The new Commissioner’s Controlled Substance Monitoring Database rule for Chapters 1140-11 and 1145-01.
The Controlled Substance Monitoring Database (CSMD) rules have not been amended since before the passage of the Tennessee Prescription Safety Act of 2016, which resulted in significant changes to the statutory scheme. The current CSMD rules are codified in the Pharmacy Chapter of the Rules and Regulations. Several of these rules apply to prescribers rather than pharmacies. The rule amendment will pull those rules that deal primarily with prescribers out of Chapter 1140 (Pharmacy) and place them in a newly created Chapter 1145 (Commissioner’s CSMD Rules).
The rule amendment also increases the list of mandatory fields for pharmacy and prescriber dispenser reporting information to the CSMD. These fields are consistent with the June 2017 version of the Telecommunications Format for Controlled Substance established by the American Society for Automation in Pharmacy (ASAP). The current rules use the 2009 version of that format. Pharmacies and prescriber dispensers will have until July 1, 2022 to become compliant with the increased number of data fields. The amended rules will also require that the CSMD must be checked before initiating a course of Schedule II amphetamines and at least every 6 months while during that course of treatment. Other changes are made to update the rule due to the changes outlined above (changes in numbering, removal of definitions of terms no longer used in the rules, and formatting changes).
Finally, a new rule is created that explicitly allows for the sharing of patient-level opioid overdose data through the CSMD. The Department is working to complete Enhanced Prescriber Report Cards (EPRs) which will pull data from the CSMD as well as opioid overdose data. The EPRs will be provided to practitioners through the CSMD.
Please note the effective date of the sections is January 26, 2022. Also provided is the link to the changes here: https://publications.tnsosfiles.com/rules_filings/10-28-21.pdf