This event was chaired by Dr. Franz Pietsch.  Federal Ministry of Health, Austria and Professor Mark Ware, McGill University, Canada.

Issues in cannabinoid prescribing

• Costs
• Off label use
• Stigma of cannabis still present
• Typically considered third or fourth line option – ie for chronic pain
• Abuse potential low

See: Ware and St. Arnaud (Addiction 2010) andWare et al (IASP 2012 in preparation)

Unique features of medical cannabis

• Patient driven initiatives, usually through courts or ballot initiatives (USA)
• Herbal product.  Complex botanical substance
• Controlled substance
• Inhaled or vaporized
• Wide variability in dose patterns
• Recreational use stigma
• Drug policy activism

Data don’t meet standards for regulatory approval.  Doctors and nurses not trained enough.  Very little education in undergraduate curricula.
Oral preparations remain in plasma longer than smoked.
Canada forced into opening up access program on the basis of court decisions 2009.  In 2009 initiation in growth in number of authorization.  Rise in number of authorization to possess for medical purposes from single regulated government grower or could grow themselves or designated producer.  There were abuses of these programs.  Rise in designated and personal production licenses.  Proliferation of licit grow operations. Proliferation of court cases.  Any access framework had to acknowledge impact on public safety.  Abuses of regulatory framework.  Organized crime selling licenses.  Doctors not prescribing well.  Investigations.

New program moved toward a prescription model.  Doesn’t appear in regulations.  Medical document at the heart of the process.  Multiple commercial producers.  Checked and audited.  Elimination of personal and designated production licenses.  Approach use and regulation as much like any narcotic drug as possible.  May issue medical documents.  Cannabis sent directly to px from grower.  No intermediary step.  June 2013 launched regulations. On April 1, 2014 will be exclusively under the new regulations.  Medical document does not require a diagnosis.  No guidelines about how to educate or screen. Px have to pay out of pocket.  Idea of choosing which company to provide cannabis is an issue.  Dosing an issue for  physicians.  Medical legal concerns.  Liability for physicians.  Response to that is from http://www.cmpa-acpm.ca/cmpapd04/docs/resources…
Conventional treatments have to have failed or been considered inappropriate by px.
Health Canada’s websit a source for this.
Showed Sample Document.  Looks like standard prescription form.
Eleven licensed producers as of yesterday.
Range of products produced.  Percentage of THC and CBD varies widely.  How a physician chooses which one for which px is unknown as yet.

Safety concerns on Driving, Psychosis, Interactions, Anxiety, Abuse/Tolerance/Dependence, Cognitive functions, Effects on Lungs, Vaporization as a smokeless cannabis delivery system.  Avoid toxic byproducts from combustion, Essential elements of medical education, Mechanism of action
Pharmacology, Prescription options, Patient screening and monitoring, Risk/benefit, Dose and interactions, When and how to say no.

Other organizations of health care professonals involved in education.  Health Canada has up to date research on cannabinoid science.

• Essential elements of clinical care
• Bona fide relationship; informed consent
• Communication with other health professionals
• Screen for contraindications and precautions
• Stablish all other options tried or considered
• Set an dmonitor meaningful treatment goals
• Adequate documentation.

Research has boomed in the last 40 years.  Clinical trials conducted with compounds.  Most have been done since 2004.  Nabalone, dronabinol, and herbal cannabis.  Major research issues are monitoring, strain phenotype correlations, alternative delivery, industry sponsored trials.

Dr Eberhard Pirich – medical preparations means preparation in pharmacy in accordance with prescription, often reimbursed by social security system. How big is the market? About 3.5kg dronabinol processed s magisterial drugs, not classified as a narcotic drug. About 3000 patients treated in different indications per year. About 50% of volume used in primary care, the other is for hospital use. On prescription and reimbursement on cannabinoids in Austria, used in growing number of diseases, promote internationally approved indications and supporting research on further therapeutic applications. On the Endocannabinoid System and Disorders: vital for the maintenance of homeostasis in all higher organisms, including for appetite control and body weigh regulation, reducing sleep disturbances, eg. in MS patients, reduces inflammatory pain. On dronabinaol and what it is and can do: what dronabinol (THC) can do in medicine: alleviates pain, spasticity and anxiety, stimulates appetite, suppresses nausea and vomiting, may be integrated into existing treatment regimens, improves quality of life. There are natural and synthetic routes to producing THC. They differ; natural dronabinol has highest purity. Therapeutic options for magisterial dronabinol, example: pain, neurodegenerative disorders (eg. MS, Alzheimer’s disease, strokes, spinal cord injury), psychiatric disorders/anxiety (fear extinction, nightmares, depression, PTSD, burn-out syndrome, ADHD, Tourette syndrome). On palliative care and dronabinol, problem is not only the doctor-patient communication, but also drug therapy and proper care of the elderly and palliative patients pose a special challenge. Patients often present with multimorbidity, eg. dementia, diabetes, cancer, usually on several medications. Consequences include diminished quality of life. Dronabinol can help. Cannabis – gateway to health: health benefits of cannabis, in which application form ever, far exceed its danger. Encourage further research on its therapeutic uses.
Gilberto Gerra – perspectives in medical use of cannabis: people ask why I speak on such a sensitive issue, don’t understand why CND should be closed to new arguments about drugs with MS and CSO. Cannabis is not a new medicine. What doesn’t help is lots of media info about drugs that is not substantiated, eg. that cannabis cures cancer. Lots of anecdotal information, eg. from Dr. Gupta. Someone doing serious research becomes involved with this crime. My branch is very much involved with this serious issue, on endogenous cannabinoids – an anandamide, name derived from Indian term for happiness. So such cannabinoids is very much related to our emotions and happiness. Cannabinoid receptors are located all over brain, related to memory and learning, emotion, appetite etc. Serious studies on scientific studies on medicinal use of cannabis, eg. on placebo studies. Cannabis appears to have treatment vale in patients with anxiety and social phobia. Cannabigerol and cannabinol no antidepressant like action, but cannabichromene and cannabinodal does and can be used in many psychiatric disorders. In psychosis cases treated with cannabinol can be used in psychiatric disorders. Cannabinol can increase appetite and food intake – good for anorexia. Another type of cannabinoid can also be used to suppress appetite and can help with obesity. Outlines steps in conducting clinical trials, in-human-studies. We have to go back to scientific aspects of drugs to revise approaches to drugs. Clinical trials need long term follow up etc. Cannabinoids are very promising as medications, should apply same approach to them as any other medication.
CSSDP: Health Canada says must destroy all previous marijuana grown themselves. Prof. Mark Ware says growing own supply is understandable, but authorities are much more comfortable with supply produced by regulated authorities. If this is to be a medicine, it must be part of a standardised supply network. Otherwise physicians will not engage in the process because of no guarantee of regulated supply.
Kevin Sabet – SAM: 4th pillar is to research and develop cannabinoids to achieve pharmacy medications. At the moment in US, most cannabis is not produced in regulated way. Confused about smoke and not smoking cannabis, Gilberto only one who said smoking is not appropriate. Prof. Ware says fundamental reality is that most medical cannabis is used through smoking, this will continue until a better way is found. If it is going to be a regulated medicine, it will not be smoked, I can see use of it with vaporiser is way forward. We still need to study smoked route because it is reality, we should know what risks are. Kevin: sativex has been approved but people still smoke. Prof. Ware: smoked route is just different. Austria: from very beginning restricted use to single substances out of cannabis plant. Home grown cannabis not tolerated? Farid of ENCOD?: concerned with allegations that cannabis can harm brain, I say this is a crime against nature. Can we consider this is crime against humanity to refuse access to plant? Israel has been most important country in support of research, but some patients there are smoking pipe in hospitals, and physicians there are very please to use cannabis there because it is very cheap medicine to treat disorders. When we legalise nature to heal people? Gilberto: it’s up to CND to decide on legalisation of cannabis.