WA State: Changes to Opioid Prescribing and Monitoring

large-scale humanitarian issue: forced opioid tapering in patients receiving long-term prescription opioid therapy for chronic pain

International Stakeholder Community of Pain Experts and Leaders Call for an Urgent Action on Forced Opioid Tapering

https://academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pny228/5218985

We, the undersigned, stand as a unified community of stakeholders and key opinion leaders deeply concerned about forced opioid tapering in patients receiving long-term prescription opioid therapy for chronic pain. This is a large-scale humanitarian issue. Our specific concerns involve:

  • rapid, forced opioid tapering among outpatients;
  • mandated opioid tapers that require aggressive opioid dose reductions over a defined period, even when that period is an extended one.

Opioid tapering guidelines were created, in part, to decrease harm to patients resulting from high-dose opioid therapy for chronic pain. However, countless “legacy patients” with chronic pain who were progressively escalated to high opioid doses, often over many years, now face additional and very serious risks resulting from rapid tapering or related policies that mandate extreme dose reductions that are aggressive and unrealistic.

Rapid forced tapering can destabilize these patients, precipitating severe opioid withdrawal accompanied by worsening pain and profound loss of function. To escape the resultant suffering, some patients may seek relief from illicit (and inherently more dangerous) sources of opioids, whereas others may become acutely suicidal. Regardless of one’s view on the advisability of high-dose opioid therapy, every thoughtful clinician recognizes rapid tapering as a genuine threat to a large number of patients who are often medically complex and vulnerable. Indeed, even slower tapers should include realistic, patient-centered goals that are achievable and account for individual patient factors.

New and grave risks now exist because of forced opioid tapering: an alarming increase in reports of patient suffering and suicides within and outside of the Veterans Affairs Healthcare System in the United States.

Reports suggest that forced tapering is also occurring in patients on opioid doses below the Centers for Disease Control and Prevention Opioid Guideline threshold of 90 morphine equivalent daily dose. These patients too are at risk of harm from overly aggressive tapering.

Patients on legacy opioid prescriptions require different considerations and careful attention to the methods by which opioid tapers might be considered and implemented. Currently, no data exist to support forced, community-based opioid tapering to drastically low levels without exposing patients to potentially life-threatening harms. Existing data that support rapid reductions of opioid doses—often to zero—were conducted in highly structured, supportive, interdisciplinary, inpatient settings or “detox” programs in which medications and other approaches were used to minimize the symptoms of withdrawal. These data do not inform community-based opioid tapering. Currently, nonconsensual tapering policies are being enacted throughout the country without careful systems that attend to patient safety. The methods by which a taper is conducted matter greatly.

We therefore call for an urgent review of mandated opioid tapering policies for outpatients at every level of health care—including prescribing, pharmacy, and insurance policies—and across borders, to minimize the iatrogenic harm that ensues from aggressive opioid tapering policies and practices.

Almost 18 million Americans are currently taking long-term prescription opioids. We ask the Department of Health and Human Services to consider the following to mitigate harms in this special, at-risk population:

  • Enact policies that prohibit or minimize rapid, forced opioid tapering in outpatients taking legacy opioid prescriptions (this includes prescribers and health care organizations, pharmacies, and insurance payors).
  • Provide compassionate systems for opioid tapering, if indicated; that includes careful selection, patient-centered methods, close monitoring, triaging of adverse events, and realistic end-dose goals that are evidence-based and derived from applicable outpatient tapering data.
  • Convene patient advisory boards at all levels of decision-making to ensure that patient-centered systems are developed and patient rights are protected within the context of pain care.
  • Require inclusion of pain management specialists at every level of decision-making about future opioid policies and guidelines.

In standing as a unified community of concerned scientists, experts, citizens, and leaders of pain organizations in our respective countries, we call for the development and implementation of policies that are humane, compassionate, patient-centered, and evidence-based in order to minimize iatrogenic harms and protect patients taking long-term prescription opioids.

Is getting Prescriptions – IN THE MAIL – SAFE ?

Virginia moves to limit mail-order specialty pharmacies following concerns of mishandling medicines for complex conditions

https://www.richmond.com/virginia-moves-to-limit-mail-order-pharmacies-following-concerns-of/article_43d79bec-a732-5434-ac0c-bec7e420e246.html

Shortly after Loretta Boesing’s son took medication delivered to the family’s home in Missouri on a hot summer day in 2012, he ended up in the hospital as the liver transplant he’d received at the age of 2 began to fail him.

Although the liver didn’t fail, he spent five weeks in the hospital. Boesing is convinced that the medicine, delivered to her door in a plastic bag, had been weakened by the heat in which it was transported, she said in an online petition she posted to Change.org that has gathered nearly 78,000 signatures from people in favor of tougher rules on mail-order specialty pharmacies and the insurance companies that require them.

These pharmacies, which focus on high-cost medication therapies to treat serious, complex conditions, such as cancer or rare diseases, are growing in popularity as insurance companies favor the cost savings that result from negotiations and personalization of the prescription to the patient.

As more people use the service, Virginia regulators are seeking greater control over the delivery of these medications from specialty pharmacies, either to a practitioner’s office — known as “white bagging” — or directly to the patient’s home — known as “brown bagging.”

The state’s Board of Pharmacy gave initial approval Wednesday to several rule changes aimed at reducing the chance of medication being mishandled due to delivery mishaps, including requiring delivering pharmacies to inform hospitals and doctors’ offices of expected arrival time and storage instructions for medicines, banning the delivery of drugs requiring special storage directly to the patient’s home, and mandating that the specialty pharmacy provide a return procedure for medications that are not delivered or administered.

Despite the associated risks, the prescription delivery model has gained traction in the U.S., at least in part due to reduced costs to insurance companies, which can negotiate prices with the pharmacies and are not generally subject to pharmacy regulations, according to a study published in April by the National Association of Boards of Pharmacy.

“Brown bagging” and “white bagging” can also save prescribers costs associated with purchasing and stocking medications and can spare them the process of billing for reimbursements, the study states.

Despite the benefits associated with the model, the NABP, as well as several health care providers who submitted public comment to the Virginia Board of Pharmacy, expressed concern about the potential for danger to patients, waste of expensive medications and unclear responsibility when something goes wrong with a delivery.

The Board of Pharmacy received five written responses during the public comment period following a public notice of intent to change regulations, which ended Sept. 5.

Cynthia Williams of Newport News-based Riverside Health System said that she supported the regulation and emphasized the lack of oversight to ensure that medications delivered in this way are not compromised.

“This not only puts the patient at risk, but puts the organization administering the medication at risk,” Williams wrote in a public comment. “For the most part, this practice is being driven solely for the financial benefit of insurance vendors, not for the benefit (or safety) of the patient or healthcare provider.”

Another commenter, Elizabeth Early, cited examples of medications sitting for hours in extreme temperatures when improperly delivered, waste when a delivered medication must be disposed of after a last-minute change to the prescription for the patient’s health, and delays in delivery endangering patients’ health and costing them financially when they must purchase new medicine.

Dr. Richard Ingram, president of the Virginia Association of Hematologists and Oncologists, wrote that his organization is “in strong opposition to ‘white bagging’ and ‘brown bagging,’ ” specifically for cancer medications, which he said require special care.

Just over a quarter of oncology drugs were distributed by delivery, according to the 2016 Genentech Oncology Trend Report, cited in the NABP report.

The proposed regulations will be subject to a 60-day comment period before the Board of Pharmacy holds an official vote, which would send them to Gov. Ralph Northam for final approval.

bbalch@timesdispatch.com

(804) 649-6601

Twitter: @bridgetbalch

Years ago there was a single test done on the mailing a prescription inhaler.  It was mailed to an address in the SW USA IN THE SUMMER… and after it arrived.. its potency was tested and it LOSS ABOUT 50% OF THE LABEL POTENCY.  If any entity has done any testing since… I have not seen any published data.

The FDA/USP has temperature storage requirement for most common meds somewhere between mid-50’s to mid-80’s.  Some medications .. like Fentanyl patches have a much lower temp storage requirements.. they use to state 72F-75F upper limit .. now they say “room temperature”.

As the laws now function, the pharma, wholesaler and pharmacy are required to maintain those storage requirement, but once a pharmacy hands off a prescription to be mailed to the carrier ( USPS, UPS, Fed-X).. they are not held to those storage requirement.

Where is the FDA/USP on this issue… or … is this just another area that the insurance industry’s lobbying power is able to get the bureaucrats to “look the other way”… since the insurance industry own the vast majority of these mail order pharmacies ?

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I sent yours, can you forward mine? Please read 28th amendment Please Read, and forward. This will only take 1 minute to read! 28th Amendment, 35 States and Counting. It will take you less than a minute to read this. If you agree, please pass it on. It’s an idea whose time has come to deal with this self-serving situation: OUR PRESENT SITUATION ! Children of Congress members do not have to pay back their college student loans. Staffers of Congress family members are also exempt from having to pay back student loans. Members of Congress can retire at full pay after only one term. Members of Congress have exempted themselves from many of the laws they have passed, under which ordinary citizens must live. For example, they are exempt from any fear of prosecution for sexual harassment. And as the latest example, they have exempted themselves from Healthcare Reform, in all of its aspects. We must not tolerate an elite class of such people, elected as public servants and then putting themselves above the law. I truly don’t care if they are Democrat, Republican, Independent, or whatever. The self-serving must stop. Governors of 35 states have filed suit against the Federal Government for imposing unlawful burdens upon their states.It only takes 38 (of the 50) States to convene a Constitutional Convention. IF??? Each person that receives this will forward it on to 20 people, in three days most people in The United States of America will have the message. Proposed 28th Amendment to the United States Constitution: “Congress shall make no law that applies to the citizens of the United States that does not apply equally to the Senators and/or Representatives; and, Congress shall make no law that applies to the Senators and/or Representatives that does not apply equally to the Citizens of the United States …”

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Has your health insurer denied your care?…. how to appeal !!!

https://coveragerights.org/

CMS proposal would leave HIV therapies as well as antidepressants and cancer treatments unprotected

Trump Medicare Plan Targets Drugs From AstraZeneca to Roche

https://www.bloomberg.com/opinion/articles/2018-11-27/will-donald-trump-stand-up-to-seniors-on-drug-prices

The latest proposal from the U.S. Centers for Medicare and Medicaid Services (CMS) to let insurers use step therapies, or to drop protections on certain classes of drugs if price increases outpace inflation, may harm a wider circle of drugmakers, ranging from GlaxoSmithKline to Gilead.

Amgen, Regeneron Pharmaceuticals and Roche Holding are often cited as the drugmakers having the most to lose in proposed changes to Medicare. Regeneron’s Eylea, Roche’s Avastin and Amgen’s franchise of blood boosters get a good part of their revenue from sales under Medicare. Yesterday’s

CMS proposal would leave HIV therapies as well as antidepressants and cancer treatments unprotected.

Gilead and Glaxo, as the top HIV manufacturers, as well as makers of anti-depressants and antipsychotics like AstraZeneca, Pfizer, Allergan, Bausch Health, Lilly and Otsuka Holdings may face new challenges and may be deterred from price hikes, Height analyst Andrea Harris wrote in a note to clients. Harris predicts “a fairly modest impact on drug manufacturers and Medicare plan sponsors” overall and says the final rule, expected by April, will likely differ from the proposal.

Veda analyst Spencer Perlman agrees. “Whether this policy will be finalized is an open question; it remains to be seen if CMS can withstand withering political pressure likely to come from patient advocacy groups concerned with the potential loss of access to certain medications.”

The proposals may be a boon for insurers though, and also favor pharmacy benefit managers. UnitedHealth, for example, is already using step-therapy, where patients try cheaper drugs first before turning to more expensive treatments, in some of its Medicare Advantage plans, Perlman noted.

New rules could benefit UnitedHealth, Humana and WellCare the most, while Aetna, Anthem and Cigna may be less affected, Leerink analyst Ana Gupte wrote. She sees insurers spending less on drugs, and an enhanced role for private plans in the future. And Evercore ISI’s Ross Muken sees PBMs getting “incremental negotiating leverage” where they previously had none.

That NOISE you hear is the Medicare Part D program CRASHING

Don’t look now… but the Medicare folks who are chronic pain pts are at risk of being sucker punched by their Part D and/or Medicare Advantage programs. Medicare open enrollment period is now open and closes on Dec 7th.

CMS has given these FOR PROFIT private insurance companies some dosing guidance on opiate and other controlled substances.  This is where things get FUZZY… apparently these companies can put into effect any limits they wish up to the limits issued by the CMS.

Apparently – per CMS – there are soft edits at 90 MME and supposedly the pharmacist can override this fairly easily and then there is a HARD EDIT at 200 MME – NOT ABOVE 200 MME – so if you are taking MS Contin 100mg twice daily… you have hit the HARD EDIT –  how stupid is that.

From what I understand once you reach the HARD EDIT level… is when the insurance companies DECIDES if you really need that high a dose… remember we are dealing with FOR PROFIT INSURANCE COMPANIES  and denial of care of pt’s medication needs… will drop directly to their net profit/bottom line.

Now here is where pts may get really screwed… in about 10 days (Dec 7th) open enrollment ends for Medicare… BUT.. the insurance companies are not going to announce/publish their final dosing limits until maybe as late as Jan 1, 2019.  So no matter what program that you are signing up for now… may end up being a “pig -in – a-poke” because what ever they claim is their policies may or may not have any relationship to what their policies are going to be come 2019.  AND… you can’t make any changes to your insurance provider until the end of 2019 for 2020.

Back in jan , 2006 when Medicare Part D program was first implemented, maybe pts should consider this may happen again in 2019 when these new dosing guidelines are implemented.  There was a lot of Medicare folks back in 2006 that showed up at the pharmacy on Jan 1, 20016 with their new Part D insurance card – out of medication – and expecting to get part of the medication costs covered..  Problem was this new system CRASHED… pharmacists in every store in every state… couldn’t get claims processed.

At that time, expecting something like this would happen … I made sure that Barb had enough medication to last until at least mid-January and when she need her refills… all of the “bugs” in the system had been worked out and refilled in a timely manner.

This year Dec 31st is a Monday and I would not be surprised to see some/many/all of these Medicare insurance programs will not publish their new dosing policies until that day.. and .. of course the next day being a national holiday… many pharmacies will be open but few/no prescriber’s office will be.

DEA law permits a prescriber to prescribe a 90 days supply of opiates and other controlled substances, state laws and insurance policies may or may not allow this.

I have already talked to our PCP about getting a 90 days supply of controls in Dec and he is fine with it.

Keep in mind that there are some 130 million people on Medicare medication program of one form or another.

This year Jan 1, 2019 is a TUESDAY, everyone is going to be coming back to work from a THREE – FOUR DAY weekend.

I would not be surprised to see these Part D programs to publish their NEW GUIDELINES late on FRIDAY Dec 28, 2018 and not be back in business until Jan 2, 2019. How many of those 130 million Medicare folks are going to be finding out that their controlled substance falls under some new dosing guidelines.. that they – and maybe their prescriber – don’t have a clue about ?

it is my recommendation to anyone needing a controlled substance filled the first of the year to talk to your prescriber and pharmacist and see if you can get 60  or 90 days supply in your state filled in December.

If the Part D implementation of 2006 is any indication of what could happen with this new implementation it could resemble a MAJOR CHAOS !!!  It is not going to be business as usual.  Pharmacies and prescriber’s offices could be TOTALLY OVERWHELMED at least the first week of Jan – which is a SHORT WORK WEEK !

Tonight 8PM EST (11/28/2018) CONSPIRACIES AGAINST WELLNESS Guest Dr. Moshe Dekel

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Some politicians – THAT LIE – didn’t get RE-ELECTED !

Claire McCaskill cites disproven figure on opioid use

https://www.politifact.com/missouri/statements/2017/may/10/claire-mccaskill/mccaskill-cites-long-disproven-figure-opioid-use/

The state of opioid abuse in America has been deemed an epidemic.

Overdose related deaths involving prescribed opioids have reached an all-time high, jumping from 19,000 in 2014 to 22,000 in 2015, according to the Centers for Disease Control and Prevention. Considering all opioids (not just prescribed ones), the figures get even worse: In 2015, 33,091 died from opioid related overdoses.

Missouri Sen. Claire McCaskill has set her sights on curbing the issue, writing an op-ed in the Kansas City Star and dedicating a page of her website to facts and figures. One tweet in particular caught our eye: “We have 5% of world population. 80% of opioids.”

Such drastic numbers paint a dire picture for the state of opioid use and abuse in America. We wanted to fact-check her claim.

What we found was that while America certainly consumes more opioids than any other country, the notion that we consume 80 percent of the global supply is greatly exaggerated.

‘One startling number’

Checking the first part of McCaskill’s claim was simple: The United States’ population is, according to the U.S. Census bureau, 324.8 million. The global population is 7.4 billion. That means the United States accounts for roughly 4.4 percent of the total world population.

Checking the other half was more complicated.

We reached out to McCaskill’s spokesperson, Drew Pusateri, and he supplied us with the source of the figure: a CNBC article published on April 27, 2016.

And while the article provides the figures McCaskill cited, it is vague about where exactly the 80 percent figure comes from. Upon its first reference it is simply “one startling number from recent years,” and later it is noted that the figure was “cited in various studies,” including one by Express Scripts.

The Express Scripts study, “A Nation In Pain,” was released on Dec. 9, 2014. And while it does cite the 80 percent figure, it was not a study designed to measure American opioid consumption or global consumption.

The reality, according to Christopher Jones, the director of the Division of Science Policy in the Department of Health and Human Services, is that America consumes 30.2 percent of globally distributed opioids.

30.2 percent

According to data collected by the International Narcotics Control Board, the United States consumed roughly 30.2 percent of opioids in 2015.

A Vienna-based “quasi-judicial expert body,” the International Narcotics Control Board is tasked with tracking global opioid consumption, among a myriad of other things.

The board releases three annual reports on narcotic drugs. “Narcotic Drugs: Estimated World Requirements for 2017; Statistics for 2015” is the most recent publication, and includes data for the year 2015.

Using the International Narcotics Control Board figures, Jones calculated that the United States consumed 173,332 kilograms of 574,693 kilograms of opioids consumed globally (382,131.6 of 1,266,981.2 pounds), or 30.2 percent.

The drugs Jones included in the measurements are: codeine, dihydrocodeine, ethylmorphine, hydrocodone, morphine, oxycodone, pholcodine, dextropropoxyphene, diphenoxylate, methadone, pethidine and tilidine. The figures also include the calculated consumption of buprenorphine.

To be clear, Jones noted, such data is limited in several ways. The first is that it is government-reported data. The second is that many drugs are marketed in one country and not another; while used frequently in the United States, hydrocodone is virtually unused elsewhere.

Additionally, some of the data include drugs that may have been exported from the country of manufacture and consumed in another country. Thus, data from INCB should be considered with great care when comparing consumption levels of narcotic drugs across countries.

And finally, the board makes special note that comparing countries by the weight of opioids consumed is not recommended. Instead they suggest using a statistical measurement called “defined daily doses.”

Defined daily doses

A defined daily dose is the quantity of a particular narcotic drug used in a day by one individual. It is not a recommended dosage, but rather it is a calculation created by the International Narcotics Control Board to statistically measure opioid use with a ratio that directly relates a country’s population to its consumption. 

For example, the daily dose of hydrocodone is 15 milligrams. So, if 60 milligrams are consumed, four defined daily doses would be recorded. The final results are calculated per million inhabitants.

The United States consumed the most using this measure from 2013 to 2015: 47,580 doses of narcotic drugs were consumed per day per million people.

Canada comes in second with 34,444 defined doses consumed per day, and Germany in third with 30,796.

Using such a measurement, it is easy to see that consumption in America, while noticeably higher than in similarly developed countries, is not as astronomical as McCaskill’s cited figure makes it appear.

‘A life of its own’

Jones said it’s common for people to cite the 80 percent figure that McCaskill did, despite its inaccuracy.

“I would say it is a commonly quoted statistic…people across a variety of disciplines, who even are somewhat expert on the topic, have repeated that statistic,” he said.

Jones said he believes the number originated as the percentage of oxycodone that America consumes compared to the world.

From there, he said, the figure has “taken a life of its own. It’s now a ‘fact’ because it’s been repeated so many times.”

But it’s not the full picture. Because while America does consume over 75 percent of oxycodone, and 99 percent of hydrocodone, it doesn’t consume even half of all opioids globally, according to the International Narcotics Control Board data.

Which, in part, according to Jones, has to do with marketing. Oxycodone and hydrocodone are marketed in America. Similar opioids are more prevalent elsewhere.

Drug control systems

Despite conflated numbers, experts agree there is a problem.

Martha Maurer, a policy program manager and researcher at the Pain and Policy Studies Group at the University of Wisconsin-Madison, agreed that opioid abuse in the United States was an epidemic.

But part of the solution, she said, was continuing to figure out how to view the problem.

“It’s clear that there has been a lot of harm associated with overdose and abuse,” Maurer said, “but it goes back to the question of where (abused) medication is coming from, which we just don’t know.”

Something worth noting, Maurer said, was that when you look at the milligram-per-person statistics, “some countries, including Germany, Austria, Denmark and Switzerland, have opioid-consumption levels comparable to that in the US, but they are not having the same problems with harms caused by overdose. Their drug-control systems ensure a balanced approach to opioid access.”

For Jones, it’s about finding the right balance.

“From a policy perspective, we’re trying to ensure that opioids are available when they are needed, but that they are being used as a part of comprehensive evidence-based pain care,” he said, “not that we’re relying on them just because they’re the easiest thing to prescribe, or there are other external pressures to prescribe them.”

Our ruling

In setting out to combat America’s opioid epidemic by holding pharmaceutical companies accountable, Missouri Sen. Claire McCaskill said that with just 5 percent of the population, the United States consumes “80 percent of opioids.”

McCaskill’s figure, widely cited as it is, is inaccurate. It presents a narrow view of opioid consumption globally, where some opioids are marketed in select countries, but not others. It also discounts using defined daily doses, which provide a far more accurate representation of consumption when comparing nations.

So, while the United States is clearly the largest consumer of opioids, it, at most, accounts for roughly 30 percent of global consumption. We rate McCaskill’s claim False.