. “If it’s true, it’s something we need to educate physicians on much earlier in their medical careers.”

Garrett, in Eugene, Ore., said she has cut back on the number of pills she gives patients since 2016. The KHN-Johns Hopkins analysis showed that seven of her 13 opioid-naïve Medicare patients undergoing minimally invasive hysterectomies filled a prescription for opioids in 2016. Those patients took home an average of 76 pills each.

Johns Hopkins guidelines call for no more than 10 opioid pills following this procedure, while Brummett’s Michigan network recommends no more than 15.

Surgeon and researcher Dr. Richard Barth, once a heavy prescriber himself, said that his own experience convinced him that physicians’ preconceptions about how much pain relief is needed are often way off.

The analysis showed his lumpectomy patients in 2013 filled an average of 33 pills in the week after surgery. By 2016, that average had dropped to seven pills. Many patients, he said, can do just fine after lumpectomy with over-the-counter medications — and often no opioids at all.

The key, he said, is to set patients’ expectations upfront.

“I tell them it’s OK to have a little discomfort, that we’re not trying to get to zero pain,” said Barth, who is chief of general surgery at Dartmouth-Hitchcock Medical Center and has published extensively on opioid prescribing.

After lumpectomy, “what I recommend is Tylenol and ibuprofen for at least a few days and to use the opioids only if the discomfort isn’t relieved by those.”

Indeed, the data analysis showed that a significant number of patients given prescriptions for opioids never filled them because they don’t need that level of pain relief.

Between 2011 and 2016, for example, only 62% of lumpectomy patients in the analysis filled prescriptions, similar to hysterectomy patients.

In 2016, patients of Dr. Kimberli Cox, a surgeon in Peoria, Ariz., were prescribed about 59 pills in the week following lumpectomy, well above the recommendations from both Johns Hopkins and others.

But the KHN-Johns Hopkins analysis of that year’s data shows that half of her patients never filled a painkiller prescription — a fact she acknowledges has changed her thinking.

“I am now starting to prescribe less because many patients say, ‘You gave me too many’ or ‘I didn’t fill it,” she said.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Oklahoma’s ‘Precedent-Setting’ Suit Puts Opioid Drugmakers On Trial

All eyes were on Oklahoma last week, when the first case in a flood of litigation against opioid drug manufacturers began Tuesday.

Jackie Fortier, StateImpact Oklahoma

All eyes were on Oklahoma last week, when the first case in a flood of litigation against opioid drug manufacturers began Tuesday.

Oklahoma Attorney General Mike Hunter’s suit alleges Johnson & Johnson, the nation’s largest drugmaker, helped ignite a public health crisis that has killed thousands of state residents.

With just two days to go before the trial, one of the remaining defendants, Teva Pharmaceutical Industries of Jerusalem, announced an $85 million settlement with the state on Sunday. The money will be used for litigation costs and an undisclosed amount will be allocated “to abate the opioid crisis in Oklahoma,” according to a press release from Hunter’s office.

In its own statement, Teva said the settlement does not establish any wrongdoing on the part of the company, adding Teva “has not contributed to the abuse of opioids in Oklahoma in any way.”

That leaves Johnson & Johnson as the sole defendant.

Court filings accuse the company of overstating the benefits of opioids and understating their risks in marketing campaigns that duped doctors into prescribing the drugs for ailments not approved by regulators.

The bench trial — with a judge and no jury — is poised to be the first of its kind to play out in court.

Nora Freeman Engstrom, a professor at Stanford Law school, said lawyers in the other cases and the general public are eager to see what proof Hunter’s office offers the court.

“We’ll all be seeing what evidence is available, what evidence isn’t available and just how convincing that evidence is,” she said.

Most states and more than 1,600 local and tribal governments are suing drugmakers and distributors. They are trying to recoup billions of dollars spent on addressing the fallout tied to opioid addiction.

Initially, Hunter’s lawsuit included Purdue Pharma, the maker of OxyContin. In March, Purdue Pharma settled with the state for $270 million. Soon after, Hunter dropped all but one of the civil claims, including fraud, against the remaining defendants. Teva settled for $85 million in May, leaving Johnson & Johnson as the only opioid manufacturer willing to go to trial with the state.

But he still thinks the case is strong.

“We have looked at literally millions of documents, taken hundreds of depositions, and we are even more convinced that these companies are the proximate cause for the epidemic in our state and in our country,” Hunter said.

Precedent-Setting Case

The companies involved have a broad concern about what their liability might be, said University of Kentucky law professor Richard Ausness.

“This case will set a precedent,” he said. “If Oklahoma loses, of course they’ll appeal if they lose, but the defendants may have to reconsider their strategy.”

With hundreds of similar cases pending — especially a mammoth case pending in Ohio — Oklahoma’s strategy will be closely watched.

“And of course lurking in the background is the multi-state litigation in Cleveland, where there will ultimately be a settlement in all likelihood, but the size of the settlement and the terms of the settlement may be influenced by Oklahoma,” Ausness said.

‘There’s Nothing Wrong with Producing Opioids”

The legal case is complicated. Unlike tobacco, where states won a landmark settlement, Ausness pointed out that opioids serve a medical purpose.

“There’s nothing wrong with producing opioids. It’s regulated and approved by the Federal Drug Administration, the sale is overseen by the Drug Enforcement Administration, so there’s a great deal of regulation in the production and distribution and sale of opioid products,” Ausness said. “They are useful products, so this is not a situation where the product is defective in some way.”

It’s an argument that has found some traction in court. Recently, a North Dakota judge dismissed all of that state’s claims against Purdue, a big court win for the company. In a written ruling that the state says it will appeal, Judge James Hill questioned the idea of blaming a company that makes a legal product for opioid-related deaths. “Purdue cannot control how doctors prescribe its products and it certainly cannot control how individual patients use and respond to its products,” the judge wrote, “regardless of any warning or instruction Purdue may give.”

Now the Oklahoma case rests entirely on a claim of public nuisance, which refers to actions that harm members of the public, including injury to public health.

“It’s sexy you know, ‘public nuisance’ makes it sound like the defendants are really bad,” Ausness said.

If the state’s claim prevails, Big Pharma could be forced to spend billions of dollars in Oklahoma helping ease the epidemic. “It doesn’t diminish the amount of damages we believe we’ll be able to justify to the judge,” Hunter said, estimating a final payout could run into the “billions of dollars.”

Hunter’s decision to go it alone and not join with a larger consolidated case could mean a quicker resolution for the state, Ausness said.

“Particularly when we’re talking about [attorneys general], who are politicians, who want to be able to tell the people, ‘Gee this is what I’ve done for you.’ They are not interested in waiting two or three years [for a settlement], they want it now,” he said. “Of course, the risk of that is you may lose.”

Looking For Treatment

Oklahoma has the second-highest uninsured rate in the nation and little money for public health. The state is trying to win money from the drug companies to pay for treatment for people like Greg, who is afraid he’ll lose his job if we use his last name.

Greg and his wife, Judy, said they haven’t been able to find the integrated treatment that Greg needs for both his opioid addiction and his bipolar disorder. It’s either one or the other.

“They don’t give you … a treatment plan for both,” Judy said. “They just say ‘Here, you can talk to this person.’ They don’t recognize that it’s like self-medicating.”

The couple live in Guthrie, Okla., about an hour north of the courthouse where the opioid trial will take place. Greg said he has been addicted to opioids for 11 years. People with prescriptions sell him their pills — sometimes Greg binges and takes 400 milligrams of morphine at once, a huge dose.

Of the $270 million Purdue settlement, $200 million is earmarked for an addiction research and treatment center in Tulsa, though no details have been released. An undisclosed amount of the $85 million Teva settlement will also go to abating the crisis. Judy said she hopes the treatment center will eventually help Greg.

“I wish he would stop using [opioids], but I love him. I’ll always be here,” she said.

This story is part of a partnership that includes StateImpact Oklahoma, NPR and Kaiser Health News.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Federal Task Force Pushes PT as an Alternative to Opioids

A report released this week by an inter-agency task force highlights the benefits of physical therapy and other modalities in combatting the opioid crisis.

An inter-agency task force, comprised of 12 public members, nine organization representative members, and eight federal members, released a report this week, entitled Pain Management Best Practices, in an effort to offer updates, gaps, inconsistencies, and recommendations regarding the opioid crisis in relation to managing acute and chronic pain.

The report, which totals 108-pages, emphasizes “patient-centered care in the diagnosis and treatment of acute and chronic pain,” and features a thorough section regarding the benefits of restorative therapies, such as therapeutic exercise, massage therapy, traction, and more. The report goes on to urge an approach of multimodality, including medications, nerve blocks, physical therapy, and others to combat acute pain conditions, in place of opioids.

As it currently stands, according to the Centers for Disease Control and Prevention, 50 million adults in the U.S. struggle with the effects of chronic pain on a daily basis, and opioids were involved in 47,600 overdose deaths in 2017—67.8% of all drug overdose deaths.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

New Opioid Approved by FDA, Mere Days After Trump Signs Opioid Bill

On October 24th, President Trump signed a package of bills designed to confront and combat the nation’s opioid epidemic. On November 2nd, the FDA approved Dsuvia.

On October 24th, President Donald Trump signed a package of bills designed to confront and combat the nation’s opioid epidemic. On November 2nd, the FDA approved Dsuvia, an opioid painkiller 1,000 times stronger than morphine.

Dsuvia is restricted to limited use, only available in health care settings, such as hospitals, surgery centers and emergency rooms. However, critics worry the opioid will add fuel to an already ugly epidemic.

The FDA seemed to be expecting the backlash, and following the approval of the drug, FDA Commissioner Scott Gottlieb, M.D., issued the following statement:

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids

The crisis of opioid addiction is an issue of great concern for our nation. Addressing it is a public health priority for the FDA. The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain. As part of these considerations, there’s been an important and robust public debate leading up to the regulatory decision on Dsuvia that merits a response. I want to take this opportunity to address some of the concerns that were raised, and more broadly, how I believe the FDA should consider the approval of new opioid pain medications that can help fill targeted medical needs.

Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that’s available to patients and providers. As we look at the public health implications of each new approval, we should evaluate whether we need to take additional steps to systematically consider new opioids relative to the comparative benefit and risks of other opioids already on the market. We should consider whether we could do more in weighing approvals to ensure that new opioids are sufficiently better than existing drugs to justify their addition to the market in the context of the current crisis of abuse.

In this particular case, Dsuvia is a sublingual (under the tongue) formulation of sufentanil that’s delivered through a disposable, pre-filled, single-dose applicator. The medicine is restricted to use in certified medically-supervised health care settings ‒ such as hospitals, surgical centers and emergency departments ‒ for administration by a health care professional. Dsuvia, which was previously approved by the European Medicines Agency in July under the brand name Dzuveo, has some unique features in that the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible. This includes potential uses on the battlefield. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine. This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield. The involvement and needs of the DoD in treating soldiers on the battlefield were discussed by the advisory committee.

There are very tight restrictions being placed on the distribution and use of this product. We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia, including requiring a Risk Evaluation and Mitigation Strategy (REMS) to accompany this drug. The REMS reflects the potential risks associated with this product and will tightly control its distribution and use. Importantly, the distribution system will restrict Dsuvia’s use to certified medically-supervised health care settings, an important step to help prevent misuse and abuse of Dsuvia. The FDA will continue to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements, and we’ll work to quickly make regulatory adjustments if problems arise.

But underlying the debate surrounding this approval is a broader issue that must be addressed head on: why do we need an oral formulation of sufentanil – a more potent form of fentanyl that’s been approved for intravenous and epidural use in the U.S. since 1984 – on the market?

This question is especially critical in the context of the crisis of opioid addiction and evidence that opioids continue to be inappropriately prescribed, marketed, diverted and abused. Given this context, we need to address the question that I believe underlies the criticism raised in advance of this approval: to what extent should we evaluate each opioid solely on its own merits, and how should we also consider, within the broader context of our public health mission including the overall therapeutic armamentarium that we have available for addressing pain, the other opioid analgesics that are already on the market, the epidemic of opioid misuse and abuse that’s gripping our nation and the risk for illicit diversion and abuse?

I’m committed to considering these key questions as part of a comprehensive process that the FDA has underway to develop a formal benefit and risk framework for how the agency evaluates the safety and efficacy of opioid medicines.

Currently, in applying our statute and regulations, we generally consider each new drug approval – and each new opioid drug approval – largely on its own merits. As part of our review, we ask whether the individual drug meets the standard for safety and effectiveness, and whether additional controls are needed to ensure safe use of that specific drug.

But opioids are a unique class of medicines. Congress recently directed us to think differently about opioids as a drug class in enacting novel and specific authorities that enable the FDA to, among other things, require post-market studies to evaluate efficacy of opioids if we have concerns that these products may not be as effective as previously thought; to consider the risks associated with the misuse and abuse of opioids as a factor in how we make pre- and post-market regulatory decisions; to require opioids to be sold in unit dose packaging; and to require that certain opioids be dispensed with packaging or systems that enable the drugs to be safely disposed.

The FDA has already begun implementing these new authorities. And, even before Congress granted the FDA these new authorities, we have started to take a different approach to the benefit-risk evaluation of opioids. In the post-market setting, we’ve taken strong actions where appropriate, such as requesting the withdrawal of reformulated Opana ER from the market. In the pre-market setting, we routinely seek advisory committee input on new opioid product approvals. For example, at an October 2018 meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, the committee recommended 10-3 that Dsuvia be approved. Committee members in attendance for the meeting included experts on pain management, medication safety, human factors and critical care nursing, who are anesthesiologists, pain specialists and pharmacists.

We’re also re-evaluating how we consider both the individual and public health impacts of new opioids as they are reviewed for approval. To that end, I’ve asked the professional staff at the FDA to evaluate a new framework for opioid analgesic approvals; one that provides a transparent process to delineate clearly, eventually in new guidance, how we intend to consider the benefits and risks of these products in the context of this crisis. As part of this process, we need to closely consider how we evaluate questions such as:

  • How does the availability of an additional opioid drug benefit the public health through its ability to, for example, provide therapeutic differentiation, promote more appropriate access, or advance safer use of these medicines?
  • Does the approval of an additional opioid drug create added risks for diversion, accidental overdose, abuse and misuse, or other concerns?
  • If the approval of an additional opioid will create such added risks, will the new drug provide sufficient clinical differentiation that can benefit certain groups of patients, or offer other important clinical benefit, such that the benefits to patients of introducing the additional opioid outweigh the risks? And can the implementation of REMS help mitigate some of these risks?

Such a framework also would need to address the potential hurdles to product innovation. So, if we develop such a framework that takes into closer consideration the overall therapeutic armamentarium as we consider new opioid product approvals, and weighs new opioid approvals against the benefits and risks of existing drugs for the treatment of pain; then we’d also need to describe how we intend to characterize the benefits and risks of opioids, and what we believe the unmet medical needs are. In this way, innovators would know up front where the opportunities are for developing new drugs that meet the FDA’s standards for safety and effectiveness.

As part of the effort to consider and apply a more holistic approach, I will also be taking these questions, and a consideration of such a framework, to my Opioid Policy Steering Committee to evaluate what additional steps we may want to take within our own authority to consider these goals and the development of such a framework. There could also be other places where we would seek additional input, as well as help from Congress. We know now that our evaluation of opioids is different than how we assess drugs in other therapeutic classes. And Congress agreed with us that opioids are different. I believe that there are population-based considerations when it comes to drugs that are subject to such widespread abuse and misuse that warrant us considering each approval within a broad public health context.

This brings us back to discussion around today’s approval.

I believe that the unique aspects of Dsuvia, including those that make this drug a high priority for the Pentagon, differentiate this new formulation of sufentanil from other sufentanil products in a way that is consistent with population-based considerations for how it fits into the overall drug armamentarium. The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds. The military application for this new medicine was carefully considered in this case. We understand the concerns about the availability of a high potency formulation of sufentanil and the associated risks. The FDA has implemented a REMS that reflects the potential risks associated with this product and mandates that Dsuvia will only be made available for use in a certified medically-supervised heath care setting, including its use on the battlefield.

To address concerns about the potential risks associated with Dsuvia, this product will have strong limitations on its use. It can’t be dispensed to patients for home use and should not be used for more than 72 hours. And it should only be administered by a health care provider using a single-dose applicator. That means it won’t be available at retail pharmacies for patients to take home. These measures to restrict the use of this product only within a supervised health care setting, and not for home use, are important steps to help prevent misuse and abuse of Dsuvia, as well reduce the potential for diversion. Because of the risks of addiction, abuse and misuse with opioids; Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia. Like all opioids, Dsuvia will also carry a boxed warning about the serious risks of misuse and abuse, which can lead to addiction, overdose and death. It also includes a boxed warning about the serious risks, including extreme sleepiness, respiratory depression, coma and death, side effects that may be potentiated by the combined use with central nervous system depressants such as drugs called benzodiazepines. Common side effects of Dsuvia include nausea, headache, vomiting, dizziness and hypotension.

But I recognize that the debate goes beyond the characteristics of this particular product or the actions that we’re taking to mitigate this drug’s risks and preserve its differentiated benefits. We won’t sidestep what I believe is the real underlying source of discontent among the critics of this approval – the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction.

It’s an important question that has surfaced in past approval decisions and will come up again in the future. As a public health agency, we have an obligation to address this question openly and directly. As a physician and regulator, I won’t bypass legitimate questions and concerns related to our role in addressing the opioid crisis.

We owe an answer to those who support us in these decisions, and to those who may disagree. We owe an answer to patients with medical pain, and the innovators who take risks to develop products to help address their needs. We owe it to Americans who want the FDA to do our part to help end one of the biggest addiction crises of modern times, while we carefully balance these grave risks against patient needs.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

How Alternatives Such as CBD Oil Make an Impact on the Opioid Epidemic

As the opioid epidemic continues to wreak havoc on the United States, we take a look at the viability of cannabidiol as an alternative.

According to the Center for Disease Control and Prevention (CDC), 40 percent of the opioid-related deaths that occurred in the United States in 2016 involved a prescription opioid. Opioids are a form of medication prescribed by a healthcare professional that are used to treat unrelenting pain, typically caused by an underlying illness or as a result of surgery. With so many patients in the United States abusing their opioid prescriptions, it is hard to comprehend why many doctors nationwide continue to prescribe these highly-addictive pain medications. However, with the easily-accessible nature of these drugs and given the severity of a patient’s pain or suffering, opioids such as Oxycodone and Hydrocodone have become a popular choice for both medicinal and recreational use.

Fortunately, alternative, non-addictive forms of pain relief are becoming more frequently prescribed to patients. While Cannabis Sativa still has a negative stigma revolving around it and receives political backlash, the pain relief it provides for users may be enough to help patients shy away from opioid use.

What is Cannabidiol (CBD)?

Cannabidiol (CBD) is one of the many compounds created by the Cannabis plant, and it is often recognized alongside Tetrahydrocannabinol (THC). The difference between these two compounds is that CBD is non-psychoactive, providing the same benefits as THC without the euphoric feeling that THC produces. This has allowed for the legal sale of products such as CBD oil, as it does not contain THC and cannot be abused or cause a dependency.

CBD oil is still a fairly new product, which has limited the scope of existing research into the health benefits of this substance. However, scientists and doctors are starting to introduce this form of pain relief amongst select patients and new data is being continuously gathered as to exactly what benefits CBD oil can provide to patients.

How Does CBD Oil Relieve Pain?

CBD oil is believed to behave the same way that opioids work within a user’s body. By interacting with pain receptors in the brain and the immune system, CBD provides relief from the pain. However, it should be noted that the CBD is not directly causing a patient pain relief. The human body contains an endocannabinoid system, which allows it to regulate substances such as CBD. According to a study conducted by Neurotherapeutics, CBD actually promotes other compounds within the endocannabinoid system from being absorbed, such as anandamide, a compound known for reducing pain. This creates an abundance of anandamide in the body, which results in pain relief.

Evidence of CBD Success

While CBD is a potential alternative to opioid pain relievers, it is also showing success amongst patients who suffer from serious diseases. In a recent study published by the New England Journal of Medicine, 76 patients with Lennox-Gastaut Syndrome, a rare and severe form of epilepsy resulting in seizures, were given 20-mg of CBD twice a day for 14 weeks. As a result, this group of patients had a 41.9 percent decrease in the number of seizures they experienced.

Epilepsy has shown some of the greatest success for CBD usage out of all diseases that have utilized this treatment method. Many epilepsy patients have to take multiple pills a day to reduce the frequency of their seizures, and some patients even have an implant that sends electrical pulses throughout the body to regulate seizures. For patients with such severe epilepsy, CBD is a breath of fresh air.

While these trial results are very promising, some researchers are still skeptical about its success amongst cancer patients. CBD has not been scientifically proven to reduce the size of cancerous tumors in humans, but studies have shown that it may be effective in treating symptoms and side effects of chemotherapy. For cancers such as mesothelioma, whose treatment options are intensive, this may be a safe and effective way for patients to relieve pain without the health risks of opioids. Aggressively spreading cancers tend to cause a severe amount of pain for the patients, and patients’ overall quality of life will improve if they do not have to worry about becoming dependent on opioids while also receiving treatment for their diseases.

The Future Of CBD

As the stigma associated with Cannabis diminishes and more countries around the world begin to legalize it, more research will be conducted involving CBD as a form of pain relief. Too many people have fallen victim to opioid addiction, and with non-addictive pain management alternatives gaining in popularity, the number of yearly opioid-related deaths is predicted to decrease.

David Haas is a health advocate specializing in mesothelioma. He works to ensure everyone has access to information about the disease and advocates for a complete ban of asbestos in the United States.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Majority of Patients Expect Opioids After Surgery

Despite campaigns by the therapy community, and the government, to loosen the grip of opioids in the U.S., patients still expect them after surgery.

Despite the mounting opioid crisis in the United States, a staggering 77% of patients expect opioids, such as morphine, fentanyl, and dilaudid, after surgery, according to a study presented at the American Society of Anesthesiologists annual meeting.

Researchers surveyed 503 adults who were scheduled to have surgery for the back, ear-nose-and-throat, abdomen, or hip or knee replacement. Survey results showed that all 503 patients expected to receive pain medication after surgery—77% expected opioids, 37% expected acetaminophen, and 18% expected a non-steroidal anti-inflammatory.

“Patients often assume they will receive opioids for pain, believing they are superior, and therefore may pressure physicians to prescribe them after surgery. But research shows opioids often aren’t necessarily more effective. Clearly, we need to provide more education to bridge that gap and help patients understand that there are many options for pain relief after surgery, including other pain medications such as acetaminophen and ibuprofen.” Nirmal B. Shah, D.O., lead author of the study and an anesthesia resident at Thomas Jefferson University Hospital, Philadelphia, is quoted as saying.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

PT Supported Opioid Bill Ready for President’s Signature

Landmark legislation to fight the opioid epidemic, supported by the APTA, is headed to the President’s desk to be signed into law.

Last week, the U.S. Senate passed legislation that aims to combat the staggering opioid epidemic that has been impacting this country at an alarming rate by a 98-1 margin, and it will now head to the White House for Donald Trump’s signature, making it law.

Being hailed as “landmark” legislation by Senate Majority Leader Mitch McConnell, it includes provisions aimed at promoting research to find alternative, less addictive medications for pain management, as well as covering treatment for opioid addiction and use disorder, and efforts to prevent foreign shipments of illegal opioids.

The legislation is supported by the APTA, as well as scores of physical therapists. “The bill now on its way to the White House represents a significant step in the right direction,” APTA congressional affairs senior specialist, Kristina Weger, is quoted as saying. “But there’s much more work to be done—there are many provisions that direct agencies to begin reviews and studies on potential changes that we may not see for years. We need to continue our advocacy and outreach to help fight this crisis.”

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Stark Facts About Opioid Misuse in the U.S.

Physical therapy is a viable alternative to opioid use. Yet, nearly 48,000 Americans died due to opioid related overdoses last year.

The news about the opioid crisis faced by the United States continues its grim and downward path. As chronicled in the latest HHS report, overdose deaths in 2017 increased by almost 10% over 2016, killing more than 70,000 Americans. Nearly 70% of those deaths were due to opioid overdose, with the sharpest upsurge seen in deaths from the synthetic opioid fentanyl.

It is no secret that physical therapy is a viable alternative to these deadly drugs, and the CDC has gone so far as to recommend nondrug approaches, such as physical therapy, over long-term or high-dosage use of addictive prescription painkillers.

In the September 20th HHS news release, Dr. Elinore McCance-Katz, Assistant Secretary for Mental Health and Substance Use, stated, “Medication-assisted treatment combined with psychosocial therapies and community-based recovery support is the gold standard for treating opioid addiction.”

As a therapy professional, here are some facts to arm yourself with in the fight against opioid addiction.

  • Every day, more than 115 people in the United States die after overdosing on opioids, and additionally, more than 1,000 people are treated in emergency departments for misusing prescription opioids.
  • Roughly 21% to 29% of patients who are prescribed opioids for chronic pain misuse them.
  • An estimated 4% to 6% of those who misuse prescription opioids transition to heroin.
  • The CDC estimates that the total “economic burden” of prescription opioid misuse in the U.S. amounts to $78.5 billion a year, including the costs of healthcare, loss of productivity, addiction treatment, and criminal justice costs.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.