WEBVTT 00:00:07.500 --> 00:00:11.537 >> Phyllis: I am delighted to be here today to 00:00:11.537 --> 00:00:15.141 present a topic of paramount importance in the realm 00:00:15.141 --> 00:00:17.977 of health care: the collaborative compass, guiding 00:00:17.977 --> 00:00:20.380 IV hydration regulation for improved patient 00:00:20.380 --> 00:00:21.614 outcomes in Mississippi. 00:00:21.614 --> 00:00:26.853 The focus will be primarily on what we have done in 00:00:26.853 --> 00:00:30.690 Mississippi, in this presentation aims to shed light 00:00:30.690 --> 00:00:34.994 on a critical aspect of patient care, exploring how 00:00:34.994 --> 00:00:38.831 collaborative efforts can serve as a compass to 00:00:38.831 --> 00:00:41.701 navigate and enhance IV hydration practices, 00:00:41.701 --> 00:00:45.038 ultimately leading to improved patient outcomes. As 00:00:45.038 --> 00:00:49.342 we delve into the subject, we will uncover key 00:00:49.342 --> 00:00:51.277 insights, evidence-based strategies, and 00:00:51.277 --> 00:00:54.147 collaborative initiatives that can revolutionize IV 00:00:54.147 --> 00:00:55.081 hydration regulation. 00:00:55.081 --> 00:00:58.685 The significance of this topic cannot be overstated, 00:00:58.685 --> 00:01:01.821 particularly in the context of Mississippi's health 00:01:01.821 --> 00:01:04.991 care landscape, where our collective efforts can 00:01:04.991 --> 00:01:09.028 make a profound impact on the well-being of our 00:01:09.028 --> 00:01:09.529 patients. 00:01:09.529 --> 00:01:14.233 Without further ado, let us embark on this journey 00:01:14.233 --> 00:01:16.869 together, navigating the collaborative compass 00:01:16.869 --> 00:01:20.573 towards a future where improved IV hydration 00:01:20.573 --> 00:01:23.743 regulation translates into tangible advancements in 00:01:23.743 --> 00:01:25.845 patient care across Mississippi. 00:01:25.845 --> 00:01:29.982 I would like to take a moment to outline the key 00:01:29.982 --> 00:01:31.851 objectives we aim to address. 00:01:31.851 --> 00:01:34.287 First, the importance of regulation. 00:01:34.287 --> 00:01:39.392 We will explore the crucial role that regulatory 00:01:39.392 --> 00:01:43.863 frameworks play in ensuring the safety, efficacy, 00:01:43.863 --> 00:01:47.700 and quality of IV hydration practices. 00:01:47.700 --> 00:01:50.703 Understanding the landscape of regulations is 00:01:50.703 --> 00:01:54.207 essential for health care professionals to deliver 00:01:54.207 --> 00:01:57.744 optimal patient care while adhering to industry 00:01:57.744 --> 00:01:58.244 standards. 00:01:58.244 --> 00:02:00.380 Second, collaboration, recognizing the 00:02:00.380 --> 00:02:03.082 interconnected nature of health care. 00:02:03.082 --> 00:02:07.453 We will delve into the significance of collaboration 00:02:07.453 --> 00:02:10.723 among the various regulatory bodies. Effective 00:02:10.723 --> 00:02:14.560 collaboration fosters a unified approach to address 00:02:14.560 --> 00:02:19.499 challenges and achieve common goals in the realm of 00:02:19.499 --> 00:02:20.600 IV hydration. 00:02:20.600 --> 00:02:23.903 Third, common indicators for IV hydration. 00:02:23.903 --> 00:02:27.240 An in-depth expiration of the common indicators and 00:02:27.240 --> 00:02:31.411 best practices in IV hydration will be a focal point 00:02:31.411 --> 00:02:32.645 in our presentation. 00:02:32.645 --> 00:02:36.749 This section aims to provide a comprehensive 00:02:36.749 --> 00:02:40.820 understanding of the clinical markers and standards 00:02:40.820 --> 00:02:44.323 that guide health care professionals in 00:02:44.323 --> 00:02:46.059 administering IV fluids. 00:02:46.059 --> 00:02:47.460 Four, scope of practice. 00:02:47.460 --> 00:02:52.932 We will discuss the defined scope of practice for 00:02:52.932 --> 00:02:57.203 health care professionals involved in IV hydration, 00:02:57.203 --> 00:03:00.239 ensuring clarity on responsibilities, competencies, 00:03:00.239 --> 00:03:03.876 and ethical considerations within their respective 00:03:03.876 --> 00:03:04.477 roles. 00:03:04.477 --> 00:03:08.114 The fifth objective, FDA and FTC regulations, an 00:03:08.114 --> 00:03:11.284 examination of the regulatory frameworks set forth 00:03:11.284 --> 00:03:15.388 by the U.S. Food and Drug Administration, FDA, and 00:03:15.388 --> 00:03:18.991 the Federal Trade Commission, FTC, it will be 00:03:18.991 --> 00:03:21.728 undertaken, shedding light on the compliance 00:03:21.728 --> 00:03:24.464 requirements and implications for practitioners in 00:03:24.464 --> 00:03:28.534 the field of IV hydration. Objective number six 00:03:28.534 --> 00:03:30.803 talks about the case studies. 00:03:30.803 --> 00:03:34.874 We will present case studies to illustrate some of 00:03:34.874 --> 00:03:37.610 the scenarios that Mississippi has encountered 00:03:37.610 --> 00:03:41.247 regarding IV hydration and the outcome of those 00:03:41.247 --> 00:03:41.748 cases. 00:03:41.748 --> 00:03:44.717 From the Nursing Regulatory Body's perspective, 00:03:44.717 --> 00:03:48.254 regulation is a mechanism to ensure public 00:03:48.254 --> 00:03:51.290 protection, and the trust in nursing. 00:03:51.290 --> 00:03:55.094 Although license requirements may vary by state, 00:03:55.094 --> 00:04:00.566 nurses in the U.S. need to be authorized to practice 00:04:00.566 --> 00:04:06.005 by a Nursing Regulatory Body or a board of nursing. 00:04:06.005 --> 00:04:09.509 NRBs, Nursing Regulatory Body's, outline the 00:04:09.509 --> 00:04:10.109 standards. 00:04:10.109 --> 00:04:15.548 Once a license is issued, the NRB will monitor the 00:04:15.548 --> 00:04:18.851 licensee's compliance to those jurisdictional laws 00:04:18.851 --> 00:04:23.222 and take action against those who have demonstrated 00:04:23.222 --> 00:04:27.593 unsafe nursing practice. Each jurisdiction has a law 00:04:27.593 --> 00:04:32.498 known as the nurse practice act, which is enforced 00:04:32.498 --> 00:04:36.869 by the NRB. NRBs might administer and enforce 00:04:36.869 --> 00:04:41.240 regulatory law and rules to accomplish their mandate 00:04:41.240 --> 00:04:42.875 of public safety. 00:04:42.875 --> 00:04:46.713 Decisions of the NRBs must be evidence-based, 00:04:46.713 --> 00:04:49.449 clearly defined, consistent, targeted, and 00:04:49.449 --> 00:04:53.319 proportionate to the level of risk determination. 00:04:53.319 --> 00:04:56.589 When you talk about collaboration, Merriam-Webster 00:04:56.589 --> 00:04:58.224 gave three definitions. 00:04:58.224 --> 00:05:02.028 The one that I prefaced here is one that defines it 00:05:02.028 --> 00:05:04.797 as to cooperate with an agency, the instrumentality 00:05:04.797 --> 00:05:07.233 with which one is not immediately connected. 00:05:07.233 --> 00:05:11.971 Also, to work jointly with others or together, 00:05:11.971 --> 00:05:14.941 especially in an intellectual endeavor. 00:05:14.941 --> 00:05:18.144 In addition, the symbiotic relationship between the 00:05:18.144 --> 00:05:21.314 Mississippi Board of nursing, the Mississippi Board 00:05:21.314 --> 00:05:24.517 of pharmacy, and the Mississippi medical licensure 00:05:24.517 --> 00:05:28.154 board is not just a testament to effective 00:05:28.154 --> 00:05:31.324 governance, but I dynamic force that significantly 00:05:31.324 --> 00:05:34.994 influences the quality and safety of health care 00:05:34.994 --> 00:05:36.796 delivery in our state. 00:05:36.796 --> 00:05:41.334 Together, they form a triad of regulatory oversight, 00:05:41.334 --> 00:05:45.838 working in harmony to ensure the highest standards 00:05:45.838 --> 00:05:49.776 of professional practice, patient care, and public 00:05:49.776 --> 00:05:50.343 safety. 00:05:50.343 --> 00:05:54.547 So, what does collaboration look like? 00:05:54.547 --> 00:05:57.950 Achievement of common goals, respect for each other, 00:05:57.950 --> 00:06:00.053 resolution of interest, safeguarding the 00:06:00.053 --> 00:06:03.456 contributions that each member makes to achieve the 00:06:03.456 --> 00:06:05.591 optimal goal of public safety. 00:06:05.591 --> 00:06:09.529 In other words, trusting each other. 00:06:09.529 --> 00:06:12.632 In response to ongoing concerns within the 00:06:12.632 --> 00:06:15.702 jurisdiction of the Federation of State medical 00:06:15.702 --> 00:06:19.238 boards, SSNB, the National Association of boards of 00:06:19.238 --> 00:06:22.775 pharmacy, and the National Council of State Boards 00:06:22.775 --> 00:06:25.878 of Nursing, a collaborative effort has been 00:06:25.878 --> 00:06:26.379 undertaken. 00:06:26.379 --> 00:06:30.116 These three organizations have partnered with the 00:06:30.116 --> 00:06:35.021 FDA and the Federal Trade Commission to conduct an 00:06:35.021 --> 00:06:37.190 educational initiative for regulators. 00:06:37.190 --> 00:06:41.761 The primary objective of this collaboration is to 00:06:41.761 --> 00:06:45.198 establish a platform for regulators and 00:06:45.198 --> 00:06:47.467 practitioners, fostering a comprehensive 00:06:47.467 --> 00:06:50.903 understanding of the evolving landscape and 00:06:50.903 --> 00:06:54.907 equipping them with the necessary insights to 00:06:54.907 --> 00:06:58.911 safeguard and educate patients in response to 00:06:58.911 --> 00:07:01.748 observed trends in this domain. 00:07:01.748 --> 00:07:05.284 Moreover, a crucial aspect of this educational 00:07:05.284 --> 00:07:08.788 endeavor is centered on patient safety. This 00:07:08.788 --> 00:07:13.326 emphasis on education is paramount to the health and 00:07:13.326 --> 00:07:16.829 safety of patients, aligning with our collective 00:07:16.829 --> 00:07:20.867 commitment to maintain the highest standards of care 00:07:20.867 --> 00:07:23.369 within our health care systems. 00:07:23.369 --> 00:07:27.640 This information was recently shared by the FDA. As 00:07:27.640 --> 00:07:33.312 you can see, this is a list of some of the most 00:07:33.312 --> 00:07:35.181 common establishments providing intravenous 00:07:35.181 --> 00:07:36.149 hydration services. 00:07:36.149 --> 00:07:39.619 The analysis of various websites reveals a spectrum 00:07:39.619 --> 00:07:43.956 of IV hydration services that claim to cater to a 00:07:43.956 --> 00:07:46.125 plethora of health care needs. 00:07:46.125 --> 00:07:50.129 These offerings reflect the evolving landscape of IV 00:07:50.129 --> 00:07:53.132 hydration services, providing individuals with a 00:07:53.132 --> 00:07:57.136 range of options to address specific health and 00:07:57.136 --> 00:08:00.139 wellness goals that is not evidence-based. 00:08:00.139 --> 00:08:04.277 It is essential for regulators and practitioners to 00:08:04.277 --> 00:08:08.381 be aware of these trends to ensure informed 00:08:08.381 --> 00:08:13.019 decision-making and the safety of the patients. IV 00:08:13.019 --> 00:08:16.622 hydration facilities may not be registered or 00:08:16.622 --> 00:08:18.157 licensed with states. 00:08:18.157 --> 00:08:21.761 State licensing boards focus on the practitioner. 00:08:21.761 --> 00:08:24.864 Involvement of multiple disciplines may cause 00:08:24.864 --> 00:08:26.899 complexities of state oversight. 00:08:26.899 --> 00:08:31.838 FDA was also concerned with the compounding of drug 00:08:31.838 --> 00:08:35.675 products by medical offices and clinics under 00:08:35.675 --> 00:08:36.776 unsanitary conditions. 00:08:36.776 --> 00:08:40.847 Investigations by the FDA ensued and revealed unsafe 00:08:40.847 --> 00:08:44.384 and unsanitary conditions and some clinics related 00:08:44.384 --> 00:08:47.954 to the preparation of IV hydration products. 00:08:47.954 --> 00:08:52.992 We first looked at what IV hydration is and the 00:08:52.992 --> 00:08:55.495 common indications for IV hydration. 00:08:55.495 --> 00:08:58.664 Intravenous hydration, commonly abbreviated as IV 00:08:58.664 --> 00:09:01.868 hydration, encompasses the administration of fluids 00:09:01.868 --> 00:09:05.605 directly into an individual's bloodstream via a 00:09:05.605 --> 00:09:06.105 vein. 00:09:06.105 --> 00:09:10.576 This serves the purpose of addressing dehydration or 00:09:10.576 --> 00:09:12.812 maintaining optimal fluid balance. 00:09:12.812 --> 00:09:17.817 The intravenous route facilitates a rapid and 00:09:17.817 --> 00:09:22.088 efficient delivery of fluids, electrolytes, and, 00:09:22.088 --> 00:09:24.957 when required, essential nutrients. 00:09:24.957 --> 00:09:28.394 This is particularly advantageous in situations 00:09:28.394 --> 00:09:32.398 where oral rehydration may prove inadequate or 00:09:32.398 --> 00:09:32.965 impractical. 00:09:32.965 --> 00:09:36.569 Primarily employed in medical settings such as 00:09:36.569 --> 00:09:40.673 hospitals or clinics, IV hydration is a valuable 00:09:40.673 --> 00:09:45.278 intervention when the oral route may not suffice, or 00:09:45.278 --> 00:09:49.382 is deemed impractical for ensuring the timely and 00:09:49.382 --> 00:09:51.951 effective restoration of fluid balance. 00:09:51.951 --> 00:09:56.622 The expedited and controlled nature of IV fluid 00:09:56.622 --> 00:10:00.126 administration makes the preferred method in 00:10:00.126 --> 00:10:03.596 situations demanding swift and precise hydration 00:10:03.596 --> 00:10:04.197 management. 00:10:04.197 --> 00:10:08.368 Intravenous hydration is typically warranted under 00:10:08.368 --> 00:10:12.572 various clinical scenarios where specific medical 00:10:12.572 --> 00:10:13.973 needs arise. 00:10:13.973 --> 00:10:19.912 Common indicators for IV hydration include severe 00:10:19.912 --> 00:10:20.747 dehydration. 00:10:20.747 --> 00:10:25.985 IV hydration is often employed in cases of severe 00:10:25.985 --> 00:10:29.455 dehydration, ensuring rapid and efficient fluid 00:10:29.455 --> 00:10:32.325 restoration. Surgery and medical procedures. 00:10:32.325 --> 00:10:36.362 Before, during, or after surgical and medical 00:10:36.362 --> 00:10:40.400 procedures, IV hydration may be prescribed to 00:10:40.400 --> 00:10:44.404 maintain optimal fluid balance and support the 00:10:44.404 --> 00:10:46.139 body's recovery process. 00:10:46.139 --> 00:10:48.941 Nausea and vomiting. Individuals experiencing 00:10:48.941 --> 00:10:53.379 persistent nausea and vomiting may benefit from IV 00:10:53.379 --> 00:10:57.283 hydration to replenish lost fluids and prevent 00:10:57.283 --> 00:10:59.519 dehydration. Electrolyte imbalances. 00:10:59.519 --> 00:11:02.989 IV hydration becomes essential in cases of 00:11:02.989 --> 00:11:05.491 electrolyte imbalances, allowing for precise 00:11:05.491 --> 00:11:07.960 administration of electrolytes to restore 00:11:07.960 --> 00:11:11.964 equilibrium. The board of pharmacy, part of the 00:11:11.964 --> 00:11:15.435 collaboration in Mississippi, uses a checklist for 00:11:15.435 --> 00:11:18.905 compliance make sure infusion clinics are operating 00:11:18.905 --> 00:11:20.907 under best practice standards. 00:11:20.907 --> 00:11:24.510 The Board of medical licensure and the board of 00:11:24.510 --> 00:11:27.347 nursing utilizes what is called the investigative 00:11:27.347 --> 00:11:30.550 questionnaire to make sure clinics are operating on 00:11:30.550 --> 00:11:32.151 the best practice standards. 00:11:32.151 --> 00:11:36.456 The diagnosis of the patient's condition and the 00:11:36.456 --> 00:11:39.659 recommendation of IV therapy constitutes the 00:11:39.659 --> 00:11:41.260 practice of medicine. 00:11:41.260 --> 00:11:46.065 Thus, only physicians, APRNs, or PAs may diagnose, 00:11:46.065 --> 00:11:51.504 treat, correct, advise, or prescribe IV meds for a 00:11:51.504 --> 00:11:55.742 person for any disease, ailment, injury, infirmity, 00:11:55.742 --> 00:12:00.580 deformity, pain, or other condition, whether real or 00:12:00.580 --> 00:12:01.180 imaginary. 00:12:01.180 --> 00:12:04.851 IV hydration is a medical procedure with risk and 00:12:04.851 --> 00:12:08.488 should be conducted in the clinical setting as any 00:12:08.488 --> 00:12:09.689 other medical procedure. 00:12:09.689 --> 00:12:14.060 It is imperative for health care providers to adhere 00:12:14.060 --> 00:12:17.964 to the boundaries of their professional scope of 00:12:17.964 --> 00:12:19.899 practice when delivering care. 00:12:19.899 --> 00:12:22.702 Full histories, examinations, diagnoses supported by 00:12:22.702 --> 00:12:25.938 medical justification, plan of care, and complete 00:12:25.938 --> 00:12:29.642 records must be maintained like any other medical 00:12:29.642 --> 00:12:30.143 condition. 00:12:30.143 --> 00:12:36.215 The patient may not select the product from a menu. 00:12:36.215 --> 00:12:40.353 The hydration and our supplements suggested must be 00:12:40.353 --> 00:12:43.456 based on medical justification and clinical 00:12:43.456 --> 00:12:47.560 decision-making by the practitioner as part of the 00:12:47.560 --> 00:12:50.663 assessment, diagnosis, and treatment plan. IV 00:12:50.663 --> 00:12:54.767 hydration is a medical procedure with risk and 00:12:54.767 --> 00:12:59.439 should be conducted in the clinical setting as any 00:12:59.439 --> 00:13:00.973 other medical procedure. 00:13:00.973 --> 00:13:04.677 Hydration status is an important aspect for health 00:13:04.677 --> 00:13:05.178 maintenance. 00:13:05.178 --> 00:13:09.015 However, evidence of the specific effects of 00:13:09.015 --> 00:13:12.919 hydration relative to the general population is 00:13:12.919 --> 00:13:14.554 scarce and inefficient. 00:13:14.554 --> 00:13:17.824 Studies are needed to field current gaps in 00:13:17.824 --> 00:13:21.027 knowledge and enable us to understand the specifics 00:13:21.027 --> 00:13:25.098 of the role of hydration in promoting health as well 00:13:25.098 --> 00:13:27.934 as to help inform public health recommendations. 00:13:27.934 --> 00:13:31.204 There are benefits to IV therapy. 00:13:31.204 --> 00:13:35.108 However, does the advertisement depicts the actual 00:13:35.108 --> 00:13:37.343 benefits of IV hydration? 00:13:37.343 --> 00:13:41.347 In addressing the landscape of IV hydration, 00:13:41.347 --> 00:13:45.351 advertisement is crucial to debunk prevalence and 00:13:45.351 --> 00:13:49.322 ensure a clear understanding of the facts 00:13:49.322 --> 00:13:53.326 surrounding this crucial aspect of health care. 00:13:53.326 --> 00:13:57.830 North America dominated the market for IV hydration 00:13:57.830 --> 00:14:03.436 therapy with a share of 46.82% in 2022, and is 00:14:03.436 --> 00:14:07.340 anticipated to maintain its dominance over the 00:14:07.340 --> 00:14:08.474 forecast period. 00:14:08.474 --> 00:14:11.778 The high share is due to the unprecedented adoption 00:14:11.778 --> 00:14:14.681 of IV hydration therapy in the United States. 00:14:14.681 --> 00:14:19.218 There is an increasing demand for energy and immune 00:14:19.218 --> 00:14:23.756 boosters in the region, owing to rising incidents of 00:14:23.756 --> 00:14:24.757 chronic diseases. 00:14:24.757 --> 00:14:28.461 The global IV hydration market has been witnessing 00:14:28.461 --> 00:14:32.632 steady growth, not only in North America but in 00:14:32.632 --> 00:14:35.401 Europe, Asia-Pacific, Latin America, the Middle 00:14:35.401 --> 00:14:36.803 East, and Africa. 00:14:36.803 --> 00:14:42.308 Some of the key players in the global market are 00:14:42.308 --> 00:14:46.145 brought medical, Baxter international, and next gen 00:14:46.145 --> 00:14:48.881 health, to name a few. 00:14:48.881 --> 00:14:52.018 The cocktails that IV vitamin therapy clinics create 00:14:52.018 --> 00:14:54.721 and administer are not supported by scientific 00:14:54.721 --> 00:14:55.221 evidence. 00:14:55.221 --> 00:14:59.525 There have been no clinical studies to show vitamin 00:14:59.525 --> 00:15:03.930 injections of this type offer any health benefit or 00:15:03.930 --> 00:15:07.333 are necessary for good health. Through 00:15:07.333 --> 00:15:11.237 collaboration with the Board of medical licensure in 00:15:11.237 --> 00:15:15.174 the board of pharmacy, discovery was made regarding 00:15:15.174 --> 00:15:17.610 two Mississippi IV hydration sites. 00:15:17.610 --> 00:15:25.118 Aqua pure drip was a mobile IV hydration service in 00:15:25.118 --> 00:15:29.655 Hattiesburg, Mississippi, RN-own, going to events 00:15:29.655 --> 00:15:31.891 offering hydration services. 00:15:31.891 --> 00:15:35.094 Another site was infusion therapy also in 00:15:35.094 --> 00:15:37.363 Hattiesburg, Mississippi, which was LPN-owned, 00:15:37.363 --> 00:15:41.000 providing clients with the menu but they could 00:15:41.000 --> 00:15:44.203 select whatever they wanted from that menu. 00:15:44.203 --> 00:15:47.707 IV hydration 2U was another site that offered many 00:15:47.707 --> 00:15:48.908 services to clients. 00:15:48.908 --> 00:15:54.280 As you can see, there is a hefty cost associated 00:15:54.280 --> 00:15:55.915 with these services. 00:15:55.915 --> 00:15:59.786 In addition to IV hydration, infusion therapy was 00:15:59.786 --> 00:16:01.721 also offering weight-loss services. 00:16:01.721 --> 00:16:05.958 As you see, they advertised the Facebook on the 00:16:05.958 --> 00:16:09.295 location and the services offered that day. 00:16:09.295 --> 00:16:13.933 The FDA is responsible for enforcing the USP 00:16:13.933 --> 00:16:18.037 standards recognized by various provisions of the 00:16:18.037 --> 00:16:23.276 Food, drug, and cosmetic act, and USP Chapter 797 00:16:23.276 --> 00:16:26.746 provides the standards for sterile compounding, 00:16:26.746 --> 00:16:29.682 including supervision of compounding personnel, 00:16:29.682 --> 00:16:33.186 training of compounding personnel, and sanitary 00:16:33.186 --> 00:16:36.656 conditions for preparation of drug compounds. 00:16:36.656 --> 00:16:41.027 IV hydration clinics must comply with both of those 00:16:41.027 --> 00:16:41.527 regulations. 00:16:41.527 --> 00:16:48.401 The purpose is to prevent unfair or deceptive acts 00:16:48.401 --> 00:16:49.936 of practices. 00:16:49.936 --> 00:16:52.672 Sections 5 and 12 of the act. 00:16:52.672 --> 00:16:56.743 The first principle is advertising must be truthful 00:16:56.743 --> 00:16:58.277 and not misleading. 00:16:58.277 --> 00:17:02.615 And before disseminating an ad, advertisers must 00:17:02.615 --> 00:17:06.319 have adequate substantiation for all objective 00:17:06.319 --> 00:17:10.656 product claims conveyed expressly or by implication 00:17:10.656 --> 00:17:13.126 to consumers acting reasonably. 00:17:13.126 --> 00:17:17.597 All health claims require competent and reliable 00:17:17.597 --> 00:17:18.865 scientific evidence. 00:17:18.865 --> 00:17:22.902 Disease treatment or cure claims require human 00:17:22.902 --> 00:17:26.372 clinical studies such as randomized studies, 00:17:26.372 --> 00:17:28.708 placebo-controlled, double-blind studies, measuring 00:17:28.708 --> 00:17:32.178 the relevant end points with statistically 00:17:32.178 --> 00:17:36.215 significant results. And advertising must have at 00:17:36.215 --> 00:17:39.686 least a level of proof claim. 00:17:39.686 --> 00:17:44.057 For example, reference to a clinical study or 00:17:44.057 --> 00:17:48.428 scientific research pay claims that a product is 00:17:48.428 --> 00:17:52.231 clinically proven or scientifically proven to work 00:17:52.231 --> 00:17:56.035 requires evidence sufficient to satisfy the relevant 00:17:56.035 --> 00:17:58.771 scientific community of the claim. 00:17:58.771 --> 00:18:04.243 Respondents operating a chain of IV clinics in Texas 00:18:04.243 --> 00:18:08.481 and Colorado, the FTC challenged false or 00:18:08.481 --> 00:18:12.752 unsubstantiated claims that the IV cocktails were 00:18:12.752 --> 00:18:15.788 first effective treatments for cancer, 00:18:15.788 --> 00:18:18.224 cardiovascular disease, multiple sclerosis, 00:18:18.224 --> 00:18:23.096 diabetes, fibromyalgia, and on and on and on. 00:18:23.096 --> 00:18:24.731 Clinically proven to treat various diseases. 00:18:24.731 --> 00:18:28.768 In the instances where the FTC was involved with 00:18:28.768 --> 00:18:32.338 these clinics, the consent order was issued that 00:18:32.338 --> 00:18:35.475 required human clinical testing for disease claims, 00:18:35.475 --> 00:18:38.611 competent and reliable scientific evidence for other 00:18:38.611 --> 00:18:43.082 health claims, and that they also agreed to send an 00:18:43.082 --> 00:18:46.652 email notice to consumers who had purchased the 00:18:46.652 --> 00:18:49.322 cocktail, informing them that scientific evidence 00:18:49.322 --> 00:18:53.359 has not shown the cocktail to be an effective 00:18:53.359 --> 00:18:55.128 treatment for any disease. 00:18:55.128 --> 00:19:00.066 The FTC has issued more than 70 warning letters 00:19:00.066 --> 00:19:02.235 challenging various IV therapies. 00:19:02.235 --> 00:19:08.708 For example, vitamins C and D and Myers cocktail. 00:19:08.708 --> 00:19:11.511 Many clinics offer IV therapies along with other 00:19:11.511 --> 00:19:12.912 alternative or compounded treatments. 00:19:12.912 --> 00:19:17.116 For example, vitamin injections, ozone, hyperbaric 00:19:17.116 --> 00:19:21.320 oxygen therapy, stem cells, and peptides. 00:19:21.320 --> 00:19:25.058 Let's talk about some legislation that has been 00:19:25.058 --> 00:19:25.558 introduced. 00:19:25.558 --> 00:19:30.396 In Florida, house Bill 227 and Senate Bill 672, 00:19:30.396 --> 00:19:32.565 which are companion bills. 00:19:32.565 --> 00:19:35.902 This bill outlines the requirements that qualified 00:19:35.902 --> 00:19:39.205 health care providers, including APRNs, RNs, and 00:19:39.205 --> 00:19:42.075 PAs, when administering IV vitamin treatment. 00:19:42.075 --> 00:19:45.878 Additionally, this bill directs the Board of nursing 00:19:45.878 --> 00:19:50.149 and other relevant health care boards to adopt rules 00:19:50.149 --> 00:19:53.019 establishing procedures to safely administer IV 00:19:53.019 --> 00:19:57.290 vitamin treatment as well as protocols to follow in 00:19:57.290 --> 00:20:00.159 the event of a health emergency. 00:20:00.159 --> 00:20:05.631 House Bill 227 was reported out of the house Health 00:20:05.631 --> 00:20:09.502 and Human Services committee on January 16th. 00:20:09.502 --> 00:20:12.872 Mississippi house Bill 648 is a bill that states 00:20:12.872 --> 00:20:15.908 that nurse practitioners and RNs license by the 00:20:15.908 --> 00:20:18.911 Mississippi Board of nursing shall be authorized to 00:20:18.911 --> 00:20:21.581 administer fluids contain vitamins for the purpose 00:20:21.581 --> 00:20:24.584 of improving a person's immune health through IV 00:20:24.584 --> 00:20:26.452 therapy in a clinical setting. 00:20:26.452 --> 00:20:30.890 The bill further states that there is no limit on 00:20:30.890 --> 00:20:34.427 the number of vitamins that may be administered 00:20:34.427 --> 00:20:38.831 through IV therapy by a nurse practitioner or RN at 00:20:38.831 --> 00:20:40.166 any one time. 00:20:40.166 --> 00:20:43.503 Now let's talk about a few case studies. 00:20:43.503 --> 00:20:47.674 The first one is an actual case that happened in 00:20:47.674 --> 00:20:50.610 Mississippi. The respondent, who is a registered 00:20:50.610 --> 00:20:53.946 nurse rather than a nurse practitioner, has been 00:20:53.946 --> 00:20:57.316 engaging in practices beyond the typical scope of 00:20:57.316 --> 00:21:00.253 the registered nurse by administering IV hydration 00:21:00.253 --> 00:21:01.487 without specific orders. 00:21:01.487 --> 00:21:05.058 The respondent enlisted with a company and operated 00:21:05.058 --> 00:21:08.628 within the framework of services provided by the 00:21:08.628 --> 00:21:09.128 franchise. 00:21:09.128 --> 00:21:12.632 Within this operational model, the administration of 00:21:12.632 --> 00:21:16.636 IVs was based on client preferences without any 00:21:16.636 --> 00:21:20.173 medical justification for the selected IV. Clients 00:21:20.173 --> 00:21:24.711 had the option to choose fluids and medications from 00:21:24.711 --> 00:21:26.746 a menu of services. 00:21:26.746 --> 00:21:29.782 The respondent executed these procedures under 00:21:29.782 --> 00:21:33.820 standing orders from a physician located in another 00:21:33.820 --> 00:21:38.891 state who did not conduct a direct assessment of the 00:21:38.891 --> 00:21:39.892 clients involved. 00:21:39.892 --> 00:21:43.329 So let's look at the outcome of this particular 00:21:43.329 --> 00:21:43.830 case. 00:21:43.830 --> 00:21:47.867 The Board issued a formal reprimand, a fine, legal 00:21:47.867 --> 00:21:52.005 aspects of nursing course, an ethics course, a scope 00:21:52.005 --> 00:21:55.241 of practice course, and a medication administration 00:21:55.241 --> 00:21:55.742 course. 00:21:55.742 --> 00:22:00.013 In another case in Mississippi, it involved a 00:22:00.013 --> 00:22:02.148 certified registered nurse anesthetist. 00:22:02.148 --> 00:22:06.919 The Board of nursing conducted an interview with the 00:22:06.919 --> 00:22:11.157 respondent, who is the owner of an anesthesia 00:22:11.157 --> 00:22:14.861 establishment. During the interview with the nurse, 00:22:14.861 --> 00:22:19.098 it was revealed that the establishment did not 00:22:19.098 --> 00:22:22.802 possess an approved practice site with the 00:22:22.802 --> 00:22:27.040 Mississippi Board of nursing. At that time, the 00:22:27.040 --> 00:22:31.778 respondent was practicing in her home and through a 00:22:31.778 --> 00:22:34.947 mobile service, thereby violating 30 Mississippi 00:22:34.947 --> 00:22:40.253 admin code part 2840, rule 1.1N, and part 2840, rule 00:22:40.253 --> 00:22:43.956 1.2D2. The respondent violated the Mississippi code 00:22:43.956 --> 00:22:47.660 73-15-20, 7D, prescribing outside the scope of 00:22:47.660 --> 00:22:52.432 practice for a licensed CRNA with said scope of 00:22:52.432 --> 00:22:56.135 practice being limited to anesthesia and analgesia. 00:22:56.135 --> 00:22:59.839 The respondent admitted to having no quality 00:22:59.839 --> 00:23:03.009 assurance, a quality improvement plan, or 00:23:03.009 --> 00:23:07.246 documentation, which again was in violation of the 00:23:07.246 --> 00:23:12.018 statute and the code, and the respondent did not 00:23:12.018 --> 00:23:16.289 have electronic medical records for the clients, and 00:23:16.289 --> 00:23:18.925 admitted to performing no exams. 00:23:18.925 --> 00:23:19.425 They did submit a collaborative agreement, dated 00:23:19.425 --> 00:23:19.926 2019. 00:23:19.926 --> 00:23:24.263 However, standing orders were not signed until 2022. 00:23:24.263 --> 00:23:27.467 The respondent backdated documents submitted. 00:23:27.467 --> 00:23:30.003 As you are aware, Mississippi is a collaborative 00:23:30.003 --> 00:23:32.505 state, and they must have a collaborative agreement, 00:23:32.505 --> 00:23:35.041 and it must be signed by the collaborative 00:23:35.041 --> 00:23:35.541 physician. 00:23:35.541 --> 00:23:40.413 What was the outcome of this case? A formal 00:23:40.413 --> 00:23:44.884 reprimand was issued, a sign was given, legal 00:23:44.884 --> 00:23:49.355 aspects of nursing course, every day ethics course, 00:23:49.355 --> 00:23:51.624 professional accountability course, documentation 00:23:51.624 --> 00:23:56.662 course, social media course, and a scope of practice 00:23:56.662 --> 00:24:01.701 course were issued as to be compliant with this 00:24:01.701 --> 00:24:02.268 order. 00:24:02.268 --> 00:24:05.138 In this next case, the respondent is a registered 00:24:05.138 --> 00:24:07.073 nurse and not a nurse practitioner. 00:24:07.073 --> 00:24:10.043 The respondent has a previous disciplinary action 00:24:10.043 --> 00:24:13.413 with another State Board of nursing for practicing 00:24:13.413 --> 00:24:17.617 outside the scope of an RN. The respondent has been 00:24:17.617 --> 00:24:21.421 practicing out of scope for a registered nurse by 00:24:21.421 --> 00:24:23.956 administering IV hydration without specific orders. 00:24:23.956 --> 00:24:29.796 The respondent is the co-owner of an IV hydration 00:24:29.796 --> 00:24:30.430 business. 00:24:30.430 --> 00:24:34.634 IVs are administered based on a client's want and 00:24:34.634 --> 00:24:38.371 there is no medical justification for the selected 00:24:38.371 --> 00:24:41.641 IV. Clients select fluids and medications, again, 00:24:41.641 --> 00:24:45.378 from a menu of services. The respondent administered 00:24:45.378 --> 00:24:49.615 the IV via standing orders from a medical doctor 00:24:49.615 --> 00:24:53.353 located in another state who never assess the 00:24:53.353 --> 00:24:53.853 client. 00:24:53.853 --> 00:24:58.624 The MD did not meet the physical practice 00:24:58.624 --> 00:25:03.463 requirement per the medical licensure code part 20 00:25:03.463 --> 00:25:05.264 6:30, chapter I. 00:25:05.264 --> 00:25:10.870 In another case, the respondent is the owner of a 00:25:10.870 --> 00:25:14.774 mobile IV hydration service, again, located in 00:25:14.774 --> 00:25:15.875 Hattiesburg, Mississippi. 00:25:15.875 --> 00:25:21.247 Allegedly, the respondent is running a weight loss 00:25:21.247 --> 00:25:27.286 clinic and acting as a nurse practitioner without MD 00:25:27.286 --> 00:25:32.625 supervision and no assessment of patient or labs 00:25:32.625 --> 00:25:35.995 collected before administration of fluids. 00:25:35.995 --> 00:25:36.496 What are your thoughts on those two cases? 00:25:36.496 --> 00:25:36.996 Hold that for the question and answer session. 00:25:36.996 --> 00:25:39.699 Let's look at a couple other cases that had been in 00:25:39.699 --> 00:25:42.402 the media recently. A woman died after receiving IV 00:25:42.402 --> 00:25:43.603 therapy in Frisco, Texas. 00:25:43.603 --> 00:25:46.572 This led to the licensure suspension for an 00:25:46.572 --> 00:25:48.041 anesthesiologist in that area. 00:25:48.041 --> 00:25:52.345 In another instance, a radio employee died after 00:25:52.345 --> 00:25:56.616 having a sudden cardiac death following IV treatment 00:25:56.616 --> 00:25:58.251 at a Medspa. 00:25:58.251 --> 00:26:04.857 The third incident involves a woman in Mississippi 00:26:04.857 --> 00:26:10.630 who died after being administered administered IV 00:26:10.630 --> 00:26:12.298 therapy in-home. 00:26:12.298 --> 00:26:16.536 This goes to show you that there are risks involved 00:26:16.536 --> 00:26:19.939 with administration of IV therapy, so you must 00:26:19.939 --> 00:26:23.743 adhere to the standard of practice, the scope of 00:26:23.743 --> 00:26:25.878 practice, when administering IV therapy. 00:26:25.878 --> 00:26:28.047 Thank you for your time and attention today. 00:26:28.047 --> 00:26:31.451 I am now open to any questions or discussions you 00:26:31.451 --> 00:26:32.151 may have. 00:26:32.151 --> 00:26:44.030 Before we conclude, however, here is a reference 00:26:44.030 --> 00:26:54.440 slide acknowledging the sources and references that 00:26:54.440 --> 00:27:00.380 have enriched our discussion. 00:27:00.380 --> 00:27:03.783 >> Michelle: Thank you so much for that excellent 00:27:03.783 --> 00:27:06.853 presentation, Phyllis, on a really hot topic that 00:27:06.853 --> 00:27:10.256 boards of nursing get question on almost weekly, is 00:27:10.256 --> 00:27:11.424 what I hear. 00:27:11.424 --> 00:27:14.360 Thanks for sharing this unique regulatory approach 00:27:14.360 --> 00:27:18.164 that you have taken in Mississippi, and I just 00:27:18.164 --> 00:27:22.802 wanted to get us started with a question as to who, 00:27:22.802 --> 00:27:26.205 what are your feelings about the benefits and 00:27:26.205 --> 00:27:28.741 drawbacks of this particular regulatory approach 00:27:28.741 --> 00:27:32.111 when you're collaborating with the Board of medicine 00:27:32.111 --> 00:27:34.213 and the board of pharmacy. 00:27:34.213 --> 00:27:36.482 >> Phyllis: Thank you, it's great to see you again 00:27:36.482 --> 00:27:36.983 today. 00:27:36.983 --> 00:27:40.720 In answer to that question, Mississippi has not been 00:27:40.720 --> 00:27:44.290 particularly in a drawback of being in collaboration 00:27:44.290 --> 00:27:48.761 with the Board of medical licensure and the Board of 00:27:48.761 --> 00:27:52.765 pharmacy. It provides an opportunity for us in a 00:27:52.765 --> 00:27:56.336 collaborative spirit to join forces and promote an 00:27:56.336 --> 00:27:59.005 interdisciplinary type of discussion about things 00:27:59.005 --> 00:28:02.575 that are happening within our state that are 00:28:02.575 --> 00:28:04.344 affecting our particular laws. 00:28:04.344 --> 00:28:09.182 One thing unique about Mississippi is that our law 00:28:09.182 --> 00:28:14.587 may have some caveats in it that, if we combined 00:28:14.587 --> 00:28:19.425 with the Board of medicine and board of pharmacy, 00:28:19.425 --> 00:28:24.797 there are laws to do our investigations in a more 00:28:24.797 --> 00:28:25.898 efficient manner. 00:28:25.898 --> 00:28:31.738 So it has been a great experience for us to be able 00:28:31.738 --> 00:28:35.608 to work together, to combine our resources together, 00:28:35.608 --> 00:28:39.512 and to go out together to investigate these 00:28:39.512 --> 00:28:43.883 complaints that we usually get from people in the 00:28:43.883 --> 00:28:48.254 public arena that helps ensure we have an optimal 00:28:48.254 --> 00:28:52.625 patient outcome when we work together and do these 00:28:52.625 --> 00:28:53.126 investigations. 00:28:53.126 --> 00:28:58.798 It also provides for safe administration of IV 00:28:58.798 --> 00:28:59.499 therapy. 00:28:59.499 --> 00:29:00.900 >> Michelle: Thank you. 00:29:00.900 --> 00:29:08.141 Next question, does this framework have a role in 00:29:08.141 --> 00:29:11.344 other APRN regulatory efforts? 00:29:11.344 --> 00:29:13.713 >> Phyllis: I would think, Michelle, that it does 00:29:13.713 --> 00:29:14.514 have a role. 00:29:14.514 --> 00:29:17.650 This framework could work and other regulatory 00:29:17.650 --> 00:29:18.151 efforts. 00:29:18.151 --> 00:29:22.088 Again, we have to remember that, as regulators, our 00:29:22.088 --> 00:29:26.092 primary objective is to protect the public, and IV 00:29:26.092 --> 00:29:29.629 hydration, although it is something that nurses use 00:29:29.629 --> 00:29:33.633 in their everyday component of being a nurse, you 00:29:33.633 --> 00:29:38.071 have to be aware that there are adverse risks or 00:29:38.071 --> 00:29:42.975 events that can occur from the use of IVs, even in 00:29:42.975 --> 00:29:46.512 the hospital setting, the clinic setting, and the 00:29:46.512 --> 00:29:47.413 appropriate settings. 00:29:47.413 --> 00:29:54.120 It is so important that our licensees understand 00:29:54.120 --> 00:29:54.987 that. 00:29:54.987 --> 00:29:58.758 So this framework could possibly work, and the 00:29:58.758 --> 00:30:02.095 framework is us working together and using 00:30:02.095 --> 00:30:04.931 evidence-based research to go into these 00:30:04.931 --> 00:30:09.702 investigations, to look at what is being done in the 00:30:09.702 --> 00:30:14.440 clinics, and then to make a determination as to, is 00:30:14.440 --> 00:30:16.809 the safe practice or not? 00:30:16.809 --> 00:30:19.412 All states have different laws, and that's the 00:30:19.412 --> 00:30:22.315 thing. What works for Mississippi may have to be 00:30:22.315 --> 00:30:24.917 tweaked in another state, because laws are different 00:30:24.917 --> 00:30:26.219 from state to state. 00:30:26.219 --> 00:30:30.256 Our laws allow us that opportunity to work together, 00:30:30.256 --> 00:30:35.228 so whatever your law would allow you to do, I think 00:30:35.228 --> 00:30:40.166 you can take this framework and tweak it to fit your 00:30:40.166 --> 00:30:43.770 particular state laws and get some great outcomes 00:30:43.770 --> 00:30:44.671 from that. 00:30:44.671 --> 00:30:48.107 >> Michelle: Thank you. Next question, what barriers 00:30:48.107 --> 00:30:51.944 did you face when you begin your collaboration with 00:30:51.944 --> 00:30:54.113 the pharmacy and medical boards? 00:30:54.113 --> 00:30:59.519 >> Phyllis: I think we are a little bit unique in 00:30:59.519 --> 00:31:03.456 Mississippi, in that, when you talk about barriers 00:31:03.456 --> 00:31:08.895 that we faced, we have been able to meet over the 00:31:08.895 --> 00:31:09.896 past years. 00:31:09.896 --> 00:31:13.800 We have what we call our own tri- regulated meetings 00:31:13.800 --> 00:31:16.169 you have on a monthly basis. 00:31:16.169 --> 00:31:21.407 So this is something we have been doing and it has 00:31:21.407 --> 00:31:26.212 worked very well for us on other entities, not just 00:31:26.212 --> 00:31:30.983 IV hydration, that other entities that we go out and 00:31:30.983 --> 00:31:34.821 investigate together. So we meet monthly, we meet 00:31:34.821 --> 00:31:37.690 with our investigator division, we discussed 00:31:37.690 --> 00:31:41.961 concerns or issues affecting us, because, as you are 00:31:41.961 --> 00:31:44.831 aware, Mississippi is a collaborative state. 00:31:44.831 --> 00:31:46.299 APRN cannot practice independent Lee. 00:31:46.299 --> 00:31:50.069 They must have a collaborative physician and they 00:31:50.069 --> 00:31:53.406 must meet certain stipulations and requirements that 00:31:53.406 --> 00:31:57.677 our law dictates in order to practice in that 00:31:57.677 --> 00:32:01.447 collaborative agreement. So it was only fitting that 00:32:01.447 --> 00:32:04.784 all three regulatory components, pharmacy, the Board 00:32:04.784 --> 00:32:09.055 of medicine, and the board of nursing, should work 00:32:09.055 --> 00:32:11.891 together and collaborate during our investigation. 00:32:11.891 --> 00:32:15.194 These joint investigations have been very efficient, 00:32:15.194 --> 00:32:19.465 very productive, and I think the patient outcome has 00:32:19.465 --> 00:32:23.736 been enhanced by us all working together and going 00:32:23.736 --> 00:32:26.105 out and doing these investigations. 00:32:26.105 --> 00:32:30.043 >> Michelle: Thank you. 00:32:30.043 --> 00:32:34.747 Can you share the specifics of the physical practice 00:32:34.747 --> 00:32:38.384 requirement for the out-of-state physicians in your 00:32:38.384 --> 00:32:39.952 example in Mississippi? 00:32:39.952 --> 00:32:43.690 >> Phyllis: Our example in Mississippi -- again, the 00:32:43.690 --> 00:32:46.959 Board of medical licensure rules and regulations -- 00:32:46.959 --> 00:32:51.664 the physician has to be licensed in the state of 00:32:51.664 --> 00:32:54.467 Mississippi, and they have specific mileage 00:32:54.467 --> 00:32:57.737 requirements if they are operating a specialty 00:32:57.737 --> 00:33:01.941 clinic and not in a general practice or hospital 00:33:01.941 --> 00:33:02.442 setting. 00:33:02.842 --> 00:33:08.681 In the case study that was mentioned, this 00:33:08.681 --> 00:33:12.352 particular physician violated the mileage 00:33:12.352 --> 00:33:17.457 requirement for collaborating with the nurse that 00:33:17.457 --> 00:33:21.861 had this particular IV hydration business. 00:33:21.861 --> 00:33:23.696 >> Michelle: Okay, thank you. 00:33:23.696 --> 00:33:30.069 How do you balance the competing goals of ensuring 00:33:30.069 --> 00:33:35.041 public protection and regulation while allowing for 00:33:35.041 --> 00:33:36.476 safe innovation? 00:33:36.476 --> 00:33:41.881 >> Phyllis: Asked me that question again. 00:33:41.881 --> 00:33:42.382 >> Michelle: 00:33:42.382 --> 00:33:42.949 [Laughs] 00:33:42.949 --> 00:33:46.953 The question is, how do you balance between ensuring 00:33:46.953 --> 00:33:49.622 public protection, regulating APRNs, and still 00:33:49.622 --> 00:33:51.391 allowing for safe innovation? 00:33:51.391 --> 00:33:53.926 It's a good question. 00:33:53.926 --> 00:33:54.427 A tough one. 00:33:54.427 --> 00:33:58.664 >> Phyllis: Boy, that is a tough question. But it is 00:33:58.664 --> 00:34:00.266 a very good question. 00:34:00.266 --> 00:34:05.505 I approach everything in my job as the regulator 00:34:05.505 --> 00:34:08.408 from a public protection standpoint. 00:34:08.408 --> 00:34:13.479 The other thing that I also utilize is, is it 00:34:13.479 --> 00:34:14.013 evidence-based? 00:34:14.013 --> 00:34:17.050 Whatever they are doing, is it evidence-based? 00:34:17.050 --> 00:34:21.220 To be have a standard of care? 00:34:21.220 --> 00:34:23.856 Are we adhering to a standard of practice guideline? 00:34:23.856 --> 00:34:25.625 What does the data show? 00:34:25.625 --> 00:34:29.896 What does the evidence show in doing that? 00:34:29.896 --> 00:34:34.300 So when you say, how do I balance that, I approach 00:34:34.300 --> 00:34:38.705 it with that mindset that we are here to protect the 00:34:38.705 --> 00:34:39.205 public. 00:34:39.205 --> 00:34:44.110 We educate our staff, we go out and we do 00:34:44.110 --> 00:34:47.647 presentations at conferences, not only to our 00:34:47.647 --> 00:34:52.652 licensees but to anyone who invites us out to talk 00:34:52.652 --> 00:34:53.653 about regulations. 00:34:53.653 --> 00:34:56.923 And we do have a public that wants us to come out 00:34:56.923 --> 00:34:59.659 and talk about what our nurses are doing and what 00:34:59.659 --> 00:35:02.628 things we look for when we go out to do that. 00:35:02.628 --> 00:35:06.032 So that's a tough question, but I think, if you 00:35:06.032 --> 00:35:08.735 always approach it from that mindset as a 00:35:08.735 --> 00:35:11.437 regulator -- and I am a practitioner, as well. 00:35:11.604 --> 00:35:14.407 I'm a family nurse practitioner and, believe it or 00:35:14.407 --> 00:35:17.176 not, would have time, I still try to practice 00:35:17.176 --> 00:35:19.345 because I love taking care of patients. 00:35:19.345 --> 00:35:23.016 But I also follow that same mindset when I'm taking 00:35:23.016 --> 00:35:26.285 care of this patient, educating them as well as 00:35:26.285 --> 00:35:28.855 these new things that are coming out. 00:35:28.855 --> 00:35:32.725 Patients always want to try them, but is it the best 00:35:32.725 --> 00:35:33.793 for the patient? 00:35:33.793 --> 00:35:38.431 So I try to balance that through education, through 00:35:38.431 --> 00:35:43.536 remembering that dumb I quit my job is as a 00:35:43.536 --> 00:35:48.174 regulator, and in that respect, as a patient care 00:35:48.174 --> 00:35:53.312 provider, I can be an advocate for my patients and 00:35:53.312 --> 00:35:54.847 for patient care. 00:35:54.847 --> 00:35:58.484 So with technology and medicine evolving, there's a 00:35:58.484 --> 00:36:03.489 lot of things that are happening and we have to just 00:36:03.489 --> 00:36:08.027 make sure that the evidence is there to support what 00:36:08.027 --> 00:36:09.862 our licensees are doing. 00:36:09.862 --> 00:36:12.298 And it's not that all the clinics in Mississippi are 00:36:12.298 --> 00:36:14.033 not doing what they're supposed be doing. 00:36:14.033 --> 00:36:18.237 We do have a couple of clinics in the state that 00:36:18.237 --> 00:36:22.075 reach out to the Board of nursing because it's a 00:36:22.075 --> 00:36:22.575 business. 00:36:22.575 --> 00:36:23.209 Anyone can own a business. 00:36:23.209 --> 00:36:26.279 They don't try to prohibit that. 00:36:26.279 --> 00:36:29.882 We just make sure that you are doing what a nurse 00:36:29.882 --> 00:36:33.486 should do and if you are operating as a nurse, you 00:36:33.486 --> 00:36:37.390 are bound by the nurse practice act. So we do have a 00:36:37.390 --> 00:36:40.326 couple of clinics who have done everything as they 00:36:40.326 --> 00:36:43.596 are supposed to do them and are doing these clinics 00:36:43.596 --> 00:36:44.897 in a safe manner. 00:36:44.897 --> 00:36:49.068 >> Michelle: Thank you. Next question, "I work with 00:36:49.068 --> 00:36:53.740 new N Ps you might not have the experience to 00:36:53.740 --> 00:36:56.976 identify practices with potential regulatory risks. 00:36:56.976 --> 00:37:01.180 What would you recommend for a new APRNs or 00:37:01.180 --> 00:37:03.516 entrepreneurs interested in offering novel 00:37:03.516 --> 00:37:07.220 approaches to the delivery of health care services 00:37:07.220 --> 00:37:11.424 to ensure that they are well within the regulatory 00:37:11.424 --> 00:37:11.924 requirements?" 00:37:11.924 --> 00:37:14.861 >> Phyllis: The first thing I would recommend is 00:37:14.861 --> 00:37:17.497 that, whatever state they are practicing in, that 00:37:17.497 --> 00:37:21.167 they reach out to that board of nursing or they are 00:37:21.167 --> 00:37:24.470 well-versed in what the law says they can or cannot 00:37:24.470 --> 00:37:24.971 do. 00:37:24.971 --> 00:37:27.407 What is their defined scope of practice? 00:37:27.407 --> 00:37:32.145 That too is a good question because we do an 00:37:32.145 --> 00:37:34.514 orientation class to all APRNs. 00:37:34.514 --> 00:37:39.619 It is here at the Board of nursing. COVID had us go 00:37:39.619 --> 00:37:43.456 to Zoom, but it can be held in person. 00:37:43.456 --> 00:37:46.459 All new graduates are required to take this 00:37:46.459 --> 00:37:49.862 orientation course, and recover all of the rules and 00:37:49.862 --> 00:37:52.532 regulations, the laws, scope of practice issues, 00:37:52.532 --> 00:37:54.801 things they can and cannot do. 00:37:54.801 --> 00:37:59.038 But I think educating them from a regulatory 00:37:59.038 --> 00:38:03.309 standpoint is really important, because, when I came 00:38:03.309 --> 00:38:08.081 out, I didn't know everything there was to know. 00:38:08.081 --> 00:38:14.687 I worked in federal government for a while so I 00:38:14.687 --> 00:38:19.959 ended up learning the thank federal regulations as 00:38:19.959 --> 00:38:23.262 well as the state regulations. 00:38:23.262 --> 00:38:25.932 You tend to operate within those confines a lot 00:38:25.932 --> 00:38:28.601 better, and the patient outcomes are a lot better. 00:38:28.601 --> 00:38:31.637 It protects you and it protects the patient, as 00:38:31.637 --> 00:38:32.138 well. 00:38:32.138 --> 00:38:34.841 So I think education is key. 00:38:34.841 --> 00:38:37.677 Whatever realm you feel the education should be 00:38:37.677 --> 00:38:41.214 provided, be it in the clinic they are going into, 00:38:41.214 --> 00:38:44.417 educating them about the type of patients being seen 00:38:44.417 --> 00:38:48.321 there, but it is they can and cannot do within that 00:38:48.321 --> 00:38:50.089 facility, things of that nature. 00:38:50.089 --> 00:38:55.261 So education and communication are key roles to play 00:38:55.261 --> 00:39:01.034 with our new NPs coming out, especially if they are 00:39:01.034 --> 00:39:06.239 going to enter into novice innovation such as IV 00:39:06.239 --> 00:39:10.276 hydration or other new techniques coming out. 00:39:10.276 --> 00:39:14.847 We have a lot of nurses coming out that want to do 00:39:14.847 --> 00:39:18.284 things, we have the decision tree we have them 00:39:18.284 --> 00:39:22.088 utilize on our website, and if we run into the 00:39:22.088 --> 00:39:25.124 problem with the decision tree model, where they 00:39:25.124 --> 00:39:28.194 can't advance and notify the board of nursing. 00:39:28.194 --> 00:39:31.798 I think it is key that we educate our young nurses 00:39:31.798 --> 00:39:35.368 or new NPs coming out in general about what they can 00:39:35.368 --> 00:39:38.304 and cannot do, and define what that scope of 00:39:38.304 --> 00:39:39.639 practice is for them. 00:39:39.639 --> 00:39:43.743 Our scope of practice is defined in our law pretty 00:39:43.743 --> 00:39:47.447 much as to what they can and cannot do. 00:39:47.447 --> 00:39:48.581 >> Michelle: Thank you. 00:39:48.581 --> 00:39:52.352 We have a couple questions around the same topic, so 00:39:52.352 --> 00:39:56.122 I'm going to combine a couple of questions. How 00:39:56.122 --> 00:39:58.024 does telehealth impact IV prescribing? 00:39:58.024 --> 00:40:01.494 Can a licensed provider conduct an assessment via 00:40:01.494 --> 00:40:05.431 telehealth with a nurse in an IV hydration clinic? 00:40:05.431 --> 00:40:10.403 >> Phyllis: In answer to that question, yes, they 00:40:10.403 --> 00:40:10.970 can. 00:40:10.970 --> 00:40:15.842 We at the board of nursing, a telehealth visit to us 00:40:15.842 --> 00:40:17.643 is a face-to-face visit. 00:40:17.643 --> 00:40:21.314 You've done an assessment on the patient, and then 00:40:21.314 --> 00:40:24.984 there must be documentation of that visit in some 00:40:24.984 --> 00:40:28.254 form or fashion in your electronic medical records. 00:40:28.254 --> 00:40:33.826 But, in answer to the question, yes, telehealth is 00:40:33.826 --> 00:40:36.295 considered a face-to-face business. 00:40:36.295 --> 00:40:39.499 It can be utilized as long as you are doing that 00:40:39.499 --> 00:40:40.666 assessment on the patient. 00:40:40.666 --> 00:40:43.369 It's when they don't utilize the telehealth and 00:40:43.369 --> 00:40:46.372 don't do an assessment, that they have no knowledge 00:40:46.372 --> 00:40:49.742 of the patient, but the issue it through a third 00:40:49.742 --> 00:40:53.112 party to say this is what this patient has chosen. 00:40:53.112 --> 00:40:56.482 What we are finding out is that the patient just 00:40:56.482 --> 00:41:00.153 goes and says, I want that from the menu, I want 00:41:00.153 --> 00:41:03.523 that from the menu, and they have a standing order 00:41:03.523 --> 00:41:06.893 that says, if they choose this, you give a list. 00:41:06.893 --> 00:41:08.194 That's not really safe practice. 00:41:08.194 --> 00:41:11.597 Because you don't know what kind of history this 00:41:11.597 --> 00:41:13.866 individual has, what underlying health conditions 00:41:13.866 --> 00:41:17.303 they may have. Everybody wants to look good, 00:41:17.303 --> 00:41:21.074 everybody wants to feel good, so if I advertise I 00:41:21.074 --> 00:41:25.611 can make you look good and feel good, if I want to 00:41:25.611 --> 00:41:29.415 feel good I might go and select something from that 00:41:29.415 --> 00:41:29.916 menu. 00:41:29.916 --> 00:41:37.223 However, they need to follow all the components of 00:41:37.223 --> 00:41:39.692 good provider care. 00:41:39.692 --> 00:41:42.228 That's that patient relationship, developing some 00:41:42.228 --> 00:41:45.198 type of relationship, having the specific assessment 00:41:45.198 --> 00:41:49.435 on that patient, be it in person or via telehealth, 00:41:49.435 --> 00:41:53.673 and executing the other things you need to do in 00:41:53.673 --> 00:41:57.043 order to ensure that patient needs that particular 00:41:57.043 --> 00:42:00.446 item that they have selected from your menu. 00:42:00.446 --> 00:42:04.250 >> Michelle: And just to add a little detail to your 00:42:04.250 --> 00:42:07.020 response, and going back to something you said 00:42:07.020 --> 00:42:09.422 earlier, in Mississippi that telehealth visit would 00:42:09.422 --> 00:42:12.191 count, but maybe in other jurisdictions in other 00:42:12.191 --> 00:42:13.226 states it doesn't. 00:42:13.226 --> 00:42:16.662 Just to clarify that you are speaking to 00:42:16.662 --> 00:42:18.798 Mississippi, just for our attendees. 00:42:18.798 --> 00:42:24.070 Eve already said that before. I just wanted to 00:42:24.070 --> 00:42:24.637 reiterate. 00:42:24.637 --> 00:42:29.976 Another question, how do you see this modality going 00:42:29.976 --> 00:42:32.311 forward, or possibly expanding? 00:42:32.311 --> 00:42:35.381 And also, excellent presentation, is in the 00:42:35.381 --> 00:42:35.882 comments. 00:42:35.882 --> 00:42:41.087 Any thoughts on that, Dr. Johnson? On what you see 00:42:41.087 --> 00:42:45.291 the future of this type of IV hydration? 00:42:45.291 --> 00:42:48.795 >> Phyllis: I will just say this, I know Michelle 00:42:48.795 --> 00:42:52.632 and I were involved -- I think it was last June or 00:42:52.632 --> 00:42:54.000 July, in a conference. 00:42:54.200 --> 00:42:55.401 It was a webinar. 00:42:55.401 --> 00:42:58.338 Hopefully many of the people on this call remember 00:42:58.338 --> 00:42:59.005 that webinar. 00:42:59.005 --> 00:43:03.176 But I worked with Michelle on this and they have 00:43:03.176 --> 00:43:07.380 done a lot of research in NCSBN. So I appreciate 00:43:07.380 --> 00:43:07.880 that. 00:43:07.880 --> 00:43:11.017 There's exponential growth growth in this particular 00:43:11.017 --> 00:43:14.687 sector. I was looking at my notes earlier. 00:43:14.687 --> 00:43:18.958 Last year, a Google search for nurse and IV 00:43:18.958 --> 00:43:21.794 hydration yielded over 31 million results. 00:43:21.794 --> 00:43:23.996 That was last year. 00:43:23.996 --> 00:43:29.369 So here we are a year later, almost, and you have 00:43:29.369 --> 00:43:34.273 the presence of mobile IVs, all of them are offering 00:43:34.273 --> 00:43:37.210 this IV hydration, and on-call infusion 00:43:37.210 --> 00:43:41.114 administration where they will come to your home. 00:43:41.114 --> 00:43:45.485 This has exponential growth and I see it continuing 00:43:45.485 --> 00:43:46.486 to grow. 00:43:46.486 --> 00:43:51.491 Financially it has impacted a lot of individuals' 00:43:51.491 --> 00:43:53.993 lives. It's a business. 00:43:53.993 --> 00:43:57.030 So I think we will continue to see growth in this 00:43:57.030 --> 00:43:57.530 arena. 00:43:57.530 --> 00:44:00.366 Here's the caveat, though. 00:44:00.366 --> 00:44:03.569 Regulators have to consider the risks. 00:44:03.569 --> 00:44:05.438 I'm speaking from a regulator component. 00:44:05.438 --> 00:44:10.443 We need to consider the risk to public protection. 00:44:10.443 --> 00:44:13.279 If we have licensees or individuals that sometimes 00:44:13.279 --> 00:44:16.516 on these clinics that have no health background, no 00:44:16.516 --> 00:44:19.352 nursing background, it's just business for them, and 00:44:19.352 --> 00:44:22.922 some of these we have no jurisdiction over, but they 00:44:22.922 --> 00:44:26.492 are giving IV therapy and they are not a medical 00:44:26.492 --> 00:44:27.560 provider at all. 00:44:27.560 --> 00:44:33.700 So that, again, is something outside of our realm, 00:44:33.700 --> 00:44:38.438 but it is a public protection component. 00:44:38.438 --> 00:44:40.673 So we follow evidence-based standards. 00:44:40.673 --> 00:44:43.309 Performing a patient history, including medications 00:44:43.309 --> 00:44:46.412 and allergies, documentation of the treatment that 00:44:46.412 --> 00:44:49.916 is being provided, and preparation to manage any 00:44:49.916 --> 00:44:51.684 complication which may occur. 00:44:51.684 --> 00:44:56.189 If you remember, on one of the slides I mentioned 00:44:56.189 --> 00:45:00.693 that one of the adverse events that had occurred was 00:45:00.693 --> 00:45:04.731 in Mississippi where a licensee went to a friend's 00:45:04.731 --> 00:45:06.999 home and administered IV therapy. 00:45:06.999 --> 00:45:10.870 And an ambulance had to be called to take the 00:45:10.870 --> 00:45:14.374 patient to the emergency room, and the patient did 00:45:14.374 --> 00:45:14.874 expire. 00:45:14.874 --> 00:45:16.109 I did not follow up on this. 00:45:16.109 --> 00:45:19.712 I don't have any information for you as to what the 00:45:19.712 --> 00:45:21.047 cause of death was. 00:45:21.047 --> 00:45:24.050 But it was so closely related to the IV 00:45:24.050 --> 00:45:26.386 administration that you could make an assumption, 00:45:26.386 --> 00:45:29.022 maybe this has something to do with it. 00:45:29.022 --> 00:45:32.759 What was the underlying health reason or health 00:45:32.759 --> 00:45:35.094 factors that this patient had? 00:45:35.094 --> 00:45:39.632 So we have to make sure that we are following the 00:45:39.632 --> 00:45:42.935 standard of care in providing care to individuals 00:45:42.935 --> 00:45:45.838 that are out there receiving IV therapy. 00:45:45.838 --> 00:45:50.510 The issue of scope of practice is one of the major 00:45:50.510 --> 00:45:52.645 things that we encounter here. 00:45:52.645 --> 00:45:55.915 The scope of practice, LPNs, we have rules and 00:45:55.915 --> 00:45:56.416 regulations. 00:45:56.416 --> 00:46:01.921 They can own an IV therapy clinic, they can own 00:46:01.921 --> 00:46:04.190 anything they want to. 00:46:04.190 --> 00:46:08.895 But if you are an LPN and you are practicing in that 00:46:08.895 --> 00:46:12.031 particular IV therapy business, what are you doing 00:46:12.031 --> 00:46:13.199 as an LPN? 00:46:13.199 --> 00:46:16.602 Because we have rules and regulations that stipulate 00:46:16.602 --> 00:46:21.240 what they can do with IVs. So we have individuals we 00:46:21.240 --> 00:46:24.644 end up disciplining because they are doing things 00:46:24.644 --> 00:46:26.746 outside their scope of practice. 00:46:26.746 --> 00:46:32.185 We have been fortunate enough that most of the 00:46:32.185 --> 00:46:36.422 violations that we have investigated, that we 00:46:36.422 --> 00:46:40.026 encounter, our scope of practice issues. 00:46:40.026 --> 00:46:43.730 There does not functioning within the scope of 00:46:43.730 --> 00:46:46.466 practice as defined by our law. 00:46:46.466 --> 00:46:47.400 >> Michelle: Thank you. 00:46:47.400 --> 00:46:52.839 We have time for just one more short question, 00:46:52.839 --> 00:46:53.439 Phyllis. 00:46:53.439 --> 00:46:57.210 That question is, you mentioned earlier kind of the 00:46:57.210 --> 00:47:00.580 shift from the health care provider, the APRN, 00:47:00.580 --> 00:47:03.950 ordering and determining what type of treatment is 00:47:03.950 --> 00:47:07.754 required to the shift is somebody going and choosing 00:47:07.754 --> 00:47:09.422 something off the menu. 00:47:09.422 --> 00:47:15.561 Could you respond to that briefly before we are out 00:47:15.561 --> 00:47:16.796 of time? 00:47:16.796 --> 00:47:19.732 >> Phyllis: Well, again, that goes to the standard 00:47:19.732 --> 00:47:20.366 of care. 00:47:20.366 --> 00:47:24.437 If they are just selecting something off the menu, 00:47:24.437 --> 00:47:28.941 again, you don't know what that person has is an 00:47:28.941 --> 00:47:32.979 underlying health issue. It's not safe to be going 00:47:32.979 --> 00:47:37.050 around with a mobile clinic on golf courses, putting 00:47:37.050 --> 00:47:42.021 up tents, and hanging IVs. It costs a lot of money 00:47:42.021 --> 00:47:46.059 for you to select from these menus, so you 00:47:46.059 --> 00:47:49.662 understand that this fluid is probably being -- so 00:47:49.662 --> 00:47:53.800 that the issue, follow the standard of care is. 00:47:53.800 --> 00:47:56.569 What should you do as a health care provider? 00:47:56.569 --> 00:47:59.672 He follow the steps and rules and regulations, the 00:47:59.672 --> 00:48:02.742 administration of the IV therapy will be within the 00:48:02.742 --> 00:48:06.179 confines of the standard of care. But we are just 00:48:06.179 --> 00:48:07.213 not seeing that. 00:48:07.213 --> 00:48:11.984 >> Phyllis: Thank you so much for an excellent 00:48:11.984 --> 00:48:14.120 presentation, really interesting and 00:48:14.120 --> 00:48:17.323 thought-provoking responses to our questions from 00:48:17.323 --> 00:48:18.391 our attendees. 00:48:18.391 --> 00:48:19.726 Thank you so much, Dr. Johnson. 00:48:19.726 --> 00:48:22.028 >> Phyllis: Thank you.