Statement of Scope
CONTROLLED SUBSTANCES BOARD
Relating to: | Operation of PDMP |
1. Finding/nature of emergency (Emergency Rule only): N/A
2. Detailed description of the objective of the proposed rule:
The objective of the proposed rule is to make minor clean-up changes.
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 proposed rule will clarify and update minor provisions based upon stakeholder feedback including the following: clarifying disclosure of PDMP data for public health and research purposes, creating a provision to allow for disclosure of audit trails to designated staff of a federal or state governmental agency, and updating provisions to reflect language in 2017 Act 59. In addition, CR 17-028 inadvertantly removed the provision, which was in the rule prior to CR 17-028, for the board to deny, suspend, revoke or otherwise restrict or limit a pharmacist’s, pharmacist delegate’s, preactitioner’s or practitioner delegate’s direct access to PDMP information. 4. Detailed explanation of statutory authority for the rule (including the statutory citation and language):
s. 961.385 (2) 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:
75 hours
6. List with description of all entities that may be affected by the proposed rule:
Licensees who are authorized to prescribe and dispense controlled substances (Advanced Practice Nurse Prescribers, Anesthesiologist Assistants, Dentists, Optometrists, Pharmacies, Pharmacists, Physicians, Physician Assistants, and Podiatrists), law enforcement, and Department of Safety and Professional Services staff.
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:
There is no existing of proposed federal regulation that is intended to address the activities regulated by the proposed rule as it relates to PDMP.
8. Anticipated economic impact of implementing the rule (note if the rule is likely to have a significant economic impact on small businesses):
Minimal or no economic impact. 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
September 26, 2018
Date Submitted
