Highlights
- •A qualitative interview-based study involving Canadian neurologists was conducted.
- •Cannabis may be a viable option for drug-resistant epilepsy but evidence gaps exist.
- •Some families are referred to non-neurology care providers for cannabis authorization.
- •Additional education about cannabis is warranted.
Abstract
Purpose
To understand the experiences with and perspectives of neurologists about the use of medical cannabis in the treatment of pediatric drug-resistant epilepsy.
Methods
In this qualitative study, we interviewed neurologists who provide care to children with drug-resistant epilepsy in Canada. Through semi-structured telephone interviews, we sought participants’ views about and experiences with medical cannabis for the treatment of drug-resistant epilepsy in children. Here we present a thematic summary of the interviews.
Results
The 12 interviewed neurologists generally perceived medical cannabis as a viable treatment option for children with drug-resistant epilepsy; however, participants identified important gaps in the evidence and implications for their practices. Six themes were generated from the content of the interviews: learning about medical cannabis; perceptions about medical cannabis; discussing medical cannabis with parents; experiences with medical cannabis authorization; barriers to authorizing medical cannabis; and the impact of medical cannabis on clinical care. Of note, while some neurologists took on all aspects of the children’s care, including medical cannabis, others referred interested families to non-neurology health care professionals.
Conclusion
Our findings highlight the diverse opinions and experiences of neurologists in Canada with medical cannabis for the treatment of drug-resistant epilepsy in children, including with the authorization process and caring for children using medical cannabis. Additional education about medical cannabis may be warranted, in order to better prepare neurologists to have informed and open conversations with parents about this treatment option and to provide care for children using medical cannabis.
Keywords
1. Introduction
Cannabis as a treatment for epilepsy dates to the 1800s in the published literature, [
[1]
] with increasing interest over the last decade in its use as a treatment for pediatric drug-resistant epilepsy, driven partly by media reports of children whose seizures have responded to cannabis [2
, 3
, 4
]. Until recently, there was little clinical evidence to support its use in this population [[5]
], and there were wide differences between the beliefs of health care professionals and the public with respect to effectiveness and safety [[6]
]. A 2015 survey by Epilepsia reported a “wide diversity of opinion on the use of medical marijuana in treating people with epilepsy” depending on whether the respondent was a neurologist or a member of the public. At that time, more than two-thirds of neurologists felt that data were insufficient to support its use, although 48 % would recommend it to patients whose “severe, catastrophic epilepsy” had not responded to approved therapy. [[6]
] The clinical landscape surrounding medical cannabis has undergone important transformations since 2015. At the time of the Epilepsia survey, there had been no randomized controlled trials (RCTs) involving children with epilepsy. [[5]
] As of May 2019, the evidence-base had grown to include 4 RCTs and 31 non-randomized studies involving children [[7]
], with the findings largely supporting a positive effect for purified cannabidiol (CBD; Epidiolex) in reducing seizures associated with drug-resistant epilepsy.Epidiolex is not available in Canada at this time, despite recently receiving approval by the US Food and Drug Administration [
[8]
] and the European Medicines Agency [[9]
]. In Canada, patients with authorization from a health care provider have access to cannabis products including fresh or dried cannabis or cannabis oil (i.e., oil containing cannabinoids extracted from cannabis [CBD-THC oil]) [[10]
]. As of December 31, 2019, Health Canada had issued licenses to 165 cannabis producers to sell cannabis products to authorized medical patients, including 61 authorized to sell CBD-THC oils [[11]
]. Notably, these products are not subject to pre-market safety and efficacy review by Health Canada and are not issued a notice of compliance or a drug identification number. While two small cohort studies have recently evaluated the efficacy of two CBD-THC oils, most have not been evaluated in clinical studies, and it is unknown how Canadian neurologists perceive medical cannabis as a treatment for children with drug-resistant epilepsy.1.1 Objective and significance
Although the evidence-base has changed over the last 5 years, little is known about the current perspectives of neurologists regarding the use of cannabis-based products for the treatment of pediatric epilepsy. In this qualitative interview-based study, we examined the perspectives of neurologists in Canada who provide care to children with drug-resistant epilepsy about the use of medical cannabis.
2. Methods
This qualitative study used an interpretive description approach [
[12]
] and was undertaken as part of a health technology assessment (HTA) of the use of cannabis as a treatment for pediatric drug-resistant epilepsy, and the findings are reported following SRQR checklist [[13]
].Interpretive description is an applied qualitative methodology intended to provide rich description of a clinical phenomenon and is commonly used to address questions that are important within the context of clinical health care. By combining aspects of traditional qualitative methodologies (e.g., grounded theory, phenomenology), interpretive description provides a pragmatic way to explore clinical phenomena and to situate the findings within existing research and clinical knowledge. [
[14]
] Interpretive description goes beyond simple description of a phenomenon, by considering the clinical implications of the findings with the aim of creating knowledge that can be applied in clinical practice by providing a “conceptual/thematic description” of the phenomenon [[12]
,[15]
].In this study, interpretive description was used to explore the perspectives about medical cannabis of neurologists in Canada whose practices include children with drug-resistant epilepsy, in order to provide insight into the use of medical cannabis in this population. We also sought to better understand the impact of medical cannabis on the health care delivery process and to describe experiences with cannabis authorization. Because medical cannabis regulations vary by country, [
[17]
] we focused on neurologists who practice in Canada. We adopted the role of learners and were not positioned either in favour or opposition of cannabis as a treatment for epilepsy. The research team included qualitative researchers (D.D., B.K.P.) and clinicians who provide care for children with drug-resistant epilepsy (B.M.). We used the reflexive practices of memoing and frequent dialogue between authors to consider ways in which our perspectives were influenced by professional and personal backgrounds, experiences, and assumptions.This study received ethics approval from the University of Ottawa Research Ethics Board.
2.1 Sampling and recruitment
We used purposive and snowball sampling to recruit neurologists practicing in Canada who provide care to children with drug-resistant epilepsy; participants were not required to have previously authorized cannabis use. Participants were identified from an online list of neurologists in Canada (https://my.aesnet.org/FindaDoctor) and from among personal contacts of the researchers, and participants were encouraged to tell their colleagues about the study. Practice details, including location and years in practice, were verified during participant interviews. We sought to maximize variation in the recruitment process by approaching neurologists from across Canada; we also sought variation in practice duration and gender. All interviews were conducted in English. Recruitment and data collection were concurrent with analysis. Saturation (no new themes, sub-themes, or codes) was reached after the 11th interview; however, we interviewed all 12 neurologists who had expressed an interest in participating, and the analysis considers data from all 12 interviews.
2.2 Data collection
All interviews were conducted by J.E. using a semi-structured interview guide (Appendix 1). Telephone interviews were selected for feasibility and to reduce social desirability bias that might result from group interaction. The interview guide was developed by the research team and was informed by a review of the published literature and a framework for undertaking health technology assessments. [
[18]
] After providing consent and answering demographic questions, participants were asked open-ended questions intended to capture their experiences and perspectives about medical cannabis for drug-resistant epilepsy. Interviews were conducted between January and September 2019 and ranged from 20 to 60 minutes. All interviews were audio-recorded, and field notes were taken.2.3 Data analysis
Data collection and analysis were concurrent. All interviews were transcribed verbatim and verified against the original recording, and transcripts were uploaded to NVivo data management software (v. 12 Pro, QSR International). Data analysis was guided by thematic analysis, including repeated reading and familiarization with the transcripts, complete coding across the dataset, and organization of thematically related codes. Codes were generated from the content of the interviews, and the coding structure was recorded in NVivo. All interviews were coded by J.E., and six interviews were independently coded by D.D. Throughout the analysis process, J.E. and D.D. discussed codes and coding structures. Findings were viewed through an HTA lens, and attention was paid to the impact of the technology (medical cannabis) on the participants (neurologists) and their interactions with end users (children with drug-resistant epilepsy and their families). In the following section, some quantifying language is used to provide a sense of consistency within themes. For example, the term “most” indicates that a theme was present in at least 10 (of 12) participant accounts, while the term “many” indicates that at least 6 accounts included the theme. The terms “some” or “several” indicate that less than half of participant accounts included a theme; however, the absence of a theme in a participant account does not indicate that a belief was not held, only that it was not raised during the interview.
3. Results
Twelve neurologists participated in this study, including 7 (58 %) who had previously authorized use of medical cannabis for children with drug-resistant epilepsy (Table 1). Most participants were male (75 %) and practiced in an academic or teaching hospital (83 %). The duration of independent practice ranged from 1 to 27 years, with most in practice for at least 10 years (58 %).
Table 1Demographic characteristics of study participants.
| Characteristic | Number (%) |
|---|---|
| Male | 9 (75) |
| Has previously authorized cannabis use | 7 (58) |
| No. years in practice | |
| 0–9 | 5 (42) |
| 10–19 | 6 (50) |
| ≥20 | 1 (8) |
| Practice location | |
| British Columbia | 2 (17) |
| Alberta | 1 (8) |
| Saskatchewan | 1 (8) |
| Manitoba | 1 (8) |
| Ontario | 5 (42) |
| Quebec | 1 (8) |
| Atlantic Canada | 1 (8) |
| Practice type | |
| Academic/teaching hospital | 10 (83) |
| Community-based | 2 (17) |
* Atlantic provinces grouped because of a small number of neurologists in some provinces.
3.1 Thematic summary
Six thematically related categories emerged from our analysis of the data: (1) learning about medical cannabis, (2) perceptions about medical cannabis, (3) discussing medical cannabis with parents, (4) experiences with medical cannabis authorization, (5) barriers to medical cannabis authorization, and (6) the impact of medical cannabis on clinical care. Here we elaborate on those themes, with selected quotations in support of the themes presented in Table 2.
Table 2Themes and illustrative quotations.
| Theme | Subtheme | Quote no. | Participant identifier | Illustrative quotations |
|---|---|---|---|---|
| 1. Learning about medical cannabis | Importance of education | 1 | Neurol 4 | “The more that we can understand this, the better, the more avenues I have to counsel my patients. It is very frustrating when [patients] come with something and you say, ‘oh, you know what, I really have no clue.’” |
| Sources of knowledge | 2 | Neurol 4 | “Well, I have attended rounds, we've had some people, like [local physician] who prescribes cannabinoids, come a couple of times and give rounds. Then seminars on the web and things like that. Nothing very formal. I haven't attended a fellowship or anything like that, it's been more like rounds and local seminars.” | |
| 2. Perceptions about medical cannabis | State of the evidence | 3 | Neurol 8 | “I don't feel that it is ready to be a standard care based on the available data…We are waiting to have some guidance. For any medication, not only for CBD oil, other medications, normally physicians who want to prescribe a medication should have approval from Health Canada. Health Canada will provide safety guidance, dosage, and monitoring.” |
| 4 | Neurol 3 | “I think it's kind of a fad right now, and everybody is really interested in it, and although a subset have really benefited, and those are the ones we tend to read about on the parent sites, I would say as a group, I'm not convinced there's really a good sustained effect. I would predict that within a few years it’s going to become a lot less popular.” | ||
| 5 | Neurol 1 | “Most of the studies included kids who had genetic epilepsies or specific syndrome diagnoses, but to my mind, the extrapolation of that is not a challenge because that is often what we encounter with research data, and so extrapolating it to clinical data, in terms of what we would use, what patient population we would consider use in, it would just be reasonable to try in all drug-resistant epilepsy.” | ||
| Line of treatment | 6 | Neurol 7 | “It's something that I'm more likely to consider as opposed to a third line or a fourth line, maybe fifth or sixth, so certainly not at the end, but certainly lower down than I would other anti-epileptic therapies.” | |
| Gaps in the evidence | 7 | Neurol 1 | “The cannabinoids as a whole are very complicated substances with hundreds of active chemicals, and we've only begun to scratch the surface in terms of what medical properties are in it. Based on what we know, it looks like cannabidiol can be effective in treating seizures, and there is potential for tiny amounts of cannabinoids such as THC to be effective, but there's a lot we don't know about other components that can be in a variety of different products.” | |
| 8 | Neurol 6 | “I'm using it in a population where they have intractable epilepsy and therefore the chances of another product making a difference for them is low, about 10−15%, so it doesn't surprise me that it's not a startling success… But it's worth a try.” | ||
| Cost and reimbursement | 9 | Neurol 4 | “Before it wasn't a surprise, it was almost like an assumption. After legalization, some families are like ‘Oh, is that right, oh, okay, I see. No, I was hoping that, now with the legalization that we would have some kind of funding, or that a percentage of it would be funded’ or ‘Oh, but what about the private insurance plans, I'm sure they would. Oh! What do you mean that they don't?’” | |
| 10 | Neurol 5 | “I think it needs to have some government or extended healthcare mechanism to fund families where it clearly is working, to have it covered. Now I think it would be reasonable that families maybe should have to pay out-of-pocket to keep it simple to see if it works. But if it works then I think that it saves the healthcare system a lot of money because kids aren’t in status, aren't having hospital visits, aren't needing to be on other medications, and so it saves the system and so there should be coverage for like any other drug, if it's efficacious for them.” | ||
| 3. Discussing medical cannabis with parents | Determining parental expectations | 11 | Neurol 5 | “Typically the goal would be looking at seizure control, but certainly families report that there's some more qualitative improvement, or subjective improvement in the level of encephalopathy or alertness that the child has, so those might be secondary measures of the efficacy. And those might be reasons why families maybe don't see a benefit from the seizure point-of-view but overall they feel the child is doing better and so that would be reason enough, if they wanted to, to continue on it with the hope that maybe over time or a slightly higher dose if they're tolerating it, it might control seizures better.” |
| Educating parents | 12 | Neurol 9 | “This medication is relatively new and counselling is very important for side effects and benefits. 'Cause often parents have false expectations for the medication. They think CBD oil can cure their epilepsy.” | |
| 13 | Neurol 12 | “All the data that they have comes from families testifying how it was miraculous for their kids. So they basically have a one-sided view of that. They don't have the other side of the coin, either the families that it did nothing for their kids or that had side effects. So it takes a lot of work to re-frame that and tell the parents that ‘Yes, technically it's a natural product, but can give serious trouble to your kid’ and they tend to be very disappointed when we have that approach, but it goes a lot better when I tell them that it's one of the tools that I have at my disposable, but just like everything else it is not miraculous.” | ||
| 14 | Neurol 11 | “Think if something did happen, if there was a significant adverse event, I think by virtue of the stigmatization of cannabis and the way that it's come to market and being available for epilepsy, that if ever that was to happen, and I was to be somebody who was put under the microscope to see what was going on, I feel like there would be an additional level of scrutiny looking at this. I recognize that and I’ve taken on that risk for the patients … I want to make sure that things are just exceptionally well documented, exceptionally covered, that patients really fully one-hundred percent understand.” | ||
| Importance of open communication | 15 | Neurol 10 | “From what I hear from families, the times they are doing that is because when they have tried to talk to their neurologist about treatments that are less evidence-based, they’ve received such negative response, their perception, the families perception, is that they've been criticized or judged, that then those families proceed without discussing it with their neurologist.” | |
| 4. Experiences with medical cannabis authorization | Authorization process | 16 | Neurol 6 | “Authorizing, well I just write a prescription. And that's it. So, there's a form the company has … I fill that in. It asks who I am and my license number and which province I'm in. Asks for the patient’s name and the medical diagnosis, and then I give the dosing and the product that I'm prescribing… If I'm prescribing to a routine pharmacy, I just use a prescription, I just write the drug and the dosing for the individual and that's that. This just requires a little bit more information, not much more but it does.” |
| 17 | Neurol 1 | “It certainly leaves one a bit unsettled about how little you actually have to enter onto the forms, and I think that’s something that should be re-evaluated because it's very important to give the specific instructions and the right products. If you look at any of the websites you’ll see that they can have six different types of oil, one could be just pure THC, and all the labels can look similar, they typically all are numbered in terms of the ratios, and it's very confusing. If you actually look at the website, they all seem to be very similar, all the different oils. And so I think it behooves us to state exactly what we want families to get, but it is not necessary, which is a little unsettling.” | ||
| Choosing between licensed producers | 18 | Neurol 6 | “Well, the simple answer…is it's free through [company]. Nobody else has offered it to us free. We were using another supplier, in the past, and there were no problems with it, it's just that they all offer the same product 20:1 CBD to THC, so why should I not use the one that's free?” | |
| 19 | Neurol 5 | “It makes me a bit uncomfortable, because then I become a salesman, right? For the company that's the nature of it. So, some companies … offer a very, very significant, like 90 % discount for pediatric patients… I point families in that direction but I feel bad because I don't know if that's, you know, ‘get them hooked on our product and then they’ll only buy from us,’ and then they’ll jack up the prices to the regular pricing, I don't know if they'll do that, but given the extreme discount they're doing, I think it seems to be their ethical approach to supplying it to kids who need it.” | ||
| Problems with authorization | 20 | Neurol 1 | “The only experience that I've had with families that have had problems with supply have been where companies simply haven't had the products. Some smaller companies have run out of oil for periods of time, and those kind of challenges have arisen for families… Most people haven't had any supply issues if they go with one of the bigger companies. Where the issues have arisen is where people have gone for artisanal preparations from smaller companies.” | |
| 5. Barriers to medical cannabis authorization | Out of scope | 21 | Neurol 3 | “I don't feel that the smaller proportion of general child neurology patients that I follow, specifically epilepsy patients, there's not sufficient volume for me to prescribe for them. And it would just be a regulatory hassle that I don't want to have to look into. It's a lot easier for me to refer them to someone else who has more expertise in it… I have no objections to CBD oil, I think it's a very reasonable medication to try. But, I also don't put in vagal nerve stimulators, and I don't do brain surgery, and I don't read EEGs, so there's a lot of stuff that is just not part of my practice… becoming more involved in CBD oil is not really something that's of interest.” |
| Restrictive policies | 22 | Neurol 4 | “We had a head of division before that was openly opposed or critical about it. So it would have seemed at that point to be a problem. I think it would have been like doing something against the position of the division head.” | |
| 23 | Neurol 4 | “It was felt that if you, by yourself instead of sharing it in a clinic with another group of colleagues, became the only person that would be prescribing it, that you suddenly would be getting the most complex cases. In every way, not just medically complex but the most demanding families or the families that would be complaining if they don't get their way.” | ||
| Referral to other care providers | 24 | Neurol 3 | “What I say to them is, ‘You know if you're interested in CBD oil, then there is a physician in [city] who prescribes it. There are other physicians elsewhere that might prescribe it. You know, there's multiple ways you could, you could access it. I myself don't prescribe it. So if you're interested, I could put a referral through.’” | |
| 25 | Neurol 2 | “I leave it to the parent to go find one. Unfortunately we're not really allowed to provide even information on the access, so we can say well, you can search Google or something like that, but not ‘Yeah there is this clinic here or there’.” | ||
| 26 | Neurol 11 | “Give me another example in medicine where we do this. We don't do this in other types of medicine, but people are so scared to learn about this stuff and so worried about it, they pass the buck and it's ridiculous. It's not great for patients, it’s not safe for them. And then what happens is that creates more unsafe situations than you're dealing with in the first place… I think the onus is on the neurologist if you're seeing neurology patients, you have to do the right thing by them and that is finding the appropriate referral. We do it for any other condition, but for some reason it’s ok to refer complex epilepsy patients to a cannabis clinic where an ER doctor with no epilepsy training whatsoever is prescribing cannabis for people. It's crazy, it's wrong.” | ||
| 27 | Neurol 12 | “I do not feel that somebody else should be handling part of the epilepsy care… just like I would not entrust somebody else to manage any other of my medications. Cannabis is one out of a few treatments that the patients are going to receive, and it's going to interact with everything else. It cannot be managed independently, it has to be managed in concurrence with everything else.” | ||
| 6. Impact of medical cannabis on clinical care | NA | 28 | Neurol 4 | “When it comes to response to seizures that are not being controlled, if they are still dealing with cannabis, which takes a while to optimize, and they call me and they say, ‘Well, Johnny is still having a lot of seizures, I feel like I need to do something.’ The conversation often will go back to cannabis. So we will say, ‘Well, we could do this, we could do that…Do you feel there is still room to optimize the cannabis oil?’ … If the answer is yes then they have to touch base again with their cannabis clinic and, as a result of that, there will be a little bit less visits, as they would normally would have, if they were taking only anticonvulsant medication.” |
| 29 | Neurol 10 | “And actually, we never receive letters from those clinics. Like if I send a kid to the endocrinologist, if an endocrinologist sees my kid with epilepsy, even if I'm not the referrer, they often send a letter to me that says ‘Tommy was seen and we're starting him on hormone treatment,’ but we never get communication from those clinics and I think that's actually a problem. You can't rely on families, unfortunately, to know what's happening because they sometimes aren't well informed.” |
3.1.1 Learning about medical cannabis
The medical cannabis field was perceived by participants to be rapidly evolving, and participants expressed a desire to learn more about cannabis, including about cannabis-based products and cannabinoids, noting that increased knowledge would allow them to better counsel patients (Table 2, quotation 1). No participants had received formal training about medical cannabis, and several expressed the need for its addition to medical school curricula. Participants reported learning about medical cannabis by attending rounds, reading journal articles, viewing web seminars, and through discussions with colleagues (quotation 2). Several participants described a desire for guidelines from Canadian professional associations, stating that it would facilitate their practice by allowing them to better counsel patients.
3.1.2 Perceptions about medical cannabis
3.1.2.1 State of the evidence
Opinions varied as to whether there is sufficient evidence to authorize medical cannabis for children with drug-resistant epilepsy, although most neurologists interviewed as part of this study felt that the data are sufficient to support a trial of cannabis. Others expressed concerns about insufficient evidence and lack of guidance (quotation 3). Several neurologists expressed a belief that the benefits of medical cannabis may be oversold (e.g., by the mass media) and that parents’ expectations may not be consistent with their clinical experience (quotation 4). One neurologist remarked that “it’s not the magic pill that everyone kind of hopes it could be” (Neurologist 7).
Some neurologists drew distinctions between the state of the evidence pertaining to different epilepsy syndromes and types of cannabis products. For example, Neurologist 2 stated that “I think there is some evidence, not enough, and only for Dravet and Lennox-Gastaut syndrome, period.” Others were more comfortable extrapolating evidence across epilepsy syndromes (quotation 5). Similarly, several participants described inferring effectiveness and adverse events associated with the cannabis oils available in Canada (which contain both CBD and THC in varying ratios [CBD:THC cannabis oils]) from studies involving Epidiolex, a purified CBD product not available in Canada. However, one neurologist cautioned that “they're not like an apple and apple comparison” because of the potential entourage effect of additional components (e.g., terpenes, other cannabinoids) in the CBD:THC cannabis oils that are not found in purified CBD (Neurologist 11).
3.1.2.2 Line of treatment
Participants noted that parents frequently sought cannabis as a first-line treatment; however, it was generally not viewed by participants as a first-line treatment, instead being considered after other treatment options have been explored (quotation 6). Participants described considering cannabis after a failure of least two antiepileptic drugs, although one described initiating discussions about cannabis after one failed drug. One community-based neurologist expressed uncertainty about when in the treatment course to consider cannabis, wondering if he was waiting longer than his hospital-based colleagues.
3.1.2.3 Gaps in the evidence
Participants noted areas where additional research is needed, in particular about components of cannabis beyond CBD and long-term effects of cannabis products. Several participants noted that cannabis is a complex substance and that little is known about its medical properties (quotation 7). The lack of evidence about the long-term effects on children was commonly described, and one participant noted that “…parents have to be willing to take that risk on their own because it's not a long-term tested product” (Neurologist 5).
Several participants noted that there is a lack of data allowing them to predict which children will benefit from treatment with medical cannabis and some noted that it was “hit or miss” which patients would benefit in terms of seizure control. Others were not surprised by the low success rate with medical cannabis given that these children have drug-resistant epilepsy, yet that it was “worth a try” (quotation 8).
3.1.2.4 Costs and reimbursement
The cost of cannabis-based products was described as being an important consideration. Most participants reported discussing costs with families, and some described working with parents to calculate costs based on the projected dose. Several participants noted that the cost of treatment sometimes limited their ability to reach a therapeutic dose because parents are typically paying out-of-pocket for the cannabis products. Neurologist 10 summarized the issue as follows: “Families sometimes don't advance the treatment to a therapeutic dose because the cost is prohibitive and in that case, I think that’s all a kind of a waste. It’s like going through the trouble of spending your money to take an aspirin a day when really you need eight aspirins a day. Wasting your money, one aspirin a day won't do anything but you'll never get up to eight because you can't afford it.” Because of this issue, some participants described choosing between licensed producers based on the availability of compassionate discounts for pediatric patients.
The lack of insurance coverage or reimbursement for cannabis-based products was raised by several participants. One neurologist reported that parents were sometimes surprised to learn that cannabis-based products are not typically covered by insurance, especially since the legalization of recreational cannabis in Canada in October 2018 (quotation 9). This was echoed by some neurologists who stated a belief that cannabis-based products should be covered by insurance programs, citing benefits to the health care system (quotation 10).
3.1.3 Discussing medical cannabis with parents
3.1.3.1 Determining expectations
Several neurologists noted that families often value benefits such as the child appearing more alert and that might be sufficient to continue treatment in the absence of seizure control (quotation 11); in contrast, one neurologist described looking for a “clinically meaningful reduction in seizures” to determine effectiveness, largely because of the potential for interactions with other medications and the out-of-pocket costs. Participants thus felt that it was important to determine the parents’ expectations prior to initiating cannabis. Further to this, several participants felt that parents may hold overly optimistic beliefs about medical cannabis and described the importance of education in combating “false expectations” (quotation 12).
3.1.3.2 Educating parents
Neurologists described varying levels of knowledge among parents about medical cannabis. Generally, participants felt that parents were more informed about medical cannabis than they are about traditional antiepileptic drugs, although many had potentially false expectations (quotation 13). Other neurologists noted that parents were coming to them having heard about cannabis from, for example, a friend or relative and were looking to the neurologist to provide answers to their questions. Educating parents about medical cannabis was felt to empower parents to make informed treatment decisions, and Neurologist 11 described wanting parents to “fully one-hundred percent understand” the treatment choices that they are making, in part as protection should a serious adverse event occur (quotation 14).
3.1.3.3 Importance of open communication
Several participants described the importance of open communication with families about all treatments that the child may be taking. However, some voiced concern that some parents may be administering medical cannabis to their children without disclosing its use. Participants speculated that this situation may arise because parents have previously been met with criticism or judgment for wanting to pursue cannabis as a treatment (quotation 15) and that this is indicative of a parent–neurologist “relationship problem.” Participants’ concerns about the non-disclosure of cannabis use included not knowing if an observed effect is owing to prescribed treatments or to non-disclosed cannabis use; not knowing if parents are following other care recommendations; parents may not be receiving guidance on dosing; and the potential for the family to be obtaining cannabis from an unlicensed source, with no guarantee of content or quality.
3.1.4 Experiences with medical cannabis authorization
3.1.4.1 Authorization process
Several neurologists described the authorization of medical cannabis as being similar to prescribing traditional pharmacologic drugs. For example, Neurologist 1 reported treating it “like a prescription,” writing in “as much as I can, based on milligrams of CBD or THC or whatever I know about the product.” This was echoed by others, and some participants noted that completing the authorization form takes time, with more information required than a traditional prescription (quotation 16). One neurologist described being concerned about the limited amount of information required on the authorization form (quotation 17); however, despite not being required to specify a particular product on the authorization form, participants described authorizing specific products for the children in their care, based on colleague recommendations, the CBD:THC ratio in the product, or based on parent request. Most neurologists described authorizing only cannabis oils with high CBD content (e.g., ≥20:1 CBD:THC ratio), although one reported considering additional factors such as terpene content when choosing between products and trialing products with higher relative THC content if an initial high-CBD product was ineffective.
3.1.4.2 Choosing between licensed producers
As of December 31, 2019, 61 licensed producers held approval from Health Canada to sell medical cannabis oil to registered patients. Participants reported selecting between the producers based on several factors, including colleagues’ recommendations, previous experience with a producer, or the number of children registered with a producer. Several participants reported choosing a licensed producer based on cost and the availability of discounts for pediatric patients (quotation 18); however, some described being uncomfortable with this approach (quotation 19), and some felt that a 20:1 CBD:THC oil from one producer may not be the same as a 20:1 oil from another (e.g., because of terpene content).
3.1.4.3 Problems with authorization
Most participants reported encountering no problems with the authorization process, although some neurologists described encountering supply problems when parents choose products from smaller companies (quotation 20), as well as backorders and delays in registering new patients. A lack of product availability may necessitate a change in licensed producer, which requires the completion of a new authorization form and may result in additional time required by the neurologist.
3.1.5 Barriers to medical cannabis authorization
Participants who had not previously authorized medical cannabis described a variety of reasons for not authorizing its use, including personal and institutional factors. Insufficient evidence or guidance: Some participants reported not authorizing medical cannabis because of a lack of evidence and/or guidance (quotation 3). Out of scope: Out of scope: Others described feeling that authorizing medical cannabis was outside their scope of practice, that they considered it a “regulatory hassle” (quotation 21), or that they could not do a “better job” than physicians at cannabis clinics. Restrictive policies: Some participants described policies at their hospital or within their department that prohibit authorization, while others reported not wanting to be seen as going against people in leadership positions (quotation 22). Several participants noted that consensus had been reached within their department or group to not authorize cannabis and that a unified position was felt to prevent any one neurologist from being given the most complex cases and/or “the most demanding families” (quotation 23).
3.1.5.1 Referral to other care providers
Participants who do not authorize medical cannabis described referring patients to other health care providers (e.g., neurologist or family physician) or to cannabis clinics, often in the patient’s community (quotation 24), or in one case, to in an adjacent province, stating that there was no closer alternative. Others described hospital or departmental policies that prevented them from referring patients, leaving it up to parents to find a cannabis clinic or care provider to provide authorization (quotation 25). Of note, some neurologists were strongly against the practice of referring patients to non-neurologists for the purpose of obtaining cannabis authorization (quotations 26, 27), citing patient safety as a key concern.
3.1.6 Impact of medical cannabis on clinical practice
Most participants reported that caring for children using medical cannabis does not affect their workflow, in terms of the number of patient visits or tests ordered. In one neurologist’s experience, the number of visits may be fewer, at least during the dose-optimization phase, for children who received authorization from another physician (quotation 28). In terms of testing, participants described treating cannabis “like another drug,” with no additional testing performed, while some order additional tests at baseline and while titrating the dose or if the child presented in a “sleepy state,” or being “a lot more cautious with the other medications” prescribed concurrently. Several neurologists described providing counselling and education to families about medical cannabis, which may add to the length of the clinical visit, and one neurologist described offering parents the opportunity to ask follow-up questions via telemedicine after an initial discussion about cannabis. One neurologist described difficulties entering non-formulary medicines into hospital electronic medical records and, for parents who receive authorization at a cannabis clinic, having to rely on parents to supply information about the treatment plan because of a lack of communication from some cannabis clinics (quotation 29).
4. Discussion
In this qualitative interview study, we explored the experiences and perceptions of neurologists in Canada about the use of medical cannabis for treatment of pediatric drug-resistant epilepsy. Most of the neurologists interviewed for this study viewed medical cannabis as a viable option, particularly after other options had been explored; however, important gaps in the evidence-base were identified, including limited knowledge about the medical properties of cannabinoids beyond CBD, the inability to predict which patients are most likely to benefit from cannabis treatment, and a lack of long-term safety data. Most neurologists reported having overall positive experiences with medical cannabis, although several commented that it’s not a magic pill and that the benefits are likely oversold by the media.
In 2013, CNN aired a documentary about Charlotte Figi, a 5-year-old girl with Dravet syndrome [
[4]
]. In an attempt to control her drug-resistant seizures, Charlotte’s parents initiated a regimen of medical cannabis, reducing her seizures by more than 90 % [[19]
]. Charlotte’s case received considerable media attention and has led, at least in part, to increased interest among parents in the use of cannabis as an alternative or complementary treatment for epilepsy [[3]
] and to increased requests to physicians for cannabis authorization [[20]
]. Participants in our study also identified the legalization of recreational cannabis in Canada in 2018 as a potential driver of additional interest in medical cannabis. Compared with the public, the medical community has been more slow to adopt cannabis as a treatment for pediatric epilepsy [[21]
], owing largely to a lack of published clinical studies. Although our study was not intended to quantify support for medical cannabis, we observed that most participants were supportive of a trial of medical cannabis for children whose epilepsy had not responded to other treatments. This is consistent with the findings of a 2019 systematic review, which reported that medical practitioners were largely supportive of the use of medical cannabis across multiple indications, with higher levels of support when other options had been “exhausted.” [[22]
]- Gardiner K.M.
- Singleton J.A.
- Sheridan J.
- Kyle G.J.
- Nissen L.M.
Health professional beliefs, knowledge, and concerns surrounding medicinal cannabis - A systematic review.
PLoS One. 2019; 14e0216556https://doi.org/10.1371/journal.pone.0216556
The Canadian League Against Epilepsy (CLAE) recently published recommendations regarding the use of medical cannabis in the treatment of epilepsy [
[23]
]. There are several consistencies between our findings and these recommendations. First, CLAE recommends that patients should make the decision to use cannabis “in consultation with their health care provider to ensure their safety.” Neurologists echoed this, voicing concerns that some parents may be administering cannabis to their children without oversight of a health care professional, which could lead to unsafe situations for the child. The use of complementary and alternative medicine is common among children with epilepsy, and parents may not disclose its use [[24]
]. This further supports the need to establish open communication between parents and health care providers.Second, CLAE “encourages clinicians and researchers to continue to seek further knowledge and education” about medical cannabis. [
[23]
] Several neurologists in our study also expressed a desire for additional and ongoing education, in order to better counsel their patients. In a 2015 educational needs assessment of Canadian physicians, 64 % of respondents perceived a strong need for cannabis education, and 70 % felt that receiving cannabis education would better allow them to care for their patients using cannabis [[25]
]. Similarly, a recent systematic review highlighted a lack of self-perceived knowledge among clinicians about medical cannabis [[22]
], and several groups have called for increased cannabis education [- Gardiner K.M.
- Singleton J.A.
- Sheridan J.
- Kyle G.J.
- Nissen L.M.
Health professional beliefs, knowledge, and concerns surrounding medicinal cannabis - A systematic review.
PLoS One. 2019; 14e0216556https://doi.org/10.1371/journal.pone.0216556
[26]
,[27]
].However, there are also several notable differences between our findings and CLAE’s recommendations. First, CLAE acknowledges the differences between purified CBD oil (Epidiolex) and the CBD:THC cannabis oils available in Canada, stating that “evidence is lacking” for products containing both CBD and THC [
[23]
]. In contrast, some participants in this study described inferring the safety and effectiveness of CBD:THC cannabis oils based on studies of Epidiolex, which further highlights the need for additional education about the differences between cannabis-based products. Notably, Epidiolex is not available in Canada at this time, and there are important differences between Epidiolex and the products available in Canada. The Canadian CBD:THC oils are whole plant isolates, containing CBD as well as THC in various ratios, as well as other phytocannabinoids (e.g., cannabichromene, cannabigerol, cannabinol, cannabidivarin), flavonoids, and terpenes [[28]
]. There is also considerable variation in terms of the CBD-THC oils available within Canada. Most licensed producers in Canada offer multiple products with various ratios and concentrations of CBD and THC, including those high in THC (and low in CBD), balanced oils (approximately equal concentration of CBD and THC), and those high in CBD (and low in THC). The concentration of cannabinoids is variable across preparations, such that a cannabinoid oil with a 20:1 ratio of CBD to THC from one producer does not necessarily contain the same concentration of CBD as a 20:1 oil from a different producer. There is also potential for variability in cannabinoid concentration between batches of the same product, leading to uncertainty that may affect dosing, cost, adverse effects, and therapeutic efficacy [[23]
]. These complex issues related to the use CBD:THC oils further reinforce the CLAE’s recommendation that clinicians continue to seek additional education about medical cannabis [[23]
].Second, some participants described referring patients and their families to cannabis clinics or to health care providers who may not be experienced in caring for patients with epilepsy. However, CLAE recommends that “treatment with CBD:THC cannabis oil be managed by a physician knowledgeable and experienced with epilepsy care and anti-seizure medications, preferably with experience in CBD:THC cannabis oil.” Some participants noted departmental policies that prevented them from authorizing cannabis or that neurologists in their group had reached consensus that none would authorize cannabis, instead referring patients to cannabis clinics or leaving families to find other health care providers to authorize use. One participant was particularly critical of the practice of referring complex neurology patients to non-neurology health care professionals, stating that “they owe it to the patient” to find an appropriate neurology referral if the family wishes to pursue medical cannabis.
4.1 Strengths and limitations
The strength of this study lies in the use of qualitative methodology to provide an in-depth exploration of the perspectives of neurologists about the use of medical cannabis for treatment of drug-resistant epilepsy. However, several limitations should be considered. First, neurologists may have been motivated to participate because of strong feelings about medical cannabis. Notably, most participants expressed an overall positive opinion toward its use in this population, although only about half had previously authorized medical cannabis. In order to capture a variety of perspectives, we sought diversity in geographical location, practice type (hospital, community), gender, and practice duration; however, most participants were based in academic centres, which may limit the application of the findings to other practice types. We continued recruiting participants until no additional codes were generated from subsequent interviews, although we acknowledge that some perspectives may have been missed. Second, all but one interview was completed before publication of the CLAE recommendations, [
[23]
] and it is possible that some participants may have subsequently changed opinions or practices. Third, this study did not capture the perspectives of other providers who may authorize medical cannabis (e.g., family physicians, nurse practitioners). Finally, we recognize that opinions of neurologists in other regions may differ, as support for medical cannabis varies by jurisdiction, depending partly on its legal status [[22]
].- Gardiner K.M.
- Singleton J.A.
- Sheridan J.
- Kyle G.J.
- Nissen L.M.
Health professional beliefs, knowledge, and concerns surrounding medicinal cannabis - A systematic review.
PLoS One. 2019; 14e0216556https://doi.org/10.1371/journal.pone.0216556
5. Conclusion
Our findings highlight the opinions and experiences of neurologists with medical cannabis for the treatment of pediatric drug-resistant epilepsy, as well as identified perceived gaps in the evidence base. Additional education about medical cannabis may better prepare neurologists to have informed and open conversations with parents, and further research into the decision-making needs of both neurologists and parents is warranted.
Author contributors
All authors contributed to the design of the study and the development of the interview guide. JE carried out all data collection; she analyzed the data (along with DD) and led the writing of the manuscript. All authors critically revised the manuscript for intellectual content and approved the final version submitted for publication.
Declaration of Competing Interest
Bláthnaid McCoy is a co-author on the Canadian League Against Epilepsy’s position statement on the use of medical cannabis for the treatment of epilepsy in Canada. The other authors have no conflicts of interest to report.
Acknowledgments
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Appendix A. Supplementary data
The following is Supplementary data to this article:
References
- Epilepsy and other chronic convulsive disorders.Growers, London1881
- Cannabis and epilepsy: an ancient treatment returns to the fore.Epilepsy Behav. 2017; 70: 292-297https://doi.org/10.1016/j.yebeh.2016.09.040
- Momentum grows for medical use of cannabis.Lancet. 2015; 386: 1615-1616https://doi.org/10.1016/S0140-6736(15)00674-1
- Why I changed my mind on weed.CNN, 2013 (accessed September 24, 2019)
- Cannabinoids for epilepsy.Cochrane Database Syst Rev. 2014; 3CD009270
- Fewer specialists support using medical marijuana and CBD in treating epilepsy patients compared with other medical professionals and patients: Result of Epilepsia’s survey.Epilepsia. 2015; 56: 1-6
- Cannabis-based products for pediatric epilepsy: an updated systematic review.Seizure. 2020; 75: 18-22https://doi.org/10.1016/j.seizure.2019.12.006
- FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy.US Food and Drug Administration, 2018 (Accessed December 23, 2018)
- G.W. Pharmaceuticals receives European Commission approval for EPIDYOLEX® (cannabidiol) for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy.2019 (Accessed December 3, 2019)
- The Cannabis act: the facts.Health Canada, 2018 (Accessed November 26, 2019)
- Licensed cultivators, processors and sellers of cannabis under the Cannabis act. Gov Canada.Health Canada, 2019 (Accessed December 8, 2019)
- Interpretive description: qualitative research for applied practice.2nd ed. Routledge, New York2016
- Standards for reporting qualitative research: a synthesis of recommendations.Acad Med. 2014; 89: 1245-1251https://doi.org/10.1097/ACM.0000000000000388
- Interpretive description: a noncategorical qualitative alternative for developing nursing knowledge.Res Nurs Health. 1997; 20: 169-177
- The analytic challenge in interpretive description.Int J Qual Methods. 2004; 3: 1-11https://doi.org/10.1177/160940690400300101
- Medical use of cannabis and cannabinoids containing products – regulations in Europe and North America.Eur J Intern Med. 2018; 49: 2-6https://doi.org/10.1016/j.ejim.2018.01.001
- The HTA Core Model — 10 years of developing an international framework to share multidimensional value assessment.Value Heal. 2017; 20: 244-250https://doi.org/10.1016/j.jval.2016.12.010
- The case for medical marijuana in epilepsy.Epilepsia. 2014; 55: 783-786https://doi.org/10.1111/epi.12610
- Cannabis for the treatment of paediatric epilepsy? An update for Canadian paediatricians.Paediatr Child Heal. 2018; 23: 368-373https://doi.org/10.1093/pch/pxy036
- Is the medical use of cannabis a therapeutic option for children?.Paediatr Child Heal. 2016; 21: 31-34
- Health professional beliefs, knowledge, and concerns surrounding medicinal cannabis - A systematic review.PLoS One. 2019; 14e0216556https://doi.org/10.1371/journal.pone.0216556
- Position statement on the use of medical cannabis for the treatment of epilepsy in Canada.Can J Neurol Sci. 2019; 46: 645-652https://doi.org/10.1017/cjn.2019.282
- CAM use in pediatric neurology: an exploration of concurrent use with conventional medicine.PLoS One. 2014; 9: 1-6https://doi.org/10.1371/journal.pone.0094078
- Cannabis in medicine: a national educational needs assessment among Canadian physicians Career choice, professional education and development.BMC Med Educ. 2015; 15: 1-7https://doi.org/10.1186/s12909-015-0335-0
- Canadian Federation of Medical Students position statement on recreational cannabis legalization.Canadian Federation of Medical Students, 2018
- Medical education on cannabis and cannabinoids: perspectives, challenges, and opportunities.Clin Pharmacol Ther. 2015; 97: 548-550https://doi.org/10.1002/cpt.103
- Quality traits of “cannabidiol oils”: cannabinoids content, terpene fingerprint and oxidation stability of european commercially available preparations.Molecules. 2018; 23: 1-22https://doi.org/10.3390/molecules23051230
Article info
Publication history
Published online: April 17, 2020
Accepted:
April 9,
2020
Received in revised form:
January 30,
2020
Received:
December 3,
2019
Identification
Copyright
© 2020 British Epilepsy Association. Published by Elsevier Ltd.
User license
Elsevier user license | How you can reuse 
Elsevier's open access license policy
Elsevier user license
Permitted
For non-commercial purposes:
- Read, print & download
- Text & data mine
- Translate the article
Not Permitted
- Reuse portions or extracts from the article in other works
- Redistribute or republish the final article
- Sell or re-use for commercial purposes
Elsevier's open access license policy
