Lethal Capacity and Potential to Kill -- "Thanks, Doc. I Was Afraid It Would Hurt."

"Addiction is a primary, chronic disease of brain reward, motivation, memory and related circuitry. Dysfunction in these circuits leads to characteristic biological, psychological, social and spiritual manifestations. This is reflected in an individual pathologically pursuing reward and/or relief by substance use and other behaviors.

"Addiction is characterized by inability to consistently abstain, impairment in behavioral control, craving, diminished recognition of significant problems with one’s behaviors and interpersonal relationships, and a dysfunctional emotional response. Like other chronic diseases, addiction often involves cycles of relapse and remission. Without treatment or engagement in recovery activities, addiction is progressive and can result in disability or premature death."

("Short Definition of Addiction," Public Policy Statement: Definition of Addiction,

American Society of Addiction Medicine, 2013)

Addiction: The "A to E" Characteristics

A.  Inability to consistently Abstain

B.  Impairment in Behavioral control

C.  Craving; or increased “hunger” for drugs or rewarding experiences

D.  Diminished recognition of significant problems with one’s behaviors and interpersonal relationships

E.  A dysfunctional Emotional response.


Although these five features are not intended to be used as “diagnostic criteria” for determining if addiction is present or not, the characteristic features are widely present in most cases of addiction, regardless of the pharmacology of the substance use or the reward that is pathologically pursued. Each feature may not be equally prominent in every case.

"The diagnosis of addiction requires a comprehensive

biological, psychological, social and spiritual assessment

by a trained and certified professional."

(American Society of Addiction Medicine, 2013)

Addiction is not a term or a diagnosis to be applied casually or dispassionately; for those truly afflicted, it is of life-consuming and mortal consequence. It is a significantly different and distinct "beast" from complex and persistent dependence.

In The War of the Gods in Addiction (2009), psychoanalyst David E. Schoen, LCSW, MSSW, describes rather dramatically what he believes are two essential components of addiction…

“First, the addictive substance… must ultimately take over complete and total control of the individual, psychologically. That is, it must take over control of normal ego functioning — thoughts, emotions, perceptions, motivations, judgments, decisions, actions, and behaviors.”           

“And the second part of this definition is crucial: the addiction takes over control in an inherently destructive and ultimately life threatening way. It is not an addiction unless it is a death sentence… of the mind, of the emotions, of the body, and of the spirit.  

"It is a death sentence to the addict’s career, community, marriage, family and friends. It is not an addiction unless it has the lethal capacity and potential, the power to kill the individual. It is not an addiction unless it is the most powerful, controlling, possessing, dictating, and determining agenda in the psyche. It must take precedence over everything else.”

My Take

Without sufficient research-based, clinical training and firsthand witness to those who can relate their personal experiences of dependence and addiction, prescribers of prescription drugs (medical doctors, dentists, etc.) cannot have the expertise needed to determine how to treat those in chronic pain.

At this time, most doctors do not have adequate training in managing those in moderate to severe pain. What little education they have received has come from pharmaceutical companies who sell pain relievers that they claim can be used to treat pain symptoms, not cure the ailments that cause the pain.

Many of these substances can lead to dependency and addiction. Voluntary compliance to complete painkiller training is in effect; however, the risk factors associated with taking many of these medications demand that doctors have mandatory training.
Look at the two definitions of addiction again. In many ways they are alike, yet the American Society of Prescription Medicine definition is much more cold and clinical than Schoen's emotional, "death sentence" definition associated with potentially destroying the human psyche and all personal social relationships.

Can you see my point? Anyone treating those racked in physical and psychological pain cannot ignore the debilitating effects of the "hurt." But, first of all, these doctors must be sufficiently educated in proper pain treatment and pain management. The public must not assume a doctor's medical degree includes sufficient completion of that specific training. In fact, in most cases, having proper prescription education depends upon the voluntary initiative and concern of the individual medical professional.

Equipped with the knowledge of how best to identify and treat pain in all its many forms, a doctor must then find the source(s) of the patient's pain and develop safe treatment based on an accurate diagnosis in order to continue with the best prognosis. These procedures are very difficult tasks that usually require repeated treatment, adjustment, and close management of pain medications.

Thus, enters the potential for dependence and addiction -- the professional decides to continue treatment of the patient's moderate to severe pain with the FDA-approved opioid painkiller. The very substance that stops the pain has the power to overcome the patient and make him/her dependent, then addicted'

An over-medicated patient is, at first, happy and unaware of any impending danger. Yet, as he soon perceives his sense of well-being is tied directed to the prescribed substance and increased resistance enters his being, he craves more significant doses to keep him "level." But, eventually he becomes impaired and exhibits most of the "A to E" characteristics, and they continue to progress with his overwhelming chemical consumption. He becomes totally dependent on his altered state of being. 

His dependence spirals into addiction, and he is rendered dysfunctional. He has become a distorted, ugly veneer of his true being. Pills possess his insides as he lives the will of his pain. As reason deserts his mind and chemical needs overtake everything else in his world, his only perception of salvation is his next fix.

You needn't tell him about the possible ways out. His only friends then are addicts, and all of them know the truth. The problem is that so many of them are so wounded that they cannot prevail to fight the odds. They know the odds are that they are headed for prison or for the grave. The exceptional addicts pull themselves up through rehabilitation with the grace of a strong will, the dedication to long and tough medical intervention, the forgiving help of loved ones, and the grace of Almighty God.

If and when death occurs, the addicts immediate family and friends are left scarred and perplexed and in deep pain themselves. An addict's death leaves holes in the world -- gaps and crevices he had no idea his demise would help create. Some of them are obvious like torn families and shattered dreams. Others are hushed and carefully concealed like debts and dark, detrimental associations.

And perhaps the biggest, most distressing fissure of all 

grows at the end of a pen

wielded by a health professional who continues

 to be an unknowing or uncaring accessory

to murderous Rx addiction

as he prescribes continuous opioid pain medication.    

FDA and Big Pharma in Bed: Sign Petition to Make Opioid Training Mandatory

Allow me to point out problems I see with the Risk Evaluation and Mitigation Strategy (REMS) for extended release/long acting opioid analgesic drug products. I am in favor of mandatory training for all doctors who prescribe these substances.

I strongly believe the FDA supports weak, ineffective instruction that is biased in the interests of Big Pharma. I urge you to help change the present REMS strategy you will read below. At the end of this blog entry, I provide you with a petition to sign.

All information concerning the petition will be collected and sent to the office of the commissioner of the FDA. Please sign and get your friends to sign. It will take only a minute of your time. There is also a place on the petition to include your comments.

In italic blue print is the present FDA Required REMS Program. I have noted areas of concern with a red asterisk (*). Then, I address each asterisk and explain the reasons for my concern in black print.

* FDA Required REMS Program for Serious Drug Risks

* I even have problems with the title of the document. The label “required” is very misleading. According to the FDA, there are about 320,000 prescribers of long-acting opioid analgesics in the U.S., and the agency expects 25% of them to be trained at the end of the program's first year. The goal is to have 60% of prescribers trained by year three.

This program is not mandatory training for prescribers; instead, it is voluntary. REMS is just encouraging prescribers to cooperative. So, REMS is “required” merely in the sense of its own creation. The FDA “required” REMS to be conducted – their goal does not even due justice to their purpose. The projected goal of 60% voluntary compliance in three years is totally unacceptable in that death and serious injury due to prescribing opioids will continue at record levels during this time.

Subject: Announcement of a Risk Evaluation and Mitigation Strategy (REMS) for all extended release/long acting opioid analgesic drug products due to their risks of misuse, abuse, addiction, and overdose.

Dear DEA‐Registered Prescriber:

Extended‐release and long‐acting (ER/LA) opioid analgesics are approved for the management of chronic * moderate-to-severe pain in the U.S., and * can be safe and effective in appropriately selected patients when used as directed. However, opioid analgesics are also associated with serious risks and are at the center of a major public health crisis of increased misuse, abuse, addiction, overdose, and death.

Several widely used instruments let patients rate pain on a scale of one to 10. The one-to-three range is described as mild, nagging pain that does not greatly interfere with a patient’s daily life. The four-to-six range is “moderate pain” that significantly interferes with a patient’s ability to perform activities of daily living such as working, cooking and doing chores. The seven-to-10 range is “severe pain” that is disabling and renders a patient unable to perform daily-life activities.

* First, the FDA should not approve these opioids for management of moderate pain. Evidence of long-term efficacy for chronic non-cancer pain (≥16 weeks) is limited and of low quality. For many patients with chronic pain, analgesic efficacy is not maintained over long time periods. These opioids can be dangerous. With daily opioid use, physical dependence and tolerance can develop in days or weeks.

Critics of REMS warn that there's no mention of the drugs' risk of addiction or dependence in the REMS patient counseling document although about 25% of patients on long-term opioid therapy exhibit DSM criteria for addiction, according to Joseph Boscarino, PhD, MPH, of the Geisinger Clinic in Danville, Pa., who has published several studies on rates of addiction and dependence among these patients.

"People who are exposed to daily opioids for years have a great deal of [difficulty] getting off these drugs," Mark Sullivan, MD, PhD, professor of psychiatry at the University of Washington in Seattle, told MedPage Today. "Few successfully get off them."

Sullivan also noted that while the document warns about the risks of drinking alcohol while taking opioids, it fails to mention the risk of concomitant sedatives -- noting that benzodiazepines like Valium are especially deadly in combination with opiates. Both increase the risk of respiratory depression.

The REMS medication guide, distributed by pharmacists, offers advice similar to that of the patient counseling document -- don't share your pills, flush the excess down the toilet, don't tamper with your tablets, and get emergency help if you take too much -- without mention of risks of addiction or concomitant use of sedatives.

In 2012, a group led by 37 physicians, the Physicians for Responsible Opioid Prescribing, petitioned the Food and Drug Administration to no longer approve the use of opioid analgesics in patients with moderate noncancer pain.

The petition asked the FDA to change the label for instant-release and extended-release opioids by:

• Striking the term “moderate” from the indication for noncancer pain.
• Limiting the maximum daily dose to the morphine equivalent of 100 mg for noncancer pain.
• Limiting daily use for noncancer pain to 90 days.

“By implementing the label changes proposed in this petition, [the] FDA has an opportunity to reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids,” said the petition, signed by prominent specialists in pain medicine, addiction medicine, occupational health and public health.

Dr. Lewis Nelson, an emergency physician and medical toxicologist at NYU Langone Medical Center, explained that “It’s time to close the loophole on opioid labels,” which he says amounts to “a mechanism that allows drug companies to promote opioids for unproven uses.” Physicians are wrong to assume that “on-label” indications are evidence-based with regard to safety and efficacy.

Yet, he FDA chose not to take action on the petition, change the labeling as requested or appoint an advisory committee to examine the matter. The agency did not even respond to a request for comment by this article’s deadline.

* Second, the claim of “safe and effective in appropriately selected patients” cannot stand scrutiny. Despite the fact that prescription opioid overdose is now the second leading cause of accidental death in the United States, killing more people than heroin and cocaine combined, doctor prescriptions for opioids flow freely across America.

Recently, researchers from the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health, found that more than half of patients who received an opioid prescription in 2009 had filled another opioid prescription within the previous 30 days. This finding was based on an extensive research sample which included 79.5 million prescriptions dispensed in the United States during 2009 (almost 40 percent of all the opioid prescriptions filled nationwide).

Most prescriptions for opioids come from primary care providers (doctors, dentists, etc.). Instead of adhering to safety, many of these medical professionals routinely over-prescribe these drugs. From 1991 to 2009, prescriptions for opioid analgesics increased almost threefold, to over 200 million. And, according to the Drug Abuse Warning Network system, which monitors drug-related emergency department visits and drug-related deaths, emergency room visits related to the nonmedical use of pharmaceutical opioids has doubled between 2005 and 2009.

The U.S. Food and Drug Administration (FDA) has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for ER/LA opioid analgesics to ensure that * the benefits continue to outweigh the risks of adverse outcomes (addiction, unintentional overdose, and death) resulting from inappropriate prescribing, abuse, and misuse. A REMS is a strategy to manage a known or potential serious risk associated with a drug product.

* The truth is that opioids are responsible for a national painkiller epidemic. Benefits of prescribing opioids do not outweigh the risks of adverse outcomes. The problem of prescription drug abuse has become so severe that drug overdose deaths attributed to opioid pain medicines such as Vicodin or Oxycontin exceed overdose deaths from heroin and cocaine combined.

The Center for Disease Control reports that in 2008, 36,450 people died from drug overdoses in the United States, and 20,044 of those were due to prescription drug overdose. Opioid pain relievers were involved in 14,800 of those 20,044 deaths.

Drug Czar Gil Kerlikowske, director of the Office of National Drug Control Policy, admitted the prescription painkiller epidemic is responsible for about 15,600 deaths in 2009, the latest year for which there are data.

In the interest of public health and to minimize the burden on the healthcare delivery system from having multiple unique REMS programs, * pharmaceutical companies subject to this REMS have joined together to implement this REMS for all ER/LA opioid analgesic drug products.

* Industry-sponsored medical education cannot be trusted. The very pharmaceutical companies that manufacture opioids are in charge of funding and administering REMS programs. Pharmaceutical companies are actually using REMS for a marketing tool to convince consumers of their utmost concern for public safety as they continue to push for higher profits and higher distribution. Lobby groups boast of their ability to “craft” legislation with the FDA. Along with the financial lobbies, the pharmaceutical and health products industries have historically been one of the biggest and most powerful lobbies in Washington. Drug companies enjoy more power and influence in America than with any other government in the world.

Please understand that the FDA does no testing on new pharmaceutical products itself, but relies on the reports produced from the testing carried out by the drug manufacturers. In too many cases the drug manufacturers ignore or down play possible side effects in these reports in order to get permission to put their drug on the market

According to one observant source:

“Trying to select the most dishonest and disreputable United States government agency would be a daunting task indeed. But the Food and Drug Administration would have to be considered a strong contender for that dubious distinction. Allegedly created to make sure the foods we eat and the drugs we take are safe, the FDA long ago abandoned its mission in order to more effectively promote the interests of agribusiness and the pharmaceutical companies. While some – but not all – of the scientists who work for the organization are honest, the bureaucrats who make the final decisions at the FDA are mostly concerned with protecting the profit margins of the industries they are allegedly regulating.

“But remember, this is a quid pro quo relationship we are talking about here, and in return for their cooperation the FDA requires the drug companies, along with the manufacturers of medical devices, to pay what are referred to as “user fees.” Ostensibly, these fees are paid to cover the costs of the testing and review process that the FDA must undertake before allowing any new drug to enter the marketplace, but critics charge these payments are little more than a form of legalized bribery that all but guarantees a favorable response every time a pharmaceutical company submits a new product for review. Given how frequently pharmaceuticals granted FDA approval end up being recalled because of the high number of deaths and permanent injuries they cause, this view would appear to have some basis in fact.”

Neither should individuals with financial ties to the drug industry be approving drugs for public use nor should they be conducting REMS training. It should be important to all of us that the FDA find honest, independent scientists and researchers who work for the public, not the pharmaceutical industry.

RISK EVALUATION AND MITIGATION STRATEGY (REMS)

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks.

The FDA has required a REMS for extended-release and long-acting (ER/LA) opioid analgesics.

Under the conditions specified in this REMS, prescribers of ER/LA opioid analgesics are strongly encouraged to do all of the following:

* Train (Educate Yourself) - Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) for your discipline.

* Counsel Your Patients - Discuss the safe use, serious risks, storage, and disposal of ER/LA opioid analgesics with patients and/or their caregivers every time you prescribe these medicines.

* Emphasize Patient and Caregiver Understanding of the Medication Guide - Stress to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an ER/LA opioid is dispensed to them.

* Consider Using Other Tools - In addition to the PCD, there are other publicly available tools to improve patient, household and community safety, as well as compliance with conditions of treatment, including Patient-Prescriber Agreement (PPA) and risk assessment instruments.

* What do you believe the likelihood of prescribers of ER/LA opioid analgesics doing these things voluntarily would be? How often have you had these experiences with your doctors concerning prescriptions? Just take a minute to consider your past experiences.

• Your doctors take time in their busy schedules to educate themselves through intensive voluntary training
  
• Your doctors counsel you about the use, risks, storage, and disposal of the drugs “every time” they prescribe your medication
  
• Your doctors “emphasize” the importance of reading the medication guides for the medicines they prescribe
  
• Your doctors advise you about other “tools” of safety, compliance, and risk

I can honesty say “no” to all of these duties in the vast majority of my appointments with doctors. Many times my pharmacist has counseled and advised me about these safety measures, but the doctors seem to be far too busy to complete such duties they most likely feel are trivial or strictly my responsibility.

The FDA has developed core messages to be communicated to prescribers in the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics ("FDA Blueprint"), which will be used by Continuing Education (CE) providers to develop the REMS-compliant training programs.

These core messages include:

* Understand how to assess patients for treatment with ER/LA opioid analgesics.
* Be familiar with how to initiate therapy, modify dose, and discontinue use of ER/LA opioid analgesics.
* Be knowledgeable about how to manage ongoing therapy with ER/LA opioid analgesics.
* Know how to counsel patients and caregivers about the safe use of ER/LA opioid analgesics, including proper storage and disposal.
* Be familiar with general and product-specific drug information concerning ER/LA opioid analgesics.

 

* The core is ineffective as long as prescriber compliance is not mandatory. Andrew Kolodny, MD, chair of psychiatry at Maimonides Medical Center in New York City. noted that the final REMS is the same version that the advisory panel voted down 2 years ago, and called it a "jackpot for the medical education companies (MECs)." He said there are about five MECs that currently handle much of the industry-sponsored education for opioids.

"These educational programs are likely going to do more harm than good," Kolodny said. "Nowhere does it say that prescribers should tell patients these drugs are addictive. And these programs give the implied message that there's evidence for using opioids in long-term, noncancer chronic pain."

What top dogs supported mandatory training? The panel of experts including Dr. Margaret A. Hamburg, the F.D.A. commissioner, and R. Gil Kerlikowske, President Obama’s top drug policy adviser, said that mandatory training was essential

• To reduce the abuse of strong painkillers, or opioids, and
  
• To make sure that pain patients were treated appropriately with them.  

Go figure. I am outraged by the present FDA Required REMS Program for Serious Drug Risks. Please, I beg you. Go to the following site and sign the petition to change this program. It is a duty of our citizenship and a commitment to better health for generations to come.

PLEASE SIGN THE PETITION ON CHANGE.ORG. Click here to sign and feel free to include your comments. Thank you so much.


CLICK HERE TO SIGN: 
http://www.change.org/petitions/f-d-a-commissioner-margaret-a-hamburg-require-doctors-to-have-mandatory-training-to-prescribe-painkillers?utm_source=guides&utm_medium=email&utm_campaign=petition_created

No Pain for 30 Days: How About Another Bottle of Pills?

 

 

"Researchers from the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health, found that more than half of patients who received an opioid prescription in 2009 had filled another opioid prescription within the previous 30 days."

The extensive research sample included 79.5 million prescriptions dispensed in the United States during 2009, which represent almost 40 percent of all the opioid prescriptions filled nationwide.

This analysis comes on the heels of a nearly 20 year increase in the use of prescription painkillers. From 1991 to 2009, prescriptions for opioid analgesics increased almost threefold, to over 200 million. According to the Drug Abuse Warning Network system, which monitors drug-related emergency department visits and drug-related deaths, emergency room visits related to the nonmedical use of pharmaceutical opioids has doubled between 2005 and 2009.

What Else Did This Extensive Study Find? 

* Leftover pills in family medicine cabinets increase opportunities for abuse, as well as a host of serious medical consequences, including addiction.

* Most abusers report getting these medications from friends and relatives who had been prescribed opioids, or they (the abusers) are abusing their own medications.

* Nearly 12 percent of opioids prescribed were to young people aged
10-29. Most of these were hydrocodone- and oxycodone-containing products, like Vicodin and Oxycontin.

* Dentists were the main prescribers for youth aged 10-19 years old.

* Nearly 46 percent of opioid prescriptions were given to patients between ages 40 and 59, and most of those were from primary care providers.

("Analysis of Opioid Prescription Practices Finds Areas of Concern," National Institutes

of Health News, The U.S. Department of Health and Human Services, April 5 2011)

According to the Centers for Disease Control and Prevention, prescription opioid overdose is now the second leading cause of accidental death in the United States, killing more people than heroin and cocaine combined. They also state that this is compelling evidence for the need to develop smart strategies to curtail abuse of opioid analgesics, without jeopardizing pain treatment.

NIDA Director Nora D. Volkow, M.D. says, "As a nation, it is important that we all become better informed about effective pain management and the risks of abusing prescription painkillers."

My Take

Volkow says "we all" must be better informed. The definition of "all" obviously includes practicing doctors who have received little formal training in pain management. Everyone is aware of the problems created by pill mills and rogue doctors who illegally prescribe opioids. Yet, we must also understand that all doctors in good standing should be required to take mandatory training before allowing them to prescribe opioids.

As they prescribe opiates, most dentists and primary care providers may not intentionally contribute to the staggering numbers of those lost to drug abuse, but, more than anyone else, they must be fully educated concerning the dangers of these substances and extremely sensitive to proper management of them. In short, we, the public, and the FDA must insist on mandatory training immediately. And, for evident reasons, the training cannot be funded and provided by Big Pharma or anyone else with possible bias. 

In America, we have too many medical professionals who are pulling their pained patients into a deadly fire as they continue to over-prescribe painkillers:

* Some of them are guilty of being greedy criminals who could care less about who swallows what medication;

* Some of them are guilty of being careless, inefficient managers of potentially harmful pain relief; and

* Some of them are ignorant, mindless accessories to all the horrors of drug addiction.  

"There is both overprescribing and underprescribing," says Director Volkow, who notes that, for instance, many dentists give opioids like Percoset too freely to teenagers after surgical procedures; in contrast, "you have individuals with very severe pain who are not given opioids or who are given doses that are [too low to treat the pain], and that in and of itself can put them at risk."

I hope you can understand in this Prescription Nation why we must insist that all of our medical professionals who write prescriptions for pain relief be sent back to the classroom -- a classroom manned by unbiased instructors armed with new, independent, research-based materials.

Myths and Facts About Chronic Opioid Therapy (COT)

In a letter to the editor of the New England Journal of Medicine, Jane Ballantyne, M.D. and Mark Sullivan, M.D. of the University of Washington Medicine in Seattle, Washington, reply to a previous article by Lembke:

 

"Lembke asks why doctors prescribe opioids

when 'fully aware that their patients are abusing

these medications or diverting them.'

(Anna Lembke, M.D. "Why Doctors Prescribe Opioids to Known Opioid Abusers."

N Engl J Med 2012; 367:1580-1581. October 25 2012)

 

"One answer is that once a commitment to long-term pain treatment with opioids has been made, it is not at all easy to stop. Does a patient's pain that once justified a commitment to opioids diminish in significance because aberrant behaviors come to light?

 

"Modern societies, to their credit, do pay attention to pain. It is not possible to verify a patient's report of pain, but it is possible to select the appropriate therapy. Evidence increasingly suggests that gains from long-term opioid therapy are small and may not justify the risk. The problem facing the United States now is how to change the culture into one that recognizes pain without conflating pain relief with opioid therapy. The treatment of pain with any number of approaches other than opioids can be held up as compassionate care. But most of them require more time than writing a prescription, and time is, as Lembke points out, 'medicine's least valued commodity.'”

 

(Jane C. Ballantyne, M.D. and Mark D. Sullivan, M.D., Ph.D. "Why Doctors Prescribe

Opioids to Known Opioid Abusers." N Engl J Med 2013; 368:484-485. January 31 2013)

In commenting about the editorial, Anna Lembke, M.D. of Stanford University School of Medicine, Stanford, California, points out the following:

"Physicians don't hesitate to switch antibiotics

when the first one isn't working, or stop chemotherapy

when side effects outweigh benefits. Why should it be

different for the treatment of pain with opioids?

Cessation of opioids in the context of addiction

 is not reneging on a “commitment” to treat pain

but recognizing and targeting the long-term pain

 caused by addiction. It is also compassionate care."

"Furthermore, as the authors point out, opioids are not a very effective treatment for chronic pain that is not related to cancer. Effective treatments for chronic pain syndromes involve behavioral interventions in combination with somatic therapies. Both addictive disorders and chronic pain syndromes are long-lasting conditions that require and deserve the best treatments we have to offer; one should not be sacrificed for the other."

 

Myths and Facts about Chronic Opioid

Therapy (COT) 

The following information is found in the "Myths and Facts Brochure for Cautious, Evidence-based, Opioid Prescribing" written by the Physicians For Responsible Opioid Prescribing.


Here is a link to their website: http://prescriptionopioidreform.com/Home_Page.html

Myth: COT for chronic pain is supported by strong  evidence.

 

Fact: Evidence of long-term efficacy for chronic non-cancer pain (≥16 weeks) is limited, (1,2,3) and of low quality. (4,5) Opioids are effective for short-term pain management. But, for many patients with chronic pain, analgesic efficacy is not maintained over long time periods. (6)

Myth: Physical dependence only happens with high doses over long periods of time.

Fact: With daily opioid use, physical dependence and tolerance can develop in days or weeks. (7,8)

Myth: Patients who develop physical dependence on opioids can easily be tapered off.

Fact: Successfully tapering chronic pain patients from opioids can be difficult – even for patients who are motivated to discontinue opioid use. (33)

Myth: Addiction is rare in patients receiving medically prescribed COT.

Fact: Estimates vary. Between 4% and 26% of patients receiving COT have an opioid use disorder. (9-12) Among patients without an opioid use disorder, more than one in ten misuse opioids by: intentional over-sedation; concurrently using alcohol for pain relief; hoarding medications; increasing dose on their own; and borrowing opioids from friends. (9,15)

Myth: Addiction is the main risk to be concerned about when prescribing opioids.

Fact: Opioids have significant risks besides addiction and misuse. (18,19) These risks include respiratory depression and unintentional overdose; (20,21) serious fractures from falls; (22,23) hypogonadism and other endocrine effects that can cause a spectrum of adverse effects; (24) increased pain sensitivity, (25) sleep-disordered breathing, (26) chronic constipation and serious fecal impaction, (27,28) and chronic dry mouth which can lead to tooth decay. (29)

Myth: Extended-release opioids are better than short-acting opioids for managing chronic pain.

Fact: Extended-release opioids have not been proto be safer or more effective than short-acting opioids for managing chronic pain. (30)

Myth: Prescribing high-dose opioid therapy (>120 mg morphine equivalents/day) is supported by strong evidence that benefits outweigh risks.

Fact: No randomized trials show long-term effectiveness of high opioid doses for chronic non-cancer pain. Many patients on high doses continue to have substantial pain and related dysfunction. (32) Higher doses come with increased risks for adverse events and side effects including overdose, fractures, hormonal changes, and increased pain sensitivity. (18-26)

Myth: Opioid overdoses only occur among drug abusers and patients who attempt suicide.

Fact: Patients using prescription opioids are at risk of unintentional overdose and death. (20) This risk increases with dose and when opioids are combined with other CNS depressants like benzodiazepines and alcohol. (21)

Myth: Dose escalation is the best response when patients experience decreased pain control.

Fact: When treating chronic pain, dose escalation has not been proven to reduce pain or increase function, but it can increase risks. (32)

 

Sources
 

1. Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain. 2004;112:372-80.

2. Papaleontiou M, Henderson CR, Turner BJ, Moore AA, Olkhovskaya Y, Amanfo L, Reid MC. Outcomes associated with opioid use in the treatment of chronic noncancer pain in older adults:

A systematic review and meta-analysis. JAGS 2010; 58:1353-1369.

3. Martell BA, O’Connor PG, Kerns RD, Becker WC, Morales KH, Kosten TR, et al. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction.

Ann Intern Med. 2007;146:116-27.

4. Chou R, Fanciullo GJ, Fine PG, Adler JA, Ballantyne JC, Davies P, Donovan MI, Fishbain DA, Foley KM, Fudin J, Gilson AM, Kelter A, Mauskop A, O’Connor PG, Passik SD, Pasternak GW, Portenoy RK, Rich BA,

Roberts RG, Todd KH, Miaskowski C; American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain.

J Pain 2009; 10:113-130.

5. American Geriatrics Society Panel on the Pharmacological Management of Persistent Pain in Older Persons. Pharmacological Management of Persistent Pain in Older Persons. JAGS 2009; 57:1331–1346, 2009.

6. Ballantyne JC, Shin NS. Efficacy of opioids for chronic pain: a review of the evidence. Clin J Pain 2008;24:469-78.

7. McQuay H. Opioids in pain management. Lancet 1999, 353: 2229-2232.

8. Baily CP and Connor M. Opioids: Cellular mechanisms of tolerance and physical dependence. Current Opinion in Pharmacology 2005; 5:60-80.

9. Fleming MF, Balousek SL, Klessig CL, Mundt MP, Brown DD. Substance Use Disorders in a Primary Care Sample Receiving Daily Opioid Therapy. J Pain 2007; 8:573-582. Banta-Green CJ, Merrill JO, Doyle SR,

Boudreau DM, Calsyn DA. Measurement of opioid problems among chronic pain patients in a general medical population. Drug and Alcohol Dependence 2009; 104:43-49. Becker WC, Fiellin DA, Gallagher RM,

Barth KS, Ross JT, Oslin DW. The association between chronic pain and prescription drug abuse in Veterans. Pain Medicine 2009; 10:531-536.

10. Banta-Green CJ, Merrill JO, Doyle SR, Boudreau DM, Calsyn DA. Measurement of opioid problems among chronic pain patients in a general medical population. Drug and Alcohol Dependence 2009; 104:43-49.

11. Becker WC, Fiellin DA, Gallagher RM, Barth KS, Ross JT, Oslin DW. The association between chronic pain and prescription drug abuse in Veterans. Pain Medicine 2009; 10:531-536.

12. Boscarino JA, Rutstalis M, Hoffman SN, Han JJ, Erlich PM, Gerhard GS, Stewart WF. Risk factors for drug dependence among out-patients on opioid therapy in a large US health-care system.

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Contributors

Physicians/Scientists:

Andrew Kolodny, MD
Gary Franklin, MD, MPH
Stephen Gelfand, MD
Petros Levounis, MD, MA
Rosemary Orr, MD

External Reviewers:

Jane Ballantyne, MD
Roger Chou, MD
Mark Edlund, MD, PhD
Richard A. Deyo, MD, MPH
Thomas Kosten, MD

Patient/Family Advocates:

Peter Jackson
Len Paulozzi, MD, MPH Betts Tully
Jon Streltzer, MD
Art Van Zee, MD
Michael Von Korff, ScD
Mark Sullivan, MD, PhD
Judith Turner, PhD


For additional information, please contact Physicians for Responsible Opiod Prescribing: Andrew Kolodny, MD, akolodny@maimonidesmed.org or Michael Von Korff, ScD, vonkorff.m@ghc.org

Mandatory Opioid Training For Doctors: Sign the Petition

 

 

 

"'The propriety of having the pharmaceutical industry develop unbiased

education for prescribers and patients is debatable,' wrote Lewis Nelson, MD,

and Jeanmarie Perrone, MD, in an opinion column published in the

Journal of the American Medical Association.

 

"'Although such education for prescribers will be offered through ostensibly independent continuing medical education providers, the expectation

of the FDA that this will be funded by the pharmaceutical industry

raises several concerns, including financial motivations

and creative risk/benefit messaging.'”

What Do We Have Now?

The FDA’s risk evaluation and mitigation strategy (REMS) allowed the following:

* Voluntary training courses for doctors precribing extended release opioids.

* 20 drug makers funding these training courses and creating non-promotional medical guides for patients on extended release opioids.

An FDA advisory committee recommended mandatory training for opioids, expressing concern that not enough doctors would volunteer their time; however, the FDA overruled the advisory board, saying mandatory training would be “potentially burdensome.”

"Burdensome" to whom? Possibly, the booming business of morticians.

The problem of prescription drug abuse has become so severe that drug overdose deaths attributed to opioid pain medicines such as Vicodin or Oxycontin exceed overdose deaths from heroin and cocaine combined. In 2008, 36,450 people died from drug overdoses in the United States, and 20,044 of those were due to prescription drug overdose. Opioid pain relievers were involved in 14,800 of those 20,044 deaths. (Center for Disease Control, 2011)

 

The FDA’s goal under the voluntary program is to have 60 percent of the nation’s doctors who prescribe opioids take the courses within three years. And, oh, by the way, the FDA has already mandated training for health care providers and patients about the use of fentanyl, another type of painkiller. Can anyone else see the inconsistency here?

"Three years" with a "goal of 60 percent"? How can the FDA, in the name of a merciful God, allow three more years of spiraling death and deformity due to rx drug abuse pass as a hopeful 60 percent of doctors complete their voluntary opioid courses? If this is an example of a typical goal set by the FDA, we should be able to see now how many of their measures are grossly ineffective.

I'm not making this up. In the midst of the biggest man-made health epidemic in history, truth is much, much stranger than fiction. Let me fill you in a little more:

* There is a significant lack of pain curriculum in medical schools.

* The voluntary training will not cover powerful short-acting opioids such as hydrocodone (Vicodin) that have an equally high potential for abuse.

* Several non-profit medical organizations -- like the American Pain Society -- have already been offering educational seminars on pain management. They call this "an outstanding educational program that industry has no control over whatsoever." (Quote from Roger B. Fillingim, PhD, president of the American Pain Society)

* Purdue Pharma’s has already established an online training course for physicians under REMS. The training program for doctors covers safe prescribing methods for OxyContin, its widely prescribed and abused painkiller. The program ends with a short quiz, but physicians are not graded on their answers and are not required to demonstrate competency before being certified that they took the program. Incidentally, the Purdue website notes that “completion of the questions does not affect your ability to prescribe OxyContin.”

* And, these courses provided by those organizations are expected to play a key role in the FDA’s training program for physicians.

I know for certain that I am IN PAIN reading about the FDA training plan. At this point, it is the duty of the American public to act by petitioning the FDA to instill mandatory training for doctors prescribing opioids; training that is not funded or conducted by pharmaceutical companies. I am making this petition available to all.

Please take a minute to sign the online petition and include any comments you deem necessary. The site is included at the bottom of this blog entry. Please, click on it to sign today. Quick and easy.

I'll leave you with a couple of quotes about the FDA training from Kristina Fiore's MedPage Today report:

"'These educational programs are likely going to do more harm than good,'" said Andrew Kolodny, MD, chair of psychiatry at Maimonides Medical Center in New York City. 'Nowhere does it say that prescribers should tell patients these drugs are addictive. And these programs give the implied message that there's evidence for using opioids in long-term, noncancer chronic pain.'
 
"Kolodny noted that the final REMS is the same version that the advisory panel voted down 2 years ago, and called it a 'jackpot for the medical education companies (MECs).' He said there are about five MECs that currently handle much of the industry-sponsored education for opioids.
 
"Instead, Kolodny said, a better option is mandatory education that's either tied to DEA licensure or has a certification process similar to that for buprenorphine (Suboxone), an opiate and addiction treatment that requires completing an 8-hour class before physicians can prescribe it."

(Kristina Fiore, "FDA Finalizes Opioid Education Plan, MedPage Today, July 9 2012)

 
The American News Report Article: http://americannewsreport.com/15222-8815222

Please Click This Address to Sign the Petition:

http://www.change.org/petitions/f-d-a-commissioner-margaret-a-hamburg-require-doctors-to-have-mandatory-training-to-prescribe-painkillers