1-ribbonFirst they came for the mentally ill addicts, and I did not speak out—
Because I was not a mentally ill addict.

Then they came for the empathetic prescribers, and I did not speak out—
Because I was not a empathetic prescriber.

Then they came for the Pharmacists, and I did not speak out—
Because I was not a Pharmacist.

Then they came for me—and there was no one left to speak for me

Death of a business by opiophobic bureaucracy ?

Pernix Therapeutics Closes Acquisition of Zohydro ER Franchise

At least one Governor and numerous state Attorney Generals took this company to court over the introduction of this product. I guess between the opiate hysteria stirred up by all these groups hurt the sales of this product and the legal expenses incurred by the company… forced them to sell off the rights to this product and liquidate the company.

http://www.businesswire.com/news/home/20150424005748/en/Pernix-Therapeutics-Closes-Acquisition-Zohydro-ER-Franchise#.VTwig5Oui1x

MORRISTOWN, N.J.–(BUSINESS WIRE)–Pernix Therapeutics Holdings, Inc. (Nasdaq:PTX) (the “Company” or “Pernix”), a specialty pharmaceutical company, announced today that it has closed its acquisition of the Zohydro® ER (hydrocodone bitartrate) franchise, comprising three extended release hydrocodone products, including an abuse-deterrent pipeline and all related intellectual property. Pernix first announced the agreement with Zogenix, Inc. to acquire this franchise on March 10th.

“The Zohydro ER franchise is an excellent strategic fit with our focus on central nervous system disorders. These products address an extremely large and underserved market, affording us a significant opportunity for growth, both organically and through life cycle management”

“The Zohydro ER franchise is an excellent strategic fit with our focus on central nervous system disorders. These products address an extremely large and underserved market, affording us a significant opportunity for growth, both organically and through life cycle management,” stated Doug Drysdale, Chairman and Chief Executive Officer of Pernix.

“We look forward to launching Zohydro ER with BeadTek™ in May and advancing ZX-007, an innovative abuse-deterrent tablet formulation of hydrocodone ER, with the goal of submitting an NDA for this third-generation product mid-2016. We are also pleased to welcome the Zohydro ER sales team from Zogenix and certain other employees to Pernix. The new Pernix Pain Management Team will double our commercial footprint. Pernix today has three strategically promoted brands, each in large markets, with significant growth potential. Through a combination of sales execution and future acquisitions, we will look to strengthen our position as a leading player in the opioid pain market and build long-term value for our shareholders.” Drysdale concluded.

A transition to Zohydro ER with BeadTek is in process with the goal of no disruption to patients’ therapy, and all previous dosage strengths will be available in this new formulation. The original formulation will no longer be manufactured after May 4, 2015.

Terms of the agreement

Under terms of the agreement (as amended), Pernix, through its wholly-owned subsidiary, Ferrimill Limited (“Ferrimill”), has paid Zogenix $70 million in cash, issued to Zogenix 1,682,086 shares of Pernix common stock and deposited an additional $10 million in cash in escrow to fund potential indemnification claims for a period of 12 months following the closing. Pernix has also purchased certain Zohydro ER inventory as part of the transaction.

Ferrimill has also agreed to make certain payments conditioned on regulatory and commercial milestones of up to $283.5 million, including $12.5 million upon approval of ZX-007, a tablet formulation of extended-release hydrocodone with abuse-deterrent properties, and up to $271 million in potential sales milestones based on the achievement of pre-determined annual product sales milestones for Zohydro ER and ZX-007. Under the terms of the acquisition agreement, over 80% of the value of the sales milestones is tied to the achievement of net sales targets ranging from $500 million to $1 billion.

Pernix will purchase a pre-defined amount of Zohydro ER product inventory. Pernix will also seek to retain certain employees of Zogenix, including the field sales force of approximately 100 sales professionals and additional personnel related to the brand.

Jefferies LLC acted as financial advisor to Pernix. The Company’s legal advisers are Lowenstein Sandler LLP and Goodwin Procter LLP. Buchanan Ingersoll & Rooney PC acted as intellectual property counsel.

About Zohydro ER with BeadTek

Zohydro ER with BeadTek is an extended-release form of hydrocodone indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zohydro ER with BeadTek does not contain acetaminophen, unlike many immediate-release hydrocodone products, such as Vicodin and Lortab, reducing the risk for potential liver toxicity due to overexposure of acetaminophen. The active ingredient, hydrocodone, is the most commonly prescribed opioid in the U.S., with over 114 million prescriptions in 2014. Zohydro ER with BeadTek is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate containing technology that contains an inactive ingredient that immediately forms a viscous gel when crushed and dissolved in liquids or solvents.

About BeadTek™

BeadTek was developed using safe, well-known excipients and proprietary manufacturing processes to create an inactive ingredient that immediately forms a viscous gel when crushed and dissolved in liquids or solvents. All of the beads within the medication capsule are indistinguishable in color, shape, density and size, and do not impact the drug release profile when taken as directed.

LIMITATIONS OF USE

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

The Consumer Watchdog looks at what can be done to fix the problem. “Prescription Impossible” Monday on NewsChannel 5 at 11.

WPTV-oxycodonepills_1395939134121_3818735_ver1.0_640_480

Injured patients can’t get their painkillers; an unexpected consequence of pill mill crackdown

http://www.wptv.com/money/consumer/injured-patients-cant-get-their-painkillers-an-unexpected-consequence-of-pill-mill-crackdown

WEST PALM BEACH – The pill mill crackdown is cutting overdose deaths, but it’s also having unintended consequences for patients in pain.

Injured patients tell the Consumer Watchdog they can’t get their medication because pharmacy after pharmacy turned them away. One patient with an injured shoulder went to 14 pharmacies.

“They wouldn’t tell me when it was coming in. They wouldn’t hold the prescription and fill it. They wouldn’t order it. They wouldn’t substitute anything,” patient Jackie Larson explained.

She finally had to get her doctor to help her get her pain medication.

“Everyone treated you like a patient in pain except the pharmacies. We have a new glitch in our medical care system that needs to be corrected,” said Larson.

The Consumer Watchdog looks at what can be done to fix the problem. “Prescription Impossible” Monday on NewsChannel 5 at 11.

Bye-Bye Brain Cells ?

lyrica

Neurontin and Lyrica are a Death Sentence for New Brain Synapses

http://www.wellnessresources.com/freedom/articles/neurontin_and_lyrica_are_a_death_sentence_for_new_brain_synapses/

Neurontin and its newer more potent version, Lyrica, are widely used for off-label indications that are an outright flagrant danger to the public. These blockbuster drugs were approved for use even though the FDA had no idea what they actually did in the brain. A shocking new study shows that they block the formation of new brain synapses1, drastically reducing the potential for rejuvenating brain plasticity – meaning that these drugs will cause brain decline faster than any substance known to mankind.

The problem of these drugs is compounded by their flagrant illegal marketing. Neurontin was approved by the FDA for epilepsy back in 1994. The drug underwent massive illegal off-label promotion that cost Warner-Lambert 430 million dollars (the very first big fine for off-label promotion). The drug is now owned by Pfizer. Pfizer also owns Lyrica, a super-potent version of Neurontin. It has been approved by the FDA for various types of pain and fibromyalgia. Lyrica is one of four drugs which a subsidiary of Pfizer illegally marketed, resulting in a $2.3 billion settlement against Pfizer.

Even though the marketing of these drugs has been heavily fined, they continue to rack up billions in sales from the off-label uses. Doctors use them for all manner of nerve issues because they are good at suppressing symptoms. However, such uses can no longer be justified because the actual mechanism of the drugs is finally understood and they are creating a significant long-term reduction in nerve health.

The researchers in the above study try to downplay the serious nature of the drugs by saying “adult neurons don’t form many new synapses.” That is simply not true. The new science is showing that brain health during aging relies on the formation of new synapses. Even these researchers managed to question the common use of these medications in pregnant women. How is a fetus supposed to make new nerve cells when the mother is taking a drug that blocks them?

These are the kind of situations the FDA should be all over. As usual, the FDA is sitting around pondering a suicide warning for Lyrica while its off-label uses include bi-polar disorder and migraine headaches. The FDA is likely to twiddle its thumbs for the next decade on the brain damage issue. Consumer beware.

It is not our fault .. it is their fault…

pointingfingers

Report: State of Indiana prescription tracking system (INSPECT) is in ‘crisis’

http://www.courierpress.com/news/state/report-state-prescription-tracking-system-is-in-crisis_65884893

INDIANAPOLIS — A state system for tracking prescriptions has been “in crisis” and created a risk of exposing patients’ personal information, according to a state-commissioned report that Gov. Mike Pence’s administration tried to keep under wraps.

The system, intended to help the state fight prescription drug abuse and doctor-shopping, faces “significant threats and weaknesses that are compromising the integrity of the program,” said the report obtained by TheStatehouseFile.com.

It attributes the problems to staff vacancies — which state officials say are now largely filled — as well as a “tug-of-war” within Pence’s executive branch over who’s in control: The Indiana Professional Licensing Agency or the Indiana Board of Pharmacy.

But Nick Goodwin, director of legislative affairs for the Professional Licensing Agency, insists no such data threats exist, and he said a second, outside analysis proves it.

Goodwin also said the initial report’s claims about management, administration, staff and governance “were not accurately represented and were unsubstantiated by an absence of data validation other than conjecture from interviews with stakeholders.”

Still, lawmakers, who had to obtain a copy of the report through back channels after the Pence administration sought to force them to sign non-disclosure agreements to read it, remain so concerned about the program that they’ve sent the governor a bill that gives the pharmacy board more authority. The bill also creates a new oversight committee made up of the system’s users.

“With so much private consumer information at stake, we simply can’t afford to shortchange the program,” said House Public Health Chair Ed Clere, R-New Albany.

And state Rep. Steve Davisson, a pharmacist and Republican from Salem, said change is necessary given the initial report’s criticism of the program’s management and its importance in providing appropriate health care.

The “program is an important tool for physicians and prescribers and pharmacists around the state,” Davisson said. “It’s one of the most important tools we have in controlling prescription drug abuse.”

At stake are millions of prescriptions written by Hoosier doctors that are tracked through INSPECT, which stands for Indiana Scheduled Prescription Electronic Collection and Tracking Program.

INSPECT collects data from pharmacies about prescriptions of narcotics, opioids and other addictive drugs and lets doctors, pharmacists and police get information from the database to track whether patients are obtaining more pills than they should.

The information in the system includes names, dates of birth, addresses, driver’s license numbers and details about prescriptions for controlled drugs — information that must be kept secure, Davisson said.

But Netlogx, the outside vendor the Professional Licensing Agency hired for more than $100,000 to produce the initial assessment, couldn’t verify whether the agency had the systems in place to ensure the information was safe.

“The risk and the consequences from exposure of sensitive data is the most significant threat to the INSPECT Program overall,” the report said.

Goodwin argues the Netlogx report was not technical in nature and therefore not an accurate assessment of the security of patient information.

Still, the initial report raised enough questions that the agency ordered a second, more in depth technical review.

That one came from Indianapolis-based information security consultant Pondurance, and aimed to determine the extent that personal data may be at risk. The second report — released just this week — found some areas for improvement, particularly in the state’s compliance with federal health care privacy rules, but it generally determined the data is safe, said Eric Burton, the agency’s application system analyst.

“We did pretty good,” Burton said. The Pondurance report said the agency is “on the right track to meet and comply with all the security requirements” of federal laws.

But Netlogx says that at the time of its report, which was dated Dec. 31, 2014, the state had left INSPECT’s quality assurance analyst position open for almost a year. That position is “critical to data integrity and protection.”

Goodwin said that’s not true. He said INSPECT did not previously have a quality assurance position and that those duties have fallen under the director since 2013. He said the agency has since created a separate quality assurance position and is now in the process of filling it.

Netlogx conducted its assessment of INSPECT over six weeks, reviewed documents and policies, and interviewed 37 people, including program staff, users and state leaders.

The report found the INSPECT program:

Was understaffed. At the time of the report, two staff members were covering five full-time positions. Goodwin said it was actually four positions and two of those have since been filled.

Has a director, Holly Walpole, who is “held in high regard” among her colleagues nationally. They were impressed by the director’s “ability to manage the INSPECT program despite crippling staff shortages.”

Is “neglected in key areas and over-managed in others causing significant problems in organization.” The director is both isolated in her duties and still responsible to two different groups — the agency administrators and the pharmacy board, which often conflict.

The report talks repeatedly about the agency’s staffing problems, which lawmakers said occurred even though the General Assembly had appropriated enough money for a full staff.

Goodwin said the positions stayed open longer than usual because two people hired to fill them opted later not to take the jobs. He said the timing of the openings just happened to coincide with the Netlogx report.

That report also said the program suffers because there’s no clear understanding of who’s in charge. The report said the Professional Licensing Agency has conflicting organizational charts and that the INSPECT director isn’t included in weekly agency director meetings.

“At the core of these issues is confusion regarding who has the authority over” the program, the report said.

Goodwin said the structure is set by law, not by the agency. And he said the director always is included in meetings dealing with her program.

The legislature intended to give the pharmacy board general oversight of the system, Davisson said. But the board is staffed by the Professional Licensing Agency, which also controls the program’s budget and staffing.

“Currently there seem to be a tug of war between both entities, and the minimal staff of INSPECT is in the middle struggling to manage operations,” the report said.

Davisson said he’s hopeful the report and the changes approved by the legislature will make a difference. But he and Clere said it has been difficult to get information from the licensing agency. In fact, just getting a copy of the Netlogx report, which the agency has deemed confidential under state public records law, proved problematic.

Initially, lawmakers said, the agency declined to give them the report, citing concerns about security.

Then, Clere and Davisson said the Pence administration asked them to sign non-disclosure agreements simply to review the report’s contents. The lawmakers said they refused, obtained the report from other sources, and then shared it with members of the House Public Health Committee.

“There’s not enough transparency,” Clere said. “No one is suggesting they ought to release information or details that are of a truly sensitive nature from a security standpoint. But most of what we’re talking about here has nothing to do with specific or proprietary security information.

“The report deals with management issues and oversight issues and other things like that,” Clere said. “It would be good for INSPECT and good for the legislative process and good for the state if there was more transparency.”

UTAH State law apparently – NEGATES – the FOURTH AMENDMENT ?

mntmolejudicialUnwarranted drug database search prompts new Utah law, lawsuits

http://www.deseretnews.com/article/865627152/Unwarranted-drug-database-search-prompts-new-Utah-law-lawsuits.html

SALT LAKE CITY — A United Fire Authority assistant chief says an unwarranted police search of the state’s prescription drug database that led to criminal charges against him turned his life upside down.

And based largely on what happened to Marlon Jones, state lawmakers earlier this year passed a bill that makes it more difficult for law enforcement to rifle through Utahns’ electronic medicine cabinets.

Jones says in a federal lawsuit filed this week that Cottonwood Heights police violated his privacy when a detective obtained his medical history through the database without probable cause or a search warrant. State prosecutors filed felony prescription fraud charges against Jones but then dropped them 18 months later.

“I had no idea that this could even happen to anybody,” Jones told a legislative committee in February.

Utah allows law enforcement unregulated access of any person’s private medical history in the database without reasonable suspicion of criminal activity, according to the complaint filed this week in U.S. District Court.

“In reality, there is zero oversight of how the database is being used by law enforcement. As a result, law enforcement is able to circumvent a person’s privacy rights on a whim by searching for that person on the database,” the lawsuit says.

“It’s the invasion into our private affairs that we’re concerned about and that’s why this is an important lawsuit,” said Jones’ attorney, Tyler Ayres.

Sen. Todd Weiler, R-Wood Cross, called what happened to Jones wrong and said his experience prompted the legislation.

“We live in the United States of America. We have protections. We have the right to privacy,” he said.

His bill, SB119, requires law enforcement to obtain a search warrant to which a specific name is attached before searching the prescription drug database. The new law takes effect May 12.

Weiler said then-Gov. Mike Leavitt warned in 1995 when the Legislature created the prescription drug database that there was a huge potential for abuse and lawmakers would have to come back and put a lid on it.

“And that’s exactly what’s happened,” Weiler said.

Jones’ ordeal began after Unified Fire Authority reported to police that vials of morphine, fentanyl and midazolam were taken from ambulances in southeast Salt Lake Valley.

Cottonwood Heights Police Chief Robbie Russo gave detective James Woods the names of 480 firefighters, including Jones’ name, to investigate regarding the missing medication. Russo got the list from Mayor Kelvyn Cullimore, a Unified Fire Authority board member, according to the lawsuit.

Woods determined through the database that Jones was dependent on opiates and seeing three different doctors. The detective then interviewed the doctors and pharmacists about Jones’ medical conditions and treatment.

The detective reported his findings to the Salt Lake County District Attorney’s Office, which charged Jones with 14 counts of obtaining a prescription under false pretenses, a third-degree felony.

Jones, 50, was being treated for a back injury suffered in an accident and two knee replacements, Ayres said. His doctors were aware of each other and didn’t think he was abusing prescription drugs, according the lawsuit.

Ayres said Jones never sought medication that was not prescribed to him nor has he abused it any way.

Prosecutors also filed felony prescription fraud charges against paramedic Ryan Pyle as a result of the database search. Those charges were later dropped. Pyle, too, has a federal lawsuit pending against Cottonwood Heights.

No one was charged with stealing narcotics from the ambulances after the investigation.

In a court response to Pyle’s lawsuit, the city denied violating his rights and asked a judge to dismiss the case.

Cottonwood Heights City Manager John Park said Thursday the city has not seen Jones’ lawsuit and had no comment.

Police arrested Jones at his home in July 2013, placing him in handcuffs and putting him in a marked patrol car in front of his family and friends. United Fire Authority put Jones, a 26-year veteran, on paid leave and suspended his access to fire stations.

“For 18 months, a man with an otherwise spotless record was held under a magnifying glass and basically tortured like an ant,” Ayres said.

He said Jones, who sometimes acted as public spokesman for Unified Fire Authority, felt embarrassed and discouraged. He couldn’t fully participate in his son’s induction ceremony into the fire service.

“There were some tears shed quite frequently. That’s a lot of pressure, that’s a lot of pressure for someone to deal with,” Ayres said. “It becomes very disheartening when it’s somebody who’s tried to do nothing but serve his community for his whole life.”

A month before Jones’ trial was to start in 3rd District Court in November 2014, prosecutors dismissed the charges against him.

Salt Lake County District Attorney Sim Gill said at the time that the evidence presented to his office when the case first came under investigation had changed.

“The evidence that was certainly available at that time gave us a good basis to believe there was a violation,” he said. “Subsequently, what we’ve discovered is that some of the evidence from some of the medical folks may not be as strong, and may actually be a basis for a defense.”

Jones, who is in Africa this week training firefighters and first responders, is back on the job as an assistant fire chief.

He told the legislative committee that the painful experience put him and his family through hell. He said his father delayed retirement so he could pay Jones’ mortgage and attorney fees.

“Thought I was healed up a little bit more,” he told the committee through tears. “Still working on it.”

Email: romboy@deseretnews.com

Don’t “POP” that cork on the champagne bottle just yet

champagnebottleCannabis Industry Happy To See DEA’s Leonhart Go, But New AG Lynch Is No Friend

http://www.forbes.com/sites/debraborchardt/2015/04/24/cannabis-industry-happy-to-see-deas-leonhart-go-but-new-ag-lynch-is-no-friend/

The cannabis industry may be thrilled that the Administrator for the Drug Enforcement Administration (DEA) Michelle Leonhart is stepping down, but with the confirmation of Loretta Lynch as the new Attorney General it may not matter. During her confirmation hearings Lynch said she did not support the legalization of marijuana and did not agree with President Obama that marijuana was less dangerous than alcohol. Almost the same positions held by Leonhart.

Leonhart has had a rocky tenure capped off by the recently issued report on sexual misconduct from the The Office of Inspector General (OIG). On April 14th the House Oversight and Government Reform Committee held a hearing on the allegations of sexual misconduct and Leonhart, who has never performed well during these types of hearings, once again dug her own grave.

The agents under her watch engaged in sex parties funded by the very drug cartels they were supposed to be working against. Some special agents also received money, expensive gifts and weapons from the drug cartels as well. No one lost their jobs and the worst punishment was between a 2 day and 10 day paid suspension. The Congressmen were very frustrated and disbelieving when she insisted she wasn’t able to fire the employees.

WASHINGTON, DC – MARCH 12: U.S. Drug Enforcement Administration Administrator Michelle Leonhart testifies before the Senate Appropriations Committee’s Commerce, Justice, Science and Related Agencies Subcommittee about the ATF’s FY2016 budget in the Dirksen Senate Office Building on Capitol Hill March 12, 2015 in Washington, DC. Leonhart and the heads of the U.S. Marshals Service, Bureau of Alcohol, Tobacco, Firearms and Explosives, and the Federal Bureau of Investigation testified about funding requests and budget justifications. (Photo by Chip Somodevilla/Getty Images)

In addition, the DEA did not give the OIG access to the open misconduct case and many interviewed said they were told not to help the OIG. Leonhart told the committee she couldn’t provide the information because of technology limitations – that she couldn’t do the computer searches asked of her. Then Michael Horowitz, the Inspector General sitting right next to her threw her under the bus and said that she told him she wouldn’t provide information for the investigation because of privacy issues. As they say in the DEA – busted. This past week, Leonhart announced she was resigning following a bi-partisan vote of no confidence in her leadership.

Leonhart had been derided by many in the pro-cannabis community for her positions on marijuana. She famously refused to state that marijuana was less dangerous than crack. She refused to stand down on marijuana raids even after Attorney General Holder said it wasn’t a priority. She also openly disagreed with President Obama. Many have been surprised she held on as long as she did.

“I don’t know any high level ranking federal official to go before congress and directly criticize the president and still have their job,” said Kris Krane, Managing Partner of 4Front Advisors and a former Associate Director of NORML. “It’s amazing she was able to survive that.”

Tennessee Congressman Steve Cohen said, “It is appropriate that Michelle Leonhart resign; she has not prioritized or concentrated on drugs that actually lead people to commit crimes like heroin and methamphetamine and she was insubordinate to the President when she criticized his acknowledgement of the fact that marijuana is no more harmful than alcohol.”

Dan Riffle Director of Federal Policies at the Marijuana Policy Project takes an even bolder approach suggesting “More importantly, the president should use this opportunity to reevaluate what the DEA’s job is, and whether that’s something we even need anymore. The DEA was created in 1973 by Richard Nixon when he launched the so-called “War on Drugs.” Today, public opinion polls show the War on Drugs is incredibly unpopular because just about everybody understands it has been a catastrophic failure that causes more harm than good. The president himself has said many times that we must end the “War on Drugs,” and that marijuana should be treated as a public health issue more than a criminal justice one. If he believes that, then it’s time to stop putting the police in charge of drug policy.

Even if the new head of the DEA is more marijuana friendly, it doesn’t look like they’ll have an ally in Lynch. Lynch has said that Federal laws should be enforced and for now that means marijuana is a schedule I drug and a controlled substance. If a new DEA head chooses to reclassify marijuana, then Lynch will have to fall in line.

“The DEA is a weird agency in that it both enforces the law by investigating illegal drug manufacturing and distribution, and helps determine the law by, for example, determining drug schedules, licensing researchers, and determining who can produce drugs for research. There’s a troubling inherent conflict there, and I think we have to pick one of the other,” said Riffle.

For now, no names have been put forward as to who will replace Leonhart and she is expected to remain in the job for another month. Riffle said he’d like to see someone in the job with a public health background. “If the DEA’s job is law enforcement, then it should be folded into the FBI or another agency. After all, as the president and drug czar have said repeatedly we’re not going to arrest and prosecute our way out of the problem. But if the DEA is to retain its traditional oversight role in the scientific process and research into medical marijuana and other substances, then we should appoint someone with a public health background to fill the role.”

Cohen also has his wish list. “Hopefully, her successor will help lead the effort to reschedule marijuana from Schedule I, where it is currently restricted at the same level as heroin and at a higher level than more harmful drugs like cocaine.”

Whoever is chosen for the position at the DEA will be facing a rapidly changing drug landscape. The new administrator will be stuck between citizens who are becoming less concerned about illegal marijuana, a Congress that has multiple forms of marijuana legislation it is considering and an new Attorney General that is not pot friendly.

What can happen when pts with mental health/addiction issues are treated like pts with a chronic condition

Here’s What’s Wrong With How U.S. Doctors Respond to Painkiller Misuse

http://www.psmag.com/health-and-behavior/heres-whats-wrong-with-how-us-doctors-respond-to-painkiller-misuse

Too often, Americans with painful medical conditions who misuse pain pills like Oxycontin are denied further treatment and even prosecuted. There are more effective, enlightened responses—as the U.K. has shown for decades.

When a patient recently came into the St. Paul, Minnesota, office of Dr. Mark Willenbring, the doctor already knew his history. Diagnosed in his 20s with a chronically painful disorder, James (not his real name) had done well on opioid painkiller Oxycontin for almost a decade.

Then, however, his pain spun out of control. He developed a craving for higher and higher doses and began misusing his medication. At that time, Willenbring started him on methadone, a synthetic opioid that offered another few years of effective pain relief.

“He went from one hour a day up and active to 16 hours up and active,” Willenbring says. “He started coaching his kids’ sports teams. He got a job.” Unfortunately, James also suffered from depression and anxiety. When he developed a phobia related to work, he dropped out of treatment and returned to his pattern of self-medicating with Oxycontin.

Now he was back. Because Willenbring specializes in addiction—he’s the former director of treatment and recovery research for the National Institute on Alcoholism and Alcohol Abuse and currently runs an addiction treatment program called Alltyr—he knew what to do. He began prescribing Suboxone, another synthetic opioid, along with treatment for James’s psychiatric problems.

Compared to no treatment, maintenance reduces mortality by around two-thirds. Since dead addicts can’t recover, failing to provide access to these medications for those who can benefit from them is literally killing people.

“He’s better,” Willenbring says. “He’s not well and I’m also modifying his depression treatment and doing psychotherapy because he’s got issues with his family and spouse and you have to treat the whole person.” Still, he is no longer taking unprescribed drugs and Willenbring sees a good prognosis.

But what if James had been caught misusing pain medication by a less educated or enlightened doctor or pharmacist? What should doctors do if they discover a patient is “doctor shopping” or has developed an addiction?

In a country where overdose deaths have overtaken car crashes as the leading cause of accidental death, with nearly 50 people dying from opioid-containing overdoses every day and 2.1 million people addicted to such drugs, these questions are increasingly urgent.

Sadly, the typical response is to refuse to prescribe more pain drugs—and, if the patient is lucky, to provide a referral to treatment. Alternatively, people caught misusing opioids or obtaining illicit prescriptions by prescription drug monitoring programs or pharmacists who serve as gun-toting narcotics control agents can be arrested and prosecuted.

Willenbring’s example suggests a better way. It’s not like we don’t know what the best currently available treatment for opioid addiction is: The CDC, the World Health Organization, the Institute of Medicine, and many other leading expert bodies have examined the data repeatedly. Studies show that long-term maintenance on either methadone, Suboxone, or even heroin—without time limits—is best.

The most important statistic is this: Compared to no treatment or abstinence-only treatment, maintenance reduces mortality by around two-thirds. Since dead addicts can’t recover, failing to provide access to these medications for those who can benefit from them is literally killing people.

However, only 39,000 Americans are currently on Suboxone treatment and nearly 312,000 are in methadone programs. In other words, more than 80 percent of opioid addicts aren’t being reached.

For a model of how to do better, we can look to our own past and to the more recent success of the “British system,” which dominated opioid treatment in the United Kingdom from the 1920s through the 1960s.

First, the American experience. After non-medical use of opiates became illegal in the United States with the Harrison Narcotics Act of 1914, initially many doctors simply prescribed for addicts and considered this as medical care. Unfortunately, in 1919 and again in 1923, the Supreme Court ruled the practice was illegal.

Drug policy became increasingly focused on criminalization, and large-scale maintenance did not re-appear in the U.S. until the introduction of methadone in the 1970s. Then, it became the most regulated drug in the pharmacopeia, with prescribing for addiction limited to specialized clinics and restrictive zoning laws typically limiting those clinics to poor neighborhoods.

In the U.K., however, maintenance prescribing was officially accepted in the early 20th century, with the 1926 Rolleston Report. It defined addiction as a disease and, therefore, a condition that can be treated with medications. For almost four decades, the U.K.’s opioid problem was limited to a few hundred addicts, who got their drugs mainly from general practitioners.

Those numbers began to increase in the 1950s due to changes in drug culture. When flagrant “pill mills” appeared—prescribing high doses with little regard for safety—this approach came under pressure. And so, in 1968 and 1969, the U.K. shifted to a system that, like ours, basically ghettoizes opioid addiction. It confined maintenance treatment to doctors with special licenses, although it did continue to allow prescription of heroin and other injectable drugs.

Then, however, came a U.S.-influenced flirtation with even more restrictive measures like time limits on prescribing in the 1980s. That led to an increase in overdose deaths. In reaction to this and, even more, to the threat of AIDS, the U.K. expanded maintenance through its clinics and licensed doctors. Together with needle exchange and other harm reduction measures, this prevented HIV from becoming an epidemic in IV drug users, as happened in the U.S., which did not respond as fast.

In the U.K., HIV infection rates never went above one percent in addicts, while in some cities in the U.S., levels reached 50 percent or higher and then led to a heterosexually transmitted epidemic in minority communities. (Unfortunately, the U.K. now is once again battling politicians who want to limit prescribing, but its medical establishment, based on the data, continues to resist.)

Doctors who would overlook a patient’s lies about, say, diet and exercise instead become personally affronted about painkiller misuse. It’s hardly surprising. Being fooled in this way can have severe legal consequences for the doctor.

And here, today, we’re still stuck with overly restrictive limits on prescribing and the segregation of addiction care from the rest of medicine. While the Food and Drug Administration did not repeat the mistake it made with methadone and limit Suboxone prescribing to specialty clinics, doctors are still only allowed to prescribe to 100 or fewer patients and they must receive special training before they do so. Methadone, when used for addiction, not pain, is still only available in clinics.

“The major health organizations, for the most part, have not stepped up to the plate in response to the crisis in opioid over-prescribing and the increase in overdose deaths,” Willenbring says. “They haven’t offered high-quality, easily accessible, insurance-based Suboxone treatment.”

Some states are starting to try to do better. Vermont, for example, has set up a “hub and spoke” system, intended to ensure that anyone with opioid addiction can be referred to a doctor or program near home who can prescribe. State policy is now aimed at deferring prosecution for addicted people who agree to seek treatment.

But while this has resulted in increased demand for treatment—with hundreds of people on waiting lists—it has been hard to increase the maintenance supply. Despite the availability of state money to pay the nurses and counselors of general practitioners willing to prescribe, only one in five such doctors have agreed to do so.

Reports NPR:

David Pattison, who has been treating addiction for eight years, says many doctors have been burned by patients who faked needing drugs for pain. They’re leery when the same patients come back for addiction treatment.

“It really feels bad to get tricked like that,” Pattison says. “They don’t want to have anything to do with those people who have been violating their trust.”

This is where stigma continues to curtail care; where doctors who would overlook a patient’s lies about, say, diet and exercise instead become personally affronted. It’s hardly surprising: Being fooled in this way can also have severe legal consequences for the doctor.

If we want to improve addiction treatment, then, we’ve got to get the criminal justice system out of the relationship between doctors and patients—or, at least, minimize its involvement. A doctor who finds out she’s been “tricked” should be able to prescribe maintenance on the spot: She shouldn’t be legally at risk for having been taken in or legally barred from helping once she realizes what’s going on.

We also need better medical education on addiction, presenting it as an actual medical disorder—not as the only disease for which the official treatment is referral to other patients to guide them in prayer and confession.

A few years ago, I saw Dr. Nora Volkow, the director of the National Institute on Drug Abuse, at a conference. I asked her whether anyone was studying or attempting to spread the practice of such prescribing, when a doctor or pharmacist catches a doctor shopper or prescription forger or simply realizes a patient has become addicted. She started to mention a program that involved a drug court and I stopped her.

I said that I meant a program that didn’t involve criminalization. She said, “Well, that’s what we would do if we saw addiction as a disease.”

This post originally appeared on Substance, a Pacific Standard partner site, as “Here’s What’s Wrong With How U.S. Doctors Respond to Painkiller Misuse.”

 

At the VA.. only the best care available… at the lowest price ?

VA clinic substituted mental-health drugs to save money

http://www.washingtonpost.com/blogs/federal-eye/wp/2015/04/23/va-clinic-substituted-mental-health-drugs-to-save-money/

A Department of Veterans Affairs medical center in West Virginia put patients at risk by substituting prescribed mental-health medications with older drugs to cut costs, according to a federal investigation.

The practice, exposed by an agency whistleblower, violated VA policy and created a “substantial and specific danger to public health and safety,” the department’s Office of Medical Inspector found.

The U.S. Office of Special Counsel, which investigates and prosecutes whistleblower cases, informed Congress and the White House of the findings in a letter Wednesday.

“At a time when many veterans are grappling with mental-health issues, this VA facility was cutting corners on needed drug therapy to save money,” U.S. Special Counsel Carolyn Lerner said in a statement Wednesday. “We only know this was happening because an employee had the courage to blow the whistle on this dangerous practice.”

VA rules bar the agency from basing drug restrictions on economics alone and require the agency to provide specific medications when necessary for a patient’s health needs.

The investigation confirmed that a VA clinic in Beckley, W.Va., implemented a “blanket restriction” on administering two antipsychotic drugs, aripiprazole and ziprasidone, to help meet its cost-saving goals for fiscal 2013.

The facility’s pharmacy committee, responsible for making such decisions, made the change without a clinical determination about the possible health impacts, according to the Office of Special Counsel. The chair of the panel at the time was not a physician.

The Office of Medical Inspector recommended that the clinic determine whether the drug substitutions affected patients’ health, in addition to disciplining the pharmacy committee’s leadership and appointing a physician to head the panel.

Lerner said the clinic took “immediate and appropriate measures” to resolve the drug-substitution issue. But she added that the whistleblower has made claims of continued wrongdoing may be occurring at the clinic.

The VA said it has begun an investigation based on the findings and recommendations of the Office of Medical Inspector report.

“We will immediately take action where it is warranted to ensure the most current medical standards are strictly followed,” the department said in a statement. “We applaud the VA employee who contacted the OSC on this matter. Secretary McDonald has made clear that employees who step forward to raise concerns have a direct bearing on the veteran outcomes we deliver, and this is an example of why that is important.”

Lerner said she closed the case “conditionally,” pending a follow-up report to address the allegations of continued wrongdoing. The analysis is due to be completed by May 11.

Customer alleges she suffered seizures after Walgreens denied her prescription for narcotics they wrongfully sold to someone else

Customer alleges she suffered seizures after Walgreens denied her prescription for narcotics they wrongfully sold to someone else

http://louisianarecord.com/news/268166-customer-alleges-she-suffered-seizures-after-walgreens-denied-her-prescription-for-narcotics-they-wrongfully-sold-to-someone-else

GRETNA – A Walgreens pharmacy is being sued by a woman who claims she suffered seizures after being denied a refill of her narcotic medication after someone else purchased it from the pharmacy without her permission or knowledge.

Susan Ferry filed suit against Walgreen Louisiana Co., doing business as Walgreens Health Initiatives Inc. and Walgreens Drug Store, and Summer Troxclair in the 24th Judicial District Court on March 6.

Ferry contends that on March 11, 2014 she visited a local Walgreens pharmacy to have a prescription filled for a narcotic medication, but was told it would not be ready to pick up until the following day. The plaintiff asserts that a third party overheard her conversation with the pharmacist, Troxclair, regarding the prescription who went to the pharmacy the following day pretending he was picking up the narcotic medication for Ferry, but instead keeping it for himself.

Ferry claims the pharmacy staff never requested photo identification from the person who purchased her medication making it impossible to determine who he was or if he was the proper person to receive the medication. The plaintiff alleges that after it was discovered someone else had purchased her medication the pharmacist at Walgreens refused to have it refilled and as a result of not getting her medication she suffered seizures.

The defendant is accused of negligence in dispensing medication, failing to comply with photo identification policy, failing to warn of a third party purchasing medication and vicarious liability.

An unspecified amount in damages is sought by the plaintiff.

Ferry is represented by attorneys Robert T. Garrity Jr. of Harahan and Peter M. Meisner of River Ridge.

The case has been assigned to Division E Judge John J. Molaison Jr.

Case no. 747-428.

This entry was posted in 24th Judicial District Court, Gretna, Issues, News, Personal Injury and tagged , , , , , , , , , , , , , , , , , , , . Bookmark the permalink.

Controlled Substances Standards Committee to address problems

Prescription drug denials gaining traction with state leaders

Controlled Substances Standards Committee to address problems

http://www.wesh.com/health/prescription-drug-denials-gaining-traction-with-state-leaders/32516338?utm_source=Social&utm_medium=FBPAGE&utm_campaign=WESH%202%20News%20-%20wesh2news&Content%20Type=Story&linkId=13712685

VIDEO on website

The committee, which is comprised of four Florida Board of Pharmacy members, will work on this issue over the summer and look at changes that can be made without legislation. Their meetings are said to be open to the public.

Prescription drug denials gaining traction with state leaders
Controlled Substances Standards Committee to address problems

TALLAHASSEE, Fla. —The state House voted Wednesday to extend what’s become known as Florida’s Pill Mill bill.

DEA, State Attorney’s staff discuss prescription drug issues
DEA State Attorney meet to discuss prescription drug problem

Staff members from Attorney General Pam Bondi’s office and Drug Enforcement Administration officials had a closed-door meeting Tuesday to discuss the prescription drug issues plaguing Florida.
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DEA, State Attorney’s staff discuss prescription drug…
DEA State Attorney meet to discuss prescription drug problem

Staff members from State Attorney Pam Bondi’s office and DEA officials met behind closed doors on Tuesday to discuss why patients with legitimate prescriptions are being denied pain medications. WESH 2’s Matt Grant (@MattGrantWESH) has the latest.
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The law brought a massive crackdown on doctors’ offices and pharmacies filling medication that fueled the state’s prescription drug overdose problem.

The same bill passed the Senate and will go to Gov. Rick Scott, who is expected to sign the legislation.

The Pill Mill law is credited with ushering a wave of restrictions causing patients with legitimate prescriptions to be denied their medication.

WESH 2 learned Wednesday that the Florida Board of Pharmacy, which operates under the Department of Health, has convened a special committee, called the Controlled Substances Standards Committee, to address the problem.

Attorney General Pam Bondi’s staff met with the DEA Monday to talk about patients in Florida who are unable to get needed medications.

Some lawmakers said that meeting is an encouraging sign.

“I’ve spoken with the attorney general. She assured me that they’re working to try to make sure this issue is being resolved,” Rep. Dwayne Taylor said.

“I’m encouraged that Attorney General Bondi is meeting with the DEA about this issue, but if I don’t see any movement over the summer I’ll be filing a bill with the best of my ability to try to at least alleviate, if not solve, the problem,” Sen. Darren Soto said. “I do know what is happening now is robbing people of legitimate prescriptions,” Soto said.

Soto called for a hearing on the topic in February, but the Senate’s Health Police Committee chairman Sen. Aaron Bean denied the request, saying it’s not a state issue.

“When it’s outside of your purview, we can call attention to it from the federal government, as we have, and let’s hope they’ll come and give that some attention,” Bean said.

“The DOH is extremely concerned about this issue,” Florida Department of Health official Lucy Gee said.

Gee also said the Department of Health plans to take action for patients, and that she and her colleagues are working to talk with wholesalers, chain pharmacies and doctors for a workable solution for patients who are denied legitimate prescriptions.

“We’re also very optimistic that we are going to come up with solutions that maintain the safety guard rails that were established by the Legislature but ensure patients receive the drugs that they need,” Gee said.

One of the things the Controlled Substances Standards Committee will examine is the red flags pharmacists are trained to look for, such as being warned not to fill prescriptions from doctors who aren’t local.

“We are very optimistic that something will change,” Gee said.

The committee, which is comprised of four Florida Board of Pharmacy members, will work on this issue over the summer and look at changes that can be made without legislation. Their meetings are said to be open to the public.

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