The Deepening Opioid Crisis Among Native Americans

The Deepening Opioid Crisis Among Native Americans

The Cherokee Nation of Oklahoma has launched a lawsuit against three national retail pharmacy chains and two of the largest national drug distributors in the country. The complaint charges that they knowingly flooded the tribal community with prescription opioids, fueling a deadly drug epidemic that has taken hundreds of lives and cost hundreds of millions of dollars.

The landmark lawsuit, filed on April 20, 2017, contends that retailers Walmart, CVS and Walgreens, and wholesalers AmerisourceBergen, McKesson, and Cardinal Health, “allowed massive amounts of opioid pills to be diverted from legitimate channels of distribution into the illicit black market in quantities that have fueled the opioid epidemic in the Cherokee Nation.

 The suit alleges the defendants ignored red flags and “turned a blind eye” to known problems in their supply chains. Todd Hembree, the Cherokee Nation Attorney General, said the drug companies failed to keep their opioids from being diverted and did nothing to prevent rampant over-prescribing.

The rate of drug-related deaths among American Indian and Alaska Native people has quadrupled since 1999 and is double the rate of the country as a whole. The diversion of millions of opioid pills over the past 18 years has contributed to nearly 400 deaths among the Cherokee Nation – double the death rate of the country at large – and 10,000 hospital visits.

 Actions like the Cherokee suit can be expensive—especially if you lose and have to cover the legal expenses.

Despite this, considering the social destruction that prescription opioids have caused the American Indian and Alaska Native populations, it’s possible we will see other tribal nations follow with their own lawsuits.

The reason: there’s strength in numbers.

Similar lawsuits have snowballed among cities, counties and states, where opioid addiction has cost taxpayers and citizens billions of dollars. From coast to coast, they’ve come to the same conclusion: Drug companies are complicit in the opioid epidemic, and they need to be held accountable.

The combined pressure is starting to have an effect. Recent federal cases against drug companies show that lobbyists and armies of lawyers are getting companies off rather lightly.

“They pay fines as a cost of doing business in an industry which generates billions of dollars in revenue,” the Cherokee suit says.

Light fines and no jail time helps fuel the problem. The industry has to start paying for its lack of responsibility.

I support the Nation’s suit, but much more legal pressure is needed.

 Almost every day we see new state, county and city laws and statutes that increase funding for local treatment and law enforcement.

At the federal level, the new 21st Century Cures Act has allocated the first half of a $1-billion grant to the states and territories for drug treatment, law enforcement and prevention programs.

Another important piece of federal legislation is the Drug Supply Chain Security Act (DSCSA). Enacted in 2013 and set for completion in 2024, the DSCSA helps ensure prescription drugs get to where they are supposed to go.

Right now, drug companies are scrambling to be in compliance by November, when on-pack label serialization and tamper-evident packaging must be in use to prevent theft and counterfeiting. These new requirements are going to make a difference.

 All of this is helping. But for communities like the opioid-devastated Cherokee Nation, it’s mostly too little too late.

In the tribal communities, which are at high risk for substance use disorders, local governments need to expand education, treatment and prevention programs now.

We need insurance regulations that add to, not take away from, coverage for treatment of substance use disorders. And we need more access to medically supervised detox programs that help ease the pain and discomfort of prescription opioid withdrawal. These encourage people to attempt recovery, not avoid it. With more effective drug detox, rehab and support programs, we can greatly reduce relapse rates and enjoy successful long-term recovery.

I urge healthcare leaders and lawmakers everywhere to strengthen and more rigorously enforce all regulations that pertain to drug diversion. We must hold manufacturers, distributors and pharmacies responsible for the failures in the supply chain that lead to illicit diversion.

I heartily applaud the Cherokee Nation for its preemptive actions to deter diversion. They have implemented their own prescription monitoring program, and eliminated some of the most widely abused opioids from their own formulary.

 As an executive deeply involved in the world of drug and alcohol recovery, I have been outraged many times over the past 10 or so years as drug company after drug company has been charged with breaches of the law, brought to court, found guilty and paid enormous fines—from hundreds of millions to even billions of dollars—only to return to the same pattern of behavior as before

No one of consequence is ever jailed.

Bryn Wesch

We deal with the results of the opioid epidemic on a daily basis. We see and hear first-hand how these situations of dependence and addiction can develop, regardless of age or station in life, and so often from a single pill or two or three, usually borrowed or innocently gifted.

Every day we hear how opioids—meant to relieve pain—can ruin lives.

It is critical that we take immediate action to prevent further loss of life, deteriorating health issues and increased economic consequences.

Bryn Wesch is Chief Financial Officer at Novus Medical Detox Center, a Joint Commission Accredited inpatient medical detox facility that is also licensed by the Florida Department of Children and Families and known for minimizing the discomfort of withdrawal from prescription medication, drugs or alcohol. She welcomes comments from readers.

It is a well known fact that Native Americans and Alaska Native people have a high incident of excessive alcohol consumption.  The questions has to be asked is why haven’t these tribes sued all the alcohol companies for fueling the known alcoholic epidemic ?

Could it be that since a number of other entities are initiating similar law suits and they are just trying to “pile on” and ride on the “coat tails” of these other lawsuits ?

And why has it taken them 18 years to take this action… where they asleep at the switch or just not paying attention ?


VA hospital in Marion abruptly cutting opiate prescriptions

VA hospital in Marion abruptly cutting opiate prescriptions


MARION, Ind. – A VA hospital once investigated for giving out too many opioids, is now cracking down hard on opiate prescriptions.

But are they going too far?

According to a number of veterans, the answer is yes. They say their opiate prescriptions were cut off, with no warning and no communication from doctors. Many of them rely on the Marion VA.

Three, who agreed to be identified on camera—Josh Keller, Rae Ann Panther and John Nelson—call the VA’s response to the opioid abuse epidemic “irresponsible” and “dangerous.”

“They’re treating us like we’re addicts, selling our prescriptions on the street,” said Nelson.

Nelson, along with the three others, acknowledges that some of their fellow veterans are addicts and may be selling their opiate prescriptions or otherwise abusing them. Their concern is that providers are now assuming everyone is an addict and treating them poorly because of that.

“None of us wants the drugs for the high,” said Panther. “We just want to live again.”

All three were left to struggle with pain and some even withdrawal symptoms, after they say their daily doses of Oxycontin, Lortab and Tramadol were suddenly cut off.

“I called back several times and finally got a nurse to say, ‘They’re not giving you any of your medication. I am extremely sorry,’” said Keller as he recounted the day he found out his prescription would not be refilled.  “And she was very upset on the line and it sounded like she was in tears. She said, ‘They’ve done it to not just you, but everybody. They’ve done this to everybody.’”

Panther had a similar experience. As a former nurse herself, she says the most unnerving part was not getting any prior communication from her doctor.

“They never contacted me to say, ‘Hey, we’re thinking about doing something, what’s your idea?’” recalled Rae Ann. “No plan of action. Cut you off, never talk with you about it.”

They say the cutoffs came just a day or two before their prescriptions ran out. They say they received no help tapering off the heavy-duty narcotics and no relief for chronic back and knee pain they spent years trying to leave behind.

For Nelson, who’s self-employed, that meant sometimes not being able to work and falling behind. For Keller, it meant using his vacation days because he was in too much pain to even get out of bed.

“I have to weigh my options,” said Keller. “Am I going to be sick? Can I call in sick today or is it going to be worse tomorrow?”

For Rae Ann, whose husband had to quit his job to care for her due to numerous illnesses years ago, the pain made her bad situation much worse.

“There’s no quality of life for people like us!” exclaimed Panther. “When they say, your pain level from 1-10. Dear God, what’s a one? We live, probably at a 4.”

They claim the doctors not only brushed off their concerns at being so abruptly cut off, but were quick to point the finger at one person, Dr. Lori Drumm, they say is making the decisions.

Dr. Drumm is not these vets’ primary physician. In fact, they say she never treated them at all.

Drumm wouldn’t speak on camera with FOX59, but her boss, Chief of Staff, Dr. Wayne McBride did.

“Dr. Drumm is a very experienced primary care provider and she is our service chief for the primary care service line,” said McBride.

He says part of Drumm’s job is to make sure providers are aligning their care with the national VA Opioid Safety Initiative. She’s also responsible for recommending changes to prescriptions.

There are two main reasons Drumm might suggest a change.

Sometimes, Dr. McBride says she might be looking through records and find that a veteran has violated what is known as a “pain contract” by taking opiates improperly. A veterans’ urinalysis that comes back negative when they’re supposed to be on an opiate might indicate they’re diverting their drugs and giving or selling them to someone else.

Dr. Drumm can also recommend changes when she believes the prescribed dose is too high.

“There have been times, I believe, when some of the providers and physicians have sought her assistance and she has then indicated to them, a certain course of action,” said Dr. McBride.

When asked why veterans are hearing these recommendations or orders from Dr. Drumm and not their own provider, McBride sympathized with the vets.

“I’m concerned, when the veteran has not received the communication from the assigned provider and Dr. Drumm is scripting this care or making those determinations,” said Dr. McBride.

With Panther’s permission, we showed Dr. McBride two My HealthyVet messages from the two times doctors said they were taking her Tramadol away.

In June of last year, a nurse tells Panther, “Dr. Drumm is not going to order additional opiates” and “Dr. Drumm is concerned about unintentional overdose.”

Panther replies, stating she’s “never been seen by Dr. Drumm.”

At the time, Dr. Drumm was covering for Panthers’ normal provider who was out on leave. But still, McBride says that doesn’t absolve her of all responsibility for what he considers proper communication with a patient.

“In this particular case, she was covering for another provider, but as I’ve acknowledged, I think it could’ve been handled better,” said McBride.

After Panther gets a nurse to help intervene, her prescription is renewed. But then in October, her nurse practitioner tries to cut her off this time.

Dr. McBride read where Panther relays to a nurse that she was told by a third party that her nurse practitioner would not refill her script.

That is not the way McBride wants these conversations to happen.

“It’s disturbing that she wouldn’t say, ‘Come in let`s talk about this,’” said Dr. McBride. “I don’t think you need this, why and have a conversation. So it’s concerning.”

Dr. McBride says his intent is for opiate reductions at the Marion VA hospital to always comply with the Opioid Safety Initiative.

“In many chronic pain conditions, opioid medications are now not thought to be the standard of care,” said McBride. “It is our intent, before we reduce the medication or even start to lower it or discontinue it, our intent is to make sure they have pain management from other sources, non-narcotic sources, where they will have access to chiropractic or physical therapy.”

Those alternative pain management sources can also include an acupuncturist or even a psychiatrist, as they’re slowly taken off opiates. But that doesn’t match the accounts from these three veterans or the many others.

“I’ve spent almost $1,200 of my own money using a doctor for acupuncture and chiropractic,” said Panther. “We ask them about it and they say, ‘Oh no you don’t need that.’ I’ve had a doctor say to me, I don’t believe in that stuff. I would believe in anything that helps me!”

McBride says he doesn’t want to see veterans spending their own money on care they should be able to receive through the VA or CHOICE program. Yet he admitted alternative pain care appointments aren’t always available quickly.

He also acknowledged that some doctors haven’t been following orders to wean veterans off their opiates.

“We have had accounts that have arisen in our healthcare system, where veterans have been removed from their opioid medications, perhaps a little bit aggressively,” said McBride.

McBride believes fear may be motivating some providers to move too swiftly.

“Concern is growing, that they may be subject to a review or their license, if they’re giving too many opioids, may be in some jeopardy,” said McBride.

But the veterans feel some primary care providers are putting their and other veterans’ lives in jeopardy.

“That’s why there’s 22 veterans committing suicide every single day,” said Panther. “Chronic pain is a killer. And in my opinion, these programs where they`re just abruptly taking medication from patients that absolutely need it, this is the cause.”

Dr. McBride’s point about the pressure doctors are feeling to cut the number of opiates they prescribe is key to why some doctors may be acting the way they are.

Under the new Comprehensive Addiction Recovery Act authored by Indiana representative Jackie Walorski, the number of opiate prescriptions provided by doctors and at VA facilities will be under review each year, starting with a report set to be filed this summer. These doctors’ prescription numbers will be under a microscope, in an attempt to keep veterans from getting hooked on the drugs in the first place.

The law clearly requires safe weaning from opiates, no matter the reason for stopping the prescription.

Her office says they’re concerned about reports of abrupt cutoffs throughout the Northern Indiana VA system. They plan to make sure a recently requested report from the system addresses potential issues at the Marion facility, as well as the Peru clinic also now under scrutiny since this investigation started.

They say they will also take into consideration that FOX59 received complaints from all over Indiana, as well as across the country, to make sure this isn’t a nationwide problem.

They volunteer to serve our country… we use/abuse them… we send them back home “broken”  and then the VA system abuses them even more.  The 535 members of Congress just sit up there on “the Hill” on their pompous asses and turn a “blind eye” to what is going on.

What a disgrace !!!

Isn’t “DRUG EDUCATION” suppose to prevent substance abuse ?

Residents of halfway house found two men dead from overdoses — their drug counselors

The man’s losing battle with heroin was laid out right there on the nightstand of the halfway house.

There were three morning devotionals, including “God Calling,” geared toward keeping a person’s thoughts pointed heavenward. Then there was the nicotine: two packs of cigarettes, a vaporizer and a case of snus to quell cravings.

And near the edge: empty packets of heroin, a spoon and a syringe half full of the last hit the man would ever inject.

It was another scene in Pennsylvania’s ballooning drug epidemic. But the case had a twist that shocked even the first-responders summoned to the quiet neighborhood in West Brandywine: The victim — and another dead, overdosed man in an adjacent room — were both drug counselors.

“If anybody is wondering how bad the opioid epidemic has become, this case is a frightening example,” Chester County District Attorney Tom Hogan said in a news release.

“The staff members in charge of supervising recovering addicts succumbed to their own addiction and died of opioid overdoses. Opioids are a monster that is slowly consuming our population.”

Authorities didn’t release the names of the counselors. The Associated Press reported that many addiction counselors are former addicts, but it was unclear if that was the case with the men who died.

The counselors lived and worked at the Freedom Ridge Recovery Lodge, which bills itself as “a special recovery home for men that provides a safe place to live.” No one returned a message from The Washington Post left with an answering service at the lodge’s listed number.

The home’s website was offline, but a cached version identified one of its key missions: “Freedom Ridge will give you a solid foundation to help free you from the bondage of addictions.”

The site says the home strives to “incorporate family in this very early stage of recovery” and mandates that residents attend addiction meetings daily for 90 days.

Residents found the counselors dead or dying Sunday afternoon. They tried to resuscitate one of the men with the drug naloxone, which counters heroin’s deadly effects, but it was too late.

Two of the heroin plastic bags had a “Superman” symbol on them. Another was stamped with the symbol for “danger.”

Police think the drugs had been laced with fentanyl, another opiate that can make a hit of heroin more potent and more deadly.

Authorities chronicling the rise in heroin deaths in Pennsylvania largely attribute the uptick to fentanyl. According to the Patriot-News, fentanyl-laced heroin contributed to Pennsylvania having the sixth-highest overdose rate in the nation in 2015.

The Centers for Disease Control and Prevention deems the state “statistically higher” than the national average. Pennsylvania shares that diagnosis with a line of neighboring Rust Belt states.

In 2015, Pennsylvania coroners reported more than 3,500 overdose deaths in 2015, a 30 percent jump from 2014, the Patriot-News reported.

In September, Gov. Tom Wolf (D) told lawmakers that the opioid epidemic facing Pennsylvania is “a public health crisis, the likes of which we have not before seen. Every day, we lose 10 Pennsylvanians to the disease of addiction. This disease does not have compassion, or show regard for status, gender, race or borders.”

“It affects each and every Pennsylvanian, and threatens entire communities throughout our commonwealth. The disease of addiction has taken thousands of our friends and family members. In the past year alone we lost over 3,500 Pennsylvanians — a thousand more lives taken than the year before.”

Across the nation, opioids killed more than 28,000 people in 2014, more than any year on record, according to the Centers for Disease Control and Prevention.

This week, shortly after the counselors’ bodies were found, authorities were trying to prevent more deaths.

They wanted the public to know about the “Superman” and “danger” stamps on the plastic bags and had one message for other area addicts: Stay away.

“They appear to be heroin laced with fentanyl and are likely to kill anybody who uses them,” Hogan said. “We will not even let law enforcement handle them without special precautions.”


Searching for solutions: Impact on jails

Not enough space, not enough money. Jailers across Kentuckiana said they are burning holes in their financial pockets. They’re trying to keep up with treating inmates who are overdosing while in their care.

LEBANON, Kentucky (WHAS11) — It’s got that small-town feel and it’s where American pride is proudly on display.  But, that Mayberry persona is masking a deadly and dangerous reality. 

White House undermines own efforts to fight opioid addiction

White House undermines own efforts to fight opioid addiction

As with so much else, the Trump administration has stumbled in its initial efforts to combat opioid addiction. Given the magnitude of the crisis, healthcare professionals have an obligation to speak out against ill-considered policies.

The more than 30,000 people who die each year from opioid overdoses—nearly two-thirds of which involve prescription drugs—are everywhere. They live in inner cities, rural communities and the suburbs.

Citizens of all political persuasions have cried out for a comprehensive approach to this scourge. Not only must the healthcare system reckon with its misguided approach to treating pain, policymakers must address the reality that the worst of the addiction crisis is being felt in communities experiencing economic decline, poverty, violence and despair.

Instead of unity in the face of those daunting challenges, recent statements by top Trump administration officials either ignored them or went against what public health officials recommend. They also were at odds with the sympathetic statements made by the president.

In late March, Trump unveiled a new Commission on Combating Drug Addiction and the Opioid Crisis. He tapped New Jersey Gov. Chris Christie to head the group. “We want to help those who have become so badly addicted,” Trump said during a listening session on opioid addiction. “The president and I both agree that addiction is a disease, and it’s a disease that can be treated,” Christie added.

In a welcome move toward bipartisanship, the president named North Carolina Gov. Roy Cooper and former Rep. Patrick Kennedy of Rhode Island, both Democrats, to the panel. Kennedy, the son of the late Sen. Edward Kennedy, repeatedly wrestled with substance abuse issues before leaving Congress to become an advocate for a more scientific approach to treatment.

He rounded out the panel with Massachusetts Gov. Charles Baker, a Republican, and Bertha Madras, a Harvard Medical School professor.

Yet before its deliberations even began, several high-ranking administration officials announced policy shifts that, if implemented, would completely undermine the commission’s work. The administration’s 2018 budget draft included plans to cut the Office of National Drug Control Policy, whose head is informally known as the “drug czar,” to just $24 million from $388 million, a 95% cut.

HHS Secretary Dr. Tom Price, during a listening tour stop in West Virginia, revealed his bias against medically assisted treatment, or MAT, with drugs such as buprenorphine and methadone. HHS expanded access to MAT last year, and most clinical practice guidelines have endorsed the approach. “If we’re just substituting one opioid for another, we’re not moving the dial much,” Price told the Charleston Gazette-Mail. He touted faith-based approaches to counseling and support, according to the newspaper.

More than 700 clinicians and public health officials immediately condemned his statement for stigmatizing addiction. “Medically assisted treatments meet the highest standard of clinical evidence for safety and efficacy,” they wrote.

Dr. Price sought to limit the damage. In a commentary posted on the CMS website, he touted community-based solutions such as finding ex-addicts jobs. “The first obstacle is finding an employer willing to hire someone with a criminal record.” He also called for helping people get access to recovery services, “including medication-assisted treatment.”

Of course, the first part of that equation won’t be made easier by Attorney General Jeff Sessions’ plan, still under review, to take the nation back to the days of mandatory minimum sentences for people convicted of low-level drug possession charges. That’s exactly the opposite of what medical professionals recommend. “Stop criminalizing substance use problems,” the clinicians’ letter said.

Downsize the agency fighting traffickers? Treat addicts like criminals? Stigmatize those seeking medical treatment? This isn’t the help that the “badly addicted” need.

FDA warns about risk of accidental overdosing of dogs with the drug Sileo

FDA Drug Safety Communication: FDA warns about risk of accidental overdosing of dogs with the drug Sileo (dexmedetomidine oromucosal gel).

May 23, 2017

The U.S. Food and Drug Administration is alerting dog owners and veterinarians about the risk of accidental overdose to dogs treated with the drug Sileo. Sileo is a prescription gel that is given to dogs by mouth to treat noise aversion (signs related to anxiety or fear due to noise).

Sileo is packaged in an oral dosing syringe with a ring-stop mechanism on the plunger that must be “dialed” and locked into place in order to set the correct dose for the dog. Overdose can result if the ring-stop is not fully locked. Therefore, it is very important that the person administering the product understands how to operate the syringe correctly before giving the product to the dog.

Zoetis began marketing Sileo in May 2016. To date, the FDA has received 28 reports involving Sileo overdoses in dogs due to the ring-stop mechanism not properly locking at the intended dose. In some cases, the entire contents of the dosing syringe were administered to the dog. In 15 out of the 28 reports, dogs experienced clinical signs of overdose, including lethargy, sedation, sleepiness, slow heart rate, loss of consciousness, shallow or slow breathing, trouble breathing, impaired balance or incoordination, low blood pressure, and muscle tremors. No deaths have been reported. At this time, the FDA has not determined if these overdoses were due to improper use of the ring-stop.

All prescribing veterinarians and users should be aware of the possibility for accidental overdose if the Sileo syringe is not properly locked before dosing. Veterinary staffs are strongly encouraged to provide education in proper operation of the syringe to dog owners before dispensing the drug. Dog owners should be aware of potential signs of overdose and they should contact their veterinarian if their dog exhibits any of these signs. Zoetis has also provided online resources which demonstrate the proper operation of the syringe and administration technique in detail for veterinarians at Sileodvmus.comdisclaimer icon, and for dog owners at Sileodogus.comdisclaimer icon.

US Attorney: Pharmacies robbed… stolen drugs sold on the street… DUH !!!

Federal charges filed in pharmacy robbery cases

INDIANAPOLIS (WISH) — Prosecutors charged nine adults and several juveniles in federal court in a string of pharmacy robberies.

There were 24 robberies total, dating back to October 2014. The US Attorney’s office traced them back to a gang known as “The Mob.”

They said the gang’s actions were funneling drugs into the streets. An operation they say is now over.

“My message now is clear: the days of the mob ruining the neighborhood is over,” said Josh Minkler, the US Attorney for Southern Indiana.

The individuals are now charged with racketeering, robbery, drug distribution, and firearms charges.

Minkler says they robbed pharmacies and then sold the stolen drugs on the streets.

They would even recruit juveniles, some as young as 12-years-old, and then intimidate them using social media.

One of the posts came from Facebook. Minkler says it read: “He got to die, if he testify. We do not work with the FBI.”

This investigation began in 2015, after someone shot and killed a 19-year-old in connection to a pharmacy robbery.

This is the same year Indiana ranked #1 for pharmacy robberies.

“Indianapolis never wants to be number 1 in those categories,” said Bryan Roach, the IMPD chief.

Authorities say the actions of the mob helped to contribute to the state’s opioid addiction problems.

“Criminal drug trafficking organizations exploit the addicted, poison our streets, and leave a trail of violence throughout our communities,” said Greg Westfall of the Drug Enforcement Agency.

One fugitive, Duwan Byers remains on the loose.

They say their work will continue even after he is captured.

“Community, we heard you. We saw a problem, we addressed the problem. We’re not done yet,” said Trevor Velinor of the Bureau of Alcohol, Tobacco, Firearms and Explosives.

Since the early – mid 70’s it has been a FEDERAL CRIME – the same as robbing a bank – when a pharmacy is robbed and controlled substances are involved.  This is the first incident – that I have seen – where that 40 y/o Federal Law is being used against those robbing a pharmacy.  Did it take 24 pharmacies being robbed to get the FBI to act ?

Where is the Board of Pharmacy, FBI, DEA taking no action against these pharmacies – mostly chains – that have been reluctant to make their Rx depts more physically robbery resistant.   What are they waiting on… Rx dept staff or customers to get hurt/killed ?  More robberies that are allowing more drugs on the streets ?

FDA: soliciting public input… BUT.. WILL THEY LISTEN ?

FDA Commissioner Asks Staff for ‘More Forceful Steps’ to Stem the Opioid Crisis

By: Scott Gottlieb, M.D.

As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the Food and Drug Administration continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases of addiction.

Dr. Scott GottliebToday, I sent an email to all of my colleagues at FDA, sharing with them the first steps I plan to take to better achieve this public health goal. With this, my first post to the FDA Voice blog, I also wanted to share my plans with you.

I believe it is within the scope of FDA’s regulatory tools – and our societal obligations – to take whatever steps we can, under our existing legal authorities, to ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients.

Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction. Moreover, as FDA does in other contexts in our regulatory portfolio, we need to consider the broader public health implications of opioid use. We need to consider both the individual and the societal consequences.

While there has been a lot of good work done by FDA to date, and many people are working hard on this problem, I have asked my FDA colleagues to see what additional, more forceful steps we might take.

As a first step, I am establishing an Opioid Policy Steering Committee that will bring together some of the agency’s most senior career leaders to explore and develop additional tools or strategies FDA can use to confront this crisis.

I have asked the Steering Committee to consider three important questions. However, the Committee will have a broad mandate to consider whatever additional questions FDA should be seeking to answer. The Committee will solicit input, and engage the public. I want the Committee to go in whatever direction the scientific and public health considerations leads, as FDA works to further its mandate to confront the crisis of opioid addiction.

The initial questions I have tasked the Steering Committee to answer are:

  1. Are there circumstances under which FDA should require some form of mandatory education for health care professionals, to make certain that prescribing doctors are properly informed about appropriate prescribing recommendations, understand how to identify the risk of abuse in individual patients, and know how to get addicted patients into treatment?
  2. Should FDA take additional steps, under our risk management authorities, to make sure that the number of opioid doses that an individual patient can be prescribed is more closely tailored to the medical indication? For example, only a few situations require a 30-day supply. In those cases, we want to make sure patients have what they need. But there are plenty of situations where the best prescription is a two- or three-day course of treatment. So, are there things FDA can do to make sure that the dispensing of opioids more consistently reflects the clinical circumstances? This might require FDA to work more closely with provider groups to develop standards for prescribing opioids in different clinical settings.
  3. Is FDA using the proper policy framework to adequately consider the risk of abuse and misuse as part of the drug review process for the approval of these medicines? Are we doing enough when we evaluate new opioid drugs for market authorization, and do we need additional policies in this area?

These are just some of the questions I will be asking this new Steering Committee to consider right away, given the scope of the emergency we face. In the coming days, I’ll continue to work closely with the senior leadership of FDA. I want to know what other important ideas my colleagues at FDA may have, so that we can lean even further into this problem, using our full authorities to work toward reducing the scope of this epidemic.

Despite the efforts of FDA and many other public health agencies, the scope of the epidemic continues to grow, and the human and economic costs are staggering. According to data from CDC and SAMHSA, nearly 2 million Americans abused or were dependent on prescription opioids in 2014, and more than 1,000 people are treated in emergency departments each day due to misusing prescription opioids.

Opioid overdose deaths involving prescription opioids have quadrupled since 1999. In 2015, opioids were involved in the deaths of 33,091 people in the United States. Most of these deaths – more than 22,000 (about 62 people per day) – involved prescription opioids.

We know that the majority of people who eventually become addicted to opioids are exposed first to prescription opioids. One recent study found that in a sample of heroin users in treatment for opioid addiction, 75% of those who began abusing opioids in the 2000s started with prescription opioid products.

This March, a study published in CDC’s Morbidity and Mortality Weekly Report, found that opioid-naïve patients who fill a prescription for a one-day supply of opioids face a 6% risk of continuing their use of opioids for more than one year. This study also found that the longer a person’s first exposure to opioids, the greater the risk that he or she will continue using opioids after one, or even three years. For example, when a person’s first exposure to opioids increases from one day to 30 days, that person’s likelihood of continuing to use opioids after one year increases from 6% to about 35%.

Working together, we need to do all we can to get ahead of this crisis. That’s why we’ll also be soliciting public input, through various forums, on what additional steps FDA should consider. I look forward to working closely with my FDA colleagues as we quickly move forward, capitalizing on good work that has already been done, and expanding those efforts in novel directions. I will keep you updated on our work as we continue to confront this epidemic.

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration

Follow Commissioner Gottlieb on Twitter @SGottliebFDA

Are more mistakes happening at pharmacies?

Are more mistakes happening at pharmacies?

(KMSP) – A Fox 9 Investigation looks at mistakes at Minnesota pharmacies and how complaints are on the rise.

In one instance a customer was given the wrong prescription, and a blood clot formed and a paralyzing stroked occurred. The damage was permanent.

A confidentiality agreement prevents the person from talking about it publicly.

The Executive Director of the MN Board of Pharmacy, Cody Wiberg, said they don’t know with certainty how often errors occur.

Drug stores are filling more prescriptions than ever, at some locations as many as 800 a day, and it’s not uncommon for some pharmacists to work 14 hours straight.

Volume often makes up for lower reimbursements from insurance.


Pharmacist Lyla Aaland is able to speak freely because she is now retired.

The Fox 9 Investigators contacted her after reviewing a file obtained from the pharmacy board.

She was among dozens of pharmacists who wrote the group to share concerns about working conditions.

“Chaos in the pharmacy, busy, phone calls, drive thru, too many interruptions, that’s what it is,” she said.

The records checked by Fox 9 offer rare insight into what’s going on behind the drug store counter.

“14 hour days with no breaks are extremely exhausting and lead to errors,” wrote one pharmacist in the reports.

Another wrote “there is no question that fatigue becomes a problem.”

Insiders said that as it all adds up, it becomes more likely that mistakes will happen.


“We’re getting more complaints than we’ve ever received,” Wiberg said.

When he joined the pharmacy board more than a decade ago, consumers filed maybe 100 complaints a year.

Now he said the number has nearly tripled.

“We also know that for every complaint that we get, there are many more errors that are never reported to us,” he said.
On occasion, the state has fined a drug store for giving a medication to the wrong patient. But regulators really have no idea when errors happen, unless someone registers a formal complaint with the pharmacy board.

That’s because drug stores are not required to report that data.

They are, however, supposed to keep an internal log of mistakes. An industry trade group said that approach “emphasizes correcting and preventing future errors.”

Aaland said while she always reported any mistakes, some of her colleagues did not, primarily because they were so busy.


When mistakes cause serious injury or even death, the cases are often settled out of court with a clause that no one can talk about it.

Personal Injury Attorney Jeff Sieben had a client who was mistakenly given pain killers instead of diabetes medicine.  It impaired his driving, causing a crash and injury.

“They don’t want the general public to know of a problem,” he said.

He added the case involved a well-known drug chain, but couldn’t disclose the name due to the settlement terms.   


Druggists are supposed to discuss every new prescription with the customer.

It’s a way to prevent errors by confirming the medication in the bag is appropriate.

“[Consults] supposed to [happen] and people will say they are doing it. But it’s the one thing that I think gets put by the wayside,” said Aaland.

According to state regulators, lack of consults is one of the main reasons why pharmacists might be disciplined; it’s considered such a crucial step in the safety process.

Fox 9 asked the National Association of Chain Drug Stores for an interview.

They declined but in a statement said “Patient safety is a pharmacy’s top priority…Pharmacies constantly pursue opportunities to improve safety..”


Under a new rule by the Pharmacy Board starting July 1, Minnesota will no longer allow pharmacists to work more than 12 hours in a row, and they’ll be required to get mandatory breaks.

“This is an attempt to relieve that stress that we acknowledge is out there so pharmacists are less likely to make errors,” said Wiberg
Customers have a safety role in all of this too. When the pharmacist asks questions, they should take the time to answer. Studies show that it’s during those discussions that mistakes come to light.

Full statement from the National Association of Chain Drug Stores:

Patient safety is a pharmacy’s top priority. Recognizing that human error is a possibility in any profession, pharmacies constantly pursue opportunities to improve safety. One example is updating and enhancing quality assurance and training programs for pharmacy personnel. Another example is using workflow and technology innovations to help reduce the chances of human error. Scanning technology is used in some instances to verify that the medication that has been prescribed matches the medication actually being dispensed. Also, the use of electronic prescribing is on the rise. E-prescribing can reduce the risk of errors from prescribers’ handwriting and from incorrectly entering prescription information.  

In addition to patient-safety-focused processes and technology, community pharmacies have provided feedback to the Minnesota Board of Pharmacy on the pharmacist work rule surrounding breaks. As responsible and highly educated professionals, pharmacists’ judgments are more effective than rigid rules when it comes to decisions about breaks. The work rule taking effect July 1 reflects input provided by community pharmacies to the Minnesota Board of Pharmacy. The Board arrived at a reasonable approach in its final work rule, and we appreciated the opportunity to provide context throughout their process. In the end, everyone agrees that the best policies should be consistent with a pharmacist’s ability to meet the needs of patients and put safety first.

Also, the pharmacy community supports legislation that fosters quality assurance programs and patient safety for all healthcare providers, including pharmacies. Further, we support voluntary reporting of medical and prescription errors in a non-punitive forum, with a focus on strategies and education to help identify an error’s root cause. This approach, common among healthcare professions, emphasizes correcting and preventing future errors.

What everyone should know about the LIES THEY TELL ABOUT OPIATES

What Everyone Should Know About Opioids

In the past 15 years or so, deaths related to heroin and prescription opioids have quadrupled in the U.S., according to the CDC. And opioid addiction is becoming an increasingly widespread issue, especially among young women. So how did we get here?
“The first thing you have to understand [is that] our opioid crisis is not a drug abuse problem — it’s not a problem of people taking dangerous drugs because it feels good and they’re accidentally harming themselves… The opioid crisis is an epidemic of opioid addiction,” says Andrew Kolodny, MD, co-director of opioid policy research collaboration at Brandeis University and a medical advisor for the recently released HBO documentary Warning: This Drug May Kill You.
However, when we talk about the opioid crisis as if it’s a drug abuse or misuse problem, Dr. Kolodny says, “that suggests that there are a lot of people behaving badly and [our issue is figuring out] how we stop them from behaving badly — and that isn’t the case.”
Ahead, we talked to Dr. Kolodny about what these drugs really are, why we’re facing this crisis now, and how we can help those most severely affected get the treatment they need.
Let’s start with the basics: What are opioid drugs?
“Opioids are drugs that come from opium. Some of the more commonly prescribed opioids are drugs like hydrocodone and oxycodone, which literally come from opium — you need opium to make them. Hydrocodone is in Vicodin and oxycodone is in Percocet and Oxycontin.
“They are both what we would term ‘semi-synthetic’ opioids because you start with something natural and you treat it chemically to create a more potent version of opium. Heroin is also a semi-synthetic opioid.
“Many people don’t realize — including many of the doctors who prescribe opioids — that the effects of drugs like oxycodone and hydrocodone are indistinguishable from the effects produced by drugs like heroin. So if you’ve ever been curious about what heroin feels like, if you’ve had a Vicodin, that’s basically the same thing.”

When taken on a daily basis long-term, opioids are really lousy drugs.

We hear so much about misuse of opioids — so what are opioid drugs supposed to be used for?
“These are very important medicines for easing suffering at the end of life. They’re also very useful when used on a short-term basis for severe acute pain, after major surgery or a serious accident, for example.
“Unfortunately, the bulk of the prescribing of opioids in the U.S. is not for end-of-life care or a couple of days after surgery — it’s for common conditions where opioids may be more likely to harm the patient than help them. In fact, we have about 10-12 million Americans who are on opioids for chronic pain. They’re taking them every day. They take a drug like Oxycontin…every day, morning and night, for months or years. We have so many people on daily opioids that drug companies that can now make money off of drugs to treat the side effects of opioids, such as constipation.
“When taken on a daily basis long-term, opioids are really lousy drugs. One reason is that they’re addictive … But also, opioids have some unique characteristics: You very quickly develop a tolerance to the pain-relieving effects, meaning you’ll need higher and higher doses in order to continue getting to get pain relief. And the other effect is what we call ‘physiological dependence,’ which means that if you try to stop taking the drug after taking it on a regular basis, you feel very sick — not just a flu-like illness, but you can also feel very severe anxiety and agonizing pain as a symptom of opioid withdrawal.
“So the other problem with taking them long-term [besides addiction] is that evidence tells us they don’t work — they can become ineffective and make pain worse.”
These drugs have been around for decades — why are we seeing the epidemic now?
“Beginning around 20 years ago, the medical community decided to prescribe [opioids] much more aggressively. The prescribing of opioids quadrupled from around 1999 to 2012. As prescribing starts to go up rapidly, it leads to this parallel increase in addiction and overdose deaths. In other words, the epidemic has been caused by doctors overprescribing opioids, and they really overexposed the U.S. population to prescription opioids.
“What led to the change in culture of prescribing? Starting in the late ’90s with the release of oxycontin by Purdue Pharma, that launched a multifaceted campaign designed to increase opioid prescribing. When they were putting Oxycontin on the market, which is extended-release oxycodone, [drugs like that were mostly] used in palliative care settings.
“Purdue wouldn’t have been able to have much financial success had it only been used in palliative care — patients at the end of their lives with cancer pain is not a common condition, and the patients won’t be under medicine for very long. They needed to see it prescribed for common, especially chronic problems.
“So the campaign they launched was focused on getting the medical community more comfortable with opioids as a class of drug. Purdue would ultimately get into trouble in 2007 for some of the specific ways they marketed Oxycontin as less addictive [than other opioids]. But what they never really got in trouble for (which was much more damaging) was to mislead the medical community about the safety and effectiveness of using opioids on a long-term basis.
“As part of the campaign, doctors started to hear that they were allowing patients to suffer needlessly because we were under-prescribing opioids. We would start hearing that the risk of addiction had been overblown, that legitimate pain patients very rarely get addicted. A statistic that was used was that ‘much less than 1%’ of our patients will get addicted. We started hearing that, for just about any complaint of pain, opioids are ‘the safest and most effective option.’
“We didn’t just hear it from the drug companies — doctors would have been smart enough to be skeptical of marketing from a drug company — but the marketing was really, in many ways, disguised as education. The medical community began hearing from pain specialists eminent in the field all of these messages, we start hearing it from professional societies, state medical boards… From just about every direction we began hearing that, ‘If you’re an enlightened, caring doctor, you’ll be different form those stingy, puritanical doctors of the past that let people suffer.’
“As we responded to this brilliant campaign and as opioid prescribing took off, it led to a public health catastrophe.”

As we responded to this brilliant campaign and as opioid prescribing took off, it led to a public health catastrophe.

What is the ideal treatment plan for opioid addiction?
“Most people with opioid addiction don’t do well with abstinence-based approaches, meaning going for detox or going to a rehab for 30 days and then coming home. That doesn’t work for many people and, in fact, when you come back from detox, rehab, or jail and your tolerance has gone back to normal, people are at a very high risk for an overdose death.
“There’s also a drug called Vivitrol, which is a monthly injection of naltrexone (an opioid blocker). Even though that’s a medicine, that’s really more of an abstinence-based approach.
“So the first-line treatment for opioid addiction is a medicine called burpenorphine (or Suboxone). In some cases methadone maintenance is a good option, especially for patients with a more severe addiction who need the structure of visiting a methadone maintenance clinic on a daily basis.
“Unfortunately there’s not adequate access to buprenorphine. There are many restrictions and rules that limit the ability of doctors to treat people with this medicine, which is pretty crazy because buprenorphine is much safer than drugs like Oxycontin. For the more dangerous opioids that are causing addiction and people are overdosing on, there are very few restrictions. Yet for the medicine used to treat opioid addiction, we have too many restrictions.”
Why is the use of buprenorphine sometimes considered “controversial” ?
“Among experts, there is no controversy about using buprenorphine. But there is a strong stigma and bias against these treatments, including very concerning statements by HHS Secretary Tom Price a few days ago. But there are many people who are making the mistake of thinking [treatment with buprenorphine] is substituting one opioid drug for another.
“I’ve treated patients with opioid addiction by prescribing them buprenorphine for many years. I didn’t have too much success getting them off buprenorphine — it’s very hard to come off without relapsing — but while my patients are on it, I’ve watched them lead very productive lives. They get married, have babies, graduate college, hold good jobs — you would never know looking at them that they were on a drug. They would tell you they felt perfectly normal.
“It’s certainly not a cure, and it would be nice if we had other options. It’s certainly always better if someone can manage a chronic illness without taking a medicine… but it’s similar to diabetes. For type 2 diabetes, if someone can really control their diet and lose weight and exercise regularly, they can get off their insulin and just be on oral hypoglycemics. And if they do a really good job, they can even get off the oral medicine. That’s definitely better than being on insulin or pills, which have side effects.
“But a lot of people can’t do it. And if you insist on it — if we told people, ‘You can only have your insulin for six months and then you have to be better,’ we’d be in a really bad place. We’d see a lot of people going blind or losing limbs from untreated diabetes. That’s kind of where we are with opioid addiction, because not enough people are accessing the treatments that are effective.”
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