ANNUAL REPORT Florida Board of the Coalition for Medical Marijuana Research and Education

Transcription

1 ANNUAL REPORT Florida Board of the Coalition for Medical Marijuana Research and Education

2 A Message from Dr. Thomas Sellers A Message from Dr. Nagi Kumar Dr. Thomas Sellers Chair, Medical Marijuana Research and Education Board Dr. Nagi Kumar Executive Director, Coalition for Medical Marijuana Research and Education The H. Lee Moffitt Cancer Center is committed to uphold the state mandate to establish the coalition for Medical Marijuana Research and Education. We accept the challenge to conduct rigorous scientific research, provide professional and public education, and disseminate evolving research that would ultimately guide policy for the adoption of a statewide policy on ordering and dosing practices for the medical use of marijuana. The critical role of the Board mandates a strategy above reproach and informed by science. Thus, in establishing Board members we sought scientists and practitioners from leading academic institutions and care providers from across the state. We deliberately excluded any members with a known conflict of interest or the appearance of an agenda that could detract from the requirement that the work of the Board be guided by impartiality and judgement based on objective evidence. The framework for the Board was influenced significantly by a consensus report of the available scientific evidence and identified gaps that were generated by an expert committee from the National Academies of Science, Engineering and Medicine. Entitled The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research provided a robust and comprehensive review and roadmap to maximize the benefits of the state investment and efforts. I d like to thank the Board members, the Executive Director, Dr. Nagi Kumar, and the expert support of staff, especially Dr. Bobbie McKee, for their commitment and efforts. We all hope that our efforts contribute to high quality research that produces new knowledge to impact policy for the benefit of our fellow citizens. As of January 2018, twenty-nine (29) states and the District of Columbia in the United States have legalized marijuana for the treatment of medical conditions. The State of Florida legalized Marijuana in There are currently 63,896 residents of the State of Florida in the Medical Marijuana Registry and 883 qualified physicians treating their patients for varied medical indications (Department of Health, December 2017). However, there continues to be a significant gap in empirical research that demonstrates the safety, effectiveness and mechanism of action by which marijuana can be used in specific medical indications. For example, there is no consistent data on concurrent use of marijuana with other standard therapies as well as harms in increasing symptoms or risk of other diseases. Most importantly, there are few data from randomized clinical trials to establish effectiveness of active components in marijuana required for treatment. Based on the lack of definitive evidence, marijuana continues to be classified as a Schedule I agent (drug with a high potential for abuse and no accepted medical use) by the Drug Enforcement Agency. The Food and Drug Administration has not approved use of marijuana as a treatment for any medical condition. The gaps in research, the public support for legalization of marijuana for medical use, the accessibility and increased availability of pharmagrade marijuana for medical use at the approved dispensaries in the State of Florida, have raised concerns among health professionals and the public with regard to public safety. Earlier in 2017, Senate Bill 8A was passed approving the establishment of this Coalition for medical marijuana Research and Education in the State of Florida. The purpose of the coalition for Medical Marijuana Research and Education is to conduct rigorous scientific research, provide professional and public education, and disseminate evolving research that would ultimately guide policy for the adoption of a statewide policy on ordering and dosing practices for the medical use of marijuana. The State funded coalition seeks to stimulate rigorous scientific research and dissemination of results statewide as well as nationally. The Florida Department of Health s (DOH) top priority is the health and safety of Florida s families. Aligned with the goals of the State of Florida and guided by the leadership of our Board of Directors, my team and I are enthusiastic and dedicated to contribute to producing a comprehensive evidence base on the short- and long-term health effects of marijuana for medical use, addressing key gaps in the evidence base.

3 Annual Report Table of Contents Executive Summary Page 4 Florida Coalition for Medical Marijuana Research and Education Overview Page 5 Medical Marijuana Research and Education Board Members Page 6 Medical Marijuana Research and Education Plan Page 7 Research and Education Projects Page 10 Community Outreach Page 12 Future Plans of the Coalition Page 13 3

4 Executive Summary In June 2017, Senate Bill (SB) 8A, the Medical Use of Marijuana Act, was passed by the Florida Legislature and subsequently signed into law by Governor Scott. Among the provisions in SB 8A was the creation of s , F.S., which established the Coalition for Medical Marijuana Research and Education within the H. Lee Moffitt Cancer Center and Research Institute, Inc., and the Medical Marijuana Research and Education Board to direct the operations of the Coalition. For Fiscal Year , a state appropriation of $750,000 was provided for the Coalition for Medical Marijuana Research and Education. The seven Medical Marijuana Research and Education Board members were appointed by Alan F. List, M.D., President and CEO of the Moffitt Cancer Center, on August 18, The first for Medical Marijuana Research and Education Board meeting was held on October 30, At this meeting, the Board: Approved the Coalition s Charter Appointed Thomas Sellers, Ph.D., M.P.H. as the Board s Chair Appointed Almut Winterstein, R.Ph., Ph.D., FISPE as the Board s Vice Chair Appointed Nagi B. Kumar, Ph.D., R.D., FADA as the Coalition Director Approved the Medical Marijuana Research and Education Plan Approved the Coalition budget for FY Approved the FY funding request of $1.75 million The purpose of the Coalition is to conduct rigorous scientific research, provide education, disseminate research, and guide adoption of a statewide policy on education and clinical practice for the he medical use of marijuana in the State of Florida. The primary goals of the Coalition are to (a) Identify and prioritize the research to be conducted through the Coalition aimed at developing a comprehensive evidence base on the short-and long-term health effects of marijuana for medical use, addressing the key gaps in the evidence base; (b) Coalesce and organize national resources and develop additional education resources to improve current knowledge of professionals and the general public, patients and caretakers in the State of Florida on medical marijuana use for specific indications. New and innovative research and education projects will be funded by the Coalition. The Board of Medicine and the Board of Osteopathic Medicine, supported by the Boards, the Division of Medical Quality Assurance, and the Office of Medical Marijuana Use were charged in section (4)(g), Florida Statutes, to oversee the registry from which data on Medical Marijuana referral and use in the State of Florida are collected. This data is to be forwarded to the Coalition. The Coalition will utilize results evolving from the innovative research conducted by the Coalition grantees as well as the data received from the State of Florida Registry to develop a comprehensive evidence base on the short- and long-term health effects of marijuana for medical use, addressing the key gaps in the evidence base. We emphasize the need for close collaboration with the Registry to ensure that scope, format, and infrastructure of data collection supports both its regulatory and research mission. The research will ultimately guide adoption of a statewide policy on education and clinical practice for the medical use of marijuana in the State of Florida. 4

5 Florida Coalition for Medical Marijuana Research and Education Overview Pursuant to section , Florida Statutes, the Coalition for Medical Marijuana Research and Education was established within the H. Lee Moffitt Cancer Center and Research Institute, Inc., and the Medical Marijuana Research and Education Board were established to direct the operations of the Coalition. The purpose of the Coalition is to conduct rigorous scientific research, provide education, disseminate research, and guide policy for the adoption of a statewide policy on ordering and dosing practices for the medical use of marijuana. The Medical Marijuana Research and Education Board is composed of seven members who are appointed to 4-year terms by the Chief Executive Officer of the H. Lee Moffitt Cancer Center and Research Institute, Inc., and have experience in a variety of scientific and medical fields. The Board is responsible for appointing a Coalition Director. The seven Medical Marijuana Research and Education Board members were appointed by Alan F. List, M.D., President and CEO of the Moffitt Cancer Center, on August 18, On October 30, 2017, the Board appointed Nagi B. Kumar, Ph.D., R.D., FADA as the Coalition Director. Dr. Kumar selected a multidisciplinary team of Moffitt research scientists, educators and clinicians termed the Coalition Faculty Steering Committee (CFSC) to collaborate on the establishment and implementation of the Coalition Research and Education Plan for FY The current CFSC members are: David Drobes, Ph.D., Senior Member, Health Outcomes & Behavior Kathleen Egan, Sc.D., Senior Member, Cancer Epidemiology Nicholas Lawrence, Ph.D., Senior Member, Drug Discovery Diane Portman, M.D., Department Chair, Supportive Care Medicine Solmaz Sahebjam, M.D., Associate Member, Neuro-Oncology The Coalition will recruit other multidisciplinary members from institutions around the State of Florida in the coming years. As experts in their field, additional roles of the Coalition Faculty Steering Committee will be to primarily support the review of research and education proposals submitted to the Coalition and to provide their recommendation for funding decisions by the Coalition Board. Per statute requirements, the Board must annually adopt a plan for medical marijuana research, known as the Medical Marijuana Research and Education Plan. The Coalition Director is responsible for preparing the Medical Marijuana Research and Education Plan for submission to the Board. The research and education efforts of the Coalition will ultimately guide adoption of a statewide policy on education and clinical practice for the medical use of marijuana in the State of Florida. 5

6 Medical Marijuana Research and Education Board Members Thomas Sellers, Ph.D., M.P.H., Chair Center Director & Executive Vice President Moffitt Cancer Center Almut Winterstein, R.Ph., Ph.D., FISPE, Vice Chair Professor & Chair, Department of Pharmaceutical Outcomes & Policy College of Pharmacy University of Florida Thomas Brandon, Ph.D. Chair, Department of Health Outcomes & Behavior Moffitt Cancer Center Jennifer Keehbauch, M.D., FAAFP Chief Medical Officer & Vice President Winter Park Memorial Hospital Leonard Rappa, Pharm.D., BCPP Professor, Pharmacy Practice & Psychiatry College of Pharmacy & Pharmaceutical Sciences Florida A&M University Sabita Roy, Ph.D. Professor, Department of Surgery Miller School of Medicine University of Miami Laufey Sigurdardottir, M.D. Physician, Division of Neurology Department of Pediatrics Nemours Childrens Hospital 6

7 Medical Marijuana Research and Education Plan (Approved by the Medical Marijuana Research and Education Board on October 30, 2017) OBJECTIVE 1: RESEARCH Identify and prioritize the research eligible to be conducted through the Coalition to develop a comprehensive evidence base on the short- and long-term health effects of marijuana for medical use, addressing the key gaps in the evidence base. All research conducted through the Coalition must be in compliance with the U.S. Drug Enforcement Administration (DEA) and the U.S. Food and Drug Administration (FDA) policies and regulations. Research conducted will, in addition, be approved by relevant Institutional Review Board/Institutional Animal Care and Use Committee (IRB/IACUC). Prioritized research streams and objectives may include, but shall not be limited to: 1a. Observational/Survey Research: Use observational research strategies to evaluate past history and current medical marijuana use, indication for use, bioavailability, potential beneficial and harmful health effects of using different forms of marijuana (such as inhaled [smoked or vaporized], tincture, sprays, suppositories, oils), among individuals prescribed medical marijuana. Document and evaluate statewide referral patterns, reported indications, benefits and adverse events with use of medicinal marijuana as a function of age, gender, race, locale, co-morbidities, other risk exposures, socio economic status and provider. Characterize public safety concerns related to medical marijuana use and evaluate existing quality assurance, safety, packaging and current standards for dispensing and patient education regarding medical marijuana products. Perform ecological evaluation contrasting statewide cause-specific death and morbidity rates in the calendar year preceding and year following passage of the law. Utilize the State of Florida Medical Marijuana Registry to characterize the health effects of medical marijuana dose and mode of administration on related overdoses and poisonings, traffic accidents, work productivity, depression, fatigue and other health endpoints. 1b. Education to improve knowledge of Health Professionals and the Public: Survey State of Florida health care providers on current state of knowledge regarding state medical and federal medical marijuana laws, perceived indications for medical marijuana, related evidence base, benefits and risks, barriers and facilitators to referral. Identify gaps in medical marijuana knowledge and related skills of health care and public health professionals and develop education programs to address these gaps. Evaluate public knowledge and understanding of known risks and benefits of medical and recreational marijuana use. Identify educational needs, develop educational programs and evaluate the impact over time. 1c. Laboratory Research: Apply state-of-the art techniques to screen phytochemical components of marijuana (and additives) and validate the potential targets in vitro and in vivo to inform potential use in specific medical use indications. Provide laboratory based evidence to determine whether medical marijuana use synergizes or antagonizes with prescribed drugs. Investigate the molecular mechanisms of these interactions and their clinical implications. 7

8 1d. Clinical Research: Informed by laboratory and preclinical studies, investigate the pharmacokinetic and pharmacodynamic properties of medical marijuana, modes of delivery, different concentrations, in various populations, including the dose response relationships of marijuana to other cannabinoids as monotherapies and in combination with standard treatment modalities. Conduct well-controlled phase I-III trials on the potential health effects of using different forms of marijuana, such as inhaled (smoked or vaporized), tincture, sprays, suppositories, oils etc.) targeting specific unstudied and understudied health endpoints. 1e. Health Policy and Health Economics Research: Identify models, including existing state marijuana policy models, for sustainable funding of national, state, and local public health surveillance systems. Investigate the economic impact of medical marijuana use on state public health and health care systems, health insurance providers, and patients. OBJECTIVE 2: PROFESSIONAL AND PUBLIC EDUCATION Build infrastructure to increase knowledge and understanding of current evidence on the short- and long-term health effects of marijuana use among health care professionals, policy makers, growers, marijuana dispensaries/pharmas, public, patients and caretakers. 2a. Health Care Guidelines Coalesce and organize national resources, including clinical practice guidelines [National Institute of Health (NIH) -National Institute of Drug Abuse (NIDA), National Cancer Institute (NCI), National Institute of Ageing (NIA), American Society of Clinical Oncology (ASCO), American Academy of Pediatrics (AAP), American Psychological Association (APA), etc.] and develop additional resources to improve knowledge on medical marijuana, targeting medical, pharmacological, nursing, paramedical and other health care professional groups in the state of Florida. Provide access to the most up-to-date research and clinical guidelines resources to guide clinical practice from national sources, including research results conducted through the Coalition. NCI: NIDA: 2b. Research Quality Conduct an annual, interactive workshop of multi-disciplinary leaders, to develop research standards and benchmarks to guide and ensure the production of high-quality medical marijuana research. Workshop objectives will include, but will not be limited to: The development of a minimum dataset for observational and clinical studies, standards for research methods and design, and guidelines for data collection methods. Adaptation of existing research-reporting standards to the needs of medical marijuana research. The development of uniform terminology for clinical and epidemiological medical marijuana research. The development of standardized and evidence-based question banks for clinical research and public health surveillance tools. 8

9 Determining the capacity to collect and reliably interpret data from diagnostic classification codes in administrative data (e.g., International Classification of Diseases-10). The establishment and utilization of state-based testing facilities to analyze the chemical composition of marijuana and products containing components of marijuana or other cannabinoids. The establishment and utilization of standardized protocols to analyze the chemical composition of marijuana and products containing components of marijuana. The development of novel diagnostic technologies that allow for rapid, accurate, and noninvasive assessment of marijuana exposure and impairment. Strategies for surveillance of harmful effects of marijuana for therapeutic use. 2c. Public Education Coalesce and organize national resources (NIH-NIDA, NCI, NIA, ASCO, AAP, APA, ANA etc.), and develop additional resources to improve current knowledge of the general public, patients and caretakers in the State of Florida on medical marijuana use (both beneficial and harmful effects) for specific indications. Provide access to the most up-to-date research and clinical guidelines resources that inform clinical practice from national sources. OBJECTIVE 3: REGULATORY ISSUES Convene a committee of experts including researchers, clinicians (ASCO, APA, ANA), regulatory (DEA, FDA, DOH) and funding organizations (State of Florida, NIH-NIDA, NCI, NIA) and task them to produce objective and evidence-based reports that fully characterize the impacts of regulatory barriers and propose strategies to mitigate these barriers. Committee objectives include, but are not be limited to proposing strategies to address: Patient barriers to the use of medical marijuana for approved indications. Clinician barriers to patient care. Research barriers, including access to research-grade marijuana. 9

10 Research and Education Projects (a) Innovative Research Projects: In , the Coalition will fund innovative pilot research and education projects. To eliminate delays due to the short funding period in , the first-year pilot funding opportunity available through the MMRE will be available to Moffitt faculty only. Research and education funding opportunities available from June 2018 onward will be available to all academic and research institutions in the State of Florida. All research and education projects conducted through the Coalition must be in compliance with the DEA and FDA policies and regulations. Review Process All applications will be reviewed and scored by a multidisciplinary team of research scientists, educators and clinicians termed the Coalition Faculty Steering Committee (CFSC). Based on the proposal received, the Faculty Steering Committee may include additional ad hoc reviewers as necessary. Projects will be reviewed on the strength of their scientific merit, innovation, measureable deliverables/milestones, potential impact, adherence to the areas of focus, qualifications of the Principal Investigator (PI), and potential to result in extramural funding or lead to informing clinical trial development or new guidelines. The CFSC will submit final critiques and scores to the Coalition Board of Directors for final award decision and funding. Timeline for submission, review and award of Research and Education Projects Fiscal Year : Letter of Intent (optional): January 15, 2018 Full Application: February 1, 2018 (4pm EST) Review of Applications by Faculty Steering Committee and Ad Hoc Reviewers: February 2-10, 2018 Review of final critique and scores for decision on funding by the Board: February 11-13, 2018 Award Announcements: February 14, 2018 Project Start Date: March 1, 2018 Project End Date: June 30, 2018 Proposals submitted to the Coalition for Medical Marijuana Research and Education Fiscal Year Grant Applicants Kristine M. Donovan, Ph.D. Diane G. Portman, M.D. David J. Drobes, Ph.D. Kathleen M. Egan, Sc.D. Research Projects Marijuana Use and Perceived Health Effects in Cancer Care Establishing a Research Program on Medical Marijuana and Tobacco Co-Use Medical Cannabis Use among Glioma Patients Treated at a FL-Based Comprehensive Cancer Center Institution Moffitt Cancer Center Moffitt Cancer Center Moffitt Cancer Center Proposals funded by the Coalition for Medical Marijuana Research and Education Fiscal Year Grant Recipient David J. Drobes, Ph.D. Research Projects Institution Moffitt Cancer Center Establishing a Research Program on Medical Marijuana and Tobacco Co-Use Kathleen M. Egan, Sc.D. Medical Cannabis Use among Glioma Patients Treated at a FL-Based Comprehensive Cancer Center Moffitt Cancer Center 10

11 (b) Evaluation and Reporting of Data from the State of Florida Medical Marijuana Registry: The Board of Medicine and the Board of Osteopathic Medicine were charged in section (4)(g), Florida Statutes (F.S.), to create a joint Physician Certification Pattern Review Panel (Panel) on medical marijuana in Florida. The Panel is responsible for reporting its findings and recommendations annually on January 1 to the Governor, the President of the Senate, and the Speaker of the House of Representatives. The Panel is supported by the Executive Directors to the Boards, the Division of Medical Quality Assurance (MQA), and the Office of Medical Marijuana Use (OMMU) oversees the registry from which data are collected. This data is to be forwarded to the Coalition for Medical Marijuana Research and Education. The Coalition Director has been working collaboratively with the Board of Medicine and the Board of Osteopathic Medicine, Bureau Chief, Executive Director, Board of Medicine and the Senior Management Analyst Supervisor, Bureau of Health Care Practitioner Regulation, Division of Medical Quality Assurance, Department of Health, to establish the (a) data elements to be completed by referring MDs/DOs and the (b) infrastructure required for secure and timely transfer of medical marijuana registry data from the state of Florida to the Coalition Research database. Recommendations have been provided by the Executive Director and the Faculty Steering Committee of the Coalition for enhancing the quality of data reported in the documentation submitted by referring physicians. Objective data regarding measurement of effectiveness (reduction in symptoms, reduction in other medication use), safety/ adverse events and any dose variation or mode of administration documented prior to renewing referral. The Medical Marijuana Research and Education Board of Directors emphasizes the critical importance of careful design of the registry to meet both its regulatory and research mission. The Board recommends that data elements and their structure are discussed jointly with the Office of Medical Marijuana and other constituencies to achieve the right balance between burden of data collection and scientific and public health value in ensuring the safety and adding evidence of about the effectiveness of medical marijuana. A data dictionary specifying each data element, its source and structure should be made available to allow researchers adequate insight for planning and design of observational studies that can address safety and effectiveness questions. Finally, the Board recommends that data transfer to the Coalition is organized directly with the Registry data vendor to accelerate data transfer for timely surveillance of medical marijuana utilization pattern and potential adverse outcomes. 11

12 Community Outreach (a) Establishment of a Website with updated information of the Coalition activities (b) Public and Professional Education Activities (i) Public Education Activities: Coalesced and organized national resources (NIH-NIDA, NCI, NIA, ASCO, AAP, APA, ANA etc.), and develop additional resources to improve current knowledge of the general public, patients and caretakers in the State of Florida on medical marijuana use (both beneficial and harmful effects) for specific indications. Provided access to the most up-to-date research and clinical guidelines resources that inform clinical practice from national sources. (ii) Professional Education Activities: Built infrastructure to increase knowledge and understanding of current evidence on the short- and long-term health effects of marijuana use among health care professionals, policy makers, growers, marijuana dispensaries/pharmas, public, patients and caretakers. Coalesced and organized national resources, including clinical practice guidelines [National Institute of Health (NIH) -National Institute of Drug Abuse (NIDA), National Cancer Institute (NCI), National Institute of Ageing (NIA), American Society of Clinical Oncology (ASCO), American Academy of Pediatrics (AAP), American Psychological Association (APA), etc.] and develop additional resources to improve knowledge on medical marijuana, targeting medical, pharmacological, nursing, paramedical and other health care professional groups in the State of Florida. Provided access to the most up-to-date research and clinical guidelines resources to guide clinical practice from national sources, including research results conducted through the Coalition. (iii) Press & Communications: Kumar NB. Coalition for Medical Marijuana Research & Education, Politico. 12/15/17 Kumar NB. Coalition for Medical Marijuana Research & Education, 83 Degrees. 12/21/17 (iv) Public/Professional Presentations: Kumar NB. Keynote Speaker: What s next in research? Medical Marijuana and Your City: Facts, Fiction and Moving Forward. Florida League of Cities Annual Conference, Orlando, Fl. 8/16/2017. Kumar NB. Coalition for Medical Marijuana Research & Education. Tampa Chamber. Tampa, Fl. 8/25/17. Kumar NB. Documentation Required for the Coalition for Medical Marijuana Research. The Board of Medicine and the Board of Osteopathic Medicine, State of Florida Medical Council. Orlando, Fl. 2/2/18. (v) Publications: Kumar NB. Editorial Board member: NCI PDQ. Chapter Co-author Kumar NB. Editorial Board member: NCI PDQ. Chapter Co-author Authors: Diane Portman, MD, Kristine A Donovan, PhD. Title: Cannabinoid Hyperemesis Syndrome: A Case Report of a Confounding Entity in Oncology Care. Manuscript Number: JOP The case report has been accepted for publication in the Journal of Oncology Practice and is in press. Authors: Coalition Faculty Steering Committee & Board of Directors, Florida Division of Medical Quality Assurance (MQA), and the Office of Medical Marijuana Use (OMMU). Title: Establishing a Coalition for Medical Marijuana Research and Education in the State of Florida: Implication for guiding adoption of a statewide policy on education and clinical practice. Manuscript: In preparation. 12

13 Future Plans of the Coalition Research Funding: To fund future work of the Coalition for Medical Marijuana Research and Education, a state appropriation of $1.75 million has been requested for Fiscal Year *The continued activities of the Coalition for Medical marijuana Research and Education including funding of research and education projects are contingent upon FY state funding for the Coalition. The funding will continue to (a) maintain the infrastructure for the coalition, (b) fund innovative research and education projects and (c) Evaluation and reporting of Registry Data from the Division of Medical Quality Assurance (MQA), and the Office of Medical Marijuana Use (OMMU), Florida Department of Health to towards guiding adoption of a statewide policy on education and clinical practice. The Coalition Director, Dr. Kumar selected a multidisciplinary team of Moffitt research scientists, educators and clinicians termed the Coalition Faculty Steering Committee (CFSC) to collaborate on the establishment and implementation of the Coalition Research and Education Plan for FY The current CFSC members are: David Drobes, Ph.D., Senior Member, Health Outcomes & Behavior Kathleen Egan, Sc.D., Senior Member, Cancer Epidemiology Nicholas Lawrence, Ph.D., Senior Member, Drug Discovery Diane Portman, M.D., Department Chair, Supportive Care Medicine Solmaz Sahebjam, M.D., Associate Member, Neuro-Oncology The Coalition will recruit other multidisciplinary members from institutions around the State of Florida in the coming years. As experts in their field, additional roles of the Coalition Faculty Steering Committee will be to primarily support the review of research and education proposals submitted to the Coalition and to provide their recommendation for funding decisions by the Coalition Board. (a) Innovative Research and Education Funding Opportunities: Funding opportunities through the Coalition will be available to all academic and research institutions in the State of Florida to fund innovative research and education focused on medical use of marijuana from June 2018 onward if funding is provided by the Legislature. Timeline for Fiscal Year Research and Education Projects: Letter of Intent (optional): March 1, 2018 Full Application: April 2, 2018 Award Announcements: June 1, 2018* Project Start Date: July 1, 2018 Project End Date: June 30, 2019 Apply for State and National research funding opportunities. (b) Evaluation and reporting of Registry Data from the Division of Medical Quality Assurance (MQA), and the Office of Medical Marijuana Use (OMMU), Florida Department of Health With data received from the department of Health, using observational research strategies, the Coalition aims to: Evaluate past history and current medical marijuana use, indication for use, bioavailability, potential beneficial and harmful health effects of using different forms of marijuana (such as inhaled [smoked or vaporized], tincture, sprays, suppositories, oils), among individuals prescribed medical marijuana. 13

14 Document and evaluate statewide referral patterns, reported indications, benefits and adverse events with use of medicinal marijuana as a function of age, gender, race, locale, co-morbidities, other risk exposures, socio-economic status, provider, and concomitant licit/illicit drug use behavior as identified through a urine toxicology screen and by the Florida Prescription Drug Monitoring Program (PDMP) database. Characterize public safety concerns related to medical marijuana use and evaluate existing quality assurance, safety, packaging and current standards for dispensing and patient education regarding medical marijuana products. Perform ecological evaluation contrasting statewide cause-specific death and morbidity rates in the calendar year preceding and year following passage of the law. Utilize the State of Florida Medical Marijuana Registry to characterize the health effects of medical marijuana dose and mode of administration on related overdoses and poisonings, traffic accidents, work productivity, depression, fatigue and other health endpoints. Professional and Public Education: Professional Education: Continue to coalesce and organize national resources, including clinical practice guidelines [National Institute of Health(NIH) -National Institute of Drug Abuse (NIDA), National Cancer Institute (NCI), National Institute of Ageing (NIA), American Society of Clinical Oncology (ASCO), American Academy of Pediatrics (AAP), American Psychological Association (APA), etc.] and develop additional resources to improve knowledge on medical marijuana, targeting medical, pharmacological, nursing, paramedical and other health care professional groups in the State of Florida. Continue to provide access to the most up-to-date research and clinical guidelines resources to guide clinical practice from national sources, including research results conducted through the Coalition. Plan and conduct an annual, interactive workshop of multi-disciplinary leaders, to develop research standards and benchmarks to guide and ensure the production of high-quality medical marijuana research. Public Education: Continue to coalesce and organize national resources (NIH-NIDA, NCI, NIA, ASCO, AAP, APA, ANA etc.),and develop additional resources to improve current knowledge of the general public, patients and caretakers in the State of Florida on medical marijuana use (both beneficial and harmful effects) for specific indications. Provide access to the most up-to-date research and clinical guidelines resources that inform clinical practice from national sources. Publish and disseminate reports of research evolving from the Coalition for MMRE. Regulatory Issues Convene a committee of experts including researchers, clinicians (ASCO, APA, ANA), regulatory (DEA, FDA, DOH) and funding organizations (State of Florida, NIH-NIDA, NCI, NIA) and task them to produce objective and evidencebased reports that fully characterize the impacts of regulatory barriers and propose strategies to mitigate these barriers. Committee objectives include, but are not be limited to proposing strategies to address: Research barriers, including access to research-grade marijuana. 14

15 Collaboration with the OMMU/DOH, Florida The Coalition Director and team will continue to work collaboratively with the Office of Medical Marijuana Use to: Identify priorities for capturing quality/meaningful data. Use of common language in terms of data and reporting. Establish an ongoing communication plan between the Medical Marijuana Research and Education Coalition, the Florida Board of Medicine s and the Board of Osteopathic Medicine s Physician Certification Pattern Review Panel, the Department of Health s Division of Medical Quality Assurance and the Office of Medical Marijuana Use. As recommended by The Medical Marijuana Research and Education Board of Directors, the MMRE will emphasize and work with OMMU on carefully designing the registry to meet both its regulatory and research mission. The Board recommends that data elements and their structure are discussed jointly with the Office of Medical Marijuana and other constituencies to achieve the right balance between burden of data collection and scientific and public health value in ensuring the safety and adding evidence of about the effectiveness and safety of medical marijuana. A data dictionary specifying each data element, its source and structure should be made available to allow researchers adequate insight for planning and design of observational studies that can address safety and effectiveness questions. Finally, the Board recommends that data transfer to the Coalition is organized directly with the Registry data vendor to accelerate data transfer for timely surveillance of medical marijuana utilization pattern and potential adverse outcomes. 15

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