Tuesday, 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.  

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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.

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3 Comments:

Blogger Dave Kline said...

If the massive effort to restrict access to vital pain medication were redirected instead to finding how to remove the addictive component of opioids the problem would be solved.

Wednesday, March 16, 2016  
Blogger Jay Caron said...

Reason pain meds work are we have particular dendrytes in the brain......that fit like a hand when opiods are introduced. Having these established brain connectors, clearly show why opiods work. As far as releiving addictive qualities.....everytime they matrix or redesign a med they kill its usefullness. And to commit to the 1/60th rule with Fentynal is purely insane and sad. I traded 13000 mgs for 10 mg dispersed over 3 days. Under any logic.....do the math. Its obvious they don't care about the individual or take anything from except support....its funny but the only other dendrytes we have the pair with a pharmokinetic is for medical marijuana. We have the wiring already set in the brain....
Why the arguement and now forced direction which will lead to as many suicides as opiate deaths from diversion gives us only we're gonna have to pull a trigger amidst the agony that was releived for 15+ years

Monday, April 04, 2016  
Blogger joyrn said...

I am a 48 year old RN, who has Osteonecrosis since March 2013 I have had 3 joint replacement and a revision of 1 of those. Both Shoulders and a Knee. My orthopedic doctor has told me the question of if I will need hips and the other knee is irrelevant the pertinent question is when I need them. The disease is a result of use of corticosteroids for asthma. Until this recommendation we have worked together on pain control, I use heat, ice topical creams nsaids and have had a couple steroid injections and yes he prescribed narcotics. He has made a decision to no longer assist in chronic pain mgmt. As a provider I understand his position, as a patient I feel I am being forced to make very difficult life altering and potentially threatening changes because of the irresponsible behavior of others. I also have a clotting disorder and have had a tracheoplasty, so surgery is not taken lightly. Joint replacement surgery is difficult and not a sure thing. My issues are well documented, I have never abused opiods, followed scripts to the letter and now I am left searching for a doctor who will help me live with the pain, which is described by health professionals as being similar to bone cancer...ironically according to the CDC I would be able to obtain opiods much easier if in fact I did have bone cancer. Cancer has impacted many of those close to me, and I support caring for the pain associated with it, but there are many diseases such as Osteonecrosis that are not commonly talked about, that don't have huge media presence. What makes patients with other ailments less worthy of proper pain control. My story is not as unique as the cdc would like the public to believe. Patients with adequate pain control don't make headlines, we make dinner and take care of our families, we live with our diseases and take each day as it comes. I happen to be a newlywed, married for the first time in October, the impact of uncontrolled pain on my wedded bliss well its too early to tell as I have not had this challenge in the two years we have been together. It is common knowledge that caregivers do grow tired of hearing I am hurting, my husband swears he will never leave me, but I have 26 years of Nursing experience that tells me even the most dedicated loving spouse will reach a point when they wonder what they have gotten themselves into. I know the issues opiods have caused many families, I have a sibling with substance abuse problems . I believe the CDC is motivated by people tired of reading headlines of suburban teenagers overdosing, but to make it impossible for people to use 21st century medicine to make their lives better and more productive can NOT be the best option. There has to be a middle ground to address those of us not wanting to make headlines we just want to walk down the street with our families, sleep more than 2-3 hours, and have more days when pain isn't the deciding factor in what one can do or not do.

Tuesday, April 12, 2016  

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