In March 2016, the FDA requested the National Academies of Science, Engineering, and Medicine (NASEM) provide a [report] on the current state of science regarding prescription opioid abuse and misuse, and its use in acute and chronic pain management.
Similar to the 2016 CDC Opioid Prescription Guidelines, the National Pain Strategy (NPS), and the very recent publication of the Joint Commission's Pain Assessment and Management Standards, the FDA Blueprint recommends the first line approach to manage acute and chronic pain to be non-pharmacological therapies.
Contrary to their message, the ten-page document contains one paragraph pertaining to non-pharmacological therapies, listing them as follows:
- Psychological approaches — e.g., cognitive behavioral therapy
- Physical rehabilitative approaches – e.g., physical therapy, occupational therapy
- Surgical approaches
- Complementary therapies — e.g., acupuncture, chiropracty
What immediately struck me was their use of the antiquated term "chiropracty," which speaks volumes about those who comprised their "expert" panel. The other obvious shortcoming was that 97 percent of the document (I counted the words) was devoted to recommending the use of non-opioid pain medications (with a paltry 3 percent addressing non-pharmacological approaches).
The Integrative Health Policy Consortium1 (IHPC), Acupuncture Now Foundation2 (ANF), and the American Society of Acupuncturists (ASA) responded to the FDA request for comments.3 I took lead on IHPC's response, with a task force of interested members of the Integrative Approaches to Pain and Addiction Committee.
The task force was comprised of Dr. Steve Welsh (former President of the International Chiropractors Association), Dr. Dan Asimus (Psychiatrist specializing in pain and addiction), and John Weeks (Journalist and founder/editor of the Integrator Blog and News Reports; www.theintegratorblog.com).
Our organizations' responses were different, but complementary, and we coordinated throughout the whole process for that specific purpose. The National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM), an IHPC partner for Health member, supported the IHPC response and independently sent out a media advisory, "FDA Proposes Doctors Should Learn About Acupuncture for Pain Management." Certified acupuncture practitioners are available to discuss the benefits of acupuncture for pain management about the new FDA guidelines and how to contact an NCCAOM nationally board certified diplomate.
IHPC supported the FDA in their elevation of non-pharmacological and complementary / integrative approaches to pain management, but recommended they offer specific guidance to practitioners regarding their education related to acupuncture, chiropractic, massage therapy, naturopathy, homeopathy, holistic nursing, music therapy, nutritional counseling, midwifery, tai chi, yoga and mindfulness meditation.
We suggested the FDA recommend that Federally Qualified Health Centers (FQHC), the Indian Health Services, and other federally supported healthcare entities staff these healthcare professionals and instructors. Finally, we offered three pages of specific additions to their document fleshing out the section dedicated to non-pharmacological approaches.
The concluding statement was, "The FDA Pain Management Blueprint offers a critical step forward in our country's battle with pain and opioid addiction in addition to the CDC Opioid Prescription Guidelines, the National Pain Strategy, and the American College of Physician's Low Back Pain Clinical Practice Guideline.
Educating HCPs on non-pharmacological options for their patients is paramount, and following the Department of Veterans Affairs lead on patient-centered pain care will reduce opioid prescriptions and needless loss of life."
The ANF also credited the FDA for their inclusion of the following statement: [Health care professionals] should be knowledgeable about the range of available therapies, when they may be helpful, and when they should be used as part of a multi-disciplinary approach to pain management.
The response letter agreed with the FDA "encouraging HCPs to advise their patients about the potential benefits of non-pharmacological therapies including complementary therapies such as acupuncture," and offered to provide information regarding acupuncture and its potential as a pain management resource.
Attached to the letter was a comprehensive 35-page white paper written by Matthew Bauer, LAc and John McDonald, PhD referencing 54 studies relating to various pain syndromes, the mechanism of acupuncture in pain management, cost effectiveness, ethics, safety and workforce issues.
The ASA began their response with the clear statement, "… we wish to advocate for clear direction to prescribers for consideration of acupuncture as a first-line, non-pharmacologic treatment method in all patients presenting with pain syndromes."
Similar to the ANF response, they took the scientific approach, referencing the recently published Acupuncture Evidence Project,4 which offers a high quality comparative literature review on the effectiveness of acupuncture on a variety of health conditions.
The letter offered nicely summarized tables of safety and cost effectiveness, and specific suggestions to embellish areas of the Blueprint to be more inclusive of non-pharmacological approaches such as acupuncture.
The conclusion was,"Our best hope in battling the opioid crisis is to decrease the use of opioids in the first place, and to minimize their use wherever else possible. The unequivocal inclusion of recommendations for evidence based, non-opioid pain control options is paramount to any success for our national strategy."
Pain Policy and AOM
Our nation's pain policy position reflected in guidelines from Federal and non-governmental agencies is one of recommending non-pharmacological approaches as the first line management of acute and chronic pain, offering exceptional opportunities to the AOM community.
In 2014, the Joint Commission (responsible for accrediting and certifying nearly 21,000 health care organizations and hospitals in the U.S.) revised their pain standard including acupuncture as one of the recommended non-pharmacological approaches, however they didn't hold hospitals accountable. In July 2017, the Joint Commission released another update mandating the use of non-pharmacological approaches in hospitals. Days later, the NCCAOM issued a press release.
To further promote the hiring of acupuncturists to provide acupuncture in the hospital setting, NCCAOM developed the Credentialing of Acupuncturists for Hospital-Based Practice: A Resource Guide for NCCAOM Diplomates.5 In addition, NCCAOM sponsored the Academic Collaborative for Integrative Health's Credentialing Licensed Acupuncture and Oriental Medicine Professionals for Practice in Healthcare Organizations.
The first paper outlines how acupuncturists can become credentialed and gain hospital privileging, (as "licensed independent practitioners," and the second publication shows how the hospital systems can employ acupuncturists.
U.S. pain policy is providing exciting avenues for acupuncturists to be employed in the VA system, hospitals and FQHCs.
The opioid crisis has taken the lives of more than 24,000 Americans in the past year alone. The good news is we can be part of the solution. As we all know, the Chinese character for "crisis" or weiji, is composed of the radical danger plus "incipient moment" or crucial point. This is the crucial point for our profession to tip the scales and step into the public spotlight as a viable solution to our opioid epidemic.
References
- Wisenski LA, et al. "Integrative Health Policy Consortium Response to FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain." IHPC, 2017.
- Bauer M, McDonald J. "Acupuncture in Pain Management." ANF, 2017.
- Miller D. "Draft Revisions to FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids; Request for Comments." ASA, 2017.
- McDonald J, Janz S. "The Acupuncture Evidence Project: A Comparative Literature Review." AACMA, 2017.
- National Certification Commission for Acupuncture and Oriental Medicine. "Diplomate Benefits." NCCAOM, 2017.
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