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.

"Just the facts, Ma'am, Just the Facts

(Jack Webb - main character, in TV series FBI, 1950's)

Myra Christopher
President and CEO
Center for Practical Bioethics

Good ethics start with good facts. The fact is: today doctors have medications and techniques to treat pain effectively. Nevertheless, many doctors do not.

One of the major reasons physicians give to explain this discrepancy is their fear of legal and regulatory oversight associated with prescribing "controlled substances" which are critical to effectively treat patients with chronic and terminal pain. This phenomenon is referred to as the "chilling effect."

A study conducted by the Center for Practical Bioethics, Federation of State Medical Boards (FSMB) and National Association of Attorneys General (NAAG) was published this week (9/09) in Pain Medicine, the journal of the American Academy of Pain Medicine. According to the best available data and records, only about one in 1,000 practicing physicians was sanctioned or tried for improperly prescribing pain medications from 1998 to 2006.

This research and that of others also indicates that there are a handful of cases where physicians have been treated unfairly. Charges have been brought and dropped; physicians have been found not guilty, or verdicts have been overturned on appeal.

It is critical that law enforcement, regulatory agencies and the medical community work collaboratively to see that all Americans receive treatment for pain when needed, that investigations of physicians alleged to have mishandled prescription drugs are efficient and fair, and that in those rare instances when physicians have engaged in criminal behavior they are denied the privilege of practicing medicine.

On September 22, the Center, FSMB and NAAG will convene a roundtable in Washington, DC to discuss these critical issues.

Good ethics do indeed start with good facts. It is our hope that this study will help responsible physicians place their locus of concern on treating pain in an informed and effective manner, not on the very small risk that they might do something that could subject them to scrutiny.

Links:

News Release, Few physicians actually tried or sanctioned for improperly prescribing pain medications, September 9

Legal risk for prescribing painkillers is small, study says, American Medical News, September 8

Treating Doctors as Drug Dealers: The DEA’s War on Prescription Painkillers, Ronald T. Libby, Cato Institute, June 16, 2005

Balanced Pain Policy Initiative

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