Ohio Cannabis Nurses Association

Ohio Cannabis Safety First

Medical Cannabis Summary and Recommendations for Ohio

AUTHORS – December 05, 2015

Janet Brenemen Dana Kovach Michelle Price Tim Johnson

Ohio Patient Compassion Act Background Paper and Recommendations

Introduction Today we have a growing number of medical cannabis laws across the United States. Twenty-three states[1] and the District of Columbia have endorsed laws that allow some patients legal access to medical cannabis. According to reports published by the Americans for Safe Access (ASA), “Most State laws provide patients with protection from arrest and prosecution. Most incorporate a production and distribution program. And most allow patients and their caregivers to cultivate a certain amount of regulated medical cannabis themselves.” States are now recognizing the importance of protecting patients from civil discrimination. It is the responsibility of local governments to meet the medical needs of its people, even when its thought to be politically incorrect. While developing medical cannabis regulations the concerns of neighbors, local businesses, law enforcement and the general public, must be taken into consideration. By working with all interested parties in advance of adopting state medical cannabis programs will ensure a successful program designed to meet the needs of patients and the communities for whom serve them. Legislative proposals must be evaluated for strengths and weaknesses within their political context. What is feasible in one state, may not be possible in another. Even the most mindful and compassionate legislators will make the mistake of passing laws that fail to adequately meet the needs of the patients. In the past legislative and regulatory proposals were developed and implemented with the intent of excluding patients and restricting safe access for the majority of the patients. The ASA reports support for legal access to medical cannabis is currently polling nationally at 85% or more. Within the last year eight states have passed some kind of legislation recognizing acceptable medical use of cannabis. That makes 34 states and the District of Columbia that have passed some kind of legislation. [1] This report was developed to assist Ohio legislators in designing a medical cannabis program that will meet the needs of Ohio residents and those residents who are seeking to use cannabis as a medicinal treatment alternative.

Cannabis as a Medicine

Background: Between 1840 and 1900, European and American medical journals published more than 100 articles on the therapeutic use of cannabis. In the early 1900s, pharmaceutical giant Eli Lilly produced whole plant cannabis extract for sale to patients whose physicians recommended it. Today, new studies are being published in peer-reviewed journals that demonstrate cannabis has medicinal value in treating patients with serious illnesses such as AIDS, glaucoma, cancer, multiple sclerosis, epilepsy and chronic pain. The US National Library of Medicine includes more than 6,500 published scientific articles on medical applications for cannabis. The federal government is no longer ignoring the medical efficacy of cannabis, many of the isolated compounds found in the cannabis plant are being re- searched and used medically. For example, Nabilone and Dronabinol, which are isolated cannabis compounds, are currently prescribed and sold for medical use in the United States. [1]

Findings: Numerous controlled clinical studies have confirmed cannabis therapeutic benefit in relieving an array of symptoms for people living with cancer, HIV/AIDS, multiple sclerosis, Alzheimer's, hepatitis, arthritis and chronic pain, among many other conditions. In addition, in February 2010, the University of California’s Center for Medicinal Cannabis Research (CMCR) presented a report to the California legislature summarizing the findings of 10 years of research on cannabis and cannabinoids. As a result of their research the CMCR presented evidence that cannabis is a promising treatment in selected pain syndromes caused by injury or diseases of the nervous system and for painful muscle spasticity due to multiple sclerosis.

Position: Clinical research affirms that cannabis can safely and effectively alleviate symptoms of serious and chronic medical conditions.1

Reclassifying Medical Cannabis

Background: Cannabis was categorized as a Schedule I substance with the passage of the Controlled Substances Act in 1970, declaring marijuana (cannabis) to have no medical value and a high potential for abuse. Several attempts have been made to remove cannabis from the Schedule 1 category without success. Some states continue to aggressively enforced federal cannabis laws, even in states that have passed laws to permit the use and distribution of cannabis for medical purposes. As of this report date cannabis remains a Schedule1drug.

Findings: The federal status of cannabis as a dangerous drug with no medical value is at the heart of the conflict between federal and state laws. As long as cannabis remains classified as a Schedule 1 substance, medical cannabis patients across the country will lack reasonable, fair and equal protection. The refusal by the federal government to recognize the medical efficacy of cannabis has directly impeded efforts to implement various state medical cannabis laws. Senator Bernie Sanders (I-Vt.) recently introduced a bill to the U.S. Senate that would end federal prohibition of cannabis. The bill known as the “Ending Federal Marijuana Prohibition Act of 2015”. This legislation would remove marijuana from the Controlled Substance Act, and allow states to decide how to deal with marijuana on their own.

Position: Noted Authors strongly support the reclassification of cannabis in order to expand research on this important and promising therapeutic substance and to better establish laws that reasonably, fair- ly and equally protect patients in the US. However, due to the politics involve, Ohio patients can't wait for this to be done the Federal level and strongly recommends that Ohio passes legislation on a state level, and giving patients access to medical cannabis immediately.

Medical Cannabis:

Background: Research has proven that cannabis could alleviate and potentially cure diseases for millions of patients in the United States. Nevertheless, other than for the four people with special permission from the federal government, medical cannabis remains illegal under federal and state medical cannabis laws that have been passed were adopted with the intention of protecting and providing safe access to a patient population that suffers from a wide array of medical conditions.

1Americans For Safe Access

Findings: The first medical cannabis law passed in California ensured that seriously/terminally ill patients have the right to obtain and use cannabis for medical purposes where that medical use is deemed appropriate and has been recommended by a physician. Subsequent state laws have also incorporated a multitude of medical conditions and have decided not to restrict medical cannabis use only to those patients who are terminally ill.

Position: Given that scientific studies have shown cannabis counteracts or mitigates a number of illnesses and side effects from other treatments, patients deserve choices in their health care options and should not be denied access to medical cannabis. [1]

Medical Cannabis Research Background: Examples of the medical use of cannabis have existed for thousands of years, not the least of which was the production and distribution of cannabis tinctures by pharmaceutical giant Eli Lilly at the turn of the twentieth-century. Yet the scientific investigation into this important and promising therapeutic substance is not what it could be. Only in the last few years have we seen the needed increases in medical cannabis research, but such studies have predominantly been outside the US. Studies inside the US have shown that cannabis can be used to effectively treat neuropathic pain for people living with HIV/AIDS and multiple sclerosis, as well as treat seizures, nausea and stimulate appetite, but government officials insist more research is needed. In 2015, research findings focused on the pharmacokinetics, efficacy and safety proving cannabis to be effective and safe in treating many medical conditions. [1]

Findings: Scientists in Israel are uncovering ways of treating Alzheimer’s with cannabis and researchers in Spain are studying the effects of cannabis on brain cancer. Unfortunately, in the US, the complicated approval process hinders scientists’ ability to obtain research grade cannabis for studies and clinical trials. As a result, scientists in the US face federal hurdles that don’t exist in other countries which skews and stifles meaningful research. Schedule 1 drugs such as MDMA (Ecstasy, Molly), have been approved for medical research in the US for potential usefulness in post traumatic stress disorder. MDMA is used recreationaly for many years and is associated with dance parties or raves. Unlike Cannabis, MDMA has been linked to numerous deaths. Cannabis is one of the safest therapeutically active substances known. No one has ever died from an overdose.

Position: According to the DEA’s own Administrative Law Judge Mary Ellen Bittner expanded medical cannabis research is “in the public's best interest.” The federal government should better invest in the therapeutic research of medical cannabis. The federal government must also create incentives for expanded research and retool the research approval process to eliminate a bias for abuse studies and the onerous requirements unique to the US. While sufficient evidence exists in the US and elsewhere of the medical value of cannabis, the federal government, under the authority of the National Institute on Drug Abuse, keeps a stranglehold on research efforts, emphasizing harm-based studies over the investigation of medical efficacy.[1]

Cannabis: Not Always the Best Medicine

Background: One of the main arguments used by opponents of medical cannabis is that other medication works better. While this is often true, there are other factors to consider. Some effective pharmaceutical medication is also toxic with harmful side effects, whereas cannabis is relatively harmless and can diminish the need for pharmaceutical medication.

Findings: While some medical conditions may respond better to pharmaceutical medication, medical cannabis is often less expensive and more effective than pharmaceutical alternatives. For example, Americans for Safe Access has received countless reports from patients who have either significantly reduced or eliminated altogether their use of narcotics and pain medication by replacing it with medical cannabis. [1]

Position: Medical cannabis may not be the best treatment for everyone nor should it be the first line of treatment for a physician to consider, but we believe most Americans agree with us that all patients and physicians should have as many effective options available to them as possible to combat pain or symptoms of a serious or chronic illness.

Legalization of Cannabis for Recreational Use

Background: As the national debate elevates around the legalization of cannabis for recreational use the Authors are focused on medical use only at this time. The purpose of was of this paper is to focus only on medical cannabis education and safe access for patients.

Findings: ASA statement regarding recreational use identifies “issues such as access, police harassment, and the price and quality of medicine will still be relevant to the patient community despite the adoption of a policy of legalization for recreational use. Any system of regulation should not be built on the backs of current medical cannabis laws.” [1]

Position: The legalization of cannabis for recreational use is a separate issue from safe and legal access to cannabis for medical use. The Authors caution policy makers against letting the debate surrounding legalization of cannabis for recreational use equivocate the science and policy regarding the medical use of cannabis.

Regulation of Medical Cannabis Distribution Centers

Background: Some states like Rhode Island, Maine, and New Mexico implemented a state-regulated medical cannabis distribution system, other states like California, Colorado, Michigan and Montana have preferred to regulate distribution at the local level. Regardless of the methodology, the movement towards enhanced access to medical marijuana as a result of regulated distribution systems is adopted by the majority.

Findings: A study on the impact of local medical cannabis dispensary regulations by ASA, discovered though increased access and availability of medical cannabis utilizing dispensaries, there was a reduction in crime and community complaints around those dispensaries [1]. Dispensaries actually helped to revitalize struggling neighborhoods in states with regulated medical cannabis dispensaries. On the contrary unreasonable or arduous regulations can have the effect of renounce access to medical cannabis.

Position: The Authors support the sensible regulation of dispensaries, and recommend such regulations recognize the legality of medical marijuana distribution and offer reasonable modus operandi to comply with local and state laws.

Patient Cultivation

Background: All State laws, with the exception of New Jersey’s, have recognized the need for patients to self-cultivate medical cannabis.[ASA, 2015]

Findings: Cannabis comes in literally thousands of different strains. Different strains of cannabis can have very different effects on the body, it is important for patients to be able to determine which strains work best for their particular condition and have the ability to cultivate them. Dispensaries can be limited to the quantity and types strains that they have available at any given time. Patients should be allowed to cultivate strains for consistency and quality to meet their particular qualifying condition/s. Patients that are restricted to obtaining cannabis through dispensaries can be expensive for patients and self-cultivation can incomparably reduce that financial burden.

Position: Patients should have the right to grow their own medical cannabis in a variety of ways. Home cultivation is necessary to ensure that patients have safe and affordable access to medical cannabis

Testing Medical Cannabis

Background: Medical cannabis has been used safely for thousands of years and there is no evidence to suggest that it represents a real harm to patients. More attention is being placed on quality control concerns as the need and demand for cannabis is growing. Because of the lack of interest and funding at the federal level in performing quality control testing of medical cannabis, such testing has been conducted more independently and at the local level. [1]

Findings: Multiple findings over the years have concluded that cannabis is relatively harmless, not the least of which was from a 1988 Drug Enforcement Administration (DEA) review of marijuana's classification as a Schedule I drug, in which Chief DEA Administrative Law Judge Francis L. Young stated that, “Marijuana, in its natural form, is one of the safest therapeutically active substances known to man.” [1] Because the federal and state governments are hesitant to test medical cannabis for quality, concerned patients, providers and scientists are requesting that testing of large cultivation sites and/or distributors be required. Establishing industry standards and guidelines for the patient will improve safety and quality of medical cannabis.

Position: The Authors have not identified any research or reports of serious harm that has resulted from consuming cannabis. Testing can help provide vital information to patients about the medication, allowing them to make Informed Decisions regarding their health . “Testing should be used as a way to enhance rather than restrict access” [1]

Who Should Qualify as a Patient?

Background: Public officials and others who oppose medical cannabis often make assumptions about people’s health. The essential trait of medical cannabis laws should be the relationship between a patient and their provider.

Findings: The health care information discussed between a patient and physician is considered private and protected under federal HIPAA laws. Some state medical boards in the states where medical cannabis is legal want the ability to assess whether a provider has appropriately recommended cannabis to a patient. States that have identified allowable conditions to guide the providers in their recommendations.

Position: Medical professionals should have an unrestricted ability to recommend cannabis if in their professional opinion is that the patient could benefit. The research is fast discovering conditions that medical cannabis can treat and should be free of restrictions to recommend therapeutic modalities such as cannabis.

Taxation of Medical Cannabis Background: Difficult economic times have forced cash-strapped local and state governments to secure more creative sources of revenue. One such source is the taxation of medical cannabis. Starting off the trend, the California Board of Equalization (BOE) voted in 2005 to implement a policy that taxed the sale of medical cannabis. Since then, the BOE has collected millions of dollars from hundreds of dispensaries across California. Colorado currently taxes both recreational and medical cannabis, but at different rates. Currently, medical cannabis is taxed at the Colorado State tax rate of 2.9% in addition to any local sales tax.

Findings: Excessive sales taxes are harmful to patients and make medical cannabis more unaffordable than it already is. Taxes invariably and unintentionally restrict access to medical cannabis. [1]

Position: Any tax on medical cannabis, is a tax on patients. The majority of organizations oppose excessive taxes that are designed to raise revenue, but it does not oppose low-impact fee structures designed to offset administrative costs.

Ohio Medical Marijuana Legislative History

Background: Whether in Ohio or Washington, DC, legislatures seem unable to pass medical cannabis legislation. Within the last fifteen years, five bills have been considered in Ohio, with the first among them floated in 2003-04. It wasn’t until February 2005 that SB 74 was introduced by then Senator Robert Hagan (D-Youngstown). SB 74 received a sponsor testimony hearing in November 2006, but went no further. SB 343 was introduced into the Ohio Senate in May 2008 by then Senator Tom Roberts (D-Dayton); it received both sponsor and proponent testimony hearings in November 2008 – the most consideration of any Ohio bill – but went no further. In April 2010, HB 478 was introduced into the Ohio House by then Rep. Kenny Yuko (D-Richmond Heights); it was referred to the Health and Aging Committee, but went no further. Representative Yuko introduced HB 214 into the Ohio House in April 2011; it was referred to the Health and Aging Committee, with no further action.

Representative Bob Hagan reintroduced HB 214 into the 2013-14 session of the General Assembly as HB 153. Like most of the others, it died in committee. Legislative history provided by Mary Jane Borden, President Ohio Rights Group.

Findings: Upon examination of the 23 states adopting medical cannabis regulations, states are reporting data. The Americans for Safe Access Foundation (ASAF) has developed “Evidence Based and Best Practices” protocols for state programs. The States Grading System for Cannabis (ASAF, October, 2015) evaluates how well the state meets the needs of patients. The grading system is divided into four categories, with each having a possible 100 points: i. Patients Rights & Civil Protection from Discrimination ii. Access to Medical Cannabis and/or Medical Cannabis Products iii. Ease of Navigation iv. Functionality (Effectiveness of current program)

The four categories combines the numeric scores and converts them to a alpha grade ranging from A to F. California, the first state to legalize Medical Cannabis in 1996 scored extremely well in 3 out of 4 categories with a final grade of B-. California’s highest category score of 93 was scored in category i.v., Functionally/Effectiveness of Current Program and their lowest score of 52 for Patients Rights & Civil Protection (category i.) with an overall average of 80%. Thirty-five states were included, highest grade went to the state or Maine receiving an overall grade of “B” with 1/3 of the state Medical Cannabis Programs receiving a failing grade of “F”.

Ohio’s HB 214 (2011) was scored using the States Grading System for Cannabis. The bill received an over grade of “D+“. Ohio HB 214 (2011) scored highest in category ii. with a score of 75, mainly due to the bill’s inclusion of home cultivation. The lowest score was in category iii. Ease of Navigation only receiving 55 of the possible 100 points largely due to the limited number of qualifying conditions in HB 214. As research continues to increase on medical cannabis the number qualifying conditions will as well. Future legislation and regulations must recognize providers rights to recommend cannabis to any patient who can receive medical benefits from it and most importantly Safe Access.

Ohio Cannabis Nurses Association/Ohio Cannabis Safety First would like to propose the revising of HB 214 (2011v) with the recommendations based on the Best Practices and Evidence Based Stan- dards identified by the Authors to develop an Ohio’s Medical Cannabis Program that will not only, meet the needs of patients, but be a model for other states considering cannabis for medical use.

“Ohio Patient Compassion Act” HB 214 (2011) OCNA/OCSF Revised (2015)

Recommendations

Establish an Ohio Medicinal Cannabis Regulatory Board. To oversee the the enforcement, regulation, licensing, retail, commerce, environmental and zoning aspects of the industry.

Establish an Ohio Medicinal Cannabis Professional Licensing Board. To oversee the creation and enforcement of a continued education division for CME, CLE, CEU, etc., credits for respective agencies and professions involved in the industry.

Address all collegiate level educational schools to introduce the medicinal cannabis instruction to their medical curriculum’s. To include physical and mental aspects.

Establish within the Ohio Medicinal Cannabis Regulatory Board, a safety commission to oversee safe packaging and labeling of products. To regulate and promulgate cannabis facility security measures.

To promulgate civil laws covering medicinal cannabis and to decriminalize all other law statutes governing cannabis as a whole.

To recognize the perceived social abuse of cannabis as a disease rather than a criminal act.

Form the creation of a mental health awareness and education system as to the relevance of cannabis.

Create a Banking system and an Insurance industry in compliance to federal laws. Where needed lobby the federal government to adapt to this national industry.

Address the rescheduling of cannabis from a schedule 1 drug to a schedule 3-5 drug.

Establish an Ohio Medicinal Cannabis Commission. This board would oversee all agencies involved with the regulations, licensing, enforcement, public health, zoning, environmental, safety and facility security guidelines. Responsible for the creation of any other boards or agencies as deemed warranted.

Promulgate new laws under civil statutes for medicinal cannabis violations. Establish new decriminal- ized statutes for violations outside medicinal cannabis to lower non criminal offenses. To include mo- tor vehicle operation, employment rights, concealed carry permits and other current controlled substances laws. Review the topic of diseases verse criminal activity.

Create mandatory CLE, CME, CEU courses for all professional career fields example; Legal counsel, Law Enforcement, Medical Health, Mental Health, Education, Corrections, Social Services, Fire/Ems services, public health and all other agencies sharing a part in the regulation of the industry. Establish a curriculum to encompass a full comprehensive course to be updated every 2-3 years, mandating mandatory attendance for qualified credit hours. Certify field experts to instruct developed curriculum. Research the implementation of curriculum’s into the medical teaching institutes in the state of Ohio.

REREARCH REFERENCES greenflowermedia.com pubmed.com leafly.com clearuk.com liftcanabis.com medpagetoday.com healer.com encod.org oaksterdam.com dbloomtucson.com cbdproject.com stinksac.com funksac.com meditainer.com unitedpatientsgroup.com webgrowstore.com law enforcement against prohibition americans for safe access drug policy alliance marijuana policy project

Janet Breneman B.S.N, R.N, Founder/C.E.O./O.C.N.A.

Janet has been in the healthcare field for over twenty years. Fourteen of those years as a registered nurse and eight years in the Public Healthcare Administration sector. Janet received her Bachelor of Science in Nursing from Lourdes College in Ohio. Janets clinical experience includes neurology, pharmacology, oncology, infectious disease and education.

In 2010 Janet returned to acute care to develop and design a patient oncology navigation program. Two weeks after accepting this position her husband was diagnosed with a rare stage four cancer. He became the first patient to be navigated through this program. Janet identified a “lack of patient education” as a hindrance for patients making informed decisions about their health care.

Medical Cannabis was not an option for the patients she worked with in Ohio, but was an option for patients in Michigan. Janet soon discovered that Michigan patients using medical cannabis in addition to chemotherapy and radiation showed better result outcomes. After her husband lost his life’s battle to cancer in 2011, Janet made the decision to focus her career in the research and education fields of medical cannabis.

Over the last four years Janet has gained extensive and valuable knowledge concerning medical cannabis. After the passage of amendment 64 in Colorado Janet experienced the privilege and opportunity to work with medical cannabis dispensaries and growers in the medical cannabis industry. Janet has further broadened her knowledge in the medical cannabis industry by attending numerous educational conferences in California, Florida, Colorado and Michigan.

Today Janet stays involved with the medical cannabis industry via research and attending various conferences and seminars throughout the Country.

Dr. Michelle Price R.Ph,Pharm.D, B.C.A.C.P. Pharmaceutical Director/Consultant

In 2006 Michelle received her doctorate of pharmacy from the University of Cincinnati. Michelle was first published in the American College of Clinical Pharmacy in 2005. In her continued education, Michelle went on to become board certified in ambulatory care by the Board of Pharmacy Specialties in 2014. Michelle has worked in a variety of healthcare settings from managed care, federal, retail, mail order, hospital and clinical environments.

Being the spouse of a U.S. Military veteran, Michelle was fortunate to become licensed in multiple states including the territory of Guam.

Over the years in her personal time, Michelle has conducted numerous hours of research in areas of pharmaceutical medications and their interactions/counteractions with the cannabis whole plant medicinal values.

Today Michelle is an active member with the American Pharmacists Association as well as various other non-profit organizations/charities. Michelle further serves as the Pharmaceutical Director on the Ohio Cannabis Nurses Association Board.

Tim W. Johnson A.S. Criminal Justice Director of Safety Services/Consultant Founder Senior Consultant O.C.S.F.

Tim is a U.S.A.F. Military Veteran and a retired Police Officer, with twenty years of service. In 1976 Tim enlisted into the United States Air Force. Upon completion of basic training, military science/technical school and combat training, Tim was assigned as a Security Forces Specialist with the U.S Air Forces of Europe. There he received training and worked with an Anti Terrorist Special Unit with British Public and Military Forces. As well he was assigned to a nuclear secured air base. After completing his tour of duty in 1979, he returned home and attended the North Central State College. In 1982 Tim completed his degree in Applied Science Law Enforcement, Criminal Justice.

In 1994 Tim received his state certification from the Ohio Police Officer Training Academy. During his twenty year career, Tim received experience in various areas and worked with federal to local task force units in drug interdiction and high profile subject protection cases. Tim's further experiences included; field training officer, critical incident team, hostage negotiator, patrol operations, investigations, defensive tactics instructor, community liaison and community policing programs. Tim found his passion in working with children in the schools and community. Tim became a state certified safe schools instructor developing and implementing various safety programs over the final 15 years of his career. During this time Tim was directly involved in drug awareness and educational programs centered around the youths and elders alike in the community and schools.

Soon after retirement Tim began research studies encompassing safety packaging and facility security aspects in the national growing cannabis industry. Tim further opened his research into reviewing numerous medicinal cannabis world wide studies covering the multitude of various uses of the whole cannabis plant. Tim keeps himself busy as the Founder/Senior Consultant of Ohio Cannabis Safety First, a representative for Law Enforcement Against Prohibition (L.E.A.P.) and serving as the Director of Safety Services on the Ohio Cannabis Nurses Association Board.

Dana Kovach Patient Advocate Director of Patient Outreach/Consultant

Dana is a Veteran of the United States Navy and a full time stay at home Mother and Spouse. In May 2010, Dana found herself becoming a full time Caretaker to her oldest son after a relapse from being diagnosed with stage four Embryonal Rhabdomyosarcoma at the young age of three. Today, at the age of 16, JC is still under his mother's watchful compassionate care and the treatment of a multitude of medications.

Early on Dana realized current therapies and medications were not working in her son's treatment. Dana began an aggressive path of advocating for her son to receive any and all forms of treatment and care that would lead to a beneficial recovery. Dana started researching natural medicines and discovered recent research in “Cancer and Cannabis” showing positive results in it's studies for patients like JC.

Dana soon found herself lobbying by writing letters and making phone calls to political and public officials alike. With little to no response she began to attend educational awareness seminars, conferences and networking to gain knowledge in the medicinal cannabis whole plant treatment studies. Only to find there were many like her researching this field for their loved ones, both young and old. With a willingness to talk with anyone she discovered the many obstacles stopping patients from receiving the treatment of medicinal cannabis.

Over the years Dana has gained extensive knowledge medicinal cannabis whole plant treatments. Dana continues seeking information, resources and advocating for her son and others as well. To her colleagues Dana is known to be a M.O.M. (mom on a mission). To this day Dana continues to advocate for the re-legalization of the whole plant medicinal cannabis. Dana currently serves as the Director of Patient Outreach on the Ohio Cannabis Nurses Association Board.