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Breaking Barriers: A New Healthcare Model for the Business of Medical Marijuana February 26, 2014

NATIONAL ASSOCIATION OF SPECIALTY PHARMACY

JASON S . PLUME, PHD

JOSEPH FRIEDMAN, R.PH. , MBA

Disclaimer The information within this CME/CE activity is for continuing education purposes only, and is not intended to substitute for the medical judgment of the healthcare provider. Recommendations for use of any particular therapeutic agents or methods are based upon the best available scientific evidence and clinical guidelines. Reference in this activity to any specific commercial products, process, service, manufacturer, or company does not constitute its endorsement or recommendation.

Faculty Biography Jason S. Plume, PhD

Independent Researcher/ Educational Consultant

Arcata, California

After earning his B.A. in History from California State University-Bakersfield, Jason went on to earn a M. A. and PhD in Political Science (subfields: American Government and Public Policy/ Administration) from the Maxwell School of Citizenship and Public Affairs at Syracuse University. Dr. Plume’s dissertation, “Cultivating Reform: Richard Nixon’s Illicit Substance Control Legacy, Medical Marijuana Social Movement Organizations, and Venue Shopping,” is an examination and analysis of how marijuana reform organizations challenged and reformed status quo legal dictates, political forces, and social perceptions. He has taught at numerous colleges and universities throughout America while giving several public talks regarding the changing landscape of regulatory policies that govern illicit substances, especially marijuana. Currently, Dr. Plume is living in Northern California while working on a book manuscript and several other pending publications.

Moderator Biography Joseph Friedman, Rph, MBA

Director of Marketing and Business Development, Mark Drugs LLC. – A Specialty Compounding Pharmacy

Deerfield, Illinois

Joseph is deeply involved in the complex process of positioning himself to open one or more medical marijuana dispensaries in Illinois. He has become a content expert in the field of medical marijuana; this includes the science, legal, political, and financial challenges of this burgeoning U.S. industry. He has contributed to published articles in the Chicago Tribune, and UIC College of Pharmacy’s newsletter, and has written a pharmacist associated medical marijuana commentary for Drug Topics December 2013 issue. He has plans to work with Illinois’ Rosalind Franklin University’s Pharmacy program to create a course teaching pharmacy students the pharmacists’ role in the business of medical marijuana.

After receiving his pharmacy degree at the University of Illinois College of Pharmacy in 1978, he completed his Masters of Business Administration degree in 1991 at Illinois’ Lake Forest Graduate School of Management. He received the Wright Cup award for marketing excellence at Lake Forest. Joseph is a seasoned professional with more than 17 years of expertise in sales, marketing, business development, and relationship management in the health and wellness field. He was Director of Pharmacy at Topco Associates LLC where he was instrumental in growing Topco’s Pharmacy department sales from $200M in 1997 to over $1.3B in 2007. He was also Senior Director of Pharmacy Marketing at the Nash Finch Company in Minneapolis where he honed his skills in pharmacy marketing and health and wellness initiatives.

Faculty Disclosure Developer discloses that he/she is a speaker, consultant, and provides research support for National Alliance of Specialty Pharmacies. He does intend to discuss non-FDA approved drugs or investigational use of any product/device. Specifically, marijuana a “Schedule I” substance according to the Controlled Substance Act of 1970 will be discussed.

Webinar summary This live webinar will explain the business aspects of administering CBMs, business opportunities, and how healthcare professionals and pharmaceutical companies can benefit from conducting research and investing in CBMs. Additionally, cost implications and the approval process for manufacturers will be covered.

Course Objectives-Slide 1 of 2 This webinar and enduring materials are focused on the Business of Medical Marijuana/ Cannabis-based Medicines (CBMs) as the substance and practices of the substances are associated with the teaching, practices, training, research, and investment regarding the Healthcare Industry. Once viewing this webinar and studying the course materials students should be:

1. Should be able to identify and describe the common and potential administrating protocols, lacunas, and goals associated with the cannabis-based medicines (CBMs)

2. Recognize existing and potential training programs as to apply such training opportunities to everyday healthcare practices

3. Identify trends associated with how medical marijuana has, is, and could impact the Healthcare Industry

4. Recognize research opportunities and benefits

Course Objectives-Slide 2 of 2 5. Be able to recognize and list Investment opportunities in the diverse markets of cannabis-based medicines (CBMs)

6. Identify and list many of the governing processes involved in pharmaceutically tested cannabis-based medicines and cultivated medical marijuana

7. Recognize and list various “cost implications” associated with administering CBMs within the Healthcare Industry

Interactive Polling

QUESTION ONE

The states of Colorado and Washington have approved, effective January 1, 2014 recreational marijuana for anyone over the age of 21 possessing a valid ID.

If yours was the deciding vote, would you vote “YES” or “NO” to recreational marijuana?

A.) YES

B.) NO

Course Outline-Slide 1 of 1 Overview: Brief History and Public Opinion

I. The Business Process of Medical Marijuana (A Brief timeline: from Cultivation to Pharmacology)

II. Administering Cannabis-based Medicines (CBMs)

III. Financial Investment and Development Opportunities of CBMs

IV. Research of CBMs for Healthcare Professionals: Benefits and Limitations

V. Governmental and Legal Processes of CBMs

VI. Cost Implications

Public Opinion 1: Legalization of Marijuana

Since 1997 (one year after California’s

Proposition 215 passed in 1996) there has

been a steady increase in public

favorability toward legalization of

marijuana. Last year was the first

year that a majority of Americans

replied in favor of legalization

Source: Gallup.com

Public Opinion 2: Medical Marijuana Public favorability for medical use of

Marijuana has continuously been

Greater than for all out legalization.

Also, all age demographics over-

whelming agree that marijuana

does have legitimate medical uses.

This is in direct contradiction to the

Federal government’s definition of

the substance

Source: Pew Research Center

Basic Facts about Cannabis and the Law- Slide 1 of 2

A. Strains (Varieties)

i. Three “distinctly” different strains of Cannabis: Cannabis Sativa, Cannabis Indicia, and Cannabis Ruderalis

a. Ruderalis is a cold weather strain and not as popular as Indicia and Sativa but used as a cross breed strain to strengthen a strain that is a cold weather outdoor grow

b. Sativa and Indicia used the most in hundreds of strains. To add, many marijuana strains are hybrids of an Indicia and Sativa mix

ii. Sativa strains are tall thin plants with narrow leaves; known for its “head buzz”; cerebral and energetic buzz (still not a stimulant)

iii. Indicia strains are short dense plants with broad leaves and more often than not are of a darker green color; known for “body buzz” and more sedative

Basic Facts about Cannabis-Slide 2 of 2 B. Medical and Legal Jurisdictions

i. 20 states and the District of Columbia allow for medical marijuana via ballot initiatives and legislation (subsequent judicial rulings have helped to sustain, articulate, and limit the industry)-allowing for cultivation, distribution, distribution via dispensary and individual cultivation*, patient registry, and caregiver status

ii. 2 states have legalized marijuana for recreational use: Colorado and Washington [CASE STUDY OF I-502]

iii. The federal government has an existing “Investigational New Drug” program allowing for a medical marijuana patient registry, cultivation of medical marijuana, and controlled distribution (in 1992, the federal government enacted a moratorium on new patients and this program is all but defunct)

iv. Medical marijuana movement speared on by cancer treatment and AIDs/HIV patient advocacy for alternative pain relief and appetite stimulant [CASE STUDY OF DENNIS PERON AND CALIFORNIA]

Interactive Polling QUESTION TWO

An estimated _____ million U.S. Citizens use marijuana regularly with 10,000 tons consumed yearly in college dorms, suburban homes, housing projects, and gated mansions.

A.) 50

B.) 35

C.) 15

D.) 5

I. Business Processes of Medical Marijuana: From Cultivation to Pharmacology -Slide 1 of 4

A. Financial/ Economic Worth

By one, peer-reviewed, economic study and assessment, marijuana is an industry worth close to $40 billion in the United States alone (Gettman 2006). This study did not take into account byproducts as well as supplemental products and services (i.e. paraphernalia and caregivers). Also, this research did not articulate the marijuana industry as to the worth of each subfield or component within the industry (e.g. medical, recreational, extracts). Either way, the economic measure and potential of cannabis’s ever-increasing and changing industries is significant. With research into the medical, energy, and material uses, cannabis is on the cusp of exponential cultivation, product, service-based, and financial growth.

I. Business Processes of Medical Marijuana: A Brief Timeline of Investment Avenues, Research Endeavors, and Practitioner Protocols-Slide 2 of 4

B. Harvesting the Product (Cutting, Drying, and Trimming)

i. acquisition of appropriate farming equipment and personnel needed along with market identification and contracting

ii. Quality assurance checks would be conducted during cultivation, harvest, and post-harvest/ Cannabinoid concentration/ percentage of THC

iii. Quality assurance checks would be conducted during cultivation, harvest, and post-harvest/ Cannabinoid concentration/ percentage of THC

iv. Purchases of cannabis for distribution beyond an investor-owned and operated dispensaries/ pharmacies would extend investment opportunities and save on contracting with cannabis “brokers” and distribution

Removing the large scale distributor also gives investors security within the marketplace by making the primary investors more relevant due to control of cannabis acquisitions, quantities, distribution, and retail sales

I. Business Processes of Medical Marijuana: A Brief Timeline of Investment Avenues, Research Endeavors, and Practitioner Protocols-Slide 3 of 4

C. Distribution of the Product

i. Targeted buyers contracted

ii. Distribution, even in leading marijuana producing states, is legally problematic

a. At this time, distribution of products must be entirely limited to intrastate (with states having medical marijuana laws)

b. due to federal marijuana prohibition, use of federal interstate byways is illegal and transporters face arrest, fines, and imprisonment (interstate trade and transportation also illegal)

II. Administering Cannabis-based Medicines (CBMs)-Slide 1 of 4

A. Professional Oversight of CBMs

i. Care and storage of CBMs

a. least amount of “hand-to-cannabis” touching by dispensary personnel should be emphasized

b. a commonality amongst medical marijuana jurisdictions mandates that all CBMs should be secure with dispensaries/ pharmacies installing proper security means (cameras, locked and enclosed areas, personnel, climate control)

ii. Various application or delivery “vehicles” options for patients

a. per gram cannabis

b. Quality control and storage protocols for edible CBMs should be created and implemented

Interactive Polling

QUESTION THREE

The Federal Government has medical marijuana program which patients can apply and receive federally grown and processed marijuana to treat severe medical conditions. The total number of patients in the history of this program is _____.

A.) 2, 517

B.) 1,616

C.) 13

D.) 767


iii. Retail protocols

a. create and test training programs for all dispensary/ pharmacy personnel:

- Over the past 5-7 years, the paradigm for pharmacist jobs has shifted from over demand to over supply. Placing pharmacists into the U.S. dispensary equation will increase the need for pharmacists.

- Pharmaceutical research will rely on properly run dispensaries (record keeping, monitoring, patient files, etc) to run the clinical trials needed for drug research and development. This presents a great opportunity for discovery.

b. create customer/ patient friendly, non-inhibiting, and discrete environment

iv. Cultivation to sales option (existing dispensary model) –visiting/ surveying dispensaries/pharmacies in medical marijuana states would aid in crafting such a model

a. sales of cannabis products (non-clone/ plant)

b. sales of cannabis products and clones


B. Patient/ Business relations

i. Answering patient question/ concerns regarding CBMs

a. informative materials created, printed, and displayed for patient acquisition

b. dispensary/ pharmacy personnel training and testing of informative materials

ii. Product and services quality control

a. dispensary/ pharmacy personnel training and testing of quality standards, product knowledge, and instruction on application implemented

b. quality assurance of CBMs conducted periodically to ensure “freshness” and potency EXAMPLES OF EDUCATOINAL MATERIALS SHOWN DURING WEBINAR


C. Quality Assurance, Dosage, and Applications

http://www.illinoiscannabispatients.org/cms/?page_id=59

i. Safety, Health, and Legal concerns of administering CBMs

ii. How much is the “correct” dose per “vehicle” of CBMs (self-dose, caregiver assistance, “pill” form, smoke, edibles, etc.)

iii. Dosage is typically based on drug’s potency and possible side effects. Bureaucratic demands regarding substances usually direct industry personnel to label substances as to their medicinal properties and effects. However, federal restrictions and obstructions on marijuana research inhibits this need. Professional lobbying of policy making institutions and collaboration with policy makers in writing regulatory policies would ameliorate these types of shortcomings. The first pharmaceutically produced CBM (Marinol) was weakly embraced by patients due to issues pertaining to dosage.

III. Financial Investment and Development Opportunities of CBMs-Slide 1 of 9

A. Wholesale (retail sales presented later)

i. Dispensary/ Pharmacy-based: wholesale of large weight/plants

a. per pound price currently ranges from $1500-$3500 per pound depending on strain, outdoor, or indoor varieties (range of price indicates difference in strain and wholesale). Only two states allow for patients/ caregivers to possess more than 8 ounces at any one time. Therefore, price per pound does not apply to patients

b. besides pounds, commonly traded weights include quarter, half, and multiple pounds as well as tonnage

ii. individual-based are limited to the prescribed weight and forms dictated by individual state medical marijuana laws-see attached state-by-state weight limits*


B. Retail Sales

i. Plant materials

a. Customized (per patient request) weights

b. Pre-packaged weights

c. edibles, recipes, and tinctures

ii. Extracts (“dabs”): Health, Safety, and Cost considerations

a. Petro-chemical extractions (i.e. butane extraction)

b. Hydro-chemical extractions (i.e. CO2)

iii. Supplemental/ Complimentary products (paraphernalia, vaporizers, recipes for edibles, informative materials, etc.)


C. Educational (TRENDS)

i. Teaching patients (options on dosage, ingestion, vechiclization)

a. Catering to seniors

b. Physically disabled patients

c. Collaboration with Medical marijuana advocacy groups

d. In-pharmacy/ dispensary instruction


ii. Teaching professionals

a. Dissemination of latest research on CBMs (targeting each medical subfield/ patient demographic)

b. One-time seminars regarding various ingestion methods/ means

iii. Teaching growers

a. Giving feedback to growers/ producers regarding patient receptivity to particular products/ strain

b. Disseminating latest research of CBMs to growers/ producers


D. Investment (EXPOTENTIAL GROWTH/ LOSS/ RATINGS/ PERCENTAGES OF INVESTMENT W/IN THE HEALTHCARE FIELD / TRENDS AS INCENTIVE)

i. Research and Development of CBM: from marijuana strains, medicinal supplements, and the Pharmaceutical Industry: “Recent research has revealed that both the principal components of cannabis, THC, and cannabidiol (CBD), have important pharmacological effects” (McPartland and Russo 2001/ 2003)

a. In the United States: National Institutes of Health (NIH) as the primary research arm of federal medical marijuana, University of California-Davis “Center for Medicinal Cannabis Research” in collaboration with public and private sector entities

b. Pharmaceutical Industry based (prominent and early studies are discussed)


ii. One federally sanctioned marijuana laboratory: Coy W. Waller Research Laboratory at the University of Mississippi

a. To obtain and research cannabis, academics must request and receive approval from the Department of Health and Human Services and the Drug Enforcement Administration

b. These agencies have enthusiastically supported research into marijuana's dangerous properties, but have been wary of inquiries into the possible benefits of the drug. A case in point; several years ago, a team of researchers developed an experiment to explore whether cannabis eased post-traumatic stress in combat veterans. The team was denied access to product from Waller.

(The University of California-Berkeley also has a Medical Marijuana Research facility but is limited in research endeavors by federal regulations and sanctioned through the state of California)

Interactive Polling

QUESTION FOUR

What is the average percent concentration of delta 9 THC within a marijuana plant?

A.) 15.60%

B.) 8.50%

C.) 3.30%

D.) 20.00%


iii. Research and Funding (Existing Platforms of Investment): Matching up Common Qualifying Illnesses and Conditions of Medical Marijuana state-based Laws with cannabis research “hot fields”

a. Chronic pain: Though marijuana is commonly associated with pain relief, there is variance from patient-to-patient regarding the degree of pain relief. Marijuana also heighten sensitivity and give the feeling of pain being “amplified.” However, many 17 out of 20 state medical marijuana laws have some type of pain (intractable, severe, chronic) as a qualifying condition. Therefore, this is a demographic/ market to be targeted in treatment, advertising, and educationally

b. AIDs/ HIV: Along with cancer treatment patients, the AIDs/HIV demographic stands as a primary impetus for the increase in medical marijuana issue saliency and legality

c. Cancer treatment (to reinvigorate appetite)


d. Multiple Sclerosis-besides smoking cannabis, application of Sativex –an FDA approved CBM- has shown to aid some patients in coping with daily problems associated with MS. Same study found long term effect of the drug’s therapeutic has value and safety of the substance’s use was confirmed-with further studies recommended.

e. Glaucoma-one of the first illness cited for medical marijuana use: United States v. Randall (1978)

f. Other, non-cancer, research:

-in October 2003 the U.S. Department of Health and Human Services was granted a patent entitled “Cannabinoids as Antioxidants and Neuroprotectants”

-peer-reviewed studies from The Pacific Medical Center show potential for CBMs being employed as anti-tumoral treatment

-Scripps University is currently examining the non-psychoactive effects of cannabinoids related to epilepsy in children

http://www.youtube.com/watch?v=IfGWuOL2xsE

(Massachusetts physician comments regarding medical marijuana uses/ latest research)


iv. Review of existing state-based qualifying illnesses/ conditions-see attached list of state-by-state qualifying conditions/ illnesses

v. Potential or “dormant” (Alternative Platforms of Investment) fields of CBM research

a. Post-Traumatic Stress Disorder (PTSD) and other Military Veteran conditions

http://www.youtube.com/watch?v=V0LKnbasbKQ

-Since the Veteran’s Administration allows for veterans living in medical marijuana states to medicate via CBMs they will not risk losing other VA benefits/ medical services, this is an area of research and marketability to be examined.

b. Childhood illnesses (i.e. epilepsy)-New Jersey has made legal provisions for children under 16 to be treated with medical marijuana through physician assistance

c. Retail alternative medical/ pharmacy products (homeopathic, acupuncture,)

IV. Research of CBMs for Healthcare Professionals: Benefits and Limitations-Slide 1 of 7

A. The Research Field in general

i. Fledging

a. Common misnomers regarding marijuana as a medicine

b. Research examples/ evidence of CBMs as medicine/ list of existing CBMs on the market (various countries) and navigating the research/ approval processes:

Sativex, Marinol, Cesamet, Dexanabinol, CT-3 , Cannabinor, HU 308, HU 331,

Acomplia, MK-0364

ii. Research limited (in U.S.) by governmental restrictions/ prohibitions

a. New drug testing petitioning and testing

b. Plant form research petitioning and testing


iii. Prominent contemporary research areas of CBMs

a. THC-Delta9 for Healthcare industry use: first identified in 1964

b. Identifying other cannabinoids (not THC-Delta 9 based) for Healthcare industry use

B. Treatment

i. As a recurring/ single dose treatment alone

ii. As part of a treatment plan

iii. Diversity of “medical” research-all of the following now have researchers of marijuana, the medicine, political objective, social cohesion, perception, legal definition, etc.


C. Review of contemporary research findings and their applications (SEE ALSO PART III, C, i-iii; Samplings of research from the following fields is detailed in the webinar and will be added to Instructor’s notes)

i. Biological

ii. Chemical

iii. Horticultural

iv. History

v. Sociology

vi. Public Policy Studies

IV. Research of CBMs for Healthcare Professionals: Benefits and Limitations- Slide 4 of 7

D. Economic possibilities founded on what has been reliably garnered knowledge from the illegal markets:

i. employment opportunities

ii. new technologies in research

iii. expansion and discovery of new economic markets from CBM research will take place

From cannabinoid research to investment trading (numerous “marijuana” companies issued IPOs last year and with legalization in Colorado and Washington along with the expansion of medical marijuana in Illinois and New Hampshire, stock prices are slowing increasing)

iv. producing not only medicines, and medical treatments but also a bevy of byproducts or supplemental platforms for development (an “all-service” dispensary exemplified)

IV. Research of CBMs for Healthcare Professionals: Benefits and Limitations- Slide 5 of 7

Medical Marijuana Related Stocks-WILL NEED UPDATING ◦ 52 week Range Current Price (as of 1/9/14)

MDBX – Medbox Inc. 8.11 – 100.99 45.80

FITX – Creative Edge Nutrition N/A 0.0275

PLPL – Planda 0.04 - .62 0.42

CBIS – Cannabis Science, Inc. 0.03 – 0.19 0.18

PHOT – Growlife, Inc. 0.01 – 0.47 0.43

CANV – ConnaVEST Corp 10.01 – 49.90 32.25

MJNA – Medical Marijuana, Inc. 0.09 – 0.50 0.22

TRTC – Tera Tech Corp 0.06 – 0.66 0.41

IV. Research of CBMs for specific Healthcare Professionals: Benefits and Limitations-Slide 6 of 7

E. Certification Programs-per capita or as part of a broader program

i. Caregivers (outside of patients and growers, the largest personnel component of the medical marijuana industry) state to state varies with only patient selection of an individual and no mandatory certification/ training programs in place

ii. Physicians: Training of currently licensed physicians is warranted as well as the promotion of seminars or whole courses on CBMs in medical schools. Presently, physicians can consult and issue “suggestive scripts” for medical marijuana. Unfortunately, medical marijuana has become a niche market in many states, producing public skepticism rather than a valid choice of pain relief within pharmacopeia and as part of broader treatment processes.

IV. Research of CBMs for specific Healthcare Professionals: Benefits and Limitations-Slide 7 of 7

iii. Nurses

a. Most responsibilities conducted by nurses for non-cannabis treated illness carried out by caregivers and physicians

b. One 2012 peer-reviewed study focused on cannabis use as abuse/ addiction possibilities found nurses reporting less knowledge, skill, and “role legitimacy” regarding cannabis use by recreational users. Therefore, though the cited study should be considered a proxy for research focused on CBMs, medical marijuana use warrants training of nurse in carrying out medical marijuana protocols (informing patients, dosage, etc.)

iv. Healthcare Administrators (Management, C-Suite members, executives, etc.)

V. Governmental and Legal Processes-Slide 1 of 2 A. Application process: pharmaceutical cannabis-based medicines and cultivation of cannabis

i. Apply to Several Federal Governmental Agencies requesting research trials on Schedule I Substance (Federal standards and answers punitively-based)-Petitioning for Rescheduling and Testing will be reviewed

a. FDA

b. DEA

c. Health and Human Services

d. EPA: Foreseeably, if marijuana is rescheduled so as to allow medical use nationwide, this is an agency that will oversee “environmental impact statements” regarding large scale cultivation

e. INTERIOR: even if marijuana was rescheduled so as to allow medical use nationwide, most likely it would remain illegal to cultivate marijuana on public lands. Therefore, the Department of Interior would play a role in detecting and pursuing any offenders

V. Government and Legal Processes-Slide 2 of 3 ii. Apply to Several State Agencies (State level laws tend toward non-punitive standards and answers)

a. BLM, Public Health, or designated agency

b. Business licenses

Locality-dependent: since some communities have decided to either limit the number of dispensaries, ban dispensaries, or defer to state authorities each licensing/ permit process differs. (Various commonalities and differences will be sampled-Rhode Island, Connecticut, California, and Illinois)

Contemplate: ideally, a dispensary located within a professional medical building occupied by a wide range of physician specialties.

c. Law Enforcement

State-dependent: since state-based laws regarding medical marijuana (marijuana in general as well) are trending toward non-punitive means, law enforcement does not play the central role in medical marijuana regulation. However, many counties/ localities cannot and do not possess the bureaucratic resources to dedicate to this policy area. Therefore, many law enforcement personnel carry out “double duty” by enforcing cultivation and distribution regulations while also enforcing non-medical marijuana laws.

Interactive Polling

QUESTION FIVE

Which specific Cannabis compound has shown therapeutic promise and advantage as an antioxidant and neuroprotectant for treatment and prophylaxis of a wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases and neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease, and HIV dementia.

A.) Delta 9 THC

B.)CBD-Cannabidiol

C.) CBG – Cannabinerol

D.) CBN – Cannabinol

E.) CBC - Cannabinchromene

V. Government and Legal Processes-Slide 3 of 3 iii. Regulatory control and responsibility to distribute CBMs/ Medical Marijuana

a. most states prescribe to the dispensary model

b. Licensed “Dispensary Personnel” must be in attendance during open hours

c. Connecticut: licensed pharmacists must be in attendance during office hours

d. All levels of government are involved with dispensary licensing; jurisdictionally variant-county, city, and state agencies are part of an articulated set of policies, especially in the last five years

e. Developing nexus of policies has too many lacunas of bureaucratic regulation/ oversight (Examples Given)

e. policies/ laws enacted via ballot initiative, legislatively, judicially, and administratively (executive directive-i.e. New York)

f. opportunities for pharmacy industry to lobby and write more developed policies regarding dispensary oversight

VI. Cost Implications-Slide 1 of 4 http://www.youtube.com/watch?v=6M99JZgr1vI

(Tour of Haborside Dispensary, Oakland, CA-one of the largest medical marijuana dispensaries)

A. Common impediments/ problems/ restrictions with the business of medical marijuana and CBMs post-research (Actual, Potential, and Hypothetical)

i. Purchasing bulk cannabis from reliable sources

ii. Transportation from growers/ buyers to dispensaries/ pharmacies

iii. Inventory

iv. Patient identification card assurance/ updating

VI. Cost Implications-Slide 2 of 4 B. “Connecting with existing markets”

i. Cultivation necessitates horticulture edification

ii. Personnel hiring/ contracts

iii. Selecting sellers

v. Developing a “line” from farm to store shelves would increase cost efficiency, build trust between associated segments of the industry, and guard against loss of product as well as product quality

VI. Cost Implications-Slide 3 of 4 C. Licensing by federal, state, and local agencies

i. Petitioning and licensing costs (Department of Public Health, Agriculture/ BLM, law enforcement)

ii. Plant quota inspections and fines (if applicable)

D. Training Programs

i. Accreditation, Hiring, Resourcing, and Updating

ii. Individuals’ costs: paying for certification courses

VI. Cost Implications-Slide 4 of 4 E. Marketing

i. Costs varying but based on one existing medical marijuana dispensary model the following costs are presented from highest to lowest common costs (varying on jurisdiction)

a. Goods (Products and Services ranging from cannabis to consultations)

b. Business and Sales taxes

c. Payroll (most dispensaries are not union or of a collective bargaining nature; however, caregivers, including medical marijuana exclusive individuals, have unionized in many states)

d. Insurance

c. Advertising and Marketing

ii. Licensing and permit fees

iii. A common federal tax filing tactic of dispensary owners is to declare income but not to itemized, keeping I.R.S. audit interest at bay (grounds for Montana dispensaries being raided by federal authorities two years ago)

WORKS REFERENCED SLIDE 1 OF 2 References:

Americans for Safe Access website: www.safeaccessnow.org

“Cannabis-Based Medicines, GW Pharmaceuticals High CBD, High THC, Medicinal Cannabis – GW Pharmaceuticals, THC:CBD.” Drugs R & D 2003, 4, 5, 306-309

Procon.org non-partisan (501) nonprofit website: last taken December 9, 2013

Gettman, John. Marijuana Production in the United States. The Bulletin of Marijuana Reform December 2006

Grant, Igor, J. Hampton Atkinson, Ben Gouaux, and Barth Wilsey. “Medical Marijuana: Clearing Away the Smoke.” The Open Neurology Journal. 2012, 6, 18-25

Illinois’ Medical Marijuana Law A Guide for Doctors and Patients. Marijuana Policy Project news letter received September 10, 2013. For more information to the Illinois medical marijuana laws: http://www.idph.state.il.us/HealthWellness/MedicalCannabis/index.htm and mpp.org/research

Lynch, Mary E. and Fiona Campbell. “Cannabinoids for Treatment of non-cancer pain: a systematic review of randomized trials.” British Journal of Clinical Pharmacology 2011, 162, 1

WORKS REFERENCED SLIDE 2 OF 2 “The Nation” online version: http://www.thenation.com/search/apachesolr_search/marijuana

Last taken on December 10, 2013

Norbert, Melissa, et al. “Screening and Managing Cannabis Use: Comparing GP’s and Nurses’ Knowledge, Beliefs and Behavior.” Substance Abuse Treatment, Prevention, and Policy 2012, 7, 31

Malott, Michael. 2009. Medical Marijuana: The Story of Dennis Peron, The San Francisco Cannabis Buyers Club and the Ensuing Road to Legalization. San Francisco, CA: Createspace Publishers

Marijuana Policy Project Annual Report 2012, Published 2013. Marijuana Policy Project website: mpp.org last taken on November 30, 2013/Marijuana Policy Project website: mpp.org

Pertwee, Roger G. “Pharmacological and Therapeutic Targets for THC-Delta9 Tetrahydrocannabinol and Cannabidiol.” Euphytica 2004, 140, 73-82

Scott, Colin and Geoffrey Guy. “Cannabinoids for the Pharmaceutical Industry.” Euphytica 2004, 140, 83-93

United Patients Group website: http://www.unitedpatientsgroup.com/resources/medical-marijuana-caregivers “How to be a Medical Marijuana Caregiver”

Wade, Makela, House, Bateman, and Robson. “Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis.” Multiple Sclerosis 2006, 12, 639-645

Post-Test Questions Slide 1 of 8 1. The two basic Cannabis strains are:

a. Ruderails and Indicia

b. Indicia and Sativa

c. Sativa and Ruderails

d. Sativa and Kush

2. A 2006 peer-reviewed economic study regarding cannabis’ market estimates the industry to be worth nearly

a. 10 billion dollars

b. 20 billion dollars

c. 30 billion dollars

d. 40 billion dollars

Post-Test Questions Slide 2 of 8 3. A common regulatory standard amongst medical marijuana states regarding cultivation and possession of medical marijuana is the _______ and ________ stipulation

a. Locked and enclosed

b. Sealed and hidden

c. Indoor and vented

d. Outdoor and out-of-sight

4. There is a dearth of pharmaceutical research of CBMs due to

a. lack of investment interest from entrepreneurs

b. Federal status of marijuana (Schedule I) and obstruction of research petitioning process

c. State government monopolization of this policy area

d. The FDA and DEA has limited the numbers of research permits

Post-Test Questions Slide 3 of 8 5. One of the most common dispensary protocols and “rules of thumb” for caregivers/ budtenders working in the CBM industry is to avoid

a. CBMs being exposed to too much sunlight

b. Storing CBMs in “locked and enclosed” areas

c. As much “hand to cannabis” touching as possible

d. Weighing marijuana for patients more than once

6. In the past, a fundamental problem with pharmaceutically created CBMs, particularly Marinol, was

a. Taste

b. Patient application of dosage and control of intake of the substance

c. Did not always stimulate appetite

d. Market price was ten times that of illegal marijuana

Post-Test Questions Slide 4 of 8 7. To date, only one state, Connecticut, mandates pharmacists to

a. Work in dispensaries

b. Be dispensary owners

c. Consult with patients regarding CBMs

d. Both a and c apply

8. The primary research oversight agency for marijuana-based research is a. Health and Human Services

b. Drug Enforcement Administration

c. National Institutes of Health

d. National Institutes of Drug Abuse

Post-Test Questions Slide 5 of 8 9. The most common medical condition (17 out of 21 jurisdictions) for a patient receiving a medical marijuana allowance is

a. MS

b. arthritis

c. chronic or severe pain

d. glaucoma

10. As of now, the two medical conditions offering the most potential for possible medical marijuana treatments are

a. MS and glaucoma

b. PTSD and tumors

c. chronic pain and arthritis

d. ADHD and hair loss

Post-Test Questions Slide 6 of 8 11. One of the few trademarks or patents issued by the United States federal government regarding CBMs was issued to the Department of Health and Human Services to research

a. glaucoma

b. multiple Sclerosis and muscle spasticity

c. cannabinoids as Antioxidants and Neuroprotectants

d. chronic pain relief

12. With the assistance of a physician, children under _________ in New Jersey can be treated for certain illnesses with CBMs

a. 13

b. 14

c. 15

d. 16

Post-Test Questions Slide 7 of 8 13. ______________ distribution of medical marijuana is illegal and not protected by state or local laws.

a. intrastate

b. interstate

c. city streets

d. all of the above

14. In a 2012 peer-reviewed study concerning CBMs, nurses reported having “less knowledge, skill, and ______________.”

a. patient relations

b. certification of CBM protocols

c. legal protections

d. role legitimacy

Post-Test Questions Slide 8 of 8 15. One way to ensure patient loyalty and safety is for dispensaries to have

a. informative materials available for patients

b. train dispensary personnel in the most up-to-date CBM caregiving protocols

c. offer patient consultations and referrals regarding CBMs

d. all of the above

16. Medical Marijuana was first legalized in __________ by the State of ___________.

a. 1996, California

b. 2008, Michigan

c. 2000, Colorado

d. 1995, California

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