Medical cannabis for pain management: the potential for informed clinical practice
The Comprehensive Addiction and Recovery Act (CARA) of 2016, a bipartisan legislation passed by an overwhelming majority in the house and the senate, included provisions to determine whether gaps in or inconsistencies between best practices for acute and chronic pain management exist and to propose updates and recommendations to those best practices. On December 28th, 2018, the Pain Management Best Practices Inter-Agency Task Force (Task Force) established through the legislation Issued a preliminary draft of their recommendations. As required by law, public comments regarding the draft are solicited before the final recommendations are made to the US congress. In the preliminary draft (68 page and 446 references,) the task force failed to mention the role of medical cannabis as a treatment option for pain related conditions or as a potential modality to address Opioid Use Disorder.
This is unfortunate especially given the patient centered focus of their report. Cannabis is playing a greater role in the management of the millions of individuals suffering with chronic pain and increasingly for individuals suffering with Opioid Use Disorder (OUD). There is a need to review the current understanding of the role of medical cannabis for pain conditions, identify gaps in our knowledge, provide suggestions for incorporating it effectively into clinical practice, and formulating a research agenda to explore best practices for utilizing cannabis in patient centered medical practice for pain disorders. Additionally, as this patient driven experiment utilizing Medical Cannabis progresses, it is essential to monitor its public health impact, including severe side effects such as psychosis, cognitive impairment, and dependence that are known potential consequences of cannabis use. The public health impact, especially the psychological trauma, of the current criminal justice approaches that incarcerates individuals for marijuana associated events (crimes) is not discussed in this paper. Furthermore, although there is a need to better understand the political ecosystem shaping the federal response and the barriers and opportunities within, the economic impact of medical cannabis for individuals and the healthcare system, these topics will be explored in a different article.
The challenge and opportunity of cannabis in the medical setting
Millions of Americans are utilizing medical cannabis to manage their chronic pain and other medical conditions. Decision making in the clinical setting is informed by patient demand and clinician openness to utilizing cannabis rather than evidence base driven informed decision making. There is a growing body of literature, consisting of basic science, animal models, clinical studies, population studies and anecdotal evidence as to the potential role of cannabis in the medical setting in general and in the management of pain in particular. Various national and international entities, based on systematic review of relevant studies have recommended a role for medical cannabis, others have questioned the evidence for any role. At times, the positions are defined more by the authors/ groups bias rather than a more scientific ethical interpretation.
This reality, not likely to change soon, calls for the exploration of the role of cannabis in patient centered care when the usual evidence base informing clinicians and patients is limited and provides inconsistent information to guide practice.
The current situation related to the clinical use of medical cannabis as challenging and controversial as it is within the medical profession and society at large, presents an opportunity to examine ways for patients, clinicians, systems, researchers and regulators to engage with a complex topic. More directly, as medical cannabis is gaining importance in the clinical setting, there is a growing need to address the challenges, gaps and inconsistencies in medical cannabis in the patient centered management of individuals suffering with pain. There is a growing need for enhanced knowledge by medical professionals of the role of medical cannabis in clinical interactions. Furthermore, recognizing that cannabis is become integral in the approach to the patient suffering with pain, there is a unique opportunity to evolve different pathways to develop the information base for patient centered cannabis ethically informed pain management. Additionally, the current, patient and business driven situation, allows the medical community and health services policy researchers to explore and better understand the new organizational ecosystems emerging in the grower to user cannabis supply chain.
Addressing the challenges and embracing the opportunities for medical cannabis in pain management
The use of cannabis for the treatment of pain is not supported by established well-controlled
clinical trials. Although some studies and guidelines support the use of cannabis, others have questioned the efficacy of cannabis in the management of pain. The patient is often provided information that is not evidence based, limiting their ability to fully participate in meaningful decision making. While some guidelines currently exist, the wide variation in existing practice patterns demonstrates these guidelines are falling short in providing necessary information and have not been widely adopted. Current inconsistencies and fragmentation of pain management within health care systems limit best practices and patient outcomes. Four related areas are discussed:
1. Clinical aspects of using cannabis in the medical setting
2. The healthcare system
3. The federal regulatory ecosystem, and
4. A research agenda.
Clinical aspects of using cannabis in the medical setting
Goal: Understanding the role of cannabis in pain management and recommendation for the individual patient. Clinicians are knowledgeable and able to incorporate medical cannabis to the assessment and management of individuals suffering with pain disorders.
General approach: Medical cannabis is considered and understood as a treatment modality in ethically sound patient centered pain management. The use of medical cannabis is part of the coordinated and collaborative effort to improve meaningful patient outcomes, including daily function and general well being.
Gap 1: Lack of sufficient evidence based information about the efficacy, dose, routes of administration, or side effects of commonly used and commercially available non FDA approved cannabis products in the United States.
Gap 2: Lack of sufficient reliable evidence based information about the potential side effects of medical cannabis products.
Gap 3: Limited information about the interaction of medical cannabis and other pharmacologic and nonpharmacologic modalities for pain management.
Gap 4: Limited patient specific information to guide the algorithmic approach to pain management and the potential role of cannabis within it.
Recommendation:
Provide guidance for patients and clinicians to incorporate cannabis into patient centered care pain management. Go to section
Provide information and tools for best outcomes for the management of individuals suffering with pain including the use of cannabis
Establish a crowdsourced database of available recommendations for medical cannabis in clinical practice for informed decision making .
Develop a reliable process to expand crowd sourced input about clinical experience of using cannabis in clinical situations.
Health care system challenges
Goal: Health care systems establish and follow a coherent policy for pain management including medical cannabis within health systems. The clinical community, payers, patients and regulators share evidence-based guidelines for non- opioid pain treatments and therapies including for the use of medical cannabis.
General approach: Patients have access to a comprehensive menu of services that help them achieve optimal outcomes for pain related problems. Evaluate current efforts on state level, academic centers, commercial entities to build a patient oriented database that informs clinical decision making. Develop a database to inform clinical decision making about the place of medical cannabis for the patient population.
Gap: Lack of knowledge of clinicians as to the medical cannabis place in the treatment and management of pain conditions.
Gap: Lack of uniformity in the legal situation guiding the use of medical cannabis in the clinical setting.
Recommendations:
Incorporate the option of medical cannabis in the collaborative stepped model of pain care, as adopted by the VA and DoD health systems.
Provide evidence-based information and tools that include the recognition of the role that medical cannabis plays for many patients to assist in clinical decision making to optimize patient care and outcomes.
Medical Cannabis is discussed with patients to evaluate their use, experience and preferences associated with medical cannabis. In pain management.
Provide tools for patients, dispensaries and clinicians to optimize outcomes, including algorithms, decision support, logs to track outcomes.
Provide a well-developed, easy to use system for reporting of side effects and harm of individuals using cannabis.
Address stigma associated with seeking help for pain conditions and using and or prescribing medical cannabis.
Develop a credible consultative service available for individuals and clinicians through various forms of media.
Education of patient and clinicians
Establish education in medical school and through CME based on clinician interest and population they treat.
Establish a process leading to clinical best practices (CPG) for the use of medical cannabis in the management of patients within the comprehensive approach to chronic pain.
Consultation for clinicians by experts through telemedicine.
Build a social media platform that provides ongoing clinical case conferences that address the potential role of cannabis.
Regulatory and professional groups
Goal: Cannabis is a health care and public health issue, federal and state agencies involved should adopt the United Nations agencies approach to human dignity in creating and enforcing criminal justice responses to regulation and enforcement. The federal efforts to address the gaps in evidence and clinical application of medical cannabis needs to be housed in a science driven agency that is part of the National Institutes of Health. Federal and state efforts are coordinated.
Approach: Provide authoritative, consistent information about the legal aspect of medical cannabis that are relevant to best use of the product. FDA and Marijuana: Questions and Answers Provide links to resources demonstrated to enhance clinical practice.
Gap: Lack of federal and state coordinated effort to address research and clinical challenges associated with the unique circumstances of cannabis.
Gap: The biochemical nature of cannabis creates a unique challenge within the current regulation scheme.
Gap: Lack of standardization of products, unfounded claims made by some in the cannabis industry.
Gap: No clearly established mechanism to monitor adverse reactions for individuals and communities
Gap: The federal government and many states have a criminal justice orientation to medical cannabis.
Gap: Potential for diversion of medical cannabis products (children and adolescents)
Recommendations:
The US Government follows the recommendation of the UN regarding drugs and human dignity.
Federal efforts of the federal government are coordinated by the National Center for Complementary and Integrative Health of the National Institutes of Health
Surveillance: Central reporting of side effects and harm FDA and Marijuana: Questions and Answers
Surveillance: The CDC will coordinate monitoring of public health harm as well as potential of medical cannabis (Potential role in Opioid Use Disorder).
Develop databases including genomics to best understand population that may best benefit from medical cannabis
Collect data from state databases and leafy as to population based experience with medical cannabis.
Remove the DEA from decision making in cannabis related matters
Harmonize medical cannabis recommendations across medical specialties
Explore developments in digital technology including block chain, AI, machine learning to evolve the knowledge base of medical cannabis.
Establish a national research agenda
Goal: The aspirational goal and organizing principle of this agenda should be to maximize the population-health impact of pain management research in general and within that cannabis research. To achieving this objective will require coordination and collaboration among citizens, researchers and research groups; support from stakeholders at the local, state, and national levels; and the concurrent pursuit of several distinct research streams, including clinical and observational research and research in the areas of health policy, health economics, public health, and public safety.
Approach: There are evolving guidelines and forums exploring the challenges and opportunities for medical cannabis. The recommendations to support and improve the cannabis research agenda made by the Committee on the Health Effects of Marijuana serve as a good foundation for advancing the gaps and inconsistencies associated with the role of cannabis in the management of pain. Based on their research conclusions, the members of the committee formulated four specific recommendations to address research gaps, improve research quality, improve surveillance capacity, address research barriers. The report’s full recommendations can be seen here.
Agenda and Abstracts | Evaluating the Therapeutic Potential of Cannabinoids: How to conduct research within the current regulatory framework
Addressing the challenge of cannabis research: Recommendations to Support and Improve the Cannabis Research Agenda, National Center for Complementary and Integrative Health (NCCIH) December 8, 2018
The recommendations made by the Task Force's addressing general gaps in the management of pain disorders are relevant to specific cannabis issues.
Recommendations:
Establish a database and collaborative process to establish, patient centered, most effective manner for using cannabis. The data may include specific patient factors, the type of pain condition, the specific product used, the forms of delivery the outcome in terms of pain levels, function and well being.
To develop a comprehensive evidence base on the short- and long-term health effects of cannabis use (both harmful and beneficial effects), public agencies,1 philanthropic and professional organizations, private companies, and clinical and public health research groups should provide funding and support for a national cannabis research agenda that addresses key gaps in the evidence base.
Use of established federal research agencies of NIH such as the National Center for Complementary and Integrative Health (NCCIH), Agency for Healthcare Research and Quality (AHRQ),
Utilize the national network of the VA and DOD to conduct research.
Evaluate and monitor the change in other pain modalities especially opioids when medical cannabis is introduced into the patient’s management of their chronic pain. (Pharmacoeconomics)
Conclusions:
Despite the increasing use of cannabis by patients suffering with pain conditions, a growing body of literature and recommendations by other national bodies, the expert task force's tasked by congress and appropriated nearly one million dollars, didn’t address the role of cannabis in the clinical setting. We believe that an expert panel of the pain community, tasked to inform congress in its efforts to address the challenges of pain management and opioid use, has the responsibility to address the challenges and opportunities associated with medical cannabis. That includes an examination of the currently available evidence so as to competently advise and inform not only congress but other jurisdictions, health care workers, patients and their relatives about the role and the responsible use of cannabis based medicines for chronic pain management. These suggestions address relevant clinical issues including the role of cannabis in the patient centered management of chronic pain, limiting adverse effects and obtaining informed consent. We offer recommendations, informed by the National Academy of Medicine’s Committee on the Health Effects of Marijuana as a foundation to build on for a research agenda.
