http://www.dailytimesleader.com/content/opioid-epidemic-prompting-prescription-changes

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Pharmacy coalition to Trump administration: Meet with us about opioid crisis

The National Conference of Pharmaceutical Organizations (NCPO), a coalition of organizations representing more than 300,000 pharmacy practitioners, pharmaceutical scientists, pharmacy regulators, and pharmacy educators, has invited the Trump administration to meet to discuss ways of addressing the nation’s opioid crisis. Noting that each day more than 90 Americans die from overdosing on opioids, the coalition, of which APhA is a part, said in a statement that it supports immediate action on components of the report of the President’s Commission on Combating Drug Addiction and the Opioid Crisis.

“We ask the White House and the Administration to work with the pharmacy community to establish and implement specific programs to address this crisis, and to identify specific goals for these programs,” said Lucinda L. Maine, PhD, RPh, executive vice president and CEO of the American Association of Colleges of Pharmacy and NCPO president.

In a related statement, APhA executive president and CEO Thomas E. Menighan, BSPharm, MBA, ScD (Hon.), FAPhA,  said, “APhA, along with the other NCPO members, is individually and jointly committed to combating this public health crisis as we implement best practices across the country. We believe such collaborative efforts are essential to meeting our country’s needs for high quality health care while working together to reduce the impact of this crisis on American families.”

Menighan highlighted pharmacists’ long-standing contributions in the fight against opioid misuse and abuse. “We work actively with patients and their communities on a daily basis, and APhA’s priority is to make sure that policy makers and our fellow health care providers know what pharmacists can do to make meaningful progress in the fight against opioids.”

According to the statement from the nearly a dozen healthcare organizations representing over 300,000 healthcare providers aligning themselves with those who believe that those who are suffering from the mental health issue of addictive personality are more deserving of appropriate care than the 100+ million chronic pain pts. Basically those with chronic pain are being

LEFT OUT IN THE COLD ?

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https://www.thestar.com/news/gta/2018/02/06/fentanyl-found-in-naloxone-kit-a-freak-accident-says-ontario-government.html

Kits used to reverse opiod overdoses that has caused thousands of deaths in recent years.

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U.S. Attorney General Talks Opioid Crisis: ‘Take Some Aspirin’

http://wusfnews.wusf.usf.edu/post/us-attorney-general-talks-opioid-crisis-take-some-aspirin

As he addressed a crowd of prosecutors and police officers at the U.S. Attorney’s Office for the Middle District of Florida, Sessions offered his opinion for preventing addiction.

“I believe – and I am operating under the assumption – that this country prescribes too many opioids,” he said. “I mean people need to take some aspirin sometimes and tough it out a little.”

Some people in the crowd laughed. Sessions then imitated Gen. John Kelly, President Trump’s chief of staff, whom the attorney general says refused to take pain medication after a recent surgery on his hand.

“He said, ‘I’m not taking any drugs!’” said Sessions. “It did hurt though, he did admit it hurt. But a lot of people, you can get through these things.”

Sessions says stopping addiction before it starts is the most important element in the nation’s fight against opioids.

He outlined ways the federal Drug Enforcement Agency is working to curb addiction. Sessions says the DEA announced earlier this week that the agency will now ask individual practitioners applying for licenses or renewing their licenses whether they have received continuing education on prescribing and dispensing opioids.

“DEA can ensure that doctors have the CDC’s latest guidance on opioid prescribing so they don’t accidently over-prescribe,” Sessions said.

Florida Gov. Rick Scott and some members of the state legislature are pushing for a three-day cap on opioid prescriptions, and a seven-day cap when medically necessary.

But opponents of the bill, including many physicians, say those limits are unreasonable for people in intense pain, like those recovering from major surgery.

While Florida has cracked down on pill mills notorious for pumping out unnecessary prescription drugs, the state is still one of the hardest hit by the opioid crisis.

During his remarks in Tampa, Sessions suggested the rise in fentanyl sold on the streets is to blame.

“Fentanyl-related deaths [in Florida] jumped 97 percent [from 2015-2016],” he said. “So the driving factor, you can see in Florida maybe more than in the nation, is fentanyl.”

Sessions told members of law enforcement in the audience that as of Tuesday, all fentanyl-related substances would become scheduled on an emergency basis by the DEA.

“Fentanyl is the No.1 killer in America,” he said. “Scheduling and restricting all forms of this drug will make it easier for you and your agents to prosecute drug traffickers.”

Over the summer Sessions deemed central Florida one of 12 opioid “hot spots” in America. That led to the appointment of Kelly Howard-Allen, who has been with the U.S. Attorney’s Office in Tampa for more than 15 years, as the area’s “opioid fraud prosecutor.”

Howard-Allen will focus solely on investigating and prosecuting opioid-related health care fraud. Sessions said her new position allowed the office in Tampa to hire another assistant U.S. attorney, Greg Pizzo.

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https://www.aclu.org/blog/disability-rights/integration-and-autonomy-people-disabilities/congress-let-important

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https://www.medscape.com/viewarticle/892412

The Centers for Medicare & Medicaid Services (CMS) is proposing that beginning in 2019, initial opioid prescriptions for acute pain be limited to 7 days.

The agency is also suggesting in the 2018 Draft Call Letter that Medicare Part D prescription drug plans monitor patients who take medications considered to be “potentiators” of opioid misuse and opioid-related adverse events — specifically, gabapentin and pregabalin.

Noting an alarming increase in gabapentin use to treat pain and concurrent opioid and gabapentin use, CMS is asking for comment on whether it is useful to more closely monitor beneficiaries receiving these prescriptions.

The CMS proposal came as a US House committee took a closer look at Medicare’s oversight of opioid use. At the February 6 hearing, members of the Ways and Means Health Subcommittee said there are few data on opioid use among older Americans and that Medicare has done a poor job of encouraging prevention and treatment.

“With 10,000 baby boomers joining Medicare each day, we must harness innovation, technology and data to get ahead of this problem,” said Subcommittee Chairman Peter Roskam (R-IL). “Unfortunately, there is a lack of available data regarding the Medicare population and the extent to which opioid abuse, overprescribing, and diversion is an issue for seniors and the disabled,” he said.

That echoed an October 2017 Government Accountability Office (GAO) report, which found that Part D plans are not sufficiently identifying and helping beneficiaries at high risk for opioid misuse. CMS established its overutilization monitoring system (OMS) in 2013, but opioid misuse continues, and thousands of baby boomers are being added to the Medicare rolls daily.

Drugs of Concern

The agency said in its latest announcement that the system has reduced “very high risk overutilization of prescription opioids in the Part D program,” but “given the urgency and scope of the continuing national prescription opioid epidemic, we will propose new strategies to more effectively address this issue for patients in Part D.”

CMS proposes the following:

• To have the OMS identify high-risk beneficiaries who use “potentiator” drugs (such as gabapentin and pregabalin) in combination with prescription opioids to ensure that plans provide appropriate case management. The agency noted in its proposal that in just 2 years (2015 to 2017), the rate of gabapentin users in Part D plans increased by 14%: from 93 to 108 users per 1000 enrollees. Opioid users had even higher gabapentin use.
• To create a new quality measure that would track how well Part D plans flag concurrent use of opioids and benzodiazepines. The OMS already flags concurrent benzodiazepine use, but there is no follow-up mechanism. According to CMS, in late 2016, when the OMS began tracking concurrent use, 64% of beneficiaries flagged as potential opioid overusers had a benzodiazepine prescription. In 2017, after monitoring, the number had dropped to 62%.
• That Part D plans to have a pharmacy point-of-sale edit that prohibits dispensing of any prescription that is more than a 90 morphine milligram equivalent, or a 7-day supply.
• That all sponsors implement soft point-of-sale edits that alert when there is duplicative therapy of multiple long-acting opioids.

CMS is taking comments on the proposal until March 5 and will publish the final requirements on April 2.

The Part D proposal builds on another CMS proposed rule, issued in December 2017. The agency was required by the Comprehensive Addiction and Recovery Act of 2016 to beef up opioid oversight.

As with that previous regulation, the newest proposal would exempt patients with cancer, in hospice, or in long-term care facilities from much of the strict oversight. 

Methadone Treatment Not Covered

Even as enrollees who misuse opioids are flagged, Medicare is not fully prepared to help. The federal health program does not pay for outpatient methadone treatment, for instance.

“We know there are significant gaps in access and coverage under Medicare,” said the top Democrat on the Ways and Means Health Subcommittee, Richard Neal (MA), at the hearing.

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http://www.thecabin.net/news/20180206/your-pharmacist-doesnt-want-to-see-you-now

If your pharmacist doesn’t look happy to see you the next time you visit, it’s probably because she’s losing money filling your prescription.

The problems are occurring with two groups of patients. The largest are those covered by Arkansas Works, which uses Medicaid dollars to purchase private health insurance for 285,000 low-income Arkansans. The other problem patients are the 68,100 Arkansans who purchase their health insurance through the online Arkansas Health Insurance Marketplace. Like Arkansas Works, the Marketplace was created by the Affordable Care Act, otherwise known as Obamacare.

Pharmacists say that, in those plans, they aren’t being fairly reimbursed by their pharmacy benefit managers. Those PBMs act as middlemen between pharmacists and insurance companies, which in Arkansas are Blue Cross, Ambetter and QualChoice.

If you’re thinking that insurance companies are supposed to be the middlemen, well, so did I. But as big as the insurers are, they’re not as big as the three PBMs that control the pharmaceutical market nationwide. The insurance companies pay the PBMs, and the PBMs reimburse the pharmacists while subtracting what’s supposed to be an administrative fee. That’s how your pharmacist gets paid.

The PBM that contracts with Blue Cross and Ambetter is CVS Caremark – the same CVS that owns your local drugstore and is buying Aetna, one of the nation’s largest insurers. A spokesperson released a statement saying it reimburses pharmacies at “competitive rates that balance the need to fairly compensate pharmacies while providing a cost-effective benefit for our clients.”

More than 300 pharmacists attended a legislative subcommittee meeting last week to voice their disagreement with that assertion. Earle pharmacist Cissy Clark said more than 22 percent of her prescriptions are for Arkansas Works patients, and she’s losing money on a “large portion.” She said one pregnant mother and her two sick children came into her pharmacy with three prescriptions for generic Tamiflu, which costs Clark $87 wholesale. The children were covered by traditional Medicaid with a reasonable reimbursement. For the mother, Clark was going to be reimbursed $36.23 by CVS Caremark. When Clark called Ambetter, she was told the insurer had paid $132.61 to the PBM, “which means that CVS made almost $100 while I lost 50,” Clark said. She eventually managed to work it out by filling a liquid version of the prescription and received a fair reimbursement.

In one sense, the system did its job by moving the mother to a lower cost drug. But that was an awful lot of running around to do for any business transaction – particularly a pharmacist trying to serve a family with sick kids. And there should be no situation in a market economy where the middleman takes that big of a cut.

State law does require the PBMs to allow pharmacists to appeal their reimbursements and ultimately have their costs covered. But of course, that means your busy, white-coated pharmacist has to go to war with a giant bureaucracy. Clark said she filed 65 appeals in the first week of this year alone and had not received any responses.

Arkansas Works and the Health Insurance Marketplace both were created by Obamacare, but the problems run much deeper. In America, health care is a profit-making enterprise, but it’s based on perverse incentives where the sellers make more money managing our illness than they do if they make us well. The payment system is a complex web of insurance companies, PBMs, big government agencies and other faceless middlemen. Their job is to shield us from the cost of our transactions. For that, they take a huge piece of the pie. Then there’s the fact that Americans have fundamentally unhealthy lifestyles. Being unhealthy is expensive.

Repeal the law, and the underlying issues will remain.

So what now? Pharmacy reimbursements will continue to be an issue in Arkansas politics. Nationally, Congress will continue to talk about health care but do little about it.

Last week, Amazon, Berkshire Hathaway and JPMorgan Chase announced they were jointly forming a new health care company to serve their employees. They didn’t offer many details because they don’t know what the company will look like. But it will be different.

Can these big businesses fix the big business of health care? At least, they can disrupt it. CVS’ stock fell 4.9 percent after the announcement.

Regardless, it’s going to take a while, and pharmacists are losing money now – or at least waiting on appeals.

when I first started working in pharmacies – late 60’s – there were virtually no generics… everything was a brand name… there was no PBM’s… and everyone PAID CASH… there was no Medicare to pay for prescriptions and Medicaid paid for a very small number… and the average prescription price was $4.00 -$5.00…

Today abt 90% of all prescriptions are generics, PMB’s price/pay/process about 90% of prescriptions and the average prescription price is pushing $60

If you apply the CPI from those days in the 60’s until today… and presuming that nothing else changed from what it was in the late 60’s..the average prescription price should be around $30 +/-. 

And just what contributed to that EXTRA $30 per prescription ?  Generics are suppose to save everyone money…

What they don’t talk about in this article and other places… these PBM’s DEMAND rebates/kickbacks etc.. from the pharmaceutical manufacturers … you may have been told that your insurance company wont’ pay for a particular medication that your doc wrote for but would pay for a “similar medication”… what they don’t tell you is that the PBM gets a LARGER kickback/rebate from the manufacturer’s product on the PBM’s formulary.  All of these “players” in the medication business are FOR-PROFIT businesses and isn’t it comforting that their decisions on what medication that you get to take – that can have a positive/negative outcome on your quality of life… is highly determined on the profitability of the insurance & PBM companies..

Here is one example of how profits by insurance/PBM come to play in your quality of life

Health insurer Anthem has sued Express Scripts Holding Co., alleging the pharmacy benefits manager is not passing along billions of dollars in savings from negotiated drug prices.

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http://www.thv11.com/news/health/pill-peril-how-pharmacists-make-sure-you-get-the-right-medication/515122789

LITTLE ROCK, Ark. (KTHV) — If you take medication every day, you’re part of the majority of Americans, but how do you know what you’re prescribed and what you’re given is correct? Mistakes happen. THV11 looked into what we can do to avoid medication errors

Eighty-two percent of American adults take at least one medication a day according to the Centers for Disease Control. This keeps pharmacists filling prescriptions all day.

“Per pharmacist probably 125 or 150 prescriptions a day,” said Philip Way, a pharmacist at Remedy Drug.

What if you were handed the wrong prescription? Or what if your doctor accidentally prescribed you the wrong medicine?

“Everyday the pharmacist is working to correct dosage,” said Dr. Scott Pace, CEO of the Arkansas Pharmacists Association.

Many of you know firsthand the possible mistakes that can happen when it comes to receiving your medicine.

“I once received the wrong birth control pills,” one viewer said.

“I was given someone else’s pills in my bottle,” another said.

“I once noticed my dad’s refill looked different. He started to fall and not remember anything,” said another viewer claiming he was given the wrong prescription.

“The right drug at the wrong dose can be prescribed, the wrong instructions can be prescribed, it can be misinterpreted at the pharmacy level,” Pace said. “A lot of selection errors have happened.”

Pace believes technology has created a new opportunity for error.

“We’ve moved away from a lot of handwritten prescriptions to electronic prescriptions,” Pace said.

When doctors send prescriptions electronically, if they click the wrong medication, the pharmacist won’t know it’s a mistake.

“It’s the technology that sometimes is changing what used to be a simple paper process and turning it into something on a computer and it’s a different workflow so with that workflow is a new opportunity for different errors,” Pace said.

“Rarely does it appear here,” Way said.

He puts prescriptions through a triple screening process to make sure those mistakes don’t happen.

“There’s a process of data entry.”

So when he gets your prescription, he reviews the patient, the doctor, and what else the patient is taking. He finds the medicine off the shelf, counts the pills, bottles them, then checks again

“Making sure the right medicines on the bottle, the right drug is on the label, the right doctor is on the label and that the patient is not already taking it or taking something that would interfere with it,” Way said.

Every year, the CDC reports more than one million emergency department visits come from adverse drug events. That’s any harm that comes from the use of medication like allergic reactions, side effects, over medication, and medication errors.

“If it’s a drug allergy they could have a reaction and depending on who they’re surrounded by and how they know how to react to that, it could be fatal,” Way said.

The final step to make sure you’re getting the right medicine is conversation.

“Communication is very important to us at the pharmacy level,” Way said. “Tell them what’s going on with your health care. They’re going to protect that information, but they need to know if you just had a baby, if you got over an infection.”

“If the color looks different than it did last month, ask. If the shape looks different, ask. If the directions look different, ask,” Pace said.

Scott Pace believes some errors come from drugs that sound alike or with similar names. The Food and Drug Administration reviews about 300 drug names a year before they’re marketed, with about a third rejected to minimize confusion.

If the pt presents a prescription and there is no drug allergy, drug interaction, or other contraindications that would suggest that the Pharmacist should not fill the prescription… but.. the pharmacist because of some personal opinion, bias , prejudiced or phobia the pharmacist refuses to fill the prescription.  Won’t give the pt a valid reason… just … NO…

Is there that much difference between a pt walking away from the pharmacy counter with the WRONG MEDICATION and the pt walking away from the pharmacy counter WITHOUT the medication that their doc had determined they had a medical necessity for…

Both pts are walking away from the pharmacy counter without the medication that their doc wanted them to have.

My money is on that if both pts filed a complaint with the state pharmacy board…the board would take some sort of punitive action against the pharmacist for giving the pt the wrong medication and it is highly unlikely they would take any action against the pharmacist for refusing to fill a legit/on time/medically necessary prescription.

In 2016, the KY board of pharmacy reported it received 15 complaints for denial of care – refusing to fill a legit/on time/medically necessary prescription and 14 complaints were dismissed without further action.  One can only surmise that for every complaint filed with the board over denial of care there was probably 100 – 1000 more incidents that the pt didn’t bother to file a complaint.

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https://www.medscape.com/viewarticle/892135

As part of its ongoing efforts to address the opioid crisis, the US Food and Drug Administration (FDA) has released a revised blueprint containing core content for training that drug manufacturers are required to make available to opioid prescribers.

“The revised Blueprint broadens content to include information on acute and chronic pain management, safe use of opioids or other non-opioid or non-drug treatments, as well as material on addiction medicine and opioid use disorders,” the FDA said.

When finalized later this year, coupled with the Opioid Analgesic Risk Evaluation and Mitigation Strategy, the blueprint will apply to manufacturers of both immediate-release opioid analgesics intended for use in the outpatient setting and extended-release/long-acting formulations. For the first time, the FDA is requiring that the guidance be offered to healthcare professionals who are involved in the management of patients with pain, including nurses and pharmacists, in addition to prescribers.

“With millions of Americans misusing prescription opioids and more than 40 people dying every day from overdoses involving opioid medications, it has become abundantly clear that we need to do everything we can, along with our partners, to get ahead of this crisis,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

“Appropriate prescribing practices and education are important steps within our statutory authority to help address the human and financial toll of this crisis. We can and must do more to arm physicians — who are the gatekeepers of prescription opioids — with the most current and comprehensive guidance on the appropriate management of pain. The Blueprint is one tool for achieving these goals,” he added.

Dr Gottlieb said the FDA will continue to seek feedback from a “broad group of stakeholders and explore a range of approaches that, when combined with other steps we’re taking to tackle this epidemic, help ensure proper treatment for pain and better addresses the crisis of opioid addiction.”

42,000 deaths… what happened to the 64,000 deaths everyone else is using… does this CLEARLY DEMONSTRATE that there is 22,000 drug overdose deaths are caused by NON-OPIATE medications?

Claiming 40% of all OD’s are from prescription opiates… still does not clarify if the person ODing had legally been prescribed the prescription opiates.. Still no reference how many of these OD’s were in fact SUICIDES…

The USA has 50,000 suicides/yr with ONE MILLION attempts…   from this article https://www.usatoday.com/story/news/nation/2013/07/21/guns-most-deadly-choice-in-suicide-attempts/2572097/  

Guns are used in about half of U.S. suicides

and what is the cause of the other HALF of suicides??? BUTTER KNIFES…. ???   I guess that it is a little more obvious about a person committing suicide by shooting themselves with a gun as opposed to take all their meds and add in a little/lot of alcohol to help assure to “get the job done”…

Are the “powers that be” so mis-focused on drug overdoses that when a opiate shows up in toxicology it is automatically concluded to be a “accidental drug overdose”… is this why the nomenclature has been changed that all deaths when toxicology shows a opiate… no further investigation needs to be done.. just label the death as a “opiate related death”

A lot of people want to talk about FAKE NEWS… but who talks about PSEUDO-FACTS…

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http://www.wjhl.com/local/addiction-psychiatrist-questions-involuntary-tapering-of-opioids/943940749

JOHNSON CITY, TN (WJHL) – A renowned author and addiction psychiatrist says the efforts of the Department of Veterans Affairs and other institutions across the country to taper people off opioids without their consent is “an outrage.”

“To take a patient who’s doing well off of medication abruptly and without their permission is not unfair. I actually think it’s malpractice,” Dr. Sally Satel said. “I think it is an outrage when you have a person who’s doing well on a dose of medication, highly functional and their pain is under good control. This is what you want. This is the clinical outcome.”

Dr. Satel is a resident scholar at the American Enterprise Institute and a lecturer at Yale University. She’s a vocal opponent of the involuntary tapering of controlled opioids.

“It shouldn’t be done without their permission,” she said. “Without the patient’s consent, the results are often disasterous.”

Mountain Home VA Medical Center is prescribing half as many opioids as it did in 2012, according to recently released federal data. Since December 2016, several veterans have voiced their frustration over what they’ve said is a mandate to taper their pain medications.

Dr. Satel says many institutions have misinterpreted the Centers for Disease Control’s pain management guidelines as mandates rather than recommendations.

“It doesn’t say anything about taking people off their medications if they don’t want to go off of it,” Dr. Satel said. “Of course, it’s frustrating, especially when it’s misinterpreted in the direction of poor patient care. It’s very frustrating.”

For decades, VA and other doctors have prescribed pain medications because they thought, at the time, that’s what patients needed. However, in recent years, they changed their approach when new research found opioids can be dangerous and ineffective.

“I understand their fear, their anxiety and their anger, but I want them to understand this is driven by our concern for their safety,” Mountain Home VA Opiate Safety Initiative Chairman Dr. Martin Eason said in December 2016.

Most recently, Mountain Home VA Chief of Staff Dr. David Hecht said the facility is proud of its 49% decrease in opioid prescriptions since 2012. He added, doctors consider every patient’s need on a case-by-case basis and taper veterans off opioids in a safe way.

“Many veterans have really understood and bought into it and it has helped us,” Dr. Hecht said. “Any time we reduce these medications, we want to reduce them in a safe environment.”

The VA maintains it has taken patients off opioids gradually and given veterans the opportunity to appeal their tapering decisions. The agency adds while opioids may help with short-term pain, they are not approved to treat chronic pain in non-cancer patients. Mountain Home is now encouraging veterans to try safer and more effective alternatives.

As we reported earlier this month, VA representatives plan to discuss preliminary data that show a link between opioid discontinuation and suicides at an upcoming summit. Dr. Satel has authored several published works alongside one of those speakers.

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