Submitted By: Paul T. Kocis, PharmD, MPH / Dept of Pharmacology, Penn State College of Medicine | |
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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 |
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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. |
Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Data Element |
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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). |
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