Statement of Scope
Controlled Substances Board
Rule No.:
CSB 4
Relating to:
Designating Gabapentin as a Monitored Drug
Rule Type:
Permanent
1. Finding/nature of emergency (Emergency Rule only): N/A
2. Detailed description of the objective of the proposed rule:
Gabapentin is a non controlled substance. Gabapentin does show characteristics of various medications associated with misuse and addiction such as benzodiazepines. It is highly sought after for use in potentiating opioids. When combined with opioids, the risk of respiratory depression and opioid-related mortality increases significantly.
In addition to our neighboring state of Michigan, Tennessee and Kentucky have scheduled Gabapentin as a Schedule V controlled substance.
In addition to our neighboring state of Minnesota, approximately 8 other states designate Gabapentin as a monitored drug to be reported to prescription drug monitoring programs.
3. Description of the existing policies relevant to the rule, new policies proposed to be included in the rule, and an analysis of policy alternatives:
The existing policy is Gabapentin in not reported to the Prescription Drug Monitoring Program. The policy proposed is to designate Gabapentin as a monitored prescription drug as having a substantial potential for abuse and required to be reported to the Prescription Drug Monitoring Program. The inclusion in the Prescription Drug Monitoring Program would be beneficial for prescribers to be aware if a patient has a prescription for Gabapentin prior to prescribing an opioid.
4. Detailed explanation of statutory authority for the rule (including the statutory citation and language):
961.385 (1) (a) “Monitored prescription drug” means a substance identified in s. 961.16, 961.18, 961.20, or 961.22 or a drug identified by the board by rule as having a substantial potential for abuse.
961.358 (2) (intro.) The board shall establish by rule a program for monitoring the dispensing of monitored prescription drugs.
5. Estimate of amount of time that state employees will spend developing the rule and of other resources necessary to develop the rule:
50 hours
6. List with description of all entities that may be affected by the proposed rule:
Pharmacies, pharmacists, prescribers, and law enforcement.
7. Summary and preliminary comparison with any existing or proposed federal regulation that is intended to address the activities to be regulated by the proposed rule:
None
8. Anticipated economic impact of implementing the rule (note if the rule is likely to have a significant economic impact on small businesses):
None to minimal. It is not likely to have a significant economic impact on small businesses.
Contact Person: Sharon Henes, Administrative Rules Coordinator, (608) 261-2377
         
Authorized Signature
August 9, 2018    
Date Submitted
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