Chiropractic Micro-Nutrient Therapy

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1 I. Background / History Chiropractic Micro-Nutrient Therapy In Idaho, since the inception of the chiropractic practice act in 1919, chiropractic physicians have been treating patients with all forms of vitamins, minerals and herbal therapies in the regular course of their practice. Clinical nutritional methods are taught in all chiropractic schools and in post-graduate programs. Some chiropractic universities include full functional medicine and human nutrition components to their chiropractic doctoral programs. In 1998, the FDA worked with Congress to pass the Food and Drug Modernization Act of 1997 (FDAMA), which amended the current language to require, at a minimum, that before dispensing, the labels of prescription drug products contain the symbol statement Rx only instead of the Caution: law prohibits dispensing without prescription. (See section 126 of FDAMA.) o o o This change also initiated adjustment in the labeling of certain vitamins and minerals, which brought about scrutiny of labeling and sales of certain types of injectable vitamins and minerals. The Idaho Board s Pharmacy and Chiropractic began being contacted by many national compounding pharmacies regarding whether chiropractors could utilize injectable forms of vitamins and minerals. In response, the State Board of Chiropractic approved and the Idaho legislature consented to Chiropractic Rule 020, which stated: 020. Clinical nutritional methods as referenced in Section , Idaho Code, include, but are not limited to the clinical use, administration, recommendation, compounding, prescribing, selling, and distributing vitamins, minerals, botanical medicine, herbals, homeopathic, phytonutrients, antioxidants, enzymes, and glandular extracts, durable and non-durable medical goods and devices in all their forms. ( ) Following a large scale outbreak of fungal meningitis at a Massachusetts compounding pharmacy that sickened over 700 and killed 64 Americans in 2012, additional labeling changes were passed by Congress via the Drug Quality and Security Act (DQSA) of The culmination of the Food and Drug Modernization Act of 1997 (FDAMA) and Drug Quality and Security Act (DQSA) of 2013 resulted in the FDA discerning that any and all substances that were injected into the body were deemed to be a drug and were required to carry the label Rx Only. Since 2012, the Idaho State Boards of Pharmacy and Chiropractic have been asked by national, regional and state suppliers regarding whether Idaho chiropractors had the right to purchase and administer injectable nutrition or micro-nutrient therapy, as they were not authorized to prescribe pharmaceuticals or drugs to their patients. In 2014, 2015 and the 2016 legislative session, following direction from the Idaho State Boards of Pharmacy and Chiropractic, the Idaho Association of Chiropractic Physicians has worked with these boards to draft legislation that would standardize and clarify the right of an Idaho chiropractic physicians to purchase and administer micro-nutrient therapy to utilize in the treatment of their patients.

2 During the 2016 legislative session, the Idaho Legislature made an adjustment to the chiropractic administrative rule with the following change: 020. Clinical nutritional methods as referenced in Section , Idaho Code, include, but are not limited to, the clinical use, administration, recommendation, compounding, prescribing, selling, and distributing vitamins, minerals, botanical medicine, herbals, homeopathic, phytonutrients, antioxidants, enzymes and glandular extracts, and durable and non-durable medical goods and devices in all their forms. Nothing herein shall allow any deviation from Section (2), Idaho Code. ( ) This change to the Administrative Rules effectively eliminated the use of injectable or IV nutrition by Idaho chiropractic physicians, limiting the use of natural substances (i.e., vitamins and minerals) to non-prescriptive and over the counter substances. In the wake of the current opioid epidemic, many respected health care organizations now recommend non-drug opioid treatment for pain management. For example, the Centers for Disease Control and Prevention, in its 2016 guidelines for prescribing opioids, notes that nonpharmacologic therapies are preferred for treating chronic pain. In addition, the National Pain Strategy, an initiative by several federal agencies, recognizes chiropractic as a central method for pain management. II Idaho Association of Chiropractic Legislation As the 2017 Session of the Idaho Legislature kicks-off, the Idaho Association of Chiropractic Physicians (IACP) is presenting legislation that will establish a specialty certification for chiropractic physicians to utilize vitamins and minerals via injectable or intravenous means in the treatment of their patients, as they have utilized in the past. The legislation will establish a specific regulatory structure for the certification; minimum educational requirements to obtain the certification; a stated, but limited, formulary of the natural substances that can be utilized during patient treatment, and a limited prescriptive right for those DCs using the natural substances. The legislation will establish a certification / license endorsement that chiropractic physicians must receive before treating their patients through micro-nutrient therapy. The Idaho legislative leaders has required that the education is required to be U.S. Department of Education accredited, post-doctoral classes that focus on the proper technique of administering micro-nutrient therapy into the human body, the effects, possible side-effects and treatment of those effects. The legislation will re-establish the right of an Idaho chiropractic physician to obtain and administer clinical nutrition or micro-nutrient therapy (as it is better known) to their patients through injectable routes of administration as part of treatment or therapy regimen. The goal of the bill is to continue to allow Idahoans increased access and choice in utilizing conservative, non-traditional, non-pharmacological care in the treatment of their bodies and ailments. The use of micro nutrient therapy has been found to be safe and effective alternative treatment in comparison to traditional pharmaceuticals in multiple treatment areas.

3 Idaho chiropractic physicians not wishing to obtain a clinical nutrition certificate will still be able to provide non-prescriptive nutritional supplements and over-the-counter substances to their patients, as a specific stated comment has been inserted into the bill to take this action (54-716(5)). Frequently Asked Questions 1. Are Idaho chiropractic physician pharmacists adequately trained to perform micro-nutrient therapy treatments? All chiropractic physicians licensed in the State of Idaho receive a Doctor of Chiropractic (DC) degree, accredited by the U.S. Department of Education, which requires a minimum of seven (7) years of education to complete (3-4 years undergraduate education and 3-4 of chiropractic college or university). Idaho DCs have been performing these types of treatments for their patients for the past 20+ years with great success, and with little or no negative outcomes. DCs receive extensive training in diagnosis, chemistry and anatomy / physiology, including training in phlebotomy. The proposed legislation will require a minimum of 101 hours of additional post-doctoral training that will focus on the following areas related to micro-nutrient therapy: o Minimum of 77 hours of didactic human nutrition, nutritional biochemistry or nutritional pharmacology; o Minimum of 24 hours of practicum in micronutrient therapy, including sterile needle practices, injection technique, intravenous safety, blood chemistry interpretation. The bill would further require that the State Board of Chiropractic establish additional continuing education (CE) requirements beyond the base required for chiropractic relicensing in order to maintain the micro-nutrient therapy certification. In addition, there will be a requirement to re-certify the basic skills through a 6-8 hour course every three years. 2. Does micro-nutrient therapy have side effects that can cause patient harm? All vitamins, minerals, herbals and nutrients being used in and/or on the body have the potential to cause side effects; however, the side effects have been documented to be significantly low or non-existent in the use of micro-nutrient therapies. DCs are trained to manage patients in distress, and the chiropractic physicians performing micronutrient therapy will be required to obtain additional training on managing side effects. Moreover, these DCs will be required to maintain basic lifesaving certifications and equipment in their office, at all times.

4 Side effects can be avoided with appropriate screening and discussions with patients in order to obtain details on all current medications and supplements that the patient may be taking. In addition, the chiropractor will be prepared to refer them to their primary care medical physician in case they are deemed to be of high risk. 3. How will you determine what a DC with a certificate to perform micro-nutrient therapy can administer to their patient? The legislation will establish a stated formulary within the statute that includes only vitamins and minerals, as well as sterile substances or supplies that are used to administer natural substances via injectable or intravenous means. The formulary currently includes the following substances and supportive solutions: o Vitamins Vitamin A; All B Vitamins; Vitamin C; o Minerals Ammonium molybdate; Calcium; Chromium; Copper; Iodine; Magnesium; Manganese; Potassium; Selenium; Sodium; and Zinc o Fluids Dextrose; Lactated ringers; Plasma lyte; Saline; and Sterile Water; o Epinephrine o Oxygen for use during emergencies or allergic reactions. Any additional substances that would wish to be added to the chiropractic clinical nutrition / micro-nutrient therapy formulary would have to be and can be presented to the Idaho Legislature via a new legislative measure, at any point in the future.

5 February 3, 2017 Chairman of the House Health and Welfare Committee and Chairwoman of the Idaho State Board of Chiropractic: The University of Western States (UWS) has been working closely with the Idaho Association of Chiropractic Physicians and members of the Idaho chiropractic community for the past several years in an effort to establish a standard of education that will provide a strong foundation for Idaho chiropractic physicians who wish to provide intravenous and injectable nutrition in the treatment of their patients. As a leading chiropractic university, the University of Western States has programmatic and institutional accreditations through agencies that are recognized by the U.S. Department of Education. UWS is pleased to provide background information to the Idaho Legislature and the Idaho Board of Chiropractic Physicians regarding the institution s ability and readiness to assist members of the Idaho chiropractic community in efforts to obtain accredited, post-doctoral education and training that will establish the foundation for the use of injectable and intravenous nutrition therapy. In working with Idaho chiropractic physicians, UWS has identified a specific set of courses from our accredited Master of Science degree program in Human Nutrition and Functional Medicine that provides the education, background and training necessary to ensure Idaho Doctors of Chiropractic are educated and prepared to deliver safe and effective intravenous and injectable nutrition therapy in the treatment of their patients. These didactic courses are available now for enrollment as they are active course within the Master of Science degree program. These graduate-level classes include proficiency testing to ensure students have an appropriate grasp of the course information: Evidence-based Nutrition (3 credits, 33 hours) This course provides core knowledge in evidence-based nutrition with a focus on the role of nutrition in health optimization and disease treatment. Students will gain a detailed understanding of the practical application of various nutrients and dietary strategies used in clinical practice. Discussions will also incorporate the three components of evidence-based healthcare (clinical expertise, patient preference, research evidence) into the decision-making and data-analysis process. Nutritional Biochemistry (2 credits, 22 hours) This course provides an overview of essential concepts in human biochemistry and links those concepts to specific applications in clinical nutrition. The course will examine the biological roles of macro- and micronutrients and their metabolism using basic knowledge in physiology, biochemistry and molecular biology. Topics include carbohydrates and energy metabolism, protein and amino acids, bioactive peptides, enzymes, fiber, lipids, the arachidonic acid cascade, minerals, water-soluble and fat-soluble micronutrients, along with an introduction to energy production, reduction-oxidization balance, and biochemical individuality. Students will explore the relationships of nutrients to major health disorders, including cardiovascular disease, diabetes and cancer. Pharmacology and Drug-Nutrient Interactions (2 credits, 22 hours) This course provides a practical overview of pharmacologic therapy used in the management of ambulatory patients with chronic illnesses or non-life threatening acute illnesses. The student will study the effects of drugs on organ systems and diseases and the mechanism of action (pharmacodynamics), the absorption, distribution, metabolism and excretion of drugs (A.D.M.E. of pharmacokinetics), potential toxic effects of medications, factors affecting the effectiveness of drugs, and interactions with drugs, botanical compounds, foods, and nutritional supplements. In addition, UWS is exploring the feasibility of developing a supervised clinical practicum course to include hands-on training and practical assessments. The practicum course(s) would require supervised education and 2900 NE 132 nd Ave. - Portland, OR

6 training with clinical experience in: intravenous therapy techniques and safety practices; injection techniques and safety practices; phlebotomy; sterile needle practices; use and expected outcomes utilizing micronutrients; response to adverse effects; lab testing and blood chemistry interpretation. The university anticipates completing the necessary internal review process for this practicum by late 2017 or early Additional external review may also be required. Following completion of the aforementioned didactic courses and the proposed practicum, Idaho chiropractic physicians will have an exceptional foundation of education and hands on training in using injectable and intravenous nutrition therapies to better serve their patients. The University of Western States looks forward to collaborating with members of the Idaho chiropractic profession and to providing important core instruction that will ensure patient safety and proper treatment techniques remain paramount in the chiropractic profession. If you have questions or need additional information, please feel free to contact me. Sincerely, Michael Haneline, DC, MPH Dean, Graduate and Undergraduate Studies

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