By: Paul R. DeMuro, PhD and Dr. Jose Valdes, PharmD, BCPP
Medical cannabis or cannabinoids (or medical marijuana as some like to call it) is now a reality in Florida. Although it can only be recommended for certain maladies and obtained in certain ways, those logistics do not necessarily affect some of the safety and key legal considerations of which those in the healthcare industry should be aware.
There are gaps in knowledge about cannabis, its efficacy , long term side effects, dosing, and optimal administration routes in part, because of the paucity of research in these areas. Cannabis is still an FDA Schedule I drug, and thus not legal from a federal perspective which places unnecessary strain on researchers trying to determine the therapeutic value of cannabis. Additionally, some clinicians may be wary of prescribing it because of potential federal ramifications. Thus, a patient’s ability to locate a clinician who will recommend cannabis might be difficult even though there are nearly 400 clinicians who have completed the required continuing education course to be able to recommend its use. As clinicians must weigh the therapeutic effects against the potential adverse health effects, generally they do not have the same type of guidance as with other prescription drugs. How can clinicians be assured that the quantity, quality and type of cannabinoid products are consistently what they say they are?
Except in a few states, the dispensing of cannabis does not have to involve a pharmacist in the process. Thus, the same assurances of pharmacist oversight which might be available for other prescription drugs might not be assured. Complicating the lack of pharmacist intervention is the fact that there does not appear to be a consensus for safe and appropriate doses for various illnesses in clinical studies, or conclusive evidence that cannabinoids are even effective for some conditions. Furthermore, the lack of pharmacist involvement in the dispensing of cannabis places the responsibility of reviewing the patient’s medication profile and medical history for potential complications, interactions, and adverse effects solely on the clinician. This removes an important second check that pharmacists are equipped to provide, and gives the clinician less assurance of safe and appropriate utilization of cannabis by their patients
Many practitioners will be concerned about the potential professional liability consequences. The traditional standards of the duty of care and breach of that duty should apply, but how will they be applied? A physician patient relationship undoubtedly will be created, but how will the standard of care be determined, and the breach of that duty determined? The latter can be a particularly thorny issue where cannabis use might cause addiction and/or respiratory problems, if inhaled. Additionally authorizing clinicians to recommend cannabis will not absolve them from rendering competent and informed medical care. Clinicians must remember that they may be recommending a non-FDA approved product that a large majority of their professional colleagues or medical associations do not fully support which may expose them to malpractice. This is especially so for clinicians who recommend its use for unproven, discredited, or unsubstantiated purposes.
For some specific symptoms, such as spasticity (seen in multiple sclerosis and amyotrophic lateral sclerosis), increased intraocular pressure (seen in glaucoma), pain and appetite stimulation (in cancer and HIV/AIDS respectively), cannabis is generally considered to be helpful. Could cannabis help wean someone off of opioids? Could it be ordered in place of opioids? Can it improve the quality of care and be more cost-effective than alternative treatments, resulting in the potential for greater use in the context of Accountable Care Organizations (ACOs) and other models which are value-based purchasing in nature? All are possible, and require further research to conclude on these points. However for other specific indications such as epilepsy, post-traumatic stress disorder, Crohn’s disease, and Parkinson’s disease the jury is still out.
Many challenges and barriers are likely to be encountered as medical cannabis moves forward in Florida. Will the research be truly evidence based medicine, given the challenges research faces because of cannabis being a Schedule I drug? Will such research be supported and will it be standardized in some form? Will the cannabis used in medical research be the same that is available to be ordered for patients? While we may be only at the tip of the iceberg in discovering what and how cannabis may be useful for and in what forms, there is still much to be learned. Until then, keeping abreast of the legal and medical data as it is published, is paramount.