In 2015, the American Academy of Pediatrics
(AAP) published an updated policy statement on marijuana in youth in
which it reaffirmed its opposition to the use of medical marijuana
outside the regulatory process of the US Food and Drug Administration
(FDA).1-3 The AAP cited the lack of evidence on the efficacy
of marijuana as medicine for children, as well as the potential
long-term harms based on data on recreational marijuana use.
The updated policy, however, did provide an exception: It recognized
that medical marijuana may be a viable option for children with
life-limiting or life-threatening conditions for whom there are no other
alternative treatments available.
Given some evidence for the potential benefits of medical marijuana, the AAP said it “strongly supports research and development of pharmaceutical cannabinoids and supports a review of policies promoting research on the medical use of these compounds.
The case for medical marijuana in children is therefore far from closed. It could be argued that it is just getting started. As such, pediatricians may be increasingly required to address this with their patients and families and to understand the complex landscape of varying state laws and regulations, the wide range of products comprised of different cannabis compounds and doses, as well as the ongoing research on the benefits and safety of these products in children.
To help pediatricians traverse this landscape—for many, foreign terrain—Elissa Miller, MD, clinical associate professor of Pediatrics, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, and Nemours/Alfred I. duPont Hospital for Children, Wilmington, Delaware, and G. Sam Wang, MD, FAAP, assistant professor of Pediatrics, University of Colorado Anschutz Medical Campus, Children’s Hospital Colorado, Aurora, co-presented a session during the 2018 AAP National Conference and Exhibition in Orlando, Florida, titled “Marijuana as medicine.”
As reflected in the title of Wang’s portion of the presentation, “Marijuana as medicine, not as easy as it sounds,” this topic is challenging and untangling all the issues involved not easy. Essential, then, is to first clearly understand what medical marijuana is and what it is not. This includes understanding common terminology (Table 1). Further understanding is needed on how patients obtain it, including eligibility requirements based on certification from a physician and where to purchase it. Other issues involve knowing how to discuss the benefits and potential risks for patients and families who come to the clinic wanting more information on whether medical marijuana may be a good option, or for those who come to the clinic already on a medical marijuana product.
Miller underscores both the complexity and discomfort of this issue for many pediatricians, including herself. “If my experience is any indication of the majority of pediatricians, they are not comfortable overseeing medical marijuana use in their patients,” she says.
In addition, Miller highlights the difficulty of talking about a potential substance for medical use for which so little evidence is available. “We’re used to knowing that new drugs have been rigorously studied,” she says. “We know the pharmacokinetics and pharmacodynamics [of drugs we prescribe], and we know the doses to give because it has been studied.”
“Medical marijuana isn’t like that,” she warns. “It is about as far away from any medicine I prescribe as possible.”
What is medical marijuana?
In defining medical marijuana, it is important to first define what it is not. Medical marijuana does not refer to the 3 cannabinoid medications approved by the US Food and Drug Administration (FDA) that are currently available by prescription in the United States. As shown in Table 2, 2 of these medications contain synthetic compounds of cannabis, and only 1 is derived directly from the marijuana plant.5,6 Known as cannabidiol, or CBD (Epidiolex), the drug contains a purified form of CBD and was approved in 2018 for severe forms of epilepsy (Lennox-Gastaut syndrome and Dravet syndrome) in children aged 2 years and older.7 As a federally controlled drug, CBD is available nationwide and dispensed through a prescription with dosing recommendations by a physician, nurse practitioner, or physician assistant.
Medical marijuana differs in several ways. None of the products are FDA approved or monitored; it is available legally only in states that have passed laws making it legal; it is dispensed through state dispensaries and not through physician offices or typical pharmacies; and there are no standard dosing or treatment duration guidelines for any specific indications. In addition, the rules and regulations on how to monitor these products for compliance of both content and contaminants vary among states, which has led to concerns by the FDA on whether label- ling of products always matches the content.
For Miller, therefore, it is important to use a very precise
definition of medical marijuana when speaking about it. “I’m defining
medical marijuana as marijuana, or cannabidiol, obtained through one of
the state dispensaries based on the changes in state law,” she says.
Although state laws differ regarding the conditions for which marijuana can be used for medicinal purposes, Miller says that, based on her review of state medical marijuana websites, common conditions for which pediatric patients are eligible include cancer, epilepsy, nausea, muscle spasm, and terminal condition.
Using this definition, prescribing medical marijuana under federal law is illegal. Patients gain legal access to medical marijuana through a physician’s certification that specifies the patient has a qualifying condition that may benefit from medical marijuana, says Miller. Once certification is provided, patients are registered in a state registry that allows them legal access to the state’s dispensary program (Figure).
For example, Wang says that in Colorado, minors need certification from 2 physicians to be eligible for registration on the state’s registry permitting them to obtain medical marijuana at one of the state’s dispensaries. As of May 2019, 330 minors (aged younger than 18 years) are registered, with seizures as the number one indication in children aged younger than 10 years old and severe pain for children aged 11 to 17 years (www.colorado.gov/pacific/cdphe/medicalmarijuana/).
For patients and families who need or want information on how to obtain medical marijuana, it is important to educate them on where these products are purchased (at state dispensaries and not at pharmacies or doctors’ offices) as well as on their variability, because as federally unregulated products there is wide variability in terms of content, dose, and cost (see “Medical vs recreational marijuana: What’s legal, what’s not”).
“States have their own rules and regulations on how to monitor these products for compliance of what the label states the products contain as well as contaminants,” says Wang, emphasizing that despite this, the FDA has published concerns about the labeling of these products.8,9 As such, he stresses the need for pediatricians and patients to be wary of false advertisement of some of these products.
The other role for pediatricians may be to certify a patient who may be a good candidate for medical marijuana. For some practices, such as Miller’s, this may be only for patients given the exception through the current 2015 policy statement (eg, children with life-debilitating or life-threatening conditions). As the evidence to date is slim on other conditions, this may be a role that emerges increasingly in the future if the data indicate a clear scientific base for it in children.
Certifying medical marijuana for children
“As pediatricians, when do we certify patients for medical marijuana?” This was a question Miller posed during her presentation.
Although the 2015 AAP policy statement opposes the medicinal use of marijuana for children outside those products approved by the FDA, it does leave open, as previously mentioned, the potential role of medical marijuana for children with life-debilitating or life-threatening conditions.
Given some evidence for the potential benefits of medical marijuana, the AAP said it “strongly supports research and development of pharmaceutical cannabinoids and supports a review of policies promoting research on the medical use of these compounds.
The case for medical marijuana in children is therefore far from closed. It could be argued that it is just getting started. As such, pediatricians may be increasingly required to address this with their patients and families and to understand the complex landscape of varying state laws and regulations, the wide range of products comprised of different cannabis compounds and doses, as well as the ongoing research on the benefits and safety of these products in children.
To help pediatricians traverse this landscape—for many, foreign terrain—Elissa Miller, MD, clinical associate professor of Pediatrics, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, and Nemours/Alfred I. duPont Hospital for Children, Wilmington, Delaware, and G. Sam Wang, MD, FAAP, assistant professor of Pediatrics, University of Colorado Anschutz Medical Campus, Children’s Hospital Colorado, Aurora, co-presented a session during the 2018 AAP National Conference and Exhibition in Orlando, Florida, titled “Marijuana as medicine.”
As reflected in the title of Wang’s portion of the presentation, “Marijuana as medicine, not as easy as it sounds,” this topic is challenging and untangling all the issues involved not easy. Essential, then, is to first clearly understand what medical marijuana is and what it is not. This includes understanding common terminology (Table 1). Further understanding is needed on how patients obtain it, including eligibility requirements based on certification from a physician and where to purchase it. Other issues involve knowing how to discuss the benefits and potential risks for patients and families who come to the clinic wanting more information on whether medical marijuana may be a good option, or for those who come to the clinic already on a medical marijuana product.
Miller underscores both the complexity and discomfort of this issue for many pediatricians, including herself. “If my experience is any indication of the majority of pediatricians, they are not comfortable overseeing medical marijuana use in their patients,” she says.
In addition, Miller highlights the difficulty of talking about a potential substance for medical use for which so little evidence is available. “We’re used to knowing that new drugs have been rigorously studied,” she says. “We know the pharmacokinetics and pharmacodynamics [of drugs we prescribe], and we know the doses to give because it has been studied.”
“Medical marijuana isn’t like that,” she warns. “It is about as far away from any medicine I prescribe as possible.”
What is medical marijuana?
In defining medical marijuana, it is important to first define what it is not. Medical marijuana does not refer to the 3 cannabinoid medications approved by the US Food and Drug Administration (FDA) that are currently available by prescription in the United States. As shown in Table 2, 2 of these medications contain synthetic compounds of cannabis, and only 1 is derived directly from the marijuana plant.5,6 Known as cannabidiol, or CBD (Epidiolex), the drug contains a purified form of CBD and was approved in 2018 for severe forms of epilepsy (Lennox-Gastaut syndrome and Dravet syndrome) in children aged 2 years and older.7 As a federally controlled drug, CBD is available nationwide and dispensed through a prescription with dosing recommendations by a physician, nurse practitioner, or physician assistant.
Medical marijuana differs in several ways. None of the products are FDA approved or monitored; it is available legally only in states that have passed laws making it legal; it is dispensed through state dispensaries and not through physician offices or typical pharmacies; and there are no standard dosing or treatment duration guidelines for any specific indications. In addition, the rules and regulations on how to monitor these products for compliance of both content and contaminants vary among states, which has led to concerns by the FDA on whether label- ling of products always matches the content.
Although state laws differ regarding the conditions for which marijuana can be used for medicinal purposes, Miller says that, based on her review of state medical marijuana websites, common conditions for which pediatric patients are eligible include cancer, epilepsy, nausea, muscle spasm, and terminal condition.
Using this definition, prescribing medical marijuana under federal law is illegal. Patients gain legal access to medical marijuana through a physician’s certification that specifies the patient has a qualifying condition that may benefit from medical marijuana, says Miller. Once certification is provided, patients are registered in a state registry that allows them legal access to the state’s dispensary program (Figure).
For example, Wang says that in Colorado, minors need certification from 2 physicians to be eligible for registration on the state’s registry permitting them to obtain medical marijuana at one of the state’s dispensaries. As of May 2019, 330 minors (aged younger than 18 years) are registered, with seizures as the number one indication in children aged younger than 10 years old and severe pain for children aged 11 to 17 years (www.colorado.gov/pacific/cdphe/medicalmarijuana/).
For patients and families who need or want information on how to obtain medical marijuana, it is important to educate them on where these products are purchased (at state dispensaries and not at pharmacies or doctors’ offices) as well as on their variability, because as federally unregulated products there is wide variability in terms of content, dose, and cost (see “Medical vs recreational marijuana: What’s legal, what’s not”).
“States have their own rules and regulations on how to monitor these products for compliance of what the label states the products contain as well as contaminants,” says Wang, emphasizing that despite this, the FDA has published concerns about the labeling of these products.8,9 As such, he stresses the need for pediatricians and patients to be wary of false advertisement of some of these products.
The other role for pediatricians may be to certify a patient who may be a good candidate for medical marijuana. For some practices, such as Miller’s, this may be only for patients given the exception through the current 2015 policy statement (eg, children with life-debilitating or life-threatening conditions). As the evidence to date is slim on other conditions, this may be a role that emerges increasingly in the future if the data indicate a clear scientific base for it in children.
Certifying medical marijuana for children
“As pediatricians, when do we certify patients for medical marijuana?” This was a question Miller posed during her presentation.
Although the 2015 AAP policy statement opposes the medicinal use of marijuana for children outside those products approved by the FDA, it does leave open, as previously mentioned, the potential role of medical marijuana for children with life-debilitating or life-threatening conditions.
Since that update, further evidence suggests
additional potential roles for medical marijuana in children. A
systematic review of studies of the use of marijuana for medical
treatment of children and adolescents published in 2017 found that the
strongest evidence for a benefit was for chemotherapy-induced nausea and
vomiting, and for seizures. (Since then, the FDA approved
Epidiolex for the treatment of severe seizures in children as noted
above; data published in 2016 and 2017 in part led to the approval.
For all other conditions, the data were too limited by inadequate study design with sufficient power to test efficacy.
The authors noted as well that they interpreted the findings of the
review in the context of the adult literature, which, they said, is more
substantive.
More data is available on the potential harms of marijuana for children. Wang provided an overview of what is known about the short- and long-term effects of marijuana use in children and adolescents.
Most of the information comes from exposure to recreational marijuana, which often, if not always, differs from medical marijuana in composition (see “Medical vs recreational marijuana: What’s legal, what’s not”).
As to short-term harm, data from a retrospective review of calls to the American Association of Poison Control Centers National Poison Data System between January 2005 and December 2011 found 985 unintentional exposures to marijuana in children aged 9 years and younger primarily through ingestion. The main symptoms, which lasted between 2 and 24 hours, were drowsiness and lethargy. Respiratory depression, brachycardia, or hypotension was found in 10 patients. Of note, the rate of exposure to marijuana increased in states that legalized marijuana.
Wang also discussed several studies documenting an increase in hospital visits, emergency departments (EDs), and urgent care (UC) centers, and regional poison centers by children unintentionally exposed to marijuana since it became legalized in Colorado. Data from one study, showing a significant increase in marijuana-related ED/UC visits by adolescents since legalization of marijuana, found that a significant percentage of patients presented with acute psychiatric conditions.
As to the long-term effects of marijuana use, Wang discussed data on adverse effects in adolescents reported in Colorado (Table 3). He underscored the many unknowns and risks remaining in understanding fully the long-term effects of marijuana in children/adolescents.
Summary
With the growing interest in and availability of marijuana for medicinal use, pediatricians need to know how to talk to patients and families about what medical marijuana is, how it is obtained, what it is indicated for, the current evidence on its efficacy and safety in children, and other challenging issues around a topic that is evolving state-by-state. For pediatricians such as Miller and Wang, the lack of scientific evidence warrants caution but challenges pediatricians to recognize when medical marijuana may be a viable option for select children/adolescents. “The evidence for marijuana as medicine for all the things it is touted as and used for is not there,” says Wang. “There still needs to be a lot more research about the potential benefits and potential harms for the use in children.”
Recognizing, however, that some patients may already be using marijuana for a medical reason, Wang emphasizes the importance of not alienating these patients. “For community pediatricians, keep an open line of communication with patients,” he says. “We can’t alienate them from their medical homes for using these products, but we have to make sure they are informed of the risks and benefits of them.”
Miller underscores that medical marijuana is not the latest quick fix hoped for by many. She stressed the importance to remember that “right now, for every disease and symptom, there is an alternative available with better evidence than medical marijuana.”
More data is available on the potential harms of marijuana for children. Wang provided an overview of what is known about the short- and long-term effects of marijuana use in children and adolescents.
Most of the information comes from exposure to recreational marijuana, which often, if not always, differs from medical marijuana in composition (see “Medical vs recreational marijuana: What’s legal, what’s not”).
As to short-term harm, data from a retrospective review of calls to the American Association of Poison Control Centers National Poison Data System between January 2005 and December 2011 found 985 unintentional exposures to marijuana in children aged 9 years and younger primarily through ingestion. The main symptoms, which lasted between 2 and 24 hours, were drowsiness and lethargy. Respiratory depression, brachycardia, or hypotension was found in 10 patients. Of note, the rate of exposure to marijuana increased in states that legalized marijuana.
Wang also discussed several studies documenting an increase in hospital visits, emergency departments (EDs), and urgent care (UC) centers, and regional poison centers by children unintentionally exposed to marijuana since it became legalized in Colorado. Data from one study, showing a significant increase in marijuana-related ED/UC visits by adolescents since legalization of marijuana, found that a significant percentage of patients presented with acute psychiatric conditions.
As to the long-term effects of marijuana use, Wang discussed data on adverse effects in adolescents reported in Colorado (Table 3). He underscored the many unknowns and risks remaining in understanding fully the long-term effects of marijuana in children/adolescents.
Summary
With the growing interest in and availability of marijuana for medicinal use, pediatricians need to know how to talk to patients and families about what medical marijuana is, how it is obtained, what it is indicated for, the current evidence on its efficacy and safety in children, and other challenging issues around a topic that is evolving state-by-state. For pediatricians such as Miller and Wang, the lack of scientific evidence warrants caution but challenges pediatricians to recognize when medical marijuana may be a viable option for select children/adolescents. “The evidence for marijuana as medicine for all the things it is touted as and used for is not there,” says Wang. “There still needs to be a lot more research about the potential benefits and potential harms for the use in children.”
Recognizing, however, that some patients may already be using marijuana for a medical reason, Wang emphasizes the importance of not alienating these patients. “For community pediatricians, keep an open line of communication with patients,” he says. “We can’t alienate them from their medical homes for using these products, but we have to make sure they are informed of the risks and benefits of them.”
Miller underscores that medical marijuana is not the latest quick fix hoped for by many. She stressed the importance to remember that “right now, for every disease and symptom, there is an alternative available with better evidence than medical marijuana.”
1 comment:
Thanks for the nice blog. It was very useful for me. I'm happy I found this blog. Thank you for sharing with us,I too always learn something new from your post. packwoods review
Post a Comment