Other Marihuana Info

Indications for the non-medicine-medical-product

The current law does not stipulate any condition and leaves this open to the physician’s discretion.

The former law stipulated: end-of-life care, multiple sclerosis, spinal cord injury or disease, cancer, HIV/AIDS, arthritis, epilepsy, or a debilitating symptom of another condition. In the past, the physician, would submit documentation to Health Canada, who in turn issued authorization to possess Marihuana to the patient. Health Canada is no longer involved in this way, and physicians are no longer compelled to disclose the medical condition to Health Canada. This places responsibility squarely on the one profession – Physicians.

Prescription cannabinoids (not cannabis leaves) – These are Health Canada approved drug products containing constituents of cannabis or similar compounds and are approved in Canada for patients not responding to conventional treatments for pain, spasticity, stimulating appetite in AIDS patients with anorexia associated with weight loss, and for the management of nausea and vomiting associated with cancer chemotherapy.

Current Medical Association guidance documents indicate Marihuana use mainly for severe neuropathic pain not responding to other treatments and state that dried cannabis is not an appropriate therapy for anxiety or insomnia.

Potential use based on clinical use and experimentation are numerous. If you are interested, click here.

Dosage Forms of the non-medicine-medical-product

As already mentioned, only dried cannabis can legally be provided to patients. The label should indicate the percentage of THC and CBD, and it should not be sold in any dosage forms (not in capsules/ suspensions/ cigarettes etc.)

Mode of Administration of the non-medicine-medical-product

For Inhalation or oral consumption, also may be administered in vaporizers or teas. Ideally, medical marihuana should not be smoked.

Patient Confidentiality

I learned that patient’s using marihuana do not have the same privacy laws protecting them that other patients have. If a police officer approaches a pharmacist for drug information about patients, a warrant is needed or patient consent required for the information to be released. However, when an RCMP officer requests such information from a farmacist, a response is required within 72 hours as to whether an individual is in fact a client or care giver of a client as well as the dose provided to the client. The farmacist only has to make reasonable efforts to determine that the requester is in fact an RCMP officer. The information disclosed must be used solely for investigation in concern or to uphold the Marihuana for Medical Purposes Act & Regulations.

Dose Limits

The current law limits the amount a patient can legally possess to 150 grams or 30 x the daily dose (whichever is less) and limits the day supply to 30 days, so farmacists can not sell more than that maximum amount within 30 days, with this period being based on the date of sale. Most patients receive a dose of < 3g/d. Physicians and Nurse practitioners may also receive supplies from licensed producers to transfer to patient. Under the new law, nobody is allowed to grow Marihuana (Except those grandfathered by the previously mentioned injunction, who have a valid Authorization to Possess prior to March 21, 2014)

Quality Control

Health Canada does inspect these licensed dealers for safety purposes. Patients can contact their producer to verify various other specific preferences ranging from organic requests to mechanization and many more specifics.

For more on the inspection process, click here.

Drug Coverage For the Non-Medicine-Medical-Product

Financial assistance may be available through government or insurance healthcare benefit programs or compassionate pricing might be offered by the producer.

Why Only Your Farmacist Sells Marihuana in Canada.

It was a regular Thursday morning complete with my usual morning ritual

– Wake. Coffee. Journal. Read Bible. Pray. Meditate. Day Dream. Run. Shower. Eat –

– Business as usual –

….till these Texts…

Marijuana

…whence it was all up hill in my mind.

By noon, I had day dreamed myself to the very top of a Medical Marihuana distributing empire.

So, as any curious pharmacist would, I called the Alberta College of Pharmacists (ACP); where, after speculations if I was indeed a pharmacist, I was transferred to speak to an expert, who turned out to be my former teacher, and who also proceeded to recognize me as the recently awarded “Preceptor of the Year” recipient! This fact did not make this conversation awkward…at all.

From this conversation and after reading several other documents to determine how exactly I could hypothetically dispense Medical Marihuana in Canada, I found out several interesting facts.


1. I am as a matter of fact not allowed to produce Medical Marihuana on Pharmacy premises

2. I am strictly forbidden from possessing, producing, selling, providing, shipping, delivering, transporting and destroying marihuana.

3. As a licensed pharmacist and the proprietor of my pharmacy; I can not at the same time obtain a license from Health Canada to become a Licensed Producer or responsible person in charge of medical marihuana supply.

4. There is an explosion of medical marihuana shops in Vancouver City.

5. Dried marihuana is not an approved drug or medicine in Canada.


These facts were very confusing to me, because the Courts compelled a requirement to provide reasonable access to a legal source of marihuana when authorized by a physician for medical purposes. Despite medical use, it is not considered a medicine. It seems to me that a product intended for medical use should be subject to the same medication management that any product intended for medical purposes are subject to through pharmacist interventions. However, in this special case, we have a legal product ordered by a physician or nurse practitioner (the only two authorized healthcare professionals in Canada, Nurse practitioners are excluded in Alberta) and dispensed to patients by licensed producers (with no requirements for medical  or pharmaceutical background/ training), physicians, nurse practitioners or from Hospitals. In Alberta, physicians are definitely not authorized to dispense or become licensed producers of Marihuana.

Marihuana Question

According to the Alberta College of Pharmacists’ Policy statement   … “A licensed producer may only provide dried marihuana to a patient; it cannot be compounded or incorporated in any other vehicle or formulation.” Yet several of these “licensed producers” distribute in several different “formulations” (using that word very loosely). The closest medication I can think of that is manufactured in edible form is Actiq (Fentanyl in lollipops) a Schedule I Narcotic medication (in lay terms: You Must Be Very Ill to Get This Medication), which I’ve only heard of in pharmacy fairytales, but never dispensed, as it is not to my knowledge, available in Canada. In pharmacy land, one is very worried about poisoning children when one includes medical ingredients in delicious edible forms … so, naturally I was very curious about how these “lisensed farmacists” were getting away with this edible business. Turns out, it started from the shady sides of the previous law.

So…

Dispensaries and compassion clubs, which developed under a grey area of the previous federal legislation, are not legal under the current legislation.

Except…

A few days ago, in a historic move, council in Vancouver city voted to regulate about 100 “dispensaries“, charging retail dealers a whopping $30,000 license fee and compassion clubs a more gracious $1000 license fee while restricting available space for these shops through this new bylaw.

Marijuana Dispensaries  = #Truth

Still…

The bylaw does not allow the sale of edible products like pot brownies, with the exception of edible oils, which would include tinctures and capsules.

However…

The Supreme Court of Canada says medical marihuana must not be sold or provided with any additive, “additive” means anything other than dried marihuana but does not include any residue of a pest control product or its components.

So, we really do have a case in which a legally prescribed treatment is being supplied illegally (as edibles) to patients.

The Medical Product that is Not a Medicine

What is a Drug Product?
– Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.
– When a product is offered for sale in Canada to treat or prevent diseases or symptoms, it is regulated as a drug under the Food and Drugs Act.
– Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product’s safety, efficacy and quality as required by the Food and Drugs Act and Regulations.

In the case of Marihuana, it is prescribed, offered to treat diseases/ symptoms with limited or inconclusive efficacy evidence and has no market authorization under the Food & Drug Act…My (former) teacher also pointed out, when I called the ACP, that the quantity of the active ingredient is also very variable per unit dose. For these reasons, on the basis of limited efficacy data and variable content in unit doses, Health Canada has not in fact reviewed safety & efficacy data, and as a result, can not consider it a Drug Product. Because it isn’t a drug product, pharmacists can not dispense it.

hmmmmm….limited or inconclusive efficacy evidence and variable content in unit doses

You know what this sounds a lot like though?

Nutritional supplements.

Why has Health Canada reviewed and so provided market authorization for nutritional supplements, when there is limited to no evidence for their efficacy and many of these products have highly variable contents some containing <20% or sometimes none of the stated doses on the package? Despite the Canadian Medical Association’s concerns about safety of Marihuana treatment, it is yet to be reviewed for market authorization.

Nonetheless.

Medical cannabis is increasingly recognized as a valuable therapeutic option for the management of a variety of symptoms.1 As of April 1, 2014, patients are no longer allowed to grow their own cannabis. A court injunction allows individuals who had a license to grow cannabis under the former legislature to continue to do so until the court case is heard or the injunction is appealed.1

Currently, the dispensing Procedures for the non-medicine-medical-product:

Step 1: Physician or Nurse practitioner (Depending on Province) assesses the patient and determines there is a medically compelling need for the non-drug product A.K.A Marihuana. In Alberta, Physicians must register with the College as an authorizer of marihuana for medical purposes.

Step 2: Prescriber provides patient with a medical document (which looks a lot like a prescription in the detailed requirements for: patient specific information, marihuana dose, instruction for use and physician specific information).

Step 3 Patient presents document to a Farmacist (Licensed Producer) in any province across Canada.

Step 4: Farmacist registers the patient and sets her/ his price for the non-drug product.

Step 5: Farmacist ships non-drug product to patient with the label which includes the patient’s information and is thus proof of legal possession of the non-drug product.

Asides from Marihuana’s obviously illicit status, there are other factors which ought to be considered in its current medical distribution.

Clinical Considerations

Marihuana has an abuse potential – There is an addiction & dependence potential

There are 5 Randomized Controlled Trials lasting 3 to 15 days that support the use of smoked or vaporized cannabis for HIV/AIDS associated weight loss, multiple sclerosis related pain and spasticity, neuropathic pain & chronic pain

Potential risks of marihuana include: psychotic symptoms (dose dependent, age dependent, genetically influenced), impaired lung function, impaired cognition & potential interactions with psychoactive drugs, infertility, neurodevelopmental disorders following exposure of a fetus, impaired driving, impact on insurance and benefits coverage, unauthorized diversion.

Adverse Health Reactions: include dry mouth, red eye, reduction in blood pressure, increased or irregular heart rate, paranoia, hallucinations, derealization, increased anxiety, altered depth perception/ coordination, increased risks of lung disease & cancer, brain changes, lowers IQ (Irreversibly in those who initiate before 18 years old), reduces testosterone and the hormones that regulate ovulation, increased risks of addiction/ diversion.

Risk of Death

To give the controversy surrounding Medical Marihuana some perspective, I thought I’d compare relative risks of death of various drugs >>

Opioids: 14.7
Cocaine: 4.7 – 7.6
Amphetamines: 6.2
Cannabis: 1
Alcohol: 0.9 – 1.52
I am as a result inclined to believe the current controversies and hypersensitivity to Marihuana use may actually be a result of the dread factor which it poses.

I think it all comes down to the Sandman Equation:

Risk = Hazard + Outrage.

….And the outrage factor for Marihuana is high, so we are more likely going to over react to it’s use, and I do not say this to in any way discredit the very real hazard factor posed by Marihuana. It is a treatment for which there are still no high quality long term studies and for which we have no credible/ formal review of overall safety & efficacy. This fact makes many Physicians uncomfortable. A survey shows that only 19% of family physicians think physicians should recommend it1. I can only speculate about what sort of care patients could potentially receive with a Health Canada approved medical marihuana dispensed within all the proper checks and balances of a pharmacy dispensary model…

 How do these Farmacists get their licenses anyway?

To become a licensed producer/ person in charge of marihuana sale, all that is required is that you:


1. Must not be a regulated professional engaging in the practice of Pharmacy (may be unique to Alberta).

2. Notify a senior official of the local police, local fire authority and local government of the proposed activities to be conducted with cannabis and the address of the site(s) and of each building within the site(s).

3. Demonstrate compliance with regulatory requirements such as quality control standards, record-keeping, and security measures to protect against diversion, obtain necessary personal security clearances, and meet physical security requirements for cultivation and storage areas.

4. Send in an application to Health Canada.

5. An inspector may at a time during normal business hours and with the reasonable assistance of the applicant, inspect the site in respect of which the application was made.

Licences are issued only after it is determined:

  • there is no risk to public health, safety and security;
  • the applicant has met the security requirements outlined in the Marihuana for Medical Purposes Regulations (MMPR);
  • all the requisite security clearances have been obtained;
  • there are no other grounds for refusing the application; and,
  • The application otherwise satisfies the conditions for obtaining a licence outlined in the MMPR.

6. Within 30 days after the issuance, a licensed producer must provide a written notice to local authorities and licensing authorities (like the College of Physicians & Surgeons in Alberta) and provide a copy of the notice to the Minister.


For a medical product that is not designated as a drug or natural health product, Marihuana has several similarities to drugs we currently dispense:

It has known Indications, dispensing procedures, dosage forms, mode of administration, dose limits, quality control procedures, drug coverage and clinical considerations. Click Here for those juicy tidbits of info

The Role of a Pharmacist?

 We usually manage adverse effects, prevent interactions, counsel on administration techniques, provide harm reduction advice (in this case, we would promote vaporizer use, counsel not to mix with tobacco, counsel against breath holding, caution about edibles, counsel on dose titration, counsel about driving safely while on marihuana, caution alcohol/opioid/ other drugs/ interacting conditions), check appropriateness (be the final check to prevent use with contraindications like in pregnancy, cardiovascular disease, because we tend to know all the different specialists involved in a patient’s care when each don’t necessarily speak with each other), check safety and efficacy of various treatments….

Marijuana Musing

I agree

In Marihuana land,

A licensed producer who sells or provides dried marihuana must provide the Minister with a case report for each serious adverse reaction to the dried marihuana, within 15 days after the day on which the producer becomes aware of the reaction.

 A licensed producer who sells or provides dried marihuana must annually prepare and maintain a summary report that contains a concise and critical analysis of all adverse reactions to the dried marihuana that have occurred during the previous 12 months.

These farmacists are also expected to “refuse to fill” when minimum medical document (prescription) requirements aren’t met

So, these farmacists without minimum stated professional training (not to mention lack of any standards of practice) will critically analyze adverse reactions? How do they determine what to watch for? On the basis of which medical training do they establish causality? And despite obvious conflicts of interests, without any professional code of ethics, they’d set their own prices for each treatment yet refuse to fill when needed? How legal are the current sources of the product being distributed to patients? 

Currently…

The Pharmacist’s role is reduced to supporting patients by providing accurate information about the new regulatory changes, making them aware that they can contact their licensed producer for more information on processes and quality of their product, ensuring that patients report their adverse effects to their farmacists and perhaps counselling when appropriate during the comprehensive annual care plan process.

PS: I did not randomly misspell Marijuana 43 times; I have spelt it as such to align with Health Canada’s spelling in the new regulations.

Sources:

1. Danial Schecter, MA, MD, CCFP; Carlene Oleksyn, B.S.P. Pharm; Moe AbdallahBSc, BscPhm, R.Ph. Understanding Canada’s Medical Cannabis Regulations >> Studied on RxBriefCase

Authorizing Dried Cannabis for Chronic Pain & Anxiety Preliminary Guidance

Advice to the Profession

Policy Set for Marihuana for Medical Purposes

Medical Use of Marijuana

Medical Marihuana: What do you need to know before signing a medical document?

Alcohol Consumption Over Time and Risk of Death: A systematic Review and Meta-analysis

Marihuana for Medical Purposes Regulations

Responding to Community Outrage: Strategies for Effective Risk Communication by Peter M.Sandman, Ph.D.

CMA Medical Marihuana Policy Statement

CMA Policy – Medical Marijuana

Information for Health Care Professionals

Medical Marijuana – Flame-On! by Launette Reib MD, MSc, CCFP, FCFP, dip ABAM from the 26th Annual Best Science Medicine Course 2015.

Why are pharmacists so important when doctors can do their job?

Our pharmacy practice roles continues to expand, registered technicians are taking on technical roles, and we are focusing more on our cognitive responsibilities. Some of our patients don’t necessarily understand these changes. I’ve started to hear this question or various shades of it like … “Isn’t that my physician’s job?” “Shouldn’t that be my Physician’s problem?” “Why do you need to know that, you are just a pharmacist?”

In the epic battle of what a physician can do, a pharmacist can do too vs. what a pharmacist can do a physician can do better, neither profession wins. It is the very essence of division of labor for maximum productivity in our society that individuals specialize and cooperate for the synergistic benefit of all. Many smart people have recognized this, I think, after Plato who wrote in The Republic

“Well then, how will our state supply these needs? It will need a farmer, a builder, and a weaver, and also, I think a shoemaker and on or two others to provide for our bodily needs. So that the minimum state would consist of four or five men…”

We view things from different perspectives to improve the overall outcome for our patients, and neither profession bears any characterization of higher intellect/ morals. The truth is, pharmacists are trained to know a whole lot more about medications than physicians, and I certainly was not trained to complete physical assessments or diagnose complex care cases. Yet, it is fascinating to me how physicians and some patients get their panties in a bunch over this topic.

Case in point, is a letter I received from a physician 3 years ago, when I had merely pointed out that our mutual patient had a significantly elevated blood ethanol level (despite denying any alcohol consumption) and was experiencing several episodes of post prandial hypoglycemia (about 3 hours after several meals every week) despite several attempts at dose changes. I had merely suggested a switch from Insulin Toronto to a rapid acting insulin, and asked the physician if he could speak to the patient about alcohol consumption (because, the patient was obviously not being upfront with me; I had hoped both I and the physician could intervene).

Instead of collaboration, I received this letter>>
Ps: This letter is now a part of the tools used to prepare my students for the worst case scenarios in attempting to collaborate with other healthcare professionals as they go about caring for our patients.

Doctor's FaxThis patient spent another 2.5 years experiencing several bouts of hypoglycemia per week with hypoglycemic unawareness. At some point this year, another specialist recommended (as I had 2.5 years ago) rapid acting insulin with each meal. I am uncertain about his current alcohol consumption, but the number of hypoglycemic episodes dropped substantially.

As a side note about some of this particular physician’s comments:
On the comments about accessing Netcare: Our Standard of Pharmacist Practice actually requires that any reasonable Pharmacist would have, in this circumstance, considered appropriate information:
Standard 3.4 Appropriate information means the following information in relation to a patient: a) health condition to be treated and history of the condition; b) symptoms or signs to be treated; c) treatment history for the condition including drug therapy and outcomes; d) age; e) pregnancy or lactation status, if applicable; f) allergies or intolerances to drugs, excipients or other products that may affect drug therapy; g) other drugs or blood products being used; h) other health care products, aids and devices or other products being used that may affect the pharmacist’s decision; i) other health conditions that may affect the pharmacist’s decision; and j) any other information that a reasonable pharmacist would require to provide the pharmacist service.
Standard 3.6 When interaction with the patient or consideration of patient-specific information indicates that a pharmacist should review laboratory data and the data is not available, the pharmacist must:
a) order the appropriate laboratory test, or
b) contact an appropriate regulated health professional and request that the laboratory test be ordered.

On the comment about my inability to interpret lab data:
I am not entirely sure how else I could have interpreted a lab value of Blood Ethanol Level: 31 mmol/l and regular occurrences of FPG <4 several times in the week.

On the comment about Physician liability:
I am 100% liable for my decisions, actions, counseling, suggestions … etc. What I suspect is that many physicians do not recognize is that we are fully aware of the implications of our actions; we check and double check several studies and texts to back our suggestions up. The whole point of a pharmacist is essentially to mitigate medication risk to our patients and optimize pharmaceutical care, and we are fully aware about the implications of our interventions with regards to keeping our license.

Why are pharmacists so important?
Because, there is a good chance the pharmacist knows the time of onset, peak, duration and other such important pharmacokinetics as well as detailed mechanisms of action, interactions, clearance patterns etc about drugs. When pharmacists contribute such knowledge in their practice, it optimizes patient’s care for the best possible results. Pharmacists are here to provide great patient care in dispensing medications and optimizing pharmaceutical care through the various activities deemed now as our “expanded role” such as medication adaptations, prescribing, and medication assessments as advocates for our patients. This is our role: To dispense and manage medication use collaboratively for optimized patient care.

Can a physician do a pharmacists job?
First do no harm…

Asides from the obvious conflict of interests involved in having the diagnostician responsible for dispensing as well, pharmacists are the final check in the system to ensure that patients receive medications that are appropriate, safe and effective. We in addition, provide follow up counselling to ensure that medications are adhered to in order to reach treatment outcomes by monitoring our patients, and by being easily accessible to our patients. It is in fact impossible for physicians to do our jobs and ensure patient safety.

So, I thank you physicians who work with us collaboratively as we focus even more on our cognitive roles… and…

I beg the other physicians who currently do not understand us, do show us some love next time you receive our intentionally helpful messages. We really do not care for infringing on your territory, we just want to stay in our lane and optimize outcomes for our patients. Tis all!