Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics—Exploring the Path Forward; Public Workshop; Request for Comments
https://www.regulations.gov/document?D=FDA-2017-N-1094-0001
https://www.regulations.gov/comment?D=FDA-2017-N-1094-0001
Summary
As part of the work by the Federal Government to address the epidemic of prescription and illicit opioid abuse, the Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop to obtain input on issues and challenges associated with Federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids (safe use of opioids) for health care providers. As discussed in this document, the workshop has three main goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. Finally, participants will be asked about the issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids.
Participants are expected to include individuals from a broad set of Federal, State, and private stakeholder groups that are working on the challenges of improving pain management while addressing the opioid abuse epidemic. The Federal Agencies participating include FDA, the Drug Enforcement Administration, the Department of Veterans Affairs, the Centers for Disease Control and Prevention, the Department of Defense, the Centers for Medicare & Medicaid Services, the National Institute on Drug Abuse, and the Substance Abuse and Mental Health Services Administration, and the Indian Health Service. Public participation and comment are encouraged.
Filed under: General Problems
Chronic pain patients should be the ones discussing what has worked or not. Just the fact that we were not warned, protected, and kept in the loop of what happened to our medications during the former administration is the first example. “the shortages”, and the “return” being mislabeled, [heavy metals], inauthentic, and incurring unnecessary medical visits directly related to the medication impostors.
The ugly non-treatment for chronic illness; triggering unnecessary pain, ptsd, allergic and poisonous side-effects from medications which were covertly altered, reduced of active ingredient by 40%,; all planned and executed with back-room deals made-to pharmacists, doctors, and insurance companies.
All of my many heath and stability issues I have now, which have resulted in increased dissed-ability, are directly a result of secret practices discussed by “healthy” people w/o any concern for us.
The CDC, FDA, and the countless ignorant people making decisions on situations they no nothing about is disgusting.
I want to be included in ALL decisions which affect every part of my life.
We are not robots, or cookie-cutter clones. The FDA, CDC, and political special interests have killed, traumatized, and created more diseases than ever before.
There is something VERY WRONG with the countless “ADHD”meds I”ve tried and returned, as-well as the “Oxycodones” Why ARE THESE NOT STANDARDIZED ???? There are more humane and safe ways to determine patient adherence.
I’m not up-to anymore secret experimentation; I was doing great before the REFORM and covert havoc on my mind, body, and sense of trust. If I have co-occurring diagnoses and I was healthier on the Genuine and generic Oxycodone, Dextroamphetamine Sulphate, and Ambien, so be it !!!! I was volunteering, incorporating additional Holistic practices into my life, such as taking a BREATHING COURSE THAT MEDICARE PAID FOR, [I didn’t need my Asthma Inhaler for 7 years until recently], MEDITATION, SPIRITUAL WORKSHOPS.
Now, I’ve been in bed for almost 2 years, with the previous years spent trying to find my original 12 year generic ADHD med, and almost dying from an Oxycodone, [KVK], dealing with countless placeboes where the drug companies outright LIED, [saying it is me, and My chemistry] I am now sick with heavy metals from fraudulently labeled medications; big pharma is getting obscenely rich from fraudulent and toxic fakes at the expense of those of us who are poor and have these diagnoses, and in- which the original medications were life-health saving.
These are outrageous crimes which no politician, advocate, non-profit admits -to [on record]. But the same corrupt organizations, politicians, “experts” are the “behind closed doors chosen ones to represent US”
The truth about how we are affected in all ways can only be determined by us-individually. We need notification of meetings that CONCERN US AND WHAT MEDICATIONS HELP US. No-one else can address these questions, complaints, criticisms and everything-else involved, as each of our mind, body, medical, medication, and situational experiences, are unique to us and ONLY US.
Why aren’t we involved ? Why weren’t we informed of drastic changes to the ingredients ? Who benefits when we suffer and become more disabled ? How is it possible that a democratically elected president be allowed to violate the constitutional oath and “erase” the most basic human rights of the most vulnerable of us, and the International Geneva convention, and get away with it ???
Are Americans, [in the know], that blind-sided as to believe that it’s okay to “disappear” the rights of other Americans in-which ANYONE could become apart of ??? becoming sick, disabled, injured, in need of human medications for which their disabilities, [ability to be able] require ??
I entered the following comment via the Federal Register gateway for such input:
Before the US government can train physicians on safe prescription practices for opioids, it must first withdraw and rewrite the March 2016 guidelines for prescription of opioids in chronic pain. It is widely understood by practicing pain management professionals that these guidelines were developed by a working group which was unduly influenced by financially self-interested anti-opioid organizations. The resulting guidelines made sweeping recommendations on the basis of weak medical evidence or unsupported opinion. Literature review was cherry-picked to support forgone conclusions, violating the most fundamental standards of science research. The result has been to drive doctors out of pain management practice in droves, directly injuring and deserting tens of thousands of chronic pain patients. Suicides from under-treatment of pain have already occurred and many more will occur if this atrocity is not corrected.
As a non-physician internet author, research analyst and patient advocate, I have communicated with thousands of chronic pain patients, family members, and doctors through more than 20 years. My experience and that of others more authoritative is distilled in a recent and very pertinent publication at the National Pain Report. The article has been picked up by Pain Week with strong support for its conclusions. “How Would Prescription Opioid Guidelines Read if Pain Patients Wrote Them?”
Pain Week chose to introduce this article in the following terms, in it’s April 11, 2017 edition:
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What if Prescribing Guidelines Were Patient Centered?
Rethinking Public Policy for Better Patient Outcomes and Expanding CDC Guidelines
An article posted earlier this week in the National Pain Report offers a comprehensive but succinct perspective on what public policy on opioid prescribing might look like if written from the point of view of pain patients themselves. Richard Lawhern, PhD, a nonphysician researcher and advocate for patients with chronic pain has compiled a “summary of principles” for the practice of pain management encompassing not only the role of opioids, but many other aspects of patient centered care as well. Members of the PAINWeek community will recognize many of Dr. Lawhern’s observations from the diverse topics explored each year in the PAINWeek Conference curriculum. As Lawhern asserts, “There should be no distinction in principle between the objectives of treating pain which is acute, chronic, or associated with advanced medical conditions assessed to be terminal. The objectives in all three cases are to alleviate suffering, promote patient functioning, and improve quality of life.”
“It is now clear that CDC Guidelines must soon be withdrawn for a major rewrite,” Lawhern contends. “Especially important in any rewriting process must be the inclusion of stakeholder voices that were largely unheard in the first writing of the Guidelines.” With respect to public policy on opioid prescribing, the context of the public health crisis of addiction and overdose death is ever present. But, Lawhern notes, the most reliable risk factors associated with addiction include adolescent status, history of family trauma, and long term unemployment, and “None of these factors is addressed by restriction of opioids prescribed to patients in pain.” Going beyond opioid therapy, Lawhern also suggests a context for nonopioid and nonpharmacologic modalities, and points to the need for rescheduling of marijuana to address the dearth of medical research on efficacy for pain.
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Also pertinent is an article which I authored for The Journal of Medicine, published by the National College Of Physicians: “The CDC’s Fictitious Opioid Epidemic.”
This article has drawn supporting comments from multiple practicing physicians.
Your organization is seeking to develop “safe prescribing education” on the basis of an unsafe and largely unsupported scientific FRAUD! It is time to stop the US Government’s war against chronic pain patients.
I can make myself available to testify before the FDA working group either in person or by webinar.