FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids
2017-313
2017-07-10 2017-07-11 2017-07-14 2017-07-11 2017-06-28 2017-05-15 2017-05-15 2017-05-22 2017-05-22 2017-07-10
FDA-2017-D-2497-0293 FDA-2017-D-2497-0445 FDA-2017-D-2497-0672 FDA-2017-D-2497-0364 FDA-2017-D-2497-0256 FDA-2017-D-2497-0025 FDA-2017-D-2497-0026 FDA-2017-D-2497-0051 FDA-2017-D-2497-0052 FDA-2017-D-2497-0291
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https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0293 https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0445 https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0672 https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0364 https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0256 https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0025 https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0026 https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0051 https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0052 https://api.regulations.gov/v4/comments/FDA-2017-D-2497-0291
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HiDear Sir and MadomI am a acupuncturist work in Virginia. acupuncture is works. I help many patient out pain or chronic pain with acupuncture. They wrote the story for me before. I put it in attachment as follow, may help you make the decision Please see uploaded file with comments A recent clinical trial comparing acupuncture to IV morphine in the Emergency Department* showed acupuncture providing comparable pain relief, with a faster onset time and fewer minor adverse events (4 versus 85).  A large meta-analysis** definitively established acupunctures efficacy over and above placebo for chronic pain -- while also showing that even the sham acupuncture (placebo) procedures used for these trials themselves had a clinical effect size of 0.33, comparable to that of NSAIDS but without their side effects (which kill over 10,000 patients per year in the United States).  Many well-meaning and otherwise expert physicians are simply not aware that acupuncture is a highly effective nonpharmaceutical alternative to opioids for acute as well as chronic pain, with an excellent safety profile.*Grissa, M. H., Baccouche, H., Boubaker, H., Beltaief, K., Bzeouich, N., Fredj, N., ...  Nouira, S. (2016). Acupuncture vs intravenous morphine in the management of acute pain in the ED. The American journal of emergency medicine, 34(11), 2112-2116.**Vickers, A. J., Cronin, A. M., Maschino, A. C., Lewith, G., MacPherson, H., Foster, N. E., ...  Acupuncture Trialists Collaboration. (2012). Acupuncture for chronic pain: individual patient data meta-analysis. Archives of internal medicine, 172(19), 1444-1453. I respectfully request that you keep the revisions or even reduce the pressure on doctors, patients, and pharmacies. Chronic pain patients have been suffering for far too long and need relief from the FDA, CDC, and DEA. Since 2010, prescriptions for opioid medications have decreased substantially. In 2015-2016 the CDC issued Opioid Prescribing Guidelines with the intention of helping doctors who have chronic pain patients, on dosing amounts. However since then they are being used as a de facto law by the DEA and other state and federal agencies. The DEA is putting pressure on doctors and pharmacies to reduce or eliminate patients from getting the opioid medications we desperately need. What this is doing is creating more pain since there are no good alternatives or when there are, insurance companies are not paying for them. Please help to ease the burden on us chronic pain patients and doctors.  With the growing opioid crisis it is imperative that prescribers are familiar with referring to alternative therapists for their patients. Acupuncture has long been used to manage pain and offers a safe, effective, addiction free alternative to opioids.  I have a concern regarding the draft revisions to the Food and Drug Administration Blueprint for Prescriber Education for ER/LA Opioids. In the draft, acupuncture is referenced as a complementary therapy for managing acute and chronic pain, however, there is no strong evidence that acupuncture is effective in treating pain. Acupuncture has proved to be no more effective than placebo in the well-controlled and large randomized clinical trials to date.The FDA must continue to protect American consumers from dangerous and/or inefficacious medical interventions. While the opioid epidemic is unfortunately negatively impacting many citizens of our country and abroad, it is important that fraudulent medical practices which claim to treat pain are not allowed to flourish. There are science-based non-pharmacological interventions that are capable of reducing pain in certain patient populations.  Physical therapy and exercise have been shown through large trials to be effective in alleviating many forms of lower back pain, and science- and evidence-based physicians and practitioners are already using and should continue to be encouraged to recommend these interventions and others which have a strong and unbiased evidence base. Researchers, physicians, health practitioners, and patients must work together in order to find and implement more strategies to treat pain. This must occur concomitantly with the removal of interventions which have been shown to be ineffective, such as acupuncture. More studies are not needed for acupuncture because the existing literature and trials focusing on acupuncture have shown the intervention to be no more than placebo.Research must be done on the interventions which show promise in treating pain. This research should be science-based and designed rigorously in order to show clinical utility and benefit above that of placebos.  The FDA cannot condone, let alone encourage, unproven modalities such as chiropractic and acupuncture. Especially in the latter case where it has been shown over and over not to work for anything. Its a pre-scientific superstition, not medicine.It is unethical and immoral for a medical care professional to even offer these quack services. The FDA would be doing a tremendous disservice by encouraging that doctors learn about using them.All doctors need to know is that these are worthless and potentially dangerous shams.Mountains of evidence about this are available at the following links:https://sciencebasedmedicine.org/category/acupuncture/https://sciencebasedmedicine.org/category/chiropractic/ I received acupuncture treatment throuout my pregnancy. It helped managr the nausea, stress and fatigue I was experiencing. This allowed me to work comfortably and longer into my pregnancy. Otgereise I would have had to take more sick days. As a mental health health professional, I oppose this draft vehemently.  There is NO scientific evidence to support chiropractic and acupuncture interventions for chronic pain. This seems a step backwards. Now more than ever, we have evidence that there is no indication for opioids for pain beyond 3 months. Use without upper limits on dose in non-malignant pain is also missing. The curriculum doesnt mention the inappropriateness of using opioids for fiber-myalgia, non-specific musculoskeletal pain, and chronic headaches. Just stick to the CDC guidelines. Why would you not stick to the CDC guidelines, especially for the upper limits. PROP gave you good advice. Please change this.