Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Data Element
Cannabinoids
Description

As the use of medical cannabis, OTC cannabidiol (CBD), and adult use cannabis (medical marijuana), and recreational cannabis is more frequent - there is the potential for drug-drug interactions; and awareness for peri-operative elective or urgent surgical procedures and/or hospitalizations. It is not just the added sedation - and perhaps safer than opioids - but the emphasis here is that cannabinoids have the real potential to affect the metabolism of OTHER medications especially those that have a narrow therapeutic index or other medications that have high-protein binding. A standardized format will provide the foundation for drug-drug interaction screening - vs. a multitude of inconsistent entries. Although medical cannabis is technically DEA class-1; there is high probability that medical cannabis may be transitioned to DEA class-3 in the very near future (see recent CSR memo added to the 'Use Case' tab). Additionally, this idea is also for cannabidiol (CBD) which is over the counter (OTC) - so not just limited to prescription Epidiolex. Additionally, medical cannabis preparations often have unique dosage forms (e.g., badder, butter).
Submitted By: Paul T. Kocis, PharmD, MPH / Dept of Pharmacology, Penn State College of Medicine
Data Element Information
Use Case Description(s)
Use Case Description Back on August 15th, 2021, I provided a written recommendation via Mathematica, which was then accepted by CMS, to include cannabinoids (medical cannabis, OTC cannabidiol, and adult use cannabis) for inclusion on the medication LIST on the electronic medical record (eMAR) - for placement in a standardized format. This was for CMS measure (CMS 68/Quality ID #130).

Please follow this hyperlink for the complete measure titled
Documentation of Current Medications in the Medical Record 12.0.000 (healthit.gov):
via this link: https://ecqi.healthit.gov/sites/default/files/ecqm/measures/CMS68v12.html
Estimate the breadth of applicability of the use case(s) for this data element In January 2023, “The FDA concluded that existing regulatory frameworks for foods and supplements are not appropriate for cannabidiol (CBD). …. Also, FDA stated a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risk.”
See following link:
https://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol

As to the above referenced FDA announcement, it would seem feasible to manage risks such as reducing unintended drug-drug interactions; thus, increasing patient safety. The same could be extrapolated to medical cannabis products (which may soon be reclassified from DEA Class 1 to Class 3 (please see recent Congressional Research Service (CRS) memo dated Sept 13, 2023)-document attached.

I’ve also added ‘The Joint Commission’ National Patient Safety Goals® Effective July 2023 for the Ambulatory Health Care Program (NPSG.03.06.01) titled: “Maintain and communicate accurate patient medication information”. (See attached PDF). This is nearly the same NPSG document for the ‘Hospital’ patient population.

Other States and medical organizations (e.g., ASHP, ASRA) and publications (e.g., JAMA) have already brought attention to this topic of placement of cannabinoids on eMAR. See referenced articles attached. If I may also emphasize again, one important aspect of this proposal (especially when reading Matson et al JAMA article) is that I'm emphasizing placement on medication LIST - not just a reference in a physician notes or other text areas. Again, the importance of viewing and/or screening for potential drug-drug interactions.

I had added formulation, dose, and routes of administration (ROA) and unique to the cannabinoids and that 'medical marijuana' may not necessarily be 1:1 THC/CBD but 1:3 (or other ratios) of THC/CBD for example (see attached xlsx document).
Link to use case project page ecqi.healthit.gov/sites/default/files/ecqm/measures/CMS68v12.html
Supporting Attachments Kocis- eMAR PPT 2023_02_22_ptk - 7 slides.pptx
ASRA Pain Medicine consensus guidelines on the management of the perioperative patient on cannabis and cannabinoids.pdf
Matson JAMA- Prevalence of Medical Cannabis Use .... Documented in EHR ...PCP in Washington State.pdf
Department of Health and Human Services Recommendation to Reschedule Marijuana_ Implications for Federal Policy-2023_09_13.pdf
Kocis - eMAR - cannabinoid med lists (1) _ 2020_03_10_ptk.pdf
Kocis - eMAR ORDERS - cannabinoid medication (2) - 2020_08_01_ptk.pdf
eMAR_Cannabinoids _ Kocis_ DRAFT v2_2021_08_27.xlsx
npsg_chapter_ahc_jul2023_0.pdf
ONC Priority
  • Address behavioral health integration with primary care and other physical care
  • Mitigate health and health care inequities and disparities
  • Address the needs of underserved communities
  • Address public health interoperability needs of reporting, investigation, and emergency response
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) N/A
Additional Specifications N/A
Current Use Not currently captured, stored, or accessed
Extent of exchange N/A
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) Unaware.
Restrictions on Use (e.g. licensing, user fees) Actually, I'm hoping for widespread adoption without any barriers for implementation. For example, I've brought this proposed idea to the attention of a committee within Observational Health Data Science & Informatics (OHDSI): Observational Medical Outcomes Partnership (OMOP) and Common Data Model (CDM) to facilitate communication and feedback.
Privacy and Security Concerns Unaware.
Estimate of Overall Burden As per the xlsx document placed on 'Use Case' tab - I had added suggested formulation, dose, and routes of administration (ROA) that are unique to the cannabinoids and that 'medical marijuana' which may not necessarily be 1:1 THC/CBD but 1:3 (or other ratios) of THC/CBD for example (see attached xlsx document). Also, as a reminder, memo I placed on 'Use Case' tab, medical cannabis products (which may soon be reclassified from DEA Class 1 to Class 3 (please see recent Congressional Research Service (CRS) memo dated Sept 13, 2023).
Other Implementation Challenges Unaware; unless concerns regarding medical cannabis (currently DEA class 1) is an issue being placed on electronic medical record. However, this is not meant to e-prescribe; but for opportunity to standardize placement on electronic medical record. If such is the case, then I would recommend focusing on over the counter cannabidiol (CBD) which would then provide the structure for the eventual DEA reclassification of medical cannabis.
ONC Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 0 - Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration.
Criterion #3
Maturity - Current Exchange		 Level 0 - Data element is electronically exchanged in limited environments, such as connectathons or pilots.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Evaluation Comment This data element represents a specific category or subset of the Medications data element (https://www.healthit.gov/isa/taxonomy/term/691/uscdi-v4) in the Medications data class in USCDI v4.

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