Pain Clinic Settles Discrimination Case

By Pat Anson, Editor

An Indiana pain management clinic has agreed to pay $30,000 to settle a federal claim that it discriminated against a pain patient by refusing to treat him.

In an unusual twist, the discrimination case filed by the U.S. Justice Department against Pain Management Care of South Bend was not based on the man’s rights as a pain patient – but because of his HIV status. The Americans with Disabilities Act (ADA) is intended to protect all people from being discriminated against because of physical or mental disability.

According to the Justice Department, the patient was referred to Pain Management Care (PMC) in November, 2014 after the closure of another pain clinic where he had been treated. The patient sought bi-monthly cortisone injections, which he had been receiving for pain management from his previous doctor.

After sending the results of an MRI exam and other medical records to PMC, the patient received a voicemail message from a clinic employee stating that Dr. Joseph Glazier would not treat him “due to the risks involved with needles and blood due to (his) condition of being HIV positive.”    

The patient asked PMC to change its position but was still refused treatment. He was not able to find another pain management doctor willing to treat him until several months later.

“PMC’s discriminatory denial caused (the patient) to endure six months without needed pain management care and to experience emotional distress,” federal prosecutors said.

The case against PMC was filed on April 7th and quickly settled out-of-court, with Dr. Glazier agreeing to pay the patient $20,000 and a $10,000 civil penalty. PMC must also develop a non-discrimination policy, provide ADA training to its staff, and submit annual reports to the government. The consent decree still needs a judge’s approval.

PMC’s website now contains this notice: “Pain Management Care, P.C., does not discriminate on the basis of disability, including HIV. All individuals, including persons with HIV, have an equal opportunity to treatment from Pain Management Care, P.C.”

“The Justice Department is committed to eradicating discrimination resulting from the unfounded fear and dangerous stereotype that someone with HIV would pose a threat to a medical provider,” said Principal Deputy Assistant Attorney General Vanita Gupta, head of the Justice Department’s Civil Rights Division.  “Discrimination by those in the medical profession breaks a trust critical to ensuring access to appropriate treatment for all.”

This settlement is part of the department’s Barrier-Free Health Care Initiative, a partnership of the Civil Rights Division and U.S. Attorney’s Offices to target enforcement efforts on access to healthcare for individuals with disabilities. 

The Americans with Disabilities Act was signed into law by President H. W. Bush in 1990. It is intended to protect against discrimination based on “physical or mental impairment that substantially limits one or more major life activities.”

For more information on the obligations of healthcare providers under the ADA, you can call the Justice Department’s toll-free hotline at 800-514-0301. ADA complaints may be filed by email to ada.complaint@usdoj.gov or by clicking here.

U.N. Report: War on Drugs a Failure

By Pat Anson, Editor

The international war on drugs has been a costly failure that has created a “public health and human rights crisis,” according to a new report commissioned by the United Nations, which is meeting in special session this week to discuss global drug policy.

The 54-page report by the Johns Hopkins–Lancet Commission on Drug Policy and Health found that many drug policies are based on ideas about drug use and dependence that “are not scientifically grounded” and have been particularly harmful to pain patients.

The commission estimates that about 5.5 billion people worldwide do not have adequate access to controlled drugs for the management of pain. 

“Inequity of access to controlled drugs for pain management and other clinical uses is now a public health and human rights crisis,” the report found. “Yet the obligation to prevent abuse of controlled substances has received far more attention than the obligation to ensure their adequate availability for medical and scientific purposes, and this has resulted in countries adopting laws and regulations that consistently and severely impede accessibility of controlled medicines.”

The commission said there were many “myths and exaggerations” about opioid use that have stigmatized people who use the drugs. And rather than lowering the risk of abuse and addiction, drug prohibition was making the problem worse by forcing some people to turn to the streets for opioids.

“Prohibition creates unregulated illegal markets in which it is impossible to control the presence of adulterants in street drugs, which add to overdose risk,” the commission said. “The idea that all drug use is dangerous and evil has led to enforcement-heavy policies and has made it difficult to see potentially dangerous drugs in the same light as potentially dangerous foods, tobacco, and alcohol.”

Four mothers who lost their children to drugs have been invited by the Canadian government to attend the U.N. assembly on drug policy. One of them is Jennifer Woodside of Vancouver, whose 21-year son Dylan died of an overdose two years ago after he took a pill he thought was oxycodone, but was actually laced with illicit fentanyl.

 “This is a big epidemic,” Woodside told The Globe and Mail. “I think we’ve got our head in the sand if you think it can’t affect you.”

“The war on drugs has been a war on our families,” said Lorna Thomas, who also lost a son to an overdose of oxycodone and will attend the U.N. conference. “The starting point for it, that we were going to punish people out of using drugs has failed. People will continue to use drugs and we need to acknowledge that reality and keep people safe.”

As Pain News Network has reported, counterfeit pain medications laced with fentanyl began appearing in the U.S. this year and are blamed for a dozen overdose deaths in California and Florida. Coincidentally, the fake pain pills appeared just as the Centers for Disease Control and Prevention (CDC) finalized new guidelines that discourage primary care physicians from prescribing opioids for chronic pain.  Many patients fear losing access to opioids because of the guidelines.

“These CDC guidelines are brand spanking new. I think it’s hard to draw any sort of conclusions from that,” said Rusty Payne, a spokesman for the Drug Enforcement Administration. “I don’t think the Mexican cartels are paying one lick of attention to what the CDC guidelines are. What they see are thousands and thousands of addicts that they can push a product on, whether it be heroin or now fentanyl. And introducing it in pill form is just another way to make a lot of money."

The U.N. report on drug policy recommends decriminalizing nonviolent drug offenses and phasing out the use of military forces to enforce drug laws.

“Policies meant to prohibit or greatly suppress drugs present a paradox. They are portrayed and defended vigorously by many policy makers as necessary to preserve public health and safety, and yet the evidence suggests that they have contributed directly and indirectly to lethal violence, communicable disease transmission, discrimination, forced displacement, unnecessary physical pain, and the undermining of people’s right to health,” the report concludes.

The president of Columbia, which has long been on the front lines of the war on drugs, will urge the U.N. to radically change drug policies.

"Vested with the moral authority of leading the nation that has carried the heaviest burden in the global war on drugs, I can tell you without hesitation that the time has come for the world to transit into a different approach in its drug policy," President Juan Manuel Santos wrote in a column published in The Guardian.       

"No other nation has had to endure the terrible effects of the world drug problem in such magnitude and over such extended period of time as Colombia. The international community can rest assured that, when we call for a new approach, we are not giving up on confronting the problem; we are moved by the aim of finding a more effective, lasting and human solution."

Fake Oxycodone Seized at US-Mexican Border

By Pat Anson, Editor

Federal prosecutors this week filed charges against an alleged smuggler caught at the California-Mexico border with nearly 1,200 fake oxycodone pills, the latest sign that Mexican drug cartels are targeting pain patients in the U.S.

The pills were made with illicit fentanyl, a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses. Counterfeit fentanyl pills are blamed for 11 deaths and dozens of overdoses in recent weeks in the Sacramento area, where they were disguised to look like Norco pain medication. Some of the victims were patients who sought painkillers on the street because they couldn’t obtain them legally.

Fake oxycodone, Percocet and Xanax pills have also been appearing in Florida, where they are blamed for at least one death.

19-year old Sergio Linyuntang Mendoza Bohon of Tijuana, Mexico was arrested at the Otay Mesa port of entry on February 10. Border patrol agents became suspicious when they saw “an unnatural looking bulge” in his underwear.

A search turned up 1,183 tablets labeled as oxycodone and 5.4 grams of powdered fentanyl. Laboratory tests later determined the pills were made with fentanyl, not oxycodone.

“This investigation involves the first interdiction of counterfeit oxycodone pills containing fentanyl that were smuggled from Mexico into the U.S. at the local ports of entry,” said Dave Shaw, special agent in charge for Homeland Security in San Diego.

FILE PHOTO of otay mesa border crossing

“While this time we’ve successfully prevented a potentially deadly drug from reaching the streets, we face an uphill battle stemming from the rapidly growing demand for pharmaceutical painkillers on the black market.”

Last year, the DEA issued a nationwide public health alert for acetyl fentanyl, a synthetic opioid produced by illegal drug labs in China and Mexico. Acetyl fentanyl is virtually identical to fentanyl, a Schedule II controlled substance that is often used in patches to treat more severe forms of chronic pain.

Acetyl fentanyl has been blamed for thousands of overdose deaths in the U.S. and Canada. It typically is mixed with heroin and cocaine to make the drugs more potent, but is now showing up in pill form – sometimes disguised as pain medication.

“These criminals are putting fentanyl into fake pills and passing them off as legitimate prescription medications.  Fentanyl is extremely powerful and can very easily lead to overdose deaths,” said William Sherman, DEA Special Agent in Charge.

“Unsuspecting individuals who illegally purchase oxycodone could potentially die from the ingestion of what turns out to be fentanyl tablets,” said U.S. Attorney Laura Duffy. “We are very concerned that these counterfeit pills could cause serious harm to users. Even miniscule amounts of fentanyl can have devastating consequences for those who abuse it or literally even touch it.”

Bohon faces up to 20 years in prison if convicted of unlawfully importing a controlled substance. His next court appearance is scheduled for May 2.

Public Health Emergency in Canada

British Columbia this week became the first province in Canada to declare a public health emergency due to a spike in fentanyl overdoses. Health officials say 201 overdose deaths were recorded in the first three months of 2016. 

Counterfeit fentanyl pills disguised as oxycodone started appearing in Canada about two years ago, where they are often called “greenies” when sold on the street.

ROYAL CANADIAN MOUNTED POLICE photo

“When it's mixed into these tablets it's highly variable from one to the next. So an individual who uses a pill they bought off the street that contains fentanyl may crush up a tablet, inject it and be fine but with the next one they do they may overdose.” Dr. Matthew Young, a substance abuse epidemiologist in Ottowa, told Vancouver Metro.

Like the United States, Canada has a serious problem with opioid abuse and addiction. Young says efforts to reduce opioid prescribing may have contributed to the current wave of fentanyl overdoses.

“That also created a market where organized crime stepped in and started selling these counterfeit tablets containing fentanyl,” he said.

Joint Commission Defends Hospital Pain Standards

(Editor’s Note: As Pain News Network has been reporting, an intense lobbying effort is underway to stop requiring U.S. hospitals to ask patients about the quality of their pain care. Critics contend the practice creates a financial incentive for hospitals to treat pain and leads to “aggressive opioid use.”  The Joint Commission, which accredits hospitals and sets pain management standards, released this statement about the controversy, which we thought you should see in its entirety.)

By David Baker, MD

In the environment of today’s prescription opioid epidemic, everyone is looking for someone to blame. Often, The Joint Commission’s pain standards take that blame.  We are encouraging our critics to look at our exact standards, along with the historical context of our standards, to fully understand what our accredited organizations are required to do with regard to pain.

The Joint Commission’s standards require that patients be assessed for pain, and if they are experiencing pain, then it should be managed. The standards DO NOT require the use of drugs to manage a patient’s pain; and when a drug is appropriate, the standards do not specify which drug should be prescribed.

Our foundational standards are quite simple. They are: 

DAVID BAKER, MD

• The hospital educates all licensed independent practitioners on assessing and managing pain.
• The hospital respects the patient's right to pain management.
• The hospital assesses and manages the patient's pain. (Requirements for this standard follow)
  1. The hospital conducts a comprehensive pain assessment that is consistent with its scope of care, treatment, and services and the patient's condition.
  2. The hospital uses methods to assess pain that are consistent with the patient's age, condition, and ability to understand.
  3. The hospital reassesses and responds to the patient's pain, based on its reassessment criteria.
  4. The hospital either treats the patient's pain or refers the patient for treatment. Note: Treatment strategies for pain may include pharmacologic and nonpharmacologic approaches. Strategies should reflect a patient-centered approach and consider the patient's current presentation, the health care providers' clinical judgment, and the risks and benefits associated with the strategies, including potential risk of dependency, addiction, and abuse.

Despite the stability and simplicity of our standards, misconceptions persist, and I would like to take this opportunity to address the most common ones:

Misconception #1: The Joint Commission endorses pain as a vital sign

The Joint Commission does not endorse pain as a vital sign, and this is not part of our standards. Starting in 1990, pain experts started calling for pain to be “made visible.” Some organizations implemented programs to try to achieve this by making pain a vital sign. The original 2001 Joint Commission standards did not state that pain needed to be treated like a vital sign. The only time that The Joint Commission referenced the fifth vital sign was when The Joint Commission provided examples of what some organizations were doing to assess patient pain. In 2002, The Joint Commission addressed the problems in the use of the 5th vital sign concept by describing the unintended consequences of this approach to pain management and described how organizations had subsequently modified their processes. 

Misconception #2: The Joint Commission requires pain assessment for all patients

This requirement was eliminated in 2009.

Misconception #3: The Joint Commission requires that pain be treated until the pain score reaches zero.

There are several variations of this misconception, including that The Joint Commission requires that patients are treated by an algorithm according to their pain score. In fact, throughout our history we have advocated for an individualized patient-centric approach that does not require zero pain. The introduction to the “Care of Patients Functional Chapter” in 2001 started by saying that the goal of care is “to provide individualized care in settings responsive to specific patient needs.”

Misconception #4: The Joint Commission standards push doctors to prescribe opioids

As stated above, the current standards do not push clinicians to prescribe opioids. We do not mention opioids at all:
The note to the standard says: Treatment strategies for pain may include pharmacologic and nonpharmacologic approaches. Strategies should reflect a patient-centered approach and consider the patient's current presentation, the health care providers' clinical judgment, and the risks and benefits associated with the strategies, including potential risk of dependency, addiction, and abuse.

Misconception #5: The Joint Commission pain standards caused a sharp rise in opioid prescriptions.

This claim is completely contradicted by data from the National Institute on Drug Abuse (Figure 1).

The number of opioid prescriptions filled at commercial pharmacies in the United States from 1991 to 2013 shows the rate had been steadily increasing for ten years prior to the standards’ release in 2001. It is likely that the increase in opioid prescriptions began in response to the growing concerns in the U.S. about under treatment of pain and efforts by pain management experts to allay physicians’ concerns about using opioids for non-malignant pain. Moreover, the standards do not appear to have accelerated the trend in opioid prescribing. If there was an uptick in the rate of increase in opioid use, it appears to have occurred around 1997-1998, two years prior to release of the standards.

The Joint Commission pain standards were designed to address a serious, intractable problem in patient care that affected millions of people, including inadequate pain control for both acute and chronic conditions. The standards were designed to be part of the solution. We believe that our standards, when read thoroughly and correctly interpreted, continue to encourage organizations to establish education programs, training, policies, and procedures that improve the assessment and treatment of pain without promoting the unnecessary or inappropriate use of opioids. 

The Joint Commission is committed to working to dispel these misunderstandings and welcomes dialogue with the dedicated individuals who are caring for patients in our accredited organizations.

David Baker, MD, is Executive Vice President of Healthcare Quality Evaluation at The Joint Commission

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Significant Decline in U.S. Opioid Prescribing

By Pat Anson, Editor

Nearly 17 million fewer prescriptions were filled for opioid pain medications in the U.S. in 2015, driven largely by a significant decline in prescriptions for hydrocodone, according to a new report by IMS Health.

The report adds further evidence that the so-called “epidemic” of opioid abuse and addiction is increasingly being fueled by illegal opioids such as heroin and illicit fentanyl, not by prescription pain medication intended for patients.

Hydrocodone was reclassified by the Drug Enforcement Administration as a Schedule II controlled substance in October, 2014 – making 2015 the first full year that more restrictive prescribing rules for the pain medication were in effect. But hydrocodone prescriptions were falling even before the rescheduling. They peaked in 2011 at 137 million and fell to 97 million in 2015, a 30% decline.

Hydrocodone is typically combined with acetaminophen to make Vicodin, Lortab, Lorcet, Norco, and other brand name hydrocodone products. The rescheduling of hydrocodone limits pain patients to an initial 90-day supply and then requires them to see a doctor for a new 30-day prescription each time they need a refill.

“It is not surprising that we have seen a dramatic drop in hydrocodone prescribing,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences. “Patients are being told they are not going to be prescribed opioids in general by many physicians. Since hydrocodone has been the most prescribed, it is the most affected. Schedule II opioids are more of a hassle so prescribers shun away from them.

“What is most striking is that the number of unintentional overdoses are still climbing despite fewer pills being prescribed.  Obviously this is a reflection that the goal to reduce harm from reduced prescribing is not working.  We have to wait to see if that trend continues.”

The Centers for Disease Control and Prevention recently adopted new guidelines that discourage primary care physicians from prescribing opioids for chronic pain. The agency also reported that 28,647 Americans died from opioid overdoses in 2014 and attributed about 19,000 of those deaths to prescription opioids. However, the CDC admits the data is flawed. Some overdoses may have been counted twice and some deaths blamed on prescription medications may have been caused by illegal opioids.

Hydrocodone Falls to #3

For several years hydrocodone was the #1 most widely filled prescription in the U.S. It now ranks third behind levothyroxine (Synthroid), which is used to treat thyroid deficiency, and lisinopril (Zestril), which is used to treat high blood pressure.

“Over 16.6 million fewer prescriptions were filled for narcotic analgesics, driven mainly by a sharp decrease in prescriptions for acetaminophen-hydrocodone, whereas prescriptions for oxymorphone, another controlled substance, increased 5.3%,” the IMS report said.

Oxymorphone is the generic name for Opana, a semisynthetic opioid that is also abused by drug addicts.  

The IMS report also found an increasing number of prescriptions being written for gabapentin (Neurontin), a medication originally developed to treat seizures that is now widely prescribed for neuropathy and other chronic pain conditions.  About 57 million prescriptions were written for gabapentin in 2015, a 42% increase since 2011.

After steadily increasing for several years, the number of prescriptions for tramadol appears to have leveled off, according to IMS. Last year about 43 million prescriptions were written for tramadol, a weaker acting opioid also used to treat chronic pain.

Overall spending in prescription drugs reached $310 billion in 2015, according to IMS, a 8.5% increase largely fueled by expensive new brand name and specialty drugs.

PROP Leads New Effort to Silence Pain Patients

By Pat Anson, Editor

Physicians for Responsible Opioid Prescribing (PROP) has joined in the lobbying effort to stop asking hospital patients about the quality of their pain care.

In a petition to the Centers for Medicare and Medicaid Services (CMS), PROP founder and Executive Director Andrew Kolodny calls on the agency to stop requiring hospitals to survey patients about their pain care because it encourages “aggressive opioid use.” PROP is funded and operated by Phoenix House, which runs a chain of addiction treatment centers, and Kolodny is its chief medical officer.

“Medication is not the only way to manage pain and should not be over-emphasized. Setting unrealistic expectations for pain relief can lead to dissatisfaction with care even when best efforts have been made to resolve pain. Aggressive management of pain should not be equated with quality healthcare,” Kolodny wrote in the petition on PROP stationary, which is co-signed by dozens of addiction treatment specialists, healthcare officials, consumer advocates and PROP board members.

The same group signed a letter, also on PROP stationary, to The Joint Commission (TJC) that accredits hospitals and healthcare organizations, asking it to change its pain management standards.

“The Pain Management Standards foster dangerous pain control practices, the endpoint of which is often the inappropriate provision of opioids with disastrous adverse consequences for individuals, families and communities. To help stem the opioid addiction epidemic, we request that TJC reexamine these Standards immediately,” the letter states.

Medicare has a funding formula that requires hospitals to prove they provide good care through a patient satisfaction survey known as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS).  The formula rewards hospitals that are rated highly by patients, while penalizing those that are not. 

The petition asks that these three questions be removed from the survey:

During this hospital stay, did you need medicine for pain?

During this hospital stay, how often was your pain well controlled?

During this hospital stay, how often did the hospital staff do everything they could to help you with your pain?

As Pain News Network has reported, 26 U.S. senators and the Americans College of Emergency Physicians have sent similar letters to Medicare asking that the pain questions by dropped from the survey. A recently introduced bill in the U.S. Senate called the PROP Act of 2016 would also amend the Social Security Act to remove "any assessments" of pain in hospitalized patients.

The PROP-led petition cites a 2013 study that found opioid pain medication was prescribed to over half of the non-surgical patients admitted to nearly 300 U.S. hospitals.

“Pain management is obviously an important part of patient care and we’ve always acknowledged that. But the problem here is that one should not have financial incentives and that’s essentially what happens through the CMS survey,” said Dr. Michael Carome of the consumer advocacy group Public Citizen, who co-signed the petition.

“The way the CMS survey and Joint Commission standards have driven the focus on pain has overemphasized its importance. We’re not saying don’t assess it at all, we’re saying the survey and standards have done more harm than good,” Carome told Pain News Network.

A top Medicare official recently wrote an article in JAMA defending the CMS survey.

"It has been alleged that, in pursuit of better patient responses and higher reimbursement, HCAHPS compels clinicians to prescribe prescription opioids. However, there is no empirical evidence that failing to prescribe opioids lowers a hospital’s HCAHPS scores," wrote Lemeneh Tefera, MD, Centers for Medicare & Medicaid Services. “Nothing in the survey suggests that opioids are a preferred way to control pain.”

Before joining Phoenix House in 2013, Kolodny was Chairman of Psychiatry at Maimonides Medical Center in New York City, a hospital that was given a one-star rating by patients in the CMS survey.   Only 61 percent of the patients said their pain was "always" well controlled at Maimonides and 11 percent said their pain was "sometimes" or "never" controlled. Only 59% of the patients said they would recommend Maimonides, compared to a national average for hospitals of 71 percent.

PROP has long been active in lobbying federal agencies to rein in the prescribing of opioids. It recently had some major successes in achieving its goals.

Five PROP board members helped draft the opioid prescribing guidelines released by the Centers for Disease Control and Prevention, which discourage primary care physicians from prescribing opioids for chronic pain. 

The Obama administration also recently asked Congress for over a billion dollars in additional funding to fight opioid abuse, with most of the money earmarked for addiction treatment programs such as those offered by Phoenix House, which operates a chain of addiction treatment clinics. A proposed rule would also double the number of patients that physicians can treat with buprenorphine, an addiction treatment drug. 

According to OpenSecrets, Phoenix House spent over a million dollars on lobbying from 2006-2012.  PROP calls itself “a program of the Phoenix House Foundation” on its website.     

PNN and the International Pain Foundation recently conducted a survey of over 1,250 pain patients and found that over half rated the quality of their pain treatment in hospitals as poor or very poor. Over 80 percent said hospital staffs are not adequately trained in pain management. Nine out of ten patients also said they should be asked about their pain care in hospital satisfaction surveys.

Canada: Abuse Deterrent Opioids Too Expensive

By Pat Anson, Editor

At a time when the U.S. Food and Drug Administration is actively promoting the development of more opioid pain medication with abuse deterrent formulas (ADFs), Canada is saying the drugs are too expensive and will have “little to no effect” in the fight against opioid abuse and addiction.

Health Canada last week rejected a proposed regulation that would require all medications containing the painkiller oxycodone to have tamper resistant properties.  ADFs generally make it harder for drug abusers to crush or liquefy opioids so they can be snorted or injected.

“(After) a review of the latest scientific evidence, the department has concluded that this specific regulatory approach, requiring tamper-resistance, would not have had the intended health and safety impact,” Health Canada said in a statement.

“Specifically, requiring tamper-resistant properties on all legitimate preparations of controlled-release oxycodone would have served to eliminate certain lower cost drugs from the market, increasing costs for patients and the health system, while having little to no effect in the fight against problematic opioid use.”

Like the United States, Canada has a severe and growing drug problem. According to the World Health Organization, Canada consumes more opioid painkillers per capita than any other country.

But Health Canada recently told drug makers to conduct more research demonstrating that ADFs do not change the safety and effectiveness of drugs. Until those studies are completed, the agency said it would rely on programs educating patients and prescribers about the safe use of opioids.

Purdue Pharma Canada released a statement saying it was disappointed in Health Canada’s decision and asked Health Minister Jane Philpott to reconsider.

“We continue to believe products with features designed to deter misuse, abuse and diversion, can and do have a positive impact on public health, based on the abundance of published evidence,” Purdue said in a statement. The company also urged Canada to “align with the FDA” by moving to require ADFs “across the entire class of opioids.”

In 2010, Purdue's OxyContin became the first opioid to be reformulated to make it harder for addicts to crush or liquefy. Since then, four other ADF opioids have been approved by the FDA and drug makers have spent hundreds of millions of dollars developing new formulas to make opioids even harder to abuse. Last month the FDA issued draft guidance encouraging drug makers to develop generic versions of opioids with ADF.

A major issue that has slowed the use of opioids with ADF is their cost. According to the Healthcare Bluebook, a website that estimates the market price of medications, the fair price for a 60-day supply of OxyContin 20mg in southern California is $352. A 60-day generic version of oxycodone -- without abuse deterrence -- retails for as little as $138.

Many health insurers have been reluctant to pay the extra cost of ADF.  A recent study found that only a third of Medicare Part D plans cover OxyContin and in many cases prior authorization is needed. Oxycodone, however, is covered by all Medicare Part D plans and prior authorization is rarely required.

Another recent study found that over a quarter of patients admitted to drug treatment facilities in the U.S. were still abusing OxyContin, five years after it was reformulated.

Fentanyl ‘Death Pills’ Spreading Coast-to-Coast

By Pat Anson, Editor

Law enforcement officials are warning that counterfeit pain and anxiety medications laced with illicit fentanyl have started appearing in Florida, where they are blamed for at least one overdose death.

The pills in Florida are disguised to look like oxycodone, Percocet or Xanax, but are actually made with fentanyl, a powerful and dangerous drug 50 times more potent than morphine. Similar counterfeit pills, made to look like Norco hydrocodone medication, are blamed for at least ten deaths and dozens of overdoses in the Sacramento, California area in recent weeks.

“I've had one of these so called super Norco’s,” said David, a 25-year old father of two, who started using street drugs for back pain.  “I only took a half just in case because of the news from the day and luckily I did. It was unlike any high I've had. It made me dizzy.  I couldn't see straight or sleep.”

As Pain News Network has reported, some of the victims in California are pain patients like David who sought opioid medication on the street because they can no longer get it prescribed legally.

"The people who have overdosed are not typically drug addicts," Olivia Kasirye of the Sacramento County health department told Agency France-Presse. “Many of the individuals said at one time or another they had a prescription and either they didn't get it refilled or the doctor said they didn't need it anymore."

Florida "Death Pills"

fake fentanyl pills disguised as norco

"It is here, it is deadly and it will continue to grow in our community,” said Danny Banks of the Florida Department of Law Enforcement in the Orlando Sentinel.

“If you are dependent upon or if you are experimenting with prescription painkillers, please make sure you are getting those painkillers from a licensed pharmacy. I cannot assure you right now, if you are buying prescription painkillers from either the black market or on the street, I cannot assure that they will not be laced with a deadly concoction that contains fentanyl. And it will kill you.”

In many cases, Banks said, neither buyers or sellers know the so-called “death pills” contain fentanyl.  He said fentanyl-laced pain pills have been seized in Osceola and Brevard counties, and have been linked to at least one fatality.

Florida’s Pinellas County Sheriff's Office has attributed nine recent fentanyl deaths to a batch of fake Xanax, an anxiety medication.

DEA Sees No Link to CDC Guidelines

In recent years, Illicit fentanyl has been blamed for thousands of overdose deaths. It is usually produced in China and then imported by Mexican drug cartels, which often mix fentanyl with heroin or cocaine before smuggling it into the U.S. The recent appearance of fentanyl in counterfeit pills is an ominous sign that drug dealers could now be targeting patients as customers, not just addicts.

But a DEA spokesman in Washington, DC disputes that notion.

“I don’t think you’re seeing that at all,” says the DEA’s Rusty Payne. “They’re going after anybody who will buy the product. By and large they are reaching hard-core addicts.”

Payne also sees no connection between the fake fentanyl pills and the recent adoption of the CDC’s opioid guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. Many patients fear losing access to opioids because of the guidelines.

“These CDC guidelines are brand spanking new. I think it’s hard to draw any sort of conclusions from that,” Payne told PNN. “I don’t think the Mexican cartels are paying one lick of attention to what the CDC guidelines are. What they see are thousands and thousands of addicts that they can push a product on, whether it be heroin or now fentanyl. And introducing it in pill form is just another way to make a lot of money."

In a survey of over 2,000 pain patients last fall by Pain News Network and the International Pain Foundation, 60 percent predicted patients would get opioids off the street or through other sources if the CDC guidelines were adopted. Another 70% said use of heroin and illegal drugs would increase.

According to a story in STAT, drug cartels are now shipping machinery into the U.S. that can manufacture pills, allowing dealers to mass produce fentanyl in pill form. In March, the DEA arrested four men in southern California who were operating four large presses to make counterfeit hydrocodone and Xanax pills.

Recently the Royal Canadian Mounted Police arrested 14 people in British Columbia, seizing firearms, diamonds, cash and about a thousand fentanyl pills.

A Brush with Death and Fake Pain Pills

By Pat Anson, Editor

At least ten deaths and 42 overdoses have now been blamed on counterfeit pain pills in the Sacramento, California area.

The pills are disguised as Norco – the brand name of a common hydrocodone medication – but they are actually made with illicit fentanyl, a dangerous and sometimes deadly drug that is 50 times more potent than morphine.      

One of those fatal overdoses could have easily been a 25-year year old father of two, who we’ll call “David” to protect his identity.

“I've had one of these so called super Norcos,” says David.  “It had the markings of a regular prescription, M367. I only took a half just in case because of the news from the day and luckily I did. It was unlike any high I've had. It made me dizzy.  I couldn't see straight or sleep.”

It’s not just street addicts who are being victimized by the fentanyl scam. Many are pain patients like David who turned to the black market for relief when they could no longer get opioid prescriptions legally.

David suffered a herniated disc several years ago. He was prescribed morphine for his pain and took it three times a day for six months before being abruptly cut off by his doctor. 

counterfeit norco pills

“I tried everything to get more and more prescription drugs prescribed. After that I had no choice but to turn to the street. It's a huge problem here in Sacramento,” David told Pain News Network.

“Ever since middle school and high school I recall the widespread use of opiates and heroin. But now there is such a high demand for the pills because of the increased regulations on them and not being able to scam an early refill. It has caused the price to spike on the streets and as soon as the word gets out someone has them they are immediately sold for ridiculous prices. It’s not all addicts and not all pain patients. The doctors around here are cutting people down on the amount they are prescribed, causing them to have nowhere else to turn but the neighborhood dealer.”

After three years of buying street drugs, David knew he had a problem and entered a treatment program, where he was prescribed Suboxone, an opioid medication that’s widely used to treat addiction. The treatment worked well for several months, but then his health insurance with Covered California lapsed and he missed a re-enrollment period. David could no longer get treatment.

“The withdrawal from that (Suboxone) was about 3 weeks and felt like it was getting worse, so I really felt as if I had no choice but to ease the pain by once again turning to the streets to feel better. I told myself I'd only do it for a month then that turned into two months, now it's going on seven and I can't stop,” said David. “I got the Norco from a friend who is usually prescribed oxycodone but had run out and he too was forced to go out and find something to get him through till his refill was due.”

David bought 16 Norco pills for $5 each, not knowing he was actually getting fentanyl.

“Adding fentanyl of course to the Norco makes it much more powerful and deadly at the same time,” says John Burke, a former drug investigator for the Cincinnati Police Department who is now president of the International Health Facility Diversion Association. “Dealers brag about the potency of their products, and even brag when someone overdoses or even dies as proof of superior product. Screwed up thought process, but nevertheless that’s the world of illicit drug dealing.”

Burke says the counterfeit Norco most likely came from Mexico, where drug cartels manufacture fentanyl before smuggling it into the United States. Usually the fentanyl is mixed with heroin or cocaine to boost their potency. By disguising fentanyl as a legitimate pain medication, the dealers are tapping into a large and growing black market for opioids sought by addicts and pain patients.

“Putting fentanyl in pill form makes it less of a problem in hiding and transporting the drugs,” says Burke. “These pills probably bring more money, especially when the testimonials roll in as to how potent they are. Their drive is their bottom line.”

The bottom line for David is that he nearly overdosed and could have died. For the sake of his children, he’s gotten rid of the remaining Norco pills and is hoping to wean himself off opioids.

“I'm starting to taper myself down. I have to, this pill scare is enough to scare someone that has a lot to lose like myself,” he said.

ER Doctors Lobby to Silence Pain Patients

By Pat Anson, Editor

A professional organization for emergency room physicians has joined in a lobbying effort to stop asking hospital patients about the quality of their pain care.

At issue is a Medicare funding formula that requires hospitals to prove they provide good care through patient satisfaction surveys. The formula rewards hospitals that are rated highly by patients, while penalizing those that are not. 

In a letter to Health and Human Services Secretary Sylvia Mathews Burwell, the head of the American College of Emergency Physicians (ACEP) claims that asking patients about their pain care could lead to overprescribing of opioid pain medication. To see the letter, click here.

“Patient experience/satisfaction surveys are important, particularly regarding issues of treating patients with dignity and respect, but questions about pain have resulted in unintended consequences and the pursuit of high patient-satisfaction scores may actually lead health professionals and institutions to practice bad medicine by honoring patient requests for unnecessary and even harmful treatments,” wrote Jay Kaplan, MD, President of ACEP, which represents over 30,000 emergency room physicians in the U.S.

“Any questions which provide an opportunity for patients to express dissatisfaction because they didn’t get the drugs they sought, provide disincentives for physicians to prescribe non-opioid analgesics which will negatively affect their scores.”

Only two questions are asked about pain in the 32-question survey known as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS):

During this hospital stay, how often was your pain well-controlled?

During this hospital stay, how often did the hospital staff do everything they could to help you with your pain?

In his letter, Kaplan states “there is no objective diagnostic method that can validate or quantify pain” and until one is developed, both pain questions should be dropped from the survey.

“We are concerned that the current evaluation system may inappropriately penalize hospitals and physicians who, in the exercise of medical judgment, opt to limit opioid pain relievers to certain patients and instead reward those who prescribe opioids more frequently,” Kaplan wrote. “We urge the Department to undertake a robust examination of whether there is a connection between these measurements and potentially inappropriate prescribing patterns, and, until that is completed, we urge you to remove pain questions from the various CAHPS surveys.”

Kaplan’s letter is similar to one sent to Secretary Burwell in February by Sen. Susan Collins (R-Maine) and 25 of her colleagues in the U.S. Senate. To see that letter and the senators who signed it, click here.

“The evidence suggests that physicians may feel compelled to prescribe opioid pain relievers in order to improve hospital performance on quality measures,” wrote Sen. Collins.

Both Collins and Kaplan cite only one piece of “evidence” – a 2013 magazine article in The Atlantic  -- that mentions a small study of “drug seeking behavior” by emergency room patients. The article's author, who is a physician, also mentions anecdotal comments from colleagues and concludes “this problem is widespread.”  

Pain News Network and the International Pain Foundation recently conducted a survey of over 1,250 pain patients and found that what is actually widespread in hospitals is poor pain care. Over half the patients surveyed said the quality of their pain treatment was poor or very poor and over 80 percent said hospital staffs are not adequately trained in pain management. Nine out of ten patients said they should be asked about their pain care in hospital satisfaction surveys.

“Before eliminating patients' right to critique their pain care, a better idea would be to ask doctors what they know about pain!” wrote one patient. 

When Pain News Network provided ACEP with the survey results, a spokesperson declined to comment on the findings.

A top Medicare official recently wrote an article in JAMA defending the HCAHPS survey.

"It has been alleged that, in pursuit of better patient responses and higher reimbursement, HCAHPS compels clinicians to prescribe prescription opioids. However, there is no empirical evidence that failing to prescribe opioids lowers a hospital’s HCAHPS scores," wrote Lemeneh Tefera, MD, Quality Measurement and Value-Based Incentives Group, Centers for Medicare & Medicaid Services.

"Although opioids are sometimes appropriate, depending on the underlying cause, other nonpharmaceutical approaches and multiple nonopioid pain medications are available to treat pain. Nothing in the survey suggests that opioids are a preferred way to control pain. On the other hand, good nurse and physician communication are strongly associated with better HCAHPS scores."

“I find this notion that we would stop asking patients how well their pain was controlled in the hospital appalling,” said Cindy Steinberg, National Director of Policy and Advocacy for the U.S. Pain Foundation. “I find it perverse that we would be more concerned with whether doctors in a hospital setting felt ‘pressure’ to provide pain relief than whether patients felt the hospital staff did all they could to help them with their pain. What ever happened to the focus on ‘patient-centered’ care?"

DEA Warns of Fake Fentanyl Pain Pills

By Pat Anson, Editor

In the wake of nine deaths and dozens of overdoses in the Sacramento, California area in recent weeks, the U.S. Drug Enforcement Administration has issued a public safety alert about illicit fentanyl being disguised as opioid pain medication and sold on the black market.

Fentanyl is a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses. Fentanyl is available by prescription to treat more severe types of chronic pain, but illicitly manufactured fentanyl is fast becoming a scourge across the U.S. and is blamed for thousands of fatal overdoses.

White fentanyl powder is usually mixed with heroin or cocaine to give those drugs an extra kick, but in Sacramento the drug was disguised as counterfeit Norco pills, a legal opioid pain medication that combines hydrocodone with acetaminophen.

“Public Health and Law Enforcement officials believe that the pills containing Fentanyl were likely sold on the street under the guise of being legitimate hydrocodone.  Additionally, the pills are marked to mimic the authentic hydrocodone product. However, the Sacramento County Department of Health and Human Services reports that test results show that some of the tested pills did not contain hydrocodone, but rather fentanyl,” the DEA said in a statement. 

IMAGE OF COUNTERFEIT NORCO

“The DEA urges the public not to take a prescription drug unless prescribed by your own physician and obtained from a reputable pharmacy."

One of the overdose victims in California was David Alfaro, a 53-year old man who suffered chronic pain from a leg injury, according to a report by KCRA-TV.

"He bought what he thought was Norco, and it ended up being fentanyl -- and it killed him," said Marinda Conway, Alfaro’s common law wife. "He wasn't a heroin addict that was looking to substitute his addiction by buying street pills. He wasn't an opioid addict by any means.”

Conway said a single fake Norco pill was enough to kill Alfaro, although autopsy results are pending.

"This has been my fear with the new CDC guidelines that more people with pain will have less access to prescription medications; therefore taking matters into their own hands, self-medicating with medications bought on the street," said Paul Gileno, president of U.S. Pain Foundation, referring to recently adopted government guidelines that discourage primary care physicians from prescribing opioids for chronic pain.

"The CDC never thought about the unintended consequences from limiting access to legitimate patients needing care whose clinicians now feel unable to prescribe or treat appropriately. My worst nightmare is the possible repercussions looming in the future due to these hindering guidelines," Gileno said.

In a survey last fall of over 2,000 pain patients by Pain News Network,  70 percent predicted that use of heroin and other illegal drugs would increase if the CDC guidelines were adopted.

The DEA says illicit fentanyl is primarily manufactured in Mexico and China before being smuggled into the U.S. Because of the nature of the drug, it’s impossible to tell if fentanyl was prescribed legally and used for medical reasons or manufactured illegally and used recreationally. The CDC admits many fentanyl overdoses may have been misclassified as deaths caused by prescription painkillers.

White House Steps Up Anti-Opioid Campaign

By Pat Anson, Editor

The Obama administration has unveiled a series of new initiatives aimed at treating addiction and educating doctors about prescription opioid abuse – amid growing signs the nation’s drug abuse epidemic is being fueled more and more by illegal opioids such as heroin and illicit fentanyl.

The new campaign, unveiled at the National Rx Drug Abuse and Heroin Summit in Atlanta, expands on a $1.1 billion funding proposal the President sent to Congress last month to address the nation’s growing drug problem.

One change that could greatly expand access to addiction treatment is a proposed rule by the Department of Health and Human Services (HHS) to double the number of prescriptions that a doctor can write for buprenorphine, an opioid used to treat addiction. Doctors currently are limited to 100 buprenorphine patients, but the new rule would expand that to 200 patients. The number of doctors trained and licensed to prescribe buprenorphine will also be increased.

HHS and the Substance Abuse and Mental Health Services Administration (SAMHSA) will also release over $100 million to expand access to addiction treatment.

"Expanding access to medication-assisted treatment for opioid-use disorders has been a top priority for this administration. Research clearly shows that this approach, when combined with behavioral therapies, is more effective at sustaining recovery and preventing overdose," said Michael Botticelli, director of the White House Office of National Drug Control Policy.

The policy changes and funding support stand to greatly benefit addiction treatment centers such as Phoenix House, whose medical director has lobbied for expanded access to buprenorphine treatment. Andrew Kolodny, MD, is also the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP) which had five board members, including Kolodny, advising the CDC about its new opioid prescribing guidelines.

While buprenorphine is considered a “safer” opioid and has long been used to treat addiction (under the brand name Suboxone), it is prized by some addicts and can be abused. A 2013 study by SAMHSA found a ten-fold increase in the number of emergency room visits involving buprenorphine. Over half of the hospitalizations were for non-medical use of buprenorphine – meaning many users took the drug to get high.

“One of the most effective medications for opioid addiction is a drug called buprenorphine or Suboxone,” said Kolodny in an interview on C-SPAN last October.

A request to Phoenix House and Kolodny for comment on the HHS buprenorphine proposal went unanswered.

The White House also announced this week that 60 medical schools will require students to take some form of prescriber education, modeled after the CDC’s opioid guidelines, in order to graduate.

The lack of pain education in medical schools has long been recognized as a problem. A 2012 study published in the Journal of Pain called pain education "lackluster" in the U.S. and Canada. Few schools required a course in pain education and many did not have any pain courses.

A recent survey by Pain News Network and the International Pain Foundation (IPain) found that 8 out of 10 patients feel that hospital staffs are not adequately trained in pain management. Over half rated the quality of their pain care in hospitals as either poor or very poor.

Some fear the new White House plan is focused more on addiction treatment and limiting access to opioids than it is on educating doctors about pain management.  

“What remains astonishing is the total deafness to the needs of people in pain. It is as if people in pain don't exist and that they are not important,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“Focusing on opioid prescribing education in medical schools without also educating medical students about pain medicine is only going to further stigmatize people in pain and those who develop addictions. This is a true Back to the Future nightmare.  We will be practicing 1950's medicine for the most prevalent public health problems in America.  Absolutely astounding to me.”  

Six Fatal Fentanyl Overdoses in California

While the Obama Administration was announcing its new plan, health officials in Sacramento, California confirmed that six people died and over two dozen were hospitalized this month after ingesting a black market version of Norco, a widely prescribed opioid painkiller.

Legitimate Norco pills are a combination of hydrocodone and acetaminophen, but the “street” Norco was laced with fentanyl, a much more potent and potentially deadly opioid. Fentanyl is odorless and cannot be easily distinguished from other drugs.

“Some who have taken it stated that they were told that it was Norco.  However, results just released indicate that some of the pills that were retrieved have been tested and show that they did not contain Hydrocodone or Acetaminophen. The lab was able to identify the pills as containing Fentanyl instead.  This indicates that they are really Fentanyl pills that have been made to look like Norco,” the Sacramento County Division of Public Health said in a statement.

Fentanyl deaths have been rising around the country – at least 22 died from fentanyl overdoses in the Cleveland, Ohio area this month alone and dozens of deaths have been reported in West Virginia.

Last year the Drug Enforcement Administration issued a nationwide alert about the abuse, diversion and illegal manufacture of fentanyl. Thousands of people are believed to have died from fentanyl overdoses, but because of the nature of the drug it is impossible to tell whether it was prescribed legally and used for medical reasons or manufactured illegally and used recreationally. The CDC admits many fentanyl overdoses may have been misclassified as deaths caused by prescription painkillers.

Meanwhile, a report this week in Maine’s Portland Press Herald suggests that there is a correlation between rising heroin use and reduced access to prescription opioids. In recent years the number of people being treated for heroin addiction has nearly tripled in Maine, at a time when the number of prescriptions written for opioids dropped by 45 percent.

How Opioid Prescribing Guidelines Use Pseudoscience

By Michael Schatman and Jeffrey Fudin, Guest Columnists

Recently, we (along with our colleague, Dr. Jacqueline Pratt Cleary) published an open access article in the Journal of Pain Research, entitled “The MEDD Myth: The Impact of Pseudoscience on Pain Research and Prescribing Guideline Development.”

In this work, we address the issue of how governmental and managed care opioid guideline prescribing committees use the flawed concept of morphine-equivalent daily dose (MEDD or MME) to arbitrarily place limits on the amount of opioids that a clinician “should” prescribe to any patient with chronic pain -- as if all patients were identical. 

The article cites excellent research that exposes the invalid concept of MEDD – and while guideline authors are fully aware of that lack of evidence, they are hypocritically fine with using MEDD as a device to thwart chronic opioid use. In the case of opioids for chronic non-cancer pain, there is at least some evidence.  But for MEDD, there is no evidence.   

One reason the MEDD concept is not legitimate is pharmacogenomic differences – that is, due to each of our unique genetic compositions, various individuals and geographical groups metabolize some opioid analgesics differently.  These differences are often enormous. 

For example, it may require Person “A” 20 milligrams of hydrocodone to achieve adequate pain relief, while Person “B” (of the same gender and weight) may require 60 milligrams of the same drug for the same type of chronic pain condition.  Does this make Person “B” an addict?  Of course not.

We believe that by arbitrarily limiting the “appropriate” amount of an opioid that a physician should prescribe to a patient (which all recent guidelines – including the CDC’s guideline – call for), physicians feel compelled to limit the amount of opioid analgesic therapy that they prescribe – irrespective of the amount of relief that a patient with chronic pain receives. 

Is this good pain medicine practice?  Hardly.  However, in the eyes of the anti-opioid zealots who have dominated recent opioid prescribing guideline committees, their agenda of taking opioids out of the picture altogether for patients with chronic pain is evidently more important than is patient well-being.

Aside from the pharmacogentic issues, we also have conversion issues because of simple mathematics.  We cite data that clearly shows there are no universally accepted opioid equivalents.  Even if there were no issues with genetic variability, there is still no consensus on how to mathematically convert one opioid to another. For example, the state of Washington may decide on a different MEDD equivalent than the one New York state chooses.

Will the anti-opioid zealots admit that they have a non-scientifically-based agenda to take opioids out of the American chronic pain management discussion?  No – because if they were to do so, they would be seen as cruel or uncaring.  Rather, they emphasize that their concerns are for the well-being of patients and society.  Their logic suggests that if clinicians stop prescribing opioid analgesics altogether, then the unfortunate number of opioid-related overdoses and deaths will decrease dramatically. 

Not surprisingly, they lack the data that supports this assertion, yet the data are clear that when this happens, heroin use increases proportionally. 

As scientists and practitioners who work with patients with chronic pain every day, we see the damage in which these guidelines result.  For example, while the guidelines are described as “voluntary” by the committees that write them, that is clearly not the case.  Although the zealots deny the existence of a chilling effect on prescribing, there are data that suggest that progressively fewer physicians are willing to prescribe opioids since these non-evidence-based guidelines have surfaced.  Despite being touted as voluntary, physicians fear regulatory sanction should they disobey them, and accordingly are taking opioids out of their treatment armamentaria. 

Are we suggesting that opioid therapy be considered the first-line treatment for chronic pain?  Certainly not.  Chronic opioid therapy should be considered only when other available treatments have proven ineffective. However, given the for-profit health insurance industry’s business ethic of cost-containment and profitability, insurance access to many treatments that may be superior to opioid therapy are out of reach for the vast majority of Americans. We also have to remember that 20% of Americans live in underserved areas in which more sophisticated and safer treatment options are completely inaccessible.

We are concerned about this ethical imbroglio, as it is extremely damaging to our patients who suffer from the disease of chronic pain.  To quote from our article, opioid prescribing guideline committees’ continued utilization of the antiquated and invalid concept of MEDD is “scientifically, ethically, and morally inexplicable.”

As a result of this highly unethical practice, “impressionist lawmakers and anti-opioid zealots are basing clinical policy decisions on flawed concepts that ultimately could adversely affect positive outcomes for legitimate pain patients.”

It’s difficult enough to suffer from chronic pain under the best circumstances.  What patients with pain and society in general certainly don’t need is a group of smug inexperienced pain policymakers, politicians, and managed care administrators impacting public policy by evoking pseudoscience. There is sufficient good science being published that demonstrates that their reliance upon the MEDD myth is highly disingenuous.

Michael E. Schatman, PhD, is a clinical psychologist who has spent the past 30 years working in multidisciplinary chronic pain management. Until recently, he served as the Executive Director of the Foundation for Ethics in Pain Care in Bellevue, WA.

Dr. Schatman is Editor-in-Chief of the Journal of Pain Research and Director of Research for the U.S. Pain Foundation.

Jeffrey Fudin, PharmD, is a Clinical Pharmacy Specialist and Director at the Pharmacy Pain Residency Programs at the Stratton Veterans Administration Medical Center in Albany, NY.  

Dr. Fudin is Diplomate to the American Academy of Pain Management and a Fellow of both the American College of Clinical Pharmacy and the American Society of Health-system Pharmacists. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Pain Patients Say Non-Opioid Meds ‘Do Not Help at All’

By Pat Anson, Editor

In recent weeks, several efforts have been launched to scale back the use of opioid pain medication in hospitals and emergency rooms.

The American Pain Society (APS) released new guidelines for post-surgical pain that encourage physicians to limit the use of opioids, and to give acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), gabapentin (Neurontin), or pregabalin (Lyrica) to patients suffering from postoperative pain. Cognitive behavioral therapy and transcutaneous elective nerve stimulation (TENS) were also recommended by the APS for post-operative pain.

Similar measures were endorsed by an expert panel at the Jefferson College of Population Health in Philadelphia, which warned that relieving a patient’s post-surgical pain with opioids could lead to addiction.

“Clearly, giving patients what they want, or think they need, is not always in their best interest,” wrote lead author Janice Clark, RN, Jefferson College of Population Health.

But most pain patients aren’t getting what they want or what they need in hospitals -- pain relief --  according to an extensive survey of over 1,250 acute and chronic pain patients by Pain News Network and the International Pain Foundation (IPain).

Over half rated the quality of their pain care in hospitals as poor or very poor, and six out of ten patients said their post-surgical pain was not adequately controlled.

And many hospitals are already very reluctant to give patients opioids. Over half (53%) the patients in our survey say they were refused opioid pain medication while hospitalized.   

“If you end up in the emergency room you will NEVER be given opioid based pain meds. They use NSAIDs. That usually isn't good enough,” said a patient who suffers from rheumatoid arthritis and spinal stenosis.

“This obsession with preventing pain sufferers from receiving adequate care is cruel and unusual. Would you deny a diabetic access to medication to control their condition?”

WERE YOU EVER REFUSED OPIOID PAIN MEDICATION WHILE HOSPITALIZED?

“They didn't want to hand out an opiate but were sure happy to go get me some Xanax,” said a patient who was hospitalized for an undiagnosed heart problem, as well as back and rib pain. “Welcome to the American standard of schooling and healthcare.”

“I went to the ER for a broken arm, and they took x-rays and told me it was broken. I asked for pain meds, even asked for non-narcotic meds, and got NOTHING, not even an aspirin with a broken arm, nothing while they put a cast on it and nothing to fill when I left,” said another patient.

“The pharma companies are using everything they can to increase the drug costs and these newer drugs are less effective and much more expensive. Soon they'll be suggesting we not use anesthesia for amputations,” said another pain sufferer.

Patients overwhelmingly agreed in our survey that non-opioid medications and therapies were ineffective in relieving pain. Nearly two-thirds (65%) said they “did not help at all” and nearly one in four said they only “helped a little.”

Just 11% said non-opioid treatments were very effective or somewhat effective at relieving pain.

“If they intend to use ‘preferred treatments’ like NSAIDs and Lyrica/Neurontin, they should have a reason for using these more dangerous, less effective meds,” wrote one patient.

“They should know that Lyrica and Neurontin can take months to build in the patient's system in order to be effective, and that NSAIDs can cause heart problems, gastric bleeding, and other side effects which can cause a host of new problems for the patient.”

“Tylenol won't help me and I'm allergic to NSAIDs. Why not do something about the real druggies that ruined it for the real patients? They get their medicines! I won't go to the ER unless I'm dying!” wrote another patient.

WAS NON-OPIOID PAIN MEDICATION OR THERAPY EFFECTIVE IN RELIEVING YOUR PAIN?

“Advil or Tylenol just don't cut it. It's ridiculous that you would not be treated for chronic pain in and out of hospital setting,” said another pain sufferer.

“I'm not surprised there's a perception that pain care is poor, in hospital or out,” said David Juurlink, MD, an internist and clinical pharmacologist at Sunnybrook Health Sciences Centre in Toronto.

“It's important that patients understand that one major reason for this is that our available pain medications (principally acetaminophen, NSAIDs and opioids, but various other drugs as well), simply don't work well for many types of pain. I see this firsthand every day, and it highlights the need for research into novel drug therapies that treat pain safely and effectively,” said Juurlink, who is also a board member of Physicians for Responsible Opioid Prescribing (PROP) and was a consultant to the CDC during development of its opioid prescribing guidelines.

“It's especially important that people not conflate ‘poor pain care’ with ‘reluctance to use opioids,’ because opioids really are no better than our other options for treating pain -- chronic pain in particular -- and they can make pain worse in a very short period of time. This phenomenon (opioid-induced hyperalgesia) is something we're just starting to understand, but it's one of many reasons why patients can have pain that persists or even worsens despite therapy. It's one more reason why doctors and patients need to de-emphasize the role of opioids in managing pain.”

One patient in our survey wishes hospitals would allow medical marijuana to be used an alternative to opioids.

“It would be better and safer if cannabis was allowed in treating pain in hospitals,” they said. ”I don't use opioids every day because I use cannabis instead. When I am in hospital I am forced back on opioids and go through withdrawal when I leave the hospital. This would not be the case if I could keep using cannabis instead.”

Still another patient discovered a novel way to get opioids in the hospital: don’t ask for them.

“I ended up learning to ask for non-opioid painkillers. That way when the painkillers they gave me didn't work, they would actually suggest them,” he said.

To see the complete survey results, click here.

A Pained Life: The Good and Bad about CDC Guidelines

By Carol Levy, Columnist

The Centers for Disease Control and Prevention begins the summary of its new opioid guidelines by stating: “This guideline provides recommendations for primary care providers who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.”

I have issue with some of the guidelines. Other parts I think are common sense, although I know many will disagree with me.

That being said, the guidelines negate themselves when they state they are not aimed at those receiving palliative care, which is described as: “Palliative care is specialized medical care for people with serious illnesses. It focuses on providing patients with relief from the symptoms and stress of a serious illness. The goal is to improve quality of life for both the patient and the family.”

That definition clearly includes those with chronic pain illnesses and disorders. As such it does not make sense to go after us as the main culprits of the alleged opioid epidemic.  I write alleged because there seems to be much controversy whether the epidemic exists, its cause, and the medications involved, some of which are either gotten illegally or are themselves illegal, such as heroin.

These are the guidelines:

1) Non-pharmacologic therapy and non-opioid medication are preferred for chronic pain. If opioids are used, they should be combined with non-opioid drugs and therapy as appropriate.

2) Before starting opioids for chronic pain, clinicians should establish treatment goals, including realistic goals for pain and function, and consider how opioid therapy will be discontinued if benefits do not outweigh risks.

3) Before starting and periodically during opioid therapy, clinicians should discuss known risks and realistic benefits of opioid therapy.

4) When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting opioids.

5) When opioids are started, clinicians should prescribe the lowest effective dosage.

6) Long-term opioid use often begins with treatment of acute pain. Clinicians should prescribe the lowest effective dose of immediate-release opioids and no greater quantity than needed for the expected duration of severe pain. Three days or less will often be sufficient; more than seven days will rarely be needed.

7) Clinicians should evaluate benefits and harms within 1 to 4 weeks of starting opioids or dose escalation, and should evaluate benefits and harms every 3 months. If harm outweighs benefits clinician should work with patients to taper opioids to lower dosages or discontinue.

8) Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms.

9) Clinicians should review the patient’s history of controlled substance prescriptions.

10) When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually.

11) Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently.

12) Clinicians should offer or arrange evidence-based treatment.

Most of these guidelines seem to be to be based on common sense; however I take great umbrage at the recommendation about urine drug testing. I do not know of any other patient group where a patient is presumed guilty or felonious. It casts cast a black mark on every person who has a chronic pain disorder and for whom opiates are prescribed.

The guidelines also miss the mark by not differentiating between patients for whom physical and alternative therapies can help and those they cannot. For instance, trigeminal neuralgia and other cranial neuropathies will get no benefit whatsoever from those kinds of therapies. Lupus, multiple sclerosis, chronic regional pain syndrome (CRPS/RSD), and many other conditions are also not responsive or greatly responsive to physical therapy, targeted injections and other types of nonopiod therapies.

Suggesting other forms of therapy for a population that is not helped by them is not palliative, in any sense of the word.

However, I think we hurt ourselves when we jump on a bandwagon and say the whole idea of guidelines are hurtful to our community. We need to look at them clearly.

It should be pro forma that the doctor talk to his patient about the harms and benefits of any prescribed treatment. It should be standard practice for a doctor to evaluate if the treatment is helping or not, and make any necessary changes.

It is only logical that the medical community treat the chronic pain community as they would any other; with professionalism, common sense, decency, and thoughtful help.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.