STATE OF WISCONSIN
Controlled Substances Board
IN THE MATTER OF RULE-MAKING PROCEEDINGS BEFORE THE CONTROLLED SUBSTANCES BOARD
PROPOSED ORDER OF THE CONTROLLED SUBSTANCES BOARD
ADOPTING RULES
(CLEARINGHOUSE RULE )
PROPOSED ORDER
An order of the Controlled Substances Board to repeal 4.03 (3); to amend CSB 4.02 (4), 4.08 (1), 4.10 (1) (c), 4.10 (2) (a), 4.11 (1), 4.11 (1) (b), 4.11 (2), 4.11 (2) (c), 4.11 (7), 4.11 (7) (c), 4.11 (8) and 4.11 (8) (c); to create 4. 15 relating to the operation of the prescription drug monitoring program.
Analysis prepared by the Department of Safety and Professional Services.
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ANALYSIS
Statutes interpreted: s. 961.385, Stats. Explanation of agency authority:
The board shall establish by rule a program for monitoring the dispensing of monitored prescription drugs. The section goes on to state several items the board shall do, including defining what constitutes suspicious or critically dangerous conduct or practices for purposes of the rules promulgated under s. 961.385 (2) (c), Stats. Related statute or rule:
Plain language analysis:
Section 1 indicates Board means the Controlled Substances Board. 2015 Act 55 changed the jurisdiction of the prescription drug monitoring program from the Pharmacy Examining Board to the Controlled Substances Board. Section 2 repeals Tramadol from the list of monitored prescription drugs, because Tramadol is now identified as a controlled substance by both federal and Wisconsin law.
Section 3 changes the “his or her” to its to be consistent with the language throughout this chapter.
Sections 4 and 5 update dispenser and dispenser delegate to pharmacist and pharmacist delegate. This change was done for clarity in CR 14-003, and there were two instances of these words that were inadvertently missed. Sections 6, 7, 8, 9, 10, 11, 12 and 13 replace the references to PDMP information with references to dispensing data. This change is to create clarity between the situations in which the Board may disclose dispensing data and when the Board may disclose other PDMP information. There are situations in which it may be inappropriate and contradictory to the purpose of the program to disclose PDMP information when dispensing data would be more appropriate. The change clearly delineates when the Board may release dispensing data and PDMP information.
Section 14 creates a section on disclosure of PDMP information when the Board identifies suspicious or critically dangerous conduct or practices in PDMP data. 2015 Act 55 directs the board to include provisions in the rules governing the Board’s disclosure of PDMP information that allow the Board to disclose information to relevant state boards and agencies, agencies of other states and law enforcement agencies under circumstances that indicate suspicious or critically dangerous conduct or practices of a pharmacy, pharmacist, practitioner or patient. This rule defines the factors that the Board will use to determine whether the conduct or practices of a pharmacy, pharmacist, practitioner or patient are suspicious or critically dangerous. When looking at the pharmacist’s or pharmacy’s practice, the factors will include: practice which deviates from accepted practice, unusual patterns in payment, history of actions taken against the pharmacist or pharmacy, type and number of monitored prescription drugs dispensed, forged prescription orders for a monitored prescription that have been dispensed, the distance patients travel to have monitored prescription drugs dispensed and the number of patients dispensed monitored prescription drugs who meet the criteria of patients engaging in suspicious or critically dangerous conduct.
When looking at the practitioner’s practice, the factors will include: prescribing practices which deviate from accepted prescribing practices, prescribing potentially dangerous combinations of monitored prescription drugs to the same patient, the type and number of monitored prescription drugs prescribed by the practitioner, history of actions taken against the practitioner, the distance patients travel to obtain monitored prescription drug prescriptions and the number of patients to whom the practitioner prescribes monitored prescriptions who meet the criteria of patients engaging in suspicious or critically dangerous conduct.
When looking at a patient, the factors will include: the number of practitioners from whom the patient has obtained a prescription for a monitored prescription drug, number of pharmacies from where the patient was dispensed a monitored prescription drug, the number of prescriptions for monitored drug obtained by the patient, the number of monitored prescription drug doses dispensed to the patient, the monitored prescription drugs dispensed to a patient which include dangerous levels of any drug, the number of times the patient is prescribed or dispensed a monitored drug before the previously dispensed amount of the same or a similar monitored prescription drug would be expected to end and the payment methodology used by the patient to obtain controlled substances.
Upon determining that there are circumstances indicating suspicious or critically dangerous conduct or practices of a pharmacy, pharmacist, practitioner or patient, the Board may disclose PDMP information to a relevant patient, pharmacist, practitioner, state board or agency, agency of another state or law enforcement agency.
Summary of, and comparison with, existing or proposed federal regulation: None
Comparison with rules in adjacent states:
