By Nikki Wilson, PharmD/MBA, Director of Pharmacy Product Development, Coventry
Cannabis is king, as we noted last week. It’s popping up in various forms all over the country. As marijuana and its offshoots proliferate, so too do questions over legality, efficacy, and possible fallout. These considerations are particularly important when they involve employers, employees, and workplace safety.
In our last installment, we looked at the increase in access to cannabis given its now widespread availability through changes in state laws governing medicinal or recreational use. We also explored the emergence of cannabidiol, better known as CBD, in everyday consumer products. Here we’ll look at some other considerations, particularly around research and regulation and the kinds of questions that workers and employers should consider.
Despite its widespread availability, we don’t have reams of research about the effects of cannabis. Advocates point to a multitude of medicinal benefits ranging from the relief of chronic pain to reducing stress levels to fighting cancer. Yet few studies have been done to better understand the efficacy, safety concerns such as drug-drug interactions and side effects, proper dosing ranges, or limitations of use related to inhaled or ingested medical cannabis.
Many clinicians believe cannabis has a different effect than synthesized cannabinoids. The plant form of cannabis has many distinctive cannabinoid and non-cannabinoid constituents that might work “synergistically.” This is the so-called entourage effect. Cannabis products might also be less expensive than pharmaceutical cannabinoids. But the more expensive prescription preparations possess excellent quality control, especially if they’re approved by the U.S. Food & Drug Administration (FDA). Plus, pharmaceutical cannabinoids involve precise dosing. Regardless of whether a patient is using cannabis, or its pharmaceutical counterparts, clinicians and consumers should consider the start-low-and-go-slow approach when it comes to dosing.
What might work and what doesn’t
While more research is needed, we do have a gathering of evidence that cannabis can bring benefits for some conditions1. Here are a few:
- Neuropathic pain: Moderate-quality evidence to support use
- Chronic pain: Conclusive or substantial evidence to support use
- Cancer pain: Cannabis can be a useful adjunct
- Nausea and vomiting: Conclusive or substantial evidence suggesting improvements
- Spasticity (multiple sclerosis (MS) or paraplegia): Moderate-quality conclusive or substantial evidence to support use
A review of the research suggests there are areas where cannabis might offer only limited evidence supporting use2. These include Tourette syndrome, HIV/AIDS (appetite/weight loss), anxiety, post-traumatic stress disorder (PTSD), and traumatic brain injury.
There are other conditions where evidence doesn’t support use of cannabis or oral cannabinoids3. These include acute pain, multiple sclerosis-related tremors, Huntington’s disease, glaucoma, schizophrenia, dementia, and depression.
The FDA has allowed some products derived from cannabis. In June 2018, the agency approved Epidiolex, a liquid extract form of CBD. It’s administered as an oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged two and above.
Other formulations have been around longer. In the 1980s, the FDA approved two other pharmaceutical-grade products derived from cannabis. They remain available by prescription. These are dronabinol (or Marinol or Syndros) and nabilone (or Cesamet) and are similar to THC or are synthetic versions of this cannabinoid. Both are indicated for the treatment of chemotherapy-induced nausea/vomiting and appetite enhancement for anorexia due to AIDS or cancer. The FDA’s product labeling includes a warning that these products can, like other cannabinoids, affect the central nervous system. The warning also notes the formulations carry the potential for misuse and to produce psychological dependence: The “effects on the mental state are similar to those of cannabis,” the agency noted.
What about hemp-derived CBD?
The Agriculture Improvement Act, also known as the Farm Bill, was signed into law in December 2018. With it came the deregulation of hemp-derived cannabis products, namely CBD derived from plants containing no more than 0.3% THC by dry weight. This legislation effectively removed these specific types of products from the definition of cannabis in the Controlled Substances Act. That meant they were no longer classified as illegal at the federal level, thus allowing for less restricted use. However, the Farm Bill explicitly preserved the FDA’s authority to regulate hemp-derived CBD products under the Food, Drug & Cosmetic Act (FDCA) and section 351 of the Public Health Service Act. This means that such goods are still subject to the same laws and requirements as any FDA-regulated product that contains any other substance.
Even though it retains oversight, challenges remain as the FDA works to keep pace with the booming CBD industry. In general, in order for a company to market a product as a drug — defined by the FDCA as any product intended to have a therapeutic or medical use — that product must receive premarket approval through the FDA’s formal drug approval process including human clinical trials or through Over-the Counter (OTC) Drug Review. Unapproved new drugs cannot be distributed or sold, and the FDA has issued more than 90 warning letters over the past 10 years to CBD companies related to fraudulent product and health claims made on websites, social media, and in stores. The FDA also asserts that it has tested the chemical contents of many of these CBD products, and a number of the results have shown inconsistent or inaccurate components. This can be of particular concern for injured workers as several of the “CBD-only” products have been found to contain THC, the component that would show up on a urine drug test.
Further, products containing CBD cannot be marketed as a food or dietary supplement because this is the same ingredient found in an FDA-approved drug product (i.e., Epidiolex). Therefore, CBD is considered a drug. The agency has concerns about the number of products claiming to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the FDA. The FDA regards this as a patient-safety issue. Overall, the FDA’s message to the consumer is buyer beware. The FDA continues to gather research data and safety and public health input to develop an applicable regulatory framework, especially when it comes to non-drug uses of cannabis.
Cannabis and Treatment Guidelines
Many widely used treatment protocols discourage use of cannabis. The Official Disability Guidelines (ODG) don’t recommend using cannabinoids to combat pain. Likewise, the American Society of Addiction Medicine (ASAM) states physicians should not recommend that their patients use marijuana for medical purposes.
A task force formed by the American College of Occupational and Environmental Medicine (ACOEM) and the American Association of Occupational Health Nurses (AAOHN) recommended that employers develop policies concerning marijuana use in the workplace and consider the following points4:
- If workers are covered by federal drug-testing regulations (for example, Department of Transportation drivers or others under a federal contract), cannabis use on or off the job is prohibited. Employers could use urine drug screening to ensure compliance.
- If workers are in safety-sensitive positions, they must not be impaired by any substance. Employers could consider banning on-the-job cannabis use even for those workers not covered by federal drug-testing regulations. Employers should also consider their policies in light of state statutes. For employers weighing whether to allow cannabis use, it also is logical to consult with a qualified health professional.
- If cannabis use is allowed, employers should establish a clear policy — with legal advice —and educate employees on the policy and how to evaluate impairment. Communication aimed at educating employees is critical. This should start when a worker is hired and occur regularly.
- If employers choose to prohibit employees from working if impaired by cannabis, there should be clear policies and procedures for supervisors to follow in identifying potential impairment. This would include a process for referring an employee suspected of impairment for an occupational medical evaluation and the resulting actions by human resources departments. Supervisors and workers should be educated about how to recognize signs that an employee might be impaired. This could result from medical cannabis, prescription medications, illicit drugs, alcohol, OTC medications, fatigue, or a combination of these factors.
- If employers are in or near states that allow use of recreational marijuana, they should consider establishing a policy around off-work use of cannabis. In many states, the employer may choose to prohibit employees from working while using or under the influence of cannabis or may choose to prohibit marijuana use both on and off the job.
While national guidelines do not recommend cannabis, this could relate to a lack of large quality-controlled trials. As we discussed last week, the drug’s designation as a Schedule I Controlled Substance has limited the ability to conduct research.
In those states that do allow use of medical cannabis (along with Washington D.C., Guam, and Puerto Rico), comprehensive programs often include provisions that provide protection from criminal penalties for using cannabis for a medical purpose, according to an analysis by the National Conference of State Legislatures. The rules also often allow people to access cannabis by growing it at home or by obtaining it through dispensaries or some other setup. The provisions also tend to allow for a variety of strains, including those more potent than “low THC.” Other rules permit smoking or vaporization of some kind of cannabis product, plant material, or extract.
What’s most clear is that the environment around cannabis is changing. This makes it imperative for those involved in the treatment of injured workers to try to keep up with the shifting rules and to consider the questions that arise in the workplace around cannabis. And employers need to consider their role, too. As use of cannabis and related products such as CBD and hemp increase, there will be more questions about what is permissible in the workplace and how to regulate it. This is a topic that will require recurring and sustained attention.
1,2,3National Academies of Sciences, Engineering, and Medicine. 2017. The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. Washington, DC: The National Academies Press. https://doi.org/10.17226/24625.
4Journal of Occupational and Environmental Medicine. Marijuana in the Workplace: Guidance for Occupational Health Professionals and Employers. 57(4):459-475. (April 2015) Available at: www.acoem.org. Accessed: March 23, 2018
About Nikki Wilson
Nikki is a Pharm.D. who graduated with her Doctor of Pharmacy and Master of Business Administration (MBA) from Creighton University. As a licensed Pharmacist, Nikki has over nine years of comprehensive industry experience through leadership roles overseeing prescription home delivery programs, clinical pharmacy operations and benefit management, and product development. Today, she is responsible for developing pharmacy product strategy and program capabilities at Coventry with a focus on enhancing patient safety and returning people to work, to play, and to life.
Coventry offers workers’ compensation care-management and cost-containment solutions for employers, insurance carriers, and third-party administrators. With roots in both clinical and network services, Coventry leverages more than 35 years of industry experience, knowledge, and data analytics. As a part of the specialty division of Aetna our mission is returning people to work, to play, and to life. And our care-management and cost-containment solutions do just that. Our networks, clinical solutions, specialty programs, and business tools will help you focus on total outcomes.
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This is NOT a paid placement.