A core recommendation of the 2011 IOM Report: Relieving Pain in America is: “The Secretary of the Department of Health and Human Services should develop a comprehensive, population health-level strategy for pain prevention, treatment, management, education, reimbursement, and research that includes specific goals, actions, time frames, and resources.” The IOM report highlighted specific objectives for the strategy:

  • Describe how efforts across government agencies, including public– private partnerships, can be established, coordinated, and integrated to encourage population-focused research, education, communication, and community-wide approaches that can help reduce pain and its consequences and remediate disparities in the experience of pain among subgroups of Americans.
    • Include an agenda for developing physiological, clinical, behavioral, psychological, outcomes, and health services research and appropriate links across these domains.
    • Improve pain assessment and management programs within the service delivery and financing programs of the federal government.
  • Proceed in cooperation with the Interagency Pain Research Coordinating Committee and the National Institutes of Health’s Pain Consortium and reach out to private-sector participants as appropriate.
  • Involve the appropriate agencies and entities.
  • Include ongoing efforts to enhance public awareness about the nature of chronic pain and the role of self-care in its management.

National Pain Strategy is the culmination of more than a decade of bipartisan work for the National Pain Care Act sponsored by Senator Orrin J. Hatch (R-UT).  The National Pain Strategy would advance chronic pain as a public health issue in the United States. Your voice matters in getting the National Pain Strategy implemented and funded by the Department of Health and Human Services, which is under the auspices of the White House.  Learn how you can make a difference here.

For additional detailed information on the NPS, please visit: http://iprcc.nih.gov/National_Pain_Strategy/NPS_Main.htm

 

April 18, 2016  


Drug Safety and Risk Management Advisory Committee
Anesthetic and Analgesic Drug Products Advisory Committee
U.S. Food and Drug Administration
% Stephanie L. Begansky
10903 New Hampshire Avenue WO31-2417
Silver Spring, MD 20993-0002

Sent via http://www.regulations.gov

RE:  Docket FDA-2016-N-0820

Dear Committee Member,


Thank you for your service to the U.S. Food and Drug Administration in an advisory capacity.  America is depending on you to balance the two issues of pain and addiction in your recommendations to them.


Why are we being forced to look at pain and addiction as a major crossroads in our nation?  Why are they not parallel roads?  Opioid medications exist because pain exists:  If there were more and better treatments for pain, there would be less need for opioid medications.  The major reason people seek healthcare is because of pain – they need pain relief to work, parent, contribute to society and maintain a quality of life worth living.


Who should have been at the helm of the research ship guiding our nation towards scientific discoveries about pain over the last two decades?  Congress designated 2000-2010 as the decade of pain with the goal of addressing this major national problem.  Recognizing the impending catastrophe, The National Pain Care Policy Act was introduced annually in Congressional sessions beginning in 2003.  Provisions from the National Pain Care Policy Act 2009 were incorporated into the Health Care Reform Bill (which resulted in the Affordable Care Act), but a pain research agenda was not advanced!


Pain care advocates stayed the course and continued their efforts to raise the importance of pain research with Congress, resulting in the June 2011 IOM Report, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.  The report recognized that 100 million American adults have life-altering, chronic pain.  However, despite the stark fact that opioid prescribing for pain was increasing, until pressured to do so, the Department of Health and Human Services chose not to engage with the IOM Report and its strong recommendations until  late in 2013.  DHHS called upon the Interagency Pain Research Coordinating Committee, a Federal advisory committee created from the Patient Protection and Affordable Care Act, to develop a National Pain Strategy (http://www.iprcc.nih.gov/National_Pain_Strategy/NPS_Main.htm).  The prompt action by the IPRCC culminated in a National Pain Strategy (NPS) that was delivered to DHHS in September 2014.  The NPS was released for 48-days of public comment in April 2015 following several public and Congressional requests.  The final NPS was released in March 2016, several days after the CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016.  After the public comment period closed, several significant changes to the NPS were made by DHHS which are supportive of the CDC Guidelines.   


To date, there still is no Federal agency, department, nor champion in DHHS who is responsible for implementing the National Pain Strategy.  There is no Congressional funding specifically for the National Pain Strategy nor major research.  What is wrong with this unbalanced picture?  Who can justify the promulgation of “unintentional policy/recommendation/laws/legislation consequences” to chronic pain patients of increased suffering, suicidal ideation, and consumption of alcohol and street drugs, etc. for pain relief?  The lack of leadership and responsibility by America’s trusted Federal health agencies and elected officials to implement a National Pain Strategy is mystifying and morally wrong.


Of major importance to pain patients and advocates is the elephant in the room:  Pain still exists.  It doesn’t disappear when accessibility to opioid medications is decreased.  One-third of America is (un)intentionally being harmed, marginalized, and de-moralized.  When laws, acts, policies, and recommendations are put into place restricting opioid pain treatments without offering effective alternative options, they are tatamount to legalizing torture.  People with serious pain are the reason opioid medications exist in the first place!  The appalling lack of concern by our elected and appointed Federal officials for the people with chronic pain is increasing their suffering and stigmatization, not to mention their diminishing livelihoods, quality of life, and health.  


Balance.  It’s a pretty simple proposition. To address the two sides of the same coin of pain and opioid addiction, implementing and funding the National Pain Strategy on par with opioid addiction efforts only makes sense.  The root problem, pain, must be addressed.  Just like a thorn deep in the flesh, it will continue to fester and affect the whole body, which is to say American society.


It is a disgrace that our nation’s most important resources are not protected:  hard working American citizens like you and I who are made vulnerable to the tentacles of inappropriately treated pain by the dearth of accessible, appropriate pain relief treatments and prevention.  Addictions occur to several substances:  tobacco, alcohol, and psychotropic drugs, and opioids.  All of these substances, except tobacco, are used to relieve pain.  Chronic pain is a disease.  Addiction is a disease.     

Being dependent on an opioid medication is villainized while dependence on thyroid medication is considered mainstream.  It is morally wrong to encourage stigmatizations about patients who are dependent on a strong pain medication as somehow being weak or inferior for needing these strong medications to relieve serious pain.  Dependence is not addiction.


Health insurance companies are for-profit entities.  No incentive exists for them to improve the coverage they provide for pain treatments.  While new opioid formularies are touted to be more effective, they often are not available due to tiered co-pays or unmet high deductibles.  From a patient perspective they are not safer than current opioid medications unless they are an abuse deterrent formulation.  Medical doctors infrequently guide pain patients to integrative treatment arrangements mostly because health insurance doesn’t cover those services.  Supportive chiropractic care compared to physical therapy, for example, has little coverage, and has become a health service for wealthier citizens.  With too few nonpharmacological tools to help their patients, physicians often turn to pain medications.   


Patients are consumers and purchasers of healthcare services.  All patients should be treated with respect and dignity.  Any changes to REMS or other documents and programs that are created should reflect that.  The current REMS Patient Counseling Document does not contain enough information for the patient to recall the many conversational points with the prescribing physician.  In the current REMS Patient Counseling Document, please incorporate the following:

  • “Talk to your healthcare provider: If the dose you are taking does not control your pain” to read:  “… if the medication you are taking does not control your pain.”
  • Opioid medications are part of an integrative treatment plan that includes physical activity, pain management goal setting, coaching, nutrition, prevention and education programs, and symptom tracking to understand causes of breakthrough pain or causal factors of increased pain.
  • Periodic evaluations of pain relief, pain control, functional goals for therapy, functional outcomes, side-effect frequency and intensity, and health-related quality of life will occur.  Use an app or a notebook to track your progress.  This will help you and your doctor have more productive medical visits.
  • How to properly dispose of unused opioids, and medications in general, should include where (i.e., toilet, drug take back locations).

A patient education training covering all REMS elements should be required for all patients receiving an opioid medication.   


All opioids should be an abuse deterrent formulation, even methadone.   


Study using a personalized medicine approach (i.e., genetic testing by PROOVE).  If more precise prescribing by matching patients with the right medication and dosages results in better pain relief and management, this could lead to a requirement that all patients have a genetic test before receiving an opioid so a prescriber knows the potential effectiveness before prescribing.


Physicians should be encouraged to prescribe opioids as part of an integrative treatment plan and not as a stand-alone intervention.


Thank you, again, for your time and service on these weighty issues.  We are depending on you to balance the two issues of pain and addiction in your recommendations.   


Sincerely yours,  


Jan Favero Chambers, President and Founder
National Fibromyalgia & Chronic Pain Association

On March 18, 2016, the National Pain Strategy was released.  The National Fibromyalgia & Chronic Pain Association is very concerned that the NPS was not funded nor assigned to a federal agency.  Please join us in advocacy efforts to implement the NPS by becoming a member of Allies Against Pain to receive specific calls to action. Join the Allies here. To read the NPS, please click here.

The U.S. government’s first coordinated plan is a roadmap to achieve a system of care in which all people receive appropriate, high quality and evidence-based care for pain.  These efforts will build on the current work underway at HHS to equip providers with the tools and information they need to make informed patient-centered treatment decisions that include safer and appropriate opioid prescribing.

The goals of the National Pain Strategy can be achieved through a broad effort in which better pain care is provided, along with safer prescribing practices, such as those recommended in the recently released  CDC Guideline for Prescribing Opioids for Chronic Pain. 

Click here for the National Pain Strategy.

Click here for the CDC Guidelines.

 

Jan Favero Chambers 5-minute Public Comments May 4, 2016 in Silver Spring, MD, White Oaks Campus May 3-4, 2016: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Re:  REMS


My name is Jan Chambers. I am the president and founder of the National Fibromyalgia & Chronic Pain Association. I have no relevant relationships to declare. Thank you for your service and the opportunity to make public comment.


Pain is a disease with neuroplasticity that increases over time if not treated. Undertreated and unmanaged pain has clinical, psychological and social consequences, including limitations in life activities, lost work productivity, reduced quality of life and stigmatization.  Families become care providers and relationships get burned out.


Chronic pain affects 100 million American adults.  Our organization conducted a 2015 survey of chronic pain patients with 6420 responders and was published in Pain Medicine of the American Academy of Pain Medicine in December 2015.  This survey was the only snapshot captured of the “unintended consequences” to people with chronic pain 100 days after the rescheduling of hydrocodone from Schedule III to II. We are now conducting the second part of that survey one year after rescheduling.


I’ll give you some statistics from that report since the rescheduling:

  • 1462 (27.2%) reported having thoughts of suicide
  • Of those who could no longer get hydrocodone, 
    • 1067 (18.1%) borrowed pain medications
    • 1007 (17.1%) turned to marijuana
    • 773 (13.1%) used alcohol
    • 135 (2%) used illicit drugs
  • Most (64.2%) respondents had to visit their healthcare providers more often
  • 1735 (30.3%) reported some type of issue interacting with their pharmacy
  • Most (88.3%) felt that the rescheduling was neither a fair nor appropriate solution to the abuse of hydrocodone
  • For those still working, 801 (46.2%) reported that they had missed work because of the stricter regulations

The FDA REMS Blueprint should include screening for mental disorders and suicidality.


Recent policies and legislation are focusing only on prescription opioids in the big picture of drug addiction and overdose. Street heroin and illegal fentanyl patches need to be accounted for in the war on drugs.


Abuse deterrent formulation on all opioids, including methadone paid for by Medicaid, are necessary.  The FDA must help in this important strategic approach to get serious about preventing opioid-naïve young people from trying them.


Please make recommendations that stop villainizing and torturing people with chronic pain.  Just like other medical conditions, they need medical care and access to pain medicine in integrative treatments.


Thank you for your time and attention.

What is PCORI? and Why should we care about it?

PCORI is the Patient Centered Research Institute created by the Affordable Care Act.

“Unfortunately, traditional medical research, for all of the remarkable advances in care it produces, hasn’t been able to answer many of the questions that patients and their clinicians face daily. And even when reliable information does exist, it’s not always available to patients, or those who care for them, in ways they can understand or use most effectively.

PCORI was established to help address these challenges. Our job is to close the gaps in evidence needed to improve key health outcomes. To do this, we identify critical research questions, fund patient-centered comparative clinical effectiveness research, or CER, and disseminate the results in ways that the end-users of our work will find useful and valuable.” (www.pcori.org)

So, PCORI funds research with patients in mind. What do patients want? What do patients want studied? PCORI also looks to patients to be involved in research in a number of ways. PCORI looks for patient involvement in developing research questions, providing feedback to the research team during the study, helping to recruit people to participate in the study, and working with the research team to disseminate the results to patients.

Your National Fibromyalgia & Chronic Pain Association President, staff, and volunteers have been invited to participate in many PCORI activities, including a round table that examined questions patients want studied about opioids and chronic pain – from our perspective as chronic pain patients. Researchers have approached us to work with them to help provide the patient’s voice in pain related research.

Why is this important to us as people who live in pain?

PCORI listens to patients. Therefore can influence what researchers will research. As people who live with chronic pain, we all have an opportunity to have researchers research prevention and interventions that will help find what works to cure or lessen our pain. And we will be informed of the results of that research and how it can help our pain.

How can I help?

As a fibromyalgia and/or chronic pain patient, you can get more involved in PCORI’s work. You can go to PCORI’s website and suggest a research question you would like studied. You can volunteer to become a patient reviewer of grant proposals. Patient reviewers look at how the proposals incorporate patient engagement. You can attend a PCORI webinar. You can get on PCORI mailing lists so you can stay informed and get involved in new opportunities as they arise. You can find the website at www.pcori.org

Page 1 of 3
EV SSL