Improving the regulation of medical cannabis in Canada to better serve pediatric patients
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- RE: Open Access Improving the regulation of medical cannabis in Canada to better serve pediatric patientsHarold A. Pupko [M.D.]Posted on: 09 January 2022
- RE: Response to Stephanie E. Lunn, PhD., Director, Medical Affairs, Aurora Cannabis Inc. commentary on Improving the regulation of medical cannabis in Canada to better serve pediatric patients. Posted: 09 December 2021Rahim Dhalla [Pharm.D., MBA]Posted on: 06 January 2022
- RE: Improving the regulation of medical cannabis in Canada to better serve pediatric patientsLauren E Kelly [PhD], Richard Huntsman [MD] and Regis Vaillancourt [PharmD]Posted on: 04 January 2022
- Independent research on commercial cannabis products for therapeutic and non-therapeutic purposesSergio Rueda [PhD], Elizabeth Limanto [MSc] and Michael Chaiton [PhD]Posted on: 02 January 2022
- RE: Improving the regulation of medical cannabis in Canada to better serve pediatric patientsStephanie E. Lunn [PhD]Posted on: 09 December 2021
- Posted on: (9 January 2022)Page navigation anchor for RE: Open Access Improving the regulation of medical cannabis in Canada to better serve pediatric patientsRE: Open Access Improving the regulation of medical cannabis in Canada to better serve pediatric patients
- Harold A. Pupko [M.D.], Primary Care Mental Health Physician, Private practice
While I agree with most of the points raised in this excellent proposal, its foundation is shaky.
"Medical" cannabis preceded the legalization of cannabis products.
Since legalization, there is no medical justification for two-tier access to cannabis products.
It is time to eliminate physician authorization forms and allow manufacturers to sell all products directly to the public, the same as any over the counter medication.
As physicians, we should be lobbying for high manufacturing standards so that we can have confidence in the products that we learn to recommend.
The Cannabis Act should at present be undergoing its mandated three year review.
We should be advocating within that review for efficiency in our medical practices for the sake of our own health.
The physician authorization process is a waste of physician mental resources.
Time to act on behalf of both our patients and ourselves.Competing Interests: None declared.References
- M3H 3S3
- Posted on: (6 January 2022)Page navigation anchor for RE: Response to Stephanie E. Lunn, PhD., Director, Medical Affairs, Aurora Cannabis Inc. commentary on Improving the regulation of medical cannabis in Canada to better serve pediatric patients. Posted: 09 December 2021RE: Response to Stephanie E. Lunn, PhD., Director, Medical Affairs, Aurora Cannabis Inc. commentary on Improving the regulation of medical cannabis in Canada to better serve pediatric patients. Posted: 09 December 2021
- Rahim Dhalla [Pharm.D., MBA], Pharmacist, Hybrid Pharm
Thank you Stephanie E. Lunn for your response to Dr. Huntsman et al.’s article entitled: Improving the regulation of medical cannabis in Canada to better serve pediatric patients. As a pharmacy owner and medical cannabis specialist, I would like to provide further commentary on your response, posted 09 December 2021, particularly addressing the need for pharmacy dispensing.
Pharmacist and pharmacies are the most accessible healthcare providers with over 11,000 community and hospital pharmacies across the country. As one of the oldest regulated professions, pharmacies are well-equipped to handle the necessary compliance and infrastructure such as logistics, compliance software, and monitoring to safely dispense narcotic/controlled substances.
In addition to our infrastructure, pharmacists also possess specialized knowledge and training in drug delivery and medication management therapy. Pharmacists currently manage complex and vulnerable patients, especially in the Veteran, addiction, and elderly populations. While Licensed Producers may hire healthcare professionals to advise and consult with patients, this practice is not common. This is not the core competency of drug manufacturers as it would be unusual for pharmaceutical companies such as Pfizer, Merck or Apotex answering patient care questions.
Furthermore, it is a conflict of interest for the manufacturers of controlled substances to be involved in direct patient care. In my experience, many...
Show MoreThank you Stephanie E. Lunn for your response to Dr. Huntsman et al.’s article entitled: Improving the regulation of medical cannabis in Canada to better serve pediatric patients. As a pharmacy owner and medical cannabis specialist, I would like to provide further commentary on your response, posted 09 December 2021, particularly addressing the need for pharmacy dispensing.
Pharmacist and pharmacies are the most accessible healthcare providers with over 11,000 community and hospital pharmacies across the country. As one of the oldest regulated professions, pharmacies are well-equipped to handle the necessary compliance and infrastructure such as logistics, compliance software, and monitoring to safely dispense narcotic/controlled substances.
In addition to our infrastructure, pharmacists also possess specialized knowledge and training in drug delivery and medication management therapy. Pharmacists currently manage complex and vulnerable patients, especially in the Veteran, addiction, and elderly populations. While Licensed Producers may hire healthcare professionals to advise and consult with patients, this practice is not common. This is not the core competency of drug manufacturers as it would be unusual for pharmaceutical companies such as Pfizer, Merck or Apotex answering patient care questions.
Furthermore, it is a conflict of interest for the manufacturers of controlled substances to be involved in direct patient care. In my experience, many patients have reported receiving advice from client care services such as switching products as well as dosing and safety. Client care representatives are not qualified to discuss therapeutics with patients which has led to inappropriate care and adverse effects.
While I may agree that pharmacies should not be the sole distributor of medical cannabis products, we must establish medical retail storefronts. In looking at consumer purchasing preferences, 88% of cannabis sales is being purchased via retail stores vs online from the Ontario Cannabis Store (OCS), while the number of medical cannabis registrations has decreased by 15% from 345,520 in Oct 2018 to 292,399 in March 2021.
A potential solution to enhance patient accessibility and reduce cost burdens from the LP side is to introduce a hybrid model in which both Licensed Producers and pharmacies can dispense and distribute medical cannabis. The pharmacies that opt in to medical cannabis distribution must obtain a license from Health Canada, with appropriate training, similar to methadone dispensing. Pharmacists are more than qualified to distribute cannabis and those willing have the necessary resources to provide proper point-of-care service in a highly regulated environment.
Show LessCompeting Interests: Rahim Dhalla is owner and founder of Hybrid Pharm, a specialty pharmacy with a medical sales license with possession.References
- National Statistics | NAPRA. (2022). Retrieved 4 January 2022, from https://napra.ca/national-statistics
- Brown, D. (2022). Ontario sold $251 million worth of cannabis from Oct-Dec 2020 - StratCann. Retrieved 5 January 2022, from https://stratcann.com/2021/03/05/ontario-sold-251-million-worth-of-cannabis-from-oct-dec-2020/
- Canada, H. (2022). Data on cannabis for medical purposes - Canada.ca. Retrieved 5 January 2022, from https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/research-data/medical-purpose.html#a3
- Posted on: (4 January 2022)Page navigation anchor for RE: Improving the regulation of medical cannabis in Canada to better serve pediatric patientsRE: Improving the regulation of medical cannabis in Canada to better serve pediatric patients
- Lauren E Kelly [PhD], Assistant Professor, Department of Pharmacology and Therapeutics, University of Manitoba
- Other Contributors:
- Richard Huntsman, Associate Professor
- Regis Vaillancourt, Pharmacist
The authors appreciate the response provided by Dr. Lunn and wish to respond. We agree that barriers to children having access to medical cannabis should be avoided. First, there is considerable potential for cannabinoids to interact with drug metabolism enzymes complicated by complex therapeutic regimens and age-related changes in pharmacology specific to children. We strongly recommend that all pediatric patients only use cannabis products under the care of a healthcare provider who has expertise in the conditions for which the medical cannabis is being used. Unfortunately, not all families can access cannabis through their existing healthcare pathways, and rely on non-specialist physicians to authorize their medical cannabis. In this situation, having the availability of a pharmacist to provide advice to the physician and child’s caregivers is especially important. Pharmacies already have the security infrastructures to dispense controlled substances and have built trust with communities including medically marginalized populations. Most pharmacies also have a home delivery system, usually at no or minimal cost to patients. Pharmacies also already have a system in place to manage reimbursement by insurance companies and already dispense cannabis in many other countries such as Germany, Brazil, Chile, Uruguay and Poland. If the current model is to be maintained, to ensure the safety of our pediatric patients, we recommend that licensed producers who sell medical cannab...
Show MoreThe authors appreciate the response provided by Dr. Lunn and wish to respond. We agree that barriers to children having access to medical cannabis should be avoided. First, there is considerable potential for cannabinoids to interact with drug metabolism enzymes complicated by complex therapeutic regimens and age-related changes in pharmacology specific to children. We strongly recommend that all pediatric patients only use cannabis products under the care of a healthcare provider who has expertise in the conditions for which the medical cannabis is being used. Unfortunately, not all families can access cannabis through their existing healthcare pathways, and rely on non-specialist physicians to authorize their medical cannabis. In this situation, having the availability of a pharmacist to provide advice to the physician and child’s caregivers is especially important. Pharmacies already have the security infrastructures to dispense controlled substances and have built trust with communities including medically marginalized populations. Most pharmacies also have a home delivery system, usually at no or minimal cost to patients. Pharmacies also already have a system in place to manage reimbursement by insurance companies and already dispense cannabis in many other countries such as Germany, Brazil, Chile, Uruguay and Poland. If the current model is to be maintained, to ensure the safety of our pediatric patients, we recommend that licensed producers who sell medical cannabis products to children have a clinical pharmacist with expertise in complex pediatric care on hand to provide advice to the authorizing physician and caregivers.
We recognize that GPP certification for cannabis products results in quality products. Our recommendation regarding GMP certification was specific to medical cannabis dispensing for children and thus would not impact adult patients’ accessibility to cannabis products (nor these existing access pathways). For the broad pediatric community to trust cannabis products and to remove access barriers due to product quality uncertainty, ensuring consistent and highest-standard quality products is paramount. Another barrier for physician authorization is a lack of high-quality research (clinical trials). Health Canada requires that clinical trials evaluate products produced under GMP. This has resulted in a disconnect where products that are considered to be of a high-enough standard for patient use, is not of sufficient quality for research. If GMP certification is not possible, Health Canada should consider a single manufacturing certification system for medical cannabis products that meets medical and research requirements and is acceptable in other jurisdictions as pediatric trials often need to be international to reach their sample size. We respect that requiring GMP may be more costly, and that government incentives for cannabis companies to participate in research with supportive regulatory pathways are needed.
Show LessCompeting Interests: This response is on behalf of the authors of the commentary. There have been no changes to our submitted COIs.References
- Richard J. Huntsman, Lauren E. Kelly, Jane Alcorn, et al. Improving the regulation of medical cannabis in Canada to better serve pediatric patients. CMAJ 2021;193:E1596-E1599.
- Posted on: (2 January 2022)Page navigation anchor for Independent research on commercial cannabis products for therapeutic and non-therapeutic purposesIndependent research on commercial cannabis products for therapeutic and non-therapeutic purposes
- Sergio Rueda [PhD], Independent Scientist and Associate Professor, Centre for Addiction and Mental Health and University of Toronto
- Other Contributors:
- Elizabeth Limanto, Student
- Michael Chaiton, Independent Scientist and Associate Professor
The commentary by Huntsman and colleagues raised a number of very important issues related to the use of cannabis for medical purposes in pediatric populations, including the need to collect adequate national data, make changes to physician authorization requirements, institute better product labelling, and enhance surveillance systems to document adverse drug reactions.
We also agree that more research funding is necessary, but the proposed solution to require Good Manufacturing Practices (GMP) certification for medical products solves only one issue associated with research into cannabis.
We would like to make the larger argument for independent research with commercial products currently available to consumers on the recreational and medical markets to assess the health impacts of these existing products (Rueda et al, 2022). Researchers need the ability to examine these widely-used products and their effects on humans. Cannabis legalization can be seen as a population-wide experiment and researchers must have the ability to provide independent evaluation of cannabis products, their use, and regulation to protect health.
The current situation—and the solution posed by Huntsman and colleagues—does not allow for independent regulatory science. It forces independent researchers to partner with industry to conduct any clinical research for any purpose because access to research products depends on the willingness of cannabis companies to develop GMP pr...
Show MoreThe commentary by Huntsman and colleagues raised a number of very important issues related to the use of cannabis for medical purposes in pediatric populations, including the need to collect adequate national data, make changes to physician authorization requirements, institute better product labelling, and enhance surveillance systems to document adverse drug reactions.
We also agree that more research funding is necessary, but the proposed solution to require Good Manufacturing Practices (GMP) certification for medical products solves only one issue associated with research into cannabis.
We would like to make the larger argument for independent research with commercial products currently available to consumers on the recreational and medical markets to assess the health impacts of these existing products (Rueda et al, 2022). Researchers need the ability to examine these widely-used products and their effects on humans. Cannabis legalization can be seen as a population-wide experiment and researchers must have the ability to provide independent evaluation of cannabis products, their use, and regulation to protect health.
The current situation—and the solution posed by Huntsman and colleagues—does not allow for independent regulatory science. It forces independent researchers to partner with industry to conduct any clinical research for any purpose because access to research products depends on the willingness of cannabis companies to develop GMP products for research. By controlling access to research products, the cannabis industry will continue to have an unacceptable level of influence on Canada's clinical research agenda. Several peer-reviewed studies with public funds have already been cancelled for lack of GMP products.
The solution is clear. Health Canada needs to allow independent researchers to test commercial products for both therapeutic and non-therapeutic purposes. This single change in regulations would not only incentivize research on medical applications but also on the safety of recreational products. If a cannabis product is safe for the commercial market, it must be safe for research purposes under rigorous oversight by Research Ethics Boards.
Show LessCompeting Interests: None declared.References
- Richard J. Huntsman, Lauren E. Kelly, Jane Alcorn, et al. Improving the regulation of medical cannabis in Canada to better serve pediatric patients. CMAJ 2021;193:E1596-E1599.
- Rueda S, Limanto E, Chaiton M. Cannabis clinical research in purgatory: Canadian researchers caught between an inflexible regulatory environment and a conflicted industry. The Lancet Regional Health - Americas 2022; 7: 100171. doi.org/10.1016/j.lana.2021.
- Posted on: (9 December 2021)Page navigation anchor for RE: Improving the regulation of medical cannabis in Canada to better serve pediatric patientsRE: Improving the regulation of medical cannabis in Canada to better serve pediatric patients
- Stephanie E. Lunn [PhD], Director, Medical Affairs, Aurora Cannabis Inc.
I would like to thank Huntsman et al. for their advocacy for the use of medical cannabis in Canada and provide further commentary around some of their proposals.
I agree that broadening access to medical cannabis is a desired goal and that pharmacists should have greater ability to authorize and dispense medical cannabis. Having pharmacists involved in the medical cannabis system may be of particular importance in patient populations who have more complicated conditions and/or who are at greater risk of developing adverse events, such as pediatric and elderly patients. However, I would caution against pharmacists being the sole point of access for medical cannabis dispensing. While this is a common model within the pharmaceutical space, availability and delivery of medical cannabis direct from Licensed Producers (LPs) to the doors of patients offers many additional benefits, such as seed to sale tracking, ease and discreet access, education and reimbursement support. A complete departure from this approach may pose a significant barrier to access for many patient populations, such as older patients and Veterans. Additionally, a negative stigma continues to exist towards medical cannabis which may prevent patients from accessing it exclusively from a pharmacy. Pharmacies also require Health Canada licenses to possess and distribute cannabis products and must have the appropriate security for storage, which may be a resource burden many pharmacies would not take on....
Show MoreI would like to thank Huntsman et al. for their advocacy for the use of medical cannabis in Canada and provide further commentary around some of their proposals.
I agree that broadening access to medical cannabis is a desired goal and that pharmacists should have greater ability to authorize and dispense medical cannabis. Having pharmacists involved in the medical cannabis system may be of particular importance in patient populations who have more complicated conditions and/or who are at greater risk of developing adverse events, such as pediatric and elderly patients. However, I would caution against pharmacists being the sole point of access for medical cannabis dispensing. While this is a common model within the pharmaceutical space, availability and delivery of medical cannabis direct from Licensed Producers (LPs) to the doors of patients offers many additional benefits, such as seed to sale tracking, ease and discreet access, education and reimbursement support. A complete departure from this approach may pose a significant barrier to access for many patient populations, such as older patients and Veterans. Additionally, a negative stigma continues to exist towards medical cannabis which may prevent patients from accessing it exclusively from a pharmacy. Pharmacies also require Health Canada licenses to possess and distribute cannabis products and must have the appropriate security for storage, which may be a resource burden many pharmacies would not take on.
I also have concerns around the call for all medical cannabis products to be GMP certified. I understand GMP certification is a widely used standard for pharmaceuticals however, the GPP requirements followed by LPs provide significant oversight for us to be able to produce high quality, safe cannabis products. And while a select number of LPs are capable of certifying their products as GMP, not all are. Furthermore, such a change would significantly limit the range of product formats available, as edible products in particular would not easily be GMP certified. Edible products are likely the most conducive for patients who cannot tolerate the taste of cannabis oils nor swallow pills (i.e. pediatric and elderly patients) and so a change in regulations could negatively impact some patient populations.
Also, such a change in requirements is likely to limit the number of companies able to produce product for the medical cannabis channel causing a reduction in the overall availability. For companies that can satisfy the GMP requirements, not all will choose to do so due to the associated costs. With fewer companies offering medical cannabis and those doing so putting considerable resources to certify all their products as GMP, the ability for any to support the much-needed research into the efficacy and safety of cannabis will be reduced.
Show LessCompeting Interests: Dr. Stephanie Lunn is the Director of Medical Affairs at Aurora Cannabis Inc, a Canadian Licensed Producer of cannabis.References
- Richard J. Huntsman, Lauren E. Kelly, Jane Alcorn, et al. Improving the regulation of medical cannabis in Canada to better serve pediatric patients. CMAJ 2021;193:E1596-E1599.
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