More DENIAL OF CARE by your friendly neighborhood Pharmacist ?

FROM MY INBOX

Good morning Steve. First of all I too would like to thank you for the work you’re doing and your efforts to assist those of us who fall victim to bias pharmacies and their employees. I am a registered nurse and I’m currently on Suboxone for dependency. It has, in short, save my life and help me to move forward to better myself in my career and family. My question is, whenever there is a floating pharmacist (much of time) at my Pharmacy, I am constantly given a hard time. They go back and count the months where I should have had extra and add it to current strips. Is this even allowed? My doctor has suggested that I fill when it is possible at 28 days so that I will have a few days Surplus. In the event that the pharmacy is out of the medication and the doctor’s office is closed, I will not be in distress and my recovery will not be hindered. Although I have explained this to many of the pharmacists, they don’t seem to listen. Upon turning in a prescription yesterday, I was told it was too early and would have to wait 2 more days. They said that would be 28 days. When I counted on the calendar 28 days was the day I turned it in. I’m tired of doing this and would like something to back me up when turning my prescriptions in. Can you help? Specifically, can you answer my question about adding previous overtures to current strips that I have or don’t have?

I was once told of a Pharmacist that went back FOUR YEARS and calculated that the pt should still have several days of his controlled medication and refused to fill the pt’s current prescription.

It would seem that some healthcare professionals (doctors, pharmacists, nurses) seem to believe that pts live in a perfect world… Pharmacies are never out of stock, prescribers never takes vacations or fail to return pts calls and/or refill requests from the pharmacy, there are natural disasters and untold number of other unknown…  unanticipated situation that could cause a pt to run out of their medication… thru no fault of the pt.

A pt can call the corporate HQ to file a complaint and almost 100% of the time.. they will get a response they they cannot force the pharmacist to fill a prescription and if the pt files a complaint with the Board of Pharmacy… they are going to take the same position…  So untold number of Pharmacists understand that they are in a “safe zone” where they can do as they damn please and the chances of them suffering some consequences is between slim and none.  Any consequences to the pt for failing to have their medically necessary medication is just too bad… They shouldn’t have abused/ become addicted/dependent to a controlled substance..  In their “small minds” addiction is a personal failure and “pain never killed anyone”… just take some Motrin or Advil…

Personally, I refused to BEG anyone to allow me to give them my money and/or allow me to do business with them.

Independent pharmacies… you are dealing with the Pharmacist/owner.. and generally you will not be forced to deal with a different “floater” every time you come in… Unlike the chain pharmacist.. the independent doesn’t get paid every two weeks… if he/she fills your prescriptions or not.. they are in business to fill prescriptions… to be healthcare PROVIDERS… Typically they do not start looking for a reason to refuse to fill a prescription… because if you start looking for a reason not to fill one… generally you will find one.

Here is a website that will help anyone find a independent pharmacy by zip code

http://www.ncpanet.org/home/find-your-local-pharmacy

I have seldom heard of a pt that has changed to a independent pharmacy regretting their decision.

 

 

***Robocall Scam Alert***

***Robocall Scam Alert***

 sharing information on a scam that uses the name of Blue Cross/Blue Shield (BCBS) to trick people.

Beware of Robo Calls where they mention Blue Cross/Blue Shield and then go on to say:

“This is not a telemarketing call. Due to the national prescription narcotic addiction crisis, BC&BS was providing a substitute medication at no cost.”

After the recorded message you are transferred to a person who will ask many probing questions designed to trick you into giving out your insurance information. If you state you don’t have BCBS they will ask who your insurance is through and will then say that they are “currently in talks” with whatever company you tell them you have. They will then offer to call you back after the first of the year.

The call comes from (508) 281-2623 and the caller ID lists it as FLOWROUTE INC. (though some people have reported seeing that number with the BCBS name, as the scammers are able to spoof the Blue Cross ID in some markets).

Who is really practicing pharmacy ?

From my INBOX:

Steve, I read your article and I have a perfect example of what has happened. I suffer and have suffered from Chronic Back pain and neuropathy in my feet for 12 years  and never have filled early and have taken them on time and as prescribed. The pharmacy has now refused to filled my prescription because of the recommended allowance. Kroger is the company that has instructed the pharmacies to stop filling them.  What can I do in the mean time.  This really is a bad thing and it is very frustrating to be called a drug addict just because I am in pain.

Thanks for the work you do. Being an advocate for something or someone is one of the best jobs you can do. You help people.

Each state has a Pharmacy practice act… which lays out the authority of what a Pharmacist can, must and can not do. I am hearing from Pharmacists and pts more and more that the EMPLOYER of the Pharmacist is establishing company policies and guidelines that dictates what a Pharmacist must do and/or can’t do.  Many times these corporate edicts attempt to supercede the authority that is granted by the practice act to the Pharmacist.

We have a growing large surplus of Pharmacists and with over half the states being a “at will employment” state.. where you can be fired … for just about any reason… even if the employer decides they don’t like the color of your eyes. 

The majority of the Pharmacy Boards – who are in charge of enforcing the practice act – are “stacked” with non-practicing corporate Pharmacists.  Who seemingly turn a “blind eye” to the fact that employers are forcing employed Pharmacist to relinquish their authority under the practice act to their employer’s dictates.

The probability of a pt filing a complaint against a Pharmacy/Pharmacist with the Pharmacy Board and getting some corrective actions is somewhere between slim and none. The majority of the pharmacy boards don’t even require pharmacies to report medication errors/mis-fills to them.  Denying a pt their  medically necessary controlled medications… would seem to be a NON-ISSUE by most/all of the boards of pharmacy.

Then there is the part of practicing medicine that involves the starting, changing or stopping a pts medication… this particular pt’s situation would seem – IMO – that the pharmacy corporation (permit holder) and the Pharmacist seem to be involved in that portion of the practice of medicine… and if so.. is doing so WITHOUT A LICENSE.

Then there is Americans with Disability Act violation/discrimination.. which is a civil rights violation.

With some of these VERY BIG CORPORATIONS with very deep pockets.. and someone can produce the documentation from the corporation stating that their employed Pharmacists must force a pt to REDUCE their medications…  it would seem like a eager attorney might be interested in a class action against these corporations – most/all of the large pharmacy corporations are doing this… this is not isolated to this one single corporation.

Some believe that the pt is put at as much risk/harm or more risk/harm by being denied their medically necessary medication as the pt that is given the WRONG MEDICATION because of a mis-fill.

One of these days, one of these PERSONAL INJURY ATTORNEYS is going to figure this out.. and all hell is going to break loose.

DEA report: Heroin, fentanyl overdoses plague most of U.S.; Fla. battles Marijuna, meth

DEA report: Heroin, fentanyl overdoses plague most of U.S.; Fla. battles marijuna, meth

http://www.orlandosentinel.com/news/breaking-news/os-drug-threat-assessment-fentanyl-20161207-story.html

This is Pam Bondi’s political ad when she ran for re-election TWO YEARS AGO… BRAGGING how the judicial system in Florida had “taken care of” all the illegal substance abuse… Of course, she has two more years in office as FL AG and she is “capped out” of running again…  It has been reported that she is in the running for White House DRUG CZAR… god help us if she is picked !

Orlando police are worried about every drug that hurts the community, but their focus lately has been on stopping two of the deadliest: heroin and illicit fentanyl.

A report released Tuesday by the Drug Enforcement Administration shows they aren’t alone.

The yearly National Drug Threat Assessment compiles survey data from nearly 1,500 law enforcement agencies across the U.S. to provide a picture of the country’s drug abuse and trafficking problem.

Heroin and the growing nationwide opioid epidemic, exacerbated by illicit fentanyl, highlighted this year’s report.

Locally, the numbers have been steadily increasing, and in 2015 Florida saw the highest number of opioid deaths in more than a decade.

In Orange and Osceola counties alone, 67 people died of a fentanyl overdose and 105 from heroin, according to a statewide medical examiner’s report.

Orlando Police Department Deputy Chief Robert Anzueto said detectives have recently seen an uptick in fentanyl use and overdoses. That worries him, he said, because fentanyl is often smuggled in from overseas and users don’t know how much, or what exactly they’re getting.

He said heroin is one thing, but when dealers mix it with fentanyl to make it cheaper, it becomes an even deadlier substance. “People have no idea what they’re ingesting,” he said.

About 129 people died each day nationwide in 2014 from a drug overdose and more than half of those were opioid or heroin related, according to the DEA.

The epidemic spread across much of the country during the past few years and has hit the Northeast and Midwest exceptionally hard, according to the report. Nationally, heroin overdose deaths more than tripled between 2010 and 2014.

Anzueto said detectives are constantly working leads and using various investigative techniques to combat the problem, and the department’s drug unit recently got two new detectives to help take on additional cases.

All of the officers were also outfitted with Narcan, a nasal-spray drug that counteracts the effects of an opioid overdose, this summer. Officers have had to use it a handful of times since, he said.

Opioids aren’t the only drugs law enforcement agencies across the country are focusing on, though. The DEA report revealed cocaine and prescription pills are still readily available across much of the country, despite drops in usage.

And agencies, especially many in the southern U.S., also worry about marijuana and methamphetamine. The DEA report showed more than 40 percent of the agencies in Florida that responded to the survey reported those two drugs as the biggest threats to their communities.

“Any drug that can cause devastation to your city no matter if it’s marijuana, crack cocaine, cocaine opiates, heroin fentanyl — they’re all a concern,” Anzueto said. “And our job is to prevent and educate and eradicate.”

sallen@orlandosentinel.com or 407-420-5417

DEA Scheduling of Marijuana, Non-Opioid Pain Treatments – National Pain Strategy

Ohio: 93 million less doses today than we had just three years ago… yet.. overdose deaths increase

Ohio Had Most Opioid Overdose Deaths In The Country. What’s Next?

http://radio.wosu.org/post/ohio-had-most-opioid-overdose-deaths-country-whats-next

The Kaiser Family Foundation says that in 2014, Ohio had the highest number of deaths from opiate overdoses in the U.S.

In Ohio in 2014, 2,106 people died from opiate overdoses, more than in either California or New York State. According to the Ohio State Medical Association’s government relations director Tim Maglione, Ohio’s opiate addiction crisis has its roots in part in medical protocols developed a quarter-century ago.

Sam Hendren: Mr. Maglione, how did we get to where we are today with the opioid overdose crisis?

Tim Maglione: You know, that’s a really good question. If you look back 20 or 25 years ago there was a kind of a theory that we were under-treating chronic pain and the protocols at that time were to be more aggressive in treating pain, particularly with the use of medications to do that.

As we move forward, you know, five or six years ago, it became very understood that that may not have been the best protocol even though it was approved by the FDA, and that these medications can, if used long term, can cause an addiction problem. And so we’re essentially having to reverse 20 to 25 years of thinking in medicine about the effectiveness and the safety of these types of medications.

Sam Hendren: The Kaiser Family Foundation has put together statistics and they say that Ohio has the largest number of overdoses in the year 2014. More opioid overdose deaths in Ohio than New York or California, which seems hard to fathom. Any idea why that would be?

Tim Maglione: Well again, I think you look back at the history of the protocols for prescribing medications and unfortunately, those had proven to be not necessarily right. And it caused an addiction problem. And we had a period of time in the state of Ohio, particularly Southern Ohio, where these illegal, unethical pill mill operations were just peddling the medications out and people got addicted.

Now what we do know is that there’s been a lot of effort to really change the way medications are prescribed to treat pain. And so we’ve really reduced the overall pill supply in this state: 93 million less doses today than we had just three years ago. But when you look at the death rate, the death rate from prescription overdoses has gone down five consecutive years.

But unfortunately because the supply of these medications on the street has really been reduced, those that have an addiction problem have moved to other substances like heroin, which is now easier to get on the street than a prescription medication illegally. Fentonyl is a stronger version of an opioid. And those things are really what we’ve seen the increase in the overdose deaths in the state of Ohio from, from those illicit and illegal substances like heroin and fentanyl.

Sam Hendren: Well, what’s been done to address the issue? What’s being done?

Tim Maglione: Well there’s there’s been so much work and the Ohio General Assembly, the Kasich administration has really been committed to getting a solution here. We have new ways to try to prevent drug abuse before it even starts, with educational programs and outreach programs in the communities.

We’ve really reduced the pill supply, as I mentioned, 93 million less doses prescribed today than just three years ago. We’re preventing diversion, so that if you have medications in your medicine cabinet there are ways to safely dispose of those through drop boxes and things like that. We’re also increasing law enforcement and interdiction efforts. Law enforcement’s done a lot to try to track this stuff down when it’s coming in illegally into our state. We’re saving lives with the use of a product called naloxone, which can reverse an overdose and save a life.

And so that’s a lot of things that have been done. We’re starting to turn the corner at least on the prescription drug abuse. Unfortunately, now, because it’s harder to get the prescriptions illegally, people have gravitated to the heroin and to the fentanyl and the carfentanyl. So from my perspective, the next real step in this fight has to be a focus on recovery and treatment.

 

Illicit fentanyl, manufactured in foreign countries…is a rising factor in the current overdose epidemic

DEA: Fentanyl-related overdose deaths rising at an alarming rate

http://www.wfmj.com/story/33949303/dea-fentanyl-related-overdose-deaths-rising-at-an-alarming-rate

The DEA can’t/won’t go after the ILLICIT IMPORTED SYNTHETIC DRUG MARKET… they even LUMP all “drug poisonings” into a larger group of OD deaths… and they won’t/can’t separate deaths from pharmaceutical opiates and other ILLEGAL OPIATES…  Opiate prescriptions peaked in 2012 and have been dropping ever since… by some 25%… yet OD’s continue to rise. The Surgeon General recently stated that ADDICTION is a “brain disease”…but the DEA continues to treat it as a CRIME… and those prescribers who write opiate prescriptions as CRIMINALS.  Today TRUMP said that FOUR BILLION was TOO MUCH MONEY for two new Air Force One’s…  How do we get him to look at the 51 BILLION/YR that we spend on the war on drugs… to make criminals out of people who are suffering from a chronic brain disease or who have turned to the street because their prescribers have “cut them off” ?

WASHINGTON – Approximately 129 people died every day in 2014 as a result of drug poisoning and nearly two-thirds of them are pharmaceutical opioid or heroin related, according to a report from the Drug Enforcement Administration.

The 2016 National Drug Threat Assessment details the extent to which illicit drugs are affecting the United States.

The report sheds light on the nationwide opioid epidemic, which is fueling a growing heroin user population and resulting in a greater amount of overdoses.

The opioid epidemic has been exacerbated by the national reemergence of fentanyl – a synthetic opioid which is much more potent than heroin, according to the findings.

Fentanyl’s strong opioid properties have made it an attractive drug of abuse. Illicit fentanyl, manufactured in foreign countries and then smuggled into the United States, is a rising factor in the current overdose epidemic. It is usually mixed into heroin products or pressed into counterfeit prescription pills, sometimes without the users’ awareness, which often leads to overdose.

The rise in overdose deaths also coincides with the arrival of carfentanil, a fentanyl-related compound, in America’s illicit drug markets. Carfentanil is approximately 10,000 times more potent than morphine.

The DEA says that the presence of carfentanil in illicit U.S. drug markets is cause for concern, as the relative strength of this drug could lead to an increase in overdoses and overdose-related deaths, even among opioid-tolerant users.

“Sadly, this report reconfirms that opioids such as heroin and fentanyl – and diverted prescription pain pills – are killing people in this country at a horrifying rate,” said Acting Administrator Rosenberg “We face a public health crisis of historic proportions. Countering it requires a comprehensive approach that includes law enforcement, education, and treatment.”

The 2016 NDTA also found that Mexican transnational criminal organizations continue to act as the biggest criminal drug threat to the United States and are the primary suppliers of heroin, cocaine, and methamphetamine.

These groups are responsible for much of the extreme violence seen in recent years in Mexico, as they have continually battled for control of territory. Within the U.S., violent gangs affiliated with these drug trafficking organizations are a significant threat to the safety and security of our communities.

The gangs receive deadly drugs like heroin from regional cartel affiliates and then supply them to American communities for profit, regardless of the human cost.

While the DEA found evidence of a slight decline in the abuse levels of controlled prescription drugs, data indicates an increase in the seizure of counterfeit prescription drugs, many of which contain the extremely potent substance fentanyl.

Heroin overdose deaths are high across the United States, particularly in the Northeast and Midwest. Nationally, overdose deaths more than tripled between 2010 and 2014, with the most recent available data reporting 10,574 people in the United States died in 2014 from heroin overdoses.

Deaths in the “synthetic opioids” category rose 79% from 3,097 in 2013 to 5,544 in 2014. While other opioids are included in this category, public health officials maintain that fentanyl is contributing to most of this increase. Fentanyl is sometimes added to heroin batches, or mixed with other adulterants and sold as counterfeit heroin, unknown to the user.

Methamphetamine continues to be readily available throughout the United States, and methamphetamine distribution and use continues to contribute to violent and property crime in the United States.

Cocaine availability and use in the United States increased across multiple fronts between 2014 and 2015 and is likely to continue increasing in the near term. Colombia will remain the primary source of supply for cocaine in the United States, and elevated levels of coca cultivation, potential pure cocaine production, and north-bound movement indicate more cocaine is available for traffickers who want to attempt to re-invigorate the U.S. cocaine market.

The National Drug Threat Assessment provides a yearly assessment of the many challenges local communities face related to drug abuse and drug trafficking. Highlights in the report include usage and trafficking trends for drugs such as heroin, prescription drugs, methamphetamine, cocaine, marijuana, and the hundreds of synthetic drugs.

 
 
 

NO OFFENSE… HEALTHCARE is just a business.. care provided C.O.D. !

Doctors And Hospitals Say ‘Show Me The Money’ Before Treating Patients

http://khn.org/news/doctors-and-hospitals-say-show-me-the-money-before-treating-patients/

Tai Boxley needs a hysterectomy. The 34-year-old single mother has uterine prolapse, a condition that occurs when the muscles and ligaments supporting the uterus weaken, causing severe pain, bleeding and urine leakage.

Boxley and her 13-year-old son have health insurance through her job as an administrative assistant in Tulsa, Okla. But the plan has a deductible of $5,000 apiece, and Boxley’s doctor said he won’t do the surgery until she prepays her share of the cost. His office estimates that will be as much as $2,500. Boxley is worried that the hospital may demand its cut as well before the surgery can be performed.

“I’m so angry,” Boxley said. “If I need medical care I should be able to get it without having to afford it up front.”

At many doctors’ offices and hospitals, a routine part of doing business these days is estimating patients’ out-of-pocket payments and trying to collect it up front. Eyeing retailers’ practice of keeping credit card information on file, “there’s certainly been a movement by health care providers to store some of this information and be able to access it with patients’ permission,” said Mark Rukavina, a principal at Community Health Advisors in Chestnut Hill, Mass., who works with hospitals on addressing financial barriers to care.

But there’s a big difference between handing over a credit card to cover a $20 copayment versus suddenly being confronted with a $2,000 charge to cover a deductible, an amount that might take months to pay off or exceed a patient’s credit limit. Doctors may refuse to dispense needed care before the payment is made, even as patient health hangs in the balance.

The strategy leaves patients financially vulnerable too. Once a charge is on a patient’s credit card, they may have trouble contesting a medical bill. Likewise, a service placed on a credit card represents a consumer’s commitment that the charge was justified, so nonpayment is more likely to harm a credit score. 

Approximately three-quarters of health care and hospital systems ask for payment at the time services are provided, a practice known as “point-of-service collections,” estimated Richard Gundling, a senior vice president at the Healthcare Financial Management Association, an industry group. He could not say how many were doing so for higher priced services or for patients with high-deductible plans, situations that would likely result in out-of-pocket outlays of hundreds or thousands of dollars.

“For providers, there’s more risk with these higher deductibles, because the chance of being able to collect it later diminishes,” Gundling said.

But the practice leaves many patients resentful.

After arriving by ambulance at the emergency department, Susan Bradshaw lay on a gurney in her hospital gown with a surgical bonnet on her head, waiting to be wheeled into surgery to remove her appendix at a hospital near her home in Maitland, Fla. A woman in street clothes approached her. Identifying herself as the surgeon’s office manager she demanded that Bradshaw make her $1,400 insurance payment before the surgery could proceed.

“I said, ‘You have got to be kidding. I don’t even have a comb,’” Bradshaw, a 68-year-old exhibit designer, told the woman on that night eight years ago. “I don’t have a credit card on me.”

The woman crossed her arms and Bradshaw remembers her saying, “You have to figure it out.”

As providers aim to maximize their collections, many contract with companies that help doctors and hospitals secure payments up front, often providing scripts that prompt staff to talk with patients about their payment obligations and discuss payment scenarios as well as software that can estimate what a patient will owe.

But as hospitals and doctors push for point-of-service payments to reduce bad debt from patients with increasingly high deductibles, the risk is that patients will delay care and end up in the emergency room, Rukavina said. “Patients are essentially paying for their procedures up front,” he said. “It may not be a significant amount compared to their salary, but they don’t necessarily have it available at the time of service.”

The higher their deductible, the less likely patients are to pay what they owe, according to an analysis of 400,000 claims by the Advisory Board, a health care research and consulting firm. While more than two-thirds of patients with a deductible of less than $1,000 were likely to pay at least some portion of what they owe, just 36 percent of those with deductibles of more than $5,000 did so, the analysis found.

Fifty-one percent of workers with insurance through their employer had a deductible of at least $1,000 for single coverage this year, according to the Kaiser Family Foundation’s annual survey of employer health insurance. (KHN is an editorially independent program of the foundation.)

Boxley pays $110 a month for her family plan. She could not afford the premiums on plans with lower deductibles that her employer offered. She plans to talk with the doctor and hospital about setting up a payment plan so she can get the surgery in January.

“I’ll make payments,” Boxley said, although she acknowledged what she could pay monthly would be small. If that doesn’t pan out, she figures she’ll have to use student loan money she got for graduate school to cover what she owes.

Still, experts say that trying to pin patients down for payment in more acute settings, such as the emergency department, may cross a line.

Under the federal Emergency Medical Treatment and Labor Act (EMTALA), a patient who has a health emergency has to be stabilized and treated before any hospital personnel can discuss payment with them. If it’s not an emergency, however, those discussions can occur before treatment, said Dr. Vidor Friedman, an emergency physician who is the secretary-treasurer of American College of Emergency Physicians’ board of directors.

Bradshaw finally got her appendix removed by calling a friend, who read his MasterCard number over the phone. The surgery was uneventful and Bradshaw was home within 24 hours.

“It’s a very murky, unclear situation,” Friedman said of Bradshaw’s experience, noting that a case might be made that her condition wasn’t life threatening. “At the very least it’s poor form, and goes against the intent if not the actual wording of EMTALA.”

Man dies of emotional distress after being forced to clean #Walgreens bathroom, widow says

happyhealthyMan dies of emotional distress after being forced to clean Walgreens bathroom, widow says

http://www.wftv.com/news/local/man-dies-of-emotional-distress-after-being-forced-to-clean-walgreens-bathroom-widow-says/473525151

ORLANDO, Fla. – The widow of a 69-year-old man has sued an Orlando Walgreens store, accusing them of holding her husband captive until he cleaned and mopped the store’s bathroom. You can also check out more details here!

Maria Elizarraras claims that the humiliation of the experience caused emotional distress so severe that it killed her husband, Fernando Elizarraras.

The lawsuit was originally filed in state court but was moved to federal court Monday, according to court documents.

According to the suit, Fernando Elizarraras went to the Walgreens on Landstar Boulevard, where he had been a long-term customer, on Oct. 15, 2012.

After using the bathroom at the store, store employees stopped Fernando as he tried to leave and physically escorted him back to the bathroom, the lawsuit alleges.

The employees insisted the 69-year-old man clean the facility because, “You left a mess, (expletive) all over the bathroom,” the suit says.

For 20 minutes, Fernando was threatened and forced to clean and mop the bathroom before he was allowed to leave the store, his wife claims in the suit.

The incident caused Fernando to be “humiliated, disgraced and injured in his feelings, emotionally and mentally,” the lawsuit says.

The emotional distress caused by the situation was so severe that it “resulted in the death of Fernando,” the suit says.

The lawsuit does not say how much time passed between the incident and Fernando’s death.

On behalf of her husband’s estate, Maria Elizarraras was suing the company for an undetermined amount, but according to court documents has a standing offer to settle for $500,000.

As of early Tuesday, Walgreens had not responded to the lawsuit in federal court.

CDC Manipulated Data to Deceive

unclesambadCDC Manipulated Data to Deceive

Durations of Opioid, Nonopioid Drug, and Behavioral Clinical Trials for Chronic Pain: Adequate or Inadequate?

CDC Manipulated Data to Deceive

This commentary presents the case that the CDC manipulated the data it used as a basis for its opioid prescribing guidelines.

By imposing an arbitrary non-standard constraint and excluding some studies that were included in earlier reports, the CDC created a different interpretation by using a different set of data.

Objectives. A recent US federal review and clinical guideline on opioids for chronic pain asserted that the literature contributes no evidence on efficacy because all trials had “inadequate duration.”

To explore the evidence, we examined durations of studies on opioid, nonopioid drug, and behavioral therapies for chronic pain.  

Methods. We retrieved Cochrane reviews of anticonvulsants, antidepressants, NSAIDs, opioids, or behavioral interventions for chronic pain. We also examined all opioid treatment studies retrieved for the federal evidence report but excluded due to “inadequate duration.”

Results. We graphed numbers of trials vs duration for the five treatments reviewed in the Cochrane Library, compared with durations of opioi12690d trials dropped from the federal evidence report. Most graphs were overdispersed Poisson distributions. Nearly all trials had active treatment durations of 12 weeks or less.

Conclusions. 

No common nonopioid treatment for chronic pain has been studied in aggregate over longer intervals of active treatment than opioids.

To dismiss trials as “inadequate” if their observation period is a year or less is inconsistent with current regulatory standards.

The literature on major drug and nondrug treatments for chronic pain reveals similarly shaped distributions across modalities.

Considering only duration of active treatment in efficacy or effectiveness trials, published evidence is no stronger for any major drug category or behavioral therapy than for opioids.

© 2016 American Academy of Pain Medicine.  

The full article details how the CDC’s conclusions are based on studies selected by using arbitrary non-standard standards of inclusion/exclusion.

Introduction

The use of opioids began in prehistory and is now standard practice in much of the world for the management of acute, chronic, and cancer-related pain.

Balancing the legitimate medical use of opioids for analgesia vs society-wide abuse, misuse, diversion, addiction, and mortality has become a major public health theme.

In March 2016, the US Centers for Disease Control and Prevention (CDC) published a guideline for prescribing opioids for chronic pain on the CDC website.

An important message communicated in the CDC guideline and related press releases is that the body of evidence addressing the effectiveness or efficacy of opioid therapy for outcomes of pain, function, or quality of life was insufficient to contribute any studies for their analyses.

In reaching this conclusion, the minimal duration for inclusion of a long-term study was set by the authors as “>1 year,” the same threshold employed by a 2014 evidence report that informed the 2016 CDC guideline.

The same consultant was the lead methodologist for both the 2014 evidence report and the 2016 CDC guideline.

However, earlier systematic reviews of the effectiveness or efficacy of opioids for chronic noncancer pain, co-authored by the same consultant and based upon the best available evidence, had identified dozens of clinical trials and systematic reviews of this topic.

Although their conclusions were guarded due to the poor overall quality of the literature, both earlier reviews concluded that selected, carefully monitored patients might benefit from such therapy.

Because the 2016 CDC literature review may be viewed as an update of the earlier reviews, it was striking that the 2016 review reached far more negative conclusions about the risk-benefit ratio for long-term opioid therapy than did the 2009 and 2010 reviews.

The 2014 evidence report and the 2016 CDC guideline relied upon the absence of studies of a year or greater duration to advance recommendations reflecting a low perceived benefit-to-risk ratio of opioid use for chronic pain.

And that is how they justified opioid prohibition.

We wondered whether a more standard approach to study retrieval and inclusion would confirm or refute this perception. Issues related to study inclusion also have implications for switching from or preferring one therapy to another

In addition, we examined studies cited in in the Cochrane Library of Systematic Reviews addressing opioids, antidepressants, anticonvulsants, NSAIDs, and behavioral treatments.

Our objective was to assess whether differences exist between the duration of treatment trials for chronic pain using each of these modalities, if analyzed without applying the one-year minimum threshold for inclusion newly introduced in the 2014 AHRQ and 2016 CDC reports.