Trump’s Pick For Drug Czar Hauled In Thousands Of Dollars From Drug Distributors He Wrote Bill To Protect

Posted on April 14, 2017 by Pharmaciststeve

Trump’s Pick For Drug Czar Hauled In Thousands Of Dollars From Drug Distributors He Wrote Bill To Protect

http://www.ibtimes.com/political-capital/trumps-pick-drug-czar-hauled-thousands-dollars-drug-distributors-he-wrote-bill

VIDEO ON ABOVE LINK

President Donald Trump recently launched a high-profile White House initiative to combat the growing problem of opioid drug abuse in America. Yet his expected selection to oversee the nation’s drug laws is a congressman from an opioid-ravaged district whose signature legislative accomplishment is a bill that shielded prescription opioid distributors from law enforcement scrutiny.

The White House is expected to name Rep. Tom Marino, R-Pa, to be the Director of the Office of National Drug Control Policy (ONDCP) — a position often referred to as the nation’s “drug czar.” Marino is a former prosecutor who has represented a rural district in northeastern Pennsylvania since 2011. The ONDCP declined to comment for this story and Marino’s office did not respond to multiple requests for comment as well.

 

If appointed, Marino would be the first member of Congress to become drug czar. He would come to the job after pulling in big money from an industry that is producing and distributing the nation’s most deadly legal drugs. Marino has received more than $150,000 in donations from the pharmaceutical industry in his political career, including $71,000 for the 2016 election, according to records at Maplight.org and Opensecrets.org. The data show Marino has received more money from the pharmaceutical industry than any other sector.

As the nation faces an opioid crisis fueled by the mass production and marketing of addictive prescription drugs, some physicians fighting the epidemic view Marino’s possible ascent to drug czar as a betrayal of rural communities ravaged by opioids — many of which voted overwhelmingly for Donald Trump.

“This is the opposite of draining the swamp,” Dr. Andrew Kolodny, the co-director of Opioid Policy Research at Brandeis University and co-founder of Physicians for Responsible Opioid Prescribing (PROP), told International Business Times. “In the midst of a public health crisis [Trump] is putting at the helm of the ONDCP someone who has worked for the opioid lobby against efforts to bring the epidemic under control.”

It’s hard to overstate how deadly the opioid epidemic has been for Americans. Since 1999, the number of overdose deaths from opioids has quadrupled, as did deaths from prescription opioids like oxycontin, fentanyl and hydrocodone, according to the Centers for Disease Control and Prevention. Many experts blame this rise on the makers of opioid prescription drugs, like Purdue Pharma, the creator of oxycontin, which pled guilty to misleading doctors about the drug’s addictiveness and agreed to pay $600 million in fines in 2007. Three Purdue executives also agreed to pay a total of $34.5 million in fines.

“This epidemic was created by pharmaceutical companies,” Georgetown University’s Dr. Adriane Fugh-Berman told IBT. She is the director of PharmedOut, a group that advocates for responsible prescribing practices. “That’s not too strong to say.”

The epidemic has only intensified since Purdue’s guilty plea in 2007, and now cities and counties are bringing lawsuits against drug distributors — the companies that sell drugs wholesale. The three largest distributors — McKesson Corp., Cardinal Health and AmerisourceBergen, which together generated $430 billion in 2015 and account for 85 percent of the drug distribution market — have agreed to pay $230 million in fines to the federal government and opioid-plagued West Virginia since late December. The fines were connected to charges that the companies failed to report suspicious orders of pharmaceuticals.

According to Maplight.org, all three companies have given multiple campaign donations, totaling between $13,000 and $15,000, each to Marino who wrote legislation that made it harder for the DEA to take companies off a registry that allows them to distribute controlled substances. If the companies were dealt this penalty, they could potentially incur a far greater financial hit than fines.

Marino introduced three versions of the Ensuring Patient Access and Effective Drug Enforcement Act between 2014 and 2015 before H.R. 471 passed the House. In the Senate, Orrin Hatch, R-Ut, who received more money from the pharmaceutical industry than anyone in Congress between 2010 and 2016, introduced a companion bill. The legislation was eventually signed by President Barack Obama last year, but not before DEA Deputy Assistant Administrator Joseph Rannazzisi had a conversation with congressional staffers that provoked the ire of Marino, who said Rannazzisi told staffers the bill’s sponsors were “supporting criminals.” (Rannazzisi told the Washington Post he said the bill would “protect defendants in our cases.”)

During a congressional hearing, Marino told Rannazzisi’s boss the comments offended him “immensely,” and the congressman even asked the Justice Department to investigate whether Rannazzisi had tried to “intimidate” members of Congress. Rannazzisi was eventually replaced at the DEA in 2015 and retired shortly after. He did not reply to multiple requests for comment for this story.

“Rep. Marino has made it very clear he is on the side of opioid manufacturers,” PharmedOut’s Fugh-Berman told IBT. “The bill he supported made it hard for the DEA to go after distributors and wholesalers of drugs. The DEA was having its hands tied even before Trump got into office but this appointment will make things much worse.”

It could also put Marino in tension with others in the Trump administration. Late March, Trump convened the first meeting of the President’s Commission on Combating Drug Addiction and the Opioid Crisis at the White House. The commission is led by New Jersey Gov. Chris Christie, who has dedicated the last year of his increasingly unpopular governorship to fighting the opioid crisis, and who governs a state that is home to 14 of the world’s 20 largest pharmaceutical companies.

Christie Governor Chris Christie speaks to supporters in West Des Moines, Iowa, Jan. 31, 2016. Photo: REUTERS/BRIAN C. FRANK

Tough On Marijuana

As drug czar, Marino’s job would be to coordinate drug policy across a variety of unrelated federal agencies such as the Department of Homeland Security, the Justice Department (which houses the DEA), Health and Human Services and the Department of Education, according to former drug czar Gil Kerlikowske.

”The job is “breaking down silos” and bringing together “all of those assets, so they can coalesce around a mission,” Kerlikowske, who served as drug czar under Obama from 2009 to 2014 before becoming the U.S. Customs and Border Protection commissioner, told IBT. “You also have the bully pulpit of being part of the White House.”

Kerlikowske was the chief of Seattle Police before taking the job, but didn’t think the czar should necessarily come from a law enforcement background.

“Coming from Congress, I think that’s healthy, and probably a good idea,” Kerlikowske said. He also added that Marino’s history as a prosecutor would be an advantage, because it would be “pretty hard to cast him in the light of being soft on drugs.”

While Marino has helped the opioid industry during his career in Congress, he has not been as friendly to the marijuana industry.

Marino voted against allowing Veterans Administration doctors to prescribe medicinal marijuana to veterans in states where the drug is legal, and also voted against lowering obstacles to the production of hemp, the non-psychoactive part of the cannabis plant. He even voted against legislation that prevented the Justice Department from pursuing medical marijuana businesses that were legal under state law.

This tough-on-marijuana view aligns Marino with Attorney General Jeff Sessions, who has said marijuana is only “slightly less awful” than heroin and has sparked concerns about a return to the “War on Drugs” policies of the past. But while the Trump administration has signaled a tough stance on marijuana with its drug czar and attorney general picks — in spite of the fact a majority of Americans support legalizing the drug —  it has simultaneously shown a deference to the pharmaceutical industry. Trump’s nominee to head the FDA is Dr. Scott Gottlieb, who has advocated for deregulation in the medical industry and received over $400,000 from pharmaceutical and medical device companies between 2013 and 2015, according to ProPublica.

Controversial End To Prosecutorial Career

During his Senate confirmation hearing, Marino could face questions about his law enforcement record — and a scandal that nearly ended his political career.

In 2007, Marino resigned from his position as a federal prosecutor after it was revealed Pennsylvania casino owner Louis DeNaples put down Marino’s name as a reference on a gaming application at the same time Marino’s office was investigating DeNaples for ties to organized crime. After his resignation, Marino went to work as in-house counsel for several DeNaples businesses. In 2010, during his first run for Congress, Allentown’s Morning Call reported Marino’s resignation came as he was being investigated by the Justice Department for his ties to DeNaples. The investigation was closed when Marino resigned, the report said.

In spite of that news, which broke just a month before election, Marino won his first term by nine percentage points over Democratic incumbent Chris Carney. The margin of victory grew to over 40 points in Marino’s election win in 2016.

It’s likely any special election held for Marino’s vacant seat will be won by a Republican. In Lycoming County, Trump trounced Hillary Clinton, getting 69 percent of the vote to the Democratic candidate’s 25 percent. That same county saw an 80 increase in drug overdose deaths between 2014 and 2015, according to the DEA. The story is the same in many places throughout the country.

“Many people in regions of the country hit very hard by the opioid addiction epidemic voted for Trump,” Kolodny said. “To the extent that many of them voted for Trump because they felt Obama failed on the opioid addiction epidemic… I expect they will be very upset by this choice.”

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Nurse fined $26,000 for using social media as “whistleblower” about bad pt care in NH

Posted on April 14, 2017 by Pharmaciststeve

Sask. nurse slapped with $26K fine after complaining about grandfather’s care

http://www.cbc.ca/news/canada/saskatoon/sask-nurse-fined-facebook-1.4060813

A Prince Albert, Sask., nurse is facing a hefty fine after complaining about her grandfather’s care on social media.

In October, the discipline committee of the Saskatchewan Registered Nurses’ Association found Carolyn Strom guilty of professional misconduct. Strom posted that staff caring for her grandfather weren’t “up to speed” on palliative care or how to “help maintain an aging senior’s dignity.”

Some of the staff at St. Joseph’s Health Centre in Macklin, Sask., complained that Strom’s comments violated her professional obligations as a nurse. According to testimony at the discipline committee, staff felt the comments were humiliating and embarrassing.

$26,000 fine imposed

Now, the association has fined the nurse $26,000. Most of the money will go towards refunding the association for the cost of holding the hearing.

Strom will also have to write a self-reflective essay on what she did wrong, and how she will change her behaviour in the future.

She will also need to complete an online course on the Canadian Nurses Association’s code of ethics.

The written decision noted the actual costs of the hearing were almost six times higher than the amount of money to be paid by Strom. The decision also said that the hearing could have been avoided through mediation, which did not happen.

Originally, the nurses’ association investigation committee had asked that Strom be fined $30,000 and that her lack of remorse should be seen as an aggravating circumstance. However, the discipline committee disagreed, writing that Strom showed accountability for her actions at the hearing.

Strom will need to pay the fine by 2020.

 

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War on drugs now 78 billion/yr – a 33% INCREASE ?? – and not going away soon ?

Posted on April 14, 2017 by Pharmaciststeve

How the opioid epidemic costs the US economy $80B a year

http://www.fox2detroit.com/news/us-and-world-news/248573030-story

WJBK) – The opioid epidemic is becoming one of the biggest issues plaguing Americans. Heroin abuse drains almost $80 billion a year from the U.S. economy. The costs start showing up as lost tax revenue as productivity among addicts drops.

Addicts inevitably make their way into the healthcare system, either through emergency room visits or substance abuse treatments. That has an annual price tag of about $28 billion. And then there’s the impact on the criminal justice system. Nearly $8 billion dollars a year is spent on prosecuting and incarcerating addicts and dealers.

 “It’s a huge deal. From the DEA’s perspective, it’s the number one drug threat facing the country,” says Drug Enforcement Administration’s assistant administrator Louis Milione. He says there are 580 new heroin users a day, and 80 percent of them started by using or misusing prescription painkillers.

“What we have over a long period of time, is we have people using prescription opioids; doctors over-prescribing them; people becoming addicted; getting on the circle of addiction. What happens now, we see on the other part of the DEA, we see Mexican cartels exploiting that prescription opiod epidemic and flooding the country with high purity, low-cost heroin now dangerously laced with fentanyl.”

Fentanyl is a synthetic opioid that’s 50 times stronger than heroin. Most of it is made in China. Just two miligrams is enough to kill you.

“Two milligrams of fentnyl, which is, let’s say, a pinch of salt, is a potentially lethal dose,” Milione says.

On Monday, the Maryland General Assembly passed a bill that will impose an additional 10 years in prison for anyone convicted of supplying fentanyl. The measure was prompted after the number of fentanyl-related deaths in the state jumped a staggering 284 percent in the last year.

“We have thrown everything we can at it. We’re trying everything we can; we put money into it and the problem continues to grow,” says Maryland Gov. Larry Hogan.

The problem isn’t going away anytime soon. During a 15-year span, Michigan has seen 10 times as many overdose deaths. That’s a 911 percent since 1999.

Many police agencies have recently began offering the Hope Not Handcuffs program, which offers treatment to any addict who walks into the police station asking for help.

The Ferndale Police Department is the first law enforcement agency in Oakland County to implement the initiative. Every police department in Macomb County also began participating earlier this year.

While the program was designed to combat heroin addiction, addicts struggling with other drugs can also participate. The program is sponsored through Families Against Narcotics.

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ACLU: standing up for discrimination and libelous statements from Wal Mart employee

Posted on April 14, 2017 by Pharmaciststeve

MSU professor files lawsuit against world’s largest retailer

http://www.abcfoxmontana.com/story/35149595/msu-professor-files-lawsuit-against-worlds-largest-retailer

BOZEMAN –  A professor at Montana State University is taking on Walmart. Court documents, filed Thursday state that MSU professor Gilbert Kolande is suing the world’s largest retailer for libel.  

Kalonde is currently working as an Assistant Professor of Technology and Education at MSU.

Court documents state in 2015, Kalonde, who was born in Zambia and is of African descent, purchased a fishing license at Walmart.

As a necessary part of obtaining a fishing license, the licensing agent, in this case the Walmart employee is required to ask for identification and occupation.

Kalonde told the Walmart employee his occupation was “faculty/professional.” However, instead of putting down his correct occupation, the Walmart employee allegedly entered “cleans toilets” into the FWP database.    

Kolande alleges the entry made was “deliberately false” and done with the purpose of exposing Kolande to “hate and ridicule.”

Bozeman is a hub for fishermen and woman, some to whom I spoke say they are shocked by the licensing agent’s alleged actions.

Bozeman resident Jack Ranieri said, “I mean, it’s an insult to say the least, where they came up with that is crazy for a college professor.”

While another Kit Williams disagreed, “Whether he has a case or not, I’m not sure. But I know that I think he should get over his own ego because I think there is a lot of good toilet cleaners and there just as much of a necessity as doctors.”

Court records show, Kolande told a faculty employee that where he’s from someone who cleans toilets is often “shunned” from society.”

Jim Taylor, Kolande’s Legal Director at the ACLU says they have tried to reach out to Walmart for a settlement.

Taylor stated, “They haven’t really responded for settlement negotiations, we have tried to resolve this in a very simple way.”

Taylor also says, in addition to the libel claim, they have filed a racial discrimination claim with the Human Rights Bureau. 

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FDA warning letter: PAPER TIGER ?

Posted on April 14, 2017 by Pharmaciststeve

FDA jumps on another Mylan plant in India, slapping it with a warning letter

http://www.fiercepharma.com/manufacturing/fda-slaps-another-mylan-plant-india-a-warning-letter

Less than two years after being slapped hard by the FDA for problems at three plants it got in its buyout of a sterile injectables specialist Agila Specialties, another Mylan plant in India has been issued a warning letter for ongoing data integrity issues.

In the warning letter, issued last week and posted by the FDA today, the agency said investigators continued to find issues with batch testing results disappearing from computers when failed tests were involved. The observations were based on an inspection of the finished pharmaceutical plant in Maharashtra, India.

In a statement today, a Mylan spokesperson said the company was working closely with the FDA to address the issues raised in the warning letter.  “Mylan has always had a deep and unwavering commitment to quality everywhere we operate.”

She noted that the plant is just one of 50 the company has and that the warning letter would not result in any supply disruptions. 

The FDA, however, noted in its warning letter that the plant had been cautioned during an inspection in 2015 about missing data.

It noted that even though the facility invalidated 101 of 139 initial out-of-specification (OOS) assay results, about 72%, employees never thoroughly investigated to find the root cause of the issues and didn’t include them in the results reported to the agency.

“Because your laboratory investigations frequently invalidate initial failures without cause, your laboratory trending excludes a large proportion of data that would otherwise alert you to problems in your laboratory system,” the FDA said, pointing out that the agency has discussed this kind of issue before.  

Further it criticized the quality control lab for not bothering to look into error signals from the HPLC computers indicating loss of data. The lab blamed the problems on power interruptions and computer connectivity problems, but couldn’t explain why they so often happened in the lab and why it didn’t bother to find a root cause.

The agency ordered Mylan to go back and document all of the missing data and figure out what impact those failed tests may have had on its drugs. It said the company needs a corrective action plan to deal with the issue so it is not repeated going forward.

In 2015, the FDA savaged three of the sterile injectables plants that it got in its $1.75 billion buyout of Agila Specialities from India’s Strides Arcolabs. It said it knew the company had only recently acquired them, but pointed out that one had been cited in a warning letter before Mylan bought it, giving the company an indication there might be manufacturing issues that needed to be addressed. Considering Mylan’s extensive experience in generic drugs, the agency said, that should have been enough for the company to get control of problems there as soon as it took over.

Related: Mylan fired workers at Agila plants after getting FDA warning letter

Mylan pledged to do better, but also went after and received from Strides a $70 million payment to help cover the costs.

Problems with data integrity have plagued many Indian drugmakers, like Sun Pharma and Wockhardt, resulting in an avalanche of FDA warning letters in the last few years.

The FDA this year issued a warning letter to a Wockhardt plant in India for issues including data integrity. It followed that up with a warning for a Wockhardt plant in the U.S. that castigated the company for not getting on top of these issues despite ongoing FDA discussions about its problems at other Mylan plants. It pointed out that the warning letter for the U.S. plant was the company’s sixth for seven Wockhardt plants, three of which have been banned from shipping to the U.S.  

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acceptance (of pain) might make the intensity of pain less important to a person’s functioning and quality of life

Posted on April 14, 2017 by Pharmaciststeve

Intensity of Chronic Pain — The Wrong Metric?

http://www.nejm.org/doi/full/10.1056/NEJMp1507136#t=article

Jane C. Ballantyne, M.D., and Mark D. Sullivan, M.D., Ph.D.

N Engl J Med 2015; 373:2098-2099November 26, 2015DOI: 10.1056/NEJMp1507136

Pain causes widespread suffering, disability, social displacement, and expense. Whether the issue is viewed from a moral, political, or public health perspective, pain that can be relieved should be relieved. Yet the most rapidly effective drugs for relieving pain — opioids — are caught up in a morass of concerns about addiction. Achieving a balance between the benefits and potential harms of opioids has become a matter of national importance.

The United States recently established a national plan to address pain, as Canada, Australia, Portugal, and Malaysia have previously done.1 This National Pain Strategy grew out of recognition by the Institute of Medicine (now the National Academy of Medicine) of the enormous burden of chronic pain in the United States. For three decades, there has been hope that more liberal use of opioids would help reduce the number of Americans with unrelieved chronic pain. Instead, it produced what has been termed an epidemic of prescription-opioid abuse, overdoses, and deaths — and no demonstrable reduction in the burden of chronic pain.2

Although the chronic-pain crisis can be attributed in part to the aging of the population, improved survival from disease and trauma, changes in disability policy, and multiple factors such as obesity that contribute to chronic ill health, the suggestion that chronic pain can and should be eliminated by opioids hasn’t helped. The National Pain Strategy concludes that current reimbursement policies, provider attitudes and training, and “myths, misunderstandings, stereotypes, and stigma” in the health care system have denied Americans the benefit of evidence-based multimodal approaches to managing chronic pain, in favor of costly interventions that don’t produce long-term benefit. Opioids are a case in point: they have good short-term efficacy, but there is little evidence supporting their long-term benefit. The National Pain Strategy emphasizes the importance of self-management and interdisciplinary treatments and recognizes that drug treatment alone has limited utility when it comes to managing chronic pain.

During the late 1980s and early 1990s, it was argued, largely on moral grounds, that opioids should be available for treating chronic pain, and physicians were persuaded that addiction to opioid treatment would be rare. Both the idea that chronic pain could be effectively and safely managed with opioids and the principles of opioid pain management were based on the successful use of these drugs to treat acute and end-of-life pain. That success was based on the “titrate to effect” principle: the correct dose of an opioid was whatever dose provided pain relief, as measured by a pain-intensity scale. The dissemination of the World Health Organization’s stepladder approach to managing cancer pain was the beginning of widespread adoption of reduction of pain intensity as the goal of drug treatment. When the Joint Commission for the Accreditation of Healthcare Organizations (now the Joint Commission) introduced a mandate that pain be recognized and treated, numerical ratings of pain intensity were chosen as the chief metric. The promotion of pain as the “fifth vital sign” was a response to that mandate.

But is a reduction in pain intensity the right goal for the treatment of chronic pain? We have watched as opioids have been used with increasing frequency and in escalating doses in an attempt to drive down pain scores — all the while increasing rates of toxic drug effects, exposing vulnerable populations to risk, and failing to relieve the burden of chronic pain at the population level. For many patients, especially those who have become dependent on opioids, maintaining low pain scores requires continuous or escalating doses of opioids at the expense of worsening function and quality of life. And for many other people, especially adolescents and young adults, increased access to opioids has led to abuse, addiction, and death.

Pain-intensity ratings aren’t necessarily a reflection of tissue damage or sensation intensity in patients with chronic pain. The intensity of chronic pain can’t be reliably predicted from the extent or severity of tissue damage, since chronic pain is not determined primarily by nociception. Functional neuroimaging studies and other prospective clinical studies have shown that what feels like the same pain is initially associated with the classic sensory “pain matrix” brain regions but is later associated with brain regions involved in emotion and reward. Thus, over time, pain intensity becomes linked less with nociception and more with emotional and psychosocial factors.3

Suffering may be related as much to the meaning of pain as to its intensity. Short-lived pain may be excruciating, but it is better tolerated and causes less suffering because it’s finite and may be necessary to attain a valuable goal, such as childbirth, healing, or athletic achievement. Persistent helplessness and hopelessness may be the root causes of suffering for patients with chronic pain yet be reflected in a report of high pain intensity. Strong support for such a relationship between the meaning of pain and the degree of suffering can be found in the relief that occurs because anxiety is reduced when the source of pain is understood, pain is no longer a threat, or effective treatment is known to be at hand.4

Many of the interdisciplinary and multimodal treatments recommended in the National Pain Strategy use coping and acceptance strategies that primarily reduce the suffering associated with pain and only secondarily reduce pain intensity. Willingness to accept pain, and engagement in valued life activities despite pain, may reduce suffering and disability without necessarily reducing pain intensity. Patients who report the greatest intensity of chronic pain are often overwhelmed, are burdened by coexisting substance use or other mental health conditions, and need the type of comprehensive psychosocial support offered by multimodal treatment approaches. Reliance on pain-intensity ratings tends to result in the use of opioid treatment for patients with mental health or substance abuse problems who are least likely to benefit from opioid treatment and most likely to be harmed by it — a phenomenon we have termed “adverse selection.”5 These patients are more likely than others to be treated long-term with opioids and sedatives, to misuse their medications, and to experience adverse drug effects leading to emergency department visits, hospitalizations, and death.

The National Pain Strategy outlines a number of initiatives to help achieve the “cultural transformation” needed to ease the burden of chronic pain in the United States. Many of these initiatives recognize that chronic pain differs from short-lived pain in its causes, psychopathology, and social meaning. Borrowing treatment principles from acute and end-of-life pain care, particularly a focus on pain-intensity scores, has had unfortunate and harmful consequences. The titrate-to-effect principle fails when pain is chronic, because our best chronic-pain treatments don’t produce an immediate or substantial change in pain intensity. Multimodal therapy encompasses behavioral, physical, and integrated medical approaches. It is not titrated to pain intensity but has a primary goal of reducing pain-related distress, disability, and suffering. When it does that successfully, a reduction in pain intensity might follow — or acceptance might make the intensity of pain less important to a person’s functioning and quality of life.

We propose that pain intensity is not the best measure of the success of chronic-pain treatment. When pain is chronic, its intensity isn’t a simple measure of something that can be easily fixed. Multiple measures of the complex causes and consequences of pain are needed to elucidate a person’s pain and inform multimodal treatment. But no quantitative summary of these measures will adequately capture the burden or the meaning of chronic pain for a particular patient. For this purpose, nothing is more revealing or therapeutic than a conversation between a patient and a clinician, which allows the patient to be heard and the clinician to appreciate the patient’s experiences and offer empathy, encouragement, mentorship, and hope.

 

Dr. Ballantyne reports receiving grants from Pfizer and being president of Physicians for Responsible Opioid Prescribing. Dr. Sullivan reports receiving grants from opioid REMS program companies and personal fees from Janssen and Relievant.

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Alabama: Alprazolam rescheduling to C-II DOA !

Posted on April 14, 2017 by Pharmaciststeve

Alabama Battle Over Alprazolam is Done. For Now.

deachronicles.quarles.com/2017/04/alabama-battle-over-alprazolam-is-done-for-now/

The battle is over! For now.

Yesterday, Alabama lawmakers blocked the proposal to move Alprazolam into Schedule II, as well as blocking the other proposed changes described in this series of client updates. See here and here. The pharmacy community in Alabama took an active role in opposing these changes. According to this article from Alabama Live, members of the Alabama Pharmacy Association opposed this change and as noted in our most recent update, the Alabama Board of Pharmacy was also encouraging pharmacists to reach out to their legislators to share their concerns. It looks like all of this hard work has paid off. Will this come back? Hard to tell, but we will continue to watch how Alabama and other states try to manage and prevent the abuse of prescription medications.

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AG Jeff Sessions: wants to enforce our laws… “Trump era of law enforcement”

Posted on April 13, 2017 by Pharmaciststeve

It has been stated that AG Session is going to “reactivate”the war on drugs.. turn back the clock to the 90’s. Except in the early 90’s there was no Americans with Disability Act and the original act was “very vague” for Congress intended for the law to be defined in our court system… which would take years.. could that have been so that the ADA and the war on drugs could co-exist ?

Back then there was no FIVE STAR RATING system for Medicare/Medicaid.. which if pts file grievances.. the vendor’s (prescriber, hospital, insurance company, pharmacy/pharmacist) could be lowered if enough grievances are filed by pts for “bad care”. To www.cms.gov – 800 Medicare.

If the prescriber lowers the pt’s chronic pain medication(s) but doesn’t increase/decrease the pt’s medication(s) for the rest of the pt’s chronic conditions… then discrimination against the pts because of their medical conditions require treatment with a controlled substances could be claimed. And a complaint can be filed with https://www.ada.gov/filing_complaint.htm     which is under AG Session’s Dept of Justice..

Elder/Senior Abuse laws are mostly at the state level.

If the prescriber claims that he/she is adopting the CDC guidelines… those guidelines are for acute pain pts… not chronic pain pts.. This means that the prescriber has adopted the CDC guidelines as their practice’s standard of care and best practices.  Failure to adhere to their own policies can be considered MALPRACTICE and can also be used to document Elder/Senior Abuse and discrimination under ADA.

Here is four quotes from the CDC opiates guidelines:

https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

“The guideline is intended to ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function.”

“Clinicians should consider the circumstances and unique needs of each patient when providing care.”

“Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context.”

“This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.”

They are using “the laws” to control what/how much medical care that pts diagnosed with subjective disease and have a medical necessity for being prescribed controlled substances…. but… there are laws on the books to protect those same pts suffering from subjective diseases from being discriminated against and/or harmed/abused.

Pts need to document what the prescribers are stating… recording audio/video… ask for a copy of the practice’s policies and procedures concerning controlled substances prescribing, or the plan of treatment that the prescriber has prepared for treating a particular pt’s disease states.

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GA Bureaucracy: With more regulation comes better outcomes.

Posted on April 13, 2017 by Pharmaciststeve

Georgia moving to regulate another industry, in the name of consumer protection

investigations.blog.ajc.com/2017/04/13/georgia-moving-to-regulate-another-industry-in-the-name-of-consumer-protection/

Georgians who need oxygen equipment, walkers, blood sugar monitors or other durable medical equipment could be impacted by legislation now awaiting the governor’s signature. But there’s debate over whether it will provide those consumers with important protections or increase medical costs by unnecessary regulations.

Under the legislation, many suppliers of durable medical equipment would have to have a state license to sell to Georgia residents. To get the license, the companies would have to have an office or place of business in Georgia. They also would have to meet state standards, such as training for all workers who deliver, maintain or repair equipment, and could be subject to other rules set by the State Board of Pharmacy.

For years, the Georgia Association of Medical Equipment Suppliers (GAMES) has lobbied for such a law. But prior versions of the bill failed after criticism that the proposals were intended primarily to protect Georgia businesses from out-of-state and internet competition.

 

Last summer, the Georgia Occupational Review Council, which reviews all bills that propose licensing of a business or profession, reported that a version of the bill then under consideration could raise costs without providing additional consumer protections.

The council also said there was no documented evidence or pattern of Georgia customers being harmed, and that Medicare and Medicaid already require suppliers to meet standards that protect customers.

But Georgia consumers now have no local agency to handle and investigate complaints about medical equipment suppliers, so there is no way of determining the number of problems people here have faced, said GAMES president Tyler Riddle.

He also said that because the state hasn’t tracked the medical equipment businesses, it doesn’t know if those who deliver the equipment to patient homes may have criminal records. “It’s kind of terrifying,” he said.

The legislation would provide state-level accountability, he said. In the medical field, he said, “With more regulation comes better outcomes.”

Only equipment prescribed by doctors and covered by Medicare, Medicaid or private insurance is covered by the legislation. Because they already monitor payment rates, Riddle said, licensing should not spike costs.

“This legislation doesn’t stop anyone from selling non-prescription items, like bedside commodes,” he also noted.

Georgia suppliers, like those nationwide, have been struggling in recent years after the federal government began competitive bidding for supplying certain durable medical equipment for people on Medicare. Under that process, Medicare establishes what it will pay based on national bid averages. Since the bidding began in 2011, Medicare says it has saved hundreds of millions of dollars.

But the industry, which has criticized the competitive bidding process as flawed, said nearly 40 percent of businesses have either closed or been sold to a national provider since bidding began.

The Georgia council last summer had reported that large national providers without bricks-and-mortar locations in Georgia have lower overhead and can offer a lower bid than in-state competitors.

Photo: City of Millville, NJ

But many states already regulate home medical equipment suppliers, and the business is primarily a local one, said Tom Ryan, president and CEO of the American Association for Homecare, an industry advocacy group. The association has found that state regulations are pro-patient and pro-small business, he said.

Often, businesses that provide equipment must conduct a home assessment, such as making sure that a home meets electrical requirements for a ventilator.

“I wouldn’t want oxygen drop-shipped to a patient’s home with an instruction sheet,” he said.

The Georgia bill was approved March 30. The governor has 30 days to approve or veto it.

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Opioids after surgery: Which patients don’t stop when they should

Posted on April 13, 2017 by Pharmaciststeve

Opioids after surgery: Which patients don’t stop when they should

http://www.foxnews.com/health/2017/04/12/opioids-after-surgery-which-patients-dont-stop-when-should.html

The first time many patients in the United States take prescription opioid painkillers is following surgery. But not everyone puts away the pills: In a new study, researchers found that 6 percent of patients continued to use the drugs for at least three months after surgery.

The researchers wanted to know more about why some people continue to use the drugs while others don’t, so they looked at the types of surgery people had. But it turned out that it didn’t matter whether someone had a major operation, such as bariatric surgery or a hysterectomy, or a minor procedure, such as varicose vein removal; there was no difference in how likely people were to continue to use opioids past the three-month mark.

However, the findings showed that the people who were more likely to continue to use the painkillers were those who smoked, drank alcohol, had certain mood disorders or had chronic pain.

The findings suggest that whether a person continues to take prescription painkillers long after his or her surgery “is not due to surgical pain but addressable patient-level” risk factors, the researchers wrote in the study.

In the study, a team of researchers led by Dr. Chad Brummett, an associate professor of pain management anesthesia at the University of Michigan Medical School, looked at data on more than 36,000 patients who received opioid painkillers after surgery in 2013 and 2014 but had not taken opioids at any point in their lives before that. The majority of the patients (80 percent) had minor surgeries, such as varicose vein removal or carpal tunnel surgery; the remaining 20 percent of the patients had major surgeries, such as bariatric surgery or surgery to remove the uterus.

The researchers found no statistically significant difference between the people who had major surgery and those who had minor operations in their likelihood to continue using opioids, according to the study.

Having ruled out the type of surgery as a predictor of who would continue to use opioid painkillers, the researchers looked to other factors.

People who smoked cigarettes, drank alcohol or had substance-abuse problems were more likely to continue taking opioids long after their surgeries, according to the study. For example, smokers were 35 percent more likely to continue taking opioids compared with people who didn’t smoke. Those who had an alcohol or substance-abuse disorder were 34 percent more likely to continue taking opioids compared with people who didn’t have one of those conditions.

In addition, people with anxiety were 25 percent more likely to continue taking opioids, the researchers found.

Finally, people who had chronic pain before their surgeries were 39 percent more likely to continue using the painkillers.

Though the study included only 36,000 patients, the researchers estimated that, based on the number of surgeries that occur in the United States each year, as many as 2 million people could start using opioids after a surgical procedure each year.

Because the study was observational, the researchers found only an association between prolonged use of opioids and certain risk factors. In other words, smoking or drinking, for example, don’t necessarily cause a person to continue to use opioid painkillers; rather the study showed that people who already smoke or drink may be more likely to do so. 

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