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THE BLOOM OF HEMP:

The Emerging Industry

& Therapeutic Impact of

CBD Hemp Extract

T.W. Taylor, RPhOwner,Williamsburg Drug Co.

Disclosure

I have no actual or potential conflict of interest in relation to this program/presentation.

O B J E C T I V E S

Define the term CBD –the phytocannabinoids derived

from a legally grown hemp plant.

Explain the physiology of the mammalian endocannabinoid system

(ECS), particularly as a messaging system for

biological activity.

List the primary therapeutic benefits within the ECS through the use of phytocannabinoids.

MY JOB DESCRIPTION

Optimize my patient’s health at every age and disease state.

How many clients come in and just don’t feel good?

• You are in the best position to help the prescriber and the patient• You are a teammate with the prescriber!• You see the patient about 30x a year more than the prescriber• You know the metabolic pathways

THE PHARMACISTS’

FUTURE

• Your job is to be a partner with your prescribers and a partner with your patients

• “Standards of Care” is the norm

• People are not standard, and pharmacists can make a huge difference!

• Find the root cause, Don’t just treat the symptom

A DIFFERENT FUTURE FOR MY PHARMACY

The opportunity of a lifetime.

Healthier Patients.Healthier Profits.

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THE PLAN

✓ Fill the gap that IS rightfully yours

– Metabolic pathways

– Drug depletions

✓ Utilize the opportunities you already have

– Your knowledge and patient base

THE BEST WAY TO PREDICT THE FUTURE

IS TO CREATE IT!

“

“ABRAHAM LINCOLN

COMMUNITY

PHARMACIES NEED TO

OWN THE CBD SPACE

WHY CBD WORKS

$1,000,000 SALES

IN 2019

• 50% Profits

• No Audits

• No DIRs

• All CASH

WILLIAMSBURG DRUG CO.

H E M P & C B D 1 0 1

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W H A T I S T H E D I F F E R E N C E B E T W E E N

HEMP AND MARIJUANA

M A R I J U A N AH E M P

CBD

NON-PSYCHOACTIVE

FEDERALLY LEGAL

AVAILABLE OTC

YES

YES

YES

YES

CBD

NON-PSYCHOACTIVE

FEDERALLY LEGAL

AVAILABLE OTC

YES

NO

NO

NO

C B D• Not psychoactive

• Will not (and cannot!) get you high

• Therapeutic potential: Anti-inflammatory, pain relieving, immunomodulating, anti-anxiety, etc.

• Risks: Minimal; Drug interactions, hepatic toxicity

• Low affinity for CB1 & CB2 receptors – “potent antagonist” (Thomas et al., 2007)

VS T H C• The compound that elicits the high in marijuana

• Highly regulated

• Federally illegal

• Therapeutic potential: Anti-nociceptive>anti-inflammatory, anti-proliferative, etc.

• Risks: Can induce anxiety & psychosis, drug interactions, hepatic toxicity

• Binds to both CB1 & Cb2 receptors – partial agonist

C A N N A B I N O I D S

The chemical compounds that hold the key to many health benefits.

T H E E N T O U R A G E E F F E C T :

I T ’ S N O T O N L Y A B O U T C B D !

WE’RE A NATION

INFLAMED.But Supporting the

Endocannabinoid System Can Help!

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I can’t list all the physiological systems and conditions affected by cannabinoids because there are too many.

T H E E N D O C A N N A B I N O I D S Y S T E M

Dr. Raphael Mechoulam,The chemist who identified the endocannabinoid system

Not widely taught in medical, nursing or pharmacy schools (~13%, may be changing)

We are “hardwired” with a master control system called the Endocannabinoid System (ECS). The ECS is made up of cell receptors that act as messengers, giving your body specific directions on what to do.

Some of these messengers are located in the brain and the spinal cord. Others are located in immune cells, gastrointestinal tract and everything outside the brain and spinal cord.

THE ECS HELPS IN REGULATING:

• Anxiety

• Appetite/Hunger

• Depression

• Digestion

• Immune Function

• Memory

• Mood

• Motor Control

• Pain

• Pleasure & Reward

• Reproduction & Fertility

• Sleep

• Temperature Regulation

CB1 Receptors are predominant in the brain.

(Hippocampus, Cerebellum, and Cerebrum)

CB2 Receptors are prevalent throughout the body.

(Immune, Digestive, Muscular, and Vascular Systems)

THE RECEPTORSActivation and upregulation of the endocannabinoid system is essential to healthy living

Outside Cell

Inside Cell

CB1

Outside Cell

Inside Cell

CB2

• CBD is safe and well tolerated in humans

• Not associated with negative public health effects

• Not associated with abuse potential

World Health Organization, & WHO Expert Committee on Drug Dependence. (2018). WHO Expert Committee on Drug Dependence: thirty-ninth report.

The World Health Organization’s Report on CBD

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I suggest that it is malpractice if you do not

offer CBD to a patient with pain, arthritis, on opiates

etc.

THERE ARE 3 KINDS OF PAIN

1. Nerve Pain (Neurontin®, Cymbalta®, Lyrica® etc)

2. Bone Pain (NSAIDs)

3. Soft Tissue Pain (Opioids, NSAIDs, Tylenol®)

CBD CAN HELP WITH ALL THREE

C A N N A B I N O I D S & P A I N

JAMA’s systematic review of cannabinoids analgesia.1

• 28 randomized clinical trials (RCTs) completed over 67 years.

• The review concluded that cannabis therapy for marked pain relief and spasticity reduction is supported by high-quality evidence.

Meta-Analysis from the National Academies of Science, Engineering & Medicine

• “Conclusive or substantial evidence” of cannabinoids’ efficacy in pain relief, spasticity, seizures.• Well tolerated

Petzke’s Systematic Review on Cannabinoids & Pain

• 15 RCTs• Conclusion: Cannabinoids effective for pain relief• Side effects of intoxication with high THC*

CBD for Opioid Reduction: WITHDRAWAL

• CBD & Fentanyl Pharmacokinetic Study

• No increased risk of respiratory depression

• No increased cardiovascular risk

• Maine Medical Center: 1,500 opioid users: patients opioids for chronic pain.

• Reduction in:

– Opioids: 76.7%

– Anxiety meds: 71.8%

– Depression meds: 37%

– Sleep meds: 65.2%

– Migraine meds: 66.7

– Alcohol: 42%

C B D F O R O P I O I D

R E D U C T I O N

Self-report from over 1,300 fibromyalgia patients on treatment efficacy of

Cymbalta, Lyrica, Savella & CBD

N A T I O N A L P A I N F O U N D A T I O N S T U D Y O N F I B R O M Y A L G I A

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Evaluating the effects of full-spectrum hemp extract on opioid use and quality of life indicators in chronic pain patients

O B S E R V A T I O N A L S T U D Y

97 PARTICIPANTS

O B S E R V A T I O N A L S T U D Y

Quantitative Statistical Analyses using ANOVA was

completed with SPSS. Improvements in scores from

baseline to week 8 were statistically significant on the

PEG scale, the PSQI, and the PDI. Score changes on the

PHQ-4 and the Willingness VAS suggested a downward

trend but were not statistically significant.

Have human patients?Here’s what you need to know.

• Dosing

• Interactions

• Monitoring

• Product Selection

DOSE RESPONSECURVE

OUR CBD SELECTION

THEY ARE PUREWhat separates Ananda Pro fessional CBD from the standard c onsum er CBD product is its purity . Accord ing t o

the FDA, 91% of all CBD products are adult erated .

THEY ARE TESTEDAnanda Professional CBD products are all th ird party t ested , verifiab le b y a Cert ificate of Analysis (COA). To

access the COA, scan the QR code on the box, enter the lot num ber and you w ill see the product ’s COA.

THEY ARE HONESTAnanda Professional p roducts stat e the specific am ount o f act ive cannab inoid oil (CBD) per m L/ d ropper.

Other p roducts give you the am ount o f hem p extract contained but th is is NO T equivalent t o CBD. Approxi -

m ately 40 -60% of hem p extract is actually CBD .

CBD OIL DOSING

Since CBD metabolism depends on a number of factors, dosing is based on w hat w orks for the individual and

fin

d

ing your sw eet spot. You may benefit from tw ice-a-day dosing. n most cases, the preferred delivery

method for CBD is a liquid tincture under the tongue w hich is absorbed directly into the blood stream.

1. Tw o Hours Before Bed

• Start w ith 10m g of CBD for th ree evenings.

• Ananda Professional: mg .m , mg .m , mg .m

• Hold under your tongue for 3-5 m inutes then sw allow .

2. If No Im provem ents y The 3rd Evening

• Add another 5m g for an add it ional tw o evenings

• Your dose is now 15m g

• Ananda Professional: 300m g = 1.5m L, 600m g = .m , mg . m

3. If No Im provem ents y The 5th Evening

• You can keep increasing your dose by 5m g every 48 hours unt il you find no greater

im provem ent in your relief.

• Once you get to that point , dose dow n to the previous 10m g increm ent.

4 . Tw ice-a-Day Dosing -

240 McLaw s Circle • 757.229.1041 | 1302 Mt. Vem on Ave • 757.229.3560

Keep a journal to track your outcom es. Write dow n how you feel before and after taking CBD. Is your sleep quality bet ter, less aches and pains, anxiety m ore m anageab le, etc. Rate your pain, anxiety, insom nia etc on a scale

from 1-10 and w atch for m easurab le suc cess.

DOSING INSTRUCTIONS

ELEVATING THE CBD BUYING

EXPERIENCE AT THE PHARMACY

600mg10mg

We do not know what dose you need

Most of my patients are between 10—60mg/day but I have had patients between 2.5mg – 300mg per day

Sweet Spot

x

________

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DERMATOME MAP

lit t le finger

THORACIC T1: upper chest and back, arm pit ,

front o f arm

T2: upper chest & back

T3: upper chest & back

T4: upper chest (area of nipp les) &

back

T5: m id-chest & back

T6: m id-chest & back

T7: m id-chest & back

T8: upper abdom en & m id-back

T9: upper abdom en & m id-back

T10: abdom en (area of belly but t on)

& m id-back

T11: abdom en & m id-back

T12: lower abdom en & m id-back

LUMBARL1: lower back, h ips, groin

L2: lower back, front and inside o f

th igh

L3: lower back, front and inside o f

th igh

L4: lower back, front o f th igh and calf,

area o f knee, inside o f ankle

L5: lower back, front & outside o f calf,

t op & bot t om of foot, first four toes

SACRALS1: lower back, back o f th igh, back

& inside o f calf, last t oe

S2: but tocks, genitals, back o f th igh

& calf

S3: but tocks, genitals

S4: but tocks

S5: but tocks

W HAT ARE THEY?A derm atom e is an area of sensory

nerves near the skin that are supp lied

by a specific sp inal ner ve root .

Derm atom es are useful for find ing

the sit e of dam age t o the sp ine.

(Ex: leg pa in f rom rad icu lopath y often

ind ica tes a prob lem to a specifi c n erve

root in the lum bar sp ine.)

USING CBD FOR PAIN1. Use the derm atom e m ap as a guide

to find out where you should app ly

the CBD salve or oil.

2. Apply the CBD salve or oil ind irect ly

to the sp ine (off to the side not

d irect ly in the m idd le).

3. Next app ly the CBD salve or oil to where the pain rad iates.

SPINAL NERVESCERVICALC2: lower jaw , back of the head

C3: upper neck, back o f the head

C4: lower neck, upper shoulders

C5: area o f the collarbones, upper

shoulders

C6: shoulders, outside o f arm , thum b

C7: upper back, back o f arm , point er

& m idd le finger

C8: upper back, inside o f arm , ring &

D R U G / D R U G I N T E R A C T I O N S

CBD INTERACTS WITH CYP 450

• Potential inhibition at CYP3A4, CYP2C9, CYP2C19, CYP2D6*

THINK GRAPEFRUIT JUICE BUT…

CLINICALLY SIGNIFICANT?

• 20mg/kg/day• Case study of Warfarin at 10mg/kg• Typical Doses much lower

FOLLOW UP COUNSELING

D R U G / D R U G I N T E R A C T I O N S

GW PHARMACEUTICALS

40mg sativex (1:1 ratio)

• No interaction with other CYP 450, other drugs

PEDIATRIC EVIDENCE

• Interaction with anti-epileptic drugs at 35mg/kg CBD

• Resulted in increased side-effects from anti-epileptic drugs

• Reduced dose of anti-epileptic drugs to reverse adverse effects

• Maintained overall reduction in seizure activity

• 70% of participants had 50% reduction in overall seizures

BUT WILL I FAIL A DRUG TEST?

Original Full Spectrum products

(0.3% THC)

• Unlikely, but possible.

• Individual metabolism varies

• False positive on immunoassay urine drug screen

Broad Spectrum, THC-free products

• THC level is zero

• No chance of a TRUE positive

• May trigger false positive with UDS*

C B D F O R P E T S

• Cornell Studies*

• Pharmacokinetics

• Efficacy

• Safety

• Dosing (2mg/kg bid)*

PROTECTING YOUR

PHARMACY AND PATIENTS

IN THE WILD WEST OF CBD

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T H E W I L D W E S T

70% of CBD products do not match label (Bon Miller et al., 2017)

91% of products do not match

packaging (2016)

S O L U T I O N ?Ask for a Certificate of Analysis (COA)

Certificate of Analysis

Should:

• Be done by a third party lab

• Include cannabinoid content

• Include tests for pesticides, microbes, chemicals

• Be lot specific

Q U E S T I O N S ?

T.W. Taylor, R.Ph

Owner, The Williamsburg Drug CompanyWilliamsburg, VA

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