DISCLOSURE MEDICAL MARIHUANA New Regulations and Current Issues No potential conflicts of interest and nothing to disclose Tammy Coderre Kells, BSP, MEd 17 Sep 2015 1 2 LEARNING OBJECTIVES Compare and contrast the current and past Health Canada regulations for acquisition of medical marihuana Examine the controversies surrounding the transition to the current Health Canada regulations for acquisition of medical marihuana Describe how clients access medical marihuana, within the new Health Canada regulations MEDICAL MARIHUANA NEW REGS AND CURRENT ISSUES Time table Compare and Contrast Regulations Prescriber Information Product Information How Patients Access MM Controversies Statistics Conclusion 3 4
MARIHUANA VS MARIJUANA MARIHUANA vs MARIJUANA Clash between legal h and casual j Official response from Health Canada Marihuana with an h is one of a number of recognized spellings in the Oxford English Dictionary. While the spelling with a j has been retained in US statute, the h has been retained in European statutes, including in the U.K. and France. This is the spelling retained in Canadian statute. Health Canada now using both spellings. H in all statutes; J for other references Weisblott, Marc. (23Oct2013) Government of Canada has started spelling the drug it called Marihuana as Marijuana. Retrieved from http://o.canada.com/health 2/marijuanamarihuana canada spelling what 5 6 MEDICAL MARIHUANA LEGAL STATUS Not an approved therapeutic substance in Canada Not been issued a N.O.C. Does not have a DIN Scientific evidence supporting the safety and efficacy of dried marihuana has not reached the level required by the FDA Health Canada. (12 June 2013) Information for Health Care Professionals. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/med/infoprof eng.php MEDICAL MARIHUANA TIMELINES DATE EVENT DESCRIPTION 30 Jul 2001 Marihuana Medical Access Regulations (MMAR) 07 Jun 2013 Marihuana for Medical Purposes Regulations (MMPR) 21 Mar 2014 Federal Court Injunction (Allard injunction) 31 Mar 2014 MMAR repealed (Transition period ended) 11 Jun 2015 Supreme Court of Canada decision R v. Smith Direct supply from HC (dried marihuana, seeds) Purchase via commercial licensed producers (dried marihuana only) Growers can continue to grow Required to destroy all plants; written notice to HC by 30 Apr 2014 Allow sale of oils and fresh leaves 7 8
CHANGES IN REGULATIONS HEALTH CANADA As of April 1, 2014, producing marihuana in a home or private dwelling is illegal The only legal source of marihuana will be produced under secure and quality controlled conditions by licensed producers Licensed producers will have to comply with strict regulatory requirements to demonstrate security and quality Health Canada does not authorize the operation of retail storefronts, "compassion clubs" or "dispensaries" Health Canada. (08 June 2015) Accessing Marijuana for Medical Purposes Information Bulletin. Retrieved from http://hc sc.gc.ca/dhpmps/marihuana/info/licencedproducer producteurautorise/access usage eng.php REASONS FOR CHANGES IN REGULATIONS 1. Aim to treat MM like other narcotics 2. Ensure quality controlled MM 3. Create conditions for commercial industry 400 applications 4. Response to concerns re: Cost Heavily subsidized 5. Response to other stakeholder concerns Health Canada. (Archived 19 June 2014) About the Marihuana Medical Access Program Frequently Asked Questions. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/about apropos/faq eng.php#a7 Health Canada. (Archived 19 June 2014) Proposed Improvements to Health Canada`s Marihuana Medical Access Program. Retrieved from http://www.hc sc.gc.ca/dhpmps/consultation/marihuana/_2011/program/consult eng.php 9 10 REASONS FOR CHANGES IN REGULATIONS Key concerns from stakeholders: Potential for diversion to illicit market Risk of home invasion Public safety risks such as electrical and fire hazards Public health risks due to excess mould, poor air quality Complexity and length of application process Time required by HC in application / review process HC provides only one strain of dried marihuana Health Canada. (Archived 19 June 2014) Proposed Improvements to Health Canada`s Marihuana Medical Access Program. Retrieved from http://www.hc sc.gc.ca/dhpmps/consultation/marihuana/_2011/program/consult eng.php COMPARE AND CONTRAST REGULATIONS 1. Accessing a supply 2. Approval to use 3. Indications for use 4. Proof of authority to possess 11 12
COMPARE AND CONTRAST ACCESSING A SUPPLY MARIHUANA MEDICAL ACCESS PROGRAM (MMAP) (Jul 2001 to 31Mar2014) Purchase via Health Canada 1. Direct supply 2. Production license personal use (PUPL) 3. Production license designated person (DPPL) Dried marihuana Marihuana seeds Health Canada. (Archived: 19 Jun3 2014) About Health Canada s Marihuana Supply for Medical Purposes Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/aboutapropos/supply approvis eng.php MARIHUANA FOR MEDICAL PURPOSES REGS (MMPR) (07 Jun 2013 to current) Purchase via commercial licensed producers Dried marihuana only Oils and fresh marihuana (11 Jun 2015) Health Canada. (08 Jun 2015) Procedures for Accessing Dried Marijuana for Medical Purposes Under the Marihuana for Medical Purposes Regulations. Retrieved from http://www.hc sc.gc.ca/dhpmps/marihuana/access acceder eng.php COMPARE AND CONTRAST APPROVAL TO USE MARIHUANA MEDICAL ACCESS PROGRAM (MMAP) Form A Application for Authorization to Possess Marihuana for Medical Purposes Form B1 Medical Practitioner 's Form for Category 1 Applicants Form B2 Medical Practitioner 's Form for Category 2 Applicants Form C Application for Licence to Produce Marihuana by Applicant Form D Application for Licence to Produce Marihuana by a Designated Person Form E1 Application to Obtain Dried Marihuana Form E2 Application to Obtain Marihuana Seeds Form F Consent of Property Owner Health Canada. (Archived 19 June 2014) Marihuana Medical Access Program Forms and Guides. Retrieved from http://hc sc.gc.ca/dhpmps/marihuana/how comment/forms eng.php MARIHUANA FOR MEDICAL PURPOSES REGS (MMPR) Medical Document Health Canada. (08 Jun 2015) Procedures for Accessing Dried Marijuana for Medical Purposes Under the Marihuana for Medical Purposes Regulations. Retrieved from http://www.hc sc.gc.ca/dhpmps/marihuana/access accedereng.php 13 14 COMPARE AND CONTRAST INDICATIONS MARIHUANA MEDICAL ACCESS PROGRAM (MMAP) As per Health Canada Restrictions Category 1 Symptoms MS, spinal cord injury, spinal cord disease, cancer, HIV/AIDS infection, severe arthritis, epilepsy Category 2 Symptoms Debilitating symptom associated with a medical condition other than above Health Canada. (Archived 19 June 2014) Marihuana Medical Access Program Forms and Guides. Retrieved from http://hcsc.gc.ca/dhp mps/marihuana/howcomment/forms eng.php MARIHUANA FOR MEDICAL PURPOSES REGS (MMPR) NO restrictions Health Canada. (08 Jun 2015) Procedures for Accessing Dried Marijuana for Medical Purposes Under the Marihuana for Medical Purposes Regulations. Retrieved from http://www.hcsc.gc.ca/dhp mps/marihuana/access acceder eng.php COMPARE AND CONTRAST AUTHORITY TO POSSESS MARIHUANA MEDICAL ACCESS PROGRAM (MMAP) Document provided by Health Canada Official document Proof of Authority to Possess (ATP) PUPL DPPL Health Canada. (Archived 19 June 2014) Marihuana Medical Access Program Forms and Guides. Retrieved from http://hc sc.gc.ca/dhpmps/marihuana/how comment/forms eng.php MARIHUANA FOR MEDICAL PURPOSES REGS (MMPR) Document provided by licensed producer Label on packaging OR Separate document c shipment Health Canada. (08 Jun 2015) Procedures for Accessing Dried Marijuana for Medical Purposes Under the Marihuana for Medical Purposes Regulations. Retrieved from http://www.hcsc.gc.ca/dhp mps/marihuana/access accedereng.php 15 16
PRESCRIBING MEDICAL MARIHUANA MEDICAL DOCUMENT (not prescription) Medical documents may be issued by an authorized health care practitioner (physician, Nurse Practitioner ) Not included in Nurse Practitioner scope of practice in BC at this time Prescriber indicates: daily quantity (g / day) period of use (days, weeks, months) Completed annually or more frequently College of Registered Nurses of B.C. (July 2015) Scope of practice for nurse practitioners. Retrieved from https://www.crnbc.ca/standards/lists/standardresources/688scopefornps.pdf Health Canada. (19 June 2013) Sample Medical Document for the Marihuana for Medical Purposes Regulations. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/info/med eng.php 17 MEDICAL DOCUMENT Patient's Given Name and Surname: Patient's Date of Birth (DD/MM/YYYY): Daily quantity of dried marihuana to be used by the patient: _ g/day The period of use is day(s) week(s) month(s). NOTE: The period of use cannot exceed one year Health care practitioner's given name and surname: Profession: Health care practitioner's business address: Full business address of the location at which the patient consulted the health care practitioner (if different than above): Phone Number: Fax Number (if applicable): Email Address (if applicable): Province(s) Authorized to Practice in: Health Care Practitioner's Licence number: By signing this document, the health care practitioner is attesting that the information contained in this document is correct and complete. Health Care Practitioner's Signature: Date Signed (DD/MM/YYYY): Health Canada. (19 June 2013) Sample Medical Document for the Marihuana for Medical Purposes Regulations. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/info/med eng.php 18 DRUG INFORMATION Information for Health Care Professionals Endocannabinoid System Clinical Pharmacology Dosing (Smoked to Estimated Oral Dose) Potential Therapeutic Uses Precautions Warnings Adverse Effects Overdose / Toxicity Health Canada. (Feb 2013) Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the cannabinoids. Retrieved from http://www.hcsc.gc.ca/dhp mps/marihuana/med/infoprof eng.php DRUG INFORMATION DOSING Highly individualized Does not fit well c typical medical model for drug prescribing Difficulty in precise dosing due to: Inter individual differences in cannabinoid receptors, metabolism Prior exposure (pharmacological tolerance) Complex pharmacology Variable potency of plant material Route of administration Health Canada. (Feb 2013) Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the cannabinoids. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/med/infoprofeng.php 19 20
DRUG INFORMATION DAILY AMOUNT Limited small short-term clinical studies (Smoked or Vapourized) 75 mg (8.4%THC) to 3.2 g (1-8% THC) Netherlands (2013) Range 0.65 0.82 g per day (average 0.68 g) Israel Medical Marihuana Program (2011 / 2012) Average 1.5 g per day Health Canada 1 3 g dried marihuana per day (orally, inhaled or combination) Joint contains 0.5 1g cannabis plant matter 3 6 joints per day No restrictions on daily amount to prescribe Possession cap of 30 times daily amount up to max of 150 g Health Canada. (Mar 2014) Marihuana for Medical Purposes Regulations Daily Amount Fact Sheet (Dosage). Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/med/daily quotidienne eng.php 21 DRUG INFORMATION ROUTES OF ADMINISTRATION Smoking not recommended by Health Canada Vapourization Alternative to smoking Oral Teas, baked goods, oils Slow and erratic absorption; delayed onset; longer duration No clinical studies for dosing (dose conversion for smoked to oral = 2.5) Topical No dosing information Rectal No dosing information Health Canada. (Feb 2013) Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the cannabinoids. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/med/infoprofeng.php 22 ROUTES OF ADMINISTRATION VAPOURIZATION Relatively new and still under scrutiny Plant material is heated to optimal temp (approx 200C) just below combustion Extraction or release into the air through vapour rather than smoke Reduces exposure to harmful combustion products Reportedly more efficient extraction of THC Health Canada advises NOT to use vapourizer near children Air quality data NOT available University of California San Francisco. (16 May 2007) Marijuana vaporizer Provides Same Level Of THC, Fewer Toxins, Study Shows. Science Daily. Retrieved from http://www.sciencedaily.com/releases/2007/05/070515151145.htm Health Canada. (Feb 2013) Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the cannabinoids. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/med/infoprof eng.php ROUTES OF ADMINISTRATION VAPOURIZATION HAND HELD VAPOURIZER $50 to $250 Battery charger vapour is released upon inhalation https://www.google.ca/search?q=vaporizer +for+medical+cannabis+images 23 24
ROUTES OF ADMINISTRATION VAPOURIZATION PRODUCT INFORMATION PLANTS DESK TOP VAPOURIZER Up to $600 vapour collects in a canister Cannabis Sativa Columbia, Mexico, Thailand, Africa Tall and thin plants Matures in 12 14 weeks Cannabis Indica Morocco, Afghanistan, Turkey, India Shorter and wider plants Matures in 8 10 weeks 100`s strains now available as hybrids Higher levels of tetrahydrocannabinol (THC) Produces more euphoric effects Cerebral high Higher levels of cannabidiol (CBD) Produces more analgesic effects Drowsiness, couch locked https://www.google.ca/search?q=vapour izer+for+medical+cannabis+images Indica vs Sativa: Understanding the Differences. (19 June 2014). Leaf Science. Retrieved from http://www.leafscience.com/2014/06/19/indica-vs-sativa-understanding-differences 25 26 SATIVA VS INDICA There is currently no scientific or clinical evidence to lend support to the anecdotal claims that one strain of marijuana may be more beneficial than another one for a particular medical condition. Health Canada. (March 2014) Marihuana for Medical Purposes Daily Amount Fact Sheet (Dosage). Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/med/daily quotidienne eng.php PRODUCT INFORMATION Dried marihuana mature flowering heads (buds) of female plants Fresh marihuana Buds or leaves but not plant material that can be used to propagate Oils No flavour or scent Can not exceed 30 mg / ml THC If in capsule, can not exceed 10mg THC Health Canada. (08 July 2015) Section 56 Class Exemption for Licensed Producers under the Marihuana for Medical Purposes Regulations. Retrieved from http://www.hc-sc.gc.ca/hc-ps/substancontrol/pol/poldocs/producers-exemption-producteurs-eng.php 27 28
HOW PATIENTS ACCESS MEDICAL MARIHUANA LICENSED PRODUCERS AUTHORIZED TO SELL 1. Obtain completed Medical Document 2. Choose a licensed producer List of authorized licensed producers available via Health Canada Website 3. Follow instructions on licensed producer website 4. Order on line or by telephone Agripharm Corp Aphria Bedrocan Canada Inc Broken Coast Cannabis Ltd Canna Farms Ltd CanniMed Ltd CannTrust Inc Delta 9 Bio-Tech Inc Emerald Health Botanicals Inc Hydropothecary MariCann Inc MedReleaf Corp Mettrum Ltd OrganiGram Inc RedeCan Pharm Peace Naturals Project Inc Tilray Tweed Farms Inc Tweed Inc Whistler Medical Marijuana Corp Health Canada. (08 June 2015) Procedures for Accessing Dried Marihuana for Medical Purposes Under the Marihuana for Medical Purposes Regulations. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/access acceder eng.php 29 Health Canada. (10Sep2015) Authorized Licenced Producers under the Marihuana for Medical Purposes Regulations. Retrieved from http://www.hc-sc.gc.ca/dhpmps/marihuana/info/list-eng.php 30 LICENSED PRODUCERS FRESH MARIHUANA AND CANNABIS OIL 11 companies Date of licensing: varies from July 31 st to Aug 28th Production only No sales LICENCED PRODUCER PRODUCTS PACKAGING Tamper proof Child resistant Packaged in re sealable plastic containers Store in a cool place; protect from light and air Health Canada. (10Sep2015) Authorized Licenced Producers under the Marihuana for Medical Purposes Regulations. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/info/list eng.php Health Canada. (07 July 2015) Consumer Information Cannabis (Marihuana, marihuana). Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/info/cons eng.php 31 32
LICENCED PRODUCER PRODUCTS PRODUCT LABEL (a)the name, telephone number and email address of licenced producer (b)the words Dried marihuana / Marihuana séchée ; (c)in respect of the dried marihuana in the container: (i) its brand name, (ii) its lot number (iii) the percentage of delta 9 tetrahydrocannabinol w/w, followed by the word delta 9 tetrahydrocannabinol, (iv) the percentage of cannabidiol w/w, followed by the word cannabidiol, (v) its net weight, in grams, (vi) its recommended storage conditions, (vii) its packaging date, and (viii) either (A) its expiry date, if a stability period for the dried marihuana has been established in accordance with section 71, or (B) a statement to the effect that no expiry date based on stability data has been determined for the dried marihuana; (d)the symbol N set out in the upper left quarter of the label in a colour contrasting with the rest of the label or in type not less than half the size of any other letters used on the label; (e)the warning KEEP OUT OF REACH OF CHILDREN / TENIR HORS DE LA PORTÉE DES ENFANTS ; and (f)the statement Important: Please read the Health Canada document provided with this package before using dried marihuana. LICENCED PRODUCER PRODUCTS PRODUCT LABEL Fresh marihuana Equivalency factor to 1g dried marihuana (5 g equivalent to 1 g dried marihuana) Oils Amount of THC / CBD in mg/ml Total ml and total amounts in container Equivalency factor to 1 g dried marihuana Health Canada. (08 July 2015) Section 56 Class Exemption for Licensed Producers under the Marihuana for Medical Purposes Regulations. Retrieved from http://www.hc-sc.gc.ca/hc-ps/substancontrol/pol/pol-docs/producers-exemptionproducteurs-eng.php Health Canada. (25 Sep 2015) Additional Information for Licensed Producers Under the Marihuana for Medical Purposes Regulations. Retrieved from http://www.hc-sc.gc.ca/dhp-mps/marihuana/info/add-supp-eng.php Health Canada. (15 June 2015) Marihuana for Medical Purposes Regulations SOR/2013 119. Retrieved from http://laws lois.justice.gc.ca/eng/regulations/sor 2013 119/page 19.html#docCont 33 34 LICENSED PRODUCER PRODUCTS CLIENT LABEL (a)the immediate container carries a label that contains the following information: (i) the given name and surname of the client, (ii) the given name, surname and profession of the health care practitioner who provided the client s medical document, (iii) the name of the licensed producer, (iv) the daily quantity of dried marihuana indicated on the client s medical document, expressed in grams, (v) the expiry date of the client s registration referred to in section 112, (vi) the shipping date, and (vii) the date referred to in subsection 124(2); and (b)a separate document containing the information referred to in paragraph (a) accompanies each shipment of the dried marihuana. Health Canada. (15 June 2015) Marihuana for Medical Purposes Regulations SOR/2013 119. Retrieved from http://laws lois.justice.gc.ca/eng/regulations/sor 2013 119/page 19.html#docCont LICENCED PRODUCER PRODUCTS PACKAGE INSERT Each package must be accompanied by a copy of the most current version of the Health Canada document entitled "Information on the Use of Marihuana for Medical Purposes Serious Warnings and Precautions What the product may be used for What the active ingredients might be What the other ingredients might be What the product does When the product should not be used Interactions with this product Dosing information and routes of administration Overdose Side effects and what to do about them Long term use may How the product is supplied How to store the product Reporting suspected Side Effects Health Canada. (07 July 2015) Consumer Information Cannabis (Marihuana, marihuana). Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/info/cons eng.php 35 36
MEDICAL MARIHUANA PRODUCTS MEDICAL MARIHUANA PRODUCTS https://peacenaturals.com/products http://www.tweed.com/collections/all strains/products/argyle nordle https://www.canntrust.ca/shop/ / http://www.delta9.ca/our_products.html https://aphria.myshopify.com https://medreleaf.com/shop 37 http://www.brokencoast.ca/products 38 MEDICAL MARIHUANA PRODUCTS THC: 9 % CBD: 9.5% produced from the tallest of any of our plants, standing around seven feet when mature. Flowers are clustered closely together on a large cola, or main flowering stem of the mature, female plant. $7.95 / g Sold in 10 g bottles 9 reviews ***** http://cannimed.ca/collections/medicalmarijuana/products/cannimed 9 9 39 MEDICAL MARIHUANA PRODUCTS HAPPY FACE THC Level: 16% (+/ 2%) CBD level: < 0.3% Happy Face has been described recently by clients as a delightfully uplifting head and upper body pain reliever. Descriptions have also included adjectives like Euphoric and Joyful. Our Happy Face variety has been used by clients in social settings and daytime use. Taste / Flavour: Mild earth tones with an essence of sweet cherry. Price per gram: $6.00 (Sold Out) https://canvasrx.com/site/strains/happy face 40
MEDICAL MARIHUANA PRODUCT SELECTION 20 companies (6 30 products) approximately 236 products 5 g 30 g containers (5 g increments) Cost $2.00 $15.00 per gram Reduced pricing c higher volumes; compassionate pricing Shipping (free $25 for same day) Free vapourizer and marijuana cookbook for every patient Health Canada. (Feb 2013) Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the cannabinoids. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/med/infoprof eng.php MEDICAL MARIHUANA PRODUCT SELECTION THC content: 0.5 25.8% Health Canada =12.5 +/- 1.5% Illicit product = 10% Cannabidiol content: 0 16% Health Canada = less than 0.5% Health Canada. (Feb 2013) Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the cannabinoids. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/med/infoprof eng.php 41 42 CONTROVERSIES TRANSITION FROM MMAR TO MMPR Represents a substantial change in direction for supply and acquisition of MM in Canada Clients, Prescribers, Canadian Medical Association, Colleges of Physicians and Surgeons CONTROVERSIES CLIENT PERSPECTIVE 1. Access 2. Amount (e.g. 3 g / day) MMAP: 15 plants (indoor) and storage qty 675 g MMPR: Possession cap 90 g (30 x daily amt) 3. Cost MMAP: $5 per gram dried MM ($20 per package of 30 seeds) (3 g / day = $450 per month) MMPR: $6.00 $15.00 per gram dried MM (3 g / day = $540 to $1,350 per month) Health Canada. (Archived 19 June 2014) About the Marihuana Medical Access Program Frequently Asked Questions. Retrieved from http://www.hc sc.gc.ca/dhpmps/marihuana/about apropos/faq eng.php#a7 43 44
CONTROVERSIES CLIENT PERSPECTIVE Federal court injunction allowing those who have production licences to continue to grow their own MM Until the court reaches a final decision Cannabis Rights Coalition Currently has over 6,600 members across Canada, actively working to prevent these regulations coming into force. Conroy, John. (14 April 2015) Cannabis Rights Coalition. Retrieved from http://www.cannabisrightscoalition.ca/ CANADIAN MEDICAL ASSOCIATION Fails to put patients first and leaves doctors with a pharmacological substance for which there is very little clinical evidence The federal government established the program and is now abdicating its role as regulator of medical marijuana Dr. Anna Reid, President of CMA Sullivan, Patrick. (21 June 2013) CMA Denounces New Medical Marijuana Rules. Retrieved from https://www.cma.ca/en/pages/cma denounces new medical marijuana rules.aspx 45 46 CANADIAN MEDICAL ASSOCIATION SURVEY TOP 3 CONCERNS concern that patients who request medical marijuana may actually want it for recreational purposes (64%) insufficient information on the risks and benefits of marijuana when used for medical purposes (57%) insufficient information regarding the appropriate use of marijuana for medical purposes (56%) COLLEGE OF PHYSICIANS AND SURGEONS OF B.C. Professional Standards and Guidelines: Marijuana for Medical Purposes (05May2015; Revised 30 July 2015) Physicians Must: 1. Document that conventional therapies were not successful 2. Assess the patient for addiction and/or risk of addiction using a validated risk tool and retain copy in record 3. Discuss risks of marihuana use and record discussion 4. Review PharmaNet prior to issuing authorization or re assessing 5. Retain a copy of the authorization in the patient s health record 6. Include processes to ID any misuse/abuse/diversion by patient in any reassessment 7. Not sell or dispense medical marihuana 8. Not complete a document for authorization unless: i) treating relationship with patient or ii) in direct communication with another physician or NP who has a treating relationship with the patient and both are in well documented agreement with the authorization Canadian Medical Association. (28 Feb 2013) CMA Response: Health Canada s Medical Marijuana Regulatory Proposal. Retrieved from https://www.cma.ca/assets/assets library/document/en/advocacy/proposed Medical Marihuana Regulations_en.pdf#search=medical%20marihuana College of Physicians and Surgeons of B.C. (05May2015;revised 30 July 2015) Professional Standards and Guidelines Marijuana for Medical Purposes. Retrieved from https://www.cpsbc.ca/files/pdf/psg Marijuana for Medical Purposes.pdf 47 48
COLLEGE OF PHYSICIANS AND SURGEONS OTHER PROVINCES Alberta must register information with the College; Re evaluate in person Q3Months Saskatchewan must obtain a signed, written treatment agreement from patients that spells out the patients' obligations, including using the marijuana as prescribed. must keep a separate record containing the names, quantities, medical conditions, and licensed producer (if known) for all relevant patients, and provide this record to the College on a regular basis and upon request. Newfoundland and Labrador must be primary treating physician Ontario can not prescribe to patients under age of 25 unless all conventional therapies have been attempted and failed Québec prohibited from providing a medical document to access medical marijuana unless the patient is enrolled in a recognized research study and only for specified conditions MEDICAL MARIHUANA STASTISTICS Grown from under 500 authorized persons to over 40,000 today Federal government projections of more than 400,000 in the next decade Canadian Medical Protective Association. (July 2015) Medical marijuana: New regulations, new College guidance for Canadian doctors. Retrieved from https://www.cmpa acpm.ca/en/legal and regulatory proceedings/ /asset_publisher/a9unchec2np9/content/medical marijuana newregulations new college guidance for canadian doctors ) Health Canada. (Archived 23 Dec 2013) Archived Marihuana Medical Access Program (MMAR) Statistics: 2013. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/stat/index eng.php 49 50 MEDICAL MARIHUANA STASTISTICS Authorization to Possess / Produce MEDICAL MARIHUANA STATISTICS British Columbia ONTARIO B.C. Ontario Alberta Nova Scotia 11,071 / 7,322 2,364 / 1,328 1,903 / 1,443 ATP: 18,383 Personal Production: 13,734 Designated Production: 2,276 Possessor/Grower: 18,000 Possessor/Grower: 34,000 Quebec Saskatchewan 1,120 / 891 952 / 423 Population = 13.5 million Population = 4.6 million Manitoba NB 855 / 735 805 / 609 31 Dec 2013 Health Canada. (Archived 23 Dec 2013) Archived Marihuana Medical Access Program (MMAR) Statistics: 2013. Retrieved from http://www.hc sc.gc.ca/dhp mps/marihuana/stat/indexeng.php Use Ratio = 1.3 / 1000 Use Ratio = 7.4 / 1000 51 52
CONCLUSION Battle to legalize marihuana Storefront availability Court injunction with 2 concurrent systems Switch MMAR to MMPR has created ++ confusion Increased quality control on product Lacks controls to prevent misuse or redirection No restrictions on indications Approval to use less onerous CONCLUSION, Cont`d Not being treated like a narcotic No triplicate prescription, no monitoring No HCP assessing validity of medical document Open to misuse and abuse No pharmanet data base Lack of standardized product Insufficient information risks, benefits, dose, route Increased demand for MM from public Challenging for prescribers and pharmacists 53 54