No. 42229 (Amendment): Rule R156-37. Utah Controlled Substances Act Rule

(Amendment)

DAR File No.: 42229
Filed: 10/16/2017 04:06:19 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

H.B. 175, passed during the 2017 General Session, modified the continuing education requirements for controlled substance licensees, to require Screening, Brief Intervention and Referral to Treatment (SBIRT) training as a condition of renewal for the licensing period beginning after 01/01/2024. This filing is made to clarify the Division of Occupational and Professional Licensing's (Division) requirements regarding SBIRT training, as mandated by H.B. 175 (2017). Nonsubstantive formatting changes are also made to certain sections of the rule for better comprehension.

Summary of the rule or change:

A new Subsection R156-37-102(5) is added to define "SBIRT training" in reference to the definition of "SBIRT" in Section 58-37-6.5, the "Screening, Brief Intervention, and Referral to Treatment approach used by the federal Substance Abuse and Mental Health Services Administration." This proposed amendment is made because Subsection 58-37-6.5(1)(e), enacted by H.B. 175 (2017), allows the Division to either promulgate a definition of "SBIRT" by rule, or to use the federal Substance Abuse and Mental Health Services Administration (SAMHSA) definition. By incorporating the federal SAMHSA definition, the Division is choosing it for the SBIRT training requirements. Section R156-37-402 is amended to refer to the new SBIRT training requirements enacted in Subsection 58-67-6.5(2)(b), and provides that the approved SBIRT training satisfies the Division's continuing education requirements for license renewal and shall be posted on the Division's website at https://dopl.utah.gov/. Sections R156-37-502, R156-37-601, and R156-37-602 are amended to make nonsubstantive formatting changes for better comprehension.

Statutory or constitutional authorization for this rule:

• Subsection 58-1-106(1)(a)
• Subsection 58-37-6(1)(a)
• Subsection 58-37f-301(1)

Anticipated cost or savings to:

the state budget:

The Division will incur a cost of approximately $75 to print and distribute the rule once the proposed amendments are made effective, and estimates that there will be no other measurable cost or savings to the state. This rule will be implemented by adding course information to the Division's existing "approved courses" web page, and verification as to whether or not licensees are taking the required courses will be accomplished by continuing education audits, which is the current practice.

local governments:

The proposed amendments apply only to persons required to be licensed as a controlled substance prescriber in Utah. Local governments are not involved in continuing education for prescribers, therefore, the Division estimates there will be no cost or savings impact on local governments.

small businesses:

The Division estimates that the proposed amendments to Section R156-37-402 will have no fiscal impact to small businesses even if they are owned, operated by, or employ controlled substance licensees. The SBIRT training that will be allowed by this rule for licensees is currently available through the Substance Abuse and Mental Health Services Administration (SAMHSA) for little or no cost; further, in accordance with Section 58-37-6.5 the SBIRT training fulfills existing continuing education hour requirements, so it will not increase the total number of state-required continuing education hours. This analysis is supported by the fiscal note to H.B. 175 (2017), which estimated that enactment of this legislation likely will not result in direct, measurable expenditures by Utah businesses. The fiscal note is available on the Utah Legislature's website at: https://le.utah.gov/~2017/bills/static/HB0175.html.

persons other than small businesses, businesses, or local governmental entities:

The Division estimates that the proposed amendments to Section R156-37-402 will have no fiscal impact to large businesses or individual controlled substance licensees. The SBIRT training that will be allowed by this rule for licensees is currently available through the Substance Abuse and Mental Health Services Administration (SAMHSA) for little or no cost; further, in accordance with Section 58-37-6.5, the SBIRT training fulfills existing continuing education hour requirements, so it will not increase the total number of state-required continuing education hours. This analysis is supported by the fiscal note to H.B. 175 (2017), which estimated that enactment of this legislation likely will not result in direct, measurable expenditures by Utah residents or businesses. The fiscal note is available on the Utah Legislature's website at: https://le.utah.gov/~2017/bills/static/HB0175.html. The proposed changes to R156-37-402 may also provide an indirect health benefit and associated fiscal savings to those who receive medical treatment after 01/01/2024, from licensees trained in SBIRT. SBIRT training educates licensees in methods to screen patients for substance use disorders and to provide resources for patient treatment. However, this fiscal benefit cannot be quantified because the relevant data as to the number of patients in 2024 and thereafter who will benefit from training is unavailable, and the cost of acquiring any relevant data is prohibitively expensive.

Compliance costs for affected persons:

The Division estimates that there will be no compliance costs to affected persons from these proposed amendments. The SBIRT training that will be allowed by this rule is currently available through the Substance Abuse and Mental Health Services Administration (SAMHSA) for little or no cost; further, in accordance with Section 58-37-6.5 the SBIRT training fulfills existing continuing education hour requirements, so it will not increase the total number of state-required continuing education hours. This analysis is supported by the fiscal note to H.B. 175 (2017), which estimated that enactment of this legislation likely will not result in direct, measurable expenditures by Utah residents or businesses. The fiscal note is available on the Utah Legislature's website at: https://le.utah.gov/~2017/bills/static/HB0175.html.

Comments by the department head on the fiscal impact the rule may have on businesses:

This proposed rule filing implements H.B. 175 passed in the 2017 General Session, which established SBIRT training as a continuing education requirement that licensees must obtain after 2024 as a condition for license renewal. The proposed rule also makes some nonsubstantive formatting changes. No additional fiscal impact to businesses is anticipated beyond those considered in passing H.B. 175 (2017).

Francine A. Giani, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Commerce
Occupational and Professional Licensing
HEBER M WELLS BLDG
160 E 300 S
SALT LAKE CITY, UT 84111-2316

Direct questions regarding this rule to:

• Larry Marx at the above address, by phone at 801-530-6254, by FAX at 801-530-6511, or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

12/01/2017

This rule may become effective on:

12/08/2017

Authorized by:

Mark Steinagel, Director

RULE TEXT

R156. Commerce, Occupational and Professional Licensing.

R156-37. Utah Controlled Substances Act Rule.

R156-37-102. Definitions.

In addition to the definitions in Title 58, Chapters 1 and 37, as used in Title 58, Chapters 1 and 37, or this rule:

(1) "DEA" means the Drug Enforcement Administration of the United States Department of Justice.

(2) "NABP" means the National Association of Boards of Pharmacy.

(3) "Principl[e] place of business or professional practice", as used in Subsection 58-37-6(2)(e), means any location where controlled substances are received or stored.

(4) "Schedule II controlled stimulant" means any material, compound, mixture or preparation listed in Subsection 58-37-4(2)(b)(iii).

(5) "SBIRT training" means training in the Screening, Brief Intervention, and Referral to Treatment approach used by the federal Substance Abuse and Mental Health Services Administration, as defined in Subsection 58-37-6.5(1)(3).

([5]6) "Unprofessional conduct", as defined in Title 58 is further defined in accordance with Subsections 58-1-203(1)(e) and 58-37-6(1)(a), in Section R156-37-502.

 

R156-37-402. Continuing Professional Education for Controlled Substance Prescribers.

In accordance with Section 58-37-6.5, qualified continuing professional education requirements for controlled substance prescribers are further established as follows:

(1) Continuing education under this section shall:

(a) be prepared and presented by individuals who are qualified by education, training , and experience to provide the controlled substance prescriber continuing education; and

(b) have a method of verification of attendance and a post -[ ]course knowledge assessment or examination.

(2) In accordance with Subsections 58-37-6.5(2)(b), 58-37-6.5[.](5), 58-37-6.5(7), and 58-37-6.5(8), the controlled substance prescribing classes and SBIRT training that satisfy the division's continuing education requirements for license renewal, and that are delivered by an accredited or approved continuing education provider recognized by the division as offering appropriate continuing education, shall be posted on the division's website at http://dopl.utah.gov/.

(3) Credit for continuing education shall be recognized as follows:

(a) Unlimited hours shall be recognized for continuing education completed in blocks of time of not less than 50 minutes;

(b) Continuing education hours for licensees who have not been licensed for the entire two-year period shall be prorated from the date of licensure;

(c) In accordance with Subsection 58-37f-304(3), the required 1/2 hour of continuing education for the online tutorial and test relating to the controlled substance database shall be waived by the division for a controlled substance prescriber renewing a license, if the prescriber attests on the license renewal form that:

(i) in the past license period, the prescriber accessed the controlled substance database; and

(ii) upon the prescriber's information and belief, the prescriber's use of the database reduced the prescribing, dispensing, and use of opioids in an unprofessional or unlawful manner, or in quantities or frequencies inconsistent with generally recognized standards of dosage for an opioid.

(4) A licensee shall maintain competent records of completed qualified continuing professional education for a period of four years after close of the two-year period to which the records pertain. The division may review controlled substance database usage by the prescriber or proxy to audit an attestation provided under Subsection R156-37-402(3)(c).

 

R156-37-502. Unprofessional Conduct.

"Unprofessional conduct" includes:

(1) a licensee with authority to prescribe or administer controlled substances:

(a) prescribing or administering to [himself]oneself any Schedule II or III controlled substance that is not lawfully prescribed by another licensed practitioner having authority to prescribe the drug;

(b) prescribing or administering a controlled substance for a condition [he]that the prescriber is not licensed or competent to treat;

(2) violating any federal or state law relating to controlled substances;

(3) failing to deliver to the Division all controlled substance license certificates issued by the Division to the Division upon an action that revokes, suspends or limits the license;

(4) failing to maintain controls over controlled substances that would be considered by a prudent practitioner to be effective against diversion, theft, or shortage of controlled substances;

(5) being unable to account for shortages of any controlled substance inventory for which the licensee has responsibility;

(6) knowingly prescribing, selling, giving away, or administering, directly or indirectly, or offering to prescribe, sell, furnish, give away, or administer any controlled substance to a drug dependent person, as defined in Subsection 58-37-2(1)(s), except for legitimate medical purposes as permitted by law;

(7) refusing to make available for inspection controlled substance stock, inventory, and records as required under this rule or other law regulating controlled substances and controlled substance records;

(8) failing to submit controlled substance prescription information to the database manager after being notified in writing to do so; or

(9) failing to obtain a DEA registration within the time frame established in Section R156-37-305.

 

R156-37-601. Access to Records, Facilities, and Inventory.

Applicants for licensure and all licensees shall make available for inspection to any person authorized to conduct an administrative inspection pursuant to this rule; Title 58, Chapter 37, the Utah Controlled Substances Act;[this rule] or federal law[, to the extent they exist,] during regular business hours and at other reasonable times in the event of an emergency, their:

(1) controlled substance stock or inventory[,];

(2) records required under the Utah Controlled Substances Act , [and ]this rule, or [under the ]Federal controlled substance laws[,]; and

(3) facilities related to activities involving controlled substances.

 

R156-37-602. Records.

(1) Records of purchase, distribution, dispensing, prescribing, and administration of controlled substances shall be kept according to state and federal law. Prescribing practitioners shall keep accurate records reflecting the examination, evaluation and treatment of all patients. Patient medical records shall accurately reflect the prescription or administration of controlled substances in the treatment of the patient, the purpose for which the controlled substance is utilized , and information upon which the diagnosis is based. Practitioners shall keep records apart from patient records of each controlled substance purchased, and with respect to each controlled substance, its disposition, whether by administration or any other means, date of disposition, to whom given , and the quantity given.

(2) Any licensee who experiences any shortage or theft of controlled substances shall immediately :

(a) file the appropriate forms with the Drug Enforcement Administration, with a copy to the Division directed to the attention of the Investigation Bureau ; and

(b) [. He shall also ]report the incident to the local law enforcement agency.

(3) All records required by federal and state laws or rules must be maintained by the licensee for a period of five years. If a licensee should sell or transfer ownership of [his files]records in any way, those [files]records shall be maintained separately from other records of the new owner.

(4) Prescription records may be maintained electronically so long as:

(a) the original of each prescription, including telephone prescriptions, is maintained in a physical file and contains all of the information required by federal and state law; and

(b) an automated data processing system is used for the storage and immediate retrieval of refill information for prescription orders for controlled substances in Schedule III and IV, in accordance with federal guidelines.

(5) All records relating to Schedule II controlled substances received, purchased, administered , or dispensed by the practitioner shall be maintained separately from all other records of the pharmacy or practice.

(6) All records relating to Schedules III, IV , and V controlled substances received, purchased, administered , or dispensed by the practitioner shall be maintained separately from all other records of the pharmacy or practice.

 

KEY: controlled substances, licensing

Date of Enactment or Last Substantive Amendment: [December 22, 2016]2017

Notice of Continuation: February 6, 2017

Authorizing, and Implemented or Interpreted Law: 58-1-106(1)(a); 58-37-6(1)(a); 58-37f-301(1)

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