Tag: opioids

Blog Posts (7)

February 3, 2017

Ethics & Society Newsfeed: February 3, 2017

  Politics Betsy DeVos’s ethics review raises further questions for Democrats and watchdogs Betsy DeVos, Trump’s nominee to lead the Education Department, promised to divest from more than 100 entities to avoid potential conflicts of interest with her new job. Questions left unanswered. Donald Trump warned over ‘unprecedented’ plan to appoint cabinet without ethics office … More Ethics & Society Newsfeed: February 3, 2017
November 28, 2016

Fordham RETI Fellow Discusses Addiction with U.S. Surgeon General on NPR

Earlier this month, the United States Surgeon General issued a report declaring substance use disorders, like addiction, the “most pressing public health crises of our time.” The report called the country to action to both help those struggling with the chronic illness of addiction and change how addiction in the U.S. is perceived as a “criminal justice problem” rather than … More Fordham RETI Fellow Discusses Addiction with U.S. Surgeon General on NPR
November 11, 2016

Ethics & Society Newsfeed: November 11, 2016

President-Elect Trump and Ethics Trump and Pence on science, in their own words Donald Trump and Mike Pence’s career and campaign track record of false claims about science, rejection of research conclusions and dangerous rhetoric on misconceptions such as vaccines and autism … Continue reading
September 30, 2016

Ethics & Society Newsfeed: September 30, 2016

Technology and Ethics Tech Giants Team Up To Tackle The Ethics Of Artificial Intelligence The Partnership on Artificial Intelligence to Benefit People and Society, consisting of Amazon, Facebook, Google, Microsoft and IBM (with Apple in talks to join), weighs in on the … Continue reading
April 8, 2016

Ethics & Society Newsfeed: April 8, 2016

Can we trust robots to make moral decisions? Last week, Microsoft inadvertently revealed the difficulty of creating moral robots. Why Bioethics Has a Race Problem Moral imagination in bioethics has largely failed African Americans. The disturbing reason some African American … Continue reading
December 15, 2015

PROPOSED CDC GUIDELINES FOR OPIOID PRESCRIBING COULD UNINTENDEDLY MAKE THE BURDEN OF CHRONIC PAIN GREATER FOR MILLIONS OF AMERICANS

Myra Christopher
Several months ago the Centers for Disease Control (CDC) announced that it was their plan to develop guidelines for opioid prescribing. Since then there has been much speculation and concern about this initiative among those advocating for a comprehensive chronic pain management approach. In mid-September a draft of the guidelines was posted on the Pain News Network’s website.  http://www.painnewsnetwork.org/stories/2015/9/16/cdc-opioids-not-preferred-treatment-for-chronic-pain

For more than a decade, the Center for Practical Bioethics has focused significant resources on the under-treatment of chronic pain in the United States. Two of us, Dr. Richard Payne (the John B. Francis Chair) and I had the privilege of serving on the Institute of Medicine’s (IOM) committee that in 2011 published Relieving Pain in America, which reported that 100 million Americans live with chronic pain and approximately a third of them live with “high impact chronic pain,” i.e., pain that is disabling. That same year the Center convened a group of leaders from more than two dozen national organizations for the purpose of advancing the 16 recommendations made in the IOM report. The Pain Action Alliance to Implement a National Strategy (PAINS) emerged from those discussions.  

PAINS is focused on driving the “cultural transformation in the way pain is perceived, judged and treated” called for in the IOM report, and over the 4 ½ years that it has existed, we have:
  1. advocated for a national population health strategy focused on pain, 
  2. encouraged those living with chronic pain and their family members to become engaged and speak out, and
  3. attempted to provide objective, well-researched information to policy decision makers about chronic pain as a disease. 


When the CDC guidelines were published, PAINS quickly reached out to Dr. Deborah Houry, Director of the Injury Prevention Center where they were developed. We indicated that PAINS could be supportive of most of the guideline content but expressed our concern about the process undertaken by the CDC, including what we perceived as lack transparency and input from those living with chronic pain. Rather than pointing out our specific concerns about dosage limits, three-day prescriptions, no mention of abuse-deterrent formulations, co-prescribing naloxone, and understanding regarding those stable and well-managed with opioid therapy, we did two things:

  1. We expressed our interest in being of help and asked for a meeting, and
  2. We offered a set of Principles for Evaluating Clinical Guidelines, including Guidelines for Opioid Prescribing. 


The following is our statement of principles:

Principles for Evaluating Clinical Guidelines, Including for Opioid Prescribing:   
All those in the healing professions are ethically obligated to treat pain to the fullest extent of their capacity and to refer patients to others when their patients’ needs exceed their capacity. This does NOT mean that those in the healing professions are obligated to prescribe opioids to all pain patients. 
Complex chronic diseases, e.g., chronic pain, require comprehensive, individualized bio-psychosocial approaches which may or may not include prescription medications, interventions, surgeries, physical therapy, nutrition counseling, complementary therapies, and/or behavioral health.    

Treatments that are “meaningful and appropriate” can only be discerned via shared decision making, i.e., by incorporating the patient’s goals and values with clinical knowledge. Therefore, a provider/ patient relationship based on trust and realistic expectations is essential to a positive therapeutic outcome.
In every treatment plan, consideration of adding any medical therapy (pharmacological or otherwise) should always include a risk benefit analysis, and only therapies for which, in the judgment of the physician, potential benefits outweigh risks should be incorporated into a plan of care.

In most instances, treatments with the least potential for harm should precede those with greater risks. Therefore, less invasive procedures should be tried first, and medication dosages should begin small and be titrated under the close supervision of the healthcare provider. 

When implementing treatment with known potential risks, the inherent ambiguity of human medicine calls for caution and ongoing monitoring by the healthcare professional who has prescribed or ordered the therapy. When outside entities require screenings and tests, it is essential that financial burdens imposed by those mandates are NOT placed on the provider or the patient.

Although never intended, iatrogenic harm/injuries do occur; in those situations, patients are owed an explanation, apology, assistance in remedying or ameliorating the problem and a new plan of care. Iatrogenic harm does not necessarily imply negligence or maleficence.  

                                                                 # # # # # # # # # #

Last week, six members of the PAINS Steering Committee went to Atlanta to meet with Dr. Houry and her team. The meeting was convivial but frank and straightforward. All those in the meeting agreed that there is significant common ground between those advocating for better pain care and those working to reduce opioid addiction and what the CDC has labeled “unintended deaths” associated with misuse of opioids. 

It is PAINS’s view that both addiction and chronic pain are serious illnesses and that both patient populations are deserving of respect, compassion and comprehensive care. Furthermore, we believe that “pitting” these patient groups against one another, for whatever reason, is inherently wrong and that a “harm-reduction approach” is necessary to mitigate both sets of public health problems, i.e., 100 million Americans living with chronic pain and an estimated 16,000 unintended deaths associated with opioid abuse/misuse.

The PAINS team assured leaders at CDC that with broader input into the guidelines, including that of chronic pain patients, and appropriate revisions, PAINS stands ready to assist the CDC in their process.  Without that, however, we will not be able to support the guidelines. PAINS is eager to work with CDC on other issues identified as common concerns, e.g., suicidal ideation among those living with chronic pain and the lack of reimbursement for comprehensive care for those who struggle to live with chronic pain and opioid addiction or both. We left Atlanta “cautiously optimistic” that CDC had heard our concerns.  

BREAKING NEWS
YOUR ATTENTION REQUESTED


CDC’s draft Guideline for Prescribing Opioids for Chronic Pain, 2016 were posted on Monday, December 14, 2015 at www.Regulations.gov for review and comment. The public comment period opened then and closes January 13, 2016. Please submit all comments and feedback at www.Regulations.gov. Enter the docket number (CDC-2015-0112) to access the docket. Here is the link to today’s Federal Register Notice (FRN): https://www.federalregister.gov/articles/2015/12/14/2015-31375/guideline-for-prescribing-opioids-for-chronic-pain

CDC will also convene the National Center for Injury Prevention and Control’s Board of Scientific Counselors (BSC), a federal advisory committee, to review the draft guideline. At a public conference call on January 7, 2016, CDC will ask the BSC to appoint a workgroup to review the draft guideline and comments received on the guideline, and present recommendations about the guideline to the BSC.

We encourage all those involved with the Center for Practical Bioethics, whether involved in our PAINS initiative or not, to review the revised guidelines and provide feedback to the CDC.  


Myra Christopher is the Kathleen M. Foley Chair in Pain and Palliative Care at the Center for Practical Bioethics and the Director of PAINS.
December 15, 2015

PROPOSED CDC GUIDELINES FOR OPIOID PRESCRIBING COULD UNINTENDEDLY MAKE THE BURDEN OF CHRONIC PAIN GREATER FOR MILLIONS OF AMERICANS

Myra Christopher
Several months ago the Centers for Disease Control (CDC) announced that it was their plan to develop guidelines for opioid prescribing. Since then there has been much speculation and concern about this initiative among those advocating for a comprehensive chronic pain management approach. In mid-September a draft of the guidelines was posted on the Pain News Network’s website.  http://www.painnewsnetwork.org/stories/2015/9/16/cdc-opioids-not-preferred-treatment-for-chronic-pain

For more than a decade, the Center for Practical Bioethics has focused significant resources on the under-treatment of chronic pain in the United States. Two of us, Dr. Richard Payne (the John B. Francis Chair) and I had the privilege of serving on the Institute of Medicine’s (IOM) committee that in 2011 published Relieving Pain in America, which reported that 100 million Americans live with chronic pain and approximately a third of them live with “high impact chronic pain,” i.e., pain that is disabling. That same year the Center convened a group of leaders from more than two dozen national organizations for the purpose of advancing the 16 recommendations made in the IOM report. The Pain Action Alliance to Implement a National Strategy (PAINS) emerged from those discussions.  

PAINS is focused on driving the “cultural transformation in the way pain is perceived, judged and treated” called for in the IOM report, and over the 4 ½ years that it has existed, we have:
  1. advocated for a national population health strategy focused on pain, 
  2. encouraged those living with chronic pain and their family members to become engaged and speak out, and
  3. attempted to provide objective, well-researched information to policy decision makers about chronic pain as a disease. 


When the CDC guidelines were published, PAINS quickly reached out to Dr. Deborah Houry, Director of the Injury Prevention Center where they were developed. We indicated that PAINS could be supportive of most of the guideline content but expressed our concern about the process undertaken by the CDC, including what we perceived as lack transparency and input from those living with chronic pain. Rather than pointing out our specific concerns about dosage limits, three-day prescriptions, no mention of abuse-deterrent formulations, co-prescribing naloxone, and understanding regarding those stable and well-managed with opioid therapy, we did two things:

  1. We expressed our interest in being of help and asked for a meeting, and
  2. We offered a set of Principles for Evaluating Clinical Guidelines, including Guidelines for Opioid Prescribing. 


The following is our statement of principles:

Principles for Evaluating Clinical Guidelines, Including for Opioid Prescribing:   
All those in the healing professions are ethically obligated to treat pain to the fullest extent of their capacity and to refer patients to others when their patients’ needs exceed their capacity. This does NOT mean that those in the healing professions are obligated to prescribe opioids to all pain patients. 
Complex chronic diseases, e.g., chronic pain, require comprehensive, individualized bio-psychosocial approaches which may or may not include prescription medications, interventions, surgeries, physical therapy, nutrition counseling, complementary therapies, and/or behavioral health.    

Treatments that are “meaningful and appropriate” can only be discerned via shared decision making, i.e., by incorporating the patient’s goals and values with clinical knowledge. Therefore, a provider/ patient relationship based on trust and realistic expectations is essential to a positive therapeutic outcome.
In every treatment plan, consideration of adding any medical therapy (pharmacological or otherwise) should always include a risk benefit analysis, and only therapies for which, in the judgment of the physician, potential benefits outweigh risks should be incorporated into a plan of care.

In most instances, treatments with the least potential for harm should precede those with greater risks. Therefore, less invasive procedures should be tried first, and medication dosages should begin small and be titrated under the close supervision of the healthcare provider. 

When implementing treatment with known potential risks, the inherent ambiguity of human medicine calls for caution and ongoing monitoring by the healthcare professional who has prescribed or ordered the therapy. When outside entities require screenings and tests, it is essential that financial burdens imposed by those mandates are NOT placed on the provider or the patient.

Although never intended, iatrogenic harm/injuries do occur; in those situations, patients are owed an explanation, apology, assistance in remedying or ameliorating the problem and a new plan of care. Iatrogenic harm does not necessarily imply negligence or maleficence.  

                                                                 # # # # # # # # # #

Last week, six members of the PAINS Steering Committee went to Atlanta to meet with Dr. Houry and her team. The meeting was convivial but frank and straightforward. All those in the meeting agreed that there is significant common ground between those advocating for better pain care and those working to reduce opioid addiction and what the CDC has labeled “unintended deaths” associated with misuse of opioids. 

It is PAINS’s view that both addiction and chronic pain are serious illnesses and that both patient populations are deserving of respect, compassion and comprehensive care. Furthermore, we believe that “pitting” these patient groups against one another, for whatever reason, is inherently wrong and that a “harm-reduction approach” is necessary to mitigate both sets of public health problems, i.e., 100 million Americans living with chronic pain and an estimated 16,000 unintended deaths associated with opioid abuse/misuse.

The PAINS team assured leaders at CDC that with broader input into the guidelines, including that of chronic pain patients, and appropriate revisions, PAINS stands ready to assist the CDC in their process.  Without that, however, we will not be able to support the guidelines. PAINS is eager to work with CDC on other issues identified as common concerns, e.g., suicidal ideation among those living with chronic pain and the lack of reimbursement for comprehensive care for those who struggle to live with chronic pain and opioid addiction or both. We left Atlanta “cautiously optimistic” that CDC had heard our concerns.  

BREAKING NEWS
YOUR ATTENTION REQUESTED


CDC’s draft Guideline for Prescribing Opioids for Chronic Pain, 2016 were posted on Monday, December 14, 2015 at www.Regulations.gov for review and comment. The public comment period opened then and closes January 13, 2016. Please submit all comments and feedback at www.Regulations.gov. Enter the docket number (CDC-2015-0112) to access the docket. Here is the link to today’s Federal Register Notice (FRN): https://www.federalregister.gov/articles/2015/12/14/2015-31375/guideline-for-prescribing-opioids-for-chronic-pain

CDC will also convene the National Center for Injury Prevention and Control’s Board of Scientific Counselors (BSC), a federal advisory committee, to review the draft guideline. At a public conference call on January 7, 2016, CDC will ask the BSC to appoint a workgroup to review the draft guideline and comments received on the guideline, and present recommendations about the guideline to the BSC.

We encourage all those involved with the Center for Practical Bioethics, whether involved in our PAINS initiative or not, to review the revised guidelines and provide feedback to the CDC.  


Myra Christopher is the Kathleen M. Foley Chair in Pain and Palliative Care at the Center for Practical Bioethics and the Director of PAINS.

News (2)

May 9, 2012 10:15 am

Senate Inquiry Into Painkiller Makers’ Ties (New York Times)

Two senior senators said on Tuesday that they had opened an investigation into financial ties between producers of prescription painkillers and pain experts, patient advocacy groups and organizations that set guidelines on how doctors use the drugs.

May 8, 2012 10:23 am

One in eight teens misuses prescription painkillers (Chicago Tribune)

Both medical and recreational use of such opioid drugs has increased across the United States over the past couple of decades, as have deaths due to painkiller overdoses. The Centers for Disease Control and Prevention estimate that 14,800 Americans died of an opioid overdose in 2008 — three times the number of overdose deaths 20 years earlier.