C A N N A B I S D O C T O R S A U S T R A L I A T M M E D I C A L C A N N A B I S D O C T O R I N F O S H E E T

It is right to be sceptical and apprehensive about prescribing a new Medication especially if there has been so much stigma and false information about it for so many years, but did you know, that Medicinal Cannabis was the most prescribed medication by Doctors through the early 1900’s until the 1937 (1). No one ever died from Medicinal Cannabis at that time, and still no-one has died from Cannabis to this very day; the LD50 is just phenomenally high (2). Various reports were done on Medicinal Cannabis, and it is far superior in safety. Some clinicians may be unfamiliar with prescribing cannabinoid therapies due to (and not limited to) minimal experience with cannabinoid therapeutics, unfamiliarity with dosing and ingestion methods, and side effect profiles. CDA Clinics clinicians are trained by experienced physicians and supported by a team of pain specialists to provide best practice treatment plans for cannabinoid therapy. Our proprietary training programs ensure physicians are specialty trained in cannabinoid treatment assessments.CDA Clinics clinicians are your partners in providing effective patient care and seek to maintain an open dialogue with referring physicians. Following patient appointments, we provide Consultation Letters, containing information on the prescription, its recommended dosage, and duration. CDA Clinics works collaboratively to ensure your patient receives the best comprehensive care possible. H O W T O R E F E R A P A T I E N T T O E M E R A L D C L I N I C S If you think your patient may benefit from prescription cannabinoids, please download and complete the Patient Referral Form below or contact us at info@cdaclinics.com.au.

THE PROCESS

ACCESS

Access to Medica l Cannabis is genera l ly v ia the federa l Specia l Access Scheme (SAS) appl icat ion, and can only be submitted by an Austra l ian-registered Medica l Pract i t ioner . The other pathways are Cl in ica l Tr ia ls or v ia a doctor who is registered to the Author ised Prescr iber Scheme.

THERAPEUTICS GOOD ACT 1989 (TGA)

The TGA has a responsib i l i ty to encourage the use of medic ines that are inc luded in the Austra l ian Register of Therapeut ic Goods (ARTG).

For th is reason, i t i s expected that doctors wi l l have cons idered a l l c l in ica l ly appropr iate t reatment opt ions that are inc luded in the ARTG before apply ing to access an unapproved medic ina l cannabis product under the SAS.

To date, the TGA has approved SAS appl icat ions inc luding, but not l imited to , the fo l lowing indicat ions :

• Chronic pain

• Neuropathic pain

• Chemotherapy- induced nausea and vomit ing

• Epi lepsy / Se izure Management

• Pal l ia t ive care

• Cancer pain

• Spast ic i ty f rom neurologica l condit ions

• Anorexia and wast ing associated with chronic i l lness (such as cancer )

• Anxiety

• Depress ion

• PTSD

• Fibromyalg ia

• Rheumatoid Arthr i t is

• Migra ine

• Chronic Regional Pa in Syndrome

• Aust ism symptoms

• Park insons Disease

• Tremor

• Dystonia

• Post CVA Neuropathy

• Opioid dependence

• Polymyalg ia Rheumat ica

• Chronic in fect ion neuropath ies

• Radiculopath ies

PatientConsultation

SelectProduct&Prescription

TGAApplication

GovtApproval Prescription Monitoring

The above l is t i s prov ided as an overv iew and does not guarantee TGA approval for appl icat ions speci fy ing these indicat ions, however CDA Cl in ics has been approved in every c lass ment ioned above. SAS Category B appl icat ions are indiv idual ly cons idered by the TGA based on the in format ion prov ided with the appl icat ion.

Potent ia l ly any medica l condit ion could be appl ied for . However , the doctor would have to just i fy why she/he is apply ing to prescr ibe you medica l cannabis . This may inc lude prov id ing studies completed on the condit ion with medic ina l cannabis .

SAS APPLICATION FORMS

Appl icat ions to the TGA must be done by the medica l pract i t ioner v ia the onl ine porta l . Below are the appl icat ion forms for reference only .

S A S B – M E D IC A L A P P L IC A T IO N S

For further in format ion about medic ina l cannabis regulat ion and access in Austra l ia p lease see the consumer in format ion brochure.

Once an approval is in p lace, your doctor ar ranges for an approved pharmacist to d ispense the medicat ion.

CONSENT

You wi l l need to g ive in formed consent and s ign that you understand that you cannot dr ive a vehic le or operate heavy machinery i f the medic ina l cannabis conta ins THC (Tetrahydrocannabinol ) .

CBD (Cannabidio l ) Cannabis medicat ions are d i f ferent , and legal to dr ive with , however p lease check with your doctor or pharmacist about CBD interact ion with other medicat ions (P450 metabol ised medicat ions) .

COST OF MEDICINAL CANNABIS

The cost depends on the cannabinoids in the product , the amount required by the pat ient , the source, sh ipping expenses, customs fees and the d ispensing fees charged by the d ispensing pharmacy.

Medic ina l cannabis is not on the Pharmaceut ica l Benef i ts Scheme (PBS) so pat ients need to pay the costs of purchas ing the product .

There is current ly no government subsidy for the cost of medic ina l cannabis for indiv idual t reatment , and the government does not regulate the pr ices for supply of approved products .

Some pat ients have been refunded for the cost of the medic ine on their health fund. P lease check with your own health fund.

Cl in ica l t r ia ls genera l ly prov ide product f ree of charge to t r ia l part ic ipants , but these are genera l ly t ime l imited.

Our genera l est imate for an average chronic pain pat ient is to spend $4 to $10 per day on Medic ina l Cannabis .

We have a ca lcu lator on our website as wel l as Recommended Reta i l Pr ice l is ts for your convenience.

COST OF MEDICINAL CANNABIS CONSULTS

Your in i t ia l medica l cannabis consultat ion wi l l take up to an hour to complete the paperwork. You wi l l be charged $199 for th is in i t ia l consultat ion.

Fol low-up consultat ions are $59. You wi l l need to have fo l low-up consultat ions with your doctor to get subsequent monthly prescr ipt ions. Addit ional admin fees are $35.

Pharmacies charge a fee to d ispense the product . We prov ide pharmacies with a recommended reta i l pr ice l is t which we hope wi l l keep the pr ices down for pat ients .

I f you decide to change your MedCan product or add an addit ional product , the doctor wi l l need to apply to the TGA again . For each new product , your doctor must make another TGA Appl icat ion on your behal f . Your doctor wi l l charge $59 for each change of product or TGA Approval .

TELEHEALTH COSTS (onl ine v ideo ca l l or phone consultat ion)

CDA TeleHealth consultat ions are $199 for the in i t ia l consultat ion and inc ludes the appl icat ion to the TGA, the prescr ipt ion and the pharmacy d ispensing. Fol low up consults / repeat prescr ipt ion consultat ions cost $59. Addit ional admin fees are $35.

P lease note that TeleHealth consultat ions wi l l not be e l ig ib le for a Medicare rebate unless you l ive in a remote area without any access to a prescr ib ing doctor .

In order to book a TeleHealth consult w ith CDA Cl in ics , you wi l l require a referra l f rom your own doctor .

CDA AFFIL IATED DOCTORS

Doctors who have been t ra ined by CDA Cl in ics are recommended by us to fo l low our pr ic ing schedule for consultat ions. Because these consultat ions have a lot o f associated paperwork and an appl icat ion to the TGA

GPs can inc lude the Med Can consult as part of a Chronic Care P lan.

HOW TO PREPARE FOR YOUR TELEHEALTH CONSULTATION

You wi l l need to br ing a referra l let ter f rom your regular doctor and ideal ly a copy of your re levant medica l h is tory with any other re levant documentat ion.

We wi l l need a l i s t of prev ious t reatments and medicat ions t r ied for the condit ion that you want Medic ina l Cannabis for . Br ing a l i s t of your current medicat ions or br ing them in a bag to your consult .

• Referra l Letter

• Medica l History

• Current Medicat ions

DO YOUR RESEARCH

Before your consultat ion, i t would be helpfu l i f you could research THC and CBD so that you are fami l iar w ith the ef fects and poss ib le s ide ef fects of these cannabinoids (cannabis components ) . There is a sect ion below that prov ides an overv iew of these.

PRODUCTS

Medica l Cannabis comes in a var iety of forms with vary ing combinat ions of cannabinoids ( i .e . THC and CBD):

• Flower/bud

• Oils

• Liquid Capsules

• Oro-mucosal spray

• Patches

• Gels

Flower LiquidCapsules

Oils

ROUTE OF ADMINISTRATION

Oral ly : spray , o i l or capsules or tablets .

Inhaled v ia vapor isat ion: us ing a vapor iser approved by the TGA as a medica l dev ice or one sourced by the pat ient .

Sk in : patches, topica l gel or topica l c ream.

MEDICINAL CANNABIS DOSING

There are two types of dos ing; regular dos ing for contro l of a cons istent symptom/condit ion, or as required dosing for an intermittent symptom/condit ion. In both cases pat ients should t ry to use the min imal e f fect ive dose. This is achieved by start ing at a low dose as inst ructed by your doctor , and gradual ly increas ing your dose unt i l you e i ther (1 ) have symptom/condit ion re l ie f , (2 ) you have a s ide ef fect , or (3 ) you reach the maximum dose prescr ibed by your doctor . I f a s ide ef fect occurs , p lease contact you prescr ib ing doctor and decrease the next dose.

Most regular dos ing is d iv ided into twice dai ly interva ls , but some pat ients f ind more regular interva ls , l ike four t imes a day, better at contro l l ing their symptom/condit ion. An example for a s lowly increas ing dose with an o i l dropper would be 1 drop twice a day, increased by 1 drop every second day, to a maximum of 10 drops twice a day. Doctors ca l l th is a t i t rat ing dose.

RESTRICTIONS

Pat ients wi l l not be approved to smoke cannabis as th is exposes them to combusted cannabis mater ia l . Vapor isat ion us ing a vapor iser heats the Medic ina l Cannabis to a lower temperature, which re leases heated cannabinoids (THC and CBD) at a temperature below combust ion.

Doctors seeking approval to use a speci f ic product wi l l need to prov ide ev idence of i ts safety and ef f icacy for the condit ion or symptom being t reated as part of the ir c l in ica l just i f icat ion to the TGA.

DRIVING

THC ( tetrahydrocannabinol ) i s the main psychoact ive component of some cannabis (some Medic ina l Cannabis products have no THC, and thus are non-psychoact ive ) . Research has shown that THC use has an ef fect on a person’s abi l i ty to dr ive .

Unl ike a lcohol , there is current ly no speci f ic concentrat ion of THC that author i t ies can use as an indicator of impairment . I t i s i l legal for any pat ient being t reated with medic ina l cannabis conta in ing THC to dr ive whi le undergoing t reatment .

CANNABINOIDS

Cannabinoids are natura l ly occurr ing compounds found in the Cannabis sat iva p lant . Of over 480 d i f ferent compounds present in the p lant ,

only around 66 are termed cannabinoids. The cannabinoids are most abundant in the female f lower head, which is used in the manufacture of medic ina l cannabis products .

The most wel l -known among these compounds is THC), which is the main psychoact ive ingredient in cannabis .

THC & CBD

The main cannabinoids in cannabis are THC and CBD:

Tetrahydrocannabinol (THC) is the most wel l -known cannabinoid due to i ts psychoact ive propert ies and therefore i ts preva lence with in b lack market cannabis that has been speci f ica l ly cu l t ivated to get a user “h igh”

THC may a lso be responsib le for some of the medic ina l e f fects of cannabis such as reduct ion of nausea, vomit ing, pain and muscle spasms as wel l as improvements in s leep and appet i te .

Cannabidio l (CBD) has been found to reduce the ‘h igh’ caused by THC, and may a lso be ef fect ive for se izures , pa in , and may reduce anxiety . CBD causes no ‘h igh’ fee l ing, and pat ients can dr ive when us ing CBD.

CBD is not psychoact ive ( i t won’t make you feel ‘h igh’ ) and i t may be usefu l in the management of se izures , pa in , and may have anxio lyt ic and ant ipsychot ic ef fects . Di f ferent cannabis s t ra ins conta in d i f ferent rat ios of THC to CBD.

Medic ina l Cannabis with THC is cons idered a 'Contro l led Drug' under Schedule 8 (S8) of the Poisons Standard.

From 1 June 2015, CBD has been inc luded under Schedule 4 (S4) Prescr ipt ion Only Medic ine of the Poisons Standard when preparat ions for therapeut ic use conta in 2% or less of other cannabinoids found in cannabis .

OTHER CANNABINOIDS

Other cannabinoids under act ive research inc lude Cannabigerol (CBG), Tetrahydrocannabivar in (THCV) , Cannabinol (CBN) and Cannabichromene (CBC).

The cannabis p lant a lso conta ins Terpenes which g ive cannabis i ts f lavour and aroma. Terpenes have their own pharmacologica l e f fects , which can be considered when prescr ib ing.

BLACK MARKET CANNABIS

• Medic ina l Cannabis and i l legal cannabis come f rom the same species fami ly but are very d i f ferent .

• I l legal cannabis is grown f rom unknown sources, and may conta in pest ic ides, moulds, and bacter ia which are harmful .

• Recreat ional cannabis has been cult ivated and bred to conta in h igh amounts of the psychoact ive cannabinoid THC. This type of cannabinoid may not be

r ight for your condit ion and you may benef i t more f rom a h igher rat io of CBD to THC.

• The manufacture of Medic ina l Cannabis is h ighly regulated and must conform to st r ic t Good Manufactur ing Pract ices (GMP) – th is means products are f ree f rom harmful ingredients or b i -products .

• The manufacture and importat ion of th is cannabis is checked and t racked by the Austra l ian government to ensure that there is legit imacy – that you get what you (and your doctor ) s igned up for .

• Black market cannabis is incons istent . Medica l Cannabis is h ighly regulated to ensure that the ef fect that the product has for a pat ient wi l l be the same f rom bott le to bott le .

• The gather ing of pat ient data in re lat ion to the posi t ive ef fects of pharmaceut ica ls w i l l a l low the government to safe ly deregulate the medica l cannabis industry . B lack market cannabis does not contr ibute to th is .

HOME GROWN CANNABIS

You cannot legal ly produce your own cannabis for medic ina l use. Home-grown medic ina l cannabis products have unknown concentrat ions of act ive ingredients and conta in potent ia l ly harmful contaminants and these home-grown products are eas i ly d iverted into the i l l ic i t drug market .

Medic ina l cannabis products need to be consistent , contaminant f ree and h igh qual i ty so doctors can make safe prescr ib ing and dosage decis ions.

SCHOOL-AGED TREATMENT

I f a pat ient is at school , they can have the prescr ibed product administered at school in the same way as other medic ines.

I t should be noted that medic ina l cannabis is of ten g iven as a twice dai ly dose, and i t i s un l ike ly that a supply of the medicat ion wi l l need to go to school with the ch i ld .

I f you need any further in format ion p lease see our websi te or contact us d i rect ly .

http ://www.CDAClin ics .com.au/

Watch our in format ive v ideos on our You Tube Channel .

REFERENCES

(1 ) Malmo-Levine D. Recent h is tory . In : Hol land J , editor . The Pot Book: A Complete Guide to Cannabis . Rochester , Vermont: Park Street Press ; 2010.

(2 ) http ://www.health .gov.au/ internet/main/publ ish ing.nsf/Content/health-pubs-drug-cannab2-ch52.htm The Health and Psychologica l Consequences of Cannabis Use, The Department of Health , The Government of Austra l ia . (3 ) Mar i juana and Medic ine: Assess ing the Sc ience Base. Inst i tute of Medic ine (US) ; Joy JE, Watson SJ Jr . , Benson JA Jr . , editors . Washington (DC) : Nat ional Academies Press (US) ; 1999.