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.  

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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.

Robert Evans’ Trip Home

Jan Evans, CPA

My husband Dave’s parents, Robert and Lydia, are exceptional people. They were born in 1920 and 1921, and grew up in untraditional households in Oklahoma. Both of Dave’s grandfathers were killed at young ages in work-related accidents, and his mother’s mother died young in childbirth. Bob and Lydia were high school and college sweethearts. They married on Bob’s graduation day from the Naval Midshipmen’s School in New York City before he went overseas during World War II.  

After returning from his service, they lived in Great Bend, Kansas, before moving to Lawrence in the mid-1970s as his engineering business was expanding. They were very happily married for more than 71 years. I have known them for 33 years, and been their daughter-in-law for 30 of them.  They have always been accomplished, strong, resilient and wonderful people: well-read, interested in world and local events, ready for travel and adventure. 

Ahead of His Time

They definitely were planners and always had a direction moving forward in life. And their first priority was always love of family. Consideration for their family was so great that, before many people ever heard of advance care planning, they made sure that their children knew what their wishes were regarding medical treatment at the end of their lives. Years ago, they talked to us about their wishes so that we would know what they wanted (and didn’t want) and so they could be confident that we would be able to fulfill those wishes.

Last summer, my father-in-law died peacefully at age 94 surrounded by his beloved family on August 22 at his home in Lawrence, Kansas. He wanted to die at home, not in a hospital. However, his final illness progressed very quickly, and it appeared that he would not be able to return home as he wanted. Once again, even in a much-weakened state, he demonstrated his strength as a person. After a day or so in the hospital, the end was inevitable, but he held on, determined to be strong enough to make the trip back home where he would be comfortable in a hospital bed with family around, listening to the music he loved, the Royals games and the conversations of many visitors. It was truly a remarkable end-of-life journey for a very remarkable man.  

Tribute Tour

But it didn’t end there. Bob’s family always knew the places and people that were most important to him. He was very interested in his family history, and he passed that interest on to his children. A few weeks after his death in mid-October, his wife, children and their spouses took his ashes on a journey to important places in his life as a tribute to him and so we could all say good-bye. 

We traveled to Great Bend, Kansas, where he had established his business over 50 years ago, raised his children, participated in civic activities, and was active in his church. We also traveled to Oklahoma – stopping in Oklahoma City at the cemetery where his family is buried. His children offered various tributes to him, like hitting golf balls sprinkled with his ashes into the stream where his family had enjoyed many afternoons of summer picnics. He was moving forward again. 

It gave the entire family a sense of calmness and peace to know exactly what he wanted at the end of his life. We were able to spend our time together then and on our trip celebrating his remarkable life.  

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Jan Evans, CPA joined the Center for Practical Bioethics in 2011 as Fund Accountant.