American Kratom Association not taking rescheduling lightly

 American Kratom Association (AKA)

Below is link to a 35 page letter send to the acting director of the DEA  Chuck Rosenberg that the law firm hired by the AKA

hogan-lovells-letter-regarding-kratom-scheduling

Alabama Governor tries to appear sympathetic to “Matthew evacuees” in need of medication… those needing controlled meds – SOL ??

Any pharmacy in a storm: Governor eases refill rule for Hurricane Matthew evacuees

http://www.al.com/news/mobile/index.ssf/2016/10/any_pharmacy_in_a_storm_govern_1.html

Evacuees coming to Alabama to avoid Hurricane Matthew might have many problems, but getting prescriptions filled while waiting to go back home shouldn’t be one of them, says Gov. Robert Bentley.

On Friday Bentley declared a state of emergency specifically aimed at helping storm evacuees with medication needs “of a chronic, urgent, or emergency nature.”

“The issuance of this State of Emergency today will help ease the burden on evacuees as they try to get an out-of-state prescription filled,” Bentley said in a statement issued Friday. “Evacuees will now have more time to get emergency prescriptions filled, instead of 72 hours; they will now have 30 days to get prescriptions filled.”

According to information released by the governor’s office, the Alabama Department of Public Health’s state health officer predicts “a significant number of displaced individuals” will have such needs.

According to Friday’s release, “This State of Emergency only applies to non-controlled prescriptions. The prescriptions may be refilled upon the presentation of the actual medication bottle indicating the name of the prescriber, copies of prescriptions, insurance billing report or insurance claim notification, or other documentation which would provide the pharmacist sufficient information to adequately identify the non-controlled medication and the dosage.”

According to the proclamation, state law specifies an emergency refill period of 72 hours; the document states that “under the current conditions, this time frame is both impractical and inadequate, and should be extended.”

Anonymous survey about how DEA’s actions have effected your quality of life

How have you been affected by the reclassification of opiate medications or changes to state laws?

https://www.surveymonkey.com/r/reportpainmanagement_prescribing

INSTRUCTIONS TO RESPONDENTS-
 
For the millions of American patients experiencing an acute medical need or living with chronic pain, opioids, when prescribed appropriately, can allow patients to manage their pain as well as significantly improve their quality of life when combined with a program of effective integrated health management.

In recent years, the FDA and CDC have become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States. While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse.

In 2009, the U.S. Drug Enforcement Administration (DEA) asked the U.S. Department of Health and Human Services (HHS) for a recommendation regarding whether to change the schedule for hydrocodone combination products, such as Vicodin. The proposed change was from Schedule III to Schedule II, which increased the controls on these products.

 
In 2015, the CDC contracted with a panel of experts to make recommendations for the development of guidelines designed to address perceived problems with increasing overdose deaths associated with the use of prescription medications and illicit, illegally obtained opiates. These Guidelines for prescribing opiates for persons with chronic pain were issued in March of 2016.
 
Throughout the period from 2012 to 2016, states began to pass legislation which changed prescribing practices for persons with chronic pain who utilize opiates and other schedule II medications for pain management.
 
States have devised and install prescription drug management programs (PDMPs), initiated drug take back programs and limited access by making changes to prescribing practices.
 
Both CDC and FDA have professed their desire to work with professional organizations, consumer and patient groups, and industry to ensure that prescriber and patient education tools are readily available so that these products are properly prescribed and appropriately used by the patients who need them most.
Nevertheless, reports from consumers indicate that their access to appropriate pain management has been disrupted by changes to scheduling, the adoption of CDC’s Guidelines for Chronic Pain Prescribing, and changes to state prescribing laws.
The following drugs have been reclassified from Schedule III to Schedule II:
  • Hydromorphone (any brand, any dose)
  • Oxycodone (any brand, any dose)
  • Hydrocodone (any brand, any dose)
  • Morphine (any brand, any dose)
  • Oxymorphone (any brand, any dose)
  • Methadone (any brand, any dose)
  • Transdermal fentanyl (any brand, any dose)
  • Transdermal buprenorphine (any brand, any dose)
  • Ritalin (any brand, any dose)
  • Adderall (any brand, any dose)
 
Reports of difficulties in access to support have emerged from the patient community. These reports include-
  • Different restrictions on opiate prescribing levels have emerged from state to state. 
  • Different physician qualifications for prescribing and training have appeared as a function of differing state laws. 
  • Refill practices are now variable from pharmacy to pharmacy and state to state.
  • Forced substitutions with less effective prescription medications.
  • Forced acceptance of interventional procedures (injections, pumps, or stimulators) as a condition for prescribing oral forms of opiates.
  • Physician discharge of patients wit

FDA and CDC have publicly stated that they want to work with patient groups to determine the impact of this change. We believe that it is important for consumers with chronic and intractable pain (for any reason) to be represented in the policy changes. This collection tool is being distributed to selected groups of consumers through social media platforms.

Please review the following questions. Your best answer to these questions will help us to determine how consumers are most affected and where our advocacy efforts should be placed. Your personal identifying information will not be shared under ANY circumstances but your email and state/zip are necessary to confirm that (1) we can follow up with you if we have questions and (2) we can examine geographic location patterns as a factor in your response. Each submission will be assigned a code for reference in order to assure anonymity.  During the data analysis process your personal name will be separated from the information and separately and securely store with a record number.

If you are a care partner to a friend or family member who cannot complete this on their own, please indicate that you have provided assistance on behalf of another.

The contact person for this survey is: Terri Lewis PhD tal7291@yahoo.com

INDIANA “Legalization Rally” Saturday from noon to 3 p.m. at the Greene County Courthouse

Our Opinion: Educate yourself before attending ‘Legalization Rally’

http://www.gcdailyworld.com/story/2346272.html

Saturday will mark what we believe to be the first “Legalization Rally” to discuss the future of marijuana use in Indiana. While the topic continues to be controversial, we suggest doing some research and showing up with an informed stance.

The rally is Saturday from noon to 3 p.m. at the Greene County Courthouse and hosted by the Higher Fellowship. In a previous story in the Greene County Daily World, Bobbie Young, executive director of The Higher Fellowship, said the goal of the rally is to raise awareness.

The rally will also offer patrons a chance to voice their opinion on a PA system during an open forum portion of the event.

Many people are either for or against such a topic, but we ask that those in attendance do their research and have a better understanding of the other’s perspective. Young said some people may be afraid to attend a public rally, but we believe this could serve as an interesting forum to discuss the topic of marijuana.

Why is it important to start the conversation? One day the public may see the question on the ballot and should be able to make an informed decision.

Several states have already approved the legal use of marijuana — some for medical reasons and others for recreational use — and a bill is sitting in the Indiana General Assembly to discuss the topic.

District 4 Sen. Karen Tallian authored Senate Bill 209 to legalize medical marijuana in January, and according to the General Assembly’s website, www.iga.in.gov, no action has been taken on the bill since its first reading early in the year, aside from forwarding it to the Committee Health and Provider Services.

So, let’s start with the arguments against.

The Drug Enforcement Administration (DEA) explains marijuana is classified as a Schedule I controlled substance.

In the 2015 DEA Resource Guide (available at www.dea.gov), “Drugs of Abuse,” describes marijuana and cannabis as a “mind-altering pschoactive drug” with THC believed to be the “main ingredient that produces psychoactive effect.”

Based on clinical studies, the guide states, use of marijuana can lead to dizziness, nausea, tachycardia, merriment, relaxation, disinhibition, heightened imagination, impaired judgment, sedation, blood shot eyes, increased heart rate, coughing, increased appetite and decreased blood pressure, just to name a few.

There are some scary words in there: Disinhibition and impairment.

Of course, alcohol causes impairment too, right? What sets these apart is there is currently a field test to check for alcohol with the Breathalyzer, making it easier for police to detect and act on the issue. But some companies are working to develop a similar portable tool to test for THC.

In addition, the guide states “Researchers have also found an association between marijuana use and an increased risk of depression, an increased risk and earlier onset of schizophrenia, and other psychotic disorders, especially for teens that have a genetic predisposition.”

The Food and Drug Administration (FDA) has not approved medical marijuana use.

The FDA’s website, www.fda.gov, states, in part, “The FDA has not approved any product containing or derived from botanical marijuana for any indication. This means that the FDA has not found any such product to be safe or effective for the treatment of any disease or condition. Study of marijuana in clinical trial settings is needed to assess the safety and effectiveness of marijuana for medical use. The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of marijuana.”

On the flip side, some states that have legalized marijuana in some form are seeing some success, especially in the sense of tax revenue.

According to www.taxfoundation.org, Colorado has a 15 percent tax on wholesale marijuana price, plus an additional 10 percent state tax. There are also business license fees included.

After voter approval in Colorado in January 2014, the state has seen continued increase in revenue generated from the taxes. In 2015, the tax revenue had grown to $113 million.

An article published by the Denver Post in May showcased where the money is being used. For example, the town of Aurora has used its $1.5 million in revenue to help with its homeless issue, working on road improvements and creating a new recreation center, with Adams County utilizing funds for $500,000 in scholarships. These are just a few examples.

In the state of Washington, taxes include a 37 percent excise tax, as well as State, Business and Occupation taxes.

In Oregon, there is a 25 percent excise tax, with local government able to add another 2 percent tax.

Aside from the potential revenue possibilities, a big push for legalization has focused on its reported medical use.

The National Institute on Drug Abuse details the reported there is scientific study that shows chemicals in marijuana have led to FDA-approved medications that include cannabinoid (CBD) chemicals.

The website, www.drugabuse.gov, says studies show CBD can help reduce pain and inflammation, control epileptic seizures and possibly treat mental illness or additions.

“For instance, recent animal studies have shown that marijuana extracts may help kill certain cancer cells and reduce the size of others. Evidence from one cell culture study suggests that purified extracts from whole-plant marijuana can slow the growth of cancer cells from one of the most serious types of brain tumors. Research in mice showed that treatment with purified extracts of THC and CBD, when used with radiation, increased the cancer-killing effects of the radiation,” the website says.

So, whether you are in favor or not, take a few minutes to hear people’s stories and educate yourself.

2015: $740.74 for each pot plant uprooted in New Hampshire

emptyheadThe DEA spent $73,000 to eradicate marijuana plants in Utah. It didn’t find any.

https://www.washingtonpost.com/news/wonk/wp/2016/10/07/the-dea-spent-73000-to-eradicate-marijuana-plants-in-utah-it-didnt-find-any/

In 2015, the Drug Enforcement Administration gave $20,000 to the state of New Hampshire to eradicate marijuana plants, according to federal documents. But the Granite State’s law enforcement agencies didn’t have much luck finding any weed to pull that year — their efforts uncovered a single outdoor grow site with a grand total of 27 plants.

Do the math, and U.S. taxpayers paid $740.74 for each pot plant uprooted in New Hampshire that year.

That’s an expensive weeding operation, but it could be worse. Utah received $73,000 in marijuana eradication funds, according to the federal documents obtained and published by journalist Drew Atkins. But agents failed to find a single pot plant to eradicate.

The DEA’s $14 million marijuana eradication program has been the subject of a fair amount of criticism in recent years. Twelve members of Congress have pushed to eliminate the program and use the money instead to fund domestic-violence prevention and deficit-reduction programs.

Its purpose is to “halt the spread of cannabis cultivation in the United States,” a mission that has become complicated as more states have legalized medical or recreational marijuana programs. Several more states have similar measures on the ballot this year.

DEA records show the program has been effective in some states, most notably California. Agents pulled 2.6 million marijuana plants in 2015, seizing more than 1,600 weapons in the process. Nearly $5.4 million was funneled into that state’s program.

Kentucky’s $1.9-million program had the next largest number of eradicated plants, more than 570,000.

Nationwide, the DEA documents show that spending on the program has shrunk from about $18 million in 2014 to $14 million in the current fiscal year. Some states — including Alaska, Colorado and Vermont — stopped receiving eradication funds completely.

Here’s where that money’s going on a state-by-state basis.

California, where medical marijuana is legal, receives the lion’s share of marijuana eradication funds, in part because the “Emerald Triangle” region of Northern California. The area has long been home to many of the state’s legal and quasi-legal marijuana production operations, but law enforcement authorities have maintained that it also has been a haven for the grow operations of Mexican drug cartels.

Kentucky also receives a large amount of money to eradicate marijuana. The state has a surprisingly rich culture of marijuana cultivation.

Rounding out the top 5 marijuana eradication states are Tennessee, Georgia and, perhaps unexpectedly, Washington. The aptly nicknamed Evergreen State legalized the recreational use of marijuana in 2012, and pot shops opened for business in 2014. So it may seem odd that the DEA is spending $760,000 this year to eradicate pot plants in the state.

But Washington is the only recreational marijuana state that doesn’t allow people to grow their own plants for recreational use. (In D.C., incidentally, the situation is reversed: Homegrows are okay, but you can’t buy weed at the store.)

Washington also receives more marijuana eradication money than any other state with a recreational pot regime in place. Oregon received $200,000 this year, while Colorado and Alaska didn’t take any federal money for marijuana eradication.

You can also look at the 2015 marijuana eradication totals to compare the states based on how much they’re spending per plant. Here’s what that map looks like.

New Hampshire, Louisiana, Delaware, Utah and New Jersey all spent well over $100 for every marijuana plant eradicated. Eleven states spent at least $50 per plant, while nearly half of the states — 23 of them — spent at least $25 in federal money for each marijuana plant they eliminated.

At the other end of the spectrum, states with big investments in marijuana eradication — like California and Kentucky — also had the most successful efforts to pull up large numbers of pot plants. So their per-plant costs are much lower.

To be perfectly clear, even in a fully legal, highly regulated market like Colorado’s there will be a need to enforce prohibitions on large-scale, unlicensed marijuana grows — similar to the way the Bureau of Alcohol, Tobacco and Firearms busts illegal home alcohol distilleries. Beyond that, authorities often make a number of arrests at cultivation sites, or seize weapons and other property from people suspected of involvement with marijuana grow operations.

Still, some lawmakers are starting to question the need dedicated this level or resources to eliminating pot plants when so many states are relaxing their own restrictions.

 

MJ plant eradication at a cost of $24/plant

potpic3_PK.jpg81-year-old woman’s garden raided for a single marijuana plant

http://www.dailyitem.com/news/year-old-woman-s-garden-raided-for-a-single-marijuana/article_285bbf44-8ca4-11e6-ab9f-0bdfc8734368.html

 

 

Margaret Holcomb, an 81-year-old woman from Amherst, Mass., grew a single marijuana plant in her garden, tucked away behind the raspberries. She used it to ease the ailments of old age: glaucoma, arthritis and the occasional sleepless night.

She hadn’t tried to get a medical marijuana card, because of the challenges of getting a doctor’s approval, she told the Daily Hampshire Gazette. And traveling to the dispensary in the next town over and paying for marijuana grown by someone else would be too costly, she feared.

So on the afternoon of Sept. 21, a team of Massachusetts State Police and Massachusetts National Guard troops sent a helicopter, several vehicles, and a handful of troopers to Holcomb’s house to chop down the plant and haul it away in a pickup truck.

 

Holcomb wasn’t the only one targeted by the marijuana raid. State police spokesman David Procopio told the Gazette that authorities also seized 43 other plants from various properties that day. The largest of these seizures involved 20 plants. Several properties netted only two plants each. None of the property owners were charged with crimes, according to Procopio.

Procopio said these operations were done under the auspices of the Drug Enforcement Administration’s Cannabis Eradication Program, which gives state authorities money to uproot pot plants. This year, the DEA gave Massachusetts $60,000 for marijuana eradication efforts, according to federal documents published by the Seattle-based nonprofit news outlet Crosscut.

Last year, Massachusetts received $75,000 and destroyed 3,138 plants under the program, a cost to federal taxpayers of about $24 per plant.

Responding to criticism from a local government official in western Massachusetts, DEA spokesman Melvin Patterson told the Boston Heraldthat the state decides when and how to conduct raids for pot plants.

The Cannabis Eradication Program’s stated goal is to “halt the spread of cannabis cultivation in the United States.” But with more and more states legalizing recreational marijuana use in recent years, some lawmakers are questioning whether an $18 million federal program to pull pot plants makes sense.

The program has also been the subject of controversy and ridicule. In the mid-2000s, DEA data revealed that most of the plants destroyed under the program were “ditchweed,” naturally growing marijuana plants that weren’t being cultivated for any particular use.

Last year in Utah, a member of an eradication team testified that a medical marijuana law could lead to an epidemic of stoned rabbits and other animals. The incident became fodder for late-night talk shows.

Even residents carrying licenses in medical marijuana states can fall prey to the program. In a Massachusetts raid last month, Procopio told the Daily Hampshire Gazette that 10 plants were seized from a couple’s back yard because they were not kept in an enclosed area protected by a lock, as the statute requires. The growers, Patti Scutari and Francesco Compagnone, dispute that, saying that their entire yard is surrounded by a fence with a locked gate. Under Massachusetts law patients may grow as many marijuana plants as necessary to meet their medical needs.

In the town of Wendel, closer to where Margaret Holcomb lives, a similar task force seized 10 marijuana plants from a man licensed to grow medical marijuana to treat issues related to his kidney cancer.

This summer, a task force consisting of National Guard troops and state troopers used a helicopter to aid in seizing four marijuana plants from 81-year-old former cancer patient Paul Jackson on Martha’s Vineyard,according to the Martha’s Vineyard Times. Like Margaret Holcomb, Jackson didn’t have a medical marijuana license.

 

“I figured what I was growing was such a small amount, what the hell was the big deal?” Jackson told the newspaper.

In 2014, marijuana eradicators in Georgia raided a retiree’s garden after mistaking okra for marijuana.

Margaret Holcomb’s case is providing additional fodder for critics of strict anti-marijuana enforcement, particularly now since voters in Massachusetts will consider whether to legalize the plant for recreational use this fall.

“This raid, and similar raids in recent weeks, exposes the rank falsity of prohibitionist claims that law enforcement resources aren’t being used on marijuana enforcement,” said Jim Borghesani of the group Yes on 4, which is running the campaign to legalize marijuana in Massachusetts. “It’s difficult to say what’s worse: the waste of taxpayer dollars or the violation of an elderly woman’s peace.”

Efforts to reach the Campaign for a Safe and Healthy Massachusetts, the group opposing legalization, were unsuccessful.

Holcomb told the Gazette she is considering simply growing another pot plant. “I don’t picture them out here and putting an 81-year-old woman in jail,” she said.

 

 

Is this the “deplorable people” that Hillary referred to ?

https://youtu.be/IwMYGZEkgbI

And you don’t believe that our country has  MAJOR MENTAL HEALTH ISSUES ?   ELECTION STRESS DISORDER ?

Eli Lilly Settles Cymbalta Withdrawal Lawsuits

lawsuit-clipart-judge-cartoon1Eli Lilly Settles Cymbalta Withdrawal Lawsuits

nationalpainreport.com/eli-lilly-settles-cymbalta-withdrawal-lawsuits-8831647.html

By Donna Gregory Burch

donnasnowday

Donna Gregory Burch

Drugmaker Eli Lilly and Company has quietly settled hundreds of personal injury lawsuits involving patients who claim they experienced withdrawal symptoms while quitting Cymbalta.

When asked for an update on the cases, Robin McCall, media relations director for Baum, Hedlund, Aristei & Goldman, P.C., one of the firms handling the cases, wrote in an email, “All we can say is that the suit has been resolved.”

Lilly is also tight-lipped about the settlement, but provided the following written statement:

“Eli Lilly and Company has reached a comprehensive resolution of all personal injury lawsuits alleging symptoms from discontinuing Lilly’s medication, Cymbalta. Lilly has defended these cases vigorously and has won every case to reach a decision on the merits, including defense verdicts in every trial. To avoid continued legal costs, Lilly reached a resolution with plaintiffs in the remaining cases. Lilly remains committed to Cymbalta and its safety and benefits, which have been repeatedly affirmed by the U.S. Food and Drug Administration.”

No additional details on the settlement were provided.

More than 200 patients were suing Lilly, claiming the drugmaker didn’t fully disclose the severity of Cymbalta’s withdrawal symptoms. The plaintiffs in the cases said they experienced headaches, dizziness, nausea, nightmares, anxiety, mania, suicidal ideation, brain zaps (which feel like a lightning bolt going off inside the head) and other symptoms after they stopped taking Cymbalta.

Cymbalta is one of three drugs approved by the U.S. Food and Drug Administration to treat fibromyalgia. It’s also used for depression, anxiety, diabetic neuropathy and certain kinds of chronic pain.

As early as 2005, research indicated a high rate of what medical professionals call “adverse events” when patients stopped taking Cymbalta. This Lilly study found that 44 percent of patients involved in several short-term trials had “adverse events” when they suddenly stopped taking duloxetine (the generic name for Cymbalta). The most common withdrawal symptoms cited were dizziness, nausea, headache, paresthesia (tingling/numbness, usually in the limbs), vomiting, irritability and nightmares. About 10 percent of these patients had “severe” withdrawal symptoms.

A longer and larger Lilly trial involving 1,279 patients found that 50 percent of patients experienced withdrawal symptoms.

The crux of Baum Hedlund’s case involved Lilly’s physicians’ prescribing guide for Cymbalta, which says 1 percent or more of patients discontinuing the drug may experience side effects including dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis and fatigue.

While the “1 percent or greater” figure is technically accurate, Baum Hedlund argued it far understated Cymbalta’s true rate of withdrawal symptoms.

“The label gives the impression that withdrawal is a rare event (somewhere around 1 percent) when in fact it is common (at least 44-50 percent),” said Baum Hedlund in an earlier interview. “We think Lilly played with semantics and the system in choosing its wording – it chose wording to minimize the risk while at the same time using language such as “or greater” as a “CYA” [cover your ass] measure. We believe the label is misleading, plain and simple. The testimony of the prescribing doctors in these cases proves it – they believed the risk was rare.”

Despite the discrepancy, Baum Hedlund had been unsuccessful at convincing a judge or jury that Lilly knowingly misled doctors and patients. Four cases heard in various federal courts last year ended in Lilly’s favor.

The lawsuits may be settled, but Cymbalta users are still dealing with the fallout of the drug’s withdrawal symptoms. The design and dosages of Cymbalta’s capsules make it challenging for patients to wean off slowly over time. Capsules come in 20mg, 30mg and 60mg strengths, meaning patients sometimes have to cut their doses in half while weaning. For some patients, that’s just too much of a reduction at one time.

In desperation, some patients are quitting Cymbalta by dumping out the contents of the capsules and then counting the tiny balls every day in an effort to slowly reduce their dosage over time.

Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She covers news, treatments, research and practical tips for living better with fibromyalgia on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.

State warns of blood infections linked to pre-filled saline flushes

State warns of blood infections linked to pre-filled saline flushes

http://www.njherald.com/20161006/state-warns-of-blood-infections-linked-to-pre-filled-saline-flushes#

TRENTON — The Centers for Disease Control and Prevention, the Food and Drug Administration, the New Jersey Board of Pharmacy, the New Jersey Department of Health and other state health departments are investigating a multistate outbreak of Burkholderia cepacia (B. cepacia) bloodstream infections possibly associated with pre-filled saline flushes, the state Department of Health said Wednesday.

The department was notified last week by the Pennsylvania and Maryland health departments about clusters of bloodstream infections in their states in patients in long-term care facilities who have histories of receiving medications via central lines. There is concern that these infections are due to a contaminated source, specifically pre-filled saline flushes from Nurse Assist, of Haltom City, Texas, according to an announcement from the state.

All long-term care facilities that received this product were contacted by the department on Sept. 30 and told to discontinue using the products and set aside until further notice. However, since this is a rapidly evolving situation, not all distribution networks have been identified, and it is unclear at this time that all the affected products have been identified.

The state Health Department recommends that any health care facilities, providers or anyone else who has received Nurse Assist pre-filled saline flushes immediately discontinue use and sequester the products until further notice.

While the investigation is ongoing, the department has so far identified two New Jersey cases, both in Bergen County, associated with the outbreak. The department is asking long-term facilities to report suspect illnesses.

For additional information on B. cepacia, visit http://www.cdc.gov/HAI/organisms/bCepacia.html.

CMS… no more pt satisfaction survey on how you are treated by healthcare professionals ?

noopiatesforyouEncouraging Integrative, Non-opioid Approaches To Pain: A Policy Agenda

healthaffairs.org/blog/2016/10/04/encouraging-integrative-non-opioid-approaches-to-pain-a-policy-agenda/

The United States is struggling to deal with an opioid epidemic that is damaging lives, resulting in overdoses, and yet not reducing chronic pain. National initiatives are underway to dramatically reduce access to prescription opioids, but these efforts lack a systematic approach to provide alternative treatments for these patients. Policy changes are urgently needed to provide better care for patients with chronic pain, and in this post, we outline three feasible policy initiatives.

Innovative reimbursement initiatives by the Centers for Medicare and Medicaid Services (CMS) could frame and stimulate use of evidence-based treatment options, and allow health providers to acquire familiarity with non-pharmaceutical treatments. Electronic medical systems could be designed to guide safe opioid tapering and provide prompts to incorporate physical, occupational, vocational, and psychological approaches to the patient’s care. And providers must be trained in state-of-the-art interdisciplinary models of pain treatment and management.

These approaches reflect contemporary evidence for optimal management of chronic pain. The national dialogue must seriously include initiatives that not only reduce use of a dangerous treatment, but also eliminate obstacles to implementation of safer treatments for persons with pain. Unless provided with alternative options, patients who are desperate for pain relief may take matters into their own hands and look to the streets.

Chronic Pain And Opioids: The Landscape

Over 100 million Americans suffer with chronic pain, 25 million of them on a daily basis. In the clinic, a patient’s expression of pain has urgency to it, and doctors are pressed to address pain reports quickly and perhaps with less focus on the future consequences of actions to stop the pain.

Other pressures include CMS’ patient satisfaction questions designed to assess pain management during a hospital stay. These outcomes have been tied to hospital reimbursement through the Hospital Value-Based Purchasing program, and they have resulted in expectation in inpatient settings to intervene quickly and completely to eliminate pain. For example, one of the CMS questions asks, “How often did the hospital staff do everything they could to help you with your pain?”

Now, in response to the opioid epidemic, CMS is proposing to remove financial incentives tied to pain satisfaction items. This proposed revision has been applauded by addiction medicine groups but criticized by pain medicine groups, illustrating both sides of the dilemma.

These pressures may explain how opioids have become so widely used in medical practice. They provide immediate pain relief, but can transition to unsafe, long-term treatment for pain. As much as 3 to 4 percent of the adult U.S. population is prescribed long-term opioid therapy, and there are nearly 19,000 prescription opioid poisoning deaths annually.

Today a person dies from prescription opioid poisoning every 29 minutes. Annual opioid sales are enough to keep every American on opioids around the clock for 1 month.

While over the past 15 years increasing numbers of patients have been using long-term opioid therapy, there has not been a decrease in Americans’ complaints of pain. Recognizing that an opioid prescription does not equate with feeling better in the long run has been difficult for patients and clinicians alike. For these reasons, alternative non-pharmacological treatments—which take time to implement and focus on long-term improvements—remain largely on the sidelines, unavailable to patients and undervalued by health care practitioners and insurance providers.

An associated concern is the belief that chronic pain is a problem best addressed by intervening directly on neurological pain pathways and discrete anatomical regions of the body. Indeed, pain education in medical schools focuses most of its 11 hours on anatomic location of pain, nociceptor activity, and use of pharmacologic treatment. However, we know that chronic pain often does not fit a simple anatomic or physiologic model. Chronic pain is driven by many factors, including genetics, gender, marital and job satisfaction, employment status,  disability policy and benefits, as well as emotional responses to pain.

When conceived of as a problem intertwined with many aspects of a person’s life (rather than solely as a sensory event), we can see more easily that pain, as a problem, is affected by circumstances that contribute to profound suffering across many domains. Unfortunately, in the clinic today, the social, psychological, and economic influences that potentiate this suffering are often unaddressed, resulting in poor treatment outcomes.

An Historical Interdisciplinary Model

Historically, medicine did not always ignore the complexities of the pain experience. In the late 1970s, a neurosurgeon, John Loeser, and a clinical psychologist, Bill Fordyce, enlisted doctors and allied health professions to work together to help persons with chronic pain. The treatment they developed addressed the many factors that contribute to pain and treated patients as active participants in therapy. Patients were taught to interpret their pain experience differently, become stronger with physical therapy, and develop self-management skills with the aid of a psychologist that would help them to lead more productive lives.

These treatments worked. Consequently, multidisciplinary pain centers flourished around the country. However, this model of care utilized considerable health service resources and required whole teams to focus on the care of each individual patient. Though patients improved, insurers that were fighting to contain costs stopped paying for multidisciplinary pain care, and most centers did not survive. In 1999, there were over 1,000 multidisciplinary chronic pain clinics in the US, compared to only 90 programs in 2015.

At the same time, physicians treating dying patients began to champion opioids as a means of proving compassionate care for patients with chronic pain who were not dying. Expert panels with limited experience in nonmalignant pain management began to write guidelines for use of opioids in primary care. The guidelines were strong on expert opinion but weak on evidence.  Most Food and Drug Administration (FDA) trials required that opioids demonstrate relief over 12 weeks — enough to address immediate symptoms without observation of long-term negative consequences. Pharmaceutical firms that produced and marketed opioids aided the initiative to expand opioid use.

By the mid-1990s, medicine’s view of pain had changed. Surprisingly, a small inpatient sample of 38 cases and an underpowered study that did not detect dependency were cited repeatedly as support for opioids as a safe means of treating chronic pain without causing addiction. On the surface, opioid therapy seemed justified to fill the void left by the decline of multidisciplinary pain centers. Since that time, however, little evidence of long-term benefit has emerged and harms have become abundantly clear.

In response to the opioid crisis, policy leaders are calling for a return to integrated chronic pain treatments. The Food and Drug Administration, the Centers for Disease Control and Prevention, the Surgeon General, and the President of the American Medical Association have each recommended that non-pharmacologic intervention be the first-line treatment for chronic pain. Yet, the pathway to an economically viable, non-pharmacologic approach to pain management remains unclear. Beyond an office visit, an MRI order, and a prescription, integrative care for chronic pain is not easily coordinated or reimbursed. Big changes are necessary to overcome our myopic view favoring immediate pain relief over safer approaches that are effective in the long term.

The Path Forward

Promoting Evidence-Based Non-opioid Treatments

We believe three policies and practices must be addressed to make non-pharmacologic treatments more widely accessible and reimbursed. First, the multidisciplinary approach seen in the 1970s and 1980s needs to be re-engineered to fit the current health care landscape. CMS needs to take a leadership role in designing innovative approaches. Rather than reacting to the opioid crisis by deemphasizing pain treatment, patients would be better served if CMS encouraged use of evidence-based non-opioid treatments for pain.

For example, CMS should consider a chronic pain shared savings program targeting accountable care organizations (ACOs), where success would be tied explicitly to patient functional outcomes. CMS could develop an objective, functional status benchmark against which ACO performance is measured to determine if care is generating a savings or loss. Organizations that meet or exceed quality performance standards would receive a portion of the savings they generate. This would effectively introduce incentives to use approaches consistent with more effective integrative interventions for pain.

The economics underlying such initiatives are clear: the annual cost of pain ($560 to $635 billion; 2010 dollars) is greater than the annual costs of heart disease ($309 billion), cancer ($243 billion), and diabetes ($188 billion).

Electronic Decision Aids

Second, policymakers need to consider systems that will encourage clinicians to make greater use of evidence-based decision aids. For example, electronic health records could trigger default schedules to taper opioids when they have resulted in inadequate pain reduction or functional impairment. They could introduce standing orders for physical, occupational, and psychological pain management therapies. Routine mental health screening could improve clinician awareness of depression and anxiety that are associated with pain and prompt referrals and care coordination efforts.

These strategies could direct patients toward services that would engage them in musculoskeletal strengthening, protective movement patterns, and self-management of emotional responses to pain. This would allow patients to return to valued life activities.

Rethinking Provider Training

Third, integrative interventions require teams of health providers who have specific training in assessment and delivery of state-of-the-art approaches to pain management. Yet such training is rare in our current health care teams. Exploring a potential solution, we recently completed a National Institutes of Health (NIH)-supported, multi-site, clinical trial that demonstrated the effectiveness of Pain Coping Skills Training (PCST)—an evidence-based 10-visit intervention based on behavioral principles—for osteoarthritis patients with chronic pain.

Whereas originally PCST was developed and delivered by clinical psychologists, this trial demonstrated that nurse practitioners, who are embedded in community medical practices, could achieve comparable outcomes with PCST. Results included reduced pain, fatigue, emotional distress, and use of pain medication relative to a usual care control group.

Based upon this success, we designed a two-and-a-half-day workshop to train nurse practitioners to deliver PCST in their clinical practices. However, right now, such training is not widely available or supported. Effective training of health care teams must include a reconceptualization that engages patients to be active in their own care and recovery, and that abandons the faulty view of patients as passive consumers of pharmaceutical treatment.

The opioid crisis has been a wake-up call for health policy experts and clinicians around the country. It has shown us that a long-term view of pain management is crucial for achieving safe and effective clinical outcomes. However, the path forward is uncertain until we make policy changes to encourage improvements in how care is delivered.

We need to train health care teams and empower patients to better manage pain. Education and guidelines aimed at clinicians are first steps. At the same time, we must develop streamlined interventions, create innovative incentive structures, and build new ways to deliver choices to clinicians.

Authors’ Note

Preparation of this publication was supported by Pfizer Independent Grants for Learning & Change under Award Number 16004615 to JEB and PB. The content is solely the responsibility of the authors and does not necessarily represent the official views of Pfizer U.S.