July 1, 2024

To:

The Drug Enforcement Administration 

Attn: DEA Federal Register Representative/DPW

8701 Morrissette Drive, Springfield, Virginia 22152

From:

The Pharmacists’ Cannabis Coalition of California (PCCC)

Subject: Docket No. DEA-1362

Medical Use of Cannabis Position by the Pharmacists’ Cannabis Coalition of California (PCCC):

Greetings,

We, the Pharmacists’ Cannabis Coalition of California (PCCC), are a 501(c)(3) non-profit organization committed to providing evidence-based education on cannabis medicine to pharmacists, healthcare professionals, and the public. We would like to respectfully submit our position in support of the rescheduling of cannabis to Schedule III of the Controlled Substances Act (CSA), and the designation of pharmacists as the providers of medical cannabis therapy to ensure patient access to a pharmacist knowledgeable about cannabis therapy for the guidance of the safe and effective use.

PCCC strongly urges DEA to consider a novel and unconventional framework of Schedule III to include a Medical Model and an Adult-Use Model, where the Adult-Use Model will continue to be regulated under state-authorized programs. A newly established Medical Model will designate cannabis products as a medicine to be dispensed to a patient by a pharmacist pursuant to patient evaluation, recommendation, and counseling by a pharmacist or other healthcare professional with specific training in medical cannabis. We recommend that the furnishing of cannabis, while retaining a controlled substance designation, shall not require a prescription, similar to what is detailed in CFR Title 21, Chap II §1306.26, but instead will be dispensed at the discretion of the pharmacist, incorporating shared decision making with the patient and other healthcare team members. Current data have described the benefit of controlled substance prescriptive authority (CSPA) among DEA-registered clinical pharmacist practitioners in healthcare systems to meet patient care needs.¹

While the current designation of Schedule III inherently implies an FDA approved drug that has been evaluated via the Center for Drug Evaluation and Research (CDER), we propose a novel method for dispensing cannabis under the new Medical Model. We recommend the establishment of botanical cannabis manufacturers that adhere to rigorous regulatory oversight for provision of products to pharmacies. Due to the current inconsistencies in the manufacturing, testing, and labeling of botanical cannabis, regulations must include standardized labeling and laboratory testing to ensure identity, strength, quality; free from impurities, contaminants or other unwanted ingredients. We also strongly support the opportunity for certified pharmacists to compound individualized botanical cannabis therapy for patients when deemed necessary, using these tested products.

The prevalence of cannabis use continues to rise among all age groups, with a steady trend of increased medical use in adults over the age of 65. Critical age-related factors may influence the health effects of cannabis in older adults, including mental, physiological and metabolic differences.  In addition, polypharmacy is more prevalent in older adults, and can potentially increase the risk of drug interactions with cannabis.² These critical factors underscore the need for an accessible medication expert to evaluate, assess, and counsel patients of all ages when using cannabis for medical therapy.

Pharmacists are the undeniable experts in medication management, with expertise to individualize drug therapy based on a patient’s age, weight, medical conditions, organ function, allergies, pharmacogenomic profile, and concurrent medications. Pharmacists are well established as the most accessible health professional and are recognized as providing direct patient care in certain circumstances. The rescheduling of cannabis to Schedule III constitutes it as a medication, therefore the management of medical cannabis falls within the purview of pharmacists.

We fully support the transfer of cannabis to Schedule III, rather than Schedule II, based on the risk/benefit profile documented in the scientific literature, experience amongst healthcare professionals, and the determining factors applicable to the classification of drugs into the CSA.  Experimental data and clinical reports demonstrate that chronic, but not acute, use of marijuana can produce both psychological and physical dependence in humans, but the symptoms associated with dependence are relatively mild for most individuals. For overdose deaths, marijuana is always in the lowest ranking among comparator drugs. These evaluations demonstrate that there is consistency across databases, across substances, and over time that risk is relatively lower than that posed by most other comparator drugs. Moreover, the National Institute on Drug Abuse concurs with FDA’s recommendation of the transfer to Schedule III instead of Schedule II.^3,4

The policies outlined above fulfill the vows and obligations of the profession of pharmacy as well as the requirements of the Single Convention on Narcotic Drugs Treaty, which requires regulation of cannabis within the framework of medical use and scientific research.⁵

Thank you for the opportunity to provide public comment on this extraordinary proposed rule by the DEA. Please contact us for any further information.

Respectfully submitted on behalf of the PCCC Board of Directors,

Jill Simonian, PharmD

President

info@pcccrx.org

¹Baum SG, Kominek C, Jorgenson TL, et al. DEA-registered clinical pharmacist practitioners: Progressing practice to increase patient care access. AJHP. 2023;80(15):984-993

²Solomon HV, Greenstein AP, DeLisi LV. Cannabis use in older adults: A perspective. Harv Rev Psychiatry. 2021;29(3):225-233.

³ Basis for the recommendation to reschedule marijuana into Schedule III of the Controlled Substances Act. Department of Health and Human Resources. Office of the Secretary. August 29, 2023. Accessed June 6, 2024. https://www.hhs.gov/sites/default/files/scheduling-recommendation.pdf

⁴Amsterdam JV, Nutt D, Van Den Brink W. et al.  European rating of drug harms. J Psychopharmacol. 2015;29(6).

⁵United Nations Conference for the Adoption of a Single Conventionon Narcotic Drugs 24 January - 25 March 1961, New York. 1961. Accessed June 11, 2024.

https://www.un.org/en/conferences/drug/newyork1961#:~:text=The%20aim%20of%20the%20Convention,medical%20and%20scientific%20purposes%20only.