Dr. D'Angelo will cover the need and best practices for maintaining a standard of care in a changing medical environment, and establish the responsibilities of the patient and provider during cannabis therapy treatments.


2. Cannabis as Medicine:
Redefining the Paradigm of the Doctor Patient Relationship
JACK B. D’ANGELO,M.D.,M.B.A
Chief Medical Officer, CITIVA LLC

3. In today’s presentation we will discuss:
• The challenges Physicians Face with Cannabis
Therapies
• The Medical Model of Patient Care and
Cannabis

4. What is a Medical Marijuana Program?
Medical Cannabis, commonly referred to as Medical
Marijuana or MMJ simply refers to the use of various
forms of the cannabis plant in the treatment of medical
conditions.
• “Medical Marijuana Program”
• Term used in most state statutes, rules, and regulations
that provide for the medical use, cultivation and
dispensing of cannabis for medical purposes, which may or
may not include specific medical conditions for which a
physician (or other licensed health care provider) may
issue a recommendation, attestation, or authorization for
a patient to obtain and use cannabis.

5. How Far We Have Come
Cannabis use in patient care has increased in
popularity nationwide since 1996 when California
voters passed Proposition 215, making it the first
state to allow cannabis to be recommended in
patient care

6. Currently, 29 states and the District of Columbia and
Guam* have enacted laws or passed ballot initiatives
establishing comprehensive medical cannabis programs.
*As May 2017

7. Cannabis vs. Marijuana-
What should
we call it?
• There are a lot of slang terms for cannabis. Some are hip, some are pejorative and
some are downright amusing.
• The term “marijuana,” given its history and the nature of prohibition, raises
eyebrows still today. Marijuana is what prohibition supporters called cannabis as
they sought to demonize its use and criminalize its consumers.
• According to H.L. Mencken there are no known examples of the use of this word
prior to 1894. It became identified as the "devil’s weed" by early supporters of
prohibition, and many Americans don't know any other name for the cannabis
plant.

8. Words Matter
Cannabis is an elegant botanical compound.
It is important to call things by the correct name.
For purposes of speaking about it’s use medically,
I use the term Cannabis.
Using this term with patients as well as in our
government will help people feel more comfortable
with its medical use and legitimacy, and allow us to
think beyond the stigma of recreational use.

9. Recommending Cannabis
Most doctors today either have patients asking
them about their opinion on using medical
cannabis, or are requesting a recommendation
for its use.
Many doctors face hurdles in finding the right
research, becoming ‘certified’ in recommending
cannabis, and/or are reluctant to enter into
non-traditional therapy with their patients.
So where do you begin to determine if its right
for your patient and your practice?

10. Getting Past the Obstacles to
Recommendation
• Fear
– Is it safe?
– Will all my patients need to get ‘high’ ?
– Will I be stigmatized?
– Will my patients have legitimate need?
– How will this affect my license?
• Time
– I have to take a class?
– I have even more paperwork?
– I can’t fit in any more patients or spend more time with them!
– It’s just easier all around to write a prescription
• Education
– This wasn’t taught in medical school…
– Where can I learn more about cannabis in patient therapies?
– What are the most recent studies? Why aren’t there more studies?
• Costs
– Patients require more visits, which in turn costs everyone more
– Medication costs aren’t covered by insurance

11. Getting Past the Fear- Patient Safety
• Patient Safety
– Cannabis has fewer side affects than any current opioid on the market
– There is not a single documented case of overdose on medical cannabis in
the world
– Cannabis therapies, when monitored by a physician, can have better
efficacy and fewer side affects than current Rx therapies.
– Not all THC is the same.
• Many, if not most, patients and even physicians correlate cannabis with ‘getting
high’. It is stigmatized by the recreational market and reinforced through years
of prohibition and purposeful misinformation
• In cannabis studies, you find that many conditions can be effectively treated
with cannabis that is well balanced in both CBD and THC or low to zero THC.
– No, your patient doesn’t need to ‘smoke’ their medication
• In almost all states where medical cannabis has been legalized, smoke-able
forms are not allowed.
• The most common and affective methods of dosing are tinctures, metered- dose
vaporization, capsules, and nasal spray.

12. Getting Past the Fear-
Manufacturing Safety
• Manufacturing Safety
– Medical cannabis in all 29 states
is tracked from seed to sale
through integrated software
systems.
– Independent tests are done at
each stage of product
development to ensure the
quality and safety of each
product

13. Getting Past the Fear-
My Medical License
• Is there risk to my medical license?
– Physicians cannot legally prescribe marijuana. The Drug Enforcement
Administration classifies it as a Schedule I drug under the Controlled Substances
Act, the same class as heroin and LSD.
• The official federal policy is that marijuana has no accepted medical use and has a
high potential for abuse.
– Physicians can only write letters of recommendation that the patient qualifies
for a certification to use the substance, and only after a thorough examination
and often other state-specific requirements.
• Physicians cannot dispense marijuana.
• The patient must go to a licensed dispensary to obtain the drug.
– In 2013, the US Department of Justice advised US attorneys not to pursue
actions against physicians in states that allow medical marijuana.
• The goal of federal policy is to prevent distribution of marijuana to minors; prevent
sales revenue from going to criminal enterprises, gangs, and cartels; prevent diversion
from legal to non-legal states.

14. Getting Past the Fear-
Will my patient base change?
Many may fear the stigma that has been
associated with cannabis use for many years.
However, medicine is still a science, and
science is telling us as physicians that cannabis is a
true medical therapy and should be considered for
many symptoms and illnesses.
With some of the biggest breakthroughs in
cannabis treatment coming from low-dose THC
therapies for epileptic children, our communities
are becoming very receptive to cannabis therapies
and are looking to their physicians for guidance,
education, and treatment.

15. The Real Faces of Cannabis Patients
*Source: MarijuanaPatients.org

16. Finding Time & The Ease of Traditional Rx
There is a very real challenge facing both physicians
and patients in starting a cannabis therapy program.
TIME
Writing a traditional prescription requires little time for the physician,
and a simple and known method of fulfilling that Rx for the patient.
Many physicians avoid recommending cannabis due to the ‘red tape’
required to comply with state regulations, and patients are often
overwhelmed and confused by the process to seek the medication.
There really is no way around this issue- the decision to work with
your patients and recommend medical cannabis in their treatments
requires your time and your willingness to educate yourself and your
patients in an ongoing relationship.

17. The Lack of Cannabis Therapy Research
• What has caused the lack of research?
• Due to the classification of cannabis as a schedule 1
drug, access to legal cannabis for medical research has
been restricted. Not only is access restricted, but all
research in the US has been done on single source THC.
• Some of the most promising medical research is being
conducted outside of the US. However, there are
sufficient studies for education and understanding of
its benefits, limitations, and indications of potential
uses in a variety of medical therapies.

18. Finding the Research
It can be challenging to cut through the myths
of cannabis curing everything to nothing.
As Physicians, we are challenged to continue
to educate ourselves and our patients to
determine the best possible treatments
options.
• Attend your state and local conferences
• Explore physician led webinars
• Good online resources
• WebMD
• “Medical Marijuana: What the Research Shows”
• www.TheCannabist.co
• “The 5 Most Important Medical Marijuana
Research Studies of 2016
• VISIT A DISPENSARY
•Almost all offer tours

19. Avoiding the Obstacles- Cost
• Cost to the Physician and to the Patient
• One of the biggest hurdles preventing patient access to
cannabis is the cost burden to both patient and physician
• Physician must pay for and take a state required course
• Patients must pay out of pocket- often for multiple visits just to get a
recommendation
• Insurance WILL NOT cover cannabis as medicine
• There are synthetic drugs coming to market that synthesize some of the
properties of THC. However, studies have continued to show that the entourage
affect of the whole plant is necessary in the most successful studies.
• There is no immediate solution to the costs for either
party.
• It will take the support and activism of us all to work through
the regulation hurdles to have cannabis recognized as
medicine federally, and continued growth in the market to
keep medication costs down for patients.

20. We Got Here Together,
Now Let’s Work Together

21. How Do Physicians and Patients
Work Together to Redefine
the Patient Doctor Relationship in the
over-regulated world of medical
cannabis?

22. Defining the Right Medical Model in this New Industry
• The solution to current medical-cannabis laws is not a
matter of supporting or prohibiting its use- with 29 states
allowing medical use, the role of the medical caretakers is
of the utmost importance.
• A proper medical model has always been composed of the
prescribing of medicine by a licensed prescriber and the
dispensing of medicine by a separate licensed entity, with
attention to appropriate dosing and therapeutic use.
Uh oh!
But we aren’t ‘Prescribing’ cannabis,
and there is no ‘Pharmacy’ for
dispensing.

23. Qualifying Conditions in the State of Florida
In the State of Florida, conditions approved for treatment
with cannabis are limited to the following*
•Cancer
•Epilepsy
•Glaucoma
•HIV/AIDS
•PTSD
•ALS or Lou Gehrig’s disease
•Crohn’s disease
•Parkinson’s disease
•Multiple sclerosis
•Other debilitating conditions of the same kind or class for which a
physician believes the use of cannabis would likely outweigh the
potential health risks for a patient.

24. Sticking to the Basics
Physician
Patient
Relationship
Patient
Evaluation
Informed and
Shared
Decision Making
Treatment Plan
& Ongoing
Management

25. • The health and well-being of patients depends upon a
collaborative effort between the physician and the patient.
• The relationship is complex and based on the mutual
understanding of the shared responsibility for the patient’s
health care.
• Establish knowledge of their history- Prior to providing a
recommendation, attestation, or authorization for cannabis to the
patient.
• At minimum, providers should have completed their state
mandated certifying course.
• Seek the continued education on cannabis therapies.
Research and patient databases are growing quickly as
medicinal use spreads, allowing for a community of caregivers
to make informed decisions and help educate their patients.
• VISIT A DISPENSARY
• Be familiar with their process, environment and staff. Know
what your patient will experience so that you can help them
understand the process.
The physician-patient relationship is fundamental to the
provision of acceptable medical care.

26. Patient Evaluation
• Documented in-person medical evaluation and collection of relevant
clinical history commensurate with the presentation of the patient
must be obtained before a decision is made as to whether to
recommend cannabis for medical use.
• Evaluation should include the patient’s history of present illness, social
history, past medical and surgical history, alcohol and substance use
history, family history with emphasis on addiction or mental illness/
psychotic disorders, physical exam, documentation of therapies with
inadequate response, and diagnosis requiring the cannabis
recommendation.

27. Informed & Shared Decision Making
• SHARE THE DECISION
• The decision to recommend cannabis should be a shared decision
between the physician and the patient.
• DISCUSS THE RISKS
• The physician should discuss the risks and benefits of the use of
cannabis with the patient.
• DISCUSS DOSAGE
• Patients should be advised of the variability of cannabis preparations
and the varying effects. The physician should explain proper dosing
(start low) and monitor the patient carefully.
• Be a Part of the Conversation
• Our community relies on our collective knowledge. Patients’
own education about cannabis and history of effectiveness is
often greater than many physicians. Encourage
communication and participate in available forums.

28. Treatment Agreement
A health care professional should document a written treatment
plan that includes:
• Review of other measures attempted to ease the suffering caused by the
terminal or debilitating medical condition that do not involve the
recommendation of cannabis.
• Some states, including Florida, have required several months of
alternative treatment before recommending cannabis.
• Advice about other options for managing the terminal or debilitating
medical condition.
• Determination that the patient with a
terminal or debilitating medical condition
may benefit from the recommendation of
cannabis.

29. Advice about the potential risks of the medical use of cannabis to
include:
• The variability of quality and concentration of cannabis, especially when
not purchased from a licensed dispensary.
• The risk of cannabis use disorder;
• Exacerbation of psychotic disorders and adverse cognitive effects for
children and young adults;
• Adverse events, exacerbation of psychotic disorder, adverse cognitive
effects for children and young adults, and other risks, including falls or
fractures;
• Use of cannabis during pregnancy or breast feeding;
• The need to safeguard all cannabis and cannabis-infused products from
children and pets or domestic animals; and
• The need to notify the patient that the cannabis is for the patient’s use
only and should not be donated or otherwise supplied to another
individual.
Advisement of Risks

30. Advice about the potential risks of the medical use of cannabis to
include:
• Where available, the physician recommending cannabis should register with the
appropriate oversight agency and provide the registry with information each time
a recommendation, attestation, authorization, or reauthorization is issued.
• Where available, the physician recommending cannabis should check the state
Prescription Drug Monitoring Program (PDMP) each time a recommendation,
attestation, authorization, or reauthorization is issued.
• The physician should regularly assess the patient’s response to the use of cannabis
and overall health and level of function. This assessment should include the
efficacy of the treatment to the patient, the goals of the treatment, and the
progress of those goals
Ongoing Management & Adapting the Treatment Plan

31. Consultation & Referral, Partner with Peers
It is the responsibility of a health care provider to have a holistic
consultation with their patients. It is important to partner with or
refer to other health care providers as needed to provide the best
overall care.
A patient who has a history of substance use disorder or a co-
occurring mental health disorder may require specialized
assessment and treatment.
The physician should seek a consultation with, or refer the patient
to, a pain management, psychiatric, addiction or mental health
specialist, as needed.

32. Accurate Medical Records
The physician should keep accurate and
complete medical records. Information that should appear in the
medical record includes, but is not necessarily limited to the
following:
• The patient’s medical history, including a review of prior medical
records as appropriate;
• Results of the physical examination, patient evaluation, diagnostic,
therapeutic, and laboratory results;
• Other treatments and prescribed medications;
• Authorization, attestation or recommendation for cannabis, to
include date, expiration, and any additional information required by state
statute;
• Instructions to the patient, including discussions of risks and
benefits, side effects and variable effects;
• Results of ongoing assessment and monitoring of patient’s response
to the use of cannabis;
• A copy of the signed Treatment Agreement, including instructions on
safekeeping and instructions on not sharing.

33. Physician Conflicts of Interest
A physician who recommends cannabis should not have a professional
office located at a dispensary or cultivation center or receive financial
compensation from or hold a financial interest in a dispensary or
cultivation center.

34. Now, Let’s Go Off and

35. Thank You
www.CITIVA.com jdangelo@citiva.com