ACEP Urges HHS to Remove Pain Questions From Patient Satisfaction Surveys

Your suffering/pain management – or lack of pain management – during your hospitalization should not be a measurement of patient satisfaction about their care in the hospital ?

March 28, 2016
The Honorable Sylvia Mathews Burwell
Secretary, Department of Health & Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Madam Secretary:
Prescription drug abuse has reached epidemic proportions with devastating
effects on families across America. In many states, it has also fostered a heroin
crisis, overwhelming our communities and families with often tragic
consequences. Recently, the Centers for Disease Control and Prevention (CDC)
announced that deaths from opioid pain relievers as a result of misuse and abuse
have soared over the last fifteen years.1 Moreover, the CDC reports that
healthcare providers wrote 259 million prescriptions for painkillers in 2012,
enough for every American adult to have a bottle of pills.2 It is alarming that
Americans consume opioids at a greater rate than any other nation, including
twice as many opioids per capita as Canada.3 The seemingly unending supply of
prescription opioids is subject to misuse and diversion, which has become one of
the foremost public health challenges facing our nation.
Of the over 136 million patient visits annually to the nation’s emergency
departments, 42% of these visits are related to painful conditions. While
emergency physicians write a considerable number of prescriptions for opioids,
we account for less than 5% of all opioid prescriptions in the US. In addition,
most are immediate release, the quantity in each prescription is generally
quite low, and refills are rare.
We also act as a bridge in the primary care system on nights, weekends, holidays,
and other times when a primary care provider is not available. We are often the
only access that patients have. Pain treatment centers regularly refer patients to
the emergency department if the patient has not followed the agreed upon
treatment plan and, as emergency physicians we must, by the EMTALA law,
evaluate every patient who presents to our departments.
1 CDC Newsroom Archives. “Drug overdose deaths hit record numbers in 2014,” December 18,
2015. Accessed from http://www.cdc.gov/media/releases/2015/p1218-drug-overdose.html.
2 “Opioid Painkiller Prescribing.” CDC Vital Signs. Accessed from
http://www.cdc.gov/vitalsigns/opioid-prescribing/.
3 Paulozzi, Leondard. “Vital Signs: Variation Among States in Prescribing of Opioid Pain
Relievers and Benzodiazepines – United States, 2012,” Morbidity and Mortality Weekly Report
2012. Accessed from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6326a2.htm.
In spite of the multiple efforts the Federal government (CDC’s revised guidelines, FDA’s Risk Evaluation and Mitigation Strategy, ONDCP educational sessions, CMS, etc.) has undertaken to tackle this crisis, we must point to a glaring issue that has worked at cross purposes not only for hospitals but soon for emergency physicians. Patient experience/satisfaction surveys are important, particularly regarding issues of treating patients with dignity and respect, but questions about pain have resulted in unintended consequences and the pursuit of high patient-satisfaction scores may actually lead health professionals and institutions to practice bad medicine by honoring patient requests for unnecessary and even harmful treatments.
On the hospital side, CMS operates the Hospital Value-Based Purchasing Program which includes a survey (HCAHPS) where discharged patients respond to questions including, “During this hospital stay, how often was your pain well-controlled?” and “During this hospital stay, how often did the hospital staff do everything they could to help you with your pain?” Less than satisfactory patient perception scores will contribute to CMS reducing hospital DRG payments starting in 2016.
Similar questions are included in third draft version of the CMS’ Emergency Department Patient Experience of Care. (EDPEC Survey 3.0) which the pilot test administered between 2-42 days after patients were treated and released. After ACEP submitted written comments to the first two versions, providing CMS with specific wording to change the pain questions, the third version now asks “during this ED visit did you have any pain, did the doctors and nurses try to help reduce your pain, and did you get medicine for pain?”
Any questions which provide an opportunity for patients to express dissatisfaction because they didn’t get the drugs they sought, provide disincentives for physicians to prescribe non-opioid analgesics which will negatively affect their scores. This has been an issue for years with private surveys such as Press Ganey4. And, it is certainly not addressing important aspects of the opioid crisis that the government is expending tremendous resources to combat.
As DHHS continues to refine measures to reward quality care in the Medicare program, it is critical to correctly measure the quality being rewarded. Currently, there is no objective diagnostic method that can validate or quantify pain. Development of such a measure would surely be a worthwhile endeavor. In the meantime, we are concerned that the current evaluation system may inappropriately penalize hospitals and physicians who, in the exercise of medical judgment, opt to limit opioid pain relievers to certain patients and instead reward those who prescribe opioids more frequently.
4 Gunderman, Richard. “When Physicians’ Careers Suffer Because They Refuse to Prescribe Narcotics,” The Atlantic 2014, http://www.theatlantic.com/health/archive/2013/10/when-physicians-careers-suffer-because-they-refuse-to-prescribe-narcotics/280995/
We urge the Department to undertake a robust examination of whether there is a
connection between these measurements and potentially inappropriate prescribing patterns, and, until that is completed, we urge you to remove pain questions from the various CAHPS surveys. We appreciate your prompt consideration of this request, and will work with you at any time to address these serious public health challenges.
Sincerely,
Jay A. Kaplan, MD, FACEP
President

Naloxone: has revived one 34-year-old man six times and other drug users three and four times each

Thousands of drug users are rescuing one another with antidote naloxone

https://www.washingtonpost.com/national/health-science/thousands-of-drug-users-are-saving-each-other-with-antidote-naloxone/2015/11/22/d1f2e408-87df-11e5-be39-0034bb576eee_story.html?tid=a_inl

BALTIMORE — Deep into a three-day heroin binge at a local hotel, Samantha told the newbie he was shooting too much. He wasn’t accustomed to heroin, she said, and hadn’t waited long enough since his last injection.

“But he didn’t listen,” she said. Sure enough, he emerged from a visit to the bathroom, eyes glazed, and collapsed from an overdose.

Samantha, who declined to give her last name to avoid trouble with her bosses at a nearby strip club, said she grabbed her naloxone, the fast-acting antidote to opioid overdoses. She was too panicked to place the atomizer on the end of the syringe, but her boyfriend wasn’t. He sprayed the mist into the nose of the unconscious drug user, who awoke minutes later.

“I always have it because I’m scared to death,” said Samantha, who said she has been shooting heroin for 22 years. “I don’t want to be helpless.”

As the opioid epidemic has exploded in small towns and suburbs in recent years, officials have scrambled to put naloxone in the hands of drug users’ families and friends, and to make it more widely available by equipping police officers with the drug.

At the same time, thousands of lives are being saved by giving the antidote to drug users. More than 80 percent of overdose victims revived by “laypeople” were rescued by other users, most of them in the past few years, according to one national survey published in June.

Baltimore has trained 12,000 people on the streets to use naloxone in the past 11 years, 2,150 of them this year alone. “If someone is using a drug that could kill them, they should also have the antidote available,” said Leana Wen, the city’s health commissioner. Chicago, New York and San Francisco also hand out thousands of doses to drug users at little or no cost.

But the rising number of rescues also highlights the shortcomings of what is, at best, a stopgap effort. With treatment for addiction available to a small portion of the people who need it, many people who survive overdoses return to drug use. Some first responders express frustration at reviving the same people again and again without hope of permanent change.

In Charleston, W.Va., where President Obama spoke about the opioid crisis last month and rescue personnel have carried naloxone for decades, Fire Capt. Mark Strickland said he has revived one 34-year-old man six times and other drug users three and four times each.

“I can’t just take everybody to the hospital,” Strickland said. “ . . . There has to be a ‘What next?’ ”

The drug’s cost also is beginning to influence anti-heroin strategy. The price of a nasally administered dose of naloxone — often known by its brand name, Narcan — has quadrupled in two years or less in many places, to nearly $50. Federal, state and local officials are pressing for discounts from Amphastar Pharmaceuticals, the only supplier of that form of the drug.

New York and Ohio have succeeded. In San Francisco, the major nonprofit distribution program for drug users has begun using cheaper injectable naloxone instead.

“No company should jeopardize the progress being made in tackling this emergency by overcharging for a critically important drug like naloxone,” Rep. Elijah E. Cummings (D-Md.) and Sen. Bernie Sanders (Vt.) said in a July letter to groups that represent U.S. mayors and counties.

Amphastar officials did not return e-mails and telephone calls seeking comment on the price increases.

[When life begins in rehab]

Deaths from heroin overdoses quadrupled to 8,260 between 2000 and 2013, according to the federal government, as did deaths from prescription opioids, which reached 16,235.

The number of people revived by naloxone is difficult to determine, but the Harm Reduction Coalition, a training and advocacy group, published a survey in June showing that 26,463 people had been revived by “laypersons” between 1996 and the first half of 2014. Nearly 83 percent of those rescues were made by other drug users.

More than 8,000 people were revived in 2013 alone, according to the coalition’s data, which covers only half of the organizations that distribute naloxone. Almost 38,000 kits were handed out to laypeople that year. These rescue efforts overwhelmingly involve people who have taken heroin, not prescription drugs.

“Drug users are the primary witnesses to drug overdoses,” said Eliza Wheeler, program manager for the coalition’s drug overdose prevention and education effort in San Francisco, who compiled the report. “This was about putting the effective tool into people’s hands.”

Baltimore started handing out naloxone in 2004, mostly through its needle-exchange program, eight years after the approach was pioneered in Chicago. Baltimore now makes it available to all residents via a prescription signed by Wen, the health commissioner, who is a former emergency room doctor. Drugstores sell it for a dollar to anyone on Medicaid. The city also trains soon-to-be-released jail inmates and others on the use of naloxone.

The only requirement for carrying it is a five-minute training course, like the one Samantha took recently in the back of the city’s needle-exchange van, parked by a seedy row of strip clubs, porn shops and food outlets known as “The Block.” A steady stream of drug users stepped into the small recreational vehicle to trade used needles for new ones, pick up condoms and register for a card that prevents police from arresting them for carrying drug paraphernalia.

Samantha was there for more naloxone. On this night, the city was handing out kits donated by the company Kaleo that sell for $575 apiece. About the size of a pack of cigarettes, the recently approved device contains two doses administered through an auto-injector, with audio instructions on how to use it.

Health educator Nathan Fields ran through the signs of an opioid overdose: slowed or nonexistent breathing; blue lips, skin and nails for whites or a grayish pallor for African Americans.

Anthony Williams was first in line that night, although he said he doesn’t use heroin. “I’m an alcoholic. I drink,” he said. But he lives in an abandoned building with several heroin users, he explained, including one who is going through a rough time.

“When you’re in a space, living with people [who] any moment they can go overdose and die, this is a very life-sustaining issue,” Williams said.

People revived by naloxone can flail or vomit when they awake, Fields warned Williams, and they will plunge immediately into the painful symptoms of withdrawal.

“That person will usually jump up, and the first thing he’ll say is what?” Fields asked.

“You f—ed up my high!” Williams responded, and they both smiled.

Naloxone hydrochloride, approved by the Food and Drug Administration in 1971, has long been carried by rescue personnel and used in emergency rooms. It works only on opioid overdoses, reversing them by blocking the receptors in the brain where opiates attach. Overdose victims usually resume breathing and awaken within minutes.

Baltimore officials long ago rejected the notion that widespread distribution of naloxone encourages drug use by prompting recklessness among drug abusers. And they are not troubled about helping “frequent fliers,” because research and experience show that relapses are common, even with treatment.

“You want to keep the person alive,” said Derrick Hunt, director of the city’s Community Risk Reduction program, “until they make better choices.”

Eight out of ten pain patients feel hospital staff have not been adequately trained in pain management

Pain Patients Fed Up with Poor Treatment in Hospitals

http://www.painnewsnetwork.org/stories/2016/3/26/pain-patients-fed-up-with-hospital-treatment

By Pat Anson, Editor

Eight out of ten pain patients feel hospital staff have not been adequately trained in pain management and over half rate the quality of their pain care in hospitals as either poor or very poor, according to a new survey.

Over 1,250 acute and chronic pain patients participated in the online survey by Pain News Network and the International Pain Foundation (IPain). The survey findings — supported by the comments and experiences of hundreds of pain patients — amount to a stinging indictment of hospital pain care in the United States.

It’s not uncommon for pain patients to suffer from a variety of chronic conditions and diseases, and many told us they’ve been hospitalized several times. 

Asked to rate the overall quality of their medical care in hospitals, pain patients were fairly even-handed in their ratings. About a third said it was good or very good, 37% said it was fair and 29% said it was poor or very poor.

But some said they were so badly treated and traumatized by the experience, they’re afraid to go back.

“It’s so bad that I will not seek treatment in an ER or hospital unless I really feel like my life is in jeopardy. They do not get it, they do not listen, and they do not care,” is how one pain patient put it.

“I refuse to go to ER. It will end up killing me because I know how sick I am, but I would rather die than deal with ignorant, condescending doctors and nurses,” wrote another.

 
 
  • 34% VERY GOOD OR GOOD
  • 37% FAIR
  • 29% VERY POOR OR POOR
HOW WOULD YOU RATE THE OVERALL QUALITY OF YOUR MEDICAL CARE IN HOSPITALS?

Several healthcare providers also wrote to us, admitting pain patients were often treated poorly.

“Many of my colleagues would refuse to medicate patients in pain, especially women in pain. They had many misconceptions that women were attention seeking, or exaggerating their pain. They also believed that even short term opioid therapy would ‘create’ addiction,” wrote a nurse.

“I am a nurse anesthetist as well as a patient with fibromyalgia and severe arthritis,” said another nurse. “The USA does a horrible job treating chronic pain. Too many suffer and too many commit suicide because of this.”

When asked to rate only the quality of their pain treatment, the survey results were decidedly negative. Over 52% said their pain treatment in hospitals was poor or very poor, 25% rated it fair, and only 23% said it was good or very good.

Many patients complained that their pain went untreated or under-treated, even though pain was usually the primary reason they were admitted to a hospital. 

“I was at the ER once crying because I was in so much pain and I had a nurse tell me to shut up and cut the act. Never been treated so inhumanely,” said one pain patient.

“I’ve had to fight for proper pain management every time I’ve been in a hospital in the last 10 years. The DEA created this problem and the CDC is only reinforcing it. It’s a travesty,” wrote another.

 
 
  • 52% VERY POOR OR POOR
  • 25% FAIR
  • 23% VERY GOOD OR GOOD
HOW WOULD YOU RATE THE QUALITY OF YOUR PAIN TREATMENT IN HOSPITALS?

“If I were an animal and was treated the way I was after surgery my owner would have been arrested for cruelty to an animal. As a human being, don’t I deserve to be treated at least as well as an animal?” asked another pain sufferer.

“I’ve stopped going to hospitals even if I feel I’m having another stroke or heart attack, due to the horrific lack of pain control,” wrote a patient who has multiple autoimmune diseases. “I’d rather die than be judged or be left writhing in pain.”

“Pain is under-treated and at times downright ignored. I believe that this is leading to the cause of chronic pain in some patients,” wrote another patient.

There is some evidence to support the claim that untreated or under-treated acute pain can turn into chronic pain. A study published in the Lancet warned that “an alarmingly high number of patients develop chronic pain after routine surgery.”

Yet when pain patients were asked in our survey if their pain was adequately controlled after surgery or treatment in a hospital, nearly two-thirds (64%) said no and only 34% said yes. 

“There is research demonstrating that the intensity of acute postoperative pain correlates with the risk of going on to develop chronic pain. This suggests that aggressive early therapy for postoperative pain is critical for preventing the pain from turning chronic,” says Cindy Steinberg, National Director of Policy and Advocacy for the U.S. Pain Foundation.

 
 
  • 64% NO
  • 34% YES
IF YOU EXPERIENCED PAIN AFTER A SURGERY OR TREATMENT IN A HOSPITAL, WAS IT ADEQUATELY CONTROLLED?

“Minimizing and deemphasizing the focus on controlling acute pain in hospital settings is likely going to set us up for potentially dramatic increases in the number of Americans with long term chronic pain.”

By treating acute pain so poorly, could our hospitals and emergency rooms be mass-producing future chronic pain patients?

And, if so, what can be done to stop it?

One solution – overwhelmingly supported by respondents to our survey – is better education in pain management for doctors, nurses and other healthcare providers.

Asked if they feel hospital staff are adequately train in pain management, nearly 83% of pain patients said no and just 9% said yes.  

“All staff should be educated and able to understand the difference between opioid dependency and opioid abuse,” wrote one pain patient. “Over the last decade I have witnessed the quality of care for pain management plummet, and I have also observed increased chronic mistreatment of pain patients.”

“I am a nurse. Anyone who has chronic pain is labeled automatically as a drug seeker. The under-education about chronic pain is alarming. The way truthful patients are treated is just deplorable,” wrote another pain sufferer.

 
 
  • 83% NO
  • 9% YES
  • 9% DON’T KNOW
OVERALL, DO YOU FEEL HOSPITAL STAFF ARE ADEQUATELY TRAINED IN PAIN MANAGEMENT?

“I think that hospital staff members are trained to be afraid of pain patients. They know what is necessary to treat pain, even chronic pain, but the fear that is instilled in them by oversight committees, the DEA, and Congress that all opiod pain prescriptions lead to drug addiction has led them to be afraid of treating pain patients. Education is the key,” wrote another pain sufferer.

“In my 20+ years of having CRPS (Chronic Regional Pain Syndrome), I have never been to an ER where the staff even knew what it was,” wrote one of several readers who lamented that doctors and nurses are often ignorant about CRPS and RSD (Reflex Sympathetic Dystrophy).

“I have experienced this myself. The nurses didn’t understand my pain conditions and how my body reacted. They didn’t understand that I had additional needs,” said Barby Ingle, president of IPain, who suffers from RSD. “I have recently had a provider ask, ‘Does it really hurt that bad?’ while doing a procedure on me under local anesthesia. I was screaming, crying, and moving so much that a normal patient gets 7 anesthetic shots. For me it took 28 and those were extremely painful.

“For a pain patient to go to a hospital for pain care and still have their pain unaddressed, under-treated, or misunderstood is clear evidence that we need better education for hospital staff.”

The lack of pain education in medical schools is not new. A 2012 study published in the Journal of Pain  called pain education “lackluster” in the U.S. and Canada. The study of 117 medical schools found that less than 4% required a course in pain education and many did not have any pain courses.

Despite that, opioid prescribing guidelines released this month by the Centers for Disease Control and Prevention only briefly mention the agency will “work with partners to support clinician education” and even that vague promise is only focused on reducing opioid use. The same is true for the Food and Drug Administration, which recently announced several sweeping changes in its opioid policies, none of which address physician education.  

Only the recently adopted National Pain Strategy (NPS) acknowledges that “most health care professions’ education programs devote little time to education and training about pain and pain care,” and suggests several ways to improve them.  But it’s unclear how the NPS will ever be implemented, since it has no budget and relies on major policy changes involving medical schools, accreditation groups,  healthcare providers, and regulatory agencies. 

“I think it’s true that many hospital providers are poorly educated about pain management, and, especially if the patient’s condition is complex, understanding what is going on and finding a good solution can be very challenging,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management, who believes providers need more empathy, as well as education.

“In my experience, I found that hospitalized patients were much more satisfied if they just felt like someone understood them and their pain, expressed a sense of caring, and made a strong effort to help. For those patients, even if you weren’t able to get their pain controlled for a little while, they really appreciated the fact that someone believed them and was trying to help. Sometimes, it’s as much about caring for the person with pain as it is treating the person with pain.”

To see the complete survey results, click here.

“education” does not always prevent substance abuse

Nurses, other health providers not immune

http://www.bostonherald.com/news/local_coverage/2016/04/nurses_other_health_providers_not_immune

Have you every notice that everyone fighting the war on drugs … they always talk about educating people as to the dangers of using/abusing various substances including Alcohol, Tobacco, Opiates.  One one think that there would not be a group more educated about the dangers of using/abusing these substances that healthcare professional… Physicians, Pharmacists, Dentists, Nursing ..etc…etc…  yet, in this one state of Massachusetts there are dozens of healthcare professionals  every year admitted to a substance abuse recovery program.  Does this suggest that education cannot overcome a person with an addictive personality disorder ?

Nearly 100 Massachusetts nurses have either sought or been sent to a state-run substance abuse program in the last two years, including some who were suspected of swiping drugs, according to state data that helps illustrate the reach of the state’s opioid epidemic, even into the world of health care.

The data, obtained by the Herald from the Department of Public Health, shows as many as 163 nurses were enrolled in the Substance Abuse Rehabilitation Program through the state’s board of nursing as of late March. Of those, 93 were admitted in 2014 and 2015 alone, some by referring themselves but others following complaints or by their employers.

The Massachusetts Nurses Association also runs its own program separate from the state’s that seeks to connect members with 25 or so peer assistants who are nurses themselves. The MNA’s Carol Mallia said the union gets on average two to five referrals a month, numbers that have remained steady even as the statewide opioid crisis has exploded in other sectors.

The so-called “non-disciplinary” state-run program is intended to connect nurses battling alcohol abuse or addiction with treatment before getting them back to work. But as the state grapples with a scourge of prescription pills and heroin, experts say it shows those on the front lines in health care aren’t immune to it, either.

“Nursing is one of those professions where there’s a high risk for substance use, where nurses can get injured on the job, and they have a skill set of working with narcotics. Sometimes that can get away from them,” Mallia said.

“I’ve always felt like we scratch the tip of the iceberg — this is a problem that nurses live in seclusion with,” she said. “We try to get the word out that this is a disease and there are resources. And don’t let it affect your practice.”

Under the state-run program, dubbed SARP, nurses aren’t allowed to practice for the first year of the five-year program, plus at least another three months after they return to work. Officials say about 60 percent of the nurses who start the program ultimately finish.

The state board of pharmacy, meanwhile, has 18 health professionals going through its own Professional Recovery System, which is open to dentists, physician assistants, pharmacists and others. Also a five-year program, it admitted seven people during the past two years.

Roughly one-third each year enter with drug or alcohol problems, and of the 120 doctors the program continues to monitor annually, roughly 90 are recovering from substance or alcohol abuse, said Dr. Steven Adelman, the program’s director and an addiction psychiatrist.

“We see people who come to work with alcohol on their breath or the pill count in the pill dispenser is short some controlled substances and they are sent here for suspicion of a problem,” Adelman said. “But the trend that we’re seeing here is actually going in the other direction. We’re getting more self-referrals (roughly 40 percent), where it’s people putting out fires when it’s one alarm or two alarm instead of waiting for it to be nine alarms.”

The “cure” to the opiate epidemic… created a HIV, HEP B&C EPIDEMIC ?

How A Painkiller Designed To Deter Abuse Helped Spark An HIV Outbreak

http://www.npr.org/sections/health-shots/2016/04/01/472538272/how-a-painkiller-designed-to-deter-abuse-helped-spark-an-hiv-outbreak

When Kevin Polly first started abusing Opana ER, a potent prescription opioid painkiller, he took pills — or fractions of pills — and crushed them into a fine powder, then snorted it.

When Opana pills are swallowed, they release their painkilling ingredient over 12 hours. If the pills were crushed and snorted, though, the drug was released in a single dose.

“Just think about it,” Polly says, “12 hours of medicine, and, ‘BAM!’ you’re getting it all at once.”

But the drug’s manufacturer, Endo Pharmaceuticals, reformulated Opana in 2012. The new pills featured a coating that was intended to make them more difficult to abuse by crushing them into powder or dissolving them.

Polly discovered he could no longer snort the medicine in the pill, to which he had become addicted. But he and other Opana users soon found a way to remove the drug’s hard coating and receive Opana’s powerful dose all at once: injection.

Polly says he used to inject Opana as many as five times a day. He often shared needles with other people.

He says he never anticipated what would happen next. In early 2015, Polly tested positive for HIV. “It was devastating news,” he says.

Kevin Polly is among the 190 people in Indiana’s Scott County who have tested positive for HIV since early 2015, in the largest HIV outbreak in Indiana history.

The Change To Opana That Was Intended To Prevent Abuse

For its part, Endo has said that its decision to reformulate Opana was a well-intended attempt to prevent abuse. As the company told the Food and Drug Administration in 2012, Endo reformulated the drug “to provide a crush-resistant product, equally as effective as Opana ER, which would discourage abuse, misuse and diversion.” Endo declined repeated requests from NPR for an interview.

According to study data, as well as interviews with Indiana residents addicted to Opana, the reformulation effectively deterred many people from snorting the drug. But the change also led a significant number of people to abuse the drug by injection. When needles are shared, the injection route can transmit HIV, hepatitis C or other infections.

And interviews with experts, court filings, documents from the FDA, as well as Endo’s own statements, suggest the company’s decision to reformulate Opana was also motivated in large part by financial interests.

Public health experts say “abuse deterrent” drugs may serve a role in reducing what the Centers for Disease Control and Prevention calls a national epidemic of prescription opioid abuse. The FDA and members of Congress have also supported their development. But the experience with Opana’s reformulation may serve as a cautionary tale for the potential effects of “abuse deterrent” drugs.

Experiences In Austin, Ind.

While NPR’s Kelly McEvers and I were reporting in Austin, Ind., people who abused Opana and were familiar with changes to the drug’s formula told us similar stories.

“The pharmaceutical company, they changed it so you can’t crush them and snort them,” said Devin, a 26-year old. “Whenever they done that, that’s when everybody started shooting them.”

Jeff, a veteran of the Army National Guard, said he became addicted to Opana after being prescribed opioid painkillers for a back injury he sustained in Iraq.

At some point, Jeff said, he began crushing and snorting pills. Then, he said, the company “reformulated them, and the only way you could do them is to inject them.”

Joy, a former registered nurse who got addicted to opioids after a back injury, said that she initially stopped using Opana after the reformulation. But that didn’t last long. “Some genius figured out, ‘Hey we can cook this down and turn [it] into a liquid and shoot it up,’ ” Joy said. “And then it took off like wildfire after that.”

(NPR is withholding Devin’s, Jeff’s and Joy’s last names to protect their privacy.)

Because of the coating added to Opana, the process of preparing it for injection does take a little work. But in the end, it’s not that difficult.

My colleague Kelly watched people prepare Opana for injection, using just the bottom of a soda can, a small lighter, a cigarette filter and tap water.

Behind The Reformulation, Public Health And Business Considerations

So why did Endo Pharmaceuticals reformulate the drug in the first place?

Volunteers search for used needles near Rural Street in Austin, Ind. Scott County, in southeastern Indiana, experienced the worst outbreak of HIV in the state's history after people began injecting the prescription painkiller Opana.

Volunteers search for used needles near Rural Street in Austin, Ind. Scott County, in southeastern Indiana, experienced the worst outbreak of HIV in the state’s history after people began injecting the prescription painkiller Opana.

Seth Herald/NurPhoto/Corbis

The answer involves both public health concerns and business considerations.

Endo Pharmaceuticals released Opana in 2006. Taken orally, Opana is about twice as powerful as OxyContin, and the company says it is “indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.”

Soon afterward, though, communities around the country began reporting abuse of Opana and even overdose deaths.

Endo said those concerns over public health and abuse were key motivations to reformulate the drug. Opana also was a major moneymaker for the company.

In 2011, for example, Opana generated $384 million in net sales for Endo, accounting for 14 percent of the company’s total revenue that year.

But the company also faced the threat of generic competition.

So Endo developed a strategy that would block its competitors and maintain Opana’s share of the market.

The company reformulated the drug, this time with features designed to prevent abuse, a move that could potentially protect Endo at a time it faced the loss of patent protection.

The FDA approved Endo’s reformulated Opana, and in 2012 the company began replacing the old versions of Opana on pharmacy shelves.

In August of that year, Endo took another step. The company filed a petition with the FDA, arguing that it had removed the old, crushable version of Opana from the market “for reasons of safety or effectiveness.” It also asked the agency to “refuse to approve” and “suspend and withdraw the approval” of generic, noncrush-resistant versions of Opana.

If the FDA agreed with Endo, the agency would effectively eliminate the company’s generic competition.

“We see this again and again in the pharmaceutical industry,” says Dr. Anna Lembke, an assistant professor of psychiatry at Stanford University Medical Center. “They come up with some new fancy formulation of basically the same old drug … and then that way they have a new drug that they can charge a lot of money for.”

change you can believe in .. if you work for the government ?

Dead body.. suicide note… syringe… opiate related death ?


Woman’s Body Sat In Car Parked At Walmart For 3… by GeoBeats

Chronic painer “forced” into buying street drugs… dies from overdose ?

After 7th Death, DEA Takes Over Search For Fentanyl Pills In Sacramento

http://sacramento.cbslocal.com/2016/03/31/after-7th-death-dea-takes-over-search-for-fentanyl-pills-in-sacramento/

SACRAMENTO (CBS13) — The Drug Enforcement Administration is taking over an investigation into how fentanyl ended up in drugs in the Sacramento area after a seventh person is believed to have been killed by the drug.

The family of Jerome Butler says he was taken off life support on Wednesday afternoon, just three days after his mother said he took a pill for chronic stomach pain he didn’t know had been laced with Fentanyl.

The drug is also believed to be responsible for 21 other hospitalizations.

CBS13 has learned recession budget cuts claimed narcotics teams in the Sacramento area who would track down drugs like Fentanyl.

Assemblyman Jim Cooper was once an undercover cop who busted drug dealers daily. He established Sacramento County’s first street narcotics team in 1988.

“It was turn and burn; you go out arrest someone, and get the next one,” he said.

His unit was dedicated to finding the guys dealing prescription pills like the ones now being blamed for multiple deaths in Sacramento County.
“It’s unfortunate, because those folks—the actual dealers selling out there right now—they’re out there unimpeded. They could do whatever they want,” he said.

The recession claimed the sheriff’s department’s team in 2008, while the Sacramento Police Department got rid of theirs in 2011. Neither has been restored.

Both agencies declined on-camera interviews, but defend their current operations. They say high-level drug task forces now pick up the slack.

“There’s lots of task forces in Sacramento, but they work on high-level drug dealers, but the street teams, they go out every night for that purpose, arresting drug dealers,” Cooper said.

He hopes the pill problem could be solved with a bill that would make locking pill bottles available to people with prescriptions, making it harder for addicts to steal the drugs.

For now, he hopes to see street teams back on the street deterring drug dealers and their deadly combinations.

“Otherwise you’re going to see more deaths with this,” he said

Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group

Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders

http://www.nejm.org/doi/full/10.1056/NEJMoa1505409#t=abstract

Background

Extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited.

 

Methods

In this five-site, open-label, randomized trial, we compared a 24-week course of extended-release naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78.

 

Results

A total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extended-release naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43% vs. 64% of participants, P<0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74% vs. 56%, P<0.001; odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46% in each group, P=0.91). The rates of other prespecified secondary outcome measures — self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration — were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P=0.02).

 

Conclusions

In this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation. (Funded by the National Institute on Drug Abuse; ClinicalTrials.gov number, NCT00781898.)

 

WV: 3,000 doses Naloxone administered, which hopefully saved 3,000 lives… we don’t know ?

‘Ahead of the curve’: Summit shows WV’s progress on drugs

http://www.herald-dispatch.com/news/ahead-of-the-curve-summit-shows-wv-s-progress-on/article_fc4301e0-89af-51dc-be12-9a1b173ff34e.html

Naloxone can be compared to finding someone starving to death.. you give them a meal/drink and hope that they stop starving.. Apparently WV… just revives people who overdose and puts them back into the environment from which they came and hope that they “get their act together”…  Is it that they just keep count of how many doses of Naloxone they have administered and that is really all that really matters.. the NUMBERS ?

HUNTINGTON – A delegation of West Virginians who face drug addiction on a daily basis represented the state at the 2016 National Prescription Drug Abuse Summit in Atlanta this week, and what they learned is West Virginia is ahead of the curve.

More than 1,500 people, including President Barack Obama, attended the summit, the largest collaboration of professionals from areas impacted by prescription drug abuse and heroin use.

Gov. Earl Ray Tomblin; U.S. Sen. Joe Manchin, D-W.Va.; U.S. Rep. Evan Jenkins, R-W.Va.; and Huntington Deputy Fire Chief Jan Rader, who is also a member of the Mayor’s Office of Drug Control Policy, were among those who presented during the three-day summit.

Tomblin was part of the keynote address Monday, and participated in a panel discussion with Manchin and U.S. Secretary of Agriculture Tom Vilsack.

He was the only governor invited to the summit, and he said Wednesday he believed that was because of the progress West Virginia has made in the fight against the opioid epidemic.

“We are really one of the leaders in the country right now as far as the things we’ve been able to do as far as shutting down pill mills, the reporting of prescriptions filled to the Board of Pharmacy – we’ve taken a very active role in letting the licensing board know who those people are who are overprescribing,” Tomblin said.

“We’ve had the medical community learn more about prescriptions they are prescribing and the problems with those pills sometimes. We’ve got our call line in place, and I think it’s still one of the only services of its kind in the country that let those people who need help to pick up the phone and they will stay on the line with you until they get you to a person who can help you.”

Tomblin said the state has also made strides with naloxone.

Just last year, our EMS administered over 3,000 doses, which hopefully saved 3,000 lives,” he said. “Now, anybody can get it without a prescription, and plus the pharmacist will teach you how to properly administer the drug, so hopefully we will save a lot more lives in our state to give people a second chance to get the help that they need.”

Tomblin signed the bill Tuesday that made naloxone available without a prescription.

He said he also thinks West Virginia is one of the first states to change the attitude toward drug abusers.

“We used to think we could just lock them up and that would help,” Tomblin said. “It’s an illness, and we are going to treat it that way.”

Jenkins said it was an honor to share a story of progress, and he said it was an energizing experience. He was one of seven on a congressional panel.

Jenkins said he focused on three areas during the panel: the potential and power of prescription drug monitoring programs, holes in Obama’s proposed $1.1 billion plan to combat opioid abuse, and the need for more centers like Lily’s Place nationwide and removing the barriers to creating them.

He said that with the state’s more proactive monitoring program, the Board of Pharmacy has been able to search the database and send more than 8,000 letters to practitioners about patients who had received a pain medication prescription from other prescribers, a practice often called pill shopping.

“We are so far ahead of the curve in West Virginia to use that database in a very proactive, effective way,” he said.

Jenkins said the next barrier is finding a way to share this data across state borders. To do so, state confidentiality programs must match. Currently, West Virginia only matches 18 states.

Treading carefully, Jenkins said he also talked about holes in the president’s proposed budget. The proposal focuses mainly on medication-assisted treatment, but Jenkins, a member of the House Appropriations Committee, said the president is proposing cutting programs that are proven to work in his district, including Cabell County, such as drug courts and the High Intensity Drug Trafficking Area.

He also talked about centers like Lily’s Place and the regulatory challenges to replicating Lily’s Place nationwide.

“I talked about the Cradle Act, which would push the federal health regulators to put in place regulatory standards to allow Lily’s Place to be replicated,” Jenkins said. “We’ve already done it in West Virginia.”

Jan Rader represented Huntington on a panel with representatives from Camden, New Jersey, about communities’ responses to heroin.

Rader said she talked about the harm-reduction program, the involvement of the whole community and other initiatives like the expansion of drug courts. She also talked about where Huntington hoped to go, including needing more detox beds. There are only 18 in Cabell County.

“Being there a couple days brought to light we are ahead of the curve,” Rader said, echoing Tomblin and Jenkins. “We’ve been doing a lot that they are doing at national level just now. We are really making do with what we have and being creative.

“We don’t deal with egos. We work together. A lot of communities are up against political battles, people not cooperating. We aren’t dealing with that. Huntington and Cabell have come together as a community to do the right thing.”

She said one thing Camden is doing that she would like to see happen here is training police in the academy how to deal with someone with addiction and how to administer naloxone. She said she would like to see fire and EMS responders receive the same training as well.

Rader said she was honored to represent Huntington, and reiterated what Mayor Steve Williams frequently says: Huntington will be known as the place that helped.

“We have a problem, but we will help turn it around,” she said.

Andrea Darr, director of the West Virginia Center for Children’s Justice; Kristi Justice, executive director for Kanawha Communities that Care; and Chad Napier, prevention and education coordinator for Appalachia HIDTA in West Virginia and Virginia, also presented during the summit.

Follow reporter Taylor Stuck on Twitter @TaylorStuckHD.